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<table><col/><col/><col/><col/><tbody><tr><td><p>28.4.2023   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>C 151/6</p></td></tr></tbody></table>
Statement of revenue and expenditure for the 2023 financial year – Single Resolution Board (SRB) – amending budget No 1
(2023/C 151/02)
REVENUE
<table><col/><col/><col/><col/><col/><tbody><tr><td><p>Title</p><p>Chapter</p></td><td><p>Heading</p></td><td><p>Budget 2023</p></td><td><p>Amending budget No 1</p></td><td><p>New amount</p></td></tr><tr><td><p><span>1</span></p></td><td><p><span>CONTRIBUTION FROM THE CREDIT INSTITUTIONS</span></p></td></tr><tr><td><p>1 0</p></td><td><p>CONTRIBUTION FROM THE CREDIT INSTITUTIONS</p></td><td><p>143 000 000</p></td><td><p>2 075 000</p></td><td><p>145 075 000</p></td></tr><tr><td><p> </p></td><td><p><span>Title 1 — Total</span></p></td><td><p><span>143 000 000</span></p></td><td><p><span>2 075 000</span></p></td><td><p><span>145 075 000</span></p></td></tr><tr><td><p><span>2</span></p></td><td><p><span>CONTRIBUTION FROM THE EUROPEAN UNION</span></p></td></tr><tr><td><p>2 0</p></td><td><p>CONTRIBUTION FROM THE EUROPEAN UNION</p></td><td><p>p.m.</p></td><td><p> </p></td><td><p>p.m.</p></td></tr><tr><td><p> </p></td><td><p><span>Title 2 — Total</span></p></td><td><p><span>p.m.</span></p></td><td><p> </p></td><td><p><span>p.m.</span></p></td></tr><tr><td><p><span>3</span></p></td><td><p><span>MISCELLANEOUS REVENUE</span></p></td></tr><tr><td><p>3 0</p></td><td><p>MISCELLANEOUS REVENUE</p></td><td><p>p.m.</p></td><td><p> </p></td><td><p>p.m.</p></td></tr><tr><td><p> </p></td><td><p><span>Title 3 — Total</span></p></td><td><p><span>p.m.</span></p></td><td><p> </p></td><td><p><span>p.m.</span></p></td></tr><tr><td><p><span>4</span></p></td><td><p><span>SINGLE RESOLUTION FUND</span></p></td></tr><tr><td><p>4 0</p></td><td><p>SINGLE RESOLUTION FUND</p></td><td><p>13 468 000 000</p></td><td><p> </p></td><td><p>13 468 000 000</p></td></tr><tr><td><p>4 9</p></td><td><p>BUDGET RESULT FROM FINANCIAL YEAR</p></td><td><p>p.m.</p></td><td><p> </p></td><td><p>p.m.</p></td></tr><tr><td><p> </p></td><td><p><span>Title 4 — Total</span></p></td><td><p><span>13 468 000 000</span></p></td><td><p> </p></td><td><p><span>13 468 000 000</span></p></td></tr><tr><td><p><span>9</span></p></td><td><p><span>RESERVE</span></p></td></tr><tr><td><p>9 0</p></td><td><p>RESERVE</p></td><td><p>p.m.</p></td><td><p> </p></td><td><p>p.m.</p></td></tr><tr><td><p> </p></td><td><p><span>Title 9 — Total</span></p></td><td><p><span>p.m.</span></p></td><td><p> </p></td><td><p><span>p.m.</span></p></td></tr><tr/><tr/><tr><td><p> </p></td><td><p><span>GRAND TOTAL</span></p></td><td><p><span>13 611 000 000</span></p></td><td><p><span>2 075 000</span></p></td><td><p><span>13 613 075 000</span></p></td></tr></tbody></table>
EXPENDITURE
<table><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Title</p><p>Chapter</p></td><td><p>Heading</p></td><td><p>Budget 2023</p></td><td><p>Amending budget No 1</p></td><td><p>New amount</p></td></tr><tr><td><p>Commitments</p></td><td><p>Payments</p></td><td><p>Commitments</p></td><td><p>Payments</p></td><td><p>Commitments</p></td><td><p>Payments</p></td></tr><tr><td><p><span>1</span></p></td><td><p><span>STAFF</span></p></td></tr><tr><td><p>1 1</p></td><td><p>STAFF IN ACTIVE EMPLOYMENT</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>65 276 000</p></td><td><p>65 276 000</p></td><td><p> </p></td><td><p> </p></td><td><p>65 276 000</p></td><td><p>65 276 000</p></td></tr><tr><td><p>1 2</p></td><td><p>MISCELLANEOUS EXPENDITURE ON STAFF RECRUITMENT AND TRANSFER</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>1 340 000</p></td><td><p>1 340 000</p></td><td><p> </p></td><td><p> </p></td><td><p>1 340 000</p></td><td><p>1 340 000</p></td></tr><tr><td><p>1 3</p></td><td><p>MISSIONS AND DUTY TRAVELS</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>10 000</p></td><td><p>10 000</p></td><td><p> </p></td><td><p> </p></td><td><p>10 000</p></td><td><p>10 000</p></td></tr><tr><td><p>1 4</p></td><td><p>SOCIO-MEDICAL INFRASTRUCTURE AND SOCIAL WELFARE</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>2 110 000</p></td><td><p>2 110 000</p></td><td><p> </p></td><td><p> </p></td><td><p>2 110 000</p></td><td><p>2 110 000</p></td></tr><tr><td><p>1 5</p></td><td><p>TRAINING</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>675 000</p></td><td><p>675 000</p></td><td><p> </p></td><td><p> </p></td><td><p>675 000</p></td><td><p>675 000</p></td></tr><tr><td><p>1 6</p></td><td><p>EXTERNAL SERVICES</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>1 788 000</p></td><td><p>1 788 000</p></td><td><p> </p></td><td><p> </p></td><td><p>1 788 000</p></td><td><p>1 788 000</p></td></tr><tr><td><p>1 7</p></td><td><p>ENTERTAINMENT AND REPRESENTATION EXPENSES</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>1 000</p></td><td><p>1 000</p></td><td><p> </p></td><td><p> </p></td><td><p>1 000</p></td><td><p>1 000</p></td></tr><tr><td><p> </p></td><td><p><span>Title 1 — Total</span></p></td><td><p><span>71 200 000</span></p></td><td><p><span>71 200 000</span></p></td><td><p> </p></td><td><p> </p></td><td><p><span>71 200 000</span></p></td><td><p><span>71 200 000</span></p></td></tr><tr><td><p><span>2</span></p></td><td><p><span>BUILDING, EQUIPMENT AND MISCELLANEOUS OPERATING EXPENDITURE</span></p></td></tr><tr><td><p>2 0</p></td><td><p>RENTAL OF BUILDINGS AND ASSOCIATED COSTS</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>9 000 000</p></td><td><p>9 000 000</p></td><td><p>2 075 000</p></td><td><p>2 075 000</p></td><td><p>11 075 000</p></td><td><p>11 075 000</p></td></tr><tr><td><p>2 1</p></td><td><p>INFORMATION AND COMMUNICATIONS TECHNOLOGY</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>9 430 000</p></td><td><p>9 430 000</p></td><td><p> </p></td><td><p> </p></td><td><p>9 430 000</p></td><td><p>9 430 000</p></td></tr><tr><td><p>2 2</p></td><td><p>MOVABLE PROPERTY AND ASSOCIATED COSTS</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>1 585 000</p></td><td><p>1 585 000</p></td><td><p> </p></td><td><p> </p></td><td><p>1 585 000</p></td><td><p>1 585 000</p></td></tr><tr><td><p>2 3</p></td><td><p>CURRENT ADMINISTRATIVE EXPENDITURE</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>1 095 000</p></td><td><p>1 095 000</p></td><td><p> </p></td><td><p> </p></td><td><p>1 095 000</p></td><td><p>1 095 000</p></td></tr><tr><td><p>2 4</p></td><td><p>POSTAGE AND TELECOMMUNICATIONS</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>990 000</p></td><td><p>990 000</p></td><td><p> </p></td><td><p> </p></td><td><p>990 000</p></td><td><p>990 000</p></td></tr><tr><td><p> </p></td><td><p><span>Title 2 — Total</span></p></td><td><p><span>22 100 000</span></p></td><td><p><span>22 100 000</span></p></td><td><p><span>2 075 000</span></p></td><td><p><span>2 075 000</span></p></td><td><p><span>24 175 000</span></p></td><td><p><span>24 175 000</span></p></td></tr><tr><td><p><span>3</span></p></td><td><p><span>OPERATING EXPENDITURES</span></p></td></tr><tr><td><p>3 1</p></td><td><p>SRB OPERATIONS</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Differentiated appropriations</p></td><td><p>31 730 000</p></td><td><p>19 650 000</p></td><td><p> </p></td><td><p> </p></td><td><p>31 730 000</p></td><td><p>19 650 000</p></td></tr><tr><td><p>3 2</p></td><td><p>SRB CONTINGENCIES</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Differentiated appropriations</p></td><td><p>40 050 000</p></td><td><p>30 050 000</p></td><td><p> </p></td><td><p> </p></td><td><p>40 050 000</p></td><td><p>30 050 000</p></td></tr><tr><td><p> </p></td><td><p><span>Title 3 — Total</span></p></td><td><p><span>71 780 000</span></p></td><td><p><span>49 700 000</span></p></td><td><p> </p></td><td><p> </p></td><td><p><span>71 780 000</span></p></td><td><p><span>49 700 000</span></p></td></tr><tr><td><p><span>4</span></p></td><td><p><span>SINGLE RESOLUTION FUND</span></p></td></tr><tr><td><p>4 0</p></td><td><p>USAGE OF THE FUND WITHIN RESOLUTION SCHEMES</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Differentiated appropriations</p></td><td><p>13 468 000 000</p></td><td><p>13 468 000 000</p></td><td><p> </p></td><td><p> </p></td><td><p>13 468 000 000</p></td><td><p>13 468 000 000</p></td></tr><tr><td><p>4 9</p></td><td><p>OTHER OPERATING EXPENDITURE</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Differentiated appropriations</p></td><td><p>p.m.</p></td><td><p>p.m.</p></td><td><p> </p></td><td><p> </p></td><td><p>p.m.</p></td><td><p>p.m.</p></td></tr><tr><td><p> </p></td><td><p><span>Title 4 — Total</span></p></td><td><p><span>13 468 000 000</span></p></td><td><p><span>13 468 000 000</span></p></td><td><p> </p></td><td><p> </p></td><td><p><span>13 468 000 000</span></p></td><td><p><span>13 468 000 000</span></p></td></tr><tr><td><p><span>9</span></p></td><td><p><span>BALANCING FROM THE RESERVE</span></p></td></tr><tr><td><p>9 0</p></td><td><p>BALANCING FROM THE RESERVE</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Differentiated appropriations</p></td><td><p>p.m.</p></td><td><p>p.m.</p></td><td><p> </p></td><td><p> </p></td><td><p>p.m.</p></td><td><p>p.m.</p></td></tr><tr><td><p> </p></td><td><p><span>Title 9 — Total</span></p></td><td><p><span>p.m.</span></p></td><td><p><span>p.m.</span></p></td><td><p> </p></td><td><p> </p></td><td><p><span>p.m.</span></p></td><td><p><span>p.m.</span></p></td></tr><tr/><tr/><tr><td><p> </p></td><td><p><span>GRAND TOTAL</span></p></td><td><p><span>13 633 080 000</span></p></td><td><p><span>13 611 000 000</span></p></td><td><p><span>2 075 000</span></p></td><td><p><span>2 075 000</span></p></td><td><p><span>13 635 155 000</span></p></td><td><p><span>13 613 075 000</span></p></td></tr></tbody></table>
Establishment plan
<table><col/><col/><col/><col/><col/><tbody><tr><td><p>Function group and grade</p></td><td><p>Single Resolution Board (SRB)</p></td></tr><tr><td><p>2023</p></td><td><p>2022</p></td></tr><tr><td><p>Authorized under the Union budget</p></td><td><p>Authorized under the Union budget</p></td></tr><tr><td><p>Permanent posts</p></td><td><p>Temporary posts</p></td><td><p>Permanent posts</p></td><td><p>Temporary posts</p></td></tr><tr/><tr/><tr><td><p>AD 16</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AD 15</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AD 14</p></td><td><p>—</p></td><td><p>1</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AD 13</p></td><td><p>—</p></td><td><p>3</p></td><td><p>—</p></td><td><p>6</p></td></tr><tr><td><p>AD 12</p></td><td><p>—</p></td><td><p>8</p></td><td><p>—</p></td><td><p>9</p></td></tr><tr><td><p>AD 11</p></td><td><p>—</p></td><td><p>11</p></td><td><p>—</p></td><td><p>13</p></td></tr><tr><td><p>AD 10</p></td><td><p>—</p></td><td><p>18</p></td><td><p>—</p></td><td><p>19</p></td></tr><tr><td><p>AD 9</p></td><td><p>—</p></td><td><p>59</p></td><td><p>—</p></td><td><p>57</p></td></tr><tr><td><p>AD 8</p></td><td><p>—</p></td><td><p>75</p></td><td><p>—</p></td><td><p>75</p></td></tr><tr><td><p>AD 7</p></td><td><p>—</p></td><td><p>76</p></td><td><p>—</p></td><td><p>71</p></td></tr><tr><td><p>AD 6</p></td><td><p>—</p></td><td><p>87</p></td><td><p>—</p></td><td><p>78</p></td></tr><tr><td><p>AD 5</p></td><td><p>—</p></td><td><p>38</p></td><td><p>—</p></td><td><p>47</p></td></tr><tr><td><p>Subtotal AD</p></td><td><p>—</p></td><td><p>376</p></td><td><p>—</p></td><td><p>375</p></td></tr><tr><td><p>AST 11</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST 10</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST 9</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST 8</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST 7</p></td><td><p>—</p></td><td><p>2</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST 6</p></td><td><p>—</p></td><td><p>7</p></td><td><p>—</p></td><td><p>3</p></td></tr><tr><td><p>AST 5</p></td><td><p>—</p></td><td><p>16</p></td><td><p>—</p></td><td><p>10</p></td></tr><tr><td><p>AST 4</p></td><td><p>—</p></td><td><p>20</p></td><td><p>—</p></td><td><p>25</p></td></tr><tr><td><p>AST 3</p></td><td><p>—</p></td><td><p>6</p></td><td><p>—</p></td><td><p>9</p></td></tr><tr><td><p>AST 2</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>4</p></td></tr><tr><td><p>AST 1</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>Subtotal AST</p></td><td><p>—</p></td><td><p>51</p></td><td><p>—</p></td><td><p>51</p></td></tr><tr><td><p>AST/SC 6</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST/SC 5</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST/SC 4</p></td><td><p>—</p></td><td><p>2</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST/SC 3</p></td><td><p>—</p></td><td><p>10</p></td><td><p>—</p></td><td><p>12</p></td></tr><tr><td><p>AST/SC 2</p></td><td><p>—</p></td><td><p>10</p></td><td><p>—</p></td><td><p>9</p></td></tr><tr><td><p>AST/SC 1</p></td><td><p>—</p></td><td><p>1</p></td><td><p>—</p></td><td><p>3</p></td></tr><tr><td><p>Subtotal AST/SC</p></td><td><p>—</p></td><td><p>23</p></td><td><p>—</p></td><td><p>24</p></td></tr><tr><td><p><span>Total</span></p></td><td><p><span>—</span></p></td><td><p><span>450</span></p></td><td><p><span>—</span></p></td><td><p><span>450</span></p></td></tr><tr><td><p><span>Grand Total</span></p></td><td><p><span>450</span></p></td><td><p><span>450</span></p></td></tr></tbody></table>
Estimate of number of contract staff (expressed in full-time equivalents) and seconded national experts
<table><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>2023</p></td><td><p>2022</p></td></tr><tr/><tr/><tr><td><p>Contract staff</p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>FG IV</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p> </p></td><td><p>FG III</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p> </p></td><td><p>FG II</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p> </p></td><td><p>FG I</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p><span>Total</span></p></td><td><p><span>—</span></p></td><td><p><span>—</span></p></td></tr><tr/><tr/><tr><td><p>Seconded national experts</p></td><td><p>35</p></td><td><p>35</p></td></tr><tr><td><p><span>Grand total</span></p></td><td><p><span>35</span></p></td><td><p><span>35</span></p></td></tr></tbody></table> | ENG | 32023B0428(02) |
<table><col/><col/><col/><col/><tbody><tr><td><p>1.2.2014   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 32/29</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) No 96/2014
of 31 January 2014
fixing the import duties in the cereals sector applicable from 1 February 2014
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) ( 1 ) ,
Having regard to Commission Regulation (EU) No 642/2010 of 20 July 2010 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of import duties in the cereals sector ( 2 ) , and in particular Article 2(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Article 136(1) of Regulation (EC) No 1234/2007 states that the import duty on products covered by CN codes 1001 19 00, 1001 11 00, ex 1001 91 20 (common wheat seed), ex 1001 99 00 (high quality common wheat other than for sowing), 1002 10 00, 1002 90 00, 1005 10 90, 1005 90 00, 1007 10 90 and 1007 90 00 is to be equal to the intervention price valid for such products on importation and increased by 55 %, minus the cif import price applicable to the consignment in question. However, that duty may not exceed the rate of duty in the Common Customs Tariff.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Article 136(2) of Regulation (EC) No 1234/2007 lays down that, in order to calculate the import duty referred to in paragraph 1 of that Article, representative cif import prices are to be established on a regular basis for the products in question.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Under Article 2(2) of Regulation (EU) No 642/2010, the price to be used for the calculation of the import duty on products covered by CN codes 1001 19 00, 1001 11 00, ex 1001 91 20 (common wheat seed), ex 1001 99 00 (high quality common wheat other than for sowing), 1002 10 00, 1002 90 00, 1005 10 90, 1005 90 00, 1007 10 90 and 1007 90 00 is the daily cif representative import price determined as specified in Article 5 of that Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Import duties should be fixed for the period from 1 February 2014 and should apply until new import duties are fixed and enter into force.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Given the need to ensure that this measure applies as soon as possible after the updated data have been made available, this Regulation should enter into force on the day of its publication,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
From 1 February 2014, the import duties in the cereals sector referred to in Article 136(1) of Regulation (EC) No 1234/2007 shall be those fixed in Annex I to this Regulation on the basis of the information contained in Annex II.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 31 January 2014.
For the Commission, On behalf of the President,
Jerzy PLEWA
Director-General for Agriculture and Rural Development
( 1 ) OJ L 299, 16.11.2007, p. 1 .
( 2 ) OJ L 187, 21.7.2010, p. 5 .
ANNEX I
Import duties on the products referred to in Article 136(1) of Regulation (EC) No 1234/2007 applicable from 1 February 2014
<table><col/><col/><col/><tbody><tr><td><p>CN code</p></td><td><p>Description</p></td><td><p>Import duties<a> (<span>1</span>)</a></p><p>(EUR/t)</p></td></tr><tr><td><p>1001 19 00</p><p>1001 11 00</p></td><td><p>Durum wheat, high quality</p></td><td><p>0,00</p></td></tr><tr><td><p>medium quality</p></td><td><p>0,00</p></td></tr><tr><td><p>low quality</p></td><td><p>0,00</p></td></tr><tr><td><p>ex 1001 91 20</p></td><td><p>Common wheat seed</p></td><td><p>0,00</p></td></tr><tr><td><p>ex 1001 99 00</p></td><td><p>High quality common wheat other than for sowing</p></td><td><p>0,00</p></td></tr><tr><td><p>1002 10 00</p><p>1002 90 00</p></td><td><p>Rye</p></td><td><p>0,00</p></td></tr><tr><td><p>1005 10 90</p></td><td><p>Maize seed other than hybrid</p></td><td><p>0,00</p></td></tr><tr><td><p>1005 90 00</p></td><td><p>Maize other than seed<a> (<span>2</span>)</a></p></td><td><p>0,00</p></td></tr><tr><td><p>1007 10 90</p><p>1007 90 00</p></td><td><p>Grain sorghum other than hybrids for sowing</p></td><td><p>0,00</p></td></tr></tbody></table>
( 1 ) The importer may benefit, under Article 2(4) of Regulation (EU) No 642/2010, from a reduction in the duty of:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>EUR 3/t, where the port of unloading is located on the Mediterranean Sea (beyond the Strait of Gibraltar) or on the Black Sea, for goods arriving in the Union via the Atlantic Ocean or the Suez Canal,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>EUR 2/t, where the port of unloading is located in Denmark, Estonia, Ireland, Latvia, Lithuania, Poland, Finland, Sweden, the United Kingdom or on the Atlantic coast of the Iberian Peninsula, for goods arriving in the Union via the Atlantic Ocean.</p></td></tr></tbody></table>
( 2 ) The importer may benefit from a flat-rate reduction of EUR 24/t where the conditions laid down in Article 3 of Regulation (EU) No 642/2010 are met.
ANNEX II
Factors for calculating the duties laid down in Annex I
17.1.2014-30.1.2014
<table><col/><col/><col/><tbody><tr><td/><td><p>1.</p></td><td><span>Averages over the reference period referred to in Article 2(2) of Regulation (EU) No 642/2010:</span><table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>(EUR/t)</p></td></tr><tr><td><p> </p></td><td><p>Common wheat<a> (<span>1</span>)</a></p></td><td><p>Maize</p></td><td><p>Durum wheat, high quality</p></td><td><p>Durum wheat, medium quality<a> (<span>2</span>)</a></p></td><td><p>Durum wheat, low quality<a> (<span>3</span>)</a></p></td></tr><tr><td><p>Exchange</p></td><td><p>Minnéapolis</p></td><td><p>Chicago</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>Quotation</p></td><td><p>178,81</p></td><td><p>123,92</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>Fob price USA</p></td><td><p>—</p></td><td><p>—</p></td><td><p>269,30</p></td><td><p>259,30</p></td><td><p>239,30</p></td></tr><tr><td><p>Gulf of Mexico premium</p></td><td><p>132,96</p></td><td><p>25,42</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>Great Lakes premium</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>2.</p></td><td><span>Averages over the reference period referred to in Article 2(2) of Regulation (EU) No 642/2010:</span><table><col/><col/><tbody><tr><td><p>Freight costs: Gulf of Mexico-Rotterdam:</p></td><td><p>18,21 EUR/t</p></td></tr><tr><td><p>Freight costs: Great Lakes-Rotterdam:</p></td><td><p>— EUR/t</p></td></tr></tbody></table></td></tr></tbody></table>
<note>
( 1 ) Premium of EUR 14/t incorporated (Article 5(3) of Regulation (EU) No 642/2010).
( 2 ) Discount of EUR 10/t (Article 5(3) of Regulation (EU) No 642/2010).
( 3 ) Discount of EUR 30/t (Article 5(3) of Regulation (EU) No 642/2010).
</note> | ENG | 32014R0096 |
<table><col/><col/><col/><col/><tbody><tr><td><p>8.11.2016   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 300/12</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2016/1949
of 7 November 2016
establishing the standard import values for determining the entry price of certain fruit and vegetables
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) ,
Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors ( 2 ) , and in particular Article 136(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the<span>Official Journal of the European Union</span>,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 November 2016.
For the Commission,
On behalf of the President,
Jerzy PLEWA
Director-General for Agriculture and Rural Development
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) OJ L 157, 15.6.2011, p. 1 .
ANNEX
Standard import values for determining the entry price of certain fruit and vegetables
<table><col/><col/><col/><tbody><tr><td><p>(EUR/100 kg)</p></td></tr><tr><td><p>CN code</p></td><td><p>Third country code<a> (<span>1</span>)</a></p></td><td><p>Standard import value</p></td></tr><tr><td><p>0702 00 00</p></td><td><p>MA</p></td><td><p>90,4</p></td></tr><tr><td><p>ZZ</p></td><td><p>90,4</p></td></tr><tr><td><p>0707 00 05</p></td><td><p>TR</p></td><td><p>142,5</p></td></tr><tr><td><p>ZZ</p></td><td><p>142,5</p></td></tr><tr><td><p>0709 93 10</p></td><td><p>MA</p></td><td><p>91,2</p></td></tr><tr><td><p>TR</p></td><td><p>142,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>116,9</p></td></tr><tr><td><p>0805 20 30 , 0805 20 50 , 0805 20 70 , 0805 20 90</p></td><td><p>JM</p></td><td><p>103,8</p></td></tr><tr><td><p>PE</p></td><td><p>139,3</p></td></tr><tr><td><p>TR</p></td><td><p>73,0</p></td></tr><tr><td><p>ZZ</p></td><td><p>105,4</p></td></tr><tr><td><p>0805 50 10</p></td><td><p>AR</p></td><td><p>67,2</p></td></tr><tr><td><p>BR</p></td><td><p>79,0</p></td></tr><tr><td><p>CL</p></td><td><p>77,0</p></td></tr><tr><td><p>TR</p></td><td><p>97,7</p></td></tr><tr><td><p>UY</p></td><td><p>38,4</p></td></tr><tr><td><p>ZA</p></td><td><p>65,7</p></td></tr><tr><td><p>ZZ</p></td><td><p>70,8</p></td></tr><tr><td><p>0806 10 10</p></td><td><p>BR</p></td><td><p>305,3</p></td></tr><tr><td><p>IN</p></td><td><p>166,0</p></td></tr><tr><td><p>PE</p></td><td><p>346,7</p></td></tr><tr><td><p>TR</p></td><td><p>139,0</p></td></tr><tr><td><p>US</p></td><td><p>380,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>267,5</p></td></tr><tr><td><p>0808 10 80</p></td><td><p>AR</p></td><td><p>260,6</p></td></tr><tr><td><p>AU</p></td><td><p>236,5</p></td></tr><tr><td><p>CL</p></td><td><p>139,2</p></td></tr><tr><td><p>NZ</p></td><td><p>139,2</p></td></tr><tr><td><p>ZA</p></td><td><p>69,9</p></td></tr><tr><td><p>ZZ</p></td><td><p>169,1</p></td></tr><tr><td><p>0808 30 90</p></td><td><p>CN</p></td><td><p>96,1</p></td></tr><tr><td><p>TR</p></td><td><p>166,9</p></td></tr><tr><td><p>ZZ</p></td><td><p>131,5</p></td></tr></tbody></table>
<note>
( 1 ) Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories ( OJ L 328, 28.11.2012, p. 7 ). Code ‘ZZ’ stands for ‘of other origin’.
</note> | ENG | 32016R1949 |
<table><col/><col/><col/><col/><tbody><tr><td><p>30.4.2019   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 114/15</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2019/677
of 29 April 2019
concerning the non-renewal of the approval of the active substance chlorothalonil, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC ( 1 ) , and in particular Article 20(1) and Article 78(2) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Commission Directive 2005/53/EC <a>(<span>2</span>)</a> included chlorothalonil as an active substance in Annex I to Council Directive 91/414/EEC <a>(<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 <a>(<span>4</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The approval of the active substance chlorothalonil, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2019.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>An application for the renewal of the approval of chlorothalonil was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 <a>(<span>5</span>)</a> within the time period provided for in that Article.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The applicants submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 2 September 2016.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>On 6 December 2017 the Authority communicated to the Commission its conclusion <a>(<span>6</span>)</a> on whether chlorothalonil can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>A critical concern was identified by the Authority in relation to the contamination of groundwater by metabolites of chlorothalonil. In particular, metabolites R417888, R419492, R471811, SYN507900, M3, M11, M2, M7 and M10 are predicted to occur above the parametric value of 0,1 μg/L in all pertinent scenarios for all proposed uses of chlorothalonil. Therefore, it cannot currently be established that the presence of metabolites of chlorothalonil in groundwater will not result in unacceptable effects on groundwater and in harmful effects on human health as required by Article 4(3)(b) of Regulation (EC) No 1107/2009. Furthermore, the Authority could not exclude a genotoxicity concern for residues to which consumers will be exposed and identified a high risk to amphibians and fish for all the uses evaluated.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>Furthermore, several areas of the risk assessment could not be finalised due to insufficient data in the dossier. In particular, the assessment of consumer risk from dietary exposure could not be completed because of lack of data to confirm the definition of the residue in plants and the livestock exposure assessment, including the toxicological assessment of a metabolite.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>Additionally, chlorothalonil is classified as carcinogen category 2 in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council <a>(<span>7</span>)</a> while in the conclusion of the Authority it is indicated that chlorothalonil should be classified as carcinogen category 1B. For the representative uses considered, residue levels as referred to in point (b) of Article 18(1) of Regulation (EC) No 396/2005 could not be confirmed for plant and animal products due to lack of data on the magnitude and toxicity of metabolites that are included in the residue definition for risk assessment. Consequently, the requirement set out in Point 3.6.3 of Annex II to Regulation (EC) No 1107/2009 is not fulfilled.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>The Commission invited the applicants to submit their comments on the conclusion of the Authority and, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, to submit comments on the draft renewal report. The applicants submitted comments, which have been carefully examined.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>However, despite the arguments put forward by the applicants, the concerns related to the substance could not be eliminated.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of the active substance chlorothalonil in accordance with Article 20(1)(b) of that Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(16)</p></td><td><p>Member States should be allowed sufficient time to withdraw authorisations for plant protection products containing chlorothalonil.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(17)</p></td><td><p>For plant protection products containing chlorothalonil, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 20 May 2020.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(18)</p></td><td><p>Commission Implementing Regulation (EU) 2018/1262 <a>(<span>8</span>)</a> extended the approval period of chlorothalonil to 31 October 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on the non-renewal of the approval is taken ahead of that extended expiry date, this Regulation should apply as soon as possible.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(19)</p></td><td><p>This Regulation does not prevent the submission of a further application for the approval of chlorothalonil in accordance with Article 7 of Regulation (EC) No 1107/2009.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(20)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Non-renewal of approval of active substance
The approval of the active substance chlorothalonil is not renewed.
Article 2
Amendments to Implementing Regulation (EU) No 540/2011
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 101, on chlorothalonil, is deleted.
Article 3
Transitional measures
Member States shall withdraw authorisations for plant protection products containing chlorothalonil as active substance by 20 November 2019 at the latest.
Article 4
Grace period
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 20 May 2020 at the latest.
Article 5
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 April 2019.
For the Commission
The President
Jean-Claude JUNCKER
<note>
( 1 ) OJ L 309, 24.11.2009, p. 1 .
( 2 ) Commission Directive 2005/53/EC of 16 September 2005 amending Council Directive 91/414/EEC to include chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl as active substances ( OJ L 241, 17.9.2005, p. 51 ).
( 3 ) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market ( OJ L 230, 19.8.1991, p. 1 ).
( 4 ) Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances ( OJ L 153, 11.6.2011, p. 1 ).
( 5 ) Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market ( OJ L 252, 19.9.2012, p. 26 ).
( 6 ) EFSA (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk assessment of the active substance chlorothalonil. EFSA Journal2018;16(1):5126, 40 pp.; https://doi.org/10.2903/j.efsa.2018.5126.
( 7 ) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1 ).
( 8 ) Commission Implementing Regulation (EU) 2018/1262 of 20 September 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, clomazone, cypermethrin, daminozide, deltamethrin, dimethenamid-p, diuron, fludioxonil, flufenacet, flurtamone, fosthiazate, indoxacarb, MCPA, MCPB, prosulfocarb, thiophanate-methyl and tribenuron ( OJ L 238, 21.9.2018, p. 62 ).
</note> | ENG | 32019R0677 |
<table><col/><col/><col/><col/><tbody><tr><td><p>28.5.2014   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 159/50</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) No 576/2014
of 27 May 2014
establishing the standard import values for determining the entry price of certain fruit and vegetables
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) ( 1 ) ,
Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors ( 2 ) , and in particular Article 136(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the<span>Official Journal of the European Union</span>,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 May 2014.
For the Commission ,
On behalf of the President ,
Jerzy PLEWA
Director-General for Agriculture and Rural Development
( 1 ) OJ L 299, 16.11.2007, p. 1 .
( 2 ) OJ L 157, 15.6.2011, p. 1 .
ANNEX
Standard import values for determining the entry price of certain fruit and vegetables
<table><col/><col/><col/><tbody><tr><td><p>(EUR/100 kg)</p></td></tr><tr><td><p>CN code</p></td><td><p>Third country code<a> (<span>1</span>)</a></p></td><td><p>Standard import value</p></td></tr><tr><td><p>0702 00 00</p></td><td><p>AL</p></td><td><p>45,8</p></td></tr><tr><td><p>MA</p></td><td><p>33,4</p></td></tr><tr><td><p>MK</p></td><td><p>75,5</p></td></tr><tr><td><p>TR</p></td><td><p>68,5</p></td></tr><tr><td><p>ZZ</p></td><td><p>55,8</p></td></tr><tr><td><p>0707 00 05</p></td><td><p>AL</p></td><td><p>36,9</p></td></tr><tr><td><p>MK</p></td><td><p>39,9</p></td></tr><tr><td><p>TR</p></td><td><p>119,9</p></td></tr><tr><td><p>ZZ</p></td><td><p>65,6</p></td></tr><tr><td><p>0709 93 10</p></td><td><p>MA</p></td><td><p>29,9</p></td></tr><tr><td><p>TR</p></td><td><p>111,2</p></td></tr><tr><td><p>ZZ</p></td><td><p>70,6</p></td></tr><tr><td><p>0805 10 20</p></td><td><p>EG</p></td><td><p>41,2</p></td></tr><tr><td><p>MA</p></td><td><p>41,0</p></td></tr><tr><td><p>TR</p></td><td><p>49,7</p></td></tr><tr><td><p>ZZ</p></td><td><p>44,0</p></td></tr><tr><td><p>0805 50 10</p></td><td><p>TR</p></td><td><p>121,8</p></td></tr><tr><td><p>ZA</p></td><td><p>139,4</p></td></tr><tr><td><p>ZZ</p></td><td><p>130,6</p></td></tr><tr><td><p>0808 10 80</p></td><td><p>AR</p></td><td><p>104,4</p></td></tr><tr><td><p>BR</p></td><td><p>97,8</p></td></tr><tr><td><p>CL</p></td><td><p>95,3</p></td></tr><tr><td><p>CN</p></td><td><p>98,7</p></td></tr><tr><td><p>MK</p></td><td><p>26,7</p></td></tr><tr><td><p>NZ</p></td><td><p>138,9</p></td></tr><tr><td><p>US</p></td><td><p>185,4</p></td></tr><tr><td><p>ZA</p></td><td><p>105,3</p></td></tr><tr><td><p>ZZ</p></td><td><p>106,6</p></td></tr></tbody></table>
<note>
( 1 ) Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 ( OJ L 354, 14.12.2006, p. 19 ). Code ‘ZZ’ stands for ‘of other origin’.
</note> | ENG | 32014R0576 |
<table><col/><col/><col/><col/><tbody><tr><td><p>2.10.2015   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 257/30</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2015/1761
of 1 October 2015
amending Commission Regulation (EC) No 378/2005 as regards the Community Reference Laboratory reports, fees and the laboratories listed in Annex II thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition ( 1 ) , and in particular the first subparagraph of Article 7(4) and the third paragraph of Article 21 thereof,
After consulting the European Food Safety Authority,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Regulation (EC) No 1831/2003 establishes the procedure for authorising the placing on the market and use of feed additives in animal nutrition. It provides that any person seeking authorisation for a feed additive or a new use of a feed additive is to submit an application for authorisation in accordance with that Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Commission Regulation (EC) No 378/2005<a> (<span>2</span>)</a> lays down detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards applications for authorisation of a feed additive or for a new use of a feed additive and the duties and tasks of the Community Reference Laboratory (‘CRL’).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Article 5 of Regulation (EC) No 378/2005 provides that the CRL is to submit a full evaluation report to the European Food Safety Authority (‘the Authority’) for each application for authorisation of a feed additive. Exceptions to the requirement to submit an evaluation report are made for applications for a new use of a feed additive or applications for changing the terms of an existing authorisation, provided that the proposed conditions for the new use or for the change in the terms of the authorisation fall within the scope of the method of analysis previously submitted in accordance with the requirements laid down in Annex II to Commission Regulation (EC) No 429/2008<a> (<span>3</span>)</a> and already evaluated. Furthermore, Article 4 of that Regulation provides that the CRL is to charge applicants fees for submitting applications for authorisation. Exception is made where no samples are required and the CRL does not need to issue a report, as the method of analysis has already been evaluated. However, applications for renewal of authorisations of feed additives do not benefit from those exceptions.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Experience has shown that the exceptions to the requirements concerning evaluation reports and submission fees should also be extended to the applications for renewal of authorisations of feed additives. Article 5 of and Annex IV to Regulation (EC) No 378/2005 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Annex II to Regulation (EC) No 378/2005 sets out a list of national reference laboratories assisting the CRL in its duties and tasks. Several Member States have informed the Commission that their national reference laboratories taking part in the consortium have changed because other laboratories have been designated for that purpose or the name or address of the laboratories have changed. Annex II to Regulation (EC) No 378/2005 should therefore be adapted accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EC) No 378/2005 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Article 5(4) is replaced by the following:</p><p>‘4.   An evaluation report shall not be required for:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>applications for a new use of a feed additive submitted in accordance with Article 4(1) of Regulation (EC) No 1831/2003, when the proposed conditions for placing the feed additive on the market for the new use fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the CRL;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>applications for changing the terms of an existing authorisation submitted in accordance with Article 13(3) of Regulation (EC) No 1831/2003, when the proposed change or the new conditions for placing the feed additive on the market fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the CRL;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>applications for renewal of an existing authorisation submitted in accordance with Article 14 of Regulation (EC) No 1831/2003, when the conditions for placing the feed additive on the market fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the CRL.</p></td></tr></tbody></table><p>Notwithstanding paragraph 4, the Commission, the CRL or the Authority may, on the basis of legitimate factors relevant to the application, consider that a new evaluation of the methods of analysis is necessary. In such cases the applicant shall be informed by the CRL.’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Annex II is replaced by the text as set out in the Annex to this Regulation;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>in Annex IV, under the title ‘Rates according to the type of application for authorisations of feed additives in accordance with Regulation (EC) No 1831/2003’, point 5 is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘5.</p></td><td><p>Renewal of an authorisation of a feed additive (Article 14 of Regulation (EC) No 1831/2003):</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Fee = component 2 = EUR 4 000</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>when Article 5(4)(c) applies: Fee = EUR 0.’</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 1 October 2015.
For the Commission
The President
Jean-Claude JUNCKER
( 1 ) OJ L 268, 18.10.2003, p. 29 .
( 2 ) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives ( OJ L 59, 5.3.2005, p. 8 ).
( 3 ) Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives ( OJ L 133, 22.5.2008, p. 1 ).
ANNEX
‘ANNEX II
Community reference laboratory and consortium of national reference laboratories, as referred to in Article 6(2)
COMMUNITY REFERENCE LABORATORY
Joint Research Centre of the European Commission. Institute for Reference Materials and Measurements. Geel, Belgium.
NATIONAL REFERENCE LABORATORIES OF THE MEMBER STATES
Belgique/België
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Federaal Laboratorium voor de Voedselveiligheid Tervuren (FLVVT –FAVV);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Vlaamse Instelling voor Technologisch Onderzoek (VITO), Mol;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Centre wallon de Recherches agronomiques (CRA-W), Gembloux.</p></td></tr></tbody></table>
Česká republika
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Ústřední kontrolní a zkušební ústav zemědělský (ÚKZÚZ), Praha.</p></td></tr></tbody></table>
Danmark
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Fødevarestyrelsens Laboratorie Aarhus (kemisk);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Fødevarestyrelsens Laboratorie Ringsted (kemisk og mikrobiologisk).</p></td></tr></tbody></table>
Deutschland
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Sachgebiet Futtermittel des Bayrischen Landesamtes für Gesundheit und Lebensmittelsicherheit (LGL), Oberschleißheim;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Landwirtschaftliche Untersuchungs- und Forschungsanstalt (LUFA), Speyer;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Staatliche Betriebsgesellschaft für Umwelt und Landwirtschaft. Geschäftsbereich 6 — Labore Landwirtschaft, Nossen;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Thüringer Landesanstalt für Landwirtschaft (TLL). Abteilung Untersuchungswesen. Jena.</p></td></tr></tbody></table>
Eesti
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Põllumajandusuuringute Keskus (PMK). Jääkide ja saasteainete labor, Saku, Harjumaa;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Põllumajandusuuringute Keskus (PMK), Taimse materjali labor, Saku, Harjumaa.</p></td></tr></tbody></table>
España
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Laboratorio Arbitral Agroalimentario. Ministerio de Agricultura, Alimentación y Medio Ambiente, Madrid;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Laboratori Agroalimentari, Departament d'Agricultura, Ramaderia, PESCA, Alimentació i Medi Natural. Generalitat de Catalunya, Cabrils.</p></td></tr></tbody></table>
France
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Laboratoire de Rennes (SCL L35), Service Commun des Laboratoires DGCCRF et DGDDI, Rennes.</p></td></tr></tbody></table>
Éire/Ireland
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The State Laboratory, Kildare.</p></td></tr></tbody></table>
Ελλάδα
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Εργαστήριο Ελέγχου Κυκλοφορίας Ζωοτροφών Θεσσαλονίκης.</p></td></tr></tbody></table>
Italia
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Istituto Superiore di Sanità. Dipartimento di Sanità Pubblica Veterinaria e Sicurezza Alimentare, Roma;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Centro di referenza nazionale per la sorveglienza ed il controllo degli alimenti per gli animali (CReAA), Torino.</p></td></tr></tbody></table>
Kypros
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Feedingstuffs Analytical Laboratory, Department of Agriculture, Nicosia.</p></td></tr></tbody></table>
Latvija
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Pārtikas drošības, dzīvnieku veselības un vides zinātniskais institūts BIOR, Rīga.</p></td></tr></tbody></table>
Lietuva
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Nacionalinis maisto ir veterinarijos rizikos vertinimo institutas, Vilnius.</p></td></tr></tbody></table>
Luxembourg
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Laboratoire de Contrôle et d'essais — ASTA, Ettelbruck.</p></td></tr></tbody></table>
Magyarország
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Nemzeti Élelmiszerlánc-biztonsági Hivatal, Élelmiszer- és Takarmánybiztonsági Igazgatóság, Takarmányvizsgáló Nemzeti Referencia Laboratórium, Budapest.</p></td></tr></tbody></table>
Nederland
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>RIKILT Wageningen UR, Wageningen.</p></td></tr></tbody></table>
Österreich
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES), Wien.</p></td></tr></tbody></table>
Polska
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Instytut Zootechniki — Państwowy Instytut Badawczy, Krajowe Laboratorium Pasz, Lublin;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Państwowy Instytut Weterynaryjny, Pulawy.</p></td></tr></tbody></table>
Portugal
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Instituto Nacional de Investigação Agrária e Veterinária, I.P. (INIAV,IP), Lisboa.</p></td></tr></tbody></table>
Slovenija
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Univerza v Ljubljani. Veterinarska fakulteta. Nacionalni veterinarski inštitut. Enota za patologijo prehrane in higieno okolja, Ljubljana;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Kmetijski inštitut Slovenije, Ljubljana.</p></td></tr></tbody></table>
Slovensko
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Skúšobné laboratórium analýzy krmív, Ústredný kontrolný a skúšobný ústav poľnohospodársky, Bratislava.</p></td></tr></tbody></table>
Suomi/Finland
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Elintarviketurvallisuusvirasto/Livsmedelssäkerhetsverket (Evira), Helsinki/Helsingfors.</p></td></tr></tbody></table>
Sverige
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avdelningen för kemi, miljö och fodersäkerhet, Statens Veterinärmedicinska Anstalt (SVA), Uppsala.</p></td></tr></tbody></table>
United Kingdom
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>LGC Ltd, Teddington.</p></td></tr></tbody></table>
NATIONAL REFERENCE LABORATORIES OF EFTA COUNTRIES
Norway
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The National Institute of Nutrition and Seafood Research (NIFES), Bergen.’</p></td></tr></tbody></table> | ENG | 32015R1761 |
<table><col/><col/><col/><col/><tbody><tr><td><p>25.10.2022   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 275/52</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2022/2044
of 18 October 2022
approving amendments to the specification for a Protected Designation of Origin or a Protected Geographical Indication (‘Roero’ (PDO))
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) , and in particular Article 99 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The Commission has examined the application for the approval of amendments to the specification for the Protected Designation of Origin ‘Roero’, forwarded by Italy in accordance with Article 105 of Regulation (EU) No 1308/2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The Commission has published the application for the approval of the amendments to the specification in the<span>Official Journal of the European Union</span> <a>(<span>2</span>)</a>, as required by Article 97(3) of Regulation (EU) No 1308/2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The amendments to the specification should therefore be approved in accordance with Article 99 of Regulation (EU) No 1308/2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Roero’ (PDO) are hereby approved.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 October 2022.
For the Commission,
On behalf of the President,
Janusz WOJCIECHOWSKI
Member of the Commission
<note>
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) OJ C 170, 25.4.2022, p. 21 .
</note> | ENG | 32022R2044 |
<table><col/><col/><col/><col/><tbody><tr><td><p>28.3.2022   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 100/6</p></td></tr></tbody></table>
COMMISSION REGULATION (EU) 2022/488
of 25 March 2022
correcting the French language version of Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 ( 1 ) , and in particular the first and third subparagraphs of Article 41(3) and Article 42(2) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The French language version of Commission Regulation (EU) No 142/2011 <a>(<span>2</span>)</a> contains an error in the title of and in point 1 of section 2 of Chapter VI of Annex XIV as regards the listing of third countries, rendering the meaning opposite to the one intended.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The French language version of Regulation (EU) No 142/2011 should therefore be corrected accordingly. The other language versions are not affected.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
(Does not concern the English language.)
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 March 2022.
For the Commission
The President
Ursula VON DER LEYEN
<note>
( 1 ) OJ L 300, 14.11.2009, p. 1 .
( 2 ) Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive ( OJ L 54, 26.2.2011, p. 1 ).
</note> | ENG | 32022R0488 |
<table><col/><col/><col/><col/><tbody><tr><td><p>20.5.2014   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 150/231</p></td></tr></tbody></table>
COUNCIL DECISION
of 14 April 2014
on the conclusion, on behalf of the European Union, of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity
(Text with EEA relevance)
(2014/283/EU)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1), in conjunction with Article 218(6)(a)(v) thereof,
Having regard to the proposal from the European Commission,
Having regard to the consent of the European Parliament ( 1 ) ,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The Union and its Member States joined the consensus of the 193 Parties to the Convention on Biological Diversity (‘CBD’) <a>(<span>2</span>)</a> that adopted the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (‘Nagoya Protocol’) on 29 October 2010.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>In accordance with Council Decision of 6 May 2011 <a>(<span>3</span>)</a>, the Nagoya Protocol was signed by the Union, subject to its conclusion at a later date. Most Member States have signed the Nagoya Protocol.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The Union is committed to the swift implementation and ratification of the Nagoya Protocol.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>In accordance with Article 34 of the CBD, any protocol to the CBD is subject to ratification, acceptance or approval by States and by regional economic integration organisations.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The Union and its Member States should endeavour to deposit simoultaneously, to the extent possible, their instruments of ratification, acceptance or approval of the Nagoya Protocol.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>The Nagoya Protocol should therefore be approved on behalf of the Union,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity is hereby approved on behalf of the Union.
The text of the Nagoya Protocol is attached to this Decision.
Article 2
The President of the Council is hereby authorised to designate the person(s) empowered to deposit, on behalf of the Union, as regards matters falling within the Union’s competence, the instrument of approval provided for in Article 33 of the Nagoya Protocol ( 4 ) . At the same time, such person(s) shall deposit the declaration set out in the Annex to this Decision, in accordance with Article 34(3) of the Convention on Biological Diversity.
Article 3
This Decision shall enter into force on the day of its adoption.
Done at Luxembourg, 14 April 2014.
For the Council
The President
A. TSAFTARIS
( 1 ) Not yet published in the Official Journal.
( 2 ) OJ L 309, 13.12.1993, p. 3 .
( 3 ) Not yet published in the Official Journal.
( 4 ) The date of entry into force of the Nagoya Protocol will be published in the Official Journal of the European Union by the General Secretariat of the Council.
ANNEX
Declaration by the european union in accordance with article 34, paragraph 3, of the convention on biological diversity
‘The European Union declares that, in accordance with the Treaty on the Functioning of the European Union, and in particular Article 191 thereof, it is competent for entering into international agreements, and for implementing the obligations resulting therefrom, which contribute to the pursuit of the following objectives:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>preserving, protecting and improving the quality of the environment;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protecting human health;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>prudent and rational utilisation of natural resources;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>promoting measures at international level to deal with regional or worldwide environmental problems, and in particular combatting climate change.</p></td></tr></tbody></table>
Moreover, the European Union adopts measures at Union level for establishing a European Research Area and for the proper functioning of its internal market.
The exercise of Union competence is by its nature subject to continous development. In order to comply with its obligations under Article 14(2)(a) of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity, the Union will keep up-to-date the list of legal instruments to be transmitted to the Access and Benefit-Sharing Clearing-House.
The European Union is responsible for the performance of those obligations resulting from this Protocol which are covered by Union law in force.’ | ENG | 32014D0283 |
<table><col/><col/><col/><col/><tbody><tr><td><p>5.8.2021   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 282/1</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2021/1294
of 4 August 2021
cancelling the protection of the designation of origin (‘Südburgenland (PDO)’)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) , and in particular Article 106 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Article 19 of Commission Delegated Regulation (EU) 2019/33 <a>(<span>2</span>)</a> provides that the procedure laid down in Article 94 and Articles 96 to 99 of Regulation (EU) No 1308/2013 shall apply<span>mutatis mutandis</span> to the cancellation of a protected designation of origin under Article 106 of Regulation (EU) No 1308/2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Pursuant to Article 19 of Delegated Regulation (EU) 2019/33, Austria’s request to cancel the protected designation of origin ‘Südburgenland’ was published in the<span>Official Journal of the European Union</span> <a>(<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>As no statement of objection under Article 98 of Regulation (EU) No 1308/2013 has been received by the Commission, the protected designation of origin ‘Südburgenland’ should be cancelled.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>In view of the cancellation of the protection of the designation of origin ‘Südburgenland’, the entry should be deleted from the Union register of protected designations of origin and protected geographical indications for wine referred to in Article 104 of Regulation (EU) No 1308/2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of Agricultural Markets,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The protection of the designation of origin ‘Südburgenland’ (PDO) is hereby cancelled.
Article 2
The entry for the designation of origin ‘Südburgenland’ (PDO) is hereby deleted from the register of protected designations of origin and protected geographical indications for wine.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 August 2021.
For the Commission
The President
Ursula VON DER LEYEN
<note>
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) Commission Delegated Regulation (EU) 2019/33 of 17 October 2018 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards applications for protection of designations of origin, geographical indications and traditional terms in the wine sector, the objection procedure, restrictions of use, amendments to product specifications, cancellation of protection, and labelling and presentation ( OJ L 9, 11.1.2019, p. 2 ).
( 3 ) OJ C 57, 17.2.2021, p. 30 .
</note> | ENG | 32021R1294 |
<table><col/><col/><col/><col/><tbody><tr><td><p>29.8.2018   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>C 303/12</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING DECISION
of 21 August 2018
on the publication in the Official Journal of the European Union of the application for registration of a name referred to in Article 49 of Regulation (EU) No 1151/2012 of the European Parliament and of the Council
(‘The Vale of Clwyd Denbigh Plum’ (PDO))
(2018/C 303/05)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs ( 1 ) , and in particular Article 50(2)(a) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The United Kingdom has sent to the Commission an application for protection of the name ‘The Vale of Clwyd Denbigh Plum’ in accordance with Article 49(4) of Regulation (EU) No 1151/2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>In accordance with Article 50 of Regulation (EU) No 1151/2012 the Commission has examined that application and concluded that it fulfils the conditions laid down in that Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>In order to allow for the submission of notices of opposition in accordance with Article 51 of Regulation (EU) No 1151/2012, the single document and the reference to the publication of the product specification referred to in Article 50(2)(a) of that Regulation for the name ‘The Vale of Clwyd Denbigh Plum’ should be published in the<span>Official Journal of the European Union</span>,</p></td></tr></tbody></table>
HAS DECIDED AS FOLLOWS:
Sole Article
The single document and the reference to the publication of the product specification referred to in Article 50(2)(a) of Regulation (EU) No 1151/2012 for the name ‘The Vale of Clwyd Denbigh Plum’ (PDO) are contained in the Annex to this Decision.
In accordance with Article 51 of Regulation (EU) No 1151/2012, the publication of this Decision shall confer the right to oppose to the registration of the name referred to in the first paragraph of this Article within three months from the date of publication of this Decision in the Official Journal of the European Union.
Done at Brussels, 21 August 2018.
For the Commission
Pierre MOSCOVICI
Member of the Commission
( 1 ) OJ L 343, 14.12.2012, p. 1 .
ANNEX
SINGLE DOCUMENT
‘THE VALE OF CLWYD DENBIGH PLUM’
EU No: PDO-GB-02287 – 8.2.2017
PDO ( X ) PGI ( )
1. Name(s)
‘The Vale of Clwyd Denbigh Plum’
2. Member State or Third Country
United Kingdom
3. Description of the agricultural product or foodstuff
3.1. Type of product
Class 1.6 Fruit, vegetables and cereals fresh or processed
3.2. Description of product to which the name in 1 applies
‘The Vale of Clwyd Denbigh Plum’ Prunus domestica Linnaeus ‘Denbigh Plum’ is the name given to the Denbigh plum grown in the designated geographical area of the Vale of Clwyd in Denbighshire in North Wales from where the plum originates. The Denbigh plum is the only plum variety native to Wales.
‘The Vale of Clwyd Denbigh Plum’ has the following characteristics depending upon whether the plum is required for culinary purposes and harvested mid-August before they are ripe or required as a dessert plum when the plum is allowed to remain and ripen on the tree and harvested in late August early September.
Culinary
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Plum firm to touch</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Orangey-red in colour with yellow patches when the plum begins to ripen</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Wax bloom starting to show</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Flesh is firm and of a rich yellow with greenish amber tint</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Flesh clings to stone</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Size 45 mm to 65 mm stalk end to tip</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>40 mm to 55 mm crossway diameter</p></td></tr></tbody></table>
Dessert
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Plum starting to soften when gently squeezed</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Size 45 mm to 65 mm stalk end to tip</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>40 mm to 55 mm crossway diameter</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Shape — Spherical or slightly elliptical</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Colour — Rich red shading towards purple, strewn with golden speckles. Fruit naturally becomes darker as the fruit ages</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Plums covered with a wax bloom (visible whitish bloom) which develops the longer they remain on the tree</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Naturally soft and juicy flesh which is a rich yellow in colour with greenish amber tint</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Flesh — only partially adheres to the stone</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Mean number of fruit per kg 9-15 (mean 12)</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Brix test (measure of sweetness) 16-19.</p></td></tr></tbody></table>
With dessert plums, the skin is soft and delicate and should be exempt from bruising. This requires handling the ripened fruit with great care.
The dessert plums have a long growing season which gives the plum more time to fully develop its depth of flavour which is sub acid and sweet. It is this depth of flavour and sweetness which makes ‘The Vale of Clwyd Denbigh Plum’ distinctive.
When cooked the depth of flavour intensifies and the natural sweetness of the plum is enhanced. The texture of the fruit melts in the mouth if eaten when warm.
Most of ‘The Vale of Clwyd Denbigh Plum’ are sold as dessert plums fresh in local markets.
3.3. Feed (for products of animal origin only) and raw materials (for processed products only)
‘The Vale of Clwyd Denbigh Plum’ must be grown in the identified designated area from trees obtained from grafting or budding by commercial tree nurseries from known specimens or from individual trees located within the designated area. The ‘Vale of Clwyd Denbigh Plum’ must NOT be derived from trees grown from seed. As pollination cannot be controlled, trees grown from seed contain genetic variation and therefore cannot be guaranteed to grow to ‘type’.
3.4. Specific steps in production that must take place in the identified geographical area
Growing
Pruning (if required)
Pest and disease management/manuring and spraying
Harvesting
Storage (if required)
3.5. Specific rules concerning slicing, grating, packaging, etc. of the product the registered name refers to
— 3.6. Specific rules concerning labelling of the product the registered name refers to
— 4. Concise definition of the geographical area
The ‘Vale of Clwyd Denbigh Plum’ is grown in the designated geographical area of the Vale of Clwyd in Denbighshire North Wales which encompasses the following wards:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Aberwheeler,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Bodfari,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Cefn Meiriadog,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Clocaenog,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Cyffylliog,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Denbigh,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Efenechtyd,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Henllan,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Llanbedr Dyffryn Clwyd,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Llandyrnog,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Llanelidan,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Llanfair Dyffryn Clwyd,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Llangynhafal,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Llanrhaeadr yng Nghinmeirch,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Llanynys,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Nantglyn,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rhuddlan,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Ruthin,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>St Asaph,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Trefnant,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Tremeirchion Cwm,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Waen.</p></td></tr></tbody></table>
And the ward of Llansannan
5. Link with the geographical area
The Denbigh Plum originates in the Vale of Clwyd and is the only plum variety native to Wales. The specific environmental and geographical factors in the Vale of Clwyd provide the perfect conditions for these native plums to thrive, and contributes to the specific characteristics of the fruit.
The Vale of Clwyd is a river valley region in North Wales, largely sheltered by surrounding hills including the Clwydian range on the eastern side which runs in a transverse direction from south-east to north-west and is only exposed to the north wind where it opens outward at the coast. The hills provide shelter from the prevailing westerly winds and often cold easterlies. This relatively sheltered environment is essential for plum production as it helps reduce damage to both the blossom and the developing plum.
The Vale of Clwyd represents the most extensive area of Grade 1 and Grade 2 land in Wales according to the Agricultural Land Classification (ALC). The ALC takes into consideration characteristics such as climate, site and soil. As Grade 1 and 2 land, The Vale of Clwyd is defined as either ‘excellent quality’ or ‘very good’ agricultural land. This land is capable of producing consistently high yields of Vale of Clwyd Denbigh Plums.
The land in the Vale of Clwyd is some of the most naturally fertile soils in the UK providing all the nutrients that the trees and plums require. The soils present in the Vale have the ability to retain nutrients such as potassium, magnesium and calcium which are key nutrient requirements for these plums.
The free draining medium textured deep soils (which are naturally occurring in the Vale of Clwyd), encourage the development of strong root architecture which is vital for the plum trees and the production of quality Vale of Clwyd Denbigh Plums.
The limestone geology underlying new soft red Triassic sandstone in the area produces lime rich soils with high pH. Most fruit such as strawberries and raspberries do better on slightly acidic soils, however these plums thrive on the high pH limestone derived soils which are prevalent in the area.
The Vale of Clwyd Denbigh Plum flowers in April and is very susceptible to spring radiation frosts which can have a deleterious effect on the blossom. The influence of the nearby gulfstream provides a microclimate to the Vale of Clwyd that provides a moderating influence and reduces the risk from frosts. In addition the cool moderate temperatures from the gulf stream both extends the flowering period which enables greater pollination, and enables the plum to slowly mature over a prolonged period which provides more time for its flavour to fully develop and intensify.
Historically this region with its fertile soils has had a tradition and reputation for the production of an array of soft fruit production including plums, all of which would have been exhibited at the Vale of Clwyd Horticultural shows, which were famous annual events since the 1850s. By the late 1890s, Denbighshire (which is the main county in the Vale of Clwyd) was the largest county area of soft fruit in Wales. The history of plum production has marked the local area, with streets and houses in Denbigh named after ‘The Vale of Clwyd Denbigh Plum’. One local property which has been in the same family for over a hundred years has an orchard which still produces ‘The Vale of Clwyd Denbigh Plum’ for the commercial market.
The knowledge and skill required for growing ‘The Vale of Clwyd Denbigh Plum’ in the designated area has developed over time. Specific human skills associated with the growing of this fruit which have been passed down from one generation to the next, including: planting and establishment of the plum trees, pruning and tree management, when to harvest, and handling the fruit.
The skin of ‘The Vale of Clwyd Denbigh Plum’ is very soft and delicate compared to more commercially produced plums; this necessitates the fruit should be handled with great care to avoid damage and bruising. Fruit pickers are trained to handle the fruit as little as possible and to pick the fruit by hand by their stems. As a result, freshly picked plums often have a whitish bloom (which protects the fruit) still visible on the fruit.
The Vale of Clwyd benefits from its own microclimate which is affected by the moderating influence of the Gulf Stream and favours the growth of these plums. Plums are among the earliest fruits to blossom and a frost free site is essential to achieve regular cropping as frost poses a severe threat to blossoming trees.
The Denbigh Plum has, unlike most other plums a natural resistance to fungal disease which enables it to remain remarkably disease free despite the warm/damp climate. The Vales climate is also cooler in comparison to other plum growing areas. This provides ‘The Vale of Clwyd Denbigh Plum’ with a long growing season which gives the plum more time to fully develop its flavour. It is this depth of flavour and sweetness which makes ‘The Vale of Clwyd Denbigh Plum’ so distinctive.
The close proximity of the sea and the river Clwyd that runs through the valley not only moderates extreme temperatures but also provides a source of natural irrigation which in combination with the natural high water table in the Vale of Clwyd, satisfies the high moisture requirements of the deep rooted plum trees preventing the need for artificial irrigation.
‘The Vale of Clwyd Denbigh Plum’ has managed not only to survive but to thrive in the natural conditions found in this area with minimal human intervention. This sheltered, flat, fertile and lime rich area’s microclimate with its moderate temperatures natural irrigation system and probability of frost free days during the plum blossoming period, provides the ideal growing conditions for ‘The Vale of Clwyd Denbigh Plum’ and contributes to their specific and unique characteristics.
Until recently, production of ‘The Vale of Clwyd Denbigh Plum’ had largely died out. However in recent years it has experienced a resurgence, bringing together communities in the designated area, and has resulted in the annual ‘The Vale of Clwyd Denbigh Plum’ Feast, which is attended by over 2 000 visitors. This festival showcases the fresh fruit, and the array of products in which it can be used.
The famous Welsh celebrity Chef, Bryn Williams, has become the patron of ‘The Vale of Clwyd Denbigh Plum’ and it is featured in his recipe book, ‘the Love of Veg.’‘The Vale of Clwyd Denbigh Plum’ is recognised throughout Wales and the rest of the UK for its excellence, and is actively sourced by local catering establishments, and has also been nominated by the Slow Food Movement for an Ark of Taste award.
Reference to publication of the specification
(the second subparagraph of Article 6(1) of this Regulation)
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/676695/pfn-vale-clwyd-denbigh-plum.pdf | ENG | 32018D0829(02) |
<table><col/><col/><col/><col/><tbody><tr><td><p>19.12.2017   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 337/60</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING DECISION (EU) 2017/2374
of 15 December 2017
setting out conditions for movement, storage and processing of certain fruits and their hybrids originating in third countries to prevent the introduction into the Union of certain harmful organisms
(notified under document C(2017) 8395)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community ( 1 ) , and in particular points 16.2(e) and 16.4(e) of Section I of Part A of Annex IV thereto,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Annex IV to Directive 2000/29/EC determines the special requirements which must be complied with for the introduction and movement of plants and plant products into and within all Member States.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Commission Implementing Directive (EU) 2017/1279<a> (<span>2</span>)</a> introduced points 16.2(e) and 16.4(e) in Section I of Part A of Annex IV to Directive 2000/29/EC. Those points lay down such special requirements in respect of certain fruits (fruits of<span>Citrus</span> L.,<span>Fortunella</span> Swingle<span>, Poncirus</span> Raf.,<span>Microcitrus</span> Swingle,<span>Naringi</span> Adans.,<span>Swinglea</span> Merr., and their hybrids) destined for industrial processing (hereinafter: ‘the specified fruits’). Pursuant to those points, the Commission is to adopt conditions for the movement within the Union, storage and processing of those fruits.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>In order to allow the responsible official bodies and the professional operators to comply with the conditions applicable to the specified fruits, it is appropriate to require the notification of details of the specified fruits before those fruits may be moved within the Union.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The movement of the specified fruits within the Union should be subject to the supervision of the responsible official bodies to ensure effective control over the compliance with the relevant conditions.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Specific conditions should be established for the industrial processing of the specified fruits to ensure the phytosanitary protection of the Union territory from harmful organisms. Those conditions should include provisions on the premises, waste and by-products and record keeping.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>In order to ensure the phytosanitary protection of the Union and control, if needed, of the storage activity, the specified fruits should be stored in a registered facility approved for that purpose by the Member State where the facility is situated and in a way which prevents any potential risk of spreading of the specified organisms. Specific conditions should be established concerning storage, to ensure effective traceability of those products, control of that activity and phytosanitary protection of the Union territory.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Since Member States are to apply their national provisions necessary to comply with Directive (EU) 2017/1279 from 1 January 2018, this Decision should start to apply on the same date.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
Subject matter
This Decision lays down conditions for the movement, storage and processing of fruits of Citrus L., Fortunella Swingle, Poncirus Raf., Microcitrus Swingle, Naringi Adans. and Swinglea Merr. and their hybrids, originating in third countries for the purposes of points 16.2(e) and 16.4(e) of Section I of Part A of Annex IV to Directive 2000/29/EC.
Article 2
Definitions
For the purpose of this Decision, the following definitions shall apply:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>‘specified organisms’ means<span>Phyllosticta citricarpa</span> (McAlpine) Van der Aa,<span>Xanthomonas citri</span> pv.<span>citri</span>, and<span>Xanthomonas citri</span> pv.<span>aurantifolii</span>;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>‘specified fruits’ means fruits of<span>Citrus</span> L.,<span>Fortunella</span> Swingle,<span>Poncirus</span> Raf.,<span>Microcitrus</span> Swingle,<span>Naringi</span> Adans. and<span>Swinglea</span> Merr. and their hybrids, originating in third countries.</p></td></tr></tbody></table>
Article 3
Movement of the specified fruits within the Union
1. The specified fruits may only be moved within the Union if the importer has notified details of each container to the responsible official body in the Member State in which the point of entry is situated and, where applicable, to the responsible official body of the Member State where the industrial processing will take place.
That notification shall include the following information:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the volume of the specified fruits;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the identification numbers of the containers;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the expected date of introduction and the point of entry into the Union;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the names, addresses and the locations of the premises referred to in Article 4.</p></td></tr></tbody></table>
2. The importers shall inform the responsible official bodies referred to in paragraph 1 of any changes to the information included in that notification, as soon as they are known.
3. Specified fruits may only be moved to a Member State, other than the Member State through which they have been introduced into the Union, if the responsible official bodies of the Member States concerned agree that such movement may take place.
4. The specified fruits shall be directly and without delay transported into the processing premises referred to in Article 4 or to a storage facility as referred to in Article 5. Movements of the specified fruits shall be under the supervision of the responsible official body of the Member State where that movement is taking place.
5. The Member States concerned with the movements shall cooperate to ensure that this Article is complied with.
Article 4
Requirements concerning industrial processing of the specified fruits
1. The specified fruits shall be processed at premises situated in an area where no specified fruit is produced. The premises shall be officially registered and approved for that purpose by the responsible official body of the Member State in which the premises are situated.
2. Waste and by-products of the specified fruits shall be used or destroyed in an area where no specified fruit is produced, located within the Member State where those fruits have been processed.
3. The waste and by-products shall be destroyed by any technically justified method approved by the responsible official body of the Member State where the specified fruits have been processed and under the supervision of that official body, in a way to prevent any potential risk for spreading the specified organisms.
4. The processors shall keep records for at least 3 years of the processed specified fruits and make them available on request to the responsible official body of the Member State where the processing takes place. Those records shall indicate the numbers and distinguishing marks of containers, the volumes of the specified fruits received and the volumes and other detailed information on the use or destruction of waste and by-products.
Article 5
Requirements concerning storage of the specified fruits
1. Where the specified fruits are not processed immediately, they shall be stored at a facility registered and approved for that purpose by the responsible official body of the Member State where the facility is situated.
2. The batches of the specified fruits shall remain separately identifiable.
3. The specified fruits shall be stored in a way which prevents any potential risk of spreading of the specified organisms.
Article 6
Date of application
This Decision shall apply from 1 January 2018.
Article 7
Addressees
This Decision is addressed to the Member States.
Done at Brussels, 15 December 2017.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
<note>
( 1 ) OJ L 169, 10.7.2000, p. 1 .
( 2 ) Commission Implementing Directive (EU) 2017/1279 of 14 July 2017 amending Annexes I to V to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community ( OJ L 184, 15.7.2017, p. 33 ).
</note> | ENG | 32017D2374 |
02019R0980 — EN — 17.09.2020 — 001.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
<table><col/><col/><tr><td><p><a>►B</a></p></td><td><p> COMMISSION DELEGATED REGULATION (EU) 2019/980</p><p>of 14 March 2019</p><p>supplementing Regulation (EU) 2017/1129 of the European Parliament and of the Council as regards the format, content, scrutiny and approval of the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Commission Regulation (EC) No 809/2004</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 166 21.6.2019, p. 26)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p> </p></td><td><p> </p></td><td><p>Official Journal</p></td></tr><tr><td><p>  No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>►M1</a></p></td><td><p><a> COMMISSION DELEGATED REGULATION (EU) 2020/1273 of 4 June 2020</a></p></td><td><p>  L 300</p></td><td><p>6</p></td><td><p>14.9.2020</p></td></tr></table>
COMMISSION DELEGATED REGULATION (EU) 2019/980
of 14 March 2019
supplementing Regulation (EU) 2017/1129 of the European Parliament and of the Council as regards the format, content, scrutiny and approval of the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Commission Regulation (EC) No 809/2004
(Text with EEA relevance)
CHAPTER I
DEFINITIONS
Article 1
Definitions
For the purposes of this Regulation, the following definitions shall apply:
(a) ‘asset-backed securities’ means non-equity securities which either:
(i) represent an interest in assets, including any rights intended to ensure the servicing of those assets, the receipt or the timely receipt by holders of those assets of the amounts payable under those assets;
(ii) are secured by assets and the terms of the securities provide for payments calculated by reference to those assets;
(b) ‘equivalent third country market’ means a third country market which has been deemed equivalent to a regulated market in accordance with the requirements set out in third and fourth subparagraphs of Article 25(4) of Directive 2014/65/EU of the European Parliament and of the Council ( 1 );
(c) ‘profit estimate’ means a profit forecast for a financial period which has expired and for which results have not yet been published;
(d) ‘profit forecast’ means a statement that expressly or by implication indicates a figure or a minimum or maximum figure for the likely level of profits or losses for current or future financial periods, or contains data from which a calculation of such a figure for future profits or losses can be made, even if no particular figure is mentioned and the word ‘profit’ is not used;
(e) ‘significant gross change’ means a variation of more than 25 % to one or more indicators of the size of the issuer’s business.
CHAPTER II
CONTENT OF THE PROSPECTUS
SECTION 1
Minimum information to be included in the registration documents
Article 2
Registration document for equity securities
1. For equity securities, the registration document shall contain the information referred to in Annex 1 to this Regulation, unless it is drawn up in accordance with Articles 9, 14 or 15 of Regulation (EU) 2017/1129.
2. By way of derogation from paragraph 1, the registration document for the following securities, where those securities are not shares or other transferrable securities equivalent to shares, may be drawn up in accordance with Article 7 of this Regulation for retail securities or Article 8 of this Regulation for wholesale securities:
(a) the securities referred to in Articles 19(1) and 20(1) of this Regulation;
(b) the securities referred to in Article 19(2) of this Regulation, where those securities are exchangeable for or convertible into shares that are or will be issued by an entity belonging to the issuer’s group and that are not admitted to trading on a regulated market;
(c) the securities referred to in Article 20(2) of this Regulation, where those securities give the right to subscribe or acquire shares that are or will be issued by an entity belonging to the issuer’s group and that are not admitted to trading on a regulated market.
Article 3
Universal registration document
A registration document that is drawn up in accordance with Article 9 of Regulation (EU) 2017/1129 shall contain the information referred to in Annex 2 to this Regulation.
Article 4
Registration document for secondary issuances of equity securities
1. A specific registration document for equity securities that is drawn up in accordance with Article 14 of Regulation (EU) 2017/1129 shall contain the information referred to in Annex 3 to this Regulation.
2. By way of derogation from paragraph 1, the registration document for the following securities, where those securities are not shares or other transferrable securities equivalent to shares, may be drawn up in accordance with Article 9:
(a) the securities referred to in Articles 19(1) and 20(1) of this Regulation;
(b) the securities referred to in Article 19(2) of this Regulation, where those securities are exchangeable for or convertible into shares that are or will be issued by an entity belonging to the issuer’s group and that are not admitted to trading on a regulated market;
(c) the securities referred to in Article 20(2) of this Regulation, where those securities give the right to subscribe or acquire shares that are or will be issued by an entity belonging to the issuer’s group and that are not admitted to trading on a regulated market.
Article 5
Registration document for units of closed-end collective investment undertakings
For units issued by collective investment undertakings of the closed-end type, the registration document shall contain the information referred to in Annex 4.
Article 6
Registration document for depository receipts issued over shares
For depository receipts issued over shares, the registration document shall contain the information referred to in Annex 5.
Article 7
Registration document for retail non-equity securities
For non-equity securities other than those referred to in Article 8(2) of this Regulation, the registration document shall contain the information referred to in Annex 6 to this Regulation, unless it is drawn up in accordance with Articles 9, 14 or 15 of Regulation (EU) 2017/1129 or contains the information referred to in Annex 1 to this Regulation.
Article 8
Registration document for wholesale non-equity securities
1. For non-equity securities as referred to in paragraph 2, the registration document shall contain the information referred to in Annex 7 to this Regulation, unless the registration document is drawn up in accordance with Articles 9, 14 or 15 of Regulation (EU) 2017/1129 or contains the information referred to in Annexes 1 or 6 to this Regulation.
2. The requirement referred to in paragraph 1 shall apply to non-equity securities that comply with one of the following conditions:
(a) they are to be traded only on a regulated market, or a specific segment thereof, to which only qualified investors can have access for the purposes of trading in such securities;
(b) they have a denomination per unit of at least than EUR 100 000 or, where there is no individual denomination, can only be acquired on issue for at least EUR 100 000 per security.
Article 9
Registration document for secondary issuances of non-equity securities
A specific registration document for non-equity securities that is drawn up in accordance with Article 14 of Regulation (EU) 2017/1129 shall contain the information referred to in Annex 8 to this Regulation, unless it contains the information referred to in Annex 3 to this Regulation.
Article 10
Registration document for asset-backed securities
By way of derogation from Articles 7 and 8, a registration document that is drawn up for asset-backed securities, shall contain the information referred to in Annex 9.
Article 11
Registration document for non-equity securities issued by third countries and their regional and local authorities
By way of derogation from Articles 7 and 8, a registration document that is drawn up for non-equity securities issued by third countries or their regional or local authorities, shall contain the information referred to in Annex 10.
SECTION 2
Minimum information to be included in the securities notes
Article 12
Securities note for equity securities or units issued by collective investment undertakings of the closed-end type
1. For equity securities or units issued by collective investment undertakings of the closed-end type, the securities note shall contain the information referred to in Annex 11 to this Regulation, unless it is drawn up in accordance with Articles 14 or 15 of Regulation (EU) 2017/1129.
2. By way of derogation from paragraph 1, the securities note for the securities referred to in paragraphs 1 and 2 of Article 19 and paragraphs 1 and 2 of Article 20 of this Regulation, where those securities are not shares or other transferrable securities equivalent to shares, shall be drawn up in accordance with Article 15 of this Regulation for retail securities or Article 16 of this Regulation for wholesale securities.
Article 13
Securities note for secondary issuances of equity securities or of units issued by collective investment undertakings of the closed-end type
1. A specific securities note for equity securities or units issued by collective investment undertakings of the closed-end type that is drawn up in accordance with Article 14 of Regulation (EU) 2017/1129 shall contain the information referred to in Annex 12 to this Regulation.
2. By way of derogation from paragraph 1, the specific securities note for the securities referred to in paragraphs 1 and 2 of Article 19 and paragraphs 1 and 2 of Article 20 of this Regulation, where those securities are not shares or other transferrable securities equivalent to shares, shall be drawn up in accordance with Article 17 of this Regulation.
Article 14
Securities note for depository receipts issued over shares
For depository receipts issued over shares, the securities note shall contain the information referred to in Annex 13.
Article 15
Securities note for retail non-equity securities
For non-equity securities other than those referred to in Article 8(2) of this Regulation, the securities note shall contain the information referred to in Annex 14 to this Regulation, unless a specific securities note is drawn up in accordance with Articles 14 or 15 of Regulation (EU) 2017/1129.
Article 16
Securities note for wholesale non-equity securities
For non-equity securities as referred to in Article 8(2) of this Regulation, the securities note shall contain the information referred to in Annex 15 to this Regulation, unless it contains the information referred to in Annex 14 to this Regulation or unless a specific securities note is drawn up in accordance with Articles 14 or 15 of Regulation (EU) 2017/1129.
Article 17
Securities note for secondary issuances of non-equity securities
A specific securities note for non-equity securities that is drawn up in accordance with Article 14 of Regulation (EU) 2017/1129 shall contain the information referred to in Annex 16 to this Regulation.
SECTION 3
Additional information to be included in the prospectus
Article 18
Complex financial history and significant financial commitment of issuers of equity securities
1. Where the issuer of an equity security has a complex financial history, or has made a significant financial commitment, additional information with respect to an entity other than the issuer shall be included in the prospectus, as referred to in paragraph 2.
2. With respect to an entity, other than the issuer, additional information shall be all information referred to in Annexes 1 and 20 to this Regulation that investors need to make an informed assessment as referred to in Article 6(1) and Article 14(2) of Regulation (EU) 2017/1129, as if that entity were the issuer of the equity security.
Such additional information shall be preceded by a clear explanation of why that information is needed for investors to make an informed assessment and shall specify the effects of the complex financial history or of the significant financial commitment on the issuer or on the issuer’s business.
3. For the purposes of paragraph 1, an issuer shall be considered as having a complex financial history where all of the following conditions are fulfilled:
(a) at the time of drawing up the prospectus, the information referred to in the relevant Annexes does not represent the issuer’s undertaking accurately;
(b) the inaccuracy referred to in point (a) affects the ability of investors to make an informed assessment as referred to in Article 6(1) and Article 14(2) of Regulation (EU) 2017/1129;
(c) additional information relating to an entity other than the issuer is needed for investors to make an informed assessment as referred to in Article 6(1) and Article 14(2) of Regulation (EU) 2017/1129.
4. For the purposes of paragraph 1, a significant financial commitment is a binding agreement to undertake a transaction that is likely to give rise to a variation of more than 25 % relative to one or more indicators of the size of the issuer’s business.
Article 19
Securities that are exchangeable for or convertible into shares
1. Where securities are exchangeable for or convertible into shares that are admitted to trading on a regulated market, the securities note shall contain as additional information the information referred to in item 2.2.2 of Annex 17.
2. Where securities are exchangeable for or convertible into shares that are or will be issued by the issuer or by an entity belonging to that issuer’s group and that are not admitted to trading on a regulated market, the securities note shall also contain the following additional information:
(a) the information referred to in items 3.1 and 3.2 of Annex 11 in respect of that issuer or of that entity belonging to the issuer’s group;
(b) the information referred to in Annex 18 in respect of the underlying share.
3. Where securities are exchangeable for or convertible into shares that are or will be issued by a third party issuer and that are not admitted to trading on a regulated market, the securities note shall contain as additional information the information referred to in Annex 18.
Article 20
Securities giving rise to payment or delivery obligations linked to an underlying asset
1. For securities other than those referred to in Article 19 that give the right to subscribe or to acquire shares that are or will be issued by the issuer or by an entity belonging to that issuer’s group and that are admitted to trading on a regulated market, the securities note shall contain as additional information the information referred to in Annex 17.
2. For securities other than those referred to in Article 19 that give the right to subscribe or acquire shares that are or will be issued by the issuer or by an entity belonging to that issuer’s group and that are not admitted to trading on a regulated market, the securities note shall also contain the following additional information:
(a) the information referred to in Annex 17 except for the information referred to in item 2.2.2 of that Annex;
(b) the information referred to in Annex 18 in respect of the underlying share.
3. For securities other than those referred to in Article 19 that are linked to an underlying other than shares referred to in paragraphs 1 and 2 of this Article, the securities note shall contain as additional information the information referred to in Annex 17.
Article 21
Asset backed securities
For asset-backed securities, the securities notes shall also contain the additional information referred to in Annex 19.
Article 22
Guarantees
For non-equity securities that include guarantees, the securities notes shall also contain the additional information referred to in Annex 21.
Article 23
Consent
Where the issuer or the person responsible for drawing up a prospectus consents to its use as referred to in the second subparagraph of Article 5(1) of Regulation (EU) 2017/1129, the prospectus shall contain the following additional information:
(a) the information referred to in items 1 and 2A of Annex 22 to this Regulation where the consent is provided to one or more specified financial intermediaries;
(b) the information referred to in items 1 and 2B of Annex 22 to this Regulation where the consent is given to all financial intermediaries.
CHAPTER III
FORMAT OF THE PROSPECTUS
Article 24
Format of a prospectus
1. Where a prospectus is drawn up as a single document, it shall be composed of the following elements set out in the following order:
(a) a table of contents;
(b) a summary, where required by Article 7 of Regulation (EU) 2017/1129;
(c) the risk factors referred to in Article 16 of Regulation (EU) 2017/1129;
(d) any other information referred to in the Annexes to this Regulation that is to be included in that prospectus.
The issuer, offeror or person asking for admission to trading on a regulated market may decide the order in which the information referred to in the Annexes to this Regulation is set out in the prospectus.
2. Where a prospectus is drawn up as separate documents, the registration document and the securities note shall be composed of the following elements set out in the following order:
(a) a table of contents;
(b) the risk factors referred to in Article 16 of Regulation (EU) 2017/1129;
(c) any other information referred to in the Annexes to this Regulation that is to be included in that registration document or that securities note.
The issuer, offeror or person asking for admission to trading on a regulated market may decide the order in which the information referred to in the Annexes to this Regulation is set out in the registration document and the securities note.
3. Where the registration document is drawn up in the form of a universal registration document, the issuer may include the risks factors referred to in point (b) of paragraph 2 amongst the information referred to in point (c) of that paragraph provided that those risk factors remain identifiable as a single section.
4. Where a universal registration document is used for the purposes of Article 9(12) of Regulation (EU) 2017/1129, the information referred to in that Article shall be presented in accordance with Commission Delegated Regulation (EU) 2019/815 ( 2 ).
5. Where the order of the information referred to in point (d) of paragraph 1 and in point (c) of paragraph 2 is different from the order in which that information is presented in the Annexes to this Regulation, competent authorities may request to provide a list of cross references indicating the items of those Annexes to which that information corresponds.
The list of cross references referred to in the first subparagraph shall identify any items set out in the Annexes to this Regulation that have not been included in the draft prospectus due to the nature or type of issuer, securities, offer or admission to trading.
6. Where no list of cross-references is requested in accordance with paragraph 5 or is not voluntarily submitted by the issuer, offeror or person asking for admission to trading on a regulated market, it shall be indicated in the margin of the draft prospectus to which information in the draft prospectus the relevant information items set out in the Annexes to this Regulation correspond.
Article 25
Format of a base prospectus
1. A base prospectus drawn up as a single document shall be composed of the following elements set out in the following order:
(a) a table of contents;
(b) a general description of the offering programme;
(c) the risk factors referred to in Article 16 of Regulation (EU) 2017/1129;
(d) any other information referred to in the Annexes to this Regulation that is to be included in the base prospectus.
The issuer, offeror or person asking for admission to trading on a regulated market may decide the order in which the information referred to in the Annexes to this Regulation is set out in the base prospectus.
2. Where a base prospectus is drawn up as separate documents, the registration document and the securities note shall be composed of the following elements set out in the following order:
(a) a table of contents;
(b) in the securities note, a general description of the offering programme;
(c) the risk factors referred to in Article 16 of Regulation (EU) 2017/1129;
(d) any other information referred to in the Annexes to this Regulation that is to be included in the registration document and the securities note.
The issuer, offeror or person asking for admission to trading on a regulated market may decide the order in which the information referred to in the Annexes to this Regulation is set out in the registration document and the securities note.
3. An issuer, offeror or person asking for admission to trading on a regulated market may compile in one single document two or more base prospectuses.
4. Where the registration document is drawn up in the form of a universal registration document, the issuer may include the risks factors referred to in point (c) of paragraph 2 amongst the information referred to in point (d) of that paragraph provided that those risk factors remain identifiable as a single section.
5. Where a universal registration document is used for the purposes of Article 9(12) of Regulation (EU) 2017/1129, the information referred to in that Article shall be presented in accordance with Commission Delegated Regulation (EU) 2019/815.
6. Where the order of the information referred to in point (d) of paragraphs 1 and 2 is different from the order in which that information is presented in the Annexes to this Regulation, competent authorities may request to provide a list of cross references indicating the items of those Annexes to which that information corresponds.
The list of cross references referred to in the first subparagraph shall identify any items set out in the Annexes to this Regulation that have not been included in the draft base prospectus due to the nature or type of issuer, securities, offer or admission to trading.
7. Where no list of cross-references is requested in accordance with paragraph 6 or is not voluntarily submitted by the issuer, offeror or person asking for admission to trading on a regulated market, it shall be indicated in the margin of the draft base prospectus to which information in the draft base prospectus the relevant information items set out in the Annexes to this Regulation correspond.
Article 26
Information to be included in the base prospectus and the final terms
1. The information referred to as ‘Category A’ in Annexes 14 to 19 and 27 to this Regulation shall be included in the base prospectus.
2. The information referred to as ‘Category B’ in Annexes 14 to 19 and 27 to this Regulation shall be included in the base prospectus except for details of that information that are not known at the time of approval of that base prospectus. Such details shall be inserted in the final terms.
3. The information referred to as ‘Category C’ in Annexes 14 to 19 and 27 to this Regulation shall be inserted in the final terms, unless it is known at the time of approval of the base prospectus, in which case it may be inserted in that base prospectus instead.
4. In addition to the information referred to in paragraphs 2 and 3 of this Article, the final terms may only contain the information referred to in Annex 28 to this Regulation. The form of the final terms referred to in Article 8(2)(a) of Regulation (EU) 2017/1129 shall indicate which of the information referred to in Annex 28 to this Regulation is to be determined in the final terms.
5. The final terms shall not contradict the information included in the base prospectus.
Article 27
Prospectus summary
1. An overview section of a prospectus shall only use the term ‘summary’ if it complies with the requirements laid down in Article 7 of Regulation (EU) 2017/1129.
2. Where the summary of a prospectus is to be supplemented in accordance with Article 23 of Regulation (EU) 2017/1129, the new information shall be integrated in the summary of that prospectus in a way that enables investors to easily identify the changes. The new information shall be integrated in the summary of the prospectus either by producing a new summary or by supplementing the original summary.
CHAPTER IV
THE EU GROWTH PROSPECTUS
Article 28
EU Growth registration document for equity securities
1. A specific registration document for equity securities drawn up in accordance with Article 15 of Regulation (EU) 2017/1129 shall contain the information referred to in Annex 24 to this Regulation.
2. By way of derogation from paragraph 1, the specific registration document for the following securities, where those securities are not shares or other transferrable securities equivalent to shares, may be drawn up in accordance with Article 29 of this Regulation:
(a) the securities referred to in Articles 19(1) and 20(1) of this Regulation;
(b) the securities referred to in Article 19(2) of this Regulation, where those securities are exchangeable for or convertible into shares that are or will be issued by an entity belonging to the issuer’s group and that are not admitted to trading on a regulated market;
(c) the securities referred to in Article 20(2) of this Regulation, where those securities give the right to subscribe or acquire shares that are or will be issued by an entity belonging to the issuer’s group and that are not admitted to trading on a regulated market.
Article 29
EU Growth registration document for non-equity securities
A specific registration document for non-equity securities that is drawn up in accordance with Article 15 of Regulation (EU) 2017/1129 shall contain the information referred to in Annex 25 to this Regulation.
Article 30
EU Growth securities note for equity securities
1. A specific securities note for equity securities drawn up in accordance with Article 15 of Regulation (EU) 2017/1129 shall contain the information referred to in Annex 26 to this Regulation.
2. By way of derogation from paragraph 1, the specific securities note for the securities referred to in paragraphs 1 and 2 of Article 19 and paragraphs 1 and 2 of Article 20 of this Regulation, where those securities are not shares or other transferrable securities equivalent to shares, shall be drawn up in accordance with Article 31 of this Regulation.
Article 31
EU Growth securities note for non-equity securities
A specific securities note for non-equity securities that is drawn up in accordance with Article 15 of Regulation (EU) 2017/1129 shall contain the information referred to in Annex 27 to this Regulation.
Article 32
Format of the EU Growth prospectus
1. An EU Growth prospectus that is drawn up as a single document shall be composed of the following elements in the following order:
(a) a table of contents;
(b) where applicable, all information incorporated by reference in accordance with Article 19 of Regulation (EU) 2017/1129;
(c) the specific summary;
(d) where the EU Growth prospectus is drawn up in the form of a base prospectus, a general description of the offering programme;
(e) the information referred to in section 1 of Annex 24 and section 1 of Annex 26, or the information referred to in section 1 of Annex 25 and section 1 of Annex 27 to this Regulation, depending on the type of securities;
(f) the information referred to in section 2 of Annex 24 or section 2 of Annex 25 to this Regulation, depending on the type of securities;
(g) for equity securities, the information referred to in item 2.1 of Annex 26 and, where equity securities are issued by an issuer with a market capitalisation above EUR 200 000 000 , the information referred to in item 2.2 of Annex 26 to this Regulation;
(h) the information referred to in section 3 of Annex 24 and section 3 of Annex 26, or the information referred to in section 3 of Annex 25 and section 2 of Annex 27, depending on the type of securities;
(i) the information referred to in section 4 of Annex 26 or in section 3 of Annex 27 to this Regulation, depending on the type of securities;
(j) the information referred to in section 5 of Annex 26 or in section 4 of Annex 27 to this Regulation, depending on the type of securities;
(k) the information referred to in section 4 of Annex 24 or section 4 of Annex 25, depending on the type of securities;
(l) the information referred to in section 5 of Annex 24 or section 5 of Annex 25 to this Regulation, depending on the type of securities;
(m) the information referred to in section 6 of Annex 24 or section 6 of Annex 25 to this Regulation, depending on the type of securities;
(n) where non-equity securities include guarantees, the information referred to in section 5 of Annex 27 to this Regulation;
(o) the information referred to in section 7 of Annex 24 or section 7 of Annex 25 to this Regulation, depending on the type of securities;
(p) where information on the underlying share is required pursuant to Article 19(2), point (b), Article 19(3) or Article 20(2), point (b) of this Regulation, the information referred to in section 6 of Annex 26 to this Regulation or the information referred to in section 6 of Annex 27 to this Regulation, depending on the type of securities;
(q) where the issuer or the person responsible for drawing up a prospectus consents to its use as referred to in the second subparagraph of Article 5(1) of Regulation (EU) 2017/1129, the information referred to in section 7 of Annex 26 or in section 7 of Annex 27 to this Regulation, depending on the type of securities.
2. Where an EU Growth prospectus is drawn up as separate documents, the EU Growth registration document and the EU Growth securities note shall contain the following elements in the following order:
(a) EU Growth registration document:
(i) a table of contents;
(ii) where applicable, all information incorporated by reference in accordance with Article 19 of Regulation (EU) 2017/1129;
(iii)
any other information referred to in Annex 24 or 25 to this Regulation that, depending on the type of securities, is to be included in the EU Growth registration document following the order of the sections set out in those Annexes.
(b) EU Growth securities note:
(i) a table of contents;
(ii) where applicable, all information incorporated by reference in accordance with Article 19 of Regulation (EU) 2017/1129;
(iii)
a general description of the programme, in the case of a base prospectus;
(iv) any other information referred to in Annex 26 or 27 to this Regulation that, depending on the type of securities, is to be included in the EU Growth securities note following the order of the sections set out in those Annexes.
3. An EU Growth prospectus drawn up either as a single document or as separate documents may take the form of a base prospectus.
4. The SMEs, issuers and offerors referred to in Article 15(1) of Regulation (EU) 2017/1129 shall follow the order of the sections of the Annexes to this Regulation. They may however deviate from the order of the information items within those sections.
Article 33
Specific summary for the EU Growth prospectus
1. The specific summary for the EU Growth prospectus shall provide the key information that investors need to understand the nature and the risks of the issuer, of the guarantor and of the securities that are being offered.
2. The content of the specific summary shall be accurate, fair, clear and not misleading.
3. The specific summary shall be consistent with the other parts of the EU Growth prospectus.
4. The specific summary shall be drawn up as a short document written in a concise manner and shall have a maximum length of six sides of A4-sized paper when printed. The specific summary shall:
(a) be presented and laid out in a way that is easy to read, using characters of readable size;
(b) be written in a clear, non-technical and concise language that facilitates the understanding of the information and its comprehensibility by investors.
The first subparagraph shall also apply where information is presented in a tabular format.
5. The specific summary shall contain the information referred to in Annex 23 to this Regulation.
6. The specific summary shall not contain cross-references to other parts of the EU Growth prospectus or incorporate information by reference.
7. The specific summary may use sub-headings to present the information referred to in sections 2, 3 and 4 of Annex 23 to this Regulation.
8. The total number of risk factors referred to in items 2.3.1, 3.3(d) and 3.4.1 of Annex 23 to this Regulation and included in the specific summary shall not exceed 15.
9. Where securities are also subject to Regulation (EU) No 1286/2014 of the European Parliament and of the Council ( 3 ), the competent authority of the home Member State may require the SMEs, the issuers and offerors referred to in Article 15(1) of Regulation (EU) 2017/1129 to substitute the information referred to in section 3 of Annex 23 to this Regulation with the information set out in points (c) to (i) of Article 8(3) of Regulation (EU) No 1286/2014.
10. Where the substitution referred to in paragraph 9 is not required by the competent authority of the home Member State, the SMEs, the issuers and offerors referred to in Article 15(1) of Regulation (EU) 2017/1129 may substitute the information referred to in section 3 of Annex 23 to this Regulation with the information set out in points (c) to (i) of Article 8(3) of Regulation (EU) No 1286/2014.
11. Where the information referred to in paragraphs 9 and 10 is substituted, it shall be included as a distinct section of the specific summary and that section shall clearly be identified as including the information set out in points (c) to (i) of Article 8(3) of Regulation (EU) No 1286/2014.
12. The maximum length of the specific summary referred to in paragraph 4 shall be extended by:
(a) one additional side of A4-sized paper where the specific summary contains information about a guarantee attached to the securities;
(b) two additional sides of A4-sized paper where a specific summary covers several securities which differ only in very limited details such as issue price or maturity date;
(c) three additional sides of A4-sized paper where there is a substitution of information as referred to in paragraphs 9 and 10.
For the purposes of point (c), three additional sides of A4-sized paper may be used for each security where the specific summary covers several securities which differ only in very limited details such as issue price or maturity date.
Article 34
Supplements to the specific summary for the EU Growth prospectus
Where the specific summary of an EU Growth prospectus is to be supplemented in accordance with Article 23 of Regulation (EU) 2017/1129, the new information shall be integrated in the specific summary of that EU Growth prospectus in a way that enables investors to easily identify the changes. The new information shall be integrated in the specific summary of the EU Growth prospectus either by producing a new specific summary or by supplementing the original specific summary.
CHAPTER V
SCRUTINY AND APPROVAL OF THE PROSPECTUS AND REVIEW OF THE UNIVERSAL REGISTRATION DOCUMENT
Article 35
Scope of the scrutiny
For the purposes of the scrutiny of the prospectus and the review of the universal registration document, references to the prospectus shall mean the prospectus or any of its constituent parts, including a universal registration document whether submitted for approval or filed without prior approval and any amendments thereto as well as supplements to the prospectus.
Article 36
Criteria for the scrutiny of the completeness of the information contained in the prospectus
1. For the purposes of scrutinising the completeness of the information in a draft prospectus, competent authorities shall consider all of the following:
(a) whether the draft prospectus is drawn up in accordance with Regulation (EU) 2017/1129 and this Regulation, depending on the type of issuer, the type of issuance, the type of security and the type of offer or admission to trading;
(b) whether the issuer has a complex financial history or has made a significant financial commitment, as referred to in Article 18.
2. For the purposes of point (b) of paragraph 1, competent authorities may require the issuer to include, modify or remove information from a draft prospectus, taking into account the following:
(a) the type of securities;
(b) the information already included in the prospectus and the existence and content of information already included in a prospectus of the entity other than the issuer, as well as the applicable accounting and auditing principles;
(c) the economic nature of the transactions by which the issuer has acquired, or disposed of, its undertaking or any part of it, and the specific nature of that undertaking;
(d) whether the issuer can obtain with reasonable effort information about the entity other than the issuer.
Article 37
Criteria for the scrutiny of the comprehensibility of the information contained in the prospectus
1. For the purposes of scrutinising the comprehensibility of the information in a draft prospectus, competent authorities shall consider all of the following:
(a) whether the draft prospectus has a clear and detailed table of contents;
(b) whether the draft prospectus is free from unnecessary reiterations;
(c) whether related information is grouped together;
(d) whether the draft prospectus uses an easily readable font size;
(e) whether the draft prospectus has a structure that enables investors to understand its contents;
(f) whether the draft prospectus defines the components of mathematical formulas and, where applicable, clearly describes the product structure;
(g) whether the draft prospectus is written in plain language;
(h) whether the draft prospectus clearly describes the nature of the issuer’s operations and its principal activities;
(i) whether the draft prospectus explains trade or industry specific terminology.
However, competent authorities shall not be required to consider points (g), (h) and (i) where a draft prospectus is to be used exclusively for the purposes of admission to trading on a regulated market of non-equity securities for which a summary is not required by Article 7 of Regulation (EU) 2017/1129.
2. For the purposes of the first paragraph, competent authorities may, on a case-by-case basis and in addition to the information referred to in Article 7 of Regulation (EU) 2017/1129 and Article 33 of this Regulation, require that certain information provided in the draft prospectus be included in the summary.
Article 38
Criteria for the scrutiny of the consistency of the information contained in the prospectus
For the purposes of scrutinising the consistency of the information in a draft prospectus, the competent authority shall consider all of the following:
(a) whether the draft prospectus is free of material discrepancies between the different pieces of information provided therein, including any information incorporated by reference;
(b) whether any material and specific risks disclosed elsewhere in the draft prospectus are included in the risk factors section;
(c) whether the information in the summary is in line with information elsewhere in the draft prospectus;
(d) whether any figures on the use of proceeds correspond to the amount of proceeds being raised and whether the disclosed use of proceeds is in line with the disclosed strategy of the issuer;
(e) whether the description of the issuer in the operating and financial review, the historical financial information, the description of the issuer’s activity and the description of the risk factors are consistent;
(f) whether the working capital statement is in line with the risk factors, the auditor’s report, the use of proceeds and the disclosed strategy of the issuer and how that strategy will be funded.
Article 39
Scrutiny of the information contained in the prospectus of specialist issuers
Competent authorities may require additional information to be included in the prospectus based on the activities of the specialist issuers falling under one of the categories set out in Annex 29.
Article 40
Additional criteria for the scrutiny of the completeness, consistency and comprehensibility of the information contained in the prospectus
Where necessary for investor protection, the competent authority may apply criteria in addition to those laid down in Articles 36, 37 and 38 for the purposes of scrutinising the completeness, comprehensibility and consistency of the information in the draft prospectus.
Article 41
Proportionate approach in the scrutiny of draft prospectuses and review of the universal registration document
1. Where a first draft of a prospectus that is submitted to a competent authority is substantially similar to a prospectus that the same competent authority has already approved, and where that draft prospectus highlights all changes made to that approved prospectus, the competent authority shall only be required to apply the criteria laid down in Articles 36, 37 and 38 to scrutinise those changes and any other information affected by them.
2. For the purposes of scrutinizing a universal registration document filed without prior approval that has already been reviewed, or an amendment to such a document, competent authorities shall only be required to apply the criteria laid down in Article 36, 37 and 38 to those parts of the universal registration document or the amendment that have not been reviewed.
3. Where a first draft of a prospectus that incorporates information by reference to a document that has been approved in accordance with Regulation (EU) 2017/1129 or in accordance with the national provisions transposing Directive 2003/71/EC of the European Parliament and of the Council ( 4 ), competent authorities shall only be required to apply the criteria laid down in Article 38 of this Regulation to scrutinise that information.
4. When applying paragraphs 1, 2 or 3, competent authorities shall request the issuer, offeror or person asking for admission to trading on a regulated market to confirm that all information in the final draft of the prospectus or universal registration document is up-to-date and contains all the information referred to in the Annexes to this Regulation applicable to that prospectus or universal registration document.
5. Where subsequent drafts of the prospectus are submitted to the competent authority, that competent authority, when scrutinising such subsequent drafts, shall only be required to apply the criteria laid down in Articles 36, 37 and 38 to changes made to the preceding draft and to any other information affected by those changes.
Article 42
Submission of an application for approval of a draft prospectus or filing of a universal registration document or of amendments thereto
1. All drafts of a prospectus shall be submitted to the competent authority in searchable electronic format via electronic means.
When submitting the first draft of the prospectus, the issuer, offeror or person asking for admission to trading on a regulated market shall provide the competent authority with a contact point for the competent authority to submit all notifications in writing and by electronic means.
2. The following information shall also be submitted to the competent authority in searchable electronic format via electronic means:
(a) the list of cross references, where requested by the competent authority in accordance with Article 24(5) of this Regulation, or when submitted on own initiative;
(b) where no list of cross reference is requested, a document that identifies any items set out in the Annexes to this Regulation that, due to the nature or type of issuer, securities, offer or admission to trading, have not been included in the draft prospectus;
(c) any information that is incorporated into the prospectus by reference as referred to in Article 19 of Regulation (EU) 2017/1129, unless such information has already been approved by or filed with the same competent authority in searchable electronic format;
(d) any reasoned request to the competent authority to authorise the omission of information from the prospectus as referred to in Article 18 of Regulation (EU) 2017/1129;
(e) any request to the competent authority to make a notification as referred to in Article 25(1) of Regulation (EU) 2017/1129;
(f) any request to the competent authority to make a notification as referred to in Article 26(2) of Regulation (EU) 2017/1129;
(g) an appendix where required by Article 26(4) of Regulation (EU) 2017/1129, unless no summary is required pursuant to the second subparagraph of Article 7(1) of that Regulation;
(h) a confirmation that, to the best of the knowledge of the issuer, all regulated information which was required to be disclosed under the national provisions transposing Directive 2004/109/EC of the European Parliament and of the Council ( 5 ), where applicable, and under Regulation (EU) No 596/2014 of the European Parliament and of the Council ( 6 ), has been filed and published in accordance with those acts over the last 18 months or over the period since the obligation to disclose that regulated information commenced, whichever is the shorter, where the issuer is submitting for approval a draft universal registration document or filing a universal registration document without prior approval and seeks to obtain the status of frequent issuer;
(i) where a universal registration document is filed without prior approval, an explanation as to how a request for amendment or supplementary information as referred to in the second subparagraph of Article 9(9) of Regulation (EU) 2017/1129 has been taken into account in the universal registration document;
(j) any other information requested by the competent authority for the purposes of the scrutiny and approval of the prospectus or the scrutiny, review and approval of the universal registration document.
3. Where a universal registration document that is filed without prior approval is annotated in the margin in accordance with Article 24(6), it shall be accompanied by an identical version without annotations in the margin.
4. Where a universal registration document is filed without prior approval or where a universal registration document is amended, the information referred to in points (a), (b), (c), (d), (h) and (i) of paragraph 2 shall be submitted at the time when the universal registration document is filed with the competent authority whilst the information referred to in point (j) of paragraph 2 shall be submitted during the review process. In all other cases, the information referred to in paragraph 2 shall be submitted together with the first draft of the prospectus submitted to the competent authority or during the scrutiny process.
5. Where a frequent issuer informs the competent authority that it intends to submit an application for approval of a draft prospectus in accordance with the second sentence of the first subparagraph of Article 20(6) of Regulation (EU) 2017/1129, that frequent issuer shall do so in writing and by electronic means.
The information referred to in the first subparagraph shall indicate the Annexes to this Regulation relevant for that draft prospectus.
Article 43
Changes to a draft prospectus during the approval procedure
1. Each version of the draft prospectus submitted after the first draft prospectus shall highlight all changes made to the preceding draft and shall be accompanied by an unmarked draft. Competent authorities shall accept marked extracts of the preceding draft prospectus where only limited changes have been made.
2. Where competent authorities, in accordance with Article 45(2) of this Regulation, have notified the issuer, offeror or person asking for admission to trading on a regulated market that the draft prospectus does not meet the standards of completeness, comprehensibility and consistency as referred to in Article 20(4) of Regulation (EU) 2017/1129, the subsequently submitted draft of the prospectus shall be accompanied by an explanation as to how the outstanding issues notified by competent authorities have been addressed.
3. Where changes made to a draft prospectus are self-explanatory or clearly address the outstanding issues notified by the competent authority, an indication of where the changes have been made to address the outstanding issues shall be considered sufficient explanation for the purposes of paragraph 2.
Article 44
Submission for approval of the final draft of the prospectus
1. The final draft of the prospectus shall be submitted for approval together with all the information referred to in Article 42(2) that has changed compared to the previous submission, with the exception of the information referred to in points (a) and (h) of that Article. The final draft of the prospectus shall not be annotated in the margin.
2. Where no changes have been made to the information referred to in Article 42(2), the issuer, offeror or person asking for admission to trading on a regulated market shall confirm so in writing and by electronic means.
Article 45
Acknowledgment of the receipt of an application for approval of a draft prospectus, or of the filing of a universal registration document or of an amendment thereto, and processing of an application for approval of a draft prospectus
1. Competent authorities shall acknowledge receipt of the initial application for approval of a draft prospectus or of the filing of a universal registration document as referred to in the second subparagraph of Article 9(2) of Regulation (EU) 2017/1129, or of an amendment to that universal registration document in writing and by electronic means as soon as possible and no later than by close of business on the second working day following the receipt of the application or filing.
Upon receipt of the initial application for approval of a draft prospectus and of the filing of a universal registration document, or of an amendment thereto, the competent authority shall inform the issuer, offeror or person asking for admission to trading on a regulated market of the following:
(a) the reference number of the application or of the filing;
(b) the contact point within the competent authority to which queries regarding the application or the filing may be addressed.
2. Where the draft prospectus does not meet the standards of completeness, comprehensibility and consistency necessary for its approval or where changes or supplementary information are needed, competent authorities shall inform the issuer, offeror or person asking for admission to trading on a regulated market thereof in writing and by electronic means.
Where the universal registration document referred to in the second subparagraph of Article 9(2) of Regulation (EU) 2017/1129, or an amendment to that universal registration document, does not meet the standards of completeness, comprehensibility and consistency or where amendments or supplementary information are needed, competent authorities shall inform the issuer thereof in writing and by electronic means. Where the shortcoming must be addressed without undue delay, as required by the third subparagraph of Article 9(9) of Regulation (EU) 2017/1129, the competent authority shall inform the issuer thereof.
3. The competent authority shall notify the issuer, offeror or person asking for admission to trading on a regulated market about its decision regarding the approval of the draft prospectus in writing and by electronic means as soon as possible and by no later than by close of business of the day on which that decision is taken.
CHAPTER VI
FINAL PROVISIONS
Article 46
Repeal
Regulation (EC) No 809/2004 is repealed.
Article 46a
Prospectuses approved between 21 July 2019 and 16 September 2020
Prospectuses that have been approved between 21 July 2019 and 16 September 2020 shall continue to be valid until the end of their validity.
Article 47
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
It shall apply from 21 July 2019.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
LIST OF ANNEXES
PART A
REGISTRATION DOCUMENTS
<table><col/><col/><tr><td><p>Annex 1:</p></td><td><p>Registration document for equity securities</p></td></tr><tr><td><p>Annex 2:</p></td><td><p>Universal registration document</p></td></tr><tr><td><p>Annex 3:</p></td><td><p>Registration document for secondary issuances of equity securities</p></td></tr><tr><td><p>Annex 4:</p></td><td><p>Registration document for units of closed-end collective investment undertakings</p></td></tr><tr><td><p>Annex 5:</p></td><td><p>Registration document for depository receipts issued over shares</p></td></tr><tr><td><p>Annex 6:</p></td><td><p>Registration document for retail non-equity securities</p></td></tr><tr><td><p>Annex 7:</p></td><td><p>Registration document for wholesale non-equity securities</p></td></tr><tr><td><p>Annex 8:</p></td><td><p>Registration document for secondary issuances of non-equity securities</p></td></tr><tr><td><p>Annex 9:</p></td><td><p>Registration document for asset-backed securities</p></td></tr><tr><td><p>Annex 10:</p></td><td><p>Registration documents for non-equity securities issued by third countries and their regional and local authorities</p></td></tr></table>
PART B
SECURITIES NOTES
<table><col/><col/><tr><td><p>Annex 11:</p></td><td><p>Securities note for equity securities or units issued by collective investment undertakings of the closed-end type</p></td></tr><tr><td><p>Annex 12:</p></td><td><p>Securities note for secondary issuances of equity securities or of units issued by collective investment undertakings of the closed-end type</p></td></tr><tr><td><p>Annex 13:</p></td><td><p>Securities note for depository receipts issued over shares</p></td></tr><tr><td><p>Annex 14:</p></td><td><p>Securities note for retail non-equity securities</p></td></tr><tr><td><p>Annex 15:</p></td><td><p>Securities note for wholesale non-equity securities</p></td></tr><tr><td><p>Annex 16:</p></td><td><p>Securities note for secondary issuances of non-equity securities</p></td></tr></table>
PART C
ADDITIONAL INFORMATION TO BE INCLUDED IN THE PROSPECTUS
<table><col/><col/><tr><td><p>Annex 17:</p></td><td><p>Securities giving rise to payment or delivery obligations linked to an underlying asset</p></td></tr><tr><td><p>Annex 18:</p></td><td><p>Underlying share</p></td></tr><tr><td><p>Annex 19:</p></td><td><p>Asset-backed securities</p></td></tr><tr><td><p>Annex 20:</p></td><td><p>Pro forma information</p></td></tr><tr><td><p>Annex 21:</p></td><td><p>Guarantees</p></td></tr><tr><td><p>Annex 22:</p></td><td><p>Consent</p></td></tr></table>
PART D
EU GROWTH PROSPECTUS
<table><col/><col/><tr><td><p>Annex 23:</p></td><td><p>Specific summary for the EU Growth prospectus</p></td></tr><tr><td><p>Annex 24:</p></td><td><p>EU Growth registration document for equity securities</p></td></tr><tr><td><p>Annex 25:</p></td><td><p>EU Growth registration document for non-equity securities</p></td></tr><tr><td><p>Annex 26:</p></td><td><p>EU Growth securities note for equity securities</p></td></tr><tr><td><p>Annex 27:</p></td><td><p>EU Growth securities note for non-equity securities</p></td></tr></table>
PART E
OTHER CATEGORIES OF INFORMATION
<table><col/><col/><tr><td><p>Annex 28:</p></td><td><p>List of additional information in final terms</p></td></tr><tr><td><p>Annex 29:</p></td><td><p>List of specialist issuers</p></td></tr></table>
ANNEX 1
REGISTRATION DOCUMENT FOR EQUITY SECURITIES
<table><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>PERSONS RESPONSIBLE, THIRD PARTY INFORMATION, EXPERTS’ REPORTS AND COMPETENT AUTHORITY APPROVAL</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Identify all persons responsible for the information or any parts of it, given in the registration document with, in the latter case, an indication of such parts. In the case of natural persons, including members of the issuer’s administrative, management or supervisory bodies, indicate the name and function of the person; in the case of legal persons indicate the name and registered office.</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>A declaration by those responsible for the registration document that to the best of their knowledge, the information contained in the registration document is in accordance with the facts and that the registration document makes no omission likely to affect its import.</p><p>Where applicable, a declaration by those responsible for certain parts of the registration document that, to the best of their knowledge, the information contained in those parts of the registration document for which they are responsible is in accordance with the facts and that those parts of the registration document make no omission likely to affect their import.</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Where a statement or report attributed to a person as an expert, is included in the registration document, provide the following details for that person:</p><p>(a)  name;</p><p>(b)  business address;</p><p>(c)  qualifications;</p><p>(d)  material interest if any in the issuer.</p><p>If the statement or report has been produced at the issuer’s request, state that such statement or report has been included in the registration document with the consent of the person who has authorised the contents of that part of the registration document for the purpose of the prospectus.</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Where information has been sourced from a third party, provide a confirmation that this information has been accurately reproduced and that as far as the issuer is aware and is able to ascertain from information published by that third party, no facts have been omitted which would render the reproduced information inaccurate or misleading. In addition, identify the source(s) of the information.</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>A statement that:</p><p>(a)  the [registration document/prospectus] has been approved by the [name of the competent authority], as competent authority under Regulation (EU) 2017/1129;</p><p>(b)  the [name of competent authority] only approves this [registration document/prospectus] as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation (EU) 2017/1129;</p><p>(c)  such approval should not be considered as an endorsement of the issuer that is the subject of this [registration document/prospectus].</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>STATUTORY AUDITORS</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>Names and addresses of the issuer’s auditors for the period covered by the historical financial information (together with their membership in a professional body).</p></td></tr><tr><td><p>Item 2.2</p></td><td><p>If auditors have resigned, been removed or have not been re-appointed during the period covered by the historical financial information, indicate details if material.</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>RISK FACTORS</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>A description of the material risks that are specific to the issuer, in a limited number of categories, in a section headed ‘Risk Factors’.</p><p>In each category, the most material risks, in the assessment undertaken by the issuer, offeror or person asking for admission to trading on a regulated market, taking into account the negative impact on the issuer and the probability of their occurrence shall be set out first. The risks shall be corroborated by the content of the registration document.</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>INFORMATION ABOUT THE ISSUER</p></td></tr><tr><td><p>Item 4.1</p></td><td><p>The legal and commercial name of the issuer.</p></td></tr><tr><td><p>Item 4.2</p></td><td><p>The place of registration of the issuer, its registration number and legal entity identifier (‘LEI’).</p></td></tr><tr><td><p>Item 4.3</p></td><td><p>The date of incorporation and the length of life of the issuer, except where the period is indefinite.</p></td></tr><tr><td><p>Item 4.4</p></td><td><p>The domicile and legal form of the issuer, the legislation under which the issuer operates, its country of incorporation, the address, telephone number of its registered office (or principal place of business if different from its registered office) and website of the issuer, if any, with a disclaimer that the information on the website does not form part of the prospectus unless that information is incorporated by reference into the prospectus.</p></td></tr><tr><td><p>SECTION 5</p></td><td><p>BUSINESS OVERVIEW</p></td></tr><tr><td><p>Item 5.1</p></td><td><p>Principal activities</p></td></tr><tr><td><p>Item 5.1.1</p></td><td><p>A description of, and key factors relating to, the nature of the issuer’s operations and its principal activities, stating the main categories of products sold and/or services performed for each financial year for the period covered by the historical financial information;</p></td></tr><tr><td><p>Item 5.1.2</p></td><td><p>An indication of any significant new products and/or services that have been introduced and, to the extent the development of new products or services has been publicly disclosed, give the status of their development.</p></td></tr><tr><td><p>Item 5.2</p></td><td><p>Principal markets</p><p>A description of the principal markets in which the issuer competes, including a breakdown of total revenues by operating segment and geographic market for each financial year for the period covered by the historical financial information.</p></td></tr><tr><td><p>Item 5.3</p></td><td><p>The important events in the development of the issuer’s business.</p></td></tr><tr><td><p>Item 5.4</p></td><td><p>Strategy and objectives</p><p>A description of the issuer’s business strategy and objectives, both financial and non-financial (if any). This description shall take into account the issuer’s future challenges and prospects.</p></td></tr><tr><td><p>Item 5.5</p></td><td><p>If material to the issuer’s business or profitability, summary information regarding the extent to which the issuer is dependent, on patents or licences, industrial, commercial or financial contracts or new manufacturing processes.</p></td></tr><tr><td><p>Item 5.6</p></td><td><p>The basis for any statements made by the issuer regarding its competitive position.</p></td></tr><tr><td><p>Item 5.7</p></td><td><p>Investments</p></td></tr><tr><td><p>Item 5.7.1</p></td><td><p>A description, (including the amount) of the issuer’s material investments for each financial year for the period covered by the historical financial information up to the date of the registration document.</p></td></tr><tr><td><p>Item 5.7.2</p></td><td><p>A description of any material investments of the issuer that are in progress or for which firm commitments have already been made, including the geographic distribution of these investments (home and abroad) and the method of financing (internal or external).</p></td></tr><tr><td><p>Item 5.7.3</p></td><td><p>Information relating to the joint ventures and undertakings in which the issuer holds a proportion of the capital likely to have a significant effect on the assessment of its own assets and liabilities, financial position or profits and losses.</p></td></tr><tr><td><p>Item 5.7.4</p></td><td><p>A description of any environmental issues that may affect the issuer’s utilisation of the tangible fixed assets.</p></td></tr><tr><td><p>SECTION 6</p></td><td><p>ORGANISATIONAL STRUCTURE</p></td></tr><tr><td><p>Item 6.1</p></td><td><p>If the issuer is part of a group, a brief description of the group and the issuer’s position within the group. This may be in the form of, or accompanied by, a diagram of the organisational structure if this helps to clarify the structure.</p></td></tr><tr><td><p>Item 6.2</p></td><td><p>A list of the issuer’s significant subsidiaries, including name, country of incorporation or residence, the proportion of ownership interest held and, if different, the proportion of voting power held.</p></td></tr><tr><td><p>SECTION 7</p></td><td><p>OPERATING AND FINANCIAL REVIEW</p></td></tr><tr><td><p>Item 7.1</p></td><td><p>Financial condition</p></td></tr><tr><td><p>Item 7.1.1</p></td><td><p>To the extent not covered elsewhere in the registration document and to the extent necessary for an understanding of the issuer’s business as a whole, a fair review of the development and performance of the issuer’s business and of its position for each year and interim period for which historical financial information is required, including the causes of material changes.</p><p>The review shall be a balanced and comprehensive analysis of the development and performance of the issuer’s business and of its position, consistent with the size and complexity of the business.</p><p>To the extent necessary for an understanding of the issuer’s development, performance or position, the analysis shall include both financial and, where appropriate, non-financial Key Performance Indicators relevant to the particular business. The analysis shall, where appropriate, include references to, and additional explanations of, amounts reported in the annual financial statements.</p></td></tr><tr><td><p>Item 7.1.2</p></td><td><p>To the extent not covered elsewhere in the registration document and to the extent necessary for an understanding of the issuer’s business as a whole, the review shall also give an indication of:</p><p>(a)  the issuer’s likely future development;</p><p>(b)  activities in the field of research and development.</p><p>The requirements set out in item 7.1 may be satisfied by the inclusion of the management report referred to in Articles 19 and 29 of Directive 2013/34/EU of the European Parliament and of the Council <a>(<span>1</span>)</a>.</p></td></tr><tr><td><p>Item 7.2</p></td><td><p>Operating results</p></td></tr><tr><td><p>Item 7.2.1</p></td><td><p>Information regarding significant factors, including unusual or infrequent events or new developments, materially affecting the issuer’s income from operations and indicate the extent to which income was so affected.</p></td></tr><tr><td><p>Item 7.2.2</p></td><td><p>Where the historical financial information discloses material changes in net sales or revenues, provide a narrative discussion of the reasons for such changes.</p></td></tr><tr><td><p>SECTION 8</p></td><td><p>CAPITAL RESOURCES</p></td></tr><tr><td><p>Item 8.1</p></td><td><p>Information concerning the issuer’s capital resources (both short term and long term).</p></td></tr><tr><td><p>Item 8.2</p></td><td><p>An explanation of the sources and amounts of and a narrative description of the issuer’s cash flows.</p></td></tr><tr><td><p>Item 8.3</p></td><td><p>Information on the borrowing requirements and funding structure of the issuer.</p></td></tr><tr><td><p>Item 8.4</p></td><td><p>Information regarding any restrictions on the use of capital resources that have materially affected, or could materially affect, directly or indirectly, the issuer’s operations.</p></td></tr><tr><td><p>Item 8.5</p></td><td><p>Information regarding the anticipated sources of funds needed to fulfil commitments referred to in item 5.7.2</p></td></tr><tr><td><p>SECTION 9</p></td><td><p>REGULATORY ENVIRONMENT</p></td></tr><tr><td><p>Item 9.1</p></td><td><p>A description of the regulatory environment that the issuer operates in and that may materially affect its business, together with information regarding any governmental, economic, fiscal, monetary or political policies or factors that have materially affected, or could materially affect, directly or indirectly, the issuer’s operations.</p></td></tr><tr><td><p>SECTION 10</p></td><td><p>TREND INFORMATION</p></td></tr><tr><td><p>Item 10.1</p></td><td><p>A description of:</p><p>(a)  the most significant recent trends in production, sales and inventory, and costs and selling prices since the end of the last financial year to the date of the registration document;</p><p>(b)  any significant change in the financial performance of the group since the end of the last financial period for which financial information has been published to the date of the registration document, or provide an appropriate negative statement.</p></td></tr><tr><td><p>Item 10.2</p></td><td><p>Information on any known trends, uncertainties, demands, commitments or events that are reasonably likely to have a material effect on the issuer’s prospects for at least the current financial year.</p></td></tr><tr><td><p>SECTION 11</p></td><td><p>PROFIT FORECASTS OR ESTIMATES</p></td></tr><tr><td><p>Item 11.1</p></td><td><p>Where an issuer has published a profit forecast or a profit estimate (which is still outstanding and valid) that forecast or estimate shall be included in the registration document. If a profit forecast or profit estimate has been published and is still outstanding, but no longer valid, then provide a statement to that effect and an explanation of why such forecast or estimate is no longer valid. Such an invalid forecast or estimate is not subject to the requirements in items 11.2 and 11.3.</p></td></tr><tr><td><p>Item 11.2</p></td><td><p>Where an issuer chooses to include a new profit forecast or a new profit estimate, or a previously published profit forecast or a previously published profit estimate pursuant to item 11.1, the profit forecast or estimate shall be clear and unambiguous and contain a statement setting out the principal assumptions upon which the issuer has based its forecast, or estimate.</p><p>The forecast or estimate shall comply with the following principles:</p><p>(a)  there must be a clear distinction between assumptions about factors which the members of the administrative, management or supervisory bodies can influence and assumptions about factors which are exclusively outside the influence of the members of the administrative, management or supervisory bodies;</p><p>(b)  the assumptions must be reasonable, readily understandable by investors, specific and precise and not relate to the general accuracy of the estimates underlying the forecast;</p><p>(c)  in the case of a forecast, the assumptions shall draw the investor’s attention to those uncertain factors which could materially change the outcome of the forecast.</p></td></tr><tr><td><p>Item 11.3</p></td><td><p>The prospectus shall include a statement that the profit forecast or estimate has been compiled and prepared on a basis which is both:</p><p>(a)  comparable with the historical financial information;</p><p>(b)  consistent with the issuer’s accounting policies.</p></td></tr><tr><td><p>SECTION 12</p></td><td><p>ADMINISTRATIVE, MANAGEMENT AND SUPERVISORY BODIES AND SENIOR MANAGEMENT</p></td></tr><tr><td><p>Item 12.1</p></td><td><p>Names, business addresses and functions within the issuer of the following persons and an indication of the principal activities performed by them outside of that issuer where these are significant with respect to that issuer:</p><p>(a)  members of the administrative, management or supervisory bodies;</p><p>(b)  partners with unlimited liability, in the case of a limited partnership with a share capital;</p><p>(c)  founders, if the issuer has been established for fewer than five years;</p><p>(d)  any senior manager who is relevant to establishing that the issuer has the appropriate expertise and experience for the management of the issuer’s business.</p><p>Details of the nature of any family relationship between any of the persons referred to in points (a) to (d).</p><p>In the case of each member of the administrative, management or supervisory bodies of the issuer and of each person referred to in points (b) and (d) of the first subparagraph, details of that person’s relevant management expertise and experience and the following information:</p><p>(a)  the names of all companies and partnerships where those persons have been a member of the administrative, management or supervisory bodies or partner at any time in the previous five years, indicating whether or not the individual is still a member of the administrative, management or supervisory bodies or partner. It is not necessary to list all the subsidiaries of an issuer of which the person is also a member of the administrative, management or supervisory bodies;</p><p>(b)  details of any convictions in relation to fraudulent offences for at least the previous five years;</p><p>(c)  details of any bankruptcies, receiverships, liquidations or companies put into administration in respect of those persons described in points (a) and (d) of the first subparagraph who acted in one or more of those capacities for at least the previous five years;</p><p>(d)  details of any official public incrimination and/or sanctions involving such persons by statutory or regulatory authorities (including designated professional bodies) and whether they have ever been disqualified by a court from acting as a member of the administrative, management or supervisory bodies of an issuer or from acting in the management or conduct of the affairs of any issuer for at least the previous five years.</p><p>If there is no such information required to be disclosed, a statement to that effect is to be made.</p></td></tr><tr><td><p>Item 12.2</p></td><td><p>Administrative, management and supervisory bodies and senior management conflicts of interests</p><p>Potential conflicts of interests between any duties to the issuer, of the persons referred to in item 12.1, and their private interests and or other duties must be clearly stated. In the event that there are no such conflicts, a statement to that effect must be made.</p><p>Any arrangement or understanding with major shareholders, customers, suppliers or others, pursuant to which any person referred to in item 12.1 was selected as a member of the administrative, management or supervisory bodies or member of senior management.</p><p>Details of any restrictions agreed by the persons referred to in item 12.1 on the disposal within a certain period of time of their holdings in the issuer’s securities.</p></td></tr><tr><td><p>SECTION 13</p></td><td><p>REMUNERATION AND BENEFITS</p></td></tr><tr><td><p> </p><div/></td><td><p>In relation to the last full financial year for those persons referred to in points (a) and (d) of the first subparagraph of item 12.1:</p></td></tr><tr><td><p>Item 13.1</p></td><td><p>The amount of remuneration paid (including any contingent or deferred compensation), and benefits in kind granted to such persons by the issuer and its subsidiaries for services in all capacities to the issuer and its subsidiaries by any person.</p><p>That information must be provided on an individual basis unless individual disclosure is not required in the issuer’s home country and is not otherwise publicly disclosed by the issuer.</p></td></tr><tr><td><p>Item 13.2</p></td><td><p>The total amounts set aside or accrued by the issuer or its subsidiaries to provide for pension, retirement or similar benefits.</p></td></tr><tr><td><p>SECTION 14</p></td><td><p>BOARD PRACTICES</p></td></tr><tr><td><p> </p><div/></td><td><p>In relation to the issuer’s last completed financial year, and unless otherwise specified, with respect to those persons referred to in point (a) of the first subparagraph of item 12.1.</p></td></tr><tr><td><p>Item 14.1</p></td><td><p>Date of expiration of the current term of office, if applicable, and the period during which the person has served in that office.</p></td></tr><tr><td><p>Item 14.2</p></td><td><p>Information about members of the administrative, management or supervisory bodies’ service contracts with the issuer or any of its subsidiaries providing for benefits upon termination of employment, or an appropriate statement to the effect that no such benefits exist.</p></td></tr><tr><td><p>Item 14.3</p></td><td><p>Information about the issuer’s audit committee and remuneration committee, including the names of committee members and a summary of the terms of reference under which the committee operates.</p></td></tr><tr><td><p>Item 14.4</p></td><td><p>A statement as to whether or not the issuer complies with the corporate governance regime(s) applicable to the issuer. In the event that the issuer does not comply with such a regime, a statement to that effect must be included together with an explanation regarding why the issuer does not comply with such regime.</p></td></tr><tr><td><p>Item 14.5</p></td><td><p>Potential material impacts on the corporate governance, including future changes in the board and committees composition (in so far as this has been already decided by the board and/or shareholders meeting).</p></td></tr><tr><td><p>SECTION 15</p></td><td><p>EMPLOYEES</p></td></tr><tr><td><p>Item 15.1</p></td><td><p>Either the number of employees at the end of the period or the average for each financial year for the period covered by the historical financial information up to the date of the registration document (and changes in such numbers, if material) and, if possible and material, a breakdown of persons employed by main category of activity and geographic location. If the issuer employs a significant number of temporary employees, include disclosure of the number of temporary employees on average during the most recent financial year.</p></td></tr><tr><td><p>Item 15.2</p></td><td><p>Shareholdings and stock options</p><p>With respect to each person referred to in points (a) and (d) of the first subparagraph of item 12.1 provide information as to their share ownership and any options over such shares in the issuer as of the most recent practicable date.</p></td></tr><tr><td><p>Item 15.3</p></td><td><p>Description of any arrangements for involving the employees in the capital of the issuer.</p></td></tr><tr><td><p>SECTION 16</p></td><td><p>MAJOR SHAREHOLDERS</p></td></tr><tr><td><p>Item 16.1</p></td><td><p>In so far as is known to the issuer, the name of any person other than a member of the administrative, management or supervisory bodies who, directly or indirectly, has an interest in the issuer’s capital or voting rights which is notifiable under the issuer’s national law, together with the amount of each such person’s interest, as at the date of the registration document or, if there are no such persons, an appropriate statement to that that effect that no such person exists.</p></td></tr><tr><td><p>Item 16.2</p></td><td><p>Whether the issuer’s major shareholders have different voting rights, or an appropriate statement to the effect that no such voting rights exist.</p></td></tr><tr><td><p>Item 16.3</p></td><td><p>To the extent known to the issuer, state whether the issuer is directly or indirectly owned or controlled and by whom and describe the nature of such control and describe the measures in place to ensure that such control is not abused.</p></td></tr><tr><td><p>Item 16.4</p></td><td><p>A description of any arrangements, known to the issuer, the operation of which may at a subsequent date result in a change in control of the issuer.</p></td></tr><tr><td><p>SECTION 17</p></td><td><p>RELATED PARTY TRANSACTIONS</p></td></tr><tr><td><p>Item 17.1</p></td><td><p>Details of related party transactions (which for these purposes are those set out in the Standards adopted in accordance with the Regulation (EC) No 1606/2002 of the European Parliament and of the Council <a>(<span>2</span>)</a>, that the issuer has entered into during the period covered by the historical financial information and up to the date of the registration document, must be disclosed in accordance with the respective standard adopted under Regulation (EC) No 1606/2002 if applicable.</p><p>If such standards do not apply to the issuer the following information must be disclosed:</p><p>(a)  the nature and extent of any transactions which are, as a single transaction or in their entirety, material to the issuer. Where such related party transactions are not concluded at arm’s length provide an explanation of why these transactions were not concluded at arm’s length. In the case of outstanding loans including guarantees of any kind indicate the amount outstanding;</p><p>(b)  the amount or the percentage to which related party transactions form part of the turnover of the issuer.</p></td></tr><tr><td><p>SECTION 18</p></td><td><p>FINANCIAL INFORMATION CONCERNING THE ISSUER’S ASSETS AND LIABILITIES, FINANCIAL POSITION AND PROFITS AND LOSSES</p></td></tr><tr><td><p>Item 18.1</p></td><td><p>Historical financial information</p></td></tr><tr><td><p>Item 18.1.1</p></td><td><p>Audited historical financial information covering the latest three financial years (or such shorter period as the issuer has been in operation) and the audit report in respect of each year.</p></td></tr><tr><td><p>Item 18.1.2</p></td><td><p>Change of accounting reference date</p><p>If the issuer has changed its accounting reference date during the period for which historical financial information is required, the audited historical information shall cover at least 36 months, or the entire period for which the issuer has been in operation, whichever is shorter.</p></td></tr><tr><td><p>Item 18.1.3</p></td><td><p>Accounting standards</p><p>The financial information must be prepared according to International Financial Reporting Standards as endorsed in the Union based on Regulation (EC) No 1606/2002.</p><p>If Regulation (EC) No 1606/2002 is not applicable, the financial information must be prepared in accordance with:</p><p>(a)  a Member State’s national accounting standards for issuers from the EEA, as required by Directive 2013/34/EU;</p><p>(b)  a third country’s national accounting standards equivalent to Regulation (EC) No 1606/2002 for third country issuers. If such third country’s national accounting standards are not equivalent to Regulation (EC) No 1606/2002 the financial statements shall be restated in compliance with that Regulation.</p></td></tr><tr><td><p>Item 18.1.4</p></td><td><p>Change of accounting framework</p><p>The last audited historical financial information, containing comparative information for the previous year, must be presented and prepared in a form consistent with the accounting standards framework that will be adopted in the issuer’s next published annual financial statements having regard to accounting standards and policies and legislation applicable to such annual financial statements.</p><p>Changes within the accounting framework applicable to an issuer do not require the audited financial statements to be restated solely for the purposes of the prospectus. However, if the issuer intends to adopt a new accounting standards framework in its next published financial statements, at least one complete set of financial statements (as defined by IAS 1 Presentation of Financial Statements as set out in Regulation (EC) No 1606/2002), including comparatives, must be presented in a form consistent with that which will be adopted in the issuer’s next published annual financial statements, having regard to accounting standards and policies and legislation applicable to such annual financial statements.</p></td></tr><tr><td><p>Item 18.1.5</p></td><td><p>Where the audited financial information is prepared according to national accounting standards, it must include at least the following:</p><p>(a)  the balance sheet;</p><p>(b)  the income statement;</p><p>(c)  a statement showing either all changes in equity or changes in equity other than those arising from capital transactions with owners and distributions to owners;</p><p>(d)  the cash flow statement;</p><p>(e)  the accounting policies and explanatory notes.</p></td></tr><tr><td><p>Item 18.1.6</p></td><td><p>Consolidated financial statements</p><p>If the issuer prepares both stand-alone and consolidated financial statements, include at least the consolidated financial statements in the registration document.</p></td></tr><tr><td><p>Item 18.1.7</p></td><td><p>Age of financial information</p><p>The balance sheet date of the last year of audited financial information may not be older than one of the following:</p><p>(a)  18 months from the date of the registration document if the issuer includes audited interim financial statements in the registration document;</p><p>(b)  16 months from the date of the registration document if the issuer includes unaudited interim financial statements in the registration document.</p></td></tr><tr><td><p>Item 18.2</p></td><td><p>Interim and other financial information</p></td></tr><tr><td><p>Item 18.2.1</p></td><td><p>If the issuer has published quarterly or half-yearly financial information since the date of its last audited financial statements, these must be included in the registration document. If the quarterly or half-yearly financial information has been audited or reviewed, the audit or review report must also be included. If the quarterly or half-yearly financial information is not audited or has not been reviewed, state that fact.</p><p>If the registration document is dated more than nine months after the date of the last audited financial statements, it must contain interim financial information, which may be unaudited (in which case that fact must be stated) covering at least the first six months of the financial year.</p><p>Interim financial information prepared in accordance with the requirements of Regulation (EC) No 1606/2002.</p><p>For issuers not subject to Regulation (EC) No 1606/2002, the interim financial information must include comparative statements for the same period in the prior financial year, except that the requirement for comparative balance sheet information may be satisfied by presenting the year’s end balance sheet in accordance with the applicable financial reporting framework.</p></td></tr><tr><td><p>Item 18.3</p></td><td><p>Auditing of historical annual financial information</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 18.3.1</p></td><td><p>The historical annual financial information must be independently audited. The audit report shall be prepared in accordance with Directive 2006/43/EC of the European Parliament and of the Council <a>(<span>5</span>)</a> and Regulation (EU) No 537/2014 of the European Parliament and of the Council <a>(<span>6</span>)</a>.</p><p>Where Directive 2006/43/EC and Regulation (EU) No 537/2014 do not apply, the historical annual financial information must be audited or reported on as to whether or not, for the purposes of the registration document, it gives a true and fair view in accordance with auditing standards applicable in a Member State or an equivalent standard.</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 18.3.1a</p></td><td><p>Where audit reports on the historical financial information have been refused by the statutory auditors or where they contain qualifications, modifications of opinion, disclaimers or an emphasis of matter<span>,</span> the reason must be given, and such qualifications, modifications, disclaimers or emphasis of matter must be reproduced in full.</p></td></tr><tr><td><p><a>▼B</a></p></td></tr><tr><td><p>Item 18.3.2</p></td><td><p>Indication of other information in the registration document that has been audited by the auditors.</p></td></tr><tr><td><p>Item 18.3.3</p></td><td><p>Where financial information in the registration document is not extracted from the issuer’s audited financial statements state the source of the information and state that the information is not audited.</p></td></tr><tr><td><p>Item 18.4</p></td><td><p>Pro forma financial information</p></td></tr><tr><td><p>Item 18.4.1</p></td><td><p>In the case of a significant gross change, a description of how the transaction might have affected the assets, liabilities and earnings of the issuer, had the transaction been undertaken at the commencement of the period being reported on or at the date reported.</p><p>This requirement will normally be satisfied by the inclusion of pro forma financial information. This pro forma financial information is to be presented as set out in Annex 20 and must include the information indicated therein.</p><p>Pro forma financial information must be accompanied by a report prepared by independent accountants or auditors.</p></td></tr><tr><td><p>Item 18.5</p></td><td><p>Dividend policy</p></td></tr><tr><td><p>Item 18.5.1</p></td><td><p>A description of the issuer’s policy on dividend distributions and any restrictions thereon. If the issuer has no such policy, include an appropriate negative statement.</p></td></tr><tr><td><p>Item 18.5.2</p></td><td><p>The amount of the dividend per share for each financial year for the period covered by the historical financial information adjusted, where the number of shares in the issuer has changed, to make it comparable.</p></td></tr><tr><td><p>Item 18.6</p></td><td><p>Legal and arbitration proceedings</p></td></tr><tr><td><p>Item 18.6.1</p></td><td><p>Information on any governmental, legal or arbitration proceedings (including any such proceedings which are pending or threatened of which the issuer is aware), during a period covering at least the previous 12 months which may have, or have had in the recent past significant effects on the issuer and/or group’s financial position or profitability, or provide an appropriate negative statement.</p></td></tr><tr><td><p>Item 18.7</p></td><td><p>Significant change in the issuer’s financial position</p></td></tr><tr><td><p>Item 18.7.1</p></td><td><p>A description of any significant change in the financial position of the group which has occurred since the end of the last financial period for which either audited financial statements or interim financial information have been published, or provide an appropriate negative statement.</p></td></tr><tr><td><p>SECTION 19</p></td><td><p>ADDITIONAL INFORMATION</p></td></tr><tr><td><p>Item 19.1</p></td><td><p>Share capital</p><p>The information in items 19.1.1 to 19.1.7 in the historical financial information as of the date of the most recent balance sheet:</p></td></tr><tr><td><p>Item 19.1.1</p></td><td><p>The amount of issued capital, and for each class of share capital:</p><p>(a)  the total of the issuer’s authorised share capital;</p><p>(b)  the number of shares issued and fully paid and issued but not fully paid;</p><p>(c)  the par value per share, or that the shares have no par value; and</p><p>(d)  a reconciliation of the number of shares outstanding at the beginning and end of the year.</p><p>If more than 10 % of capital has been paid for with assets other than cash within the period covered by the historical financial information, state that fact.</p></td></tr><tr><td><p>Item 19.1.2</p></td><td><p>If there are shares not representing capital, state the number and main characteristics of such shares.</p></td></tr><tr><td><p>Item 19.1.3</p></td><td><p>The number, book value and face value of shares in the issuer held by or on behalf of the issuer itself or by subsidiaries of the issuer.</p></td></tr><tr><td><p>Item 19.1.4</p></td><td><p>The amount of any convertible securities, exchangeable securities or securities with warrants, with an indication of the conditions governing and the procedures for conversion, exchange or subscription.</p></td></tr><tr><td><p>Item 19.1.5</p></td><td><p>Information about and terms of any acquisition rights and or obligations over authorised but unissued capital or an undertaking to increase the capital.</p></td></tr><tr><td><p>Item 19.1.6</p></td><td><p>Information about any capital of any member of the group which is under option or agreed conditionally or unconditionally to be put under option and details of such options including those persons to whom such options relate.</p></td></tr><tr><td><p>Item 19.1.7</p></td><td><p>A history of share capital, highlighting information about any changes, for the period covered by the historical financial information.</p></td></tr><tr><td><p>Item 19.2</p></td><td><p>Memorandum and Articles of Association</p></td></tr><tr><td><p>Item 19.2.1</p></td><td><p>The register and the entry number therein, if applicable, and a brief description of the issuer’s objects and purposes and where they can be found in the up to date memorandum and articles of association.</p></td></tr><tr><td><p>Item 19.2.2</p></td><td><p>Where there is more than one class of existing shares, a description of the rights, preferences and restrictions attaching to each class.</p></td></tr><tr><td><p>Item 19.2.3</p></td><td><p>A brief description of any provision of the issuer’s articles of association, statutes, charter or bylaws that would have an effect of delaying, deferring or preventing a change in control of the issuer.</p></td></tr><tr><td><p>SECTION 20</p></td><td><p>MATERIAL CONTRACTS</p></td></tr><tr><td><p>Item 20.1</p></td><td><p>A summary of each material contract, other than contracts entered into in the ordinary course of business, to which the issuer or any member of the group is a party, for the two years immediately preceding publication of the registration document.</p><p>A summary of any other contract (not being a contract entered into in the ordinary course of business) entered into by any member of the group which contains any provision under which any member of the group has any obligation or entitlement which is material to the group as at the date of the registration document.</p></td></tr><tr><td><p>SECTION 21</p></td><td><p>DOCUMENTS AVAILABLE</p></td></tr><tr><td><p>Item 21.1</p></td><td><p>A statement that for the term of the registration document the following documents, where applicable, can be inspected:</p><p>(a)  the up to date memorandum and articles of association of the issuer;</p><p>(b)  all reports, letters, and other documents, valuations and statements prepared by any expert at the issuer’s request any part of which is included or referred to in the registration document.</p><p>An indication of the website on which the documents may be inspected.</p></td></tr><tr><td><div><a>(<span>1</span>)   </a><p>Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC (OJ L 182, 29.6.2013, p. 19).</p></div><div><a>(<span>2</span>)   </a><p>Regulation (EC) No 1606/2002 of the European Parliament and of the Council of 19 July 2002 on the application of international accounting standards (OJ L 243, 11.9.2002, p. 1).</p></div><div><a>(<span>3</span>)   </a><p>Directive 2014/56/EU of the European Parliament and Council of 16 April 2014 amending Directive 2006/43/EC on statutory audits of annual accounts and consolidated accounts (OJ L 158, 27.5.2014, p. 196).</p></div><div><a>(<span>4</span>)   </a><p>Regulation (EU) No 537/2014 of the European Parliament and of the Council of 16 April 2014 on specific requirements regarding statutory audit of public-interest entities and repealing Commission Decision 2005/909/EC (OJ L 158, 27.5.2014, p. 77).</p></div><div><a>(<span>5</span>)   </a><p>Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts, amending Council Directives 78/660/EEC and 83/349/EEC and repealing Council Directive 84/253/EEC (OJ L 157, 9.6.2006, p. 87).</p></div><div><a>(<span>6</span>)   </a><p>Regulation (EU) No 537/2014 of the European Parliament and of the Council of 16 April 2014 on specific requirements regarding statutory audit of public-interest entities and repealing Commission Decision 2005/909/EC (OJ L 158, 27.5.2014, p. 77).</p></div></td></tr></tbody></table>
ANNEX 2
UNIVERSAL REGISTRATION DOCUMENT
<table><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>INFORMATION TO BE DISCLOSED ABOUT THE ISSUER</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>The issuer shall disclose information in accordance with the disclosure requirements for the registration document for equity securities laid down in Annex 1.</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>When the universal registration document is approved, item 1.5 of Annex 1 shall be supplemented with a statement that the universal registration document may be used for the purposes of an offer to the public of securities or admission of securities to trading on a regulated market if completed by amendments, if applicable, and a securities note and summary approved in accordance with Regulation (EU) 2017/1129.</p><p>When the universal registration document is filed and published without prior approval, item 1.5 of Annex 1 shall be replaced with a statement that:</p><p>(a)  the universal registration document has been filed with the [name of the competent authority] as competent authority under Regulation (EU) 2017/1129 without prior approval pursuant to Article 9 of Regulation (EU) 2017/1129;</p><p>(b)  the universal registration document may be used for the purposes of an offer to the public of securities or admission of securities to trading on a regulated market if approved by the [insert name of competent authority] together with any amendments, if applicable, and a securities note and summary approved in accordance with Regulation (EU) 2017/1129.</p></td></tr></tbody></table>
ANNEX 3
REGISTRATION DOCUMENT FOR SECONDARY ISSUANCES OF EQUITY SECURITIES
<table><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>PERSONS RESPONSIBLE, THIRD PARTY INFORMATION, EXPERTS’ REPORTS AND COMPETENT AUTHORITY APPROVAL</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Identify all persons responsible for the information or any parts of it, given in the registration document with, in the latter case, an indication of such parts. In the case of natural persons, including members of the issuer’s administrative, management or supervisory bodies, indicate the name and function of the person; in the case of legal persons indicate the name and registered office.</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>A declaration by those responsible for the registration document that to the best of their knowledge, the information contained in the registration document is in accordance with the facts and that the registration document makes no omission likely to affect its import.</p><p>Where applicable, a declaration by those responsible for certain parts of the registration document that, to the best of their knowledge, the information contained in those parts of the registration document for which they are responsible is in accordance with the facts and that those parts of the registration document make no omission likely to affect their import.</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Where a statement or report attributed to a person as an expert is included in the Registration Document, provide the following details for that person:</p><p>(a)  name;</p><p>(b)  business address;</p><p>(c)  qualifications;</p><p>(d)  material interest if any in the issuer.</p><p>If the statement or report has been produced at the issuer’s request, state that such statement or report has been included in the registration document with the consent of the person who has authorised the contents of that part of the registration document for the purpose of the prospectus.</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Where information has been sourced from a third party, provide a confirmation that this information has been accurately reproduced and that as far as the issuer is aware and is able to ascertain from information published by that third party, no facts have been omitted which would render the reproduced information inaccurate or misleading. In addition, identify the source(s) of the information.</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>A statement that:</p><p>(a)  the [registration document/prospectus] has been approved by the [name of competent authority], as competent authority under Regulation (EU) 2017/1129;</p><p>(b)  the [name of competent authority] only approves this [registration document/prospectus] as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation (EU) 2017/1129;</p><p>(c)  such approval shall not be considered as an endorsement of the issuer that it the subject of this [registration document/prospectus].</p><p>(d)  that the [registration document/prospectus] has been drawn up as part of a simplified prospectus in accordance with Article 14 of Regulation (EU) 2017/1129.</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>STATUTORY AUDITORS</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>Names of the issuer’s auditors for the period covered by the historical financial information (together with their membership in a professional body).</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>RISK FACTORS</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>A description of the material risks that are specific to the issuer, in a limited number of categories, in a section headed ‘Risk Factors’.</p><p>In each category, the most material risks, in the assessment undertaken by the issuer, offeror or person asking for admission to trading on a regulated market, taking into account the negative impact on the issuer and the probability of their occurrence shall be set out first. The risks shall be corroborated by the content of the registration document.</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>INFORMATION ABOUT THE ISSUER</p></td></tr><tr><td><p>Item 4.1</p></td><td><p>The legal and commercial name of the issuer.</p></td></tr><tr><td><p>Item 4.2</p></td><td><p>The domicile and legal form of the issuer, legal entity identifier (‘LEI’), the legislation under which the issuer operates, its country of incorporation, the address, telephone number of its registered office (or principal place of business if different from its registered office) and website of the issuer, if any, with a disclaimer that the information on the website does not form part of the prospectus unless that information is incorporated by reference into the prospectus.</p></td></tr><tr><td><p>SECTION 5</p></td><td><p>BUSINESS OVERVIEW</p></td></tr><tr><td><p>Item 5.1</p></td><td><p>A brief description of:</p><p>(a)  the key principal activities of the issuer;</p><p>(b)  of any significant changes impacting the issuer’s operations and principal activities since the end of the period covered by the latest published audited financial statements, including the following:</p><p>(i)  an indication of any significant new products and services that have been introduced;</p><p>(ii)  the status of the development of new products or services to the extent that they have been publicly disclosed;</p><p>(iii)  any material changes in the issuer’s regulatory environment since the period covered by the latest published audited financial statements.</p></td></tr><tr><td><p>Item 5.2</p></td><td><p>Investments</p></td></tr><tr><td><p>Item 5.2.1</p></td><td><p>A description of the issuer’s material investments made since the date of the last published financial statements and which are in progress and/or for which firm commitments have already been made, together with the anticipated source of funds.</p></td></tr><tr><td><p>SECTION 6</p></td><td><p>TREND INFORMATION</p></td></tr><tr><td><p>Item 6.1</p></td><td><p>A description of:</p><p>(a)  the most significant recent trends in production, sales and inventory, and costs and selling prices since the end of the last financial year to the date of the registration document;</p><p>(b)  any significant change in the financial performance of the group since the end of the last financial period for which financial information has been published to the date of the registration document, or provide an appropriate negative statement;</p><p>(c)  information on any known trends, uncertainties, demands, commitments or events that are reasonably likely to have a material effect on the issuer’s prospects for at least the current financial year.</p></td></tr><tr><td><p>SECTION 7</p></td><td><p>PROFIT FORECASTS OR ESTIMATES</p></td></tr><tr><td><p>Item 7.1</p></td><td><p>Where an issuer has published a profit forecast or a profit estimate (which is still outstanding and valid), that forecast or estimate shall be included in the registration document. If a profit forecast or profit estimate has been published and is still outstanding, but no longer valid, then provide a statement to that effect and an explanation of why such forecast or estimate is no longer valid. Such an invalid forecast or estimate is not subject to the requirements in items 7.2 and 7.3.</p></td></tr><tr><td><p>Item 7.2</p></td><td><p>Where an issuer chooses to include a new profit forecast or a new profit estimate, or where the issuer includes a previously published profit forecast or a previously published profit estimate pursuant to item 7.1, the profit forecast or estimate shall be clear and unambiguous and shall contain a statement setting out the principal assumptions upon which the issuer has based its forecast, or estimate.</p><p>The forecast or estimate shall comply with the following principles:</p><p>(a)  there must be a clear distinction between assumptions about factors which the members of the administrative, management or supervisory bodies can influence and assumptions about factors which are exclusively outside the influence of the members of the administrative, management or supervisory bodies;</p><p>(b)  the assumptions must be reasonable, readily understandable by investors, specific and precise and not relate to the general accuracy of the estimates underlying the forecast;</p><p>(c)  in the case of a forecast, the assumptions shall draw the investor’s attention to those uncertain factors which could materially change the outcome of the forecast.</p></td></tr><tr><td><p>Item 7.3</p></td><td><p>The prospectus shall include a statement that the profit forecast or estimate has been compiled and prepared on a basis which is both:</p><p>(a)  comparable with the historical financial information;</p><p>(b)  consistent with the issuer’s accounting policies.</p></td></tr><tr><td><p>SECTION 8</p></td><td><p>ADMINISTRATIVE, MANAGEMENT AND SUPERVISORY BODIES AND SENIOR MANAGEMENT</p></td></tr><tr><td><p>Item 8.1</p></td><td><p>Names, business addresses and functions within the issuer of the following persons and an indication of the principal activities performed by them outside of that issuer where these are significant with respect to that issuer:</p><p>(a)  members of the administrative, management or supervisory bodies;</p><p>(b)  partners with unlimited liability, in the case of a limited partnership with a share capital;</p><p>(c)  founders, if the issuer has been established for fewer than five years;</p><p>(d)  any senior manager who is relevant to establishing that the issuer has the appropriate expertise and experience for the management of the issuer’s business.</p><p>Details of the nature of any family relationship between any of the persons referred to in points (a) to (d).</p><p>To the extent not already disclosed, and in the case of new members of the administrative, management or supervisory bodies of the issuer (since the date of the latest audited annual financial statements) and of each person referred to in points (b) and (d) of the first subparagraph the following information:</p><p>(a)  the names of all companies and partnerships where those persons have been a member of the administrative, management or supervisory bodies or partner at any time in the previous five years, indicating whether or not the individual is still a member of the administrative, management or supervisory bodies or partner. It is not necessary to list all the subsidiaries of an issuer of which the person is also a member of the administrative, management or supervisory bodies;</p><p>(b)  details of any convictions in relation to fraudulent offences for at least the previous five years;</p><p>(c)  details of any bankruptcies, receiverships, liquidations or companies put into administration in respect of those persons described in points (a) and (d) of the first subparagraph who acted in one or more of those capacities for at least the previous five years;</p><p>(d)  details of any official public incrimination and/or sanctions involving such persons by statutory or regulatory authorities (including designated professional bodies) and whether they have ever been disqualified by a court from acting as a member of the administrative, management or supervisory bodies of an issuer or from acting in the management or conduct of the affairs of any issuer for at least the previous five years.</p><p>If there is no such information required to be disclosed, a statement to that effect is to be made.</p></td></tr><tr><td><p>Item 8.2</p></td><td><p>Potential conflicts of interest between any duties carried out on behalf of the issuer by the persons referred to in item 8.1 and their private interests or other duties must be clearly stated. In the event that there are no such conflicts a statement to that effect must be made.</p><p>Any arrangement or understanding with major shareholders, customers, suppliers or others, pursuant to which any person referred to in item 8.1 was selected as a member of the administrative, management or supervisory bodies or member of senior management.</p><p>Details of any restrictions agreed by the persons referred to in item 8.1 on the disposal within a certain period of time of their holdings in the issuer’s securities.</p></td></tr><tr><td><p>SECTION 9</p></td><td><p>MAJOR SHAREHOLDERS</p></td></tr><tr><td><p>Item 9.1</p></td><td><p>In so far as is known to the issuer, the name of any person other than a member of the administrative, management or supervisory bodies who, directly or indirectly, has an interest in the issuer’s capital or voting rights which is notifiable under the issuer’s national law, together with the amount of each such person’s interest, as of the date of the registration document or, if there are no such persons, an appropriate statement to that that effect that no such person exists.</p></td></tr><tr><td><p>Item 9.2</p></td><td><p>Whether the issuer’s major shareholders have different voting rights, or an appropriate statement to the effect that no such voting rights exist.</p></td></tr><tr><td><p>Item 9.3</p></td><td><p>To the extent known to the issuer, state whether the issuer is directly or indirectly owned or controlled and by whom and describe the nature of such control and describe the measures in place to ensure that such control is not abused.</p></td></tr><tr><td><p>Item 9.4</p></td><td><p>A description of any arrangements, known to the issuer, the operation of which may at a subsequent date result in a change in control of the issuer.</p></td></tr><tr><td><p>SECTION 10</p></td><td><p>RELATED PARTY TRANSACTIONS</p></td></tr><tr><td><p>Item 10.1</p></td><td><p>Details of related party transactions (which for these purposes are those set out in the Standards adopted in accordance with Regulation (EC) No 1606/2002), that the issuer has entered into since the date of the last financial statements, must be disclosed in accordance with the respective standard adopted under Regulation (EC) No 1606/2002 if applicable.</p><p>If such standards do not apply to the issuer the following information must be disclosed:</p><p>(a)  the nature and extent of any transactions which are, as a single transaction or in their entirety, material to the issuer. Where such related party transactions are not concluded at arm’s length provide an explanation of why these transactions were not concluded at arm’s length. In the case of outstanding loans including guarantees of any kind indicate the amount outstanding;</p><p>(b)  the amount or the percentage to which related party transactions form part of the turnover of the issuer.</p></td></tr><tr><td><p>SECTION 11</p></td><td><p>FINANCIAL INFORMATION CONCERNING THE ISSUER’S ASSETS AND LIABILITIES, FINANCIAL POSITION AND PROFITS, AND LOSSES</p></td></tr><tr><td><p>Item 11.1</p></td><td><p>Financial statements</p><p>Financial statements (annual and half-yearly) are required to be published covering the period of 12 months prior to the approval of the prospectus.</p><p>Where both annual and half-yearly financial statements have been published, only the annual statements shall be required where they postdate the half-yearly financial statements.</p></td></tr><tr><td><p>Item 11.2</p></td><td><p>Auditing of annual financial information</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 11.2.1</p></td><td><p>Audit report</p><p>The annual financial statements must be independently audited. The audit report shall be prepared in accordance with Directive 2006/43/EC and Regulation (EU) No 537/2014.</p><p>Where Directive 2006/43/EC and Regulation (EU) No 537/2014 do not apply, the annual financial statements must be audited or reported on as to whether or not, for the purposes of the registration document, it gives a true and fair view in accordance with auditing standards applicable in a Member State or an equivalent standard. Otherwise, the following information must be included in the registration document:</p><p>(a)  a prominent statement disclosing which auditing standards have been applied;</p><p>(b)  an explanation of any significant departures from International Standards on Auditing.</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 11.2.1a</p></td><td><p>Where audit reports on the annual financial statements have been refused by the statutory auditors or where they contain qualifications, modifications of opinion, disclaimers or an emphasis of matter, the reason must be given, and such qualifications, modifications, disclaimers or emphasis of matter must be reproduced in full.</p></td></tr><tr><td><p><a>▼B</a></p></td></tr><tr><td><p>Item 11.2.2</p></td><td><p>Indication of other information in the registration document which has been audited by the auditors.</p></td></tr><tr><td><p>Item 11.2.3</p></td><td><p>Where financial information in the registration document is not extracted from the issuer’s audited financial statements state the source of the data and state that the data is not audited.</p></td></tr><tr><td><p>Item 11.3</p></td><td><p>Legal and arbitration proceedings</p><p>Information on any governmental, legal or arbitration proceedings (including any such proceedings which are pending or threatened of which the issuer is aware), during a period covering at least the previous 12 months which may have, or have had in the recent past significant effects on the issuer and/or group’s financial position or profitability, or provide an appropriate negative statement.</p></td></tr><tr><td><p>Item 11.4</p></td><td><p>Significant change in the issuer’s financial position</p><p>A description of any significant change in the financial position of the group which has occurred since the end of the last financial period for which either audited financial statements or interim financial information have been published, or provide an appropriate negative statement.</p></td></tr><tr><td><p>Item 11.5</p></td><td><p>Pro forma financial information</p><p>In the case of a significant gross change, a description of how the transaction may have affected the assets and liabilities and earnings of the issuer, had the transaction been undertaken at the commencement of the period being reported on or at the date reported.</p><p>This requirement will normally be satisfied by the inclusion of pro forma financial information. This pro forma financial information must be presented as set out in Annex 20 and must include the information indicated therein.</p><p>Pro forma financial information must be accompanied by a report prepared by independent accountants or auditors.</p></td></tr><tr><td><p>Item 11.6</p></td><td><p>Dividend policy</p><p>A description of the issuer’s policy on dividend distributions and any restrictions thereon.</p></td></tr><tr><td><p>Item 11.6.1</p></td><td><p>The amount of the dividend per share for the last financial year adjusted, where the number of shares in the issuer has changed, to make it comparable.</p></td></tr><tr><td><p>SECTION 12</p></td><td><p>ADDITIONAL INFORMATION</p></td></tr><tr><td><p>Item 12.1</p></td><td><p>Share capital</p><p>The information in items 12.1.1 and 12.1.2 in the annual financial statements as of the date of the most recent balance sheet.</p></td></tr><tr><td><p>Item 12.1.1</p></td><td><p>The amount of any convertible securities, exchangeable securities or securities with warrants, with an indication of the conditions governing and the procedures for conversion, exchange or subscription.</p></td></tr><tr><td><p>Item 12.1.2</p></td><td><p>Information about and terms of any acquisition rights and or obligations over authorised but unissued capital or an undertaking to increase the capital.</p></td></tr><tr><td><p>SECTION 13</p></td><td><p>REGULATORY DISCLOSURES</p></td></tr><tr><td><p>Item 13.1</p></td><td><p>A summary of the information disclosed under Regulation (EU) No 596/2014 over the last 12 months which is relevant as at the date of the prospectus. The summary shall be presented in an easily analysable, concise and comprehensible form and shall not be a replication of information already published under Regulation (EU) No 596/2014.</p><p>The summary shall be presented in a limited number of categories depending on their subject.</p></td></tr><tr><td><p>SECTION 14</p></td><td><p>MATERIAL CONTRACTS</p></td></tr><tr><td><p>Item 14.1</p></td><td><p>A brief summary of each material contract, other than contracts entered into in the ordinary course of business, to which the issuer or any member of the group is a party, for the two years immediately preceding publication of the registration document.</p><p>A brief summary of any other contract (not being a contract entered into in the ordinary course of business) entered into by any member of the group which contains any provision under which any member of the group has any obligation or entitlement which is material to the group as at the date of the registration document.</p></td></tr><tr><td><p>SECTION 15</p></td><td><p>DOCUMENTS AVAILABLE</p></td></tr><tr><td><p>Item 15.1</p></td><td><p>A statement that for the term of the registration document the following documents, where applicable, can be inspected:</p><p>(a)  the up to date memorandum and articles of association of the issuer;</p><p>(b)  all reports, letters, and other documents, valuations and statements prepared by any expert at the issuer’s request any part of which is included or referred to in the registration document.</p><p>An indication of the website on which the documents may be inspected.</p></td></tr></tbody></table>
ANNEX 4
REGISTRATION DOCUMENT FOR UNITS OF CLOSED-END COLLECTIVE INVESTMENT UNDERTAKINGS
<table><col/><col/><tbody><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p> </p><div/></td><td><p>In addition to the information required in this Annex, a collective investment undertaking must provide the information required in sections/items 1, 2, 3, 4, 6, 7.1, 7.2.1, 8.4, 9 (although the description of the regulatory environment that the issuer operates in, need only relate to the regulatory environment relevant to the issuer’s investments), 11, 12, 13, 14, 15.2, 16, 17, 18 (except for pro forma financial information), 19, 20 and 21 of Annex 1 to this Regulation, or, where the collective investment undertaking meets the requirements of Article 14(1) of Regulation (EU) 2017/1129, the information required in sections/items 1, 2, 3, 4, 7, 8, 9, 10, 11 (except for pro forma financial information), 12, 13, 14 and 15 of Annex 3 to this Regulation.</p><p>Where units are issued by a collective investment undertaking which is constituted as a common fund managed by a fund manager, the information referred to in sections/items 6, 12, 13, 14, 15.2, 16 and 20 of Annex 1 to this Regulation shall be disclosed in relation to the fund manager, while the information referred to in items 2, 4 and 18 of Annex 1 to this Regulation shall be disclosed in relation to both the fund and the fund manager.</p></td></tr><tr><td><p><a>▼B</a></p></td></tr><tr><td><p>SECTION 1</p></td><td><p>INVESTMENT OBJECTIVE AND POLICY</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>(a)  description of the investment policy, strategy and objectives of the collective investment undertaking;</p><p>(b)  information on where the underlying collective investment undertaking(s) is/are established if the collective investment undertaking is a fund comprising of funds;</p><p>(c)  a description of the types of assets in which the collective investment undertaking may invest;</p><p>(d)  the techniques it may employ and all associated risks together with the circumstances in which the collective investment undertaking may use leverage;</p><p>(e)  the types and sources of leverage permitted and the associated risks;</p><p>(f)  any restrictions on the use of leverage and any collateral and asset reuse arrangements;</p><p>(g)  the maximum level of leverage which may be employed on behalf of the collective investment undertaking.</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>A description of the procedures by which the collective investment undertaking may change its investment strategy or investment policy, or both.</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>The leverage limits of the collective investment undertaking. If there are no such limits, include a statement to that effect.</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>The regulatory status of the collective investment undertaking together with the name of any regulator in its country of incorporation.</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>The profile of a typical investor for whom the collective investment undertaking is designed.</p></td></tr><tr><td><p>Item 1.6</p></td><td><p>A statement confirming the following:</p><p>(a)  the [registration document/prospectus] has been approved by the [name of competent authority], as competent authority under Regulation (EU) 2017/1129;</p><p>(b)  the [name of competent authority] only approves this [registration document/prospectus] as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation (EU) 2017/1129;</p><p>(c)  such approval should not be considered as an endorsement of the issuer that is the subject of this [registration document/prospectus].</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>INVESTMENT RESTRICTIONS</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>A statement of the investment restrictions which apply to the collective investment undertaking, if any, and an indication of how the holders of securities will be informed of the actions that the investment manager will take in the event of a breach.</p></td></tr><tr><td><p>Item 2.2</p></td><td><p>Certain information is required to be disclosed, where more than 20 % of the gross assets of any collective investment undertaking (except where the registration document is being prepared for an entity as a result of the application of item 2.3 or 2.5) may be either:</p><p>(a)  invested in, either directly or indirectly, or loaned to any single underlying issuer (including the underlying issuer’s subsidiaries or affiliates);</p><p>(b)  invested in one or more collective investment undertakings which may invest in excess of 20 % of its gross assets in other collective investment undertakings (open-end and/or closed-end type);</p><p>(c)  exposed to the creditworthiness or solvency of any one counterparty (including its subsidiaries or affiliates);</p><p>The information, referred to in the introductory sentence, shall comprise the following in either of the following circumstances:</p><p>(i)  where the underlying securities are not admitted to trading on a regulated or equivalent third country market or an SME Growth Market, information relating to each underlying issuer/collective investment undertaking/counterparty as if it were an issuer for the purposes of the minimum disclosure requirements for the registration document for equity securities (in the case of point (a)) or minimum disclosure requirements for the registration document for units issued by closed-end collective investment undertakings (in the case of point (b)) or the minimum disclosure requirements for the registration document for wholesale non-equity securities (in the case of point (c));</p><p>(ii)  if the securities issued by the underlying issuer/collective investment undertaking/counterparty have already been admitted to trading on a regulated or equivalent third country market or an SME Growth Market, or the obligations are guaranteed by an entity admitted to trading on a regulated or equivalent market or an SME Growth Market, the name, address, country of incorporation, nature of business and name of the market in which its securities are admitted.</p><p>The disclosure requirement referred to in points (i) and (ii) shall not apply where the 20 % threshold is exceeded due to appreciations or depreciations, changes in exchange rates, or by reason of the receipt of rights, bonuses, benefits in the nature of capital or by reason of any other action affecting every holder of that investment, provided the investment manager has regard to the threshold when considering changes in the investment portfolio.</p><p>Where the collective investment undertaking can reasonably demonstrate to the competent authority that it is unable to access some or all of the information required under point (i), the collective investment undertaking must disclose all of the information that it is able to access, that it is aware of, and/or that it is able to ascertain from information published by the underlying issuer/collective investment undertaking/counterparty in order to satisfy as far as is practicable the requirements laid down in point (i). In this case, the prospectus must include a prominent warning that the collective investment undertaking has been unable to access specified items of information that would otherwise be required to be included in the prospectus and therefore a reduced level of disclosure has been provided in relation to a specified underlying issuer, collective investment undertaking or counterparty.</p></td></tr><tr><td><p>Item 2.3</p></td><td><p>Where a collective investment undertaking invests in investments in excess of 20 % of its gross assets in other collective investment undertakings (open ended and/or closed ended), a description of the investment and how the risk is spread in relation to those investments shall be disclosed. In addition, item 2.2 shall apply, in addition to all underlying investments of the collective investment undertaking as if those investments had been made directly.</p></td></tr><tr><td><p>Item 2.4</p></td><td><p>With reference to point (c) of item 2.2, if collateral is advanced to cover that portion of the exposure to any one counterparty in excess of 20 % of the gross assets of the collective investment undertaking, set out the details of such collateral arrangements.</p></td></tr><tr><td><p>Item 2.5</p></td><td><p>Where a collective investment undertaking invests in investments in excess of 40 % of its gross assets in another collective investment undertaking, then one of the following must be disclosed:</p><p>(a)  information relating to each underlying collective investment undertaking as if it were an issuer under minimum disclosure requirements as set out in this Annex;</p><p>(b)  if securities issued by an underlying collective investment undertaking have already been admitted to trading on a regulated or equivalent third country market or an SME Growth Market, or the obligations are guaranteed by an entity admitted to trading on a regulated or equivalent market or an SME Growth Market, then the name, address, country of incorporation, nature of business and name of the market in which its securities are admitted.</p><p>Where the collective investment undertaking can reasonably demonstrate to the competent authority that it is unable to access some or all of the information required under point (i), the collective investment undertaking must disclose all of the information that it is able to access, that it is aware of, and/or that it is able to ascertain from information published by the underlying issuer/collective investment undertaking/counterparty in order to satisfy as far as is practicable the requirements laid down in point (a). In this case, the prospectus must include a prominent warning that the collective investment undertaking has been unable to access specified items of information that would otherwise be required to be included in the prospectus and therefore a reduced level of disclosure has been provided in relation to a specified underlying issuer, collective investment undertaking or counterparty.</p></td></tr><tr><td><p>Item 2.6</p></td><td><p>Physical commodities</p><p>Where a collective investment undertaking invests directly in physical commodities a disclosure of that fact and the percentage of the gross assets that will be so invested.</p></td></tr><tr><td><p>Item 2.7</p></td><td><p>Property collective investment undertakings</p><p>Where a collective investment undertaking holds property as part of its investment objective, the percentage of the portfolio that is to be invested in property, the description of the property and any material costs relating to the acquisition and holding of such property shall be disclosed. In addition, a valuation report relating to the properties must be included.</p><p>The disclosure requirements set out in item 4.1 shall apply to:</p><p>(a)  the entity producing the valuation report;</p><p>(b)  any other entity responsible for the administration of the property.</p></td></tr><tr><td><p>Item 2.8</p></td><td><p>Derivatives financial instruments/money market instruments/currencies</p><p>Where a collective investment undertaking invests in derivatives, financial instruments, money market instruments or currencies other than for the purposes of efficient portfolio management namely solely for the purpose of reducing, transferring or eliminating investment risk in the underlying investments of a collective investment undertaking, including any technique or instrument used to provide protection against exchange and credit risks, a statement of whether those investments are used for hedging or for investment purposes, and a description of where and how risk is spread in relation to those investments.</p></td></tr><tr><td><p>Item 2.9</p></td><td><p>Item 2.2 does not apply to investment in securities issued or guaranteed by a government, government agency or instrumentality of any Member State, its regional or local authorities, or of any OECD Member State.</p></td></tr><tr><td><p>Item 2.10</p></td><td><p>Point (a) of item 2.2 does not apply to a collective investment undertaking whose investment objective is to track, without material modification, a broadly based and recognised published index. A statement setting out details of where information about the index can be obtained shall be included.</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>THE APPLICANT’S SERVICE PROVIDERS</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>The actual or estimated maximum amount of all material fees payable directly or indirectly by the collective investment undertaking for any services provided under arrangements entered into on or prior to the date of the registration document and a description of how these fees are calculated.</p></td></tr><tr><td><p>Item 3.2</p></td><td><p>A description of any fee payable directly or indirectly by the collective investment undertaking which cannot be quantified under item 3.1 and which is or which may be material.</p></td></tr><tr><td><p>Item 3.3</p></td><td><p>If any service provider to the collective investment undertaking is in receipt of any benefits from third parties (other than the collective investment undertaking) by virtue of providing any services to the collective investment undertaking, and those benefits may not accrue to the collective investment undertaking, a statement of that fact, the name of that third party, if available, and a description of the nature of the benefits shall be disclosed.</p></td></tr><tr><td><p>Item 3.4</p></td><td><p>The identity of the service providers and a description of their duties and the investor’s rights.</p></td></tr><tr><td><p>Item 3.5</p></td><td><p>A description of any material potential conflicts of interest which any of the service providers to the collective investment undertaking may have as between their duty to the collective investment undertaking and duties owed by them to third parties and their other interests. A description of any arrangements which are in place to address such potential conflicts.</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>INVESTMENT MANAGER/ADVISERS</p></td></tr><tr><td><p>Item 4.1</p></td><td><p>In respect of any Investment Manager the information required to be disclosed under items 4.1 to 4.4 and, if material, under item 5.3 of Annex 1 together with a description of its regulatory status and experience.</p></td></tr><tr><td><p>Item 4.2</p></td><td><p>In respect of any entity providing investment advice in relation to the assets of the collective investment undertaking, the name and a brief description of the entity.</p></td></tr><tr><td><p>SECTION 5</p></td><td><p>CUSTODY</p></td></tr><tr><td><p>Item 5.1</p></td><td><p>A full description of how the assets of the collective investment undertaking will be held and by whom and any fiduciary or similar relationship between the collective investment undertaking and any third party in relation to custody:</p><p>Where a depositary, trustee, or other fiduciary is appointed, the following shall be provided:</p><p>(a)  such information as is required to be disclosed under items 4.1 to 4.4 and, if material, under item 5.3 of Annex 1;</p><p>(b)  a description of the obligations of each party under the custody or similar agreement;</p><p>(c)  any delegated custody arrangements;</p><p>(d)  the regulatory status of each party and their delegates.</p></td></tr><tr><td><p>Item 5.2</p></td><td><p>Where any entity other than those entities referred to in item 5.1, holds any assets of the collective investment undertaking, a description of how these assets are held together with a description of any additional risks.</p></td></tr><tr><td><p>SECTION 6</p></td><td><p>VALUATION</p></td></tr><tr><td><p>Item 6.1</p></td><td><p>A description of the valuation procedure and of the pricing methodology for valuing assets.</p></td></tr><tr><td><p>Item 6.2</p></td><td><p>Details of all circumstances in which valuations may be suspended and a statement of how such suspension will be communicated or made available to investors.</p></td></tr><tr><td><p>SECTION 7</p></td><td><p>CROSS LIABILITIES</p></td></tr><tr><td><p>Item 7.1</p></td><td><p>In the case of an umbrella collective investment undertaking, a statement of any cross liability that may occur between classes of investments in other collective investment undertakings and any action taken to limit such liability.</p></td></tr><tr><td><p>SECTION 8</p></td><td><p>FINANCIAL INFORMATION</p></td></tr><tr><td><p>Item 8.1</p></td><td><p>Where a collective investment undertaking has not commenced operations and no financial statements have been made up as at the date of the registration document, since the date of incorporation or establishment, a statement to that effect.</p><p>Where a collective investment undertaking has commenced operations, the provisions of section 18 of Annex 1 or section 11 of Annex 3 shall apply as appropriate.</p></td></tr><tr><td><p>Item 8.2</p></td><td><p>A comprehensive and meaningful analysis of the collective investment undertaking’s portfolio. Where the portfolio is not audited, this must be clearly marked as such.</p></td></tr><tr><td><p>Item 8.3</p></td><td><p>An indication of the latest net asset value of the collective investment undertaking or the latest market price of the unit or share of the collective investment undertaking. Where the net asset value or the latest market price of the unit or share is not audited, this must be clearly marked as such.</p></td></tr></tbody></table>
ANNEX 5
REGISTRATION DOCUMENT FOR DEPOSITORY RECEIPTS ISSUED OVER SHARES
<table><col/><col/><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>INFORMATION ABOUT THE ISSUER OF THE UNDERLYING SHARES</p></td></tr><tr><td><p> </p><div/></td><td><p>For depository receipts issued over shares, the information about the issuer of the underlying share shall be provided in accordance with Annex 1 to this Regulation.</p><p>For depository receipts issued over shares that meet the requirements of Article 14(1) of Regulation (EU) 2017/1129, the information about the issuer of the underlying share shall be provided in accordance with Annex 3 to this Regulation.</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>INFORMATION ABOUT THE ISSUER OF THE DEPOSITORY RECEIPTS</p></td><td><p>Primary Issuance</p></td><td><p>Secondary Issuances</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>Name, registered office, legal entity identifier (‘LEI’) and principal administrative establishment if different from the registered office.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 2.2</p></td><td><p>Date of incorporation and length of life of the issuer, except where the period is indefinite.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 2.3</p></td><td><p>Legislation under which the issuer operates and legal form which it has adopted under that legislation.</p></td><td><p>√</p></td><td><p>√</p></td></tr></tbody></table>
ANNEX 6
REGISTRATION DOCUMENT FOR RETAIL NON-EQUITY SECURITIES
<table><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>PERSONS RESPONSIBLE, THIRD PARTY INFORMATION, EXPERTS’ REPORTS AND COMPETENT AUTHORITY APPROVAL</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Identify all persons responsible for the information or any parts of it, given in the registration document with, in the latter case, an indication of such parts. In the case of natural persons, including members of the issuer’s administrative, management or supervisory bodies, indicate the name and function of the person; in the case of legal persons indicate the name and registered office.</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>A declaration by those responsible for the registration document that to the best of their knowledge, the information contained in the registration document is in accordance with the facts and that the registration document makes no omission likely to affect its import.</p><p>Where applicable, a declaration by those responsible for certain parts of the registration document that, to the best of their knowledge, the information contained in those parts of the registration document for which they are responsible is in accordance with the facts and that those parts of the registration document make no omission likely to affect their import.</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Where a statement or report attributed to a person as an expert is included in the registration document, provide the following in relation to that person:</p><p>(a)  name;</p><p>(b)  business address;</p><p>(c)  qualifications;</p><p>(d)  material interest if any in the issuer.</p><p>If the statement or report has been produced at the issuer’s request, state that such statement or report has been included in the registration document with the consent of the person who has authorised the contents of that part of the registration document for the purpose of the prospectus.</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Where information has been sourced from a third party, provide a confirmation that this information has been accurately reproduced and that as far as the issuer is aware and is able to ascertain from information published by that third party, no facts have been omitted which would render the reproduced information inaccurate or misleading. In addition, identify the source(s) of the information.</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>A statement that:</p><p>(a)  the [registration document/prospectus] has been approved by the [name of competent authority], as competent authority under Regulation (EU) 2017/1129;</p><p>(b)  the [name of competent authority] only approves this [registration document/prospectus] as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation (EU) 2017/1129;</p><p>(c)  such approval should not be considered as an endorsement of the issuer that is the subject of this [registration document/prospectus].</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>STATUTORY AUDITORS</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>Names and addresses of the issuer’s auditors for the period covered by the historical financial information (together with their membership in a professional body).</p></td></tr><tr><td><p>Item 2.2</p></td><td><p>If auditors have resigned, been removed or have not been re-appointed during the period covered by the historical financial information, indicate details if material.</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>RISK FACTORS</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>A description of the material risks that are specific to the issuer and that may affect the issuer’s ability to fulfil its obligations under the securities, in a limited number of categories, in a section headed ‘Risk Factors’.</p><p>In each category the most material risks, in the assessment of the issuer, offeror or person asking for admission to trading on a regulated market, taking into account the negative impact on the issuer and the probability of their occurrence, shall be set out first. The risk factors shall be corroborated by the content of the registration document.</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>INFORMATION ABOUT THE ISSUER</p></td></tr><tr><td><p>Item 4.1</p></td><td><p>History and development of the issuer</p></td></tr><tr><td><p>Item 4.1.1</p></td><td><p>The legal and commercial name of the issuer</p></td></tr><tr><td><p>Item 4.1.2</p></td><td><p>The place of registration of the issuer, its registration number and legal entity identifier (‘LEI’).</p></td></tr><tr><td><p>Item 4.1.3</p></td><td><p>The date of incorporation and the length of life of the issuer, except where the period is indefinite.</p></td></tr><tr><td><p>Item 4.1.4</p></td><td><p>The domicile and legal form of the issuer, the legislation under which the issuer operates, its country of incorporation, the address, telephone number of its registered office (or principal place of business if different from its registered office) and website of the issuer, if any, with a disclaimer that the information on the website does not form part of the prospectus unless that information is incorporated by reference into the prospectus.</p></td></tr><tr><td><p>Item 4.1.5</p></td><td><p>Details of any recent events particular to the issuer and which are to a material extent relevant to an evaluation of the issuer’s solvency.</p></td></tr><tr><td><p>Item 4.1.6</p></td><td><p>Credit ratings assigned to an issuer at the request or with the cooperation of the issuer in the rating process. A brief explanation of the meaning of the ratings if this has previously been published by the rating provider.</p></td></tr><tr><td><p>Item 4.1.7</p></td><td><p>Information on the material changes in the issuer’s borrowing and funding structure since the last financial year;</p></td></tr><tr><td><p>Item 4.1.8</p></td><td><p>Description of the expected financing of the issuer’s activities</p></td></tr><tr><td><p>SECTION 5</p></td><td><p>BUSINESS OVERVIEW</p></td></tr><tr><td><p>Item 5.1</p></td><td><p>Principal activities</p></td></tr><tr><td><p>Item 5.1.1</p></td><td><p>A description of the issuer’s principal activities, including:</p><p>(a)  the main categories of products sold and/or services performed;</p><p>(b)  an indication of any significant new products or activities;</p><p>(c)  the principal markets in which the issuer competes.</p></td></tr><tr><td><p>Item 5.2</p></td><td><p>The basis for any statements made by the issuer regarding its competitive position.</p></td></tr><tr><td><p>SECTION 6</p></td><td><p>ORGANISATIONAL STRUCTURE</p></td></tr><tr><td><p>Item 6.1</p></td><td><p>If the issuer is part of a group, a brief description of the group and the issuer’s position within the group. This may be in the form of, or accompanied by, a diagram of the organisational structure if this helps to clarify the structure.</p></td></tr><tr><td><p>Item 6.2</p></td><td><p>If the issuer is dependent upon other entities within the group, this must be clearly stated together with an explanation of this dependence.</p></td></tr><tr><td><p>SECTION 7</p></td><td><p>TREND INFORMATION</p></td></tr><tr><td><p>Item 7.1</p></td><td><p>A description of:</p><p>(a)  any material adverse change in the prospects of the issuer since the date of its last published audited financial statements;</p><p>(b)  any significant change in the financial performance of the group since the end of the last financial period for which financial information has been published to the date of the registration document.</p><p>If neither of the above are applicable then the issuer shall include an appropriate statement to the effect that no such changes exist.</p></td></tr><tr><td><p>Item 7.2</p></td><td><p>Information on any known trends, uncertainties, demands, commitments or events that are reasonably likely to have a material effect on the issuer’s prospects for at least the current financial year.</p></td></tr><tr><td><p>SECTION 8</p></td><td><p>PROFIT FORECASTS OR ESTIMATES</p></td></tr><tr><td><p>Item 8.1</p></td><td><p>Where an issuer includes on a voluntary basis a profit forecast or a profit estimate (which is still outstanding and valid), that forecast or estimate included in the registration document must contain the information set out in items 8.2 and 8.3. If a profit forecast or profit estimate has been published and is still outstanding, but no longer valid, then provide a statement to that effect and an explanation of why such profit forecast or estimate is no longer valid. Such an invalid forecast or estimate is not subject to the requirements in items 8.2 and 8.3.</p></td></tr><tr><td><p>Item 8.2</p></td><td><p>Where an issuer chooses to include a new profit forecast or a new profit estimate, or where the issuer includes a previously published profit forecast or a previously published profit estimate pursuant to item 8.1, the profit forecast or estimate shall be clear and unambiguous and contain a statement setting out the principal assumptions upon which the issuer has based its forecast, or estimate.</p><p>The forecast or estimate shall comply with the following principles:</p><p>(a)  there must be a clear distinction between assumptions about factors which the members of the administrative, management or supervisory bodies can influence and assumptions about factors which are exclusively outside the influence of the members of the administrative, management or supervisory bodies;</p><p>(b)  the assumptions must be reasonable, readily understandable by investors, specific and precise and not relate to the general accuracy of the estimates underlying the forecast; and</p><p>(c)  In the case of a forecast, the assumptions shall draw the investor’s attention to those uncertain factors which could materially change the outcome of the forecast.</p></td></tr><tr><td><p>Item 8.3</p></td><td><p>The prospectus shall include a statement that the profit forecast or estimate has been compiled and prepared on a basis which is both:</p><p>(a)  comparable with the historical financial information;</p><p>(b)  consistent with the issuer’s accounting policies.</p></td></tr><tr><td><p>SECTION 9</p></td><td><p>ADMINISTRATIVE, MANAGEMENT, AND SUPERVISORY BODIES</p></td></tr><tr><td><p>Item 9.1</p></td><td><p>Names, business addresses and functions within the issuer of the following persons and an indication of the principal activities performed by them outside of that issuer where these are significant with respect to that issuer:</p><p>(a)  members of the administrative, management or supervisory bodies;</p><p>(b)  partners with unlimited liability, in the case of a limited partnership with a share capital.</p></td></tr><tr><td><p>Item 9.2</p></td><td><p>Administrative, management, and supervisory bodies’ conflicts of interests</p><p>Potential conflicts of interests between any duties to the issuer, of the persons referred to in item 9.1, and their private interests and or other duties must be clearly stated. In the event that there are no such conflicts, a statement to that effect must be made.</p></td></tr><tr><td><p>SECTION 10</p></td><td><p>MAJOR SHAREHOLDERS</p></td></tr><tr><td><p>Item 10.1</p></td><td><p>To the extent known to the issuer, state whether the issuer is directly or indirectly owned or controlled and by whom and describe the nature of such control and describe the measures in place to ensure that such control is not abused.</p></td></tr><tr><td><p>Item 10.2</p></td><td><p>A description of any arrangements, known to the issuer, the operation of which may at a subsequent date result in a change in control of the issuer.</p></td></tr><tr><td><p>SECTION 11</p></td><td><p>FINANCIAL INFORMATION CONCERNING THE ISSUER’S ASSETS AND LIABILITIES, FINANCIAL POSITION AND PROFITS AND LOSSES</p></td></tr><tr><td><p>Item 11.1</p></td><td><p>Historical financial information</p></td></tr><tr><td><p>Item 11.1.1</p></td><td><p>Audited historical financial information covering the latest two financial years (or such shorter period as the issuer has been in operation) and the audit report in respect of each year.</p></td></tr><tr><td><p>Item 11.1.2</p></td><td><p>Change of accounting reference date</p><p>If the issuer has changed its accounting reference date during the period for which historical financial information is required, the audited historical financial information shall cover at least 24 months, or the entire period for which the issuer has been in operation, whichever is shorter.</p></td></tr><tr><td><p>Item 11.1.3</p></td><td><p>Accounting Standards</p><p>The financial information must be prepared according to International Financial Reporting Standards as endorsed in the Union based on Regulation (EC) No 1606/2002.</p><p>If Regulation (EC) No 1606/2002 is not applicable, the financial information must be prepared in accordance with either:</p><p>(a)  a Member State’s national accounting standards for issuers from the EEA, as required by the Directive 2013/34/EU;</p><p>(b)  a third country’s national accounting standards equivalent to Regulation (EC) No 1606/2002 for third country issuers. If such third country’s national accounting standards are not equivalent to Regulation (EC) No 1606/2002, the financial statements shall be restated in compliance with that Regulation.</p></td></tr><tr><td><p>Item 11.1.4</p></td><td><p>Change of accounting framework</p><p>The last audited historical financial information, containing comparative information for the previous year, must be presented and prepared in a form consistent with the accounting standards framework that will be adopted in the issuer’s next published annual financial statements.</p><p>Changes within the issuer’s existing accounting framework do not require the audited financial statements to be restated. However, if the issuer intends to adopt a new accounting standards framework in its next published financial statements, the latest year of financial statements must be prepared and audited in line with the new framework.</p></td></tr><tr><td><p>Item 11.1.5</p></td><td><p>Where the audited financial information is prepared according to national accounting standards, the financial information required under this heading must include at least the following:</p><p>(a)  the balance sheet;</p><p>(b)  the income statement;</p><p>(c)  the cash flow statement;</p><p>(d)  the accounting policies and explanatory notes.</p></td></tr><tr><td><p>Item 11.1.6</p></td><td><p>Consolidated financial statements</p><p>If the issuer prepares both stand-alone and consolidated financial statements, include at least the consolidated financial statements in the registration document.</p></td></tr><tr><td><p>Item 11.1.7</p></td><td><p>Age of financial information</p><p>The balance sheet date of the last year of audited financial information statements may not be older than 18 months from the date of the registration document.</p></td></tr><tr><td><p>Item 11.2</p></td><td><p>Interim and other financial information</p></td></tr><tr><td><p>Item 11.2.1</p></td><td><p>If the issuer has published quarterly or half yearly financial information since the date of its last audited financial statements, these must be included in the registration document. If the quarterly or half yearly financial information has been reviewed or audited, the audit or review report must also be included. If the quarterly or half yearly financial information is not audited or has not been reviewed state that fact.</p><p>If the registration document is dated more than nine months after the date of the last audited financial statements, it must contain interim financial information, which may be unaudited (in which case that fact must be stated) covering at least the first six months of the financial year.</p><p>Interim financial information prepared in accordance with either the requirements of the Directive 2013/34/EU or Regulation (EC) No 1606/2002 as the case may be.</p><p>For issuers not subject to either Directive 2013/34/EU or Regulation (EC) No 1606/2002, the interim financial information must include comparative statements for the same period in the prior financial year, except that the requirement for comparative balance sheet information may be satisfied by presenting the year’s end balance sheet.</p></td></tr><tr><td><p>Item 11.3</p></td><td><p>Auditing of historical annual financial information</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 11.3.1</p></td><td><p>The historical annual financial information must be independently audited. The audit report shall be prepared in accordance with Directive 2006/43/EC and Regulation (EU) No 537/2014.</p><p>Where Directive 2006/43/EC and Regulation (EU) No 537/2014 do not apply, the historical financial information must be audited or reported on as to whether or not, for the purposes of the registration document, it gives a true and fair view in accordance with auditing standards applicable in a Member State or an equivalent standard.</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 11.3.1 a</p></td><td><p>Where audit reports on the historical financial information have been refused by the statutory auditors or where they contain qualifications, modifications of opinion, disclaimers or an emphasis of matter, the reason must be given, and such qualifications, modifications, disclaimers or emphasis of matter must be reproduced in full.</p></td></tr><tr><td><p><a>▼B</a></p></td></tr><tr><td><p>Item 11.3.2</p></td><td><p>Indication of other information in the registration document which has been audited by the auditors.</p></td></tr><tr><td><p>Item 11.3.3</p></td><td><p>Where financial information in the registration document is not extracted from the issuer’s audited financial statements state the source of the data and state that the data is not audited.</p></td></tr><tr><td><p>Item 11.4</p></td><td><p>Legal and arbitration proceedings</p></td></tr><tr><td><p>Item 11.4.1</p></td><td><p>Information on any governmental, legal or arbitration proceedings (including any such proceedings which are pending or threatened of which the issuer is aware), during a period covering at least the previous 12 months which may have, or have had in the recent past significant effects on the issuer and/or group’s financial position or profitability, or provide an appropriate negative statement.</p></td></tr><tr><td><p>Item 11.5</p></td><td><p>Significant change in the issuer’s financial position</p></td></tr><tr><td><p>Item 11.5.1</p></td><td><p>A description of any significant change in the financial position of the group which has occurred since the end of the last financial period for which either audited financial information or interim financial information have been published, or provide an appropriate negative statement.</p></td></tr><tr><td><p>SECTION 12</p></td><td><p>ADDITIONAL INFORMATION</p></td></tr><tr><td><p>Item 12.1</p></td><td><p>Share capital</p><p>The amount of the issued capital, the number and classes of the shares of which it is composed with details of their principal characteristics, the part of the issued capital still to be paid up with an indication of the number, or total nominal value and the type of the shares not yet fully paid up, broken down where applicable according to the extent to which they have been paid up.</p></td></tr><tr><td><p>Item 12.2</p></td><td><p>Memorandum and Articles of Association</p><p>The register and the entry number therein, if applicable, and a description of the issuer’s objects and purposes and where they can be found in the memorandum and articles of association.</p></td></tr><tr><td><p>SECTION 13</p></td><td><p>MATERIAL CONTRACTS</p></td></tr><tr><td><p>Item 13.1</p></td><td><p>A brief summary of all material contracts that are not entered into in the ordinary course of the issuer’s business, which could result in any group member being under an obligation or an entitlement that is material to the issuer’s ability to meet its obligations to security holders in respect of the securities being issued.</p></td></tr><tr><td><p>SECTION 14</p></td><td><p>DOCUMENTS AVAILABLE</p></td></tr><tr><td><p>Item 14.1</p></td><td><p>A statement that for the term of the registration document the following documents, where applicable, can be inspected:</p><p>(a)  the up to date memorandum and articles of association of the issuer;</p><p>(b)  all reports, letters, and other documents, valuations and statements prepared by any expert at the issuer’s request any part of which is included or referred to in the registration document.</p><p>An indication of the website on which the documents may be inspected.</p></td></tr></tbody></table>
ANNEX 7
REGISTRATION DOCUMENT FOR WHOLESALE NON-EQUITY SECURITIES
<table><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>PERSONS RESPONSIBLE, THIRD PARTY INFORMATION, EXPERTS’ REPORTS AND COMPETENT AUTHORITY APPROVAL</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Identify all persons responsible for the information or any parts of it, given in the registration document with, in the latter case, an indication of such parts. In the case of natural persons, including members of the issuer’s administrative, management or supervisory bodies, indicate the name and function of the person; in the case of legal persons indicate the name and registered office.</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>A declaration by those responsible for the registration document that to the best of their knowledge, the information contained in the registration document is in accordance with the facts and that the registration document makes no omission likely to affect its import.</p><p>Where applicable, a declaration by those responsible for certain parts of the registration document that, to the best of their knowledge, the information contained in those parts of the registration document for which they are responsible is in accordance with the facts and that those parts of the registration document make no omission likely to affect their import.</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Where a statement or report attributed to a person as an expert is included in the registration document, provide the following information in relation to that person:</p><p>(a)  name;</p><p>(b)  business address;</p><p>(c)  qualifications;</p><p>(d)  material interest if any in the issuer.</p><p>If the statement or report has been produced at the issuer’s request, state that such statement or report has been included in the registration document with the consent of the person who has authorised the contents of that part of the registration document for the purpose of the prospectus.</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Where information has been sourced from a third party, provide a confirmation that this information has been accurately reproduced and that as far as the issuer is aware and is able to ascertain from information published by that third party, no facts have been omitted which would render the reproduced information inaccurate or misleading. In addition, identify the source(s) of the information.</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>A statement that:</p><p>(a)  the [registration document/prospectus] has been approved by the [name of competent authority], as competent authority under Regulation (EU) 2017/1129;</p><p>(b)  the [name of competent authority] only approves this [registration document/prospectus] as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation (EU) 2017/1129;</p><p>(c)  such approval should not be considered as an endorsement of the issuer that is the subject of this [registration document/prospectus].</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>STATUTORY AUDITORS</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>Names and addresses of the issuer’s auditors for the period covered by the historical financial information (together with their membership in a professional body).</p></td></tr><tr><td><p>Item 2.2</p></td><td><p>If auditors have resigned, been removed or have not been re-appointed during the period covered by the historical financial information, indicate details if material.</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>RISK FACTORS</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>A description of the material risks that are specific to the issuer and that may affect the issuer’s ability to fulfil its obligations under the securities, in a limited number of categories, in a section headed ‘Risk Factors’.</p><p>In each category the most material risks, in the assessment of the issuer, offeror or person asking for admission to trading on a regulated market, taking into account the negative impact on the issuer and the probability of their occurrence, shall be set out first. The risk factors shall be corroborated by the content of the registration document.</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>INFORMATION ABOUT THE ISSUER</p></td></tr><tr><td><p>Item 4.1</p></td><td><p>History and development of the Issuer</p></td></tr><tr><td><p>Item 4.1.1</p></td><td><p>The legal and commercial name of the issuer</p></td></tr><tr><td><p>Item 4.1.2</p></td><td><p>The place of registration of the issuer, its registration number and legal entity identifier (‘LEI’).</p></td></tr><tr><td><p>Item 4.1.3</p></td><td><p>The date of incorporation and the length of life of the issuer, except where the period is indefinite.</p></td></tr><tr><td><p>Item 4.1.4</p></td><td><p>The domicile and legal form of the issuer, the legislation under which the issuer operates, its country of incorporation, the address, telephone number of its registered office (or principal place of business if different from its registered office) and website of the issuer, if any, with a disclaimer that the information on the website does not form part of the prospectus unless that information is incorporated by reference into the prospectus.</p></td></tr><tr><td><p>Item 4.1.5</p></td><td><p>Any recent events particular to the issuer and which are to a material extent relevant to an evaluation of the issuer’s solvency.</p></td></tr><tr><td><p>Item 4.1.6</p></td><td><p>Credit ratings assigned to the issuer at the request or with the cooperation of the issuer in the rating process.</p></td></tr><tr><td><p>SECTION 5</p></td><td><p>BUSINESS OVERVIEW</p></td></tr><tr><td><p>Item 5.1</p></td><td><p>Principal activities</p></td></tr><tr><td><p>Item 5.1.1</p></td><td><p>A brief description of the issuer’s principal activities stating the main categories of products sold and/or services performed.</p></td></tr><tr><td><p>Item 5.1.2</p></td><td><p>The basis for any statements made by the issuer regarding its competitive position.</p></td></tr><tr><td><p>SECTION 6</p></td><td><p>ORGANISATIONAL STRUCTURE</p></td></tr><tr><td><p>Item 6.1</p></td><td><p>If the issuer is part of a group, a brief description of the group and the issuer’s position within the group. This may be in the form of, or accompanied by, a diagram of the organisational structure if this helps to clarify the structure.</p></td></tr><tr><td><p>Item 6.2</p></td><td><p>If the issuer is dependent upon other entities within the group, this must be clearly stated together with an explanation of this dependence.</p></td></tr><tr><td><p>SECTION 7</p></td><td><p>TREND INFORMATION</p></td></tr><tr><td><p>Item 7.1</p></td><td><p>A description of:</p><p>(a)  any material adverse change in the prospects of the issuer since the date of its last published audited financial statements; and</p><p>(b)  any significant change in the financial performance of the group since the end of the last financial period for which financial information has been published to the date of the registration document.</p><p>If neither of the above are applicable then the issuer should include (an) appropriate negative statement(s).</p></td></tr><tr><td><p>SECTION 8</p></td><td><p>PROFIT FORECASTS OR ESTIMATES</p></td></tr><tr><td><p>Item 8.1</p></td><td><p>Where an issuer includes on a voluntary basis a profit forecast or a profit estimate, that profit forecast or estimate shall be clear and unambiguous and contain a statement setting out the principal assumptions upon which the issuer has based its forecast or estimate.</p><p>The forecast or estimate shall comply with the following principles:</p><p>(a)  there must be a clear distinction between assumptions about factors which the members of the administrative, management or supervisory bodies can influence and assumptions about factors which are exclusively outside the influence of the members of the administrative, management or supervisory bodies;</p><p>(b)  the assumptions must be reasonable, readily understandable by investors, specific and precise and not relate to the general accuracy of the estimates underlying the forecast.</p><p>(c)  in the case of a forecast, the assumptions shall draw the investor’s attention to those uncertain factors which could materially change the outcome of the forecast.</p></td></tr><tr><td><p>Item 8.2</p></td><td><p>The prospectus shall include a statement that the profit forecast or estimate has been compiled and prepared on a basis which is both:</p><p>(a)  comparable with the historical financial information;</p><p>(b)  consistent with the issuer’s accounting policies.</p></td></tr><tr><td><p>SECTION 9</p></td><td><p>ADMINISTRATIVE, MANAGEMENT, AND SUPERVISORY BODIES</p></td></tr><tr><td><p>Item 9.1</p></td><td><p>Names, business addresses and functions within the issuer of the following persons and an indication of the principal activities performed by them outside of that issuer where these are significant with respect to that issuer:</p><p>(a)  members of the administrative, management or supervisory bodies;</p><p>(b)  partners with unlimited liability, in the case of a limited partnership with a share capital.</p></td></tr><tr><td><p>Item 9.2</p></td><td><p>Administrative, management, and supervisory bodies conflicts of interests</p><p>Potential conflicts of interests between any duties to the issuer, of the persons referred to in item 9.1, and their private interests and or other duties must be clearly stated. In the event that there are no such conflicts, a statement to that effect must be made.</p></td></tr><tr><td><p>SECTION 10</p></td><td><p>MAJOR SHAREHOLDERS</p></td></tr><tr><td><p>Item 10.1</p></td><td><p>To the extent known to the issuer, state whether the issuer is directly or indirectly owned or controlled and by whom and describe the nature of such control and describe the measures in place to ensure that such control is not abused.</p></td></tr><tr><td><p>Item 10.2</p></td><td><p>A description of any arrangements, known to the issuer, the operation of which may at a subsequent date result in a change in control of the issuer.</p></td></tr><tr><td><p>SECTION 11</p></td><td><p>FINANCIAL INFORMATION CONCERNING THE ISSUER’S ASSETS AND LIABILITIES, FINANCIAL POSITION AND PROFITS AND LOSSES</p></td></tr><tr><td><p>Item 11.1</p></td><td><p>Historical financial information</p></td></tr><tr><td><p>Item 11.1.1</p></td><td><p>Historical financial information covering the latest two financial years (at least 24 months) or such shorter period as the issuer has been in operation and the audit report in respect of each year.</p></td></tr><tr><td><p>Item 11.1.2</p></td><td><p>Change of accounting reference date</p><p>If the issuer has changed its accounting reference date during the period for which historical financial information is required, the audited historical financial information shall cover at least 24 months, or the entire period for which the issuer has been in operation, whichever is shorter.</p></td></tr><tr><td><p>Item 11.1.3</p></td><td><p>Accounting standards</p><p>The financial information must be prepared according to International Financial Reporting Standards as endorsed in the Union based on Regulation (EC) No 1606/2002.</p><p>If Regulation (EC) No 1606/2002 is not applicable the financial statements must be prepared according to:</p><p>(a)  a Member State’s national accounting standards for issuers from the EEA as required by Directive 2013/34/EU;</p><p>(b)  a third country’s national accounting standards equivalent to Regulation (EC) No 1606/2002 for third country issuers.</p><p>Otherwise the following information must be included in the registration document:</p><p>(a)  a prominent statement that the financial information included in the registration document has not been prepared in accordance with International Financial Reporting Standards as endorsed in the Union based on Regulation (EC) No 1606/2002 and that there may be material differences in the financial information had Regulation (EC) No 1606/2002 been applied to the historical financial information;</p><p>(b)  immediately following the historical financial information a narrative description of the differences between Regulation (EC) No 1606/2002 as adopted by the Union and the accounting principles adopted by the issuer in preparing its annual financial statements.</p></td></tr><tr><td><p>Item 11.1.4</p></td><td><p>Where the audited financial information is prepared according to national accounting standards, the financial information must include at least the following:</p><p>(a)  the balance sheet;</p><p>(b)  the income statement;</p><p>(c)  the accounting policies and explanatory notes.</p></td></tr><tr><td><p>Item 11.1.5</p></td><td><p>Consolidated financial statements</p><p>If the issuer prepares both stand-alone and consolidated financial statements, include at least the consolidated financial statements in the registration document.</p></td></tr><tr><td><p>Item 11.1.6</p></td><td><p>Age of financial information</p><p>The balance sheet date of the last year of audited financial information may not be older than 18 months from the date of the registration document</p></td></tr><tr><td><p>Item 11.2</p></td><td><p>Auditing of Historical financial information</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 11.2.1</p></td><td><p>The historical annual financial information must be independently audited. The audit report shall be prepared in accordance with Directive 2006/43/EC and Regulation (EU) No 537/2014.</p><p>Where Directive 2006/43/EC and Regulation (EU) No 537/2014 do not apply, the historical financial information must be audited or reported on as to whether or not, for the purposes of the registration document, it gives a true and fair view in accordance with auditing standards applicable in a Member State or an equivalent standard. Otherwise, the following information must be included in the registration document:</p><p>(a)  a prominent statement disclosing which auditing standards have been applied;</p><p>(b)  an explanation of any significant departures from International Standards on Auditing.</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 11.2.1a</p></td><td><p>Where audit reports on the historical financial information have been refused by the statutory auditors or where they contain qualifications, modifications of opinion, disclaimers or an emphasis of matter, the reason must be given, and such qualifications, modifications, disclaimers or emphasis of matter must be reproduced in full.</p></td></tr><tr><td><p><a>▼B</a></p></td></tr><tr><td><p>Item 11.2.2</p></td><td><p>Indication of other information in the registration document which has been audited by the auditors.</p></td></tr><tr><td><p>Item 11.2.3</p></td><td><p>Where financial information in the registration document is not extracted from the issuer’s audited financial statements state the source of the data and state that the data is not audited.</p></td></tr><tr><td><p>Item 11.3</p></td><td><p>Legal and arbitration proceedings</p></td></tr><tr><td><p>Item 11.3.1</p></td><td><p>Information on any governmental, legal or arbitration proceedings (including any such proceedings which are pending or threatened of which the issuer is aware), during a period covering at least the previous 12 months which may have, or have had in the recent past significant effects on the issuer and/or group’s financial position or profitability, or provide an appropriate negative statement.</p></td></tr><tr><td><p>Item 11.4</p></td><td><p>Significant change in the issuer’s financial position</p></td></tr><tr><td><p>Item 11.4.1</p></td><td><p>A description of any significant change in the financial position of the group which has occurred since the end of the last financial period for which either audited financial information or interim financial information have been published, or provide an appropriate negative statement.</p></td></tr><tr><td><p>SECTION 12</p></td><td><p>MATERIAL CONTRACTS</p></td></tr><tr><td><p>Item 12.1</p></td><td><p>A brief summary of all material contracts that are not entered into in the ordinary course of the issuer’s business, which could result in any group member being under an obligation or entitlement that is material to the issuer’s ability to meet its obligations to security holders in respect of the securities being issued.</p></td></tr><tr><td><p>SECTION 13</p></td><td><p>DOCUMENTS AVAILABLE</p></td></tr><tr><td><p>Item 13.1</p></td><td><p>A statement that for the term of the registration document the following documents, where applicable, can be inspected:</p><p>(a)  the up to date memorandum and articles of association of the issuer;</p><p>(b)  all reports, letters, and other documents, valuations and statements prepared by any expert at the issuer’s request any part of which is included or referred to in the registration document.</p><p>An indication of the website on which the documents may be inspected.</p></td></tr></tbody></table>
ANNEX 8
REGISTRATION DOCUMENT FOR SECONDARY ISSUANCES OF NON-EQUITY SECURITIES
<table><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>PERSONS RESPONSIBLE, THIRD PARTY INFORMATION, EXPERTS’ REPORTS AND COMPETENT AUTHORITY APPROVAL</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Identify all persons responsible for the information or any parts of it, given in the registration document with, in the latter case, an indication of such parts. In the case of natural persons, including members of the issuer’s administrative, management or supervisory bodies, indicate the name and function of the person; in the case of legal persons indicate the name and registered office.</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>A declaration by those responsible for the registration document that to the best of their knowledge, the information contained in the registration document is in accordance with the facts and that the registration document makes no omission likely to affect its import.</p><p>Where applicable, a declaration by those responsible for certain parts of the registration document that, to the best of their knowledge, the information contained in those parts of the registration document for which they are responsible is in accordance with the facts and that those parts of the registration document make no omission likely to affect their import.</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Where a statement or report attributed to a person as an expert is included in the registration document, provide the following details for that person:</p><p>(a)  name;</p><p>(b)  business address;</p><p>(c)  qualifications;</p><p>(d)  material interest if any in the issuer.</p><p>If the statement or report has been produced at the issuer’s request, state that such statement or report has been included in the registration document with the consent of the person who has authorised the contents of that part of the registration document for the purpose of the prospectus.</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Where information has been sourced from a third party, provide a confirmation that this information has been accurately reproduced and that as far as the issuer is aware and is able to ascertain from information published by that third party, no facts have been omitted which would render the reproduced information inaccurate or misleading. In addition, identify the source(s) of the information.</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>A statement that:</p><p>(a)  the [registration document/prospectus] has been approved by the [name of competent authority], as competent authority under Regulation (EU) 2017/1129;</p><p>(b)  the [name of competent authority] only approves this [registration document/prospectus] as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation (EU) 2017/1129;</p><p>(c)  such approval shall not be considered as an endorsement of the issuer that it the subject of this [registration document/prospectus].</p><p>(d)  that the [registration document/prospectus] has been drawn up as part of a simplified prospectus in accordance with Article 14 of Regulation (EU) 2017/1129.</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>STATUTORY AUDITORS</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>Names of the issuer’s auditors for the period covered by the historical financial information (together with their membership in a professional body).</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>RISK FACTORS</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>A description of the material risks that, are specific to the issuer and that may affect the issuer’s ability to fulfil its obligations under the securities, in a limited number of categories, in a section headed ‘Risk Factors’.</p><p>In each category the most material risks, in the assessment of the issuer, offeror or person asking for admission to trading on a regulated market, taking into account the negative impact on the issuer and the probability of their occurrence, shall be set out first. The risk factors shall be corroborated by the content of the registration document.</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>INFORMATION ABOUT THE ISSUER</p></td></tr><tr><td><p>Item 4.1</p></td><td><p>The legal and commercial name of the issuer.</p></td></tr><tr><td><p>Item 4.2</p></td><td><p>The domicile and legal form of the issuer, legal entity identifier (‘LEI’), the legislation under which the issuer operates, its country of incorporation, the address, telephone number of its registered office (or principal place of business if different from its registered office) and website of the issuer, if any, with a disclaimer that the information on the website does not form part of the prospectus unless that information is incorporated by reference into the prospectus.</p></td></tr><tr><td><p>SECTION 5</p></td><td><p>BUSINESS OVERVIEW</p></td></tr><tr><td><p>Item 5.1</p></td><td><p>A brief description of the issuer’s principal activities stating the main categories of products sold and/or services performed.</p></td></tr><tr><td><p>SECTION 6</p></td><td><p>TREND INFORMATION</p></td></tr><tr><td><p>Item 6.1</p></td><td><p>A description of:</p><p>(a)  any material adverse change in the prospects of the issuer since the date of its last published audited financial statements;</p><p>(b)  any significant change in the financial performance of the group since the end of the last financial period for which financial information has been published to the date of the registration document.</p><p>If neither of points (a) or (b) are applicable, then the issuer should include an appropriate negative statement.</p></td></tr><tr><td><p>Item 6.2 (Retail only)</p></td><td><p>Information on any known trends, uncertainties, demands, commitments or events that are reasonably likely to have a material effect on the issuer’s prospects for at least the current financial year.</p></td></tr><tr><td><p>SECTION 7</p></td><td><p>PROFIT FORECASTS OR ESTIMATES</p></td></tr><tr><td><p>Item 7.1</p></td><td><p>Where an issuer includes on a voluntary basis a profit forecast or a profit estimate (which is still outstanding and valid) that forecast or estimate included in the registration document must contain the information set out in items 7.2 and 7.3. If a profit forecast or profit estimate has been published and is still outstanding, but no longer valid, then provide a statement to that effect and an explanation of why such profit forecast or estimate is no longer valid. Such an invalid forecast or estimate is not subject to the requirements in items 7.2 to 7.3.</p><p>Inclusion of the profit forecast or estimate shall be at the discretion of the issuer. Where such a forecast or estimate is included, the registration document shall contain the information set out in items 7.2 and 7.3.</p></td></tr><tr><td><p>Item 7.2</p></td><td><p>Where an issuer chooses to include a new profit forecast or a new profit estimate, or where the issuer includes a previously published profit forecast or a previously published profit estimate pursuant to item 7.1, the profit forecast or estimate shall be clear and unambiguous and shall contain a statement setting out the principal assumptions upon which the issuer has based its forecast, or estimate.</p><p>The forecast or estimate shall comply with the following principles:</p><p>(a)  there must be a clear distinction between assumptions about factors which the members of the administrative, management or supervisory bodies can influence and assumptions about factors which are exclusively outside the influence of the members of the administrative, management or supervisory bodies;</p><p>(b)  the assumptions must be reasonable, readily understandable by investors, specific and precise and not relate to the general accuracy of the estimates underlying the forecast; and</p><p>(c)  in the case of a forecast, the assumptions shall draw the investor’s attention to those uncertain factors which could materially change the outcome of the forecast.</p></td></tr><tr><td><p>Item 7.3</p></td><td><p>The prospectus shall include a statement that the profit forecast or estimate has been compiled and prepared on a basis which is both:</p><p>(a)  comparable with the historical financial information;</p><p>(b)  consistent with the issuer’s accounting policies.</p></td></tr><tr><td><p>SECTION 8</p></td><td><p>ADMINISTRATIVE, MANAGEMENT AND SUPERVISORY BODIES AND SENIOR MANAGEMENT</p></td></tr><tr><td><p>Item 8.1</p></td><td><p>Names, business addresses and functions within the issuer of the following persons and an indication of the principal activities performed by them outside of that issuer where these are significant with respect to that issuer:</p><p>(a)  members of the administrative, management or supervisory bodies;</p><p>(b)  partners with unlimited liability, in the case of a limited partnership with a share capital.</p></td></tr><tr><td><p>Item 8.2</p></td><td><p>Potential conflicts of interest between any duties carried out on behalf of the issuer, by the persons referred to in item 8.1 and their private interests or other duties must be clearly stated. In the event that there are no such conflicts a statement to that effect must be made.</p></td></tr><tr><td><p>SECTION 9</p></td><td><p>MAJOR SHAREHOLDERS</p></td></tr><tr><td><p>Item 9.1</p></td><td><p>To the extent known to the issuer, state whether the issuer is directly or indirectly owned or controlled and by whom and describe the nature of such control and describe the measures in place to ensure that such control is not abused.</p></td></tr><tr><td><p>Item 9.2</p></td><td><p>A description of any arrangements, known to the issuer, the operation of which may at a subsequent date result in a change in control of the issuer.</p></td></tr><tr><td><p>SECTION 10</p></td><td><p>FINANCIAL INFORMATION CONCERNING THE ISSUER’S ASSETS AND LIABILITIES, FINANCIAL POSITION AND PROFITS, AND LOSSES</p></td></tr><tr><td><p>Item 10.1</p></td><td><p>Financial statements</p><p>Financial statements (annual and half-yearly) required to be published covering the period of 12 months prior to the approval of the prospectus.</p><p>Where both annual and half-yearly financial statements have been published, only the annual statements shall be required where they postdate the half-yearly financial statements.</p></td></tr><tr><td><p>Item 10.2</p></td><td><p>Auditing of annual financial information</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 10.2.1</p></td><td><p>Audit report</p><p>The annual financial statements must be independently audited. The audit report shall be prepared in accordance with Directive 2006/43/EC and Regulation (EU) No 537/2014.</p><p>Where Directive 2006/43/EC and Regulation (EU) No 537/2014 do not apply, the annual financial statements must be audited or reported on as to whether or not, for the purposes of the registration document, it gives a true and fair view in accordance with auditing standards applicable in a Member State or an equivalent standard. Otherwise, the following information must be included in the registration document:</p><p>(a)  a prominent statement disclosing which auditing standards have been applied;</p><p>(b)  an explanation of any significant departures from International Standards on Auditing.</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 10.2.1a</p></td><td><p>Where audit reports on the annual financial statements have been refused by the statutory auditors or where they contain qualifications, modifications of opinion, disclaimers or an emphasis of matter, the reason must be given, and such qualifications, modifications, disclaimers or emphasis of matter must be reproduced in full.</p></td></tr><tr><td><p><a>▼B</a></p></td></tr><tr><td><p>Item 10.2.2</p></td><td><p>Indication of other information in the registration document which has been audited by the auditors.</p></td></tr><tr><td><p>Item 10.2.3</p></td><td><p>Where financial information in the registration document is not extracted from the issuer’s audited financial statements, state the source of the data and identify the data that has not been audited.</p></td></tr><tr><td><p>Item 10.3</p></td><td><p>Legal and arbitration proceedings</p><p>Information on any governmental, legal or arbitration proceedings (including any such proceedings which are pending or threatened of which the issuer is aware), during a period covering at least the previous 12 months which may have, or have had in the recent past significant effects on the issuer and/or group’s financial position or profitability, or provide an appropriate negative statement.</p></td></tr><tr><td><p>Item 10.4</p></td><td><p>Significant change in the issuer’s financial position</p><p>A description of any significant change in the financial position of the group which has occurred since the end of the last financial period for which either audited financial statements or interim financial information have been published, or provide an appropriate negative statement.</p></td></tr><tr><td><p>SECTION 11</p></td><td><p>REGULATORY DISCLOSURES</p></td></tr><tr><td><p>Item 11.1</p></td><td><p>A summary of the information disclosed under Regulation (EU) No 596/2014 over the last 12 months which is relevant as at the date of the prospectus. The summary shall be presented in an easily analysable, concise and comprehensible form and shall not be a replication of information already published under Regulation (EU) No 596/2014.</p><p>The summary shall be presented in a limited number of categories depending on their subject.</p></td></tr><tr><td><p>SECTION 12</p></td><td><p>MATERIAL CONTRACTS</p></td></tr><tr><td><p>Item 12.1</p></td><td><p>A brief summary of all material contracts that are not entered into in the ordinary course of the issuer’s business, which could result in any group member being under an obligation or an entitlement that is material to the issuer’s ability to meet its obligations to security holders in respect of the securities being issued.</p></td></tr><tr><td><p>SECTION 13</p></td><td><p>DOCUMENTS AVAILABLE</p></td></tr><tr><td><p>Item 13.1</p></td><td><p>A statement that for the term of the registration document the following documents, where applicable, can be inspected:</p><p>(a)  the up to date memorandum and articles of association of the issuer;</p><p>(b)  all reports, letters, and other documents, valuations and statements prepared by any expert at the issuer’s request any part of which is included or referred to in the registration document.</p><p>An indication of the website on which the documents may be inspected.</p></td></tr></tbody></table>
ANNEX 9
REGISTRATION DOCUMENT FOR ASSET-BACKED SECURITIES
<table><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>PERSONS RESPONSIBLE, THIRD PARTY INFORMATION, EXPERTS’ REPORTS AND COMPETENT AUTHORITY APPROVAL</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Identify all persons responsible for the information or any parts of it, given in the registration document with, in the latter case, an indication of such parts. In the case of natural persons, including members of the issuer’s administrative, management or supervisory bodies, indicate the name and function of the person; in the case of legal persons indicate the name and registered office.</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>A declaration by those responsible for the registration document that to the best of their knowledge, the information contained in the registration document is in accordance with the facts and that the registration document makes no omission likely to affect its import.</p><p>Where applicable, a declaration by those responsible for certain parts of the registration document that, to the best of their knowledge, the information contained in those parts of the registration document for which they are responsible is in accordance with the facts and that those parts of the registration document make no omission likely to affect their import.</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Where a statement or report attributed to a person as an expert is included in the registration document, provide the following details for that person:</p><p>(a)  name;</p><p>(b)  business address;</p><p>(c)  qualifications;</p><p>(d)  material interest if any in the issuer.</p><p>If the statement or report has been produced at the issuer’s request, state that such statement or report has been included in the registration document with the consent of the person who has authorised the contents of that part of the registration document for the purpose of the prospectus..</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Where information has been sourced from a third party, provide a confirmation that this information has been accurately reproduced and that as far as the issuer is aware and is able to ascertain from information published by that third party, no facts have been omitted which would render the reproduced information inaccurate or misleading In addition, the issuer shall identify the source(s) of the information.</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>A statement that:</p><p>(a)  the [registration document/prospectus] has been approved by the [name of competent authority], as competent authority under Regulation (EU) 2017/1129;</p><p>(b)  the [name of competent authority] only approves this [registration document/prospectus] as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation (EU) 2017/1129;</p><p>(c)  such approval should not be considered as an endorsement of the issuer that is the subject of this [registration document/prospectus].</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>STATUTORY AUDITORS</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>Names and addresses of the issuer’s auditors for the period covered by the historical financial information (together with any membership in a professional body).</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>RISK FACTORS</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>A description of the material risks that are specific to the issuer in a limited number of categories, in a section headed ‘Risk Factors’.</p><p>In each category the most material risks, in the assessment of the issuer, offeror or person asking for admission to trading on a regulated market, taking into account the negative impact on the issuer and the probability of their occurrence, shall be set out first. The risk factors shall be corroborated by the content of the registration document.</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>INFORMATION ABOUT THE ISSUER</p></td></tr><tr><td><p>Item 4.1</p></td><td><p>A statement whether the issuer has been established as a special purpose vehicle or entity for the purpose of issuing asset backed securities.</p></td></tr><tr><td><p>Item 4.2</p></td><td><p>The legal and commercial name of the issuer and the legal entity identifier (‘LEI’).</p></td></tr><tr><td><p>Item 4.3</p></td><td><p>The place of registration of the issuer and its registration number.</p></td></tr><tr><td><p>Item 4.4</p></td><td><p>The date of incorporation and the length of life of the issuer, except where the period is indefinite.</p></td></tr><tr><td><p>Item 4.5</p></td><td><p>The domicile and legal form of the issuer, the legislation under which the issuer operates, its country of incorporation, the address and telephone number of its registered office (or principal place of business if different from its registered office) and website of the issuer, if any, or website of a third party or guarantor, with a disclaimer that the information on the website does not form part of the prospectus unless that information is incorporated by reference into the prospectus.</p></td></tr><tr><td><p>Item 4.6</p></td><td><p>Description of the amount of the issuer’s authorised and issued capital and the amount of any capital agreed to be issued, the number and classes of the securities of which it is composed.</p></td></tr><tr><td><p>SECTION 5</p></td><td><p>BUSINESS OVERVIEW</p></td></tr><tr><td><p>Item 5.1</p></td><td><p>A brief description of the issuer’s principal activities.</p></td></tr><tr><td><p>SECTION 6</p></td><td><p>ADMINISTRATIVE, MANAGEMENT AND SUPERVISORY BODIES</p></td></tr><tr><td><p>Item 6.1</p></td><td><p>Names, business addresses and functions within the issuer of the following persons, and an indication of the principal activities performed by them outside of that issuer where these are significant with respect to that issuer:</p><p>(a)  members of the administrative, management or supervisory bodies;</p><p>(b)  partners with unlimited liability, in the case of a limited partnership with a share capital.</p></td></tr><tr><td><p>SECTION 7</p></td><td><p>MAJOR SHAREHOLDERS</p></td></tr><tr><td><p>Item 7.1</p></td><td><p>To the extent known to the issuer, state whether the issuer is directly or indirectly owned or controlled and by whom, and describe the nature of such control and describe the measures in place to ensure that such control is not abused.</p></td></tr><tr><td><p>SECTION 8</p></td><td><p>FINANCIAL INFORMATION CONCERNING THE ISSUER’S ASSETS AND LIABILITIES, FINANCIAL POSITION, AND PROFITS AND LOSSES</p></td></tr><tr><td><p>Item 8.1</p></td><td><p>Where, since the date of incorporation or establishment, an issuer has not commenced operations and no financial statements have been drawn up as at the date of the registration document, a statement to that effect shall be provided in the registration document.</p></td></tr><tr><td><p>Item 8.2</p></td><td><p>Historical Financial Information</p><p>Where, since the date of incorporation or establishment, an issuer has commenced operations and financial statements have been drawn up, the registration document must contain audited historical financial information covering the latest two financial years (at least 24 months or such shorter period as the issuer has been in operation) and the audit report in respect of each year.</p></td></tr><tr><td><p>Item 8.2.1</p></td><td><p>Change of accounting reference date</p><p>If the issuer has changed its accounting reference date during the period for which historical financial information is required, the historical financial information shall cover at least 24 months, or the entire period for which the issuer has been in operation, whichever is the shorter.</p></td></tr><tr><td><p>Item 8.2.2</p></td><td><p>Accounting standards</p><p>The financial information must be prepared according to International Financial Reporting Standards as endorsed in the Union based on Regulation (EC) No 1606/2002.</p><p>If Regulation (EC) No 1606/2002 is not applicable the financial statements must be prepared in accordance with:</p><p>(a)  a Member State’s national accounting standards for issuers from the EEA as required by Directive 2013/34/EU;</p><p>(b)  a third country’s national accounting standards equivalent to Regulation (EC) No 1606/2002 for third country issuers. If such third country’s national accounting standards are not equivalent to Regulation (EC) No 1606/2002 the financial statements shall be restated in compliance with Regulation (EC) No 1606/2002.</p></td></tr><tr><td><p>Item 8.2.3</p></td><td><p>Change of accounting framework</p><p>The last year’s historical financial information, containing comparative information for the previous year, must be presented and prepared in a form consistent with the accounting standards framework that will be adopted in the issuer’s next annual published financial statements having regard to accounting standards and policies and legislation applicable to such annual financial statements.</p><p>Changes within the issuer’s existing accounting framework do not require the audited financial statements to be restated. However, if the issuer intends to adopt a new accounting standards framework in its next published financial statements, at least one complete set of financial statements, (as defined by IAS 1 Presentation of Financial Statements), including comparatives, must be presented in a form consistent with that which will be adopted in the issuer’s next published annual financial statements, having regard to accounting standards and policies and legislation applicable to such annual financial statements.</p></td></tr><tr><td><p>Item 8.2.4</p></td><td><p>Where the audited financial information is prepared according to national accounting standards, financial information required under this heading must include at least the following:</p><p>(a)  the balance sheet;</p><p>(b)  the income statement;</p><p>(c)  the accounting policies and explanatory notes.</p></td></tr><tr><td><p>Item 8.2.a</p></td><td><p><span>This paragraph (items 8.2.a, 8.2.a.1, 8.2.a.2 and 8.2.a.3) may be used only for issues of asset-backed securities having a denomination per unit of at least EUR 100 000 or which are to be traded only on a regulated market, and/or a specific section thereof, to which only qualified investors have access for the purpose of trading in the securities.</span></p><p>Historical financial information</p><p>Where, since the date of incorporation or establishment, an issuer has commenced operations and financial statements have been drawn up, the registration document must contain historical financial information covering the latest two financial years (at least 24 month or such shorter period as the issuer has been in operation) and the audit report in respect of each year.</p></td></tr><tr><td><p>Item 8.2.a.1</p></td><td><p>Accounting standards</p><p>The financial information must be prepared according to International Financial Reporting Standards as adopted by the Union based on Regulation (EC) No 1606/2002.</p><p>If Regulation (EC) No 1606/2002 is not applicable, the financial statements must be prepared in accordance with:</p><p>(a)  a Member State’s national accounting standards for issuers from the EEA as required by the Directive 2013/34/EU;</p><p>(b)  a third country’s national accounting standards equivalent to Regulation (EC) No 1606/2002 for third country issuers.</p><p>Otherwise the following information must be included in the registration document:</p><p>(a)  a prominent statement that the financial information included in the registration document has not been prepared in accordance with Regulation (EC) No 1606/2002 as adopted by the Union and that there may be material differences in the financial information had Regulation (EC) No 1606/2002 been applied to the historical financial information;</p><p>(b)  immediately following the historical financial information a narrative description of the differences between Regulation (EC) No 1606/2002 as adopted by the Union and the accounting principles adopted by the issuer in preparing its annual financial statements.</p></td></tr><tr><td><p>Item 8.2.a.2</p></td><td><p>Where the audited financial information is prepared according to national accounting standards, it must include at least the following:</p><p>(a)  the balance sheet;</p><p>(b)  the income statement;</p><p>(c)  the accounting policies and explanatory notes.</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 8.2.a.3</p></td><td><p>Audit report</p><p>The historical annual financial information must be independently audited. The audit report shall be prepared in accordance with Directive 2006/43/EC and Regulation (EU) No 537/2014.</p><p>Where Directive 2006/43/EC and Regulation (EU) No 537/2014 do not apply, the historical financial information must be audited or reported on as to whether or not, for the purposes of the registration document, it gives a true and fair view in accordance with auditing standards applicable in a Member State or an equivalent standard. Otherwise, the following information must be included in the registration document:</p><p>(a)  a prominent statement disclosing which auditing standards have been applied;</p><p>(b)  an explanation of any significant departures from International Standards on Auditing.</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 8.2.a.4</p></td><td><p>A statement that the historical financial information has been audited. Where audit reports on the historical financial information have been refused by the statutory auditors or where they contain qualifications, modifications of opinion, disclaimers or an emphasis of matter, the reason must be given, and such qualifications, modifications, disclaimers or emphasis of matter must be reproduced in full.</p></td></tr><tr><td><p><a>▼B</a></p></td></tr><tr><td><p>Item 8.3</p></td><td><p>Legal and arbitration proceedings</p><p>Information on any governmental, legal or arbitration proceedings (including any such proceedings which are pending or threatened of which the company is aware), during a period covering at least the previous 12 months, which may have, or have had in the recent past, significant effects on the issuer and/or group’s financial position or profitability, or provide an appropriate negative statement.</p></td></tr><tr><td><p>Item 8.4</p></td><td><p>Material adverse change in the issuer’s financial position</p><p>Where an issuer has prepared financial statements, include a statement that there has been no material adverse change in the financial position or prospects of the issuer since the date of its last published audited financial statements. Where a material adverse change has occurred, this must be disclosed in the registration document.</p></td></tr><tr><td><p>SECTION 9</p></td><td><p>DOCUMENTS AVAILABLE</p></td></tr><tr><td><p>Item 9.1</p></td><td><p>A statement that for the term of the registration document the following documents, where applicable, may be inspected:</p><p>(a)  the memorandum and up to date articles of association of the issuer;</p><p>(b)  all reports, letters, and other documents, historical financial information, valuations and statements prepared by any expert at the issuer’s request any part of which is included or referred to in the registration document.</p><p>An indication of the website on which the documents may be inspected.</p></td></tr></tbody></table>
ANNEX 10
REGISTRATION DOCUMENT FOR NON-EQUITY SCURITIES ISSUED BY THIRD COUNTRIES AND THEIR REGIONAL AND LOCAL AUTHORITIES
<table><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>PERSONS RESPONSIBLE, THIRD PARTY INFORMATION, EXPERTS’ REPORTS AND COMPETENT AUTHORITY APPROVAL</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Identify all persons responsible for the information or any parts of it, given in the registration document with, in the latter case, an indication of such parts. In the case of natural persons, including members of the issuer’s administrative, management or supervisory bodies, indicate the name and function of the person; in the case of legal persons indicate the name and registered office.</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>A declaration by those responsible for the registration document that to the best of their knowledge, the information contained in the registration document is in accordance with the facts and that the registration document makes no omission likely to affect its import.</p><p>Where applicable, a declaration by those responsible for certain parts of the registration document that, to the best of their knowledge, the information contained in those parts of the registration document for which they are responsible is in accordance with the facts and that those parts of the registration document make no omission likely to affect their import.</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Where a statement or report, attributed to a person as an expert, is included in the registration document, provide the following details for that person:</p><p>(a)  such person’s name;</p><p>(b)  business address;</p><p>(c)  qualifications;</p><p>(d)  material interest if any in the issuer.</p><p>If the statement or report has been produced at the issuer’s request, state that such statement or report has been included in the registration document with the consent of the person who has authorised the contents of that part of the registration document for the purpose of the prospectus.</p><p>To the extent known to the issuer, provide information in respect of any interest relating to such expert which may affect the independence of the expert in the preparation of the report.</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>A statement that:</p><p>(a)  the [registration document/prospectus] has been approved by the [name of competent authority], as competent authority under Regulation (EU) 2017/1129;</p><p>(b)  the [name of competent authority] only approves this [registration document/prospectus]as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation (EU) 2017/1129;</p><p>(c)  such approval should not be considered as an endorsement of the issuer that is the subject of this [registration document/prospectus];</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>RISK FACTORS</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>A description of the material risks that are specific to the issuer in a limited number of categories, in a section headed ‘Risk Factors’.</p><p>In each category the most material risks, in the assessment of the issuer, offeror or person asking for admission to trading on a regulated market, taking into account the negative impact on the issuer and the probability of their occurrence, shall be set out first.</p><p>The risk factors shall be corroborated by the content of the registration document.</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>INFORMATION ABOUT THE ISSUER</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>History and development of the issuer</p><p>The legal name of the issuer and a brief description of the issuer’s position within the national governmental framework.</p></td></tr><tr><td><p>Item 3.2</p></td><td><p>The domicile or geographical location and legal form of the issuer and its contact address, telephone number and website of the issuer, if any, with a disclaimer that the information on the website does not form part of the prospectus unless that information is incorporated by reference into the prospectus.</p></td></tr><tr><td><p>Item 3.3</p></td><td><p>Any recent events relevant to the evaluation of the issuer’s solvency.</p></td></tr><tr><td><p>Item 3.4</p></td><td><p>A description of the issuer’s economy including:</p><p>(a)  the structure of the economy with details of the main sectors of the economy;</p><p>(b)  gross domestic product with a breakdown by the issuer’s economic sectors for the previous two fiscal years.</p></td></tr><tr><td><p>Item 3.5</p></td><td><p>A general description of the issuer’s political system and government including details of the governing body of the issuer.</p></td></tr><tr><td><p>Item 3.6</p></td><td><p>Any credit ratings assigned to the issuer at the request or with the cooperation of the issuer in the rating process.</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>PUBLIC FINANCE AND TRADE</p></td></tr><tr><td><p>Item 4.1</p></td><td><p>Information on the following for the two fiscal years prior to the date of the registration document:</p><p>(a)  the tax and budgetary systems;</p><p>(b)  gross public debt including a summary of the debt, the maturity structure of outstanding debt (particularly noting debt with a residual maturity of less than one year) and debt payment record, and of the parts of debt denominated in the domestic currency of the issuer and in foreign currencies;</p><p>(c)  foreign trade and balance of payment figures;</p><p>(d)  foreign exchange reserves including any potential encumbrances to such foreign exchange reserves as forward contracts or derivatives;</p><p>(e)  financial position and resources including liquid deposits available in domestic currency;</p><p>(f)  income and expenditure figures.</p><p>Description of any auditing or independent review procedures on the accounts of the issuer.</p></td></tr><tr><td><p>SECTION 5</p></td><td><p>SIGNIFICANT CHANGE</p></td></tr><tr><td><p>Item 5.1</p></td><td><p>Details of any significant changes to the information provided pursuant to item 4 which have occurred since the end of the last fiscal year, or an appropriate negative statement.</p></td></tr><tr><td><p>SECTION 6</p></td><td><p>LEGAL AND ARBITRATION PROCEEDINGS</p></td></tr><tr><td><p>Item 6.1</p></td><td><p>Information on any governmental, legal or arbitration proceedings (including any such proceedings which are pending or threatened of which the issuer is aware), during a period covering at least the previous 12 months which may have, or have had in the recent past, significant effects on the issuer’s financial position, or provide an appropriate negative statement.</p></td></tr><tr><td><p>Item 6.2</p></td><td><p>Information on any immunity the issuer may have from legal proceedings.</p></td></tr><tr><td><p>SECTION 7</p></td><td><p>DOCUMENTS AVAILABLE</p></td></tr><tr><td><p>Item 7.1</p></td><td><p>A statement that for the term of the registration document the following documents, where applicable, can be inspected:</p><p>(a)  financial and audit reports for the issuer covering the last two fiscal years and the budget for the current fiscal year;</p><p>(b)  all reports, letters, and other documents, valuations and statements prepared by any expert at the issuer’s request any part of which is included or referred to in the registration document.</p><p>An indication of the website on which the documents may be inspected.</p></td></tr></tbody></table>
ANNEX 11
SECURITIES NOTE FOR EQUITY SECURITIES OR UNITS ISSUED BY COLLECTIVE INVESTMENT UNDERTAKINGS OF THE CLOSED-END TYPE
<table><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>PERSONS RESPONSIBLE, THIRD PARTY INFORMATION, EXPERTS’ REPORTS AND COMPETENT AUTHORITY APPROVAL</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Identify all persons responsible for the information or any parts of it, given in the securities note with, in the latter case, an indication of such parts. In the case of natural persons, including members of the issuer’s administrative, management or supervisory bodies, indicate the name and function of the person; in the case of legal persons indicate the name and registered office.</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>A declaration by those responsible for the securities note that to the best of their knowledge, the information contained in the securities note is in accordance with the facts and that the securities note makes no omission likely to affect its import.</p><p>Where applicable, a declaration by those responsible for certain parts of the securities note that, to the best of their knowledge, the information contained in those parts of the securities note for which they are responsible is in accordance with the facts and that those parts of the securities note make no omission likely to affect their import.</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Where a statement or report attributed to a person as an expert, is included in the securities note, provide the following in relation to that person:</p><p>(a)  name;</p><p>(b)  business address;</p><p>(c)  qualifications;</p><p>(d)  material interest, if any, in the issuer.</p><p>If the statement or report has been produced at the issuer’s request, state that such statement or report has been included in the securities note with the consent of the person who has authorised the contents of that part of the securities note for the purpose of the prospectus.</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Where information has been sourced from a third party, provide a confirmation that this information has been accurately reproduced and that as far as the issuer is aware and is able to ascertain from information published by that third party, no facts have been omitted which would render the reproduced information inaccurate or misleading. In addition, identify the source(s) of the information.</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>A statement that:</p><p>(a)  this [securities note/prospectus] has been approved by the name of competent authority], as competent authority under Regulation (EU) 2017/1129;</p><p>(b)  the [name of competent authority] only approves this [securities note/prospectus] as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation (EU) 2017/1129;</p><p>(c)  such approval should not be considered as an endorsement of [the quality of the securities that are the subject of this [securities note/prospectus];</p><p>(d)  investors should make their own assessment as to the suitability of investing in the securities.</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>RISK FACTORS</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>A description of the material risks that are specific to the securities being offered and/or admitted to trading in a limited number of categories, in a section headed ‘Risk Factors’.</p><p>In each category the most material risks, in the assessment of the issuer, offeror or person asking for admission to trading on a regulated market, taking into account the negative impact on the issuer and the securities and the probability of their occurrence, shall be set out first. The risks shall be corroborated by the content of the securities note.</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>ESSENTIAL INFORMATION</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>Working capital statement</p><p>Statement by the issuer that, in its opinion, the working capital is sufficient for the issuer’s present requirements or, if not, how it proposes to provide the additional working capital needed.</p></td></tr><tr><td><p>Item 3.2</p></td><td><p>Capitalisation and indebtedness</p><p>A statement of capitalisation and indebtedness (distinguishing between guaranteed and unguaranteed, secured and unsecured indebtedness) as of a date no earlier than 90 days prior to the date of the document. The term ‘indebtedness’ also includes indirect and contingent indebtedness.</p><p>In the case of material changes in the capitalisation and indebtedness position of the issuer within the 90 day period, additional information shall be given through the presentation of a narrative description of such changes or through the updating of those figures.</p></td></tr><tr><td><p>Item 3.3</p></td><td><p>Interest of natural and legal persons involved in the issue/offer</p><p>A description of any interest, including a conflict of interest that is material to the issue/offer, detailing the persons involved and the nature of the interest.</p></td></tr><tr><td><p>Item 3.4</p></td><td><p>Reasons for the offer and use of proceeds</p><p>Reasons for the offer and, where applicable, the estimated net amount of the proceeds broken into each principal intended use and presented in order of priority of such uses. If the issuer is aware that the anticipated proceeds will not be sufficient to fund all the proposed uses, then state the amount and sources of other funds needed. Details must be also given with regard to the use of the proceeds, in particular when they are being used to acquire assets, other than in the ordinary course of business, to finance announced acquisitions of other business, or to discharge, reduce or retire indebtedness.</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>INFORMATION CONCERNING THE SECURITIES TO BE OFFERED/ADMITTED TO TRADING</p></td></tr><tr><td><p>Item 4.1</p></td><td><p>A description of the type and the class of the securities being offered and/or admitted to trading, including the international security identification number (‘ISIN’).</p></td></tr><tr><td><p>Item 4.2</p></td><td><p>Legislation under which the securities have been created.</p></td></tr><tr><td><p>Item 4.3</p></td><td><p>An indication whether the securities are in registered form or bearer form and whether the securities are in certificated form or book-entry form. In the latter case, name and address of the entity in charge of keeping the records.</p></td></tr><tr><td><p>Item 4.4</p></td><td><p>Currency of the securities issue.</p></td></tr><tr><td><p>Item 4.5</p></td><td><p>A description of the rights attached to the securities, including any limitations of those rights and procedure for the exercise of those rights:</p><p>(a)  dividend rights:</p><p>(i)  fixed date(s) on which entitlement arises;</p><p>(ii)  time limit after which entitlement to dividend lapses and an indication of the person in whose favour the lapse operates;</p><p>(iii)  dividend restrictions and procedures for non-resident holders;</p><p>(iv)  rate of dividend or method of its calculation, periodicity and cumulative or non-cumulative nature of payments;</p><p>(b)  voting rights;</p><p>(c)  pre-emption rights in offers for subscription of securities of the same class;</p><p>(d)  right to share in the issuer’s profits;</p><p>(e)  rights to share in any surplus in the event of liquidation;</p><p>(f)  redemption provisions;</p><p>(g)  conversion provisions.</p></td></tr><tr><td><p>Item 4.6</p></td><td><p>In the case of new issues, a statement of the resolutions, authorisations and approvals by virtue of which the securities have been or will be created and/or issued.</p></td></tr><tr><td><p>Item 4.7</p></td><td><p>In the case of new issues, the expected issue date of the securities.</p></td></tr><tr><td><p>Item 4.8</p></td><td><p>A description of any restrictions on the transferability of the securities.</p></td></tr><tr><td><p>Item 4.9</p></td><td><p>Statement on the existence of any national legislation on takeovers applicable to the issuer which may frustrate such takeovers if any.</p><p>A brief description of the shareholders’ rights and obligations in case of mandatory takeover bids and/or squeeze-out or sell-out rules in relation to the securities.</p></td></tr><tr><td><p>Item 4.10</p></td><td><p>An indication of public takeover bids by third parties in respect of the issuer’s equity, which have occurred during the last financial year and the current financial year. The price or exchange terms attaching to such offers and the outcome thereof must be stated.</p></td></tr><tr><td><p>Item 4.11</p></td><td><p>A warning that the tax legislation of the investor’s Member State and of the issuer’s country of incorporation may have an impact on the income received from the securities.</p><p>Information on the taxation treatment of the securities where the proposed investment attracts a tax regime specific to that type of investment.</p></td></tr><tr><td><p>Item 4.12</p></td><td><p>Where applicable, the potential impact on the investment in the event of resolution under Directive 2014/59/EU of the European Parliament and of the Council <a>(<span>1</span>)</a>.</p></td></tr><tr><td><p>Item 4.13</p></td><td><p>If different from the issuer, the identity and contact details of the offeror of the securities and/or the person asking for admission to trading, including the legal entity identifier (‘LEI’) where the offeror has legal personality.</p></td></tr><tr><td><p>SECTION 5</p></td><td><p>TERMS AND CONDITIONS OF THE OFFER OF SECURITIES TO THE PUBLIC</p></td></tr><tr><td><p>Item 5.1</p></td><td><p>Conditions, offer statistics, expected timetable and action required to apply for the offer.</p></td></tr><tr><td><p>Item 5.1.1</p></td><td><p>Conditions to which the offer is subject.</p></td></tr><tr><td><p>Item 5.1.2</p></td><td><p>Total amount of the issue/offer, distinguishing the securities offered for sale and those offered for subscription; if the amount is not fixed, an indication of the maximum amount of securities to be offered (if available) and a description of the arrangements and the time period for announcing to the public the definitive amount of the offer.</p><p>Where the maximum amount of securities cannot be provided in the prospectus, the prospectus shall specify that acceptances of the purchase or subscription of securities may be withdrawn for not less than two working days after the amount of securities to be offered to the public has been filed.</p></td></tr><tr><td><p>Item 5.1.3</p></td><td><p>The time period, including any possible amendments, during which the offer will be open and description of the application process.</p></td></tr><tr><td><p>Item 5.1.4</p></td><td><p>An indication of when, and under which circumstances, the offer may be revoked or suspended and whether revocation can occur after dealing has begun.</p></td></tr><tr><td><p>Item 5.1.5</p></td><td><p>A description of any possibility to reduce subscriptions and the manner for refunding amounts paid in excess by applicants.</p></td></tr><tr><td><p>Item 5.1.6</p></td><td><p>Details of the minimum and/or maximum amount of application (whether in number of securities or aggregate amount to invest).</p></td></tr><tr><td><p>Item 5.1.7</p></td><td><p>An indication of the period during which an application may be withdrawn, provided that investors are allowed to withdraw their subscription.</p></td></tr><tr><td><p>Item 5.1.8</p></td><td><p>Method and time limits for paying up the securities and for delivery of the securities.</p></td></tr><tr><td><p>Item 5.1.9</p></td><td><p>A full description of the manner and date in which results of the offer are to be made public.</p></td></tr><tr><td><p>Item 5.1.10</p></td><td><p>The procedure for the exercise of any right of pre-emption, the negotiability of subscription rights and the treatment of subscription rights not exercised.</p></td></tr><tr><td><p>Item 5.2</p></td><td><p>Plan of distribution and allotment.</p></td></tr><tr><td><p>Item 5.2.1</p></td><td><p>The various categories of potential investors to which the securities are offered. If the offer is being made simultaneously in the markets of two or more countries and if a tranche has been or is being reserved for certain of these, indicate any such tranche.</p></td></tr><tr><td><p>Item 5.2.2</p></td><td><p>To the extent known to the issuer, an indication of whether major shareholders or members of the issuer’s management, supervisory or administrative bodies intend to subscribe in the offer, or whether any person intends to subscribe for more than five per cent of the offer.</p></td></tr><tr><td><p>Item 5.2.3</p></td><td><p>Pre-allotment Disclosure:</p><p>(a)  the division into tranches of the offer including the institutional, retail and issuer’s employee tranches and any other tranches;</p><p>(b)  the conditions under which the claw-back may be used, the maximum size of such claw-back and any applicable minimum percentages for individual tranches;</p><p>(c)  the allotment method or methods to be used for the retail and issuer’s employee tranche in the event of an over-subscription of these tranches;</p><p>(d)  a description of any pre-determined preferential treatment to be accorded to certain classes of investors or certain affinity groups (including friends and family programmes) in the allotment, the percentage of the offer reserved for such preferential treatment and the criteria for inclusion in such classes or groups;</p><p>(e)  whether the treatment of subscriptions or bids to subscribe in the allotment may be determined on the basis of which firm they are made through or by;</p><p>(f)  a target minimum individual allotment if any within the retail tranche;</p><p>(g)  the conditions for the closing of the offer as well as the date on which the offer may be closed at the earliest;</p><p>(h)  whether or not multiple subscriptions are admitted, and where they are not, how any multiple subscriptions will be handled.</p></td></tr><tr><td><p>Item 5.2.4</p></td><td><p>Process for notifying applicants of the amount allotted and an indication whether dealing may begin before notification is made.</p></td></tr><tr><td><p>Item 5.3</p></td><td><p>Pricing</p></td></tr><tr><td><p>Item 5.3.1</p></td><td><p>An indication of the price at which the securities will be offered and the amount of any expenses and taxes charged to the subscriber or purchaser.</p><p>If the price is not known, then pursuant to Article 17 of Regulation (EU) 2017/1129 indicate either:</p><p>(a)  the maximum price as far as it is available;</p><p>(b)  the valuation methods and criteria, and/or conditions, in accordance with which the final offer price has been or will be determined and an explanation of any valuation methods used.</p><p>Where neither point (a) nor (b) can be provided in the securities note, the securities note shall specify that acceptances of the purchase or subscription of securities may be withdrawn up to two working days after the final offer price of securities to be offered to the public has been filed.</p></td></tr><tr><td><p>Item 5.3.2</p></td><td><p>Process for the disclosure of the offer price.</p></td></tr><tr><td><p>Item 5.3.3</p></td><td><p>If the issuer’s equity holders have pre-emptive purchase rights and this right is restricted or withdrawn, an indication of the basis for the issue price if the issue is for cash, together with the reasons for and beneficiaries of such restriction or withdrawal.</p></td></tr><tr><td><p>Item 5.3.4</p></td><td><p>Where there is or could be a material disparity between the public offer price and the effective cash cost to members of the administrative, management or supervisory bodies or senior management, or affiliated persons, of securities acquired by them in transactions during the past year, or which they have the right to acquire, include a comparison of the public contribution in the proposed public offer and the effective cash contributions of such persons.</p></td></tr><tr><td><p>Item 5.4</p></td><td><p>Placing and underwriting</p></td></tr><tr><td><p>Item 5.4.1</p></td><td><p>Name and address of the coordinator(s) of the global offer and of single parts of the offer and, to the extent known to the issuer or to the offeror, of the placers in the various countries where the offer takes place.</p></td></tr><tr><td><p>Item 5.4.2</p></td><td><p>Name and address of any paying agents and depository agents in each country.</p></td></tr><tr><td><p>Item 5.4.3</p></td><td><p>Name and address of the entities agreeing to underwrite the issue on a firm commitment basis, and name and address of the entities agreeing to place the issue without a firm commitment or under best ‘efforts’ arrangements. Indication of the material features of the agreements, including the quotas. Where not all of the issue is underwritten, a statement of the portion not covered. Indication of the overall amount of the underwriting commission and of the placing commission.</p></td></tr><tr><td><p>Item 5.4.4</p></td><td><p>When the underwriting agreement has been or will be reached.</p></td></tr><tr><td><p>SECTION 6</p></td><td><p>ADMISSION TO TRADING AND DEALING ARRANGEMENTS</p></td></tr><tr><td><p>Item 6.1</p></td><td><p>An indication as to whether the securities offered are or will be the object of an application for admission to trading, with a view to their distribution in a regulated market or third country market, SME Growth Market or MTF with an indication of the markets in question. This circumstance must be set out, without creating the impression that the admission to trading will necessarily be approved. If known, the earliest dates on which the securities will be admitted to trading.</p></td></tr><tr><td><p>Item 6.2</p></td><td><p>All the regulated markets, third country markets, SME Growth Market or MTFs on which, to the knowledge of the issuer, securities of the same class of the securities to be offered or admitted to trading are already admitted to trading.</p></td></tr><tr><td><p>Item 6.3</p></td><td><p>If simultaneously or almost simultaneously with the application for the admission of the securities to a regulated market, securities of the same class are subscribed for or placed privately or if securities of other classes are created for public or private placing, give details of the nature of such operations and of the number, characteristics and price of the securities to which they relate.</p></td></tr><tr><td><p>Item 6.4</p></td><td><p>In case of an admission to trading on a regulated market, details of the entities which have given a firm commitment to act as intermediaries in secondary trading, providing liquidity through bid and offer rates and a description of the main terms of their commitment.</p></td></tr><tr><td><p>Item 6.5</p></td><td><p>Details of any stabilisation in line with items 6.5.1 to 6.6 in case of an admission to trading on a regulated market, third country market, SME Growth Market or MTF, where an issuer or a selling shareholder has granted an over-allotment option or it is otherwise proposed that price stabilising activities may be entered into in connection with an offer:</p></td></tr><tr><td><p>Item 6.5.1</p></td><td><p>The fact that stabilisation may be undertaken, that there is no assurance that it will be undertaken and that it may be stopped at any time;</p></td></tr><tr><td><p>Item 6.5.1.1</p></td><td><p>The fact that stabilisation transactions aim at supporting the market price of the securities during the stabilisation period;</p></td></tr><tr><td><p>Item 6.5.2</p></td><td><p>The beginning and the end of the period during which stabilisation may occur;</p></td></tr><tr><td><p>Item 6.5.3</p></td><td><p>The identity of the stabilisation manager for each relevant jurisdiction unless this is not known at the time of publication;</p></td></tr><tr><td><p>Item 6.5.4</p></td><td><p>The fact that stabilisation transactions may result in a market price that is higher than would otherwise prevail;</p></td></tr><tr><td><p>Item 6.5.5</p></td><td><p>The place where the stabilisation may be undertaken including, where relevant, the name of the trading venue(s).</p></td></tr><tr><td><p>Item 6.6</p></td><td><p>Over-allotment and ‘green shoe’:</p><p>In case of an admission to trading on a regulated market, SME Growth Market or an MTF:</p><p>(a)  the existence and size of any over-allotment facility and/or ‘green shoe’;</p><p>(b)  the existence period of the over-allotment facility and/or ‘green shoe’;</p><p>(c)  any conditions for the use of the over-allotment facility or exercise of the ‘green shoe’.</p></td></tr><tr><td><p>SECTION 7</p></td><td><p>SELLING SECURITIES HOLDERS</p></td></tr><tr><td><p>Item 7.1</p></td><td><p>Name and business address of the person or entity offering to sell the securities, the nature of any position office or other material relationship that the selling persons has had within the past three years with the issuer or any of its predecessors or affiliates.</p></td></tr><tr><td><p>Item 7.2</p></td><td><p>The number and class of securities being offered by each of the selling security holders.</p></td></tr><tr><td><p>Item 7.3</p></td><td><p>Where a major shareholder is selling the securities, the size of its shareholding both before and immediately after the issuance.</p></td></tr><tr><td><p>Item 7.4</p></td><td><p>In relation to lock-up agreements, provide details of the following:</p><p>(a)  the parties involved;</p><p>(b)  the content and exceptions of the agreement;</p><p>(c)  an indication of the period of the lock up.</p></td></tr><tr><td><p>SECTION 8</p></td><td><p>EXPENSE OF THE ISSUE/OFFER</p></td></tr><tr><td><p>Item 8.1</p></td><td><p>The total net proceeds and an estimate of the total expenses of the issue/offer.</p></td></tr><tr><td><p>SECTION 9</p></td><td><p>DILUTION</p></td></tr><tr><td><p>Item 9.1</p></td><td><p>A comparison of:</p><p>(a)  participation in share capital and voting rights for existing shareholders before and after the capital increase resulting from the public offer, with the assumption that existing shareholders do not subscribe for the new shares;</p><p>(b)  the net asset value per share as of the date of the latest balance sheet before the public offer (selling offer and/or capital increase) and the offering price per share within that public offer.</p></td></tr><tr><td><p>Item 9.2</p></td><td><p>Where existing shareholders will be diluted regardless of whether they subscribe for their entitlement, because a part of the relevant share issue is reserved only for certain investors (e.g. an institutional placing coupled with an offer to shareholders), an indication of the dilution existing shareholders will experience shall also be presented on the basis that they do take up their entitlement (in addition to the situation in item 9.1 where they do not).</p></td></tr><tr><td><p>SECTION 10</p></td><td><p>ADDITIONAL INFORMATION</p></td></tr><tr><td><p>Item 10.1</p></td><td><p>If advisors connected with an issue are referred to in the Securities Note, a statement of the capacity in which the advisors have acted.</p></td></tr><tr><td><p>Item 10.2</p></td><td><p>An indication of other information in the securities note which has been audited or reviewed by statutory auditors and where auditors have produced a report. Reproduction of the report or, with permission of the competent authority, a summary of the report.</p></td></tr><tr><td><div><a>(<span>1</span>)   </a><p>Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190).</p></div></td></tr></tbody></table>
ANNEX 12
SECURITIES NOTE FOR SECONDARY ISSUANCES OF EQUITY SECURITIES OR OF UNITS ISSUED BY COLLECTIVE INVESTMENT UNDERTAKINGS OF THE CLOSED-END TYPE
<table><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>PERSONS RESPONSIBLE, THIRD PARTY INFORMATION, EXPERTS’ REPORTS AND COMPETENT AUTHORITY APPROVAL</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Identify all persons responsible for the information or any parts of it, given in the securities note with, in the latter case, an indication of such parts. In the case of natural persons, including members of the issuer’s administrative, management or supervisory bodies, indicate the name and function of the person; in the case of legal persons indicate the name and registered office.</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>A declaration by those responsible for the securities note that to the best of their knowledge, the information contained in the securities note is in accordance with the facts and that the securities note makes no omission likely to affect its import.</p><p>Where applicable, a declaration by those responsible for certain parts of the securities note that, to the best of their knowledge, the information contained in those parts of the securities note for which they are responsible is in accordance with the facts and that those parts of the securities note make no omission likely to affect their import.</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Where a statement or report attributed to a person as an expert is included in the securities note, provide the following details for that person:</p><p>(a)  name;</p><p>(b)  business address;</p><p>(c)  qualifications;</p><p>(d)  material interest if any in the issuer.</p><p>If the statement or report has been produced at the issuer’s request, state that such statement or report has been included in the securities note with the consent of the person who has authorised the contents of that part of the securities note for the purpose of the prospectus.</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Where information has been sourced from a third party, provide a confirmation that this information has been accurately reproduced and that as far as the issuer is aware and is able to ascertain from information published by that third party, no facts have been omitted which would render the reproduced information inaccurate or misleading. In addition, identify the source(s) of the information.</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>A statement that:</p><p>(a)  this [securities note/prospectus] has been approved by the [name of competent authority], as competent authority under Regulation (EU) 2017/1129;</p><p>(b)  the [name of competent authority] only approves this [securities note/prospectus] as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation (EU) 2017/1129;</p><p>(c)  such approval should not be considered as an endorsement of the quality of the securities that are the subject of this [securities note/prospectus];</p><p>(d)  investors should make their own assessment as to the suitability of investing in the securities;</p><p>(e)  that the [securities note/prospectus] has been drawn up as part of a simplified prospectus in accordance with Article 14 of Regulation (EU) 2017/1129.</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>RISK FACTORS</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>A description of the material risks that are specific to the securities being offered and/or admitted to trading, in a limited number of categories, in a section headed ‘Risk Factors’.</p><p>In each category the most material risks, in the assessment of the issuer, offeror or person asking for admission to trading on a regulated market, taking into account the negative impact on the issuer and the securities and the probability of their occurrence, shall be set out first. The risks shall be corroborated by the content of the securities note.</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>ESSENTIAL INFORMATION</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>Interest of natural and legal persons involved in the issue/offer</p><p>A description of any interest, including a conflict of interest that is material to the issue/offer, detailing the persons involved and the nature of the interest.</p></td></tr><tr><td><p>Item 3.2</p></td><td><p>Reasons for the offer and use of proceeds</p><p>Reasons for the offer and, where applicable, the estimated net amount of the proceeds broken into each principal intended use and presented in order of priority of such uses. If the issuer is aware that the anticipated proceeds will not be sufficient to fund all the proposed uses, then state the amount and sources of other funds needed. Details must also be given with regard to the use of the proceeds, in particular when they are being used to acquire assets, other than in the ordinary course of business, to finance announced acquisitions of other business, or to discharge, reduce or retire indebtedness.</p></td></tr><tr><td><p>Item 3.3</p></td><td><p>Working capital statement</p><p>Statement by the issuer that, in its opinion, the working capital is sufficient for the issuer’s present requirements or, if not, how it proposes to provide the additional working capital needed.</p></td></tr><tr><td><p>Item 3.4</p></td><td><p>Capitalisation and indebtedness</p><p>A statement of capitalisation and indebtedness (distinguishing between guaranteed and unguaranteed, secured and unsecured indebtedness) as of a date no earlier than 90 days prior to the date of the document. The term ‘indebtedness’ also includes indirect and contingent indebtedness.</p><p>In the case of material changes in the capitalisation and indebtedness position of the issuer within the 90 day period additional information shall be given through the presentation of a narrative description of such changes or through the updating of those figures.</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>INFORMATION CONCERNING THE SECURITIES TO BE OFFERED/ADMITTED TO TRADING</p></td></tr><tr><td><p>Item 4.1</p></td><td><p>A description of the type, class and amount of the securities being offered and/or admitted to trading, including the international security identification number (‘ISIN’).</p></td></tr><tr><td><p>Item 4.2</p></td><td><p>Currency of the securities issue.</p></td></tr><tr><td><p>Item 4.3</p></td><td><p>In the case of new issues, a statement of the resolutions, authorisations and approvals by virtue of which the securities have been or will be created and/or issued.</p></td></tr><tr><td><p>Item 4.4</p></td><td><p>A description of any restrictions on the transferability of the securities.</p></td></tr><tr><td><p>Item 4.5</p></td><td><p>A warning that the tax legislation of the investor’s Member State and of the issuer’s country of incorporation may have an impact on the income received from the securities.</p><p>Information on the taxation treatment of the securities where the proposed investment attracts a tax regime specific to that type of investment.</p></td></tr><tr><td><p>Item 4.6</p></td><td><p>If different from the issuer, the identity and contact details of the offeror, of the securities and/or the person asking for admission to trading including the legal entity identifier (‘LEI’) where the offeror has legal personality.</p></td></tr><tr><td><p>Item 4.7</p></td><td><p>A description of the rights attached to the securities, including any limitations of those rights, and procedure for the exercise of those rights:</p><p>(a)  Dividend rights:</p><p>(i)  fixed date(s) on which the entitlement arises;</p><p>(ii)  time limit after which entitlement to dividend lapses and an indication of the person in whose favour the lapse operates;</p><p>(iii)  dividend restrictions and procedures for non-resident holders;</p><p>(iv)  rate of dividend or method of its calculation, periodicity and cumulative or non-cumulative nature of payments.</p><p>(b)  voting rights.</p><p>(c)  pre-emption rights in offers for subscription of securities of the same class.</p><p>(d)  right to share in the issuer’s profits.</p><p>(e)  rights to share in any surplus in the event of liquidation.</p><p>(f)  redemption provisions.</p><p>(g)  conversion provisions.</p></td></tr><tr><td><p>Item 4.8</p></td><td><p>Statement on the existence of national legislation on takeovers applicable to the issuer which may frustrate such takeovers, if any.</p></td></tr><tr><td><p>Item 4.9</p></td><td><p>An indication of public takeover bids by third parties in respect of the issuer’s equity, which have occurred during the last financial year and the current financial year. The price or exchange terms attaching to such offers and the outcome thereof must be stated.</p></td></tr><tr><td><p>SECTION 5</p></td><td><p>TERMS AND CONDITIONS OF THE OFFER</p></td></tr><tr><td><p>Item 5.1</p></td><td><p>Conditions, offer statistics, expected timetable and action required to apply for the offer</p></td></tr><tr><td><p>Item 5.1.1</p></td><td><p>Conditions to which the offer is subject.</p></td></tr><tr><td><p>Item 5.1.2</p></td><td><p>The time period, including any possible amendments, during which the offer will be open and a description of the application process together with the issue date of new securities.</p></td></tr><tr><td><p>Item 5.1.3</p></td><td><p>A description of any possibility to reduce subscriptions and the manner for refunding amounts paid in excess by applicants.</p></td></tr><tr><td><p>Item 5.1.4</p></td><td><p>Details of the minimum and/or maximum amount of application (whether in number of securities or aggregate amount to invest).</p></td></tr><tr><td><p>Item 5.1.5</p></td><td><p>Method and time limits for paying up the securities and for delivery of the securities.</p></td></tr><tr><td><p>Item 5.1.6</p></td><td><p>A full description of the manner and date in which results of the offer are to be made public.</p></td></tr><tr><td><p>Item 5.1.7</p></td><td><p>The procedure for the exercise of any right of pre-emption, the negotiability of subscription rights and the treatment of subscription rights not exercised.</p></td></tr><tr><td><p>Item 5.1.8</p></td><td><p>Total amount of the issue/offer, distinguishing the securities offered for sale and those offered for subscription; if the amount is not fixed, an indication of the amount of securities to be offered (if available) and a description of the arrangements and time for announcing to the public the definitive amount of the offer.</p><p>Where the maximum amount of securities to be offered cannot be provided in the securities note, the securities note shall specify that acceptances of the purchase of subscription of securities may be withdrawn up to two working days after the amount of securities to be offered to the public has been filed.</p></td></tr><tr><td><p>Item 5.1.9</p></td><td><p>An indication of when, and under which circumstances, the offer may be revoked or suspended and whether revocation can occur after dealing has begun.</p></td></tr><tr><td><p>Item 5.1.10</p></td><td><p>An indication of the period during which an application may be withdrawn, provided that investors are allowed to withdraw their subscription.</p></td></tr><tr><td><p>Item 5.2</p></td><td><p>Plan of distribution and allotment</p></td></tr><tr><td><p>Item 5.2.1.</p></td><td><p>Process for notifying applicants of the amount allotted and an indication whether dealing may begin before notification is made.</p></td></tr><tr><td><p>Item 5.2.2</p></td><td><p>To the extent known to the issuer, an indication of whether major shareholders or members of the issuer’s management, supervisory or administrative bodies intended to subscribe in the offer, or whether any person intends to subscribe for more than five per cent of the offer.</p></td></tr><tr><td><p>Item 5.3</p></td><td><p>Pricing</p></td></tr><tr><td><p>Item 5.3.1</p></td><td><p>An indication of the price at which the securities will be offered and the amount of any expenses and taxes charged to the subscriber or purchaser.</p><p>If the price is not known, then pursuant to Article 17 of Regulation (EU) 2017/1129 indicate either:</p><p>(a)  the maximum price of securities, as far as they are available;</p><p>(b)  the valuation methods and criteria, and/or conditions, in accordance with which the final offer price is to be determined and an explanation of any valuation methods used.</p><p>Where neither (a) nor (b) can be provided in the securities note, the securities note shall specify that acceptances of the purchase or subscription of securities may be withdrawn up to two working days after the final offer price of securities to be offered to the public has been filed.</p></td></tr><tr><td><p>Item 5.3.2</p></td><td><p>Process for the disclosure of the offer price.</p></td></tr><tr><td><p>Item 5.3.3</p></td><td><p>If the issuer’s equity holders have pre-emptive purchase rights and this right is restricted or withdrawn, an indication of the basis for the issue price if the issue is for cash, together with the reasons for and beneficiaries of such restriction or withdrawal.</p></td></tr><tr><td><p>Item 5.4</p></td><td><p>Placing and underwriting</p></td></tr><tr><td><p>Item 5.4.1</p></td><td><p>Name and address of the coordinator(s) of the global offer and of single parts of the offer and, to the extent known by the issuer or to the offeror, of the placers in the various countries where the offer takes place</p></td></tr><tr><td><p>Item 5.4.2</p></td><td><p>Name and address of any paying agents and depository agents in each country.</p></td></tr><tr><td><p>Item 5.4.3</p></td><td><p>Name and address of the entities agreeing to underwrite the issue on a firm commitment basis, and name and address of the entities agreeing to place the issue without a firm commitment or under ‘best efforts’ arrangements. Indication of the material features of the agreements, including the quotas. Where not all of the issue is underwritten, a statement of the portion not covered. Indication of the overall amount of the underwriting commission and of the placing commission.</p></td></tr><tr><td><p>Item 5.4.4</p></td><td><p>When the underwriting agreement has been or will be reached.</p></td></tr><tr><td><p>SECTION 6</p></td><td><p>ADMISSION TO TRADING AND DEALING ARRANGEMENTS</p></td></tr><tr><td><p>Item 6.1</p></td><td><p>An indication as to whether the securities offered are or will be the object of an application for admission to trading, with a view to their distribution in a regulated market, other equivalent third country markets or an SME Growth Market with an indication of the markets in question. This circumstance must be set out, without creating the impression that the admission to trading will necessarily be approved. If known, the earliest dates on which the securities will be admitted to trading.</p></td></tr><tr><td><p>Item 6.2</p></td><td><p>All the regulated markets equivalent third country markets or SME Growth Markets on which, to the knowledge of the issuer, securities of the same class of the securities to be offered or admitted to trading are already admitted to trading.</p></td></tr><tr><td><p>Item 6.3</p></td><td><p>If simultaneously or almost simultaneously with the application for admission of the securities to a regulated market, securities of the same class are subscribed for or placed privately or if securities of other classes are created for public or private placing, give details of the nature of such operations and of the number, characteristics and price of the securities to which they relate.</p></td></tr><tr><td><p>Item 6.4</p></td><td><p>Details of the entities which have given a firm commitment to act as intermediaries in secondary trading, providing liquidity through bid and offer rates and description of the main terms of their commitment.</p></td></tr><tr><td><p>SECTION 7</p></td><td><p>SELLING SECURITIES HOLDERS</p></td></tr><tr><td><p>Item 7.1</p></td><td><p>Lock-up agreements</p><p>In relation to lock up agreements, provide details of the following:</p><p>(a)  the parties involved;</p><p>(b)  content and exceptions of the agreement;</p><p>(c)  an indication of the period of the lock up.</p></td></tr><tr><td><p>SECTION 8</p></td><td><p>EXPENSE OF THE ISSUE/OFFER</p></td></tr><tr><td><p>Item 8.1</p></td><td><p>The total net proceeds and an estimate of the total expenses of the issue/offer.</p></td></tr><tr><td><p>SECTION 9</p></td><td><p>DILUTION</p></td></tr><tr><td><p>Item 9.1</p></td><td><p>A comparison of</p><p>(a)  participation in share capital and voting rights for existing shareholders before and after the capital increase resulting from the public offer, with the assumption that existing shareholders do not subscribe for the new shares;</p><p>(b)  the net asset value per share as of the date of the latest balance sheet before the public offer (selling offer and/or capital increase) and the offering price per share within that public offer.</p></td></tr><tr><td><p>Item 9.2</p></td><td><p>Where existing shareholders will be diluted regardless of whether they subscribe for their entitlement, because a part of the relevant share issue is reserved only for certain investors (e.g. an institutional placing coupled with an offer to shareholders), an indication of the dilution existing shareholders will experience should also be presented on the basis that they do take up their entitlement (in addition to the situation where they do not).</p></td></tr><tr><td><p>SECTION 10</p></td><td><p>ADDITIONAL INFORMATION</p></td></tr><tr><td><p>Item 10.1</p></td><td><p>If advisors connected with an issue are referred to in the securities note, a statement of the capacity in which the advisors have acted.</p></td></tr><tr><td><p>Item 10.2</p></td><td><p>An indication of other information in the securities note which has been audited or reviewed by statutory auditors and where auditors have produced a report. Reproduction of the report or, with permission of the competent authority, a summary of the report.</p></td></tr></tbody></table>
ANNEX 13
SECURITIES NOTE FOR DEPOSITORY RECEIPTS ISSUED OVER SHARES
<table><col/><col/><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>ESSENTIAL INFORMATION</p></td><td><p>Primary Issuance</p></td><td><p>Secondary Issuances</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Working Capital Statement</p><p>Statement by the issuer of the underlying securities that, in its opinion, the working capital is sufficient for the issuer of the underlying securities’ present requirements or, if not, how it proposes to provide the additional working capital needed.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>Capitalisation and indebtedness</p><p>A statement of capitalisation and indebtedness of the issuer of the underlying securities (distinguishing between guaranteed and unguaranteed, secured and unsecured indebtedness) as of a date no earlier than 90 days prior to the date of the document. The term ‘indebtedness’ also includes indirect and contingent indebtedness.</p><p>In the case of material changes in the capitalisation and indebtedness position of the issuer within the 90 day period additional information shall be given through the presentation of a narrative description of such changes or through the updating of those figures.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>A description of the type and the class of the underlying shares including the international security identification number (‘ISIN’)</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Legislation under which the securities have been created.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>An indication whether the underlying shares are in registered form or bearer form and whether the underlying shares are in certificated form or book-entry form. In the latter case, name and address of the entity in charge of keeping the records.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.6</p></td><td><p>Currency of the underlying shares.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.7</p></td><td><p>A description of the rights, including any limitations of these, attached to the underlying shares and procedure for the exercise of those rights.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.8</p></td><td><p>Dividend rights:</p><p>(a)  fixed date(s) on which the entitlement arises;</p><p>(b)  time limit after which entitlement to dividend lapses and an indication of the person in whose favour the lapse operates;</p><p>(c)  dividend restrictions and procedures for non-resident holders;</p><p>(d)  rate of dividend or method of its calculation, periodicity and cumulative or non-cumulative nature of payments.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.9</p></td><td><p>Voting rights.</p><p>Pre-emption rights in offers for subscription of securities of the same class.</p><p>Right to share in the issuer’s profits.</p><p>Rights to share in any surplus in the event of liquidation.</p><p>Redemption provisions.</p><p>Conversion provisions.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.10</p></td><td><p>The issue date of the underlying shares if new underlying shares are being created for the issue of depository receipts and they are not in existence at the time of issue of the depository receipts.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.11</p></td><td><p>If new underlying shares are being created for the issue of the depository receipts, state the resolutions, authorisations and approvals by virtue of which the new underlying shares have been or will be created or issued.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.12</p></td><td><p>A description of any restrictions on the transferability of the underlying shares.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.13</p></td><td><p>A warning that the tax legislation of the investor’s Member State and of the issuer’s country of incorporation may have an impact on the income received from the securities.</p><p>Information on the taxation treatment of the securities where the proposed investment attracts a tax regime specific to that type of investment.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.14</p></td><td><p>(a)  Statement on the existence of any national legislation on takeovers applicable to the issuer which may frustrate such takeovers, if any.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>(b)  A brief description of the shareholders’ rights and obligations in case of mandatory takeover bids and/or squeeze-out or sell-out rules in relation to the securities.</p></td><td><p>√</p></td><td><p> </p><div/></td></tr><tr><td><p>Item 1.15</p></td><td><p>An indication of public takeover bids by third parties in respect of the issuer’s equity, which have occurred during the last financial year and the current financial year. The price or exchange terms attaching to such offers and the outcome thereof must be stated.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.16</p></td><td><p>Where applicable, the potential impact on the investment in the event of resolution under the Directive 2014/59/EU.</p></td><td><p>√</p></td><td><p> </p><div/></td></tr><tr><td><p>Item 1.17</p></td><td><p>Lock-up agreements</p><p>(a)  The parties involved.</p><p>(b)  Content and exceptions of the agreement.</p><p>(c)  An indication of the period of the lock up.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.18</p></td><td><p>Information about selling shareholders if any.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.18.1</p></td><td><p>Name and business address of the person or entity offering to sell the underlying shares, the nature of any position office or other material relationship that the selling persons has had within the past three years with the issuer or any of its predecessors or affiliates.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.19</p></td><td><p>Dilution</p></td></tr><tr><td><p>Item 1.19.1</p></td><td><p>A comparison of:</p><p>(a)  participation in share capital and voting rights for existing shareholders before and after the capital increase resulting from the public offer, with the assumption that existing shareholders do not subscribe for the new shares;</p><p>(b)  the net asset value per share as of the date of the latest balance sheet before the public offer (selling offer and/or capital increase) and the offering price per share within that public offer.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.19.2</p></td><td><p>Where existing shareholders will be diluted regardless of whether they subscribe for their entitlement, because a part of the relevant share issue is reserved only for certain investors (e.g. an institutional placing coupled with an offer to shareholders), an indication of the dilution existing shareholders will experience shall also be presented on the basis that they do take up their entitlement (in addition to the situation in 1.19.1 where they do not).</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.20</p></td><td><p>Additional information where there is a simultaneous or almost simultaneous offer or admission to trading of the same class of underlying shares as those underlying shares over which the depository receipts are being issued.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.20.1</p></td><td><p>If simultaneously or almost simultaneously with the creation of the depository receipts for which admission to a regulated market is being sought underlying shares of the same class as those over which the depository receipts are being issued are subscribed for or placed privately, details are to be given of the nature of such operations and of the number and characteristics of the underlying shares to which they relate.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.20.2</p></td><td><p>Disclose all regulated markets or equivalent markets on which, to the knowledge of the issuer of the depository receipts, underlying shares of the same class as those over which the depository receipts are being issued are offered or admitted to trading.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 1.20.3</p></td><td><p>To the extent known to the issuer of the depository receipts, indicate whether major shareholders, members of the administrative, management or supervisory bodies intended to subscribe in the offer, or whether any person intends to subscribe for more than five per cent of the offer.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>INFORMATION ABOUT THE DEPOSITORY RECEIPTS</p></td><td><p>Primary Issuance</p></td><td><p>Secondary Issuances</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>Indicate the number of shares represented by each depository receipts</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 2.2</p></td><td><p>A description of the type and class of depository receipts being offered and/or admitted to trading</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 2.3</p></td><td><p>Legislation under which the depository receipts have been created.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 2.4</p></td><td><p>An indication whether the depository receipts are in registered or bearer form and whether the depository receipts are in certificated or book-entry form. In the latter case, include the name and address of the entity in charge of keeping the records.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 2.5</p></td><td><p>Currency of the depository receipts</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 2.6</p></td><td><p>Describe the rights attaching to the depository receipts, including any limitations of these attached to the depository receipts and the procedure if any for the exercise of these rights.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 2.7</p></td><td><p>If the dividend rights attaching to depository receipts are different from the dividend rights disclosed in relation to the underlying shares, disclose the following information about dividend rights:</p><p>(a)  fixed date(s) on which the entitlement arises;</p><p>(b)  time limit after which entitlement to dividend lapses and an indication of the person in whose favour the lapse operates;</p><p>(c)  dividend restrictions and procedures for non-resident holders;</p><p>(d)  rate of dividend or method of its calculation, periodicity and cumulative or non-cumulative nature of payments.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 2.8</p></td><td><p>If the voting rights attaching to the depository receipts are different from the voting rights disclosed in relation to the underlying shares disclose the following about those rights:</p><p>(a)  voting rights;</p><p>(b)  pre-emption rights in offers for subscription of securities of the same class;</p><p>(c)  right to share in the issuer’s profits;</p><p>(d)  rights to share in any surplus in the event of liquidation;</p><p>(e)  redemption provisions;</p><p>(f)  conversion provisions.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 2.9</p></td><td><p>Describe the exercise of and benefit from rights attaching to the underlying shares, in particular voting rights, the conditions on which the issuer of the depository receipts may exercise such rights, and measures envisaged to obtain the instructions of the depository receipt holders – and the right to share in profits and any liquidation surplus which are not passed on to the holder of the depository receipt.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 2.10</p></td><td><p>The expected issue date of the depository receipts.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 2.11</p></td><td><p>A description of any restrictions on the transferability of the depository receipts.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 2.12</p></td><td><p>A warning that the tax legislation of the investor’s Member State and of the issuer’s country of incorporation may have an impact on the income received from the securities.</p><p>Information on the taxation treatment of the depository receipts where the proposed investment attracts a tax regime specific to that type of investment.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 2.13</p></td><td><p>Bank or other guarantees attached to the depository receipts and intended to underwrite the issuer’s obligations.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 2.14</p></td><td><p>Possibility of obtaining the delivery of the depository receipts into original shares and procedure for such delivery.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>INFORMATION ABOUT THE TERMS AND CONDITIONS OF THE OFFER OF THE DEPOSITORY RECEIPTS</p></td><td><p>Primary Issuance</p></td><td><p>Secondary Issuances</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>Conditions, offer statistics, expected timetable and action required to apply for the offer</p></td></tr><tr><td><p>Item 3.1.1</p></td><td><p>Total amount of the issue/offer, distinguishing the securities offered for sale and those offered for subscription; if the amount is not fixed, an indication of the maximum amount of securities to be offered (if available) and a description of the arrangements and the time period for announcing to the public the definitive amount of the offer.</p><p>Where the maximum amount of securities to be offered cannot be provided in the prospectus, the prospectus shall specify that acceptances of the purchase or subscription of securities may be withdrawn for not less than two working days after the amount of securities to be offered to the public has been filed.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.1.2</p></td><td><p>The time period, including any possible amendments, during which the offer will be open and description of the application process.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.1.3</p></td><td><p>An indication of when, and under which circumstances, the offer may be revoked or suspended and whether revocation can occur after dealing has begun.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.1.4</p></td><td><p>A description of the possibility to reduce subscriptions and the manner for refunding amounts paid in excess by applicants.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.1.5</p></td><td><p>Details of the minimum and/or maximum amount of application (whether in number of securities or aggregate amount to invest).</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.1.6</p></td><td><p>An indication of the period during which an application may be withdrawn, provided that investors are allowed to withdraw their subscription.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.1.7</p></td><td><p>Method and time limits for paying up the securities and for delivery of the securities.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.1.8</p></td><td><p>A full description of the manner and date in which results of the offer are to be made public.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.1.9</p></td><td><p>The procedure for the exercise of any right of pre-emption, the negotiability of subscription rights and the treatment of subscription rights not exercised.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.2</p></td><td><p>Plan of distribution and allotment</p></td></tr><tr><td><p>Item 3.2.1</p></td><td><p>The various categories of potential investors to which the securities are offered. If the offer is being made simultaneously in the markets of two or more countries and if a tranche has been or is being reserved for certain of these, indicate any such tranche.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.2.2</p></td><td><p>To the extent known to the issuer, an indication of whether major shareholders or members of the issuer’s management, supervisory or administrative bodies intended to subscribe in the offer, or whether any person intends to subscribe for more than five per cent of the offer.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.2.3</p></td><td><p>Pre-allotment disclosure:</p><p>(a)  the division into tranches of the offer including the institutional, retail and issuer’s employee tranches and any other tranches;</p><p>(b)  the conditions under which the claw- back may be used, the maximum size of such claw back and any applicable minimum percentages for individual tranches;</p><p>(c)  the allotment method or methods to be used for the retail and issuer’s employee tranche in the event of an over-subscription of these tranches;</p><p>(d)  a description of any pre-determined preferential treatment to be accorded to certain classes of investors or certain affinity groups (including friends and family programmes) in the allotment, the percentage of the offer reserved for such preferential treatment and the criteria for inclusion in such classes or groups;</p><p>(e)  whether the treatment of subscriptions or bids to subscribe in the allotment may be determined on the basis of which firm they are made through or by;</p><p>(f)  a target minimum individual allotment if any within the retail tranche;</p><p>(g)  the conditions for the closing of the offer as well as the date on which the offer may be closed at the earliest;</p><p>(h)  whether or not multiple subscriptions are admitted, and where they are not, how any multiple subscriptions will be handled.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.2.4</p></td><td><p>Process for notifying applicants of the amount allotted and an indication whether dealing may begin before notification is made.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.3</p></td><td><p>Pricing</p></td></tr><tr><td><p>Item 3.3.1</p></td><td><p>An indication of the price at which the securities will be offered and the amount of any expenses and taxes charged to the subscriber or purchaser.</p><p>If the price is not known, then pursuant to Article 17 of Regulation (EU) 2017/1129 indicate either:</p><p>(a)  the maximum price of the securities, as far as they are available;</p><p>(b)  the valuation methods and criteria, and/or conditions, in accordance with which the final offer price has been or will be determined and an explanation of any valuation methods used.</p><p>Where neither (a) nor (b) can be provided in the prospectus, the prospectus shall specify that acceptances of the purchase or subscription of securities may be withdrawn for not less than two working days after the final offer price of securities to be offered to the public has been filed.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.3.2</p></td><td><p>Process for the disclosure of the offer price.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.3.3</p></td><td><p>Where there is or could be a material disparity between the public offer price and the effective cash cost to members of the administrative, management or supervisory bodies or senior management, or affiliated persons, of securities acquired by them in transactions during the past year, or which they have the right to acquire, include a comparison of the public contribution in the proposed public offer an the effective cash contributions of such persons.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.4</p></td><td><p>Placing and Underwriting</p></td></tr><tr><td><p>Item 3.4.1</p></td><td><p>Name and address of the coordinator(s) of the global offer and of single parts of the offer and, to the extent known to the issuer or to the offeror, of the placers in the various countries where the offer takes place.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.4.2</p></td><td><p>Name and address of any paying agents and depository agents in each country.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.4.3</p></td><td><p>Name and address of the entities agreeing to underwrite the issue on a firm commitment basis, and name and address of the entities agreeing to place the issue without a firm commitment or under best efforts’ arrangements. Indication of the material features of the agreements, including the quotas. Where not all of the issue is underwritten, a statement of the portion not covered. Indication of the overall amount of the underwriting commission and of the placing commission.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 3.4.4</p></td><td><p>When the underwriting agreement has been or will be reached.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>ADMISSION TO TRADING AND DEALING ARRANGEMENTS IN THE DEPOSITORY RECEIPTS</p></td><td><p>Primary Issuance</p></td><td><p>Secondary Issuances</p></td></tr><tr><td><p>Item 4.1</p></td><td><p>An indication as to whether the securities offered are or will be the object of an application for admission to trading, with a view to their distribution in a regulated market or equivalent third country market, SME Growth Market or MTF with an indication of the markets in question. This circumstance must be set out, without creating the impression that the admission to trading will necessarily be approved. If known, the earliest dates on which the securities will be admitted to trading.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 4.2</p></td><td><p>All the regulated markets or equivalent third country markets, SME Growth Market or MTFs on which, to the knowledge of the issuer, securities of the same class of the securities to be offered or admitted to trading are already admitted to trading.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 4.3</p></td><td><p>If simultaneously or almost simultaneously with the creation of the securities for which admission to a regulated market is being sought securities of the same class are subscribed for or placed privately or if securities of other classes are created for public or private placing, give details of the nature of such operations and of the number and characteristics of the securities to which they relate.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>In case of an admission to trading on a regulated market, details of the entities which have a firm commitment to act as intermediaries in secondary trading, providing liquidity through bid and offer rates and description of the main terms of their commitment.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 4.4</p></td><td><p>The issue price of the securities</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Details of stabilisation: where an issuer or a selling shareholder has granted an over-allotment option or it is otherwise proposed that price stabilising activities may be entered into in connection with an offer:</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>The fact that stabilisation may be undertaken, that there is no assurance that it will be undertaken and that it may be stopped at any time.</p></td><td><p>√</p></td><td><p> </p><div/></td></tr><tr><td><p>Item 4.5</p></td><td><p>The fact that stabilisation transactions aim at supporting the market price of the securities during the stabilisation period.</p></td><td><p>√</p></td><td><p> </p><div/></td></tr><tr><td><p>The beginning and the end of the period during which stabilisation may occur.</p></td><td><p>√</p></td><td><p> </p><div/></td></tr><tr><td><p>The identity of the stabilisation manager for each relevant jurisdiction unless this is not known at the time of publication.</p></td><td><p>√</p></td><td><p> </p><div/></td></tr><tr><td><p>The fact that stabilisation transactions may result in a market price that is higher than would otherwise prevail.</p></td><td><p>√</p></td><td><p> </p><div/></td></tr><tr><td><p>Item 4.6</p></td><td><p>The place where the stabilisation may be undertaken including, where relevant, the name of the trading venue(s).</p></td><td><p>√</p></td><td><p> </p><div/></td></tr><tr><td><p>Over-allotment and ‘green shoe’:</p><p>In case of an admission to trading on a regulated market:</p><p>(a)  the existence and size of any over-allotment facility and/or ‘green shoe’;</p><p>(b)  the existence period of the over-allotment facility and/or ‘green shoe’;</p><p>(c)  any conditions for the use of the over-allotment facility or exercise of the ‘green shoe’.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>SECTION 5</p></td><td><p>ESSENTIAL INFORMATION ABOUT THE ISSUANCE OF THE DEPOSITORY RECEIPTS</p></td><td><p>Primary Issuance</p></td><td><p>Secondary Issuances</p></td></tr><tr><td><p>Item 5.1</p></td><td><p>Reasons for the offer and use of proceeds</p></td></tr><tr><td><p>Item 5.1.1</p></td><td><p>Reasons for the offer and, where applicable, the estimated net amount of the proceeds broken into each principal intended use and presented in order of priority of such uses. If the issuer is aware that the anticipated proceeds will not be sufficient to fund all the proposed uses, then state the amount and sources of other funds needed. Details must also be given with regard to the use of the proceeds, in particular when they are being used to acquire assets, other than in the ordinary course of business, to finance announced acquisitions of other business, or to discharge, reduce or retire indebtedness.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 5.2</p></td><td><p>Interest of natural and legal persons involved in the issuer/offer</p></td></tr><tr><td><p>Item 5.2.1</p></td><td><p>A description of any interest, including a conflict of interest that is material to the issue/offer, detailing the persons involved and the nature of the interest.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>Item 5.3</p></td><td><p>Risk Factors</p></td></tr><tr><td><p>Item 5.3.1</p></td><td><p>A description of the material risks that are specific to the securities being offered and/or admitted to trading in a limited number of categories, in a section headed ‘Risk Factors’.</p><p>In each category the most material risks, in the assessment of the issuer, offeror or person asking for admission to trading on a regulated market, taking into account the negative impact on the issuer and the securities and the probability of their occurrence, shall be set out first. The risks shall be corroborated by the content of the prospectus.</p></td><td><p>√</p></td><td><p>√</p></td></tr><tr><td><p>SECTION 6</p></td><td><p>EXPENSE OF THE ISSUE/OFFER OF THE DEPOSITORY RECEIPTS</p></td><td><p>Primary Issuance</p></td><td><p>Secondary Issuances</p></td></tr><tr><td><p>Item 6.1</p></td><td><p>The total net proceeds and an estimate of the total expenses of the issue/offer.</p></td><td><p>√</p></td><td><p>√</p></td></tr></tbody></table>
ANNEX 14
SECURITIES NOTE FOR RETAIL NON-EQUITY SECURITIES
<table><col/><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>PERSONS RESPONSIBLE, THIRD PARTY INFORMATION, EXPERTS’ REPORTS AND COMPETENT AUTHORITY APPROVAL</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Identify all persons responsible for the information or any parts of it, given in the securities note with, in the latter case, an indication of such parts. In the case of natural persons, including members of the issuer’s administrative, management or supervisory bodies, indicate the name and function of the person; in the case of legal persons indicate the name and registered office.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>A declaration by those responsible for the securities note that to the best of their knowledge, the information contained in the securities note is in accordance with the facts and that the securities note makes no omission likely to affect its import.</p><p>Where applicable, a declaration by those responsible for certain parts of the securities note that, to the best of their knowledge, the information contained in those parts of the securities note for which they are responsible is in accordance with the facts and that those parts of the securities note make no omission likely to affect their import.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Where a statement or report, attributed to a person as an expert, is included in the securities note, provide the following details for that person:</p><p>(a)  name;</p><p>(b)  business address;</p><p>(c)  qualifications;</p><p>(d)  material interest if any in the issuer.</p><p>If the statement or report has been produced at the issuer’s request, state that such statement or report has been included in the securities note with the consent of the person who has authorised the contents of that part of the securities note for the purpose of the prospectus.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Where information has been sourced from a third party, provide a confirmation that this information has been accurately reproduced and that as far as the issuer is aware and is able to ascertain from information published by that third party, no facts have been omitted which would render the reproduced information inaccurate or misleading. In addition, identify the source(s) of the information.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>A statement that:</p><p>(a)  this [securities note/prospectus] has been approved by the [name of competent authority], as competent authority under Regulation (EU) 2017/1129.</p><p>(b)  the [name of competent authority] only approves this [securities note/prospectus] as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation (EU) 2017/1129;</p><p>(c)  such approval should not be considered as an endorsement of [the quality of the securities that are the subject of this [securities note/prospectus];</p><p>(d)  investors should make their own assessment as to the suitability of investing in the securities.</p></td><td><p>Category A</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>RISK FACTORS</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>A description of the material risks that are specific to the securities being offered and/or admitted to trading in a limited number of categories, in a section headed ‘Risk Factors’.</p><p>Risks to be disclosed shall include:</p><p>(a)  those resulting from the level of subordination of a security and the impact on the expected size or timing of payments to holders of the securities under bankruptcy, or any other similar procedure, including, where relevant, the insolvency of a credit institution or its resolution or restructuring in accordance with Directive 2014/59/EU;</p><p>(b)  in cases where the securities are guaranteed, the specific and material risks related to the guarantor to the extent they are relevant to its ability to fulfil its commitment under the guarantee.</p><p>In each category the most material risks, in the assessment of the issuer, offeror or person asking for admission to trading on a regulated market, taking into account the negative impact on the issuer and the securities and the probability of their occurrence, shall be set out first. The risks shall be corroborated by the content of the securities note.</p></td><td><p>Category A</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>ESSENTIAL INFORMATION</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>Interest of natural and legal persons involved in the issue/offer</p></td><td><p> </p><div/></td></tr><tr><td><p>A description of any interest, including a conflict of interest that is material to the issue/offer, detailing the persons involved and the nature of the interest.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 3.2</p></td><td><p>Reasons for the offer and use of proceeds</p></td><td><p> </p><div/></td></tr><tr><td><p>Reasons for the offer to the public or for the admission to trading. Where applicable, disclosure of the estimated total expenses of the issue/offer and the estimated net amount of the proceeds. These expenses and proceeds shall be broken into each principal intended use and presented in order of priority of such uses. If the issuer is aware that the anticipated proceeds will not be sufficient to fund all the proposed uses, then state the amount and sources of other funds needed.</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>INFORMATION CONCERNING THE SECURITIES TO BE OFFERED TO THE PUBLIC/ADMITTED TO TRADING</p></td></tr><tr><td><p>Item 4.1</p></td><td><p>(a)  A description of the type and the class of the securities being offered to the public and/or admitted to trading.</p></td><td><p>Category B</p></td></tr><tr><td><p>(b)  The international security identification number (‘ISIN’) for those classes of securities referred to in (a).</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.2</p></td><td><p>Legislation under which the securities have been created.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 4.3</p></td><td><p>(a)  An indication of whether the securities are in registered form or bearer form and whether the securities are in certificated form or book-entry form.</p></td><td><p>Category A</p></td></tr><tr><td><p>(b)  In the case of securities registered in book-entry form, the name and address of the entity in charge of keeping the records.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.4</p></td><td><p>Total amount of the securities offered to the public/admitted to trading. If the amount is not fixed, an indication of the maximum amount of the securities to be offered (if available) and a description of the arrangements and time for announcing to the public the definitive amount of the offer.</p><p>Where the maximum amount of securities to be offered cannot be provided in the securities note, the securities note shall specify that acceptances of the purchase or subscription of securities may be withdrawn up to two working days after the amount of securities to be offered to the public has been filed.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.5</p></td><td><p>Currency of the securities issue.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.6</p></td><td><p>The relative seniority of the securities in the issuer’s capital structure in the event of insolvency, including, where applicable, information on the level of subordination of the securities and the potential impact on the investment in the event of a resolution under Directive 2014/59/EU.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 4.7</p></td><td><p>A description of the rights attached to the securities, including any limitations of those rights, and procedure for the exercise of those rights.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 4.8</p></td><td><p>(a)  The nominal interest rate;</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  the provisions relating to interest payable;</p></td><td><p>Category B</p></td></tr><tr><td><p>(c)  the date from which interest becomes payable;</p></td><td><p>Category C</p></td></tr><tr><td><p>(d)  the due dates for interest;</p></td><td><p>Category C</p></td></tr><tr><td><p>(e)  the time limit on the validity of claims to interest and repayment of principal.</p></td><td><p>Category B</p></td></tr><tr><td><p>Where the rate is not fixed:</p></td><td><p> </p><div/></td></tr><tr><td><p>(a)  a statement setting out the type of underlying;</p></td><td><p>Category A</p></td></tr><tr><td><p>(b)  a description of the underlying on which the rate is based;</p></td><td><p>Category C</p></td></tr><tr><td><p>(c)  the method used to relate the rate with the underlying;</p></td><td><p>Category B</p></td></tr><tr><td><p>(d)  an indication where information about the past and the future performance of the underlying and its volatility can be obtained by electronic means and whether or not it can be obtained free of charge;</p></td><td><p>Category C</p></td></tr><tr><td><p>(e)  a description of any market disruption or settlement disruption events that affect the underlying;</p></td><td><p>Category B</p></td></tr><tr><td><p>(f)  any adjustment rules with relation to events concerning the underlying;</p></td><td><p>Category B</p></td></tr><tr><td><p>(g)  the name of the calculation agent;</p></td><td><p>Category C</p></td></tr><tr><td><p>(h)  if the security has a derivative component in the interest payment, a clear and comprehensive explanation to help investors understand how the value of their investment is affected by the value of the underlying instrument(s), especially under the circumstances when the risks are most evident.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 4.9</p></td><td><p>(a)  Maturity date.</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  Details of the arrangements for the amortisation of the loan, including the repayment procedures. Where advance amortisation is contemplated, on the initiative of the issuer or of the holder, it shall be described, stipulating the amortisation terms and conditions.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 4.10</p></td><td><p>(a)  An indication of yield.</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  Description of the method whereby the yield in point (a) is to be calculated in summary form.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 4.11</p></td><td><p>Representation of non-equity security holders including an identification of the organisation representing the investors and provisions applying to such representation. Indication of the website where the public may have free access to the contracts relating to these forms of representation.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 4.12</p></td><td><p>In the case of new issues, a statement of the resolutions, authorisations and approvals by virtue of which the securities have been or will be created and/or issued.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.13</p></td><td><p>The issue date or in the case of new issues, the expected issue date of the securities.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.14</p></td><td><p>A description of any restrictions on the transferability of the securities.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 4.15</p></td><td><p>A warning that the tax legislation of the investor’s Member State and of the issuer’s country of incorporation may have an impact on the income received from the securities.</p><p>Information on the taxation treatment of the securities where the proposed investment attracts a tax regime specific to that type of investment.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 4.16</p></td><td><p>If different from the issuer, the identity and contact details of the offeror, of the securities and/or the person asking for admission to trading, including the legal entity identifier (‘LEI’) where the offeror has legal personality.</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 5</p></td><td><p>TERMS AND CONDITIONS OF THE OFFER OF SECURITIES TO THE PUBLIC</p></td></tr><tr><td><p>Item 5.1</p></td><td><p>Conditions, offer statistics, expected timetable and action required to apply for the offer.</p></td></tr><tr><td><p>Item 5.1.1</p></td><td><p>Conditions to which the offer is subject.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.1.2</p></td><td><p>The time period, including any possible amendments, during which the offer will be open.A description of the application process.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.1.3</p></td><td><p>A description of the possibility to reduce subscriptions and the manner for refunding amounts paid in excess by applicants.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.1.4</p></td><td><p>Details of the minimum and/or maximum amount of the application, (whether in number of securities or aggregate amount to invest).</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.1.5</p></td><td><p>Method and time limits for paying up the securities and for delivery of the securities.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.1.6</p></td><td><p>A full description of the manner and date in which results of the offer are to be made public.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.1.7</p></td><td><p>The procedure for the exercise of any right of pre-emption, the negotiability of subscription rights and the treatment of subscription rights not exercised.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.2</p></td><td><p>Plan of distribution and allotment.</p></td></tr><tr><td><p>Item 5.2.1</p></td><td><p>The various categories of potential investors to which the securities are offered.</p><p>If the offer is being made simultaneously in the markets of two or more countries and if a tranche has been or is being reserved for certain of these, indicate any such tranche.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.2.2</p></td><td><p>Process for notifying applicants of the amount allotted and an indication whether dealing may begin before notification is made.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.3</p></td><td><p>Pricing</p></td></tr><tr><td><p>Item 5.3.1</p></td><td><p>(a)  An indication of the expected price at which the securities will be offered.</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  Where an indication of the expected price cannot be given, a description of the method of determining the price, pursuant to Article 17 of Regulation (EU) 2017/1129, and the process for its disclosure.</p></td><td><p>Category B</p></td></tr><tr><td><p>(c)  Indication of the amount of any expenses, and taxes charged to the subscriber or purchaser. Where the issuer is subject to Regulation (EU) No 1286/2014 or Directive 2014/65/EU and to the extent that they are known, include those expenses contained in the price.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.4</p></td><td><p>Placing and Underwriting</p></td></tr><tr><td><p>Item 5.4.1</p></td><td><p>Name and address of the coordinator(s) of the global offer and of single parts of the offer and, to the extent known to the issuer or to the offeror, of the placers in the various countries where the offer takes place.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.4.2</p></td><td><p>Name and address of any paying agents and depository agents in each country.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.4.3</p></td><td><p>Name and address of the entities agreeing to underwrite the issue on a firm commitment basis, and name and address of the entities agreeing to place the issue without a firm commitment or under ‘best efforts’ arrangements. Indication of the material features of the agreements, including the quotas. Where not all of the issue is underwritten, a statement of the portion not covered. Indication of the overall amount of the underwriting commission and of the placing commission.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.4.4</p></td><td><p>When the underwriting agreement has been or will be reached.</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 6</p></td><td><p>ADMISSION TO TRADING AND DEALING ARRANGEMENTS</p></td></tr><tr><td><p>Item 6.1</p></td><td><p>(a)  an indication as to whether the securities offered are or will be the object of an application for admission to trading, with a view to their distribution in a regulated market, other third country markets, SME Growth Market or MTF with an indication of the markets in question. This circumstance must be set out, without creating the impression that the admission to trading will necessarily be approved.</p></td><td><p>Category B</p></td></tr><tr><td><p>(b)  If known, give the earliest dates on which the securities will be admitted to trading.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 6.2</p></td><td><p>All the regulated markets or third country markets, SME Growth Market or MTFs on which, to the knowledge of the issuer, securities of the same class of the securities to be offered to the public or admitted to trading are already admitted to trading.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 6.3</p></td><td><p>In the case of admission to trading on a regulated market, the name and address of the entities which have a firm commitment to act as intermediaries in secondary trading, providing liquidity through bid and offer rates and description of the main terms of their commitment.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 6.4</p></td><td><p>The issue price of the securities.</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 7</p></td><td><p>ADDITIONAL INFORMATION</p></td></tr><tr><td><p>Item 7.1</p></td><td><p>If advisors connected with an issue are referred to in the securities note, a statement of the capacity in which the advisors have acted.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 7.2</p></td><td><p>An indication of other information in the securities note which has been audited or reviewed by statutory auditors and where auditors have produced a report. Reproduction of the report or, with permission of the competent authority, a summary of the report.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 7.3</p></td><td><p>Credit ratings assigned to the securities at the request or with the cooperation of the issuer in the rating process. A brief explanation of the meaning of the ratings if this has previously been published by the rating provider.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 7.4</p></td><td><p>Where the summary is substituted in part with the information set out in points (c) to (i) of paragraph 3 of Article 8 of Regulation (EU) No 1286/2014, all such information to the extent it is not already disclosed elsewhere in the securities note, must be disclosed.</p></td><td><p>Category C</p></td></tr></tbody></table>
ANNEX 15
SECURITIES NOTE FOR WHOLESALE NON-EQUITY SECURITIES
<table><col/><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>PERSONS RESPONSIBLE, THIRD PARTY INFORMATION, EXPERTS’ REPORTS AND COMPETENT AUTHORITY APPROVAL</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Identify all persons responsible for the information or any parts of it, given in the securities note with, in the latter case, an indication of such parts. In the case of natural persons, including members of the issuer’s administrative, management or supervisory bodies, indicate the name and function of the person; in the case of legal persons indicate the name and registered office.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>A declaration by those responsible for the securities note that to the best of their knowledge, the information contained in the securities note is in accordance with the facts and that the securities note makes no omission likely to affect its import.</p><p>Where applicable, a declaration by those responsible for certain parts of the securities note that, to the best of their knowledge, the information contained in those parts of the securities note for which they are responsible is in accordance with the facts and that those parts of the securities note make no omission likely to affect their import.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Where a statement or report, attributed to a person as an expert, is included in the securities note, provide the following details for that person:</p><p>(a)  name;</p><p>(b)  business address;</p><p>(c)  qualifications;</p><p>(d)  material interest if any in the issuer.</p><p>If the statement or report has been produced at the issuer’s request, state that such statement or report has been included in the securities note with the consent of the person who has authorised the contents of that part of the securities note for the purpose of the prospectus.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Where information has been sourced from a third party, provide a confirmation that this information has been accurately reproduced and that as far as the issuer is aware and is able to ascertain from information published by that third party, no facts have been omitted which would render the reproduced information inaccurate or misleading. In addition, identify the source(s) of the information.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>A statement that:</p><p>(a)  this [securities note/prospectus] has been approved by the [name of competent authority], as competent authority under Regulation (EU) 2017/1129;</p><p>(b)  the [name of competent authority] only approves this [securities note/prospectus] as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation (EU) 2017/1129;</p><p>(c)  such approval should not be considered as an endorsement of the quality of the securities that are the subject of this [securities note/prospectus]; and</p><p>(d)  investors should make their own assessment as to the suitability of investing in the securities.</p></td><td><p>Category A</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>RISK FACTORS</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>A description of the material risks that are specific to the securities being offered and/or admitted to trading in a limited number of categories, in a section headed ‘Risk Factors’.</p><p>Risks to be disclosed shall include:</p><p>(a)  those resulting from the level of subordination of a security and the impact on the expected size or timing of payments to holders of the securities under bankruptcy, or any other similar procedure, including, where relevant, the insolvency of a credit institution or its resolution or restructuring in accordance with Directive 2014/59/EU;</p><p>(b)  in cases where the securities are guaranteed, the specific and material risks related to the guarantor to the extent they are relevant to its ability to fulfil its commitment under the guarantee.</p><p>In each category the most material risks, in the assessment of the issuer, offeror or person asking for admission to trading on a regulated market, taking into account the negative impact on the issuer and the securities and the probability of their occurrence, shall be set out first. The risks shall be corroborated by the content of the securities note.</p></td><td><p>Category A</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>ESSENTIAL INFORMATION</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>Interest of natural and legal persons involved in the issue.</p><p>A description of any interest, including a conflict of interest that is material to the issue, detailing the persons involved and the nature of the interest.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 3.2</p></td><td><p>The use and estimated net amount of the proceeds.</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>INFORMATION CONCERNING THE SECURITIES TO BE ADMITTED TO TRADING</p></td></tr><tr><td><p>Item 4.1</p></td><td><p>Total amount of securities being admitted to trading.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.2</p></td><td><p>(a)  A description of the type and the class of the securities being admitted to trading;</p></td><td><p>Category B</p></td></tr><tr><td><p>(b)  The international security identification number (‘ISIN’).</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.3</p></td><td><p>Legislation under which the securities have been created.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 4.4</p></td><td><p>(a)  An indication of whether the securities are in registered or bearer form and whether the securities are in certificated or book-entry form.</p></td><td><p>Category A</p></td></tr><tr><td><p>(b)  In the case of securities registered in book-entry form, the name and address of the entity in charge of keeping the records.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.5</p></td><td><p>Currency of the securities issue.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.6</p></td><td><p>The relative seniority of the securities in the issuer’s capital structure in the event of insolvency, including, where applicable, information on the level of subordination of the securities and the potential impact on the investment in the event of a resolution under Directive 2014/59/EU.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 4.7</p></td><td><p>A description of the rights, including any limitations of these, attached to the securities and procedure for the exercise of said rights.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 4.8</p></td><td><p>(a)  The nominal interest rate;</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  the provisions relating to interest payable;</p></td><td><p>Category B</p></td></tr><tr><td><p>(c)  the date from which interest becomes payable;</p></td><td><p>Category C</p></td></tr><tr><td><p>(d)  the due dates for interest;</p></td><td><p>Category C</p></td></tr><tr><td><p>(e)  the time limit on the validity of claims to interest and repayment of principal.</p></td><td><p>Category B</p></td></tr><tr><td><p>Where the rate is not fixed:</p></td><td><p> </p><div/></td></tr><tr><td><p>(a)  a statement setting out the type of underlying;</p></td><td><p>Category A</p></td></tr><tr><td><p>(b)  a description of the underlying on which the rate is based;</p></td><td><p>Category C</p></td></tr><tr><td><p>(c)  the method used to relate the rate with the underlying;</p></td><td><p>Category B</p></td></tr><tr><td><p>(d)  a description of any market disruption or settlement disruption events that affect the underlying;</p></td><td><p>Category B</p></td></tr><tr><td><p>(e)  any adjustment rules with relation to events concerning the underlying;</p></td><td><p>Category C</p></td></tr><tr><td><p>(f)  the name of the calculation agent.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.9</p></td><td><p>(a)  Maturity date.</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  Details of the arrangements for the amortisation of the loan, including the repayment procedures. Where advance amortisation is contemplated, on the initiative of the issuer or of the holder, it shall be described, stipulating amortisation terms and conditions.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 4.10</p></td><td><p>An indication of yield.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.11</p></td><td><p>Representation of debt security holders including an identification of the organisation representing the investors and provisions applying to such representation. Indication of the website where investors may have free access to the contracts relating to these forms of representation.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 4.12</p></td><td><p>A statement of the resolutions, authorisations and approvals by virtue of which the securities have been created and/or issued.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.13</p></td><td><p>The issue date of the securities.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.14</p></td><td><p>A description of any restrictions on the transferability of the securities.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 4.15</p></td><td><p>If different from the issuer, the identity and contact details of the offeror of the securities and/or the person asking for admission to trading, including the legal entity identifier (‘LEI’) where the offeror has legal personality.</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 5</p></td><td><p>ADMISSION TO TRADING AND DEALING ARRANGEMENTS</p></td></tr><tr><td><p>Item 5.1</p></td><td><p>(a)  An indication of the regulated market, or other third country market, SME Growth Market or MTF where the securities will be traded and for which a prospectus has been published.</p></td><td><p>Category B</p></td></tr><tr><td><p>(b)  If known, give the earliest dates on which the securities will be admitted to trading.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.2</p></td><td><p>Name and address of any paying agents and depository agents in each country.</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 6</p></td><td><p>EXPENSE OF THE ADMISSION TO TRADING</p></td></tr><tr><td><p>Item 6.1</p></td><td><p>An estimate of the total expenses related to the admission to trading.</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 7</p></td><td><p>ADDITIONAL INFORMATION</p></td></tr><tr><td><p>Item 7.1</p></td><td><p>If advisors are referred to in the Securities Note, a statement of the capacity in which the advisors have acted.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 7.2</p></td><td><p>An indication of other information in the Securities Note which has been audited or reviewed by auditors and where auditors have produced a report. Reproduction of the report or, with permission of the competent authority, a summary of the report.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 7.3</p></td><td><p>Credit ratings assigned to the securities at the request or with the cooperation of the issuer in the rating process. A brief explanation of the meaning of the ratings if this has previously been published by the rating provider.</p></td><td><p>Category C</p></td></tr></tbody></table>
ANNEX 16
SECURITIES NOTE FOR SECONDARY ISSUANCES OF NON-EQUITY SECURITIES
<table><col/><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>PERSONS RESPONSIBLE, THIRD PARTY INFORMATION, EXPERTS’ REPORTS AND COMPETENT AUTHORITY APPROVAL</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Identify all persons responsible for the information or any parts of it, given in the securities note with, in the latter case, an indication of such parts. In the case of natural persons, including members of the issuer’s administrative, management or supervisory bodies, indicate the name and function of the person; in the case of legal persons indicate the name and registered office.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>A declaration by those responsible for the securities note that to the best of their knowledge, the information contained in the securities note is in accordance with the facts and that the securities note makes no omission likely to affect its import.</p><p>Where applicable, a declaration by those responsible for certain parts of the securities note that, to the best of their knowledge, the information contained in those parts of the securities note for which they are responsible is in accordance with the facts and that those parts of the securities note make no omission likely to affect their import.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Where a statement or report attributed to a person as an expert is included in the Securities Note, provide the following details for that person:</p><p>(a)  name;</p><p>(b)  business address;</p><p>(c)  qualifications;</p><p>(d)  material interest if any in the issuer.</p><p>If the statement or report has been produced at the issuer’s request, state that such statement or report has been included in the securities note with the consent of the person who has authorised the contents of that part of the securities note for the purpose of the prospectus.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Where information has been sourced from a third party, provide a confirmation that this information has been accurately reproduced and that as far as the issuer is aware and is able to ascertain from information published by that third party, no facts have been omitted which would render the reproduced information inaccurate or misleading. In addition, identify the source(s) of the information.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>A statement that:</p><p>(a)  this [securities note/prospectus] has been approved by the [name of competent authority], as competent authority under Regulation (EU) 2017/1129;</p><p>(b)  the [name of competent authority] only approves this [securities note/prospectus] as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation (EU) 2017/1129;</p><p>(c)  such approval should not be considered as an endorsement of the quality of the securities that are the subject of this [securities note/prospectus];</p><p>(d)  investors should make their own assessment as to the suitability of investing in the securities; and</p><p>(e)  that the [securities note/prospectus] has been drawn up as a simplified prospectus in accordance with Article 14 of Regulation (EU) 2017/1129.</p></td><td><p>Category A</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>RISK FACTORS</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>A description of the material risks that are specific to the securities being offered and/or admitted to trading, in a limited number of categories, in a section headed ‘Risk Factors’.</p><p>Risks to be disclosed shall include:</p><p>(a)  those resulting from the level of subordination of a security and the impact on the expected size or timing of payments to holders of the securities under bankruptcy, or any other similar procedure, including, where relevant, the insolvency of a credit institution or its resolution or restructuring in accordance with Directive 2014/59/EU;</p><p>(b)  in cases where the securities are guaranteed, the specific and material risks related to the guarantor to the extent they are relevant to its ability to fulfil its commitment under the guarantee.</p><p>In each category the most material risks, in the assessment of the issuer, offeror or person asking for admission to trading on a regulated market, taking into account the negative impact on the issuer and the securities and the probability of their occurrence, shall be set out first. The risks shall be corroborated by the content of the securities note.</p></td><td><p>Category A</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>ESSENTIAL INFORMATION</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>Interest of natural and legal persons involved in the issue/offer</p><p>A description of any interest, including a conflict of interest that is material to the issue/offer, detailing the persons involved and the nature of the interest.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 3.2 (Retail only)</p></td><td><p>Reasons for the offer to the public or for the admission to trading if different from making profit and/or hedging certain risks. In case of an offer to the public, disclosure of the estimated total expenses of the issue/offer and the estimated net amount of the proceeds. These expenses and proceeds shall be broken into each principal intended use and presented in order of priority of such uses. If the issuer is aware that the anticipated proceeds will not be sufficient to fund all the proposed uses, then state the amount and sources of other funds needed.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 3.3 (Wholesale only)</p></td><td><p>Reasons for the issuance if different from making profit and/or hedging certain risks</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>INFORMATION CONCERNING THE SECURITIES TO BE OFFERED/ADMITTED TO TRADING</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 4.1</p></td><td><p>(a)  a description of the type, class and amount of the securities being offered to the public and/or admitted to trading;</p><p>(b)  the international security identification number (‘ISIN’) of the securities being offered to the public and/or admitted to trading.</p></td><td><p>Category B</p><p>Category C</p></td></tr><tr><td><p><a>▼B</a></p></td></tr><tr><td><p>Item 4.2</p></td><td><p>Currency of the securities issue.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.3</p></td><td><p>In the case of new issues, a statement of the resolutions, authorisations and approvals by virtue of which the securities have been or will be created and/or issued.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.4</p></td><td><p>A description of any restrictions on the transferability of the securities.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 4.5 (Retail only)</p></td><td><p>A warning that the tax legislation of the investor’s Member State and of the issuer’s country of incorporation may have an impact on the income received from the securities.</p><p>Information on the taxation treatment of the securities where the proposed investment attracts a tax regime specific to that type of investment.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 4.6</p></td><td><p>If different from the issuer, the identity and contact details of the offeror, of the securities and/or the person asking for admission to trading including the legal entity identifier (‘LEI’) where the offeror has legal personality.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.7</p></td><td><p>The relative seniority of the securities in the issuer’s capital structure in the event of insolvency, including, where applicable, information on the level of subordination of the securities and the potential impact on the investment in the event of a resolution under Directive 2014/59/EU.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 4.8</p></td><td><p>A description of the rights attached to the securities, including any limitations of those rights.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 4.9</p></td><td><p>(a)  The nominal interest rate;</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  the provisions relating to interest payable;</p></td><td><p>Category B</p></td></tr><tr><td><p>(c)  the date from which interest becomes payable and the due dates for interest.</p></td><td><p>Category C</p></td></tr><tr><td><p>(d)  the time limit on the validity of claims to interest and repayment of principal.</p></td><td><p>Category B</p></td></tr><tr><td><p>Where the rate is not fixed:</p></td><td><p> </p><div/></td></tr><tr><td><p>(a)  a statement setting out the type of underlying;</p></td><td><p>Category A</p></td></tr><tr><td><p>(b)  a description of the underlying on which the rate is based and of the method used to relate the rate with the underlying;</p></td><td><p>Category C</p></td></tr><tr><td><p>(c)  in the case of retail non-equity securities, an indication where information about the past and the future performance of the underlying and its volatility can be obtained;</p></td><td><p>Category C</p></td></tr><tr><td><p>(d)  a description of any market disruption or settlement disruption events that affect the underlying;</p></td><td><p>Category B</p></td></tr><tr><td><p>(e)  any adjustment rules with relation to events concerning the underlying;</p></td><td><p>Category B</p></td></tr><tr><td><p>(f)  the name of the calculation agent;</p></td><td><p>Category C</p></td></tr><tr><td><p>(g)  in the case of retail non-equity securities, if the security has a derivative component in the interest payment, a clear and comprehensive explanation to help investors understand how the value of their investment is affected by the value of the underlying instrument(s), especially under the circumstances when the risks are most evident,.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 4.10</p></td><td><p>(a)  Maturity date.</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  Details of the arrangements for the amortisation of the loan, including the repayment procedures.</p><p>Where advance amortisation is contemplated, on the initiative of the issuer or of the holder, it shall be described, stipulating amortisation terms and conditions.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 4.11</p></td><td><p>(a)  An indication of yield.</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  In the case of retail non-equity securities, description of the method of how the yield is calculated in summary form.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 4.15</p></td><td><p>Representation of debt securities holders including an identification of the organisation representing the investors and provisions applying to such representation. Indication of the website where the public may have free access to the contracts relating to these forms of representation.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 4.16</p></td><td><p>Where there is no offer, the issue date of the securities.</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 5</p></td><td><p>TERMS AND CONDITIONS OF THE OFFER (RETAIL ONLY)</p></td></tr><tr><td><p>Item 5.1</p></td><td><p>Conditions, offer statistics, expected timetable and action required to apply for the offer</p></td></tr><tr><td><p>Item 5.1.1</p></td><td><p>Conditions to which the offer is subject.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.1.2</p></td><td><p>The time period, including any possible amendments, during which the offer will be open and a description of the application process together with the issue date of new securities.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.1.3</p></td><td><p>A description of the possibility to reduce subscriptions and the manner for refunding amounts paid in excess by applicants.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.1.4</p></td><td><p>Details of the minimum and/or maximum amount of application (whether in number of securities or aggregate amount to invest).</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.1.5</p></td><td><p>Method and time limits for paying up the securities and for delivery of the securities.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.1.6</p></td><td><p>A full description of the manner and date in which results of the offer are to be made public.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.1.7</p></td><td><p>The procedure for the exercise of any right of pre-emption, the negotiability of subscription rights and the treatment of subscription rights not exercised.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.1.8</p></td><td><p>Total amount of the issue/offer; if the amount is not fixed an indication of the amount of securities to be offered (if available) and a description of the arrangements and time for announcing to the public the definitive amount of the offer.</p><p>Where the maximum amount of securities to be offered cannot be provided in the prospectus, the prospectus shall specify that acceptances of the purchase of subscription of securities may be withdrawn for not less than two working days after the amount of securities to be offered to the public has been filed.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.2</p></td><td><p>Plan of distribution and allotment</p></td></tr><tr><td><p>Item 5.2.1</p></td><td><p>Process notifying applicants of the amount allotted and an indication whether dealing may begin before notification is made.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.3</p></td><td><p>Pricing</p></td></tr><tr><td><p>Item 5.3.1</p></td><td><p>(a)  an indication of the price at which the securities will be offered; or</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  a description of the method for determining the price and the process for its disclosure.</p></td><td><p>Category B</p></td></tr><tr><td><p>(c)  Indication of the amount of any expenses and taxes charged to the subscriber or purchaser. Where the issuer is subject to Regulation (EU) No 1286/2014 or Directive 2014/65/EU and to the extent that they are known, include those expenses contained in the price.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.4.</p></td><td><p>Placing and underwriting</p></td></tr><tr><td><p>Item 5.4.1</p></td><td><p>Name and address of the coordinator(s) of the global offer and of single parts of the offer and, to the extent known to the issuer or to the offeror, of the placers in the various countries where the offer takes place</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.4.2</p></td><td><p>Name and address of any paying agents and depository agents in each country.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.4.3</p></td><td><p>Name and address of the entities agreeing to underwrite the issue on a firm commitment basis, and name and address of the entities agreeing to place the issue without a firm commitment or under ‘best efforts’ arrangements. Indication of the material features of the agreements, including the quotas. Where not all of the issue is underwritten, a statement of the portion not covered. Indication of the overall amount of the underwriting commission and of the placing commission.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 5.4.4</p></td><td><p>When the underwriting agreement has been or will be reached.</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 6</p></td><td><p>ADMISSION TO TRADING AND DEALING ARRANGEMENTS</p></td></tr><tr><td><p>Item 6.1</p></td><td><p>An indication as to whether the securities offered are or will be the object of an application for admission to trading, with a view to their distribution in a regulated market, other equivalent third country markets or an SME Growth Market with an indication of the markets in question. This circumstance must be set out, without creating the impression that the admission to trading will necessarily be approved. If known, the earliest dates on which the securities will be admitted to trading.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 6.2 (Retail only)</p></td><td><p>All the regulated markets, equivalent third country markets or SME Growth Markets on which, to the knowledge of the issuer, securities of the same class of the securities to be offered or admitted to trading are already admitted to trading.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 6.3 (Retail only)</p></td><td><p>The issue price of the securities.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 6.4 (Wholesale only)</p></td><td><p>An estimate of the total expenses related to the admission to trading.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 6.5</p></td><td><p>Name and address of any paying agents and depositary agents in each country.</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 7</p></td><td><p>ADDITIONAL INFORMATION</p></td></tr><tr><td><p>Item 7.1</p></td><td><p>If advisors connected with an issue are referred to in the securities note, a statement of the capacity in which the advisors have acted.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 7.2</p></td><td><p>An indication of other information in the securities note which has been audited or reviewed by statutory auditors and where auditors have produced a report. Reproduction of the report or, with permission of the competent authority, a summary of the report.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 7.3 (Retail only)</p></td><td><p>Credit ratings assigned to the securities at the request or with the cooperation of the issuer in the rating process. A brief explanation of the meaning of the ratings if this has previously been published by the rating provider.</p></td><td><p>Category C</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 7.3.a (Retail only)</p></td><td><p>Where the summary is substituted in part with the information set out in points (c) to (i) of paragraph 3 of Article 8 of Regulation (EU) No 1286/2014, all such information must be disclosed to the extent it is not already disclosed elsewhere in the securities note.</p></td><td><p>Category C</p></td></tr><tr><td><p><a>▼B</a></p></td></tr><tr><td><p>Item 7.4 (Wholesale only)</p></td><td><p>An estimate of the total expenses related to the admission to trading.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 7.5 (Wholesale only)</p></td><td><p>Credit ratings assigned to the securities at the request or with the cooperation of the issuer in the rating process.</p></td><td><p>Category C</p></td></tr></tbody></table>
ANNEX 17
SECURITIES GIVING RISE TO PAYMENT OR DELIVERY OBLIGATIONS LINKED TO AN UNDERLYING ASSET
<table><col/><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>RISK FACTORS</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Prominent disclosure of risk factors that are material to the securities being offered and/or admitted to trading in order to assess the market risk associated with these securities in a section headed ‘Risk Factors’. If applicable, this must include a risk warning to the effect that investors may lose the value of their entire investment or part of it, as the case may be, and, if the investor’s liability is not limited to the value of his investment, a statement of that fact, together with a description of the circumstances in which such additional liability arises and the likely financial effect.</p></td><td><p>Category A</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>INFORMATION CONCERNING THE SECURITIES TO BE OFFERED/ADMITTED TO TRADING</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>Information concerning the securities</p></td></tr><tr><td><p>Item 2.1.1</p></td><td><p>A clear and comprehensive explanation to help investors understand how the value of their investment is affected by the value of the underlying instrument(s), especially in the circumstances where the risks are most evident, unless the securities have a denomination per unit of at least EUR 100 000 , or can only be acquired for at least EUR 100 000 per security, or are to be traded on a regulated market or a specific segment of a regulated market to which only qualified investors can have access.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 2.1.2</p></td><td><p>The expiration or maturity date of the derivative securities and their exercise date or final reference date.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 2.1.3</p></td><td><p>A description of the settlement procedure of the derivative securities.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 2.1.4</p></td><td><p>A description of:</p></td><td><p> </p><div/></td></tr><tr><td><p>(a)  how any return on derivative securities takes place;</p></td><td><p>Category B</p></td></tr><tr><td><p>(b)  the payment or delivery date;</p></td><td><p>Category C</p></td></tr><tr><td><p>(c)  the way it is calculated.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 2.2</p></td><td><p>Information concerning the underlying</p></td></tr><tr><td><p>Item 2.2.1</p></td><td><p>The exercise price or the final reference price of the underlying.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 2.2.2</p></td><td><p>A statement setting out the type of the underlying.</p></td><td><p>Category A</p></td></tr><tr><td><p>Details of where information on the underlying can be obtained including an indication of where information about the past and the future performance of that underlying and its volatility can be obtained by electronic means, and whether or not it can be obtained free of charge.</p></td><td><p>Category C</p></td></tr><tr><td><p>Where the underlying is a security:</p></td><td><p> </p><div/></td></tr><tr><td><p>(a)  the name of the issuer of the security;</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  the international security identification number (‘ISIN’);</p></td><td><p>Category C</p></td></tr><tr><td><p>where the underlying is a reference entity or reference obligation (for credit-linked securities):</p></td><td><p> </p><div/></td></tr><tr><td><p>(a)  where the reference entity or reference obligation comprises of a single entity or obligation, or in the case of a pool of underlying where a single reference entity or reference obligation represents 20 % or more of the pool:</p></td><td><p> </p><div/></td></tr><tr><td><p>(i)  if the reference entity (or issuer of the reference obligation) has no securities admitted to trading on a regulated market, equivalent third country market or SME Growth Market, so far as the issuer is aware and/or able to ascertain from information published by the reference entity (or by the issuer of the reference obligation), information relating to the reference entity (or to the issuer of the reference obligation) as if it were the issuer (in accordance with the registration document for wholesale non-equity securities);</p></td><td><p>Category A</p></td></tr><tr><td><p>(ii)  if the reference entity (or the issuer of the reference obligation) has securities already admitted to trading on a regulated market, equivalent third country market or SME Growth Market, so far as the issuer is aware and/or able to ascertain from information published by the reference entity (or by the issuer of the reference obligation), its name, ISIN, address, country of incorporation, industry or industries in which the reference entity (or the issuer of the reference obligation) operates and the name of the market in which its securities are admitted.</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  in the case of a pool of underlying, where a single reference entity or reference obligation represents less than 20 % of the pool:</p></td><td><p> </p><div/></td></tr><tr><td><p>(i)  the names of the reference entities or issuers of the reference obligation; and</p></td><td><p>Category C</p></td></tr><tr><td><p>(ii)  the ISIN.</p></td><td><p>Category C</p></td></tr><tr><td><p>Where the underlying is an index:</p></td><td><p> </p><div/></td></tr><tr><td><p>(a)  the name of the index;</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  a description of the index if it is composed by the issuer or by any legal entity belonging to the same group;</p></td><td><p>Category A</p></td></tr><tr><td><p>(c)  a description of the index provided by a legal entity or a natural person acting in association with, or on behalf of, the issuer, unless the prospectus contains the following statements:</p><p>(i)  the complete set of rules of the index and information on the performance of the index are freely accessible on the issuer’s or on the index provider’s website;</p><p>(ii)  the governing rules (including methodology of the index for the selection and the re-balancing of the components of the index, description of market disruption events and of adjustment rules) are based on predetermined and objective criteria.</p></td><td><p>Category B</p></td></tr><tr><td><p>Points (b) and (c) do not apply where the administrator of the index is included in the public register maintained by ESMA under Article 36 of Regulation (EU) 2016/1011 <a>(<span>1</span>)</a>.</p></td><td><p> </p><div/></td></tr><tr><td><p>(d)  Where the index is not composed by the issuer, an indication of where information about the index can be obtained.</p></td><td><p>Category C</p></td></tr><tr><td><p>Where the underlying is an interest rate, a description of the interest rate.</p></td><td><p>Category C</p></td></tr><tr><td><p>Where the underlying does not fall within the categories specified above, the securities note shall contain equivalent information.</p></td><td><p>Category C</p></td></tr><tr><td><p>Where the underlying is a basket of underlying, a disclosure for each underlying as described above and disclosure of the relevant weightings of each underlying in the basket.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 2.2.3</p></td><td><p>A description of any market disruption or settlement disruption or credit events that affect the underlying.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 2.2.4</p></td><td><p>Adjustment rules with relation to events concerning the underlying.</p></td><td><p>Category B</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>ADDITIONAL INFORMATION</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>An indication in the prospectus whether or not the issuer intends to provide post issuance information. Where the issuer has indicated that it intends to report such information, the issuer shall specify in the prospectus what information will be reported and where such information can be obtained.</p></td><td><p>Category C</p></td></tr><tr><td><div><a>(<span>1</span>)   </a><p>Regulation (EU) 2016/1011 of the European Parliament and of the Council of 8 June 2016 on índices used as benchmarks in financial instruments and financial contracts or to measure the performance of investment funds and amending Directives 2008/48/EC and 2014/17/EU and Regulation (EU) No 596/2014 (OJ L 171, 29.6.2016, p. 1) .</p></div></td></tr></tbody></table>
ANNEX 18
UNDERLYING SHARE
<table><col/><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>DESCRIPTION OF THE UNDERLYING SHARE</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Description of the type and the class of the shares.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>Legislation under which the shares have been or will be created.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>(a)  Indication whether the securities are in registered form or bearer form and whether the securities are in certificated form or book-entry form.</p></td><td><p>Category A</p></td></tr><tr><td><p>(b)  In the case of securities registered in book-entry form, the name and address of the entity in charge of keeping the records.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Indication of the currency of the shares issue</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>A description of the rights, including any limitations of these, attached to the securities and procedure for the exercise of those rights:</p><p>(a)  dividend rights:</p><p>(i)  fixed date(s) on which the entitlement arises;</p><p>(ii)  time limit after which entitlement to dividend lapses and an indication of the person in whose favour the lapse operates;</p><p>(iii)  dividend restrictions and procedures for non-resident holders;</p><p>(iv)  rate of dividend or method of its calculation, periodicity and cumulative or non-cumulative nature of payments.</p><p>(b)  voting rights;</p><p>(c)  pre-emption rights in offers for subscription of securities of the same class;</p><p>(d)  right to share in the issuer’s profits;</p><p>(e)  rights to share in any surplus in the event of liquidation;</p><p>(f)  redemption provisions;</p><p>(g)  conversion provisions.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.6</p></td><td><p>In the case of new issues, a statement of the resolutions, authorisations and approvals by virtue of which the shares have been or will be created and/or issued and indication of the issue date.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 1.7</p></td><td><p>Where and when the shares will be or have been admitted to trading.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 1.8</p></td><td><p>Description of any restrictions on the transferability of the shares.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.9</p></td><td><p>Statement on the existence of any national legislation on takeovers applicable to the issuer which may frustrate such takeovers, if any. Brief description of the shareholders’ rights and obligations in case of mandatory takeover bid, squeeze-out or sell-out.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.10</p></td><td><p>Indication of public takeover bids by third parties in respect of the issuer’s equity, which have occurred during the last financial year and the current financial year.</p><p>The price or exchange terms attaching to such offers and the outcome thereof must be stated.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 1.11</p></td><td><p>A comparison of:</p></td><td><p> </p><div/></td></tr><tr><td><p>(a)  participation in share capital and voting rights for existing shareholders before and after the capital increase resulting from the public offer, with the assumption that existing shareholders do not subscribe for the new shares;</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  the net asset value per share as of the date of the latest balance before the public offer (selling offer and/or capital increase) and the offering price per share within that public offer.</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>INFORMATION TO BE PROVIDED WHERE THE ISSUER OF THE UNDERLYING IS AN ENTITY BELONGING TO THE SAME GROUP</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>When the issuer of the underlying is an entity belonging to the same group, the information to provide on this issuer is the one required by the registration document for equity securities or, if applicable, the registration document for secondary issuances of equity securities or the EU Growth registration document for equity securities.</p></td><td><p>Category A</p></td></tr></tbody></table>
ANNEX 19
ASSET-BACKED SECURITIES
<table><col/><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>THE SECURITIES</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>A statement that a notification has been, or is intended to be communicated to ESMA, as regards simple, transparent and standardised securitisation (‘STS’) compliance, where applicable. This should be accompanied by an a explanation of the meaning of such notification together with a reference or hyperlink to ESMA’s data base indicating that the STS-notification is available for download there if deemed necessary.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>Where the prospectus includes a statement that the transaction is STS compliant, a warning that the STS status of a transaction is not static and that investors should verify the current status of the transaction on ESMA’s website.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>The minimum denomination of an issue.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Where information is disclosed about an undertaking/obligor which is not involved in the issue, provide a confirmation that the information relating to the undertaking/obligor has been accurately reproduced from information published by the undertaking/obligor. So far as the issuer is aware and is able to ascertain from information published by the undertaking/obligor no facts have been omitted which would render the reproduced information misleading.</p><p>In addition, identify the source(s) of information in the securities note that has been reproduced from information published by an undertaking/obligor.</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>THE UNDERLYING ASSETS</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>Confirmation that the securitised assets backing the issue have characteristics that demonstrate capacity to produce funds to service any payments due and payable on the securities.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 2.2</p></td><td><p>In respect of a pool of discrete assets backing the issue:</p></td></tr><tr><td><p>Item 2.2.1</p></td><td><p>The legal jurisdiction by which the pool of assets is governed.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 2.2.2</p></td><td><p>(a)  In the case of a small number of easily identifiable obligors a general description of each obligor.</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  In all other cases, a description of the general characteristics of the obligors and the economic environment.</p></td><td><p>Category B</p></td></tr><tr><td><p>(c)  In relation to those obligors referred to in point (b), any global statistical data referred to the securitised assets.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 2.2.3</p></td><td><p>The legal nature of the assets.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 2.2.4</p></td><td><p>The expiry or maturity date(s) of the assets.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 2.2.5</p></td><td><p>The amount of the assets.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 2.2.6</p></td><td><p>Loan to value ratio or level of collateralisation.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 2.2.7</p></td><td><p>The method of origination or creation of the assets, and for loans and credit agreements, the principal lending criteria and an indication of any loans which do not meet these criteria and any rights or obligations to make further advances.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 2.2.8</p></td><td><p>An indication of significant representations and collateral given to the issuer relating to the assets.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 2.2.9</p></td><td><p>Any rights to substitute the assets and a description of the manner in which and the type of assets which may be so substituted; if there is any capacity to substitute assets with a different class or quality of assets a statement to that effect together with a description of the impact of such substitution.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 2.2.10</p></td><td><p>A description of any relevant insurance policies relating to the assets. Any concentration with one insurer must be disclosed if it is material to the transaction.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 2.2.11</p></td><td><p>Where the assets comprise obligations of 5 or fewer obligors which are legal persons or are guaranteed by 5 or fewer legal persons or where an obligor or entity guaranteeing the obligations accounts for 20 % or more of the assets, or where 20 % or more of the assets are guaranteed by a single guarantor, so far as the issuer is aware and/or is able to ascertain from information published by the obligor(s) or guarantor(s) indicate either of the following:</p></td><td><p> </p><div/></td></tr><tr><td><p>(a)  information relating to each obligor or guarantor as if it were an issuer drafting a registration document for non-equity securities with an individual denomination of at least EUR 100 000 and/or that are to be traded only on a regulated market, or a specific segment thereof, to which only qualified investors can have access for the purposes of trading in such securities;</p></td><td><p>Category A</p></td></tr><tr><td><p>(b)  if an obligor or guarantor has securities already admitted to trading on a regulated or equivalent third country market or SME Growth Market its name, address, country of incorporation, significant business activities/investment policy and the name of the market in which its securities are admitted.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 2.2.12</p></td><td><p>If a relationship exists that is material to the issue, between the issuer, guarantor and obligor, details of the principal terms of that relationship.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 2.2.13</p></td><td><p>Where the assets comprise obligations that are traded on regulated or equivalent third country market or SME Growth Market, a brief description of the securities, the market and an electronic link where the documentation in relation to the obligations can be found on the regulated or equivalent third country market or SME Growth Market.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 2.2.14</p></td><td><p>Where the assets comprise obligations that are not traded on a regulated or equivalent third country market or SME Growth Market, a description of the principal terms and conditions in relation to the obligations.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 2.2.15</p></td><td><p>Where the assets comprise equity securities that are admitted to trading on a regulated or equivalent third country market or SME Growth Market indicate the following:</p></td><td><p>Category C</p></td></tr><tr><td><p>(a)  a description of the securities;</p></td><td><p> </p><div/></td></tr><tr><td><p>(b)  a description of the market on which they are traded including its date of establishment, how price information is published, an indication of daily trading volumes, information as to the standing of the market in the country, the name of the market’s regulatory authority and an electronic link where the documentation in relation to the securities can be found on the regulated or equivalent third country market or SME Growth Market;</p></td><td><p>Category C</p></td></tr><tr><td><p>(c)  the frequency with which prices of the relevant securities, are published.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 2.2.16</p></td><td><p>Where more than 10 % of the assets comprise equity securities that are not traded on a regulated or equivalent third country market or SME Growth Market, a description of those equity securities and equivalent information to that contained in the registration document for equity securities or where applicable, the registration document for securities issued by closed-end collective investment undertakings in respect of each issuer of those securities.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 2.2.17</p></td><td><p>Where a material portion of the assets are secured on or backed by real property, a valuation report relating to the property setting out both the valuation of the property and cash flow/income streams.</p><p>Compliance with this disclosure is not required if the issue is of securities backed by mortgage loans with property as security, where there has been no revaluation of the properties for the purpose of the issue, and it is clearly stated that the valuations quoted are as at the date of the original initial mortgage loan origination.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 2.3</p></td><td><p>In respect of an actively managed pool of assets backing the issue:</p></td></tr><tr><td><p>Item 2.3.1</p></td><td><p>Equivalent information to that contained in items 2.1 and 2.2 to allow an assessment of the type, quality, sufficiency and liquidity of the asset types in the portfolio which will secure the issue.</p></td><td><p>See items 2.1 and 2.2</p></td></tr><tr><td><p>Item 2.3.2</p></td><td><p>The parameters within which investments can be made, the name and description of the entity responsible for such management including a description of that entity’s expertise and experience, a summary of the provisions relating to the termination of the appointment of such entity and the appointment of an alternative management entity and a description of that entity’s relationship with any other parties to the issue.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 2.4</p></td><td><p>Where an issuer proposes to issue further securities backed by the same assets, a prominent statement to that effect and unless those further securities are fungible with or are subordinated to those classes of existing debt, a description of how the holders of that class will be informed.</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>STRUCTURE AND CASH FLOW</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>Description of the structure of the transaction containing an overview of the transaction and the cash flows, including a structure diagram.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 3.2</p></td><td><p>Description of the entities participating in the issue and description of the functions to be performed by them in addition to information on the direct and indirect ownership or control between those entities.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 3.3</p></td><td><p>Description of the method and date of the sale, transfer, novation or assignment of the assets or of any rights and/or obligations in the assets to the issuer or, where applicable, the manner and time period in which the proceeds from the issue will be fully invested by the issuer.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 3.4</p></td><td><p>An explanation of the flow of funds including:</p></td></tr><tr><td><p>Item 3.4.1</p></td><td><p>(a)  how the cash flow from the assets will meet the issuer’s obligations to holders of the securities, including, if necessary:</p></td><td><p>Category A</p></td></tr><tr><td><p>(b)  a financial service table and a description of the assumptions used in developing that table;</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 3.4.2</p></td><td><p>information on any credit enhancements, an indication of where potentially material liquidity shortfalls may occur and the availability of any liquidity supports and indication of provisions designed to cover interest/principal shortfall risks;</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 3.4.3</p></td><td><p>(a)  the risk retention requirement applicable to the transaction, where applicable;</p></td><td><p>Category A</p></td></tr><tr><td><p>(b)  the material net economic interest retained by the originator, the sponsor or the original lender <a>(<span>1</span>)</a>;</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 3.4.4</p></td><td><p>without prejudice to item 3.4.2, details of any subordinated debt finance;</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 3.4.5</p></td><td><p>an indication of any investment parameters for the investment of temporary liquidity surpluses and description of the parties responsible for such investment;</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 3.4.6</p></td><td><p>how payments are collected in respect of the assets;</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 3.4.7</p></td><td><p>the order of priority of payments made by the issuer to the holders of the class of securities in question;</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 3.4.8</p></td><td><p>details of any other arrangements upon which payments of interest and principal to investors are dependent;</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 3.5</p></td><td><p>the name, address and significant business activities of the originators of the securitised assets.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 3.6</p></td><td><p>Where the return on, and/or repayment of the security is linked to the performance or credit of other assets or underlyings which are not assets of the issuer, for each such reference asset or underlying furnish one of the following;</p><p>(a)  disclosure in accordance with items 2.2 and 2.3;</p><p>(b)  where the principal is not at risk, the name of the issuer of the reference asset, the international security identification number (‘ISIN’), and an indication where information about the past and the current performance of the reference asset can be obtained;</p><p>(c)  where the reference asset is an index, parts 1 and 2 of Annex 17.</p></td><td><p>See Annex 17</p></td></tr><tr><td><p>Item 3.7</p></td><td><p>The name, address and significant business activities of the administrator, calculation agent or equivalent, together with a summary of the administrator’s/calculation agents responsibilities, their relationship with the originator or the creator of the assets and a summary of the provisions relating to the termination of the appointment of the administrator/calculation agent and the appointment of an alternative administrator/calculation agent;</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 3.8</p></td><td><p>The names and addresses and brief description of:</p></td><td><p> </p><div/></td></tr><tr><td><p>(a)  any swap counterparties and any providers of other material forms of credit/liquidity enhancement;</p></td><td><p>Category A</p></td></tr><tr><td><p>(b)  the banks with which the main accounts relating to the transaction are held.</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>POST ISSUANCE REPORTING</p></td></tr><tr><td><p>Item 4.1</p></td><td><p>An indication in the prospectus of where the issuer is under an obligation to, or where the issuer intends to, provide post-issuance transaction information regarding securities to be admitted to trading and the performance of the underlying collateral. The issuer shall indicate what information will be reported, where such information can be obtained, and the frequency with which such information will be reported.</p></td><td><p>Category C</p></td></tr><tr><td><div><a>(<span>1</span>)   </a><p>This may change depending on the final securitisation regulation requirements.</p></div></td></tr></tbody></table>
ANNEX 20
PRO FORMA INFORMATION
<table><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>CONTENTS OF PRO FORMA FINANCIAL INFORMATION</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>The pro forma financial information shall consist of:</p><p>(a)  an introduction setting out:</p><p>(i)  the purpose for which the pro forma financial information has been prepared, including a description of the transaction or significant commitment and the businesses or entities involved;</p><p>(ii)  the period or date covered by the pro forma financial information;</p><p>(iii)  the fact that the pro forma financial information has been prepared for illustrative purposes only;</p><p>(iv)  an explanation that:</p><p>(i)  the pro forma financial information illustrates the impact of the transaction as if the transaction had been undertaken at an earlier date;</p><p>(ii)  the hypothetical financial position or results included in the pro forma financial information may differ from the entity’s actual financial position or results;</p><p>(b)  a profit and loss account, a balance sheet or both, depending on the circumstances presented in a columnar format composed of:</p><p>(i)  historical unadjusted information;</p><p>(ii)  accounting policy adjustments, where necessary;</p><p>(iii)  pro forma adjustments;</p><p>(iv)  the results of the pro forma financial information in the final column;</p><p>(c)  accompanying notes explaining:</p><p>(i)  the sources from which the unadjusted financial information has been extracted and whether or not an audit or review report on the source has been published;</p><p>(ii)  the basis upon which the pro forma financial information is prepared;</p><p>(iii)  source and explanation for each adjustment;</p><p>(iv)  whether each adjustment in respect of a pro forma profit and loss statement is expected to have a continuing impact on the issuer or not;</p><p>(d)  where applicable, the financial information and interim financial information of the (or to be) acquired businesses or entities used in the preparation of the pro forma financial information must be included in the prospectus.</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>PRINCIPLES IN PREPARING AND PRESENTING PRO FORMA FINANCIAL INFORMATION</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>The pro forma financial information shall be identified as such in order to distinguish it from historical financial information.</p><p>The pro forma financial information must be prepared in a manner consistent with the accounting policies adopted by the issuer in its last or next financial statements.</p></td></tr><tr><td><p>Item 2.2</p></td><td><p>Pro forma information may only be published in respect of:</p><p>(a)  the last completed financial period; and/or</p><p>(b)  the most recent interim period for which relevant unadjusted information has been published or are included in the registration document/prospectus.</p></td></tr><tr><td><p>Item 2.3</p></td><td><p>Pro forma adjustments must comply with the following:</p><p>(a)  be clearly shown and explained;</p><p>(b)  present all significant effects directly attributable to the transaction;</p><p>(c)  be factually supportable.</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>REQUIREMENTS FOR AN ACCOUNTANT/AUDIT REPORT</p></td></tr><tr><td><p> </p><div/></td><td><p>The prospectus shall include a report prepared by the independent accountants or auditors stating that in their opinion:</p><p>(a)  the pro forma financial information has been properly compiled on the basis stated;</p><p>(b)  that the basis referred to in (a) is consistent with the accounting policies of the issuer.</p></td></tr></tbody></table>
ANNEX 21
GUARANTEES
<table><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>NATURE OF THE GUARANTEE</p></td></tr><tr><td><p> </p><div/></td><td><p>A description of any arrangement intended to ensure that any obligation material to the issue will be duly serviced, whether in the form of guarantee, surety, Keep well Agreement, Mono-line Insurance policy or other equivalent commitment (‘guarantees’) and their provider (‘guarantor’).</p><p>Such arrangements encompass commitments, including those under conditions, to ensure that the obligations to repay non-equity securities and/or the payment of interest are fulfilled and their description shall set out how the arrangement is intended to ensure that the guaranteed payments will be duly serviced.</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>SCOPE OF THE GUARANTEE</p></td></tr><tr><td><p> </p><div/></td><td><p>Details shall be disclosed about the terms and conditions and scope of the guarantee. These details should cover any conditionality on the application of the guarantee in the event of any default under the terms of the security and the material terms of any Mono-line Insurance or Keep well Agreement between the issuer and the guarantor. Details must also be disclosed of any guarantor’s power of veto in relation to changes to the security holder’s rights, such as is often found in Mono-line Insurance.</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>INFORMATION TO BE DISCLOSED ABOUT THE GUARANTOR</p></td></tr><tr><td><p> </p><div/></td><td><p>The guarantor must disclose information about itself as if it were the issuer of that same type of security that is the subject of the guarantee.</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>DOCUMENTS AVAILABLE</p></td></tr><tr><td><p> </p><div/></td><td><p>Indication of the website where the public may have access to the material contracts and other documents relating to the guarantee.</p></td></tr></tbody></table>
ANNEX 22
CONSENT
<table><col/><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>INFORMATION TO BE PROVIDED REGARDING CONSENT BY THE ISSUER OR PERSON RESPONSIBLE FOR DRAWING UP THE PROSPECTUS</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Express consent by the issuer or person responsible for drawing up the prospectus to the use of the prospectus and a statement that such person accepts responsibility for the content of the prospectus also with respect to the subsequent resale or final placement of securities by any financial intermediary which was given consent to use the prospectus.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>Indication of the period for which consent to use the prospectus is given.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Indication of the offer period upon which subsequent resale or final placement of the securities by financial intermediaries can be made.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Indication of the Member States in which the financial intermediaries may use the prospectus for subsequent resale or final placement of the securities.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>Any other clear and objective conditions attached to the consent which are relevant for the use of the prospectus.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 1.6</p></td><td><p>Notice in bold informing investors that, in the event of an offer being made by a financial intermediary, the financial intermediary will provide information to investors on the terms and conditions of the offer at the time the offer is made.</p></td><td><p>Category A</p></td></tr><tr><td><p>SECTION 2A</p></td><td><p>ADDITIONAL INFORMATION TO BE PROVIDED WHERE CONSENT IS GIVEN TO ONE OR MORE SPECIFIED FINANCIAL INTERMEDIARIES</p></td></tr><tr><td><p>Item 2A.1</p></td><td><p>List and identify (name and address) the financial intermediary or intermediaries that are allowed to use the prospectus.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 2A.2</p></td><td><p>Indication of how any new information with respect to the financial intermediaries, unknown at the time of the approval of the prospectus, the base prospectus or the filing of the final terms, as the case may be, is to be published and where it can be found.</p></td><td><p>Category A</p></td></tr><tr><td><p>SECTION 2B</p></td><td><p>ADDITIONAL INFORMATION TO BE PROVIDED WHERE CONSENT IS GIVEN TO ALL FINANCIAL INTERMEDIARIES</p></td></tr><tr><td><p>Item 2B.1</p></td><td><p>Notice in bold informing investors that any financial intermediary using the prospectus has to state on its website that it uses the prospectus in accordance with the consent and the conditions attached thereto.</p></td><td><p>Category A</p></td></tr></tbody></table>
ANNEX 23
SPECIFIC SUMMARY FOR THE EU GROWTH PROSPECTUS
<table><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>INTRODUCTION</p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Name and international securities identification number (‘ISIN’) of the securities.</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>Identity and contact details of the issuer, including its legal entity identifier (‘LEI’).</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Identity and contact details of the competent authority that approved the prospectus and, where different, the competent authority that approved the registration document.</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Date of approval of the EU Growth prospectus.</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>Warnings</p></td></tr><tr><td><p>Item 1.5.1</p></td><td><p>Statements by the issuer with regard to the following:</p><p>(a)  the summary should be read as an introduction to the EU Growth prospectus and that any decision to invest in the securities should be based on a consideration of the EU Growth prospectus as a whole by the investor;</p><p>(b)  where applicable, that the investor could lose all or part of the invested capital and, where the investor’s liability is not limited to the amount of the investment, a warning that the investor could lose more than the invested capital and the extent of such potential loss;</p><p>(c)  where a claim relating to the information contained in an EU Growth prospectus is brought before a court, the plaintiff investor may, under the national law of the Member States, have to bear the costs of translating the EU Growth prospectus before the legal proceedings are initiated;</p><p>(d)  the fact that civil liability attaches only to those persons who have tabled the summary including any translation thereof, but only where the summary is misleading, inaccurate or inconsistent when read together with the other parts of the EU Growth prospectus, or where it does not provide, when read together with the other parts of the EU Growth prospectus, key information in order to aid investors when considering whether to invest in such securities;</p><p>(e)  where applicable, the comprehension alert required in accordance with point (b) of Article 8(3) of Regulation (EU) No 1286/2014.</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>KEY INFORMATION ON THE ISSUER</p></td></tr><tr><td><p>Item 2.1</p></td><td><p>Who is the issuer of the securities?</p></td></tr><tr><td><p>Item 2.1.1</p></td><td><p>Information about the issuer:</p><p>(a)  its legal form, the law under which it operates and its country of incorporation;</p><p>(b)  its principal activities;</p><p>(c)  its controlling shareholder(s), including whether it is directly or indirectly controlled;</p><p>(d)  name of the Chief Executive Officer (or equivalent).</p></td></tr><tr><td><p>Item 2.2</p></td><td><p>What is the key financial information regarding the issuer?</p></td></tr><tr><td><p>Item 2.2.1</p></td><td><p>Key financial information presented for each financial year of the period covered by the historical financial information, and if included in the prospectus any subsequent interim financial period accompanied by comparative data from the same period in the prior financial year. The requirement for comparative balance sheet information shall be satisfied by presenting the year-end balance sheet information.</p><p>The key financial information shall include financial measures, which appear in the prospectus. These financial measures should provide information on:</p><p>(a)  revenue, profitability, assets, capital structure and, where included in the prospectus, cash flows; and</p><p>(b)  key performance indicators, where included in the prospectus.</p><p>The key financial information shall, where applicable, include:</p><p>(c)  condensed pro forma financial information and a brief explanation of what the pro forma financial information illustrates and the material adjustments done;</p><p>(d)  a brief description of any qualifications in the audit report relating to the historical financial information.</p></td></tr><tr><td><p>Item 2.3</p></td><td><p>What are the key risks that are specific to the issuer?</p></td></tr><tr><td><p>Item 2.3.1</p></td><td><p>A brief description of the most material risk factors specific to the issuer contained in the EU Growth prospectus, while not exceeding the total number of risk factors set out in Article 33(8) of this Regulation.</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>KEY INFORMATION ON THE SECURITIES</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>What are the main features of the securities?</p></td></tr><tr><td><p>Item 3.1.1</p></td><td><p>Information about the securities:</p><p>(a)  their type and class;</p><p>(b)  where applicable, their currency, denomination, the number of securities issued and the term of the securities;</p><p>(c)  the rights attached to the securities;</p><p>(d)  the relative seniority of the securities in the issuer’s capital structure in the event of insolvency including, where applicable, information on the level of subordination of the securities;</p><p>(e)  where applicable, the dividend or pay-out policy.</p></td></tr><tr><td><p>Item 3.2</p></td><td><p>Where will the securities be traded?</p></td></tr><tr><td><p>Item 3.2.1</p></td><td><p>Where applicable, information as to whether the securities are or will be the subject to an application for admission to trading on an MTF or an SME Growth market, the identity of all the markets where the securities are or are to be traded and the details of the admission to trading on an MTF or an SME Growth market.</p></td></tr><tr><td><p>Item 3.3</p></td><td><p>Is there a guarantee attached to the securities?</p><p>(a)  A brief description of the nature and scope of the guarantee;</p><p>(b)  a brief description of the guarantor, including its legal entity identifier (LEI);</p><p>(c)  the relevant key financial information for the purpose of assessing the guarantor’s ability to fulfil its commitments under the guarantee;</p><p>(d)  a brief description of the most material risk factors pertaining to the guarantor contained in the EU Growth prospectus in accordance with Article 16(3) of Regulation (EU) 2017/1129, while not exceeding the total number of risk factors set out in Article 33(8) of this Regulation.</p></td></tr><tr><td><p>Item 3.4</p></td><td><p>What are the key risks that are specific to the securities?</p></td></tr><tr><td><p>Item 3.4.1</p></td><td><p>A brief description of the most material risk factors specific to the securities contained in the EU Growth prospectus, while not exceeding the total number of risk factors set out in Article 33(8) of this Regulation.</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>KEY INFORMATION ON THE OFFER OF SECURITIES TO THE PUBLIC</p></td></tr><tr><td><p>Item 4.1</p></td><td><p>Under which conditions and timetable can I invest in this security?</p><p>Where applicable, the general terms, conditions and expected timetable of the offer, the plan for distribution, the amount and percentage of immediate dilution resulting from the offer and an estimate of the total expenses of the issue and/or offer, including estimated expenses charged to the investor by the issuer or the offeror.</p></td></tr><tr><td><p>Item 4.2</p></td><td><p>Why is this EU Growth prospectus being produced?</p></td></tr><tr><td><p>Item 4.2.1</p></td><td><p>A brief description of the reasons for the offer as well as, where applicable:</p><p>(a)  the use and estimated net amount of the proceeds;</p><p>(b)  where the offer is subject to an underwriting agreement on a firm commitment basis, state any portion not covered;</p><p>(c)  a description of any material conflict of interest pertaining to the offer or the admission to trading that are described in the prospectus.</p></td></tr><tr><td><p>Item 4.3</p></td><td><p>Who is the offeror and/or the person asking for admission to trading?</p></td></tr><tr><td><p>Item 4.3.1</p></td><td><p>If different from the issuer, a brief description of the offeror of the securities and/or the person asking for admission to trading on an MTF or an SME Growth Market, including its domicile and legal form, the law under which it operates and its country of incorporation.</p></td></tr></tbody></table>
ANNEX 24
EU GROWTH REGISTRATION DOCUMENT FOR EQUITY SECURITIES
<table><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>PERSONS RESPONSIBLE, THIRD PARTY INFORMATION, EXPERTS’ REPORTS AND COMPETENT AUTHORITY APPROVAL</p><p><span>This section shall provide information on the persons who are responsible for the content of the EU Growth registration document. The purpose of this section is to provide comfort to investors on the accuracy of the information disclosed in the prospectus. Moreover, this section provides information on the legal basis of the EU Growth registration document and its approval by the competent authority.</span></p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Identify all persons responsible for the information or any parts of it, given in the registration document with, in the latter case, an indication of such parts. In the case of natural persons, including members of the issuer’s administrative, management or supervisory bodies, indicate the name and function of the person; in the case of legal persons indicate the name and registered office.</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>A declaration by those responsible for the registration document that to the best of their knowledge, the information contained in the registration document is in accordance with the facts and that the registration document makes no omission likely to affect its import.</p><p>Where applicable, a declaration by those responsible for certain parts of the registration document that, to the best of their knowledge, the information contained in those parts of the registration document for which they are responsible is in accordance with the facts and that those parts of the registration document make no omission likely to affect their import.</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Where a statement or report attributed to a person as an expert, is included in the registration document, provide the following details for that person:</p><p>(a)  name;</p><p>(b)  business address;</p><p>(c)  qualifications;</p><p>(d)  material interest if any in the issuer.</p><p>If the statement or report has been produced at the issuer’s request, state that such statement or report has been included in the registration document with the consent of the person who has authorised the contents of that part of the registration document for the purpose of the prospectus.</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Where information has been sourced from a third party, provide a confirmation that this information has been accurately reproduced and that as far as the issuer is aware and is able to ascertain from information published by that third party, no facts have been omitted which would render the reproduced information inaccurate or misleading. In addition, identify the source(s) of the information.</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>A statement that:</p><p>(a)  the [registration document/prospectus] has been approved by the [name of the competent authority], as competent authority under Regulation (EU) 2017/1129;</p><p>(b)  the [name of the competent authority] only approves this [registration document/prospectus]as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation (EU) 2017/1129;</p><p>(c)  such approval should not be considered as an endorsement of the issuer that is the subject of this [registration document/prospectus];</p><p>(d)  the [registration document/prospectus] has been drawn up as part of an EU Growth prospectus in accordance with Article 15 of Regulation (EU) 2017/1129.</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>STRATEGY, PERFORMANCE AND BUSINESS ENVIRONMENT</p><p><span>The purpose of this section is to disclose information on the identity of the issuer, its business, strategy and objectives. By reading this section, investors should have a clear understanding of the issuer’s activities and the main trends affecting its performance, its organisational structure and material investments. Where applicable the issuer shall disclose in this section estimates or forecasts of its future performance. Moreover, issuers with market capitalisation above EUR 200 000 000 shall provide a fair and balanced review of the company’s past performance in this section.</span></p></td></tr><tr><td><p>Item 2.1</p></td><td><p>Information about the issuer:</p><p>(a)  the legal and commercial name of the issuer;</p><p>(b)  the place of registration of the issuer, its registration number and legal entity identifier (‘LEI’);</p><p>(c)  the date of incorporation and the length of life of the issuer, except where the period is indefinite;</p><p>(d)  the domicile and legal form of the issuer, the legislation under which the issuer operates, its country of incorporation the address, telephone number of its registered office (or principal place of business if different from its registered office) and website of the issuer, if any, with a disclaimer that the information on the website does not form part of the prospectus unless that information is incorporated by reference into the prospectus.</p></td></tr><tr><td><p>Item 2.1.1</p></td><td><p>Information on the material changes in the issuer’s borrowing and funding structure since the end of the last financial period for which information has been provided in the registration document. Where the registration document contains interim financial information, this information may be provided since the end of the last interim period for which financial information has been included in the registration document;</p></td></tr><tr><td><p>Item 2.1.2</p></td><td><p>A description of the expected financing of the issuer’s activities</p></td></tr><tr><td><p>Item 2.2</p></td><td><p>Business overview</p></td></tr><tr><td><p>Item 2.2.1</p></td><td><p>Strategy and objectives</p><p>A description of the issuer’s business strategy and strategic objectives (both financial and non-financial, if any). This description shall take into account the issuer’s future challenges and prospects.</p><p>Where relevant the description shall take into account the regulatory environment in which the issuer operates.</p></td></tr><tr><td><p>Item 2.2.2</p></td><td><p>Principal Activities</p><p>A description of the issuer’s principal activities, including:</p><p>(a)  the main categories of products sold and/or services performed;</p><p>(b)  an indication of any significant new products, services or activities that have been introduced since the publication of the latest audited financial statements.</p></td></tr><tr><td><p>Item 2.2.3</p></td><td><p>Principal Markets</p><p>A description of the principal markets in which the issuer competes.</p></td></tr><tr><td><p>Item 2.3</p></td><td><p>Organisational structure</p></td></tr><tr><td><p>Item 2.3.1</p></td><td><p>If the issuer is part of a group and where not covered elsewhere in the registration document and to the extent necessary for an understanding of the issuer’s business as a whole, a diagram of the organisational structure.</p><p>At the choice of the issuer, such diagram may be replaced, or accompanied, by a brief description of the group and the issuer’s position within the group, if this helps to clarify the structure.</p></td></tr><tr><td><p>Item 2.3.2</p></td><td><p>If the issuer is dependent upon other entities within the group this must be clearly stated together with an explanation of this dependence.</p></td></tr><tr><td><p>Item 2.4</p></td><td><p>Investments</p></td></tr><tr><td><p>Item 2.4.1</p></td><td><p>To the extent not covered elsewhere in the registration document a description, (including the amount) of the issuer’s material investments from the end of the period covered by the historical financial information included in the prospectus up to the date of the registration document.</p></td></tr><tr><td><p>Item 2.4.2</p></td><td><p>A description of any material investments of the issuer’s that are in progress or for which firm commitments have already been made, including, if material to the issuer’s business, the method of financing (internal or external).</p></td></tr><tr><td><p>Item 2.5</p></td><td><p>Operating and financial review (to be provided by equity issuers with market capitalisation above EUR 200 000 000 only when the Management Report presented and prepared in accordance with Articles 19 and 29 of Directive 2013/34/EU is not included in the EU Growth prospectus).</p></td></tr><tr><td><p>Item 2.5.1</p></td><td><p>To the extent not covered elsewhere in the registration document and to the extent necessary for an understanding of the issuer’s business as a whole, provide the following:</p><p>(a)  a balanced and comprehensive analysis of the development and performance of the issuer’s business and of its position consistent with the size and complexity of the business for each year for which historical financial information is required including the causes of material changes;</p><p>(b)  an indication of:</p><p>(i)  the issuer’s likely future development;</p><p>(ii)  activities in the field of research and development.</p><p>To the extent necessary for an understanding of the issuer’s development, performance or position, the analysis shall include both financial and, where appropriate, non-financial Key Performance Indicators relevant to the particular business, including information relating to environmental and employee matters. This analysis shall, where appropriate, include references to, and additional explanations of, amounts reported in the annual financial statements.</p></td></tr><tr><td><p>Item 2.6</p></td><td><p>Trend information</p></td></tr><tr><td><p>Item 2.6.1</p></td><td><p>A description of the most significant recent trends in production, sales, inventory, costs and selling prices since the end of the last financial year to the date of the registration document.</p></td></tr><tr><td><p>Item 2.7</p></td><td><p>Profit forecasts or estimates</p></td></tr><tr><td><p>Item 2.7.1</p></td><td><p>Where an issuer has published a profit forecast or a profit estimate (which is still outstanding and valid) that forecast or estimate shall be included in the registration document.</p><p>If a profit forecast or profit estimate has been published and is still outstanding, but no longer valid, then provide a statement to that effect and an explanation of why such forecast or estimate is no longer valid. Such an invalid forecast or estimate is not subject to the requirements in items 2.7.2 to 2.7.3.</p></td></tr><tr><td><p>Item 2.7.2</p></td><td><p>Where an issuer chooses to include a new profit forecast or a new profit estimate, or where the issuer includes a previously published profit forecast or a previously published profit estimate pursuant to item 2.7.1, the profit forecast or estimate shall be clear and unambiguous and shall contain a statement setting out the principal assumptions upon which the issuer has based its forecast, or estimate.</p><p>The forecast or estimate shall comply with the following principles:</p><p>(a)  there must be a clear distinction between assumptions about factors which the members of the administrative, management or supervisory bodies can influence and assumptions about factors which are exclusively outside the influence of the members of the administrative, management or supervisory bodies;</p><p>(b)  the assumptions must be reasonable, readily understandable by investors, specific and precise and not relate to the general accuracy of the estimates underlying the forecast;</p><p>(c)  in the case of a forecast, the assumptions shall draw the investor’s attention to those uncertain factors which could materially change the outcome of the forecast.</p></td></tr><tr><td><p>Item 2.7.3</p></td><td><p>The prospectus shall include a statement that the profit forecast or estimate has been compiled and prepared on a basis which is both:</p><p>(a)  comparable with the annual financial statements;</p><p>(b)  consistent with the issuer’s accounting policies.</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>RISK FACTORS</p><p><span>The purpose of this section is to describe the main risks faced by the issuer and their impact on the issuer’s future performance.</span></p></td></tr><tr><td><p>Item 3.1</p></td><td><p>A description of the material risks that are specific to the issuer, in a limited number of categories, in a section headed ‘Risk Factors’.</p><p>In each category, the most material risks in the assessment of the issuer or offeror, taking into account the negative impact on the issuer and the probability of their occurrence, shall be set out first. The risks shall be corroborated by the content of the registration document.</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>CORPORATE GOVERNANCE</p><p><span>This section shall explain the issuer’s administration and the role of the persons involved in the management of the company. It will furthermore provide information on the background of senior management, their remuneration and its potential link to the issuer’s performance.</span></p></td></tr><tr><td><p>Item 4.1</p></td><td><p>Administrative, management, and supervisory bodies and senior management</p></td></tr><tr><td><p>Item 4.1.1</p></td><td><p>Names, business addresses and functions within the issuer of the following persons and an indication of the principal activities performed by them outside of the issuer where these are significant with respect to that issuer:</p><p>(a)  members of the administrative, management and/or supervisory bodies;</p><p>(b)  partners with unlimited liability, in the case of a limited partnership with a share capital;</p><p>(c)  any senior manager who is relevant to establishing that the issuer has the appropriate expertise and experience for the management of the issuer’s business.</p><p>Details of the nature of any family relationship between any of the persons referred to in points (a) to (c).</p></td></tr><tr><td><p>Item 4.1.2</p></td><td><p>In the case of each member of the administrative, management or supervisory bodies of the issuer and of each person referred to in points (b) and (c) of the item 4.1.1, details of that person’s relevant management expertise and experience and the following information:</p><p>(a)  details of any convictions in relation to fraudulent offences for at least the previous five years;</p><p>(b)  details of any official public incrimination and/or sanctions involving such persons by statutory or regulatory authorities (including designated professional bodies) and whether they have ever been disqualified by a court from acting as a member of the administrative, management or supervisory bodies of an issuer or from acting in the management or conduct of the affairs of any issuer for at least the previous five years.</p><p>If there is no such information required to be disclosed, a statement to that effect is to be made.</p></td></tr><tr><td><p>Item 4.2</p></td><td><p>Remuneration and benefits</p><p>To the extent not covered elsewhere in the registration document in relation to the last full financial year for those persons referred to in points (a) and (c) of item 4.1.1.</p></td></tr><tr><td><p>Item 4.2.1</p></td><td><p>The amount of remuneration paid (including any contingent or deferred compensation), and benefits in kind granted to such persons by the issuer and its subsidiaries for services in all capacities to the issuer and its subsidiaries by any person. That information must be provided on an individual basis unless individual disclosure is not required in the issuer’s home country or is not otherwise publicly disclosed by the issuer.</p></td></tr><tr><td><p>Item 4.2.2</p></td><td><p>The total amounts set aside or accrued by the issuer or its subsidiaries to provide pension, retirement or similar benefits.</p></td></tr><tr><td><p>Item 4.3</p></td><td><p>Shareholdings and stock options</p><p>With respect to each person referred to in points (a) and (c) of item 4.1.1 provide information as to their share ownership and any stock options in the issuer as of the most recent practicable date.</p></td></tr><tr><td><p>SECTION 5</p></td><td><p>FINANCIAL INFORMATION AND KEY PERFORMANCE INDICATORS (KPIs)</p><p><span>This section shall provide historical financial information by disclosing the issuer’s financial information and key performance indicators. It shall also provide information on the issuer’s dividend policy and where applicable it shall disclose pro forma financial information.</span></p></td></tr><tr><td><p>Item 5.1</p></td><td><p>Historical financial information</p></td></tr><tr><td><p>Item 5.1.1</p></td><td><p>Audited historical financial information covering the latest two financial years (or such shorter period as the issuer has been in operation) and the audit report in respect of each year.</p></td></tr><tr><td><p>Item 5.1.2</p></td><td><p>Change of accounting reference date</p><p>If the issuer has changed its accounting reference date during the period for which historical financial information is required, the audited historical information shall cover at least 24 months or the entire period for which the issuer has been in operation, whichever is shorter.</p></td></tr><tr><td><p>Item 5.1.3</p></td><td><p>Accounting Standards</p><p>The financial information must be prepared according to International Financial Reporting Standards as endorsed in the Union based on Regulation (EC) No 1606/2002.</p><p>If Regulation (EC) No 1606/2002 is not applicable the financial information must be prepared according to:</p><p>(a)  a Member State’s national accounting standards for issuers from the EEA, as required by Directive 2013/34/EU;</p><p>(b)  a third country’s national accounting standards equivalent to Regulation (EC) No 1606/2002 for third country issuers. If such third country’s national accounting standards are not equivalent to Regulation (EC) No 1606/2002 the financial statements shall be restated in accordance with that Regulation.</p></td></tr><tr><td><p>Item 5.1.4</p></td><td><p>Change of accounting framework</p><p>The last audited historical financial information, containing comparative information for the previous year, must be presented and prepared in a form consistent with the accounting standards framework that will be adopted in the issuer’s next published annual financial statements having regard to accounting standards and policies and legislation applicable to such annual financial statements.</p><p>Changes within the accounting framework applicable to the issuer do not require the audited financial statements to be restated. However, if the issuer intends to adopt a new accounting standards framework in its next published financial statements, at least one complete set of financial statements, (as defined by IAS 1 Presentation of Financial Statements), including comparatives, must be prepared in a form consistent with that which will be adopted in the issuer’s next published annual financial statements, having regard to accounting standards and policies and legislation applicable to such annual financial statements.</p></td></tr><tr><td><p>Item 5.1.5</p></td><td><p>Where the audited financial information is prepared according to national accounting standards, they must include at least the following:</p><p>(a)  the balance sheet;</p><p>(b)  the income statement;</p><p>(c)  the accounting policies and explanatory notes.</p></td></tr><tr><td><p>Item 5.1.6</p></td><td><p>Consolidated financial statements</p><p>If the issuer prepares both stand-alone and consolidated financial statements, include at least the consolidated financial statements in the registration document</p></td></tr><tr><td><p>Item 5.1.7</p></td><td><p>Age of Financial Information</p><p>The balance sheet date of the last year of audited financial information may not be older than one of the following:</p><p>(a)  18 months from the date of the registration document if the issuer includes audited interim financial statements in the registration document;</p><p>(b)  16 months from the date of the registration document if the issuer includes interim financial statements in the registration document which is not audited.</p><p>Where the registration document contains no interim financial information, the balance sheet date of the last year of audited financial statements may not be older than 16 months from the date of the registration document.</p></td></tr><tr><td><p>Item 5.2</p></td><td><p>Interim and other financial information</p></td></tr><tr><td><p>Item 5.2.1</p></td><td><p>If the issuer has published quarterly or half-yearly financial information since the date of its last audited financial statements, these must be included in the registration document. If the quarterly or half-yearly financial information has been audited or reviewed, the audit or review report must also be included. If the quarterly or half-yearly financial information is not audited or has not been reviewed, state that fact.</p><p>Interim financial information prepared in accordance with the requirements of the Directive 2013/34/EU or Regulation (EC) No 1606/2002 as the case may be.</p><p>For issuers not subject to either the Directive 2013/34/EU or Regulation (EC) No 1606/2002, the interim financial information must include comparative statements for the same period in the prior financial year, except that the requirement for comparative balance sheet information may be satisfied by presenting the year’s end balance sheet in accordance with the applicable financial reporting framework.</p></td></tr><tr><td><p>Item 5.3</p></td><td><p>Auditing of annual financial information</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 5.3.1</p></td><td><p>The historical annual financial information must be independently audited. The audit report shall be prepared in accordance with Directive 2006/43/EC and Regulation (EU) No 537/2014.</p><p>Where Directive 2006/43/EC and Regulation (EU) No 537/2014 do not apply, the historical financial information must be audited or reported on as to whether or not, for the purposes of the registration document, it gives a true and fair view in accordance with auditing standards applicable in a Member State or an equivalent standard.</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 5.3.1a</p></td><td><p>Where audit reports on the historical financial information have been refused by the statutory auditors or where they contain qualifications, modifications of opinion, disclaimers or an emphasis of matter, the reason must be given, and such qualifications, modifications, disclaimers or emphasis of matter must be reproduced in full.</p></td></tr><tr><td><p><a>▼B</a></p></td></tr><tr><td><p>Item 5.3.2</p></td><td><p>Indication of other information in the registration document, which has been audited by the auditors.</p></td></tr><tr><td><p>Item 5.3.3</p></td><td><p>Where financial information in the registration document is not extracted from the issuer’s audited financial statements state the source of the information and state that the information is not audited.</p></td></tr><tr><td><p>Item 5.4</p></td><td><p>Key Performance Indicators (KPIs)</p></td></tr><tr><td><p>Item 5.4.1</p></td><td><p>To the extent not disclosed elsewhere in the registration document and where an issuer has published KPIs, financial and/or operational, or chooses to include such in the registration document, a description of the issuer’s KPIs for each financial year for the period covered by the historical financial information shall be included in the registration document.</p><p>KPIs must be calculated on a comparable basis. Where the KPIs have been audited by the auditors, that fact must be stated.</p></td></tr><tr><td><p>Item 5.5</p></td><td><p>Significant change in the issuer’s financial position</p><p>A description of any significant change in the financial position of the group which has occurred since the end of the last financial period for which either audited financial statements or interim financial information have been published, or provide an appropriate negative statement.</p></td></tr><tr><td><p>Item 5.6</p></td><td><p>Dividend policy</p><p>A description of the issuer’s policy on dividend distributions and any restrictions thereon. If the issuer has no such policy, include an appropriate negative statement.</p><p>the amount of the dividend per share for each financial year for the period covered by the annual financial statements adjusted, where the number of shares in the issuer has changed, to make it comparable, if not disclosed in the financial statements.</p></td></tr><tr><td><p>Item 5.7</p></td><td><p>Pro forma financial information</p><p>In the case of a significant gross change, a description of how the transaction might have affected the assets and liabilities and earnings of the issuer, had the transaction been undertaken at the commencement of the period being reported on or at the date reported.</p><p>This requirement will normally be satisfied by the inclusion of pro forma financial information. This pro forma financial information is to be presented as set out in Annex 20 and must include the information indicated therein.</p><p>Pro forma financial information must be accompanied by a report prepared by independent accountants or auditors.</p></td></tr><tr><td><p>SECTION 6</p></td><td><p>SHAREHOLDER AND SECURITY HOLDER INFORMATION</p><p><span>This section shall provide information on the issuer’s major shareholders, the existence of potential conflicts of interest between senior management and the issuer, the issuer’s share capital as well as information on related party transactions, legal and arbitration proceedings and material contracts.</span></p></td></tr><tr><td><p>Item 6.1</p></td><td><p>Major shareholders</p></td></tr><tr><td><p>Item 6.1.1</p></td><td><p>In so far as known to the issuer, the name of any person who, directly or indirectly, has an interest in the issuer’s capital or voting rights which is equal or above 5 % of capital or total voting rights, together with the amount of each such person’s interest, as at the date of the registration document or, if there are no such persons, an appropriate negative statement.</p></td></tr><tr><td><p>Item 6.1.2</p></td><td><p>Whether the issuer’s major shareholders have different voting rights, or an appropriate negative statement.</p></td></tr><tr><td><p>Item 6.1.3</p></td><td><p>To the extent known to the issuer, state whether the issuer is directly or indirectly owned or controlled and by whom and describe the nature of such control and describe the measures in place to ensure that such control is not abused.</p></td></tr><tr><td><p>Item 6.1.4</p></td><td><p>A description of any arrangements, known to the issuer, the operation of which may at a subsequent date result in or prevent a change in control of the issuer.</p></td></tr><tr><td><p>Item 6.2</p></td><td><p>Legal and arbitration proceedings</p></td></tr><tr><td><p>Item 6.2.1</p></td><td><p>Information on any governmental, legal or arbitration proceedings (including any such proceedings which are pending or threatened of which the issuer is aware), during a period covering at least the previous 12 months which may have, or have had in the recent past significant effects on the issuer and/or group’s financial position or profitability, or provide an appropriate negative statement.</p></td></tr><tr><td><p>Item 6.3</p></td><td><p>Administrative, Management and Supervisory bodies’ and Senior Management’s conflicts of interests</p></td></tr><tr><td><p>Item 6.3.1</p></td><td><p>Potential conflicts of interests between any duties to the issuer, of the persons referred to in item 4.1.1, and their private interests and or other duties must be clearly stated. In the event that there are no such conflicts, a statement to that effect must be made.</p><p>Any arrangement or understanding with major shareholders, customers, suppliers or others, pursuant to which any person referred to in item 4.1.1 was selected as a member of the administrative, management or supervisory bodies or member of senior management.</p><p>Details of any restrictions agreed by the persons referred to in item 4.1.1 on the disposal within a certain period of time of their holdings in the issuer’s securities.</p></td></tr><tr><td><p>Item 6.4</p></td><td><p>Related party transactions</p></td></tr><tr><td><p>Item 6.4.1</p></td><td><p>If the International Financial Reporting Standards adopted in accordance with Regulation (EC) No 1606/2002 do not apply to the issuer, the following information must be disclosed for the period covered by the historical financial information and up to the date of the registration document:</p><p>(a)  the nature and extent of any related party transactions <a>(<span>1</span>)</a> which are, as a single transaction or in their entirety, material to the issuer. Where such related party transactions are not concluded at arm’s length provide an explanation of why these transactions were not concluded at arm’s length. In the case of outstanding loans including guarantees of any kind indicate the amount outstanding;</p><p>(b)  the amount or the percentage to which related party transactions form part of the turnover of the issuer.</p><p>If the International Financial Reporting Standards adopted in accordance with Regulation (EC) No 1606/2002 apply to the issuer, the information set out in points (a) and (b) must be disclosed only for transactions that have occurred since the end of the last financial period for which audited financial information have been published.</p></td></tr><tr><td><p>Item 6.5</p></td><td><p>Share capital</p></td></tr><tr><td><p>Item 6.5.1</p></td><td><p>The following information in items 6.5.2 to 6.5.7 in the annual financial statements as of the date of the most recent balance sheet:</p></td></tr><tr><td><p>Item 6.5.2</p></td><td><p>The amount of issued capital, and for each class of share capital:</p><p>(a)  the total of the issuer’s authorised share capital;</p><p>(b)  the number of shares issued and fully paid and issued but not fully paid;</p><p>(c)  the par value per share, or that the shares have no par value; and</p><p>(d)  a reconciliation of the number of shares outstanding at the beginning and end of the year.</p><p>If more than 10 % of the capital has been paid for with assets other than cash within the period covered by the annual financial statements, state that fact.</p></td></tr><tr><td><p>Item 6.5.3</p></td><td><p>If there are shares not representing capital, state the number and main characteristics of such shares.</p></td></tr><tr><td><p>Item 6.5.4</p></td><td><p>The number, book value and face value of shares in the issuer held by or on behalf of the issuer itself or by subsidiaries of the issuer.</p></td></tr><tr><td><p>Item 6.5.5</p></td><td><p>The amount of any convertible securities, exchangeable securities or securities with warrants, with an indication of the conditions governing and the procedures for conversion, exchange or subscription.</p></td></tr><tr><td><p>Item 6.5.6</p></td><td><p>Information about and terms of any acquisition rights and or obligations over authorised but unissued capital or an undertaking to increase the capital.</p></td></tr><tr><td><p>Item 6.5.7</p></td><td><p>Information about any capital of any member of the group which is under option or agreed conditionally or unconditionally to be put under option and details of such options including those persons to whom such options relate.</p></td></tr><tr><td><p>Item 6.6</p></td><td><p>Memorandum and Articles of Association</p></td></tr><tr><td><p>Item 6.6.1</p></td><td><p>A brief description of any provision of the issuer’s articles of association, statutes, charter or bylaws that would have an effect of delaying, deferring or preventing a change in control of the issuer.</p></td></tr><tr><td><p>Item 6.7</p></td><td><p>Material contracts</p></td></tr><tr><td><p>Item 6.7.1</p></td><td><p>A brief summary of any material contracts, other than contracts entered into in the ordinary course of business, to which the issuer or any member of the group is a party, for the last year immediately preceding publication of the registration document.</p></td></tr><tr><td><p>SECTION 7</p></td><td><p>DOCUMENTS AVAILABLE</p></td></tr><tr><td><p>Item 7.1</p></td><td><p>A statement that for the term of the registration document the following documents, where applicable, can be inspected:</p><p>(a)  the up to date memorandum and articles of association of the issuer;</p><p>(b)  all reports, letters, and other documents, valuations and statements prepared by any expert at the issuer’s request any part of which is included or referred to in the registration document.</p><p>An indication of the website on which the documents may be inspected.</p></td></tr><tr><td><div><a>(<span>1</span>)   </a><p>Related party transactions for these purposes are those set out in the standards adopted in accordance with Regulation (EC) No 1606/2002.</p></div></td></tr></tbody></table>
ANNEX 25
EU GROWTH REGISTRATION DOCUMENT FOR NON-EQUITY SECURITIES
<table><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>PERSONS RESPONSIBLE, THIRD PARTY INFORMATION, EXPERTS’ REPORTS AND COMPETENT AUTHORITY APPROVAL</p><p><span>This section shall provide information on the persons who are responsible for the content of the EU Growth registration document. The purpose of this section is to provide comfort to investors on the accuracy of the information disclosed in the prospectus. Moreover, this section provides information on the legal basis of the EU Growth registration document and its approval by the competent authority.</span></p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Identify all persons responsible for the information or any parts of it, given in the registration document with, in the latter case, an indication of such parts. In the case of natural persons, including members of the issuer’s administrative, management or supervisory bodies, indicate the name and function of the person; in the case of legal persons indicate the name and registered office.</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>A declaration by those responsible for the registration document that to the best of their knowledge, the information contained in the registration document is in accordance with the facts and that the registration document makes no omission likely to affect its import.</p><p>Where applicable, a declaration by those responsible for certain parts of the registration document that, to the best of their knowledge, the information contained in those parts of the registration document for which they are responsible is in accordance with the facts and that those parts of the registration document make no omission likely to affect their import.</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Where a statement or report attributed to a person as an expert is included in the registration document, provide the following details for that person:</p><p>(a)  name;</p><p>(b)  business address;</p><p>(c)  qualifications;</p><p>(d)  material interest if any in the issuer.</p><p>If the report has been produced at the issuer’s request, state that the report has been included in the registration document with the consent of the person who has authorised the contents of that part of the registration document for the purpose of the prospectus.</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Where information has been sourced from a third party, provide a confirmation that this information has been accurately reproduced and that as far as the issuer is aware and is able to ascertain from information published by that third party, no facts have been omitted which would render the reproduced information inaccurate or misleading. In addition, identify the source(s) of the information.</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>A statement that:</p><p>(a)  the [registration document/prospectus] has been approved by the [name of the competent authority], as competent authority under Regulation (EU) 2017/1129;</p><p>(b)  the [name of the competent authority] only approves this [registration document/prospectus]as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation (EU) 2017/1129;</p><p>(c)  such approval should not be considered as an endorsement of the issuer that is the subject of this [registration document/prospectus];</p><p>(d)  the [registration document/prospectus] has been drawn up as part of an EU Growth prospectus in accordance with Article 15 of Regulation (EU) 2017/1129.</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>STRATEGY, PERFORMANCE AND BUSINESS ENVIRONMENT</p><p><span>The purpose of this section is to disclose information on the identity of the issuer, its business, strategy and objectives. By reading this section, investors should have a clear understanding of the issuer’s activities and the main trends affecting its performance, its organisational structure and material investments. Where applicable the issuer shall disclose in this section estimates or forecasts of its future performance.</span></p></td></tr><tr><td><p>Item 2.1</p></td><td><p>Information about the issuer:</p><p>(a)  the legal and commercial name of the issuer;</p><p>(b)  the place of registration of the issuer, its registration number and legal entity identifier (‘LEI’);</p><p>(c)  the date of incorporation and the length of life of the issuer, except where the period is indefinite;</p><p>(d)  the domicile and legal form of the issuer, the legislation under which the issuer operates, its country of incorporation, the address, telephone number of its registered office (or principal place of business if different from its registered office) and website of the issuer, if any, with a disclaimer that the information on the website does not form part of the prospectus unless that information is incorporated by reference into the prospectus;</p><p>(e)  any recent events particular to the issuer and which are to a material extent relevant to an evaluation of the issuer’s solvency;</p><p>(f)  credit ratings assigned to an issuer at the request or with the cooperation of the issuer in the rating process.</p></td></tr><tr><td><p>Item 2.1.1</p></td><td><p>Information on the material changes in the issuer’s borrowing and funding structure since the end of the last financial period for which information has been provided in the registration document. Where the registration document contains interim financial information, this information may be provided since the end of the last interim period for which financial information has been included in the registration document;</p></td></tr><tr><td><p>Item 2.1.2</p></td><td><p>A description of the expected financing of the issuer’s activities</p></td></tr><tr><td><p>Item 2.2</p></td><td><p>Business overview</p></td></tr><tr><td><p>Item 2.2.1</p></td><td><p>Principal Activities</p><p>A description of the issuer’s principal activities, including:</p><p>(a)  the main categories of products sold and/or services performed;</p><p>(b)  an indication of any significant new products, services or activities that have been introduced since the publication of the latest audited financial statements.</p></td></tr><tr><td><p>Item 2.2.2</p></td><td><p>Principal Markets</p><p>A description of the principal markets in which the issuer competes.</p></td></tr><tr><td><p>Item 2.3</p></td><td><p>Organisational structure</p></td></tr><tr><td><p>Item 2.3.1</p></td><td><p>If the issuer is part of a group and where not covered elsewhere in the registration document and to the extent necessary for an understanding of the issuer’s business as a whole, a diagram of the organisational structure.</p><p>At the choice of the issuer, such diagram may be replaced, or accompanied, by a brief description of the group and the issuer’s position within the group, if this helps to clarify the structure.</p></td></tr><tr><td><p>Item 2.3.2</p></td><td><p>If the issuer is dependent upon other entities within the group this must be clearly stated together with an explanation of this dependence.</p></td></tr><tr><td><p>Item 2.4</p></td><td><p>Trend information</p></td></tr><tr><td><p>Item 2.4.1</p></td><td><p>A description of:</p><p>(a)  any material adverse change in the prospects of the issuer since the date of its last published audited financial statements;</p><p>(b)  any significant change in the financial performance of the group since the end of the last financial period for which financial information has been published to the date of the registration document.</p><p>If points (a) and (b) are not applicable then the issuer should include (an) appropriate negative statement(s) to that effect.</p></td></tr><tr><td><p>Item 2.5</p></td><td><p>Profit forecasts or estimates</p></td></tr><tr><td><p>Item 2.5.1</p></td><td><p>Where an issuer includes on a voluntary basis a profit forecast or estimate in the prospectus, the profit forecast or estimate shall be clear and unambiguous and shall contain a statement setting out the principal assumptions upon which the issuer has based its forecast, or estimate.</p><p>The forecast or estimate shall comply with the following principles:</p><p>(a)  there must be a clear distinction between assumptions about factors which the members of the administrative, management or supervisory bodies can influence and assumptions about factors which are exclusively outside the influence of the members of the administrative, management or supervisory bodies;</p><p>(b)  the assumptions must be reasonable, readily understandable by investors, specific and precise and not relate to the general accuracy of the estimates underlying the forecast;</p><p>(c)  in the case of a forecast, the assumptions shall draw the investor’s attention to those uncertain factors which could materially change the outcome of the forecast.</p></td></tr><tr><td><p>Item 2.5.2</p></td><td><p>The prospectus shall include a statement that the profit forecast or estimate has been compiled and prepared on a basis which is both:</p><p>(a)  comparable with the annual financial statements;</p><p>(b)  consistent with the issuer’s accounting policies.</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>RISK FACTORS</p><p><span>The purpose of this section is to describe the main risks faced by the issuer and their impact on the issuer’s future performance.</span></p></td></tr><tr><td><p>Item 3.1</p></td><td><p>A description of the material risks that are specific to the issuer and that may affect the issuer’s ability to fulfil its obligations under the securities, in a limited number of categories, in a section headed ‘Risk Factors’.</p><p>In each category the most material risks, in the assessment of the issuer or offeror, taking into account the negative impact on the issuer and the probability of their occurrence, shall be set out first. The risks shall be corroborated by the content of the registration document.</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>CORPORATE GOVERNANCE</p><p><span>This section shall explain the issuer’s administration and the role of the persons involved in the management of the company.</span></p></td></tr><tr><td><p>Item 4.1</p></td><td><p>Administrative, management, and supervisory bodies and senior management</p></td></tr><tr><td><p>Item 4.1.1</p></td><td><p>Names, business addresses and functions within the issuer of the following persons and an indication of the principal activities performed by them outside of that issuer where these are significant with respect to that issuer:</p><p>(a)  members of the administrative, management and/or supervisory bodies;</p><p>(b)  partners with unlimited liability, in the case of a limited partnership with a share capital.</p></td></tr><tr><td><p>SECTION 5</p></td><td><p>FINANCIAL INFORMATION AND KEY PERFORMANCE INDICATORS</p><p><span>This section shall provide historical financial information by disclosing the issuer’s financial information and KPIs.</span></p></td></tr><tr><td><p>Item 5.1</p></td><td><p>Historical financial information</p></td></tr><tr><td><p>Item 5.1.1</p></td><td><p>Audited historical financial information covering the last financial year (or such shorter period as the issuer has been in operation) and the audit report in respect of that year.</p></td></tr><tr><td><p>Item 5.1.2</p></td><td><p>Change of accounting reference date</p><p>If the issuer has changed its accounting reference date during the period for which historical financial information is required, the audited historical information shall cover at least 12 months or the entire period for which the issuer has been in operation, whichever is shorter.</p></td></tr><tr><td><p>Item 5.1.3</p></td><td><p>Accounting Standards</p><p>The financial information must be prepared according to International Financial Reporting Standards as endorsed in the Union based on Regulation (EC) No 1606/2002.</p><p>If Regulation (EC) No 1606/2002 is not applicable the financial information must be prepared in accordance with:</p><p>(a)  a Member State’s national accounting standards for issuers from the EEA, as required by 2013/34/EU;</p><p>(b)  a third country’s national accounting standards equivalent to Regulation (EC) No 1606/2002 for third country issuers. If such third country’s national accounting standards are not equivalent to Regulation (EC) No 1606/2002 the financial statements shall be restated in compliance with that Regulation.</p></td></tr><tr><td><p>Item 5.1.4</p></td><td><p>Change of accounting framework</p><p>The last audited historical financial information must be presented and prepared in a form consistent with the accounting standards framework that will be adopted in the issuer’s next published annual financial statements.</p><p>Changes within the issuer’s existing accounting framework do not require the audited financial statements to be restated. However, if the issuer intends to adopt a new accounting standards framework in its next published financial statements, the latest year of financial statements must be prepared and audited in line with the new framework.</p></td></tr><tr><td><p>Item 5.1.5</p></td><td><p>Where the audited financial information is prepared according to national accounting standards, they must include at least the following:</p><p>(a)  the balance sheet;</p><p>(b)  the income statement;</p><p>(c)  the accounting policies and explanatory notes.</p></td></tr><tr><td><p>Item 5.1.6</p></td><td><p>Consolidated financial statements</p><p>If the issuer prepares both stand-alone and consolidated financial statements, include at least the consolidated financial statements in the registration document</p></td></tr><tr><td><p>Item 5.1.7</p></td><td><p>Age of Financial Information</p><p>The balance sheet of the last year of audited financial information may not be older than 18 months from the date of the registration document.</p></td></tr><tr><td><p>Item 5.2</p></td><td><p>Interim and other financial information</p></td></tr><tr><td><p>Item 5.2.1</p></td><td><p>If the issuer has published quarterly or half-yearly financial information since the date of its last audited financial statements, these must be included in the registration document. If the quarterly or half-yearly financial information has been audited or reviewed, the audit or review report must also be included. If the quarterly or half-yearly financial information is not audited or has not been reviewed, state that fact.</p><p>Interim financial information prepared in accordance with the requirements of the Directive 2013/34/EU or Regulation (EC) No 1606/2002 as the case may be.</p><p>For issuers not subject to either the Directive 2013/34/EU or Regulation (EC) No 1606/2002, the interim financial information must include comparative statements for the same period in the prior financial year, except that the requirement for comparative balance sheet information may be satisfied by presenting the year’s end balance sheet in accordance with the applicable financial reporting framework.</p></td></tr><tr><td><p>Item 5.3</p></td><td><p>Auditing of historical annual financial information</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 5.3.1</p></td><td><p>The historical annual financial information must be independently audited. The audit report shall be prepared in accordance with Directive 2006/43/EC and Regulation (EU) No 537/2014.</p><p>Where Directive 2006/43/EC and Regulation (EU) No 537/2014 do not apply, the historical financial information must be audited or reported on as to whether or not, for the purposes of the registration document, it gives a true and fair view in accordance with auditing standards applicable in a Member State or an equivalent standard.</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 5.3.1a</p></td><td><p>Where audit reports on the historical financial information have been refused by the statutory auditors or where they contain qualifications, modifications of opinion, disclaimers or an emphasis of matter<span>,</span> the reason must be given, and such qualifications, modifications, disclaimers or emphasis of matter must be reproduced in full.</p></td></tr><tr><td><p><a>▼B</a></p></td></tr><tr><td><p>Item 5.3.2</p></td><td><p>Indication of other information in the registration document, which has been audited by the auditors.</p></td></tr><tr><td><p>Item 5.3.3</p></td><td><p>Where financial information in the registration document is not extracted from the issuer’s audited financial statements state the source of the information and state that the information is not audited.</p></td></tr><tr><td><p>Item 5.4</p></td><td><p>Key Performance Indicators (‘KPIs’)</p></td></tr><tr><td><p>Item 5.4.1</p></td><td><p>To the extent not disclosed elsewhere in the registration document and where an issuer has published KPIs, financial and/or operational, or chooses to include such in the registration document a description of the issuer’s key performance indicators for each financial year for the period covered by the historical financial information shall be included in the registration document.</p><p>KPIs must be calculated on a comparable basis. Where the KPIs have been audited by the auditors, that fact must be stated.</p></td></tr><tr><td><p>Item 5.5</p></td><td><p>Significant change in the issuer’s financial position</p><p>A description of any significant change in the financial position of the group which has occurred since the end of the last financial period for which either audited financial statements or interim financial information have been published, or provide an appropriate negative statement.</p></td></tr><tr><td><p>SECTION 6</p></td><td><p>SHAREHOLDER AND SECURITY HOLDER INFORMATION</p><p><span>This section shall provide information on the issuer’s major shareholders, the existence of potential conflicts of interest between senior management and the issuer, the issuer’s share capital as well as information on related party transactions, legal and arbitration proceedings and material contracts.</span></p></td></tr><tr><td><p>Item 6.1</p></td><td><p>Major shareholders</p></td></tr><tr><td><p>Item 6.1.1</p></td><td><p>To the extent known to the issuer, state whether the issuer is directly or indirectly owned or controlled and by whom and describe the nature of such control and describe the measures in place to ensure that such control is not abused.</p></td></tr><tr><td><p>Item 6.1.2</p></td><td><p>A description of any arrangements, known to the issuer, the operation of which may at a subsequent date result in or prevent a change in control of the issuer.</p></td></tr><tr><td><p>Item 6.2</p></td><td><p>Legal and arbitration proceedings</p></td></tr><tr><td><p>Item 6.2.1</p></td><td><p>Information on any governmental, legal or arbitration proceedings (including any such proceedings which are pending or threatened of which the issuer is aware), during a period covering at least the previous 12 months which may have, or have had in the recent past significant effects on the issuer and/or group’s financial position or profitability, or provide an appropriate negative statement.</p></td></tr><tr><td><p>Item 6.3</p></td><td><p>Administrative, Management and Supervisory bodies’ and Senior Management’s conflicts of interests</p></td></tr><tr><td><p>Item 6.3.1</p></td><td><p>Potential conflicts of interests between any duties to the issuer, of the persons referred to in item 4.1.1., and their private interests and or other duties must be clearly stated. In the event that there are no such conflicts of interest, a statement to that effect must be made.</p></td></tr><tr><td><p>Item 6.4</p></td><td><p>Material contracts</p></td></tr><tr><td><p>Item 6.4.1</p></td><td><p>A brief summary of any material contract that are not entered into in the ordinary course of the issuer’s business which could result in any group member being under an obligation or entitlement that is material to the issuer’s ability to meet its obligations to security holders in respect of the securities being issued.</p></td></tr><tr><td><p>SECTION 7</p></td><td><p>DOCUMENTS AVAILABLE</p></td></tr><tr><td><p>Item 7.1</p></td><td><p>A statement that for the term of the registration document the following documents, where applicable, can be inspected:</p><p>(a)  the up to date memorandum and articles of association of the issuer;</p><p>(b)  all reports, letters, and other documents, valuations and statements prepared by any expert at the issuer’s request any part of which is included or referred to in the registration document.</p><p>An indication of the website on which the documents may be inspected.</p></td></tr></tbody></table>
ANNEX 26
EU GROWTH SECURITIES NOTE FOR EQUITY SECURITIES
<table><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>PURPOSE, PERSONS RESPONSIBLE, THIRD PARTY INFORMATION, EXPERTS’ REPORTS AND COMPETENT AUTHORITY APPROVAL</p><p><span>This section shall provide information on the persons who are responsible for the content of the EU Growth securities note. The purpose of this section is to provide comfort to investors on the accuracy of the information disclosed in the prospectus. In addition, this section provides information on the interests of persons involved in the offer, as well as the reasons of the offer, the use of proceeds and the expenses of the offer. Moreover, the section provides information on the legal basis of the EU Growth securities note and its approval by the competent authority.</span></p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Identify all persons responsible for the information or any parts of it, given in the securities note with, in the latter case, an indication of such parts. In the case of natural persons, including members of the issuer’s administrative, management or supervisory bodies, indicate the name and function of the person; in the case of legal persons indicate the name and registered office.</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>A declaration by those responsible for the securities note that to the best of their knowledge, the information contained in the securities note is in accordance with the facts and that the securities note makes no omission likely to affect its import.</p><p>Where applicable, a declaration by those responsible for certain parts of the securities note that, to the best of their knowledge, the information contained in those parts of the securities note for which they are responsible is in accordance with the facts and that those parts of the securities note make no omission likely to affect their import.</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Where a statement or report attributed to a person as an expert is included in the securities note, provide the following details for that person:</p><p>(a)  name;</p><p>(b)  business address;</p><p>(c)  qualifications;</p><p>(d)  material interest if any in the issuer.</p><p>If the statement or report has been produced at the issuer’s request, state that such statement or report has been included in the securities note with the consent of the person who has authorised the contents of that part of the securities note for the purpose of the prospectus.</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Where information has been sourced from a third party, provide a confirmation that this information has been accurately reproduced and that as far as the issuer is aware and is able to ascertain from information published by that third party, no facts have been omitted which would render the reproduced information inaccurate or misleading. In addition, identify the source(s) of the information.</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>A statement that:</p><p>(a)  this [securities note/prospectus] has been approved by the [insert name of competent authority], as competent authority under Regulation (EU) 2017/1129;</p><p>(b)  the [name of competent authority] only approves this [securities note/prospectus] as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation 2017/EU/1129;</p><p>(c)  such approval should not be considered as an endorsement of the quality of the securities that are the subject of this [securities note/prospectus];</p><p>(d)  investors should make their own assessment as to the suitability of investing in the securities; and</p><p>(e)  that the [securities note/prospectus] has been drawn up as part of an EU Growth prospectus in accordance with Article 15 of Regulation (EU) 2017/1129.</p></td></tr><tr><td><p>Item 1.6</p></td><td><p>Interest of natural and legal persons involved in the issue/offer</p><p>A description of any interest, including a conflict of interest that is material to the issue/offer, detailing the persons involved and the nature of the interest.</p></td></tr><tr><td><p>Item 1.7</p></td><td><p>Reasons for the offer, use of proceeds and expenses of the issue/offer</p></td></tr><tr><td><p>Item 1.7.1</p></td><td><p>Reasons for the offer and, where applicable, the estimated net amount of the proceeds broken into each principal intended use and presented in order of priority of such uses. If the issuer is aware that the anticipated proceeds will not be sufficient to fund all the proposed uses, then state the amount and sources of other funds needed. Details must also be given with regard to the use of the proceeds, in particular when they are being used to acquire assets, other than in the ordinary course of business, to finance announced acquisitions of other business, or to discharge, reduce or retire indebtedness. The total net proceeds and an estimate of the total expenses of the issue/offer.</p></td></tr><tr><td><p>Item 1.7.2</p></td><td><p>An explanation about how the proceeds from this offer align with the business strategy and strategic objectives described in the registration document.</p></td></tr><tr><td><p>Item 1.8</p></td><td><p>Additional information</p></td></tr><tr><td><p>Item 1.8.1</p></td><td><p>If advisors connected with an issue are referred to in the securities note, a statement of the capacity in which the advisors have acted.</p></td></tr><tr><td><p>Item 1.8.2</p></td><td><p>An indication of other information in the securities note which has been audited or reviewed by statutory auditors and where auditors have produced a report. Reproduction of the report or, with permission of the competent authority, a summary of the report.</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>SECTION 2</p></td><td><p>WORKING CAPITAL STATEMENT AND STATEMENT OF CAPITALISATION AND INDEBTEDNESS</p><p><span>The disclosure under this section provides information on the issuer’s working capital requirements and its capitalisation and indebtedness.</span></p></td></tr><tr><td><p><span>Item 2.1</span></p></td><td><p>Working capital statement</p><p>Statement by the issuer that, in its opinion, the working capital is sufficient for the issuer’s present requirements or, if not, how it proposes to provide the additional working capital needed.</p></td></tr><tr><td><p><span>Item 2.2</span></p><p>Issuers with market capitalisation above EUR 200 000 000 only</p></td><td><p>Capitalisation and indebtedness</p><p>A statement of capitalisation and indebtedness (distinguishing between guaranteed and unguaranteed, secured and unsecured indebtedness) as of a date no earlier than 90 days prior to the date of the document. The term ‘indebtedness’ also includes indirect and contingent indebtedness.</p><p>In the case of material changes in the capitalisation and indebtedness position of the issuer within the 90 day period, additional information shall be given through the presentation of a narrative description of such changes or through the updating of those figures.</p></td></tr><tr><td><p><a>▼B</a></p></td></tr><tr><td><p>SECTION 3</p></td><td><p>RISK FACTORS</p><p><span>The purpose of this section is to describe the main risks which are specific to the securities of the issuer.</span></p></td></tr><tr><td><p>Item 3.1</p></td><td><p>A description of the material risks that are specific to the securities being offered in a limited number of categories, in a section headed ‘Risk Factors’.</p><p>In each category the most material risks, in the assessment of the issuer or offeror taking into account their impact on the issuer and the securities and the probability of their occurrence, shall be set out first. The risks shall be corroborated by the content of the securities note.</p></td></tr><tr><td><p>SECTION 4</p></td><td><p>TERMS AND CONDITIONS OF THE SECURITIES</p><p><span>The purpose of this section is to set out the terms and conditions of the securities and provides a detailed description of their characteristics.</span></p></td></tr><tr><td><p>Item 4.1</p></td><td><p>Information concerning the securities to be offered.</p></td></tr><tr><td><p>Item 4.1.1</p></td><td><p>A description of the type and the class of the securities being offered, including the international security identification number (‘ISIN’).</p></td></tr><tr><td><p>Item 4.1.2</p></td><td><p>Legislation under which the securities have been created.</p></td></tr><tr><td><p>Item 4.1.3</p></td><td><p>An indication whether the securities are in registered form or bearer form and whether the securities are in certificated form or book-entry form.</p><p>In the case of book-entry form, the name and address of the entity in charge of keeping the records.</p></td></tr><tr><td><p>Item 4.1.4</p></td><td><p>Currency of the securities issue.</p></td></tr><tr><td><p>Item 4.1.5</p></td><td><p>A description of the rights attached to the securities, including any limitations of those rights, and procedure for the exercise of those rights:</p><p>(a)  dividend rights:</p><p>(i)  fixed date(s) on which the entitlement arises;</p><p>(ii)  time limit after which entitlement to dividend lapses and an indication of the person in whose favour the lapse operates;</p><p>(iii)  dividend restrictions and procedures for non-resident holders;</p><p>(iv)  rate of dividend or method of its calculation, periodicity and cumulative or non-cumulative nature of payments;</p><p>(b)  voting rights;</p><p>(c)  pre-emption rights in offers for subscription of securities of the same class;</p><p>(d)  right to share in the issuer’s profits;</p><p>(e)  right to share in any surplus in the event of liquidation;</p><p>(f)  redemption provisions;</p><p>(g)  conversion provisions.</p></td></tr><tr><td><p>Item 4.1.6</p></td><td><p>In the case of new issues a statement of the resolutions, authorisations and approvals by virtue of which the securities have been or will be created and/or issued.</p></td></tr><tr><td><p>Item 4.1.7</p></td><td><p>The issue date (for non-equity securities) or in the case of new issues the expected issue date of the securities.</p></td></tr><tr><td><p>Item 4.1.8</p></td><td><p>A description of any restrictions on the transferability of the securities.</p></td></tr><tr><td><p>Item 4.1.9</p></td><td><p>A warning that the tax legislation of the investor’s Member State and of the issuer’s country of incorporation may have an impact on the income received from the securities.</p><p>Information on the taxation treatment of the securities where the proposed investment attracts a tax regime specific to that type of investment.</p></td></tr><tr><td><p>Item 4.1.10</p></td><td><p>If different from the issuer, the identity and contact details of the offeror of the securities and/or the person asking for admission to trading, including the legal entity identifier (‘LEI’) where the offeror has legal personality.</p></td></tr><tr><td><p>Item 4.1.11</p></td><td><p>(a)  Statement on the existence of national legislation or rules on takeovers applicable to the issuer and the possibility for frustrating measures if any;</p><p>(b)  a brief description of the shareholders’ rights and obligations in case of mandatory takeover bid, and/or squeeze-out or sell-out rules in relation to the securities;</p><p>(c)  an indication of public takeover bids by third parties in respect of the issuer’s equity, which have occurred during the last financial year and the current financial year. The price or exchange terms attaching to such offers and the outcome thereof must also be stated.</p></td></tr><tr><td><p>Item 4.1.12</p></td><td><p>Where applicable, the potential impact on the investment in the event of resolution under Directive 2014/59/EU.</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 4.2</p></td><td><p>In the case of issuance of shares with warrants, the information referred to in Article 20(2).</p></td></tr><tr><td><p><a>▼B</a></p></td></tr><tr><td><p>SECTION 5</p></td><td><p>DETAILS OF THE OFFER/ADMISSION TO TRADING</p><p><span>The purpose of this section is to set out the specific information on the offer of the securities, the plan for their distribution and allotment, an indication of their pricing. Moreover, it presents information on the placing of the securities, any underwriting agreements and arrangements relating to admission to trading. It also sets out information on the persons selling the securities and dilution to existing shareholders.</span></p></td></tr><tr><td><p>Item 5.1</p></td><td><p>Terms and conditions of the offer of securities to the public.</p><p>Conditions, offer statistics, expected timetable and action required to apply for the offer.</p></td></tr><tr><td><p>Item 5.1.1</p></td><td><p>Conditions to which the offer is subject.</p></td></tr><tr><td><p>Item 5.1.2</p></td><td><p>Total amount of the issue/offer distinguishing the securities offered for sale and those offered for subscription; if the amount is not fixed, an indication of the maximum amount of securities to be offered (if available) and a description of the arrangements and the time period for announcing to the public the definitive amount of the offer.</p><p>Where the maximum amount of securities cannot be provided in the prospectus, the prospectus shall specify that acceptances of the purchase or subscription of securities may be withdrawn for not less than two working days after the amount of securities to be offered to the public has been filed.</p></td></tr><tr><td><p>Item 5.1.3</p></td><td><p>The time period, including any possible amendments, during which the offer will be open and description of the application process.</p></td></tr><tr><td><p>Item 5.1.4</p></td><td><p>An indication of when, and under which circumstances, the offer may be revoked or suspended and whether revocation can occur after dealing has begun.</p></td></tr><tr><td><p>Item 5.1.5</p></td><td><p>A description of any possibility to reduce subscriptions and the manner for refunding amounts paid in excess by applicants.</p></td></tr><tr><td><p>Item 5.1.6</p></td><td><p>Details of the minimum and/or maximum amount of application (whether in number of securities or aggregate amount to invest).</p></td></tr><tr><td><p>Item 5.1.7</p></td><td><p>An indication of the period during which an application may be withdrawn, provided that investors are allowed to withdraw their subscription.</p></td></tr><tr><td><p>Item 5.1.8</p></td><td><p>Method and time limits for paying up the securities and for delivery of the securities.</p></td></tr><tr><td><p>Item 5.1.9</p></td><td><p>A full description of the manner and date in which results of the offer are to be made public.</p></td></tr><tr><td><p>Item 5.1.10</p></td><td><p>The procedure for the exercise of any right of pre-emption, the negotiability of subscription rights and the treatment of subscription rights not exercised.</p></td></tr><tr><td><p>Item 5.2</p></td><td><p>Plan of distribution and allotment</p></td></tr><tr><td><p>Item 5.2.1</p></td><td><p>The various categories of potential investors to which the securities are offered.</p><p>If the offer is being made simultaneously in the markets of two or more countries and if a tranche has been or is being reserved for certain of these, indicate any such tranche.</p></td></tr><tr><td><p>Item 5.2.2</p></td><td><p>To the extent known to the issuer, an indication of whether major shareholders or members of the issuer’s management, supervisory or administrative bodies intended to subscribe in the offer, or whether any person intends to subscribe for more than five per cent of the offer.</p></td></tr><tr><td><p>Item 5.2.3</p></td><td><p>Pre-allotment Disclosure:</p><p>(a)  the division into tranches of the offer including the institutional, retail and issuer’s employee tranches and any other tranches;</p><p>(b)  the conditions under which the claw-back may be used, the maximum size of such claw back and any applicable minimum percentages for individual tranches;</p><p>(c)  the allotment method or methods to be used for the retail and issuer’s employee tranche in the event of an over-subscription of these tranches;</p><p>(d)  a description of any pre-determined preferential treatment to be accorded to certain classes of investors or certain affinity groups (including friends and family programmes) in the allotment, the percentage of the offer reserved for such preferential treatment and the criteria for inclusion in such classes or groups;</p><p>(e)  whether the treatment of subscriptions or bids to subscribe in the allotment may be determined on the basis of which firm they are made through or by;</p><p>(f)  a target minimum individual allotment if any within the retail tranche;</p><p>(g)  the conditions for the closing of the offer as well as the date on which the offer may be closed at the earliest;</p><p>(h)  whether or not multiple subscriptions are admitted, and where they are not, how any multiple subscriptions will be handled.</p></td></tr><tr><td><p>Item 5.3</p></td><td><p>Process for notifying applicants of the amount allotted and an indication whether dealing may begin before notification is made.</p></td></tr><tr><td><p>Item 5.4</p></td><td><p>Pricing</p></td></tr><tr><td><p>Item 5.4.1</p></td><td><p>An indication of the price at which the securities will be offered and the amount of any expenses and taxes charged to the subscriber or purchaser.</p></td></tr><tr><td><p>Item 5.4.2</p></td><td><p>If the price is not known, then pursuant to Article 17 of Regulation (EU) 2017/1129 indicate either:</p><p>(a)  the maximum price as far as it is available;</p><p>(b)  the valuation methods and criteria, and/or conditions, in accordance with which the final offer price has been or will be determined and an explanation of any valuation methods used.</p><p>Where neither point (a) nor (b) can be provided in the securities note, the securities note shall specify that acceptances of the purchase or subscription of securities may be withdrawn up to two working days after the final offer price of securities to be offered to the public has been filed.</p></td></tr><tr><td><p>Item 5.4.3</p></td><td><p>Process for the disclosure of the offer price.</p><p>If the issuer’s equity holders have pre-emptive purchase rights and this right is restricted or withdrawn, an indication of the basis for the issue price if the issue is for cash, together with the reasons for and beneficiaries of such restriction or withdrawal.</p><p>Where there is or could be a material disparity between the public offer price and the effective cash cost to members of the administrative, management or supervisory bodies or senior management, or affiliated persons, of securities acquired by them in transactions during the past year, or which they have the right to acquire, include a comparison of the public contribution in the proposed public offer and the effective cash contributions of such persons.</p></td></tr><tr><td><p>Item 5.5</p></td><td><p>Placing and Underwriting</p></td></tr><tr><td><p>Item 5.5.1</p></td><td><p>Name and address of the coordinator(s) of the global offer and of single parts of the offer and, to the extent known to the issuer or to the offeror, of the placers in the various countries where the offer takes place.</p></td></tr><tr><td><p>Item 5.5.2</p></td><td><p>Name and address of any paying agents and depository agents in each country.</p></td></tr><tr><td><p>Item 5.5.3</p></td><td><p>Name and address of the entities agreeing to underwrite the issue on a firm commitment basis, and name and address of the entities agreeing to place the issue without a firm commitment or under ‘best efforts’ arrangements. Indication of the material features of the agreements, including the quotas. Where not all of the issue is underwritten, a statement of the portion not covered. Indication of the overall amount of the underwriting commission and of the placing commission.</p></td></tr><tr><td><p>Item 5.5.4</p></td><td><p>When the underwriting agreement has been or will be reached.</p></td></tr><tr><td><p>Item 5.6</p></td><td><p>Admission to trading and dealing arrangements</p></td></tr><tr><td><p>Item 5.6.1</p></td><td><p>An indication as to whether the securities offered are or will be the object of an application for admission to trading on an SME growth Market or an MTF, with a view to their distribution in an SME Growth Market or an MTF with an indication of the markets in question. This circumstance must be set out, without creating the impression that the admission to trading will necessarily be approved. If known, the earliest dates on which the securities will be admitted to trading.</p></td></tr><tr><td><p>Item 5.6.2</p></td><td><p>All the SME growth markets or MTFs on which, to the knowledge of the issuer, securities of the same class of the securities to be offered tor admitted to trading are already admitted to trading.</p></td></tr><tr><td><p>Item 5.6.3</p></td><td><p>If simultaneously or almost simultaneously with the creation of the securities for which admission on an SME growth Market or MTF is being sought or which are offered to the public, securities of the same class are subscribed for or placed privately or if securities of other classes are created for public or private placing, give details of the nature of such operations and of the number and characteristics of the securities to which they relate.</p></td></tr><tr><td><p>Item 5.6.4</p></td><td><p>In case of an admission to trading on an SME growth market or an MTF, details of the entities which have a firm commitment to act as intermediaries in secondary trading, providing liquidity through bid and offer rates and description of the main terms of their commitment.</p></td></tr><tr><td><p>Item 5.6.5</p></td><td><p>Details of stabilisation in line with items 5.6.5.1 to 5.6.5.6 in the case of an admission to trading on an SME growth market or an MTF, where an issuer or a selling shareholder has granted an over-allotment option or it is otherwise proposed that price stabilising activities may be entered into in connection with an offer:</p></td></tr><tr><td><p>Item 5.6.5.1</p></td><td><p>The fact that stabilisation may be undertaken, that there is no assurance that it will be undertaken and that it may be stopped at any time;</p></td></tr><tr><td><p>Item 5.6.5.2</p></td><td><p>The fact that stabilisation transactions aim at supporting the market price of the securities during the stabilisation period;</p></td></tr><tr><td><p>Item 5.6.5.3</p></td><td><p>The beginning and the end of the period during which stabilisation may occur;</p></td></tr><tr><td><p>Item 5.6.5.4</p></td><td><p>The identity of the stabilisation manager for each relevant jurisdiction unless this is not known at the time of publication;</p></td></tr><tr><td><p>Item 5.6.5.5</p></td><td><p>The fact that stabilisation transactions may result in a market price that is higher than would otherwise prevail; and</p></td></tr><tr><td><p>Item 5.6.5.6</p></td><td><p>The place where the stabilisation may be undertaken including, where relevant, the name of the trading venue(s).</p></td></tr><tr><td><p>Item 5.6.6</p></td><td><p>Over-allotment and ‘green shoe’</p><p>In the case of an admission to trading on an SME growth market or an MTF:</p><p>(a)  the existence and size of any over-allotment facility and/or ‘green shoe’;</p><p>(b)  the existence period of the over-allotment facility and/or ‘green shoe’; and</p><p>(c)  any conditions for the use of the over-allotment facility or exercise of the ‘green shoe’.</p></td></tr><tr><td><p>Item 5.7</p></td><td><p>Selling securities holders</p></td></tr><tr><td><p>Item 5.7.1</p></td><td><p>Name and business address of the person or entity offering to sell the securities, the nature of any position office or other material relationship that the selling persons has had within the past three years with the issuer or any of its predecessors or affiliates.</p></td></tr><tr><td><p>Item 5.7.2</p></td><td><p>The number and class of securities being offered by each of the selling security holders.</p></td></tr><tr><td><p>Item 5.7.3</p></td><td><p>In relation to lock-up agreements, provide details of the following:</p><p>(a)  the parties involved;</p><p>(b)  the content and exceptions of the agreement;</p><p>(c)  an indication of the period of the lock up.</p></td></tr><tr><td><p>Item 5.8</p></td><td><p>Dilution</p></td></tr><tr><td><p>Item 5.8.1</p></td><td><p>A comparison of participation in share capital and voting rights for existing shareholders before and after the capital increase resulting from the public offer, with the assumption that existing shareholders do not subscribe for the new shares.</p></td></tr><tr><td><p>Item 5.8.2</p></td><td><p>Where existing shareholders will be diluted regardless of whether they subscribe for their entitlement, because a part of the relevant share issue is reserved only for certain investors (e.g. an institutional placing coupled with an offer to shareholders), an indication of the dilution existing shareholders will experience should also be presented on the basis that they do take up their entitlement (in addition to the situation in item 5.8.1 where they do not).</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>SECTION 6</p></td><td><p>UNDERLYING SHARE INFORMATION (WHERE APPLICABLE)</p></td></tr><tr><td><p>Item 6.1</p></td><td><p>Where applicable, the information referred to in Annex 18.</p></td></tr><tr><td><p>SECTION 7</p></td><td><p>CONSENT INFORMATION (WHERE APPLICABLE)</p></td></tr><tr><td><p>Item 7.1</p></td><td><p>Where the issuer or the person responsible for drawing up a prospectus consents to its use as referred to in the second subparagraph of Article 5(1) of Regulation (EU) 2017/1129, the following additional information:</p><p>(a)  the information referred to in sections 1 and 2A of Annex 22 to this Regulation where the consent is provided to one or more specified financial intermediaries;</p><p>(b)  the information referred to in sections 1 and 2B of Annex 22 to this Regulation where the consent is given to all financial intermediaries.</p></td></tr><tr><td><p><a>▼B</a></p></td></tr></tbody></table>
ANNEX 27
EU GROWTH SECURITIES NOTE FOR NON-EQUITY SECURITIES
<table><col/><col/><col/><tbody><tr><td><p>SECTION 1</p></td><td><p>PURPOSE, PERSONS RESPONSIBLE, THIRD PARTY INFORMATION, EXPERTS’ REPORTS AND COMPETENT AUTHORITY APPROVAL</p><p><span>This section shall provide information on the persons who are responsible for the content of the EU Growth securities note. The purpose of this section is to provide comfort to investors on the accuracy of the information disclosed in the prospectus. In addition, this section provides information on the interests of persons involved in the offer, as well as the reasons of the offer, the use of proceeds and the expenses of the offer. Moreover, the section provides information on the legal basis of the EU Growth securities note and its approval by the competent authority.</span></p></td></tr><tr><td><p>Item 1.1</p></td><td><p>Identify all persons responsible for the information or any parts of it, given in the securities note with, in the latter case, an indication of such parts. In the case of natural persons, including members of the issuer’s administrative, management or supervisory bodies, indicate the name and function of the person; in the case of legal persons indicate the name and registered office.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.2</p></td><td><p>A declaration by those responsible for the securities note that to the best of their knowledge, the information contained in the securities note is in accordance with the facts and that the securities note makes no omission likely to affect its import.</p><p>Where applicable, a declaration by those responsible for certain parts of the securities note that, to the best of their knowledge, the information contained in those parts of the securities note for which they are responsible is in accordance with the facts and that those parts of the securities note make no omission likely to affect their import.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.3</p></td><td><p>Where a statement or report attributed to a person as an expert is included in the securities note, provide the following in relation to that person:</p><p>(a)  name;</p><p>(b)  business address;</p><p>(c)  qualifications;</p><p>(d)  material interest if any in the issuer.</p><p>If the statement or report has been produced at the issuer’s request, state that such statement or report has been included in the securities note with the consent of the person who has authorised the contents of that part of the securities note for the purpose of the prospectus.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.4</p></td><td><p>Where information has been sourced from a third party, provide a confirmation that this information has been accurately reproduced and that as far as the issuer is aware and is able to ascertain from information published by that third party, no facts have been omitted which would render the reproduced information inaccurate or misleading. In addition, identify the source(s) of the information.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 1.5</p></td><td><p>A statement that:</p><p>(a)  this [securities note/prospectus] has been approved by the [insert name of the competent authority], as competent authority under Regulation (EU) 2017/1129;</p><p>(b)  /the [name of the competent authority] only approves this [securities note/prospectus] as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation 2017/EU/1129;</p><p>(c)  such approval should not be considered as an endorsement of the quality of the securities that are the subject of this [securities note/prospectus];</p><p>(d)  investors should make their own assessment as to the suitability of investing in the securities; and</p><p>(e)  that the [securities note/prospectus] has been drawn up as an EU Growth prospectus in accordance with Article 15 of Regulation (EU) 2017/1129.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.6</p></td><td><p>Interest of natural and legal persons involved in the issue/offer</p><p>A description of any interest, including a conflict of interest that is material to the issue/offer, detailing the persons involved and the nature of the interest.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 1.7</p></td><td><p>Reasons for the offer, use of proceeds and expenses of the issue/offer</p><p>Reasons for the offer to the public or for the admission to trading. Where applicable, disclosure of the estimated total expenses of the issue/offer and the estimated net amount of the proceeds. These expenses and proceeds shall be broken into each principal intended use and presented in order of priority of such uses. If the issuer is aware that the anticipated proceeds will not be sufficient to fund all the proposed uses, then state the amount and sources of other funds needed.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 1.8</p></td><td><p>Additional information</p></td></tr><tr><td><p>Item 1.8.1</p></td><td><p>If advisors connected with an issue are referred to in the securities note, a statement of the capacity in which the advisors have acted.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 1.8.2</p></td><td><p>An indication of other information in the securities note which has been audited or reviewed by statutory auditors and where auditors have produced a report. Reproduction of the report or, with permission of the competent authority, a summary of the report.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 1.8.3</p></td><td><p>Credit ratings assigned to the securities at the request or with the cooperation of the issuer in the rating process. A brief explanation of the meaning of the ratings if this has previously been published by the rating provider.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 1.8.4</p></td><td><p>Where the summary is substituted in part with the information set out in points (c) to (i) of paragraph 3 of Article 8 of Regulation (EU) No 1286/2014, all such information to the extent it is not already disclosed elsewhere in the securities note</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 2</p></td><td><p>RISK FACTORS</p><p><span>The purpose of this section is to describe the main risks which are specific to the securities of the issuer.</span></p></td></tr><tr><td><p>Item 2.1</p></td><td><p>A description of the material risks that are specific to the securities being offered in a limited number of categories, in a section headed ‘Risk Factors’.</p><p>Risks to be disclosed shall include:</p><p>(a)  those resulting from the level of subordination of a security and the impact on the expected size or timing of payments to holders of the securities under bankruptcy, or any other similar procedure, including, where relevant, the insolvency of a credit institution or its resolution or restructuring in accordance with Directive 2014/59/EU;</p><p>(b)  in cases where the securities are guaranteed, the specific and material risks related to the guarantor to the extent they are relevant to its ability to fulfil its commitment under the guarantee.</p><p>In each category the most material risks, in the assessment of the issuer or offeror taking into account their impact on the issuer and the securities and the probability of their occurrence, shall be set out first. The risks shall be corroborated by the content of the securities note.</p></td><td><p>Category A</p></td></tr><tr><td><p>SECTION 3</p></td><td><p>TERMS AND CONDITIONS OF THE SECURITIES</p></td></tr><tr><td><p>Item 3.1</p></td><td><p>Information concerning the securities to be offered</p></td></tr><tr><td><p>Item 3.1.1</p></td><td><p>A description of the type and the class of the securities being offered.</p></td><td><p>Category A</p></td></tr><tr><td><p>The international security identification number (‘ISIN’) of the securities being offered.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 3.1.2</p></td><td><p>Legislation under which the securities have been created.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 3.1.3</p></td><td><p>An indication whether the securities are in registered form or bearer form and whether the securities are in certificated form or book-entry form.</p></td><td><p>Category A</p></td></tr><tr><td><p>In the case of book-entry form, the name and address of the entity in charge of keeping the records.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 3.1.4</p></td><td><p>Currency of the securities issue.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 3.1.5</p></td><td><p>The relative seniority of the securities in the issuer’s capital structure in the event of insolvency, including, where applicable, information on the level of subordination of the securities and the potential impact on the investment in the event of a resolution under Directive 2014/59/EU.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 3.1.6</p></td><td><p>A description of the rights attached to the securities, including any limitations of those rights, and procedure for the exercise of those rights.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 3.1.7</p></td><td><p>(a)  The nominal interest rate;</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  the provisions relating to interest payable;</p></td><td><p>Category B</p></td></tr><tr><td><p>(c)  the date from which interest becomes payable;</p></td><td><p>Category C</p></td></tr><tr><td><p>(d)  the due dates for interest;</p></td><td><p>Category C</p></td></tr><tr><td><p>(e)  the time limit on the validity of claims to interest and repayment of principal.</p></td><td><p>Category B</p></td></tr><tr><td><p>Where the rate is not fixed:</p></td><td><p> </p><div/></td></tr><tr><td><p>(a)  a statement setting out the type of underlying;</p></td><td><p>Category A</p></td></tr><tr><td><p>(b)  a description of the underlying on which the rate is based;</p></td><td><p>Category C</p></td></tr><tr><td><p>(c)  of the method used to relate the rate with the underlying;</p></td><td><p>Category B</p></td></tr><tr><td><p>(d)  an indication where information about the past and the further performance of the underlying and its volatility can be obtained by electronic means and whether or not it can be obtained free of charge;</p></td><td><p>Category C</p></td></tr><tr><td><p>(e)  a description of any market disruption or settlement disruption events that affect the underlying;</p></td><td><p>Category B</p></td></tr><tr><td><p>(f)  any adjustment rules with relation to events concerning the underlying;</p></td><td><p>Category B</p></td></tr><tr><td><p>(g)  the name of the calculation agent;</p></td><td><p>Category C</p></td></tr><tr><td><p>(h)  if the security has a derivative component in the interest payment, a clear and comprehensive explanation to help investors understand how the value of their investment is affected by the value of the underlying instrument(s), especially under the circumstances when the risks are most evident.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 3.1.8</p></td><td><p>(a)  Maturity date.</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  Details of the arrangements for the amortisation of the loan, including the repayment procedures. Where advance amortisation is contemplated, on the initiative of the issuer or of the holder, it shall be described, stipulating amortisation terms and conditions</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 3.1.9</p></td><td><p>(a)  An indication of yield.</p></td><td><p>Category C</p></td></tr><tr><td><p>(b)  A description of the method whereby that yield is calculated in summary form.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 3.1.10</p></td><td><p>Representation of non-equity security holders including an identification of the organisation representing the investors and provisions applying to such representation. Indication of the website where the public may have free access to the contracts relating to these forms of representation.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 3.1.11</p></td><td><p>In the case of new issues, a statement of the resolutions, authorisations and approvals by virtue of which the securities have been or will be created and/or issued.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 3.1.12</p></td><td><p>The issue date or in the case of new issues, the expected issue date of the securities.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 3.1.13</p></td><td><p>A description of any restrictions on the transferability of the securities.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 3.1.14</p></td><td><p>A warning that the tax legislation of the investor’s Member State and of the issuer’s country of incorporation may have an impact on the income received from the securities.</p><p>Information on the taxation treatment of the securities where the proposed investment attracts a tax regime specific to that type of investment.</p></td><td><p>Category A</p></td></tr><tr><td><p>Item 3.1.15</p></td><td><p>If different from the issuer, the identity and contact details of the offeror of the securities and/or the person asking for admission to trading, including the legal entity identifier (‘LEI’) where the offeror has legal personality.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 3.1.16</p></td><td><p>Where applicable, the potential impact on the investment in the event of resolution under Directive 2014/59/EU.</p></td><td><p> </p><div/></td></tr><tr><td><p><a>▼M1</a> —————</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Item 3.2</p></td><td><p>Information on derivative securities</p><p>In the case of issuance of derivative securities, the following information:</p><p>(a)  for derivative securities referred to in Article 20(1), the information referred to in that paragraph;</p><p>(b)  for derivative securities referred to in Article 20(2), the information referred to in that paragraph;</p><p>(c)  for derivative securities referred to in Article 20(3), the information referred to in that paragraph.</p></td><td><p> </p><div/></td></tr><tr><td><p><a>▼B</a></p></td></tr><tr><td><p>SECTION 4</p></td><td><p>DETAILS OF THE OFFER/ADMISSION TO TRADING</p><p><span>The purpose of this section is to set out the specific information on the offer of the securities, the plan for their distribution and allotment, an indication of their pricing. Moreover, it presents information on the placing of the securities, any underwriting agreements and arrangements relating to admission to trading. It also sets out information on the persons selling the securities and dilution to existing shareholders.</span></p></td></tr><tr><td><p>Item 4.1</p></td><td><p>Terms and conditions of the offer of securities to the public</p><p>(Conditions, offer statistics, expected timetable and action required to apply for the offer)</p></td></tr><tr><td><p>Item 4.1.1</p></td><td><p>Conditions to which the offer is subject</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.1.2</p></td><td><p>Total amount of the securities offered to the public. If the amount is not fixed, an indication of the maximum amount of the securities to be offered (if available) and a description of the arrangements and the time period for announcing to the public the definitive amount of the offer.</p><p>Where the maximum amount of securities to be offered cannot be provided in the prospectus, the prospectus shall specify that acceptances of the purchase of subscription of securities may be withdrawn for not less than two working days after the amount of securities to be offered to the public has been filed.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.1.3</p></td><td><p>The time period, including any possible amendments, during which the offer will be open and description of the application process.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.1.4</p></td><td><p>A description of any possibility to reduce subscriptions and the manner for refunding amounts paid in excess by applicants.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.1.5</p></td><td><p>Details of the minimum and/or maximum amount of application (whether in number of securities or aggregate amount to invest).</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.1.6</p></td><td><p>Method and time limits for paying up the securities and for delivery of the securities.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.1.7</p></td><td><p>A full description of the manner and date in which results of the offer are to be made public.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.1.8</p></td><td><p>The procedure for the exercise of any right of pre-emption, the negotiability of subscription rights and the treatment of subscription rights not exercised.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.2</p></td><td><p>Plan of distribution and allotment</p></td></tr><tr><td><p>Item 4.2.1</p></td><td><p>The various categories of potential investors to which the securities are offered.</p><p>If the offer is being made simultaneously in the markets of two or more countries and if a tranche has been or is being reserved for certain of these, indicate any such tranche.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.3</p></td><td><p>Process for notifying applicants of the amount allotted and an indication whether dealing may begin before notification is made.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.4</p></td><td><p>Pricing</p></td></tr><tr><td><p>Item 4.4.1</p></td><td><p>An indication of the expected price at which the securities will be offered;</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.4.2</p></td><td><p>In the alternative to item 4.4.1, a description of the method of for determining the price, pursuant to Article 17 of Regulation (EU) 2017/1129 and the process for its disclosure.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 4.4.3</p></td><td><p>Indicate the amount of any expenses and taxes charged to the subscriber or purchaser. Where the issuer is subject to Regulation (EU) No 1286/2014 and/or Directive 2014/65/EU, and to the extent that they are known, include those expenses contained in the price.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.5</p></td><td><p>Placing and underwriting</p></td></tr><tr><td><p>Item 4.5.1</p></td><td><p>Name and address of the coordinator(s) of the global offer and of single parts of the offer and, to the extent known to the issuer or to the offeror, of the placers in the various countries where the offer takes place.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.5.2</p></td><td><p>Name and address of any paying agents and depository agents in each country.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.5.3</p></td><td><p>Name and address of the entities agreeing to underwrite the issue on a firm commitment basis, and name and address of the entities agreeing to place the issue without a firm commitment or under ‘best efforts’ arrangements. Indication of the material features of the agreements, including the quotas. Where not all of the issue is underwritten, a statement of the portion not covered. Indication of the overall amount of the underwriting commission and of the placing commission.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.5.4</p></td><td><p>When the underwriting agreement has been or will be reached.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.6</p></td><td><p>Admission to trading and dealing arrangements</p></td></tr><tr><td><p>Item 4.6.1</p></td><td><p>An indication as to whether the securities offered are or will be the object of an application for admission to trading on an SME growth Market or an MTF, with a view to their distribution in an SME Growth Market or an MTF with an indication of the markets in question. This circumstance must be set out, without creating the impression that the admission to trading will necessarily be approved. If known, the earliest dates on which the securities will be admitted to trading.</p></td><td><p>Category B</p></td></tr><tr><td><p>Item 4.6.2</p></td><td><p>All the SME growth Markets or MTFs on which, to the knowledge of the issuer, securities of the same class of the securities to be offered tor admitted to trading are already admitted to trading.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.6.3</p></td><td><p>In the case of an admission to trading on an SME growth market or an MTF, details of the entities which have a firm commitment to act as intermediaries in secondary trading, providing liquidity through bid and offer rates and description of the main terms of their commitment.</p></td><td><p>Category C</p></td></tr><tr><td><p>Item 4.6.4</p></td><td><p>The issue price of the securities</p></td><td><p>Category C</p></td></tr><tr><td><p>SECTION 5</p></td><td><p>GUARANTOR INFORMATION (IF APPLICABLE)</p></td></tr><tr><td><p>Item 5.1</p></td><td><p>In the case of a guarantee attached to the securities, the information that is required in Annex 21.</p></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>SECTION 6</p></td><td><p>UNDERLYING SHARE INFORMATION (WHERE APPLICABLE)</p></td></tr><tr><td><p>Item 6.1</p></td><td><p>(a)  Where applicable, the information referred to in items 2.1 and 2.2 of Annex 26 in respect of the issuer of the underlying share.</p><p>(b)  Where applicable, the information referred to in Annex 18.</p></td></tr><tr><td><p>SECTION 7</p></td><td><p>CONSENT INFORMATION (WHERE APPLICABLE)</p></td></tr><tr><td><p>Item 7.1</p></td><td><p>Where the issuer or the person responsible for drawing up a prospectus consents to its use as referred to in the second subparagraph of Article 5(1) of Regulation (EU) 2017/1129, the following additional information:</p><p>(a)  the information referred to in sections 1 and 2A of Annex 22 to this Regulation where the consent is provided to one or more specified financial intermediaries;</p><p>(b)  the information referred to in sections 1 and 2B of Annex 22 to this Regulation where the consent is given to all financial intermediaries.</p></td></tr><tr><td><p><a>▼B</a></p></td></tr></tbody></table>
ANNEX 28
LIST OF ADDITIONAL INFORMATION IN THE FINAL TERMS
1. Example(s) relating to complex derivative securities to explain how the value of the investment is affected by the value of the underlying and the nature of those securities.
2. Additional provisions, not required by the relevant securities note annex, which relate to the underlying.
3. Country(ies) where the offer((s) to the public takes place.
4. Country(ies) where admission to trading on the regulated market(s) is being sought.
5. Country(ies) where the relevant base prospectus has been notified.
6. ECB eligibility.
7. Series number.
8. Tranche number.
ANNEX 29
LIST OF SPECIALIST ISSUERS
(a) Property companies;
(b) Mineral companies;
(c) Investment companies;
(d) Scientific research based companies;
(e) Start-up companies;
(f) Shipping companies.
<note>
( 1 ) Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349).
( 2 ) Commission Delegated Regulation (EU) 2019/815 of 17 December 2018 supplementing Directive 2004/109/EC of the European Parliament and of the Council with regard to regulatory technical standards on the specification of a single electronic reporting format (OJ L 143, 29.5.2019, p. 1).
( 3 ) Regulation (EU) No 1286/2014 of the European Parliament and of the Council of 26 November 2014 on key information documents for packaged retail and insurance-based investment products (PRIIPs) (OJ L 352, 9.12.2014, p. 1).
( 4 ) Directive 2003/71/EC of the European Parliament and of the Council of 4 November 2003 on the prospectus to be published when securities are offered to the public or admitted to trading and amending Directive 2001/34/EC (OJ L 345, 31.12.2003, p. 64).
( 5 ) Directive 2004/109/EC of the European Parliament and of the Council of 15 December 2004 on the harmonisation of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market and amending Directive 2001/34/EC (OJ L 390, 31.12.2004, p. 38).
( 6 ) Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation) and repealing Directive 2003/6/EC of the European Parliament and of the Council and Commission Directives 2003/124/EC, 2003/125/EC and 2004/72/EC (OJ L 173, 12.6.2014, p. 1).
</note> | ENG | 02019R0980-20200917 |
<table><col/><col/><col/><col/><tbody><tr><td><p>20.2.2020   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>LI 47/7</p></td></tr></tbody></table>
COUNCIL DECISION (EU) 2020/235
of 17 February 2020
appointing a member and an alternate member, proposed by the Republic of Austria, of the Committee of the Regions
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 305 thereof,
Having regard to the proposal of the Austrian Government,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>On 10 December 2019, 20 January 2020 and 3 February 2020, the Council adopted Decisions (EU) 2019/2157 <a>(<span>1</span>)</a>, (EU) 2020/102 <a>(<span>2</span>)</a> and (EU) 2020/144 <a>(<span>3</span>)</a> appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2020 to 25 January 2025.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>A member’s seat on the Committee of the Regions has become vacant following the end of the term of office of Ms Barbara EIBINGER-MIEDL.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>An alternate member’s seat has become vacant following the end of the term of office of Ms Doris KAMPUS,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
The following are hereby appointed to the Committee of the Regions for the remainder of the current term of office, which runs until 25 January 2025:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>as a member</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Mr Christopher DREXLER, Member of a Regional Executive:<span>State Government of Styria;</span></p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>as an alternate member:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Ms Barbara EIBINGER-MIEDL, Member of a Regional Executive:<span>State Government of Styria.</span></p></td></tr></tbody></table></td></tr></tbody></table>
Article 2
This Decision shall enter into force on the date of its adoption.
Done at Brussels, 17 February 2020.
For the Council
The President
J. BORRELL FONTELLES
<note>
( 1 ) Council Decision (EU) 2019/2157 of 10 December 2019 appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2020 to 25 January 2025 ( OJ L 327, 17.12.2019, p. 78 ).
( 2 ) Council Decision (EU) 2020/102 of 20 January 2020 appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2020 to 25 January 2025 ( OJ L 20, 24.1.2020, p. 2 ).
( 3 ) Council Decision (EU) 2020/144 of 3 February 2020 appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2020 to 25 January 2025 ( OJ L 32, 4.2.2020, p. 16 )
</note> | ENG | 32020D0235 |
02022R0127 — EN — 13.01.2023 — 001.003
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
<table><col/><col/><tr><td><p><a>►B</a></p></td><td><p>COMMISSION DELEGATED REGULATION (EU) 2022/127</p><p>of 7 December 2021</p><p><a>supplementing Regulation (EU) 2021/2116 of the European Parliament and of the Council with rules on paying agencies and other bodies, financial management, clearance of accounts, securities and use of euro</a></p><p>(OJ L 020 31.1.2022, p. 95)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p> </p></td><td><p> </p></td><td><p>Official Journal</p></td></tr><tr><td><p>  No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>►M1</a></p></td><td><p><a>COMMISSION DELEGATED REGULATION (EU) 2023/57 of 31 October 2022</a></p></td><td><p>  L 5</p></td><td><p>7</p></td><td><p>6.1.2023</p></td></tr><tr><td><p><a>►M2</a></p></td><td><p><a>COMMISSION DELEGATED REGULATION (EU) 2023/1309 of 26 April 2023</a></p></td><td><p>  L 162</p></td><td><p>3</p></td><td><p>28.6.2023</p></td></tr></table>
COMMISSION DELEGATED REGULATION (EU) 2022/127
of 7 December 2021
supplementing Regulation (EU) 2021/2116 of the European Parliament and of the Council with rules on paying agencies and other bodies, financial management, clearance of accounts, securities and use of euro
CHAPTER I
Paying agencies and other bodies
Article 1
Conditions for the accreditation of paying agencies
1. Member States shall accredit as paying agencies departments or bodies, which fulfil the conditions laid down in this paragraph and meet the criteria referred to in paragraphs 2 and 3. Paying agencies carrying out the management and control of expenditure as provided for in Article 9(1) of Regulation (EU) 2021/2116 shall provide, in respect of payments made by them and as regards communicating and keeping information, sufficient guarantees that:
(a) as regards types of intervention referred to in Regulation (EU) 2021/2115, the expenditure matches the corresponding reported output and that it has been effected in accordance with the applicable governance systems;
(b) payments are legal and regular as regards the measures laid down in Regulations (EU) No 228/2013 ( 1 ), (EU) No 229/2013 ( 2 ), (EU) No 1308/2013 and (EU) No 1144/2014 of the European Parliament and of the Council ( 3 );
(c) accurate and exhaustive accounts are kept of the payments made;
(d) the checks laid down by Union legislation are made;
(e) the requisite documents are presented within the time limits and in the form set out by Union rules;
(f) the documents are accessible and kept in a manner which ensures their completeness, validity and legibility over time, including with regard to electronic documents within the meaning of Union rules.
2. In order to be accredited, a paying agency shall have an administrative organisation and a system of internal control which comply with the criteria set out in Annex I regarding:
(a) internal environment;
(b) control activities;
(c) information and communication;
(d) monitoring.
3. Member States may lay down further accreditation criteria to take account of the size, responsibilities and other specific features of the paying agency.
Article 2
Conditions for the accreditation of coordinating bodies
1. Where more than one paying agency is accredited, in accordance with Article 10(1) of Regulation (EU) 2021/2116, the Member State concerned shall accredit as coordinating bodies departments or bodies, which fulfil the conditions laid down in paragraph 2 and meet the criteria referred to in paragraphs 3 and 4. That Member State shall, by a formal act at ministerial level, decide on the accreditation of the coordinating body after it has satisfied itself that the administrative arrangements of that body guarantee that it is capable of fulfilling the tasks referred to in that Article.
2. In order to be accredited, the coordinating body shall ensure that:
(a) declarations to the Commission are based on information from properly authorised sources;
(b) the annual performance report referred to in Article 54(1) of Regulation (EU) 2021/2116 and Article 134 of Regulation (EU) 2021/2115 is covered by the scope of the opinion referred to in Article 12(2) of Regulation (EU) 2021/2116 and its transmission is accompanied by a management declaration covering the compilation of the entire report;
(c) declarations to the Commission are properly authorised before transmission;
(d) a proper audit trail exists to support the information transmitted to the Commission;
(e) a record of information received and transmitted is securely stored in computerised format.
3. In order to be accredited, a coordinating body shall have an administrative organisation and a system of internal control as regards the compilation of the annual performance report, which complies with requirements set by the competent authority as regards the procedures involved, and especially the criteria on information and communication as set out in Annex II.
4. Member States may lay down further accreditation criteria to take account of the size, responsibilities and other specific features of the coordinating body.
Article 3
Obligations of the paying agency as regards public intervention
1. The paying agencies referred to in Article 9(1) of Regulation (EU) 2021/2116 shall manage and ensure control of the operations linked to intervention measures relating to public storage for which they are responsible, under the terms laid down in Annex III to this Regulation and, where appropriate, in the sectoral agricultural legislation, in particular on the basis of the minimum checking rates fixed in that Annex.
The paying agencies may delegate their powers in relation to public intervention measures to intervention agencies which meet the conditions of approval laid down in point 1.D of Annex I to this Regulation or act through other paying agencies.
2. The paying agencies or intervention agencies may, without prejudice to their overall responsibility relating to public storage:
(a) entrust the management of certain public storage measures to natural or legal persons storing bought-in agricultural products (‘storers’);
(b) mandate natural or legal persons to carry out certain specific tasks laid down by the sectoral agricultural legislation.
If the paying agencies entrust the management to storers as referred to in the first subparagraph, point (a), such management shall be carried out under storage contracts on the basis of the obligations and general principles set out in Annex IV.
3. The obligations of paying agencies with regard to public storage shall be, in particular, as follows:
(a) to keep stock accounts and financial accounts for each product covered by an intervention measure involving public storage, based on the operations they carry out from 1 October of one year to 30 September of the following year, this period being referred to as an ‘accounting year’;
(b) to keep an up-to-date list of the storers with whom they have concluded public storage contracts. This list shall contain references allowing the exact identification of all storage points, their capacity, the number of warehouses, cold stores and silos, and drawings and diagrams thereof;
(c) to make available to the Commission the standard contracts used for public storage, the rules laid down for the taking-over of products, their storage and removal from the storehouses of the storers, and the rules applicable to the liability of storers;
(d) to keep centralised, computerised stock accounts of all stocks, covering all storage places, all products and all the quantities and qualities of the different products, specifying in each case the weight (net and gross, where applicable) or the volume;
(e) to perform all operations relating to the storage, conservation, transport or transfer of intervention products in accordance with Union and national legislation, without prejudice to the responsibility of the purchasers, of the other paying agencies involved in an operation and of any other persons acting on instruction in this regard;
(f) to conduct checks on places where intervention stocks are held, throughout the year, at irregular intervals and without prior warning. However, provided that the purpose of the control is not jeopardised, advance notice may be given, but shall be strictly limited to the minimum time-period necessary. Such notice shall not exceed 24 hours, except in duly justified cases;
(g) to conduct an annual stocktaking in accordance with Article 4.
Where, in a Member State, management of the public storage accounts for one or more products is carried out by more than one paying agency, the stock accounts and financial accounts referred to in the first subparagraph, points (a) and (d), shall be consolidated at Member State level before the corresponding information is notified to the Commission.
4. The paying agencies shall ensure:
(a) that products covered by Union intervention measures are properly conserved by checking the quality of stored products at least once a year;
(b) the integrity of intervention stocks.
5. The paying agencies shall inform the Commission immediately:
(a) of cases where extending the storage period of a product is likely to result in its deterioration;
(b) of quantitative losses or deterioration of the product due to natural disasters.
Where situations referred to in the first subparagraph are applicable, the Commission shall adopt the appropriate decision:
(a) as regards the situations referred to in the first subparagraph, point (a), in accordance with the examination procedure referred to in Article 229(2) of Regulation (EU) No 1308/2013;
(b) as regards the situations referred to in the first subparagraph, point (b), in accordance with the examination procedure referred to in Article 102(3) of Regulation (EU) 2021/2116.
6. The paying agencies shall bear any financial consequences of poor conservation of products covered by Union intervention measures, in particular those resulting from unsuitable storage methods. Without prejudice to any recourse against storers, the paying agencies shall bear financial responsibility for failure to comply with their undertakings or obligations.
7. The paying agencies shall make the public storage accounts and all documents, contracts and files drawn up or received in the context of intervention operations permanently available to Commission agents or persons mandated by the Commission, either electronically or at the premises of the paying agencies.
Article 4
Inventory
1. During each accounting year, the paying agencies shall draw up an inventory for each product, which has been the subject of Union intervention.
They shall compare the results of the inventory with the accounting data. Any differences in quantities found, and the amounts resulting from differences in quality found during checks, shall be accounted for in accordance with the rules adopted pursuant to Article 47(3), point (a) of Regulation (EU) 2021/2116.
2. For the purposes of paragraph 1, missing quantities resulting from normal storage operations shall be equal to the difference between the theoretical stock shown by the accounts inventory, on the one hand, and the actual physical stock as established on the basis of the inventory provided for in paragraph 1 or the stock shown as remaining on the books after the physical stock of a store has been exhausted, on the other hand and shall be subject to the tolerance limits set out in Annex V.
CHAPTER II
Financial management
Article 5
Non-compliance with the latest payment deadline
1. Payments to a beneficiary made after the latest possible payment date may be considered eligible under the circumstances and conditions laid down in paragraphs 2 to 6.
2. Where European Agricultural Guarantee Fund (EAGF) expenditure under Article 5(2) or European Agricultural Fund for Rural Development (EAFRD) expenditure under Article 6 for interventions referred to in Article 65(2) of Regulation (EU) 2021/2116 effected after the deadline laid down by Union law is equal to the threshold of 5 % or less of the expenditure effected before the deadlines for the EAGF and the EAFRD respectively, no reduction of the monthly or interim payments shall be made.
Where EAGF or EAFRD expenditure effected after the deadlines laid down by Union law is above the threshold of 5 % for the EAGF and the EAFRD respectively, all further expenditure effected late shall be reduced in accordance with the following rules:
(a) for EAGF expenditure:
(i) expenditure effected in the first month following the month in which the payment deadline expired shall be reduced by 10 %;
(ii) expenditure effected in the second month following the month in which the payment deadline expired shall be reduced by 25 %;
(iii)
expenditure effected in the third month following the month in which the payment deadline expired shall be reduced by 45 %;
(iv) expenditure effected in the fourth month following the month in which the payment deadline expired shall be reduced by 70 %;
(v) expenditure effected later than the fourth month following the month in which the payment deadline expired shall be reduced by 100 %;
(b) for EAFRD expenditure:
(i) expenditure effected between 1 July and 15 October of the year in which the payment deadline expired shall be reduced by 25 %;
(ii) expenditure effected between 16 October and 31 December of the year in which the payment deadline expired shall be reduced by 60 %;
(iii)
expenditure effected later than 31 December of the year in which the payment deadline expired shall be reduced by 100 %.
3. By way of derogation from paragraph 2, the following conditions shall apply:
(a) where for expenditure for interventions in the form of direct payments or EAFRD expenditure the threshold referred to in paragraph 2, first subparagraph, has not been used in full for payments made in respect of calendar year N no later than 15 October of year N + 1 for the EAGF and no later than 31 December of year N + 1 for the EAFRD and the remainder of the threshold exceeds 2 %, that remainder shall be reduced to 2 %;
(b) during a financial year N + 1, payments for interventions in the form of direct payments, other than payments provided for in Regulations (EU) No 228/2013 and (EU) No 229/2013, in respect of calendar years N-1 or earlier made after the payment deadline shall only be eligible for financing by the EAGF if the total amount of interventions in the form of direct payments made within financial year N+1, where applicable corrected to amounts before the adjustment provided for in Article 17 of Regulation (EU) 2021/2116, does not exceed the ceiling laid down in Annex V to Regulation (EU) 2021/2115 in respect of calendar year N, in accordance with Article 87(1) of that Regulation;
(c) expenditure exceeding the limits referred to in point (a) or (b) shall be reduced by 100 %.
The amounts of the reimbursements referred to in Article 17(3), second subparagraph, of Regulation (EU) 2021/2116 shall not be taken into account to check whether the condition laid down in the first subparagraph, point (b), of this paragraph is fulfilled.
4. Where exceptional management conditions are encountered for certain interventions and measures or where justified reasons are advanced by the Member States, the Commission shall apply either different time scales from those laid down in paragraphs 2 and 3, and/or lower reductions or apply no reduction at all.
However, the first subparagraph shall not apply for expenditure exceeding the ceiling referred to in paragraph 3, first subparagraph, point (b).
5. Checks on compliance with the payment deadline shall be made once each financial year on expenditure made by 15 October.
Any overrun of payment deadline shall be taken into account in the accounts clearance decision referred to in Article 53 of Regulation (EU) 2021/2116, at the latest.
6. The reductions referred to in this Article shall be applied without prejudice to the subsequent decision on annual performance clearance, referred to in Article 54 of Regulation (EU) 2021/2116 and the conformity procedure, referred to in Article 55 of that Regulation.
Article 6
Non-compliance with the earliest date of payment
As regards EAGF expenditure, if Member States are allowed to pay advances up to a certain maximum amount before the earliest payment date laid down by Union law, this expenditure shall be considered as expenditure eligible for Union financing. Any expenditure paid above this maximum amount shall be ineligible for Union financing except in duly justified cases where exceptional management conditions are encountered for certain interventions or measures or where justified reasons are provided by the Member States. In such cases, the expenditure paid above the maximum amount shall be eligible for Union financing subject to a reduction of 10 %.
The corresponding reduction shall be taken into account in the accounts clearance decision referred to in Article 53 of Regulation (EU) 2021/2116, at the latest.
Article 7
Compensation by paying agencies
1. In its decision on the monthly payments to be adopted pursuant to Article 21(3) of Regulation (EU) 2021/2116, the Commission shall establish the balance of the expenditure declared by each Member State in its monthly declarations, less the assigned revenue which that Member State has included in its declarations of expenditure. This set-off shall be regarded as equivalent to collection of the corresponding revenue.
Commitment appropriations and payment appropriations generated by assigned revenue shall be open once this revenue has been assigned to budget lines.
2. If the amounts referred to in Article 45(1), point (b), of Regulation (EU) 2021/2116 were withheld before the payment of the aid concerned by the irregularity or negligence, they shall be deducted from the corresponding expenditure.
3. The amounts of the EAFRD contributions recovered from beneficiaries under the Member State’s CAP Strategic Plan concerned during each reference period shall be deducted from the amount to be paid by the EAFRD in the declaration of expenditure for that period.
4. The greater or lesser amounts resulting, where applicable, from the annual financial clearance may be re-used under the EAFRD and shall be added to or deducted from the amount of the EAFRD contribution when the first declaration after the clearance of accounts decision is drawn up.
5. Financing from the EAGF shall be equal to the expenditure, calculated on the basis of the information notified by the paying agency, after deduction of any revenue accruing from the intervention measures, validated by the computerised system set up by the Commission and included by the paying agency in its declaration of expenditure.
Article 8
Late adoption of Union budget
1. If the Union budget has not been adopted by the beginning of the budgetary year, the monthly payments referred to in Article 21 of Regulation (EU) 2021/2116 and the interim payments referred to in Article 32 of that Regulation shall be made proportionally to the authorised appropriations per chapter as a percentage of the declarations of expenditure received from each Member State, for the EAGF and the EAFRD respectively, and within the limits laid down in Article 16 of Regulation (EU, Euratom) 2018/1046.
The Commission shall take into account the balance of amounts not reimbursed to the Member States in subsequent payments.
2. As regards the EAFRD, if the Union budget has not been adopted by the beginning of the budgetary year as regards the budgetary commitments referred to in Article 29 of Regulation (EU) 2021/2116, the first annual instalments following the adoption of the Member States’ CAP Strategic Plans shall respect the order of adoption of those plans. The budget commitments for the subsequent annual instalments shall be made in the order of the Member States’ CAP Strategic Plans having exhausted the respective commitments. The Commission may make partial annual commitments to the Member States’ CAP Strategic Plans if the available commitment appropriations are limited. The remaining balance for those plans shall be committed only once additional commitment appropriations become available.
Article 9
Deferral of monthly payments
The monthly payments referred to in Article 21 of Regulation (EU) 2021/2116 to the Member States may be deferred where the communications as referred to in Article 90(1), point (c)(i) and (ii), of that Regulation arrive late or contain discrepancies, which necessitate further checks. The Commission shall inform the Member States concerned in due time of its intention to defer payments.
Article 10
Suspension of payments in relation to the annual clearance
1. Where the Commission suspends the monthly payments referred to in Article 21(3) of Regulation (EU) 2021/2116 pursuant to Article 40(1), first subparagraph, of that Regulation, the following rates of suspension of payments shall apply:
(a) if the Member State does not submit the documents referred to in Articles 9(3) and 12(2) of Regulation (EU) 2021/2116 by 1 March, 1 % of the total amount of the monthly payments referred to in Article 21(3) of that Regulation;
(b) if the Member State does not submit the documents referred to in Articles 9(3) and 12(2) of Regulation (EU) 2021/2116 by 1 April, 1,5 % of the total amount of the monthly payments referred to in Article 21(3) of that Regulation.
2. The suspension shall be lifted after the submission of all the relevant documents referred to in Articles 9(3) and 12(2) of Regulation (EU) 2021/2116.
Article 11
Suspension of payments in relation to the performance clearance
1. Where the Commission suspends the monthly payments referred to in Article 21(3) of Regulation (EU) 2021/2116 or the interim payments referred to in Article 32 of that Regulation pursuant to Article 40(2) of that Regulation following the performance clearance as referred to in Article 54 of Regulation (EU) 2021/2116, the rate of suspension shall correspond to the difference between the reduction rate applied pursuant to Article 54(1) of Regulation (EU) 2021/2116 and 50 percentage points, multiplied by 2. The rate of suspension to be applied shall not be less than 10 %.
2. The suspensions referred to in paragraph 1 shall be without prejudice to Articles 53 and 55 of Regulation (EU) 2021/2116.
Article 12
Applicable exchange rate for drawing up declarations of expenditure
1. In accordance with Article 94(4) of Regulation (EU) 2021/2116, as regards the EAGF, for drawing up their declarations of expenditure, Member States which have not adopted the euro shall apply the same exchange rate as that which they used to make payments to beneficiaries or receive revenue, in accordance with Chapter V of this Regulation and the sectoral agricultural legislation.
2. As regards the EAFRD, for drawing up their declarations of expenditure, Member States which have not adopted the euro shall apply, for each payment or recovery operation, the last-but-one exchange rate established by the European Central Bank prior to the month in which the operations are registered in the accounts of the paying agency.
3. As regards the clearance decisions referred to in Articles 53 and 54 of Regulation (EU) 2021/2116 and the conformity procedure referred to in Article 55 of that Regulation, the first exchange rate established by the European Central Bank after the date of adoption of the clearance implementing acts shall be used.
4. In cases other than those referred to in paragraphs 1, 2 and 3, as well as for operations for which an operative event has not been laid down by Union law, the applicable exchange rate for Member States which have not adopted the euro shall be the last-but-one exchange rate established by the European Central Bank before the month in respect of which the expenditure or assigned revenue is declared.
CHAPTER III
Clearance of accounts and other checks
Article 13
Criteria and methodology for applying reductions in the framework of the performance clearance
1. For the purpose of adopting the decision pursuant to Article 54(1) of Regulation (EU) 2021/2116 on the amounts to be reduced from Union financing, the Commission shall assess the annual expenditure declared by the Member State for the intervention against its corresponding output as reported in the annual performance report referred to in Article 54(1) of Regulation (EU) 2021/2116, submitted pursuant to Article 9(3), first subparagraph, point (b), and Article 10(1), point (b), of that Regulation, and Article 134 of Regulation (EU) 2021/2115.
2. Where the declared expenditure does not have a corresponding output for the relevant financial year and where such deviations as regards the outputs and the realised unit amounts have not been previously explained by the Member State in accordance with Article 134(5) to (9) of Regulation (EU) 2021/2115 in the annual performance report or where the justifications for the deviations are insufficient, the Member State shall provide further justifications within the time-periods set by the Commission. The justifications shall cover the expenditure declared that does not have a corresponding output in the relevant budgetary year.
3. The justifications to be provided by the Member State shall contain relevant information explaining the deviation at unit amount level and the period concerned. It shall contain quantitative information, as well as, qualitative explanations, where necessary.
The Member State shall also provide explanations regarding the extent and effect of the corrective actions already taken to remedy the deviation and to prevent it from reoccurring.
Where the Member State cannot provide justifications for the deviations in accordance with paragraph 2, it may provide justifications for a part of the deviations.
4. Where the Member State fails to provide duly justified reasons for the deviations or where those are considered insufficient by the Commission in accordance with paragraphs 2 and 3, or cover only part of the deviations, the Commission shall reduce the relevant amounts from Union financing. The Commission shall notify the Member State of its opinion in a separate communication
5. The reductions referred to in this Article shall be applied without prejudice to the subsequent decision on conformity clearance referred to in Article 55 of Regulation (EU) 2021/2116.
Article 14
Criteria and methodology for applying corrections in the framework of the conformity procedure for the expenditure outside the scope of Regulation (EU) 2021/2115 or for the crop-specific payment for cotton and support for early retirement
1. For the purpose of adopting the decision on the amounts to be excluded from Union financing pursuant to Article 55(1) of Regulation (EU) 2021/2116, the Commission shall distinguish between those amounts or parts of the amounts identified as amounts unduly spent and those determined by applying extrapolated or flat rate corrections.
In order to determine the amounts that may be excluded from Union financing, when finding that expenditure outside the scope of Regulation (EU) 2021/2115, for the crop-specific payment for cotton or support for early retirement under Title III, Chapter II, Section 3, Subsection 2, and Article 155(2) of that Regulation, respectively, has not been incurred in conformity with Union law, the Commission shall use its own findings and shall take into account the information made available by the Member States during the conformity clearance procedure carried out in accordance with Article 55 of Regulation (EU) 2021/2116.
2. The Commission shall base the exclusion on the identification of the amounts unduly spent only if those amounts may be identified with proportionate effort. Where the amounts unduly spent cannot be identified by the Commission with proportionate effort, Member States may, within the time-periods set by the Commission during the conformity clearance procedure, submit data concerning the verification of those amounts on the basis of an examination of all individual cases potentially affected by the non-conformity. The verification shall cover the entire expenditure incurred in breach of applicable law and charged to the Union budget. The data submitted shall include all individual amounts which are ineligible due to that non-conformity.
3. Where the amounts unduly spent cannot be identified in accordance with paragraph 2, the Commission may determine the amounts to be excluded by applying extrapolated corrections. To enable the Commission to determine the relevant amounts, Member States may, within the time-periods set by the Commission during the conformity clearance procedure, submit a calculation of the amount to be excluded from Union financing by extrapolating through statistical means the results of checks carried out on a representative sample of those cases. The sample shall be drawn from the population for which the identified non-conformity is reasonably expected to occur.
4. In order to take into consideration the results submitted by Member States as referred to in paragraphs 2 and 3, the Commission shall be in a position to:
(a) assess the methods used for identifying or extrapolating, which shall be clearly described by the Member States;
(b) check the representativeness of the sample referred to in paragraph 3;
(c) check the content and results of the identification or extrapolation submitted to it;
(d) obtain sufficient and relevant audit evidence regarding the underlying data.
5. When applying extrapolated corrections as foreseen in paragraph 3, the Member States may use the paying agencies’ control statistics as confirmed by the certification body, or such body’s assessment of the level of error in the context of its audit referred to in Article 12 of Regulation (EU) 2021/2116, provided that:
(a) the Commission is satisfied with the work carried out by the certification bodies, both in terms of audit strategy and concerning the content, extent and quality of the actual audit work;
(b) the scope of the certification bodies’ work is consistent with the scope of the conformity clearance enquiry in question, in particular with regard to the measures or schemes;
(c) the amount of the penalties that should have been applied was taken into account in the assessments.
6. Where the conditions for determining the amounts to be excluded from Union financing as referred to in paragraphs 2 and 3 are not met or the nature of the case is such that the amounts to be excluded cannot be determined on the basis of those paragraphs, the Commission shall apply the appropriate flat-rate corrections, taking into account the nature and gravity of the infringement and its own estimation of the risk of financial damage caused to the Union budget.
The level of flat-rate correction shall be established by taking into consideration in particular the type of non-conformity identified. To this effect, control deficiencies shall be divided between those relating to key and ancillary controls as follows:
(a) key controls shall be the administrative and on-the-spot checks necessary to determine the eligibility of the aid and the relevant application of reductions and penalties;
(b) ancillary controls shall be all other administrative operations required to correctly process claims.
If, in the framework of the same conformity clearance procedure, different non-conformities which would individually lead to distinct flat-rate corrections are established, then only the highest flat-rate correction shall apply.
7. When establishing the level of flat-rate corrections, the Commission shall specifically take into account one or more of the following circumstances demonstrating a higher gravity of the deficiencies revealing a greater risk of loss for the Union budget:
(a) one or more key controls are not applied or are applied so poorly or so infrequently that they are deemed ineffective in determining the eligibility of the claim or in preventing irregularities;
(b) three or more deficiencies are detected with respect to the same control system;
(c) the Member State’s application of a control system is found to be absent or gravely deficient, and there is evidence of wide-spread irregularity and negligence in countering irregular or fraudulent practices;
(d) similar deficiencies in the same sector are detected in a Member State in an enquiry that follows an enquiry in which they have been first detected and communicated to the Member State, account taken however of the corrective or compensating measures already taken by the Member State.
8. Where a Member State submits certain objective elements, which do not fulfil the requirements laid down in paragraphs 2 and 3 of this Article, but which demonstrate that the maximum loss for the EAGF and the EAFRD is limited to a sum lower than what would derive from the application of the flat-rate proposed, the Commission shall use that lower flat rate to decide on the amounts to be excluded from Union financing pursuant to Article 55 of Regulation (EU) 2021/2116.
9. Amounts effectively recovered from the beneficiaries and credited to the EAGF and the EAFRD before a relevant date, to be established by the Commission in the course of the conformity clearance procedure, shall be deducted from the amount that the Commission decides to exclude from Union financing pursuant to Article 55 of Regulation (EU) 2021/2116.
Article 15
Criteria and methodology for applying corrections in the framework of the conformity procedure for expenditure within the scope of Regulation (EU) 2021/2115
1. For the purpose of adopting the decision on the amounts to be excluded from Union financing pursuant to Article 55(1) of Regulation (EU) 2021/2116, the Commission shall use its own findings and shall take into account the information made available by the Member States during the conformity procedure carried out in accordance with Article 55(3) of that Regulation. The amount to be excluded from Union financing shall as much as possible correspond to the actual financial loss or risk for the Union budget.
2. Where the Commission finds that the expenditure has not been effected in conformity with Union law, the Commission may determine the amounts to be excluded by applying flat-rate corrections, taking into account the nature and gravity of the infringement and its own estimation of the risk of financial damage caused to the Union.
The level of flat-rate correction shall be established by taking into consideration in particular the type of serious deficiency identified. To this effect, account shall be taken of the elements of the governance systems affected by the serious deficiencies.
If, in the framework of the same conformity procedure, different serious deficiencies which would individually lead to distinct flat-rate corrections are established, then only the highest flat-rate correction shall apply.
3. When establishing the level of flat-rate corrections, the Commission shall specifically take into account one or more of the following circumstances demonstrating a higher gravity of the deficiencies, revealing a greater risk of loss for the Union budget:
(a) serious deficiencies in one or more elements of the governance systems;
(b) the Member State’s application of an element of the governance system is found to be absent, and there is evidence of wide-spread irregularity and negligence in countering irregular or fraudulent practices;
(c) similar deficiencies in the same sector are detected in a Member State in an enquiry that follows an enquiry in which they have been first detected and communicated to the Member State, account taken however of the corrective or compensating measures already taken by the Member State.
4. Where a Member State demonstrates that the maximum loss for the EAGF and the EAFRD is limited to a sum lower than what would derive from the application of the flat-rate proposed, the lower flat-rate may be applied or the certification body’s assessment of the governance systems in the context of its audit referred to in Article 12 of Regulation (EU) 2021/2116 may be used by the Commission in order to determine the amounts to be excluded from Union financing during the conformity procedure referred to in Article 55 of that Regulation.
5. Where appropriate, Member States may, within the time-periods set by the Commission during the conformity procedure, submit data concerning the verification of those amounts on the basis of an examination of all individual cases potentially affected by the deficiency. The verification shall cover the entire expenditure incurred in breach of Union law and charged to the Union budget. The data submitted shall include all amounts, which are ineligible due to that non-conformity with Union law. Alternatively, Member States may provide an assessment of the risk, based on a statistically valid and representative sample of the population affected by the deficiency, provided the Member States cannot calculate the amounts unduly spent with proportionate effort. The certification body shall confirm the Member State’s assessment of the deficiency.
6. In order to take into consideration the results submitted by Member States as referred to in paragraph 5, the Commission shall assess the method, content and results of the verification or extrapolation submitted. Where the Commission is satisfied with the method, content and results of the verification or extrapolation submitted, it shall use the results submitted by Member States pursuant to paragraph 5, in order to determine the amounts to be excluded from Union financing pursuant to Article 55 of Regulation (EU) 2021/2116.
7. Amounts effectively recovered from the beneficiaries and credited to the EAGF and the EAFRD before a relevant date, to be established by the Commission in the course of the conformity procedure, shall be deducted from the amount that the Commission decides to exclude from Union financing pursuant to Article 55 of Regulation (EU) 2021/2116.
CHAPTER III a
Specific conditions for the payment of advances
Article 15a
Specific conditions for the payment of advances referred to in Article 44(3a) of Regulation (EU) 2021/2116
1. The payment of advances referred to in Article 44(3a) of Regulation (EU) 2021/2116 shall not exceed 80 % of the forecasted expenditure of the approved operational programme or, where relevant, of the interventions referred to in Articles 55 and 58 of Regulation (EU) 2021/2115.
2. The payment of advances referred to in paragraph 1 shall be subject to the lodging of a security at least equivalent to the amount of the advance.
CHAPTER IV
Securities
Section 1
Scope and use of terms
Article 16
Scope
This Chapter shall apply in all cases where the sectoral agricultural legislation provides for a security whether or not the particular term ‘security’ is used.
This Chapter shall not apply to securities given to ensure payment of import and export duties referred to in Regulation (EU) No 952/2013 of the European Parliament and of the Council ( 4 ).
Article 17
Terms used in this Chapter
For the purposes of this Chapter:
(a) ‘competent authority’ means either a party authorised to accept a security or a party authorised to decide in accordance with the relevant regulation if a security is to be released or forfeited;
(b) ‘block security’ means a security made available to the competent authority with the purpose of ensuring that more than one obligation is met;
(c) ‘the relevant part of the sum secured’ means the part of the sum secured corresponding to the quantity for which a requirement has been breached.
Section 2
Requirement of a security
Article 18
Responsible party
A security shall be given by or on behalf of the party responsible for paying the sum of money due if an obligation is not met.
Article 19
Waiver of a security requirement
1. The competent authority may waive the security requirement where the party responsible for meeting the obligation is either:
(a) a public body responsible for executing the duties of a public authority; or
(b) a private body executing duties referred to in point (a) under State supervision.
2. The competent authority may waive the security requirement where the value of the sum secured is less than EUR 500. In that case, the party concerned shall undertake in writing to pay a sum equal to the security waived if the corresponding obligation is not met.
In applying the first subparagraph, the value of the security shall be calculated as comprising all the relevant obligations linked with a same operation.
Article 20
Conditions applying to securities
1. The competent authority shall refuse to accept or shall require the replacement of any security which it considers inadequate or unsatisfactory or which does not provide cover for a sufficient period.
2. Where cash is deposited by transfer, it shall not be regarded as establishing a security until the competent authority is satisfied that it has the amount at its disposal.
3. A cheque for a sum whose payment is guaranteed by a financial institution recognised for that purpose by the Member State of the competent authority concerned shall be treated as a cash deposit. The competent authority need not to present such a cheque for payment until the period for which it is guaranteed is about to expire.
A cheque, other than as referred to in the first subparagraph, shall constitute a security only when the competent authority is satisfied that it has the amount at its disposal.
4. Any charges by a financial institution shall be borne by the party giving the security.
5. No interest shall be paid to the party giving a security in the form of a cash deposit.
Article 21
Use of euro
1. Securities shall be constituted in euro.
2. If the security is accepted in a Member State which has not adopted the euro, the amount of the security in euro shall be converted into the applicable national currency in accordance with Chapter V. The undertaking corresponding to the security and any amount withheld in the event of irregularities or breaches shall remain fixed in euro.
Article 22
The guarantor
1. The guarantor shall have his officially registered residence or an establishment in the Union and, subject to the provisions of the Treaty concerning freedom to supply services, be approved by the competent authority of the Member State in which the security is given. The guarantor shall be bound by a written guarantee.
2. The written guarantee shall state at least:
(a) the obligation or, in the case of a block security, the type(s) of obligation against whose fulfilment it guarantees the payment of a sum of money;
(b) the maximum liability to pay that the guarantor accepts;
(c) that the guarantor undertakes jointly and severally with the party responsible for meeting the obligation to pay, within 30 days upon demand by the competent authority, any sum, within the limit of the guarantee, due once a security is declared forfeit.
3. Where a written block security has already been given, the competent authority shall determine the procedure to be followed by which all or part of the block security shall be allocated to a particular obligation.
Article 23
Application of force majeure
Any person responsible for an obligation covered by a security claiming that the non-respect of the obligation is due to force majeure shall prove to the satisfaction of the competent authorities that force majeure applies. If the competent authority recognises a case of force majeure , the obligation is cancelled for the sole purpose of releasing the security.
Section 3
Release and forfeiture of securities other than those referred to in Section 4
Article 24
Forfeiting of securities
1. The obligation referred to in Article 64(1) of Regulation (EU) 2021/2116 is the requirement to perform or to refrain from performing an action, basic to the purposes of the Regulation imposing it.
2. If an obligation is not fulfilled and no time limit for fulfilment has been given, the security shall be forfeited when the competent authority establishes that it was not fulfilled.
3. If the fulfilment of an obligation is subject to a certain time limit, and the fulfilment took only place beyond that time limit, the security shall be forfeited.
In such case the security shall be forfeited for 10 % at once and further an additional percentage over the remaining balance shall be applied for:
(a) 2 % per calendar day exceeding the time limit if the obligation concerns the importing of products into a third country;
(b) 5 % per calendar day exceeding the time limit if the obligation concerns the leaving of products of the customs territory of the Union.
4. If an obligation is fulfilled timely, and the presentation of the proof of fulfilment is subject to a fixed time limit, the security covering that obligation shall be forfeited for each calendar day exceeding that time limit according to the formula 0,2/time limit in days set and taking account of Article 26.
If the proof referred to in the first subparagraph consists of the submission of a used or expired import or export licence, the security to be forfeited shall be 15 % if that proof is submitted after the fixed time limit referred to in the first subparagraph but at the latest on the 730th calendar day after the expiry date of the licence. After those 730 calendar days, the remaining security shall be forfeited in whole.
5. The amount of security to be forfeited shall be rounded to the first lower amount in whole euro or the applicable national currency.
Article 25
Releasing of securities
1. Once the proof as laid down by the specific Union rules that an obligation has been fulfilled, or the security has been partially forfeited in accordance with Article 64(2) of Regulation (EU) 2021/2116 and Article 24 of this Regulation, the security, or where applicable, the remainder of the security shall be released without delay.
2. A security shall on request be released in part where the relevant evidence has been furnished in relation to part of a quantity of product, provided that that part is not less than any minimum quantity specified in the regulation requiring the security, or, in the absence, as specified by the Member State.
3. Where no time-period is laid down for producing the evidence needed to release a sum secured, such period shall be 365 calendar days from the time limit specified for respecting the obligation for which the security was lodged. Where no time limit is specified for respecting the obligation for which the security was lodged, the period for producing the evidence needed to release a sum secured shall be 365 calendar days from the date by which all obligations have been fulfilled.
The period laid down in the first subparagraph shall not exceed 1 095 calendar days from the time the security was assigned to a particular obligation.
Article 26
Thresholds
1. The total sum forfeited shall not exceed 100 % of the relevant part of the sum secured.
2. The competent authority may waive the forfeiture of an amount less than EUR 100, provided that similar national provisions for comparable cases are laid down by law, regulation or administrative action.
Section 4
Securities with respect to advance payments
Article 27
Scope
This Section shall apply in cases where specific Union rules provide that a sum may be advanced before the obligation established to obtain any aid or advantage has been met.
Article 28
Release of securities
1. The security shall be released:
(a) either when final entitlement to the sum granted as an advance has been established;
(b) or when the sum granted, plus any addition provided for in the specific Union rules, has been repaid.
1 a .
Applications for the release of the security relating to advance payments shall be accompanied by supporting documents proving final entitlement to the sum granted or that the sum granted, plus any addition provided for in the specific Union rules, has been repaid.
2. Once the deadline for proving final entitlement to the sum granted has passed without production of evidence of entitlement, the competent authority shall immediately follow the procedure for forfeiting the security.
However, where specific Union rules so provide, evidence may still be produced after that date against partial repayment of the security.
CHAPTER V
Use of euro
Article 29
Trade with third countries
1. For amounts relating to imports and for export taxes, fixed in euro by Union law relating to the common agricultural policy and applicable by the Member States in national currency, the conversion rate shall be specifically equal to the rate applicable pursuant to Article 53(1) of Regulation (EU) No 952/2013.
2. For prices and amounts expressed in euro in Union agricultural legislation regarding trade with third countries, the operative event for the exchange rate shall be the acceptance of the customs declaration.
3. For the purpose of calculating the standard import value of fruit and vegetables, in order to determine the entry price, the operative event for the exchange rate for the representative prices used to calculate that standard value and the amount of the reduction shall be the day to which the representative prices relate.
Article 30
Specific types of aid
1. For aid granted by quantity of marketed product or product to be used in a specific way, without prejudice to Articles 32 and 33, the operative event for the exchange rate shall be the first operation which guarantees, after the products are taken over by the operator concerned, the appropriate use of the products in question and entails grant of the aid.
2. For private storage aid the operative event for the exchange rate shall be the first day of the period in respect of which the aid relating to one and the same contract is granted.
3. For aid other than that referred to in paragraphs 1 and 2 of this Article, and in Articles 32 and 33, the operative event for the exchange rate shall be the deadline for the submission of applications.
Article 31
Wine sector
1. The operative event for the exchange rate shall be the first day of the financial year in which the support is granted for the following:
(a) restructuring and conversion of vineyards referred to in Article 58(1), first subparagraph, point (a), of Regulation (EU) 2021/2115;
(b) temporary and degressive assistance to cover administrative costs of setting-up of mutual funds referred to in Article 58(1), first subparagraph, point (l), of Regulation (EU) 2021/2115;
(c) harvest insurance against income losses resulting from adverse climatic events assimilated to natural disasters, adverse climatic events, damages caused by animals, plant diseases or pest infestations referred to in Article 58(1), first subparagraph, point (d), of Regulation (EU) 2021/2115.
2. For the green harvesting operations referred to in Article 58(1), first subparagraph, point (c), of Regulation (EU) 2021/2115, the operative event for the exchange rate shall be the day on which the green harvesting operation takes place
3. For the distillation of by-products of wine-making carried out in accordance with the restrictions laid down in Part II, Section D, of Annex VIII to Regulation (EU) No 1308/2013, referred to in Article 58(1), first subparagraph, point (g), of Regulation (EU) 2021/2115, the operative event for the exchange rate shall be the first day of the financial year in which the by-product is delivered.
4. For the investments referred to in Article 58(1), first subparagraph, points (b), (e) and (m), of Regulation (EU) 2021/2115, the operative event for the exchange rate shall be 1 January of the year in which the decision to grant the aid is taken.
5. For the types of intervention referred to in Article 58(1), first subparagraph, points (f), (h), (i), (j) and (k), of Regulation (EU) 2021/2115 the operative event for the exchange rate shall be the last-but-one exchange rate established by the European Central Bank before the month in respect of which the expenditure or assigned revenue is declared.
Article 31a
Apiculture programmes
For amounts paid as aid under apiculture programmes pursuant to Article 55 of Regulation (EU) No 1308/2013, the operative event for the exchange rate shall be 1 January of the year when the payment is made.
Article 32
Amounts and payments of aid linked to the implementation of the school scheme
For aid granted for the implementation of the school scheme referred to in Part II, Title I, Chapter II, Section I, of Regulation (EU) No 1308/2013, the operative event for the exchange rate shall be 1 January preceding the school year concerned.
Article 33
Support of structural or environmental character
For rural development support paid in accordance with Title III, Chapter IV, of Regulation (EU) No 2021/2115, as well as for payments relating to measures approved under Regulation (EU) No 1305/2013, the operative event for the exchange rate shall be 1 January of the year in which the decision to grant the aid is taken.
However, where, under Union rules, payment of the amounts referred to in the first subparagraph is staggered over several years, the operative event for the exchange rate for each of the annual instalments shall be l January of the year for which the instalment in question is paid.
Article 34
Other amounts and prices
For prices or amounts other than those referred to in Articles 30 to 33, or amounts linked to those prices, expressed in euro in Union legislation, or expressed in euro by a tendering procedure, the operative event for the exchange rate shall be the day on which one of the following legal acts occurs:
(a) for purchases, when the valid offer has been received;
(b) for sales, when the valid offer has been received;
(c) for withdrawals of products the day on which the withdrawal takes place;
(d) for non-harvesting and green harvesting operations the day on which the non-harvesting and green harvesting operation takes place;
(e) for costs of transport, processing or public storage and for amounts allocated to studies as part of a tendering procedure, the final day for the submission of tenders;
(f) for the recording of prices, amounts or tenders on the market, the day in respect of which the price, amount or tender is recorded;
(g) for penalties linked to non-compliance with agricultural legislation, the date of the act of the competent authority which establishes the facts.
Article 35
Payment of advances
For advances, the operative event for the exchange rate shall be the operative event applicable to the price or amount to which the advance relates, where this event has occurred by the time the advance is paid, or, in other cases, the date of setting in euro of the advance or, failing that, the date of payment of the advance. The operative event for the exchange rate shall be applied to advances without prejudice to the application to the entire price or amount in question of the operative event for that price or amount.
Article 36
Securities
For securities, the operative event for the exchange rate shall be the date on which the security is lodged.
However, the following exceptions shall apply:
(a) for securities relating to advances, the operative event for the exchange rate shall be the operative event as defined for the amount of the advance, where that event has occurred by the time the security is paid;
(b) for securities relating to the submission of tenders, the operative event for the exchange rate shall be the day on which the tender is submitted;
(c) for securities relating to the performance of tenders, the operative event for the exchange rate shall be the closing date of the invitation to tender.
Article 37
Determination of the exchange rate
When an operative event is fixed under Union legislation, the exchange rate to be used shall be the most recent rate set by the European Central Bank prior to the first day of the month in which the operative event occurs.
However, the exchange rate to be used shall be:
(a) for the cases referred to in Article 29(2) of this Regulation in which the operative event for the exchange rate is the acceptance of the customs declaration, the rate referred to in Article 53(1) of Regulation (EU) No 952/2013;
(b) for intervention expenditure incurred in the context of public storage operations, the rate resulting from the application of Article 3(2) of Commission Delegated Regulation (EU) No 906/2014 ( 5 ).
Article 38
Scrutiny of transactions
The amounts in euro resulting from the application of Title IV, Chapter III, of Regulation (EU) 2021/2116 shall be converted, where appropriate, into national currencies by applying the rate of exchange operating on the first working date of the year when the scrutiny period begins and as published in the C series of the Official Journal of the European Union .
CHAPTER VI
Transitional and final provisions
Article 39
Transitional provisions
1. Where a paying agency, accredited in accordance with Regulation (EU) No 1306/2013, assumes responsibility for expenditure for which it was not previously responsible, it shall be accredited with the new responsibilities before 1 January 2023.
2. The measures listed in Annex VI to Delegated Regulation (EU) No 907/2014 shall not be subject to the system of scrutiny established by Title IV, Chapter III, of Regulation (EU) 2021/2116.
Article 40
Repeal
Delegated Regulation (EU) No 907/2014 is repealed with effect from 1 January 2023.
However:
(a) Article 5, 5a, Article 7(3) and (4), Article 10, Article 11(1), second subparagraph, Article 11(2), Article 12, Article 13 and Article 41(5) of that Delegated Regulation shall continue to apply:
(i) in relation to expenditure incurred and payments made for support schemes under Regulation (EU) No 1307/2013 of the European Parliament and of the Council ( 6 ) in respect of the calendar year 2022 and before;
(ii) for measures implemented until 31 December 2022 under Regulations (EU) No 228/2013, (EU) No 229/2013, (EU) No 1308/2013 and (EU) No 1144/2014;
(iii)
for the aid schemes referred to in Article 5(6), first subparagraph, point (c), and Article 5(7) of Regulation (EU) 2021/2117 of the European Parliament and of the Council ( 7 ) in relation to expenditure incurred and payments made for operations implemented pursuant to Regulation (EU) No 1308/2013 after 31 December 2022 and until the end of those aid schemes; and
(iv) as regards the EAFRD, in relation to expenditure incurred by the beneficiaries and payments made by the paying agency in the framework of the implementation of rural development programmes pursuant to Regulation (EU) No 1305/2013.
(b) Article 13 of that Regulation shall continue to apply for ongoing recoveries launched under Article 54 of Regulation (EU) No 1306/2013.
Article 41
Entry into force and application
This Regulation shall enter into force on the 7th day following that of its publication in the Official Journal of the European Union .
It shall apply from 1 January 2023.
However, Article 39 shall apply from the date of entry into force of this Regulation.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
Accreditation criteria for paying agencies referred to in Article 1(2)
1. INTERNAL ENVIRONMENT
(A) Organisational structure
The paying agency’s organisational structure shall allow it to execute the following main functions in respect of EAGF and EAFRD expenditure:
(i) authorisation and control of payments to establish that the amount to be paid to a beneficiary is in conformity with Union rules, which shall include, in particular, administrative and on-the-spot controls;
(ii) execution of payments of the authorised amount to beneficiaries (or their assignees) or, in the case of rural development, the Union co-financing part;
(iii)
accounting to record all payments in the paying agency’s separate accounts for EAGF and EAFRD expenditure, in the form of an information system, and the preparation of periodic summaries of expenditure, including the monthly (for the EAGF), quarterly (for the EAFRD) and annual declarations to the Commission. The paying agency’s accounts shall also record the assets financed by the EAGF and the EAFRD, in particular concerning intervention stocks, uncleared advances, securities and debtors;
(iv) as regards types of intervention referred to in Regulation (EU) 2021/2115, the paying agency’s organisational structure shall also ensure the execution of the performance reporting on output indicators for the purposes of the annual performance clearance referred to in Article 54 of Regulation (EU) 2021/2116 and the performance reporting on result indicators for the multiannual performance monitoring referred to in Article 134 of Regulation (EU) 2021/2115, demonstrating that Article 37 of Regulation (EU) 2021/2116 is complied with.
The paying agency’s organisational structure shall provide for clear assignment of authority and responsibility at all operational levels and for separation of the functions referred to in the first paragraph, points (i), (ii) and (iii), the responsibilities of which shall be defined in an organisational chart that includes the reporting lines. It shall include the technical services and the internal audit service referred to in point 4.
(B) Human-resource standard
The paying agency shall demonstrate a commitment to integrity and ethical values. All management levels shall respect integrity and ethical values in their instructions, actions and behaviour. The integrity and ethical values shall be set out in standards of conduct and understood at all levels of the organisation, as well as by outsourced service providers and beneficiaries. Processes shall be in place to assess whether individuals and entities are aligned with the standards of conduct and to address deviations in a timely manner. The paying agency shall also demonstrate a commitment to attract, develop, and retain competent individuals in alignment with its objectives.
In particular, the agency shall ensure that:
(i) appropriate human resources are allocated to carry out operations and existence of appropriate technical skills as required at different operational levels;
(ii) the division of duties is such that no official has responsibility for more than one of the responsibilities for authorising, paying or accounting of sums charged to the EAGF or to the EAFRD, and no official performs any of those tasks without supervision;
(iii)
the responsibilities of each official are defined in a written job description, including the setting of financial limits to his/her authority. The latter may be defined in the system;
(iv) staff training is appropriate at all operational levels, including fraud awareness, and there is a policy for rotating staff in sensitive positions, or alternatively for increased supervision;
(v) appropriate measures are taken to avoid and detect a possible risk of conflict of interests within the meaning of Article 61 of Regulation (EU, Euratom) 2018/1046 as regards implementing paying agency’s functions vis-a-vis people with influence and sensitive positions inside and outside the paying agency. Where there is a risk of a conflict of interests, measures shall be in place to ensure that that Article is applied.
(C) Risk assessment
The paying agency shall ensure:
(i) the identification of objectives of the paying agency to enable the identification and assessment of risks relating to those objectives;
(ii) the identification of the risks, including potential irregularities or fraud, to the achievement of its objectives and the analysis of those risks as a basis for determining how the risk should be managed;
(iii)
as regards the risk of potential fraud, an anti-fraud strategy, which shall include measures to counter fraud and any illegal activities affecting the financial interests of the Union. These measures shall include the prevention and detection of, and conditions for investigating fraud; and reparation and deterrence measures, with proportionate and dissuasive sanctions;
(iv) the implementation of measures to prevent and mitigate the risks;
(v) the identification and assessment of changes that could significantly impact the internal control system;
(vi) the regular review of the risk assessment and of the measures put in place to prevent or mitigate the identified risks.
(D) Delegation
(D.1) If the paying agency delegates any of its tasks to another body in accordance with Article 9(1) of Regulation (EU) 2021/2116 the following conditions shall be fulfilled:
(i) a written agreement must be concluded between the paying agency and that body specifying, apart from the delegated tasks, the nature of the information and the supporting documents to be submitted to the paying agency and the time limit within which they must be submitted. The agreement must enable the paying agency to comply with the accreditation criteria;
(ii) the paying agency shall in all cases remain responsible for the efficient management of the funds concerned. It remains fully responsible for the legality and regularity of the underlying transactions, including protecting the Union’s financial interest, as well as for declaring the corresponding expenditure to the Commission and for preparing the accounts accordingly;
(iii)
the responsibilities and obligations of the other body, notably concerning the control and verification of the compliance with Union rules, shall be clearly defined;
(iv) the paying agency shall ensure that the other body has effective systems for ensuring that it fulfils its tasks in a satisfactory manner;
(v) the other body shall explicitly confirm to the paying agency that it fulfils its tasks and shall describe the means employed;
(vi) the paying agency shall regularly review the tasks delegated to confirm that the work performed is of satisfactory standard and that it is in compliance with Union rules.
(D.2) The conditions set out in points (D.1)(i), (ii), (iii) and (v) shall apply mutatis mutandis in the cases where paying agency functions are performed by another body as part of its regular tasks on the basis of national legislation.
2. CONTROL ACTIVITIES
(A) Procedures for authorising claims
The paying agency shall adopt procedures to comply with the following rules:
(i) the paying agency shall lay down detailed procedures for the receipt, recording and processing of claims, including a description of all documents and the information system to be used;
(ii) each official responsible for authorisation shall have at his/her disposal a detailed checklist of the verifications to be carried out, and shall attest in the supporting documents of the claim that those checks have been carried out. That attestation may be made by electronic means. There shall be evidence of systematic, such as sample, system or plan based review of the work by a senior staff member;
(iii)
a claim shall be authorised for payment only after sufficient checks have been carried out to ensure compliance with Union rules.
(iv) the checks shall include those required by the relevant regulation governing the specific measure under which aid is claimed, and those required pursuant to Article 59 of Regulation (EU) 2021/2116 to prevent and detect fraud and irregularity with particular regard to the risks incurred. For the EAFRD, there shall in addition be procedures for verifying that the conditions for the granting of aid, including contracting, have been respected and that all applicable Union rules, including those fixed in the CAP Strategic Plan, have been complied with;
(v) the management of the paying agency shall, at an appropriate level, be informed on a regular and timely basis of the results of administrative and on-the-spot checks carried out, so that the sufficiency of those controls may always be taken into account before a claim is settled;
(vi) the work performed shall be detailed in a report accompanying each claim, batch of claims or, if appropriate, in a report covering one marketing year. The report shall be accompanied by an attestation of the eligibility of the approved claims and of the nature, scope and limits of the work done. This may be made by electronic means. In addition, for the EAFRD there shall be an assurance that the criteria for the granting of aid, including contracting, have been respected and that all applicable Union rules, including those fixed in the CAP Strategic Plan, have been complied with. If any physical or administrative checks are not exhaustive, but performed on a sample of claims, the claims selected shall be identified, the sampling method described, the results of all inspections and the measures taken in respect of discrepancies and irregularities reported upon. The supporting documents (in paper or electronic form) shall be sufficient to provide assurance that all the required checks on the eligibility of the authorised claims have been performed;
(vii)
where documents (in paper or electronic form) relating to the claims authorised and controls made are retained by other bodies, both those bodies and the paying agency shall set up procedures to ensure that those documents or electronic data records are kept and available to the paying agency.
(B) Procedures for payment
The paying agency shall adopt the necessary procedures to ensure that payments are made only to bank accounts belonging either to beneficiaries or to their assignees. The payment shall be made by the paying agency’s bank, or, as appropriate, a governmental payments office, within 5 working days of the date of charge to the EAGF or to the EAFRD. Procedures shall be adopted to ensure that all payments for which transfers are not executed are not declared to the EAGF or to the EAFRD for reimbursement. If such payments have already been declared to the EAGF or to the EAFRD, these should be re-credited to those Funds via the next monthly/quarterly declarations or in the annual accounts at the latest. No payments shall be made in cash. The approval of the authorising official and/or his/her supervisor may be made by electronic means, provided an appropriate level of security over those means is ensured, and the identity of the signatory is entered into the electronic records.
(C) Procedures for accounting
The paying agency shall adopt the following procedures:
(i) accounting procedures shall ensure that monthly (for the EAGF), quarterly (for the EAFRD) and annual declarations are complete, accurate and timely, and that any errors or omissions are detected and corrected, in particular through checks and reconciliations performed at regular intervals;
(ii) the accounting for intervention storage shall ensure that the quantities and associated costs are correctly and promptly processed and recorded per identifiable lot and in the correct account at each stage from the acceptance of an offer to the physical disposal of the product, in compliance with the applicable regulations, and ensure that the quantity and nature of stocks at every location may be determined at any time.
(D) Procedures for the performance reporting
As regards types of intervention referred to in Regulation (EU) 2021/2115, the paying agency shall ensure that an information system is in place to collect, record and store in computerised form data on each claim and operation. In addition, the system shall provide a breakdown of data on all relevant output indicators per intervention to guarantee that the annual performance reporting shows that the expenditure was made in accordance with Article 37 of Regulation (EU) 2021/2116, as well as the data for the result indicators, including targets and milestones.
(E) Procedures for advances and securities
Procedures shall be adopted to ensure that:
(i) payments of advances are separately identified in the accounting or subsidiary records;
(ii) guarantees are obtained only from financial institutions which fulfil the conditions of Chapter IV of this Regulation and which are approved by the appropriate authorities and which remain valid until cleared or called upon, on the simple request of the paying agency;
(iii)
The advances are cleared within the stipulated time limits and those overdue for clearing are promptly identified and the guarantees promptly called upon.
(F) Procedures for debts
All the criteria provided for in sections (A) to (E) shall apply, mutatis mutandis , to levies, forfeited guarantees, reimbursed payments, assigned revenues etc. which the paying agency is required to collect on behalf of the EAGF and of the EAFRD.
The paying agency shall set up a system for the recognition of all amounts due and for the recording in a single debtor’s ledger of all such debts prior to their receipt. The debtor’s ledger shall be inspected at regular intervals and action shall be taken to collect debts that are overdue.
(G) Audit trail
The information regarding documentary evidence of the authorisation, accounting and payment of claims, performance reporting and handling of advances, securities and debts shall be available in the paying agency to ensure at all times a sufficiently detailed audit trail.
3. INFORMATION AND COMMUNICATION
(A) Communication
The paying agency shall adopt the necessary procedures to ensure that every change in the Union’s regulations, and in particular the rates of aid applicable, are recorded and the instructions, databases and checklists updated in good time.
(B) Information systems security
The information systems security shall be certified in accordance with International Standards Organisation 27001: Information Security management systems – Requirements (ISO).
Member States may certify, provided it is authorised by the Commission, the information systems security in accordance with other accepted standards if those standards guarantee a level of security at least equivalent to that provided by ISO 27001.
The first and second paragraphs shall not apply to paying agencies responsible for the management and control of a yearly expenditure not higher than EUR 400 million, if the Member State concerned has informed the Commission of its decision to apply one of the following standards instead:
— International Standards Organisation 27002: Code of practice for Information Security controls (ISO);
— Bundesamt für Sicherheit in der Informationstechnik: IT-Grundschutzhandbuch/IT Baseline Protection Manual (BSI);
— Information Systems Audit and Control Association: Control objectives for Information and related Technology (COBIT).
4. MONITORING
(A) Ongoing monitoring via internal control activities
The internal control activities shall cover at least the following areas:
(i) monitoring of the technical services and delegated bodies responsible for carrying out the controls and other functions to ensure a proper implementation of regulations, guidelines and procedures;
(ii) initiating of system changes in order to improve control systems in general;
(iii)
reviewing claims and requests submitted to the paying agency as well as other information providing suspicion of irregularities;
(iv) monitoring procedures to prevent and detect fraud and irregularity with particular regard to those areas of CAP expenditure under the paying agency’s competence which are exposed to a significant risk of fraud or other serious irregularities.
Ongoing monitoring shall be built into the normal, recurring operating activities of the paying agency. At all levels the daily operations and controls activities of the agency shall be monitored on an ongoing basis to ensure a sufficiently detailed audit trail.
(B) Separate evaluations via an internal audit service
The paying agency shall adopt procedures to comply with the following rules:
(i) the internal audit service shall be independent of the paying agency’s other departments and shall report directly to the paying agency’s director;
(ii) the internal audit service shall verify that procedures adopted by the agency are adequate to ensure that compliance with Union rules is verified and that the accounts are accurate, complete and timely. Verifications may be limited to selected measures and to samples of transactions provided that an audit plan ensures that all significant areas, including the departments responsible for authorisation, are covered over a period not exceeding 5 years;
(iii)
the internal audit service’s work shall be performed in accordance with internationally accepted standards, shall be recorded in working papers and shall result in reports and recommendations addressed to the agency’s top management.
ANNEX II
Accreditation criteria for coordinating bodies referred to in Article 2(3) as regards the compilation of the Annual Performance Report
1. INFORMATION AND COMMUNICATION
(A) Communication
The coordinating body shall adopt the necessary procedures to ensure that every change in the Union’s regulations are recorded and the instructions and databases updated in good time.
(B) Information systems security
The information systems security shall be certified in accordance with International Standards Organisation 27001: Information Security management systems – Requirements (ISO).
Member States may certify, provided it is authorised by the Commission, the information systems security in accordance with other accepted standards if those standards guarantee a level of security at least equivalent to that provided by ISO 27001. When a paying agency acts as a coordinating body, its certification fulfils this condition.
ANNEX III
Obligations of the paying agencies referred to in Article 3(1)
I. OBLIGATIONS OF THE PAYING AGENCIES
A. Checks
1. Frequency and representativeness
Each storage point shall be inspected at least once every year in accordance with the rules set out in part II, to ascertain in particular:
(a) the procedure for collecting information on public storage;
(b) whether the accounting data held on the spot by the storer tallies with the information sent to the paying agency;
(c) physical presence shall be established by a sufficiently representative physical inspection, covering at least the percentages set out in part II and making it possible to conclude that the entire quantities listed in the stock accounts are actually present.
(d) checks on quality shall comprise visual, olfactory and/or organoleptic checks and, if there are any doubts, in-depth analyses.
2. Additional checks
If an anomaly is detected during the physical inspection, a further percentage of the quantities in intervention storage shall be inspected using the same method. If necessary, inspection may extend to weighing all the products in the lot or store being inspected.
B. Inspection reports
1. The internal inspection body of the paying agency or the body authorised by the latter shall draw up a report on each of the checks or physical inspections carried out.
2. The report shall contain at least the following information:
(a) the name of the storer, the address of the store visited and the description of the lots inspected;
(b) the date and time when the inspection began and ended;
(c) the place where the inspection took place and a description of the conditions of storage, packaging and accessibility;
(d) the full identity of the persons conducting the inspection, their status and the terms of their authorisation;
(e) the inspection measures undertaken and procedures used to establish volume, such as measuring methods, calculations, interim and final results, and the conclusions drawn;
(f) for each lot or quality stored, the quantity in the paying agency’s books, the quantity in the store’s books and any discrepancies between the two sets of books;
(g) for each lot or quality physically inspected, the information referred to in point (f) and the quantity verified on the spot and any discrepancies, the lot or quality number, the pallets, boxes, silos, vats or other receptacles involved and the weight (both net and gross if appropriate) or volume;
(h) the statements made by the storer where there are discrepancies or differences;
(i) the place, date and signature of the person drawing up the report and of the storer or representative;
(j) any extended inspection conducted in the case of anomalies, specifying the percentage of the stored quantities covered by the extended inspection, discrepancies found and explanations given.
3. The reports shall be sent immediately to the head of the department responsible for keeping the accounts of the paying agency.
Immediately after receipt of the report, the paying agency’s accounts shall be corrected in the light of the discrepancies and differences detected.
4. The reports shall be available to Commission staff and persons authorised by the Commission.
5. A summary document shall be drawn up by the paying agency listing:
(a) the checks carried out, clearly indicating which are physical inspections (inventory checks);
(b) the quantities checked;
(c) the anomalies detected in relation to the monthly and annual statements, and the reasons for those anomalies.
The quantities checked and the anomalies detected shall be indicated for each product concerned, in terms of weight or volume and as a percentage of the total quantities held.
This summary document shall list separately the checks to verify the quality of the products stored. It shall be sent to the Commission at the same time as the annual accounts referred to in Article 9(3), first subparagraph, point (a), of Regulation (EU) 2021/2116.
II. PHYSICAL INSPECTION PROCEDURE BY SECTOR OF THE CAP FOR THE CHECKS PROVIDED FOR IN PART I
A. Butter
1. The sample of the lots to be checked shall represent at least 5 % of the total quantity in public storage. The lots to be checked shall be selected prior to the visit to the store on the basis of the paying agency’s accounting data, but the storer shall not be informed.
2. The presence of the lots selected and their composition shall be verified on the spot by:
(a) identifying the control numbers of the lots and boxes on the basis of purchase or entry notes;
(b) weighing the pallets (one in 10) and the boxes (one per pallet);
(c) visually checking the contents of a box (one in five pallets);
(d) checking the condition of the packaging.
3. A description of the lots physically inspected and any shortcomings noted shall be included in the inspection report.
B. Skimmed-milk powder
1. The sample of the lots to be checked shall represent at least 5 % of the quantity in public storage. The lots to be checked shall be selected prior to the visit to the store on the basis of the paying agency’s accounting data, but the storer shall not be informed.
2. The presence of the lots selected and their composition shall be verified on the spot by:
(a) identifying the control numbers of the lots and bags on the basis of purchase or entry notes;
(b) weighing the pallets (one in 10) and bags (one in 10);
(c) visually checking the contents of a bag (one in five pallets);
(d) checking the condition of the packaging.
3. A description of the lots physically inspected and any shortcomings noted shall be included in the inspection report.
C. Cereals and rice
1. Physical inspection procedure
The inspection shall be carried out as follows:
(a) Selection of bins or storerooms to be checked, representing at least 5 % of the total quantity of cereals or rice in public storage.
Selection shall be based on the paying agency’s stock records, but the storer shall not be informed.
(b) Physical inspection:
(i) verification of the presence of cereals or rice in the selected bins or storerooms,
(ii) identification of the cereals or rice;
(iii)
inspection of storage conditions and check on the quality of the products stored in the conditions provided for in Commission Delegated Regulation (EU) 2016/1238 ( 8 );
(iv) comparison of the place of storage and identity of the cereals or rice with the store’s records;
(v) evaluation of the quantities stored by a method previously approved by the paying agency, a description of which shall be lodged at its head office.
2. Procedure where discrepancies are found
Some tolerance is permitted when verifying the volume.
The rules laid down in Annex IV, section II, shall thus apply where the weight of the products stored as recorded during the physical inspection differs from the book weight by 5 % or more for cereals and for rice in the case of storage in silos or on-floor storage.
Where cereals or rice are stored in a warehouse, the quantities weighed on entry into storage may be recorded instead of those resulting from a volume assessment if the latter does not provide an adequate degree of accuracy and provided the difference between the two figures is not excessive.
The paying agency shall make use of this option where justified by circumstances, on a case-by-case basis and on its own responsibility. It shall indicate that it has done so in its inspection report, based on the following indicative model:
CEREALS – STOCK INSPECTION
<table><col/><col/><col/><tbody><tr><td><p>Product:</p></td><td><p>Storer: Store, silo:</p><p>Cell number:</p></td><td><p>Date:</p></td></tr><tr><td><p>Lot</p></td><td><p>Quantity stated in stock accounts</p></td></tr></tbody></table>
(a) Stocks in silo
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Chamber No</p></td><td><p>Volume stated in specification m<span>3</span> (A)</p></td><td><p>Free volume recorded m<span>3</span> (B)</p></td><td><p>Volume of stored cereals m<span>3</span> (A-B)</p></td><td><p>Specific gravity recorded kg/hl = 100</p></td><td><p>Weight of cereals or rice</p></td></tr><tr><td><p> </p><div/></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p> </p><div/></td></tr></tbody></table>
Total (a): …
(b) Stocks in on-floor storage
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p> </p><div/></td><td><p>Storeroom No</p></td><td><p>Storeroom No</p></td><td><p>Storeroom No</p></td></tr><tr><td><p>Area covered …</p><p>Height …</p></td><td><p>…</p></td><td><p>…</p></td><td><p>…</p></td><td><p>…</p></td><td><p>…</p></td><td><p>…</p></td></tr><tr><td><p>m<span>2</span></p></td><td><p>…</p></td><td><p>m<span>2</span></p></td><td><p>…</p></td><td><p>m<span>2</span></p></td><td><p>…</p></td></tr><tr><td><p>…</p></td><td><p>m<span>3</span></p></td><td><p>…</p></td><td><p>m<span>3</span></p></td><td><p>…</p></td><td><p>m<span>3</span></p></td></tr><tr><td><p>…</p></td><td><p>…</p></td><td><p>…</p></td><td><p>…</p></td><td><p>…</p></td><td><p> </p><div/></td></tr><tr><td><p>… m</p></td><td><p> </p><div/></td><td><p>… m</p></td><td><p> </p><div/></td><td><p>… m</p></td><td><p> </p><div/></td></tr><tr><td><p>Corrections …</p></td><td><p>… m<span>3</span></p></td><td><p>… m<span>3</span></p></td><td><p>… m<span>3</span></p></td></tr><tr><td><p>Volume …</p></td><td><p>… m<span>3</span></p></td><td><p>… m<span>3</span></p></td><td><p>… m<span>3</span></p></td></tr><tr><td><p>Specific gravity …</p></td><td><p>… kg/hl</p></td><td><p>… kg/hl</p></td><td><p>… kg/hl</p></td></tr><tr><td><p>Total weight</p></td><td><p>… tonnes</p></td><td><p>… tonnes</p></td><td><p>… tonnes</p></td></tr></tbody></table>
Total (b): …
Total weight in the store: …
Difference from book weight: …
In %: …
…, [date]
… (Stamp and signature)
Paying agency inspector:
D. Beef and veal
1. The sample of the lots to be checked shall represent at least 5 % of the total quantity in public storage. The lots to be checked shall be selected prior to the visit to the store on the basis of the paying agency’s accounting data, but the storer shall not be informed.
2. On-the-spot verification of the presence of the lots selected and of their composition. Verification shall comprise:
(a) for bone-in meat:
(i) identification of the lots and verification of the number of pieces;
(ii) verification, for each type of cut and/or quality, of the weight of 20 % of the pieces;
(iii)
visual check on the condition of the packaging.
(b) for boned meat:
(i) identifying the lots and pallets and verifying the number of boxes;
(ii) checking the weight of 10 % of the pallets or containers;
(iii)
checking the weight of 10 % of the boxes from each pallet weighed;
(iv) visually checking the contents of the boxes and the condition of the packaging in each box.
The pallets shall be chosen having regard to the different cuts in store.
3. A description of the lots physically inspected and any shortcomings noted shall be included in the inspection report.
ANNEX IV
Obligations and general principles relating to storers’ responsibilities, to be included in storage contracts concluded between paying agencies and storers referred to in Article 3(2)
I. GENERAL OBLIGATIONS OF STORERS
Storers shall be responsible for ensuring that the products covered by Union intervention measures are properly conserved. They shall bear the financial consequences of any failure to do so.
They shall keep available a plan of the warehouse and the measurements for each silo or storeroom at each storage point.
The cereals or rice shall be stored in such a way that their volume may be verified.
II. QUALITY OF PRODUCTS
Where the quality of intervention products in storage deteriorates as a result of poor or inappropriate storage conditions, the losses shall be borne by the storer and entered in the public storage accounts as a loss resulting from deterioration of the product due to storage conditions.
III. MISSING QUANTITIES
1. The storer shall be responsible for all discrepancies between the quantities in store and the details given in the stock statements sent to the paying agency.
2. Where the missing quantities exceed those allowed under the relevant tolerance limit(s), in accordance with Article 4, Annex III, part II, section C, point 2, and Annex V, or under sectoral agricultural legislation, the entire amount shall be charged to the storer as an unidentifiable loss. Storers contesting the missing quantities may require the product to be weighed or measured, in which case they shall bear the costs of the operation unless it is found that the quantities declared are actually present or the difference does not exceed the relevant tolerance limit(s), in which case the costs of weighing or measuring shall be charged to the paying agency.
The tolerance limits set out in Annex III, part II, section C, point 2, shall apply without prejudice to the other tolerances referred to in the first paragraph of this point.
IV. SUPPORTING DOCUMENTS AND MONTHLY AND ANNUAL DECLARATIONS
1. Supporting documents and monthly declarations
(a) The documents relating to the entry, storage and removal of products used to draw up the annual accounts must be in the storer’s possession and contain at least the following information:
(i) place of storage (with identification of the bin or vat where relevant);
(ii) quantity carried over from the previous month;
(iii)
entries and removals by lot;
(iv) stock at the end of the period.
These documents shall permit precise identification of the quantities in store at any time, and shall take account of purchases and sales that have been agreed but for which the corresponding entries or removals of stock have not yet occurred.
(b) The documents relating to the entry, storage and removal of products shall be sent by the storer to the paying agency at least once a month, in support of a summary monthly stock statement. They shall must be in the paying agency’s possession before the tenth day of the month following that to which the stock statement relates.
(c) A specimen summary monthly stock statement (indicative model) is set out below. It shall be made available to storers in electronic form by the paying agencies.
Monthly stock statement
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Products:</p></td><td><p>Storer:</p><p>Store: No:</p><p>Address:</p></td><td><p>Month:</p></td></tr><tr><td><p>Lot</p></td><td><p>Description</p></td><td><p>Quantity (kg, tonnes, boxes, items, etc.)</p></td><td><p>Date</p></td><td><p>Comments</p></td></tr><tr><td><p>Entry</p></td><td><p>Exit</p></td></tr><tr><td><p> </p><div/></td><td><p>Quantity carried over</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p> </p><div/></td><td><p>Quantity to be carried over</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p> </p><div/></td></tr></tbody></table>
(Stamp and signature)
Place and date:
Name:
2. Annual declaration
(a) The storer shall prepare an annual stock declaration on the basis of the monthly statements described in point 1. It shall be sent to the paying agency no later than the 15 October following the closure of the accounting year.
(b) The annual stock declaration shall give a summary of the quantities in store, broken down by product and place of storage, and shall give for each product the quantities in store, the lot numbers (except in the case of cereals), the year of their entry into store and an explanation of any anomalies detected.
(c) A specimen summary annual stock declaration (indicative model) is set out below.
It shall be made available to storers in electronic form by the paying agencies.
Annual stock statement
<table><col/><col/><col/><col/><tbody><tr><td><p>Products:</p></td><td><p>Storer:</p><p>Store: No:</p><p>Address:</p></td><td><p>Year:</p></td></tr><tr><td><p>Lot</p></td><td><p>Description</p></td><td><p>Quantity and/or weight booked</p></td><td><p>Comments</p></td></tr><tr><td><p> </p><div/></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p> </p><div/></td></tr></tbody></table>
(Stamp and signature)
Place and date:
Name:
V. COMPUTERISED STOCK ACCOUNTS AND AVAILABILITY OF INFORMATION
Public storage contracts concluded between the paying agency and the storer shall contain provisions which make it possible to guarantee compliance with Union legislation.
They shall require the following:
(a) the keeping of computerised intervention stock accounts;
(b) direct, immediate availability of a permanent inventory;
(c) availability at all times of all the documents relating to the entry, storage and removal of stock and the accounting documents and records drawn up in accordance with this Regulation and held by the storer;
(d) permanent access to those documents for staff of the paying agency and the Commission, and for any person duly authorised by them.
VI. FORM AND CONTENT OF THE DOCUMENTS SENT TO THE PAYING AGENCY
The form and content of the documents referred to in section IV shall be established in accordance with Article 92 of Regulation (EU) 2021/2116.
VII. KEEPING OF DOCUMENTS
Supporting documents relating to all public storage operations shall be kept by the storer for the full period required under the rules adopted based on Article 92 of Regulation (EU) 2021/2116 for the clearance of accounts procedures, without prejudice to the relevant national provisions.
ANNEX V
Tolerance limits referred to in Article 4(2)
1. For quantity losses resulting from normal storage operations carried out in accordance with the rules, the following tolerance limits shall apply for each agricultural product which is the subject of a public storage measure:
(a) cereals 0,2 %;
(b) paddy rice, maize 0,4 %;
(c) skimmed-milk powder 0,0 %;
(d) butter 0,0 %;
(e) beef and veal 0,6 %.
2. The percentage for allowable losses during boning of beef shall be 32. This percentage shall apply to all quantities boned during the accounting year.
3. The tolerance limits referred to in point 1 shall be fixed as a percentage of the actual weight, without packaging, of the quantities entering storage and taken over during the accounting year in question, plus the quantities in storage at the beginning of that year.
These tolerances shall apply during the physical stock inspections. They shall be calculated, for each product, on the basis of all the quantities stored by a paying agency.
The actual weight at entry and removal shall be the recorded weight minus the standard packaging weight, as laid down in the conditions of entry or, where no such conditions have been laid down, minus the average packaging weight used by the paying agency.
4. The tolerance shall not cover losses in terms of number of packages or number of registered pieces.
5. Losses arising from theft or other identifiable losses shall not be included in the calculation of tolerance limits provided for in points 1 and 2.
<note>
( 1 ) Regulation (EU) No 228/2013 of the European Parliament and of the Council of 13 March 2013 laying down specific measures for agriculture in the outermost regions of the Union and repealing Council Regulation (EC) No 247/2006 (OJ L 78, 20.3.2013, p. 23).
( 2 ) Regulation (EU) No 229/2013 of the European Parliament and of the Council of 13 March 2013 laying down specific measures for agriculture in favour of the smaller Aegean islands and repealing Council Regulation (EC) No 1405/2006 (OJ L 78, 20.3.2013, p. 41).
( 3 ) Regulation (EU) No 1144/2014 of the European Parliament and of the Council of 22 October 2014 on information provision and promotion measures concerning agricultural products implemented in the internal market and in third countries and repealing Council Regulation (EC) No 3/2008 (OJ L 317, 4.11.2014, p. 56).
( 4 ) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1).
( 5 ) Commission Delegated Regulation (EU) No 906/2014 of 11 March 2014 supplementing Regulation (EU) No 1306/2013 of the European Parliament and of the Council with regard to public intervention expenditure (OJ L 255, 28.8.2014, p. 1).
( 6 ) Regulation (EU) No 1307/2013 of the European Parliament and of the Council of 17 December 2013 establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy and repealing Council Regulation (EC) No 637/2008 and Council Regulation (EC) No 73/2009 (OJ L 347, 20.12.2013, p. 608).
( 7 ) Regulation (EU) 2021/2117 of the European Parliament and of the Council of 2 December 2021 amending Regulations (EU) No 1308/2013 establishing a common organisation of the markets in agricultural products, (EU) No 1151/2012 on quality schemes for agricultural products and foodstuffs, (EU) No 251/2014 on the definition, description, presentation, labelling and the protection of geographical indications of aromatised wine products and (EU) No 228/2013 laying down specific measures for agriculture in the outermost regions of the Union (OJ L 435, 6.12.2021, p. 262).
( 8 ) Commission Delegated Regulation (EU) 2016/1238 of 18 May 2016 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to public intervention and aid for private storage ( OJ L 206, 30.7.2016, p. 15).
</note> | ENG | 02022R0127-20230113 |
<table><col/><col/><col/><col/><tbody><tr><td><p>21.5.2021   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 180/3</p></td></tr></tbody></table>
COMMISSION DELEGATED REGULATION (EU) 2021/805
of 8 March 2021
amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC ( 1 ) , and in particular Article 146(2) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>It is appropriate to substantially update the requirements set out in Annex II to Regulation (EU) 2019/6, which took over the dossier requirements set out in Annex I to Directive 2001/82/EC of the European Parliament and of the Council <a>(<span>2</span>)</a>, as that Regulation did not update those dossier requirements at the time of repealing that Directive. The dossier requirements set out in Annex I to Directive 2001/82/EC had last been updated in 2009. Therefore, Annex II should be amended to take account of scientific progress and developments since 2009, including international guidance from the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), World Health Organisation (WHO) and the organisation of Economic cooperation and development (OECD) standards.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>It is also appropriate to set out requirements for biological veterinary medicinal products and novel therapy veterinary medicinal products introduced as new categories of veterinary medicinal products by Regulation (EU) 2019/6. For those products, specific technical requirements to be presented when applying for a marketing authorisation should be defined.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Recognising that antimicrobial resistance to medicinal products is a growing health problem in the Union and worldwide, Regulation (EU) 2019/6 introduced specific legal provisions aimed at limiting the risk of development of antimicrobial resistance to medicinal products. It is therefore appropriate to introduce specific technical requirements for antimicrobial veterinary medicinal products.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>This Regulation should apply from 28 January 2022 in accordance with Article 153(3) of Regulation (EU) 2019/6.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Regulation (EU) 2019/6 should therefore be amended accordingly,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Annex II to Regulation (EU) 2019/6 is replaced by the text in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
It shall apply from 28 January 2022.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 March 2021.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 4, 7.1.2019, p. 43 .
( 2 ) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products ( OJ L 311, 28.11.2001, p. 1 ).
ANNEX
‘ANNEX II
REQUIREMENTS REFERRED TO IN ARTICLE 8(1), POINT (B)
Table of Contents
<table><col/><col/><col/><tbody><tr><td><p>SECTION I</p></td><td>GENERAL PRINCIPLES AND REQUIREMENTS</td><td>11</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>I.1.</p></td><td><span>General principles</span></td><td>11</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>I.2.</p></td><td><span>Dossier composition requirements</span></td><td>11</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>I.2.1.</p></td><td><span>Part 1: Summary of the dossier</span></td><td>11</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>I.2.2.</p></td><td><span>Part 2: Quality documentation (physicochemical, biological or microbiological information)</span></td><td>12</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>I.2.3.</p></td><td><span>Part 3: Safety documentation (safety and residues tests)</span></td><td>13</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>I.2.4.</p></td><td><span>Part 4: Efficacy documentation (pre-clinical studies and clinical trial(s))</span></td><td>13</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>I.2.5.</p></td><td><span>Detailed requirements for different types of veterinary medicinal products or marketing authorisation dossiers</span></td><td>14</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>SECTION II</p></td><td>REQUIREMENTS FOR VETERINARY MEDICINAL PRODUCTS OTHER THAN BIOLOGICAL VETERINARY MEDICINAL PRODUCTS</td><td>14</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.1.</p></td><td><span>Part 1: Summary of the dossier</span></td><td>14</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2.</p></td><td><span>Part 2: Quality documentation (physicochemical, biological or microbiological information)</span></td><td>14</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2A.</p></td><td><span>Product description</span></td><td>14</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2A1.</p></td><td><span>Qualitative and quantitative composition</span></td><td>14</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2A2.</p></td><td><span>Product development</span></td><td>16</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2B.</p></td><td><span>Description of the manufacturing method</span></td><td>16</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2C.</p></td><td><span>Production and control of starting material</span></td><td>16</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2C1.</p></td><td><span>Active substance(s)</span></td><td>17</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2C1.1.</p></td><td><span>Active substances listed in pharmacopoeias</span></td><td>18</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2C1.2.</p></td><td><span>Active substances not listed in a pharmacopoeia</span></td><td>18</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2C1.3.</p></td><td><span>Physicochemical characteristics liable to affect bioavailability</span></td><td>18</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2C2.</p></td><td><span>Excipients</span></td><td>19</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2C3.</p></td><td><span>Packaging (container-closure systems)</span></td><td>19</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2C3.1.</p></td><td><span>Active substance</span></td><td>19</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2C3.2.</p></td><td><span>Finished product</span></td><td>19</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2C4.</p></td><td><span>Substances of biological origin</span></td><td>20</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2D.</p></td><td><span>Control tests carried out on isolated intermediates during the manufacturing process</span></td><td>20</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2E.</p></td><td><span>Control tests on the finished product</span></td><td>20</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2E1.</p></td><td><span>General characteristics of the finished product</span></td><td>21</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2E2.</p></td><td><span>Identification and assay of active substance(s)</span></td><td>21</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2E3.</p></td><td><span>Identification and assay of excipient components</span></td><td>21</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2E4.</p></td><td><span>Microbiological controls</span></td><td>21</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2E5.</p></td><td><span>Batch-to-batch consistency</span></td><td>21</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2E6.</p></td><td><span>Other controls</span></td><td>22</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2F.</p></td><td><span>Stability test</span></td><td>22</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2F1.</p></td><td><span>Active substance(s)</span></td><td>22</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2F2.</p></td><td><span>Finished product</span></td><td>22</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.2G.</p></td><td><span>Other information</span></td><td>23</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.3</p></td><td><span>Part 3: Safety documentation (safety and residues tests)</span></td><td>23</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.3A.</p></td><td><span>Safety tests</span></td><td>23</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.3A1.</p></td><td><span>Precise identification of the product and of its active substance(s)</span></td><td>24</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.3A2.</p></td><td><span>Pharmacology</span></td><td>24</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.3A2.1.</p></td><td><span>Pharmacodynamics</span></td><td>24</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.3A2.2.</p></td><td><span>Pharmacokinetics</span></td><td>25</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.3A3.</p></td><td><span>Toxicology</span></td><td>25</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.3A4.</p></td><td><span>Other requirements</span></td><td>26</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.3A.4.1.</p></td><td><span>Special studies</span></td><td>26</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.3A.4.2.</p></td><td><span>Observations in humans</span></td><td>26</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.3A.4.3.</p></td><td><span>Development of resistance and related risk in humans</span></td><td>27</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.3A5.</p></td><td><span>User safety</span></td><td>27</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.3A6.</p></td><td><span>Environmental risk assessment</span></td><td>27</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.3B.</p></td><td><span>Residue tests</span></td><td>28</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.3B1.</p></td><td><span>Identification of the product</span></td><td>28</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.3B2.</p></td><td><span>Depletion of residues (metabolism and residue kinetics)</span></td><td>28</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.3B3.</p></td><td><span>Residue analytical method</span></td><td>29</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.4.</p></td><td><span>Part 4: Efficacy documentation (pre-clinical studies and clinical trial(s))</span></td><td>29</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.4A.</p></td><td><span>Pre-clinical studies</span></td><td>29</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.4A1.</p></td><td><span>Pharmacology</span></td><td>29</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.4A.1.1.</p></td><td><span>Pharmacodynamics</span></td><td>29</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.4A.1.2.</p></td><td><span>Pharmacokinetics</span></td><td>29</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.4A2.</p></td><td><span>Development of resistance and related risk in animals</span></td><td>30</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.4A3.</p></td><td><span>Dose determination and confirmation</span></td><td>30</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.4A4.</p></td><td><span>Tolerance in the target animal species</span></td><td>30</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.4B.</p></td><td><span>Clinical trial(s)</span></td><td>31</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.4B1.</p></td><td><span>General principles</span></td><td>31</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.4B2.</p></td><td><span>Documentation</span></td><td>31</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.4B2.1.</p></td><td><span>Results of pre-clinical studies</span></td><td>31</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>II.4B2.2.</p></td><td><span>Results of clinical trials</span></td><td>32</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>SECTION III</p></td><td>REQUIREMENTS FOR BIOLOGICAL VETERINARY MEDICINAL PRODUCTS</td><td>32</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>SECTION IIIa</p></td><td>REQUIREMENTS FOR BIOLOGICAL VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS</td><td>33</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.1.</p></td><td><span>Part 1: Summary of the dossier</span></td><td>33</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2.</p></td><td><span>Part 2: Quality documentation (physicochemical, biological or microbiological information)</span></td><td>33</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2A.</p></td><td><span>Product description</span></td><td>33</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2A1.</p></td><td><span>Qualitative and quantitative composition</span></td><td>33</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2A2.</p></td><td><span>Product development</span></td><td>34</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2A3.</p></td><td><span>Characterisation</span></td><td>34</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2A3.1.</p></td><td><span>Elucidation of structure and other characteristics</span></td><td>34</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2A3.2.</p></td><td><span>Impurities</span></td><td>35</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2B.</p></td><td><span>Description of the manufacturing method</span></td><td>35</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2C.</p></td><td><span>Production and control of starting materials</span></td><td>35</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2C1.</p></td><td><span>Starting materials listed in pharmacopoeias</span></td><td>36</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2C2.</p></td><td><span>Starting materials not listed in a pharmacopoeia</span></td><td>36</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2C2.1.</p></td><td><span>Starting materials of biological origin</span></td><td>36</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2C2.2.</p></td><td><span>Starting materials of non-biological origin</span></td><td>37</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2D.</p></td><td><span>Control tests during the manufacturing process</span></td><td>37</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2E.</p></td><td><span>Control tests on the finished product</span></td><td>38</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2E1</p></td><td><span>Finish product specification</span></td><td>38</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2E2</p></td><td><span>Method descriptions and validation of release tests</span></td><td>38</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2E3.</p></td><td><span>Reference standards or materials</span></td><td>39</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2F.</p></td><td><span>Batch-to-batch consistency</span></td><td>39</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2F1.</p></td><td><span>Active substance</span></td><td>39</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2F2.</p></td><td><span>Finished product</span></td><td>39</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2G.</p></td><td><span>Stability tests</span></td><td>39</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.2H.</p></td><td><span>Other information</span></td><td>40</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3.</p></td><td><span>Part 3: Safety documentation (safety and residues tests)</span></td><td>40</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A.</p></td><td><span>Safety tests</span></td><td>41</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A1.</p></td><td><span>Precise identification of the product and of its active substance(s):</span></td><td>41</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A2.</p></td><td><span>Pharmacology</span></td><td>41</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A2.1.</p></td><td><span>Pharmacodynamics</span></td><td>42</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A2.2.</p></td><td><span>Pharmacokinetics</span></td><td>42</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A3.</p></td><td><span>Toxicology</span></td><td>42</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A3.1.</p></td><td><span>Single-dose toxicity</span></td><td>42</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A3.2.</p></td><td><span>Repeat-dose toxicity</span></td><td>42</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A3.3.</p></td><td><span>Tolerance in the target species</span></td><td>43</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A3.4.</p></td><td><span>Reproductive toxicity including developmental toxicity</span></td><td>43</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A3.5.</p></td><td><span>Genotoxicity</span></td><td>43</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A3.6.</p></td><td><span>Carcinogenicity</span></td><td>43</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A3.7.</p></td><td><span>Exceptions</span></td><td>43</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A4.</p></td><td><span>Other requirements</span></td><td>44</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A4.1.</p></td><td><span>Special studies</span></td><td>44</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A4.2.</p></td><td><span>Observations in humans</span></td><td>44</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A4.3.</p></td><td><span>Development of resistance and related risk in humans</span></td><td>44</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A5.</p></td><td><span>User safety</span></td><td>45</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A6.</p></td><td><span>Environmental risk assessment</span></td><td>45</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A6.1.</p></td><td><span>Environmental risk assessment of veterinary medicinal products not containing or consisting of genetically modified organisms</span></td><td>45</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3A6.2.</p></td><td><span>Environmental risk assessment for veterinary medicinal products containing or consisting of genetically modified organisms</span></td><td>45</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3B.</p></td><td><span>Residue tests</span></td><td>46</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3B1.</p></td><td><span>Identification of the product</span></td><td>46</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3B2.</p></td><td><span>Depletion of residues</span></td><td>46</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.3B3.</p></td><td><span>Residue analytical method</span></td><td>46</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.4.</p></td><td><span>Part 4: Efficacy documentation (pre-clinical studies and clinical trial(s))</span></td><td>47</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.4A.</p></td><td><span>Pre-clinical studies</span></td><td>47</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.4A1.</p></td><td><span>Pharmacology</span></td><td>47</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.4A1.1.</p></td><td><span>Pharmacodynamics</span></td><td>47</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.4A1.2.</p></td><td><span>Pharmacokinetics</span></td><td>47</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.4A2.</p></td><td><span>Development of resistance and related risk in animals</span></td><td>48</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.4A3.</p></td><td><span>Dose determination and confirmation</span></td><td>48</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.4A4.</p></td><td><span>Tolerance in the target animal species</span></td><td>48</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.4B.</p></td><td><span>Clinical trials</span></td><td>48</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.4B1.</p></td><td><span>General principles</span></td><td>48</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.4B2.</p></td><td><span>Documentation</span></td><td>49</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.4B2.1.</p></td><td><span>Clinical trials</span></td><td>49</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIa.4B2.2.</p></td><td><span>Clinical trials</span></td><td>49</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>SECTION IIIb</p></td><td>REQUIREMENTS FOR IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS</td><td>50</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.1.</p></td><td><span>Part 1: Summary of the dossier</span></td><td>50</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.2.</p></td><td><span>Part 2: Quality documentation (physicochemical, biological and microbiological information)</span></td><td>50</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.2.A.</p></td><td><span>Product description</span></td><td>50</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.2A1.</p></td><td><span>Qualitative and quantitative composition</span></td><td>50</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.2A2.</p></td><td><span>Product development</span></td><td>51</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.2B.</p></td><td><span>Description of the manufacturing method</span></td><td>52</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.2C.</p></td><td><span>Production and control of starting materials</span></td><td>52</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.2C1.</p></td><td><span>Starting materials listed in pharmacopoeias</span></td><td>53</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.2C2.</p></td><td><span>Starting materials not listed in a pharmacopoeia</span></td><td>53</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.2C2.1.</p></td><td><span>Starting materials of biological origin</span></td><td>53</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.2C2.2.</p></td><td><span>Starting materials of non-biological origin</span></td><td>54</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.2D.</p></td><td><span>Control tests during the manufacturing process</span></td><td>54</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.2E.</p></td><td><span>Control tests on the finished product</span></td><td>55</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.2F.</p></td><td><span>Batch-to-batch consistency</span></td><td>56</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.2G.</p></td><td><span>Stability tests</span></td><td>56</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.2H.</p></td><td><span>Other information</span></td><td>57</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.3.</p></td><td><span>Part 3: Safety documentation (safety and residues tests)</span></td><td>57</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.3A.</p></td><td><span>General requirements</span></td><td>57</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.3B.</p></td><td><span>Pre-clinical studies</span></td><td>58</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.3C.</p></td><td><span>Clinical trials</span></td><td>60</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.3D.</p></td><td><span>Environmental risk assessment</span></td><td>60</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.3E.</p></td><td><span>Assessment required for veterinary medicinal products containing or consisting of genetically modified organisms</span></td><td>61</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.3F.</p></td><td><span>Residue tests to be included in the laboratory studies</span></td><td>61</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.4.</p></td><td><span>Part 4: Efficacy documentation (pre-clinical studies and clinical trial(s))</span></td><td>61</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.4A.</p></td><td><span>General requirements</span></td><td>61</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.4B.</p></td><td><span>Pre-clinical studies</span></td><td>62</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IIIb.4C.</p></td><td><span>Clinical trials</span></td><td>63</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>SECTION IV</p></td><td>REQUIREMENTS FOR SPECIFIC MARKETING AUTHORISATION APPLICATIONS</td><td>64</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IV.1.</p></td><td><span>Applications for generic veterinary medicinal products</span></td><td>64</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IV.2.</p></td><td><span>Applications for hybrid veterinary medicinal products</span></td><td>65</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IV.3.</p></td><td><span>Applications for combination veterinary medicinal products</span></td><td>66</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IV.4.</p></td><td><span>Applications based on informed consent</span></td><td>66</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IV.5.</p></td><td><span>Applications based on bibliographic data</span></td><td>66</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IV.6.</p></td><td><span>Applications for limited markets</span></td><td>68</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>IV.7.</p></td><td><span>Applications in exceptional circumstances</span></td><td>68</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>SECTION V</p></td><td>REQUIREMENTS FOR MARKETING AUTHORISATION APPLICATIONS FOR PARTICULAR VETERINARY MEDICINAL PRODUCTS</td><td>68</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>V.1.</p></td><td><span>Novel therapies veterinary medicinal products</span></td><td>68</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>V.1.1</p></td><td><span>General requirements</span></td><td>68</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>V.1.2.</p></td><td><span>Quality requirements</span></td><td>69</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>V.1.3.</p></td><td><span>Safety requirements</span></td><td>70</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>V.1.4.</p></td><td><span>Efficacy requirements</span></td><td>70</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>V.1.5.</p></td><td><span>Specific data requirements for particular types of novel therapy products</span></td><td>70</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>V.1.5.1.</p></td><td><span>Principles</span></td><td>70</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>V.1.5.2.</p></td><td><span>Gene therapy veterinary medicinal products</span></td><td>70</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>V.1.5.3.</p></td><td><span>Regenerative medicine, tissue engineering and cell therapy veterinary medicinal products</span></td><td>71</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>V.1.5.4.</p></td><td><span>Veterinary medicinal product specifically designed for phage therapy</span></td><td>72</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>V.1.5.5.</p></td><td><span>Veterinary medicinal product issued from nanotechnologies</span></td><td>72</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>V.1.5.6.</p></td><td><span>RNA antisense therapy and RNA interference therapy products</span></td><td>73</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>V.2.</p></td><td><span>Vaccine antigen master file</span></td><td>74</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>V.3.</p></td><td><span>Multi-strain dossier</span></td><td>75</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>V.4.</p></td><td><span>Vaccine platform technology</span></td><td>75</td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>V.5.</p></td><td><span>Authorised homeopathic veterinary medicinal products</span></td><td>76</td></tr></tbody></table>
SECTION I
GENERAL PRINCIPLES AND REQUIREMENTS
I.1. General principles
<table><col/><col/><col/><tbody><tr><td/><td><p>I.1.1.</p></td><td><span>The documentation accompanying an application for a marketing authorisation pursuant to Articles 8, and 18 to 25 shall be presented in accordance with the requirements set out in this Annex and shall take into account the guidance documents published by the Commission and the requirements for electronic format published by the Agency.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>I.1.2.</p></td><td><span>In assembling the dossier for application for a marketing authorisation, applicants shall also take into account the most up-to-date veterinary medicinal knowledge and the scientific guidelines relating to the quality, safety and efficacy of veterinary medicinal products published by the Agency.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>I.1.3.</p></td><td><span>For veterinary medicinal products, all relevant monographs of the European Pharmacopoeia, including general monographs and the general chapters, are applicable for the appropriate parts of the dossier.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>I.1.4.</p></td><td><span>The manufacturing processes for the active substance(s) and finished product shall comply with Good Manufacturing Practice (GMP).</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>I.1.5.</p></td><td><span>All information which is relevant to the evaluation of the veterinary medicinal product concerned shall be included in the application, whether favourable or unfavourable to the product. In particular, all relevant details related to any incomplete or abandoned study or trial relating to the veterinary medicinal product shall be given.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>I.1.6.</p></td><td><span>Pharmacological, toxicological, residue and pre-clinical studies shall be carried out in conformity with the provisions related to Good Laboratory Practice (GLP) laid down in Directives 2004/10/EC <a>(<span>1</span>)</a> and 2004/9/EC of the European Parliament and of the Council <a>(<span>2</span>)</a>.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>I.1.7.</p></td><td><span>All experiments on animals shall be conducted taking into account the principles laid down in Directive 2010/63/EU, notwithstanding the place of conduct of the experiments.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>I.1.8.</p></td><td><span>The environmental risk assessment connected with the release of veterinary medicinal products containing or consisting of Genetically Modified Organisms (GMOs) within the meaning of Article 2 of Directive 2001/18/EC shall be provided in the dossier as a separate document. The information shall be presented in accordance with the provisions of Directive 2001/18/EC, taking into account guidance published by the Commission.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>I.1.9.</p></td><td><span>The applicant shall confirm in Part 1 of the dossier for an application for marketing authorisation that all submitted data relevant to the quality, safety and efficacy of the veterinary medicinal product, including data publicly available, are not subject to protection of technical documentation.</span></td></tr></tbody></table>
I.2. Dossier composition requirements
Any dossier for an application for marketing authorisation for a veterinary medicinal product shall consist of the following parts:
I.2.1. Part 1: Summary of the dossier
Part 1 shall include administrative information as outlined in Annex I, as follows:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>Part 1A: points 1 to 4 and 6.1 to 6.4;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>Part 1B: point 5;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>Part 1C: point 6.5.</p></td></tr></tbody></table>
With regard to Part 1B, point 5.1, in connection to Article 35(1), point (l), an application proposing classification of a veterinary medicinal product as "not subject to veterinary prescription" shall include a critical review of the product characteristics in order to justify the suitability of such classification taking into consideration target and non-target animal safety, public health as well as environmental safety, as outlined in the criteria given in Article 34(3), points (a) to (g).
Each critical expert report shall be prepared with regard to the state of scientific knowledge at the time of submission of the application. It shall contain an evaluation of the various tests and trials which constitute the marketing authorisation dossier, and shall address all aspects relevant to the assessment of the quality, safety and efficacy of the veterinary medicinal product. It shall give detailed results of the tests and trials submitted and precise bibliographic references. Copies of the bibliographic references cited shall be provided.
The critical expert reports shall be signed and dated by the author of those reports, and information about the author’s educational background, training and occupational experience shall be attached. The professional relationship of the author with the applicant shall be declared.
The critical expert reports and the appendices shall contain precise and clear cross-references to the information contained in the technical documentation.
Where Part 2 is presented using the format of the Common Technical Document (CTD), the quality overall summary (QOS) shall be used for the critical expert report on quality.
For Parts 3 and 4 the critical expert report shall also include a tabulated summary of all technical documentation and relevant data submitted.
I.2.2. Part 2: Quality documentation (physicochemical, biological or microbiological information)
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The pharmaceutical quality (physicochemical, biological or microbiological) data shall include for the active substance(s) and for the finished veterinary medicinal product information on the manufacturing process, the characterisation and properties, the quality control procedures and requirements, the stability as well as a description of the composition, the development and presentation of the veterinary medicinal product.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>All monographs, including specific monographs, general monographs and general chapters of the European Pharmacopoeia are applicable. For immunological veterinary medicinal products, all monographs, including specific monographs, general monographs and general chapters of the European Pharmacopoeia are applicable, unless otherwise justified. In the absence of a European Pharmacopoeia monograph, the monograph of a Member State pharmacopoeia may be applied. In cases where a substance is described neither in the European Pharmacopoeia nor in the pharmacopoeia of a Member State, compliance with the monograph of a third country pharmacopoeia may be accepted if its suitability is demonstrated; in such cases, the applicant shall submit a copy of the monograph accompanied by a translation where appropriate. Data to demonstrate the ability of the monograph to adequately control the quality of the substance shall be presented.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>If tests other than those mentioned in the pharmacopoeia are used, the use of such tests shall be justified by providing proof that the materials, if tested in accordance with the pharmacopoeia, would meet the quality requirements of the relevant pharmacopoeial monograph.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>All test procedures for analysis and quality control shall take account of established guidance and requirements. The results of the validation studies shall be provided. All the test procedure(s) shall be described in sufficient detail so as to be reproducible in control tests, carried out at the request of the competent authority and in order to be properly assessed by the competent authority. Any special apparatus and equipment, which may be used shall be described in adequate manner, accompanied by a diagram, if relevant. The formulae of the laboratory reagents shall be supplemented, if necessary, by the method of preparation. In the case of test procedures included in the European Pharmacopoeia or the pharmacopoeia of a Member State, this description may be replaced by a detailed reference to the pharmacopoeia in question.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>Where available, chemical and biological reference material of the European Pharmacopoeia shall be used. If other reference preparations and standards are used, they shall be identified and described in detail.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>The pharmaceutical quality (physicochemical, biological or microbiological) data for the active substance and/or the finished product may be included in the dossier in Common Technical Document (CTD) format.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(7)</p></td><td><span>For biological veterinary medicinal products, including immunologicals, information on solvents needed for making the final product preparation shall be included in the dossier. A biological veterinary medicinal product is regarded as one product even when more than one solvent is required so that different preparations of the final product can be prepared, which may be for administration by different routes or methods of administration. Solvents supplied with biological veterinary medicinal products may be packed together with the active substance vials or separately.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(8)</p></td><td><span>In accordance with Directive 2010/63/EU and the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes, tests shall be carried out in such a way as to use the minimum number of animals and to cause the least pain, suffering, distress or lasting harm. If available, an alternative<span>in vitro</span> test shall be used when this leads to replacement or reduction of animal use or reduction of suffering.</span></td></tr></tbody></table>
I.2.3. Part 3: Safety documentation (safety and residues tests)
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The dossier on the safety studies shall include the following:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>synthesis of the tests which have been carried out in compliance with this Part, with detailed references to the published literature containing an objective discussion of all the results obtained. Omission of any tests or trials listed and inclusion of an alternative type of study shall be indicated and discussed;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a statement of compliance with good laboratory practice for pre-clinical studies, where applicable, together with a discussion of the contribution that any non-GLP study may make to the overall risk assessment, and justification of non-GLP status.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The dossier shall include the following:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>an index of all studies and trials included in the dossier;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a justification for the omission of any type of study and trial;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>an explanation of the inclusion of an alternative type of study or trial;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>a discussion of the contribution that any non-GLP study or trial may make to the overall risk assessment and justification of non-GLP status.</p></td></tr></tbody></table></td></tr></tbody></table>
I.2.4. Part 4: Efficacy documentation (pre-clinical studies and clinical trial(s))
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The dossier on efficacy shall include all pre-clinical and clinical documentation, whether favourable or unfavourable to the veterinary medicinal products, in order to enable an objective overall assessment of the benefit/risk balance of the product.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The dossier on the efficacy studies shall include the following:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>synthesis of the tests which have been carried out in compliance with this Part, with detailed references to the published literature containing an objective discussion of all the results obtained. Omission of any tests or trials listed and inclusion of an alternative type of study shall be indicated and discussed;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a statement of compliance with good laboratory practice for pre-clinical studies, where applicable, together with a discussion of the contribution that any non-GLP study may make to the overall risk assessment, and justification of non-GLP status.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The dossier shall include the following:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>an index of all studies included in the dossier;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a justification for the omission of any type of study;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>an explanation of the inclusion of an alternative type of study.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>The purpose of the trials described in this Part is to demonstrate the efficacy of the veterinary medicinal product. All claims made by the applicant with regard to the properties, effects and use of the product shall be fully supported by results of specific trials contained in the application for marketing authorisation.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>All efficacy trials shall be conducted in accordance with a fully considered detailed protocol, which shall be recorded in writing prior to commencement of the trial. The welfare of the trial animals shall be subject to veterinary supervision and shall be taken fully into consideration during the elaboration of any trial protocol and throughout the conduct of the trial.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>Clinical trials (field trials) shall be conducted in accordance with established principles of good clinical practice, unless otherwise justified.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(7)</p></td><td><span>Before the commencement of any field trial, the informed consent of the owner of the animals to be used in the trial shall be obtained and documented. In particular, the animal owner shall be informed in writing of the consequences of participation in the trial for the subsequent disposal of treated animals or for the taking of foodstuffs from treated animals.</span></td></tr></tbody></table>
I.2.5. Detailed requirements for different types of veterinary medicinal products or marketing authorisation dossiers
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Detailed requirements for different types of veterinary medicinal products or specific types of marketing authorisation dossiers are outlined in the following Sections of this Annex:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>Section II describes the standardised requirements for applications for veterinary medicinal products other than biological veterinary medicinal products;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>Section III describes the standardised requirements for applications for biological veterinary medicinal products:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>Section IIIa describes the standardised requirements for applications for biological veterinary medicinal products other than immunological veterinary medicinal products;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>Section IIIb describes the standardised requirements for applications for immunological veterinary medicinal products;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>Section IV describes the dossier requirements for specific types of marketing authorisation dossiers;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>Section V describes the dossier requirements for particular types of veterinary medicinal products.</p></td></tr></tbody></table></td></tr></tbody></table>
SECTION II
REQUIREMENTS FOR VETERINARY MEDICINAL PRODUCTS OTHER THAN BIOLOGICAL VETERINARY MEDICINAL PRODUCTS
The following detailed requirements shall apply to veterinary medicinal products other than biological veterinary medicinal products, except where otherwise set out in Section IV.
II.1. Part 1: Summary of the dossier
Please refer to Section I.
II.2. Part 2: Quality documentation (physicochemical, biological or microbiological information)
II.2A. Product description
II.2A1. Qualitative and quantitative composition
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Qualitative composition of all the constituents of the medicinal product shall mean the designation or description of:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>active substance(s);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>excipients, the constituents of the excipients, whatever their nature or the quantity used, including colouring matter, preservatives, adjuvants, stabilisers, thickeners, emulsifiers, flavouring and aromatic substances;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>other constituents, intended to be ingested or otherwise administered to animals, of the outer covering of the veterinary medicinal products, such as capsules, gelatine capsules, intraruminal devices;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>any relevant data concerning the immediate packaging and if relevant the outer packaging and, where appropriate, its manner of closure, together with details of devices with which the veterinary medicinal product will be used or administered and which will be supplied with the medicinal product.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The usual terminology to be used in describing the constituents of veterinary medicinal products means, notwithstanding the application of the other provisions of Article 8:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>in respect of substances which appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States, the main title at the head of the monograph in question, with reference to the pharmacopoeia concerned;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in respect of other substances, the international non-proprietary name (INN) recommended by the World Health Organisation (WHO), which may be accompanied by another non-proprietary name, or, failing these, the exact scientific designation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>constituents not having an international non-proprietary name or an exact scientific designation shall be described by a statement of how and from what they were prepared, supplemented, where appropriate, by any other relevant details;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>in respect of colouring matter, designation by the “E” code assigned to them by Directive 2009/35/EC of the European Parliament and Council.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>In order to give the quantitative composition of all the active substances and excipients of the veterinary medicinal products, it is necessary, depending on the pharmaceutical form concerned, to specify the mass, or the number of units of biological activity, either per dosage-unit or per unit of mass or volume, of each active substance and excipient.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>Units of biological activity shall be used for substances which cannot be defined chemically. Where an international unit of biological activity has been defined, this shall be used. Where no international unit has been defined, the units of biological activity shall be expressed in such a way as to provide unambiguous information on the activity of the substances by using where applicable the European Pharmacopoeia Units.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>Quantitative composition shall be supplemented:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>in respect of single-dose preparations: by the mass or units of biological activity of each active substance in the unit container, taking into account the usable volume of the product, after reconstitution, where appropriate;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in respect of veterinary medicinal products to be administered by drops: by the mass or units of biological activity of each active substance contained per drop or contained in the number of drops corresponding to 1 ml or 1 g of the preparation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>in respect of pharmaceutical forms to be administered in measured quantities: by the mass or units of biological activity of each active substance per measured quantity.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>Active substances present in the form of compounds or derivatives shall be described quantitatively by their total mass, and if necessary or relevant, by the mass of the active entity or entities of the molecule.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(7)</p></td><td><span>For veterinary medicinal products containing an active substance which is the subject of an application for marketing authorisation in the Union for the first time, the quantitative statement of an active substance which is a salt or hydrate shall be systematically expressed in terms of the mass of the active entity or entities in the molecule. All subsequently authorised veterinary medicinal products in the Member States shall have their quantitative composition stated in the same way for the same active substance.</span></td></tr></tbody></table>
II.2A2. Product development
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>An explanation shall be provided with regard to the choice of composition, constituents, packaging, the intended function of the excipients in the finished product and the method of manufacture including justification of the selection of the method and details of the sterilisation processes and/or aseptic procedures used of the finished product. This explanation shall be supported by scientific data on development pharmaceutics. Any overage, with justification thereof, shall be stated. The microbiological characteristics (microbiological purity and antimicrobial activity) and usage instructions shall be proven to be appropriate for the intended use of the veterinary medicinal product as specified in the marketing authorisation application dossier.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>A study of the interaction between finished product and the primary packaging shall be submitted wherever the risk of such interaction is regarded as possible, especially where injectable preparations are concerned.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The proposed pack sizes shall be justified in relation to the proposed route of administration, the posology and the target species in particular for antimicrobial (active) substances.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>When a dosing device is provided with the finished product, the accuracy of the doses(s) shall be demonstrated.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>When an accompanying test is recommended to be used with the finished product (e.g. a diagnostic test), relevant information about the test shall be provided.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>For veterinary medicinal products intended for incorporation into feed, information shall be provided on inclusion rates, instructions for incorporation, homogeneity in-feed and compatibility/suitable feed.</span></td></tr></tbody></table>
II.2B. Description of the manufacturing method
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The description of the manufacturing method accompanying the application for marketing authorisation pursuant to Article 8 shall be drafted in such a way as to give an adequate synopsis of the nature of the operations employed.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>For that purpose, it shall include at least:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the actual manufacturing formula for the proposed commercial batch size(s), with the quantitative particulars of all the substances used. Any substances that may disappear in the course of manufacture shall be stated; any overage shall be indicated;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>description of the various stages of manufacture with information on process operating conditions, in a narrative way accompanied by a process flow chart;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>in the case of continuous manufacture, full details of precautions taken to ensure the homogeneity of the finished product. Information as to how a batch is defined shall be provided (for example, expressed in terms of a period of time or a quantity of product, and may be expressed as ranges);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>a list of in-process controls including the stage of manufacture at which they are conducted and the acceptance criteria;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>experimental studies validating the manufacturing process and, where appropriate, a process validation scheme for production scale batches;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>for sterile products, where non-pharmacopoeial sterilisation conditions are used, details of the sterilisation processes and/or aseptic procedures used.</p></td></tr></tbody></table></td></tr></tbody></table>
II.2C. Production and control of starting material
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>For the purposes of this point, “starting materials” shall mean active substances, excipients and packaging (immediate packaging with its closure system and, if applicable, outer packaging and any dosing device supplied with the veterinary medicinal product).</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The dossier shall include the specifications and information on the tests to be conducted for quality control of all batches of starting materials.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The routine tests carried out on starting materials shall be carried out in the same manner as stated in the dossier.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>Where a certificate of suitability has been issued by the European Directorate for the Quality of Medicines and HealthCare for a starting material, active substance or excipient, that certificate constitutes the reference to the relevant monograph of the European Pharmacopoeia.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>Where a certificate of suitability is referred to, the manufacturer shall give an assurance in writing to the applicant that the manufacturing process has not been modified since the granting of the certificate of suitability by the European Directorate for the Quality of Medicines and HealthCare. In case the field “<span>box of access</span>” in the certificate is completed and signed, that requirement shall be deemed to be fulfilled without the need for additional assurance.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>Certificates of analysis shall be presented for the starting materials in order to demonstrate compliance with the defined specification.</span></td></tr></tbody></table>
II.2C1. Active substance(s)
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The required data shall be submitted in one of the three ways as detailed in points (2) to (4).</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The following details shall be submitted:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>information on the identity, structure and a list of physicochemical and other relevant properties of the active substance shall be provided, in particular physicochemical properties that potentially affect the safety and efficacy of the active substance. Where relevant, evidence of molecular structure shall include the schematic amino acid sequence and relative molecular mass;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>information on the manufacturing process shall include a description of the active substance manufacturing process that represents the applicant’s commitment for the manufacture of the active substance. All materials needed in order to manufacture the active substance(s) shall be listed, identifying where each material is used in the process. Information on the quality and control of those materials shall be provided. Information demonstrating that materials meet standards which are appropriate for their intended use shall be provided;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>information on quality control shall contain tests (including acceptance criteria) carried out at every critical step, information on the quality and control of intermediates and process validation and/or evaluation studies as appropriate. It shall also contain validation data for the analytical methods applied to the active substance, where appropriate;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>information on impurities shall indicate predictable impurities together with the levels and nature of observed impurities. It shall also contain information on the safety of those impurities where relevant.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Active Substance Master File</span><p>For a non-biological active substance, the applicant may arrange for the information on active substance in point (2) to be supplied directly to the competent authorities by the manufacturer of the active substance as an Active Substance Master File. In this case, the manufacturer of the active substance shall provide the applicant with all the data (applicant’s part of the Active Substance Master File) which may be necessary for the latter to take responsibility for the veterinary medicinal product. A copy of the data provided by the active substance manufacturer to the applicant shall be included in the medicinal product dossier. The manufacturer of the active substance shall confirm in writing to the applicant that he shall ensure batch-to-batch consistency and not modify the manufacturing process or specifications without informing the applicant.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>Certificate of suitability issued by the European Directorate for the Quality of Medicines and HealthCare</span><p>The certificate of suitability and any additional data relevant to the dosage form not covered by the certificate of suitability shall be provided.</p></td></tr></tbody></table>
II.2C1.1. Active substances listed in pharmacopoeias
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Active substances fulfilling the requirements of the European Pharmacopoeia or, in the absence of a European Pharmacopoeia monograph, the pharmacopoeia of one of the Member States shall be deemed to comply sufficiently with Article 8. In this case the description of the analytical methods and procedures shall be replaced in each relevant section by an appropriate reference to the pharmacopoeia in question.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>In cases where a specification contained in a monograph of the European Pharmacopoeia or in the national pharmacopoeia of a Member State is insufficient to ensure the quality of the substance, the competent authorities may request more appropriate specifications from the applicant, including acceptance criteria for specific impurities with validated test procedures.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The competent authorities shall inform the authorities responsible for the pharmacopoeia in question. The marketing authorisation holder shall provide the authorities of that pharmacopoeia with the details of the alleged insufficiency and the additional specifications applied.</span></td></tr></tbody></table>
II.2C1.2. Active substances not listed in a pharmacopoeia
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Active substances which are not listed in any pharmacopoeia shall be described in the form of a monograph under the following headings:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the name of the constituent, meeting the requirements of Part II.2A1, point (2) shall be supplemented by any trade or scientific synonyms;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the definition of the substance, set down in a form similar to that used in the European Pharmacopoeia, shall be accompanied by any necessary explanatory evidence, in particular concerning the molecular structure. Where substances may only be described by their manufacturing method, the description shall be sufficiently detailed to characterise a substance which is constant both on its composition and in its effects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>methods of identification may be described in the form of complete techniques as used for production of the substance, and in the form of tests which ought to be carried out as a routine matter;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>purity tests shall be described in relation to each individual predictable impurity, especially those which may have a harmful effect, and, if necessary, those which, having regard to the combination of substances to which the application refers, might adversely affect the stability of the medicinal product or distort analytical results;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>tests and acceptance criteria to control parameters relevant to the finished product, such as sterility shall be described and methods shall be validated where relevant;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>with regard to complex substances of plant or animal origin, a distinction shall be made between the case where multiple pharmacological effects render chemical, physical or biological control of the principal components necessary, and the case of substances containing one or more groups of principles having similar activity, in respect of which an overall method of assay may be accepted.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Those data shall demonstrate that the proposed set of test procedures is sufficient to control the quality of the active substance from the defined source.</span></td></tr></tbody></table>
II.2C1.3. Physicochemical characteristics liable to affect bioavailability
The following data concerning active substances shall be provided as part of the general description of the active substances if the bioavailability of the veterinary medicinal product depends on them:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>crystalline form and solubility;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>particle size;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>state of hydration;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>oil/water coefficient of partition;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>pK/pH values.</p></td></tr></tbody></table>
Points (a) to (c) are not applicable to substances used solely in solution.
II.2C2. Excipients
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Excipients fulfilling the requirements of the European Pharmacopoeia or, in the absence of a European Pharmacopoeia monograph, the pharmacopoeia of one of the Member States shall be deemed to comply sufficiently with Article 8. In that case, the description of the analytical methods and procedures shall be replaced in each relevant section by an appropriate reference to the pharmacopoeia in question. Where appropriate, additional tests to control parameters such as particle size, sterility, and/or residual solvents, shall supplement the requirements of the monograph.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>In the absence of a pharmacopoeial monograph a specification shall be proposed and justified. The requirements for specifications as set out in Part II.2C1.2(1) points (a) to (e) for the active substance shall be followed. The proposed methods and their supporting validation data shall be presented.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>A declaration shall be submitted to confirm that colouring matters for inclusion in veterinary medicinal products satisfy the requirements of Directive 2009/35/EC of the European Parliament and of the Council <a>(<span>3</span>)</a> except where the application for a marketing authorisation concerns certain veterinary medicinal products for topical use, such as medicated collars and ear tags.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>A declaration shall be submitted to confirm that colouring matters used meet the purity criteria laid down in Commission Regulation (EU) No 231/2012 <a>(<span>4</span>)</a>.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>For novel excipients, that is to say excipient(s) used for the first time in the Union in a veterinary medicinal product or by a new route of administration, details of manufacture, characterisation, and controls, with cross references to support both clinical and non-clinical safety data shall be provided. For colouring matters, the declarations of compliance in points (3) and (4) shall be considered sufficient.</span></td></tr></tbody></table>
II.2C3. Packaging (containers and closure systems)
II. 2C3.1. Active substance
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Information on the container and its closure system for the active substance including the identity of each immediate packaging material and their specifications shall be given. The level of information required shall be determined by the physical state (liquid, solid) of the active substance.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Where a certificate of suitability for the active substance from the proposed source is submitted and specifies a container and its closure system, the detailed information on these for the active substance from that source may be replaced by a reference to the valid certificate of suitability.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Where an Active Substance Master File from the proposed source is submitted and specifies a container and its closure system, the detailed information on these for the active substance from that source may be replaced by a reference to the Active Substance Master File.</span></td></tr></tbody></table>
II. 2C3.2. Finished product
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Information on the container and its closure system and any device for the finished product including the identity of each immediate packaging material and their specifications shall be given. The level of information required shall be determined by the route of administration of the veterinary medicinal product and the physical state (liquid, solid) of the dosage form.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>In the absence of a pharmacopoeial monograph, a specification shall be proposed and justified for the packaging material.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>For packaging materials that are used for the first time in the Union and that are in contact with the product, information on their composition, manufacture and safety shall be presented.</span></td></tr></tbody></table>
II.2C4. Substances of biological origin
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Information on the source, processing, characterisation and control of all materials of biological origin (human, animal, herbal or from microorganisms) used in the manufacture of the veterinary medicinal products shall be provided, including viral safety data, in accordance with relevant guidelines.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Documentation shall be supplied to demonstrate that materials originating from animal species relevant for the transmission of transmissible spongiform encephalopathies (TSE) comply with the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products, as well as with the corresponding monograph of the European Pharmacopoeia. Certificates of Suitability issued by the European Directorate for the Quality of Medicines and HealthCare, with reference to the relevant monograph of the European Pharmacopoeia, may be used to demonstrate compliance.</span></td></tr></tbody></table>
II.2D. Control tests carried out on isolated intermediates during the manufacturing process
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>For the purposes of this section, “isolated intermediate” shall mean partly processed material that may be stored for a defined amount of time and that shall undergo further processing step(s) before it becomes finished product.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>A specification shall be set for each intermediate and the analytical methods shall be described and validated, if applicable.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Information on the primary packaging of the intermediate product shall be provided if different from that for the finished product.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>A shelf life and storage conditions for the intermediate product shall be defined on the basis of the data resulting from stability studies.</span></td></tr></tbody></table>
II.2E. Control tests on the finished product
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>For the control of the finished product, a batch of a finished product comprises all the units of a pharmaceutical form which are made from the same initial quantity of material and have undergone the same series of manufacturing and/or sterilisation operations. In case of continuous manufacture, the batch size may be expressed in terms of a period of time or a quantity of product, and may be expressed as ranges.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The tests, which are carried out on the finished product shall be listed. A justification for the proposed specification shall be provided. The frequency of the tests which are not carried out routinely shall be stated and justified. Acceptance criteria for release shall be indicated.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The dossier shall include particulars relating to control tests on the finished product at release and their validation. They shall be submitted in accordance with the following requirements.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>If test procedures and acceptance criteria other than those mentioned in the relevant monographs and general chapters of the European Pharmacopoeia, or failing this, in the pharmacopoeia of a Member State are used, those procedures and criteria shall be justified by providing proof that the finished product would, if tested in accordance with those monographs, meet the quality requirements of that pharmacopoeia for the pharmaceutical form concerned.</span></td></tr></tbody></table>
II.2E1. General characteristics of the finished product
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Certain tests of the general characteristics of a product shall always be included among the tests on the finished product. Those tests shall, wherever applicable, relate to the control of average masses/volumes and maximum deviations, to mechanical, physical tests, visual appearance, physical characteristics such as, pH or particle size. For each of those characteristics, standards and acceptance criteria shall be specified by the applicant.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The conditions of the tests, where appropriate, the equipment/apparatus employed and the standards shall be described in sufficient detail whenever they are not given in the European Pharmacopoeia or the pharmacopoeia of a Member State; the same shall apply in cases where the methods prescribed by such pharmacopoeias are not applicable.</span></td></tr></tbody></table>
II.2E2. Identification and assay of active substance(s)
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Identification and assay of the active substance(s) shall be carried out either in a representative sample from the production batch or in a number of dosage units analysed individually.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Unless there is appropriate justification, the maximum acceptable deviation in the active substance content of the finished product shall not exceed ± 5 % at the time of manufacture.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>In certain cases of particularly complex mixtures, where assay of active substances which are very numerous or present in very low amounts would necessitate an intricate investigation difficult to carry out in respect of each production batch, the assay of one or more active substances in the finished product may be omitted, on the express condition that such assays are made at intermediate stages in the production process. That simplified technique may not be extended to the characterisation of the substances concerned. It shall be supplemented by a method of quantitative evaluation, enabling the competent authority to have the conformity of the medicinal product with its specification verified after it has been placed on the market.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>An<span>in vivo</span> or<span>in vitro</span> biological assay shall be obligatory when physicochemical methods cannot provide adequate information on the quality of the product. Such an assay shall, whenever possible, include reference materials and statistical analysis allowing calculation of confidence limits. Where those tests cannot be carried out on the finished product, they may be performed at an intermediate stage, as late as possible in the manufacturing process.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>The maximum acceptable levels of individual and total degradation products immediately following manufacture shall be indicated. The rationale for the inclusion or exclusion of degradation products in the specification shall be presented.</span></td></tr></tbody></table>
II.2E3. Identification and assay of excipient components
An identification test and an upper and lower limit test shall be obligatory for each individual antimicrobial preservative and for any excipient that is liable to affect the bioavailability of the active substance, unless the bioavailability is guaranteed by other appropriate tests. An identification test and an upper limit test shall be obligatory for any antioxidant and for any excipient liable to adversely affect physiological functions, with a lower limit test also included for antioxidants at time of release.
II.2E4. Microbiological controls
Particulars of microbiological tests, such as sterility and bacterial endotoxins, shall be included in the analytical particulars wherever such tests shall be undertaken as a matter of routine in order to verify the quality of the product.
II.2E5. Batch-to-batch consistency
In order to ensure the quality of the product is consistent from batch to batch and to demonstrate conformity with the specification, batch data shall be provided giving the results for all tests performed in general on [3] batches manufactured at the proposed manufacturing site(s) according to the described production process.
II.2E6. Other controls
Any other test considered necessary to confirm the quality of the medicinal product shall be controlled.
II.2F. Stability test
II.2F1. Active substance(s)
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>A retest period and storage conditions for the active substance shall be specified except when the manufacturer of the finished product fully retests the active substance immediately before its use in the manufacture of the finished product.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Stability data shall be presented to provide evidence on how the quality of an active substance varies with time under the influence of a variety of environmental factors and to support the defined retest period and storage conditions, if applicable. The type of stability studies conducted, protocols used, the analytical procedures used and their validation together with the detailed results shall be presented.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Where a certificate of suitability for the active substance from the proposed source is available and specifies a retest period and storage conditions, stability data for the active substance from that source may be replaced by a reference to the valid certificate of suitability.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>Where an Active Substance Master File from the proposed source is submitted and specifies stability data, the detailed information on the stability for the active substance from that source may be replaced by a reference to the Active Substance Master File.</span></td></tr></tbody></table>
II.2F2. Finished product
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>A description shall be given of the investigations by which the shelf life, the recommended storage conditions and the specifications at the end of the shelf life proposed by the applicant have been determined.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The type of stability studies conducted, protocols used, the analytical procedures used and their validation together with the detailed results shall be presented.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Where a finished product requires reconstitution or dilution prior to administration, details of the proposed shelf life and specification for the reconstituted/diluted product are required, supported by relevant stability data.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>In the case of multi-dose containers, where relevant, stability data shall be presented to justify a shelf life for the product after it has been broached or opened for the first time and an in-use specification shall be defined.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>Where a finished product is liable to give rise to degradation products, the applicant shall declare those products and indicate the identification methods and test procedures used.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>Where the stability data show that the assay of the active substance declines on storage, the description of the control tests on the finished product shall include, where appropriate, the chemical and, if necessary, the toxico-pharmacological investigation of the changes that this substance has undergone, and possibly the characterisation and/or assay of the degradation products.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(7)</p></td><td><span>The maximum acceptable level of individual and total degradation products at the end of shelf life shall be indicated and justified.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(8)</p></td><td><span>On the basis of the stability test results, the tests and their acceptance criteria, that are carried out on the finished product over the course of the shelf life shall be listed and justified.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(9)</p></td><td><span>The conclusions shall contain the results of analyses, justifying the proposed shelf life and if appropriate, the in-use shelf life, under the recommended storage conditions.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(10)</p></td><td><span>Additionally, for veterinary medicinal products intended for incorporation into feed, information shall be provided on the stability and the proposed shelf life after incorporation into feed. A specification for the medicated feed manufactured using those veterinary medicinal products in accordance with the recommended instructions for use shall also be provided.</span></td></tr></tbody></table>
II.2G. Other information
Information relating to the quality of the veterinary medicinal product not covered elsewhere in this Part may be included in the dossier under this point.
II.3 Part 3: Safety documentation (safety and residues tests)
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Each study report shall include:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>a copy of the study plan (protocol);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a statement of compliance with good laboratory practice, where applicable;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>a description of the methods, apparatus and materials used;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>a description and justification of the test system;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>a description of the results obtained, in sufficient detail, to allow the results to be critically evaluated independently of their interpretation by the author;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>a statistical analysis of the results where appropriate;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>a discussion of the results, with comment on observed and no-observed-effect levels, and on any unusual findings;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>the name of the laboratory;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the name of the study director;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(j)</p></td><td><p>signature and date;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(k)</p></td><td><p>place and period of time during which the study was undertaken;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(l)</p></td><td><p>key for abbreviations and codes, irrespective of whether they are internationally accepted or not;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(m)</p></td><td><p>description of mathematical and statistical procedures.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Published studies may be accepted if they contain a sufficient amount of data and sufficient details to allow an independent assessment. The experimental techniques shall be described in such detail as to allow them to be reproduced, and the investigator shall establish their validity. Summaries of studies for which detailed reports are not available shall not be accepted as valid documentation. When the substance has been previously evaluated for the establishment of maximum residues limit (“MRL”) to address certain safety requirements reference may be made to the European public MRL assessment reports (“EPMARs”). Where reference to EPMAR is made there is no need to submit studies already evaluated as part of the MRL evaluation; only new studies not available for the MRL assessment shall be provided. If the route of exposure (for example, for the user) is not identical to the route used in accordance with Commission Regulation (EU) 2018/782 <a>(<span>5</span>)</a>, new studies might be necessary.</span></td></tr></tbody></table>
II.3A. Safety tests
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The safety documentation shall be adequate for assessment of:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the potential toxicity of the veterinary medicinal product and any dangerous or undesirable effects in target species which may occur under the proposed conditions of use;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the potential risks which may result from the exposure of human beings to the veterinary medicinal product, for example, during its administration to the animal;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the potential risks to the environment resulting from the use of the veterinary medicinal product.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>In some cases it may be necessary to test the metabolites of the parent compound where these represent the residues of concern.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>An excipient used for the first time in a veterinary medicinal product or by a new route of administration shall be treated in the same way as an active substance.</span></td></tr></tbody></table>
II.3A1. Precise identification of the product and of its active substance(s)
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>International Non-proprietary Name (INN);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>International Union of Pure and Applied Chemistry Name (IUPAC);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>Chemical Abstract Service (CAS) number;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>therapeutic, pharmacological and chemical classification;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>synonyms and abbreviations;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>structural formula;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>molecular formula,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>molecular weight;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>degree of purity;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(j)</p></td><td><p>qualitative and quantitative composition of impurities;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(k)</p></td><td><p>description of physical properties:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>melting point,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>boiling point,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>vapour pressure,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>solubility in water and organic solvents expressed in g/l, with indication of temperature,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><p>density,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(vi)</p></td><td><p>refraction of light, optical rotation, etc.;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(l)</p></td><td><p>formulation of the product.</p></td></tr></tbody></table>
II.3A2. Pharmacology
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Pharmacological studies are of fundamental importance in clarifying the mechanisms by which the veterinary medicinal product produces its therapeutic effects, and therefore pharmacological studies conducted in experimental and target species of animal shall be included. Cross reference may be made, if applicable, to studies submitted in Part 4 of the dossier.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Where a veterinary medicinal product produces pharmacological effects in the absence of a toxic response, or at doses lower than those required to elicit toxicity, those pharmacological effects shall be taken into account during the evaluation of the safety for the user of the veterinary medicinal product.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The safety documentation shall always be preceded by details of pharmacological investigations undertaken in laboratory animals and all relevant information observed during clinical studies in the target animal.</span></td></tr></tbody></table>
II.3A2.1. Pharmacodynamics
Information on the mechanism of action of the active substance(s) shall be provided, together with information on primary and secondary pharmacodynamic effects in order to assist in the understanding of any adverse effects in the animal studies. Detailed reporting of pharmacodynamic properties relating to the therapeutic effect shall be reported in Part 4A of the dossier.
II.3A2.2. Pharmacokinetics
Data on the fate of the active substance and its metabolites in laboratory animals shall be provided, covering absorption, distribution, metabolism and excretion (ADME). The data shall be related to the dose/effect findings in the pharmacological and toxicological studies, to determine adequate exposure.
II.3A3. Toxicology
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The documentation on toxicology shall follow the guidance published by the Agency on the general approach to testing and guidance on particular studies. Generally, toxicity studies shall be conducted with the active substance(s), not with the formulated product, unless specifically required otherwise.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Animal studies shall be conducted in established strains of laboratory animals for which (preferably) historical data are available.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Single-dose toxicity</span><p>Single-dose toxicity studies may be used to predict:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the possible effects of acute overdose in the target species;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the possible effects of accidental administration to humans;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the doses which may usefully be employed in the repeat dose studies.</p></td></tr></tbody></table><p>Single-dose toxicity studies shall reveal the acute toxic effects of the substance and the time course for their onset and remission.</p><p>The studies to be carried out shall be selected with a view to providing information on user safety, for example, if substantial exposure by inhalation or dermal contact of the user of the veterinary medicinal product is anticipated, those routes of exposure shall be studied.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>Repeat-dose toxicity</span><p>Repeat-dose toxicity tests are intended to reveal any physiological and/or pathological changes induced by repeated administration of the active substance or combination of active substances under examination, and to determine how those changes are related to dosage.</p><p>A repeat-dose toxicity study in one species of experimental animal shall normally be sufficient. This study may be replaced by a study conducted in the target animal. The frequency and route of administration, and the duration of the study shall be chosen having regard to the proposed conditions of clinical use and/or user exposure. The applicant shall give his reasons for the extent and duration of the studies and the dosages chosen.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>Tolerance in the target species</span><p>A summary shall be provided of any signs of intolerance which have been observed during studies conducted, usually with the final formulation, in the target species in accordance with the requirements of Part II.4A4 (Tolerance in the target animal species). The studies concerned, the dosages at which the intolerance occurred, and the species and breeds concerned shall be identified. Details of any unexpected physiological changes shall also be provided. The full reports of those studies shall be included in Part 4 of the dossier.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>Reproductive toxicity including developmental toxicity</span><p>Study of the effects on reproduction</p><p>For products intended for use in breeding animals, reproductive safety studies in line with VICH GL43 shall be provided. Reproduction toxicity studies in laboratory animals are not expected for the evaluation of effects on the user.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(7)</p></td><td><span>Study of developmental toxicity</span><p>For the evaluation of effects in the target animal species, developmental toxicity studies are not required for products intended only for use in non-breeding animals. For other products a study of developmental toxicity shall be performed in at least one species, which may be the target species. If the study is conducted in the target species, a summary shall be provided here, and the full report of the study shall be included in Part 4 of the dossier.</p><p>For the evaluation of user safety, standard developmental toxicity testing in accordance with standard tests based on established guidance (including VICH GL32 and OECD tests) shall be performed in all cases where significant user exposure may be expected.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(8)</p></td><td><span>Genotoxicity</span><p>Tests for genotoxic potential shall be performed to reveal changes which a substance may cause in the genetic material of cells. Any substance intended to be included in a veterinary medicinal product for the first time shall be assessed for genotoxic properties.</p><p>A standard battery of genotoxicity tests in accordance with standard tests based on established guidance (including VICH GL23 and OECD tests) shall be carried out on the active substance(s).</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(9)</p></td><td><span>Carcinogenicity</span><p>The decision on whether carcinogenicity testing is required shall take into account the results of genotoxicity tests, structure-activity relationships and the findings in repeat dose toxicity tests that may demonstrate the potential for hyper-/neo-plastic changes.</p><p>Any known species specificity of the mechanism of toxicity shall be considered, as well as any differences in metabolism between the test species, target animal species, and human beings.</p><p>Carcinogenicity testing shall be conducted according to standard tests based on established guidance (including VICH GL28 and OECD tests).</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(10)</p></td><td><span>Exceptions</span><p>Where a veterinary medicinal product is intended for topical use, systemic absorption shall be investigated in the target animal species. If it is proved that systemic absorption is negligible, the repeated dose toxicity tests, the tests for reproductive and developmental toxicity and the carcinogenicity tests may be omitted, unless:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>under the intended conditions of use, oral ingestion of the veterinary medicinal product by the animal is to be expected, or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>under the intended conditions of use, oral exposure of the user of the veterinary medicinal product is to be expected.</p></td></tr></tbody></table></td></tr></tbody></table>
II.3A4. Other requirements
II.3A.4.1. Special studies
For particular groups of substances or if the effects observed during repeated dose studies in animals include changes indicative of, for example, immunotoxicity, neurotoxicity or endocrine dysfunction, further testing shall be required, for example, sensitisation studies or delayed neurotoxicity tests. Depending on the nature of the product, it may be necessary to conduct additional studies to assess the underlying mechanism of the toxic effect or the irritation potential.
For products for which there may be exposure to skin and eyes, irritation and sensitisation studies shall be provided. Those studies shall be conducted with the final formulation.
The state of latest scientific knowledge and established guidance shall be taken into account when designing such studies and evaluating their results.
II.3A.4.2. Observations in humans
Information shall be provided showing whether the pharmacologically active substances of the veterinary medicinal product are used as medicinal products in human therapy. If that is the case, a compilation shall be made of all the effects observed (including adverse reactions) in humans and of their cause, to the extent that they may be important for the assessment of the safety of the veterinary medicinal product, where appropriate including results from published studies; where constituents of the veterinary medicinal products are themselves not used or are no longer used as medicinal products in human therapy, the reasons shall be stated, if publicly available.
II.3A.4.3. Development of resistance and related risk in humans
The data requirements described in this point are related to antibacterial substances and may not be fully applicable to other types of antimicrobial (namely antivirals, antifungals and antiprotozoals) although, in principle, the requirements may be followed, where applicable.
Data on the potential emergence of resistant bacteria or resistance determinants of relevance for human health and which are associated with the use of veterinary medicinal products are necessary for those products. The mechanism of the development and selection of such resistance is particularly important in this regard. Where necessary, measures to limit resistance development from the intended use of the veterinary medicinal product shall be proposed by the applicant.
Resistance data relevant for clinical use of the product in target animals shall be addressed in accordance with Part II.4A2. Where relevant, cross reference shall be made to the data set out in Part II.4A2.
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>For food-producing animals the risk assessment shall address:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the identification of resistant bacteria or resistance determinants that could be associated with human illness (zoonotic and/or commensal bacteria) and are selected by the use of the antimicrobial veterinary medicinal product in target animals (hazard identification);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the probability of release of the identified hazard(s) from the target animal species as a result of the use of the veterinary medicinal product under consideration;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the probability of subsequent human exposure to the identified hazard(s) via the foodborne route or through direct contact, and the resulting consequences (adverse health effects) to human health. Guidance is available in VICH GL27 and EU GLs.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>For companion animals consideration of risk to human or public health shall address:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the identification of resistant bacteria or resistance determinants that could be associated with human illness and are selected by the use of the antimicrobial veterinary medicinal product in target animals;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>an estimate of exposure of zoonotic and commensal bacteria in the target animal species based on the conditions of use of the veterinary medicinal product under consideration;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>consideration of subsequent human exposure to antimicrobial resistance (AMR), and the resulting consequences to human health.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Resistance in the environment shall be addressed.</span></td></tr></tbody></table>
II.3A5. User safety
This section shall include an assessment of the effects found in Part II.3A to II.3A4 and relate this to the type and extent of human exposure to the product with a view to formulating appropriate user warnings and other risk management measures.
User safety shall be addressed in accordance with Committee for Medicinal Products for Veterinary Use (CVMP) guidelines.
II.3A6. Environmental risk assessment
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>An environmental risk assessment shall be performed to assess the potential harmful effects that the use of the veterinary medicinal product may cause to the environment and to identify the risk of such effects. The assessment shall also identify any precautionary measures which may be necessary to reduce such risk.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>This assessment consists of two phases. The first phase of the assessment shall always be performed. The details of the assessment shall be provided in accordance with guidance published by the Agency. It shall indicate the potential exposure of the environment to the product and the level of risk associated with any such exposure, in particular taking into account the following items:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the target animal species, and the proposed pattern of use;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the method of administration, in particular the likely extent to which the product will enter directly into environmental systems;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the possible excretion of the product, its active substances or relevant metabolites into the environment by treated animals; persistence in such excreta;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the disposal of unused veterinary medicinal product or other waste product.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>In the second phase, further specific investigation of the fate and effects of the product on particular ecosystems shall be conducted, in accordance with guidance published by the Agency. The extent of exposure of the product to the environment, and the available information about the physical/chemical, pharmacological and/or toxicological properties of the substance(s) concerned, including metabolites in case of an identified risk, which has been obtained during the conduct of the other tests and trials required by this Regulation, shall be taken into consideration.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>For products intended for food producing species, persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances shall be classified according to the criteria in Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council <a>(<span>6</span>)</a> (REACH Regulation) and assessed according to the guidance for PBT and vPvB assessment of substances in veterinary medicines published by the Agency.</span></td></tr></tbody></table>
II.3B. Residue tests
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>For the purposes of this point, the definitions of Regulation (EC) No 470/2009 shall apply.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The purpose of studying the depletion of residues from the edible tissues or from eggs, milk and honey (wax, if appropriate) derived from treated animals is to determine under what conditions and to what extent residues may persist in foodstuffs produced from those animals. In addition, the studies shall enable the determination of a withdrawal period.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>In the case of veterinary medicinal products intended for use in food-producing animals, the residue documentation shall show:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>to what extent, and for how long residues of the veterinary medicinal product or its metabolites persist in the edible tissues of the treated animal or in milk, eggs and/or honey (wax, if appropriate) obtained therefrom;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>that in order to prevent any risk to the health of the consumer of foodstuffs from treated animals, it is possible to establish realistic withdrawal periods which may be observed under practical farming conditions;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>that the analytical method(s) used in the residues depletion study are sufficiently validated to provide the necessary reassurance that the residues data submitted are suitable as the basis for a withdrawal period.</p></td></tr></tbody></table></td></tr></tbody></table>
II.3B1. Identification of the product
An identification of the veterinary medicinal product(s) used in the testing shall be provided, including:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>composition;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the physical and chemical (potency and purity) test results for the relevant batch(es);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>batch identification.</p></td></tr></tbody></table>
II.3B2. Depletion of residues (metabolism and residue kinetics)
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The purpose of these studies, which measure the rate at which residues deplete in the target animal after the last administration of the veterinary medicinal product, is to permit the determination of withdrawal periods necessary to ensure that no residues which may constitute a hazard for consumers are present in foodstuffs obtained from treated animals.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The current status of the MRL for the components of the veterinary medicinal product in the relevant target species shall be reported.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The levels of residues present shall be determined at a sufficient number of time points after the test animals have received the final dose of the veterinary medicinal product. The studies in mammals and birds shall be performed according to VICH GL48 and other relevant guidelines. Residue studies in honey shall be performed according to VICH GL56 and depletion studies in aquatic species according to VICH GL57.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>Based on the evaluation, the rationale for the proposed withdrawal period shall be addressed.</span></td></tr></tbody></table>
II.3B3. Residue analytical method
The residue depletion study (studies), the analytical method(s) and its (their) validation shall be performed in accordance with VICH GL49.
The analytical method shall have regard to the state of scientific and technical knowledge at the time the application is submitted.
II.4. Part 4: Efficacy documentation (pre-clinical studies and clinical trial(s))
II.4A. Pre-clinical studies
Pre-clinical studies aim to investigate the target animal safety and efficacy of the product and are required to establish the pharmacological activity, pharmacokinetic properties, dose and dosing interval, resistance (if applicable) and the target animal tolerance of the product.
II.4A1. Pharmacology
II.4A.1.1. Pharmacodynamics
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The pharmacodynamic effects of the active substance(s) included in the veterinary medicinal product shall be characterised.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The mode of action and the pharmacological effects on which the recommended application is based in practice shall be adequately described, including secondary effects (if any). In general, the effects on the main body functions shall be investigated. The results shall be expressed in quantitative terms (for example, using dose-effect curves and/or time-effect curves) and, wherever possible, in comparison with a substance the activity of which is well known (where the activity is claimed to be higher in comparison to the substance the activity of which is well known, the difference shall be demonstrated and shown to be statistically significant).</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Any effect of the other characteristics of the products (such as the route of administration or formulation) on the pharmacological activity of the active substance shall be investigated.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>The experimental techniques, unless they are standard procedures, shall be described in such detail as to allow them to be reproduced, and their validity to be established. The experimental results shall be set out clearly and the outcome of any statistical comparisons presented.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>Unless good reasons are given to the contrary, any quantitative modification of responses resulting from repeated administration of the substance shall also be investigated.</span></td></tr></tbody></table>
II.4A.1.2. Pharmacokinetics
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Basic pharmacokinetic data on the active substance are required in the context of assessment of the target animal safety and efficacy of the veterinary medicinal product in the target species, in particular if this concerns a new substance or formulation.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The objectives of pharmacokinetic studies in the target animal species may be divided into four main areas:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>to describe the basic pharmacokinetic characteristics (namely absorption, distribution, metabolism and excretion) of the active substance in the formulation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>use of this basic pharmacokinetic characteristics to investigate the relationships between dosage regimen, plasma and tissue concentration over time and pharmacological, therapeutic or toxic effects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>where appropriate, to compare pharmacokinetic parameters between different target species and to explore possible species differences having an impact on target animal safety and efficacy of the veterinary medicinal product;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>where appropriate, to compare bioavailability to support bridging of safety and efficacy information between different products, pharmaceutical forms, strengths or routes of administration, or to compare the impact of changes in manufacturing or composition.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>In the target animal species, pharmacokinetic studies are, as a rule, necessary as a complement to the pharmacodynamic studies to support the establishment of safe and effective dosage regimens (route and site of administration, dose, dosing interval, number of administrations, etc.). Additional pharmacokinetic studies may be required to establish dosage regimens according to certain population variables.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>Where pharmacokinetic studies have been submitted under Part 3 of the dossier, cross reference to such studies may be made. For fixed combinations, please refer to Section IV.</span></td></tr></tbody></table>
II.4A2. Development of resistance and related risk in animals
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>For relevant veterinary medicinal products (for example, antimicrobials, antiparasitics), information on current resistance (if applicable) and on the potential emergence of resistance of clinical relevance for the claimed indication in the target animal species shall be provided. Where possible, information on the resistance mechanism(s), the molecular genetic basis of resistance, and the rate of transfer of resistance determinants shall be presented. Whenever relevant, information on co-resistance and cross-resistance shall be presented. Measures to limit resistance development in organisms of clinical relevance for the intended use of the veterinary medicinal product shall be proposed by the applicant.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Resistance relevant for risks to humans shall be addressed in accordance with Part II.3A4, point (3). Where relevant, cross-reference shall be made to data set out in Part II.3A4, point (3).</span></td></tr></tbody></table>
II.4A3. Dose determination and confirmation
Appropriate data shall be provided to justify the proposed dose, dosing interval, duration of treatment and any re-treatment interval.
For studies conducted under field conditions, relevant information shall be provided as outlined in Part II.4B, unless duly justified.
II.4A4. Tolerance in the target animal species
The local and systemic tolerance of the veterinary medicinal product shall be investigated in the target animal species. The purpose of target animal safety studies is to characterise signs of intolerance and to establish an adequate margin of safety using the recommended route(s) of administration. This may be achieved by increasing the dose and/or the duration of treatment. The study report(s) shall contain details of all expected pharmacological effects and all adverse reactions. The conduct of target animal safety studies shall be in accordance with the international guidelines of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (“VICH”) and relevant guideline(s) published by the Agency.. Other pre-clinical studies, including studies provided in part 3, and clinical trials, along with relevant information from the published literature, may also provide information on safety in the target species. Studies on developmental toxicity performed in the target animal species shall be included here, and a summary shall be provided in Part 3 of the dossier.
II.4B. Clinical trial(s)
II.4B1. General principles
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Clinical trials shall be designed, carried out and reported taking due account of the international guidelines on good clinical practice of the VICH and relevant guidance published by the Agency. Data stemming from clinical trials conducted outside the Union may be taken into consideration for the assessment of an application for a marketing authorisation only if the data are sufficiently representative for the Union situation.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Experimental data such as exploratory/pilot trials, or results from non-experimental approaches shall be confirmed by clinical trials, unless otherwise justified.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The purpose of clinical trials is to examine under field conditions the target animal safety and efficacy of a veterinary medicinal product under normal conditions of animal husbandry and/or as part of good veterinary practice. They shall demonstrate the effect of the veterinary medicinal product after administration to the intended target species using the proposed dosage regimen and the proposed route(s) of administration. The trial design shall aim to support the indications and to take into account any contra-indications according to species, age, breed and sex, directions for use of the veterinary medicinal product as well as any adverse reactions which it may have.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>All veterinary clinical trials shall be conducted in accordance with a detailed trial protocol.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>For formulations intended for use in veterinary clinical trials in the Union, the words “for veterinary clinical trial use only” shall appear prominently and indelibly on the labelling.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>Unless otherwise justified, clinical trials shall be carried out with control animals (controlled clinical trials). The efficacy results obtained with the new product shall be compared with those from the target animal species that have received a veterinary medicinal product authorised in the Union that has demonstrated an acceptable level of efficacy and been approved for the proposed indication(s) for use in the same target animal species, or a placebo or no treatment. All the results obtained, whether positive or negative, shall be reported.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(7)</p></td><td><span>Established statistical principles in accordance with the relevant guidance published by the Agency shall be used in protocol design, analysis and evaluation of clinical trials, unless otherwise justified.</span></td></tr></tbody></table>
II.4B2. Documentation
II.4B2.1. Results of pre-clinical studies
Wherever possible, particulars shall be given of the results of:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>tests demonstrating pharmacological activity, including tests demonstrating the pharmacodynamic mechanisms underlying the therapeutic effect and tests demonstrating the main pharmacokinetic profile;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>tests and investigations on resistance, if applicable;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>tests demonstrating target animal safety;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>tests to determine and confirm the dose (including dose interval, duration of treatment and any re-treatment interval).</p></td></tr></tbody></table>
Where unexpected results occur during the course of the tests, those results shall be described in detail. Omission of any of those data shall be justified. The following particulars shall be provided in all pre-clinical study reports:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>a summary;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a study protocol;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>a detailed description of the objectives, design and conduct to include methods, apparatus and materials used, details such as species, age, weight, sex, number, breed or strain of animals, identification of animals, dose, route and schedule of administration;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>a statistical analysis of the results, if applicable;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>an objective discussion of the results obtained, leading to conclusions on the efficacy and target animal safety of the veterinary medicinal product.</p></td></tr></tbody></table>
II.4B2.2. Results of clinical trials
All the particulars shall be supplied by each of the investigators on individual record sheets in the case of individual treatment and collective record sheets in the case of collective treatment.
The marketing authorisation holder shall make all necessary arrangements to ensure that the original documents, which formed the basis of the data supplied, are kept for at least five years after the veterinary medicinal product is no longer authorised.
In respect of each clinical trial, the clinical observations shall be summarised in a synopsis of the trials and the results thereof, indicating in particular:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the number of control and test animals treated either individually or collectively, with a breakdown according to species, breed or strain, age and sex;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the number of animals withdrawn prematurely from the trials and the reasons for such withdrawal;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>in the case of control animals, whether they have:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>received no treatment,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>received a placebo, or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>received another veterinary medicinal product authorised in the Union that has demonstrated an acceptable level of efficacy and been approved for the proposed indication(s) for use in the same target animal species, or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>received the same active substance under investigation in a different formulation or by a different route;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the frequency of observed adverse reactions;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>observations as to the effect on animal performance, if appropriate;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>details concerning test animals which may be at increased risk owing to their age, their mode of rearing or feeding, or the purpose for which they are intended, or animals the physiological or pathological condition of which requires special consideration;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>a statistical evaluation of the results.</p></td></tr></tbody></table>
The main investigator shall draw general conclusions on the efficacy and target animal safety of the veterinary medicinal product under the proposed conditions of use and in particular any information relating to indications and contraindications, dosage and average duration of treatment and, where appropriate, any interactions observed with other veterinary medicinal products or feed additives as well as any special precautions to be taken during treatment and the clinical signs of overdose, when observed.
SECTION III
REQUIREMENTS FOR BIOLOGICAL VETERINARY MEDICINAL PRODUCTS
Without prejudice to specific requirements laid down in Union legislation for the control and eradication of specific infectious animal diseases, the following requirements shall apply to biological veterinary medicinal products, except when the products are intended for use in some species or with specific indications as defined in Sections IV and V and in relevant guidelines.
SECTION IIIa
REQUIREMENTS FOR BIOLOGICAL VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS
The following requirements shall apply to biological veterinary medicinal products as defined in Article 4(6), except products defined in Article 4(5) or where otherwise set out in Section IV.
Flexibility is allowed regarding compliance to the requirements specified in this Section, but any deviations from the requirements in this Annex shall be scientifically justified and based on specific properties of the biological product. For particular substances, safety data in addition to the requirements listed in this Section may be required depending on the nature of the product.
IIIa.1. Part 1: Summary of the dossier
Please refer to Section I.
IIIa.2. Part 2: Quality documentation (physicochemical, biological or microbiological information)
IIIa.2A. Product description
IIIa.2A1. Qualitative and quantitative composition
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The qualitative and quantitative composition of the biological veterinary medicinal product shall be stated. This section shall include information regarding:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the active substance(s);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the constituent(s) of the excipients, whatever their nature or the quantity used, including adjuvants, preservatives, stabilisers, thickeners, emulsifiers, colouring matter, flavouring and aromatic substances, markers, etc.;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the composition, that is to say, list of all components of the dosage form and their amount on a per-unit basis (including overages, if any), the function of the components, and a reference to their quality standards (for example, compendial monographs or manufacturer’s specifications);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>accompanying reconstitution solvent(s);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>the type of container and its closure used for the dosage form and for any accompanying reconstitution solvents and devices, if applicable. If the device is not delivered together with the biological veterinary medicinal product, relevant information about the device shall be provided.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>In order to give the quantitative composition of all the active substances and excipients of the veterinary medicinal products, it is necessary, depending on the pharmaceutical form concerned, to specify the mass, or the number of units of biological activity, either per dosage-unit or per unit of mass or volume, of each active substance and excipient.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Where possible, biological activity per units of mass or volume shall be indicated. Where an international unit of biological activity has been defined, this shall be used, unless otherwise justified. Where no international unit has been defined, the units of biological activity shall be expressed in such a way as to provide unambiguous information on the activity of the substances by using, where applicable, the European Pharmacopoeia Units.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>The “usual terminology” to be used in describing the constituents of biological veterinary medicinal products notwithstanding the application of the other provisions of Article 8, shall mean:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>in respect of substances which appear in the European Pharmacopoeia or, failing this, in the pharmacopoeia of one of the Member States, the main title of the monograph in question, which will be obligatory for all such substances, with reference to the pharmacopoeia concerned;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in respect of other substances, the INN recommended by the WHO, which may be accompanied by another non-proprietary name or, failing these, the exact scientific designation; substances not having an international non-proprietary name or an exact scientific designation shall be described by a statement of how and from what they were prepared, supplemented, where appropriate, by any other relevant details;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>in respect of colouring matter, designation by the “E” code assigned to them in Directive 2009/35/EC.</p></td></tr></tbody></table></td></tr></tbody></table>
IIIa.2A2. Product development
An explanation shall be provided including but not limited to:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the choice of composition and the choice of the constituents, in particular relative to their intended functions and their respective concentrations;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the inclusion of a preservative in the composition shall be justified;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the immediate packaging and the suitability of the container and its closure system used for the storage and use of the finished product. A study of the interaction between the finished product and the primary packaging shall be submitted wherever the risk of such interaction is regarded as possible, especially where injectable preparations are concerned;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the microbiological characteristics (microbiological purity and antimicrobial activity) and usage instructions;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>the possible further packaging, outer packaging, if relevant;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>the proposed pack sizes related to the proposed route of administration, the posology and the target species;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>any overage(s) in the formulation to guarantee minimum potency at end of shelf life with justification;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>the selection of the manufacturing process of the active substance and the finished product;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>differences between the manufacturing process(es) used to produce batches used in clinical trials and the process described in the application for marketing authorisation shall be discussed;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(j)</p></td><td><p>when a dosing device is provided with the finished product, the accuracy of the doses(s) shall be demonstrated;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(k)</p></td><td><p>when an accompanying test is recommended to be used with the finished product (e.g. a diagnostic test), relevant information about the test shall be provided.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(l)</p></td><td><p>This explanation shall be supported by scientific data on product development.</p></td></tr></tbody></table>
IIIa.2A3. Characterisation
IIIa.2A3.1. Elucidation of structure and other characteristics
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Characterisation of a biotechnological or biological substance (which includes the determination of physicochemical properties, biological activity, immuno-chemical properties, purity and impurities) by appropriate techniques is necessary to allow a suitable specification to be established. Reference to literature data only is not acceptable, unless otherwise justified by prior knowledge from similar molecules for modifications where there is no safety concern. Adequate characterisation shall be performed in the development phase and, where necessary, following significant process changes.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>All relevant information available on the primary, secondary and higher-order structure including post- translational (for example, glycoforms) and other modifications of the active substance shall be provided.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Details shall be provided on the biological activity (namely the specific ability or capacity of a product to achieve a defined biological effect). Usually, the biological activity shall be determined or evaluated using an appropriate, reliable and qualified method. Lack of such an assay shall be justified. It is recognised that the extent of characterisation data will increase during development.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>The rationale for selection of the methods used for characterisation shall be provided and their suitability shall be justified.</span></td></tr></tbody></table>
IIIa.2A3.2. Impurities
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Process-related impurities (for example, host cell proteins, host cell DNA, media residues, column leachables) and product-related impurities (for example, precursors, cleaved forms, degradation products, aggregates) shall be addressed. Quantitative information on impurities shall be provided including maximum amount for the highest dose. For certain process-related impurities (for example, antifoam agents), an estimation of clearance may be justified.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>In the case that only qualitative data are provided for certain impurities, this shall be justified.</span></td></tr></tbody></table>
IIIa.2B. Description of the manufacturing method
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The description of the manufacturing method accompanying the application for marketing authorisation pursuant to Article 8 shall be drafted in such a way as to give an adequate description of the nature of the operations employed.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The name(s) and address(es) and responsibilities of each manufacturer, including contractors, and each proposed production site or facility involved in manufacture, testing and batch release shall be provided.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The description of the manufacturing process shall include at least:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the various stages of manufacture, including production of the active substance and description of the purification steps;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a process flow chart of all successive steps shall be given so that an assessment can be made of the reproducibility of the manufacturing procedure and of the risks of adverse effects on the finished products, such as microbiological contamination;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>in the case of continuous manufacture, full details concerning precautions taken to ensure the homogeneity and consistency of each batch of the finished product. Information on how a batch is defined and on the proposed commercial batch size(s) shall be provided;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>listing of all the substances at the appropriate steps where they are used, including those which cannot be recovered in the course of manufacturing;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>the details of the blending, with the quantitative particulars of all the substances used, including an example for a representative production batch;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>list of in-process controls including the stage of manufacture at which they are conducted and acceptance criteria;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>for sterile products, where non-pharmacopoeial sterilisation conditions are used, details of the sterilisation processes and/or aseptic procedures used.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>Description, documentation, and results of the validation and/or evaluation studies shall be provided for critical steps or critical assays used in the manufacturing process (for example, validation of the sterilisation process or aseptic processing or filling) and the validation of the production process as a whole shall be demonstrated with provision of results of three consecutive batches produced using the method described.</span></td></tr></tbody></table>
IIIa.2C. Production and control of starting materials
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>For the purposes of this point “starting materials” means all components, including the active substances used in the production of the biological veterinary medicinal product. Culture media used for production of the active substances shall be regarded as one starting material.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The qualitative and quantitative composition shall be presented insofar as the authorities consider that this information is relevant to the quality of the finished product and any risks that might be posed.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>If materials of animal origin are used for preparation of those culture media, the animal species and the tissue used have to be included and compliance with the relevant monographs including general monographs and general chapters of the European Pharmacopoeia shall be demonstrated.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>The applicant shall supply documentation to demonstrate that the starting materials, including seed materials, cell seeds, batches of serum and other material originating from animal species relevant for the transmission of TSE and the manufacturing of the veterinary medicinal product is in compliance with the requirements of the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products, as well as with the requirements of the corresponding monograph of the European Pharmacopoeia.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>Certificates of Suitability issued by the European Directorate for the Quality of Medicines and HealthCare, with reference to the relevant monograph of the European Pharmacopoeia, may be used to demonstrate compliance.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>The dossier shall include the specifications, information on the tests to be conducted for the quality control of all batches of starting materials and results from a batch of all components used and shall be submitted in accordance with the following provisions.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(7)</p></td><td><span>Certificates of Analysis shall be presented for the starting materials in order to demonstrate compliance with the defined specification.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(8)</p></td><td><span>Colouring matter shall in all cases satisfy the requirements of Directive 2009/35/EC.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(9)</p></td><td><span>The use of antibiotics during production and preservatives shall be in compliance with the European Pharmacopoeia.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(10)</p></td><td><span>For novel excipients – excipient(s) used for the first time in the Union in a veterinary medicinal product or by a new route of administration – details of manufacture, characterisation, and controls, with cross references to supporting safety data, both clinical and non-clinical, shall be provided. For colouring matters the declarations of compliance as mentioned under Part II.2C2, points (3) and (4) shall be considered sufficient.</span></td></tr></tbody></table>
IIIa.2C1. Starting materials listed in pharmacopoeias
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The monographs of the European Pharmacopoeia shall be applicable to all starting materials appearing in it, unless adequate justification is provided.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>In respect of other substances, each Member State may require observance of its own national pharmacopoeia with regard to products manufactured in its territory.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The description of the analytical methods may be replaced by a detailed reference to the pharmacopoeia in question.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>The routine tests carried out on each batch of starting materials shall be as stated in the application for marketing authorisation. If tests other than those mentioned in the pharmacopoeia are used, proof shall be supplied that the starting materials meet the quality requirements of that pharmacopoeia.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>Where a specification or other provisions contained in a monograph of the European Pharmacopoeia or in the pharmacopoeia of a Member State might be insufficient to ensure the quality of the substance, the competent authorities may request more appropriate specifications from the applicant for marketing authorisation. The alleged insufficiency shall be reported to the authorities responsible for the pharmacopoeia in question.</span></td></tr></tbody></table>
IIIa.2C2. Starting materials not listed in a pharmacopoeia
IIIa.2C2.1. Starting materials of biological origin
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Where source materials such as microorganisms, tissues of either plant or animal origin, cells or fluids (including blood) of human or animal origin or biotechnological cell constructs are used in the manufacture of veterinary medicinal products, the origin, including geographical region, and history of starting materials shall be described and documented. The origin, general health and immunological status of animals used for production shall be indicated and defined pools of source materials shall be used.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Freedom from extraneous agents (bacteria, mycoplasma, fungi and viruses) shall be demonstrated in compliance with the European Pharmacopoeia for seed materials, including cell seeds and pools of serum and, whenever possible, the source materials from which they are derived.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Information shall be provided on all substances of biological origin used at any stage in the manufacturing procedure. The information shall include the manufacturing strategy, purification and inactivation procedures with their validation and all in-process control procedures designed to ensure the quality, safety and batch to batch consistency of the finished product as well as details of any tests for contamination carried out on each batch of the substance. Any special precautions which may be necessary during storage of the starting material and, if necessary, its storage life shall be given.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>When starting materials of animal or human origin are used, the measures used to ensure freedom from extraneous agents shall be described. If the presence of extraneous agents is detected or suspected, the corresponding material shall be discarded or processed to reduce the risk of presence with a validated treatment. If after treatment presence is detected or suspected, the corresponding material shall be used only when further processing of the product ensures their elimination and/or inactivation; elimination and/or inactivation of such extraneous agents shall be demonstrated.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>When cell seeds are used, the cell characteristics shall be shown to have remained unchanged up to the highest passage level used for the production.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>For genetically engineered starting materials this information shall include details such as the description of the starting cells or strains, the construction of the expression vector (name, origin, function of the replicon, promoter enhancer and other regulator elements), control of the sequence of DNA or RNA effectively inserted, oligonucleotide sequences of plasmid vector in cells, plasmid used for cotransfection, added or deleted genes, biological properties of the final construct and the genes expressed, copy number and genetic stability.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(7)</p></td><td><span>In the case of veterinary medicinal products containing or consisting of genetically modified organisms (GMO), the quality part of the application shall also be accompanied by the documents required in accordance with Directive 2001/18/EC.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(8)</p></td><td><span>When required, samples of the biological starting material or reagents used in the testing procedures shall be provided to enable the competent authority to arrange for check tests to be carried out.</span></td></tr></tbody></table>
IIIa.2C2.2. Starting materials of non-biological origin
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The description shall be given in the form of a monograph under the following headings:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the name of the starting material meeting the requirements of point IIIa.2A1(4) shall be supplemented by any trade or scientific synonyms;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the description of the starting material, set down in a form similar to that used in a descriptive item in the European Pharmacopoeia;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the function of the starting material;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>methods of identification;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>any special precautions which may be necessary during storage of the starting material and, if necessary, its storage life shall be given.</p></td></tr></tbody></table></td></tr></tbody></table>
IIIa.2D. Control tests during the manufacturing process
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The dossier shall include particulars relating to the in-process control tests, which are carried out on intermediate stages of manufacture with a view to verify the consistency of the manufacturing process and the final product. Specifications shall be set for each control test and the analytical methods shall be described. Validation of the control tests shall be provided, unless otherwise justified.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The specification for the batch(es) of active substance shall define acceptance criteria together with the tests used to exert sufficient control of the quality of the active substance. A test for biological activity shall be included unless otherwise justified. Upper limits, taking into account safety considerations, shall be set for the impurities. Microbiological quality for the active substance shall be specified. Freedom from extraneous agents (bacteria, mycoplasma, fungi and viruses) shall be demonstrated according to the European Pharmacopoeia.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>In accordance with Directive 2010/63/EU and the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes, tests shall be carried out in such a way as to use the minimum number of animals and to cause the least pain, suffering, distress or lasting harm. If available, an alternative in vitro test shall be used when this leads to replacement or reduction of animal use or reduction of suffering.</span></td></tr></tbody></table>
IIIa.2E. Control tests on the finished product
IIIa.2E1 Finish product specification
For all tests, the description of the techniques for analysing the finished product shall be set out in sufficient detail for quality assessment.
Where appropriate monographs exist, if test procedures and limits other than those mentioned in the monographs of the European Pharmacopoeia, or failing this, in the pharmacopoeia of a Member State, are used, proof must be supplied that the finished product would, if tested in accordance with those monographs, meet the quality requirements of that pharmacopoeia for the pharmaceutical form concerned. The application for marketing authorisation shall list those tests, which are carried out on representative samples of each batch of finished product. The frequency of the tests carried out on the final bulk instead of on the batch or batches prepared from it, shall be stated, if applicable. The frequency of the tests which are not carried out routinely shall be justified. Acceptance criteria for release shall be indicated and justified. Validation of the control tests carried out on the finished product shall be provided.
Upper limits, taking into account safety considerations, shall be set for the impurities.
IIIa.2E2 Method descriptions and validation of release tests
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>General characteristics</span><p>The tests of general characteristics shall, wherever applicable, relate to the appearance of the finished product and to physical or chemical tests, such as, pH, osmolality, etc. For each of those characteristics, specifications, with appropriate confidence limits, shall be established by the applicant in each particular case.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Identification and potency test</span><p>Where necessary, a specific test for identification of the active substance shall be carried out. When appropriate, the identification test may be combined with the potency test.</p><p>An activity test or test for quantification of the active substance or test to quantitatively measure the functionality (biological activity/functional effect) which is linked to relevant biological properties shall be implemented to show that each batch will contain the appropriate potency to ensure its safety and efficacy.</p><p>A biological assay shall be obligatory when physicochemical methods does not provide adequate information on the quality of the product. Such an assay shall, whenever possible, include reference materials and statistical analysis allowing calculation of confidence limits. Where those tests may not be carried out on the finished product, they may be performed at an intermediate stage, as late as possible in the manufacturing process.</p><p>Where degradation occurs during manufacture of the finished product, the maximum acceptable levels of individual and total degradation products immediately following manufacture shall be indicated.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Identification and assay of excipient components</span><p>Insofar as is necessary, the excipient(s) shall be subject at least to identification tests. An upper and lower limit test shall be obligatory in respect of preserving agents. An upper limit test for any other excipient components liable to give rise to an adverse reaction shall be obligatory. If applicable, the quantity and nature of the adjuvant and its components shall be verified on the finished product, unless otherwise justified.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>Sterility and purity tests</span><p>Freedom from extraneous agents (bacteria, mycoplasma, fungi and bacterial endotoxin when relevant) shall be demonstrated in compliance with the European Pharmacopoeia. Appropriate tests to demonstrate the absence of contamination by other substances, shall be carried out according to the nature of the biological veterinary medicinal product, the method and the conditions of manufacture. If fewer tests than required by the relevant European Pharmacopoeia are routinely employed for each batch, the tests carried out shall be critical to the compliance with the monograph. Proof shall be supplied that the biological veterinary medicinal product would meet the requirements, if fully tested according to the monograph.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>Residual humidity</span><p>Each batch of lyophilised product or tablet shall be tested for residual humidity.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>Filling volume</span><p>Appropriate tests to demonstrate the correct filling volume shall be carried out.</p></td></tr></tbody></table>
IIIa.2E3. Reference standards or materials
Information regarding the manufacturing process used to establish the reference material shall be provided. If more than one reference standard has been used for a particular test during product development, a qualification history shall be provided describing how the relationship between the different standards was maintained.
If other reference preparations and standards than those of the European Pharmacopoeia are used, they shall be identified and described in detail.
IIIa.2F. Batch-to-batch consistency
IIIa.2F1. Active substance
In order to ensure that quality of the active substance is consistent from batch to batch and to demonstrate conformity with specifications data from representative batches shall be provided.
IIIa.2F2. Finished product
In order to ensure that quality of the product is consistent from batch to batch and to demonstrate conformity with specifications a full protocol of three consecutive batches representative of the routine production shall be provided.
IIIa.2G. Stability tests
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Stability tests cover stability of the active substance and the finished product, including solvent(s), if relevant. If active substance(s) are stored, the intended conditions and duration of storage shall be defined on the basis of stability data; they may be obtained either through testing of the active substances themselves or through appropriate testing of the finished product.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>A description shall be given of the tests undertaken to support the shelf life, the recommended storage conditions and the specifications at the end of the shelf life proposed by the applicant. Those tests shall always be real-time studies; they shall be carried out on not fewer than three representative batches produced according to the described production process and on products stored in the final container(s); those tests include biological and physicochemical stability tests carried out at regular intervals, for the finished product until the claimed end of the shelf life.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The conclusions shall contain the results of analyses, justifying the proposed shelf life under all proposed storage conditions. The results obtained during the stability study shall be taken into account when defining appropriate formulation and release specifications to ensure the conformity of the product with the claimed shelf life.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>In the case of products administered in feed, information shall also be given as necessary on the shelf life of the product, at the different stages of mixing, when mixed in accordance with the recommended instructions.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>Where a finished product requires reconstitution prior to administration or is administered in drinking water, details of the proposed shelf life are required for the product reconstituted as recommended. Data in support of the proposed shelf life for the reconstituted product shall be submitted.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>In the case of multi-dose containers, where relevant, stability data shall be presented to justify a shelf life for the product after it has been broached or opened for the first time and an in-use specification shall be defined.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(7)</p></td><td><span>Where a finished product is liable to give rise to degradation products, the applicant shall declare those products and indicate the identification methods and test procedures used.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(8)</p></td><td><span>Stability data obtained from combined products may be used where adequately justified for derivative products containing one or more of the same components.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(9)</p></td><td><span>The efficacy of any preservative system shall be demonstrated. Information on the efficacy of preservatives in other similar biological veterinary medicinal products from the same manufacturer may be sufficient.</span></td></tr></tbody></table>
IIIa.2H. Other information
Information relating to the quality of the biological veterinary medicinal product not covered by Part IIIa.2 to IIIa2G may be included in the dossier.
IIIa.3. Part 3: Safety documentation (safety and residues tests)
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Each study report shall include:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>a copy of the study plan (protocol);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a statement of compliance with good laboratory practice, where applicable;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>a description of the methods, apparatus and materials used;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>a description and justification of the test system;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>a description of the results obtained, in sufficient detail to allow the results to be critically evaluated independently of their interpretation by the author;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>a statistical analysis of the results where appropriate;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>a discussion of the results, with comment on observed and no-observed-effect levels, and on any unusual findings;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>the name of the laboratory;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the name of the study director;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(j)</p></td><td><p>signature and date;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(k)</p></td><td><p>place and period of time during which the study was undertaken;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(l)</p></td><td><p>key for abbreviations and codes, irrespective of whether they are internationally accepted or not;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(m)</p></td><td><p>description of mathematical and statistical procedures.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Published studies may be accepted if they contain a sufficient amount of data and sufficient details to allow an independent assessment. The experimental techniques shall be described in such detail as to allow them to be reproduced, and the investigator shall establish their validity. Summaries of studies for which detailed reports are not available shall not be accepted as valid documentation. To address certain safety requirements reference may be made to EPMAR when the substance has been previously evaluated for the establishment of MRLs. Where reference to EPMARs is made there is no need to submit studies already evaluated as part of the MRL evaluation; only new studies not available for the MRL assessment shall be provided. If the route of exposure (for example, for the user) is not identical to the route used in accordance with Regulation (EU) 2018/78, new studies may be necessary.</span></td></tr></tbody></table>
IIIa.3A. Safety tests
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The safety documentation shall be adequate for assessment of:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the potential toxicity of the veterinary medicinal product and any dangerous or undesirable effects in target species which may occur under the proposed conditions of use;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the potential risks which may result from the exposure of human beings to the veterinary medicinal product, for example, during its administration to the animal;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the potential risks to the environment resulting from the use of the veterinary medicinal product.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>In some cases, it may be necessary to test the metabolites of the parent compound where these represent the residues of concern.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>An excipient used for the first time in a veterinary medicinal product or by a new means of administration shall be treated like an active substance.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>All sections listed in Part IIIa.3A shall be addressed. Depending on the nature of the product, certain sections may not be relevant and studies may be omitted, where justified.</span></td></tr></tbody></table>
IIIa.3A1. Precise identification of the product and of its active substance(s):
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>international non-proprietary name (INN);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>International Union of Pure and Applied Chemistry Name (IUPAC);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>Chemical Abstract Service (CAS) number;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>therapeutic, pharmacological and chemical classification;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>synonyms and abbreviations;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>structural formula;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>molecular formula;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>molecular weight;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>degree of impurity;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(j)</p></td><td><p>qualitative and quantitative composition of impurities;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(k)</p></td><td><p>description of physical properties;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(l)</p></td><td><p>solubility in water and organic solvents expressed in g/l, with indication of temperature;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(m)</p></td><td><p>refraction of light, optical rotation, etc.;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(n)</p></td><td><p>formulation of the product.</p></td></tr></tbody></table>
IIIa.3A2. Pharmacology
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Pharmacological studies are of fundamental importance in clarifying the mechanisms by which the veterinary medicinal product produces its therapeutic effects, and therefore pharmacological studies conducted in the target species of animal and where applicable in non-target species, shall be included. Cross-reference may be made, if applicable, to studies submitted in Part 4 of the dossier.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Pharmacological studies may also assist in the understanding of toxicological phenomena. Where a veterinary medicinal product produces pharmacological effects in the absence of a toxic response, or at doses lower than those required to elicit toxicity, those pharmacological effects shall be taken into account during the evaluation of the safety of the veterinary medicinal product.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The safety documentation shall always be preceded by details of pharmacological investigations undertaken in laboratory animals and all relevant information observed during clinical studies in the target animal.</span></td></tr></tbody></table>
IIIa.3A2.1. Pharmacodynamics
Information on the mechanism of action of the active substance(s) shall be provided, together with information on primary and secondary pharmacodynamic effects in order to assist in the understanding of any adverse effects in the animal studies. Detailed reporting of pharmacodynamic properties relating to the therapeutic effect shall be reported in Part 4A of the dossier.
IIIa.3A2.2. Pharmacokinetics
Data on the fate of the active substance and its metabolites in laboratory animals shall be provided, covering absorption, distribution, metabolism and excretion (ADME). The data shall be related to the dose/effect findings in the pharmacological and toxicological studies, to determine adequate exposure.
IIIa.3A3. Toxicology
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The documentation on toxicology shall follow the guidance published by the Agency on the general approach to testing and guidance on particular studies. This guidance includes toxicological data required for the establishment of user safety, and the assessment of adverse effects in target animals and the environment.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Toxicity studies shall be conducted with the active substance(s), not with the formulated product, unless specifically required otherwise.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Animal studies shall be conducted in established strains of laboratory animals for which (preferably) historical data are available.</span></td></tr></tbody></table>
IIIa.3A3.1. Single-dose toxicity
Single-dose toxicity studies may be used to predict:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the possible effects of acute overdose in the target species;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the possible effects of accidental administration to humans;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the doses which may usefully be employed in the repeat dose studies.</p></td></tr></tbody></table>
Single-dose toxicity studies shall reveal the acute toxic effects of the substance and the time course for their onset and remission.
The studies to be carried out shall be selected with a view to providing information on user safety, for example, if substantial exposure by inhalation or dermal contact of the user of the veterinary medicinal product is anticipated, those routes of exposure shall be studied.
IIIa.3A3.2. Repeat-dose toxicity
Repeat-dose toxicity tests are intended to reveal any physiological and/or pathological changes induced by repeated administration of the active substance or combination of active substances under examination, and to determine how those changes are related to dosage.
A repeat-dose toxicity study in one species of experimental animal shall normally be sufficient. This study may be replaced by a study conducted in the target animal. The frequency and route of administration, and the duration of the study shall be chosen having regard to the proposed conditions of clinical use and/or user exposure. The applicant shall give his reasons for the extent and duration of the studies and the dosages chosen.
IIIa.3A3.3. Tolerance in the target species
A summary shall be provided of any signs of intolerance which have been observed during studies conducted, usually with the final formulation, in the target species in accordance with the requirements of Part IIIa.4A4 (target animal safety). The studies concerned, the dosages at which the intolerance occurred, and the species and breeds concerned shall be identified. Details of any unexpected physiological changes shall also be provided. The full reports of those studies shall be included in Part 4 of the dossier.
IIIa.3A3.4. Reproductive toxicity including developmental toxicity
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Study of the effects on reproduction</span><p>For products intended for use in breeding animals, reproductive safety studies in line with VICH GL43 shall be provided. Reproduction toxicity studies in laboratory animals are not expected for the evaluation of effects on the user.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Study of developmental toxicity</span><p>For the evaluation of effects in the target animal species, developmental toxicity studies are not required for products intended only for use in non-breeding animals. For other products a study of developmental toxicity shall be performed in at least one species, which may be the target species.</p><p>For the evaluation of user safety, standard developmental toxicity testing in accordance with standard tests based on established guidance (including VICH GL32 and OECD tests) shall be performed in all cases where significant user exposure may be expected.</p></td></tr></tbody></table>
IIIa.3A3.5. Genotoxicity
Tests for genotoxic potential shall be performed, unless otherwise justified, to reveal changes which a substance may cause in the genetic material of cells. Any substance intended to be included in a veterinary medicinal product for the first time shall be assessed for genotoxic properties.
A standard battery of genotoxicity tests in accordance with standard tests based on established guidance (including VICH GL23 and OECD tests) shall usually be carried out on the active substance(s).
IIIa.3A3.6. Carcinogenicity
The decision on whether carcinogenicity testing is required shall take into account the results of genotoxicity tests, structure-activity relationships and the findings in repeat dose toxicity tests that may demonstrate the potential for hyper-/neo-plastic changes.
Any known species specificity of the mechanism of toxicity shall be considered, as well as any differences in metabolism between the test species, target animal species, and human beings.
Carcinogenicity testing shall be conducted in accordance with standard tests based on established guidance (including VICH GL28 and OECD tests).
IIIa.3A3.7. Exceptions
Where a veterinary medicinal product is intended for topical use, systemic absorption shall be investigated in the target animal species. If it is proved that systemic absorption is negligible, the repeated dose toxicity tests, the tests for developmental toxicity and the carcinogenicity tests may be omitted, unless:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>under the intended conditions of use, oral ingestion of the veterinary medicinal product by the animal is to be expected, or</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>under the intended conditions of use, oral exposure of the user of the veterinary medicinal product is to be expected.</p></td></tr></tbody></table>
IIIa.3A4. Other requirements
IIIa.3A4.1. Special studies
For particular groups of substances, or if the effects observed during repeated dose studies in animals include changes indicative of, for example, immunogenicity, immunotoxicity, neurotoxicity or endocrine dysfunction, further testing shall be required, for example, sensitisation studies or delayed neurotoxicity tests. Depending on the nature of the product, it may be necessary to conduct additional studies to assess the underlying mechanism of the toxic effect or the irritation potential.
For products for which there may be exposure to skin and eyes, irritation and sensitisation studies shall be provided. Those studies shall usually be conducted with the final formulation.
The state of scientific knowledge and established guidance shall be taken into account when designing such studies and evaluating their results.
IIIa.3A4.2. Observations in humans
Information shall be provided on whether the pharmacologically active substances of the veterinary medicinal product are used as medicinal products in human therapy; if this the case, a compilation shall be made from published studies of all the effects observed (including adverse reactions) in humans and of their cause, to the extent that they may be important for the assessment of the safety of the veterinary medicinal product, where constituents of the veterinary medicinal products are themselves not used or are no longer used as medicinal products in human therapy for safety reasons, they shall be stated if publicly available.
IIIa.3A4.3. Development of resistance and related risk in humans
The data requirements mentioned in this point are related to antibacterial substances and may not be applicable to other types of antimicrobial (namely antivirals, antifungals and antiprotozoals); for substances other than antibacterial for which the existence of antimicrobial resistance is well established, the same requirements may be followed, where applicable.
Data on the potential emergence of resistant bacteria or resistance determinants of relevance for human health which are associated with the use of veterinary medicinal products are necessary. The mechanism of the development and selection of such resistance is particularly important in this regard. Where necessary, measures to limit resistance development from the intended use of the veterinary medicinal product shall be proposed.
Resistance data relevant for clinical use of the product in target animals shall be addressed in accordance with Part IIIa.4A2. Where relevant, cross reference shall be made to the data set out in Part IIIa.4A2.
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>For food-producing animals the risk assessment shall address:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the identification of resistant bacteria or resistance determinants that could be associated with human illness (zoonotic and/or commensal bacteria) and are selected by the use of the antimicrobial veterinary medicinal product in target animals (hazard identification);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the probability of release of the identified hazard(s) from the target animal species as a result of the use of the veterinary medicinal product under consideration;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the probability of subsequent human exposure to the identified hazard(s) via the foodborne route or through direct contact, and the resulting consequences (adverse health effects) to human health. Guidance is available in VICH GL27 and EU GLs.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>For companion animals, consideration of risk to human or public health shall address:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the identification of resistant bacteria or resistance determinants that could be associated with human illness and are selected by the use of the antimicrobial veterinary medicinal product in target animals;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>an estimate of exposure of zoonotic and commensal bacteria in the target animal species based on the conditions of use of the veterinary medicinal product under consideration;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>consideration of subsequent human exposure to AMR, and the resulting consequences to human health.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Resistance in the environment shall be addressed.</span></td></tr></tbody></table>
IIIa.3A5. User safety
The user safety section shall include an assessment of the effects found in Part IIIa.3A to IIIa.3A4 and relate this to the type and extent of human exposure to the product with a view to formulating appropriate user warnings and other risk management measures.
User safety shall be addressed in accordance with CVMP guidelines.
IIIa.3A6. Environmental risk assessment
IIIa.3A6.1. Environmental risk assessment of veterinary medicinal products not containing or consisting of genetically modified organisms
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>An environmental risk assessment shall be performed to assess the potential harmful effects, which the use of the veterinary medicinal product may cause to the environment and to identify the risk of such effects. The assessment shall also identify any precautionary measures which may be necessary to reduce such risk.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>This assessment consists of two phases. The first phase of the assessment shall always be performed. The details of the assessment shall be provided in accordance with guidance published by the Agency. It shall indicate the potential exposure of the environment to the product and the level of risk associated with any such exposure taking into account in particular the following items:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the target animal species, and the proposed pattern of use;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the method of administration, in particular the likely extent to which the product will enter directly into environmental systems;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the possible excretion of the product, its active substances or relevant metabolites into the environment by treated animals; persistence in such excreta;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the disposal of unused veterinary medicinal product or other waste product.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>In the second phase, further specific investigation of the fate and effects of the product on particular ecosystems shall be conducted, in accordance with guidance published by the Agency. The extent of exposure of the product to the environment, and the available information about the physical/chemical, pharmacological and/or toxicological properties of the substance(s) concerned, including metabolites in case of an identified risk, which has been obtained during the conduct of the other tests and trials required by this Regulation, shall be taken into consideration.</span><p>For products intended for food producing species persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances shall be classified according to the criteria in Annex XIII to the REACH Regulation and assessed in accordance with the guidance for PBT and vPvB assessment of substances in veterinary medicines published by the Agency</p></td></tr></tbody></table>
IIIa.3A6.2. Environmental risk assessment for veterinary medicinal products containing or consisting of genetically modified organisms
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>In the case of a veterinary medicinal product containing or consisting of genetically modified organisms the application shall also be accompanied by the documents required under Article 2 and Part C of Directive 2001/18/EC.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Potential adverse effects on human health and the environment, which may occur through gene transfer from GMOs to other organisms or arise from genetic modifications, shall be accurately assessed on a case-by-case basis. The objective of such an environmental risk assessment is to identify and evaluate potential direct and indirect, immediate or delayed adverse effects of the GMO on human health and the environment (including plants and animals) and shall be carried out in accordance with the principles of Annex II to Directive 2001/18/EC.</span></td></tr></tbody></table>
IIIa.3B. Residue tests
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>For the purposes of this point, the definitions of Regulation (EC) No 470/2009 shall apply.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The purpose of studying the depletion of residues from the edible tissues or from eggs, milk and honey (wax if appropriate) derived from treated animals is to determine under what conditions and to what extent residues may persist in foodstuffs produced from those animals. In addition, the studies shall enable the determination of a withdrawal period.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>In the case of veterinary medicinal products intended for use in food-producing animals, the residue documentation shall show:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>to what extent, and for how long, residues of the veterinary medicinal product or its metabolites persist in the edible tissues of the treated animal or in milk, eggs and/or honey (wax if appropriate) obtained therefrom;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>that in order to prevent any risk to the health of the consumer of foodstuffs from treated animals, it is possible to establish realistic withdrawal periods which may be observed under practical farming conditions;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>that the analytical method(s) used in the residue depletion study are sufficiently validated to provide the necessary reassurance that the residues data submitted are suitable as the basis for a withdrawal period.</p></td></tr></tbody></table></td></tr></tbody></table>
IIIa.3B1. Identification of the product
An identification of the veterinary medicinal product(s) used in the testing shall be provided, including:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>composition;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the physical and chemical (potency and purity) test results for the relevant batch(es);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>batch identification.</p></td></tr></tbody></table>
IIIa.3B2. Depletion of residues
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The purpose of these studies, which measure the rate at which residues deplete in the target animal after the last administration of the veterinary medicinal product, is to permit the determination of withdrawal periods necessary to ensure that no residues which might constitute a hazard for consumers are present in foodstuffs obtained from treated animals.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The current status of the maximum residue limits for the components of the veterinary medicinal product in the relevant target species shall be reported.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The levels of residues present shall be determined at a sufficient number of time points after the test animals have received the final dose of the veterinary medicinal product. The studies in mammals and birds shall be performed according to VICH GL48 and other relevant guidelines. Residue studies in honey shall be performed according to VICH GL56 and depletion studies in aquatic species according to VICH GL57.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>Based on the evaluation, the rationale for the proposed withdrawal period shall be addressed.</span></td></tr></tbody></table>
IIIa.3B3. Residue analytical method
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The residue depletion study (studies), the analytical method(s) and its (their) validation shall be performed in accordance with VICH GL49.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The suitability of the analytical method proposed shall be evaluated with regard to the state of scientific and technical knowledge at the time the application is submitted.</span></td></tr></tbody></table>
IIIa.4. Part 4: Efficacy documentation (pre-clinical studies and clinical trial(s))
IIIa.4A. Pre-clinical studies
Pre-clinical studies aim to investigate the target animal safety and efficacy of the product and are required to establish the pharmacological activity, pharmacokinetic properties, dose and dosing interval, resistance (if applicable) and the target animal tolerance of the product.
IIIa.4A1. Pharmacology
IIIa.4A1.1. Pharmacodynamics
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The pharmacodynamic effects of the active substance(s) included in the veterinary medicinal product shall be characterised.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The mode of action and the pharmacological effects on which the recommended application in practice is based shall be adequately described, including secondary effects (if any). In general, the effects on the main body functions shall be investigated. The results shall be expressed in quantitative terms (using, for example, dose-effect curves, time-effect curves, etc.) and, wherever possible, in comparison with a substance the activity of which is well known. Where a higher activity is being claimed for an active substance, the difference shall be demonstrated and shown to be statistically significant.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Any effect of the other characteristics of the products (such as the route of administration or formulation) on the pharmacological activity of the active substance shall be investigated.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>The experimental techniques, unless they are standard procedures, shall be described in such detail as to allow them to be reproduced, and their validity to be established. The experimental results shall be set out clearly and the outcome of any statistical comparisons presented.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>Unless adequate reasons are given to the contrary, any quantitative modification of responses resulting from repeated administration of the substance shall also be investigated.</span></td></tr></tbody></table>
IIIa.4A1.2. Pharmacokinetics
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Basic pharmacokinetic data on the active substance are required in the context of assessment of the target animal safety and efficacy of the veterinary medicinal product in the target species, particularly if this concerns a new substance or formulation.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The objectives of pharmacokinetic studies in the target animal species may be divided into four main areas:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>to describe the basic pharmacokinetic characteristics (namely absorption, distribution, metabolism and excretion) of the active substance in the formulation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>to investigate the relationships between dosage regimen, plasma and tissue concentration over time and pharmacological, therapeutic or toxic effects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>where appropriate, to compare pharmacokinetic parameters between different target species and to explore possible species differences having an impact on target animal safety and efficacy of the veterinary medicinal product;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>where appropriate, to compare bioavailability to support bridging of safety and efficacy information between different products, pharmaceutical forms, strengths or routes of administration, or to compare the impact of changes in manufacturing or composition, including pilot and final formulations.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>In the target animal species, pharmacokinetic studies are, as a rule, necessary as a complement to the pharmacodynamic studies to support the establishment of safe and effective dosage regimens (route and site of administration, dose, dosing interval, number of administrations, etc.). Additional pharmacokinetic studies may be required to establish dosage regimens according to certain population variables.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>Where pharmacokinetic studies have been submitted under Part 3 of the dossier, cross-reference to such studies may be made.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>For fixed combinations, please refer to Section IV.</span></td></tr></tbody></table>
IIIa.4A2. Development of resistance and related risk in animals
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>For relevant biological veterinary medicinal products (for example, substances with antimicrobial and antiparasitic activity), information on current resistance (if applicable) and on the potential emergence of resistance of clinical relevance for the claimed indication in the target animal species shall be provided. Where possible, information on the resistance mechanism(s), the molecular genetic basis of resistance, and the rate of transfer of resistance determinants shall be presented. Whenever relevant, information on co-resistance and cross-resistance shall be presented. Measures to limit resistance development in organisms of clinical relevance for the intended use of the veterinary medicinal product shall be proposed by the applicant.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Resistance relevant for risks to humans shall be addressed in Part 3 of the dossier. Where relevant, cross-reference shall be made to data set out in Part 3 of the dossier.</span></td></tr></tbody></table>
IIIa.4A3. Dose determination and confirmation
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Appropriate data shall be provided to justify the proposed dose, dosing interval, duration of treatment and any re-treatment interval.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>For studies conducted under field conditions, relevant information shall be provided as outlined under clinical studies.</span></td></tr></tbody></table>
IIIa.4A4. Tolerance in the target animal species
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The local and systemic tolerance of the veterinary medicinal product shall be investigated in the target animal species. The purpose of target animal safety studies is to characterise signs of intolerance and to establish an adequate margin of safety using the recommended route(s) of administration. This may be achieved by increasing the dose and/or the duration of treatment.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The study report(s) shall contain details of all expected pharmacological effects and all adverse reactions. The conduct of target animal safety studies shall be in accordance with VICH and relevant guidance published by the Agency. Other pre-clinical studies and clinical studies, along with relevant information from the published literature may also provide information on safety in the target species.</span></td></tr></tbody></table>
IIIa.4B. Clinical trials
IIIa.4B1. General principles
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Clinical trials shall be designed, carried out and reported taking into account VICH and relevant guidance published by the Agency. Data stemming from clinical trials conducted outside the Union may be taken into consideration for the assessment of an application for a marketing authorisation only, if the data are sufficiently representative of the Union situation.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Experimental data such as exploratory/pilot trials, or results from non-experimental approaches shall be confirmed by data obtained under normal field conditions, unless otherwise justified.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The purpose of clinical trials is to examine under field conditions the target animal safety and efficacy of a veterinary medicinal product under normal conditions of animal husbandry and/or as part of good veterinary practice. They shall demonstrate the effect of the veterinary medicinal product after administration to the intended target species using the proposed dosage regimen and the proposed route(s) of administration. The trial design shall aim to support the indications and take into account any contra-indications according to species, age, breed and sex, directions for use of the veterinary medicinal product as well as any adverse reactions which it may have.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>All veterinary clinical trials shall be conducted in accordance with a detailed trial protocol. For formulations intended for use in veterinary clinical trials in the Union, the words “for veterinary clinical trial use only” shall appear prominently and indelibly on the labelling.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>Unless otherwise justified, clinical trials shall be carried out with control animals (controlled clinical trials). The efficacy results obtained with the new product shall be compared with those from the target animal species that have received a veterinary medicinal product authorised in the Union that has demonstrated an acceptable level of efficacy and been approved for the proposed indication(s) for use in the same target animal species, or a placebo or no treatment. All the results obtained, whether positive or negative, shall be reported.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>Established statistical principles in accordance with the relevant guidance published by the Agency shall be used in protocol design, analysis and evaluation of clinical trials, unless otherwise justified.</span></td></tr></tbody></table>
IIIa.4B2. Documentation
The dossier on efficacy shall include all pre-clinical and clinical documentation, whether favourable or unfavourable to the veterinary medicinal products, in order to enable an objective overall assessment of the benefit/risk balance of the product.
IIIa.4B2.1. Results of pre-clinical studies
Wherever possible, particulars shall be given of the results of:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>tests demonstrating pharmacological activity;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>tests demonstrating the pharmacodynamic mechanisms underlying the therapeutic effect;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>tests demonstrating the main pharmacokinetic profile;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>tests demonstrating target animal safety;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>tests to determine and confirm the dose (including dose interval, duration of treatment and any re-treatment interval);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>tests and investigations on resistance, if applicable.</p></td></tr></tbody></table>
In the case where unexpected results occur during the course of the tests, those results shall be sufficiently detailed. Additionally, the following particulars shall be provided in all pre-clinical study reports.
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>a summary;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a study protocol;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>a detailed description of the objectives, design and conduct to include methods, apparatus and materials used, details such as species, age, weight, sex, number, breed or strain of animals, identification of animals, dose, route and schedule of administration;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>a statistical analysis of the results;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>an objective discussion of the results obtained, leading to conclusions on the efficacy and target animal safety of the veterinary medicinal product.</p></td></tr></tbody></table>
Omission of any of those data shall be justified.
IIIa.4B2.2. Results of clinical trials
All the particulars shall be supplied by each of the investigators on individual record sheets in the case of individual treatment and collective record sheets in the case of collective treatment.
The marketing authorisation holder shall make all necessary arrangements to ensure that the original documents, which formed the basis of the data supplied, are kept for at least five years after the veterinary medicinal product is no longer authorised.
In respect of each clinical trial, the clinical observations shall be summarised in a synopsis of the trials and the results thereof, indicating in particular:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the number of control and test animals treated either individually or collectively, with a breakdown according to species, breed or strain, age and sex;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the number of animals withdrawn prematurely from the trials and the reasons for such withdrawal;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>in the case of control animals, whether they have:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>received no treatment;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>received a placebo;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>received another veterinary medicinal product authorised in the Union that has demonstrated an acceptable level of efficacy and been approved for the proposed indication(s) for use in the same target animal species; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>received the same active substance under investigation in a different formulation or by a different route;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the frequency of observed adverse reactions;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>observations as to the effect on animal performance, if appropriate;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>details concerning test animals which may be at increased risk owing to their age, their mode of rearing or feeding, or the purpose for which they are intended, or animals the physiological or pathological condition of which requires special consideration;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>a statistical evaluation of the results.</p></td></tr></tbody></table>
The main investigator shall draw general conclusions on the efficacy and target animal safety of the veterinary medicinal product under the proposed conditions of use, and in particular any information relating to indications and contraindications, dosage and average duration of treatment and, where appropriate, any interactions observed with other veterinary medicinal products or feed additives as well as any special precautions to be taken during treatment and the clinical signs of overdoseage, when observed.
SECTION IIIb
REQUIREMENTS FOR IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS
The following requirements shall apply to immunological veterinary medicinal products as defined in Article 4(5), except where otherwise set out in Section IV.
IIIb.1. Part 1: Summary of the dossier
Please refer to Section I.
IIIb.2. Part 2: Quality documentation (physicochemical, biological and microbiological information)
IIIb.2.A. Product description
IIIb.2A1. Qualitative and quantitative composition
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Qualitative composition of all the constituents of the immunological veterinary medicinal product shall mean the designation or description of:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the active substance(s);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the constituents of the adjuvants;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the constituent(s) of other excipients, whatever their nature or the quantity used, including preservatives, stabilisers, colouring matter, flavouring and aromatic substances, markers, etc.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>accompanying reconstitution solvents.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Those data in point (1) shall be supplemented by any relevant data concerning the immediate packaging and if relevant the outer packaging and, where appropriate, its manner of closure, together with details of devices with which the immunological veterinary medicinal product will be used or administered and which will be delivered with the medicinal product. If the device is not delivered together with the immunological veterinary medicinal product, relevant information about the device shall be provided, where necessary for the assessment of the product.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The usual terminology to be used in describing the constituents of immunological veterinary medicinal products, notwithstanding the application of the other provisions of Article 8, means:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>in respect of substances which appear in the European Pharmacopoeia or, failing this, in the pharmacopoeia of one of the Member States, the main title of the monograph in question, which will be obligatory for all such substances, with reference to the pharmacopoeia concerned;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in respect of other substances, the INN recommended by the WHO, which may be accompanied by another non-proprietary name or, failing these, the exact scientific designation; substances not having an international non-proprietary name or an exact scientific designation shall be described by a statement of how and from what they were prepared, supplemented, where appropriate, by any other relevant details;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>in respect of colouring matter designation by the “E” code assigned to them in Directive 2009/35/EC.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>In order to give the quantitative composition of the active substances of an immunological veterinary medicinal product, it is necessary to specify whenever possible the number of organisms, the specific protein content, the mass, the number of International Units (IU) or units of biological activity, either per dosage-unit or volume, and with regard to the adjuvant and to the constituents of the excipients, the mass or the volume of each of them, with due allowance for the details provided in Part IIb.2B.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>Where an international unit of biological activity has been defined, this shall be used.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>The units of biological activity for which no published data exist shall be expressed in such a way as to provide unambiguous information on the activity of the ingredients, for example, by stating the amount as determined by titration or potency testing of the final product.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(7)</p></td><td><span>The composition shall be given in terms of minimum quantities and, if appropriate, with maximum quantities.</span></td></tr></tbody></table>
IIIb.2A2. Product development
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Explanation shall be provided with regard to, but may not be limited to:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the choice of composition and the choice of the constituents, in particular relative to their intended functions and their respective concentrations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the inclusion of a preservative in the composition shall be justified;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the immediate packaging and the suitability of the container and its closure system used for the storage and use of the finished product. A study of the interaction between finished product and the primary packaging shall be submitted wherever the risk of such interaction is regarded as possible, especially where injectable preparations are concerned;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the possible further packaging, outer packaging if relevant;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>the proposed pack sizes related to the proposed route of administration, the posology and the target species;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>any overage(s) in the formulation to guarantee minimum potency/antigen content at end of shelf life with justification;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>the selection of the manufacturing process of the active substance and the finished product;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>differences between the manufacturing process(es) used to produce batches used in clinical trials and the process described in the application for marketing authorisation shall be discussed;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>when an accompanying test is recommended to be used with the finished product (e.g. diagnostic test), relevant information about the test shall be provided.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>This explanation shall be supported by scientific data on product development.</span></td></tr></tbody></table>
IIIb.2B. Description of the manufacturing method
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The description of the manufacturing method accompanying the application for marketing authorisation pursuant to Article 8 shall be drafted in such a way as to give an adequate description of the nature of the operations employed, including the identification of the key stages in the production process.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The description of the manufacturing process shall include at least:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the various stages of manufacture (including production of the antigen and purification procedures) accompanied by a process flow chart so that an assessment may be made of the reproducibility of the manufacturing procedure and of the risks of adverse effects on the finished products, such as microbiological contamination;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in the case of continuous manufacture, full details concerning precautions taken to ensure the homogeneity and consistency of each batch of the finished product. Information on how a batch is defined and on the proposed commercial batch size(s) shall be provided;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>listing of all the substances at the appropriate steps where they are used, including those which cannot be recovered in the course of manufacturing;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the details of the blending, with the quantitative particulars of all the substances used, including an example for a representative production batch;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>list of in-process controls including the stage of manufacture at which they are conducted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>for sterile products, where non-pharmacopoeial sterilisation conditions are used, details of the sterilisation processes and/or aseptic procedures used.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Validation of all the methods of control used in the manufacturing process shall be described, documented and the results provided, unless otherwise justified. The validation of key stages in the production process shall be demonstrated and the validation of the production process as a whole shall be demonstrated with provision of results of three consecutive batches produced using the method described.</span></td></tr></tbody></table>
IIIb.2C. Production and control of starting materials
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>For the purposes of this Part, “starting materials” means all components used in the production of the immunological veterinary medicinal product.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Commercially available ready-to-use adjuvant systems designated by a brand name as well as culture media used for production of the active substance consisting of several components shall be regarded as one starting material. Nevertheless, the qualitative and quantitative composition shall be presented insofar as the authorities consider that this information is relevant to the quality of the finished product and any risks that might be posed.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>If materials of animal origin are used for preparation of those culture media or adjuvant systems, the animal species and the tissue used have to be included and compliance with the relevant monographs including general monographs and general chapters of the European Pharmacopoeia shall be demonstrated.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>The applicant shall supply documentation to demonstrate that the starting materials, including seed materials, cell seeds, batches of serum and other material originating from animal species relevant for the transmission of TSE and the manufacturing of the veterinary medicinal product is in compliance with the requirements of the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products, as well as with the requirements of the corresponding monograph of the European Pharmacopoeia. Certificates of Suitability issued by the European Directorate for the Quality of Medicines and HealthCare, with reference to the relevant monograph of the European Pharmacopoeia, may be used to demonstrate compliance.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>The dossier shall include the specifications, information on the tests to be conducted for the quality control of all batches of starting materials and results for a batch for all components used and shall be submitted in accordance with the requirements of this Part.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>Certificates of analysis shall be presented for the starting materials in order to demonstrate compliance with the defined specification.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(7)</p></td><td><span>Colouring matter shall, in all cases, satisfy the requirements of Directive 2009/35/EC.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(8)</p></td><td><span>The use of antibiotics during production and the inclusion of preservatives in the composition of the finished product shall be justified and in compliance with the European Pharmacopoeia.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(9)</p></td><td><span>For novel excipients, that is to say excipient(s) used for the first time in the Union in a veterinary medicinal product or by a new route of administration, details of manufacture, characterisation, and controls, with cross references to supporting safety data, both clinical and non- clinical, shall be provided. For colouring matters the declarations of compliance as mentioned under Part II.2C2, points (3) and (4) shall be considered sufficient.</span></td></tr></tbody></table>
IIIb.2C1. Starting materials listed in pharmacopoeias
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The monographs of the European Pharmacopoeia shall be applicable to all starting materials appearing in it, unless proper justification is provided.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>In respect of other substances, each Member State may require observance of its own national pharmacopoeia with regard to products manufactured in its territory.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The description of the analytical methods may be replaced by a detailed reference to the pharmacopoeia in question.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>The routine tests carried out on each batch of starting materials shall be as stated in the application for marketing authorisation. If tests other than those mentioned in the pharmacopoeia are used, proof shall be supplied that the starting materials meet the quality requirements of that pharmacopoeia.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>In cases where a specification or other provisions contained in a monograph of the European Pharmacopoeia or in the pharmacopoeia of a Member State might be insufficient to ensure the quality of the substance, the competent authorities may request more appropriate specifications from the applicant for marketing authorisation. The alleged insufficiency shall be reported to the authorities responsible for the pharmacopoeia in question.</span></td></tr></tbody></table>
IIIb.2C2. Starting materials not listed in a pharmacopoeia
IIIb.2C2.1. Starting materials of biological origin
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The description shall be given in the form of a monograph.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Vaccine production shall be based on a seed lot system and on established cell seeds, whenever possible. For the production of immunological veterinary medicinal products consisting of serum, the origin, general health and immunological status of the producing animals shall be indicated and defined pools of source materials shall be used.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The origin, including geographical region, and history of starting materials shall be described and documented.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>For genetically engineered starting materials this information shall include details such as the description of the starting cells or strains, the construction of the expression vector (name, origin, function of the replicon, promoter enhancer and other regulator elements), control of the sequence of DNA or RNA effectively inserted, oligonucleotide sequences of plasmid vector in cells, plasmid used for cotransfection, added or deleted genes, biological properties of the final construct and the genes expressed, copy number and genetic stability.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>In the case of veterinary medicinal products containing or consisting of genetically modified organisms (GMO), the quality part of the application shall also be accompanied by the documents required in accordance with Directive 2001/18/EC.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>Seed materials, including cell seeds and raw serum for anti-serum production shall be tested for identity and the absence of extraneous agents shall be demonstrated according to the European Pharmacopoeia.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(7)</p></td><td><span>Information shall be provided on all substances of biological origin used at any stage in the manufacturing procedure. The information shall include:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>details of the source of the materials;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>details of any processing, purification and inactivation applied, with data on the validation of those processes and controls during production;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>details of any tests for contamination carried out on each batch of the substance.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(8)</p></td><td><span>If the presence of extraneous agents is detected or suspected, the corresponding material shall be discarded or processed to reduce the risk of presence with a validated treatment. If after treatment presence is detected or suspected, the corresponding material shall be used only when further processing of the product ensures their elimination and/or inactivation; elimination and/or inactivation of such extraneous agents shall be demonstrated.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(9)</p></td><td><span>When cell seeds are used, the cell characteristics shall be shown to have remained unchanged up to the highest passage level used for the production.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(10)</p></td><td><span>For live attenuated vaccines, confirmation of the stability of the attenuation characteristics of the seed shall be provided. Unless a specific characteristic is associated with the attenuation (e.g. genetic marker, thermal stability), this is typically achieved through absence of reversion to virulence in the target animal species.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(11)</p></td><td><span>When required, samples of the biological starting material or reagents used in the testing procedures shall be provided to enable the competent authority to arrange for check tests to be carried out.</span></td></tr></tbody></table>
IIIb.2C2.2. Starting materials of non-biological origin
The description shall be given in the form of a monograph under the following headings:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the name of the starting material meeting the requirements of point (3) of Part IIIb.2A1. shall be supplemented by any trade or scientific synonyms;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the description of the starting material, set down in a form similar to that used in a descriptive item in the European Pharmacopoeia;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the function of the starting material;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>methods of identification;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>any special precautions which may be necessary during storage of the starting material and, if necessary, its storage life shall be given.</p></td></tr></tbody></table>
IIIb.2D. Control tests during the manufacturing process
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The dossier shall include particulars relating to the control tests, which are carried out on intermediate stages of manufacture with a view to verifying the consistency of the manufacturing process and the final product. Specifications shall be set for each control test and the analytical methods shall be described. Validation of the control tests for parameters considered critical to the manufacturing process shall be provided unless otherwise justified.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>For inactivated or detoxified vaccines, inactivation or detoxification shall be tested during each production run as soon as possible after the end of the inactivation or detoxification process and after neutralisation if this occurs, but before the next step of production.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>In accordance with the provisions of Directive 2010/63/EU and the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes, tests shall be carried out in such a way as to use the minimum number of animals and to cause the least pain, suffering, distress or lasting harm. If available, an alternative in vitro test shall be used when this leads to replacement or reduction of animal use or reduction of suffering.</span></td></tr></tbody></table>
IIIb.2E. Control tests on the finished product
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>For all tests, the description of the techniques for analysing the finished product shall be set out in sufficient detail for a quality assessment.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Where appropriate monographs exist, if test procedures and limits other than those mentioned in the monographs of the European Pharmacopoeia, or failing this, in the pharmacopoeia of a Member State, are used, proof shall be supplied that the finished product would, if tested in accordance with those monographs, meet the quality requirements of that pharmacopoeia for the pharmaceutical form concerned. The application for marketing authorisation shall list those tests, which are carried out on representative samples of each batch of finished product. The frequency of the tests carried out on the final bulk vaccine instead of on the batch or batches prepared from it, shall be stated. Release limits shall be indicated and justified. Validation of the control tests carried out on the finished product shall be provided.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Information regarding the establishment and replacement of reference material shall be provided. If more than one reference standard has been used, a qualification history shall be provided describing how the relationship between the different standards was maintained.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>Where available, chemical and biological reference material of the European Pharmacopoeia shall be used. If other reference preparations and standards are used, they shall be identified and described in detail.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>In accordance with the provisions of Directive 2010/63/EU and the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes, tests shall be carried out in such a way as to use the minimum number of animals and to cause the least pain, suffering, distress or lasting harm. If available, an alternative<span>in vitro</span> test shall be used when this leads to replacement or reduction of animal use or reduction of suffering.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>General characteristics of the finished product</span><p>The tests of general characteristics shall, wherever applicable, relate to the appearance and to physical or chemical tests, such as, conductivity, pH, viscosity, etc. For each of those characteristics, specifications, with appropriate acceptance limits, shall be established by the applicant.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(7)</p></td><td><span>Identification of active substance(s)</span><p>Where necessary, a specific test for identification shall be carried out. When appropriate, the identification test may be combined with the batch titre or potency test.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(8)</p></td><td><span>Batch titre or potency</span><p>A quantification of the active substance shall be carried out on each batch to show that each batch will contain the appropriate potency or titre to ensure its safety and efficacy.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(9)</p></td><td><span>Identification and assay of adjuvants</span><p>The quantity and nature of the adjuvant and its components shall be verified on the finished product, unless otherwise justified.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(10)</p></td><td><span>Identification and assay of excipient components</span><p>Insofar as is necessary, the excipient(s) shall be subject at least to identification tests.</p><p>An upper and lower limit test shall be obligatory in respect of preserving agents. An upper limit test for any other excipient components liable to give rise to an adverse reaction shall be obligatory.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(11)</p></td><td><span>Sterility and purity test</span><p>Freedom from extraneous agents (bacteria, mycoplasma, fungi and bacterial endotoxin when relevant) shall be demonstrated for parenterally administered products in compliance with the European Pharmacopoeia. For non-liquid, non-parenterally administered products, where adequately justified, compliance to a maximum bioburden limit instead of sterility test may be acceptable.</p><p>Appropriate tests to demonstrate the absence of contamination by extraneous agents or other substances, shall be carried out according to the nature of the immunological veterinary medicinal product, the method and the conditions of manufacture. A risk-based approach to demonstrate the absence of extraneous agents as described in the European Pharmacopoeia shall be used.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(12)</p></td><td><span>Residual humidity</span><p>Each batch of lyophilised product shall be tested for residual humidity.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(13)</p></td><td><span>Filling volume</span><p>Appropriate tests to demonstrate the correct filling volume shall be carried out.</p></td></tr></tbody></table>
IIIb.2F. Batch-to-batch consistency
In order to ensure that quality of the product is consistent from batch to batch and to demonstrate conformity with specifications a full protocol of three consecutive batches representative of the routine production giving the results for all tests performed during production and on the finished product shall be provided. Consistency data obtained from combined products may be used for derivative products containing one or more of the same components.
IIIb.2G. Stability tests
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Stability tests cover stability of the active substance and the finished product, including solvent(s), if relevant.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>A description shall be given of the tests undertaken to support the shelf life, the recommended storage conditions and the specifications at the end of the shelf life proposed for the active substance and the finished product. Those tests shall always be real-time studies.</span><p>If intermediate products obtained at various stages of the manufacturing process are stored, the intended conditions and duration of storage shall be adequately justified on the basis of the stability data available.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Stability tests for the finished product shall be carried out on not fewer than three representative batches produced according to the described production process and on products stored in the final container(s); those tests include biological and physicochemical stability tests carried out at regular intervals, for the finished product until 3 months beyond the claimed end of the shelf life.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>The conclusions shall contain the results of analyses, justifying the proposed shelf life under all proposed storage conditions. The results obtained during the stability study shall be taken into account when defining appropriate formulation and release specifications to ensure the conformity of the product with the claimed shelf life</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>In the case of products administered in feed, information shall also be given as necessary on the shelf life of the product, at the different stages of mixing, when mixed in accordance with the recommended instructions.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>Where a finished product requires reconstitution prior to administration or is administered in drinking water, details of the proposed shelf life are required for the product reconstituted as recommended. Data in support of the proposed shelf life for the reconstituted product shall be submitted.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(7)</p></td><td><span>Stability data obtained from combined products may be used where adequately justified for derivative products containing one or more of the same components.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(8)</p></td><td><span>In the case of multi-dose containers, where relevant, stability data shall be presented to justify a shelf life for the product after it has been broached or opened for the first time and an in-use shelf-life specification shall be defined.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(9)</p></td><td><span>The efficacy of any preservative system shall be demonstrated.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(10)</p></td><td><span>Information on the efficacy of preservatives in other similar immunological veterinary medicinal products from the same manufacturer may be sufficient.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(11)</p></td><td><span>If active substances are stored, the intended conditions and duration of storage shall be defined on the basis of stability data. Those data may be obtained either through testing of the active substances themselves or through appropriate testing of the finished product.</span></td></tr></tbody></table>
IIIb.2H. Other information
Information relating to the quality of the immunological veterinary medicinal product not covered by this Section may be included in the dossier.
IIIb.3. Part 3: Safety documentation (safety and residues tests )
IIIb.3A. General requirements
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The safety documentation shall be adequate for the assessment of:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the safety of the immunological veterinary medicinal product when administered to the target species and any undesirable effects which may occur under the proposed conditions of use; those undesirable effects shall be evaluated in relation to potential benefits of the product;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the potential harmful effects to man of residues of the veterinary medicinal product or substance in foodstuffs obtained from treated animals;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the potential risks which may result from the exposure of human beings to the veterinary medicinal product, for example, during its administration to the animal;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the potential risks to the environment resulting from the use of the veterinary medicinal product.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Pre-clinical studies shall be carried out in compliance with good laboratory practice (GLP) requirements.</span><p>Non-GLP studies may be accepted for non-target species studies as well as studies evaluating immunological, biological or genetic properties of the vaccine strains, under adequately controlled conditions. Other deviations shall be justified.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>All safety trials shall be conducted in accordance with a fully considered detailed protocol, which shall be recorded in writing prior to commencement of the trial. The welfare of the trial animals shall be subject to veterinary supervision and shall be taken fully into consideration during the elaboration of any trial protocol and throughout the conduct of the trial.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>Pre-established systematic written procedures for the organisation, conduct, data collection, documentation and verification of safety trials shall be required.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>Clinical trials (field trials) shall be conducted in compliance with established principles of good clinical practice (GCP). Deviations shall be justified.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>The safety studies shall be in line with the relevant European Pharmacopeia requirements. Deviations shall be justified.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(7)</p></td><td><span>The safety studies shall be carried out in the target species. The dose to be used shall be the quantity of the product to be recommended for use and the batch used for safety testing shall be taken from a batch or batches produced according to the manufacturing process described in Part 2 of the application.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(8)</p></td><td><span>For laboratory tests described in Sections B.1, B.2 and B.3, the dose of the veterinary medicinal product shall contain the maximum titre, antigen content or potency. If necessary, the concentration of the antigen may be adjusted to achieve the required dose.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(9)</p></td><td><span>The safety of an immunological veterinary medicinal product shall be demonstrated for each category of target animal species in which its use is recommended, by each recommended route and method of administration and using the proposed schedule of administration. A worst-case scenario for route and method of administration may be used if scientifically justified.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(10)</p></td><td><span>In the case of immunological veterinary medicinal products consisting of live organisms, special requirements are included under B.6.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(11)</p></td><td><span>The particulars and documents which shall accompany the application for marketing authorisation shall be submitted in accordance with the requirements for pre-clinical studies and clinical trials described in Parts IIIb.4B, point (4), and IIIb.4C, point (3)..</span></td></tr></tbody></table>
IIIb.3B. Pre-clinical studies
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Safety of the administration of one dose</span><p>The immunological veterinary medicinal product shall be administered at the recommended dose and by each recommended route and method of administration to animals of each species and each relevant category (e.g. minimum age, pregnant animals, as appropriate) in which it is intended for use.</p><p>The animals shall be observed and examined daily for signs of systemic and local reactions until reactions may no longer be expected, but in all cases, at least 14 days after administration. Where appropriate, those studies shall include detailed post-mortem macroscopic and microscopic examinations of the injection site. Other objective criteria shall be recorded, such as rectal temperature and performance measurements.</p><p>This study may be part of the repeated dose study required under point 3 or omitted if the results of the overdose study required under point 2 have revealed no major signs of systemic or local reactions. If omitted, the systemic or local reactions seen in the overdose study shall be taken as the basis for describing safety of the product in the Summary of Product Characteristics.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Safety of one administration of an overdose</span><p>Only live immunological veterinary medicinal products require overdose testing.</p><p>An overdose of the immunological veterinary medicinal product, normally consisting of ten doses, shall be administered by each recommended route(s) and method(s) of administration to animals of the most sensitive categories of the target species, unless the selection of the most sensitive of several similar routes is justified. In the case of immunological veterinary medicinal products administered by injection, the doses and route(s) and method(s) of administration shall be chosen to take account of the maximum volume, which can be administered at any one single injection site.</p><p>The animals shall be observed and examined daily for at least 14 days after administration for signs of systemic and local reactions. Other criteria shall be recorded, such as rectal temperature and performance measurements.</p><p>Where appropriate, those studies shall include detailed post-mortem macroscopic and microscopic examinations of the injection site if this has not been done under point 1.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Safety of the repeated administration of one dose</span><p>In the case of immunological veterinary medicinal products to be administered more than once, as part of the basic administration scheme, a study of the repeated administration of one dose shall be required to reveal any adverse effects induced by such administration.</p><p>The test shall be carried out on the most sensitive categories of the target species (such as certain breeds, age groups), using each recommended route and method of administration.</p><p>The number of administrations shall not be less than the maximum number recommended; for vaccines, this shall take account of the number of administrations for primary vaccination and the first re-vaccination.</p><p>The interval between administrations may be shorter than the one claimed in the Summary of Product Characteristics. The chosen interval shall be justified with respect to the proposed conditions of use.</p><p>The animals shall be observed and examined daily for at least 14 days after the last administration for signs of systemic and local reactions. Other objective criteria shall be recorded, such as rectal temperature and performance measurements.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>Examination of reproductive performance</span><p>Examination of reproductive performance shall be considered when the immunological veterinary product is intended for use or may be used in pregnant animals or laying birds and when data suggest that the starting material from which the product is derived may be a potential risk factor.</p><p>Reproductive performance of males and non-pregnant and pregnant females shall be investigated with the recommended dose and by the most sensitive route and method of administration.</p><p>For immunological veterinary medicinal products that are recommended for use in pregnant animals, examination of the reproductive performance shall address safety of administration during the entire gestation period or during specific period of gestation taking into account the intended use of the product.</p><p>The observation period shall be extended to parturition to investigate possible harmful effects on the progeny, including teratogenic and abortifacient effects.</p><p>Those studies may form part of the safety studies described in points 1, 2, 3 or of the field trials provided for in Section IIIb.3C.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>Examination of immunological functions</span><p>Where the immunological veterinary medicinal product might adversely affect the immune response of the vaccinated animal or of its progeny, suitable tests on immunological function shall be carried out.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(6)</p></td><td><span>Special requirements for live vaccines</span></td></tr></tbody></table>
(1) Spread of the vaccine strain
Spread of the vaccine strain from vaccinated to unvaccinated target animals shall be investigated, using the recommended route of administration most likely to result in the spread. Moreover, it may be necessary to investigate the spread to non-target animal species which could be highly susceptible to a live vaccine strain. An assessment of the number of animal-to-animal passages likely to occur under normal conditions of use and potential consequences shall be provided.
(2) Dissemination in the vaccinated animal
Faeces, urine, milk, eggs, oral, nasal and other secretions shall be tested for the presence of the organism as appropriate. Moreover, studies may be required of the dissemination of the vaccine strain in the body, with particular attention being paid to the predilection sites for replication of the organism. In the case of live vaccines for zoonoses within the meaning of Directive 2003/99/EC of the European Parliament and of the Council to be used for food producing animals, those studies shall take particularly into account the persistence of the organism at the injection site.
(3) Increase in virulence
Increase in or reversion to virulence shall be investigated with the master seed. If the master seed is not available in sufficient quantity the lowest passage seed used for the production shall be examined. Use of another passage option shall be justified. The initial vaccination shall be carried out using the route and method of administration most likely to lead to an increase in virulence indicative of reversion to virulence. Serial passages shall be made in target animals through five groups of animals, unless there is justification to make more passages or the organism disappears from the test animals sooner. Where the organism fails to replicate adequately, as many passages as possible shall be carried out in the target species.
(4) Biological properties of the vaccine strain
Other tests may be necessary to determine as precisely as possible the intrinsic biological properties of the vaccine strain (e.g. neurotropism).
For vaccines containing live genetically modified organism(s), where the product of a foreign gene is incorporated into the strain as a structural protein, the risk of changing the tropism or virulence of the strain shall be addressed and, where necessary, specific tests shall be conducted.
(5) Recombination or genomic reassortment of strains
The probability of recombination or genomic reassortment with field or other strains shall be evaluated and the consequences of such events discussed.
<table><col/><col/><col/><tbody><tr><td/><td><p>(7)</p></td><td><span>User safety</span><p>This section shall include a discussion of the effects found in Part IIIb.3A to IIIb.3B and relate those effects to the type and extent of human exposure to the product with a view to formulating appropriate user warnings and other risk management measures.</p><p>User safety shall be addressed in accordance with relevant guidance published by the Agency.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(8)</p></td><td><span>Interactions</span><p>If there is a compatibility statement with other veterinary medicinal products in the summary of product characteristics the safety of the association shall be investigated. Any other known interactions with veterinary medicinal products shall be described.</p></td></tr></tbody></table>
IIIb.3C. Clinical trials
Unless otherwise justified, results from pre-clinical studies shall be supplemented with data from clinical trials, using batches representative of the manufacturing process described in the marketing authorisation application. Both safety and efficacy may be investigated in the same clinical trials.
IIIb.3D. Environmental risk assessment
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>An environmental risk assessment shall be performed to assess the potential harmful effects, which the use of the veterinary medicinal product may cause to the environment and to identify the risk of such effects. The assessment shall also identify any precautionary measures which may be necessary to reduce such risk.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>This assessment consists of two phases. The first phase of the assessment shall always be performed. The details of the assessment shall be provided in accordance with guidance published by the Agency. It shall indicate the potential exposure of the environment to the product and the level of risk associated with any such exposure, taking into account in particular the following items:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the target animal species and the proposed pattern of use;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the route and method of administration, in particular the likely extent to which the product will enter directly into the environmental system;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the possible excretion or secretion of the product, its active substances into the environment by treated animals, persistence in such excreta or secreta;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the disposal of unused or waste product.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>In the case of live vaccine strains which may be zoonotic, the risk to humans shall be assessed.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>Where the conclusions of the first phase indicate a relevant potential risk for the environment of the product, the applicant shall proceed to the second phase and evaluate the potential risk(s) that the veterinary medicinal product might pose to the environment. Where necessary, further investigations on the impact of the product (soil, water, air, aquatic systems, non-target organisms) shall be carried out.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>For DNA vaccines, a specific safety concern is the potential risk of migration of the DNA to gonadal tissues and potential DNA transfer into germ line cells of vaccinated male and female animals and thus potential transmission to offspring. The applicant shall evaluate and discuss potential risk(s) such immunological veterinary medicinal products might pose on human health and the environment (including plants and animals). If potential risk(s) are identified, investigations on the impact of the vaccine depending on its use in companion animals or in food producing animals shall be carried out to provide information on this point.</span></td></tr></tbody></table>
IIIb.3E. Assessment required for veterinary medicinal products containing or consisting of genetically modified organisms
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>In the case of veterinary medicinal products containing or consisting of genetically modified organisms (GMOs) the application shall also be accompanied by the documents required under Article 2 and Part C of Directive 2001/18/EC and the specific guidance dealing with GMOs.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Potential adverse effects on human health and the environment, which may occur through gene transfer from GMOs to other organisms or arise from genetic modifications, shall be accurately assessed on a case-by-case basis. The objective of such an environmental risk assessment is, to identify and evaluate potential direct and indirect, immediate or delayed adverse effects of the GMO on human health and the environment (including plants and animals) and shall be carried out in accordance with the principles of Annex II to Directive 2001/18/EC.</span></td></tr></tbody></table>
IIIb.3F. Residue tests to be included in the pre-clinical studies
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>For immunological veterinary medicinal products, it will normally not be necessary to undertake a study of residues.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Where antibiotics, adjuvants, preservatives or any other excipient are used in the manufacture of immunological veterinary medicinal products intended for food producing animals and/or are included in the final formulation, consideration shall be given to the possibility of consumer exposure to residues in foodstuffs derived from treated animals and compliance with MRLs legislation. Consumer safety implications arising from their potential presence in the finished product shall be addressed.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>In the case of live vaccines for well-established zoonotic diseases, in addition to the studies of dissemination, the determination of residual vaccine organisms at the injection site may be required. If necessary, the effects of such residues shall be investigated.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>A proposal for a withdrawal period shall be made and its adequacy shall be discussed in relation to any residue studies which have been undertaken.</span></td></tr></tbody></table>
IIIb.4. Part 4: Efficacy documentation (pre-clinical studies and clinical trial(s))
IIIb.4A. General requirements
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The following general requirements shall be complied with:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the efficacy studies shall be in line with the general European Pharmacopeia requirements; Deviations shall be justified.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the primary parameter on which determination of efficacy is based needs to be defined by the investigator at the time of study design and shall not be changed after the study is completed;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the planned statistical analysis shall be described in detail in the study protocols;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the choice of antigens or vaccine strains shall be justified on the basis of epizoological data;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>efficacy trials carried out in the laboratory shall be controlled trials, including untreated control animals unless this is not justified for animal welfare reasons and efficacy can be otherwise demonstrated.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>In general, pre-clinical studies shall be supported by trials carried out in field conditions.</span><p>When pre-clinical studies fully support the claims made in the summary of product characteristics, trials carried out in field conditions are not required.</p><p>Unless otherwise justified, results from pre-clinical studies shall be supplemented with data from clinical trials, using batches representative of the manufacturing process described in the marketing authorisation application. Both safety and efficacy may be investigated in the same clinical trials.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>All trials shall be described in sufficient detail so as to be properly assessed by the competent authorities. The validity of all techniques used in the trial shall be demonstrated.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>All results obtained, whether favourable or unfavourable, shall be reported:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>The efficacy of an immunological veterinary medicinal product shall be demonstrated for each category of target animal species in which its use is recommended, by each recommended route and method of administration and using the proposed schedule of administration. Unless otherwise justified, the onset and duration of immunity shall be established and supported by data from trials.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>The influence of passively acquired maternally derived antibodies on the efficacy of vaccines when administered to animals at an age at which maternally acquired immunity is still present shall be adequately evaluated, if appropriate.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>The efficacy of each of the components of multivalent and combined immunological veterinary medicinal products shall be demonstrated. If the product is recommended for administration in combination with or at the same time as another veterinary medicinal product, to the efficacy of the association shall be demonstrated by appropriate studies. Any known interactions with any other veterinary medicinal products shall be described.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>Whenever a product forms part of a vaccination scheme recommended by the applicant, the priming or booster effect or the contribution of the veterinary immunological product to the efficacy of the scheme as a whole shall be demonstrated.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>The dose to be used shall be the quantity of the product to be recommended for use and the batch used for efficacy testing shall be taken from a batch or batches produced according to the manufacturing process described in Part 2 of the application.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>For diagnostic immunological veterinary medicinal products administered to animals, the applicant shall indicate how reactions to the product are to be interpreted.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>For vaccines intended to allow a distinction between vaccinated and infected animals (marker vaccines), where the efficacy claim is reliant on<span>in vitro</span> diagnostic tests, sufficient data on the diagnostic tests shall be provided to allow adequate assessment of the claims related to the marker properties.</p></td></tr></tbody></table></td></tr></tbody></table>
IIIb.4B. Pre-clinical studies
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>In principle, demonstration of efficacy shall be undertaken under well-controlled laboratory conditions by challenge after administration of the immunological veterinary medicinal product to the target animal under the recommended conditions of use. Insofar as possible, the conditions under which the challenge is carried out shall reflect the natural conditions for infection. Details of the challenge strain and its relevance shall be provided.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>For live vaccines, the product used for efficacy testing shall be taken from a batch or batches containing the minimum titre or potency. For other products, product from batches containing the minimum active content or potency expected at the end of the period of validity shall be used, unless otherwise justified.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>If possible, the immune mechanism (cell-mediated/humoral, local/general classes of immunoglobulin) which is initiated after the administration of the immunological veterinary medicinal product to target animals by the recommended route of administration shall be specified and documented.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>The following shall be provided for all pre-clinical studies:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>a summary;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a statement of compliance with good laboratory practice for pre-clinical studies, where applicable;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the name of the body having carried out the studies;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>a detailed experimental protocol giving a description of the methods, apparatus and materials used, details such as species or breed of animals, categories of animals, where they were obtained, their identification and number, the conditions under which they were housed and fed (stating, inter alia, whether they were free from any specified pathogens and/or specified antibodies, the nature and quantity of any additives contained in the feed), dose, route, schedule and dates of administration, a description and a justification of the statistical methods used;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>in the case of control animals, whether they received a placebo or no treatment;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>in the case of treated animals and, where appropriate, whether they received the test product or another product authorised in the Union;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>all general and individual observations and results obtained (with averages and standard deviations), whether favourable or unfavourable. The data shall be described in sufficient detail to allow the results to be critically evaluated independently of their interpretation by the author. The individual data shall be presented in tabular form. By way of explanation and illustration, the results may be accompanied by reproductions of recordings, photomicrographs, etc.;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>the nature, frequency and duration of observed adverse reactions;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the number of animals withdrawn prematurely from the studies and reasons for such withdrawal;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(j)</p></td><td><p>a statistical analysis of the results, where such is called for by the test programme, and variance within the data;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(k)</p></td><td><p>occurrence and course of any intercurrent disease;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(l)</p></td><td><p>all details concerning veterinary medicinal products (other than the product under study), the administration of which was necessary during the course of the study;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(m)</p></td><td><p>any other observations and deviations from the protocol and possible impact on the results;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(n)</p></td><td><p>an objective discussion of the results obtained, leading to conclusions on the safety and efficacy of the product.</p></td></tr></tbody></table></td></tr></tbody></table>
IIIb.4C. Clinical trials
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>Unless otherwise justified, results from pre-clinical studies shall be supplemented with data from field trials, using batches representative of the manufacturing process described in the marketing authorisation application. Both safety and efficacy may be investigated in the same field trial.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Where pre-clinical studies cannot be supportive of efficacy, the performance of field trials alone may be acceptable.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Particulars concerning field trials shall be sufficiently detailed to enable an objective judgement to be made. They shall include the following:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>a summary;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a statement of compliance with good clinical practice;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>name, address, function and qualifications of the investigator in charge;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>place and date of administration, identity code that may be linked to the name and address of the owner of the animal(s);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>details of the trial protocol, giving a description of the methods, apparatus and materials used, details such as the route and method of administration, the schedule of administration, the dose, the categories of animals, the duration of observation, the serological response and other investigations carried out on the animals after administration;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>in the case of control animals, whether they received a placebo, a competitor product or no treatment;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>identification of the treated and control animals (collective or individual, as appropriate), such as species, breeds or strains, age, weight, sex, physiological status;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>a brief description of the method of rearing and feeding, stating the nature and quantity of any additives contained in the feed;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>all the particulars on observations, performances and results (with averages and standard deviation); individual data shall be indicated when tests and measurements on individuals have been carried out;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(j)</p></td><td><p>a statistical analysis of the results, where such is called for by the test programme, and variance within the data;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(k)</p></td><td><p>all observations and results of the trials, whether favourable or unfavourable, with a full statement of the observations and the results of the objective tests of activity required to evaluate the product; the techniques used shall be specified and the significance of any variations in the results explained;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(l)</p></td><td><p>effects on the animals’ performance;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(m)</p></td><td><p>the number of animals withdrawn prematurely from the trials and reasons for such withdrawal;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(n)</p></td><td><p>the nature, frequency and duration of observed adverse reactions;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(o)</p></td><td><p>occurrence and course of any intercurrent disease;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(p)</p></td><td><p>all details concerning veterinary medicinal products (other than the product under study) which have been administered either prior to or concurrently with the test product or during the observation period; details of any interactions observed;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(q)</p></td><td><p>any other observations and deviations for the protocol and possible impact on the results;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(r)</p></td><td><p>an objective discussion of the results obtained, leading to conclusions on the safety and efficacy of the product.</p></td></tr></tbody></table></td></tr></tbody></table>
SECTION IV
REQUIREMENTS FOR SPECIFIC MARKETING AUTHORISATION APPLICATIONS
IV.1. Applications for generic veterinary medicinal products
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.1.1.</p></td><td><span>Applications based on Article 18 (generic veterinary medicinal products) shall contain the data referred to in Parts 1 and 2 of Section II of this Annex. If required, pursuant to Article 18(7) an environmental risk assessment shall be included. In addition, the dossier shall contain data demonstrating that the product has the same qualitative and quantitative composition in active substance(s) and the same pharmaceutical form as the reference medicinal product; and data, showing bioequivalence with the reference medicinal product or a justification as to why such studies were not performed with reference to established guidance. All immediate-release oral pharmaceutical forms shall be considered to be the same pharmaceutical form.</span><p>For biological (including immunological) veterinary medicinal products, the standard generic approach is in principle not considered appropriate, and a hybrid approach shall be followed (see Part IV.2.).</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.1.2.</p></td><td><span>For generic veterinary medicinal products, the critical expert reports on safety and efficacy shall particularly focus on the following elements:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the grounds for claiming bioequivalence;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a summary of impurities present in batches of the active substance(s) as well as those of the finished medicinal product (and where relevant decomposition products arising during storage) together with an evaluation of those impurities;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>an evaluation of the bioequivalence studies or other information that may provide support for claiming bioequivalence in accordance with relevant guidance published by the Agency;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>any additional data in order to demonstrate the equivalence of safety and efficacy properties of different salts, esters or derivatives of an authorised active substance;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>a review of the user safety risk assessment focusing on differences between the generic and reference veterinary medicinal products (for example, composition in excipients);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>a review of environmental risk assessment, where relevant.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.1.3.</p></td><td><span>For a generic veterinary medicinal product application containing an antimicrobial substance, information about the level of resistance, as known from bibliographic data, shall be provided.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.1.4.</p></td><td><span>For a generic veterinary medicinal product containing an antiparasitic substance, information about the level of resistance, as known from bibliographic data, shall be provided.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.1.5.</p></td><td><span>For generic veterinary medicinal products intended to be administered by intramuscular, subcutaneous or transdermal routes, the following additional data shall be provided:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>evidence to demonstrate equivalent or differing depletion of residues from the administration site, which may be substantiated by appropriate residue depletion studies;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>evidence to demonstrate target animal tolerance at the administration site, which may be substantiated by appropriate target animal tolerance studies.</p></td></tr></tbody></table></td></tr></tbody></table>
IV.2. Applications for hybrid veterinary medicinal products
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.2.1.</p></td><td><span>Applications based on Article 19 (hybrid veterinary medicinal products) concern veterinary medicinal products, which are similar to a reference veterinary medicinal product, but which do not meet the conditions in the definition of generic veterinary medicinal product.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.2.2.</p></td><td><span>For such applications, the following information shall be supplied:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>all the data referred to in Parts 1 and 2 of Sections II or III, as appropriate, of this Annex;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>for Parts 3 and 4 of the dossier, hybrid applications may rely in part on the results of the appropriate safety, residue, pre-clinical studies and clinical trials for an already authorised reference veterinary medicinal product, and in part on new data. New data shall include a user safety risk assessment and an environmental risk assessment in accordance with Article 18(7), if applicable. In addition, for relevant products (for example, antimicrobials, antiparasitics) the risk of development of resistance shall be addressed, if applicable.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.2.3.</p></td><td><span>In the case of biological (including immunological) veterinary medicinal products, a comprehensive comparability review, addressing the quality, safety and efficacy part shall be provided.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.2.4.</p></td><td><span>Where reference is made to data originating from another authorised veterinary medicinal product, a justification for the use and relevance of those data for the new product shall be provided.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.2.5.</p></td><td><span>The extent of new data required to support safety and efficacy will depend on the specific characteristics of the individual new product, and its differences to the reference veterinary medicinal product, and shall be determined on a case-by-case basis. New pre-clinical and clinical data for the new product shall be presented for all aspects where the reference veterinary medicinal product does not provide relevant support.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.2.6.</p></td><td><span>If new studies are conducted with batches of a reference veterinary medicinal product authorised in a third country, the applicant shall demonstrate that the reference veterinary medicinal product has been authorised in accordance with requirements equivalent to those established in the Union, and are so highly similar that they may substitute each other in the pre-clinical studies or clinical trials.</span></td></tr></tbody></table>
IV.3. Applications for combination veterinary medicinal products
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.3.1.</p></td><td><span>An application for a fixed combination product with individual active substances, which have already been the object of a marketing authorisation for a veterinary medicinal product in the EEA, shall be submitted under Article 20.</span><p>A fixed combination product containing at least one new active substance which has not yet been authorised for a veterinary medicinal product in the EEA, shall be submitted under Article 8.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.3.2.</p></td><td><span>For applications submitted under Article 20, a full dossier containing Parts 1, 2, 3 and 4 shall be provided.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.3.3.</p></td><td><span>A sound scientific justification based on valid therapeutic principles for the combination of active substances, including clinical data, shall be provided, which demonstrates the need for and contribution of all active substances at the moment of treatment.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.3.4.</p></td><td><span>In general, all the data on the safety and efficacy shall be provided for the fixed combination product, and safety and efficacy data for the individual active substances alone are not required, except to clarify their individual pharmacological properties.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.3.5.</p></td><td><span>If data on the safety and efficacy of an individual known active substance are available to the applicant with sufficient amount of detail, those data could be provided to obviate the need for some studies with the fixed combination, or contributing relevant information. In that case, possible interaction between active substances shall also be investigated.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.3.6.</p></td><td><span>User safety assessment, environmental risk assessment, residues depletion studies, and clinical studies shall be conducted with the fixed combination product.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.3.7.</p></td><td><span>Unless the omission is justified, a target animal safety study with the final formulation shall be provided.</span></td></tr></tbody></table>
IV.4. Applications based on informed consent
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.4.1.</p></td><td><span>Applications based on Article 21 concern products with identical composition, pharmaceutical form and manufacturing process (including raw and starting materials, process parameters and manufacturing sites) as the already authorised veterinary medicinal products.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.4.2.</p></td><td><span>The dossier for such applications shall only include data for Part 1A and 1B, as described in Annex I (points 1 to 6.4), provided that the marketing authorisation holder for the already authorised veterinary medicinal product has given the applicant his written consent to refer to the content of Parts 1C, 2, 3 and 4 of the dossier of that product. In that case, there is also no need to submit quality, safety and efficacy critical expert reports. The applicant shall provide proof of the written consent with their application.</span></td></tr></tbody></table>
IV.5. Applications based on bibliographic data
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.5.1.</p></td><td><span>For veterinary medicinal products for which the active substance(s) has or have been in well-established veterinary use as referred to in Article 22, with recognised efficacy and an acceptable level of safety, the following specific rules shall apply.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.5.2.</p></td><td><span>A full dossier (containing Parts 1, 2, 3 and 4) shall be provided. The applicant shall submit Parts 1 and 2 as described in this Annex. For Parts 3 and 4, a detailed scientific bibliography together with information demonstrating the appropriate bridging between bibliographic references and the veterinary medicinal product shall be submitted to address safety and efficacy. The bibliographic data may need to be complemented by some documentation specific to the product, for example, user safety and environmental risk assessments, or residue study data to justify any proposed withdrawal period(s).</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.5.3.</p></td><td><span>The specific rules set out in Part IV.5.3.1 to IV.5.3.12 shall apply in order to demonstrate well-established veterinary use.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.5.3.1.</p></td><td><span>In order to establish a well-established veterinary medicinal use of constituents of veterinary medicinal products, the following factors shall be taken into account:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the time over which an active substance has been regularly used in the target species using the proposed route of administration and dosage regimen;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>quantitative aspects of the use of the active substance(s), taking into account the extent to which the substance(s) has or have been used in practice, and the extent of use on a geographical basis;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the degree of scientific interest in the use of the active substance(s) (reflected in the published scientific literature);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the coherence of scientific assessments.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.5.3.2.</p></td><td><span>Different periods of time may be necessary for establishing well-established use of different active substances. In any case, the period of time required for establishing a well-established veterinary use of a constituent of a medicinal product shall not be less than 10 years from the first systematic and documented use of that substance as a veterinary medicinal product in the Union.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.5.3.3.</p></td><td><span>Veterinary use does not exclusively mean use as an authorised veterinary medicinal product. Well-established veterinary use refers to the use for a specific therapeutic purpose in the target species.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.5.3.4.</p></td><td><span>If a substance in well-established use is proposed for entirely new therapeutic indications, it is not possible to solely refer to a well-established veterinary use. Additional data on the new therapeutic indication, together with appropriate safety and residue tests and preclinical and clinical data shall be provided and, in such a case, applications based on Article 21 is not possible.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.5.3.5.</p></td><td><span>The published documentation submitted by the applicant shall be freely available to the public and published by a reputable source, preferably peer-reviewed.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.5.3.6.</p></td><td><span>The documentation shall contain sufficient details to allow an independent assessment.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.5.3.7.</p></td><td><span>The documentation shall cover all aspects of the safety and/or efficacy assessment of the product for the proposed indication in the target species using the proposed route of administration and dosage regimen. It shall include or refer to a review of the relevant literature, taking into account pre- and post-marketing studies and published scientific literature concerning experience in the form of epidemiological studies and, in particular, of comparative epidemiological studies.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.5.3.8.</p></td><td><span>All documentation, both favourable and unfavourable, shall be communicated. With respect to the provisions on well-established veterinary use, it is in particular necessary to clarify that bibliographic reference to other sources of evidence (post-marketing studies, epidemiological studies etc.) and not just data related to tests and trials may serve as a valid proof of safety and efficacy of a product if the applicant explains and justifies the use of those sources of evidence satisfactorily.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.5.3.9.</p></td><td><span>Public assessment reports or freedom of information summaries cannot be considered to supply sufficient information, apart from the assessment report published by the Agency following the evaluation of an application for the establishment of maximum residue limits, which may be used in an appropriate manner as literature, particularly for the safety tests.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.5.3.10.</p></td><td><span>Particular attention shall be paid to any missing information, and justification shall be given as to why demonstration of an acceptable level of safety and/or efficacy may be supported although some information is lacking.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.5.3.11.</p></td><td><span>The critical expert reports regarding safety and efficacy shall explain the relevance of any data submitted, which concern a product different from the product intended for marketing. A judgement shall be made whether or not the product studied in the bibliography may be satisfactorily or scientifically bridged to the product, for which the application for a marketing authorisation has been made in spite of the existing differences.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.5.3.12.</p></td><td><span>Post-marketing experience with other products containing the same constituents is of particular importance and applicants shall put a special emphasis on this issue.</span></td></tr></tbody></table>
IV.6. Applications for limited markets
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.6.1.</p></td><td><span>A marketing authorisation may be granted for a limited market in the absence of comprehensive safety and/or efficacy data when, as provided for in Article 23, the applicant demonstrates that the product is intended for use in a limited market and that the benefit of availability of the new product outweighs the risk associated with the omission of some of the safety or efficacy data required by this Annex.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.6.2.</p></td><td><span>For such applications, the applicant shall submit Parts 1 and 2 as described in this Annex.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.6.3.</p></td><td><span>For Parts 3 and 4, some of the safety or efficacy data required by this Annex may be omitted. As regards the extent of safety and efficacy data that may be omitted, the relevant guidance published by the Agency shall be taken into account.</span></td></tr></tbody></table>
IV.7. Applications in exceptional circumstances
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.7.1.</p></td><td><span>In exceptional circumstances related to animal or public health, a marketing authorisation may be granted under Article 25 for a veterinary medicinal product, subject to certain specific obligations, conditions and/or restrictions.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.7.2.</p></td><td><span>For such applications, the applicant shall submit Part 1 as described in this Annex, together with a justification as to why the benefit of the immediate availability on the market of the veterinary medicinal product concerned outweighs the risk inherent in the fact that certain quality, safety or efficacy documentation has not been provided.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.7.3.</p></td><td><span>For Parts 2, 3 and 4, certain quality, safety or efficacy data required by this Annex may be omitted, if the applicant justifies that those data cannot be provided at the time of submission. For the identification of the essential requirements for all such applications, the relevant guidance published by the Agency shall be taken into account.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>IV.7.4.</p></td><td><span>Post-authorisation studies may be requested as part of the conditions for marketing authorisation, and shall be designed, conducted, analysed and presented according to the general principles for quality, safety and efficacy tests set out in this Annex, and relevant guidance documents, as applicable depending on the issue to be addressed in the study.</span></td></tr></tbody></table>
SECTION V
REQUIREMENTS FOR MARKETING AUTHORISATION APPLICATIONS FOR PARTICULAR VETERINARY MEDICINAL PRODUCTS
This Section lays down specific requirements for identified veterinary medicinal products related to the nature of the active substances contained therein.
V.1. Novel therapies veterinary medicinal products
V.1.1 General requirements
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.1.1.</p></td><td><span>Depending on the active substance and the mode of action, a novel therapy veterinary medicinal product could fall under any of the three product categories:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>veterinary medicinal products other than biological veterinary medicinal products;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>biological veterinary medicinal products other than immunological veterinary medicinal products;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>immunological veterinary medicinal products.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.1.2.</p></td><td><span>In general, marketing authorisation applications for novel therapy veterinary medicinal products, as defined in Article 4(43), shall follow the format and data requirements described in Section II or III of this Annex depending on how the novel therapy is categorised. A full dossier containing Parts 1, 2, 3 and 4 shall normally be provided in accordance with the requirements described in Section II or III and any relevant guidance published by the Agency. Deviations from the requirements of this Annex may be possible when justified. Where appropriate and taking into account the specificities of novel therapy products, additional requirements may be relevant for particular types of products.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.1.3.</p></td><td><span>The manufacturing processes for novel therapy veterinary medicinal products shall comply with the principles of Good Manufacturing Practice (GMP) adapted where necessary, to reflect the specific nature of those products. Guidelines specific to novel therapy veterinary products shall be drawn up, to properly reflect the particular nature of their manufacturing process.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.1.4.</p></td><td><span>According to the specific nature of a novel therapy product the use of the product may potentially be associated with specific risks. Those risks shall be identified applying a risk profiling methodology to identify the risks inherent to the specific product and the risk factors contributing to those risks. In this context, risks would be any potential unfavourable effects that may be attributed to the use of the novel therapy product which are of concern to the target population and/or the user, the consumer, and/or the environment. The risk analysis may cover the entire development. Risk factors that may be considered include the origin of the starting material (cells etc.), the mode of action in the animal (proliferation, initiation of an immune response, permanence in the body, etc.), the level of cell manipulation (for example, the manufacturing process), the combination of the active substance with bioactive molecules or structural materials, the extent of replication competence of viruses or micro-organisms used<span>in vivo</span>, the level of integration of nucleic acids sequences or genes into the genome, the long-time functionality, the risk of oncogenicity, the off-target effects and the mode of administration or use.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.1.5.</p></td><td><span>Based on the evaluation of the information on the identified risks and risk factors a specific profile of each individual risk associated with a specific product shall be established and may be used to determine and justify how the data set provided gives the necessary assurances for quality, safety and efficacy and is adequate to support a marketing authorisation application, especially for those aspects of novel therapy products that are beyond current knowledge.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.1.6.</p></td><td><span>To address data gaps or uncertainties at the time of product authorisation, implementation of post-authorisation measures or studies may be considered on a case-by-case basis. In order to detect early or delayed signals of adverse reactions, to prevent clinical consequences of such reactions and to ensure timely treatment and to gain information on the long-term safety and efficacy of novel therapy veterinary medicinal products a risk management plan shall detail the measures envisaged to ensure such follow up.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.1.7.</p></td><td><span>For any novel therapy product, in particular those considered as a nascent field in veterinary medicine, it is recommended to seek the advice of the Agency in a timely manner before submission of the marketing authorisation dossier in order to classify the product, determine the applicable dossier structure and to receive relevant information about the additional data set which may be necessary to support quality, safety and efficacy.</span></td></tr></tbody></table>
V.1.2. Quality requirements
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.2.1.</p></td><td><span>In general, description of the composition, the manufacturing method, consistency of production, controls of starting materials, controls implemented during the manufacturing process, finished product testing including implementation of an activity test or a quantification of the active substance and stability data shall be submitted.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.2.2.</p></td><td><span>The data requirements for manufacturing and testing for novel therapy veterinary medicinal products of biological origin and classified as a biological product or as an immunological product shall in general be in accordance with those for biological or immunological medicinal products (as described in Section III of this Annex) including the need for a relevant potency test. There may be cases where additional requirements are applicable, for example, cells and vector gene constructs.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.2.3.</p></td><td><span>For novel therapy veterinary medicinal products constructed by chemical synthesis, data requirements as for veterinary medicinal products other than biological products (as described in Section II of this Annex) are generally applicable. There may be cases where additional requirements are applicable, for example, a relevant potency test.</span></td></tr></tbody></table>
V.1.3. Safety requirements
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.3.1.</p></td><td><span>Depending on the nature of the product and its intended use, further data to evaluate safety for the target animal, the user, the consumer or the environment could be relevant as determined by a risk analysis in each case.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.3.2.</p></td><td><span>The requirements of Directive 2001/18/EC shall be taken into consideration when the treated animal itself could become a genetically modified organism. While Directive 2001/18/EC applies to finished products containing genetic modified organisms, it remains the best technical guide currently available for listing the necessary data. In particular, a main issue is the integration rate of DNA into germ cells (thus transmissible to offspring) or the potential transmission of the genetically modified cells to offspring. It shall also be noted that this problem is not completely the same when considering companion animals and food-producing animals (human consumption of products containing genetic modified organisms).</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.3.3.</p></td><td><span>For substances intended for integration into or editing of the genome, appropriate tests shall be performed to evaluate the risk of off-target modifications and/or insertional mutagenesis.</span></td></tr></tbody></table>
V.1.4. Efficacy requirements
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.4.1.</p></td><td><span>Efficacy data requirements differ primarily depending on the intended indications for use in the target species. Depending on the novel therapy product categorisation and the intended use in the target species, the efficacy requirements set out in Sections II or III may be applicable for a novel therapy veterinary medicinal product.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.4.2.</p></td><td><span>The indications claimed shall be supported by appropriate data in the target species.</span></td></tr></tbody></table>
V.1.5. Specific data requirements for particular types of novel therapy products
V.1.5.1. Principles
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.1.1.</p></td><td><span>Taking into account the specificities of novel therapy products, specific requirements additional to the standard requirements for evaluation of quality, safety and efficacy may be appropriate.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.1.2.</p></td><td><span>The following sections highlight specific requirements to be considered for particular type of novel therapy products. Those specific requirements established for a particular type of novel therapy product represent a non-exhaustive list of requirements that may need to be adapted to the specific product concerned on a case-by-case basis and based on a risk analysis.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.1.3.</p></td><td><span>In all cases and especially for novel therapies that are considered nascent in the field of veterinary medicine, applicants will need to take into account the current state of veterinary medicinal knowledge and the scientific guidance published by the Agency and the Commission, consistent with Section I of this Annex.</span></td></tr></tbody></table>
V.1.5.2. Gene therapy veterinary medicinal products
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.2.1.</p></td><td><span>Gene therapy products are biological veterinary medicinal products that contain an active substance which contains or consists of a recombinant nucleic acid used in or administered to animals with a view to regulating, repairing, replacing, adding or deleting a genetic sequence. Their therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence they contain, or to the product of genetic expression of this sequence.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.2.2.</p></td><td><span>In addition to the data requirements set out in Sections II or III the following requirements shall apply:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>information shall be provided on all the starting materials used for the manufacture of the active substance, including the products necessary for the genetic modification of cells, as applicable, subsequent culture and preservation of the genetically modified cells, taking into consideration the possible absence of purification steps;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>for products containing a microorganism or a virus, data on the genetic modification, sequence analysis, attenuation of virulence, tropism for specific tissues and cell types, cell cycle dependence of the microorganism or virus, pathogenicity and characteristics of the parental strain shall be provided;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>process-related impurities and product-related impurities shall be described in the relevant sections of the dossier and in particular replication competent virus contaminants if the vector is designed to be replication incompetent;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>for plasmids, quantification of the different plasmid forms shall be undertaken throughout the shelf life of the product;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>for genetically modified cells, the characteristics of the cells before and after the genetic modification, as well as before and after any subsequent freezing/storage procedures, shall be tested. For genetically modified cells, in addition to the specific requirements for gene therapy medicinal products, the quality requirements for cell therapy medicinal products and tissue engineered products shall apply;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>off-target insertions (leading, for example, to tumours/cancer, metabolic dysfunctions) and insertional mutagenesis and genotoxicity (insertion of genetic elements and the expression of DNA-modifying proteins as mediators of genotoxic side effects) in target species need to be considered;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>germline transmission studies shall be provided, unless otherwise justified.</p></td></tr></tbody></table></td></tr></tbody></table>
V.1.5.3. Regenerative medicine, tissue engineering and cell therapy veterinary medicinal products
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.3.1.</p></td><td><span>Regenerative medicines are considered to encompass a wide area of products and therapies with a general purpose of restoring functions. Those medicines include cell-based therapies in which tissue engineered products are included.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.3.2.</p></td><td><span>Cell therapy veterinary medicinal products are biological veterinary medicinal products that contain or consist of cells or tissues that have been subject to substantial manipulation in either nature or function so that biological characteristics, physiological functions or structural properties relevant for the intended clinical use have been altered, or of cells or tissues that are not intended to be used for the same essential function(s) in the recipient and the donor. They are presented as having properties for, or are used in or administered to animals with a view to treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues or to regenerating, repairing or replacing a tissue.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.3.3.</p></td><td><span>In addition to the data requirements set out in Sections II or III the following requirements shall apply:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>summary information shall be provided on procurement and testing of the animal tissue and cells used as starting materials. If non-healthy cells or tissues are used as starting materials, their use shall be justified;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the potential variability introduced through the animal tissues and cells shall be addressed as part of the validation of the manufacturing process, characterisation of the active substance and the finished product, development of assays, setting of specifications and stability;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>for the genetic modification of the cells, the technical requirements specified for gene therapy products shall apply;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>relevant information shall be provided on the characterisation of the cell population or cell mixture in terms of identity, purity (for example, extraneous agents and cellular contaminants), viability, potency, karyology, tumourigenicity and suitability for the intended medicinal use. The genetic stability of the cells shall be demonstrated;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>the impact and interactions of any components likely to interact (directly or as a result of degradation or metabolism) with the active substance shall be investigated;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>where a three-dimensional structure is part of the intended function, the differentiation state, structural and functional organisation of the cells and, where applicable, the extracellular matrix generated shall be part of the characterisation for those cell-based products.</p></td></tr></tbody></table></td></tr></tbody></table>
V.1.5.4. Veterinary medicinal product specifically designed for phage therapy
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.4.1.</p></td><td><span>Bacteriophages are viruses that depend on bacterial hosts for proliferation and act very specifically on certain bacterial strains. Phage therapy may be used, for example, as an alternative to antibiotics. Generally, bacteriophages consist of a genome, comprised of single or double stranded DNA or RNA, encapsulated by a protein capsid. Due to the diversity of the intended targets for treatment and the specificity of the bacteriophages, it will be necessary to choose the suitable bacteriophage strain against the disease-causing bacterial strain on a case-by-case basis for the individual outbreak of the disease.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.4.2.</p></td><td><span>The quality and quantity of the bacteriophages to be used in the finished product are normally variable. Therefore, a fixed qualitative and quantitative composition of bacteriophages will not be the usual situation as the phages need to be adapted on an ongoing basis. Based on this a seed stock of bacteriophages strains need to be established and maintained (comparable with a multi-strain approach).</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.4.3.</p></td><td><span>Bacteriophages as well as host bacteria/master cell banks for manufacturing shall preferably be produced based on a master seed system. Confirmation shall be provided that the bacteriophage used is lytic.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.4.4.</p></td><td><span>The absence of resistance gene(s) and the absence of genes coding for virulence factors shall be shown on all master seeds.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.4.5.</p></td><td><span>The indication shall be for prophylactic, metaphylactic and/or therapeutic treatment of one or several specific infection(s) or infectious disease(s). Efficacy of treatment is linked to the lytic activity of phages that confers bactericidal activity on those bacteriophages with specificity for the bacterial strain concerned.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.4.6.</p></td><td><span>For genetically modified phages, the genetic modification shall be described.</span></td></tr></tbody></table>
V.1.5.5. Veterinary medicinal product issued from nanotechnologies
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.5.1.</p></td><td><span>Nanotechnologies are seen primarily as a technology to generate carriers for chemically synthesised substances but may also be carriers for biological substances. The use of nanoparticles may be a way of controlling delivery of substances with low solubility or toxic compounds.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.5.2.</p></td><td><span>“Nanotechnology” corresponds to the design, characterisation, and production of nanomaterials by controlling shape and size at the nanoscale (up to around 100 nm).</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.5.3.</p></td><td><span>“Nanoparticles” are considered to have two or more dimensions at the nanoscale.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.5.4.</p></td><td><span>Within the veterinary field, nanoparticles for drug delivery system are relevant as “products issued from nanotechnologies”: nanoparticles are conjugated with substances in order to change the pharmacokinetic and/or pharmacodynamic properties. mRNA drugs are rather encapsulated in nanoparticle delivery systems.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.5.5.</p></td><td><span>In addition to the quality data requirements set out in Sections II or III the following requirements shall apply:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>size distribution of particles shall be determined;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a suitable<span>in vitro</span> test for their function and possible delivery capacity (if used as drug delivery system) shall be used.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.5.6.</p></td><td><span>With regard to safety, the kind of hazards that are introduced by using nanoparticles for drug delivery may be beyond conventional hazards imposed by chemicals in classical delivery matrices. Therefore, the following aspects shall be considered with regard to safety:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>The nanoparticles for drug delivery could influence the toxicity of the medicinal product. The toxicity of the active substance is pivotal to the product but the toxicity of the nanoparticle for drug delivery shall also be considered, as they may introduce specific risks (agglomerates, cytotoxicity), may convey impurities by adsorption, may generate toxic materials by degradation or solubilisation, or may be transferred through physiological barrier (haemato-encephalic, foeto-placental, cell and nuclear membranes, etc.). In this context:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>when physiological barriers are crossed, the impact of nanoparticles for drug delivery shall be investigated on the corresponding organ(s);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>the impact of agglomerates shall be investigated in the different targeted organs, focusing in particular on the risk of embolism in the smaller blood vessels;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>safety issues of the nanoparticles for drug delivery may be linked to a cumulative effect, a degradation profile or persistence in the body with negative effects on the functions of the targeted organs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>safety issues might also be perceived at the cell level. Cells might not always be able to eliminate the nanoparticles conveyed through the cell membrane, leading to cytotoxicity especially via the induction of an oxidative stress. The toxicological assays to be implemented shall be able to assess this cytotoxicity and the related aspects, such as the generation of toxic free radicals and biopersistence.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>The toxicology profile of the active substances contained in nanoparticles for drug delivery may differ as they may be distributed differently into various internal organs (different solubility in biological matrices), or as they may unexpectedly cross various biological barriers within the body, such as the brain barrier.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>The side effects linked to the active substances may be exacerbated when they are delivered by nanoparticles.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>Immunosafety issues such as immunotoxicity (direct damage to immune cells), immunostimulation, immunosuppression and immunomodulation (such as complement activation, inflammation, activation of the innate or adaptive immunity), were already identified for nanomedicines.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>The capacity of nanoparticles to create inflammatory or allergic reactions shall be considered. The capacity to penetrate into the blood stream and to induce inflammatory reactions may lead to disseminated intravascular coagulation or fibrinolysis with further consequences such as thrombosis. The haemocompatibility of the nanoparticles shall therefore be checked.</p></td></tr></tbody></table></td></tr></tbody></table>
V.1.5.6. RNA antisense therapy and RNA interference therapy products
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.6.1.</p></td><td><span>Antisense therapy and interference therapy products may be generated by synthesis or through recombinant techniques.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.6.2.</p></td><td><span>Antisense RNA is a single stranded RNA that is complementary to a protein coding messenger RNA with which it hybridises, and thereby blocks its translation into protein.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.6.3.</p></td><td><span>RNA interference is a biological process in which RNA molecules inhibit gene expression or translation, by neutralising targeted mRNA molecules.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.1.5.6.4.</p></td><td><span>In addition to the data requirements set out in Sections II or III the following requirements shall apply:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the minimum amount of RNA segments per volume needs to be established as part of control tests of the finished product, as well as the confirmation that the RNA segments present the correct sequence;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>for certain antisense therapy products falling under Section II of this Annex a potency bioassay may be needed for their release testing;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>stability studies shall include a test to monitor the degradation rate of the RNA segments over time;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>for RNA antisense therapy products, the possible harmful effects due to on- or off-target binding shall be addressed as well as possible non-antisense harmful effects due to, for example, accumulation, pro-inflammatory responses and aptamer binding;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>for RNAi therapy products, the possible harmful effects of off-target interference (due to the positive RNAi strand) shall be addressed, as well as the possibility of crossing the blood-brain barrier and causing central nervous system disorders;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>for RNA antisense therapy and RNA interference therapy products intended for gene therapy the requirements for gene therapy veterinary medicinal product shall be considered.</p></td></tr></tbody></table></td></tr></tbody></table>
V.2. Vaccine Antigen Master File
For particular immunological veterinary medicinal products and by derogation from Section IIIb, Part 2, the concept of a Vaccine Antigen Master File is introduced.
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.1.</p></td><td><span>Principles</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.1.1.</p></td><td><span>For the purpose of this Annex, a Vaccine Antigen Master File means a stand-alone part of the marketing authorisation application dossier for a vaccine, which contains all relevant information on quality concerning each of the active substances, which are part of the veterinary medicinal product. The stand-alone part may be common to one or more monovalent and/or combined vaccines presented by the same applicant or marketing authorisation holder.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.1.2.</p></td><td><span>The use of Vaccine Antigen Master Files is optional. For combined vaccines, the vaccine antigen(s) to be included in Vaccine Antigen Master File(s) shall be specified and a separate Vaccine Antigen Master File shall be required for each of them.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.1.3.</p></td><td><span>The submission and approval of a Vaccine Antigen Master File shall comply with the relevant guidance published by the Agency.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.2.</p></td><td><span>Content</span><p>The Vaccine Antigen Master File dossier shall contain the information in Parts V.2.2.1 to V.2.3.3 extracted from the relevant sections of Part 1 (Summary of the dossier) and Part 2 (Quality documentation) as set out in Section IIIb of this Annex:</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.2.1.</p></td><td><span>Summary of the dossier (Part 1)</span><p>The name and address of the manufacturer(s) and the site(s) involved in the different stages of manufacture and control of the active substance, accompanied by copies of the corresponding manufacturing authorisations, shall be given.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.2.2.</p></td><td><span>Qualitative and quantitative particulars of the constituents (Part 2.A)</span><p>The complete and exact name of the active substance (for example, virus or bacteria strain, antigen) shall be provided, in the same way as mentioned in any finished product. Information on product development relevant to the active substance shall be provided.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.2.3.</p></td><td><span>Description of the manufacturing method (Part 2.B)</span><p>The description of the manufacturing method for the active substance shall be provided including validation of the key stages of production and justification, if relevant, of any intermediate storage proposed. For inactivated vaccines, data relevant to the inactivation of the active substance, including the validation of the inactivation process shall be provided.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.2.4.</p></td><td><span>Production and control of starting materials (Part 2.C)</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.2.4.1.</p></td><td><span>The standard requirements described in Section IIIb.2C and relevant to the active substance shall apply.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.2.4.2.</p></td><td><span>Information on the active substance (for example, virus/bacteria strain), the substrate/s (cells, culture medium) and all the raw materials (pharmacopoeia or non-pharmacopoeia, biological or non-biological) used in the production of the active substance shall be provided.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.2.4.3.</p></td><td><span>The dossier shall include the specifications, information on the processes implemented and on the tests to be conducted for the quality control of all batches of starting materials and results for a batch for all components used.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.2.4.4.</p></td><td><span>TSE and extraneous agents (EA) risk assessment shall be provided, where applicable. It is to be noted that the target species retained for the finished products making reference to the Vaccine Antigen Master File shall be considered for the TSE and EA risk assessment. Warnings or restrictions of use may be brought in at the Vaccine Antigen Master File level depending on the information presented, which may be mitigated during the risk analysis at the level of the finished product.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.2.4.5.</p></td><td><span>If the active substance is obtained by recombinant techniques, all corresponding relevant data on the genetically modified virus/bacteria shall be provided.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.2.5.</p></td><td><span>Control tests during the manufacturing process (Part 2.D)</span><p>The standard requirements described in Section IIIb.2D shall apply for the in-process control tests carried out during the manufacture of the active substance, including validations of key control tests and, if relevant, any intermediate storage proposed (prior to blending).</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.2.6.</p></td><td><span>Batch-to-batch consistency (Part 2.F)</span><p>The standard requirements described in Section IIIb.2F shall apply for the demonstration of consistency in the manufacture of the antigen.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.2.7.</p></td><td><span>Stability (Part 2.G)</span><p>The standard requirements described in Section IIIb.2G to demonstrate the stability of the antigen and, where relevant any intermediate storage, shall apply.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.3.</p></td><td><span>Evaluation and certification</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.3.1.</p></td><td><span>For vaccines containing new vaccine antigen(s) where no Vaccine Antigen Master File already exists, the applicant shall submit to the Agency a full marketing authorisation application dossier including all the Vaccine Antigen Master Files corresponding to each single vaccine antigen for which the use of a Vaccine Antigen Master File is intended. A scientific and technical evaluation of each Vaccine Antigen Master File shall be carried out by the Agency. A positive evaluation shall result in a certificate of compliance with Union legislation for each Vaccine Antigen Master File, which shall be accompanied by the evaluation report. The certificate shall apply throughout the Union.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.3.2.</p></td><td><span>Part V.2.3.1 shall also apply to every vaccine, which consists of a novel combination of vaccine antigens, irrespective of whether or not one or more of those vaccine antigens are part of vaccines already authorised in the Union.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.2.3.3.</p></td><td><span>Changes to the content of a Vaccine Antigen Master File for a vaccine authorised in the Union shall be subject to a scientific and technical evaluation carried out by the Agency. In the case of a positive evaluation, the Agency shall issue a certificate of compliance with Union legislation for the Vaccine Antigen Master File. The certificate issued shall apply throughout the Union.</span></td></tr></tbody></table>
V.3. Multi-strain dossier
<table><col/><col/><col/><tbody><tr><td/><td><p>V.3.1.</p></td><td><span>For certain immunological veterinary medicinal products and by derogation from the provisions of Section IIIb, Part 2, the concept of the use of a multi-strain dossier is introduced.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.3.2.</p></td><td><span>A multi-strain dossier means a single dossier containing the relevant data for a unique and thorough scientific assessment of the different options of strains/combinations of strains permitting the authorisation of inactivated vaccines against antigenically variable viruses or bacteria for which rapid or frequent change in the composition of vaccine formulations is needed to ensure efficacy with regard to the epidemiological situation in the field. According to the epidemiological situation where the vaccine is intended to be used, a number of strains could be selected from those included in the dossier to formulate a final product.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.3.3.</p></td><td><span>Each multi-strain dossier is applicable only to one virus species, bacteria genus or vector for a given disease; mixtures of various viruses belonging to different families, genera, species or bacteria belonging to different families or genera cannot be approved in the context of a multi-strain dossier.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.3.4.</p></td><td><span>For new applications to multi-strain dossier marketing authorisations where no authorised multi-strain vaccine already exists for a particular virus/bacterium/disease, eligibility for the multi-strain dossier approach shall be confirmed by the Agency before submission of the application.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.3.5.</p></td><td><span>The submission of multi-strain dossiers shall comply with relevant guidance published by the Agency.</span></td></tr></tbody></table>
V.4. Vaccine platform technology
<table><col/><col/><col/><tbody><tr><td/><td><p>V.4.1.</p></td><td><span>Principles</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.4.1.1.</p></td><td><span>Vaccine platform technology is a collection of technologies that have in common the use of a “backbone” carrier or vector that is modified with a different antigen or set of antigens for each vaccine derived from the platform. This includes, but may not be limited to, protein-based platforms (virus-like particles), DNA vaccine platforms, mRNA based platforms, replicons (self-replicating RNA) and viral and bacterial vector vaccines.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.4.1.2.</p></td><td><span>Applications for marketing authorisations of immunological veterinary medicinal products manufactured based on vaccine platform technologies are considered to be eligible for reduced data requirements. A full dossier is required for the first product from a manufacturer based on a particular platform technology for a particular target species. At the time of submission of the first (full) dossier based on the platform technology, the applicant may submit in parallel a “Platform Technology Master File” comprising all data relative to the platform for which there is reasonable scientific certainty that will remain unchanged regardless of the antigen(s)/gene(s) of interest added to the platform. The nature of the data to be included in the Platform Technology Master File will depend on the type of platform.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.4.1.3.</p></td><td><span>Once a Platform Technology Master File is certified, the certificate may be used to fulfil the relevant data requirements in subsequent applications for marketing authorisations based on the same platform and intended for the same target species.</span></td></tr></tbody></table>
V.4.2. Evaluation and certification
<table><col/><col/><col/><tbody><tr><td/><td><p>V.4.2.1.</p></td><td><span>The submission of Platform Technology Master Files shall comply with relevant guidance published by the Agency. A scientific and technical evaluation of a Platform Technology Master File shall be carried out by the Agency. A positive evaluation shall result in a certificate of compliance with Union legislation for the Platform Technology Master File, which shall be accompanied by the evaluation report. The certificate shall apply throughout the Union.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.4.2.2.</p></td><td><span>Changes to the content of a Platform Technology Master File for a vaccine authorised in the Union shall be subject to a scientific and technical evaluation carried out by the Agency.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.4.2.3.</p></td><td><span>In the case of a positive evaluation the Agency shall issue a certificate of compliance with Union legislation for the Platform Technology Master File.</span></td></tr></tbody></table>
V.5. Authorised homeopathic veterinary medicinal products
<table><col/><col/><col/><tbody><tr><td/><td><p>V.5.1.</p></td><td><span><span>Quality (Part 2)</span></span><p>The provisions of Section II.2. Part 2 shall apply to the documents for authorisation of homeopathic veterinary medicinal products referred to in Article 85(2) with the following modifications.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.5.2.</p></td><td><span><span>Terminology</span></span><p>The Latin name of the homeopathic stock described in the marketing authorisation application dossier shall be in accordance with the Latin title of the European Pharmacopoeia or, in absence thereof, of an official pharmacopoeia of a Member State. Where relevant the traditional name(s) used in each Member State shall be provided.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.5.3.</p></td><td><span><span>Control of starting materials</span></span><p>The particulars and documents on the starting materials, that is to say, all of the materials used including raw materials and intermediates up to the final dilution to be incorporated into the finished authorised homeopathic veterinary medicinal product, accompanying the application, shall be supplemented by additional data on the homeopathic stock.</p><p>The general quality requirements shall apply to all of the starting and raw materials as well as intermediate steps of the manufacturing process up to the final dilution to be incorporated into the finished homeopathic product. Where a toxic component is present, this shall be controlled, if possible, in the final dilution. If this is not possible because of the high dilution, the toxic component shall normally be controlled at an earlier stage. Every step of the manufacturing process from the starting materials up to the final dilution to be incorporated into the finished product shall be fully described.</p><p>Where dilutions are involved, those dilution steps shall be done in accordance with the homeopathic manufacturing methods laid down in the relevant monograph of the European Pharmacopoeia or, in absence thereof, in an official pharmacopoeia of a Member State.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.5.4.</p></td><td><span><span>Control tests on the finished medicinal product</span></span><p>The general quality requirements shall apply to the homeopathic finished veterinary medicinal products. Any exception shall be duly justified by the applicant.</p><p>Identification and assay of all the toxicologically relevant constituents shall be carried out. If justified that identification and/or an assay on all the toxicologically relevant constituents is not possible, for example, due to their dilution in the finished medicinal product the quality shall be demonstrated by complete validation of the manufacturing and dilution process.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.5.5.</p></td><td><span><span>Stability tests</span></span><p>The stability of the finished product shall be demonstrated. Stability data from the homeopathic stocks are generally transferable to dilutions/potentisations obtained thereof. If no identification or assay of the active substance is possible due to the degree of dilution, stability data of the pharmaceutical form may be considered.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>V.5.6.</p></td><td><span><span>Safety documentation (Part 3)</span></span><p>Part 3 shall apply to homeopathic veterinary medicinal products referred to in Article 4(10) of this Regulation with the following specification, without prejudice to the provisions of Commission Regulation (EU) No 37/2010 <a>(<span>7</span>)</a> on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin.</p><p>Any missing information shall be justified, for example, justification shall be given as to why demonstration of an acceptable level of safety may be supported, even where some studies are lacking.</p></td></tr></tbody></table>
’ ( 1 ) Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances ( OJ L 50, 20.2.2004, p. 44 ).
<note>
( 2 ) Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) ( OJ L 50, 20.2.2004, p. 28 ).
( 3 ) Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products ( OJ L 109, 30.4.2009, p. 10 ).
( 4 ) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council ( OJ L 83, 22.3.2012, p. 1 ).
( 5 ) Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 ( OJ L 132, 30.5.2018, p. 5 ).
( 6 ) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC ( OJ L 396, 30.12.2006, p. 1 ).
( 7 ) Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin ( OJ L 15, 20.1.2010, p. 1 ).
</note> | ENG | 32021R0805 |
<table><col/><col/><col/><col/><tbody><tr><td><p>23.1.2018   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 17/50</p></td></tr></tbody></table>
COMMISSION RECOMMENDATION (EU) 2018/103
of 20 December 2017
regarding the rule of law in Poland complementary to Recommendations (EU) 2016/1374, (EU) 2017/146 and (EU) 2017/1520
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>On 27 July 2016, the Commission adopted a Recommendation regarding the rule of law in Poland<a> (<span>1</span>)</a>, setting out its concerns on the situation of the Constitutional Tribunal and recommending how these should be addressed. On 21 December 2016 and on 26 July 2017, the Commission adopted complementary Recommendations regarding the rule of law in Poland<a> (<span>2</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The Recommendations of the Commission were adopted under the Rule of Law Framework<a> (<span>3</span>)</a>. The Rule of Law Framework sets out how the Commission will react should clear indications of a threat to the rule of law emerge in a Member State of the Union and explains the principles which the rule of law entails. The Rule of Law Framework provides guidance for a dialogue between the Commission and the Member State in order to prevent the emergence of a systemic threat to the rule of law that could develop into a ‘clear risk of a serious breach’ which would potentially trigger the use of the ‘Article 7 TEU Procedure’. Where there are clear indications of a systemic threat to the rule of law in a Member State, the Commission can initiate a dialogue with that Member State under the Rule of Law Framework.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The European Union is founded on a common set of values enshrined in Article 2 of the Treaty on European Union (‘TEU’), which include the respect for the rule of law. The Commission, beyond its task to ensure the respect of EU law, is also responsible, together with the European Parliament, the Member States and the Council, for guaranteeing the common values of the Union.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Case law of the Court of Justice of the European Union and of the European Court of Human Rights, as well as documents drawn up by the Council of Europe, building notably on the expertise of the European Commission for Democracy through Law (‘<span>Venice Commission</span>’), provides a non-exhaustive list of these principles and hence defines the core meaning of the rule of law as a common value of the Union in accordance with Article 2 TEU. Those principles include legality, which implies a transparent, accountable, democratic and pluralistic process for enacting laws; legal certainty; prohibition of arbitrariness of the executive powers; independent and impartial courts; effective judicial review including respect for fundamental rights; and equality before the law<a> (<span>4</span>)</a>. In addition to upholding those principles and values, State institutions also have the duty of loyal cooperation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>In its Recommendation of 27 July 2016, the Commission explained the circumstances in which it decided, on 13 January 2016, to examine the situation under the Rule of Law Framework and in which it adopted, on 1 June 2016, an Opinion concerning the rule of law in Poland. The Recommendation also explained that the exchanges between the Commission and the Polish Government were not able to resolve the concerns of the Commission.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>In its Recommendation, the Commission found that there was a systemic threat to the rule of law in Poland and recommended that the Polish authorities take appropriate action to address this threat as a matter of urgency.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>In its Recommendation of 21 December 2016, the Commission took into account the latest developments in Poland that had occurred since the Commission's Recommendation of 27 July 2016. The Commission found that whereas some of the issues raised in its last Recommendation had been addressed, important issues remained unresolved, and new concerns had arisen in the meantime. The Commission also found that the procedure which had led to the appointment of a new President of the Tribunal raised serious concerns as regards the rule of law. The Commission concluded that there continued to be a systemic threat to the rule of law in Poland. The Commission invited the Polish Government to solve the problems identified as a matter of urgency, within two months, and to inform the Commission of the steps taken to that effect. The Commission noted that it remained ready to pursue a constructive dialogue with the Polish Government on the basis of the Recommendation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>On 26 July 2017, the Commission adopted a third Recommendation regarding the Rule of Law in Poland, complementary to its Recommendations of 27 July and 21 December 2016. In its Recommendation, the Commission took into account the developments that had occurred in Poland since the Commission's Recommendation of 21 December 2016. The concerns of the Commission relates to the lack of an independent and legitimate constitutional review and to the adoption by the Polish Parliament of new legislation relating to the Polish judiciary which raises grave concerns as regards judicial independence and increases significantly the systemic threat to the rule of law in Poland. In its Recommendation, the Commission considers that the situation of a systemic threat to the rule of law in Poland as presented in its Recommendations of 27 July 2016 and 21 December 2016 has seriously deteriorated.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>In particular, the Recommendation underlines that the law on the National Council for the Judicary of 15 July 2017 and the law on the Supreme Court of 22 July 2017, should they enter into force, would structurally undermine the independence of the judiciary in Poland and would have an immediate and concrete impact on the independent functioning of the judiciary as a whole. Given that the independence of the judiciary is a key component of the rule of law, these new laws increase significantly the systemic threat to rule of law as identified in the previous Recommendations. The Recommendation underlines that the dismissal of Supreme Court judges, their possible reappointment and other measures contained in the law on the Supreme Court would very seriously aggravate the systemic threat to the rule of law. Among the recommended action, the Commission recommends that the Polish authorities ensure that the two laws on the Supreme Court and on the National Council for the Judiciary do not enter into force and that any justice reform uphold the rule of law and comply with EU law and with European standards on the independence of the judiciary and is prepared in close cooperation with the judiciary and all interested parties. The Commission also asked the Polish authorities not to take any measure to dismiss or force the retirement of the Supreme Courts judges as these measures will very seriously aggravate the systemic threat to the rule of law. The Commission stated that should the Polish authorities take any measure of this kind, it would stand ready to immediately activate Article 7(1) TEU.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>The Commission invited the Polish Government to solve the problems identified in this Recommendation within one month of receipt of the Recommendation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>On 31 July 2017, the<span>Sejm</span> was formally notified about the decision of the President of the Republic to veto the law amending the Law on National Council for the Judiciary and the Law on the Supreme Court.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>On 4 August and on 16 August 2017 the Polish Government wrote to the Commission with a request for clarifications to its Recommendation of 26 July 2017, to which the Commission responded by letters of 8 August and 21 August 2017 respectively.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>On 28 August 2017, the Polish Government sent a reply to the Recommendation of 26 July 2017. The reply disagreed with all the issues raised in the Recommendation and did not announce any new action to address the concerns identified by the Commission.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>On 30 August 2017, the opinion of the OSCE Office for Democratic Institutions and Human Rights (ODIHR) concluded that the suspended law on the Supreme Court does not comply with international standards on judicial independence<a> (<span>5</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>On 11 September 2017, the Polish Government initiated a campaign named ‘Fair Courts’ aimed at gaining social support for the ongoing judicial reform. The National Council for the Judiciary and ordinary courts published several statements rectifying allegations directed against courts, judges and the Council during the campaign.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(16)</p></td><td><p>On 11 September 2017, the Constitutional Tribunal in a panel of five judges declared the unconstitutionality of certain provisions of the Code of Civil Procedure allowing ordinary courts and the Supreme Court to assess the legality of the appointment of the President and the Vice-President of the Tribunal<a> (<span>6</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(17)</p></td><td><p>On 13 September 2017, the Minister of Justice started exercising the powers to dismiss court presidents and vice-presidents pursuant to the new law on Ordinary Courts Organisation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(18)</p></td><td><p>On 15 September and 18 October 2017, the National Council for the Judiciary criticised the Minister of Justice's decisions to dismiss court presidents. The Council indicated that such an arbitrary power of the Minister of Justice violates the constitutional principle of independence of courts and might adversely affect the impartiality of judges.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(19)</p></td><td><p>On 15 September 2017, the<span>Sejm</span> appointed a person to an already occupied position of the Constitutional Tribunal, and the President of the Republic accepted the oath on 18 September 2017.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(20)</p></td><td><p>On 15 September 2017 the<span>Sejm</span> adopted the law on the National Freedom Institute – Centre for Civil Society Development which centralises the distribution of funds including for civil society organisations.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(21)</p></td><td><p>On 22 September 2017, the United Nations Human Rights Council discussed the reports on Poland submitted within the framework of the third periodic review which contain recommendations on judicial independence and the rule of law.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(22)</p></td><td><p>On 25 September 2017, the Commission informed the Council on the situation of the rule of law in Poland. There was broad agreement on the fact that the Rule of Law is a common interest and a common responsibility and on the need for Poland and the Commission to engage in a dialogue in order to find a solution.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(23)</p></td><td><p>On 26 September 2017, the President of the Republic transmitted to the<span>Sejm</span> two new draft laws on the Supreme Court and on the National Council for the Judiciary.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(24)</p></td><td><p>On 3 October 2017, the<span>Sejm</span> sent the two presidential draft laws on the Supreme Court and the National Council for Judiciary for consultation to relevant stakeholders, including the Ombudsman, the Supreme Court and the National Council for the Judiciary.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(25)</p></td><td><p>On 6 and 25 October 2017, the Supreme Court published its opinions on the two new draft laws on the Supreme Court and the National Council for the Judiciary. The opinions consider that the draft law on the Supreme Court would substantially curb its independence and that the draft law on the Council for the Judiciary cannot be reconciled with the concept of a democratic state governed by the rule of law.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(26)</p></td><td><p>On 11 October 2017, the Parliamentary Assembly of the Council of Europe adopted a resolution on new threats to the rule of law in Council of Europe member States, expressing concerns also about developments in Poland, which put at risk respect for the rule of law, and, in particular, the independence of the judiciary and the principle of the separation of powers<a> (<span>7</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(27)</p></td><td><p>On 13 October 2017, the European Network of Councils for the Judiciary (ENCJ) issued an opinion<a> (<span>8</span>)</a> on the new draft law on the National Council for the Judiciary, underlining its inconsistency with European standards on Councils for the Judiciary.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(28)</p></td><td><p>On 23 October 2017, following the third cycle of the Universal Periodic Review of Poland, the UN High Commissioner for Human Rights requested that the Polish authorities accept the UN recommendations on upholding judicial independence.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(29)</p></td><td><p>On 24 October 2017, the Constitutional Tribunal in a panel including two unlawfully appointed judges declared the unconstitutionality of provisions of the law on the Supreme Court, on the basis of which, inter alia, the current First President of the Supreme Court had been appointed.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(30)</p></td><td><p>On 24 October 2017, the Constitutional Tribunal, in a panel comprising two unlawfully appointed judges, declared the constitutionality of provisions of the three laws on the Constitutional Tribunal of December 2016, including the provisions on the basis of which the two unlawfully appointed judges adjudicating in the case had been allowed to adjudicate in the Constitutional Tribunal. The motion of the Polish Ombudsman on recusal of the two unlawfully appointed judges from this case had been rejected by the Constitutional Tribunal.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(31)</p></td><td><p>On 27 October 2017, the United Nations Special Rapporteur for the Independence of Judges and Lawyers, Mr Diego García-Sayán, presented his preliminary observations<a> (<span>9</span>)</a>, according to which the two draft laws on the Supreme Court and the National Council for the Judiciary raise a series of concerns as regards judicial independence.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(32)</p></td><td><p>On 31 October 2017, the National Council of the Judiciary adopted an opinion on the new draft law on the National Council for the Judiciary presented by the President of the Republic. The Council observes that the draft law is fundamentally inconsistent with the Polish Constitution by providing the<span>Sejm</span> with the power to appoint judges-members of the Council and by prematurely terminating constitutionally protected terms of office of the current judges-members of the Council.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(33)</p></td><td><p>On 10 November 2017, the Consultative Council of European Judges (CCJE) adopted a statement raising concerns on the judicial independence in Poland<a> (<span>10</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(34)</p></td><td><p>On 11 November 2017, the Ombudsman sent a letter to the President of the Republic comprising an assessment of the two new draft laws on the Supreme Court and on the National Council for the Judiciary and recommending that they should not be adopted as they would not guarantee that the judicial branch will remain independent from the executive branch and that citizens will be able to exercise their constitutional right to have access to an independent court.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(35)</p></td><td><p>On 13 November 2017, the OSCE Office for Democratic Institutions and Human Rights (ODIHR) adopted an opinion on the new draft law on the Supreme Court asserting that the reviewed provisions are incompatible with international standards on judicial independence<a> (<span>11</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(36)</p></td><td><p>On 15 November 2017, the European Parliament adopted a resolution on the situation of the rule of law and democracy in Poland, expressing support for the Rule of Law Recommendations issued by the Commission, as well as for the infringement proceedings, and considering that the current situation in Poland represents a clear risk of a serious breach of the values referred to in Article 2 of the TEU<a> (<span>12</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(37)</p></td><td><p>On 24 November 2017, the Council of Bars and Law Societies of Europe (CCBE) called on Polish authorities not to adopt the two draft laws on the Supreme Court and on the National Council for the Judiciary as they could undermine the separation of powers guaranteed by the Polish constitution<a> (<span>13</span>)</a>. On 29 November 2017, the Organisation of Judges ‘Iustitia’, the Helsinki Foundation for Human Rights and Amnesty International issued a joint statement criticising the legislative procedure on the two presidential draft laws.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(38)</p></td><td><p>On 5 December 2017 the European Network of Councils for the Judiciary (ENCJ) adopted an opinion criticising the draft law on the National Council for the Judiciary for not respecting the ENCJ's standards<a> (<span>14</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(39)</p></td><td><p>On 8 December 2017, the Venice Commission, at the request of the Parliamentary Assembly of the Council of Europe, adopted an opinion on the draft law on the National Council for the judiciary, the draft law on the Supreme Court, and the law on the Ordinary Courts Organisation, as well as opinion on the law on the public prosecutor's office<a> (<span>15</span>)</a>. The Venice Commission has come to the conclusion that the law and the draft laws, especially taken together and seen in the context of the 2016 law on the public prosecutor's office, enable the legislative and executive powers to interfere in a severe and extensive manner in the administration of justice, and thereby pose a grave threat to the judicial independence as a key element of the rule of law. It calls on the President of the Republic to withdraw his proposals and start a dialogue before the procedure of legislation continues. It also urges the Polish Parliament to reconsider the recent amendments to the law on Ordinary Courts Organisation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(40)</p></td><td><p>On 8 December 2017, the Council of Europe Commissioner for Human Rights issued a statement regretting the adoption by the<span>Sejm</span> of the laws on the Supreme Court and on the National Council for the Judiciary which would further undermine the independence of the judiciary.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(41)</p></td><td><p>On 8 December 2017, the two draft laws were adopted by the<span>Sejm</span>. On 15 December 2017, the two laws were approved by the Senate.</p></td></tr></tbody></table>
HAS ADOPTED THIS RECOMMENDATION:
<table><col/><col/><col/><tbody><tr><td/><td><p>1.</p></td><td><p>The Republic of Poland should duly take into account the Commission's analysis set out hereafter and take the measures figuring in section 4 of this Recommendation so that the concerns identified are addressed within the time limit set.</p></td></tr></tbody></table>
1. SCOPE AND OBJECTIVE OF THE RECOMMENDATION
<table><col/><col/><col/><tbody><tr><td/><td><p>2.</p></td><td><p>The present Recommendation complements the Recommendations of 27 July 2016, 21 December 2016 and 26 July 2017. In addition to the concerns raised in these Recommendations, it raises new concerns of the Commission with regard to the rule of law in Poland which have arisen since then. The concerns relate to the following issues:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the law on the Supreme Court, adopted by the<span>Sejm</span> on 8 December 2017;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the law amending the law on the National Council for the Judiciary and certain other laws (‘law on the National Council for the Judiciary’), adopted by the<span>Sejm</span> on 8 December 2017.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>3.</p></td><td><p>The concerns and the recommended actions set out in the Recommendation of 26 July 2017 relating to the Constitutional Tribunal, the law on Ordinary Court Organisation and the law on the National School of Judiciary<a> (<span>16</span>)</a> remain valid.</p></td></tr></tbody></table>
2. THE THREATS TO JUDICIAL INDEPENDENCE
<table><col/><col/><col/><tbody><tr><td/><td><p>4.</p></td><td><p>The law on the Supreme Court and the law on the National Council for the Judiciary contain a number of provisions which raise grave concerns as regards the principles of judicial independence and separation of powers.</p></td></tr></tbody></table>
2.1. The Supreme Court
2.1.1. Dismissal and compulsory retirement of current Supreme Court judges
<table><col/><col/><col/><tbody><tr><td/><td><p>5.</p></td><td><p>The law on the Supreme Court lowers the general retirement age of Supreme Court judges from 70 to 65<a> (<span>17</span>)</a>. This measure applies to all judges currently in office. Judges who attained 65 years of age, or will attain that age within 3 months from the entry into force of the law, will be retired<a> (<span>18</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>6.</p></td><td><p>By lowering the retirement age and applying it to current Supreme Court judges, the law terminates the mandate and potentially retires a significant number of current Supreme Court judges: 31 of the 83 (37 %) according to the Supreme Court. Applying such a lowered retirement age to current judges of the Supreme Court has a particular strong negative impact on this specific Court, which is composed of judges who are by nature at the end of their career. Such compulsory retirement of a significant number of the current Supreme Court judges allows for a far reaching and immediate recomposition of the Supreme Court. That possibility raises particular concerns in relation to the separation of powers, in particular when considered in combination with the simultaneous reforms of the National Council for the Judiciary. In fact: due to the lowering of the retirement age all new judges will be appointed by the President of the Republic on the recommendation of the newly composed National Council for the Judiciary, which will be largely dominated by the political appointees. A forced retirement of current Supreme Court judges also raises concerns as regards the principle of irremovability of judges, which is a key element of the independence of judges as enshrined in the case law of the Court of Justice and of the European Court of Human Rights<a> (<span>19</span>)</a>, and in European standards<a> (<span>20</span>)</a>. In its opinion on the draft law on the Supreme Court, the Venice Commission underlines that the early retirement of the currently sitting judges undermines both their security of tenure and the independence of the Court in general<a> (<span>21</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>7.</p></td><td><p>Judges should be protected against dismissal through the existence of effective safeguards against undue intervention or pressure from other State powers<a> (<span>22</span>)</a>. Judicial independence requires guarantees sufficient to protect the person of those who have the task of adjudicating in a dispute<a> (<span>23</span>)</a>. The irremovability of judges during their term of office is a consequence of their independence and thus included in the guarantees of Article 6(1) ECHR<a> (<span>24</span>)</a>. As a consequence, judges must only be dismissed individually, if this is justified on the basis of a disciplinary procedure concerning their individual activity and presenting all guarantees for the defence in a democratic society. Judges cannot be dismissed as a group and judges cannot be dismissed for general reasons not related to individual behaviour. The above guarantees and safeguards are lacking in the present case and the provisions concerned constitute a flagrant violation of the independence of judges of the Supreme Court and of the separation of powers<a> (<span>25</span>)</a>, and therefore of the rule of law.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>8.</p></td><td><p>In addition, the mandate of six years of the current First President, established in the constitution, will be prematurely terminated (constitutionally it should end in 2020). If the mandate of the First President is terminated, the appointment of an ‘acting First President’ by the President of the Republic will occur outside the normal procedure<a> (<span>26</span>)</a>: according to the constitution the First President should be appointed by the President of the Republic from among candidates proposed by the general assembly of the Supreme Court<a> (<span>27</span>)</a>. Such a premature termination of a constitutionally enshrined mandate constitutes a serious violation of the principle of irremovability and security of tenure. The appointment of an acting First President according to an ad hoc procedure without involvement of the judiciary raises serious concerns as regards the principle of separation of powers.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>9.</p></td><td><p>According to the explanatory memorandum of the law, the recomposition of the Supreme Court is indispensable because of the way the Supreme Court handled after 1989 the ‘decommunisation’ cases and because there are still judges in the Court who either worked for, or adjudicated under, the previous regime<a> (<span>28</span>)</a>. The European Court of Human Rights has clearly underlined that a lustration process must be individualised (e.g. distinctions must be made between different levels of involvement with the former regime) and considers that lustration measures taking place long after the end of the communist regime may be less justified in view of the diminishing risks existing over newly created democracies<a> (<span>29</span>)</a>. There are other proportionate measures which the state could adopt in order to deal with individual judges having a communist background (which would include transparent proceedings applied in individual cases before impartial organs acting on the basis of criteria pre-established by law)<a> (<span>30</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>10.</p></td><td><p>In its opinion on the draft law on the Supreme Court, the Venice Commission considers that it is hard to see why a person who was deemed fit to perform official duties for several more years to come would suddenly be considered unfit. The explanatory memorandum of the law may be understood as implying that, as a result of the reform, most senior judges, many of whom have served under the previous regime, would retire. If this reading is correct, such approach is unacceptable: if the authorities doubt the loyalty of individual judges, they should apply the existing disciplinary or lustration procedures, and not change the retirement age.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>11.</p></td><td><p>The Venice Commission concludes that the early removal of a large number of justices of the Supreme Court (including the First President) by applying to them, with immediate effect, a lower retirement age violates their individual rights and jeopardises the independence of the judiciary as a whole; they should be allowed to serve until the currently existing retirement age<a> (<span>31</span>)</a>. The Venice Commission underlines in particular that the early retirement of the currently sitting judges undermines both their security of tenure and the independence of the Court in general<a> (<span>32</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>12.</p></td><td><p>Finally, these provisions raise constitutionality concerns. As noted by the Supreme Court and the Ombudsman, the dismissal and forced retirement of current Supreme Court judges violate the principle of judicial independence and directly affects the right to an independent court. The Ombudsman notes that the institution of an acting First President of the Supreme Court constitutes a violation of the rule of law by breaching the principle of non-assumption of competences of state powers, the principle of separation and balance of powers, and the principle of judicial independence.</p></td></tr></tbody></table>
2.1.2. The power to prolong the mandate of Supreme Court judges
<table><col/><col/><col/><tbody><tr><td/><td><p>13.</p></td><td><p>According to the law, Supreme Court judges affected by the lowered retirement age and wishing to prolong their active mandate can make a request to the President of the Republic<a> (<span>33</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>14.</p></td><td><p>As regards the power of the President of the Republic to decide to prolong the active mandate of Supreme Court judges, there are no criteria, no time-frame for taking a decision and no judicial review provided for in the law. A judge who has asked for the prolongation is ‘at the mercy’ of the decision of the President of the Republic. In addition, the President of the Republic will be in position to decide<span>twice</span> on the prolongation (each time for 3 years). These elements affect the security of tenure and will allow the President of the Republic to exert influence over active Supreme Court judges. The regime is contrary to the 2010 CoE Recommendation which requires that decisions concerning the selection and career of judges should be based on objective criteria pre-established by law and that there should be an independent and competent authority drawn in substantial part from the judiciary authorised to make recommendations or express opinions which the relevant appointing authority follows in practice<a> (<span>34</span>)</a>. It also requires that judges concerned should have the right to challenge a decision relating to their career<a> (<span>35</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>15.</p></td><td><p>The new retirement regime adversely impacts the independence of judges<a> (<span>36</span>)</a>. The new rules create an additional tool through which the President of the Republic can exert influence on individual judges. In particular, the lack of any criteria for prolongation of the mandates allow for undue discretion, undermining the principle of irremovability of judges. While decreasing the retirement age, the law allows judges to have their mandate extended by the President of the Republic for up to 6 years. Also, there is no time-frame for the President of the Republic to make a decision on the extension of the mandate, which allows the President to retain influence over the judges concerned for the remaining time of their judicial mandate. Even before the retirement age is reached, the mere prospect of having to request the President for such a prolongation could exert pressure on the judges concerned.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>16.</p></td><td><p>In its opinion on the draft law on the Supreme Court, the Venice Commission underlines that this power of the President of the Republic gives him excessive influence over Supreme Court judges who are<span>approaching</span> retirement age. For this reason, the Venice Commission concludes that the President of the Republic as an elected politician should not have the discretionary power to extend the mandate of a Supreme Court judge beyond the retirement age<a> (<span>37</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>17.</p></td><td><p>The new rules also raise constitutionality concerns. According to the Supreme Court and the Ombudsman's opinions, the new mechanism of prolongation of judicial mandates does not respect the principle of legality and separation of powers.</p></td></tr></tbody></table>
2.1.3. The extraordinary appeal
<table><col/><col/><col/><tbody><tr><td/><td><p>18.</p></td><td><p>The law introduces a new form of judicial review of final and binding judgements and decisions, the extraordinary appeal<a> (<span>38</span>)</a>. Within three years<a> (<span>39</span>)</a> from the entry into force of the law the Supreme Court will be able to overturn<a> (<span>40</span>)</a> completely or in part<a> (<span>41</span>)</a> any final judgement delivered by a Polish court in the past 20 years, including judgements delivered by the Supreme Court, subject to some exceptions<a> (<span>42</span>)</a>. The power to lodge the appeal is vested in, inter alia, the Prosecutor General and the Ombudsman<a> (<span>43</span>)</a>. The grounds for the appeal are broad: the extraordinary appeal can be lodged if it is necessary to ensure the rule of law and social justice and the ruling cannot be repealed or amended by way of other extraordinary remedies, and either it (1) violates the principles or the rights and freedoms of persons and citizens enshrined in the Constitution; or (2) it is a flagrant breach of the law on the grounds of misinterpretation or misapplication; or (3) there is an obvious contradiction between the court's findings and the evidence collected<a> (<span>44</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>19.</p></td><td><p>This new extraordinary appeal procedure raises concerns as regards the principle of legal certainty which is a key component of the rule of law<a> (<span>45</span>)</a>. As noted by the Court of Justice, attention should be drawn to the importance, both for the EU legal order and national legal systems, of the principle of<span>res judicata</span>: ‘in order to ensure both stability of the law and legal relations and the sound administration of justice, it is important that judicial decisions which have become definitive after all rights of appeal have been exhausted or after expiry of the time-limits provided for in that connection can no longer be called in question’<a> (<span>46</span>)</a>. As noted by the European Court of Human Rights, extraordinary review should not be an ‘appeal in disguise’, and ‘the mere possibility of there being two views on the subject is not a ground for re-examination’<a> (<span>47</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>20.</p></td><td><p>In its opinion on the draft law on the Supreme Court, the Venice Commission underlined that the extraordinary appeal procedure is dangerous for the stability of the Polish legal order. The opinion notes that it will be possible to reopen any case decided in the country in the past 20 years on virtually any ground and the system could lead to a situation in which no judgement will ever be final anymore<a> (<span>48</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>21.</p></td><td><p>The new extraordinary appeal also raises constitutionality concerns. According to the Supreme Court and the Ombudsman, the law affects the principle of stability of jurisprudence and the finality of judgements<a> (<span>49</span>)</a>, the principle of protecting trust in the state and law as well as the right to have a case heard within a reasonable time<a> (<span>50</span>)</a>.</p></td></tr></tbody></table>
2.1.4. Other provisions
<table><col/><col/><col/><tbody><tr><td/><td><p>22.</p></td><td><p>As underlined in the opinion of the Venice Commission and of other bodies<a> (<span>51</span>)</a>, a number of other provisions in the Law on the Supreme Court raise concerns as regards the principles of judicial independence and separation of powers.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>23.</p></td><td><p>The new law establishes a new disciplinary regime for Supreme Court judges. Two types of disciplinary officers are foreseen:<span>the disciplinary officer of the Supreme Court</span> appointed by the College of the Supreme Court for a four-year term of office<a> (<span>52</span>)</a>, and the<span>extraordinary disciplinary officer appointed on a case-by-case basis by the President of the Republic</span> from among Supreme Court judges, ordinary judges, military court judges and prosecutors<a> (<span>53</span>)</a>. Under Polish law, only disciplinary officers can decide on the initiation of disciplinary proceedings against judges. The appointment of an extraordinary officer by the President of the Republic occurs without involvement of the judiciary and equals to a request to initiate a preliminary investigation. Appointment of an extraordinary disciplinary officer to an ongoing disciplinary proceeding excludes the disciplinary officer of the Supreme Court from that proceeding<a> (<span>54</span>)</a>. The fact that the President of the Republic (and in some cases also the Minister of Justice<a> (<span>55</span>)</a>) has the power to exercise influence over disciplinary proceedings against Supreme Court judges by appointing a disciplinary officer who will investigate the case (‘disciplinary officer’) which will exclude the disciplinary officer of the Supreme Court from an on-going proceeding, creates concerns as regards the principle of separation of powers and may affect judicial independence. Such concerns have also been raised in the opinions of the OSCE-ODHIR and of the Supreme Court<a> (<span>56</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>24.</p></td><td><p>The law also removes a set of procedural guarantees in disciplinary proceedings conducted against ordinary judges<a> (<span>57</span>)</a> and Supreme Court judges<a> (<span>58</span>)</a>: evidence gathered in violation of the law could be used against a judge<a> (<span>59</span>)</a>; under certain conditions evidence presented by the judge concerned could be disregarded<a> (<span>60</span>)</a>; the time-barring for disciplinary cases would be suspended for the period of disciplinary proceedings, which means that a judge could be subject to a proceeding for an indefinite duration<a> (<span>61</span>)</a>; finally, disciplinary proceedings could continue even if the judge concerned was absent (including when the absence was justified)<a> (<span>62</span>)</a>. The new disciplinary regime also raises concerns as to its compliance with the due process requirements of Art. 6(1) ECHR which are applicable to disciplinary proceedings against judges<a> (<span>63</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>25.</p></td><td><p>The law modifies the internal structure of the Supreme Court, supplementing it with two new chambers. A new chamber of extraordinary control and public matters will assess cases brought under the new extraordinary appeal procedure<a> (<span>64</span>)</a>. This new chamber will be composed in majority of new judges<a> (<span>65</span>)</a> and will ascertain the validity of general and local elections and examining electoral disputes, including electoral disputes in European Parliament elections<a> (<span>66</span>)</a>. In addition, a new autonomous<a> (<span>67</span>)</a> disciplinary chamber composed solely of new judges<a> (<span>68</span>)</a> will be tasked with reviewing in the first and second instance disciplinary cases against Supreme Court judges<a> (<span>69</span>)</a>. These two new largely autonomous chambers composed with new judges raise concerns as regards the separation of powers. As noted by the Venice Commission, while both chambers are part of the Supreme Court, in practice they are above all other chambers, creating a risk that the whole judicial system will be dominated by these chambers which are composed of new judges elected with a decisive influence of the ruling majority<a> (<span>70</span>)</a>. Also, the Venice Commission underlines that the law will make the judicial review of electoral disputes particularly vulnerable to political influence, creating a serious risk for the functioning of Polish democracy<a> (<span>71</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>26.</p></td><td><p>The law introduces lay judges, to be appointed by the Senate of the Republic<a> (<span>72</span>)</a>, to proceedings before the Supreme Court concerning the extraordinary appeals and disciplinary cases examined by the Supreme Court. As observed by the Venice Commission, introducing lay judges to the two new chambers of the Supreme Court puts the efficiency and quality of justice in danger<a> (<span>73</span>)</a>.</p></td></tr></tbody></table>
2.2. The National Council for the Judiciary
<table><col/><col/><col/><tbody><tr><td/><td><p>27.</p></td><td><p>According to the Polish Constitution the independence of judges is safeguarded by the National Council for the Judiciary<a> (<span>74</span>)</a>. The role of the National Council for the Judiciary has a direct impact on the independence of judges in particular as regards their promotion, transfer, disciplinary proceedings, dismissal and early retirement. For example, the promotion of a judge (e.g. from district court to regional court) requires the President of the Republic to once again appoint the judge, and therefore the procedure for judicial assessment and nomination involving the National Council for the Judiciary will have to be followed again. Also assistant judges who are already performing tasks of a judge must be assessed by the National Council for the Judiciary prior to their appointment as judge by the President of the Republic.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>28.</p></td><td><p>For this reason, in Member States where a Council for the Judiciary has been established, its independence is particularly important for avoiding undue influence from the Government or the Parliament on the independence of judges<a> (<span>75</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>29.</p></td><td><p>The law on the National Council for the Judiciary increases the concerns regarding the overall independence of the judiciary by providing the premature termination of the mandate of all judges-members of the National Council for the Judiciary, and by establishing an entirely new regime for the appointment of its judges-members which allows a high degree of political influence.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>30.</p></td><td><p>According to Article 6 of the law on the National Council for the Judiciary the mandates of all the current judges-members of the National Council for the Judiciary will be terminated prematurely. This termination decided by the legislative powers raises concerns for the independence of the Council and the separation of powers. The Parliament will gain a decisive influence on the composition of the Council to the detriment of the influence of judges themselves. This recomposition of the National Council for the Judiciary could already occur within one and a half month after the publication of the law<a> (<span>76</span>)</a>. The premature termination also raises constitutionality concerns, as underlined in the opinion of the National Council for the Judiciary, of the Supreme Court and of the Ombudsman.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>31.</p></td><td><p>Also, the new regime for appointing judges-members of the National Council for the Judiciary raises serious concerns. Well established European standards, in particular the 2010 Recommendation of the Committee of Ministers of the Council of Europe, stipulate that ‘not less than half the members of [Councils for the Judiciary] should be judges chosen by their peers from all levels of the judiciary and with respect for pluralism inside the judiciary’<a> (<span>77</span>)</a>. It is up to the Member States to organise their justice systems, including whether or not to establish a Council for the Judiciary. However, where such a Council has been established, as it is the case in Poland, its independence must be guaranteed in line with European standards.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>32.</p></td><td><p>Until the adoption of the law on the National Council for the Judiciary, the Polish system was fully in line with these standards since the National Council for the Judiciary was composed of a majority of judges chosen by judges. Articles 1(1) and 7 of the law amending the law on the National Council for the Judiciary would radically change this regime by providing that the 15 judges-members of the National Council for the Judiciary will be appointed, and can be re-appointed, by the<span>Sejm</span><a> (<span>78</span>)</a>. In addition, there is no guarantee that under the new law the<span>Sejm</span> will appoint judges-members of the Council endorsed by the judiciary, as candidates to these posts can be presented not only by groups of 25 judges, but also by groups of of at least 2 000 citizens<a> (<span>79</span>)</a>. Furthermore, the final list of candidates to which the<span>Sejm</span> will have to give its approval<span>en bloc</span> is pre-established by a committee of the<span>Sejm</span><a> (<span>80</span>)</a>. The new rules on appointment of judges-members of the National Council for the Judiciary significantly increase the influence of the Parliament over the Council and adversely affect its independence in contradiction with the European standards. The fact that the judges-members will be appointed by the<span>Sejm</span> with a three fifths majority does not alleviate this concern, as judges-members will still not be chosen by their peers. In addition, in case such a three fifths majority is not reached, judges-members of the Council will be appointed by the<span>Sejm</span> with absolute majority of votes.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>33.</p></td><td><p>This situation raises concerns from the point of view of the independence of the judiciary. For example, a district court judge who has to deliver a judgment in a politically sensitive case, while the judge is at the same time applying for a promotion to become a regional court judge, may be inclined to follow the position favoured by the political majority in order not to put his/her chances to obtain the promotion into jeopardy. Even if this risk does not materialise, the new regime does not provide for sufficient guarantees to secure the appearance of independence which is crucial to maintain the confidence which tribunals in a democratic society must inspire in the public<a> (<span>81</span>)</a>. Also assistant judges will have to be assessed by a politically influenced National Council for the Judiciary prior to their appointment as judge.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>34.</p></td><td><p>The Venice Commission concludes that the election of the 15 judicial members of the National Council of the Judiciary by Parliament, in conjunction with the immediate replacement of the currently sitting members, will lead to a far reaching politicisation of this body. The Venice Commission recommends that, instead, judicial members of the National Council for the Judiciary should be elected by their peers, as in the current Act<a> (<span>82</span>)</a>. It also observed that the law weakens the independence of the Council with regard to the majority in Parliament and contributes to a weakening of the independence of justice as a whole<a> (<span>83</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>35.</p></td><td><p>In their opinions concerning the draft law, the Supreme Court, the National Council for the Judiciary and the Ombudsman raised a number of concerns as regards the constitutionality of the new regime. In particular, the National Council for the Judiciary notes that under the Polish constitution, the Council serves as a counterweight to the parliament which has been constitutionally authorized to decide on the content of law. The political appointment of judges-members and the premature termination of mandates of the current judges-members of the Council therefore violates the principles of separation of powers and judicial independence. As explained in the previous Recommendations, an effective constitutional review of these provisions is currently not possible.</p></td></tr></tbody></table>
3. FINDING OF A SYSTEMIC THREAT TO THE RULE OF LAW
<table><col/><col/><col/><tbody><tr><td/><td><p>36.</p></td><td><p>For the reasons set out above, the Commission considers that the concerns expressed in the Rule of Law Recommendation of 26 July 2017 relating to the laws on the Supreme Court and the National Council for the Judiciary have not been addressed by the two new laws on the Supreme Court and the National Council for the Judiciary.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>37.</p></td><td><p>Furthermore, the Commission observes that none of the other concerns set out in the Recommendation of 26 July 2017 relating to the Constitutional Tribunal, the law on Ordinary Courts Organisation and the law on the National School of Judiciary have been addressed.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>38.</p></td><td><p>Consequently, the Commission considers that the situation of a systemic threat to the rule of law in Poland as presented in its Recommendations of 27 July 2016, 21 December 2016, and 26 July 2017 has seriously deteriorated further. The law on the National Council for the Judiciary and the law on the Supreme Court, also in combination with the law on the National School of Judiciary, and the law on the Ordinary Courts Organisation significantly increase the systemic threat to the rule of law as identified in the previous Recommendations. In particular:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>the compulsory retirement of a significant number of the current Supreme Court judges combined with the possibility of prolonging their active judicial mandate, as well as the new disciplinary regime for Supreme Court judges, structurally undermine the independence of the Supreme Court judges, whilst the independence of the judiciary is a key component of the rule of law;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>the compulsory retirement of a significant number of the current Supreme Court judges also allows for a far reaching and immediate recomposition of the Supreme Court. That possibility raises concerns in relation to the separation of powers, in particular when considered in combination with the simultaneous reforms of the National Council for the Judiciary. In fact all new Supreme Court judges will be appointed by the President of the Republic on the recommendation of the newly composed National Council for the Judiciary, which will be largely dominated by the political appointees. As a result, the current parliamentary majority will be able to determine, at least indirectly, the future composition of the Supreme Court to a much larger extent than this would be possible in a system where existing rules on the duration of judicial mandates operate normally – whatever that duration is and with whichever state organ the power to decide on judicial appointments lies;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>the new extraordinary appeal procedure raises concerns in relation to legal certainty and, when considered in combination with the possibility of a far reaching and immediate recomposition of the Supreme Court, in relation to the separation of powers;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>the termination of the mandate of all judges-members of the National Council for the Judiciary as well as the reappointment of its judges-members according to a process which allows a high degree of political influence, equally are a serious case for concern;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>the new laws raise serious concerns as regards their compatibility with the Polish Constitution as underlined by a number of opinions, in particular from the Supreme Court, the National Council for the Judiciary and the Ombudsman. However, as explained in the Rule of Law Recommendation of 26 July 2017, an effective constitutional review of these laws is no longer possible.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>39.</p></td><td><p>The Commission underlines that whatever the model of the justice system chosen, the rule of law requires to safeguard the independence of the judiciary, separation of powers and legal certainty. It is up to the Member States to organise their justice systems, including whether or not to establish a Council for the Judiciary the role of which is to safeguard judicial independence. However, where such a Council has been established by a Member State, as it is the case in Poland where the Polish Constitution has entrusted explicitly the National Council for the Judiciary with the task of safeguarding judicial independence, the independence of such Council must be guaranteed in line with European standards. It is with great concern that the Commission observes that as a consequence of the new laws referred to above, the legal regime in Poland would no longer comply with these requirements.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>40.</p></td><td><p>Moreover, actions and public statements against judges and courts in Poland made by the Polish Government and by members of Parliament from the ruling majority have damaged the trust in the justice system as a whole. The Commission underlines the principle of loyal cooperation between state organs which is, as highlighted in the opinions of the Venice Commission, a constitutional precondition in a democratic state governed by the rule of law.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>41.</p></td><td><p>Respect for the rule of law is not only a prerequisite for the protection of all the fundamental values listed in Article 2 TEU. It is also a prerequisite for upholding all rights and obligations deriving from the Treaties and for establishing mutual trust of citizens, businesses and national authorities in the legal systems of all other Member States.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>42.</p></td><td><p>The proper functioning of the rule of law is also essential in particular for the seamless operation of the Internal Market because economic operators must know that they will be treated equally under the law. This cannot be assured without an independent judiciary in each Member State.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>43.</p></td><td><p>The Commission notes that a wide range of actors at European and international level have expressed their deep concern about the two new laws on the Supreme Court and the National Council for the Judiciary, in particular the Venice Commission, the United Nations Special Rapporteur for the Independence of Judges and Lawyer, the OSCE Office for Democratic Institutions and Human Rights and the representatives of the judiciary across Europe, including the Consultative Council of European Judges, European Network of Councils for the Judiciary and the Council of Bars and Law Societies of Europe.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>44.</p></td><td><p>In its resolution of 15 November 2017 on the situation of the rule of law and democracy in Poland, the European Parliament stated that it is deeply concerned at the redrafted legislation relating to the Polish judiciary and called on the Polish President not to sign new laws unless they fully guarantee the independence of the judiciary.</p></td></tr></tbody></table>
4. RECOMMENDED ACTION
<table><col/><col/><col/><tbody><tr><td/><td><p>45.</p></td><td><p>The Commission recommends that the Polish authorities take appropriate action to address the systemic threat to the rule of law identified in section 2 as a matter of urgency.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>46.</p></td><td><p>In particular, the Commission recommends that the Polish authorities take the following actions with regard to the newly adopted laws in order to ensure their compliance with the requirements of safeguarding the independence of the judiciary, of separation of powers and of legal certainty as well as with the Polish Constitution and European standards on judicial independence:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>ensure that the law on the Supreme Court is amended so as to:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>not apply a lowered retirement age to the current Supreme Court judges;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>remove the discretionary power of the President of the Republic to prolong the active judicial mandate of the Supreme Court judges;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>remove the extraordinary appeal procedure;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>ensure that the law on the National Council for the Judiciary is amended so that the mandate of judges-members of the National Council for the Judiciary is not terminated and the new appointment regime is removed in order to ensure election of judges-members by their peers;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>refrain from actions and public statements which could undermine further the legitimacy of the Supreme Court, the ordinary courts, the judges, individually or collectively, or the judiciary as a whole.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>47.</p></td><td><p>In addition, the Commission recalls that none of the following actions, recommended in its Recommendation of 26 July 2017, relating to the Constitutional Tribunal, the law on Ordinary Courts Organisation and the law on the National School of Judiciary have been taken and therefore reiterates its recommendation to take the following actions:</p><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>restore the independence and legitimacy of the Constitutional Tribunal as guarantor of the Polish Constitution by ensuring that its judges, its President and its Vice-President are lawfully elected and appointed and by implementing fully the judgments of the Constitutional Tribunal of 3 and 9 December 2015 which require that the three judges that were lawfully nominated in October 2015 by the previous legislature can take up their function of judge in the Constitutional Tribunal, and that the three judges nominated by the new legislature without a valid legal basis no longer adjudicate without being validly elected;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>publish and implement fully the judgments of the Constitutional Tribunal of 9 March 2016, 11 August 2016 and 7 November 2016;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>ensure that the law on Ordinary Courts Organisation and on the National School of Judiciary is withdrawn or amended in order to ensure its compliance with the Constitution and European standards on judicial independence; concretely, the Commission recommends in particular to:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>remove the new retirement regime for judges of ordinary courts, including the discretionary power of the Minister of Justice to prolong their mandate;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>remove the discretionary power of the Minister of Justice to appoint and dismiss presidents of courts and remedy decisions already taken;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>ensure that any justice reform upholds the rule of law and complies with EU law and the European standards on judicial independence and is prepared in close cooperation with the judiciary and all interested parties.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>48.</p></td><td><p>The Commission underlines that the loyal cooperation which is required amongst the different state institutions in rule of law related matters is essential in order to find a solution in the present situation. The Commission also encourages the Polish authorities to implement the opinions of the Venice Commission on the law on the National Council for the Judiciary, the law on the Ordinary Courts Organisation and the law on the Supreme Court as well as to seek the views of the Venice Commission on any new legislative proposal aiming to reform the justice system in Poland.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>49.</p></td><td><p>The Commission invites the Polish Government to solve the problems identified in this Recommendation within three months of receipt of this Recommendation, and to inform the Commission of the steps taken to that effect.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>50.</p></td><td><p>The present Recommendation is issued at the same time as the reasoned proposal presented by the Commission in accordance with Article 7(1) TEU regarding the rule of law in Poland. The Commission is ready, in close consultation with the European Parliament and the Council, to reconsider that reasoned proposal, should the Polish authorities implement the recommended actions set out in the present Recommendation within the time prescribed.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>51.</p></td><td><p>On the basis of this Recommendation, the Commission is ready to pursue a constructive dialogue with the Polish Government.</p></td></tr></tbody></table>
Done at Brussels, 20 December 2017.
For the Commission
Frans TIMMERMANS
First Vice-President
<note>
( 1 ) Commission Recommendation (EU) 2016/1374 of 27 July 2016 regarding the rule of law in Poland ( OJ L 217, 12.8.2016, p. 53 ).
( 2 ) Commission Recommendation (EU) 2017/146 of 21 December 2016 regarding the rule of law in Poland complementary to Recommendation (EU) 2017/146 ( OJ L 22, 27.1.2017, p. 65 ); and Commission Recommendation (EU) 2017/1520 of 26 July 2017 regarding the rule of law in Poland complementary to Recommendation (EU) 2016/1374 and (EU) 2017/146 ( OJ L 228, 2.9.2017, p. 19 ).
( 3 ) Communication from the Commission to the European Parliament and the Council of 11 March 2014, ‘ A new EU Framework to Strengthen the Rule of Law ’, COM(2014) 158 final.
( 4 ) See COM(2014) 158 final, section 2, Annex I.
( 5 ) OSCE Office for Democratic Institutions and Human Rights (ODIHR), 30 August 2017, Opinion on Certain Provisions of the Draft Act on the Supreme Court of Poland.
( 6 ) K 10/17.
( 7 ) PACE, 11 October 2017, Resolution 2188 (2017), New threats to the rule of law in Council of Europe member States: selected examples.
( 8 ) ENCJ, 13 October 2017, Opinion of the ENCJ Executive Board on the request of the Krajowa Rada Sądownictwa (National Council for the Judiciary) of Poland.
( 9 ) United Nations Special Rapporteur on the independence of judges and lawyers, 27 October 2017, Preliminary observations on the official visit to Poland (23-27 October 2017).
( 10 ) CCJE(2017)9, 10 November 2017, Statement as regards the Situation on the Independence of the Judiciary in Poland.
( 11 ) OSCE-ODIHR, 13 November 2017, Opinion on Certain Provisions of the Draft Act on the Supreme Court of Poland (as of 26 September 2017).
( 12 ) European Parliament resolution of 15 November 2017 on the situation of the rule of law and democracy in Poland (2017/2931(RSP).
( 13 ) CCBE, 24 November 2017, Resolution of the Plenary Session of the Council of Bars and Law Societies of Europe (CCBE).
( 14 ) ENCJ, 5 December 2017, Opinion of the ENCJ Executive Board on the adoption of the amendments to the law on the National Council for the Judiciary.
( 15 ) Opinion 904/2017 CDL(2017)035 of the Venice Commission on the draft act amending the Act on the National Council of the Judiciary, on the draft act amending the Act on the Supreme Court proposed by the President of Poland, and on the Act on the Organisation of Ordinary Courts (‘CDL(2017)035’), and Opinion 892/2017 CDL(2017)037 of the Venice Commission on the Act on the Public Prosecutor's Office as amended (‘CDL(2017)037’).
( 16 ) The law amending the law on the National School of Judiciary and Public Prosecution, the law on Ordinary Courts Organisation and certain other laws (‘law on the National School of Judiciary’).
( 17 ) Article 37(1) of the law on the Supreme Court. This provision also applies to Supreme Administrative Court judges since Article 49 of the law of 25 July 2002 on administrative court organisation stipulates that matters related to the Supreme Administrative Court that are not governed by that act (the retirement regime is not) are governed mutatis mutandis by the law on the Supreme Court.
( 18 ) Article 111(1) of the law on the Supreme Court. In addition, according to Article 111(3) of the law on the Supreme Court, all judges of the military chamber (regardless of their age) will be dismissed and retired without the possibility to ask the President of the Republic for prolongation of their active mandate.
( 19 ) ECtHR Case Campbell and Fell v The United Kingdom , 28 June 1984, para 80; Case Henryk Urban and Ryszard Urban v Poland , 30 November 2011 (final), para 45; Case Fruni v Slovakia , 21 June 2011 (final) para 145; and Case Brudnicka and others v Poland , 3 March 2005 (final) para 41.
( 20 ) Para 49 and 50 of the Recommendation CM/Rec(2010)12 of the Committee of Ministers to Member States on judges: independence, efficiency and responsibilities (‘2010 CoE Recommendation’).
( 21 ) CDL(2017)035 para 48.
( 22 ) Judgement of 31 May 2005 in Case C-53/03 Syfait and Others , ECLI:EU:C:2005:333, para 31; Judgement of 4 February 1999 in Case C-103/97 Köllensperger and Atzwanger , ECLI:EU:C:1999:52, para 20.
( 23 ) Judgement of 9 October 2014 in Case C-222/13 TDC , ECLI:EU:C:2014:2265, para 29-32; Judgement of 19 September 2006 in Case C-506/04 Wilson , ECLI:EU:C:2006:587, para 53; Judgement of 4 February 1999 in Case C-103/97 Köllensperger and Atzwanger , ECLI:EU:C:1999:52, para 20-23; Judgement of 17 September 1997 in Case C-54/96 Dorsch Consult , ECLI:EU:C:1997:413, para 36; Judgement of 29 November 2001 in Case C-17/00, De Coster , ECLI:EU:C:2001:651, para 18-21; Judgement of 13 December 2017 in Case C-403/16, Hassani, ECLI:EU:C:2017:960, para 40; ECtHR Case Baka v. Hungary , 20261/12, 23 June 2016, para 121.
( 24 ) ECtHR Case Campbell and Fell v The United Kingdom , A80 (1984), 28 June 1984, para 80.
( 25 ) The new rules contradict the principle of irremovability of judges as a key element of the independence of judges as enshrined in the 2010 CoE Recommendation (para 49). Accordingly, Supreme Court judges should have guaranteed tenure, and their mandates should not be prematurely terminated. Also decisions concerning the selection and career of judges should be based on objective criteria pre-established by law or by the competent authorities, and where the government or the legislative power take decisions concerning the selection and career of judges, an independent and competent authority drawn in substantial part from the judiciary should be authorised to make recommendations or express opinions which the relevant appointing authority follows in practice (para 44-48).
( 26 ) According to Article 111(4) of the law on the Supreme Court the President of the Republic will entrust heading of the Supreme Court to a Supreme Court judge of his own choosing. Such an ‘acting First President’ will exercise their functions until the General Assembly of judges presents 5 candidates to the post of the First President of the Supreme Court (Article 12). The General Assembly of Supreme Court judges will be able to at present these candidates no sooner than at least 110 judges of the Supreme Court have been appointed.
( 27 ) Article 183(3) of the Polish constitution stipulates that the First President of the Supreme Court shall be appointed by the President of the Republic for a 6-year term of office from amongst candidates proposed by the General Assembly of the Judges of the Supreme Court.
( 28 ) Page 2 of the explanatory memorandum.
( 29 ) ECtHR Case Sõro v. Estonia , 3 September 2015, para 60-62.
( 30 ) Para 44-47 and 50 of the 2010 CoE Recommendation.
( 31 ) Opinion CDL(2017)035 para 130.
( 32 ) Opinion CDL(2017)035 para 48.
( 33 ) The request is to be made via the First President of the Supreme Court who provides an opinion on a judge's request. For the prolongation of the First President's mandate, the First President needs to provide to the President of the Republic the opinion of the college of the Supreme Court. In the process of making the decision, the President of the Republic may seek a non-binding opinion of the NCJ (cf. Article 37(2) in conjunction with Article 111(1) of the law on the Supreme Court. It is noted that according to the Supreme Court's opinion, under the constitution such a decision by the President of the Republic would require a countersignature of the Prime Minister, in accordance with Article 144(1) and (2) of the Polish constitution.
( 34 ) Para 46 and 47. This regime would also raise concerns with the Council of Europe Plan of Action on Strengthening Judicial Independence and Impartiality CM(2016)36 final (at C. ii; ‘2016 CoE Action Plan’) and CCJE benchmarks (Opinion No 1 on Standards concerning the Independence of the Judiciary and the Irremovability of Judges (para 25)).
( 35 ) Para 48 of the 2010 CoE Recommendation.
( 36 ) Para 49 of the 2010 CoE Recommendation.
( 37 ) Cf. Opinion CDL(2017)035 para 51 and 130.
( 38 ) Article 89(1) of the law on the Supreme Court.
( 39 ) Article 115 of the law on the Supreme Court. After the three-year period the appeal would need to be lodged within five years from a moment when the judgement concerned became final and lawful and within one year if the cassation appeal has been made, unless extraordinary appeal is brought to the detriment of the defendant, in such a case the appeal can be lodged no later than one year after the ruling becomes final (or, if the cassation has been lodged, no later than six months upon the examination of the cassation; cf. Article 89(4) of the Law on the Supreme Court).
( 40 ) If five years have elapsed since the contested ruling became final and the ruling has had irreversible legal effects or if warranted by the principles or the rights and freedoms of persons and citizens enshrined in the Constitution, the Supreme Court may confine itself to confirming that the contested ruling is in breach of the law and indicating the circumstances which led it to issue such a decision (Cf. Article 89(4) and Article 115(2) of the law on the Supreme Court).
( 41 ) Article 91(1) of the law on the Supreme Court.
( 42 ) Criminal cases cannot be extraordinarily appealed from to the detriment of the defendant more than one year after the ruling becomes final (or, if the cassation has been lodged, no later than six months upon the examination of the cassation); there is also no possibility of appeals against judgements establishing the nullity of a marriage, annulling a marriage or pronouncing a divorce (only in so far as one or both of the parties remarried after the ruling became final) or a decision on adoption. The extraordinary appeal cannot concern petty offences or minor tax offences; cf. Article 89(3) and 90(3) and (4) of the law on the Supreme Court.
( 43 ) Article 89(2) of the law on the Supreme Court.
( 44 ) Article 89(1) items 1-3 of the law on the Supreme Court.
( 45 ) ECtHR Case Brumărescu v. Romania , 28 October 1999, para 61; Case Ryabykh v. Russia , 3 March 2003, para 54 and 57; Case Miragall Escolano and others v Spain , 25 January 2000, para 33; also Phinikaridou v Cyprus , 20 December 2007 para 52.
( 46 ) Judgement of 30 September 2003 in Case C-224/01 Köbler , ECLI:EU:C:2003:513, para 38.
( 47 ) Moreira Ferreira v. Portugal (No 2) , 11 July 2017 (final), para 62.
( 48 ) Opinion CDL(2017)035 para 58, 63 and 130.
( 49 ) Both principles have been considered to be part of the rule of law by the Constitutional Tribunal; cf. judgements of the Constitutional Tribunal SK 7/06 of 24 October 2007 and SK 77/06 of 1 April 2008.
( 50 ) Judgement SK 19/05 of 28 November 2006; SK 16/05 of 14 November 2007.
( 51 ) In particular opinions of the Supreme Court of 6 and 23 October, and 30 November 2017, the opinion of the Ombudsman of 11 November 2017 and the OSCE-ODIHR opinion of 13 November 2017.
( 52 ) Article 74 of the law on the Supreme Court.
( 53 ) Article 76(8) of the law on the Supreme Court; the President of the Republic can appoint the extraordinary disciplinary officer from among prosecutors proposed by the State Prosecutor if a disciplinary case concerns disciplinary misconduct that satisfies the criteria of an intentional crime prosecuted by public indictment or of intentional tax crimes.
( 54 ) Article 76(8) of the law on the Supreme Court.
( 55 ) According to article 76(9) of the law on the Supreme Court, the Minister of Justice can notify the President of the Republic about the need to appoint an extraordinary disciplinary officer if there is a case of disciplinary misconduct that satisfies the criteria of an intentional crime prosecuted by public indictment or intentional tax crime. It appears that whether a case satisfies these criteria will be determined autonomously by the Minister of Justice and the President of the Republic as their decisions on appointing the extraordinary disciplinary officer cannot be appealed from.
( 56 ) OSCE-ODIHR opinion of 13 November 2017; para 119-121; Supreme Court opinion of 6 October, page 34.
( 57 ) According to Article 108(17)-(19) of the law on the Supreme Court, the Minister of Justice is given the power to set the number of and appoint disciplinary judges for ordinary court judges without consulting the judiciary. Additionally, the Minister of Justice would be able to personally control disciplinary cases conducted against ordinary court judges through disciplinary officers and an extraordinary disciplinary officer of the Minister of Justice appointed by himself (including under certain circumstances also from the prosecutors). Disciplinary officers appointed by the Minister of Justice would be able to reopen closed investigations at request of the Minister of Justice.
( 58 ) According to the law, provisions enshrined in the Law on Ordinary Court Organisation including those concerning procedural aspects of disciplinary proceedings apply mutatis mutandis to Supreme Court judges; cf. Article 72(1) and Article 108 in conjunction with Article 10(1) of the law on the Supreme Court. The law on the Supreme Court amends in its Article 108 the law on Ordinary Courts Organisation.
( 59 ) Article 108(23) of the law on the Supreme Court in terms of Article 115c added to the law on Ordinary Courts Organisation.
( 60 ) If the evidence was presented after time prescribed, cf. Article 108(22) of the law on the Supreme Court.
( 61 ) Article 108(13) item b of the law on the Supreme Court.
( 62 ) Article 108(23) of the law on the Supreme Court.
( 63 ) ECtHR Case Vilho Eskelinen and others v Finland , 19 April 2007 para 62;Case Olujić v Croatia , 5 February 2009, para 34-43; Case Harabin v Slovakia , 20 November 2012 para 118-124; and Case Baka v Hungary , 23 June 2016, para 100-119.
( 64 ) Article 26 and Article 94 of the law on the Supreme Court.
( 65 ) Article 134 of the law on the Supreme Court; the former chamber of labour, social security and public affairs is split into two chambers, the chamber of labour and social security and the new chamber of extraordinary control and public affairs; this new chamber will be composed by new judges as all current judges are transferred to the chamber of labour and social security; current Supreme Court judges can request a transfer to this new chamber.
( 66 ) A full list of tasks dealt with by this chamber is found in Article 26.
( 67 ) The president of the disciplinary chamber is autonomous vis-à-vis the First President of the Supreme Court and budget of that chamber can be substantially increased in comparison to the overall budget of the Supreme Court (cf. Article 7(2) and (4), and Article 20 of the law on the Supreme Court).
( 68 ) According to Article 131 of the law on the Supreme Court, until all the judges of the Supreme Court in the Disciplinary Chamber have been appointed, other Supreme Court judges cannot be transferred to a post in that Chamber.
( 69 ) A full list of tasks dealt with by the disciplinary chamber is found in Article 27 of the law on the Supreme Court.
( 70 ) Opinion CDL(2017)035 para 92.
( 71 ) Opinion CDL(2017)035 para 43.
( 72 ) Article 61(2) of the law on the Supreme Court.
( 73 ) Opinion CDL(2017)035 para 67.
( 74 ) Article 186(1) of the Polish Constitution: ‘The National Council of the Judiciary shall safeguard the independence of the courts and judges’.
( 75 ) For example, in the context of disciplinary proceedings against judges conducted by a Council, the European Court of Human Rights has questioned the level of influence of the legislative or executive authorities given that the Council was composed by a majority of members appointed directly by these authorities; ECtHR Case Ramos Nunes de Carvalho E Sá v Portugal , 55391/13, 57728/13 and 74041/13, 21 June 2016, para 77.
( 76 ) Mandates of current judges-members would expire on the day preceding the beginning of a joint term of office of the new judges-members of the Council, but no later than 90 days from the entry into force of the law. The timeline is as follows: within three days following publication of the law, the Marshal of the Sejm announces the start of the nomination procedure. Within 21 days from this announcement candidates to posts of judges-members of the Council are presented to the Marshal of the Sejm by the authorized entities (groups of at least 25 judges or 2 000 citizens). Upon the lapse of this 21days term, the Marshal transmits the list of candidates to parliamentary clubs which will have seven days to propose up to nine candidates from that list. Subsequently the appointment procedure according to regular provisions takes place (see below); cf. Article 6 and 7 of the law amending the law on the National Council for the Judiciary and Article 1(1), and (3) in terms of added Articles 11a and 11d of the law amending the law on the National Council for the Judiciary.
( 77 ) Para 27; see also C item (ii) of the 2016 CoE Action Plan; para 27 of the. CCJE Opinion No 10 on the Council for the Judiciary in the service of society; and para 2.3 of the ENCJ standards in ‘Councils for the Judiciary’ Report 2010-11.
( 78 ) The Constitution stipulates that the National Council for the Judiciary is composed of ex officio members (the First President of the Supreme Court, the Minister of Justice, the President of the Supreme Administrative Court and a presidential appointee) and elected members. The elected members consist of four deputies ‘ chosen by the Sejm ’, two senators ‘ chosen by the Senate ’ and 15 judges (‘ chosen from amongst ’ the common, administrative and military courts and the Supreme Court).
( 79 ) Article 1(3) of the law on the National Council for the Judiciary adding an Article 11a(2) and (3): it is noted that each group (of judges and of citizens) may lodge more than one nomination for a judge-member of the Council.
( 80 ) If parliamentary clubs do not present, in total, 15 candidates, the Presidium of the Sejm will choose them in order to create a list of 15 candidates which is then transmitted to the Sejm committee (cf. Article 1(3) adding Article 11c and Article 11d(1)-(4)).
( 81 ) ECtHR Cases Morice v France , 29369/10, 23 April 2015, para 78; Cyprus v. Turkey , 25781/94, 10 May 2001, para 233.
( 82 ) Opinion CDL(2017)035 para 130.
( 83 ) Opinion CDL(2017)035 para 31.
</note> | ENG | 32018H0103 |
<table><col/><col/><col/><col/><tbody><tr><td><p>23.6.2016   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 165/4</p></td></tr></tbody></table>
COMMISSION REGULATION (EU) 2016/1005
of 22 June 2016
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards asbestos fibres (chrysotile)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC ( 1 ) , and in particular Article 68(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Entry 6 of Annex XVII to Regulation (EC) No 1907/2006 prohibits the manufacture, placing on the market and use of asbestos fibres, and of articles and mixtures containing these fibres added intentionally.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Member States could exempt the placing on the market and use of diaphragms containing chrysotile fibres for existing electrolysis installations. This included the possibility to exempt the placing on the market of chrysotile fibres for use in the manufacture or maintenance of such diaphragms and the use of chrysotile fibres for these purposes.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Out of five electrolysis installations in relation to which Member States reported<a> (<span>2</span>)</a> in 2011 that they had granted exemptions, only two, in Sweden and Germany, remain in operation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>On 18 January 2013, pursuant to the obligation in paragraph 1 of entry 6, the European Commission requested the European Chemicals Agency (‘the Agency’) to prepare an Annex XV dossier in accordance with Article 69(1) of REACH with a view to prohibiting the placing on the market and use of diaphragms containing chrysotile. On 17 January 2014, the Agency finalised the Annex XV dossier, which proposed to amend the existing restriction by limiting the duration of the exemptions granted by Member States for the placing on the market and use of diaphragms containing chrysotile and of chrysotile fibres used exclusively in their maintenance to 31 December 2025 and enabling Member States to impose a reporting requirement to allow better monitoring and enforcement.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The dossier was subsequently put out to public consultation and submitted for examination by the Committee for Risk Assessment (hereinafter ‘RAC’) and the Committee for Socio-Economic Analysis (hereinafter ‘SEAC’).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>On 26 November 2014 RAC adopted an opinion concluding that there is no worker exposure to chrysotile in one plant and that in the other exposure is minimised by risk management measures which are effective in controlling potential risks from the use of chrysotile to a risk level of low concern. The opinion further concluded that there is no release of chrysotile to the environment and therefore the health and environment benefits of immediate closure of the two plants would be negligible. Furthermore, due to process and technology specific considerations in one of the plants, no suitable alternative was available.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>In order to further the objective of phasing out the use of chrysotile in the EU and to improve the clarity and transparency of the existing exemption, RAC agreed with the proposed amendment set out in the Annex XV dossier. The opinion also concluded that action on a Union-wide basis is necessary.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>On 9 March 2015, SEAC adopted an opinion noting that in one plant the existing asbestos containing cells would be dismantled by 2025 and that in the other, the operator claimed that ongoing production level testing using chrysotile-free diaphragms in its current installation would lead to full substitution at the latest by 2025. SEAC also concluded that immediate closure of this plant would result in costs in terms of lost value added and jobs and took note of the commitment of the operator of the latter plant to cease all imports of chrysotile by the end of 2017. Given the overall objective of phasing out the use of chrysotile in the EU and in order to improve the clarity and transparency of the existing exemption, SEAC advised that the duration of the exemptions granted by Member States for the placing on the market of diaphragms and fibres should be limited to the end of 2017 and concluded that the proposed amendment of the existing restriction, as modified by SEAC, is the most appropriate Union wide measure.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>Commission Implementing Decision 2013/732/EU<a> (<span>3</span>)</a>, establishing the best available techniques (BAT) conclusions under Directive 2010/75/EU of the European Parliament and of the Council<a> (<span>4</span>)</a> on industrial emissions (IED), stipulates that the use of asbestos diaphragms is not considered BAT and accordingly permit conditions for chlor-alkali installations operated in the Union must be updated by 12 December 2017 so that those installations do no longer use asbestos diaphragms from that date. However, unlike for mercury cells which are not considered BAT under any circumstances, Member States may determine that, in specific and exceptional circumstances, asbestos diaphragms may be used in a particular installation for a well-defined longer period and under conditions consistent with the environmental objectives of the IED, provided that the conditions and duration of such use are specified in a legally binding way.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>Since the adoption of the SEAC opinion, the operator of the plant in which full substitution is envisaged by 2025 has entered into a binding agreement with the authorities of the Member State concerned with a view to guaranteeing the gradual substitution of diaphragms containing chrysotile by a non-asbestos alternative material from 2014 on and achieving full substitution at the latest by 30 June 2025. Therefore it is appropriate that the duration of the exemption granted by Member States to permit the use of diaphragms containing chrysotile and of chrysotile fibres used exclusively in their maintenance is limited to 30 June 2025 at the latest.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>Moreover, although under the binding agreement the operator undertook to stop importing chrysotile fibres and diaphragms containing chrysotile by the end of 2017, it subsequently confirmed that imports have already ceased as it has acquired sufficient chrysotile fibres to manage the transition to an alternative material. Therefore it is appropriate to terminate the possibility that allows Member States to permit the placing on the market of diaphragms containing chrysotile and of chrysotile fibres exclusively for their maintenance.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>A report indicating the amount of chrysotile used in diaphragms in the installations benefiting from exemptions should be transmitted to the Commission. Union legislation on the protection of workers' health and safety already provides that employers must reduce workers' exposure to chrysotile fibres to a minimum and in any case below an established limit value. Member States may set more stringent limit values for such fibres in air and may require their regular measurement/monitoring. The results of any such measurement/monitoring should be included in the report.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>The Forum for Exchange of Information on Enforcement was consulted and its recommendations were taken into account.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>Regulation (EC) No 1907/2006 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 June 2016.
For the Commission
The President
Jean-Claude JUNCKER
( 1 ) OJ L 396, 30.12.2006, p. 1 .
( 2 ) Exemptions granted by EU countries and EEA-EFTA States on asbestos contained in articles pursuant to Entry 6 of Annex XVII to Regulation (EC) No 1907/2006 (REACH).
http://ec.europa.eu/DocsRoom/documents/13170
( 3 ) Commission Implementing Decision 2013/732/EU of 9 December 2013 establishing the best available techniques (BAT) conclusions, under Directive 2010/75/EU of the European Parliament and of the Council on industrial emissions, for the production of chlor-alkali ( OJ L 332, 11.12.2013, p. 34 ).
( 4 ) Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) ( OJ L 334, 17.12.2010, p. 17 ).
ANNEX
In Annex XVII, entry 6, paragraph 1 of column 2 is replaced by the following:
<table><col/><col/><tbody><tr><td><p> </p></td><td><table><col/><col/><tbody><tr><td><p>‘1.</p></td><td><p>The manufacture, placing on the market and use of these fibres and of articles and mixtures containing these fibres added intentionally is prohibited.</p><p>However, if the use of diaphragms containing chrysotile for electrolysis installations in use on 13 July 2016 had been exempted by a Member State in accordance with the version of this paragraph in force until that date, the first subparagraph shall not apply until 1 July 2025 to the use in those installations of such diaphragms or of chrysotile used exclusively in the maintenance of such diaphragms, provided that such use is carried out in compliance with the conditions of a permit set in accordance with Directive 2010/75/EU of the European Parliament and of the Council<a> (<span>*</span>)</a>.</p><p>Any downstream user benefiting from such an exemption shall send, by 31 January of each calendar year to the Member State in which the relevant electrolysis installation is located, a report indicating the amount of chrysotile used in diaphragms pursuant to the exemption. The Member State shall transmit a copy to the European Commission.</p><p>Where, in order to protect the health and safety of workers, a Member State requires monitoring of chrysotile in air by downstream users, the results shall be included in that report.</p></td></tr></tbody></table></td></tr></tbody></table> | ENG | 32016R1005 |
<table><col/><col/><col/><tbody><tr><td><img/></td><td><p>Official Journal<br/>of the European Union</p></td><td><p>EN</p><p>Series L</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>2023/2216</p></td><td><p>18.10.2023</p></td></tr></tbody></table>
COUNCIL DECISION (EU) 2023/2216
of 16 October 2023
on the signing, on behalf of the Union, of the Agreement in the form of an Exchange of Letters between the European Union and the Argentine Republic amending the Agreement in the form of an Exchange of Letters between the European Union and the Argentine Republic pursuant to Article XXVIII of the General Agreement on Tariffs and Trade (GATT) 1994 relating to the modification of concessions on all the tariff-rate quotas included in the EU Schedule CLXXV as a consequence of the United Kingdom’s withdrawal from the European Union
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207(4), first subparagraph, in conjunction with Article 218(5) thereof,
Having regard to the proposal from the European Commission,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>On 10 May 2021, the European Union (‘the Union’) signed an Agreement with the Argentine Republic (‘Argentina’), on the modification of concessions on all the tariff-rate quotas included in the EU Schedule CLXXV, pursuant to Article XXVIII of the General Agreement on Tariffs and Trade (‘GATT 1994’) as a consequence of the United Kingdom’s withdrawal from the Union <a>(<span>1</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>According to the Agreement of 10 May 2021, the Union shall inform Argentina if the result of the negotiations with World Trade Organisation (WTO) Members with rights under Article XXVIII of GATT 1994 would change the shares agreed in their bilateral negotiations.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>As a result of negotiations with other WTO Members, the Union has agreed to change the shares of two tariff-rate quotas for which Argentina has negotiating rights.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The Union has informed Argentina about those modifications, and the discussions were successfully concluded on 15 June 2023 by the initialling of an Agreement in the form of an Exchange of Letters (‘the Agreement’).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The objective of the Agreement is to amend the Agreement of 10 May 2021 in relation to the volume of two tariff-rate quotas and to provide for the apportionment of the tariff-rate quotas included in the EU Schedule CLXXV of GATT 1994 following the United Kingdom’s withdrawal from the Union.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Therefore, the Agreement should be signed on behalf of the Union, subject to its conclusion at a later date,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
The signing, on behalf of the Union, of the Agreement in the form of an Exchange of Letters between the European Union and the Argentine Republic amending the Agreement in the form of an Exchange of Letters between the European Union and the Argentine Republic pursuant to Article XXVIII of the General Agreement on Tariffs and Trade (GATT) 1994 relating to the modification of concessions on all the tariff-rate quotas included in the EU Schedule CLXXV as a consequence of the United Kingdom’s withdrawal from the European Union, is hereby authorised, subject to the conclusion of the said Agreement ( 2 ) .
Article 2
The President of the Council is hereby authorised to designate the person(s) empowered to sign the Agreement on behalf of the Union.
Article 3
This Decision shall enter into force on the date of its adoption.
Done at Luxembourg, 16 October 2023.
For the Council
The President
T. RIBERA RODRÍGUEZ
( 1 ) Agreement in the form of an Exchange of Letters between the European Union and the Argentine Republic pursuant to Article XXVIII of the general agreement on tariffs and trade (GATT) 1994 relating to the modification of concessions on all the tariff rate quotas included in the EU schedule CLXXV as a consequence of the United Kingdom’s withdrawal from the European Union ( OJ L 264, 26.7.2021, p. 3 ).
( 2 ) The text of the Agreement will be published together with the decision on its conclusion.
ELI: http://data.europa.eu/eli/dec/2023/2216/oj
ISSN 1977-0677 (electronic edition) | ENG | 32023D2216 |
02021R0630 — EN — 10.10.2022 — 002.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
<table><col/><col/><tr><td><p><a>►B</a></p></td><td><p> COMMISSION DELEGATED REGULATION (EU) 2021/630</p><p>of 16 February 2021</p><p>supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards certain categories of goods exempted from official controls at border control posts and amending Commission Decision 2007/275/EC</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 132 19.4.2021, p. 17)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p> </p></td><td><p> </p></td><td><p>Official Journal</p></td></tr><tr><td><p>  No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>►M1</a></p></td><td><p><a> COMMISSION DELEGATED REGULATION (EU) 2022/887 of 28 March 2022</a></p></td><td><p>  L 154</p></td><td><p>23</p></td><td><p>7.6.2022</p></td></tr><tr><td><p><a> M2</a></p></td><td><p><a> COMMISSION DELEGATED REGULATION (EU) 2022/1615 of 22 April 2022</a></p></td><td><p>  L 243</p></td><td><p>1</p></td><td><p>20.9.2022</p></td></tr></table>
COMMISSION DELEGATED REGULATION (EU) 2021/630
of 16 February 2021
supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards certain categories of goods exempted from official controls at border control posts and amending Commission Decision 2007/275/EC
(Text with EEA relevance)
Article 1
Subject matter
This Regulation establishes rules concerning:
(1) the cases where and the conditions under which composite products are exempted from official controls at border control posts and when such exemption is justified;
(2) the performance of specific official controls on composite products exempted from official controls at border control posts.
Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
(1) ‘composite product’ means composite product as defined in point (14) of Article 2 of Delegated Regulation (EU) 2019/625;
(2) ‘shelf-stable composite products’ means products that do not need to be transported or stored under controlled temperatures.
Article 3
Composite products exempted from official controls at border control posts
1. The following shelf-stable composite products shall be exempted from official controls at border control posts:
(a) shelf-stable composite products that do not contain colostrum-based products or processed meat other than gelatine, collagen or highly refined products referred to in Section XVI of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council ( 1 ), provided they meet the following requirements:
(i) they comply with the requirements for entry into the Union laid down in Article 12(2) of Delegated Regulation (EU) 2019/625;
(ii) any dairy and egg products contained in the shelf-stable composite products comply with Article 163(1) of Delegated Regulation (EU) 2020/692;
(iii)
they are identified as intended for human consumption;
(iv) they are securely packaged or sealed; and
(v) they are listed in the Annex to this Regulation;
(b) shelf-stable composite products where all the animal products present in the final composite product fall within the scope of Regulation (EC) No 1332/2008 of the European Parliament and of the Council ( 2 ), Regulation (EC) No 1333/2008 of the European Parliament and of the Council ( 3 ) or Regulation (EC) No 1334/2008 of the European Parliament and of the Council ( 4 ), or that animal part is vitamin D3 only.
2. At the time of placing on the market, shelf-stable composite products referred to in paragraph 1 shall be accompanied by a private attestation in accordance with the model laid down in Annex V to Commission Implementing Regulation (EU) 2020/2235 ( 5 ).
Article 4
Official controls on composite products exempted from official controls at border control posts
1. The competent authorities shall perform official controls on shelf-stable composite products referred to in Article 3 regularly, on a risk basis and with appropriate frequency, taking into account the criteria referred to in Article 44(2) of Regulation (EU) 2017/625.
2. The official controls referred to in paragraph 1 shall be performed at any of the following places within the customs territory of the Union:
(a) the place of destination;
(b) the point of release for free circulation in the Union;
(c) the warehouses or the premises of the operator responsible for the consignment.
3. The official controls referred to in paragraph 1 shall be performed in accordance with Articles 45 and 46 of Regulation (EU) 2017/625.
Article 5
Amendments to Decision 2007/275/EC
Decision 2007/275/EC is amended as follows:
(1) Article 6 is deleted;
(2) Annex II is deleted.
Article 6
Entry into force and date of application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
It shall apply from 21 April 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
List of composite products exempted from official controls at border control posts (Article 3)
This list sets out composite products, in accordance with the Combined Nomenclature (CN) in use in the Union, that do not need to be submitted for official controls at border control posts.
Notes relating to the table:
Column (1) – CN code
This column indicates the CN code. The CN, established by Regulation (EEC) No 2658/87, is based on the Harmonized Commodity Description and Coding System (‘Harmonized System (HS)’) drawn up by the Customs Cooperation Council, now the World Customs Organisation, and approved by Council Decision 87/369/EEC ( 6 ). The CN reproduces the headings and subheadings of the HS to six digits. The seventh and eighth digits identify further CN subheadings.
Where a four-, six- or eight-digit code not marked with ‘ex’ is used, and unless otherwise specified, all composite products prefixed with or covered by these four-, six- or eight-digits are not required to be submitted for official controls at border control posts.
Where only certain specified composite products under any four-, six- or eight-digit code contain animal products and no specific subdivision under this code exists in the CN, the code is marked ‘ex’. For example, with respect to ‘ ex 2001 90 65 ’, checks at border control posts are not required for the products outlined in column (2).
Column (2) – Explanations
This column gives details of the composite products covered by the exemption from official controls at border control posts.
<table><col/><col/><tbody><tr><td><p>CN codes</p></td><td><p>Explanations</p></td></tr><tr><td><p>(1)</p></td><td><p>(2)</p></td></tr><tr><td><p>1704 , ex 1806 20 , ex 1806 31 00 , ex 1806 32 , ex 1806 90 11 , ex 1806 90 19 , ex 1806 90 31 , ex 1806 90 39 , ex 1806 90 50 , ex 1806 90 90</p></td><td><p>Confectionery (including sweets), chocolate and other food preparations containing cocoa that meet the requirements of Article 3(1)</p></td></tr><tr><td><p>ex 1902 19 , ex 1902 30 , ex 1902 40</p></td><td><p>Pasta, noodles and couscous that meet the requirements of Article 3(1)</p></td></tr><tr><td><p>ex 1905 10 , ex 1905 20 , ex 1905 31 , ex 1905 32 , ex 1905 40 , ex 1905 90</p></td><td><p>Bread, cakes, biscuits, waffles and wafers, rusks, toasted bread and similar toasted products that meet the requirements of Article 3(1)</p></td></tr><tr><td><p>ex 2001 90 65 , ex 2005 70 00 , ex  16 04</p></td><td><p>Olives stuffed with fish that meet the requirements of Article 3(1)</p></td></tr><tr><td><p>2101</p></td><td><p>Extracts, essences and concentrates, of coffee, tea or maté and preparations with a basis of these products or with a basis of coffee, tea or mate thereof that meet the requirements of Article 3(1). Roasted chicory and other roasted coffee substitutes, and extracts, essences and concentrates thereof that meet the requirements of Article 3(1).</p></td></tr><tr><td><p>ex  21 04</p></td><td><p>Soup stocks and flavourings packaged for the final consumer that meet the requirements of Article 3(1)</p></td></tr><tr><td><p>ex  21 06</p></td><td><p>Food supplements packaged for the final consumer, containing processed animal products (including glucosamine, chondroitin or chitosan) that meet the requirements of Article 3(1)</p></td></tr><tr><td><p>ex 2208 70</p></td><td><p>Liqueurs and cordials that meet the requirements of Article 3(1)</p></td></tr></tbody></table>
<note>
( 1 ) Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55).
( 2 ) Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97 (OJ L 354, 31.12.2008, p. 7).
( 3 ) Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16).
( 4 ) Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, p. 34).
( 5 ) Commission Implementing Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates, model official certificates and model animal health/official certificates, for the entry into the Union and movements within the Union of consignments of certain categories of animals and goods, official certification regarding such certificates and repealing Regulation (EC) No 599/2004, Implementing Regulations (EU) No 636/2014 and (EU) 2019/628, Directive 98/68/EC and Decisions 2000/572/EC, 2003/779/EC and 2007/240/EC (OJ L 442, 30.12.2020, p. 1).
( 6 ) Council Decision 87/369/EEC of 7 April 1987 concerning the conclusion of the International Convention on the Harmonized Commodity Description and Coding System and of the Protocol of Amendment thereto (OJ L 198, 20.7.1987, p. 1).
</note> | ENG | 02021R0630-20221010 |
2012R0236 — EN — 17.09.2014 — 001.001
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
<table><col/><col/><tr><td><p><a>►B</a></p></td><td><p>REGULATION (EU) No 236/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL</p><p>of 14 March 2012</p><p>on short selling and certain aspects of credit default swaps</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 086, 24.3.2012, p.1)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p> </p></td><td><p> </p></td><td><p>Official Journal</p></td></tr><tr><td><p>  No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>►M1</a></p></td><td><p><a>REGULATION (EU) No 909/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 July 2014</a></p></td><td><p>  L 257</p></td><td><p>1</p></td><td><p>28.8.2014</p></td></tr></table>
REGULATION (EU) No 236/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 14 March 2012
on short selling and certain aspects of credit default swaps
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Central Bank ( 1 ),
Having regard to the opinion of the European Economic and Social Committee ( 2 ),
Acting in accordance with the ordinary legislative procedure ( 3 ),
Whereas:
<table><col/><col/><tr><td><p>(1)</p></td><td><p>At the height of the financial crisis in September 2008, competent authorities in several Member States and supervisory authorities in third countries such as the United States of America and Japan adopted emergency measures to restrict or ban short selling in some or all securities. They acted due to concerns that at a time of considerable financial instability, short selling could aggravate the downward spiral in the prices of shares, notably in financial institutions, in a way which could ultimately threaten their viability and create systemic risks. The measures adopted by Member States were divergent as the Union lacks a specific common regulatory framework for dealing with short selling issues.</p></td></tr></table>
<table><col/><col/><tr><td><p>(2)</p></td><td><p>To ensure the proper functioning of the internal market and to improve the conditions of its functioning, in particular with regard to the financial markets, and to ensure a high level of consumer and investor protection, it is therefore appropriate to lay down a common regulatory framework with regard to the requirements and powers relating to short selling and credit default swaps and to ensure greater coordination and consistency between Member States where measures have to be taken in exceptional circumstances. It is necessary to harmonise the rules for short selling and certain aspects of credit default swaps, to prevent the creation of obstacles to the proper functioning of the internal market, as otherwise it is likely that Member States continue taking divergent measures.</p></td></tr></table>
<table><col/><col/><tr><td><p>(3)</p></td><td><p>It is appropriate and necessary for those rules to take the legislative form of a regulation in order to ensure that provisions directly imposing obligations on private parties to notify and disclose net short positions relating to certain instruments and regarding uncovered short selling are applied in a uniform manner throughout the Union. A regulation is also necessary to confer powers on the European Supervisory Authority (European Securities and Markets Authority) (ESMA) established by Regulation (EU) No 1095/2010 of the European Parliament and of the Council (<a><span>4</span></a>) to coordinate measures taken by competent authorities or to take measures itself.</p></td></tr></table>
<table><col/><col/><tr><td><p>(4)</p></td><td><p>The scope of this Regulation should be as broad as possible to provide for a preventive regulatory framework to be used in exceptional circumstances. That framework should cover all financial instruments but should provide for a proportionate response to the risks that short selling of different instruments could represent. It is therefore only in the case of exceptional circumstances that competent authorities and ESMA should be entitled to take measures concerning all types of financial instruments, going beyond the permanent measures that only apply to particular types of instruments where there are clearly identified risks that need to be addressed.</p></td></tr></table>
<table><col/><col/><tr><td><p>(5)</p></td><td><p>To end the current fragmented situation in which some Member States have taken divergent measures and to restrict the possibility that divergent measures are taken by competent authorities it is important to address the potential risks arising from short selling and credit default swaps in a harmonised manner. The requirements to be imposed should address the identified risks without unduly detracting from the benefits that short selling provides to the quality and efficiency of markets. While in certain situations it could have adverse effects, under normal market conditions, short selling plays an important role in ensuring the proper functioning of financial markets, in particular in the context of market liquidity and efficient price formation.</p></td></tr></table>
<table><col/><col/><tr><td><p>(6)</p></td><td><p>References in this Regulation to natural and legal persons should include registered business associations without legal personality.</p></td></tr></table>
<table><col/><col/><tr><td><p>(7)</p></td><td><p>Enhanced transparency relating to significant net short positions in specific financial instruments is likely to be of benefit to both the regulator and market participants. For shares admitted to trading on a trading venue in the Union, a two-tier model that provides for greater transparency of significant net short positions in shares at the appropriate level should be introduced. At the lower threshold, notification of a position should be made privately to the regulators concerned to enable them to monitor and, where necessary, investigate short selling that could create systemic risks, be abusive or create disorderly markets; at the higher threshold, positions should be publicly disclosed to the market in order to provide useful information to other market participants about significant individual short positions in shares.</p></td></tr></table>
<table><col/><col/><tr><td><p>(8)</p></td><td><p>A requirement to notify regulators of significant net short positions relating to sovereign debt in the Union should be introduced as such notification would provide important information to assist regulators in monitoring whether such positions are in fact creating systemic risks or being used for abusive purposes. Such a requirement should only include private disclosure to regulators as publication of information to the market for such instruments could have a detrimental effect on sovereign debt markets where liquidity is already impaired.</p></td></tr></table>
<table><col/><col/><tr><td><p>(9)</p></td><td><p>The notification requirements relating to sovereign debt should apply to the debt instruments issued by a Member State and by the Union, including the European Investment Bank, a Member State’s government department, agency, special purpose vehicle or international financial institution established by two or more Member States that issues debt on behalf of a Member State or on behalf of several Member States, such as the European Financial Stability Facility or the prospective European Stability Mechanism. In the case of federal Member States, the notification requirements should also apply to debt instruments issued by a member of the federation. They should not, however, apply to other regional or local bodies or quasi-public bodies in a Member State that issue debt instruments. The objective of debt instruments issued by the Union is to provide balance of payments or financial stability support to Member States or macro-financial assistance to third countries.</p></td></tr></table>
<table><col/><col/><tr><td><p>(10)</p></td><td><p>In order to ensure comprehensive and effective transparency, it is important that the notification requirements cover not only short positions created by trading shares or sovereign debt on trading venues but also short positions created by trading outside trading venues and net short positions created by the use of derivatives, such as options, futures, index-related instruments, contracts for differences and spread bets relating to shares or sovereign debt.</p></td></tr></table>
<table><col/><col/><tr><td><p>(11)</p></td><td><p>To be useful to regulators and markets, any transparency regime should provide complete and accurate information about a natural or legal person’s positions. In particular, information provided to the regulator or to the market should take into account both short and long positions so as to provide valuable information about the natural or legal person’s net short position in shares, sovereign debt and credit default swaps.</p></td></tr></table>
<table><col/><col/><tr><td><p>(12)</p></td><td><p>The calculation of short or long positions should take into account any form of economic interest which a natural or legal person has in relation to the issued share capital of a company or to the issued sovereign debt of a Member State or of the Union. In particular, it should take into account such an economic interest obtained directly or indirectly through the use of derivatives such as options, futures, contracts for differences and spread bets relating to shares or sovereign debt, and indices, baskets of securities and exchange traded funds. In the case of positions relating to sovereign debt it should also take into account credit default swaps relating to sovereign debt issuers.</p></td></tr></table>
<table><col/><col/><tr><td><p>(13)</p></td><td><p>In addition to the transparency regime provided for in this Regulation, the Commission should consider, in the context of its revision of Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments (<a><span>5</span></a>), whether inclusion by investment firms of information about short sales in transaction reports to competent authorities would provide useful supplementary information to enable competent authorities to monitor levels of short selling.</p></td></tr></table>
<table><col/><col/><tr><td><p>(14)</p></td><td><p>Buying credit default swaps without having a long position in underlying sovereign debt or any assets, portfolio of assets, financial obligations or financial contracts the value of which is correlated to the value of the sovereign debt, can be, economically speaking, equivalent to taking a short position on the underlying debt instrument. The calculation of a net short position in relation to sovereign debt should therefore include credit default swaps relating to an obligation of a sovereign debt issuer. The credit default swap position should be taken into account both for the purposes of determining whether a natural or legal person has a significant net short position relating to sovereign debt that needs to be notified to a competent authority and where a competent authority suspends restrictions on uncovered credit default swap transactions for the purposes of determining the significant uncovered position in a credit default swap relating to a sovereign debt issuer that needs to be notified to the competent authority.</p></td></tr></table>
<table><col/><col/><tr><td><p>(15)</p></td><td><p>To enable ongoing monitoring of positions, the transparency regime should also include notification or disclosure where a change in a net short position results in an increase or decrease above or below certain thresholds.</p></td></tr></table>
<table><col/><col/><tr><td><p>(16)</p></td><td><p>In order to be effective, it is important that the transparency regime apply regardless of where the natural or legal person is located, including in a third country, where that person has a significant net short position in a company that has shares admitted to trading on a trading venue in the Union or a net short position in sovereign debt issued by a Member State or by the Union.</p></td></tr></table>
<table><col/><col/><tr><td><p>(17)</p></td><td><p>The definition of a short sale should not include a repurchase agreement between two parties where one party sells the other a security at a specified price with a commitment to buy the security back at a later date at another specified price or a derivative contract where it is agreed to sell securities at a specified price at a future date. The definition should not include a transfer of securities under a securities lending agreement.</p></td></tr></table>
<table><col/><col/><tr><td><p>(18)</p></td><td><p>Uncovered short selling of shares and sovereign debt is sometimes viewed as increasing the potential risk of settlement failure and volatility. To reduce such risks it is appropriate to place proportionate restrictions on uncovered short selling of such instruments. The detailed restrictions should take into account the different arrangements currently used for covered short selling. These include a separate repurchase agreement on the basis of which the person selling a security short buys back an equivalent security in due time to allow settlement of the short sale transaction and includes collateral arrangements if the collateral taker can use the security for settling the short sale transaction. Further examples include rights issues (offerings) of companies to existing shareholders, lending pools and repurchase agreement facilities provided, for instance, by trading venues, clearing systems or central banks.</p></td></tr></table>
<table><col/><col/><tr><td><p>(19)</p></td><td><p>In relation to uncovered short selling of shares it is necessary for a natural or legal person to have an arrangement with a third party under which the third party has confirmed that the share has been located, which means that the third party confirms that it considers that it can make the share available for settlement when it is due. In order to give this confirmation it is necessary for measures to be taken vis-à-vis third parties for the natural or legal person to have a reasonable expectation that settlement can be effected when it is due. This includes measures such as a third party having allocated the shares for borrowing or purchase so that settlement can be effected when it is due. With regard to short sales to be covered by purchase of the share during the same day this includes confirmation by the third party that it considers the share to be easy to borrow or to purchase. The liquidity of the shares, in particular the level of turnover and the ease with which buying, selling and borrowing can take place with minimum market impact, should be taken into account by ESMA in determining what measures are necessary in order to have a reasonable expectation that settlement can be effected when it is due.</p></td></tr></table>
<table><col/><col/><tr><td><p>(20)</p></td><td><p>In relation to uncovered short selling of sovereign debt, the fact that a short sale will be covered by the purchase of the sovereign debt during the same day can be considered as an example of offering a reasonable expectation that settlement can be effected when it is due.</p></td></tr></table>
<table><col/><col/><tr><td><p>(21)</p></td><td><p>Sovereign credit default swaps should be based on the insurable interest principle whilst recognising that there can be interests in a sovereign issuer other than bond ownership. Such interests include hedging against the risk of default of the sovereign issuer where a natural or legal person has a long position in the sovereign debt of that issuer or hedging against the risk of a decline in the value of the sovereign debt where the natural or legal person holds assets or is subject to liabilities which refer to public or private sector entities in the Member State concerned, the value of which is correlated to the value of the sovereign debt. Such assets should include financial contracts, a portfolio of assets or financial obligations, as well as interest rate or currency swap transactions with respect to which the sovereign credit default swap is used as a counterparty risk management tool for hedging exposure on financial and foreign trade contracts. No position or portfolio of positions used in the context of hedging exposures to a sovereign should be considered an uncovered position in a sovereign credit default swap. This includes any exposures to the central, regional and local administration, public sector entities or any exposure guaranteed by any referred entity. Furthermore, exposure to private sector entities established in the Member State concerned should also be included. All exposures should be considered in this context including loans, counterparty credit risk (including potential exposure when regulatory capital is required to such exposure), receivables and guarantees. This also includes indirect exposures to any of the referred entities obtained, inter alia, through exposure to indices, funds or special purpose vehicles.</p></td></tr></table>
<table><col/><col/><tr><td><p>(22)</p></td><td><p>Since entering into a sovereign credit default swap without underlying exposure to the risk of a decline in the value of the sovereign debt could have an adverse impact on the stability of sovereign debt markets, natural or legal persons should be prohibited from entering into such uncovered credit default swap positions. However, at the very first signal that the sovereign debt market is not functioning properly, the competent authority should be able to suspend such a restriction temporarily. Such a suspension should be based on the belief of the competent authority based on objective grounds following an analysis of the indicators set out in this Regulation. Competent authorities should also be able to use additional indicators.</p></td></tr></table>
<table><col/><col/><tr><td><p>(23)</p></td><td><p>It is also appropriate to include requirements on central counterparties relating to buy-in procedures and fines for failed settlement of transactions in shares. The buy-in procedures and late settlement requirements should set basic standards relating to settlement discipline. The buy-in and fining requirements should be sufficiently flexible to permit the central counterparty that is responsible for ensuring such procedures are in place to be able to rely on another market participant to perform operationally the buy-in or impose the fine. However, for the proper functioning of financial markets it is essential to address wider aspects of settlement discipline in a horizontal legislative proposal.</p></td></tr></table>
<table><col/><col/><tr><td><p>(24)</p></td><td><p>Measures relating to sovereign debt and sovereign credit default swaps including increased transparency and restrictions on uncovered short selling should impose requirements which are proportionate and at the same time avoid an adverse impact on the liquidity of sovereign bond markets and sovereign bond repurchase markets.</p></td></tr></table>
<table><col/><col/><tr><td><p>(25)</p></td><td><p>Shares are increasingly admitted to trading on different trading venues within the Union and in third countries. Many large companies based in a third country also have shares admitted to trading on a trading venue within the Union. For reasons of efficiency, it is appropriate to exempt securities from certain notification and disclosure requirements, where the principal venue for trading of that instrument is in a third country.</p></td></tr></table>
<table><col/><col/><tr><td><p>(26)</p></td><td><p>Market making activities play a crucial role in providing liquidity to markets within the Union and market makers need to take short positions to perform that role. Imposing requirements on such activities could severely inhibit their ability to provide liquidity and have a significant adverse impact on the efficiency of the Union markets. Furthermore market makers would not be expected to take significant short positions except for very brief periods. It is therefore appropriate to exempt natural or legal persons involved in such activities from requirements which could impair their ability to perform such a function and therefore adversely affect the Union markets. In order for such requirements to capture equivalent third-country entities a procedure is necessary to assess the equivalence of third-country markets. The exemption should apply to the different types of market-making activity but not to proprietary trading. It is also appropriate to exempt certain primary market operations such as those relating to sovereign debt and stabilisation schemes as they are important activities that assist the efficient functioning of markets. Competent authorities should be notified of the use of exemptions and should have the power to prohibit a natural or legal person from using an exemption if they do not fulfil the relevant criteria in the exemption. Competent authorities should also be able to request information from the natural or legal person to monitor their use of the exemption.</p></td></tr></table>
<table><col/><col/><tr><td><p>(27)</p></td><td><p>In the case of adverse developments which constitute a serious threat to financial stability or to market confidence in a Member State or the Union, competent authorities should have powers of intervention to require further transparency or to impose temporary restrictions on short selling, credit default swap transactions or other transactions in order to prevent a disorderly decline in the price of a financial instrument. Such measures could be necessary due to a variety of adverse events or developments including not just financial or economic events but also for example natural disasters or terrorist acts. Furthermore, some adverse events or developments requiring measures could arise in a single Member State and have no cross-border implications. Such powers need to be flexible enough to enable competent authorities to deal with a range of different exceptional circumstances. In taking such measures, competent authorities should pay due regard to the principle of proportionality.</p></td></tr></table>
<table><col/><col/><tr><td><p>(28)</p></td><td><p>As this Regulation addresses only restrictions on short selling and credit default swaps to prevent a disorderly decline in the price of a financial instrument, the need for other types of restrictions such as position limits or restrictions on products, which may give rise to serious investor protection concerns, are more appropriately considered in the context of the Commission’s revision of Directive 2004/39/EC.</p></td></tr></table>
<table><col/><col/><tr><td><p>(29)</p></td><td><p>While competent authorities are usually best placed to monitor market conditions and to react initially to an adverse event or development by deciding if a serious threat to financial stability or to market confidence has arisen and whether it is necessary to take measures to address such a situation, powers in this regard and the conditions and procedures for their use should be harmonised as far as possible.</p></td></tr></table>
<table><col/><col/><tr><td><p>(30)</p></td><td><p>In the case of a significant fall in the price of a financial instrument on a trading venue a competent authority should also have the ability to restrict temporarily short selling of the financial instrument on that venue within its own jurisdiction or to request that ESMA restrict such short selling in other jurisdictions in order to be able to intervene rapidly where appropriate and for a short period to prevent a disorderly decline in price of the instrument concerned. The competent authority should also be required to notify ESMA of such a decision so that ESMA can immediately inform the competent authorities of other Member States with venues which trade the same instrument, coordinate the taking of measures by those other Member States and, if necessary, assist them in reaching an agreement or take a decision itself, in accordance with Article 19 of Regulation (EU) No 1095/2010.</p></td></tr></table>
<table><col/><col/><tr><td><p>(31)</p></td><td><p>Where an adverse event or development extends beyond a single Member State or has other cross-border implications, for example if a financial instrument is admitted to trading on different trading venues in a number of different Member States, close consultation and cooperation between competent authorities is essential. ESMA should perform a key coordination role in such a situation and should try to ensure consistency between competent authorities. The composition of ESMA, which includes representatives of competent authorities, will assist it in the performance of such a role. In addition, competent authorities should have power to take measures where they have an interest in intervening.</p></td></tr></table>
<table><col/><col/><tr><td><p>(32)</p></td><td><p>In addition to coordinating measures by competent authorities, ESMA should ensure that measures are taken by competent authorities only where necessary and proportionate. ESMA should be able to give opinions to competent authorities on the use of powers of intervention.</p></td></tr></table>
<table><col/><col/><tr><td><p>(33)</p></td><td><p>While competent authorities will often be best placed to monitor and to react quickly to an adverse event or development, ESMA should also have the power to take measures where short selling and other related activities threaten the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the Union, where there are cross-border implications and competent authorities have not taken sufficient measures to address the threat. ESMA should consult the European Systemic Risk Board (ESRB) established by Regulation (EU) No 1092/2010 of the European Parliament and of the Council of 24 November 2010 on European Union macro-prudential oversight of the financial system and establishing a European Systemic Risk Board (<a><span>6</span></a>) where possible, and other relevant authorities where such a measure could have effects beyond the financial markets, as could be the case for commodity derivatives which are used to hedge physical positions.</p></td></tr></table>
<table><col/><col/><tr><td><p>(34)</p></td><td><p>ESMA’s powers under this Regulation to restrict short selling and other related activities in exceptional circumstances are in accordance with Article 9(5) of Regulation (EU) No 1095/2010. Those powers should be without prejudice to the powers of ESMA in an emergency situation under Article 18 of Regulation (EU) No 1095/2010. In particular, ESMA should be able to adopt individual decisions requiring competent authorities to take measures or individual decisions addressed to financial market participants under Article 18 of Regulation (EU) No 1095/2010.</p></td></tr></table>
<table><col/><col/><tr><td><p>(35)</p></td><td><p>References in this Regulation to Articles 18 and 38 of Regulation (EU) No 1095/2010 are of a declaratory nature. Those articles apply even in the absence of such references.</p></td></tr></table>
<table><col/><col/><tr><td><p>(36)</p></td><td><p>Powers of intervention of competent authorities and ESMA to restrict short selling, credit default swaps and other transactions should be only of a temporary nature and should be exercised only for such a period and to the extent necessary to deal with the specific threat.</p></td></tr></table>
<table><col/><col/><tr><td><p>(37)</p></td><td><p>Because of the specific risks which can arise from the use of credit default swaps, such transactions require close monitoring by competent authorities. In particular, competent authorities should, in exceptional cases, have the power to require information from natural or legal persons entering into such transactions about the purpose for which the transaction is entered into.</p></td></tr></table>
<table><col/><col/><tr><td><p>(38)</p></td><td><p>ESMA should be given power to conduct an inquiry into an issue or practice relating to short selling or the use of credit default swaps to assess whether that issue or practice poses any potential threat to financial stability or to market confidence. ESMA should publish a report setting out its findings where it conducts such an inquiry.</p></td></tr></table>
<table><col/><col/><tr><td><p>(39)</p></td><td><p>As some of the provisions of this Regulation apply to natural or legal persons and actions in third countries, it is necessary that competent authorities and supervisory authorities in third countries cooperate in certain situations. Competent authorities should therefore enter into arrangements with supervisory authorities in third countries. ESMA should coordinate the development of such cooperation arrangements and the exchange between competent authorities of information received from third countries.</p></td></tr></table>
<table><col/><col/><tr><td><p>(40)</p></td><td><p>This Regulation respects the fundamental rights and observes the principles recognised in particular in the Treaty on the Functioning of the European Union (TFEU) and in the Charter of Fundamental Rights of the European Union (Charter), in particular the right to the protection of personal data provided for in Article 16 TFEU and in Article 8 of the Charter. Transparency regarding significant net short positions, including public disclosure above a certain threshold, where provided for under this Regulation, is necessary for reasons of financial market stability and investor protection. Such transparency will enable regulators to monitor the use of short selling in connection with abusive strategies and the implications of short selling on the proper functioning of the markets. In addition, such transparency could help reduce information asymmetries, ensuring that all market participants are adequately informed about the extent to which short selling is affecting prices. Any exchange or transmission of information by competent authorities should take place in accordance with the rules on the transfer of personal data as laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (<a><span>7</span></a>). Any exchange or transmission of information by ESMA should take place in accordance with the rules on the transfer of personal data as laid down in Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (<a><span>8</span></a>), which should be fully applicable to the processing of personal data for the purposes of this Regulation.</p></td></tr></table>
<table><col/><col/><tr><td><p>(41)</p></td><td><p>Taking into consideration the principles set out in the Commission’s Communication on reinforcing sanctioning regimes in the financial services sector and legal acts of the Union adopted as a follow-up to that Communication, Member States should lay down rules on penalties and administrative measures applicable to infringements of the provisions of this Regulation and should ensure that they are implemented. Those penalties and administrative measures should be effective, proportionate and dissuasive. They should be based on guidelines adopted by ESMA to promote convergence and cross-sector consistency of penalty regimes in the financial sector.</p></td></tr></table>
<table><col/><col/><tr><td><p>(42)</p></td><td><p>In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (<a><span>9</span></a>). The Commission should keep the European Parliament informed of progress relating to decisions determining the equivalence of third-country legal and supervisory frameworks with requirements of this Regulation.</p></td></tr></table>
<table><col/><col/><tr><td><p>(43)</p></td><td><p>The power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of details concerning calculating short positions, where a natural or legal person has an uncovered position in a credit default swap, notification or disclosure thresholds and further specification of criteria and factors for determining in which cases an adverse event or development creates a serious threat to financial stability or to market confidence in a Member State or the Union. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at the level of experts of the relevant institutions, authorities and agencies, where appropriate. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.</p></td></tr></table>
<table><col/><col/><tr><td><p>(44)</p></td><td><p>The Commission should submit a report to the European Parliament and the Council assessing the appropriateness of the notification and public disclosure thresholds provided for, the operation of the restrictions and requirements relating to the transparency of net short positions, and whether any other restrictions or conditions on short selling or credit default swaps are appropriate.</p></td></tr></table>
<table><col/><col/><tr><td><p>(45)</p></td><td><p>Since the objectives of this Regulation cannot be sufficiently achieved by the Member States, although competent authorities are better placed to monitor, and have better knowledge of, market developments, the overall impact of the problems relating to short selling and credit default swaps can be fully perceived only in a Union context, and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.</p></td></tr></table>
<table><col/><col/><tr><td><p>(46)</p></td><td><p>Since some Member States have already put in place restrictions on short selling and since this Regulation provides for delegated acts and binding technical standards which should be adopted before it can be usefully applied, it is necessary to provide for a sufficient period of time for transitional purposes. Since it is essential to specify, before 1 November 2012, key non-essential elements which will facilitate compliance by market participants with this Regulation and enforcement by competent authorities, it is also necessary to provide the Commission with the means to adopt the technical standards and delegated acts before that date,</p></td></tr></table>
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Scope
1. This Regulation shall apply to the following:
(a) financial instruments within the meaning of point (a) of Article 2(1) that are admitted to trading on a trading venue in the Union, including such instruments when traded outside a trading venue;
(b) derivatives referred to in points (4) to (10) of Section C of Annex I to Directive 2004/39/EC that relate to a financial instrument referred to in point (a) or to an issuer of such a financial instrument, including such derivatives when traded outside a trading venue;
(c) debt instruments issued by a Member State or the Union and derivatives referred to in points (4) to (10) of Section C of Annex I to Directive 2004/39/EC that relate or are referenced to debt instruments issued by a Member State or the Union.
2. Articles 18, 20 and 23 to 30 shall apply to all financial instruments within the meaning of point (a) of Article 2(1).
Article 2
Definitions
1. For the purpose of this Regulation, the following definitions apply:
(a) ‘financial instrument’ means an instrument listed in Section C of Annex I to Directive 2004/39/EC;
(b) ‘short sale’ in relation to a share or debt instrument means any sale of the share or debt instrument which the seller does not own at the time of entering into the agreement to sell including such a sale where at the time of entering into the agreement to sell the seller has borrowed or agreed to borrow the share or debt instrument for delivery at settlement, not including:
(i) a sale by either party under a repurchase agreement where one party has agreed to sell the other a security at a specified price with a commitment from the other party to sell the security back at a later date at another specified price;
(ii) a transfer of securities under a securities lending agreement; or
(iii) entry into a futures contract or other derivative contract where it is agreed to sell securities at a specified price at a future date;
(c) ‘credit default swap’ means a derivative contract in which one party pays a fee to another party in return for a payment or other benefit in the case of a credit event relating to a reference entity and of any other default, relating to that derivative contract, which has a similar economic effect;
(d) ‘sovereign issuer’ means any of the following that issues debt instruments:
(i) the Union;
(ii) a Member State, including a government department, an agency, or a special purpose vehicle of the Member State;
(iii) in the case of a federal Member State, a member of the federation;
(iv) a special purpose vehicle for several Member States;
(v) an international financial institution established by two or more Member States which has the purpose of mobilising funding and provide financial assistance to the benefit of its members that are experiencing or threatened by severe financing problems; or
(vi) the European Investment Bank;
(e) ‘sovereign credit default swap’ means a credit default swap where a payment or other benefit will be paid in the case of a credit event or default relating to a sovereign issuer;
(f) ‘sovereign debt’ means a debt instrument issued by a sovereign issuer;
(g) ‘issued sovereign debt’ means the total of sovereign debt issued by a sovereign issuer that has not been redeemed;
(h) ‘issued share capital’ in relation to a company, means the total of ordinary and any preference shares issued by the company but does not include convertible debt securities;
(i) ‘home Member State’ means:
(i) in relation to an investment firm within the meaning of point (1) of Article 4(1) of Directive 2004/39/EC, or to a regulated market within the meaning of point (14) of Article 4(1) of Directive 2004/39/EC, the home Member State within the meaning of point (20) of Article 4(1) of Directive 2004/39/EC;
(ii) in relation to a credit institution, the home Member State within the meaning of point (7) of Article 4 of Directive 2006/48/EC of the European Parliament and of the Council of 14 June 2006 relating to the taking up and pursuit of the business of credit institutions ( 10 );
(iii) in relation to a legal person not referred to in point (i) or (ii), the Member State in which its registered office is situated or, if it has no registered office, the Member State in which its head office is situated;
(iv) in relation to a natural person, the Member State in which that person’s head office is situated, or, where there is no head office, the Member State in which that person is domiciled;
(j) ‘relevant competent authority’ means:
(i) in relation to sovereign debt of a Member State, or, in the case of a federal Member State, in relation to sovereign debt of a member of the federation, or a credit default swap relating to a Member State or a member of a federation, the competent authority of that Member State;
(ii) in relation to sovereign debt of the Union or a credit default swap relating to the Union, the competent authority of the jurisdiction in which the department issuing the debt is situated;
(iii) in relation to sovereign debt of several Member States acting through a special purpose vehicle or a credit default swap relating to such a special purpose vehicle, the competent authority of the jurisdiction in which the special purpose vehicle is established;
(iv) in relation to sovereign debt of an international financial institution established by two or more Member States, which has the purpose to mobilise funding and provide financial assistance to the benefit of its members that are experiencing or threatened by severe financing problems, the competent authority of the jurisdiction in which the international financial institution is established;
(v) in relation to a financial instrument other than an instrument referred to in points (i) to (iv), the competent authority for that financial instrument as defined in point (7) of Article 2 of Commission Regulation (EC) No 1287/2006 ( 11 ) and determined in accordance with Chapter III of that Regulation;
(vi) in relation to a financial instrument that is not covered under points (i) to (v), the competent authority of the Member State in which the financial instrument was first admitted to trading on a trading venue;
(vii) in relation to a debt instrument issued by the European Investment Bank, the competent authority of the Member State in which the European Investment Bank is located;
(k) ‘market making activities’ means the activities of an investment firm, a credit institution, a third-country entity, or a firm as referred to in point (l) of Article 2(1) of Directive 2004/39/EC, which is a member of a trading venue or of a market in a third country, the legal and supervisory framework of which has been declared equivalent by the Commission pursuant to Article 17(2) where it deals as principal in a financial instrument, whether traded on or outside a trading venue, in any of the following capacities:
(i) by posting firm, simultaneous two-way quotes of comparable size and at competitive prices, with the result of providing liquidity on a regular and ongoing basis to the market;
(ii) as part of its usual business, by fulfilling orders initiated by clients or in response to clients’ requests to trade;
(iii) by hedging positions arising from the fulfilment of tasks under points (i) and (ii);
(l) ‘trading venue’ means a regulated market within the meaning of point (14) of Article 4(1) of Directive 2004/39/EC, or a multilateral trading facility within the meaning of point (15) of Article 4(1) of Directive 2004/39/EC;
(m) ‘principal venue’ in relation to a share means the venue for the trading of that share with the highest turnover;
(n) ‘authorised primary dealer’ means a natural or legal person who has signed an agreement with a sovereign issuer or who has been formally recognised as a primary dealer by or on behalf of a sovereign issuer and who, in accordance with that agreement or recognition, has committed to dealing as principal in connection with primary and secondary market operations relating to debt issued by that issuer;
(o) ‘central counterparty’ means a legal entity which interposes itself between the counterparties to the contracts traded within one or more financial markets, becoming the buyer to every seller and the seller to every buyer and which is responsible for the operation of a clearing system;
(p) ‘trading day’ means a trading day as referred to in Article 4 of Regulation (EC) No 1287/2006;
(q) ‘turnover’ of a share means turnover within the meaning of point (9) of Article 2 of Regulation (EC) No 1287/2006.
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 42 specifying the definitions laid down in paragraph 1 of this Article, in particular specifying when a natural or legal person is considered to own a financial instrument for the purposes of the definition of short sale in point (b) of paragraph 1.
Article 3
Short and long positions
1. For the purposes of this Regulation, a position resulting from either of the following shall be considered to be a short position relating to issued share capital or issued sovereign debt:
(a) a short sale of a share issued by a company or of a debt instrument issued by a sovereign issuer;
(b) entering into a transaction which creates or relates to a financial instrument other than an instrument referred to in point (a) where the effect or one of the effects of the transaction is to confer a financial advantage on the natural or legal person entering into that transaction in the event of a decrease in the price or value of the share or debt instrument.
2. For the purposes of this Regulation, a position resulting from either of the following shall be considered to be a long position relating to issued share capital or issued sovereign debt:
(a) holding a share issued by a company or a debt instrument issued by a sovereign issuer;
(b) entering into a transaction which creates or relates to a financial instrument other than an instrument referred to in point (a) where the effect or one of the effects of the transaction is to confer a financial advantage on the natural or legal person entering into that transaction in the event of an increase in the price or value of the share or debt instrument.
3. For the purposes of paragraphs 1 and 2, the calculation of a short or a long position, in respect of any position held by the relevant person indirectly, including through or by way of any index, basket of securities or any interest in any exchange traded fund or similar entity, shall be determined by the natural or legal person in question acting reasonably having regard to publicly available information as to the composition of the relevant index or basket of securities, or of the interests held by the relevant exchange traded fund or similar entity. In calculating such a short or long position, no person shall be required to obtain any real-time information as to such composition from any person.
For the purposes of paragraphs 1 and 2 the calculation of a short or long position relating to sovereign debt shall include any sovereign credit default swap that relates to the sovereign issuer.
4. For the purposes of this Regulation, the position remaining after deducting any long position that a natural or legal person holds in relation to the issued share capital from any short position that that natural or legal person holds in relation to that capital shall be considered a net short position in relation to the issued share capital of the company concerned.
5. For the purposes of this Regulation, the position remaining after deducting any long position that a natural or legal person holds in relation to issued sovereign debt and any long position in debt instruments of a sovereign issuer the pricing of which is highly correlated to the pricing of the given sovereign debt from any short position that that natural or legal person holds in relation to the same sovereign debt shall be considered a net short position in relation to the issued sovereign debt of the sovereign issuer concerned.
6. The calculation of sovereign debt under paragraphs 1 to 5 shall be for each single sovereign issuer even if separate entities issue sovereign debt on behalf of the sovereign issuer.
7. The Commission shall be empowered to adopt delegated acts in accordance with Article 42 specifying:
(a) cases in which a natural or legal person is considered to hold a share or debt instrument for the purposes of paragraph 2;
(b) cases in which a natural or legal person has a net short position for the purposes of paragraphs 4 and 5 and the method of calculation of such position;
(c) the method of calculating positions for the purposes of paragraphs 3, 4 and 5 when different entities in a group have long or short positions or for fund management activities relating to separate funds.
For the purposes of point (c) of the first subparagraph, the method of calculation shall take into account, in particular, whether different investment strategies are pursued in relation to a particular issuer through more than one separate fund managed by the same fund manager, whether the same investment strategy is pursued in relation to a particular issuer through more than one fund, and whether more than one portfolio within the same entity is managed on a discretionary basis pursuing the same investment strategy in relation to a particular issuer.
Article 4
Uncovered position in a sovereign credit default swap
1. For the purposes of this Regulation, a natural or legal person shall be considered to have an uncovered position in a sovereign credit default swap where the sovereign credit default swap does not serve to hedge against:
(a) the risk of default of the issuer where the natural or legal person has a long position in the sovereign debt of that issuer to which the sovereign credit default swap relates; or
(b) the risk of a decline of the value of the sovereign debt where the natural or legal person holds assets or is subject to liabilities, including but not limited to financial contracts, a portfolio of assets or financial obligations the value of which is correlated to the value of the sovereign debt.
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 42 specifying, for the purposes of paragraph 1 of this Article:
(a) cases in which a sovereign credit default swap transaction is considered to be hedging against a default risk or the risk of a decline of the value of the sovereign debt, and the method of calculation of an uncovered position in a sovereign credit default swap;
(b) the method of calculating positions where different entities in a group have long or short positions or for fund management activities relating to separate funds.
CHAPTER II
TRANSPARENCY OF NET SHORT POSITIONS
Article 5
Notification to competent authorities of significant net short positions in shares
1. A natural or legal person who has a net short position in relation to the issued share capital of a company that has shares admitted to trading on a trading venue shall notify the relevant competent authority, in accordance with Article 9, where the position reaches or falls below a relevant notification threshold referred to in paragraph 2 of this Article.
2. A relevant notification threshold is a percentage that equals 0,2 % of the issued share capital of the company concerned and each 0,1 % above that.
3. The European Supervisory Authority (European Securities and Markets Authority) (ESMA) may issue an opinion to the Commission on adjusting the thresholds referred to in paragraph 2, taking into account the developments in financial markets.
4. The Commission shall be empowered to adopt delegated acts in accordance with Article 42 modifying the thresholds referred to in paragraph 2 of this Article, taking into account the developments in financial markets.
Article 6
Public disclosure of significant net short positions in shares
1. A natural or legal person who has a net short position in relation to the issued share capital of a company that has shares admitted to trading on a trading venue shall disclose details of that position to the public, in accordance with Article 9, where the position reaches or falls below a relevant publication threshold referred to in paragraph 2 of this Article.
2. A relevant publication threshold is a percentage that equals 0,5 % of the issued share capital of the company concerned and each 0,1 % above that.
3. ESMA may issue an opinion to the Commission on adjusting the thresholds referred to in paragraph 2, taking into account the developments in financial markets.
4. The Commission shall be empowered to adopt delegated acts in accordance with Article 42 modifying the thresholds referred to in paragraph 2 of this Article, taking into account the developments in financial markets.
5. This Article is without prejudice to laws, regulations and administrative provisions adopted in relation to takeover bids, merger transactions and other transactions affecting the ownership or control of companies regulated by the supervisory authorities appointed by Member States pursuant to Article 4 of Directive 2004/25/EC of the European Parliament and of the Council of 21 April 2004 on takeover bids ( 12 ) that require disclosure of short positions beyond the requirements of this Article.
Article 7
Notification to competent authorities of significant net short positions in sovereign debt
1. A natural or legal person who has a net short position relating to issued sovereign debt shall notify the relevant competent authority, in accordance with Article 9, where such a position reaches or falls below the relevant notification thresholds for the sovereign issuer concerned.
2. The relevant notification thresholds shall consist of an initial amount and then additional incremental levels in relation to each sovereign issuer, as specified in the measures taken by the Commission in accordance with paragraph 3. ESMA shall publish on its website the notification thresholds for each Member State.
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 42 specifying the amounts and incremental levels referred to in paragraph 2 of this Article.
The Commission shall:
(a) ensure that the thresholds are not set at such a level as to require notification of positions which are of minimal value;
(b) take into account the total amount of outstanding issued sovereign debt for each sovereign issuer, and the average size of positions held by market participants relating to the sovereign debt of that sovereign issuer; and
(c) take into account the liquidity of each sovereign bond market.
Article 8
Notification to competent authorities of uncovered positions in sovereign credit default swaps
Where a competent authority suspends restrictions in accordance with Article 14(2), a natural or legal person who has an uncovered position in a sovereign credit default swap shall notify the relevant competent authority where such a position reaches or falls below the relevant notification thresholds for the sovereign issuer, as specified in accordance with Article 7.
Article 9
Method of notification and disclosure
1. Any notification or disclosure under Article 5, 6, 7 or 8 shall set out details of the identity of the natural or legal person who holds the relevant position, the size of the relevant position, the issuer in relation to which the relevant position is held and the date on which the relevant position was created, changed or ceased to be held.
For the purposes of Articles 5, 6, 7 and 8, natural and legal persons that hold significant net short positions shall keep, for a period of 5 years, records of the gross positions which make a significant net short position.
2. The relevant time for calculation of a net short position shall be at midnight at the end of the trading day on which the natural or legal person holds the relevant position. That time shall apply to all transactions irrespective of the means of trading used, including transactions executed through manual or automated trading, and irrespective of whether the transactions have taken place during normal trading hours. The notification or disclosure shall be made not later than at 15.30 on the following trading day. The times specified in this paragraph shall be calculated according to the time in the Member State of the relevant competent authority to whom the relevant position must be notified.
3. The notification of information to a relevant competent authority shall ensure the confidentiality of the information and incorporate mechanisms for authenticating the source of the notification.
4. The public disclosure of information set out in Article 6 shall be made in a manner ensuring fast access to information on a non-discriminatory basis. That information shall be posted on a central website operated or supervised by the relevant competent authority. The competent authorities shall communicate the address of that website to ESMA, which, in turn, shall put a link to all such central websites on its own website.
5. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the details of the information to be provided for the purposes of paragraph 1.
ESMA shall submit those draft regulatory technical standards to the Commission by 31 March 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
6. In order to ensure uniform conditions of application of paragraph 4, ESMA shall develop draft implementing technical standards specifying the means by which information may be disclosed to the public.
ESMA shall submit those draft implementing technical standards to the Commission by 31 March 2012.
Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010.
Article 10
Application of notification and disclosure requirements
The notification and disclosure requirements under Articles 5, 6, 7 and 8 apply to natural or legal persons domiciled or established within the Union or in a third country.
Article 11
Information to be provided to ESMA
1. The competent authorities shall provide information in summary form to ESMA on a quarterly basis on net short positions relating to issued share capital and to issued sovereign debt, and on uncovered positions relating to sovereign credit default swaps, for which it is the relevant competent authority and receives notifications under Articles 5, 7 and 8.
2. ESMA may request at any time, in order to carry out its duties under this Regulation, additional information from a relevant competent authority on net short positions relating to issued share capital and to issued sovereign debt, or on uncovered positions relating to sovereign credit default swaps.
The competent authority shall provide the requested information to ESMA at the latest within 7 calendar days. Where there are adverse events or developments which constitute a serious threat to financial stability or to market confidence in the Member State concerned or in another Member State, the competent authority shall provide ESMA with any available information based on the notification requirements under Articles 5, 7 and 8 within 24 hours.
3. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the details of the information to be provided in accordance with paragraphs 1 and 2.
ESMA shall submit those draft regulatory technical standards to the Commission by 31 March 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
4. In order to ensure uniform conditions of application of paragraph 1, ESMA shall develop draft implementing technical standards defining the format of information to be provided in accordance with paragraphs 1 and 2.
ESMA shall submit those draft implementing technical standards to the Commission by 31 March 2012.
Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010.
CHAPTER III
UNCOVERED SHORT SALES
Article 12
Restrictions on uncovered short sales in shares
1. A natural or legal person may enter into a short sale of a share admitted to trading on a trading venue only where one of the following conditions is fulfilled:
(a) the natural or legal person has borrowed the share or has made alternative provisions resulting in a similar legal effect;
(b) the natural or legal person has entered into an agreement to borrow the share or has another absolutely enforceable claim under contract or property law to be transferred ownership of a corresponding number of securities of the same class so that settlement can be effected when it is due;
(c) the natural or legal person has an arrangement with a third party under which that third party has confirmed that the share has been located and has taken measures vis-à-vis third parties necessary for the natural or legal person to have a reasonable expectation that settlement can be effected when it is due.
2. In order to ensure uniform conditions of application of paragraph 1, ESMA shall develop draft implementing technical standards to determine the types of agreements, arrangements and measures that adequately ensure that the share will be available for settlement. In determining what measures are necessary to have a reasonable expectation that settlement can be effected when it is due, ESMA shall take into account, inter alia, the intraday trading and the liquidity of the shares.
ESMA shall submit those draft implementing technical standards to the Commission by 31 March 2012.
Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010.
Article 13
Restrictions on uncovered short sales in sovereign debt
1. A natural or legal person may enter into a short sale of sovereign debt only where one of the following conditions is fulfilled:
(a) the natural or legal person has borrowed the sovereign debt or has made alternative provisions resulting in a similar legal effect;
(b) the natural or legal person has entered into an agreement to borrow the sovereign debt or has another absolutely enforceable claim under contract or property law to be transferred ownership of a corresponding number of securities of the same class so that settlement can be effected when it is due;
(c) the natural or legal person has an arrangement with a third party under which that third party has confirmed that the sovereign debt has been located or otherwise has a reasonable expectation that settlement can be effected when it is due.
2. The restrictions in paragraph 1 do not apply if the transaction serves to hedge a long position in debt instruments of an issuer, the pricing of which has a high correlation with the pricing of the given sovereign debt.
3. Where the liquidity of sovereign debt falls below the threshold determined in accordance with the methodology referred to in paragraph 4, the restrictions referred to in paragraph 1 may be temporarily suspended by the relevant competent authority. Before suspending those restrictions, the relevant competent authority shall notify ESMA and the other competent authorities about the proposed suspension.
A suspension shall be valid for an initial period not exceeding 6 months from the date of its publication on the website of the relevant competent authority. The suspension may be renewed for periods not exceeding 6 months if the grounds for the suspension continue to apply. If the suspension is not renewed by the end of the initial period or of any subsequent renewal period it shall automatically expire.
ESMA shall, within 24 hours of notification by the relevant competent authority, issue an opinion based on paragraph 4 on the notified suspension or renewal of suspension. The opinion shall be published on ESMA’s website.
4. The Commission shall adopt delegated acts in accordance with Article 42 specifying the parameters and methods for calculating the threshold of liquidity referred to in paragraph 3 of this Article in relation to issued sovereign debt.
The parameters and methods for Member States to calculate the threshold shall be set in such a way that where it is reached, it represents a significant decline relative to the average level of liquidity for the sovereign debt concerned.
The threshold shall be defined based on objective criteria specific to the relevant sovereign debt market, including the total amount of outstanding issued sovereign debt for each sovereign issuer.
5. In order to ensure uniform conditions of application of paragraph 1, ESMA may develop draft implementing technical standards to determine the types of agreements or arrangements that adequately ensure that the sovereign debt will be available for settlement. ESMA shall, in particular, take into account the need to preserve liquidity of markets, especially sovereign bond and sovereign bond repurchase markets.
ESMA shall submit those draft implementing technical standards to the Commission by 31 March 2012.
Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010.
Article 14
Restrictions on uncovered sovereign credit default swaps
1. A natural or legal person may enter into sovereign credit default swap transactions only where that transaction does not lead to an uncovered position in a sovereign credit default swap as referred to in Article 4.
2. A competent authority may temporarily suspend restrictions referred to in paragraph 1, where it has objective grounds for believing that its sovereign debt market is not functioning properly and that such restrictions might have a negative impact on the sovereign credit default swap market, especially by increasing the cost of borrowing for sovereign issuers or affecting the sovereign issuers’ ability to issue new debt. Those grounds shall be based on the following indicators:
(a) a high or rising interest rate on the sovereign debt;
(b) a widening of interest rate spreads on the sovereign debt compared to the sovereign debt of other sovereign issuers;
(c) a widening of the sovereign credit default swap spreads compared to the own curve and compared to other sovereign issuers;
(d) the timeliness of the return of the price of the sovereign debt to its original equilibrium after a large trade;
(e) the amounts of sovereign debt that can be traded.
The competent authority may also use indicators other than those set out in points (a) to (e) of the first subparagraph.
Before suspending restrictions under this Article, the relevant competent authority shall notify ESMA and the other competent authorities of the proposed suspension and the grounds on which it is based.
A suspension shall be valid for an initial period not exceeding 12 months from the date of its publication on the website of the relevant competent authority. The suspension may be renewed for periods not exceeding 6 months if the grounds for the suspension continue to apply. If the suspension is not renewed by the end of the initial period or of any subsequent renewal period, it shall automatically expire.
ESMA shall, within 24 hours of the notification by the relevant competent authority, issue an opinion on the intended suspension or on the renewal of that suspension, irrespective of whether the competent authority has based the suspension on the indicators set out in points (a) to (e) of the first subparagraph or on other indicators. Where the intended suspension or renewal of a suspension is based on the second subparagraph, that opinion shall also include an assessment of the indicators used by the competent authority. The opinion shall be published on ESMA’s website.
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CHAPTER IV
EXEMPTIONS
Article 16
Exemption where the principal trading venue is in a third country
1. Articles 5, 6, 12 and 15 shall not apply to shares of a company admitted to trading on a trading venue in the Union where the principal venue for the trading of the shares is located in a third country.
2. The relevant competent authority for shares of a company that are traded on a trading venue in the Union and a venue located in a third country shall determine, at least every 2 years, whether the principal venue for the trading of those shares is located in a third country.
The relevant competent authority shall notify ESMA of any such shares identified as having their principal trading venue located in a third country.
Every 2 years ESMA shall publish the list of shares for which the principal trading venue is located in a third country. The list shall be effective for a 2-year period.
3. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the method for calculation of the turnover to determine the principal venue for the trading of a share.
ESMA shall submit those draft regulatory technical standards to the Commission by 31 March 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
4. In order to ensure uniform conditions of application of paragraphs 1 and 2 ESMA shall develop draft implementing technical standards to determine:
(a) the date on which and period in respect of which any calculation determining the principal trading venue for a share is to be made;
(b) the date by which the relevant competent authority shall notify ESMA of those shares for which the principal trading venue is in a third country;
(c) the date from which the list is to be effective following publication by ESMA.
ESMA shall submit those draft implementing technical standards to the Commission by 31 March 2012.
Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010.
Article 17
Exemption for market making activities and primary market operations
1. Articles 5, 6, 7, 12, 13 and 14 shall not apply to transactions performed due to market making activities.
2. The Commission may, in accordance with the procedure referred to in Article 44(2), adopt decisions determining that the legal and supervisory framework of a third country ensures that a market authorised in that third country complies with legally binding requirements which are, for the purpose of the application of the exemption set out in paragraph 1, equivalent to the requirements under Title III of Directive 2004/39/EC, under Directive 2003/6/EC of the European Parliament and of the Council of 28 January 2003 on insider dealing and market manipulation (market abuse) ( 13 ) and under Directive 2004/109/EC of the European Parliament and of the Council of 15 December 2004 on the harmonisation of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market ( 14 ), and which are subject to effective supervision and enforcement in that third country.
The legal and supervisory framework of a third country may be considered equivalent where that third country’s:
(a) markets are subject to authorisation and to effective supervision and enforcement on an ongoing basis;
(b) markets have clear and transparent rules regarding admission of securities to trading so that such securities are capable of being traded in a fair, orderly and efficient manner, and are freely negotiable;
(c) security issuers are subject to periodic and ongoing information requirements ensuring a high level of investor protection; and
(d) market transparency and integrity are ensured by preventing market abuse in the form of insider dealing and market manipulation.
3. Articles 7, 13 and 14 shall not apply to the activities of a natural or legal person where, acting as an authorised primary dealer pursuant to an agreement with a sovereign issuer, it is dealing as principal in a financial instrument in relation to primary or secondary market operations relating to the sovereign debt.
4. Articles 5, 6, 12, 13 and 14 of this Regulation shall not apply to a natural or legal person where it enters into a short sale of a security or has a net short position in relation to the carrying out of a stabilisation under Chapter III of Commission Regulation (EC) No 2273/2003 of 22 December 2003 implementing Directive 2003/6/EC of the European Parliament and of the Council as regards exemptions for buy-back programmes and stabilisation of financial instruments ( 15 ).
5. The exemption referred to in paragraph 1 shall apply only where the natural or legal person concerned has notified the competent authority of its home Member State in writing that it intends to make use of the exemption. The notification shall be made not less than 30 calendar days before the natural or legal person first intends to use the exemption.
6. The exemption referred to in paragraph 3 shall apply only where the authorised primary dealer has notified the relevant competent authority in relation to the sovereign debt concerned in writing that it intends to make use of the exemption. The notification shall be made not less than 30 calendar days before the natural or legal person acting as authorised primary dealer first intends to use the exemption.
7. The competent authority referred to in paragraphs 5 and 6 may prohibit the use of the exemption if it considers that the natural or legal person does not satisfy the conditions of the exemption. Any prohibition shall be imposed within the 30 calendar day period referred to in paragraph 5 or 6 or subsequently if the competent authority becomes aware that there have been changes in the circumstances of the natural or legal person so that it no longer satisfies the conditions of the exemption.
8. A third-country entity that is not authorised in the Union shall send the notification referred to in paragraphs 5 and 6 to the competent authority of the main trading venue in the Union in which it trades.
9. A natural or legal person who has given a notification under paragraph 5 shall as soon as possible notify in writing the competent authority of its home Member State where there are any changes affecting that person’s eligibility to use the exemption, or if it no longer wishes to use the exemption.
10. A natural or legal person who has given a notification under paragraph 6 shall as soon as possible notify in writing the relevant competent authority in relation to sovereign debt concerned where there are any changes affecting that person’s eligibility to use the exemption, or if it no longer wishes to use the exemption.
11. The competent authority of the home Member State may request information, in writing, from a natural or legal person operating under the exemptions set out in paragraph 1, 3 or 4 about short positions held or activities conducted under the exemption. The natural or legal person shall provide the information not later than 4 calendar days after the request is made.
12. A competent authority shall notify ESMA within 2 weeks of notification in accordance with paragraph 5 or 9 of any market makers and in accordance with paragraph 6 or 10 of any authorised primary dealers who are making use of the exemption and of any market makers and authorised primary dealers who are no longer making use of the exemption.
13. ESMA shall publish and keep up to date on its website a list of market makers and authorised primary dealers who are using the exemption.
14. A notification under this Article may be made by a person to a competent authority and by a competent authority to ESMA at any time within 60 calendar days before 1 November 2012.
CHAPTER V
POWERS OF INTERVENTION OF COMPETENT AUTHORITIES AND OF ESMA
SECTION 1
Powers of competent authorities
Article 18
Notification and disclosure in exceptional circumstances
1. Subject to Article 22, a competent authority may require natural or legal persons who have net short positions in relation to a specific financial instrument or class of financial instruments to notify it or to disclose to the public details of the position where the position reaches or falls below a notification threshold fixed by the competent authority and where:
(a) there are adverse events or developments which constitute a serious threat to financial stability or to market confidence in the Member State concerned or in one or more other Member States; and
(b) the measure is necessary to address the threat and will not have a detrimental effect on the efficiency of financial markets which is disproportionate to its benefits.
2. Paragraph 1 of this Article shall not apply to financial instruments in respect of which transparency is already required under Articles 5 to 8. A measure under paragraph 1 may apply in circumstances or be subject to exceptions specified by the competent authority. Exceptions may in particular be specified to apply to market making activities and primary market activities.
Article 19
Notification by lenders in exceptional circumstances
1. Subject to Article 22, a competent authority may take the measure referred to in paragraph 2 of this Article where:
(a) there are adverse events or developments which constitute a serious threat to financial stability or to market confidence in the Member State concerned or in one or more other Member States; and
(b) the measure is necessary to address the threat and will not have a detrimental effect on the efficiency of financial markets which is disproportionate to its benefits.
2. A competent authority may require natural or legal persons engaged in the lending of a specific financial instrument or class of financial instruments to notify any significant change in the fees requested for such lending.
Article 20
Restrictions on short selling and similar transactions in exceptional circumstances
1. Subject to Article 22, a competent authority may take one or more of the measures referred to in paragraph 2 of this Article where:
(a) there are adverse events or developments which constitute a serious threat to financial stability or to market confidence in the Member State concerned or in one or more other Member States; and
(b) the measure is necessary to address the threat and will not have a detrimental effect on the efficiency of financial markets which is disproportionate to its benefits.
2. A competent authority may prohibit or impose conditions relating to natural or legal persons entering into:
(a) a short sale; or
(b) a transaction other than a short sale which creates, or relates to, a financial instrument and the effect or one of the effects of that transaction is to confer a financial advantage on the natural or legal person in the event of a decrease in the price or value of another financial instrument.
3. A measure taken under paragraph 2 may apply to transactions concerning all financial instruments, financial instruments of a specific class or a specific financial instrument. The measure may apply in circumstances or be subject to exceptions specified by the competent authority. Exceptions may in particular be specified to apply to market making activities and primary market activities.
Article 21
Restrictions on sovereign credit default swap transactions in exceptional circumstances
1. Subject to Article 22, a competent authority may restrict the ability of natural or legal persons to enter into sovereign credit default swap transactions or may limit the value of sovereign credit default swap positions that those persons are permitted to enter into where:
(a) there are adverse events or developments which constitute a serious threat to financial stability or to market confidence in the Member State concerned or in one or more other Member States; and
(b) the measure is necessary to address the threat and will not have a detrimental effect on the efficiency of financial markets which is disproportionate to its benefits.
2. A measure taken under paragraph 1 may apply to sovereign credit default swap transactions of a specific class or to specific sovereign credit default swap transactions. The measure may apply in circumstances or be subject to exceptions specified by the competent authority. Exceptions may in particular be specified to apply to market making activities and primary market activities.
Article 22
Measures by other competent authorities
Without prejudice to Article 26, a competent authority in relation to a financial instrument for which it is not the relevant competent authority may impose or renew a measure under Article 18, 19, 20 or 21 only with the consent of the relevant competent authority.
Article 23
Power to restrict short selling of financial instruments temporarily in the case of a significant fall in price
1. Where the price of a financial instrument on a trading venue has fallen significantly during a single trading day in relation to the closing price on that venue on the previous trading day, the competent authority of the home Member State for that venue shall consider whether it is appropriate to prohibit or restrict natural or legal persons from engaging in short selling of the financial instrument on that trading venue or otherwise limit transactions in that financial instrument on that trading venue in order to prevent a disorderly decline in the price of the financial instrument.
Where the competent authority is satisfied under the first subparagraph that it is appropriate to do so, it shall in the case of a share or a debt instrument, prohibit or restrict natural and legal persons from entering into a short sale on that trading venue or in the case of another type of financial instrument, limit transactions in that financial instrument on that trading venue in order to prevent a disorderly decline in the price of the financial instrument.
2. The measure under paragraph 1 shall apply for a period not exceeding the end of the trading day following the trading day on which the fall in price occurs. If, at the end of the trading day following the trading day on which the fall in price occurs, there is, despite the measure being imposed, a further significant fall in value of at least half of the amount specified in paragraph 5 of the financial instrument from the closing price of the first trading day, the competent authority may extend the measure for a further period not exceeding 2 trading days after the end of the second trading day.
3. The measure under paragraph 1 shall apply in circumstances or be subject to exceptions specified by the competent authority. Exceptions may in particular be specified to apply to market making activities and primary market activities.
4. A competent authority of the home Member State of a venue where a financial instrument has during a single trading day fallen by the value referred to in paragraph 5 shall notify ESMA about the decision taken under paragraph 1 at the latest 2 hours after the end of that trading day. ESMA shall immediately inform the competent authorities of the home Member States of venues which trade the same financial instrument.
If a competent authority disagrees with the action taken by another competent authority on a financial instrument traded on different venues regulated by different competent authorities, ESMA may assist those authorities in reaching an agreement in accordance with Article 19 of Regulation (EU) No 1095/2010.
The conciliation shall be completed before midnight at the end of the same trading day. If the competent authorities concerned fail to reach an agreement within the conciliation phase, ESMA may take a decision in accordance with Article 19(3) of Regulation (EU) No 1095/2010. The decision shall be taken before the opening of the next trading day.
5. The fall in value shall be 10 % or more in the case of a liquid share, as defined in Article 22 of Regulation (EC) No 1287/2006, and for illiquid shares and other classes of financial instruments an amount to be specified by the Commission.
6. ESMA may issue and send to the Commission an opinion on adjusting the threshold referred to in paragraph 5, taking into account the developments in financial markets.
The Commission shall be empowered to adopt delegated acts in accordance with Article 42 modifying the thresholds referred to in paragraph 5 of this Article, taking into account the developments in financial markets.
7. The Commission shall adopt delegated acts in accordance with Article 42 specifying what constitutes a significant fall in value for financial instruments other than liquid shares, taking into account the specificities of each class of financial instrument and the differences of volatility.
8. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the method of calculation of the 10 % fall for liquid shares and of the fall in value specified by the Commission as referred to in paragraph 7.
ESMA shall submit those draft regulatory technical standards to the Commission by 31 March 2012.
Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.
Article 24
Period of restrictions
A measure imposed under Article 18, 19, 20 or 21 shall be valid for an initial period not exceeding 3 months from the date of publication of the notice referred to in Article 25.
The measure may be renewed for further periods not exceeding 3 months if the grounds for taking the measure continue to apply. If the measure is not renewed by the end of such a 3-month period, it shall automatically expire.
Article 25
Notice of restrictions
1. A competent authority shall publish on its website notice of any decision to impose or renew any measure referred to in Articles 18 to 23.
2. The notice shall specify at least details of:
(a) the measures imposed including the instruments and classes of transactions to which they apply and their duration;
(b) the reasons why the competent authority believes it is necessary to impose the measures including the evidence supporting those reasons.
3. A measure under Articles 18 to 23 shall take effect when the notice is published or at a time specified in the notice that is after its publication and shall only apply in relation to a transaction entered into after the measure takes effect.
Article 26
Notification to ESMA and other competent authorities
1. Before imposing or renewing any measure under Article 18, 19, 20 or 21 and before imposing any restriction under Article 23, a competent authority shall notify ESMA and the other competent authorities of the measure it proposes.
2. The notification shall include details of the proposed measures, the classes of financial instruments and transactions to which they will apply, the evidence supporting the reasons for those measures and when the measures are intended to take effect.
3. Notification of a proposal to impose or renew a measure under Article 18, 19, 20 or 21 shall be made not less than 24 hours before the measure is intended to take effect or to be renewed. In exceptional circumstances, a competent authority may make the notification less than 24 hours before the measure is intended to take effect where it is not possible to give 24 hours notice. A notification of a restriction under Article 23 shall be made before the measure is intended to take effect.
4. A competent authority that receives notification under this Article may take measures in accordance with Articles 18 to 23 in that Member State where it is satisfied that the measure is necessary to assist the competent authority making the notification. The competent authority that receives notification shall also give notice in accordance with paragraphs 1 to 3 where it proposes to take measures.
SECTION 2
Powers of ESMA
Article 27
Coordination by ESMA
1. ESMA shall perform a facilitation and coordination role in relation to measures taken by the competent authorities under Section 1. In particular ESMA shall ensure that a consistent approach is taken by competent authorities regarding measures taken, especially regarding where it is necessary to use powers of intervention, the nature of any measures imposed and the commencement and duration of such measures.
2. After receiving notification under Article 26 of any measure that is to be imposed or renewed under Article 18, 19, 20 or 21, ESMA shall within 24 hours issue an opinion on whether it considers the measure or proposed measure is necessary to address the exceptional circumstances. The opinion shall state whether ESMA considers that adverse events or developments have arisen which constitute a serious threat to financial stability or to market confidence in one or more Member States, whether the measure or proposed measure is appropriate and proportionate to address the threat and whether the proposed duration of any such measure is justified. If ESMA considers that the taking of any measure by the other competent authorities is necessary to address the threat, it shall also state this in its opinion. The opinion shall be published on ESMA’s website.
3. Where a competent authority proposes to take or takes measures contrary to an ESMA opinion under paragraph 2 or declines to take measures contrary to an ESMA opinion under that paragraph, it shall publish on its website within 24 hours of receiving ESMA’s opinion a notice fully explaining its reasons for doing so. Where such a situation arises ESMA shall consider whether the conditions are satisfied and it is an appropriate case for the use of its powers of intervention under Article 28.
4. ESMA shall review measures under this Article regularly and in any event at least every 3 months. If the measure is not renewed by the end of such a 3-month period, it shall automatically expire.
Article 28
ESMA intervention powers in exceptional circumstances
1. In accordance with Article 9(5) of Regulation (EU) No 1095/2010, ESMA shall, subject to paragraph 2 of this Article, either:
(a) require natural or legal persons who have net short positions in relation to a specific financial instrument or class of financial instruments to notify a competent authority or to disclose to the public details of any such position; or
(b) prohibit or impose conditions on, the entry by natural or legal persons into a short sale or a transaction which creates, or relates to, a financial instrument other than financial instruments referred to in point (c) of Article 1(1) where the effect or one of the effects of the transaction is to confer a financial advantage on such person in the event of a decrease in the price or value of another financial instrument.
A measure may apply in particular circumstances, or be subject to exceptions specified by ESMA. Exceptions may in particular be specified to apply to market-making activities and primary market activities.
2. ESMA shall take a decision under paragraph 1 only if:
(a) the measures listed in points (a) and (b) of paragraph 1 address a threat to the orderly functioning and integrity of financial markets or to the stability of the whole or part of the financial system in the Union and there are cross-border implications; and
(b) no competent authority has taken measures to address the threat or one or more of the competent authorities have taken measures that do not adequately address the threat.
3. Where taking measures referred to in paragraph 1 ESMA shall take into account the extent to which the measure:
(a) significantly addresses the threat to the orderly functioning and integrity of financial markets or to the stability of the whole or part of the financial system in the Union or significantly improves the ability of the competent authorities to monitor the threat;
(b) does not create a risk of regulatory arbitrage;
(c) does not have a detrimental effect on the efficiency of financial markets, including by reducing liquidity in those markets or creating uncertainty for market participants, that is disproportionate to the benefits of the measure.
Where one or more competent authorities have taken a measure under Article 18, 19, 20 or 21, ESMA may take any of the measures referred to in paragraph 1 of this Article without issuing the opinion provided for in Article 27.
4. Before deciding to impose or renew any measure referred to in paragraph 1, ESMA shall consult the ESRB and, where appropriate, other relevant authorities.
5. Before deciding to impose or renew any measure referred to in paragraph 1, ESMA shall notify the competent authorities concerned of the measure it proposes to take. The notification shall include details of the proposed measures, the class of financial instruments and transactions to which they will apply, the evidence supporting the reasons for those measures and when the measures are intended to take effect.
6. The notification shall be made not less than 24 hours before the measure is to take effect or to be renewed. In exceptional circumstances, ESMA may make the notification less than 24 hours before the measure is intended to take effect where it is not possible to give 24 hours’ notice.
7. ESMA shall publish on its website notice of any decision to impose or renew any measure referred to in paragraph 1. The notice shall at least specify:
(a) the measures imposed including the instruments and classes of transactions to which they apply, and their duration; and
(b) the reasons why ESMA is of the opinion that it is necessary to impose the measures including the evidence supporting those reasons.
8. After deciding to impose or renew any measure referred to in paragraph 1, ESMA shall immediately notify the competent authorities of the measures taken.
9. A measure shall take effect when the notice is published on the ESMA website or at a time specified in the notice that is after its publication and shall only apply in relation to a transaction entered into after the measure takes effect.
10. ESMA shall review the measures referred to in paragraph 1 at appropriate intervals and at least every 3 months. If the measure is not renewed by the end of such a 3-month period it shall automatically expire. Paragraphs 2 to 9 shall apply to a renewal of measures.
11. A measure adopted by ESMA under this Article shall prevail over any previous measure taken by a competent authority under Section 1.
Article 29
ESMA’s powers in emergency situations relating to sovereign debt
In the case of an emergency situation relating to sovereign debt or sovereign credit default swaps, Articles 18 and 38 of Regulation (EU) No 1095/2010 shall apply.
Article 30
Further specification of adverse events or developments
The Commission shall be empowered to adopt delegated acts in accordance with Article 42 specifying criteria and factors to be taken into account by the competent authorities and by ESMA in determining in which cases the adverse events or developments referred to in Articles 18 to 21 and Article 27 and the threats referred to in point (a) of Article 28(2) arise.
Article 31
Inquiries by ESMA
ESMA may, on the request of one or more of the competent authorities, the European Parliament, the Council or the Commission or on its own initiative conduct an inquiry into a particular issue or practice relating to short selling or relating to the use of credit default swaps to assess whether that issue or practice poses any potential threat to financial stability or market confidence in the Union.
ESMA shall publish a report setting out its findings and any recommendations relating to the issue or practice within 3 months as from the end of any such inquiry.
CHAPTER VI
ROLE OF COMPETENT AUTHORITIES
Article 32
Competent authorities
Each Member State shall designate one or more of the competent authorities for the purpose of this Regulation.
Where a Member State designates more than one competent authority, it shall clearly determine their respective roles and it shall designate the authority to be responsible for coordinating the cooperation and the exchange of information with the Commission, ESMA and the competent authorities of the other Member States.
Member States shall inform the Commission, ESMA and the competent authorities of the other Member States of those designations.
Article 33
Powers of competent authorities
1. In order to fulfil their duties under this Regulation, the competent authorities shall have all the supervisory and investigatory powers that are necessary for the exercise of their functions. They shall exercise their powers in any of the following ways:
(a) directly;
(b) in collaboration with other authorities;
(c) by application to the competent judicial authorities.
2. In order to fulfil their duties under this Regulation, the competent authorities shall, in accordance with national law, have the power:
(a) to gain access to any document in any form and to receive or take a copy thereof;
(b) to require information from any natural or legal person and if necessary to summon and question a natural or legal person with a view to obtaining information;
(c) to carry out on-site inspections with or without prior announcement;
(d) to require existing telephone and existing data traffic records;
(e) to require the cessation of any practice that is contrary to the provisions in this Regulation;
(f) to require the freezing and/or the sequestration of assets.
3. The competent authorities shall, without prejudice to points (a) and (b) of paragraph 2, have the power in individual cases to require a natural or legal person entering into a credit default swap transaction to provide:
(a) an explanation about the purpose of the transaction and whether it is for the purposes of hedging against a risk or otherwise; and
(b) information verifying the underlying risk where the transaction is for hedging purposes.
Article 34
Professional secrecy
1. The obligation of professional secrecy shall apply to all natural or legal persons who work or who have worked for the competent authority or for any authority or natural or legal person to whom the competent authority has delegated tasks, including auditors and experts contracted by the competent authority. Confidential information covered by professional secrecy may not be disclosed to any other natural or legal person or authority except where such disclosure is necessary for legal proceedings.
2. All the information exchanged between the competent authorities under this Regulation that concerns business or operational conditions and other economic or personal affairs shall be considered confidential and shall be subject to the requirements of professional secrecy, except where the competent authority states at the time of communication that such information may be disclosed or such disclosure is necessary for legal proceedings.
Article 35
Obligation to cooperate
The competent authorities shall cooperate where necessary or expedient for the purposes of this Regulation. In particular, the competent authorities shall, without undue delay, supply each other with information which is relevant for the purposes of carrying out their duties under this Regulation.
Article 36
Cooperation with ESMA
The competent authorities shall cooperate with ESMA for the purposes of this Regulation in accordance with Regulation (EU) No 1095/2010.
The competent authorities shall provide, without delay, ESMA with all the information necessary to carry out its duties in accordance with Regulation (EU) No 1095/2010.
Article 37
Cooperation in case of request for on-site inspections or investigations
1. The competent authority of one Member State may request assistance from the competent authority of another Member State with regard to on-site inspections or investigations.
The requesting competent authority shall inform ESMA of any request referred to in the first subparagraph. In case of an investigation or an inspection with cross-border effects, ESMA may and if requested shall coordinate the investigation or inspection.
2. Where a competent authority receives a request from a competent authority of another Member State to carry out an on-site inspection or an investigation, it may:
(a) carry out the on-site inspection or investigation itself;
(b) allow the competent authority which submitted the request to participate in an on-site inspection or investigation;
(c) allow the competent authority which submitted the request to carry out the on-site inspection or investigation itself;
(d) appoint auditors or experts to carry out the on-site inspection or investigation;
(e) share specific tasks relating to supervisory activities with the other competent authorities.
3. ESMA may request the competent authorities to carry out specific investigatory tasks and on-site inspections where information is reasonably required by ESMA to enable it to exercise a power expressly conferred on it by this Regulation.
Article 38
Cooperation with third countries
1. The competent authorities shall, where possible, conclude cooperation arrangements with supervisory authorities of third countries concerning the exchange of information with supervisory authorities of third countries, the enforcement of obligations arising under this Regulation in third countries and the taking of similar measures in third countries by their supervisory authorities to complement measures taken under Chapter V. These cooperation arrangements shall ensure at least an efficient exchange of information that allows the competent authorities to carry out their duties under this Regulation.
A competent authority shall inform ESMA and the competent authorities of the other Member States where it proposes to enter into such an arrangement.
2. The cooperation arrangement shall contain provisions on the exchange of data and information necessary for the relevant competent authority to comply with the obligation set out in Article 16(2).
3. ESMA shall coordinate the development of cooperation arrangements between the competent authorities and the relevant supervisory authorities of third countries. For that purpose, ESMA shall prepare a template document for cooperation arrangements that may be used by the competent authorities.
ESMA shall also coordinate the exchange between the competent authorities of information obtained from supervisory authorities of third countries that may be relevant to the taking of measures under Chapter V.
4. The competent authorities shall conclude cooperation arrangements on the exchange of information with the supervisory authorities of third countries only where the information disclosed is subject to guarantees of professional secrecy which are at least equivalent to those set out in Article 34. Such exchange of information shall be intended for the performance of the tasks of those competent authorities.
Article 39
Transfer and retention of personal data
With regard to transfer of personal data between Member States or between Member States and a third country, Member States shall apply Directive 95/46/EC. With regard to transfer of personal data by ESMA to Member States or to a third country, ESMA shall comply with Regulation (EC) No 45/2001.
Personal data referred to in the first paragraph shall be retained for a maximum period of 5 years.
Article 40
Disclosure of information to third countries
A competent authority may transfer to a supervisory authority of a third country data and the analysis of data where the conditions laid down in Article 25 or 26 of Directive 95/46/EC are fulfilled but such transfer shall be made only on a case-by-case basis. The competent authority shall be satisfied that the transfer is necessary for the purposes of this Regulation. Any such transfer shall be made under agreement that the third country shall not transfer the data to the supervisory authority of another third country without the express written authorisation of the competent authority.
A competent authority shall disclose information which is confidential pursuant to Article 34 and which is received from a competent authority of another Member State to a supervisory authority of a third country only where the competent authority has obtained the express agreement of the competent authority which transmitted the information and, where applicable, the information is disclosed solely for the purposes for which that competent authority gave its agreement.
Article 41
Penalties
Member States shall establish rules on penalties and administrative measures, applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. Those penalties and administrative measures shall be effective, proportionate and dissuasive.
In accordance with Regulation (EU) No 1095/2010, ESMA may adopt guidelines to ensure a consistent approach is taken concerning the penalties and administrative measures to be established by Members States.
Member States shall notify the Commission and ESMA of the provisions referred to in the first and second subparagraphs by 1 July 2012 and shall notify them without delay of any subsequent amendment affecting those provisions.
ESMA shall publish on its website and update regularly a list of existing penalties and administrative measures applicable in each Member State.
Member States shall provide ESMA annually with aggregate information regarding the penalties and administrative measures imposed. If a competent authority discloses to the public the fact that a penalty or an administrative measure has been imposed, it shall, contemporaneously, notify ESMA thereof.
CHAPTER VII
DELEGATED ACTS
Article 42
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 2(2), Article 3(7), Article 4(2), Article 5(4), Article 6(4), Article 7(3), Article 17(2), Article 23(5) and Article 30 shall be conferred on the Commission for an indeterminate period of time.
3. The delegation of power referred to in Article 2(2), Article 3(7), Article 4(2), Article 5(4), Article 6(4), Article 7(3), Article 17(2), Article 23(5) and Article 30 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. The decision to revoke shall take effect on the day following its publication in the Official Journal of the European Union or on a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. A delegated act adopted pursuant to Article 2(2), Article 3(7), Article 4(2), Article 5(4), Article 6(4), Article 7(3), Article 17(2), Article 23(5) and Article 30 shall enter into force only if no objection has been expressed by either the European Parliament or the Council within a period of 3 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 3 months at the initiative of the European Parliament or of the Council.
Article 43
Deadline for the adoption of delegated acts
The Commission shall adopt the delegated acts under Article 2(2), Article 3(7), Article 4(2), Article 5(4), Article 6(4), Article 7(3), Article 17(2), Article 23(5) and Article 30 by 31 March 2012.
The Commission may extend the deadline referred to in the first paragraph by 6 months.
CHAPTER VIII
IMPLEMENTING ACTS
Article 44
Committee procedure
1. The Commission shall be assisted by the European Securities Committee established by Commission Decision 2001/528/EC ( 16 ). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
CHAPTER IX
TRANSITIONAL AND FINAL PROVISIONS
Article 45
Review and report
By 30 June 2013, the Commission shall, in light of discussions with the competent authorities and ESMA, report to the European Parliament and the Council on:
(a) the appropriateness of the notification and disclosure thresholds under Articles 5, 6, 7 and 8;
(b) the impact of the individual disclosure requirements under Article 6, in particular with regard to the efficiency and volatility of financial markets;
(c) the appropriateness of direct, centralised reporting to ESMA;
(d) the operation of the restrictions and requirements in Chapters II and III;
(e) the appropriateness of the restrictions on the uncovered sovereign credit default swaps and the appropriateness of any other restrictions or conditions on short selling or credit default swaps.
Article 46
Transitional provision
1. Existing measures falling within the scope of this Regulation, in force before 15 September 2010, may remain applicable until 1 July 2013 provided that they are notified to the Commission by 24 April 2012.
2. Credit default swap transactions resulting in an uncovered position in a sovereign credit default swap that have been concluded before 25 March 2012 or during a suspension of restrictions on uncovered sovereign credit default swaps in accordance with Article 14(2) may be held until the maturity date of the credit default swap contract.
Article 47
Staff and resources of ESMA
By 31 December 2012, ESMA shall assess its staffing and resources needs arising from the assumption of its powers and duties under this Regulation and submit a report to the European Parliament, the Council and the Commission.
Article 48
Entry into force
This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union .
It shall apply from 1 November 2012.
However, Article 2(2), Article 3(7), Article 4(2), Article 7(3), Article 9(5), Article 11(3) and (4), Article 12(2), Article 13(4) and (5), Article 16(3) and (4), Article 17(2), Article 23(5), (7) and (8), and Articles 30, 42, 43 and 44 shall apply from 25 March 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
<note>
( 1 ) OJ C 91, 23.3.2011, p. 1.
( 2 ) OJ C 84, 17.3.2011, p. 34.
( 3 ) Position of the European Parliament of 15 November 2011 (not yet published in the Official Journal) and decision of the Council of 21 February 2012.
( 4 ) OJ L 331, 15.12.2010, p. 84.
( 5 ) OJ L 145, 30.4.2004, p. 1.
( 6 ) OJ L 331, 15.12.2010, p. 1.
( 7 ) OJ L 281, 23.11.1995, p. 31.
( 8 ) OJ L 8, 12.1.2001, p. 1.
( 9 ) OJ L 55, 28.2.2011, p. 13.
( 10 ) OJ L 177, 30.6.2006, p. 1.
( 11 ) Commission Regulation (EC) No 1287/2006 of 10 August 2006 implementing Directive 2004/39/EC of the European Parliament and of the Council as regards record-keeping obligations for investment firms, transaction reporting, market transparency, admission of financial instruments to trading, and defined terms for the purposes of that Directive (OJ L 241, 2.9.2006, p. 1).
( 12 ) OJ L 142, 30.4.2004, p. 12.
( 13 ) OJ L 96, 12.4.2003, p. 16.
( 14 ) OJ L 390, 31.12.2004, p. 38.
( 15 ) OJ L 336, 23.12.2003, p. 33.
( 16 ) OJ L 191, 13.7.2001, p. 45.
</note> | ENG | 02012R0236-20140917 |
<table><col/><col/><col/><col/><tbody><tr><td><p>13.6.2023   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 152/7</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2023/1153
of 12 June 2023
amending Annex IV to Implementing Regulation (EU) 2021/404 as regards the entry for China in the list of third countries, territories or zones thereof authorised for the entry into the Union of consignments of certain equine animals
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) ( 1 ) , and in particular Article 230(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Regulation (EU) 2016/429 lays down, inter alia, the animal health requirements for the entry into the Union of consignments of animals, germinal products and products of animal origin, and it applies from 21 April 2021. One of those animal health requirements is that those consignments must come from a third country or territory, or zone or compartment thereof, listed in accordance with Article 230(1) of that Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Commission Delegated Regulation (EU) 2020/692 <a>(<span>2</span>)</a> supplements Regulation (EU) 2016/429 as regards the animal health requirements for the entry into the Union of consignments of certain species and categories of animals, germinal products and products of animal origin from third countries or territories, or zones or compartments thereof. Delegated Regulation (EU) 2020/692 provides that consignments of animals, germinal products and products of animal origin falling within its scope may only be permitted to enter into the Union if they come from a third country or territory, or zone or compartment thereof, listed for the particular species and categories of animals, germinal products and products of animal origin, in accordance with the animal health requirements laid down in that Delegated Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Commission Implementing Regulation (EU) 2021/404 <a>(<span>3</span>)</a> establishes the lists of third countries or territories, or zones or compartments thereof, from which the entry into the Union of those species and categories of animals, germinal products and products of animal origin, that fall within the scope of Delegated Regulation (EU) 2020/692, is permitted. The lists and certain general rules concerning the lists are set out in Annexes I to XXII to that Delegated Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Annex IV to Implementing Regulation (EU) 2021/404 sets out the list of third countries, territories or zones thereof authorised for the entry into the Union of consignments of equine animals.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>In order to host the equestrian events of the 19th Asian Games, China has requested the recognition of an equine disease-free zone established at the Tonglu Equestrian Center in the part of Yaolin town in the north-western part of Tonglu County, Fuyang District, Hangzhou Municipality, Zhejiang Province in China, connected with the Hangzhou Xiaoshan International Airport. A number of registered horses originating from the Union will take part in the 19th Asian Games.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>In view of the temporary nature of those equestrian events, it is appropriate to foresee only a temporary approval of that equine disease-free zone from 15 September 2023 to 13 November 2023 to provide enough time for the registered horses originating from the Union to enter and leave that zone.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>China has provided guarantees, in particular as regards the notifiability in their country of the listed diseases referred to in point 1 of Annex I to Delegated Regulation (EU) 2020/692 relevant for equine animals, and guarantees regarding compliance or equivalence with the relevant animal health requirements applicable in the Union. In addition, China has informed the Commission that the entire group of registered horses originating from the Union and competing in those events, will be kept separated from any equidae not of the same origin and health status.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>At the same time, the self-declaration by China for the establishment of the equine disease-free zone for the 19th Asian Games has been published at the World Organisation for Animal Health webpage <a>(<span>4</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>In the light of those guarantees and information provided by China, the re-entry of registered horses from a designated equine disease-free zone in that third country after the temporary export in accordance with the requirements of Delegated Regulation (EU) 2020/692 and accompanied by an animal health certificate issued in accordance with a model set out in Chapters 16 and 17 of Annex II to Commission Implementing Regulation (EU) 2021/403 <a>(<span>5</span>)</a> should be permitted for a limited period. This period should be limited to maximum of 60 days in line with point II.3.2, second option, of the model animal health certificate set out in Chapter 17 of Annex II to Impelementing Regulation (EU) 2021/403.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>Annex IV to Implementing Regulation (EU) 2021/404 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>As Implementing Regulation (EU) 2021/404 applies from 21 April 2021, in the interest of legal certainty and to facilitate trade, the amendments to be made to Implementing Regulation (EU) 2021/404 by this Regulation should take effect as a matter of urgency.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Annex IV to Implementing Regulation (EU) 2021/404 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 June 2023.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 84, 31.3.2016, p. 1 .
( 2 ) Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin ( OJ L 174, 3.6.2020, p. 379 ).
( 3 ) Commission Implementing Regulation (EU) 2021/404 of 24 March 2021 laying down the lists of third countries, territories or zones thereof from which the entry into the Union of animals, germinal products and products of animal origin is permitted in accordance with Regulation (EU) 2016/429 of the European Parliament and the Council ( OJ L 114, 31.3.2021, p. 1 ).
( 4 ) https://www.woah.org/en/what-we-offer/self-declared-disease-status/
( 5 ) Commission Implementing Regulation (EU) 2021/403 of 24 March 2021 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates and model animal health/official certificates, for the entry into the Union and movements between Member States of consignments of certain categories of terrestrial animals and germinal products thereof, official certification regarding such certificates and repealing Decision 2010/470/EU ( OJ L 113, 31.3.2021, p. 1 ).
ANNEX
Annex IV to Implementing Regulation (EU) 2021/404 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Part 1, in the entry for China, the following zone CN-3 is added after the zone CN-2:</p><table><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>‘<span>CN</span></p><p>China</p></td><td><p>CN-3</p></td><td><p>G</p></td><td><p>Registered horses</p></td><td><p>EQUI-RE-ENTRY-30,</p><p>EQUI-RE-ENTRY-90-COMP</p></td><td><p> </p></td><td><p> </p></td><td><p>13.11.2023</p></td><td><p>15.9.2023’</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in Part 2, in the entry for China, the following description of the zone CN-3 is added after the zone CN-2:</p><table><col/><col/><col/><col/><col/><tbody><tr><td><p>‘China</p></td><td><p>CN-3</p></td><td><p>The 19th Asian Games equine disease-free zone established in the part of Yaolin town north of the Fenshui River in the north-western part of Tonglu County, Fuyang District, Hangzhou Municipality, Zhejiang Province, and including the Biosecurity Highway Passage (see details below):</p></td></tr><tr><td><p>Core zone:</p></td><td><p>The area of 1 300 km<span>2</span> in the north-western part of Tonglu County comprising the Tonglu Equestrian Center (29°54′40.66″N, 119°32′15.33″E) in the part of Yaolin town north of Fenshui River (a contributor to the Fuchun River) with the following delimitation:</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Western boundary:</p></td></tr></tbody></table></td><td><p>Chun’an County,</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Northern boundary:</p></td></tr></tbody></table></td><td><p>Lin’an District,</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eastern boundary:</p></td></tr></tbody></table></td><td><p>Fuyang District,</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>South-eastern boundary:</p></td></tr></tbody></table></td><td><p>Fuchun River in Fuchunjiang Town, Tonglu County South Street, Fengchuan Street,</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>South-western boundary:</p></td></tr></tbody></table></td><td><p>Jiande City.</p></td></tr><tr><td><p>Protection zone:</p></td><td><p>The area of 12 300 km<span>2</span> surrounding the core zone with the following delimitation:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>the districts of Fuyang and Lin’an to the north and the Chun’an County and the City of Jiande to the south;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>the part of Tonglu County east of Fuchun River, including the Chengnan and Fengchuan Subdistricts, Jiangnan Town, Xinhe Township and the part of Fuchunjiang Town east of the Fuchun River.</p></td></tr></tbody></table></td></tr><tr><td><p>Biosecurity Highway Passage:</p></td><td><p>Highway network connecting the equine disease-free zone with the Hangzhou Xiaoshan International Airport (including Airport Expressway, Hangzhou Bay Ring Expressway, Shanghai-Kunming Expressway, Caihong Expressway, G25 Hangzhou Xinjing Expressway) and areas within 1 km on both sides of those highways.’</p></td></tr></tbody></table></td></tr></tbody></table> | ENG | 32023R1153 |
<table><col/><col/><col/><col/><tbody><tr><td><p>20.8.2016   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 227/3</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2016/1399
of 19 August 2016
establishing the standard import values for determining the entry price of certain fruit and vegetables
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) ,
Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors ( 2 ) , and in particular Article 136(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the<span>Official Journal of the European Union</span>,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 August 2016.
For the Commission,
On behalf of the President,
Jerzy PLEWA
Director-General for Agriculture and Rural Development
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) OJ L 157, 15.6.2011, p. 1 .
ANNEX
Standard import values for determining the entry price of certain fruit and vegetables
<table><col/><col/><col/><tbody><tr><td><p>(EUR/100 kg)</p></td></tr><tr><td><p>CN code</p></td><td><p>Third country code<a> (<span>1</span>)</a></p></td><td><p>Standard import value</p></td></tr><tr><td><p>0702 00 00</p></td><td><p>MA</p></td><td><p>186,9</p></td></tr><tr><td><p>ZZ</p></td><td><p>186,9</p></td></tr><tr><td><p>0707 00 05</p></td><td><p>TR</p></td><td><p>116,3</p></td></tr><tr><td><p>ZZ</p></td><td><p>116,3</p></td></tr><tr><td><p>0709 93 10</p></td><td><p>TR</p></td><td><p>143,2</p></td></tr><tr><td><p>ZZ</p></td><td><p>143,2</p></td></tr><tr><td><p>0805 50 10</p></td><td><p>AR</p></td><td><p>186,2</p></td></tr><tr><td><p>CL</p></td><td><p>125,1</p></td></tr><tr><td><p>MA</p></td><td><p>99,8</p></td></tr><tr><td><p>TR</p></td><td><p>154,0</p></td></tr><tr><td><p>UY</p></td><td><p>178,5</p></td></tr><tr><td><p>ZA</p></td><td><p>168,3</p></td></tr><tr><td><p>ZZ</p></td><td><p>152,0</p></td></tr><tr><td><p>0806 10 10</p></td><td><p>EG</p></td><td><p>218,8</p></td></tr><tr><td><p>TR</p></td><td><p>137,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>178,2</p></td></tr><tr><td><p>0808 10 80</p></td><td><p>AR</p></td><td><p>115,3</p></td></tr><tr><td><p>BR</p></td><td><p>102,1</p></td></tr><tr><td><p>CL</p></td><td><p>126,6</p></td></tr><tr><td><p>CN</p></td><td><p>160,3</p></td></tr><tr><td><p>NZ</p></td><td><p>142,6</p></td></tr><tr><td><p>US</p></td><td><p>141,5</p></td></tr><tr><td><p>UY</p></td><td><p>93,8</p></td></tr><tr><td><p>ZA</p></td><td><p>93,0</p></td></tr><tr><td><p>ZZ</p></td><td><p>121,9</p></td></tr><tr><td><p>0808 30 90</p></td><td><p>AR</p></td><td><p>93,2</p></td></tr><tr><td><p>CL</p></td><td><p>129,5</p></td></tr><tr><td><p>TR</p></td><td><p>143,3</p></td></tr><tr><td><p>ZA</p></td><td><p>115,9</p></td></tr><tr><td><p>ZZ</p></td><td><p>120,5</p></td></tr><tr><td><p>0809 30 10 , 0809 30 90</p></td><td><p>TR</p></td><td><p>130,8</p></td></tr><tr><td><p>ZZ</p></td><td><p>130,8</p></td></tr></tbody></table>
<note>
( 1 ) Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories ( OJ L 328, 28.11.2012, p. 7 ). Code ‘ZZ’ stands for ‘of other origin’.
</note> | ENG | 32016R1399 |
<table><col/><col/><col/><col/><tbody><tr><td><p>23.9.2014   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 279/1</p></td></tr></tbody></table>
COMMISSION REGULATION (EU) No 991/2014
of 19 September 2014
amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fosetyl in or on certain products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC ( 1 ) , and in particular Article 14(1)(a) and Article 16(1)(a) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>For fosetyl, maximum residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) No 396/2005.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The residue definition for monitoring applicable to fosetyl comprises the parent compound fosetyl, the degradation product phosphorous acid and their salts. Salts of phosphorous acid are named phosphonates.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The Commission received information from Member States and business operators showing the presence of phosphonates in or on certain products leading to higher residues than the MRL of 2 mg/kg laid down in Regulation (EC) No 396/2005 for those products, corresponding to the limit of determination.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The Commission collected monitoring data in 2014 to investigate the presence of phosphonates in food. Those data were generated by food business operators and showed that phosphonates are present at levels that vary depending on the source and product, but frequently exceed the MRL set at the limit of determination of 2 mg/kg. Further data analysis indicated that the vast majority of non-compliant samples contain residues of phosphorous acid and its salts in excess of the limit of determination while residues of fosetyl and its salts remain below the limit of determination.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Although phosphonates have not been included in Annex I to Regulation (EC) No 2003/2003 of the European Parliament and of the Council<a> (<span>2</span>)</a> by virtue of Article 14 of that Regulation, they could be contained in fertilisers authorised at national level, notably certain fertiliser products applied to the leaves of plants (foliar fertilisers). Given the lack of relevant authorisations for plant protection products containing fosetyl both in the Union and in third countries that are important exporters of the concerned food products into the Union, the scarcity of detectable residues for fosetyl and its salts, and the use of phosphonates as ingredient in foliar fertiliser products, it can be reasonably assumed that residues are a consequence of the application of foliar fertiliser products containing phosphonates.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>The Commission asked the European Food Safety Authority, hereinafter ‘the Authority’, to give an opinion on public health risks of phosphonate residues in or on certain products. Given the urgency the Authority issued a statement, referring to several remaining uncertainties, rather than a reasoned opinion<a> (<span>3</span>)</a>. It forwarded that statement to the Commission and the Member States and made it available to the public.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The Authority concluded in its statement that the proposed temporary MRLs are expected to sufficiently protect consumers. The lifetime exposure to phosphonate residues via consumption of all food products that may contain them did not show that there is a risk that the acceptable daily intake (ADI) is exceeded. The Authority did not perform an acute consumer exposure assessment due to the low acute toxicity of phosphonate. The Authority pointed out that its statement is affected by uncertainties and proposed to change the residue definition.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>To avoid significant market disruptions in the trade of the concerned products and as there is no risk for consumers identified from the current scientific data, it is appropriate to set temporary MRLs for fosetyl, based on the available monitoring data and on the statement of the Authority. Those temporary MRLs should apply only until measures to prevent the occurrence of phosphonate residues in relevant crops in future growing seasons take effect.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>Based on the statement of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modification to the MRL fulfils the requirements of Article 14(2) of Regulation (EC) No 396/2005.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>Regulation (EC) No 396/2005 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Annex III to Regulation (EC) No 396/2005 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 September 2014.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 70, 16.3.2005, p. 1 .
( 2 ) Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers ( OJ L 304, 21.11.2003, p. 1 ).
( 3 ) European Food Safety Authority; Statement on the dietary risk assessment for proposed temporary maximum residue levels (t-MRLs) for fosetyl-Al in certain crops. EFSA Journal 2014;12(5):3695, 22 pp.
ANNEX
Annex III to Regulation (EC) No 396/2005 is amended as follows:
In part A, the column for fosetyl is replaced by the following:
‘ANNEX III
PART A
Pesticide residues and maximum residue levels (mg/kg)
<table><col/><col/><col/><tbody><tr><td><p>Code number</p></td><td><p>Groups and examples of individual products to which the MRLs apply<a> (<span>2</span>)</a></p></td><td><p>Fosetyl-Al (sum of fosetyl, phosphonic acid and their salts, expressed as fosetyl)</p></td></tr><tr><td><p>0100000</p></td><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><span>FRUIT FRESH OR FROZEN NUTS</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0110000</p></td><td><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><span>Citrus fruit</span></td></tr></tbody></table></td><td><p>75</p></td></tr><tr><td><p>0110010</p></td><td><p>Grapefruit (Shaddocks, pomelos, sweeties, tangelo (except mineola), ugli and other hybrids)</p></td><td><p> </p></td></tr><tr><td><p>0110020</p></td><td><p>Oranges (Bergamot, bitter orange, chinotto and other hybrids)</p></td><td><p> </p></td></tr><tr><td><p>0110030</p></td><td><p>Lemons (Citron, lemon, Buddha's hand (<span>Citrus medica</span> var.<span>sarcodactylis</span>))</p></td><td><p> </p></td></tr><tr><td><p>0110040</p></td><td><p>Limes</p></td><td><p> </p></td></tr><tr><td><p>0110050</p></td><td><p>Mandarins (Clementine, tangerine, mineola and other hybrids tangor (<span>Citrus reticulata</span> ×<span>sinensis</span>))</p></td><td><p> </p></td></tr><tr><td><p>0110990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0120000</p></td><td><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><span>Tree nuts</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0120010</p></td><td><p>Almonds</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0120020</p></td><td><p>Brazil nuts</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0120030</p></td><td><p>Cashew nuts</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0120040</p></td><td><p>Chestnuts</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0120050</p></td><td><p>Coconuts</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0120060</p></td><td><p>Hazelnuts (Filbert)</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0120070</p></td><td><p>Macadamia</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0120080</p></td><td><p>Pecans</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0120090</p></td><td><p>Pine nuts</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0120100</p></td><td><p>Pistachios</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0120110</p></td><td><p>Walnuts</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0120990</p></td><td><p>Others</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0130000</p></td><td><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><span>Pome fruit</span></td></tr></tbody></table></td><td><p>75</p></td></tr><tr><td><p>0130010</p></td><td><p>Apples (Crab apple)</p></td><td><p> </p></td></tr><tr><td><p>0130020</p></td><td><p>Pears (Oriental pear)</p></td><td><p> </p></td></tr><tr><td><p>0130030</p></td><td><p>Quinces</p></td><td><p> </p></td></tr><tr><td><p>0130040</p></td><td><p>Medlar</p></td><td><p> </p></td></tr><tr><td><p>0130050</p></td><td><p>Loquat</p></td><td><p> </p></td></tr><tr><td><p>0130990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0140000</p></td><td><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><span>Stone fruit</span></td></tr></tbody></table></td><td><p>75 (+)</p></td></tr><tr><td><p>0140010</p></td><td><p>Apricots</p></td><td><p> </p></td></tr><tr><td><p>0140020</p></td><td><p>Cherries (Sweet cherries, sour cherries)</p></td><td><p> </p></td></tr><tr><td><p>0140030</p></td><td><p>Peaches (Nectarines and similar hybrids)</p></td><td><p> </p></td></tr><tr><td><p>0140040</p></td><td><p>Plums (Damson, greengage, mirabelle, sloe, red date/Chinese date/Chinese jujube (<span>Ziziphus zizyphus</span>))</p></td><td><p> </p></td></tr><tr><td><p>0140990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0150000</p></td><td><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><span>Berries & small fruit</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0151000</p></td><td><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><span>Table and wine grapes</span></td></tr></tbody></table></td><td><p>100</p></td></tr><tr><td><p>0151010</p></td><td><p>Table grapes</p></td><td><p> </p></td></tr><tr><td><p>0151020</p></td><td><p>Wine grapes</p></td><td><p> </p></td></tr><tr><td><p>0152000</p></td><td><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><span>Strawberries</span></td></tr></tbody></table></td><td><p>75</p></td></tr><tr><td><p>0153000</p></td><td><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><span>Cane fruit</span></td></tr></tbody></table></td><td><p>75 (+)</p></td></tr><tr><td><p>0153010</p></td><td><p>Blackberries</p></td><td><p> </p></td></tr><tr><td><p>0153020</p></td><td><p>Dewberries (Loganberries, tayberries, boysenberries, cloudberries and other<span>Rubus</span> hybrids)</p></td><td><p> </p></td></tr><tr><td><p>0153030</p></td><td><p>Raspberries (Wineberries, arctic bramble/raspberry, (<span>Rubus arcticus</span>), nectar raspberries (<span>Rubus arcticus</span> ×<span>Rubus idaeus</span>))</p></td><td><p> </p></td></tr><tr><td><p>0153990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0154000</p></td><td><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><span>Other small fruit & berries</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0154010</p></td><td><p>Blueberries (Bilberries)</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0154020</p></td><td><p>Cranberries (Cowberries/red bilberries (<span>V. vitis-idaea</span>))</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0154030</p></td><td><p>Currants (red, black and white)</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0154040</p></td><td><p>Gooseberries (Including hybrids with other<span>Ribes</span> species)</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0154050</p></td><td><p>Rose hips</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0154060</p></td><td><p>Mulberries (Arbutus berry)</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0154070</p></td><td><p>Azarole (mediteranean medlar) (Kiwiberry (<span>Actinidia arguta</span>))</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0154080</p></td><td><p>Elderberries (Black chokeberry/appleberry, mountain ash, buckthorn/sea sallowthorn, hawthorn, serviceberries, and other treeberries)</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0154990</p></td><td><p>Others</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0160000</p></td><td><table><col/><col/><tbody><tr><td><p>(vi)</p></td><td><span>Miscellaneous fruit</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0161000</p></td><td><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><span>Edible peel</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0161010</p></td><td><p>Dates</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0161020</p></td><td><p>Figs</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0161030</p></td><td><p>Table olives</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0161040</p></td><td><p>Kumquats (Marumi kumquats, nagami kumquats, limequats (<span>Citrus aurantifolia</span> ×<span>Fortunella</span> spp.))</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0161050</p></td><td><p>Carambola (Bilimbi)</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0161060</p></td><td><p>Persimmon</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0161070</p></td><td><p>Jambolan (java plum) (Java apple/water apple, pomerac, rose apple, Brazilean cherry, Surinam cherry/grumichama (<span>Eugenia uniflora</span>))</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0161990</p></td><td><p>Others</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0162000</p></td><td><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><span>Inedible peel, small</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0162010</p></td><td><p>Kiwi</p></td><td><p>150</p></td></tr><tr><td><p>0162020</p></td><td><p>Lychee (Litchi) (Pulasan, rambutan/hairy litchi, longan, mangosteen, langsat, salak)</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0162030</p></td><td><p>Passion fruit</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0162040</p></td><td><p>Prickly pear (cactus fruit)</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0162050</p></td><td><p>Star apple</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0162060</p></td><td><p>American persimmon (Virginia kaki) (Black sapote, white sapote, green sapote, canistel/yellow sapote, mammey sapote)</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0162990</p></td><td><p>Others</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0163000</p></td><td><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><span>Inedible peel, large</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0163010</p></td><td><p>Avocados</p></td><td><p>50</p></td></tr><tr><td><p>0163020</p></td><td><p>Bananas (Dwarf banana, plantain, apple banana)</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0163030</p></td><td><p>Mangoes</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0163040</p></td><td><p>Papaya</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0163050</p></td><td><p>Pomegranate</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0163060</p></td><td><p>Cherimoya (Custard apple, sugar apple/sweetsop, ilama (<span>Annona diversifolia</span>) and other medium sized<span>Annonaceae</span> fruits)</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0163070</p></td><td><p>Guava (Red pitaya/dragon fruit (<span>Hylocereus undatus</span>))</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0163080</p></td><td><p>Pineapples</p></td><td><p>50</p></td></tr><tr><td><p>0163090</p></td><td><p>Bread fruit (Jackfruit)</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0163100</p></td><td><p>Durian</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0163110</p></td><td><p>Soursop (guanabana)</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0163990</p></td><td><p>Others</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0200000</p></td><td><table><col/><col/><tbody><tr><td><p>2.</p></td><td><span>VEGETABLES FRESH OR FROZEN</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0210000</p></td><td><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><span>Root and tuber vegetables</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0211000</p></td><td><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><span>Potatoes</span></td></tr></tbody></table></td><td><p>30</p></td></tr><tr><td><p>0212000</p></td><td><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><span>Tropical root and tuber vegetables</span></td></tr></tbody></table></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0212010</p></td><td><p>Cassava (Dasheen, eddoe/Japanese taro, tannia)</p></td><td><p> </p></td></tr><tr><td><p>0212020</p></td><td><p>Sweet potatoes</p></td><td><p> </p></td></tr><tr><td><p>0212030</p></td><td><p>Yams (Potato bean/yam bean, Mexican yam bean)</p></td><td><p> </p></td></tr><tr><td><p>0212040</p></td><td><p>Arrowroot</p></td><td><p> </p></td></tr><tr><td><p>0212990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0213000</p></td><td><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><span>Other root and tuber vegetables except sugar beet</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0213010</p></td><td><p>Beetroot</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0213020</p></td><td><p>Carrots</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0213030</p></td><td><p>Celeriac</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0213040</p></td><td><p>Horseradish (Angelica roots, lovage roots, gentiana roots)</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0213050</p></td><td><p>Jerusalem artichokes (Crosne)</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0213060</p></td><td><p>Parsnips</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0213070</p></td><td><p>Parsley root</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0213080</p></td><td><p>Radishes (Black radish, Japanese radish, small radish and similar varieties, tiger nut (<span>Cyperus esculentus</span>))</p></td><td><p>25</p></td></tr><tr><td><p>0213090</p></td><td><p>Salsify (Scorzonera, Spanish salsify/Spanish oysterplant, edible burdock)</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0213100</p></td><td><p>Swedes</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0213110</p></td><td><p>Turnips</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0213990</p></td><td><p>Others</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0220000</p></td><td><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><span>Bulb vegetables</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0220010</p></td><td><p>Garlic</p></td><td><p>50 (+)</p></td></tr><tr><td><p>0220020</p></td><td><p>Onions (Other bulb onions, silverskin onions)</p></td><td><p>50</p></td></tr><tr><td><p>0220030</p></td><td><p>Shallots</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0220040</p></td><td><p>Spring onions and welsh onions (Other green onions and similar varieties)</p></td><td><p>30</p></td></tr><tr><td><p>0220990</p></td><td><p>Others</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0230000</p></td><td><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><span>Fruiting vegetables</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0231000</p></td><td><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>Solanacea</p></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0231010</p></td><td><p>Tomatoes (Cherry tomatoes,<span>Physalis</span> spp., gojiberry, wolfberry (<span>Lycium barbarum</span> and<span>L. chinense</span>), tree tomato)</p></td><td><p>100</p></td></tr><tr><td><p>0231020</p></td><td><p>Peppers (Chilli peppers)</p></td><td><p>130</p></td></tr><tr><td><p>0231030</p></td><td><p>Aubergines (egg plants) (Pepino, antroewa/white eggplant (<span>S. macrocarpon</span>))</p></td><td><p>100</p></td></tr><tr><td><p>0231040</p></td><td><p>Okra (lady's fingers)</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0231990</p></td><td><p>Others</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0232000</p></td><td><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><span>Cucurbits — edible peel</span></td></tr></tbody></table></td><td><p>75</p></td></tr><tr><td><p>0232010</p></td><td><p>Cucumbers</p></td><td><p> </p></td></tr><tr><td><p>0232020</p></td><td><p>Gherkins</p></td><td><p> </p></td></tr><tr><td><p>0232030</p></td><td><p>Courgettes (Summer squash, marrow (patisson), lauki (<span>Lagenaria siceraria</span>), chayote, sopropo/bitter melon, snake gourd, angled luffa/teroi)</p></td><td><p> </p></td></tr><tr><td><p>0232990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0233000</p></td><td><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><span>Cucurbits-inedible peel</span></td></tr></tbody></table></td><td><p>75</p></td></tr><tr><td><p>0233010</p></td><td><p>Melons (Kiwano)</p></td><td><p> </p></td></tr><tr><td><p>0233020</p></td><td><p>Pumpkins (Winter squash, marrow (late variety))</p></td><td><p> </p></td></tr><tr><td><p>0233030</p></td><td><p>Watermelons</p></td><td><p> </p></td></tr><tr><td><p>0233990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0234000</p></td><td><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><span>Sweet corn (Baby corn)</span></td></tr></tbody></table></td><td><p>5</p></td></tr><tr><td><p>0239000</p></td><td><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><span>Other fruiting vegetables</span></td></tr></tbody></table></td><td><p>5</p></td></tr><tr><td><p>0240000</p></td><td><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><span>Brassica vegetables</span></td></tr></tbody></table></td><td><p>10</p></td></tr><tr><td><p>0241000</p></td><td><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><span>Flowering brassica</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0241010</p></td><td><p>Broccoli (Calabrese, Broccoli raab, Chinese broccoli)</p></td><td><p> </p></td></tr><tr><td><p>0241020</p></td><td><p>Cauliflower</p></td><td><p> </p></td></tr><tr><td><p>0241990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0242000</p></td><td><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><span>Head brassica</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0242010</p></td><td><p>Brussels sprouts</p></td><td><p> </p></td></tr><tr><td><p>0242020</p></td><td><p>Head cabbage (Pointed head cabbage, red cabbage, savoy cabbage, white cabbage)</p></td><td><p> </p></td></tr><tr><td><p>0242990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0243000</p></td><td><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><span>Leafy brassica</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0243010</p></td><td><p>Chinese cabbage (Indian or Chinese) mustard, pak choi, Chinese flat cabbage/ai goo choi), choi sum, Peking cabbage/pe-tsai)</p></td><td><p> </p></td></tr><tr><td><p>0243020</p></td><td><p>Kale (Borecole/curly kale, collards, Portuguese Kale, Portuguese cabbage, cow cabbage)</p></td><td><p> </p></td></tr><tr><td><p>0243990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0244000</p></td><td><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><span>Kohlrabi</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0250000</p></td><td><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><span>Leaf vegetables & fresh herbs</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0251000</p></td><td><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><span>Lettuce and other salad plants including<span>Brassicacea</span></span></td></tr></tbody></table></td><td><p>75</p></td></tr><tr><td><p>0251010</p></td><td><p>Lamb's lettuce (Italian corn salad)</p></td><td><p> </p></td></tr><tr><td><p>0251020</p></td><td><p>Lettuce (Head lettuce, lollo rosso (cutting lettuce), iceberg lettuce, romaine (cos) lettuce)</p></td><td><p> </p></td></tr><tr><td><p>0251030</p></td><td><p>Scarole (broad-leaf endive) (Wild chicory, red-leaved chicory, radicchio, curly leaf endive, sugar loaf (<span>C. endivia</span> var.<span>crispum</span>/<span>C. intybus</span> var.<span>foliosum</span>), dandelion greens)</p></td><td><p> </p></td></tr><tr><td><p>0251040</p></td><td><p>Cress (Mung bean sprouts, alfalfa sprouts)</p></td><td><p> </p></td></tr><tr><td><p>0251050</p></td><td><p>Land cress</p></td><td><p> </p></td></tr><tr><td><p>0251060</p></td><td><p>Rocket, Rucola (Wild rocket (<span>Diplotaxis</span> spp.))</p></td><td><p> </p></td></tr><tr><td><p>0251070</p></td><td><p>Red mustard</p></td><td><p> </p></td></tr><tr><td><p>0251080</p></td><td><p>Leaves and sprouts of<span>Brassica</span> spp, including turnip greens (Mizuna, leaves of peas and radish and other babyleaf crops, including brassica crops (crops harvested up to 8 true leaf stage), kohlrabi leaves)</p></td><td><p> </p></td></tr><tr><td><p>0251990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0252000</p></td><td><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><span>Spinach & similar (leaves)</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0252010</p></td><td><p>Spinach (New Zealand spinach, amaranthus spinach (pak-khom, tampara), tajer leaves, bitterblad/bitawiri)</p></td><td><p>75</p></td></tr><tr><td><p>0252020</p></td><td><p>Purslane (Winter purslane/miner's lettuce, garden purslane, common purslane, sorrel, glassworth, agretti (<span>Salsola soda</span>))</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0252030</p></td><td><p>Beet leaves (chard) (Leaves of beetroot)</p></td><td><p>15</p></td></tr><tr><td><p>0252990</p></td><td><p>Others</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0253000</p></td><td><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><span>Vine leaves (grape leaves) (Malabar nightshade, banana leaves, climbing wattle (<span>Acacia pennata</span>))</span></td></tr></tbody></table></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0254000</p></td><td><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><span>Water cress (Morning glory/Chinese convolvulus/water convolvulus/water spinach/kangkung (<span>Ipomea aquatica</span>), water clover, water mimosa)</span></td></tr></tbody></table></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0255000</p></td><td><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><span>Witloof</span></td></tr></tbody></table></td><td><p>75</p></td></tr><tr><td><p>0256000</p></td><td><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><span>Herbs</span></td></tr></tbody></table></td><td><p>75</p></td></tr><tr><td><p>0256010</p></td><td><p>Chervil</p></td><td><p> </p></td></tr><tr><td><p>0256020</p></td><td><p>Chives</p></td><td><p> </p></td></tr><tr><td><p>0256030</p></td><td><p>Celery leaves (Fennel leaves, coriander leaves, dill leaves, caraway leaves, lovage, angelica, sweet cisely and other<span>Apiacea</span> leaves, culantro/stinking/long coriander/stink weed (<span>Eryngium foetidum</span>))</p></td><td><p> </p></td></tr><tr><td><p>0256040</p></td><td><p>Parsley (leaves of root parsley)</p></td><td><p> </p></td></tr><tr><td><p>0256050</p></td><td><p>Sage (Winter savory, summer savory,<span>Borago officinalis</span> leaves)</p></td><td><p> </p></td></tr><tr><td><p>0256060</p></td><td><p>Rosemary</p></td><td><p> </p></td></tr><tr><td><p>0256070</p></td><td><p>Thyme (Marjoram, oregano)</p></td><td><p> </p></td></tr><tr><td><p>0256080</p></td><td><p>Basil (Balm leaves, mint, peppermint, holy basil, sweet basil, hairy basil, edible flowers (marigold flower and others), pennywort, wild betel leaf, curry leaves)</p></td><td><p> </p></td></tr><tr><td><p>0256090</p></td><td><p>Bay leaves (laurel) (Lemon grass)</p></td><td><p> </p></td></tr><tr><td><p>0256100</p></td><td><p>Tarragon (Hyssop)</p></td><td><p> </p></td></tr><tr><td><p>0256990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0260000</p></td><td><table><col/><col/><tbody><tr><td><p>(vi)</p></td><td><span>Legume vegetables (fresh)</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0260010</p></td><td><p>Beans (with pods) (Green bean/French beans/snap beans, scarlet runner bean, slicing bean, yard long beans, guar beans, soya beans)</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0260020</p></td><td><p>Beans (without pods) (Broad beans, flageolets, jack bean, lima bean, cowpea)</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0260030</p></td><td><p>Peas (with pods) (Mangetout/sugar peas/snow peas)</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0260040</p></td><td><p>Peas (without pods) (Garden pea, green pea, chickpea)</p></td><td><p>75 (+)</p></td></tr><tr><td><p>0260050</p></td><td><p>Lentils</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0260990</p></td><td><p>Others</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0270000</p></td><td><table><col/><col/><tbody><tr><td><p>(vii)</p></td><td><span>Stem vegetables (fresh)</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0270010</p></td><td><p>Asparagus</p></td><td><p>50 (+)</p></td></tr><tr><td><p>0270020</p></td><td><p>Cardoons (<span>Borago officinalis</span> stems)</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0270030</p></td><td><p>Celery</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0270040</p></td><td><p>Fennel</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0270050</p></td><td><p>Globe artichokes (Banana flower)</p></td><td><p>50</p></td></tr><tr><td><p>0270060</p></td><td><p>Leek</p></td><td><p>30</p></td></tr><tr><td><p>0270070</p></td><td><p>Rhubarb</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0270080</p></td><td><p>Bamboo shoots</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0270090</p></td><td><p>Palm hearts</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0270990</p></td><td><p>Others</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0280000</p></td><td><table><col/><col/><tbody><tr><td><p>(viii)</p></td><td><span>Fungi</span></td></tr></tbody></table></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0280010</p></td><td><p>Cultivated fungi (Common mushroom, oyster mushroom, shiitake,<span>fungus mycelium</span> (vegetative parts))</p></td><td><p> </p></td></tr><tr><td><p>0280020</p></td><td><p>Wild fungi (Chanterelle, truffle, morel, cep)</p></td><td><p> </p></td></tr><tr><td><p>0280990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0290000</p></td><td><table><col/><col/><tbody><tr><td><p>(ix)</p></td><td><span>Sea weeds</span></td></tr></tbody></table></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0300000</p></td><td><table><col/><col/><tbody><tr><td><p>3.</p></td><td><span>PULSES, DRY</span></td></tr></tbody></table></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0300010</p></td><td><p>Beans (Broad beans, navy beans, flageolets, jack beans, lima beans, field beans, cowpeas)</p></td><td><p> </p></td></tr><tr><td><p>0300020</p></td><td><p>Lentils</p></td><td><p> </p></td></tr><tr><td><p>0300030</p></td><td><p>Peas (Chickpeas, field peas, chickling vetch)</p></td><td><p> </p></td></tr><tr><td><p>0300040</p></td><td><p>Lupins</p></td><td><p> </p></td></tr><tr><td><p>0300990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0400000</p></td><td><table><col/><col/><tbody><tr><td><p>4.</p></td><td><span>OILSEEDS AND OILFRUITS</span></td></tr></tbody></table></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0401000</p></td><td><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><span>Oilseeds</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0401010</p></td><td><p>Linseed</p></td><td><p> </p></td></tr><tr><td><p>0401020</p></td><td><p>Peanuts</p></td><td><p> </p></td></tr><tr><td><p>0401030</p></td><td><p>Poppy seed</p></td><td><p> </p></td></tr><tr><td><p>0401040</p></td><td><p>Sesame seed</p></td><td><p> </p></td></tr><tr><td><p>0401050</p></td><td><p>Sunflower seed</p></td><td><p> </p></td></tr><tr><td><p>0401060</p></td><td><p>Rape seed (Bird rapeseed, turnip rape)</p></td><td><p> </p></td></tr><tr><td><p>0401070</p></td><td><p>Soya bean</p></td><td><p> </p></td></tr><tr><td><p>0401080</p></td><td><p>Mustard seed</p></td><td><p> </p></td></tr><tr><td><p>0401090</p></td><td><p>Cotton seed</p></td><td><p> </p></td></tr><tr><td><p>0401100</p></td><td><p>Pumpkin seeds (Other seeds of<span>Cucurbitaceae</span>)</p></td><td><p> </p></td></tr><tr><td><p>0401110</p></td><td><p>Safflower</p></td><td><p> </p></td></tr><tr><td><p>0401120</p></td><td><p>Borage (Purple viper's bugloss/Canary flower (<span>Echium plantagineum</span>), Corn Gromwell (<span>Buglossoides arvensis</span>))</p></td><td><p> </p></td></tr><tr><td><p>0401130</p></td><td><p>Gold of pleasure</p></td><td><p> </p></td></tr><tr><td><p>0401140</p></td><td><p>Hempseed</p></td><td><p> </p></td></tr><tr><td><p>0401150</p></td><td><p>Castor bean</p></td><td><p> </p></td></tr><tr><td><p>0401990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0402000</p></td><td><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><span>Oilfruits</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0402010</p></td><td><p>Olives for oil production</p></td><td><p> </p></td></tr><tr><td><p>0402020</p></td><td><p>Palm nuts (palmoil kernels)</p></td><td><p> </p></td></tr><tr><td><p>0402030</p></td><td><p>Palmfruit</p></td><td><p> </p></td></tr><tr><td><p>0402040</p></td><td><p>Kapok</p></td><td><p> </p></td></tr><tr><td><p>0402990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0500000</p></td><td><table><col/><col/><tbody><tr><td><p>5.</p></td><td><span>CEREALS</span></td></tr></tbody></table></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0500010</p></td><td><p>Barley</p></td><td><p> </p></td></tr><tr><td><p>0500020</p></td><td><p>Buckwheat (Amaranthus, quinoa)</p></td><td><p> </p></td></tr><tr><td><p>0500030</p></td><td><p>Maize</p></td><td><p> </p></td></tr><tr><td><p>0500040</p></td><td><p>Millet (Foxtail millet, teff, finger millet, pearl millet)</p></td><td><p> </p></td></tr><tr><td><p>0500050</p></td><td><p>Oats</p></td><td><p> </p></td></tr><tr><td><p>0500060</p></td><td><p>Rice (Indian/wild rice (<span>Zizania aquatica</span>))</p></td><td><p> </p></td></tr><tr><td><p>0500070</p></td><td><p>Rye</p></td><td><p> </p></td></tr><tr><td><p>0500080</p></td><td><p>Sorghum</p></td><td><p> </p></td></tr><tr><td><p>0500090</p></td><td><p>Wheat (Spelt, triticale)</p></td><td><p> </p></td></tr><tr><td><p>0500990</p></td><td><p>Others (Canary grass seeds (<span>Phalaris canariensis</span>))</p></td><td><p> </p></td></tr><tr><td><p>0600000</p></td><td><table><col/><col/><tbody><tr><td><p>6.</p></td><td><span>TEA, COFFEE, HERBAL INFUSIONS AND COCOA</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0610000</p></td><td><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><span>Tea</span></td></tr></tbody></table></td><td><p>5<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0620000</p></td><td><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><span>Coffee beans</span></td></tr></tbody></table></td><td><p>5<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0630000</p></td><td><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><span>Herbal infusions (dried)</span></td></tr></tbody></table></td><td><p>500</p></td></tr><tr><td><p>0631000</p></td><td><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><span>Flowers</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0631010</p></td><td><p>Camomille flowers</p></td><td><p> </p></td></tr><tr><td><p>0631020</p></td><td><p>Hybiscus flowers</p></td><td><p> </p></td></tr><tr><td><p>0631030</p></td><td><p>Rose petals</p></td><td><p> </p></td></tr><tr><td><p>0631040</p></td><td><p>Jasmine flowers (Elderflowers (<span>Sambucus nigra</span>))</p></td><td><p> </p></td></tr><tr><td><p>0631050</p></td><td><p>Lime (linden)</p></td><td><p> </p></td></tr><tr><td><p>0631990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0632000</p></td><td><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><span>Leaves</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0632010</p></td><td><p>Strawberry leaves</p></td><td><p> </p></td></tr><tr><td><p>0632020</p></td><td><p>Rooibos leaves (Ginkgo leaves)</p></td><td><p> </p></td></tr><tr><td><p>0632030</p></td><td><p>Maté</p></td><td><p> </p></td></tr><tr><td><p>0632990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0633000</p></td><td><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><span>Roots</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0633010</p></td><td><p>Valerian root</p></td><td><p> </p></td></tr><tr><td><p>0633020</p></td><td><p>Ginseng root</p></td><td><p> </p></td></tr><tr><td><p>0633990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0639000</p></td><td><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><span>Other herbal infusions</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0640000</p></td><td><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><span>Cocoabeans (fermented or dried)</span></td></tr></tbody></table></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0650000</p></td><td><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><span>Carob (st johns bread)</span></td></tr></tbody></table></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0700000</p></td><td><table><col/><col/><tbody><tr><td><p>7.</p></td><td><span>HOPS (dried)</span></td></tr></tbody></table></td><td><p>1 500</p></td></tr><tr><td><p>0800000</p></td><td><table><col/><col/><tbody><tr><td><p>8.</p></td><td><span>SPICES</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0810000</p></td><td><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><span>Seeds</span></td></tr></tbody></table></td><td><p>400</p></td></tr><tr><td><p>0810010</p></td><td><p>Anise</p></td><td><p> </p></td></tr><tr><td><p>0810020</p></td><td><p>Black caraway</p></td><td><p> </p></td></tr><tr><td><p>0810030</p></td><td><p>Celery seed (Lovage seed)</p></td><td><p> </p></td></tr><tr><td><p>0810040</p></td><td><p>Coriander seed</p></td><td><p> </p></td></tr><tr><td><p>0810050</p></td><td><p>Cumin seed</p></td><td><p> </p></td></tr><tr><td><p>0810060</p></td><td><p>Dill seed</p></td><td><p> </p></td></tr><tr><td><p>0810070</p></td><td><p>Fennel seed</p></td><td><p> </p></td></tr><tr><td><p>0810080</p></td><td><p>Fenugreek</p></td><td><p> </p></td></tr><tr><td><p>0810090</p></td><td><p>Nutmeg</p></td><td><p> </p></td></tr><tr><td><p>0810990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0820000</p></td><td><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><span>Fruits and berries</span></td></tr></tbody></table></td><td><p>400</p></td></tr><tr><td><p>0820010</p></td><td><p>Allspice</p></td><td><p> </p></td></tr><tr><td><p>0820020</p></td><td><p>Sichuan pepper (Anise pepper, Japan pepper)</p></td><td><p> </p></td></tr><tr><td><p>0820030</p></td><td><p>Caraway</p></td><td><p> </p></td></tr><tr><td><p>0820040</p></td><td><p>Cardamom</p></td><td><p> </p></td></tr><tr><td><p>0820050</p></td><td><p>Juniper berries</p></td><td><p> </p></td></tr><tr><td><p>0820060</p></td><td><p>Pepper, black, green and white (Long pepper, pink pepper)</p></td><td><p> </p></td></tr><tr><td><p>0820070</p></td><td><p>Vanilla pods</p></td><td><p> </p></td></tr><tr><td><p>0820080</p></td><td><p>Tamarind</p></td><td><p> </p></td></tr><tr><td><p>0820990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0830000</p></td><td><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><span>Bark</span></td></tr></tbody></table></td><td><p>400</p></td></tr><tr><td><p>0830010</p></td><td><p>Cinnamon (Cassia)</p></td><td><p> </p></td></tr><tr><td><p>0830990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0840000</p></td><td><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><span>Roots or rhizome</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0840010</p></td><td><p>Liquorice</p></td><td><p>400</p></td></tr><tr><td><p>0840020</p></td><td><p>Ginger</p></td><td><p>400</p></td></tr><tr><td><p>0840030</p></td><td><p>Turmeric (Curcuma)</p></td><td><p>400</p></td></tr><tr><td><p>0840040</p></td><td><p>Horseradish</p></td><td><p>(+)</p></td></tr><tr><td><p>0840990</p></td><td><p>Others</p></td><td><p>400</p></td></tr><tr><td><p>0850000</p></td><td><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><span>Buds</span></td></tr></tbody></table></td><td><p>400</p></td></tr><tr><td><p>0850010</p></td><td><p>Cloves</p></td><td><p> </p></td></tr><tr><td><p>0850020</p></td><td><p>Capers</p></td><td><p> </p></td></tr><tr><td><p>0850990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0860000</p></td><td><table><col/><col/><tbody><tr><td><p>(vi)</p></td><td><span>Flower stigma</span></td></tr></tbody></table></td><td><p>400</p></td></tr><tr><td><p>0860010</p></td><td><p>Saffron</p></td><td><p> </p></td></tr><tr><td><p>0860990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0870000</p></td><td><table><col/><col/><tbody><tr><td><p>(vii)</p></td><td><span>Aril</span></td></tr></tbody></table></td><td><p>400</p></td></tr><tr><td><p>0870010</p></td><td><p>Mace</p></td><td><p> </p></td></tr><tr><td><p>0870990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>0900000</p></td><td><table><col/><col/><tbody><tr><td><p>9.</p></td><td><span>SUGAR PLANTS</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>0900010</p></td><td><p>Sugar beet (root)</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0900020</p></td><td><p>Sugar cane</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>0900030</p></td><td><p>Chicory roots</p></td><td><p>75</p></td></tr><tr><td><p>0900990</p></td><td><p>Others</p></td><td><p>2<a> (<span>1</span>)</a></p></td></tr><tr><td><p>1000000</p></td><td><table><col/><col/><tbody><tr><td><p>10.</p></td><td><span>PRODUCTS OF ANIMAL ORIGIN-TERRESTRIAL ANIMALS</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>1010000</p></td><td><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><span>Tissue</span></td></tr></tbody></table></td><td><p>0,5<a> (<span>1</span>)</a></p></td></tr><tr><td><p>1011000</p></td><td><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><span>Swine</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>1011010</p></td><td><p>Muscle</p></td><td><p> </p></td></tr><tr><td><p>1011020</p></td><td><p>Fat</p></td><td><p> </p></td></tr><tr><td><p>1011030</p></td><td><p>Liver</p></td><td><p> </p></td></tr><tr><td><p>1011040</p></td><td><p>Kidney</p></td><td><p> </p></td></tr><tr><td><p>1011050</p></td><td><p>Edible offal</p></td><td><p> </p></td></tr><tr><td><p>1011990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>1012000</p></td><td><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><span>Bovine</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>1012010</p></td><td><p>Muscle</p></td><td><p> </p></td></tr><tr><td><p>1012020</p></td><td><p>Fat</p></td><td><p> </p></td></tr><tr><td><p>1012030</p></td><td><p>Liver</p></td><td><p> </p></td></tr><tr><td><p>1012040</p></td><td><p>Kidney</p></td><td><p> </p></td></tr><tr><td><p>1012050</p></td><td><p>Edible offal</p></td><td><p> </p></td></tr><tr><td><p>1012990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>1013000</p></td><td><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><span>Sheep</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>1013010</p></td><td><p>Muscle</p></td><td><p> </p></td></tr><tr><td><p>1013020</p></td><td><p>Fat</p></td><td><p> </p></td></tr><tr><td><p>1013030</p></td><td><p>Liver</p></td><td><p> </p></td></tr><tr><td><p>1013040</p></td><td><p>Kidney</p></td><td><p> </p></td></tr><tr><td><p>1013050</p></td><td><p>Edible offal</p></td><td><p> </p></td></tr><tr><td><p>1013990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>1014000</p></td><td><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><span>Goat</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>1014010</p></td><td><p>Muscle</p></td><td><p> </p></td></tr><tr><td><p>1014020</p></td><td><p>Fat</p></td><td><p> </p></td></tr><tr><td><p>1014030</p></td><td><p>Liver</p></td><td><p> </p></td></tr><tr><td><p>1014040</p></td><td><p>Kidney</p></td><td><p> </p></td></tr><tr><td><p>1014050</p></td><td><p>Edible offal</p></td><td><p> </p></td></tr><tr><td><p>1014990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>1015000</p></td><td><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><span>Horses, asses, mules or hinnies</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>1015010</p></td><td><p>Muscle</p></td><td><p> </p></td></tr><tr><td><p>1015020</p></td><td><p>Fat</p></td><td><p> </p></td></tr><tr><td><p>1015030</p></td><td><p>Liver</p></td><td><p> </p></td></tr><tr><td><p>1015040</p></td><td><p>Kidney</p></td><td><p> </p></td></tr><tr><td><p>1015050</p></td><td><p>Edible offal</p></td><td><p> </p></td></tr><tr><td><p>1015990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>1016000</p></td><td><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><span>Poultry -chicken, geese, duck, turkey and Guinea fowl-, ostrich, pigeon</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>1016010</p></td><td><p>Muscle</p></td><td><p> </p></td></tr><tr><td><p>1016020</p></td><td><p>Fat</p></td><td><p> </p></td></tr><tr><td><p>1016030</p></td><td><p>Liver</p></td><td><p> </p></td></tr><tr><td><p>1016040</p></td><td><p>Kidney</p></td><td><p> </p></td></tr><tr><td><p>1016050</p></td><td><p>Edible offal</p></td><td><p> </p></td></tr><tr><td><p>1016990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>1017000</p></td><td><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><span>Other farm animals (Rabbit, kangaroo, deer)</span></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>1017010</p></td><td><p>Muscle</p></td><td><p> </p></td></tr><tr><td><p>1017020</p></td><td><p>Fat</p></td><td><p> </p></td></tr><tr><td><p>1017030</p></td><td><p>Liver</p></td><td><p> </p></td></tr><tr><td><p>1017040</p></td><td><p>Kidney</p></td><td><p> </p></td></tr><tr><td><p>1017050</p></td><td><p>Edible offal</p></td><td><p> </p></td></tr><tr><td><p>1017990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>1020000</p></td><td><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><span>Milk</span></td></tr></tbody></table></td><td><p>0,1<a> (<span>1</span>)</a></p></td></tr><tr><td><p>1020010</p></td><td><p>Cattle</p></td><td><p> </p></td></tr><tr><td><p>1020020</p></td><td><p>Sheep</p></td><td><p> </p></td></tr><tr><td><p>1020030</p></td><td><p>Goat</p></td><td><p> </p></td></tr><tr><td><p>1020040</p></td><td><p>Horse</p></td><td><p> </p></td></tr><tr><td><p>1020990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>1030000</p></td><td><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><span>Bird eggs</span></td></tr></tbody></table></td><td><p>0,1<a> (<span>1</span>)</a></p></td></tr><tr><td><p>1030010</p></td><td><p>Chicken</p></td><td><p> </p></td></tr><tr><td><p>1030020</p></td><td><p>Duck</p></td><td><p> </p></td></tr><tr><td><p>1030030</p></td><td><p>Goose</p></td><td><p> </p></td></tr><tr><td><p>1030040</p></td><td><p>Quail</p></td><td><p> </p></td></tr><tr><td><p>1030990</p></td><td><p>Others</p></td><td><p> </p></td></tr><tr><td><p>1040000</p></td><td><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><span>Honey (Royal jelly, pollen, honey comb with honey (comb honey))</span></td></tr></tbody></table></td><td><p>0,5<a> (<span>1</span>)</a></p></td></tr><tr><td><p>1050000</p></td><td><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><span>Amphibians and reptiles (Frog legs, crocodiles)</span></td></tr></tbody></table></td><td><p>0,5<a> (<span>1</span>)</a></p></td></tr><tr><td><p>1060000</p></td><td><table><col/><col/><tbody><tr><td><p>(vi)</p></td><td><span>Snails</span></td></tr></tbody></table></td><td><p>0,5<a> (<span>1</span>)</a></p></td></tr><tr><td><p>1070000</p></td><td><table><col/><col/><tbody><tr><td><p>(vii)</p></td><td><span>Other terrestrial animal products (Wild game)</span></td></tr></tbody></table></td><td><p>0,5<a> (<span>1</span>)</a></p></td></tr><tr><td/></tr></tbody></table>
( 1 ) Indicates lower limit of analytical determination
( 2 ) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
Fosetyl-Al (sum of fosetyl, phosphonic acid and their salts, expressed as fosetyl)
<table><col/><col/><tbody><tr><td><p>(+)</p></td><td><p>MRL applicable until 31 December 2015, after that date 2 (*) will be applicable unless modified by a Regulation.</p><table><col/><col/><tbody><tr><td><p><span>0120010</span></p></td><td><p><span>Almonds</span></p></td></tr><tr><td><p><span>0120030</span></p></td><td><p><span>Cashew nuts</span></p></td></tr><tr><td><p><span>0120060</span></p></td><td><p><span>Hazelnuts (Filbert)</span></p></td></tr><tr><td><p><span>0120070</span></p></td><td><p><span>Macadamia</span></p></td></tr><tr><td><p><span>0120100</span></p></td><td><p><span>Pistachios</span></p></td></tr><tr><td><p><span>0120110</span></p></td><td><p><span>Walnuts</span></p></td></tr><tr><td><p><span>0140000</span></p></td><td><table><col/><col/><tbody><tr><td><p><span>(iv)</span></p></td><td><span>Stone fruit</span></td></tr></tbody></table></td></tr><tr><td><p><span>0140010</span></p></td><td><p><span>Apricots</span></p></td></tr><tr><td><p><span>0140020</span></p></td><td><p><span>Cherries (Sweet cherries, sour cherries)</span></p></td></tr><tr><td><p><span>0140030</span></p></td><td><p><span>Peaches (Nectarines and similar hybrids)</span></p></td></tr><tr><td><p><span>0140040</span></p></td><td><p><span>Plums (Damson, greengage, mirabelle, sloe, red date/Chinese date/Chinese jujube (<span>Ziziphus zizyphus</span>))</span></p></td></tr><tr><td><p><span>0140990</span></p></td><td><p><span>Others</span></p></td></tr><tr><td><p><span>0153000</span></p></td><td><table><col/><col/><tbody><tr><td><p><span>(c)</span></p></td><td><span>Cane fruit</span></td></tr></tbody></table></td></tr><tr><td><p><span>0153010</span></p></td><td><p><span>Blackberries</span></p></td></tr><tr><td><p><span>0153020</span></p></td><td><p><span>Dewberries (Loganberries, tayberries, boysenberries, cloudberries and other<span>Rubus</span> hybrids)</span></p></td></tr><tr><td><p><span>0153030</span></p></td><td><p><span>Raspberries (Wineberries, arctic bramble/raspberry, (<span>Rubus arcticus</span>), nectar raspberries (<span>Rubus arcticus</span> ×<span>Rubus idaeus</span>))</span></p></td></tr><tr><td><p><span>0153990</span></p></td><td><p><span>Others</span></p></td></tr><tr><td><p><span>0154010</span></p></td><td><p><span>Blueberries (Bilberries)</span></p></td></tr><tr><td><p><span>0154030</span></p></td><td><p><span>Currants (red, black and white)</span></p></td></tr><tr><td><p><span>0154040</span></p></td><td><p><span>Gooseberries (Including hybrids with other<span>Ribes</span> species)</span></p></td></tr><tr><td><p><span>0161020</span></p></td><td><p><span>Figs</span></p></td></tr><tr><td><p><span>0161040</span></p></td><td><p><span>Kumquats (Marumi kumquats, nagami kumquats, limequats (<span>Citrus aurantifolia</span> ×<span>Fortunella</span> spp.))</span></p></td></tr><tr><td><p><span>0161060</span></p></td><td><p><span>Persimmon</span></p></td></tr><tr><td><p><span>0162030</span></p></td><td><p><span>Passion fruit</span></p></td></tr><tr><td><p><span>0163040</span></p></td><td><p><span>Papaya</span></p></td></tr><tr><td><p><span>0163050</span></p></td><td><p><span>Pomegranate</span></p></td></tr><tr><td><p><span>0220010</span></p></td><td><p><span>Garlic</span></p></td></tr><tr><td><p><span>0260010</span></p></td><td><p><span>Beans (with pods) (Green bean/French beans/snap beans, scarlet runner bean, slicing bean, yard long beans, guar beans, soya beans)</span></p></td></tr><tr><td><p><span>0260020</span></p></td><td><p><span>Beans (without pods) (Broad beans, flageolets, jack bean, lima bean, cowpea)</span></p></td></tr><tr><td><p><span>0260030</span></p></td><td><p><span>Peas (with pods) (Mangetout/sugar peas/snow peas)</span></p></td></tr><tr><td><p><span>0260040</span></p></td><td><p><span>Peas (without pods) (Garden pea, green pea, chickpea)</span></p></td></tr><tr><td><p><span>0270010</span></p></td><td><p><span>Asparagus</span></p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(+)</p></td><td><p>The applicable maximum residue level for horseradish (<span>Armoracia rusticana</span>) in the spice group (code 0840040) is the one set for horseradish (<span>Armoracia rusticana</span>) in the Vegetables category, root and tuber vegetables group (code 0213040) taking into account changes in the levels by processing (drying) according to Art. 20 (1) of Regulation (EC) No 396/2005.</p><table><col/><col/><tbody><tr><td><p><span>0840040</span></p></td><td><p><span>Horseradish’</span></p></td></tr></tbody></table></td></tr></tbody></table> | ENG | 32014R0991 |
<table><col/><col/><col/><col/><tbody><tr><td><p>16.1.2019   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 14/1</p></td></tr></tbody></table>
COMMISSION DECISION (EU) 2019/56
of 28 May 2018
on aid scheme SA.34045 (2013/c) (ex 2012/NN) implemented by Germany for baseload consumers under Paragraph 19 StromNEV
(notified under document C(2018) 3166)
(Only the German version is authentic)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union, and in particular the first subparagraph of Article 108(2) thereof,
Having regard to the Agreement on the European Economic Area, and in particular Article 62(1)(a) thereof,
Having given notice to the parties concerned to submit their comments ( 1 ) and having regard to their comments,
Whereas:
1. PROCEDURE
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>By complaints submitted by the<span>Bund der Energieverbraucher e.V.</span> on 28 November 2011, by the<span>GWS Stadtwerke Hameln GmbH</span> on 8 December and by citizens since December 2011, the Commission was informed that Germany had implemented since 2011 a full exemption from network charges for certain large electricity consumers. By letter dated 29 June 2012, Germany provided the Commission with further information on that aid scheme.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>By letter dated 6 March 2013 (‘the Opening Decision’), the Commission informed Germany that it had decided to initiate the procedure laid down in Article 108(2) of the Treaty on the Functioning of the European Union (hereafter: TFEU or Treaty) in respect of the aid scheme. Germany submitted its comments on the Opening Decision on 8 April 2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The Opening Decision was published in the<span>Official Journal of the European Union</span> <a>(<span>2</span>)</a>. The Commission invited interested parties to submit their comments on the aid scheme.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The Commission received comments from interested parties. It forwarded them to Germany, which was given the opportunity to react; its comments were received by letter dated 5 November 2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>During a meeting of 17 October 2013 and by letters notified on 7 April 2015, 20 July 2016, 6 July 2017, 18 September 2017, 3 October 2017 and 23 October 2017, the Commission requested Germany to provide information.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Germany submitted replies to those requests on 6 December 2013, 28 May 2015, 15 September 2015, 14 October 2016, 3 August 2017, 20 September 2017, 24 October 2017 and 26 October 2017. The latest information was submitted on 11 December 2017.</p></td></tr></tbody></table>
2. DETAILED DESCRIPTION OF THE AID
2.1. NETWORK CHARGES IN GERMANY
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The system of network charges in Germany is governed by the German Energy Act (<span>Energiewirtschaftsgesetz, ‘EnWG’</span>). For the purposes of this Decision, only the EnWG as modified by Article 1 of the Law of 26 July 2011 on the review of provisions governing the energy market <a>(<span>3</span>)</a> (‘the Law of 26 July 2011’) and before the amendments introduced by Article 1 of the Law of 26 July 2016 on the further development of the electricity market <a>(<span>4</span>)</a> (‘EnWG 2011’) is relevant.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Paragraph 21 of the EnWG 2011 requires that the charges that the network operators <a>(<span>5</span>)</a> charge to their end users are<span>proportionate (‘angemessen’)</span>, non-discriminatory, transparent and are calculated on the basis of the costs of an efficient network management. Paragraph 24 of the EnWG 2011 empowers the federal government to lay down detailed rules on the methodology for the calculation of network charges by ordinance. Point 1 of the first sentence of Paragraph 24 of the EnWG 2011 empowers the federal government to determine the general methodology of calculating network charges. Point 3 of the same sentence empowers the federal government to determine in which cases of atypical network use individual network charges can be approved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>Adopted on the basis of Paragraph 24 of the EnWG 2011, the Ordinance on Electricity Network Charges (<span>Stromnetzentgeltverordnung, ‘StromNEV’</span> <a>(<span>6</span>)</a>) contains detailed provisions on the determination of network charges. Paragraph 3(2) of the StromNEV clarifies that network charges are paid for the services provided by the network operator at the network level to which a user is connected as well as all for the use of all upstream network levels. Paragraph 16(1) of the StromNEV establishes the guiding principle according to which network charges need to reflect the costs actually caused by network users.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>Against this background and in line with the empowerment laid down in point 1 of the first sentence of Paragraph 24 of the EnWG 2011, the StromNEV provides for the general methodology that network operators have to follow for calculating network charges. This calculation methodology is laid down in Paragraphs 4 to 14 of the StromNEV 2011.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>This methodology consists of first taking the various annual cost elements of all networks together. Those are the construction costs of the electricity network (transmission and distribution lines, substations), the maintenance and the costs for operating the network, including the costs linked to so-called system services (primary, secondary and minute reserves <a>(<span>7</span>)</a>, re-dispatching <a>(<span>8</span>)</a> and electricity to cover network losses <a>(<span>9</span>)</a>). Their annual amount is calculated based on the profit and loss account of the network operators (Paragraph 4 of the StromNEV 2011). They include not only material costs and personnel costs but also loan interests (Paragraph 5 of the StromNEV), depreciation (Paragraph 6 of the StromNEV 2011), a remuneration for the network operator's own capital (Paragraph 7 of the StromNEV 2011) and taxes (Paragraph 8 of the StromNEV 2011). Revenues like connection costs and subsidies have to be deducted (Paragraph 9 of the StromNEV). Metering costs, however, are not included in the network costs and are also subject to separate metering fees. The costs linked to the purchase of balancing energy <a>(<span>10</span>)</a> are not included in the network costs as it is invoiced separately to the users responsible for the imbalance.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>The total annual costs of the networks are then allocated to the different network and network levels (high voltage, substation levels, medium voltage, low voltage). Annex 2 of the StromNEV 2011 contains the list of those network levels.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>The next step in the determination of the network charges will be to convert the total annual costs of the networks into the network charges. They are determined top-down for each voltage level (from high voltage to low voltage). First the so-called specific annual costs of the high voltage level are determined by dividing the total annual costs of the high voltage level by the annual peak load measured on that high voltage level, as the peak load of the network level is viewed as the main cost determining factor. This is expressed in EUR/kW. Via the ‘simultaneity function’ of each grid level described in recital 14 below, the specific annual costs will be converted into a price per connection capacity, in EUR/kW and into a price per unit of electricity consumed, in EUR/kWh. The same exercise is then done for the next voltage level. However the total annual costs of the next voltage level will be composed on its own costs and of rolled-over costs from the upstream voltage level. The rolled over costs correspond to the total costs of the upstream level minus the network charges obtained from network users (final consumers and electricity suppliers directly connected to that voltage level). The following figure 1 shows the roll-over of costs. In a network in which electricity flows top-down, network users will thus have to bear the costs of the network level to which they are connected, as well as part of the costs of the upstream networks as those networks are used to transmit the electricity to them as well.</p><p><span>Figure 1</span></p><p><span>Roll-over of network costs for the determination of network charges</span> (<span>1</span>)</p><img/><p>Revenues of the level</p><p>HS</p><p>HS/MS</p><p>MS</p><p>MS/NS</p><p>NS</p><p>Costs of the level</p><p>Rolled-over costs</p><table><col/><col/><tbody><tr><td><p>(<span>1</span>)</p></td><td>In the figure, HS stands for high voltage, MS stands for medium voltage, NS stands for low voltage, HS/MS stands for the substation in which high voltage is transformed to medium voltage, MS/NS stands for the substation converting medium voltage to low voltage. Source: Commission based on description provided by Germany and completed with the information contained in Figure 1 of the BNetzA Report ‘Netzentgeltsystematik Elektrizität’ of December 2015 available under https://www.bundesnetzagentur.de/SharedDocs/Downloads/DE/Sachgebiete/Energie/Unternehmen_Institutionen/Netzentgelte/Netzentgeltsystematik/Bericht_Netzentgeltsystematik_12-2015.pdf?__blob=publicationFile&v=1.</td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>In order to ensure an allocation to the various network users reflecting the actual costs caused by an individual network user as required by Paragraph 16(1) of the StromNEV, the simultaneity function is applied for the voltage level being considered. The simultaneity function referred to above under recital 13 is described in Paragraph 16(2) StromNEV and Annex 4 of StromNEV 2011. This function attributes to each network user a ‘simultaneity factor’ between 0 and 1. The simultaneity factor expresses the probability — based on historical figures — that the electricity consumption of the individual network user in question contributes to the annual peak load of the network level concerned. The simultaneous annual peak load of the network is an important cost driver of the network given that this annual peak load is important for the dimensioning of network in which electricity is flowing top-down. The idea behind the simultaneity function is that network users which have a higher probability of contributing to the annual peak load will pay a higher capacity tariff. The users of each network level are the final consumers directly connected to the high voltage level as well as downstream network levels. The simultaneity factors of all network users of the network level considered are then introduced into a graph on the y-axis and put in correlation with the number of annual hours of full use (x-axis). This results into the simultaneity function. This function is linear and continuous but composed of two linear parts which intersect at a kink <a>(<span>11</span>)</a> at 2 500 annual usage hours made <a>(<span>12</span>)</a>. The simultaneity function is then converted into a tariff per connection capacity <a>(<span>13</span>)</a> in EUR/kW and into a tariff per unit of electricity consumed <a>(<span>14</span>)</a> in EUR/kWh.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>When establishing the network charges, network operators must also take into account the maximum revenue level allowed for each one of them by the Federal Network Agency (<span>Bundesnetzagentur</span>, ‘BNetzA’) (on the maximum revenue level allowed, see also recital 43). In practice, this maximum revenue level, which is established by benchmarking with other network operators, will have as consequence that high costs resulting from inefficiencies cannot be recovered through network charges. This system aims at improving the efficiency of the network operators. Where a modification of the maximum revenue level authorized would lead to a reduction of network charges, the network operator has to adapt the network charges (Paragraph 17(2) of the Ordinance on the introduction of efficiency incentives for energy supply networks –<span>Verordnung über die Anreizregulierung der Energieversorgungsnetze</span>, ARegV 2011 <a>(<span>15</span>)</a>).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(16)</p></td><td><p>The methodology described in recitals 11 to 15 above implements the ‘principle of cost-causality’ when determining the network charges for the majority of network users. Paragraph 19 of the StromNEV addresses the network charges to be paid in line with the principle of cost-causality by so-called atypical network users, i.e. users with a consumption or load pattern that differs significantly from the consumption or load profile of the other users as provided for in point 3 of the first sentence of Paragraph 24 of the EnWG 2011. The heading of Paragraph 19 of the StromNEV is ‘atypical network use’.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(17)</p></td><td><p>Paragraph 19(2) of the StromNEV identifies two groups of atypical network users: Firstly, users whose annual peak load predictably and significantly deviates from the simultaneous annual peak load of all other network users connected to the same network (first sentence of Paragraph 19(2) of the StromNEV). Typically this concerns network users who are systematically consuming outside peak load times because for instance they are running equipment at night. This first category of atypical network users is hereinafter designated as ‘non-peak consumers’. Secondly, users with an annual electricity consumption reaching minimum 7 000 hours of use <a>(<span>16</span>)</a> and exceeding 10 gigawatt hours (GWh) (second sentence of Paragraph 19(2) of the StromNEV). This second category of atypical network users is hereinafter designated as ‘baseload consumers’.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(18)</p></td><td><p>Before the amendment introduced by Article 7 of the Law of 26 July 2011 and described more in detail below in section 2.2, Paragraph 19(2) of the StromNEV as amended by the Law of 3 September 2010 (‘StromNEV 2010’ <a>(<span>17</span>)</a>) stated that both non-peak and baseload consumers were to pay individual network charges as also explicitly provided under the empowerment laid down in point 3 of the first sentence of Paragraph 24 of the EnWG 2011 (see recital 7 above).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(19)</p></td><td><p>Such individual network charges were to take due account of the consumption pattern of the atypical network user. More precisely, the third sentence of Paragraph 19(2) of the StromNEV 2010 required that the individual network charge should reflect the contribution of the atypical network user to a reduction of the overall network charges or their contribution to avoiding an increase in network charges. To this end, in 2010, the BNetzA published a guidance paper <a>(<span>18</span>)</a> outlining the so-called ‘physical path methodology’ that should be applied to determine the network costs caused by the baseload consumers and thereby their individual network charges. The physical path methodology aims at identifying the stand-alone costs of a particular network user. It measures the costs of a virtual use of an existing direct line from the consumption site to an adequate generation installation by computing the capital and operational expenditures of the part of the network used to connect the baseload consumer to the closest power plant that can cover the entire needs of the baseload consumer and adding the costs of network services <a>(<span>19</span>)</a> that the baseload consumer has been using, if any.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(20)</p></td><td><p>The second sentence of Paragraph 19(2) of the StromNEV 2010, however, required both non-peak and baseload consumers to pay a minimum contribution of at least 20 % of the published network charge, that is to say the individual network charge calculated based on the contribution of the atypical network user to a reduction of the overall network charges or their contribution to avoiding an increase in network charges could not be lower than 20 % of the published network charge. Germany has explained that this minimum contribution aims at guaranteeing that also atypical network users pay a minimum contribution to the management of the public grid to which they are connected. Concerning baseload consumers in particular, Germany has indicated that if they are located very close to a baseload power plant <a>(<span>20</span>)</a>, the network charges calculated based on the physical path methodology could be close to zero. Those baseload consumers, however, still benefit from the public network and the secured electricity supply that it provides. Germany has moreover explained that the minimum contribution was taking account of the fact that the physical path methodology can only serve as a proxy to determine the individual network costs.</p></td></tr></tbody></table>
2.2. THE FULL EXEMPTION BETWEEN 2011 AND 2013
<table><col/><col/><tbody><tr><td><p>(21)</p></td><td><p>In the StromNEV as amended by Article 7 of the Law of 26 July 2011, which entered into force on 4 August 2011 but was retroactively applicable as of 1 January 2011 (‘StromNEV 2011’ <a>(<span>21</span>)</a>), the system of individual network charges for baseload consumers was abolished and replaced by a full exemption from the obligation to pay network charges. Individual network charges for non-peak consumers remained in place as well as their obligation to pay at least 20 % of the published network charge.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(22)</p></td><td><p>According to the second sentence of Paragraph 19(2) of the StromNEV 2011 end users were to be exempted from network charges if their annual energy consumption reaches at least 7 000 hours of full use and exceeds 10 GWh of consumption. That exemption (‘the full exemption’) constitutes the subject-matter of both the Opening Decision and this Decision.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(23)</p></td><td><p>The threshold of 7 000 hours of full use is what characterizes a baseload consumer in the sense that this threshold can only be reached if the end user concerned remains almost constantly connected to the network with the same load. Hours of (full) use are defined under Paragraph 2(2) of the StromNEV as the quotient of the annual power output and the annual peak load of the respective network user.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(24)</p></td><td><p>Pursuant to the third sentence of Paragraph 19(2) of the StromNEV 2011, the exemption provided for in the second sentence of the same paragraph was to be granted only once the competent regulatory authority (either the BNetzA or one of the regional regulators, ‘<span>Landesregulierungsbehörde</span>’ <a>(<span>22</span>)</a>) had verified that the legal conditions were fulfilled. Once that verification was completed, the BNetzA or the Landesregulierungsbehörde delivered an authorisation that entitled the baseload consumer to the full exemption as of 1 January 2011 (provided all conditions were met at that date) and for an indefinite period (provided that the requirements continued to be met).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(25)</p></td><td><p>The full exemption resulted in a reduction of revenues for network operators. This financial loss has been compensated through a special surcharge as of 2012 (see section 2.4 below). For the year 2011, however, no special surcharge was introduced and the financial loss was borne by the network operators in 2011.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(26)</p></td><td><p>The full exemption was abolished by an amendment <a>(<span>23</span>)</a> to the StromNEV as of 1 January 2014.</p></td></tr></tbody></table>
2.3. BENEFICIARIES AND AID AMOUNT
<table><col/><col/><tbody><tr><td><p>(27)</p></td><td><p>Germany has provided a provisional list of undertakings entitled to an exemption under the second sentence of Paragraph 19(2) of the StromNEV 2011. Based on this information, more than 200 undertakings were exempted from network charges under the second sentence of Paragraph 19(2) of the StromNEV 2011 in the period 2011 to 2013. The large majority of those undertakings belong to various branches of the manufacturing sector, in particular, the chemical industry (including industrial gases), paper, textile, steel, non-ferrous metal industry, oil refineries and glass manufacturing. Only occasionally have undertakings involved in the service sector (for instance web hosting) obtained a full exemption. Those undertakings were undertakings with large data centres.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(28)</p></td><td><p>The estimates provided by Germany indicate that the losses incurred by the network operators due to the full exemption over the period 2011 to 2013 amount to approximately EUR 900 million compared to a situation in which baseload consumers would have paid the normal charge. The loss is, however, probably lower as in the calculation of the 2011 network charges network operators normally took into account the fact that the baseload consumers would have been eligible for individual network charges under Paragraph 19(2) of the StromNEV 2010. However, the estimation is further complicated by the fact that the threshold for eligibility for individual charges had changed as of 1 January 2011 (7 000 hours of full use instead of 7 500 hours of full use), and that the individual charges may not have been attractive for certain baseload consumers, because it may not have led to a significant reduction of their network charges, depending on their geographical location and other factors influencing the calculation of the individual network charges.</p></td></tr></tbody></table>
2.4. FINANCING MECHANISM
2.4.1. THE FINANCING MECHANISM AS DESCRIBED IN PARAGRAPH 19 OF THE STROMNEV 2011
<table><col/><col/><tbody><tr><td><p>(29)</p></td><td><p>Given that the exempted baseload consumers were connected to different network levels, the full exemption led to losses in revenue both for the transmission system operators (‘TSO’) and the distribution system operators (‘DSO’). The sixth sentence of Paragraph 19(2) of the StromNEV 2011 obliged the TSO to compensate the DSO for their losses in revenue resulting from the full exemption. However, for the reasons set out in detail under section 2.4.3, such compensation<span>de facto</span> only took place as of 2012. In 2011, the losses were born by the TSO and DSO to whose network the exempted baseload consumers were connected.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(30)</p></td><td><p>Furthermore, pursuant to the seventh sentence of Paragraph 19(2) of the StromNEV 2011, the TSO had to set off the sum of their payments to the DSO and their own losses amongst themselves. For the detailed rules on how to carry out that set-off, Paragraph 19(2) of the StromNEV 2011 referred to Paragraph 9 of the Combined Heat and Power Generation Act (<span>Kraft-Wärme-Kopplungsgesetz, ‘KWKG’</span>) <a>(<span>24</span>)</a> applicable at the time, which was to be applied by analogy. The set-off served to spread the financial burden between the TSO in such a way that each TSO bore the same burden in proportion to the electricity supplied to final consumers (directly or indirectly) connected to their respective network area. Paragraph 9 of the KWKG, to which the seventh sentence of Paragraph 19(2) of the StromNEV 2011 referred, established the system by which TSOs were compensated through the so-called CHP-surcharge for the extra costs resulting from their obligation to pay support to producers of cogenerated electricity connected to their network under the KWKG and their obligation to compensate DSOs for the support that they also paid to producers of cogenerated electricity connected to their network under the KWKG <a>(<span>25</span>)</a>. The analogous application of Paragraph 9 of the KWKG implied that network operators could introduce a surcharge to obtain compensation for the financial losses resulting from the full exemption and that the revenues collected from this surcharge had to be transferred from DSOs to the TSOs <a>(<span>26</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(31)</p></td><td><p>In addition, Paragraph 19(2) of the StromNEV 2011 stipulated that Paragraph 20 of the StromNEV 2011 was applicable by analogy. Paragraph 20 of the StromNEV 2011 stated that electricity grid operators had to make sure, prior to publishing their network charges for electricity, that the revenues of the charges were sufficient to cover their expected costs.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(32)</p></td><td><p>Since the entry into force of the<span>ARegV</span>, which establishes a regulatory system that is aimed at incentivising network operators to a more efficient network management, network charges do not need to be approved by the BNetzA anymore (as a result of Paragraph 23a of the EnWG). Instead, point 1 of Paragraph 32(1) ARegV 2011 provides that the BNetzA approves the maximum revenue level that network operators are allowed to obtain from network users. According to Paragraph 17 ARegV 2011 this authorized maximum revenue level must be respected when network operators determine network charges.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(33)</p></td><td><p>Network operators continue, however, to be obliged to make sure prior to publishing their network charges for electricity, that the revenues of the charges were sufficient to cover their expected costs (but within the limit of the authorized maximum revenue level).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(34)</p></td><td><p>As explained below, the BNetzA adopted a regulatory decision in order to regulate more in detail the surcharge system, which was eventually put in place as of 2012 (see section 2.4.2). By contrast, in 2011, the sixth and seventh sentences of Paragraph 19(2) of the StromNEV 2011 were not implemented and each network operator bore its own costs (see section 2.4.3).</p></td></tr></tbody></table>
2.4.2. FINANCING VIA THE ‘PARAGRAPH 19-SURCHARGE’ AS OF 2012
<table><col/><col/><tbody><tr><td><p>(35)</p></td><td><p>The legal framework for the compensation and the set-off of the losses in revenue resulting from the full exemption was concretized by a regulatory decision of the BNetzA adopted on 14 December 2011 <a>(<span>27</span>)</a> (‘the regulatory decision of 14 December 2011’) on the basis of Paragraph 29(1) of the EnWG and point 6 of Paragraph 30(2) of the StromNEV 2011 <a>(<span>28</span>)</a>. The decision imposed on the DSO the obligation to collect from end users a surcharge called the ‘Paragraph 19-surcharge’. The BNetzA further imposed on the DSO the obligation to transfer the proceeds from this surcharge to the TSO on a monthly basis (as also provided for under Paragraph 9(5) of the KWKG to which the seventh sentence of Paragraph 19(2) of the StromNEV 2011 refers).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(36)</p></td><td><p>The purpose of the Paragraph 19-surcharge was to establish a financing mechanism that distributes the financial burden resulting from the application of Paragraph 19(2) of the StromNEV 2011 in a transparent and homogenous way and thus to create equal conditions for all electricity consumers across Germany.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(37)</p></td><td><p>The amount of the Paragraph 19-surcharge was not calculated by the BNetzA but needed to be calculated each year by the TSO on the basis of the methodology set out by the BNetzA. This implied that the TSO had to determine on the one hand the forecasted financial losses resulting from the full exemption compared to the full network charge and on the other hand the forecasted consumption in order to determine the Paragraph 19-surcharge per kWh. For the first year of operation (that is to say 2012), however, the BNetzA set the amount that needed to be recovered through the Paragraph 19-surcharge at EUR 440 million. This amount served as a basis for the calculation of the surcharge. Of this amount, EUR 300 million needed to be recovered in order to compensate for the losses in revenue resulting from the full exemption. The remaining EUR 140 million were destined to cover the losses in revenue resulting from individual network charges based on the first sentence of Paragraph 19(2) of the StromNEV 2011.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(38)</p></td><td><p>Before the amendments introduced by Article 7 of the Law of 26 July 2011 in the StromNEV, the loss of revenues resulting from individual network charges for atypical network users were recouped, to the extent that the network operator was an efficient company and hence could under the ARegV recoup its entire costs, through network charges: as network operators knew in advance that some users would pay less, they could already factor that in in the calculation of network charges under Paragraph 20 of the StromNEV. Under the sixth and seventh sentence of Paragraph 19(2) of the StromNEV 2011, however, the loss of revenues resulting from individual network charges for non-peak consumers and the full exemption for baseload consumers had to be compensated through a dedicated surcharge.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(39)</p></td><td><p>In addition, the regulatory decision of 14 December 2011 provided that the TSO had to establish for each year what the real need in terms of financial resources was for the previous year. Where the proceeds from the Paragraph 19-surcharge exceeded the amount actually needed to compensate the TSO for the losses in revenue resulting from the full exemption and the compensation of DSO, the surcharge in the subsequent year would have to be reduced by the difference. Where the proceeds were insufficient, the surcharge was increased accordingly.</p></td></tr></tbody></table>
2.4.3. FINANCING MECHANISM FOR 2011
<table><col/><col/><tbody><tr><td><p>(40)</p></td><td><p>The regulatory decision of 14 December 2011 explicitly stated that the losses in revenue incurred in 2011 were not covered by the compensation and set-off mechanism described in recital 30.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(41)</p></td><td><p>As regards the losses incurred in 2011, the DSO were thus not entitled to be compensated by the TSO. Both the DSO and the TSO had to cover those losses in revenue from their own resources.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(42)</p></td><td><p>They could include those losses in their so-called regulatory accounts (‘<span>Regulierungskonto</span>’) established under the ARegV.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(43)</p></td><td><p>As mentioned in recital 32, the ARegV established a regulatory system that is aimed at incentivising network operators to a more efficient network management and under which network operators are subject to a maximum revenue level established by the BNetzA. This authorized maximum revenue level is established for a regulatory period of 5 years the maximum. In order to establish this maximum revenue level, network operators are obliged to provide the BNetzA with various accounting data (including costs and revenues) prior to the start of a regulatory period. In addition, the maximum revenue level that network operators are allowed to obtain from network users is evolving during the 5 year regulatory period to take into account inefficiencies of network operators in order to induce them to increase efficiency. This implies that the approved maximum revenue will decrease during the regulatory period. The efficiency of a network operator is measured prior to the regulatory period based on a comparison of the network operators by the BNetzA. The first regulatory period was from 2009 to 2013. The second regulatory period started in 2014 to end in 2018.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(44)</p></td><td><p>The positive or negative differences <a>(<span>29</span>)</a> between the approved maximum revenue level and the actually obtained revenues are booked on a special regulatory account, which is an accounting tool administered by the BNetzA (Paragraph 5 of the ARegV) in order to steer network operators towards more efficiency.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(45)</p></td><td><p>At the end of the 5 year period 2009-2013, excess revenues were set off against excess revenue reductions. The resulting positive balance or negative balance was transferred to the next regulatory period (Paragraph 5(4) of the ARegV 2011) and spread over the five years of the second regulatory period as a decrease or increase of the otherwise applicable maximum revenue level.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(46)</p></td><td><p>However, if the revenues obtained in a given year of the regulatory period were to exceed by more than 5 % the approved maximum revenue level, the network operator concerned would have to adapt its network charges (to avoid that the same situations occurs again in the following year and to avoid that the reduction of network charges would be postponed until the next regulatory period). If the revenues obtained in a given year of the regulatory period were to be below the approved maximum revenue level by more than 5 %, the network operator concerned would have the right to adapt its network charges (to avoid that the same situations occurs again in the following year and avoid a sudden increase of network charges in the next regulatory period). The network operator has, however, in the latter case the choice to adapt the network charges or not..</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(47)</p></td><td><p>It is in this framework that the losses in revenue incurred by the network operators due to the full exemption in 2011 had to be compensated. At the time of the ‘Verprobung <a>(<span>30</span>)</a>’ for 2011 (and which took place in 2010), the full exemption was not known and could not have been taken into account when network charges were established for 2011. As Germany has confirmed by Email of 24 October 2017, based on the then applicable ARegV 2011, the losses in revenue incurred in 2011 (that is to say the difference between allowed revenues and actually obtained revenues) could not be recouped by an adaptation of the 2011 network charges given that network charges had to be set in advance in the framework of the ‘Verprobung’ pursuant to Paragraph 20 of the StromNEV and could not be modified over the course of that year. They were actually obliged to set this loss off with profits from other years of the regulatory period. This is also why network operators challenged the full exemption and the BNetzA regulatory decision of 14 December 2011.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(48)</p></td><td><p>The losses in revenue incurred by the network operators due to the full exemption could also not be recouped through an increase in network charges in 2012 given that network charges for 2012 could only be linked to forecasted costs to be incurred in 2012. By contrast, the losses in revenue – if not already compensated by efficiency gains in 2011 – had to be booked on the<span>Regulierungskonto</span>. Where, at the end of the first regulatory period, the losses in revenue for 2011 were set off against additional revenues in other years of that regulatory period, no compensation of the losses would occur. Only where the losses could not be set off against additional revenues in the regulatory period ending in 2013 could the loss of revenues in 2011 lead to an indirect compensation over the next regulatory period by leading to a slight increase of the approved maximum revenue level of the next regulatory period. However, even in that situation, as the ARegV does not compensate full costs, but only costs of an efficient operator, there would normally not be a full compensation.</p></td></tr></tbody></table>
2.5. OBJECTIVE OF THE FULL EXEMPTION
<table><col/><col/><tbody><tr><td><p>(49)</p></td><td><p>It follows from the explanatory memorandum to the StromNEV 2011 that the full exemption for baseload consumers had been introduced because of the alleged stabilizing effects that baseload consumers have on the network <a>(<span>31</span>)</a>.</p></td></tr></tbody></table>
2.6. GROUNDS FOR INITIATING THE PROCEDURE
<table><col/><col/><tbody><tr><td><p>(50)</p></td><td><p>In its Opening Decision, the Commission concluded that the full exemption conferred a selective advantage on such baseload consumers that have an annual electricity consumption exceeding 7 000 hours of full use and 10 GWh of consumption. Moreover, the Commission found that the Paragraph 19-surcharge, which was introduced in 2012, constituted a State resource and that the TSO had been appointed to administer it while being monitored by the BNetzA through the<span>Regulierungskonto.</span> As regards the year 2011, the Commission expressed its concerns that the full exemption could have been financed through State resources already before the Paragraph 19-surcharge was imposed. The Commission indicated that the existence of State resources could be derived from the fact that Paragraph 9 of the KWKG entitled the network operators to levy a surcharge from the network users, the proceeds of which would be administered by the TSO. Also, the Commission considered that the losses in revenue due to the full exemption in 2011 could have been compensated via the<span>Regulierungskonto</span> which the Commission found to be monitored by the BNetzA.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(51)</p></td><td><p>The Commission also noted that Germany had not presented any compatibility ground for the aid and had merely referred to the stabilising impact on networks without quantifying that impact. The Commission therefore opened the formal investigation procedure.</p></td></tr></tbody></table>
2.7. DEVELOPMENTS AFTER THE OPENING DECISION
<table><col/><col/><tbody><tr><td><p>(52)</p></td><td><p>As network operators were not guaranteed that they would recoup the loss of revenues resulting from the full exemption in 2011, several of them challenged exemption decisions of the BNetzA and also directly the regulatory decision of 14 December 2011. By order of 8 May 2013, the Higher Regional Court of Düsseldorf <a>(<span>32</span>)</a> concluded that the full exemption in place between 2011 and 2013 was illegal and revoked the full exemption granted to the undertaking concerned by the procedure before that Court. The Higher Regional Court found that the full exemption granted under the second sentence of Paragraph 19(2) of the StromNEV 2011 did not respect the limits of Paragraph 24 of the EnWG 2011 which entitled the federal government merely to define the modalities of calculating individual network charges, but not to introduce a full exemption from network charges. The Higher Regional Court further observed that network charges are the price for a service supplied to them (that is to say the access to and the use of the network) and that the full exemption could not be seen as an individual network charge or a price for a service but corresponded to a privilege, an exception to the principle that a proportionate network charge should be paid to network operators for the use of the network. It noted that the stabilising effect of baseload consumers could at most justify a reduced network charge but not a full exemption given that also those baseload consumers were using the network. Finally the Higher Regional Court observed that the Paragraph 19-surcharge did not correspond to a network charge but to a surcharge that is collected in addition to network charges; it did not correspond to the price for the use of the network but merely corresponded to a surcharge introduced to cover the financial losses caused to network operators by the full exemption..</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(53)</p></td><td><p>By judgment of 6 October 2015 <a>(<span>33</span>)</a>, the Federal Court of Justice confirmed the order of the Higher Regional Court of Düsseldorf of 8 May 2013. The Federal Court of Justice confirmed that the full exemption granted under the second sentence of Paragraph 19(2) of the StromNEV 2011 did not respect the limits of Paragraph 24 of the EnWG 2011 which entitled the government merely to define the modalities of calculating individual network charges, but not to introduce a full exemption from network charges. The Federal Court of Justice further observed that the first and the third sentence of Paragraph 24(1) of the EnWG 2011 were based on the principle that network operators are entitled to a compensation for the use of their networks and that the stabilising effect of baseload consumers could not be seen as a compensation to the network operator for the use of the network given that this stabilising impact was not a compensation paid in exchange of the use of the network but simply the consequence of the use of the network. The Federal Court of Justice also observed that while this stabilising impact could be of economic interest to network operators and could justify reduced network charges, it cannot automatically be assumed to justify a full exemption simply based on the number of hours of full use, in particular given that also baseload consumers are contributing to the peak load of the network. Reductions will have to take account of the specific impact of each baseload consumer on the network. Finally, the Federal Court of Justice also confirmed that the Paragraph 19-surcharge did not correspond to a network charge but to a surcharge that is collected in addition to network charges; it did not correspond to the price for the use of the network but merely corresponded to a surcharge introduced to cover the financial losses caused to network operators by the full exemption.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(54)</p></td><td><p>Both the Higher Regional Court of Düsseldorf and Federal Court of Justice declared the full exemption in the second sentence of Paragraph 19(2) of the StromNEV 2011 and the individual exemption granted on that basis for void. However, it appears from German Administrative Law that the German State could de facto not ask for reimbursement by the beneficiaries due to prescription rules. Moreover, as described in recital 55, the new Paragraph 32(7) of the StromNEV 2014 provides that the exemption decisions adopted on the basis of the second sentence of Paragraph 19(2) of the StromNEV 2011 stopped being valid only on 1 January 2014.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(55)</p></td><td><p>By ordinance of 14 August 2013 <a>(<span>34</span>)</a> Germany abolished the full exemption as of 1 January 2014 and reintroduced as of that date individual network charges for end users with an annual electricity consumption reaching 10 GWh and at least 7 000 hours of full use. The BNetzA was required to lay down detailed rules on the methodology for determining the individual network costs under the StromNEV as amended by Article 1 of the ordinance of 14 August 2013 (‘StromNEV 2014’). To this end, the BNetzA reintroduced the physical path methodology by a regulatory decision <a>(<span>35</span>)</a> adopted on the basis of Paragraph 29 of the EnWG. Although slightly modified, the methodology corresponds in substance to the physical path methodology as it was applied for the calculation of individual network charges under the StromNEV 2010 (see recital 19 of this Decision). The regulatory decision on the physical path methodology was upheld by order of 13 December 2016 of the Federal Court of Justice <a>(<span>36</span>)</a>. The Federal Court of Justice specifically acknowledged that the physical path methodology ensures an assessment of the network costs caused by baseload consumers in line with the cost-causality principle.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(56)</p></td><td><p>Both the order of 8 May 2013 of the Higher Regional Court of Düsseldorf and the order of 6 October 2015 of the Federal Court of Justice had an effect only on the parties to the procedure and did not lead to a general revocation of all exemption decisions. Paragraph 32(7) of the StromNEV 2014 therefore provides that exemption decisions adopted by a regulator on the basis of the second sentence of Paragraph 19(2) of the StromNEV 2011 would stop to be valid as of 1 January 2014. Pending requests for exemption decisions adopted by a regulator on the basis of Paragraph 19(2) of the StromNEV 2011 as well as cases in which the exemption decision was revoked by a Court would be subject to the second sentence of Paragraph 19(2) of the StromNEV 2014 (with retroactive effect as of 1 January 2012. For 2011 in those same cases, the StromNEV as predating the introduction of the full exemption was applied (i.e. the individual network charges based on the physical path – if relevant).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(57)</p></td><td><p>By order of 12 April 2016 <a>(<span>37</span>)</a>, the Federal Court of Justice annulled the regulatory decision of 14 December 2011 (see recitals 35 to 39 of this Decision). The Court found that that decision was not covered by the empowerment laid down in Paragraph 24 of the EnWG. In the aftermath of that judgment the German legislator amended Paragraph 24 of the EnWG and thereby retroactively remedied the lack of an empowerment for the Paragraph 19-surcharge <a>(<span>38</span>)</a>.</p></td></tr></tbody></table>
3. COMMENTS FROM INTERESTED PARTIES
<table><col/><col/><tbody><tr><td><p>(58)</p></td><td><p>The Commission received comments from Ahlstrom GmbH, AlzChem AG, Aurubis AG, Bender GmbH, Fitesa Germany GmbH, Evonik Industries AG, Hans Adler OHG, Lindes Gas Produktionsgesellschaft, Norske Skog Walsum GmbH, Oxxynova GmbH, Ruhr Oel GmbH, Saalemühle Alsleben GmbH, Sasol Wax GmbH, SETEX-Textil GmbH, Bundesverband der Energieabnehmer e.V., Currenta GmbH & Co. KG, Air Liquide Deutschland GmbH, InfraServ GmbH & Co. KG, Naturin Viscofan GmbH, Wirtschaftsvereinigung Stahl, Wirtschaftsvereinigung Metalle, Hydro Aluminium Rolled Products GmbH, Norsk Hydro ASA, Papierfabrik Scheufelen GmbH & Co. KG, ThyssenKrupp Steel Europe AG, Trimet Aluminium AG, UPM GmbH, Verband der Chemischen Industrie e.V., Verband der Industriellen Energie- und Kraftwirtschaft e.V. and Xstrata Zink GmbH/Glencore. All comments received argue that the full exemption does not constitute State aid. The arguments put forward by the various comments in order to support this view are summarized in the following recitals.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(59)</p></td><td><p>The interested parties consider that the full exemption did not confer an advantage on the exempted baseload consumers. According to the interested parties, the full exemption was a compensation for the baseload consumers' contribution to the overall stability of the electricity network. One interested party considers that the full exemption corresponds to the compensation of a service of general economic interest within the meaning of the Altmark judgment <a>(<span>39</span>)</a>. In particular, it is put forward that the baseload consumption qualifying for the full exemption was a prerequisite for a continuous electricity generation from power plants equipped with synchronous generators. The latter are considered necessary for the stability of the network as they help to avoid frequency shifts. Several interested parties refer in this respect to a study of 20 January 2012 into the minimum generation by conventional <a>(<span>40</span>)</a> power plants needed in Germany to ensure a secured network management in the context of high renewable penetration <a>(<span>41</span>)</a> (the ‘2012 Study’). Alternatively, several interested parties consider the advantage not to be selective but to be justified by the logic and nature of network charges in Germany. They explain in this respect that the predictability of the consumption pattern of the baseload consumers leads to a significant reduction of network costs as it would reduce the need for balancing energy and reserves. Moreover, the continuous consumption pattern would conserve the network equipment longer and thereby reduce material costs. The aforementioned costs would otherwise have to be borne by the TSO as part of their network responsibilities defined in Paragraph 11 of the EnWG. Some of the interested parties also argue that baseload consumers contribute to voltage control and the prevention of black-outs and that the full exemption compensates them for that. Finally, the comments consider the exempted baseload consumption to guarantee the feed-in of electricity produced from intermittent renewable energy sources. Thereby, both grid expansion costs and compensation payments under the Renewable Energy Act (<span>Erneuerbare Energien Gesetz, ‘EEG’</span>) <a>(<span>42</span>)</a> would be reduced.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(60)</p></td><td><p>Furthermore, the interested parties consider the full exemption not to be financed through State resources. According to the interested parties, the second sentence of Paragraph 19(2) of the StromNEV 2011 was part of the overall system of network charges and therefore constituted a mere price regulation. The fact that the full exemption is dependent on an authorization to be delivered by the BNetzA is considered to be a purely formal act which in itself would not suffice to establish that the full exemption is financed through State resources.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(61)</p></td><td><p>The interested parties argue in particular that the full exemption could not be regarded to be financed through State resources following the introduction of the Paragraph 19-surcharge in 2012. The Paragraph 19-surcharge is considered to be part of the overall system of network charges. Accordingly, the interested parties reject the qualification of the Paragraph 19-surcharge as a parafiscal levy. By way of explanation, the interested parties submit that the amount of the Paragraph 19-surcharge was not determined by the State, but was rather calculated by the network operators on the basis of the losses in revenue resulting from the full exemption. The Paragraph 19-surcharge would serve the mere purpose of equalising the financial burden resulting from the full exemption for all network users in Germany. Also, the proceeds of the Paragraph 19-surcharge would neither accrue to the State budget nor be under State control. In this regard, the interested parties explain that the TSO had a discretion as to the use of the proceeds of the Paragraph 19-surcharge. The interested parties reject the finding that the TSO centralised the proceeds of the Paragraph 19-surcharge and thereby acted similarly to a fund. It is explained that the joint project group<span>‘Horizontaler Belastungsausgleich’ (PG HOBA)</span>, to which the Opening Decision refers, was created on a voluntary basis and merely served the purpose of a technical coordination between the TSO.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(62)</p></td><td><p>The interested parties also submit that the Paragraph 19-surcharge was not hypothecated to the financing of the exemption from network charges. The advantage of the exemption would have also materialized without the Paragraph 19-surcharge in which case the losses in revenue resulting from the full exemption would have to be borne by the network operators. The compensation mechanism described in section 2.4 of this Decision needed to be regarded independently from the advantage granted to baseload consumers. Without the compensation mechanism the network operators would have simply taken the losses in revenue into account when calculating the network charges for the non-exempted undertakings as in 2011.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(63)</p></td><td><p>The interested parties submit that the exemption from network charges did not distort competition or affect trade between Member States, as it only reduced the financial burden and competitive disadvantage that result from network charges in Germany, which are considered to be significantly higher than in other Member States.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(64)</p></td><td><p>Only a limited number of interested parties argue that the exemption from network charges is compatible with the Internal Market. Their arguments essentially refer to the contribution of baseload consumers to the stability of the network and hence to security of supply in Europe. Moreover, they argue that in light of the Union's climate policies the exemption would strengthen the competitiveness of energy-intensive undertakings and therefore prevent them from shifting their activities to outside of the Union, which would result in negative consequences for the Union's economy, as it would e.g. lead to a loss of value chains and increase the Union's dependency on imports.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(65)</p></td><td><p>Finally, a limited number of interested parties claim that any recovery would be in violation of the principle of the protection of legitimate expectations. To this end, they argue that by finding that the full exemption was financed through State resources, the Commission would deviate from the interpretation of the State aid notion applied prior to the full exemption both in its own case practice as well as the case-law of the European Court of Justice, in particular its interpretation of State resources in the<span>PreussenElektra</span>-judgment.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(66)</p></td><td><p>After expiry of the deadline for interested party comments, the Commission received comments from two additional interested parties (Wacker Chemie AG and Koehler Kehl GmbH). Wacker Chemie AG submitted comments on the physical path methodology developed by the BNetzA to determine individual network charges of baseload consumers as of 2014. Wacker considered that the physical path method was not an adequate way to determine individual charges because the network charge would depend on whether the baseload consumer would be located close to a baseload power plant or not. Wacker also criticized the fact that hydro plants were not considered as baseload plants and that the plant in question had to be able to cover the entire potential load of the baseload consumer. Wacker considered that the full exemption had been a simpler principle adequately reflecting the contribution of the baseload consumer to the stability of the network. Wacker, however, did not provide any elements describing the stabilizing effects of baseload consumers. Koehler Kehl GmbH submitted comments on a report published by the BNetzA on 20 March 2015 <a>(<span>43</span>)</a>. Koehler Kehl GmbH refers to statements in the report, which confirm the contribution of baseload electricity consumption to the network stability in the period of 2011-2013. On that basis, Koehler Kehl GmbH argues that a different treatment of baseload consumers does not amount to a selective advantage. To the extent that the evaluation report suggests that stable baseload electricity consumption is becoming less relevant for network stability, Koehler Kehl GmBH however questions the validity of the report. To this end, its comments challenge the methodology applied to establish the report as being inaccurate, as the report relies e.g. on statements made by low voltage network operators to which, however, no baseload consumer is connected. The report therefore would not contain any valid statement that would reject the stabilizing effect of baseload consumption. In addition, the comments highlight the continuous need for baseload generation plants and thus baseload consumption for providing network stabilizing.</p></td></tr></tbody></table>
4. COMMENTS FROM GERMANY
<table><col/><col/><tbody><tr><td><p>(67)</p></td><td><p>Germany considers the full exemption subject of the Opening Decision not to be State aid, as it neither conferred a selective advantage nor was financed through State resources. Alternatively, they consider the exemption to be compatible with the internal market. In this regard, they also stress the need of keeping a level-playing field for energy-intensive industries in Europe while the share of electricity from renewable energies increases.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(68)</p></td><td><p>Germany considers that the full exemption was within the logic of the system of network charges in Germany, in particular with the principle that network charges should be proportionate (to costs) and non-discriminatory. They submit that the principle of cost-causality enshrined in Paragraph 16(1) of the StromNEV as well as the requirement set out in the second sentence of Paragraph 17(1) of the StromNEV, according to which network charges have to reflect the actual hours of use, made it necessary to treat baseload consumers differently than other end consumers. They added that the exemption should be viewed as an adequate compensation for the baseload consumers' contribution to the stability of the network.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(69)</p></td><td><p>Germany explains that baseload consumers are very different from ‘typical consumers’. While typical consumers had a volatile consumption that cannot entirely be predicted, baseload consumers were consumers that are constantly withdrawing the same amount of electricity from the grid. The high predictability of baseload electricity consumption reduced the need for balancing electricity and reserves as well as the need for re-dispatching. In general, the high predictability facilitates network planning and maximized the use of the generation fleet (provided that the generation fleet is mostly composed of conventional plants). However, if they were subject to the network charges calculated according to Paragraph 16 and Paragraph 17 of the StromNEV, baseload consumers would have to fully contribute to all those costs while they are not causing such costs. As baseload consumers were generally located in the vicinity of electricity generation capacities, they were using a smaller portion of the grid and there were less grid losses connected to their consumption. Moreover, the exempted baseload consumption would not contribute to an increased need for grid development (unless they are themselves the reason for the grid expansion) as only the variation of load on top of the constant baseload consumption were to be taken into account for capacity reinforcement of the grid. Finally, baseload consumers also had a positive impact on frequency regulation given that a constant load of a certain size could mitigate frequency disturbances and give the network operator more time to react.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(70)</p></td><td><p>Germany further explains that the general system of network charges did not adequately reflect the network costs caused by the exempted baseload consumption in comparison to consumers with variable consumption patterns. In particular, the simultaneity function was based on historical figures but could not guarantee that variable consumers would consume at the same time as they did in the past. Hence, while variable consumers with a low amount of hours of full use were empirically also characterized by a low simultaneity factor, their electricity consumption nevertheless could (due to the unpredictability of the consumption) fluctuate around the annual peak load. This obliged network operators to build in a safety margin when they develop the network. This safety margin was not needed for baseload consumer. As a consequence, the simultaneity function would overestimate the costs caused by baseload consumption in relation to variable consumers.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(71)</p></td><td><p>Finally, Germany explains that a large and stable load lead to economies of scale that the network charge determination on the basis of the simultaneity function did not take into account. The network charge determination on the basis of the simultaneity function would therefore overestimate the network charges due by baseload consumers.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(72)</p></td><td><p>Germany concludes on this point that compared to variable consumers baseload consumers lead to a series of cost reductions and cost savings that benefitted all network users. Those savings could not be calculated with accuracy but they could be computed indirectly by allocating the individual costs of the baseload consumer (incremental costs).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(73)</p></td><td><p>Germany considers that the legal requirement of having an electricity consumption exceeding 10 GWh and reaching 7 000 hours of full use was justified and consistent as it ensured stable and significant baseload consumption. In order to reach 7 000 hours of use, end users would need to take electricity out of the network corresponding to the maximum annual peak load in every quarter of an hour over a period corresponding to 80 % of the year. The 7 000 hours of full use were thus not a function of the quantity of electricity consumed but of the stability of the consumption. In other terms, 7 000 hours of full use could be reached only if the consumer had exactly the same take off at least 80 % of the entire year. Germany also explains that the 10 GWh-requirement has been defined as such because network users would consider leaving the general system of network charges only at a certain level of electricity consumption <a>(<span>44</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(74)</p></td><td><p>With regard to the potential involvement of State resources, Germany considers that the State did not exercise any control over the financing of the exemption. It submits that the mere approval of the exemption by the regulatory authorities was not sufficient to establish such control.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(75)</p></td><td><p>Furthermore, Germany argues that the Paragraph 19-surcharge did not qualify as a levy within the meaning of the Essent judgment <a>(<span>45</span>)</a>. In support of that argument, Germany submits that the Paragraph 19-surcharge was not determined by the State, but by the TSO, which were mainly private companies. Also, contrary to the Essent judgment, no surplus of the Paragraph 19-surcharge would accrue to the State budget. Finally, the TSO were considered to be free in the use of the proceeds of the Paragraph 19-surcharge.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(76)</p></td><td><p>Germany also contends that the mere fact that the Paragraph 19-surcharge had been introduced by the BNetzA was not in itself sufficient to establish State control. In this regard, Germany explains that the Paragraph 19-surcharge was introduced in order to allow for an equalisation of the losses in revenue following the exemption. Such equalisation across Germany was necessary due to the regulatory specificities in Germany, where the transmission network is divided into four geographical areas and four TSO. The alternative would have consisted in increasing the network charges for the non-exempted end users within a concerning network area, which however would have led to geographically different cost burdens in Germany. The amount of the cost burden thus depended on the amount of exemptions within the respective network area.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(77)</p></td><td><p>As regards 2011, Germany explains that the losses in revenues that occurred in 2011 could not be recouped through network charges in 2011 as network charges had to be established in advance. They could also not be recouped in 2012 as network charges have to be calculated based on the forecasted network costs. Hence, in the absence of the Paragraph 19-surcharge, losses in revenue following the exemption may have partially, if at all, been compensated via the<span>Regulierungskonto</span> in accordance with the provisions laid down in Paragraph 5 of the ARegV 2011. If then the losses in revenue would have led to a negative difference between the obtained revenues and the authorized maximum revenue level, this difference would be booked on the regulatory account. If at the end of the regulatory there was still a negative balance, it might translate into an increase of the maximum authorized revenue levels in the next regulatory period. In this regard, Germany explains furthermore that the competent regulatory authority neither had ownership of the<span>Regulierungskonto</span> nor control over it. The<span>Regulierungskonto</span> served the mere purpose of offsetting the proceeds from network charges that exceed the approved maximum revenue level over the course of specific regulatory period under the system described in recital 41. Accordingly, no liquid assets were registered on the<span>Regulierungskonto</span> that could be used to finance the losses in revenue resulting from the exemption.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(78)</p></td><td><p>Germany also considers the full exemption not to be creating an additional burden on the State budget. In particular, the TSO could not be assimilated to the State. By coordinating their procedures as to the administration of the Paragraph 19-surcharge for the purpose of efficiency and transparency, they would not have acted similarly to a fund.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(79)</p></td><td><p>Germany moreover expressed its view that the full exemption from network charges did not create a distortion of competition in the internal market. In this regard, Germany referred to the high level of electricity costs that would burden energy-intensive undertakings active in Germany more than their competitors active in other Member States. In this regard, Germany also argued that it should be allowed for Member States to adopt measures which maintain the competitiveness of the European industry, in particular energy-intensive industries and highlight in this respect that Germany had a very ambitious renewable policy compared to other Member States and that this ambitious policy required important network investments. Network charges would thus increase. A limitation of the energy costs that resulted from the deployment of renewable energy was necessary to ensure a level playing field compared with industries in other Member States or in third countries. Without the limitation, the German industry would be threatened.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(80)</p></td><td><p>Furthermore, Germany explains that even if the full exemption would qualify as aid it would in any event constitute compatible aid under Article 107(3)(b) or (c) of the Treaty given that the full exemption in place between 2011 and 2013 was necessary in order to incentivize an electricity consumption pattern that was beneficial for the network and its stability. Germany explains in this respect that the full exemption was necessary to keep baseload consumers within the system of general electricity supply and to prevent that they switch to a system of self-supply or to build a direct line to a power plant at the detriment of network stability. In that way, the full exemption contributed to the objective of security of supply. In that connection, Germany repeats that baseload consumers facilitate a secure network management through their predictability and stable consumption. In addition, Germany stresses that the exempted baseload consumption was a prerequisite for the minimum conventional electricity generation necessary to guarantee the stability of the network and referred also to the 2012 Study. In particular, Germany explains that in the period 2011-2013 the electricity mix in Germany was still dominated by conventional power plants and was not yet very flexible. Without a large and constant offtake of electricity conventional power plants with synchronous generators would not have been able to run on a continuous mode and deliver the same ancillary services <a>(<span>46</span>)</a>. This would be relevant in particular in the light of the increasing share of electricity produced from intermittent renewable energy sources and the decision to close 8 nuclear plants after the Fukushima accident. Without the conventional power plants with synchronous generators, the network operators would have been required to implement other network stabilizing measures, which would in turn have increased the general network costs. Germany therefore is of the view that the objective of the full exemption was in line with the overall objectives set out in Paragraph 1 of the EnWG, namely a safe, reasonably priced and efficient electricity supply. Germany also argues that the full exemption was needed to facilitate the development of renewable electricity given that it guaranteed that there would always be consumers to consume the renewable electricity whenever it was produced. Absent the baseload consumers there was a risk that renewable electricity would be produced at times when there is no electricity demand. This would, however, oblige network operators to curtail renewable electricity installations and compensate them, thereby increasing the costs of renewable electricity support.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(81)</p></td><td><p>Finally, Germany explains that the full exemption also aimed at implementing Article 14 of Regulation (EC) No 714/2009 of the European Parliament and of the Council <a>(<span>47</span>)</a> as well as recital 32 and Article 32(1) of Directive 2009/72/EC of the European Parliament and of the Council <a>(<span>48</span>)</a>, which require network charges to be applied in a non-discriminatory manner. Germany claims that the full exemption ensured that the network charges reflected the different cost-causalities of baseload and normal electricity consumption.</p></td></tr></tbody></table>
5. ASSESSMENT OF THE AID SCHEME
<table><col/><col/><tbody><tr><td><p>(82)</p></td><td><p>The assessment below is based on and limited to an assessment of the legal framework, the market situation, the electricity mix and the network situation in the years 2011 to 2013 only.</p></td></tr></tbody></table>
5.1. EXISTENCE OF AID WITHIN THE MEANING OF ARTICLE 107(1) OF THE TREATY
<table><col/><col/><tbody><tr><td><p>(83)</p></td><td><p>Under Article 107(1) of the Treaty, any aid granted by a Member State or through State resources in any form whatsoever which distorts or threatens to distort competition by favouring certain undertakings or the production of certain goods, in so far as it affects trade between Member States, is incompatible with the internal market <a>(<span>49</span>)</a>.</p></td></tr></tbody></table>
5.1.1. EXISTENCE OF AN ADVANTAGE
<table><col/><col/><tbody><tr><td><p>(84)</p></td><td><p>The concept of advantage within the meaning of Article 107(1) of the Treaty embraces not only positive benefits, such as subsidies, but also measures which, in various forms, mitigate the charges which are normally included in the budget of an undertaking and which, therefore, without being subsidies in the strict sense of the word, are similar in character and have the same effect <a>(<span>50</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(85)</p></td><td><p>Electricity consumers normally have to pay a charge for using the electricity network. This charge reflects the cost created by that consumer for the network. For undertakings using the electricity network, network charges thus constitute part of their normal production costs. By fully exempting baseload consumers with an annual electricity consumption exceeding 10 GWh and reaching 7 000 hours of full use, the second sentence of Paragraph 19(2) of the StromNEV 2011 relieved them from a financial burden and production costs that they otherwise would have to bear. The second sentence of Paragraph 19(2) of the StromNEV 2011 therefore conferred an advantage to baseload consumers fulfilling the eligibility criteria.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(86)</p></td><td><p>Some interested parties have claimed that the exemption did not constitute an advantage because it amounted to the payment for a service (stable consumption) at market conditions (invoking the so-called Market Economy Operator Principle, ‘MEOP’) or to the payment of a compensation for a service of general economic interest.</p></td></tr></tbody></table>
No compensation for a service of general economic interest
<table><col/><col/><tbody><tr><td><p>(87)</p></td><td><p>In its ‘Altmark’ ruling, the Court of Justice has clarified that following four criteria must all be met for a compensation for a service of general economic interest not to constitute State aid under Art. 107(1) of the Treaty <a>(<span>51</span>)</a>:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the recipient undertaking must actually have public service obligations to discharge and the obligations must be clearly defined;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the parameters on the basis of which the compensation is calculated must be established in advance in an objective and transparent manner, to avoid it conferring an economic advantage which may favour the recipient undertaking over competing undertakings;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the compensation cannot exceed what is necessary to cover all or part of the costs incurred in the discharge of public service obligations, taking into account the relevant receipts and a reasonable profit for discharging those obligations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>where the undertaking which is to discharge public service obligations, in a specific case, is not chosen pursuant to a public procurement procedure which would allow for the selection of the tenderer capable of providing those services at the least cost to the community, the level of compensation needed must be determined on the basis of an analysis of the costs which a typical undertaking, well run and adequately provided with the necessary means, would have incurred in discharging those obligations, taking into account the relevant receipts and a reasonable profit for discharging the obligations.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(88)</p></td><td><p>However, it is observed that those four cumulative conditions are not fulfilled in the present case. First, the German legislation does not identify any service of general economic interest that would consist in stable consumption and it does not entrust baseload consumers with any public service obligation <a>(<span>52</span>)</a>. Second, the law does not contain any parameters on the basis of which costs should be calculated to avoid overcompensation. Third, for many of the baseload consumers, having a consumption reaching 7 000 hours of full use and exceeding 10 GWh simply corresponds to their normal consumption profile and does not imply any particular costs. The full exemption is in those cases then necessarily leading to overcompensation as it exceeds what compensation would have been necessary to cover the extra costs related to the alleged public service obligation. Finally, the undertakings were not chosen pursuant to a public procurement procedure and the exemption has not been determined on the basis of an analysis of the costs which a typical undertaking, well run and adequately provided with the necessary means, would have incurred in discharging those obligations, taking into account the relevant receipts and a reasonable profit for discharging the obligations. Germany has on the contrary indicated that it was hard to quantify the value that stable load had for the network.</p></td></tr></tbody></table>
The full exemption does not correspond to the behaviour of a market operator
<table><col/><col/><tbody><tr><td><p>(89)</p></td><td><p>As to the argument that the full exemption was akin to the payment that a market operator would make to buy the service in questions, it is observed that no convincing argument has been submitted that would demonstrate that the value of the full exemption corresponds to the price at which network operators would be – absent the provision of the second sentence of Paragraph 19(2) of the StromNEV 2011 – willing to purchase the alleged service from baseload consumers.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(90)</p></td><td><p>First, the fact that network operators have challenged the exemption in front of national courts (see recitals 52 and 53) shows that network operators would not by themselves have bought the alleged service against the full exemption going beyond the level of individual network charges (on individual network charges, see below section 5.1.2). The BNetzA conducted a survey amongst network operators for the purposes of an evaluation report of 30 March 2015 on the impact of Paragraph 19(2) of the StromNEV on the management of electricity networks and focussing on data relating to the period 2011 to 2013 (the ‘2015 Evaluation Report’) <a>(<span>53</span>)</a>. That report reveals that network operators having baseload consumers connected to their grid are divided over the usefulness of baseload consumers for the stability of the network. Some indicated that in the period 2011 to 2013 baseload consumers caused lower network costs – but crucially still did cause costs — compared to other network users with variable and non-predictable load while others explained that flexible load would be more useful to regulate volatility <a>(<span>54</span>)</a>. Also one TSO explained that the contribution of baseload consumers to the stability of the networks depended on the specific circumstances of the network <a>(<span>55</span>)</a>. Finally, several of those network operators had observed that the concerned baseload consumers had already the same load pattern before the introduction of the exemption so that the exemption would not be needed in order for them to modify their behaviour. In other words: the service had been provided in any event, already absent the measure. Those findings further confirm that network operators would not all on their own motion ‘purchase’ the stable load from baseload consumers, and none of them at the price of a full exemption.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(91)</p></td><td><p>Second, even assuming that in some cases the network operators would have actively purchased the alleged service, they would have procured it only to the limit necessary to facilitate the management of the grid and against a price reflecting the differentiated contribution to stability. By contrast, the full exemption is granted to baseload consumers reaching 7 000 hours of full use and exceeding 10 GWh without consideration being given to either the network level at which they are connected, or their effective contribution to the stability of the networks <a>(<span>56</span>)</a>, or the fact that there might already be enough of those baseload consumers to enable a stable management of the network. Also, if stable demand (rather than cost reduction) were the key to the safe management of the network, there is no reason to exclude from the exemption stable consumers consuming less than 10 GWh.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(92)</p></td><td><p>Third, it is noted that German Courts also concluded that the full exemption could not be seen as the payment for a service first because for many baseload consumers the ‘service’ merely corresponded to their normal consumption mode and second because the full exemption did not take into consideration the concrete stability increase delivered. According to those Courts, only a reduction taking into account the concrete impact of each baseload consumer on the network could have been justified (see recitals 52 and 52).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(93)</p></td><td><p>Part of the interested parties based the argument that the full exemption corresponded to the payment that a market operator would make to buy baseload consumers' service on the 2012 Study (see recital 59 of this Decision).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(94)</p></td><td><p>It is observed, first, that the exemption has been introduced by a regulatory act, by the State acting in its capacity as regulatory authority. In that regard, it is necessary to apply the most recent case-law of the General Court,<span>EDF</span> v<span>Commission</span> <a>(<span>57</span>)</a>. According to that judgment, the Member State needs to demonstrate, where it invokes the MEOP, that its regulatory decision was taken in its capacity as shareholder, and not in its capacity as public authority. In the present case, Germany (at federal level) has no shareholding in the network operators. In any event, Germany has not submitted any documents that would indicate that it took into consideration shareholdings of regional and local authorities in the network operators. Germany has, indeed, not produced any contemporaneous evidence showing any commercial considerations, nor have interested parties. The study postdates the BNetzA regulatory decision of 14 December 2011. Hence, the MEOP is not applicable in the present case.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(95)</p></td><td><p>It is observed, second, even if the MEOP was applicable, quod non, that this study post-dates the introduction of the exemption. Hence, a market economy operator could not have relied on it when deciding the exemption.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(96)</p></td><td><p>Even if the 2012 Study was relevant for the application of the MEOP, quod non, it does not support the claims made. The interested parties claim that in order to secure the necessary minimum generation by such power plants, there is a need for a stable and large demand as this will ensure the profitability of the plant concerned and ensure that they are not mothballed. It must, however, be noted that the 2012 Study itself does not at all relate to the usefulness of baseload consumers for maintaining the required minimum generation from conventional power plants in Germany to ensure a secured network management. It is not the object of the 2012 Study and baseload consumers are in fact not mentioned in it. By contrast, the summary of the results of the study <a>(<span>58</span>)</a> underlines that the minimum generation capacity needed in Germany to ensure a secured network management has been estimated based on the demand existing in Germany. In other words, the minimum generation capacity needed in Germany to ensure a secured network management depends on the consumption volume but also type of load that needs to be satisfied. If the demand had been smaller or if there was no need to ensure baseload generation in order to cover baseload consumption, the minimum generation capacity needed in Germany would have been different. Baseload consumers are part of the reason why this amount of generation capacity is needed in the first place. Their demand can therefore hardly be described as a service. In any event, the mere existence of baseload consumers would not be sufficient to ensure that the concerned power plants remain on the market. This will ultimately depend on the price at which the electricity is sold. If this price is too low, it will not enable the baseload power plant to remain on the market. It will also depend on the production level of renewable electricity. At times of low demand but high renewable electricity production, the renewable electricity has priority dispatch and priority access over power plants using fossil fuels. Finally, it should be noted that part of the conventional power plants mentioned in the 2012 study on the minimum generation from conventional power plants are not baseload power plants but conventional power plants that can be ramped up rapidly like gas turbines. Baseload consumers will not constitute an incentive for this type of plants to remain on the market as their profitability is linked to the possibility to obtain higher electricity prices when the system is under stress.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(97)</p></td><td><p>Some interested parties have also argued that the exemption is justified because baseload consumers are part of the five stage load shedding plan that has been put in place by TSOs to avoid blackouts when the system is overloaded. This plan is described in the Transmission Code 2007 (Network and System Rules of the German Transmission System Operators). They also claim that this load shedding would occur outside any contractual relationship and without compensation and that the full exemption compensates them for their contribution to security of supply.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(98)</p></td><td><p>On this point, it is noted first that these claims are contradicted by the Transmission Code 2007 itself. Article 7.3.4(6) of the Transmission Code 2007 explicitly indicates that load shedding will be assured by contractual arrangements with the network customers. In addition there is no correlation between the full exemption and the load shedding in the sense that the inclusion in the five stage load shedding plan is not a requirement to be eligible for the full exemption. Interested parties admit on this point that their stable consumption only increases the likelihood to be included in the plan. Also consumers who do not qualify as baseload consumers can be part of the plan. In fact, the five stage load shedding plan will have to include consumers other than baseload consumers. Indeed, it includes between 35 % to 50 % of the system load (after shedding of pumps) <a>(<span>59</span>)</a>. Based on the information submitted by Germany the beneficiaries of the full exemption would in total reach a peak load of around 3,5 GW which represents around 4,2 % of peak demand in Germany in 2013 <a>(<span>60</span>)</a>. Hence, even assuming that the exemption could constitute remuneration for the inclusion in the five stage plan it would still constitute a selective advantage given that it would be limited to baseload consumers and excluded for all other consumers that are also part of the five stage load shedding plan.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(99)</p></td><td><p>Finally some interested parties seem to imply that baseload consumers would need to comply with specific technical specifications when connecting to the grid and that to meet those specifications baseload consumers would need to make investments in devices that improve the stability of the network because delivering reactive power <a>(<span>61</span>)</a> but for which they are not compensated.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(100)</p></td><td><p>It is noted, however, that the full exemption cannot be seen as remuneration for this alleged service that a market economy operator would have paid. Indeed, the situation described by the interested parties does not correspond to a service that network operators would buy. It corresponds to a technical specification that consumers need to meet in order to be connected to the network. In particular, they need to ensure that their shift factor remains between – 0,9 and + 0,9. Depending on the circumstances, this might indeed require the consumer to invest into specific equipment that make sure that their shift factor remains between the prescribed values. This cannot be considered as a service to the grid but constitutes a preventive measure against bigger network disturbances. If consumers, including baseload consumers, were not complying with that technical specification, they would be responsible for significant voltage disturbance in the grid. Interested parties themselves acknowledge that this specification is necessary to ensure safe network management. In addition, technical specifications apply to any consumer requesting connection to the concerned network and not specifically to baseload consumers so even if the exemption could be seen as a ‘remuneration’ (which however is not the case), it would still constitute a selective advantage given that it would be limited to baseload consumers and excluded for all other consumers that are subject to the same requirement.</p></td></tr></tbody></table>
5.1.2. EXISTENCE OF A SELECTIVE ADVANTAGE
<table><col/><col/><tbody><tr><td><p>(101)</p></td><td><p>Both the interested parties and Germany have argued that the full exemption did not constitute a selective advantage as that exemption was justified by the nature and logic of the network charge system in Germany. They underline that the network charge system in Germany is based on cost-causality but that baseload consumers have a consumption and load pattern that is very different from typical network users, which have a variable and unpredictable consumption and load. Baseload consumers contributed to the reduction of various network costs which justified the full exemption.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(102)</p></td><td><p>The full exemption can only amount to State aid to the extent that the advantage granted to baseload consumers is selective. In order to establish that an advantage is selective, the Commission has to demonstrate that a measure differentiates between economic operators who are, in light of the objective of the reference system identified, in a comparable factual and legal situation and that such a differentiation cannot be justified by the nature or the general scheme of the reference system <a>(<span>62</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(103)</p></td><td><p>In order to verify whether, under the relevant legal regime, the full exemption constitutes a selective advantage for certain undertakings over others which are, in the light of the objective pursued by that regime, in a comparable factual and legal situation, it is necessary to first define the reference framework within which the measure concerned fits <a>(<span>63</span>)</a>.</p></td></tr></tbody></table>
5.1.2.1. The reference system
<table><col/><col/><tbody><tr><td><p>(104)</p></td><td><p>The Commission agrees that, for the purposes of the present decision, the relevant reference framework is the German network charge system. This network charge system is based on the principle that network charges must be cost-based and non-discriminatory. Indeed, Paragraph 21 of the EnWG establishes the principle that network charges must be proportionate (‘angemessen’), non-discriminatory and transparent (see recital 7 of this Decision). The cost-causality principle is enshrined in Paragraph 16 of the StromNEV and implicit in Paragraph 3 of the StromNEV which states that network charges correspond to the payment for the use of the networks. The StromNEV sets out detailed rules on the methodology for a cost-reflective determination of network charges.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(105)</p></td><td><p>Paragraph 24 of the EnWG 2011 empowers the federal government to specify by ordinance the methodology for determining the general network charges to be paid. As set out in recital 7 of this Decision, Paragraph 24 of the EnWG makes a distinction in this respect between the generality of users and atypical network users which can be charged an individual network charge. The StromNEV implements this distinction and also contains two sets of methodologies: the methodology applicable to typical network users (Paragraphs 15, 16 and 17 of the StromNEV) and the methodology applicable to atypical network users (see recitals 17 to 20 of this Decision).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(106)</p></td><td><p>Paragraphs 15, 16 and 17 of the StromNEV provide for the general calculation method to determine the network charges. This methodology has been described in recitals 10 and 14 of this Decision. In particular, the simultaneity function described in Paragraph 16(2) of the StromNEV and Annex 4 to the StromNEV allows for an allocation of the network costs to the various network users according to the probability that the electricity consumption of the individual user in question contributes to the annual peak. Germany has submitted that in a system in which electricity flows from the top down, the annual peak element is one of the main cost drivers of the network.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(107)</p></td><td><p>Germany has however demonstrated that while this general methodology enables a reliable determination of the network costs caused by most end users, the simultaneity function – if applied in the same way to all network users – de facto overestimated the costs caused by baseload consumers in the period 2011-2013. This is explained by the fact that the calculation methodology based on the simultaneity function spreads the entire network costs between all users while these costs contain costs that baseload consumers did not cause, or caused in the period 2011-2013 to a much lower degree. In particular, the costs that are linked to balancing out sudden variations in the demand are not caused by baseload consumers, as they have a predictable and a much more constant consumption. The same is true for measures that need to be taken to keep the frequency of the network despite variations in load.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(108)</p></td><td><p>It is true that baseload consumers contribute to peak load like all other network users and that peak load is relevant for the dimensioning of the network, and hence for one factor creating network costs. However, it is not relevant for allocating other network costs (for example the costs linked to the reserves needed to supply balancing energy). If all network users had unpredictable and variable consumption patterns, it would still be rational to allocate those costs using the same allocation key, i.e. in proportion to their contribution to peak load. However, baseload consumers have a predictable and much more stable load pattern. In 2011-2013 given the energy mix, baseload consumers generated much less need for system services than other network users. Hence, in a network charge system based on the cost–causality principle, costs for system services that are not needed for baseload consumers could not be allocated to them by using the same key as for network users having a variable and unpredictable load.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(109)</p></td><td><p>Also, the calculation methodology based on the simultaneity function does not take into account economies of scale. Where a network is constantly used up to its full capacity, the costs per unit are much lower than for where the same network is used by variable consumers only from time to time up to its full capacity but generally only up to 30 % of its capacity. Finally, due to the variability and unpredictability of the consumption of users in general, network operators have to take a safety margin into account when they dimension the network. Indeed, the simultaneity factor only expresses the likelihood that a given consumer will consume at the moment of peak load but cannot guarantee this. Such a safety margin is however not needed to the same degree for baseload consumers, if at all. Hence if the network charges of baseload consumers would be calculated on the basis of the network charge methodology using the simultaneity function, they would again be overestimated</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(110)</p></td><td><p>The Commission therefore considers that the possibility provided for in Paragraph 24 of the EnWG 2011 to determine individual network charges for atypical users such as baseload consumers is in line with the principle of cost-causality and non-discrimination. It must be regarded as an integral part of the reference system as it serves as a corrective to take into account the network costs actually caused by atypical network users such as baseload consumers.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(111)</p></td><td><p>The Commission also considers that the provision according to which the individual network charges paid by atypical network users cannot go below 20 % of the published network charges forms an integral part of the rules governing individual network charges under the StromNEV. First, this minimum contribution has continuously been a requirement as regards the group of atypical network users addressed in the first sentence of Paragraph 19(2) of the StromNEV and was in particular applicable in the period 2011 to 2013 (see recital 21 of this Decision). Second, it also applied to baseload consumers under the StromNEV 2010 (see recital 20 of this Decision). And finally, the minimum contribution network charge of 20 % for atypical end users such as baseload consumers corresponds – as Germany has explained (see recital 20) – to a safety net that ensures that atypical consumers contribute to a minimum to remunerating the benefit that derives from being connected to the network. Specifically as regards baseload consumers, the minimum contribution of 20 % also takes into account that the physical path methodology, while mirroring closely the network costs caused by baseload consumers, still implies a certain approximation.</p></td></tr></tbody></table>
5.1.2.2. Deviation from the reference system
<table><col/><col/><tbody><tr><td><p>(112)</p></td><td><p>However, the Commission considers that the full exemption introduced by the Law of 26 July 2011 is at odds with the concept of individual network charges set out in point 3 of the first sentence of Paragraph 24 of the EnWG 2011 pursuant to which atypical forms of network use might be subject to individual network charges.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(113)</p></td><td><p>The cost-causality principle and the principle that network charges should be proportionate and non-discriminatory imply that network charges are determined based on the individual network costs attributable to a given network user. The full exemption from network charges would therefore be in line with those principles only if it were demonstrated that baseload consumers do not cause any network costs. This has however not been demonstrated. On the contrary, baseload consumers do cause network costs in particular when they are being newly connected to an existing network given that their connection might necessitate an increase of the capacity of such a network. Likewise, where a network has not yet been built, it would need to be dimensioned so as to satisfy at least the demand of baseload consumers. This has also been recognized by German regional courts and the Federal Court of Justice. They have explicitly concluded that the full exemption was contrary to Paragraph 24 of the EnWG 2011 (see recitals 52 and 52 of this Decision). It must further be observed that the other category of atypical network users referred to in the first sentence of Paragraph 19(2) of the StromNEV continued to be subject to individual network charges calculated on the basis of their individual load profile during the years 2011 to 2013 (see recital 21 of this Decision). The full exemption for baseload consumers therefore introduced a discrimination against both other groups of atypical network users that were still subject to individual network charges and all other end users given that the full exemption deviates from the principle of cost causality and proportionality of network charges.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(114)</p></td><td><p>It is noted that before the full exemption introduced from 2011 baseload consumers were subject to individual network charges that had to be determined so as to take into account the reduction of network costs or the mitigation of increases in network costs that were due to baseload consumers. Those individual network charges might however not be lower than 20 % of the published network charges. In order to calculate those costs, the BNetzA had defined the physical path methodology (see recital 19). The Commission considers that this methodology is a reliable methodology to approximate the costs caused by baseload consumers in the period 2011 to 2013 given the characteristics of the electricity system at that time. Indeed, this methodology determines the network charges based on the costs that can be attributed to the baseload consumer, that is to say the capital costs and fixed operating costs related to the part of the network that connects the baseload consumer to the nearest baseload power plant that can de facto cover its entire demand. While it is true that this method leads – as one interested party has criticized — to differentiated network charges depending to the location of the baseload consumer on the network, this is precisely the point of individual network charges, namely to verify the costs caused to the network by each baseload consumer individually. If a baseload consumer is further away from a baseload power plant, it also means that he will be using a much large portion of the network to have the electricity transported from the power plant that is able to de facto cover its demand. Also the fact that the physical path is calculated by reference to a power plant covering the entire demand of the baseload consumer is justified. If the power plant were to cover only part of the demand of the baseload consumer, it would imply that he is using again several parts of the network in order to cover his demand and is thus also responsible for higher network costs. As to the fact that the physical path methodology would not accept hydropower plants as baseload power plants, it is noted that the 2010 guidance paper of of the BNetzA referred to under recital 19 above accepts hydro power plants as baseload power plants. In addition, the physical path methodology also takes into account network losses and any network services that the baseload consumer has been using, if any. The adequacy of the physical path methodology to determine the network costs caused by baseload consumers has notably been confirmed by the Federal Court of Justice in 2016 <a>(<span>64</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(115)</p></td><td><p>The Commission considers thus that a different treatment of atypical users (i.e. non-peak consumers and baseload consumers) compared to the other network users is an integral part of the reference system and expressed in its structure, as long as it is based on the concept of individual network costs attributable to a given network user.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(116)</p></td><td><p>The full exemption in force between 2011 and 2013 however deviates from the determination of individual network charges applicable to atypical users given that the full exemption does not rest on an individual determination of the costs caused by the caseload consumer. Although both non-peak consumers and baseload consumers are in light of the objective of the network charge system, in a comparable factual and legal situation (they are atypical users for which the published network charges would between 2011-2013 not have led to cost-reflective network charges) they were treated differently.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(117)</p></td><td><p>In addition, the full exemption also deviates from the reference system in that it does not require the baseload consumer to pay at least 20 % of the published network charges as required for other atypical users, namely the non-peak consumers. This difference in treatment corresponds to a discrimination given that there is no reason why baseload consumers should be exempted from that requirement. In particular, there is no reason why individual network charges for non-peak consumers should be subject to a safety net while baseload consumers would not, knowing that also baseload consumers – like non-peak consumers benefit from being connected to the network. Also, the individual network charges calculated by using the physical path methodology will imply a certain approximation.</p></td></tr></tbody></table>
5.1.2.3. No justification in the nature and logic of the network charge system
<table><col/><col/><tbody><tr><td><p>(118)</p></td><td><p>The concept of aid does not encompass measures creating different treatment of undertakings in relation to charges where that difference is attributable to the nature and general scheme of the system of charges in question <a>(<span>65</span>)</a>. The burden of proof for that latter part of the test is on the Member State.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(119)</p></td><td><p>It is observed that Germany has not put forward any element showing that the full exemption would be justified by the nature and general scheme of the network charge system in Germany. It has put forward that the full exemption could help ensuring security of supply by securing the existence of conventional power plants needed to ensure security of supply and could also help facilitating the promotion of renewable electricity. Those objectives, however, are external to network charges and must therefore be examined under the compatibility assessment in line with the case law of the Court <a>(<span>66</span>)</a> (see section 3.3.1).</p></td></tr></tbody></table>
5.1.2.4. Conclusion
<table><col/><col/><tbody><tr><td><p>(120)</p></td><td><p>The full exemption cannot be justified by the logic of the network charges in Germany to the extent that it goes beyond a reduction of the published network charges reflecting the contribution of baseload consumers to cost savings or the avoidance of costs. The full exemption notably constitutes an unjustified deviation from the reference system as it exempts the baseload consumers from the costs that the reference system would allocate to them, that is to say the individual network costs calculated on the basis of the physical path methodology and which cannot go below 20 % of the published network charges.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(121)</p></td><td><p>The Commission therefore concludes that insofar as baseload consumers were exempted from paying network charges going beyond the network costs caused by their consumption or, where those costs amounted to less than the minimum contribution of 20 % of the published network charges, were exempted from that minimum contribution, the exemption is not within the logic of the reference system, and does confer a selective advantage.</p></td></tr></tbody></table>
5.1.3. IMPUTABILITY
<table><col/><col/><tbody><tr><td><p>(122)</p></td><td><p>The full exemption has been provided by Article 7 of the Law of 26 July 2011 (see recital 21 of this Decision), and has been implemented by administrative acts confirming the exemption requests (see recitals 24 of this Decision). It is therefore imputable to the State.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(123)</p></td><td><p>Also the Paragraph 19-surcharge that financed the exemption is imputable to the State. First, the Paragraph 19-surcharge was provided for by Article 7 of the Law of 26 July 2011 (see recital 21 of this Decision) and was further implemented by the BNetzA, a government agency (see section 2.4.2 and footnote 22 of this Decision). The fact that the calculation of the charge is carried out by private entities mandated by law to do so does not affect that conclusion, because those private entities – the TSO – have no margin of discretion when carrying out that task, and have been mandated by the State to carry out that task, as part of their entrustment pursuant to Paragraph 19(2) of the StromNEV 2011 as TSO. Furthermore, the BNetzA has the normal supervisory powers over the TSO, and can address binding decisions to the TSO, if they fail to comply with their obligations (Paragraphs 29 and 54 of the EnWG 2011). Finally, for the year 2012, the BNetzA directly determined which total amount had to be compensated from the Paragraph 19-surcharge (see recital 37 of this Decision).</p></td></tr></tbody></table>
5.1.4. EXISTENCE OF STATE RESOURCES
<table><col/><col/><tbody><tr><td><p>(124)</p></td><td><p>For selective advantages to amount to aid within the meaning of Article 107(1) of the Treaty, they must be granted directly or indirectly through State resources. The concept of ‘intervention through State resources’ covers not only advantages which are granted directly by the State but also ‘those granted through a public or private body appointed or established by that State to administer the aid’ <a>(<span>67</span>)</a>. In this sense, Article 107(1) of the Treaty covers all the financial means by which the public authorities may actually support undertakings, irrespective of whether or not those means are permanent assets of the public sector <a>(<span>68</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(125)</p></td><td><p>The mere fact that the advantage is not financed directly from the State budget is not sufficient to exclude that State resources are involved. It results from the case-law of the Court of Justice of the European Union that it is not necessary to establish in every case that there has been a transfer of money from the budget or from a public entity for the advantage granted to one or more undertakings to be capable of being regarded as a State aid within the meaning of Article 107(1) of the Treaty <a>(<span>69</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(126)</p></td><td><p>The private nature of the resources does not prevent them from being regarded as State resources within the meaning of Article 107(1) of the Treaty <a>(<span>70</span>)</a>. This was also recalled in the ruling<span>France</span> v<span>Commission</span> <a>(<span>71</span>)</a> ruling where the General Court concluded that the relevant criterion for assessing whether the resources are public, regardless their initial origin, is the degree of intervention of the public authority in the definition of the measures in question and their methods of financing. Hence, the mere fact that a subsidy scheme benefiting certain economic operators in a given sector is wholly or partially financed by contributions imposed by the public authorities and levied on certain undertakings is not sufficient to take away from that scheme its status of aid granted by the State within the meaning of Article 107(1) of the Treaty <a>(<span>72</span>)</a>. Equally, the fact that the resources would at no moment be the property of the State does not exclude that the resources might constitute State resources, if they are under the control of the State <a>(<span>73</span>)</a>. In fact the concept of aid granted through State resources serves to bring within the scope of Article 107(1) of the Treaty not only aid granted directly by the State, but also aid granted by public or private bodies designated or established by the State <a>(<span>74</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(127)</p></td><td><p>This line of reasoning was also applied in<span>Essent</span> <a>(<span>75</span>)</a>. In that case, the Court of Justice had to assess a law which provided that the operators of the Dutch electricity network had to collect a price surcharge on electricity consumed by private electricity clients and pass on the proceeds of that surcharge to SEP, a joint subsidiary of the four electricity generators, in order to compensate the latter for so-called ‘stranded costs’. This surcharge had to be transmitted by network operators to SEP which had to collect the proceeds and use them up to a certain amount defined in the law for the purposes of covering stranded costs. In this regard, the Court observed that SEP had been appointed by the law to manage a State resource <a>(<span>76</span>)</a>. The Court found that the Dutch system involved State resources <a>(<span>77</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(128)</p></td><td><p>On the basis of this case-law, it can be concluded that subsidies financed through parafiscal charges or contributions imposed by the State and managed and apportioned in accordance with the provisions of the legislation imply a transfer of State resources, even where they are not administered by public authorities but by private entities designated by the State that are separate from the public authorities.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(129)</p></td><td><p>This has been confirmed by the Court of Justice in the<span>Vent de Colère</span> case <a>(<span>78</span>)</a> where the Court in particular observed that the fact that part of the funds collected were not channelled to the<span>Caisse des Dépôts et Consignations</span> but were retained by the undertakings subject to the obligation to purchase renewable electricity at feed-in tariffs was not sufficient to exclude an intervention through State resources.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(130)</p></td><td><p>The Court of Justice excluded the transfer of State resources in only very specific circumstances: For instance, the Court <a>(<span>79</span>)</a> considered that a decision by which a national authority extends to all traders in a certain sector an agreement which introduces the levying of a contribution in an inter-trade organisation recognised by that national authority, thus rendering that contribution compulsory, in order to make it possible to implement certain promotional and public relations activities, does not constitute State aid. The Court noted in this respect that the measure was not financed from State resources since it was not the State but the inter-trade organisation that decided how to use the resources stemming from the levy. Those resources were entirely dedicated to pursuing objectives determined by that organisation. Hence, the resources were not constantly under public control and were not available to State authorities.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(131)</p></td><td><p>In<span>PreussenElektra</span>, the Court found that the Electricity feed-in Act (<span>Stromeinspeisungsgesetz</span>) <a>(<span>80</span>)</a>, in its version applicable in 1998, did not involve a public or private body established or appointed to administer the aid <a>(<span>81</span>)</a>. This conclusion was based on the observation that the<span>Stromeinspeisungsgesetz</span> put in place a mechanism that was limited at directly obliging electricity supply undertakings and upstream electricity network operators to purchase renewable electricity at a fixed price, without any body administering the stream of payments <a>(<span>82</span>)</a>. The situation under the<span>Stromeinspeisungsgesetz</span> was characterized by a multitude of bilateral relationships between renewable electricity generators and electricity suppliers. There was no surcharge established by the State to compensate the electricity suppliers for the financial burden resulting from the supply obligation. Therefore, nobody had been appointed to administer such a surcharge and the corresponding financial flows.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(132)</p></td><td><p>By contrast, the Court indicated in the<span>Vent de Colère</span> case that the French support system was different from the situation examined in the<span>PreussenElektra</span> case in two respects: In<span>PreussenElektra</span> the private undertakings concerned had not been appointed by the Member State concerned to manage a State resource, but were bound by an obligation to purchase by means of their own financial resources. In addition, in<span>PreussenElektra</span> there was no mechanism established and regulated by the State for offsetting additional costs arising from the purchase obligation and through which the State offered the private operators bound by the obligation to purchase the certain prospect that the additional costs would be covered in full <a>(<span>83</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(133)</p></td><td><p>The Court has recently confirmed this differentiated approach to the assessment of State resources. In the<span>ENEA S.A.</span> case, the Court ruled that a national measure placing an obligation on both private and public undertakings to purchase electricity produced by cogeneration does not constitute an intervention by the State or through State resources when the extra costs resulting from that purchase obligation cannot be passed on entirely to end users and are not financed by a compulsory contribution imposed by the State or by a full offset mechanism <a>(<span>84</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(134)</p></td><td><p>In light of those principles, for the purposes of examining whether the financing of the full exemption, as resulting from the second sentence of Paragraph 19(2) of the StromNEV 2011, involves State resources, it is necessary to differentiate between the financing of the full exemption in 2011 and the financing of that exemption during the years 2012 and 2013, that is to say following the introduction of the § 19-surcharge.</p></td></tr></tbody></table>
5.1.4.1. Financing through State resources after the BNetzA imposed the Paragraph 19-surcharge (years 2012 and 2013)
<table><col/><col/><tbody><tr><td><p>(135)</p></td><td><p>Based on the compensation mechanism provided for in the sixth and the seventh sentence of Paragraph 19(2) of the StromNEV 2011 described under section 2.4 of this Decision, the BNetzA imposed by regulatory decision of 14 December 2011 on the DSO the obligation to collect from end users the Paragraph 19-surcharge and to transfer the proceeds from this surcharge to the TSO on a monthly basis.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(136)</p></td><td><p>In recitals 49 to 84 of the Opening Decision, the Commission indicated why it considered that the full exemption had to be regarded as financed from State resources. Those reasons can be summarized as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the full exemption corresponds to a policy of the State;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the network operators are being provided a guarantee in the law that the financial losses resulting from the full exemption will be fully compensated through a surcharge on the electricity consumption of network users; that is to say they do not need to finance the exemption from their own financial means;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the TSO have been entrusted with the management of the financial flows resulting from the exemption and the Paragraph 19-surcharge;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the TSO are not free to use the proceeds of the surcharge as they wish given that the Paragraph 19-surcharge must be limited to the financial losses resulting from the exemption; any excess revenues resulting from the surcharge must be deducted from the surcharges to be paid in following years;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>the Paragraph 19-surcharge does not correspond to the payment for a service or a good.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(137)</p></td><td><p>The Commission does not share the view expressed by both Germany and the interested parties that the full exemption could not be regarded as financed through State resources because the financial resources that finance the exemption would not transit through the State budget. As recalled in recitals 125 to 129 of this Decision, the Court has repeatedly ruled that the concept of State resources can also be fulfilled if the aid is financed through private means, which are imposed by the State and managed and apportioned in accordance with the provisions of the legislation. According to the Court, such a financing scheme implies a transfer of State resources, despite the fact that those resources are not administered by the public authorities but by private entities designated by the State that are separate from the public authorities</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(138)</p></td><td><p>The Commission considers that the losses in revenue resulting from the full exemption from network charges in 2012 and 2013 were passed on entirely to end users by a full offset mechanism financed by a compulsory contribution imposed on them by the State.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(139)</p></td><td><p>As described in recitals 35 to 39 of this Decision, the legal framework in place in 2012 and 2013 provided for a financing mechanism that would offset the losses in revenue encountered by the network operator to which the exempted baseload consumers was connected. The TSO were obliged to compensate the DSO for their losses in revenue and equalise this additional financial burden amongst them. Pursuant to the regulatory decision of the BNetzA of 14 December 2011 adopted on the basis of Paragraph 29(1) of the EnWG and point 6 of Paragraph 30(2) of the StromNEV 2011, the TSO were compensated for this financial burden through the Paragraph 19-surcharge.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(140)</p></td><td><p>The Paragraph 19-surcharge constituted a parafiscal levy on end users. As such, it did not form part of the general system of network charges as suggested by the comments submitted by the interested parties. The BNetzA itself has explained in its decision of 14 December 2011 that the Paragraph 19-surcharge had a special purpose, namely to compensate TSO for their financial losses, and therefore did not correspond to a general network charge but rather constituted ‘<span>another charge</span>’ within the meaning of Paragraph 17(8) of the StromNEV, that has to be collected separately from the general network charges. This was further confirmed by German courts and in particular by the Federal Court of Justice, which concluded that the Paragraph 19-surcharge did not correspond to a network charge but corresponded to a surcharge that was aiming at covering the financial losses resulting from the exemption provided under the second sentence of Paragraph 19(2) of the StromNEV 2011 (see recitals 52 and 53 of this Decision).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(141)</p></td><td><p>The Paragraph 19-surcharge amounts to a compulsory contribution imposed by the State. It had been provided for in the StromNEV 2011 and has then been introduced via binding regulatory decision of the BNetzA, a high federal public authority entrusted with administrative and regulatory tasks and acting under the supervision of the Ministry for economic affairs and energy. Its president and vice-presidents are nominated by the Minister, while its council is composed of representatives of the Bundesrat and Bundestag <a>(<span>85</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(142)</p></td><td><p>Furthermore, the network operators had been appointed to levy and administer the Paragraph 19-surcharge in accordance with the legal framework in place. In this regard, it is to be recalled that the Court has repeatedly ruled that also a private entity can be appointed with the administration of State resource. Also, it follows from the Essent-judgment that more than just one entity can be appointed to carry out the administration of the surcharge.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(143)</p></td><td><p>First, the DSOs and the TSOs were obliged to levy and collect the Paragraph 19-surcharge from the end users and DSOs were obliged to transfer the Paragraph 19-surcharge to the TSO.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(144)</p></td><td><p>Second, the TSO could use the proceeds from the Paragraph 19-surcharge for the sole purpose of compensating for the losses in revenue stemming from the exemption for baseload consumers under the second sentence of Paragraph 19(2) StromNEV 2011 and the equalisation mechanism described in recital 35 of this Decision. This is demonstrated by the fact that the amount of the Paragraph 19-surcharge was adapted to the financial needs triggered by the full exemption. In particular, any proceeds in year x in excess of the amount required to compensate for that financial burden led to a reduction of the surcharge in year x + 2 (see recital 39). The Commission therefore does not share the view of Germany and the interested parties according to which the network operators could use the proceeds of the Paragraph 19-surcharge as they wish.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(145)</p></td><td><p>In light of the above, it is noted that the introduction of the Paragraph 19-surcharge gave a guarantee for the network operators that their losses in revenue resulting from the exemption granted under the second sentence of Paragraph 19(2) of the StromNEV 2011 were fully compensated and is therefore different from both the PreussenElektra and the ENEA <a>(<span>86</span>)</a> cases in which the undertakings on which the purchase obligation rested had to finance the obligation through their own financial means and could not pass on the costs to their customers.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(146)</p></td><td><p>In that respect, the view presented by the interested parties that the proceeds of the Paragraph 19-surcharge were not hypothecated to the financing of the exemption under the second sentence of Paragraph 19(2) of the StromNEV 2011 cannot be accepted. Indeed, as of 2012, the exemption from network charges could not be financed differently than via the Paragraph 19-surcharge which was calculated so as to correspond exactly to the financial needs created by the exemption.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(147)</p></td><td><p>Based on those elements, the Commission maintains its conclusion that the advantage granted to baseload consumers in the form of the full exemption in 2012 and 2013 must be considered as financed through State resources.</p></td></tr></tbody></table>
5.1.4.2. Financing through State resources before the Paragraph 19-surcharge was imposed (year 2011)
<table><col/><col/><tbody><tr><td><p>(148)</p></td><td><p>While the full exemption under the second sentence of Paragraph 19(2) StromNEV 2011 was applicable as of 1 January 2011, the Paragraph 19-surcharge only entered into force on 1 January 2012 (see recital 40 of this Decision). In its Opening Decision, the Commission therefore questioned whether the exemptions granted in 2011 were equally financed through State resources and invited Germany to provide additional information on how the full exemption was financed in 2011.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(149)</p></td><td><p>On the basis of the additional information provided by Germany, but also taking into account the comments made by interested parties, the Commission does not consider the financing mechanism in place in 2011 to involve State resources.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(150)</p></td><td><p>As Germany has explained (see recital 77) and as the BNetzA has explicitly stated in the regulatory decision of 14 December 2011, no compensation and set-off mechanism was in place in 2011. In particular, the sixth and the seventh sentence of Paragraph 19(2) of the StromNEV 2011 were not yet applicable. Accordingly, the losses incurred due to the full exemption from network charges in 2011 were not passed on to the end users by a full offset mechanism or – in the absence of the Paragraph 19-surcharge in 2011 – by a compulsory contribution imposed by the State.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(151)</p></td><td><p>Instead, as the regulatory decision of 14 December 2011 establishes, the DSO and the TSO had to cover the losses in revenues encountered due to the full exemption in 2011 from their own resources.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(152)</p></td><td><p>They were entitled to include those losses as costs in their regulatory accounts established under the ARegV 2011. However, as set out in recital 47, the losses in revenue incurred in 2011 could not be recouped by an adaptation of the 2011 network charges given that those charges have to be set in advance and cannot be modified in the course of the year. The loss in revenues – if not compensated by other increases in revenues, and hence own resources of the TSO and DSO, for 2011 – had to be booked on the<span>Regulierungskonto</span>. Where at the end of the regulatory period ending in 2013 the losses in revenue for 2011 were compensated by additional revenues in other years of that regulatory period, then no compensation of the losses would occur, and the losses would be covered by own resources of the TSO and DSO. Only where the losses could not be set off against additional revenues in the regulatory period ending in 2013 could the losses of revenue encountered in 2011 lead to compensation over the next regulatory period. However, even in that situation, there was no guarantee of full compensation. Rather, the level of compensation depended on other factors, in particular the efficiency (or not) of the DSO and TSO, as the ARegV is not based on real costs, but on ideal costs of an efficient undertaking.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(153)</p></td><td><p>The network operators therefore enjoyed no guarantee that their losses in revenue resulting from the full exemption in 2011 would be compensated. In other words, in 2011, the network operators had to finance the full exemption from their own financial means.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(154)</p></td><td><p>The Commission therefore concludes that the advantage granted to baseload consumers in the form of a full exemption from network charges in 2011 had to be financed through the own resources of the network operators and was not financed through State resources <a>(<span>87</span>)</a>.</p></td></tr></tbody></table>
5.1.5. EFFECT ON TRADE BETWEEN MEMBER STATES
<table><col/><col/><tbody><tr><td><p>(155)</p></td><td><p>In accordance with the Court's settled case-law, for the purpose of categorising a national measure as State aid, it is necessary, not to establish that the aid has a real effect on trade between Member States but only to examine whether that aid is liable to affect such trade <a>(<span>88</span>)</a>. In particular, when aid granted by a Member State strengthens the position of an undertaking compared with other undertakings competing in intra-Community trade, the latter must be regarded as affected by that aid <a>(<span>89</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(156)</p></td><td><p>As indicated above, the large majority of the undertakings concerned are active in the chemical industry (including industrial gases), paper, textile, steel, non-ferrous metal industry, oil refineries and glass manufacturing. Some beneficiaries also operate data centres as service providers. All those sectors are open to trade between Member States with cross-border exchanges of goods. By exempting the undertakings concerned from a cost that undertakings active in the same sector in other Member States normally have to bear (network charges), the full exemption is strengthening the position of the exempted undertakings as compared with other undertakings competing in intra-community trade, the full exemption from network charges is therefore liable to affect trade between Member States.</p></td></tr></tbody></table>
5.1.6. IMPACT ON COMPETITION
<table><col/><col/><tbody><tr><td><p>(157)</p></td><td><p>A measure granted by the State is considered to distort or threaten to distort competition when it is liable to improve the competitive position of the recipient compared to other undertakings with which it competes <a>(<span>90</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(158)</p></td><td><p>The manufacturing sectors, in which the exempted undertakings are typically active, as well as the market for data centres, are open to competition. In many of these sectors electricity costs represent a large share of production costs, which Germany has confirmed in its letter of 6 December 2013 as concerns the paper, the cement, the chemical sectors and the aluminium and other metal industries. In this context, the full exemption from network charges lowers the production costs of the exempted undertakings. It is therefore liable to improve the competitive position of the beneficiaries of the exemption compared to their competitors in other Member States. It is also likely to improve their competitive position compared to undertakings that do not reach an annual electricity consumption of 10 GWh and 7 000 hours of full use but which are active in the same sector. The full exemption hence threatens to distort competition.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(159)</p></td><td><p>It is noted that neither an effect on trade nor a distortive effect on competition can be excluded because of an allegedly higher level of electricity costs in Germany compared to the electricity costs in other Member States. The second sentence of Paragraph 19(2) of the StromNEV 2011 granted a full exemption from network charges to baseload consumers. As a consequence, these consumers did not experience any financial burden from using the electricity grid, whereas competing undertakings in other Member States had to pay network charges. In addition, the Court has already ruled that a Member State was seeking to approximate, by unilateral measures, the conditions of competition in a particular sector of the economy to those prevailing in other Member States cannot deprive the measures in question of their aid character <a>(<span>91</span>)</a>.</p></td></tr></tbody></table>
5.1.7. CONCLUSION ON THE EXISTENCE OF AID
<table><col/><col/><tbody><tr><td><p>(160)</p></td><td><p>In light of the above the full exemption from network charges in place in 2012 and 2013 for baseload consumers exceeding an annual electricity consumption of 10 GWh and reaching 7 000 hours of full use amounts to State aid to the extent that it exempted those consumers from the network costs caused by their electricity consumption and from the minimum contribution of 20 % of the published network charge.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(161)</p></td><td><p>The exemption from network charges granted in 2011 was not financed through State resources and therefore did not amount to State aid.</p></td></tr></tbody></table>
5.2. UNLAWFULNESS
<table><col/><col/><tbody><tr><td><p>(162)</p></td><td><p>By failing to notify the measure before its implementation, Germany did not fulfil their obligations under Article 108(3) of the Treaty. The aid measure thus constitutes unlawful State aid.</p></td></tr></tbody></table>
5.3. COMPATIBILITY WITH THE INTERNAL MARKET
<table><col/><col/><tbody><tr><td><p>(163)</p></td><td><p>The compatibility assessment below only covers the full exemption granted to baseload consumers in 2012 and 2013 to the extent that it constitutes aid (see recital 160).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(164)</p></td><td><p>In its Opening Decision, the Commission raised doubts as to whether the full exemption from network charges for baseload consumers could be declared compatible with the internal market. Accordingly, the Commission invited Germany to submit additional comments as regards the compatibility of the full exemption with the internal market.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(165)</p></td><td><p>Germany has submitted that the full exemption could be declared compatible based on Article 107(3)(b) or (c) of the Treaty given that it aimed at the following objectives:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>guaranteeing security of electricity supply;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>facilitating the promotion of renewable electricity;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>implementing a system of access to the network system without discrimination between system users as required by Article 32 of Directive 2009/72/EC;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>ensuring that network charges reflect the actual costs incurred as required by Article 14 of Regulation (EC) No 714/2009.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(166)</p></td><td><p>In general, Germany also considered that the full exemption would reinforce the competitiveness of the European industry and be in line with the Union objective of reindustrialising Europe.</p></td></tr></tbody></table>
5.3.1. COMPATIBILITY BASED ON ARTICLE 107(3)(b)
<table><col/><col/><tbody><tr><td><p>(167)</p></td><td><p>With regard to Germany's first compatibility base, it is noted that the full exemption is not linked to any specific and concrete ‘important project of common European interest’. Germany has not described any such project the execution of which would be promoted through the full exemption from network charges. Germany has also not submitted any information that would show that the full exemption would remedy a serious disturbance of the economy in Germany. The full exemption can thus not be justified under Article 107(3)(b) of the Treaty.</p></td></tr></tbody></table>
5.3.2. COMPATIBILITY BASED ON ARTICLE 107(3)(c)
<table><col/><col/><tbody><tr><td><p>(168)</p></td><td><p>Article 107(1) of the Treaty provides for the general principle of prohibition of State aid within the Union. However, the Commission may declare an aid measure compatible directly under Article 107(3)(c) of the Treaty if it is aimed at and is appropriate to reach a well-defined objective of common interest <a>(<span>92</span>)</a>, is necessary to reach this objective, has an incentive effect and is proportionate, provided that the positive effects for the common objective outweigh the negative effects on competition and trade.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(169)</p></td><td><p>The Member State has the burden of proof for compatibility <a>(<span>93</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(170)</p></td><td><p>As Germany has argued that the full exemption was helping to promote the production of electricity from renewable sources and security of supply, the Commission has verified that the measure at stake would fall within the scope of the Community Guidelines on State Aid for Environmental Protection <a>(<span>94</span>)</a> (‘EAG’). However, the EAG do not contain compatibility rules for measures aimed at ensuring security of supply. As to the promotion of renewable electricity, they only contain compatibility criteria for aid granted to installations producing renewable electricity (Section 1.5.6 of the EAG). These criteria, however, do not relate to measures such as the one concerned in the present case, which would consist of exempting consumers of electricity from the network charges in order to ‘incentivize’ them to remain connected to the grid so that when electricity from renewable installations is produced, there would be a higher likelihood that consumers would also consume the electricity. The EAG do not apply to the measure examined here. The Commission has thus examined the compatibility of the full exemption directly under Article 107(3)(c) of the Treaty.</p></td></tr></tbody></table>
5.3.2.1. Objective of common interest and appropriateness of the aid
5.3.2.1.1. Compliance with European legislation on network charges
<table><col/><col/><tbody><tr><td><p>(171)</p></td><td><p>With regard to that argument, it is referred to the findings in recitals 85 to 121 of this Decision. As demonstrated in those findings, the full exemption granted to eligible baseload consumers between 2011 and 2013 conferred a selective advantage to the extent that it also exempted them from the network costs caused by their electricity consumption. This is not in line with the objective of ensuring that network charges reflect the actual costs incurred as required by Article 14 of Regulation (EC) No 714/2009 and is also not in line with the non-discrimination principle. The Commission therefore does not share the view of Germany that the full exemption from network charges contributes to these objectives, or would be required on the basis of European legislation.</p></td></tr></tbody></table>
5.3.2.1.2. Promotion of security of supply and of renewable electricity.
<table><col/><col/><tbody><tr><td><p>(172)</p></td><td><p>Germany claims that the full exemption was contributing to security of supply and to the promotion of renewable electricity in three different manners (see recital 165):</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It first argues argued that the baseload consumers delivered a necessary stability service in the period 2011 to 2013 before the network stabilizing measures could be introduced. Germany has argued that the continuous and constant electricity consumption by the exempted baseload consumers would relieve and stabilize the network. The predictability of the exempted baseload consumption would contribute to an efficient utilization of the generation capacities, while frequency and voltage deviations would be reduced. This would reduce the need for reserves and balancing electricity. Furthermore, Germany has explained that the exempted baseload consumers are often located close to large power plants. Therefore, the distance over which the electricity needs to be transported is relatively low, which would reduce transport losses and the need to have devices to ensure reactive power. Interested parties have also underlined that baseload consumers are often included in the 5 steps load shedding plan of TSOs without any contract and without any compensation. Also certain interested parties have indicated that end users are subject to technical specifications when they want to be connected to the grid and that this requires certain investments which improve voltage control without being remunerated.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Also, Germany argues that conventional power plants were needed to ensure a secured management of the network at a time when renewable electricity started to be deployed more rapidly and when flexibility solutions for the electricity system had not yet been developed (like demand-response <a>(<span>95</span>)</a>) as they deliver important ancillary services to the network and that in order to maintain the existence of those conventional power plants, baseload consumers were needed, in particular in the light of the increasing share of electricity produced from renewable energy sources.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>At the same time, Germany argues that the stable offtake of electricity by baseload consumers ensured that renewable electricity was always consumed when it was produced, which reduced the necessity to adopt (other and more costly) network stabilizing measures (curtailment). This facilitated the energy transition and contributed to the promotion of renewable electricity.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(173)</p></td><td><p>It is noted in general that the objectives of ensuring security of supply and of promoting renewable electricity have been recognized as constituting objectives of common interest <a>(<span>96</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(174)</p></td><td><p>It is noted however, that it is not clearly established that the full exemption could contribute to and was appropriate to reach the attainment of the objectives of security of supply and the promotion of renewable electricity. In particular, Germany has not demonstrated that the full exemption could contribute and was appropriate to reach the objectives pursued. As will be explained below, the full exemption leads to contradictory results in terms of the objectives attained and could even constitute a hindrance for the attainment of the objectives concerned.</p></td></tr></tbody></table>
5.3.2.1.2.1. Baseload consumption can constitute an obstacle to the objective of promoting renewable electricity and security of supply
<table><col/><col/><tbody><tr><td><p>(175)</p></td><td><p>In order to demonstrate that the full exemption from network charges granted under the second sentence of Paragraph 19(2) sentence of the StromNEV 2011 could contribute to and was appropriate to ensure security of supply between 2011 and 2013, Germany has referred to a certain number of characteristics of baseload consumers that facilitate network management and that benefit all network users: their stable and predictable demand reduces the need for balancing measures, reserves and re-dispatching. Also, being located generally closer to power plants, they cause less electricity losses during transport and less need for reactive power compensation devices.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(176)</p></td><td><p>It is noted that these elements can reduce network costs and facilitate network management and could indirectly be considered as facilitating the TSO's obligations in ensuring security of supply. However, assuming that exactly the same characteristics that were already taken into account to justify individual network charges can again be taken into account to consider that the exemption would pursue an objective of common interest, the exemption would in any event not be necessary, would not have any additional incentive effect and would not ensure the proportionality of the aid as explained more in detail below (sections 5.3.2.2 to 5.3.2.4). In addition, as will be seen below, the exemption and the conditions under which it is granted could also constitute a hindrance to flexibility measures that Germany introduced in 2013 to promote security of supply (recital 179 below) and could also increase the costs of the promotion of renewable electricity (recital 181 below). For those reasons, the exemption cannot be viewed as appropriate to reach the objectives of security of supply and promotion of renewable electricity.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(177)</p></td><td><p>Germany and interested parties also mention that the full exemption would be useful for frequency regulation and voltage control.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(178)</p></td><td><p>It is noted, however, that the frequency regulation and the voltage control that Germany and interested parties are referring to do not correspond to a service delivered by the baseload consumers but by conventional power plants, which both Germany and interested parties admit in their submissions. In fact, the argument made is that baseload consumers are needed to maintain the viability of conventional power plants. This argument is examined under recitals 183-188 and reference is made to those findings. As far as the contribution to the five stage load shedding plan is concerned, reference is made to the observations made under recital 97 where it is concluded that the full exemption could not be viewed as the remuneration for participation in the five stage load shedding plan. As to devices that baseload consumers need to install in order to comply with the requirement that the shift factor remains between + 0,9 and – 0,9, it has already been observed that this obligation aims at ensuring the safe and normal management of the grid and is imposed on any consumer requesting for access to the grid and not just baseload consumers (see recital 99 and following). It can thus hardly be seen as justifying an exemption for baseload consumers.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(179)</p></td><td><p>It is noted further that in its submissions Germany indicated that the full exemption induced value for security of supply only for a transitory period (2011 to 2013) pending the introduction of various measures to make the electricity system more flexible. However, already in 2012 did Germany adopt the Ordinance on interruptible load contracts (‘ABLAV Ordinance’) <a>(<span>97</span>)</a> aiming at purchasing three gigawatt (‘GW’) of interruptible load to flexibilise demand. It entered into force in 2013 (the last year of the full exemption) and was based on Paragraph 13(4a) of the EnWG 2011. The purpose was to make available to network operators interruptible loads to address situations in which there is too much demand compared to the available generation. Those situations can occur more often in electricity systems with high (intermittent) renewable penetration given that a sudden drop in the wind or the sun radiation leads to a sudden decrease of generation. Also wind and solar energy can be lower than initially expected based on the weather forecast. It is observed however, that the full exemption for baseload consumers actually constitutes an incentive for those consumers not to offer interruptible load under the ABLAV Ordinance given that they would then not reach the 7 000 hours of full use and thus runs against the objectives of another measure aimed at security of supply. For 2013, the full exemption therefore constituted a hindrance to another measure ensuring security of supply by de-incentivizing baseload consumers from offering interruptible load.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(180)</p></td><td><p>In addition, Germany has argued that the exempted baseload consumption would contribute to the promotion of renewable electricity by reducing the costs of such promotion. In particular, Germany has indicated that the stable offtake of electricity by baseload consumers ensured that renewable electricity was always consumed when it was produced, which reduced the necessity to curtail and compensate the renewable electricity installations in case of curtailment.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(181)</p></td><td><p>It is noted that indeed, in the absence in 2011-2013 of storage installations coupled with renewable electricity installations and in the absence also of flexible demand and incentives to increase consumption at times when renewable electricity is abundant, the existence of baseload consumption could indirectly reduce the likelihood that renewable electricity installations be curtailed. The exemption could therefore be viewed as facilitating the promotion of renewable electricity. However, the exemption could also indirectly increase the costs of the promotion of renewable electricity. Indeed, when renewable electricity is not available due to the sudden decrease of wind or sun, the inflexibility of baseload consumers induced by the exemption will make it necessary to ramp up conventional power plants, most likely coal-fired or gas-fired power plants to cover the demand of baseload consumers in case of sudden drops in intermittent renewable electricity generation. This could be perceived as increasing the costs of the promotion of renewable electricity.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(182)</p></td><td><p>Finally, it is noted that the exemption is granted to baseload consumers irrespective of where they are located. However, as the 2012 Study shows (section 2.3) under certain conditions the network can be congested because the electricity produced for instance in the North is exceeding the transmission capacity needed to deliver the electricity to the South where the consumption point is located. That congestion could be linked to strong wind conditions. In fact the 2012 Study contains a scenario (Figure 2.3) in which strong wind conditions are simulated to identify potential network bottlenecks. In such situation, it is necessary to curtail power plants that are located before the bottleneck and ramp up power plants located after the bottleneck. Redispatching measures involve compensation both to the curtailed power plants and to the power plants that need to ramp up. If the baseload consumer is located after the bottleneck, he will not reduce the costs of renewable electricity support but increase them. As the full exemption is devoid of any locational signal and being granted without any consideration for network bottlenecks, the exemption could increase the costs of renewable electricity deployment.</p></td></tr></tbody></table>
5.3.2.1.2.2. Unclear link between the full exemption and the security of supply
<table><col/><col/><tbody><tr><td><p>(183)</p></td><td><p>Germany has also argued that the exemption would (indirectly) contribute to security of supply because it would ensure the presence of constant consumption which is itself a prerequisite for conventional generation capacities, which it considers to be necessary not only to provide network stabilizing services but also to meet the electricity demands in a market environment that is increasingly marked by flexible and decentralized generation capacities based on renewables energies. Germany and several interested parties have submitted that conventional power plants (equipped with synchronous generators) deliver a certain number of important network services that network operators need to keep the network in operation, principally voltage regulation and frequency regulation. They argue that if conventional plants do not run on a continuous basis, those system services would be more difficult to acquire and in any event more expensive (for instance due to the need for a larger reserve). Conventional power plants could however only operate on a constant basis if there is sufficient constant demand to consume the electricity produced. More specifically, Germany claims that the 2012 Study shows that Germany would need in coming years between 8 and 25 GW of conventional power plants to ensure secured network management and has argued that in order to maintain those conventional power plants a constant and stable demand was needed.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(184)</p></td><td><p>It is noted first that the 2012 Study was realised after the full exemption was granted, which excludes its use to show the necessity of the full exemption to ensure the viability of the concerned conventional power plants. In addition, as will be shown below, the contribution of the exemption to the security of supply is not established.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(185)</p></td><td><p>Second, the 2012 Study does not itself refer to the need to secure a certain minimum constant consumption nor has Germany indicated how the baseload consumers relate to the minimum conventional generation needs. Germany has merely explained that the baseload consumers by their constant offtake constituted an incentive for conventional power plants to remain on the market. However, the 2012 Study makes a distinction between conventional baseload plants (i.e. to nuclear power plants, run-of-river power plants and lignite power plants) and conventional power plants that are more flexible. The minimum generation need refers to both types of generation. Germany and third parties, however, in their arguments do not make this distinction and have not explained how baseload consumption relates to both types of generation. When they refer to conventional power plants, they seem to refer to baseload power plants only given that they refer to constant production and the need to have equally constant consumption. By contrast, the 2012 Study makes clear that the conventional generation needed cannot only be baseload. The 2012 Study in fact insists on the flexibility needs of the system and the time necessary to modify and adapt generation to fluctuations. It is hard to see what the relationship is between those flexible plants and baseload consumers. Indeed, as already mentioned in recital 96, for conventional power plants that can be ramped up rapidly like gas turbines, baseload consumers will not constitute an incentive to remain on the market as their profitability is linked to the possibility to obtain higher electricity prices when the system is under stress.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(186)</p></td><td><p>In addition, the argument that the exemption would contribute to security of supply because helping to secure the existence of (baseload) conventional power plants is based on a circular reasoning: As baseload consumers themselves require continuous electricity supply they are themselves accountable for a part of the minimum generation identified in the 2012 Study. By arguing that baseload consumers are needed to maintain the operation of power plants, Germany and the interested parties are using a circular argument insofar as those power plants are required to cover those consumers' own demand. Such an argument cannot support the view that the full exemption was appropriate to achieve security of supply.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(187)</p></td><td><p>Finally, it is noted that Germany's and interested parties' argument rests on the assumption that baseload consumers are decisive to secure the offtake of the electricity produced by those plants and their viability.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(188)</p></td><td><p>However, the 2012 Study reveals that the existence of baseload consumers is not sufficient to ensure constant offtake from baseload power plants and to guarantee their viability. On page 1 of the 2012 Study, it is observed that the continuous deployment of renewable electricity installations and the priority dispatch of renewable electricity lead to a reduction of electricity supply by conventional (including conventional baseload) power plants. In addition, Germany itself admits that at times of lower demand and high renewable electricity production, the baseload consumers would consume the renewable electricity due to priority dispatch and access instead of consuming the electricity that would normally have been supplied by conventional baseload power plants. This shows that the consumption by baseload consumers will not ensure the viability of conventional baseload power plants and will not make redundant the system stability measures (higher reserve requirements, quick ramping up of power plants when renewable production decreases, etc.) that Germany and interested parties claim could be spared with a continuous operation of conventional power plants.</p></td></tr></tbody></table>
5.3.2.1.2.3. Conclusion on the appropriateness of the aid to ensure security of supply and to promote renewable electricity
<table><col/><col/><tbody><tr><td><p>(189)</p></td><td><p>Based on the above elements, the Commission concludes that Germany has not demonstrated that the full exemption could contribute to and was appropriate to contribute to the security of supply or indirectly to the promotion of renewable electricity.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(190)</p></td><td><p>Even assuming that full exemption from network charges of baseload consumers was appropriate to contribute to the objective of ensuring the security of supply and indirectly the deployment of electricity from renewable sources it still is necessary to verify whether it can be considered as necessary to reach those objectives, has an incentive effect, is proportionate and whether the negative impact of the measure remain smaller than its positive effect. It will be demonstrated below that these requirements have not been fulfilled. This reasoning constitutes subsidiary reasoning, as the Commission considers that the aid cannot be declared compatible already for the sole reason that it is not, in reality, capable of contributing to an objective of common interest.</p></td></tr></tbody></table>
5.3.2.1.3. Competitiveness of the European industry
<table><col/><col/><tbody><tr><td><p>(191)</p></td><td><p>Germany has underlined that the decision to phase out nuclear energy and to increase the share of renewable electricity would imply an increase in electricity costs (both costs related to electricity production and electricity transmission) which will penalize in particular electro-intensive industries like paper, cement, chemical, aluminium and other non-ferrous metal industries in comparison to competitors in other Member States facing significantly less costs from renewable policies. The exemption would create a level playing field.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(192)</p></td><td><p>It is noted however that the exemption is not creating a level playing field nor is it linked to costs that would be induced by renewable energy policies. Indeed, the full exemption from network charges representing the individual costs of the baseload consumers is exempting German baseload consumers from their entire network costs, including the costs of the network path that is connecting the baseload consumer to the closest baseload power plant. Those costs have no relationship with renewable energy policies and correspond to costs that competitors in other Member States have to pay as part of their normal production costs and that consumers and competitors in Germany need to compensate via the Paragraph 19-surcharge.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(193)</p></td><td><p>Finally, it is noted that the full exemption aiming at improving the competitiveness of the concerned consumers seems to be contrary to Article 14 of Regulation (EC) No 714/2009 as not being cost-reflective, and to Article 32 of Directive 2009/72/EC as not in line with the non-discrimination principle. In addition, exemptions from network charges decided by the legislator or the Government do not seem in line with Article 37(1)(a) of Directive 2009/72/EC establishing the principle that tariffs must be established by the regulator.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(194)</p></td><td><p>For those reasons, it is concluded that the full exemption from network charges corresponding to the individual costs attributable to the baseload consumers concerned in so far as it would aim at reinforcing the competitiveness of the beneficiaries is not capable of contribution to an objective of common interest.</p></td></tr></tbody></table>
5.3.2.2. Necessity of the full exemption
<table><col/><col/><tbody><tr><td><p>(195)</p></td><td><p>In any event, as is demonstrated below (recitals 197 to 199, even assuming that Germany had demonstrated that the full exemption could contribute to and was appropriate to ensure indirectly the promotion of renewable electricity and security of supply, it is not demonstrated that the full exemption was needed in 2012-2013 to reach those objectives. This would only have been the case if Germany had demonstrated that the full exemption was necessary to maintain baseload consumption and prevent baseload consumers from disconnecting from the network.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(196)</p></td><td><p>However, as the elements below show, Germany did not demonstrate that without the full exemption, baseload consumers would leave the public network and would either construct a direct line to a power plant or become self-suppliers. Also, Germany did not demonstrate that absent the full exemption, the beneficiaries concerned would change their consumption pattern and have variable unpredictable load profile.</p></td></tr></tbody></table>
The full exemption is not needed to avoid that baseload consumers build a direct line
<table><col/><col/><tbody><tr><td><p>(197)</p></td><td><p>Germany has not demonstrated that if the baseload consumers benefiting of the exemption would still be subject to individual network charges as would normally result from Paragraph 24 of the EnWG, they would stop contributing to the objective of common interest (stabilizing the network and promotion of renewable electricity) by building a direct connection to a power plant.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(198)</p></td><td><p>This seems highly unlikely given that individual network charges would be calculated based on the physical path methodology which examines the costs related to the use of the network path between the connection point of the baseload consumer to the network (offtake point) and the nearest baseload power plant. In that sense, individual network charges are mimicking the costs that would be implied by the construction of a direct line to the nearest baseload power plant suitable to match the baseload demand of the baseload consumer. All costs being equal, a baseload consumer will prefer to remain connected to the network instead of engaging in a lengthy and uncertain permit procedure. Given that the direct line will in many cases go through properties that do not belong to the baseload consumer, various permits and authorisation will be required and they are difficult to obtain as the general public often opposes electric lines). In addition, in most instances, individual network charges will actually be lower than the costs involved in the construction of a direct line. Indeed, a direct line would imply for the concerned baseload consumer significant investment costs and would also require lengthy and costly permit procedures to build the line. All fixed costs of the line would have to be borne by one single user while under the physical path methodology he only bears his share of those fixed costs.</p></td></tr></tbody></table>
The full exemption is not needed to avoid that baseload consumers become self-suppliers
<table><col/><col/><tbody><tr><td><p>(199)</p></td><td><p>Germany has not demonstrated either that if the beneficiaries of the full exemption would be subject to individual network charges as would normally result from Paragraph 24 of the EnWG, they would be at risk of becoming self-suppliers. Germany has not submitted any documents which would show a trend of baseload consumers becoming self-suppliers due to the level of their individual network charges before the introduction of the full exemption. On the contrary, the data submitted by Germany shows that the full exemption is not impacting on the decision of baseload consumers to engage in self-supply. Germany has provided figures for the ten largest beneficiaries in terms of electricity consumption for the period 2013 to 2015 (a period covering the last year of the full exemption and two years during which individual network charges were applied). This data shows that six out of these 10 undertakings did not have a self-supply installation in 2013 and did not acquire any self-supply installation after the reintroduction of individual network charges <a>(<span>98</span>)</a>. The data relating to the four other companies <a>(<span>99</span>)</a> reveal that one of those companies entirely injects into the grid the electricity produced. The remaining three companies all had self-supply installations already in 2013 and continued to use them throughout the entire period 2013 to 2015 with a decreasing trend for one, an increasing trend for the second and a rather stable trend for the third company. This confirms that the full exemption is not necessary for preventing self-supply and that baseload consumers chose self-supply models on the basis of other factors. This has been confirmed by Germany in its comments regarding State aid SA.46526 (2017/N) <a>(<span>100</span>)</a> in which Germany first indicated that self-supply solutions in the energy-intensive industry <a>(<span>101</span>)</a> were driven by synergies with heat requirements, synergies with waste gases and production residues and not by the possibility to escape payment of the charge on electricity that consumers pay in Germany to finance the support of renewable electricity (the so-called EEG-surcharge) <a>(<span>102</span>)</a>. Germany in addition showed that despite a significant increase of the EEG-surcharge in the period 2011 to 2014 (with the EEG-surcharge representing more than the electricity wholesale price as of 2013), self-supply in the four main sectors resorting to self-supply (paper, chemical industry, steel manufacturing, oil refineries) remained stable in the period 2010 to 2014 <a>(<span>103</span>)</a>.</p></td></tr></tbody></table>
The alleged contribution to the stability of the grid is already taken into account in individual network charges
<table><col/><col/><tbody><tr><td><p>(200)</p></td><td><p>In order to justify the full exemption Germany has referred to the stability and predictability of baseload consumption as an important element to facilitate network management and thus indirectly facilitate security of supply.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(201)</p></td><td><p>It is noted, however, that all these elements are already taken into account for the calculation of individual network charges given that this calculation allocates to each baseload consumer only the costs linked to the network connection between that baseload consumer and the nearest baseload power plant that can cover its demand. Costs for balancing energy are anyway not included in network charges in general neither in the individual network charges. Costs for the various reserves and re-dispatching costs are not included in the individually calculated network charges and energy losses due to the transport of electricity are allocated in proportion to the network portion used. Also the reduced need for reactive power compensation devices will be taken into account given that those devices will only be included in the calculation of the individual network charges if they are located on the network path between the baseload power plant and the baseload consumer.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(202)</p></td><td><p>Given that this calculation allocates to each baseload consumer only the costs linked to the network connection between that baseload consumer and the nearest baseload power plant that can cover its demand, it must be concluded, that the individual network charges already adequately take into account the benefits induced by baseload consumers in terms of network management and indirectly security of supply. There is thus no need for any aid measure in the form of a full exemption and Germany has not brought forward any element that would show that with network charges based on individual costs (for instance by using the physical path methodology), the beneficiaries would become consumers with a variable and unpredictable consumption profile.</p></td></tr></tbody></table>
5.3.2.3. Incentive effect
<table><col/><col/><tbody><tr><td><p>(203)</p></td><td><p>Further, Germany has not demonstrated that the full exemption from network charges would have an incentive effect. An aid has an incentive effect when it changes the behaviour of the undertakings concerned in such a way that they engage in an additional activity which they would not carry out without the aid or which they would carry out in a restricted or different manner.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(204)</p></td><td><p>Several elements in the file show that in many cases the full exemption was granted to baseload consumers for adopting a consumption pattern that corresponds to their usual consumption pattern given that their production process involves constant electricity consumption. Individual network charges for baseload consumers exist since 2005. Initially those individual network charges were possible only for baseload consumers reaching 7 500 hours of full use. At least for baseload consumers who were already benefitting from individual network charges under that initial regime, the full exemption did hence not change their behaviour compared with their behaviour during the application of individual network charges and thus had no incentive effect. In addition, the number of baseload consumers obtaining individual network charges in 2014 is very close to the number of baseload consumers having obtained an exemption in 2011 to 2013 and the applicants are often the same. This also confirms that for most of the baseload consumers, the full exemption has not modified their behaviour compared to what they would anyway do based on individual network charges. The German national courts have made the same observations (see recital 52). Finally, the 2015 Evaluation Report also highlights that several network operators had observed that the baseload consumers concerned already had the same consumption pattern before the full exemption had been introduced <a>(<span>104</span>)</a>.</p></td></tr></tbody></table>
5.3.2.4. Proportionality, negative impact on trading conditions and overall balance
<table><col/><col/><tbody><tr><td><p>(205)</p></td><td><p>Even assuming that for some baseload consumers the full exemption was appropriate, and necessary to contribute to an objective of common interest and had an incentive effect, it should be noted that the full exemption was not proportionate and that the negative impact of the aid outweigh its hypothetical positive impact.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(206)</p></td><td><p>In order to be proportionate, the full exemption would have had to be limited to the amount necessary to trigger the change in the behaviour of the concerned baseload consumer that is beneficial for either the security of supply or the promotion of renewable electricity.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(207)</p></td><td><p>However, Germany has not demonstrated that the full exemption is calibrated to being limited to what would be necessary to incentivize a change in the consumption pattern of baseload consumers, nor that the full exemption is the least distortive tool to keep the baseload consumers' contribution to the stability and security of the network. In this respect, some interested parties have claimed that in order to be sure that they would reach the 7 000 hours of full use, their employees needed to reserve part of their time to the monitoring of the consumption and that a continuous consumption also involved continuous production and thus possibly increased stocks when product demand was decreasing. However, the same interested party admits that those costs differed for each company. Therefore, even assuming that in order to reach 7 000 hours of full use some of the baseload consumers would face additional costs, there was no guarantee that the exemption would in all cases correspond to what would have been necessary to cover those extra costs and Germany did not demonstrate that it had been the case.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(208)</p></td><td><p>It is noted in addition that the measure does not seem to promote security of supply beyond what is already taken into account to compute individual network charges. Such additional contribution has not been demonstrated. In any event, both Germany and interested parties admit that it cannot be quantified.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(209)</p></td><td><p>In addition, it is noted that even if it was assumed that baseload consumers would contribute to security of supply beyond the stabilizing effect on networks already taken into account in the determination of individual network charges and would also indirectly contribute to the promotion of renewable electricity, Germany has not demonstrated that the aid is limited to what would be necessary to achieve those positive effects. In its 2015 Evaluation Report, the BNetzA noted that network operators having baseload consumers connected to their network were split between those finding that baseload consumers had stabilizing effects and those finding that they had no such stabilizing effects (see figures 6 and 7 of the report and the findings on p. 38 of the report). As the report does not make this distinction, it is unclear whether for those network operators having identified stabilizing effects, the effects concerned would go beyond those already taken into account to calculate individual network charges. One TSO explained that the contribution of baseload consumers to the stability of the networks depended on the specific circumstances of the network: in the event of overload, baseload consumers were threatening network stability while at times of underload, they were contributing to it so that the key to network stability was actually flexible load <a>(<span>105</span>)</a>. However, baseload consumers by definition do not constitute flexible load but stable and inflexible load. Indeed, if the baseload consumers were to offer flexibility services (reduction of consumption upon request of the network operator for instance), they would not comply with the definition of baseload consumers anymore as they would not reach the 7 000 hours of full use anymore. This confirms at the very least, that — assuming that under certain conditions baseload consumers contribute to network stability beyond what is already taken into account to compute individual network charges — baseload consumers' additional contribution to stability would depend on each case but cannot be automatically presumed for any baseload consumer exceeding 10 GWh of consumption and reaching 7 000 hours of full use. Nor can it be presumed that it would warrant a full exemption from network charges in all cases.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(210)</p></td><td><p>In addition, as to Germany's and interested parties' argument that the exemption would secure the existence of baseload conventional power plants which are themselves important providers of ancillary services, it should be noted that the argument rests on the assumption that the minimum generation needs identified in the 2012 Study would remain constant irrespective of demand in Germany, which is not the case. On the contrary, as mentioned in recital 93 of this Decision, the 2012 Study underlines on page (i) (part ‘Ergebniszusammenfassung’) that the extent of the minimum generation is highly dependent on the current situation, in particular the renewable production but also the demand load. Germany has not provided any elements that would demonstrate that the full exemption is limited to the baseload consumption that is allegedly needed to secure the existence of baseload conventional power plants nor that it would over time be calibrated to adapt to changing needs.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(211)</p></td><td><p>Germany has argued that there would be no undue distortion of trading conditions as the impact on competition would be limited given that the measure significantly contributed to security of supply and would hardly have any impact on competition with undertakings from other Member States given the very high electricity prices in Germany compared to other Member States.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(212)</p></td><td><p>However, as result from the findings under section 5.3.2.1 to 5.3.2.4 it is not demonstrated that the full exemption would be appropriate to achieve security of supply and promotion of renewable electricity, nor that it would be necessary and have an incentive effect. Also, as demonstrated under (205)-(211) of this Decision, the aid is not limited to amount needed to reach the objectives and leads to overcompensation. The hypothetical positive impact of the aid is therefore extremely limited, if existing at all.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(213)</p></td><td><p>By contrast, the full exemption does not seem to observe Article 32 of Directive 2009/72/EC and Article 14 of Regulation (EC) No 714/2009.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(214)</p></td><td><p>Concerning the distortion of competition with other Member States and contrary to Germany's views, they cannot be considered as being insignificant. First, the measure fully exempts the beneficiaries from network charges while all their competitors remain under the obligation to pay network charges in their respective Member States, in line with the applicable European legislation. This can have an important distortive impact on competition given that, as Germany has pointed out itself, most of the beneficiaries are electro-intensive undertakings. Electricity costs are thus an important factor of their competitiveness. Second, the circumstance that electricity prices would be high in Germany and would heavily burden the production costs of electro-intensive companies in Germany has not been demonstrated. It is noted to the contrary that between 2011 and 2013 electro-intensive users benefitted in Germany from reductions of the electricity tax, of the EEG-surcharge and of the CHP-surcharge</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(215)</p></td><td><p>Based on those elements, it is concluded that the negative impact of the aid exceeds the hypothetical positive contribution that it might have had in terms of the promotion of renewable electricity or the security of supply.</p></td></tr></tbody></table>
5.3.3. CONCLUSION
<table><col/><col/><tbody><tr><td><p>(216)</p></td><td><p>The aid granted in 2012 and 2013 is not compatible with the internal market.</p></td></tr></tbody></table>
6. RECOVERY
<table><col/><col/><tbody><tr><td><p>(217)</p></td><td><p>According to the Treaty and the Court's established case-law, the Commission is competent to decide that the Member State concerned must abolish or alter aid when it has found that it is incompatible with the internal market <a>(<span>106</span>)</a>. The Court has also consistently held that the obligation on a Member State to abolish aid regarded by the Commission as being incompatible with the internal market is designed to re-establish the previously existing situation <a>(<span>107</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(218)</p></td><td><p>In this context, the Court has established that this objective is attained once the recipient has repaid the amounts granted by way of unlawful aid, thus forfeiting the advantage which it had enjoyed over its competitors on the market, and the situation prior to the payment of the aid is restored <a>(<span>108</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(219)</p></td><td><p>In line with the case-law, Article 16(1) of Council Regulation (EU) 2015/1589 <a>(<span>109</span>)</a> stated that ‘where negative decisions are taken in cases of unlawful aid, the Commission shall decide that the Member State concerned shall take all necessary measures to recover the aid from the beneficiary […]’.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(220)</p></td><td><p>Thus, given that the aid in question was implemented in violation of Article 108(3) of the Treaty and is incompatible with the internal market, it must be recovered from the beneficiaries in order to re-establish the situation that existed on the market prior to their granting. Recovery should cover the time from when the advantage accrued to the beneficiary, that is to say when the aid was put at the disposal of the beneficiary, until effective recovery, and the sums to be recovered should bear interest from the date on which they accrued to the beneficiary until effective recovery.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(221)</p></td><td><p>As regards the claim put forward by some interested parties that the recovery would be in violation of the principle of the protection of legitimate expectations, it should be pointed out that the Court of Justice has repeatedly held that the right to rely on the principle of the protection of legitimate expectations extends to any person in a situation where a Union institution has caused him to entertain expectations which are justified by precise assurances provided to him. However, if a prudent and alert economic operator could have foreseen the adoption of a Union measure likely to affect his interests, he cannot plead that principle if the measure is adopted <a>(<span>110</span>)</a>. In light of that case-law, the judgment in<span>PreussenElektra</span> could not create any legitimate expectations because it has not put into question the possibility to mandate private bodies to administer an aid scheme and to qualify parafiscal levies and charges as State resources. Rather, it concerned one narrow situation already identified in<span>Van Tiggele</span> <a>(<span>111</span>)</a>. In addition, the Commission has concluded on the existence of State aid in a big number of schemes financed on the basis of a surcharge imposed by the State <a>(<span>112</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(222)</p></td><td><p>In any event, the Court clarified in<span>Essent</span> <a>(<span>113</span>)</a> the boundaries of the<span>PreussenElektra</span> judgment and repeated its earlier case law that also qualifies as State resource an advantage financed from surcharge imposed by the State and managed by an entity designated by the State.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(223)</p></td><td><p>The interpretation of State resources adopted in this decision is in line with the well-established case law of the Court as well as the decisional practice of the Commission. As it could have been foreseen by any prudent and alert economic operator, recovery would not be in violation of the principle of the protection of legitimate expectations.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(224)</p></td><td><p>In light of the above, especially with respect to recital 216, the aid should be recovered as it is incompatible with the internal market and the sums to be recovered should bear interest from the date on which they accrued to the beneficiary until effective recovery.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(225)</p></td><td><p>Recovery should only cover the full exemption from network charges granted during the period from 1 January 2012 until 31 December 2013 by comparison of the individual network charges that would have been due absent the exemption, as only that part qualifies as State aid.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(226)</p></td><td><p>The recoverable amounts are for each of the years concerned, the individual network charges that the beneficiaries would have had to pay without the full exemption.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(227)</p></td><td><p>The individual network charges referred to in the previous recital should be calculated on the basis of the physical path methodology as it was set out by the BNetzA in its guidance document ‘<span>Leitfaden zur Genehmigung individueller netzentgeltvereinbarungen nach § 19 Abs. 2 S. 1 und 2 StromNEV</span>’ issued on 26 October 2010.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(228)</p></td><td><p>The recoverable amount, for each of the years concerned, equals at least 20 % of the amount that the beneficiary would have paid if he had had to pay the published network charges.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(229)</p></td><td><p>Where the total amount of advantage received by a beneficiary is less than EUR 200 000 and where the advantage meets all the other criteria laid down in either Commission Regulation (EU) No 1407/2013 <a>(<span>114</span>)</a> or Commission Regulation (EC) No 1998/2006 <a>(<span>115</span>)</a>, such advantage should be deemed not to constitute State aid in the meaning of Article 107(1) of the Treaty, and should therefore not be subject to recovery.</p></td></tr></tbody></table>
7. CONCLUSION
<table><col/><col/><tbody><tr><td><p>(230)</p></td><td><p>It is concluded that Germany has unlawfully put into effect during the period 1 January 2012 until 31 December 2013 aid in the form of a full exemption from network charges for baseload consumers reaching an annual electricity consumption of at least 10 GWh and 7 000 hours of full use in breach of Article 108(3) of the Treaty.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(231)</p></td><td><p>The State aid amounts to the network costs actually caused by the exempted baseload consumers in 2012 and 2013 or, where those network costs amount to less than the minimum network charges of 20 % of the published network charges, to those minimum network charges. To this extent, the full exemption granted under the second sentence of Paragraph 19(2) of the StromNEV 2011 deviates from the reference system as it was in place. Accordingly, the State aid amounts to the value of the individual network charges that the baseload consumers did not pay in 2012 to 2013 and corresponds to at least 20 % of the network charges published in the respective years.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(232)</p></td><td><p>The State aid does not meet the conditions of any of the derogations provided for in Article 107(2) and (3) of the Treaty and cannot be considered compatible with the internal market for any other reason. Consequently, it is incompatible with the internal market.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(233)</p></td><td><p>In accordance with Article 16(1) of Regulation (EU) 2015/1589 the Commission must require that the Member State concerned takes all necessary measures to recover the aid from the beneficiaries. Germany should therefore be required to recover the incompatible aid,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
1. The full exemption of baseload consumers in Germany from paying network charges, which Germany has unlawfully put into effect in 2012 and 2013, constitutes State aid within the meaning of Article 107(1) of the Treaty insofar as those consumers were exempted from paying network charges corresponding to the network costs caused by them or, where those network costs amounted to less than the minimum network charges of 20 % of the published network charges, from paying those minimum network charges.
2. The State aid referred to in paragraph 1 was put into effect by Germany in breach of Article 108(3) of the Treaty and is incompatible with the internal market.
Article 2
Individual aid granted under the scheme referred to in Article 1 does not constitute State aid if, at the time it is granted, it fulfils the conditions laid down by the regulation adopted pursuant to Article 2 of Council Regulation (EC) No 994/98 ( 116 ) which is applicable at the time the aid is granted.
Article 3
(1) Germany shall recover the incompatible aid granted under the scheme referred to in Article 1 from the beneficiaries.
(2) The sums to be recovered shall bear interest from the date on which they were put at the disposal of the beneficiaries until their actual recovery.
(3) The interest shall be calculated on a compound basis in accordance with Chapter V of Commission Regulation (EC) No 794/2004 ( 117 ) .
(4) Germany shall cancel all outstanding payments of aid under the scheme referred to in Article 1 with effect from the date of adoption of this Decision.
Article 4
(1) Recovery of the aid granted under the scheme referred to in Article 1 shall be immediate and effective.
(2) Germany shall ensure that this Decision is implemented within four months following the date of notification of this Decision.
Article 5
(1) Within two months following notification of this Decision, Germany shall submit the following information:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the list of beneficiaries that have received aid under the scheme referred to in Article 1 and the total amount of aid received by each of them under the scheme;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the total amount (principal and recovery interests) to be recovered from each beneficiary;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>a detailed description of the measures already taken and those planned to comply with this Decision;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>documents demonstrating that the beneficiaries have been ordered to repay the aid referred to in Article 1.</p></td></tr></tbody></table>
(2) Germany shall keep the Commission informed of the progress of the national measures taken to implement this Decision until recovery of the aid granted under the scheme referred to in Article 1 has been completed. Upon a simple request by the Commission, Germany shall immediately submit information on the measures already taken and those planned to comply with this Decision. It shall also provide detailed information concerning the amounts of aid and interest already recovered from the beneficiaries.
Article 6
This Decision is addressed to the Federal Republic of Germany.
Done at Brussels, 28 May 2018.
For the Commission
Margrethe VESTAGER
Member of the Commission
( 1 ) OJ C 128, 4.5.2013, p. 43 .
( 2 ) Commission Decision of 6 March 2013 on state aid SA.34045 (2012/C) – Germany – Exemption from network charges for large electricity consumers (§19 StromNEV) – Invitation to submit comments pursuant to Article 108(2) of the Treaty on the Functioning of the European Union ( OJ C 128, 4.5.2013, p. 43 ).
( 3 ) BGBl. I p. 1554.
( 4 ) BGBl. I p. 1786.
( 5 ) A network operator is the operator responsible for the operation and safe management of an electric network. Network operators are generally distinguished between transmission system operators and distribution system operators depending on whether they operate a transmission network or a distribution network.
( 6 ) While the StromNEV had been first introduced in 2005, it has been amended various times. This decision refers to ‘StromNEV’ in general, where the relevant provision has not been modified by the various amendments. However, where a quoted provision has been modified, this decision explicitly refers to the relevant version of the StromNEV as follows:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>‘StromNEV 2010’ refers to the version of the StromNEV as amended by Article 6 of the Law of 3 September 2010 (BGBl. I p. 2074);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>‘StromNEV 2011’ refers to the version of the StromNEV as amended by Article 7 of the Law of 26 July 2011 (BGBl. I p. 1554);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>‘StromNEV 2014’ refers to the version of the StromNEV as amended by Article 1 of the Ordinance of 14 August 2013 (BGBl. I p. 3250).</p></td></tr></tbody></table>
( 7 ) An electric grid needs to be constantly in balance between the electricity injected and consumed. Imbalances can occur when the consumption is different from what had been forecasted, or in case of a power plant failure or the sudden drop of wind or sun. The Transmission System Operators (TSOs) have the responsibility to keep the network in balance and to inject electricity when consumption is higher than electricity effectively injected and to obtain that production is reduced or consumption increased when consumption is lower than injection. As electricity cannot easily be stored, a TSO must ensure that he can very quickly (within seconds or minutes) resort to positive or negative energy. TSOs therefore contract reserves (also called ‘Regelleistung’). In Germany a distinction is made between three main network reserves: (a) the primary reserve under which energy must be made available to the TSO within 30 seconds after request; (b) the secondary reserve under which the energy must be made available within five minutes and the minute reserve (also called tertiary reserve) under which the energy must be made available within 15 minutes (see BNetzA website: https://www.smard.de/blueprint/servlet/page/home/wiki-article/446/396).
( 8 ) Re-dispatching measures are linked to network congestion management. Network congestion occurs when the electricity generated exceeds the capacity of the network elements that connect the generation facilities to the consumption points. By lowering the real power output of one or more power plants at one end of the congested area and at the same time increasing the real power output of one or more other power plants at the other end, it is possible to relieve congestion while keeping the total real power in the grid close to constant. Redispatch is a request issued by the transmission system operator to power plants to adjust the real power they inject in order to avoid or eliminate network congestion. The TSO has to compensate the power plants for the redispatching order (https://www.bundesnetzagentur.de/DE/Sachgebiete/ElektrizitaetundGas/Unternehmen_Institutionen/Versorgungssicherheit/Engpassmanagement/Redispatch/redispatch-node.html).
( 9 ) When electricity is transported, part of it is lost in the transmission so that additional electricity must be injected to match the quantity of electricity that was initially fed into the grid.
( 10 ) Germany has explained that in the case of balancing costs, a distinction must be made between the costs linked to the reserves and the actual supply of the negative or positive balancing energy. Under the reserves, the service providers are remunerated for their availability. However, when energy is actually withdrawn from them based on a call of the TSO, they are in addition remunerated for the energy actually supplied. The costs of the actual (positive or negative) energy supply are directly invoiced to the operator responsible for the imbalance.
( 11 ) Germany has explained that though this kink at 2 500 annual hours of full use is now a convention, it is based on empirical figures. Empirically, the simultaneity function is never entirely linear but increases with a softer slope around 2 500 full hours of full use while it increases with a steep slope below 2 500 annual hours of full use. That leads to two segments in the simultaneity function and therefore also leads to four network tariffs: one consumption and capacity tariff for users below 2 500 hours of full use and one consumption and capacity tariff for users above 2 500 hours of full use. The only alternative would be to build the simultaneity function as a concave curve but that would result in the necessity to calculate an individual consumption tariff for each network user in Germany (as the slope of the function changes on each point of the curve). This would have considerably increased the administrative burden linked to the determination of network charges in Germany, delayed the calculation of network charges for network users and reduced transparency and predictability of network charges for network users.
( 12 ) For an example of the simultaneity function, see Bericht der Bundesnetzagentur zur Netzentgeltsystematik Elektrizität , Stand Dezember 2015, available under: https://www.bundesnetzagentur.de/SharedDocs/Downloads/DE/Sachgebiete/Energie/Unternehmen_Institutionen/Netzentgelte/Netzentgeltsystematik/Bericht_Netzentgeltsystematik_12-2015.pdf?__blob=publicationFile&v=1.
( 13 ) It is obtained by multiplying the specific annual costs of the network level with the value at which the simultaneity function crosses the x-axis at 0 and at 2 500 annual hours of full use (respectively for users with annual hours of full use below and above 2 500 hours). For instance, for 2017, Amprion applied the following capacity tariff for the high voltage level:
<table><col/><col/><tbody><tr><td><p>< 2 500 h/a</p></td><td><p>≥ 2 500 h/a</p></td></tr><tr><td><p>6,3 EUR/kWa</p></td><td><p>36,55 EUR/kWa</p></td></tr></tbody></table>
( 14 ) It is obtained by multiplying the specific annual costs of the network level concerned with the slope of the simultaneity function up to its kink at 2 500 hours of full use (for users with annual hours of full use below 2 500 hours) and with the slope of the simultaneity function above its kink at 2 500 hours of full use (for users with more than 2 500 hours of full use). For instance, for 2017, Amprion applied the following consumption tariff for the high voltage level:
<table><col/><col/><tbody><tr><td><p>< 2 500 h/a</p></td><td><p>≥ 2 500 h/a</p></td></tr><tr><td><p>1,512 ct/kWh</p></td><td><p>0,302 ct/kWh</p></td></tr></tbody></table>
( 15 ) Ordinance of 29 October 2007, BGBl. I p. 2529. The ARegV has been modified several times. This decision refers to ‘ARegV’ in general, where the relevant provision has not been modified by the various amendments. However, where a quoted provision has been modified, this decision explicitly refers to the relevant version of the ARegV as follows:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>‘ARegV 2011’ refers to the version of the ARegV as amended by Article 5 of the Law of 28 July 2011 (BGBl. I p. 1690).</p></td></tr></tbody></table>
( 16 ) The requirement of 7 000 hours of full use was foreseen by StromNEV 2010 to be applicable as of 1 January 2011 and hence applied already prior to the introduction of the complete exemption of baseload consumers. Prior to that amendment, the requirement had been 7 500 hours of full use.
( 17 ) See footnote 6.
( 18 ) BNetzA, Leitfaden zur Genehmigung von individuellen Netzentgelten nach § 19 Abs. 2 S. 1 und S. 2 StromNEV ab 2011 (29.9.2010).
( 19 ) Network services are services delivered by the network operator to keep the network in balance. The main network services are the reserves, re-dispatching measures and energy for network losses.
( 20 ) A baseload power plant is a power station that usually provides a continuous supply of electricity throughout the year with some minimum power generation requirement. Baseload power plants will only be turned off during periodic maintenance, upgrading, overhaul or service. Several interested parties indicate that baseload power plants generally reach 7 500 hours of full use per year and are typically nuclear power plants, lignite-fired power plants, run-of-river power plants and to a certain extent coal-fired power plants. They can be distinguished from medium load power plants reaching between 3 000 and 5 000 hours of full use per year, typically coal-fired power plants and gas turbines and from peak power plants generally running around 1 000 hours of full use over the year and typically constituted of pumping stations, gas turbines and oil-fired power plants. Also the BNetzA lists the following power plants as baseload power plants: nuclear power plants, run-of-river power plants and lignite-fired power plants. Coal-fired power plants can be considered as baseload power plants but only with a derating factor of 0,8 (see Leitfaden zur Genehmigung individueller netzentgeltvereinbarungen nach § 19 Abs. 2 S. 1 und 2 StromNEV, Paragraph 1.3.2.2.1). Coal-fired power plants can be considered as baseload power plants but only up to 80 %.
( 21 ) See also footnote 6.
( 22 ) The BNetzA is a federal government agency of the German Federal Ministry of Economics and Technology. Its core task is to ensure compliance with the Telecommunications Act (TKG), Postal Act (PostG) and Energy Act (EnWG) and their respective ordinances in order to guarantee the liberalisation of the markets for telecommunications, post and energy. It also assumes responsibility for rail regulation. In all those regulatory areas, it monitors non-discriminatory access to the networks under transparent circumstances, and examines the access charges. To achieve its regulatory aims, the Bundesnetzagentur has effective procedures and instruments at its disposal, including rights of information and investigation along with the power to impose graded sanctions and the right to adopt regulatory decisions. It has an Advisory Council consisting of 16 members of the German Bundestag and 16 representatives of the German Bundesrat; the Bundesrat representatives must be members or political representatives of the government of a federal state. The members and deputy members of the Advisory Council are appointed by the federal government upon the proposal of the German Bundestag and the German Bundesrat (Paragraph 5 of the Act on the Federal Network Agency for Electricity, Gas, Telecommunications, Posts, and Railways of 7 July 2005, BGBl. I p. 1970. The BNetzA is directed by a president and two vice-presidents. They are proposed by the Advisory Council to the Government (Paragraph 3 of the Act on the Federal Network Agency for Electricity, Gas, Telecommunications, Posts, and Railways of 7 July 2005, BGBl. I p. 1970). They are nominated by the President of the Federal Republic of Germany. The BNetzA is however not the only regulatory authority in Germany. In some of the Bundesländer separate regulatory authorities have been established (the Landesregulierungsbehörden ).
( 23 ) Article 1 of Ordinance of 14 August 2013 amending several ordinances in the area of the energy markets, BGBl. I p. 3250.
( 24 ) Law for the Support of Combined Heat and Power Generation of 25 October 2008 (BGBl. I p. 2101). This law has been amended by Article 11 of the Law on the Review of the Legal Framework for the Support of Electricity Production from Renewable Energy Sources of 28 July 2011 (BGBl. I p. 1634). Paragraph 9 of the KWKG has not changed between 1 January 2011 and 31 December 2013. The KWKG was overhauled on 21 December 2015 by the Law for maintaining, modernizing and deployment of Combined Heat and Power Generation (BGBl. I p. 2498); however, the compensation mechanism foreseen by Paragraph 9 was maintained (though more detailed) and was included in Paragraphs 26 to 28 of the KWKG of 21 December 2015. The Law for maintaining, modernizing and deployment of Combined Heat and Power Generation was again amended by law of 22 December 2016 amending the provisions on electricity production from cogeneration and autogeneration (BGBl. I p. 3106).
( 25 ) For a detailed description of the compensation system under Paragraph 9 KWKG (which became Paragraph 29 of the KWKG 2016 after the amendments introduced by law of 22 December 2016 amending the provisions on electricity production from cogeneration and autogeneration (BGBl. I p. 3106), see Commission decision of 23 May 2017 on the aid scheme SA.42393 (2016/C) (ex 2015/N) implemented by Germany for certain end consumers (reduced CHP surcharge, section 2.3).
( 26 ) See in particular Paragraph 9(7) of the KWKG providing for the introduction of the surcharge per electricity consumed on top of network charges and Paragraph 9(4) of the KWKG giving the TSOs the right to obtain compensatory payment from the DSOs (i.e. to obtain that DSOs transfer the revenues of the surcharge to the TSOs).
( 27 ) BK8-11-024.
( 28 ) While Paragraph 29(1) of the EnWG empowers the BNetzA to determine by regulatory decision which is binding on the network operators the concrete modalities of grid access, point 6 of Paragraph 30(2) of the StromNEV 2011 stated that such regulatory decision in particular can concern the determination of appropriate network charges.
( 29 ) Before being booked, the amounts are first corrected in function of the volume of electricity transmitted to avoid that the difference in revenues results from the mere fact that network users consumed more or less electricity in comparison to the assumptions used for the determination of the approved maximum revenue level.
( 30 ) When network operators set network charges, they have to verify in accordance with Paragraph 20 of the StromNEV that network charges that are aimed to be published are suitable to cover the costs listed in Paragraph 4 of the StromNEV. This is designated as the ‘Verprobung’ of the network charges.
( 31 ) BT-Drs. 17/6365, p. 34.
( 32 ) VI-3 Kart 178/12 (V). On 6 March 2013 the Higher Regional Court had rendered a similar judgment after having been seized by a network operator challenging the regulatory decision of 14 December 2011.
( 33 ) EnVR 32/13.
( 34 ) Ordinance amending several Ordinances in the field of Energy Law (BGBl. I p. 3250).
( 35 ) BK4-13-739.
( 36 ) EnVR 34/15.
( 37 ) EnVR 25/13.
( 38 ) See Paragraph 24 of the EnWG as amended by Article 1 of the Act on the electricity market of 26.7.2016 (BGBl. I p. 1786).
( 39 ) Judgment of 24 July 2003, Altmark Trans GmbH and Regierungspräsidium Magdeburg v Nahverkehrsgesellschaft Altmark GmbH , C -280/00, ECLI:EU:C:2003:415.
( 40 ) Conventional power plants are generally opposed to power plants like wind turbines and solar panels that developed in recent years. The following power plants are generally considered as conventional power plants: nuclear power plants, coal, oil, lignite and gas-fired power plants and hydro power plants.
( 41 ) IAEW/Consentec/FGH, Studie zur Ermittlung der technischen Mindesterzeugung des konventionellen Kraftwerksparks zur Gewährleistung der Systemstabilität in den deutschen Übertragungsnetzen bei hoher Einspeisung aus erneuerbarer Energien, Abschlussbericht 20. Januar 2012 .
( 42 ) BGBl. I p. 2074 and BGBl. I p. 1634.
( 43 ) BNetzA, Evaluierungsbericht zu den Auswirkungen des § 19 Abs. 2 StromNEV auf den Betrieb von Elektrizitätsversorgungsnetzen – Evaluierungsbericht gemäß § 32 Abs. 11 StromNEV , 20.3.2015.
( 44 ) The cumulative requirements of exceeding 10 GWh of consumption and reaching 7 000 hours of full use can already be reached with a load of 1,4 MW.
( 45 ) Judgment of 17 July 2008, Essent Netwerk Noord , C-206/06, ECLI:EU:C:2008:413.
( 46 ) Directive 2009/72/EC defines ancillary service as: ‘a service necessary for the operation of a transmission or distribution system.’ Examples of such services that TSOs can acquire from generators are frequency (balancing of the system) and non-frequency (voltage control and black-start) ancillary services to ensure the management of the system.
( 47 ) Regulation (EC) No 714/2009 of the European Parliament and of the Council of 13 July 2009 on conditions for access to the network for cross-border exchanges in electricity and repealing Regulation (EC) No 1228/2003 ( OJ L 211, 14.8.2009, p. 15 ).
( 48 ) Directive 2009/72/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in electricity and repealing Directive 2003/54/EC ( OJ L 211, 14.8.2009, p. 55 ).
( 49 ) The assessment is without prejudice to the ongoing infringement case 2014/2285 on Paragraph 24 of the EnWG.
( 50 ) Judgment of 23 February 1961, De Gezamenlijke Steenkolenmijnen in Limburg v High Authority , 30/59, ECLI:EU:C:1961:2; Judgment of 19 May 1999, Italy v Commission , C-6/97, ECLI:EU:C:1999:251, paragraph 15; Judgment of 5 October 1999, France v Commission , C-251/97, ECLI:EU:C:1999:480, paragraph 35.
( 51 ) Judgment of 24 July 2003, Altmark Trans GmbH and Regierungspräsidium Magdeburg v Nahverkehrsgesellschaft Altmark GmbH , C -280/00, ECLI:EU:C:2003:415, paragraphs 87-93.
( 52 ) See also judgment of 26 November 2015, Spain v Commission , T-461/13, ECLI:EU:T:2015:891, paragraphs 67-75.
( 53 ) Evaluierungsbericht zu den Auswirkungen des § 19 Abs. 2 StromNEV auf den Betrieb von Elektrizitätsversorgungsnetzen, BNetzA, 30 March 2015. See also replies of the Federal Government on this report to Members of the German Parliament (BT-Drucksache 18/5763, available under: http://dipbt.bundestag.de/doc/btd/18/057/1805763.pdf).
( 54 ) See negative replies in figures 6 and 7 of the report and the findings on p. 38 of the 2015 Evaluation Report.
( 55 ) See p. 38 of the 2015 Evaluation Report.
( 56 ) For the purposes of the full exemption, no distinction is made between consumers with an absolutely stable consumption over 8 760 hours of full use and consumers whose consumption is less stable.
( 57 ) Judgment of 16 January 2018, EDF v Commission , T-747/15, ECLI:EU:T:2018:6, paragraphs 218 to 251.
( 58 ) See p. (i) of the 2012 Study, under the heading ‘Ergebniszusammenfassung’.
( 59 ) Stage 1: 49,8 Hz Alerting of personnel and scheduling of the power station capacity not yet activated, according to the TSO's directions, shedding of pumps.
Stage 2: 49,0 Hz Instantaneous load shedding of 10 - 15 % of the system load.
Stage 3: 48,7 Hz Instantaneous load shedding of a further 10 - 15 % of the system load.
Stage 4: 48,4 Hz Instantaneous load shedding of a further 15 - 20 % of the system load.
Stage 5: 47,5 Hz Disconnection of all generating facilities from the network.
<note>
( 60 ) Peak demand in Germany accounted for 83,1 GW in 2013, see RAP (2015): Report on the German power system. Version 1.0. Study commissioned by Agora Energiewende available under https://www.agora-energiewende.de/fileadmin/downloads/publikationen/CountryProfiles/Agora_CP_Germany_web.pdf
( 61 ) In a network using alternative current, both real power and reactive power are needed for electricity to be transmitted. The real power is the power consumed and transported over the electric lines. Reactive power by contrast is needed to maintain the voltage of the line (see for instance explanations provided by Amprion: https://www.amprion.net/%C3%9Cbertragungsnetz/Physikalische-Grundlagen/Blind-Wirkleistung/). It is produced by synchronous generators and other reactive power compensation devices. Reactive power tends to decrease when the electric lines are long so that long lines require the installation of reactive power compensation devices in the middle of the line.
( 62 ) Judgment of 29 April 2004, Netherlands v Commission , C-159/01, ECLI:EU:C:2004:246, paragraph 43; Judgment of 6 September 2006, Portugal v Commission , C-88/03, ECLI:EU:C:2006:511, paragraph 80; Judgment of 8 September 2011, Commission v Netherlands , C-279/08 P, ECLI:EU:C:2011:551, paragraph 62; Judgment of 21 December 2016, Commission v Hansestadt Lübeck , C-524/14 P, ECLI:EU:C:2016:971, paragraphs 53-60; Judgment of 21 December 2016, Commission v Workd Duty Free Group SA , joined cases C-20/15 P and C-21/15 P, ECLI:EU:C:2016:981, paragraphs 92-94.
( 63 ) Judgment of 6 September 2006, Portugal v Commission , C-88/03, ECLI:EU:C:2006:511, paragraph 56 and Judgment of 21 December 2016, Commission v Hansestadt Lübeck , C-524/14 P, ECLI:EU:C:2016:971, paragraph 55.
( 64 ) EnVR 34/15, paragraph 27.
( 65 ) Judgment of 29 April 2004, Netherlands v Commission , C-159/01, ECLI:EU:C:2004:246, paragraph 42; Judgment of 8 September 2011, Commission v Netherlands , C-279/08 P, ECLI:EU:C:2011:551, paragraph 62.
( 66 ) See Commission Notice on the notion of State aid as referred to in Article 107(1) of the Treaty on the Functioning of the European Union ( OJ C 262, 19.7.2016, p. 1 ), point 138; See Judgment of 8 September 2011, Paint Graphos and others , joined cases C-78/08 to C-80/08, ECLI:EU: C:2011:550, paragraphs 69 and 70; Judgment of 6 September 2006, Portugal v Commission , C-88/03, ECLI:EU:C:2006:511, paragraph 81; Judgment of 8 September 2011, Commission v Netherlands , C-279/08 P, ECLI:EU: C:2011:551; Judgment of 22 December 2008, British Aggregates v Commission , C-487/06 P, ECLI:EU:C:2008:757; Judgment of 18 July 2013, P Oy , C-6/12, ECLI:EU:C:2013:525, paragraphs 27 et seq.
( 67 ) Judgment of 22 March 1977, Steinike & Weinlig v Germany , C-78/76, ECLI:EU:C:1977:52, paragraph 21; judgment of 13 March 2001, PreussenElektra , C-379/98, ECLI:EU:C:2001:160, paragraph 58; judgment of 30 May 2013, Doux Elevage , C-677/11, ECLI:EU:C:2013:348, paragraph 26; judgment of 19 December 2013, Association Vent de Colère , C-262/12, ECLI:EU:C:2013:851, paragraph 20; judgment of 17 March 1993, Sloman Neptun , joined cases C-72/91 and C-73/91, ECLI:EU:C:1993:97, paragraph 19; judgment of 9 November 2017, Commission v TV2/Danmark , C-656/15 P, ECLI:EU:C:2017:836, paragraph 44.
( 68 ) Judgment of 30 May 2013, Doux Elevage and Cooperative agricole UKL-ARREE , C-677/11, ECLI:EU:C:2013:348, paragraph 34; judgment of 27 September 2012, France v Commission , T-139/09, ECLI:EU:T:2012:496, paragraph 36; judgment of 19 December 2013, Association Vent de Colère , C-262/12, ECLI:EU:C:2013:851, paragraph 21.
( 69 ) See judgment of 16 May 2002, France v Commission , C-482/99, ECLI:EU:C:2002:294, paragraph 36; judgment of 17 July 2008, Essent Netwerk Noord , C-206/06, ECLI:EU:C:2008:413, paragraph 70; judgment of 19 December 2013, Association Vent De Colère! and Others , C-262/12, ECLI:EU:C:2013:851, paragraphs 19-21; judgment of 13 September 2017, ENEA , C-329/15, ECLI:EU:C:2017:671, paragraph 25; see also judgment of 30 May 2013, Doux Elevage and Cooperative agricole UKL-ARREE , C-677/11, ECLI:EU:C:2013:348, paragraph 34 and judgment of 19 March 2013, Bouygues Telecom v Commission , joined cases C-399/10 P et C-401/10 P , ECLI:EU:C:2013:175, paragraph 100.
( 70 ) Judgment of 12 December 1996, Air France v Commission , T-358/94, ECLI:EU:T:1996:194, paragraphs 63-65; judgment of 9 November 2017, Commission v TV2/Danmark , C-656/15 P, ECLI:EU:C:2017:836, paragraph 48.
( 71 ) Judgment of 27 September 2012, France v Commission , T-139/09, ECLI:EU:T:2012:496.
( 72 ) Judgment of 27 September 2012, France v Commission , T-139/09, ECLI:EU:T:2012:496, paragraph 61.
( 73 ) Judgment of 12 December 1996, Air France v Commission , T-358/94, ECLI:EU:T:1996:194, paragraphs 65-67; judgment of 16 May 2002, France v Commission , C-482/99, ECLI:EU:C:2002:294, paragraph 37; judgment of 30 May 2013, Doux Elevage and Cooperative agricole UKL-ARREE , C-677/11, ECLI:EU:C:2013:348, paragraph 35.
( 74 ) To this effect, see judgment of 22 March 1977, Steinike & Weinlig , C-78/76, ECLI:EU:C:1977:52, paragraph 21; judgment of 17 March 1993, Sloman Neptun , joined cases C-72/91 and C-73/91, ECLI:EU:C:1993:97, paragraph 19, and judgment of 10 May 2016, Germany v Commission , T-47/15, ECLI:EU:T:2016:281, paragraph 81; judgment of 9 November 2017, Commission v TV2/Danmark , C-657/15 P, ECLI:EU:C:2017:837, paragraph 36.
( 75 ) Judgment of 17 July 2008, Essent Netwerk Noord , C-206/06, ECLI:EU:C:2008:413.
( 76 ) Judgment of 17 July 2008, Essent Netwerk Noord , C-206/06, ECLI:EU:C:2008:413, paragraph 74.
( 77 ) Judgment of 17 July 2008, Essent Netwerk Noord , C-206/06, ECLI:EU:C:2008:413, point 66.
( 78 ) Judgment of 19 December 2013, Association Vent de Colère , C-262/12, ECLI:EU:C:2013:851, paragraph 27.
( 79 ) Judgment of 30 May 2013, Doux Elevage , C-677/11, EU:C:2013:348; judgment of 15 July 2004, Pearle, C-345/02, EU:C:2004:448.
( 80 ) BGBl. I p. 2633.
( 81 ) Judgment of 13 March 2001, PreussenElektra , C-379/98, ECLI:EU:C:2001:160, paragraphs 58 and 59.
( 82 ) Judgment of 13 March 2001, PreussenElektra , C-379/98, ECLI:EU:C:2001:160, paragraph 56. See also judgment of 17 July 2008, Essent Netwerk Noord , C-206/06, ECLI:EU:C:2008:413, paragraph 74, where the Court notes that in PreussenElektra , the undertakings had not been appointed by the State to manage a State resource.
( 83 ) Judgment of 19 December 2013, Association Vent de Colère , C-262/12, ECLI:EU:C:2013:851, paragraphs 34-36.
( 84 ) Judgment of 13 September 2017, ENEA , C-329/15, ECLI:EU:C:2017:671, paragraph 30.
( 85 ) See Paragraphs 1, 3, 4 and 5 of the Act on the Federal Network Agency for Electricity, Gas, Telecommunications, Postal Services and Railways of 7 July 2005 (BGBl. I p. 1970, 2009).
( 86 ) Judgment of 13 March 2001, PreussenElektra , C-379/98, ECLI:EU:C:2001:160 and judgment of 13 September 2017, ENEA , C-329/15, ECLI:EU:C:2017:671.
( 87 ) Judgment of 13 March 2001, PreussenElektra , C-379/98, ECLI:EU:C:2001:160 and judgment of 13 September 2017, ENEA , C-329/15, ECLI:EU:C:2017:671.
( 88 ) Judgment of 8 May 2013, Libert and Others , joined cases C-197/11 and C-203/11, ECLI:EU:C:2013:288, paragraph 76.
( 89 ) Judgment of 8 May 2013, Libert and Others , joined cases C-197/11 and C-203/11, ECLI:EU:C:2013:288, paragraph 77
( 90 ) See judgment of 17 September 1980, Phillip Morris , 730/79, ECLI:EU:C:1980:209, paragraph 11
( 91 ) Judgment of 3 March 2005, Wolfgang Heiser v Finanzamt Innsbruck , C-172/03, ECLI:EU:C:2004:678, paragraph 54.
( 92 ) Judgment of 14 January 2009, Kronoply v Commission , T-162/06, ECLI:EU:T:2009:2, especially paragraphs 65, 66, 74 and 75; judgment of 8 June 1995, Siemens v Commission , T-459/93, ECLI:EU:T:1995:100, paragraph 48.
( 93 ) Judgment of 28 April 1993, Italy v Commission , C-364/90, ECLI:EU:C:1993:157, paragraph 20; judgment of 15 June 2005, Regione autonoma della Sardegna v Commission , T-171/02, ECLI:EU:T:2005:219, paragraphs 166-168.
( 94 ) Community Guidelines on State Aid for Environmental Protection (2008/C 82/01) ( OJ C 82, 1.4.2008, p. 1 ).
( 95 ) Demand-response designates changes in electric usage by final consumers from their normal consumption patterns in response to changes in the price of electricity over time (reduce their consumption when prices are high and increase consumption when prices are low).
( 96 ) On security of supply, see Article 194(1)(b) of the Treaty and Article 3(11) of Directive 2009/72/EC and judgment of 22 October 2013, Staat der Nederlanden v Essent and Others , joined cases C-105/12 to C-107/12, ECLI:EU:C:2013:677, paragraph 59; on the promotion of renewable energy, see Article 194(1)(c) of the Treaty and Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources ( OJ L 140, 5.6.2009, p. 16 ), Paragraph 48 of the EAG and recital 231 of Commission Decision of 23 July 2014 on State aid SA.38632 – Germany – EEG 2014 – Reform of the Renewable Energy Law ( OJ C 325 of 2 October 2015, p. 4 ).
( 97 ) BGBl. I p. 2998.
( 98 ) Those companies belonged to the […] and to the […] sector.
( 99 ) Those companies belonged to the […] sector, the […] sector and the […] industry.
( 100 ) Commission Decision of 19 December 2017 on SA.46526 (2017/N) – Germany – Reduced surcharge for self-generation under EEG 2017.
( 101 ) Germany has indicated that most baseload consumers were energy-intensive undertakings.
( 102 ) See recital 60 of the Commission decision in case SA.46526.
( 103 ) See recital 61 of the Commission decision in case SA.46526.
( 104 ) See p. 38 of the 2015 Evaluation Report.
( 105 ) See p. 38 of the 2015 Evaluation Report.
( 106 ) See judgment of 12 July 1973, Commission v Germany , C-70/72, ECLI:EU:C:1973:87, paragraph 13.
( 107 ) See judgment of 14 September 1994, Spain v Commission , joined cases C-278/92, C-279/92 and C-280/92, ECLI:EU:C:1994:325, paragraph 75.
( 108 ) See judgment of 17 June 1999, Belgium v Commission , C-75/97, ECLI:EU:C:1999:311, paragraphs 64 and 65.
( 109 ) Council Regulation (EU) 2015/1589 of 13 July 2015 laying down detailed rules for the application of Article 108 of the Treaty on the Functioning of the European Union ( OJ L 248, 24.9.2015, p. 9 ).
( 110 ) See judgment of 22 June 2006, Forum 187 v Commission , joined cases C-182/03 and C-217/03, ECLI:EU:C:2006:416, paragraph 147.
( 111 ) See judgment of 24 January 1978, Van Tiggele , C-82/77, ECLI:EU:C:1978:10.
( 112 ) See for example: Commission Decision of 4 July 2006 on State aid NN162a/2003 and N317a/2006 – Austria – Support of renewable Electricity Production under the Austrian Green Electricity Act ( OJ C 221 of 14 September 2006, p. 8 ); Commission Decision of 8 February 2012 on State aid SA.33384 – Austria – Green Electricity Act 2012 ( OJ C 156 of 2 June 2012, p. 1 ); Commission Decision of 14 April 2010 on State aid N94/2010 – UK – Feed in tariffs to support the generation of renewable electricity from low carbon sources ( OJ C 166 of 25 June 2010, p. 2 ); Commission Decision of 24 April 2007 on State aid C 7/2005 – Slovenia – Slovenian Electricity Tariffs ( OJ C 219 of 24 August 2007, p. 9 ); Commission Decision of 26 October 2009 on State aid N 354/2009 – Slovenia – Support for production of electricity from renewable energy sources and in co-generation installations ( OJ C 285 of 26 November 2009, p. 2 ); Commission Decision of 25 September 2007 on State aid N 571/2006 – Ireland – RES-E support programme ( OJ C 311 of 21 December 2007, p. 2 ); Commission Decision of 18 October 2011 on State aid SA.31861 – Ireland – Biomass electricity generation ( OJ C 361 of 10 December 2011, p. 2 ); Commission Decision of 2 July 2009 on State aid N 143/2009 – Cyprus – Aid scheme to encourage electricity generation from large commercial wind, solar, photovoltaic systems and biomass ( OJ C 247 of 15 October 2009, p. 2 ); Commission Decision of 19 March 2003 on State aid N 707/2002 and N 708/2002 – Netherlands – MEP stimulering duurzame energie & MEP Stimulering warmtekrachtkoppeling ( OJ C 148 of 25 June 2003, p. 8 ); Commission Decision of 5 June 2002 on State aid C 43/2002 (ex NN 75/2001) – Luxembourg – Compensation fund for the organisation of the electricity market ( OJ L 159 of 20 June 2009, p. 11 ); Commission Decision of 23 July 2014 on State aid SA.38632 – Germany – EEG 2014 – Reform of the Renewable Energy Law ( OJ C 325 of 2 October 2015, p. 4 ); Commission Decision of 8 March 2011 on State aid C 24/2009 – Austria – State aid for energy-intensive businesses under the Green Electricity Act in Austria ( OJ L 235 of 10 September 2011, p. 42 ).
( 113 ) See judgment of 17 July 2008, Essent Netwerk Noord , C-206/06, ECLI:EU:C:2008:413, paragraph 74.
( 114 ) Commission Regulation (EU) No 1407/2013 of 18 December 2013 on the application of Articles 107 and 108 of the Treaty on the Functioning of the European Union to de minimis aid ( OJ L 352, 24.12.2013, p. 1 ).
( 115 ) Commission Regulation (EC) No 1998/2006 of 15 December 2006 on the application of Articles 87 and 88 of the Treaty to de minimis aid ( OJ L 379, 28.12.2006, p. 5 ).
( 116 ) Council Regulation (EC) No 994/98 of 7 May 1998 on the application of Articles 92 and 93 of the Treaty establishing the European Community to certain categories of horizontal State aid ( OJ L 142, 14.5.1998, p. 1 ).
( 117 ) Commission Regulation (EC) No 794/2004 of 21 April 2004 implementing Council Regulation (EU) 2015/1589 laying down detailed rules for the application of Article 108 of the Treaty on the Functioning of the European Union ( OJ L 140, 30.4.2004, p. 1 ).
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<table><tr><td><p><span><img/></span></p></td><td><p><span>EUROPEAN COMMISSION</span></p><p/><p/><p/><p/><p/></td></tr></table>
Brussels, 23.2.2017
C(2017) 1391 final
PUBLIC VERSION
To the notifying party
Subject : Case M. 8248 - TECH DATA / AVNET'S TECHNOLOGY SOLUTIONS Commission decision pursuant to Article 6(1 )( b) of Council Regulation No 139 /2004 1 and Article 57 of the Agreement on the European Economic Area 2
Dear Sir or Madam,
(1) On 19 January 2017 , the European Commission received notification of a proposed concentration pursuant to Article 4 of the Merger Regulation by which the undertaking Tech Data Corporation ( " Tech Data " or the "Notifying Party" , United States of America) acquires within the meaning of Article 3 (1 )( b) of the Merger Regulation control of the Technology Solutions business of Avnet, Inc. ( " Avnet TS " , United States of America) by way of purchase of shares (the "Proposed Transaction") . 3 Tech Data and Avnet TS are designated hereinafter as the "P arties " .
1. The parties
(1) Tech Data is a distributor of technology products. Tech Data has 11 logistics centers in the EEA from which it delivers products. Tech Data can also provide its customers with a range of services, including logistics, after-sale technical support and training, marketing support, financial services, and strategic management consultancy and sales training. Tech Data, which is listed on NASDAQ Stock Market Inc., achieved global revenues of approximately EUR 23.9 billion in its last financial year (ended 31 January 2016), of which approximately EUR [ … ] billion were generated in the EEA .
(2) Avnet TS is one of the two operating groups of Avnet, Inc. (“Avnet”) (the other operating group being Electronics Marketing). Avnet is active globally in the distribution of electronic components, computer products and technology services. Through Avnet TS, Avnet is active in the value-added distribution of technology products, services and solutions. In the EEA, Avnet TS delivers its products and services through 3 own logistic centres and via 8 centres operated by third parties. Avnet is listed on the New York Stock Exchange. In its most recent fiscal year (ended 2 July 2016), Avnet TS achieved worldwide revenues of approximately EUR 8.7 billion, of which approximately EUR [ … ] billion were generated in the EEA.
2. The concentration
(3) On 19 September 2016, Tech Data concluded a definitive agreement to buy Avnet TS, which was announced publicly on the same day. The Proposed Transaction will be implemented by way of an Interest Purchase Agreement. After completion of the Proposed Transaction, Tech Data will become the sole shareholder of Avnet TS.
(4) The Proposed Transaction therefore constitutes a concentration within the meaning of Article 3(1 )( b) of the Merger Regulation.
3. EU D IMENSION
(5) The undertakings concerned have a combined aggregate world-wide turnover of more than EUR 5 000 million 4 (Tech Data: EUR 23 910 million; Avnet TS: EUR 8 706 million) . Each of them has a n EU- wide turnover in excess of EUR 250 million (Tech Data: EUR [ … ] million; Avnet TS: EUR [ … ] million) , but they do not achieve more than two-thirds of their aggregate EU- wide turnover within one and the same Member State. The notified operation therefore has an EU dimension pursuant to Article 1(3) of the Merger Regulation .
4. Relevant markets
4.1. Overview of the IT distribution sector
(6) Information technology ("IT") distribution involves the supply of IT products (such as servers, software, storage devices, PCs, etc.), by different IT manufacturers (or “vendors,” e.g., IBM, HPE, Dell, Cisco, Apple and Microsoft) to wholesale distributors (such as Tech Data, Ingram, Arrow, Esprinet , and ALSO) and to resellers (such as Insight, Systemax, Computacenter, Atea , Bechtle , and Media-Saturn), who then sell the products to end customers .
(7) In general, IT manufacturers have two ways of getting their product to end consumers: direct sales to end users and indirect sales to distributors and resellers. “Direct sales” are made by manufacturers to end customers directly, without using any intermediary. “Indirect sales” are sales where the product passes through one or more intermediaries (IT distributors or resellers) before reaching the end user. IT manufacturers choose direct or indirect routes to market based on factors such as geographical reach, logistical capability and efficiency, and familiarity with the relevant product; almost all manufacturers use both channels. Similarly, IT product purchasers have two basic options for acquiring almost any product: buying directly from the manufacturer or buying from a reseller.
(8) Indirect sales can occur through one-tier or two-tier routes to market. In one-tier distribution, manufacturers supply resellers, which then supply end users. In two-tier distribution, manufacturers supply wholesale distributors, such as the Parties, which in turn supply resellers, which then supply end users. Resellers may operate simultaneously under both one-tier and two-tier models, acquiring some products directly from manufacturers and others from wholesale distributors .
(9) A range of different services may be associated with the distribution of IT products. Basic, large-scale delivery of products is generally referred to as “ broadline ” distribution. Broadline distribution is typically complemented by services such as credit services, e-commerce, logistical services and certain marketing services. Additional services, such as consulting or system configuration support, sales training, marketing, repair and financial solutions can also be offered by IT distributors. These services are generally referred to as “value added” services (or value added distribution, “VAD”). Resellers who also offer such additional services are commonly referred to as value-added resellers (“VARs”).
4.2. Product m arket definition
4.2.1. Previous Commission decisions
(10) In previous decisions, the Commission concluded that the distribution of IT products should be distinguished from the distribution of other electronic products. 5 Related services such as after-sales support, training and financial services to customers were considered as part of the same market. 6 Further distinctions between different product categories 7 or different sales channels 8 have been considered but left open.
4.2.2. Notifying Party's view
(11) The Notifyin g Party submits that the relevant product market consists of the distribution of all electronic products, including IT, consumer electronics and telecom products. However, if one were to distinguish between the distribution of IT, consumer electronics and telecom products, the Notifying Party considers that the relevant product market should not be narrower than a n overall IT distribution market.
(12) As regards a potential differentiation by products or by product categories, the Notifying Party argues that the services provided by distributors would be largely the same for all products. In addition, in the view of the Notifying Party, the growth of cloud services would further blur the distinctions between different IT products as they would be offered on a pay-per-use basis substituting a number of different categories of traditional IT equipment.
(13) Concerning a potential distinction between direct sales by manufacturers to end-customers and indirect sales via an IT distributor, the Notifying Party submits that both sale s channels would form part of an overall market for IT distribution because end-users and resellers would often switch between procuring products via direct or indirect sale s channels and that almost all IT manufacturers would also sell directly to end users.
(14) Furthermore, the Notifying Party claims that no distinction should be made between broadline distribution and VAD. The Notifying Party argues that there are no clear boundaries between these distribution models and that such boundaries c ould change t h roughout the life cycle of a product. Moreover, the type of services would often depend on the complexity and costs of the product. For this reason, a distinction between broadline distribution and VAD within high-end and midrange enterprise servers, enterprise network or enterprise storage equipment would not change significantly the shares in such market compared to the overall shares within such product category.
4.2.3. Results of the market investigation and Commission's assessment
(15) A small majority of respond e nts to the market investigation, including competitors, customers and vendors, considered that there is an overall market for the distribution of IT products that should not be further subdivided , while most of the others indicated that the market for IT distribution should be further subdivided . 9 Differentiations by product categories, between direct and indirect sales and by distribution models have been considered relevant each by th ose respond e nts which were in favour of additional distinctions within the market for IT distribution. 10
(16) As regards the conditions of supply by wholesale distributors of different categories of IT products, a small majority considered that there are no significant differences between different categories. 11 The market investigation also confirmed that the majority of distributors typically distr i b ut e several types of products. 12
(17) Concerning the sales channels, a small majority of the respondents to the market investigation considered that end customers would buy products indifferently direct ly from manufacturers or indirectly from wholesalers. 13 Moreover , in the view of the respondents, the supply in indirect sale s channels is to some extent constrained by the direct supply of manufacturers. 14
(18) As regards different distribution models, a majority of respondents replied that resellers and end-users would not consider broadline distribution and VAD as interchangeable. 15
(19) Based on the above, the Commission considers that the market investigation does not provide clear indication s as to the exact scope of the relevant product market . In any event , the definition of the relevant product market can be left open for the purposes of the present Decision as the Proposed Transaction does not raise serious doubts as to its compatibility with the internal market under any plausible product market definition.
4.3. Geographic market definition
4.3.1. Previous Commission decisions
(20) In previous decisions, the Commission left the exact geographic market definition for the distribution of IT products open. 16 Geographic market definitions considered for the distribution of IT products are EEA-wide, regional or national.
4.3.2. Notifying Party's view
(21) The Notifying Party submits that the relevant geographic market is EEA-wide or at least regional.
(22) The Notifying Party argues that , on the supply side, the leading manufacturers would operate on a global basis and would often have EEA-wide price lists. In addition, expanding into neighbouring countries would require only minimal investments for distributors and the growth of cloud services would further decrease national boundaries.
(23) On the demand side, according to the Notifying Party, prices of products would be often similar or identical in different Member States, resellers would receive shipments centrally and distribute them to other countries themselves and the requirements by customers in different Member States would be very similar and usually available in several language versions at no or limited extra costs.
4.3.3. Results of the market investigation and Commission's assessment
(24) During the market investigation, competitors of the Parties and manufacturers have been asked for which area distribution contracts are typically entered into. A majority of the respondents ticked the checkbox "national" (multiple answers have been possible), while less than half answered "regional (several countries within the EEA )", followed by the replies "EEA-wide" and, least often, "worldwide". 17 According to competitors and customers of the Parties, contracts between distributors and their customers are most often entered into on a national basis, followed by regional , EEA-wide and wor l d-wide. 18
(25) As to price lists used by manufacturers, a similar number of respondents stated that such price lists would typically cover each of the EEA, regions within the EEA or individual Member States . 19 Asked whether a national presence would be a key requirement for the distribution of IT products, more respondents answered "no" than "yes" , without, however, providing detailed reasons to support their answer. 20
(26) The Commission notes that these responses do not provide a clear indication as to the exact scope of the relevant geographic markets. In any event, t he definition of the geographic scope of the relevant product markets can, however, be left open for the purposes of the present Decision as the Proposed Transaction does not raise serious doubts as to its compatibility with the internal market under any plausible geographic market definition.
5. Competitive assessment
(27) The activities of the Parties overlap horizontally on the market for the wholesale distribution of IT products and some of its segments in the EEA and at the national level .
(28) The Proposed Transaction does not give rise to any vertical relationships as the Parties are not active in markets which are upstream or downstream from one another.
5.1. Wholesale distribution of all IT products
(29) On a market for the wholesale distribution of all IT products ( including direct and indirect sales ) the Proposed Transaction does not give rise to affected markets . A t EEA level the Parties' combined market share in 2015 would be [ 5 -10 ] % (Tech Data: [0-5] % and Avnet TS: [ 0 -5] %) and at national level below [ 1 0-20] % in all Member States where the P arties ' activities overlap .
(30) Similarly, on a market for the wholesale distribution of all IT products including indirect sales only, there are no affected markets . The market share of the Parties would be [5-10 ] % at EEA level (Tech Data: [5-10] % and Avnet TS: [0-5] %) and below [10-20] % at national level.
5.2. Wholesale distribution of narrower product segments
(31) Under possible narrower markets for the wholesale distribution of different IT products (including narrower markets for indirect and direct sales) , the Proposed Transaction gives rise to affected markets in potential national markets for the distribution of enterprise storage ( Austria, Belgium, Czech Republic, Germany, Luxembourg and the Netherlands ) , enterprise network (Belgium, Czech Republic, France, Germany, Luxembourg, the Netherlands, Poland and the United Kingdom) , non-enterprise storage and components (France) ; and, servers (high-end and midrange on the one hand, and volume servers on the other) (Austria, Belgium, Czech Republic, France, Germany, Ireland, Luxembourg, the Netherlands and the United Kingdom) .
(32) Conversely, the potential markets for the wholesale distribution of devices 21 , infrastructure 22 and software 23 product segments would not give rise to affected markets.
(33) In addition, the Proposed Transaction gives rise to affected markets in potential regional markets for the wholesale distribution of different IT products (including narrower markets for indirect and direct sales) , within the EEA. 24 T he following potential markets would be affected: (i) h igh-end and m idrange e nterprise s ervers in Czech Republic Served Region, GerAus and the UK region; (ii) v olume s ervers in Benelux, Czech Republic Served Region, GerAus and the UK region; (iii) e nterprise s torage in Benelux, Czech Republic Served Region and GerAus ; and, (iv) e nterprise n etwork in Benelux, Iberia and the UK region .
(34) Finally, according to data submitted by the Notifying Party, the Proposed Transaction does not give rise to affected markets 25 if the overall market for IT distribution would be split between VAD and broadline distribution on an EEA-wide, regional or national level . In addition , a further distinction between broadline distribution and VAD at the level of specific product categories in individual Member States would not lead to a significant change of the Parties' market shares on such markets . 26
(35) Sections 5.2.1 and 5.2.2 below describe respectively the Notifying Party's views on the Proposed Transaction and the Commission's assessment of the affected markets.
5.2.1. Notifying Party's view
(36) The Notifying Party argues that no competition concerns can be expected to arise in potential national or regional market s for the wholesale distribution of specific product segments for the following reasons .
(37) The Notifying Party submits that the IT distribution sector is highly fragmented as the Parties compete with manufacturers , other distributors and resellers. In most affected national market s , the Parties would have a low combined market share with low increments . 27 If the market within the EEA were sub-segmented in regional markets the Parties’ shares at the regional level would not be materially higher than those at the national level.
(38) A ccording to the Notifying Part y , there are many strong competitors in each potentially affected market segment (including ALSO, Ingram Micro, Arrow, Esprinet , Westcon - Comstor ) . Resellers who sell the products on to end users ( such as Bechtle , Computacenter, Media-Saturn, FNAC and Amazon), would also constitute alternatives to the Parties. In addition, m anufacturers would typically use several distributors in each geographic region. 28 Therefore, reseller customers 29 would also have a range of options to switch to. For a given product, most customers multisource from distributors of varying sizes and product portfolios. The key factors of competition are price and service quality, on which all distributors compete.
(39) Furthermore, manufacturers who sell directly to end-users establish end-user prices and therefore, distributors would have negligible pricing power. In addition, barriers to entry and expansion would be low, the Parties would not be particularly close competitors and technological innovation in the IT sector (notably the growth in cloud services) would give rise to increased competitive pressure. Finally, the Proposed Transaction would benefit consumers.
5.2.2. Commission 's assessment
5.2.2.1. General assessment of the affected markets
(40) T he Parties' and their competitors' market shares on each of the affected national markets are discussed in Sections 5.2.2.2 to 5.2.2.5 . Section 5.2.2.6 addresses specifically the potential regional markets .
(41) As will be shown, in most of the affected markets the combined market shares of the Parties are below 25% or the market share increment is small . According to the Guidelines on the assessment of horizontal mergers under the Council Regulation on the control of concentrations between undertakings ( the "Horizontal Guidelines") 30 , combined market shares below 25% may indicate that the concentration is not likely to impede effective competition. The market investigation has not revealed special circumstances which would indicate otherwise.
(42) The Commission notes that the Parties' combined market shares in countries where both Parties operate ( i.e. , have a physical presence) may not necessarily be representative since vendors who have few distributors (including the Parties), could decide to appoint additional distributors to compensate for the reduction in distributors compared to the volume of business. 31 As stated by a competitor: " the Transaction will open up opportunities for some distributors to obtain licences and grow their business. It is not unusual for a vendor to terminate an agreement with a distributor following an acquisition. Vendors who previously used both Avnet and Tech Data will wish to maintain the diversity of their route to market and will therefore appoint new distributors. Customers will also seek to diversify their sources of supply. " 32
(43) On all o f the affected markets ( including those where the combined market shares of the Parties would be higher than 25% ) the merged entity will continue to face competition from several strong competitor s which a re present on these markets and will continue to exert competitive constraint on the merged entity .
(44) During the market investigation the claims of the P arties were tested. R espondents to t he market investigation stated that manufacturers entrust the distribution of their IT products usually to three or four distributors per geographic area. 33 While for certain manufacturers the Parties distribute the same products in the same countries 34 , following the Transaction manufacturers will still have a choice between a sufficient number of distributors. 35 These alternative distributors include Ingram Micro, Arrow, ALSO , Esprinet , Copaco , Exertis and others. 36 The market investigation also did not bring to light any element that would indicate that vendors would not be able to appoint additional distributors for the ir products if they choose to do so . 37
(45) With regard to the customers of distributors, r espondents to the market investigation stated that c ustomers have many sources of supply and a large part of them procure from more than 5 distributors. 38 Most customers and competitors who responded to the market investigation consider that post-Transaction customers will have a sufficient number of distributors for the wholesale supply of IT products . 39 Distributors from which customers could purchase IT product s post-transaction include Ingram Micro, Arrow, ALSO, Copaco , Exertis , Westcon, TIM and others . 40
(46) Therefore, despite the fact that the market investigation has indicated that the distribution of IT products entails significant investment costs that make it difficult to enter this market 41 , sufficient players will remain post-transaction.
(47) While Tech Data and Avnet TS are seen by a large group of respondents as compet ing head-to-head for the distribution of IT products of manufacturers 42 , the market investigation did not provide a clear indication whether Tech Data and Avnet TS compet e closely for the supply of their IT products to customers . 43
(48) Most respondents do not see any negative impact of the transaction on their business 44 or in the affected markets. 45 A minority of competitors and customers stated that the transaction would have a negative impact in certain Member States due to the red u ction of distributors without further substantiating their concerns. 46 However, based on the feedback received by the vast majority of the respondents to the market investigation , it seems that , post merger , a sufficient number of distributors will continue to be active, including in those Member States where these unsubstantiated concerns were raised.
(49) With regard to the claims by certain respondents to the market investigation that the Proposed Transaction would have an impact in (all or some) affected markets 47 , the Commission refers to Sections 5.2.2.2 to 5.2.2.5 discussing the markets shares of the main distributors active in each affected market. For example, a few respondents claimed that the Proposed Transaction would have a negative impact in Austria, France, Germany, the Netherlands and the United Kingdom . Based on the submissions of the Notifying Party, i n these countries , among others, are active ALSO, Arrow Electronics, Ingram Micro, Westcon- Comstor and Nuvias .
5.2.2.2. Wholesale distribution of enterprise storage
(50) The Proposed Transaction gives rise to affected markets in the potential market for wholesale distribution of enterprise storage (indirect sales only) in Austria, Belgium, Czech Republic, Germany, Luxembourg and the Netherlands. In addition, the Proposed Transaction would lead to an affected market in the potential market for wholesale distribution of enterprise storage (direct and indirect sales) in the Czech Republic.
(51) An enterprise storage system is used to support the processing, management, and storage of digital data. International Data Corporation ("IDC"), a market analyst , defines an enterprise storage system (or disk system) as a set of storage elements, including controllers, cables, and (in some instances) a host bus adapter associated with three or more mass storage devices (hard disk drives (“HDDs”) or solid state drives (“SSDs”)) with the exception of entry-level business storage.
(52) The Parties' combined market shares for enterprise storage (indirect sales only) in 2015 would be:
Table 1 – Overview of the Parties' market shares (by value) in wholesale distribution of enterprise storage (indirect sales only)
<table><tr><td><p><span>2015</span></p></td><td><p><span>Tech Data</span></p></td><td><p><span>Avnet TS</span></p></td><td><p><span>Combined</span></p></td></tr><tr><td><p><span>Austria</span></p></td><td><p><span>[5-10]</span><span>%</span></p></td><td><p><span>[20-30]%</span></p></td><td><p><span>[30-40]%</span></p></td></tr><tr><td><p><span>Belgium</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>Czech Republic</span></p></td><td><p><span>[0-5]%</span></p></td><td><p><span>[30-40]%</span></p></td><td><p><span>[30-40]%</span></p></td></tr><tr><td><p><span>Germany</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>Luxembourg</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>Netherlands</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr></table>
Source: Form CO based on IDC, Context and the Parties
(53) On the basis of the information provided by the Notifying Party, the Parties' combined market shares would be [ 30 -40] % in Austria (Tech Data [ 5 -10] % and Avnet TS [ 2 0-30] %). The merged entity would become the largest distributor of enterprise storage in Austria. However, the merged entity will continue to face competition from AXIANS ICT (5-10%) and numerous other players , such as Ingram Micro, Arrow Electronics, ALSO, Kapsch BusinessCom , Dimension Data, A1 Telekom Austria , with a limited market share (each with <5%), but, at least in some cases (such as, for example, for Ingram Micro, Arrow Electronics and ALSO) , with the capability to significantly grow their business in case an important vendor decided to switch some of its business away from the merged entity .
(54) In Belgium the Parties would have a combined market share of [ 2 0-30 ] % (Tech Data: [ 1 0-20] % and Avnet TS [5-10] %) on th is potential market . Other competitors on this market include Arrow ( [ 20- 30 ] % ) , Ingram Micro ( [ 5-10 ] % ) , Copaco ( [ 5-10 ] % ) , Getronics ( [ 5-10 ] % ) , Econocom ( [ 5-10 ] % ) , Cegeka ( [ 5-10 ] % ) and others.
(55) In the Czech Republic , the merged entity would have a market share of [ 3 0-40 ] % ( Tech Data [0-5] % and Avnet TS [ 3 0-40] % ). However, the increment brought about by the Proposed Transaction would be [0-5 ] % , thus increasing only marginally Avnet TS' position in this potential market. Other players include DNS ( [ 20 -30 ] % ), Arrow ( [ 5-10 ] %) and other s .
(56) The Parties would have a combined market share of [ 2 0-30 ] % in Germany ( Tech Data [5-10] % and A vnet TS [10-20] % ). However, many other players remain , including TIM, ALSO , Ingram, Arrow, Westcon- Comstor and others . These distributors have a limited market share (each <5%), but, at least in some cases (such as, for example, for Ingram and Arrow), they have the capability to significantly grow their business in case an important vendor would decide to switch some of its business away from the merged entity .
(57) T he merged entity would have a market share in Luxembourg of [ 20 -30 ] % ( Tech Data [ 10 -20] % and Avnet TS [5-10] % ) , thus becoming the largest distributor on this potential market. However, the merged entity will continue to face competition from Arrow ( [ 10- 20 ] % ), Econocom Lux ( [ 10- 20] % ), Copaco ( [ 5-10 ] % ), Ingram Micro ( [ 5-10 ] % ), Post Lux ( [ 5-10 ] % ), Dimension Data Lux ( [ 5-10 ] % ), Telindus Lux ( [ 5-10 ] % ) and other distributors.
(58) In t he Netherlands the Parties would have a combined market share of [ 2 0-30 ] % ( Tech Data [ 5 -10] % and Avnet TS [ 10 -20] % ) . Post-Transaction, the Parties would become the largest distributor in the Netherlands in this potential market . However, a strong competitor of the Parties would be Copaco ( [ 20- 30 ] % ) as well as other smaller distributors with each less than 5% market share (including Ingram, ALSO , Westcon- Comstor and many others).
(59) The Parties' combined market share for enterprise storage (direct and indirect sales) in 2015 in the Czech Republic would be:
Table 2 – Overview of the Parties' market shares (by value) in wholesale distribution of enterprise storage (direct and indirect sales) (Czech Republic)
<table><tr><td><p><span>2015</span></p></td><td><p><span>Tech Data</span></p></td><td><p><span>Avnet TS</span></p></td><td><p><span>Combined</span></p></td></tr><tr><td><p><span>Czech Republic</span></p></td><td><p><span>[0-5]%</span></p></td><td><p><span>[20-30]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr></table>
Source: Form CO based on IDC, Context and the Parties
(60) The merged entity's market share in the Czech Republic would amount to [ 2 0-30 ] % (Tech Data [0-5] % and Avnet TS [ 2 0-30] % ). As in the potential market including only indirect sales, the increment would be low ( [0-5 ] % ). In addition, other players on the market include DNS ( [ 1 0 -20 ] % ) and many small players with less than 5% market share (including Arrow, AutoCont , ATOS, Comparex, HPE, IBM and Oracle) .
(61) Therefore, the Proposed Transaction does not raise serious doubts as regards its compatibility with the internal market with respect to the w holesale distribution of enterprise storage.
5.2.2.3. Wholesale distribution of enterprise network
(62) The Proposed Transaction gives rise to affected markets in the potential market for wholesale distribution of enterprise network (indirect sales only) in Belgium, Czech Republic, France, Germany, Luxembourg, the Netherlands, Poland and the United Kingdom. In addition, the Proposed Transaction would lead to an affected market in the potential market for wholesale distribution of enterprise network (direct and indirect sales) in Belgium and the Netherlands.
(63) IDC defines enterprise network as hardware purchased by enterprise customers for the implementation of wired and wireless computer networks, which may be utilized for the transfer of data and voice traffic. IDC’s definition of enterprise network includes the following products: router, switch, analog -to-digital converter, wide area network optimization (“WAN”), IP telephony, enterprise videoconferencing, and wireless local area network (“WLAN”).
(64) The Parties' combined market shares for enterprise network (indirect sales only) in 2015 would be:
Table 3 – Overview of the Parties' market shares (by value) in wholesale distribution of enterprise network (indirect sales only)
<table><tr><td><p><span>2015</span></p></td><td><p><span>Tech Data</span></p></td><td><p><span>Avnet TS</span></p></td><td><p><span>Combined</span></p></td></tr><tr><td><p><span>Belgium</span></p></td><td><p><span>[20-30]%</span></p></td><td><p><span>[0-5]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>Czech Republic</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>France</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[0-5]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>Germany</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>Luxembourg</span></p></td><td><p><span>[20-30]%</span></p></td><td><p><span>[0-5]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>Netherlands</span></p></td><td><p><span>[20-30]%</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>Poland</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>United Kingdom</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr></table>
Source: Form CO based on IDC, Context and the Parties
(65) In Belgium the combined market share of the Parties would be [ 2 0-30 ] % (Tech Data [20-30] % and Avnet TS [0-5] %). The market share increment resulting from the Transaction would be low ( [0-5 ] % ), hence Tech Data will marginally increase its position on the market in Belgium. In addition, the merged entity will face competition from Westcon- Comstor ( [ 2 0 -30 ] % ), Ingram Micro ( [ 10- 20] %), Dimension Data ( [ 10- 20] %) and others.
(66) In the Czech Republic the merged entity 's market share would be [ 2 0-30 ] % (Tech Data [ 1 0-20] % and Avnet TS [5-10] % ). In this potential market there are numerous other players such as DNS, Arrow, AutoCont , Comparex, ATOS and other distributors , with a limited market share (each with <5%), but, at least in some cases (such as, for example, for Arrow), with the capability to significantly grow their business in case an important vendor decided to switch some of its business away from the merged entity.
(67) T he Parties would have a combined market share in France of [ 20 -30 ] % (Tech Data [ 1 0-20] % and Avnet TS [0-5] %) . The market share increment resulting from the Proposed Transaction would be low ( [0-5 ] % ). Competitors of the Parties on this potential market would include Westcon- Comstor ( [ 1 0 -20 ] % ), Arrow ( [ 10- 20] %), ALSO ( [ 10- 20] %), DistriWan ( [ 5-10 ] %), Ingram ( [ 5-10 ] %), Axians ( [ 5-10 ] %), SCC ( [ 5-10 ] %) and others.
(68) T he merged entity would have a [ 20 -30 ] % market share in Germany (Tech Data [ 1 0-20] % and Avnet TS [5-10] %) , thus becoming the largest distributor on this potential market. However, the merged entity will continue to face competition from Ingram ( [ 1 0 -20 ] % ) and Westcon- Comstor ( [ 1 0 -20 ] %).
(69) The market share in Luxembourg of the Parties would be [ 20 -30 ] % (Tech Data [ 2 0-30] % and Avnet TS [0-5] %) , resulting in a low increment ( [0-5] %) of the market share of Tech Data. Therefore , the Proposed Transaction will only marginally increase Tech Data's position in this potential market. Competitors of the merged entity include Westcon- Comstor ( [ 10- 20 ] % ), Ingram Micro ( [ 5-10 ] %), Dimension Data Lux ( [ 5-10 ] %), Telindus Lux ( [ 5-10 ] %), Post Lux ( [ 5-10 ] %), Econocom Lux ( [ 5-10 ] %) and others.
(70) The merged entity's market share in the Netherlands would be [ 20 -30 ] % (Tech Data [ 2 0-30] % and Avnet TS [ 5 -10] %) . However, post-Transaction the Parties will continue to face competition from Westcon- Comstor ( [ 20- 30 ] % ), Dimension Data ( [ 1 0 -20 ] %), Ingram ( [ 5-10 ] %), KPN ( [ 5-10 ] %) and others.
(71) T he Parties ' market share in Poland would be [ 2 0-30 ] % (Tech Data [ 1 0-20] % and Avnet TS [ 10 -20] %) . While the Parties would gain a larger share of the market compared to pre-Transaction , RRC would still be the largest distributor in Poland ( [ 2 0 -30 ] % ) . Other competitors of the merged entity include Asseco Poland ( [ 20- 30 ] % ) , Qumak ( [ 5-10 ] % ) , Wasko ( [ 5-10 ] % ) and others.
(72) The merged entity would have a market share in the United Kingdom of [ 2 0-30 ] % (Tech Data [ 1 0-20] % and Avnet TS [5-10] % ) and become the second largest distributor in the United Kingdom. However, the merged entity will be facing competition from the strong competitors including Westcon- Comstor ( [ 2 0 -30 ] % ), Ingram ( [ 10- 20]% ) and BT ( [ 10- 20] %). In addition, smaller players with less than 5% on this potential market include Westcoast , Arrow, Exertis , SCC, C- Center , CDW, Insight, Softcat and others.
(73) The Parties' combined market shares for enterprise network (direct and indirect sales) in 2015 would be:
Table 4 – Overview of the Parties' market shares (by value) in wholesale distribution of enterprise network (direct and indirect sales)
<table><tr><td><p><span>2015</span></p></td><td><p><span>Tech Data</span></p></td><td><p><span>Avnet TS</span></p></td><td><p><span>Combined</span></p></td></tr><tr><td><p><span>Belgium</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[0-5]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>Netherlands</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[0-5]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr></table>
Source: Form CO based on IDC, Context and the Parties
(74) The Parties' combined market share in Belgium would be slightly above [ 20 -30 ] % if direct sales were included (Tech Data [ 1 0-20] % and Avnet TS [0-5] %). As in the market inc l uding indirect sales only, the market share increment resulting from the Transaction would be low ( [0-5 ] % ). In addition, the merge d entity will face competition from Westcon- Comstor ( [ 20- 30 ] % ), Cisco ( [ 1 0 -20 ] %), Dimension Data ( [ 10- 20] %), Ingram Micro ( [ 5-10 ] %) and others.
(75) In the Netherlands , the merged entity would have a market share (including direct sales) of [ 2 0-30 ] % (Tech Data [ 10 -20] % and Avnet TS [0-5] %). In this larger potential market, the Proposed Transaction would result in a low increment ( [0-5 ] % ). Many other strong competitors would remain in this market, including Westcon- Comstor ( [ 1 0 -20 ] % ), Dimension Data ( [ 10- 20] %), Cisco ( [ 10- 20] %), Ingram ( [ 5-10 ] %), KPN ( [ 5-10 ] %) and others.
(76) Therefore, the Proposed Transaction does not raise serious doubts as regards its compatibility with the internal market with respect to the w holesale distribution of enterprise network.
5.2.2.4. Wholesale distribution of non-enterprise storage and components
(77) The Proposed Transaction gives rise to affected markets in the potential market for wholesale distribution of non-enterprise storage and components ( indirect sales only) in France.
(78) Non-Enterprise storage and components includes the Parties’ sales of storage products which are not captured by the IDC segment “Enterprise Storage”. This segment includes hardware products such as autoloaders, graphics cards, HDD/SSD accessories, HDDs, SSDs, and removable memory .
(79) The Parties' combined market share for non-enterprise storage and components (indirect sales only) in 2015 would be:
Table 5 – Overview of the Parties' market shares (by value) in wholesale distribution of non-enterprise storage and components (indirect sales only)(France)
<table><tr><td><p><span>2015</span></p></td><td><p><span>Tech Data</span></p></td><td><p><span>Avnet TS</span></p></td><td><p><span>Combined</span></p></td></tr><tr><td><p><span>France</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[0-5]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr></table>
Source: Form CO based on IDC, Context and the Parties
(80) T he Parties' combined market share in France would be [ 2 0-30 ] % (Tech Data [ 1 0-20] % and Avnet TS [0-5] %). Tech Data would reinforce its position as the largest distributor in this potential market. However , the market share increment resulting from t he Proposed Transaction would be low ( [0-5 ] % ) and many other competitors remain on th is market including Ingram Micro ( [ 10- 20] % ), Acadia Infromatique ( [ 5-10 ] % ), Asialand ( [ 5-10 ] % ), ALSO ( [ 5-10 ] % ), Exertis ( [ 5-10 ] % ), Arrow ( [ 5-10 ] % ), and others.
(81) Therefore, the Proposed Transaction does not raise serious doubts as regards its compatibility with the internal market with respect to the w holesale distribution of non-enterprise storage and components .
5.2.2.5. Wholesale distribution of servers
(82) The Proposed Transaction gives rise to the following affected markets :
(a) the potential market s for wholesale distribution of high-end and midrange enterprise servers ( i ndirect s ales only) in Austria, France, Germany, Ireland and the Netherlands;
(b) the potential market for wholesale distribution of high-end and midrange enterprise servers ( direct and i ndirect s ales) in Austria; and,
(c) the potential market s for wholesale distribution of volume servers ( i ndirect s ales only) in Austria, Belgium, Czech Republic, Germany, Luxembourg a nd the United Kingdom.
(83) IDC defines a server system as a multi-user computing device that accesses and delivers services via a network. The server and the applications that run on it are typically shared by multiple users. Unlike a client device, a server does not usually have a user interface that is intended for human-machine interaction. IDC defines midrange enterprise server markets as all systems with an average selling value of USD 25 000–249 999, and high-end servers as those with an average selling value above USD 250 000.
(84) The Parties' combined market shares for h igh - e nd and m idrange e nterprise s ervers ( i ndirect s ales only ) in 2015 would be:
Table 6 – Overview of the Parties' market shares (by value) in wholesale distribution of high-end and midrange enterprise servers (indirect sales only)
<table><tr><td><p><span>2015</span></p></td><td><p><span>Tech Data</span></p></td><td><p><span>Avnet TS</span></p></td><td><p><span>Combined</span></p></td></tr><tr><td><p><span>Austria</span></p></td><td><p><span>[20-30]%</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[30-40]%</span></p></td></tr><tr><td><p><span>France</span></p></td><td><p><span>[20-30]%</span></p></td><td><p><span>[0-5]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>Germany</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[0-5]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>Ireland</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[50-60]%</span></p></td><td><p><span>[50-60]%</span></p></td></tr><tr><td><p><span>Netherlands</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr></table>
Source: Form CO based on IDC, Context and the Parties
(85) The merged entity would have a market share of [ 30 -40 ] % (Tech Data [ 2 0-30] % and Avnet TS [0-5] %) and become the largest distributor of High - End and Midrange Enterprise Servers in Austria . However, t he Parties will still face competition from Kapsch BusinessCom ( [ 1 0 -20 ] % ), Ingram ( [ 5-10 ] %), ALSO ( [ 5-10 ] %), Dimension Data ( [ 5-10 ] %), AXIANS ICT ( [ 5-10 ] %) and others.
(86) I n France the Parties' combined market share would be [ 2 0-30 ] % (Tech Data [ 20 -30] % and Avnet TS [0-5] %) . The Proposed Transaction will result in a low market share increment ( [0-5 ] % ) and many other strong competitors remain on the market including SCC ( [ 20- 30] %), ITS ( [ 1 0 -20 ] %), Axians ( [ 10- 20] %), Arrow ( [ 5-10 ] %), Also ( [ 5-10 ] %) and others.
(87) In Germany the merged entity would have a [ 20 -30 ] % market share (Tech Data [ 1 0-20] % and Avnet TS [0-5] %) . The market share increment resulting from the Proposed Transaction will be low ( [0-5 ] % ) and th e merged entity will continue to face competition from such players as ALSO ( [ 5-10 ] %), Arrow ( [ 5-10 ] %), Ingram ( [ 5-10 ] %) and others.
(88) The Parties' combined market shares in Ireland would be [ 5 0-60 ] % (Tech Data [5-10] % and Avnet TS [ 50 - 6 0] %) . However, based on the Notifying Party's submission E xertis is a strong er competitor than the Parties o n this market . In addition, Commtech , as well as o ther distributors with smaller market shares , would also exert competitive constraint on the merged entity. 48 As a result , post-Transaction, vendors would have sufficient alternative distributors to swi t ch to should they consider that the merged entity accounted for too high a share of their sales . In any event , during the market investigation, no respondent raised concerns concerning the impact of the Proposed Transaction on this potential market.
(89) The merged entity would have a market share of [ 2 0-30 ] % in the Netherlands (Tec h Data [ 1 0-20] % and Avnet TS [5-10] %). Other competitors on this market include Copaco ( [ 5-10 ] %), SLTN ( [ 5-10 ] %), KPN ( [ 5-10 ] %) and numerous other players, such as Ingram, Westcon- Comstor , ALSO , Dimension Data, Infotheek , Insight and Comparex , with a limited market share (each with <5%), but, at least in some cases (such as, for example, for Ingram and ALSO), with the capability to significantly grow their business in case an important vendor decided to switch some of its business away from the merged entity .
(90) The Parties' combined market share for high-end and midrange enterprise servers ( d irect a nd i ndirect s ales ) in 2015 would be:
Table 7 – Overview of the Parties' market shares (by value) in wholesale distribution of high-end and midrange enterprise servers (direct and indirect sales)
<table><tr><td><p><span>2015</span></p></td><td><p><span>Tech Data</span></p></td><td><p><span>Avnet TS</span></p></td><td><p><span>Combined</span></p></td></tr><tr><td><p><span>Austria</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[0-5]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr></table>
Source: Form CO based on IDC, Context and the Parties
(91) The merged entity would have a market share of [ 20 -30 ] % (Tech Data [ 1 0-20] % and Avnet TS [0-5] %) and become the largest distributor of High - End and Midrange Enterprise Servers in Austria also if direct sales were included. However, the Parties would still face competition from Kapsch BusinessCom ( [ 10- 20 ] % ), Dell-EMC ( [ 10- 20] %), Cisco ( [ 10- 20] %), Ingram ( [ 5-10 ] %), Dimension Data ( [ 5-10 ] % ), HPE ( [ 5-10 ] %) and others.
(92) The Parties' combined market shares for v olume s ervers ( i ndirect s ales only ) in 2015 would be:
Table 8 – Overview of the Parties' market shares (by value) in wholesale distribution of volume servers (indirect sales only)
<table><tr><td><p><span>2015</span></p></td><td><p><span>Tech Data</span></p></td><td><p><span>Avnet TS</span></p></td><td><p><span>Combined</span></p></td></tr><tr><td><p><span>Austria</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>Belgium</span></p></td><td><p><span>[20-30]%</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[30-40]%</span></p></td></tr><tr><td><p><span>Czech Republic</span></p></td><td><p><span>[0-5]%</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>Germany</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>Luxembourg</span></p></td><td><p><span>[50-60]%</span></p></td><td><p><span>[0-5]%</span></p></td><td><p><span>[50-60]%</span></p></td></tr><tr><td><p><span>United Kingdom</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr></table>
Source: Form CO based on IDC, Context and the Parties
(93) The merged entity would have a market share post-Transaction which is slightly above [ 20 -30 ] % (Tech Data [5-10] % and Avnet TS [10-20] %) in Austria and would be the second largest distributor behind ACP Group ( [ 40- 50] % ) . The merged entity will still face competition from other competitors including Kapsch BusinessCom ( [ 10- 20 ] % ) and Ingram ( [ 5-10 ] %).
(94) In Belgium , the Parties' combined market share would be [ 3 0-40 ] % (Tech Data [ 2 0-30] % and Avnet TS [5-10] % ), strengthening T e ch Data's postion as the current largest player. However, the Parties will face competition from Ingram Micro ( [ 1 0 -20 ] % ), Arrow ( [ 5-10 ] %), Econocom ( [ 5-10 ] %) and several other players.
(95) In the Czech Republic , the merged entity would have a market share of [ 2 0-30 ] % (Tech Data [0-5] % and Avnet TS [10-20] %). The Proposed Transaction would result in a low market share increment ( [0-5 ] % ), slightly reinforcing Avnet TS ' place a s the distributor with the second largest market share behind DNS ( [ 2 0 -30 ] %). Other distributors with smaller market shares (<5%) on this potential market would include Arrow, AutoCont , ATOS and Comparex.
(96) The Parties' combined market share in Germany would be [ 2 0-30 ] % (Tech Data [5-10] % and Avnet TS [ 1 0-20] %) . The merged entity would become the largest distributor in Germany. However, other significant distributors on this potential market include ALSO ( [ 1 0 -20 ] % ), Ingram ( [ 1 0 -20 ] %) and TIM ( [ 5-10 ] %).
(97) The market share of the merged entity in Luxembourg would be [ 50 -60 ] % (Tech Data [ 50 -60] % and Avnet TS [0-5] %) , thus slightly increasing Tech Data's position as the largest distributor in Luxembourg. However, the market share increment resulting from the Proposed Transaction would be low ( [0-5] %) and there are many other players on this market , such as Arrow ( [ 5-10 ] %), Ingram Micro ( [ 5-10 ] %), Copaco ( [ 5-10 ] %), Econocom Lux ( [ 5-10 ] %), Telindus Lux ( [ 5-10 ] %), Dimension Data Lux ( [ 5-10 ] %), Post Lux ( [ 5-10 ] %) and others.
(98) In the United Kingdom the combined market share of the Parties would be [ 2 0-30 ] % (Tech Data [ 1 0-20] % and Avnet TS [ 1 0-20] %). However, post-Transaction the Parties will face strong competition from Westcoast ( [ 1 0 -20 ] % ), Ingram ( [ 5-10 ] %), Exertis ( [ 5-10 ] %), Westcon- Comstor ( [ 5-10 ] %) and BT ( [ 5-10 ] %). Other players with less than 5% on this potential market include Arrow, C- Center , Insight, Softcat , CDW, SCC and others.
(99) Therefore, the Proposed Transaction does not raise serious doubts as regards its compatibility with the internal market with respect to the w holesale distribution of servers .
5.2.2.6. Assessment of potential regional markets
(100) In potential regional markets for certain IT product segments, the Proposed Transaction would give rise to the following affected markets:
(a) Excluding direct sales (i.e. indirect channel):
– High-end and Midrange Enterprise Servers in Czech Republic Served Region, GerAus , and the UK region;
– Volume Servers in Benelux, Czech Republic Served Region, GerAus , and the UK region;
– Enterprise Storage in Benelux, Czech Republic Served Region, and GerAus ; and,
– Enterprise Network in Benelux, Iberia, and the UK region.
(b) Including direct sales: Enterprise Network in Benelux .
(101) The Parties ' combined market shares for these regions in 2015 would be:
Table 9 – Overview of the Parties' market shares (by value) in potential regional markets (indirect sales only unless indicated otherwise)
<table><tr><td><p><span>2015</span></p></td><td><p/></td><td><p><span>Tech Data</span></p></td><td><p><span>Avnet TS</span></p></td><td><p><span>Combined</span></p></td></tr><tr><td><p><span>Enterprise Network (direct and indirect sales)</span></p></td><td><p><span>Benelux</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[0-5]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>Enterprise Network</span></p></td><td><p><span>Benelux</span></p></td><td><p><span>[20-30]%</span></p></td><td><p><span>[0-5]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p/></td><td><p><span>Iberia</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[0-5]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p/></td><td><p><span>UK Region</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>Enterprise Storage</span></p></td><td><p><span>Benelux</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p/></td><td><p><span>Czech Republic Served Region</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p/></td><td><p><span>GerAus</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>Volume Servers</span></p></td><td><p><span>Benelux</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p/></td><td><p><span>Czech Republic Served Region</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p/></td><td><p><span>GerAus</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p/></td><td><p><span>UK Region</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p><span>High-end and Midrange Enterprise Servers</span></p></td><td><p><span>Czech Republic Served Region</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p/></td><td><p><span>GerAus</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr><tr><td><p/></td><td><p><span>UK Region</span></p></td><td><p><span>[10-20]%</span></p></td><td><p><span>[5-10]%</span></p></td><td><p><span>[20-30]%</span></p></td></tr></table>
Source: Form CO based on IDC, Context and the Parties
(102) The merged entity would have a market share below 25% i n these potentially affected markets , except in e nterprise n etwork in Benelux ( [ 2 0-30 ] % ) and volume servers in the UK Region ( [ 2 0-30] %). However, as discussed for the affected national markets in Sections 5.2.2.2 to 5.2.2.5 , in all affected markets post-Transaction the merged entity will continue to face competition from numerous competitors.
(103) The only additional geographic area where there is an affected market (compared to the potential national markets) is Iberia, where e nterprise n etwork is an affected market in the indirect channel, despite the fact that it is not an affected market in either Spain or Portugal . 49 In this potential market, the combined market shares of the Parties post transaction would be [ 20 -30 ] % . However, the market share increment brough about by the Proposed Transaction would be low ( [0-5 ] % ). Based on the Parties' submission, other distributors that remain active in this region include Esprinet , Exertis , ADVEO and I nfotheek . 50
(104) Therefore, the Proposed Transaction does not raise serious doubts as regards its compatibility with the internal market with respect to the w holesale distribution of high-end and midrange enterprise servers, volume servers, enterprise storage and enterprise networ k in potential regional markets.
6. Conclusion
(105) For the above reasons, the European Commission has decided not to oppose the notified operation and to declare it compatible with the internal market and with the EEA Agreement. This decision is adopted in application of Article 6(1 )( b) of the Merger Regulation and Article 57 of the EEA Agreement .
For the Commission (Signed)
Margrethe VESTAGER Member of the Commission
<note>
(1) OJ L 24, 29.1.2004, p. 1 (the ' Merger Regulation ' ). With effect from 1 December 2009, the Treaty on the Functioning of the European Union ( ' TFEU ' ) has introduced certain changes, such as the replacement of ' Community ' by ' Union ' and ' common market ' by ' internal market ' . The terminology of the TFEU will be used throughout this decision.
(2) OJ L 1, 3.1.1994, p. 3 (the 'EEA Agreement').
(3) Publication in the Official Journal of the European Union No C 27 , 27.01.2017 , p. 20 .
(4) Turnover calculated in accordance with Article 5 of the Merger Regulation .
(5) See, for example, Commission decision M.6323 – Tech Data Europe/ MuM VAD Business, dated 27 October 2011, paragraph 12; Commission decision M.6577 – Avnet/ Magirus , dated 21 September 2012, paragraph 10; Commission decision M.7708 – ALSO/ PCF, dated 21 October 2015, paragraph 10.
(6) See, for example, Commission decision M.6323 – Tech Data Europe/ MuM VAD Business, dated 27 October 2011, paragraph 12; Commission decision M.6577 – Avnet/ Magirus , dated 21 September 2012, paragraph 10; Commission decision M.7708 – ALSO/ PCF, dated 21 October 2015, paragraph 10.
(7) See, for example, Commission decision M.5091 – Tech Data/ Scribona , dated 28 April 2008, paragraph 24; Commission decision M.6577 – Avnet/ Magirus , dated 21 September 2012, paragraph 16.
(8) See, for example, Commission decision M.6323 – Tech Data Europe/ MuM VAD Business, dated 27 October 2011, paragraph 24; Commission decision M.6577 – Avnet/ Magirus , dated 21 September 2012, paragraph 20.
(9) See replies to Q1 – questionnaire to competitors , question 5; replies to Q2 – questionnaire to customers , question 5; replies to Q3 – questionnaire to vendors , question 5.
(10) Multiple answers have been possible, s ee replies to Q1 – questionnaire to competitors , question 5.1; replies to Q2 – questionnaire to customers , question 5.1; replies to Q3 – questionnaire to vendors , question 5.1.
(11) See replies to Q1 – questionnaire to competitors , question 6; replies to Q2 – questionnaire to customers , question 6; replies to Q3 – questionnaire to vendors , question 6.
(12) See replies to Q1 – questionnaire to competitors , question 7; replies to Q2 – questionnaire to customers , question 7; replies to Q3 – questionnaire to vendors , question 7.
(13) See replies to Q1 – questionnaire to competitors , question 8; replies to Q2 – questionnaire to customers , question 8; replies to Q3 – questionnaire to vendors , question 8.
(14) On a scale between 1 (very much constrained) and 5 (not constrained), the average responses over all respondents in relation to price, speed of delivery, trade credit and after-sales support rank slightly below the middle; s ee replies to Q1 – questionnaire to competitors , question 9; replies to Q2 – questionnaire to customers , question 9; replies to Q3 – questionnaire to vendors , question 9.
(15) See replies to Q1 – questionnaire to competitors , question 12; replies to Q2 – questionnaire to customers , question 12; replies to Q3 – questionnaire to vendors , question 12.
(16) See, for example, Commission decision M.6323 – Tech Data Europe/ MuM VAD Business, dated 27 October 2011, paragraph 28; Commission decision M.6577 – Avnet/ Magirus , dated 21 September 2012, paragraph 27; Commission decision M.7708 – ALSO/ PCF, dated 21 October 2015, paragraph 17.
(17) See replies to Q1 – questionnaire to competitors , question 14; replies to Q3 – questionnaire to vendors , question 14.
(18) See replies to Q1 – questionnaire to competitors , question 15; replies to Q2 – questionnaire to customers , question 14.
(19) See replies to Q1 – questionnaire to competitors , question 16; replies to Q3 – questionnaire to vendors , question 15.
(20) See replies to Q1 – questionnaire to competitors , question 18; replies to Q2 – questionnaire to customers , question 16; replies to Q3 – questionnaire to vendors , question 16.
(21) The Parties' combined market share for the wholesale distribution of devices (direct and indirect sales) is [ 5-10 ] % at EEA level (Tech Data: [ 5-10 ] % and Avnet TS: [ 0-5 ] % ) and below [ 10-20 ] % at the national level. Excluding direct sales, the Parties' market share would be [ 5-10 ] % at EEA level (Tech Data: [ 5-10 ]% and Avnet TS: [ 0-5 ] % ) and below 20% at the national level.
(22) On the potential market for the wholesale distribution of infrastructure, the Parties' combined market share is, at EEA level, [ 5-10]% (Tech Data: [ 0-5 ] % and Avnet TS: [ 0-5 ] % )(direct and indirect sales) and [ 10-20]% excluding direct sales (Tech Data: [ 5-10]% and Avnet TS: [ 0-5 ] % ). On this potential market the Parties' market share would be below [ 10-20 ]% at the national level (direct and indirect sales). Excluding direct sales, the Parties' combined market shares would be below [ 10-20]% at the national level, except in Luxembourg, where the Paries ' combined market share would be [ 2 0- 3 0]% (Tech Data: [ 10-20]% and Avnet TS: [ 0-5 ] % ). However, the Commission notes that in Luxembourg, the market share increment resulting from the Proposed Transaction will be low [ 0-5 ] % ). In addition, there appear to be strong competitors active in Luxembourg including Arrow Electronics, Westcom-Comstor , Ingram Micro, Exclusive Networks and Nuvias .
(23) T he Parties' combined market share o n the potential market for the wholesale distribution of software , is, at EEA level, [ 0-5 ] % (Tech Data: [ 0-5 ] % and Avnet TS: [ 0-5 ] % )(direct and indirect sales) and [ 5-10]% excluding direct sales (Tech Data: [ 5-10]% and Avnet TS: [ 0-5 ] % ). On this potential market the Parties' market share would be below [ 5-10 ]% at the national level (direct and indirect sales). Excluding direct sales, the Parties' combined market shares would be below [ 10 - 2 0 ]% at the national level .
(24) The affected regional markets considered for the purpose of this decision are […] : " Benelux " (Belgium, the Netherlands, Luxembourg) ; " GerAus " (Germany and Austria) ; " Iberia " (Spain and Portugal) ; and, the " UK region " ( UK and Ireland ) . In addition, […] Austria, Czech Republic, Germany and Slovakia ( " Czech Republic Served Region " ).
(25) The Notifying Party provided market share estimates for 2013, 2014 and 2015. On the basis of the data for 2013, the potential markets for VAD and for broadline distribution (indirect sales only) in the Netherlands would be affected (with market shares of [ 10 - 2 0]% and an increment of [ 0 - 5 ]% for VAD and of [ 20 - 3 0]% and an increment of [ 0 - 5 ]% for broadline distribution). However, on the basis of the data for 2014 and 2015, these potential markets would not be affected.
(26) According to the Notifying Party, certain products – generally higher priced, complex products – would typically be purchased via VAD services while other products – generally more commoditised products – would typically be purchased via broadline distribution services. The Notifying Party states that most of the affected markets concern products that tend to be sold by VADs. Notably concerning products in the Infrastructure market segment, which includes inter alia the product categories "Enterprise Storage", "Enterprise Network" and "High-End & Mid-Range Servers", the Notifying Party states that [a very large part] of the sales of Tech Data can be attributed to its VAD business units. Therefore, even if one would consider further distinguishing between VAD and broadline distribution on markets for specific product categories in individual Member States, the shares in such potential markets would not change significantly and the assessment of such markets as laid out in this decision would also apply to them.
(27) According to the Notifying Party, t he possible affected markets in which the Parties’ combined shares are high er are the possible market for indirect sales of high- and mid-range servers in Ireland ( [50-60 ] % ) and the possible market for indirect sales of volume servers in Luxembourg ( [50-60] %). The Notifying Party submits that the total size of these markets is small (EUR [ … ] million and EUR [ … ] million, respectively) and that due to cross-border trade and commonality of market participants between Ireland and the UK, and Belgium and Luxembourg, the Parties' combined market shares for the UK ( [10-20] %) and Belgium ( [30-40] %) would be more reflective of market reality.
(28) As far as vendors are concerned, the Notifying Party submits that several vendors (such as Cisco, IBM, Lenovo, and HPE) all have policies of having two to three distributors at a time per country or region. For a given country or region, vendors typically work with a combination of pan-European distributors and local/regional distributors.
(29) According to the Notifying Party, resellers in the EEA typically multi-source products from between 4 to 8 separate distributors and they constantly shift orders between these suppliers.
(30) Guidelines on the assessment of horizontal mergers under the Council Regulation on the control of concentrations between undertakings, OJ C31, 5.02.2004, p. 5, paragraph 18.
(31) S e ver a l resp ond e n ts to the market investigation stated that , following the Transaction , the y w o u ld assess the distribution landscape for their products and services. As a manufacturer stated: " we will take the opportunity to nominate additional Distributors in countries in the EEA, where the number of Distributors is low in comparison to the potential volume of business " . Ot h er r espond ent s sta ted that they would not likely enter into a distribution agreement with an additional distributor. A manufacturer responded that it " already entrusts the distribution of the products in scope to a sufficient number of distributors " . See replies to Q3 – questionnaire to vendors, questions 20.2 and 20.2.1.
(32) See replies to Q1 – questionnaire to competitors, question 34.6.
(33) See replies to Q1 – questionnaire to competitors, question 20; see replies to Q3 – questionnaire to vendors, question 18. Respondents to the market investigation mentioned that the number of distributors per vendor depends on factors, such as the size of the market, the size of the vendor or the range of products distributed.
(34) See replies to Q3 – questionnaire to vendors, questions 20 and 20.1.
(35) See replies to Q1 – questionnaire to competitors, question 22; see replies to Q3 – questionnaire to vendors, question 21.
(36) See replies to Q1 – questionnaire to competitors, question 23; see replies to Q3 – questionnaire to vendors, question 22.
(37) See replies to Q3 – questionnaire to vendors, question 20.2. 1.
(38) See replies to Q1 – questionnaire to competitors, question 24; see replies to Q2 – questionnaire to customers, question 18.
(39) See replies to Q1 – questionnaire to competitors, question 26; see replies to Q2 – questionnaire to customers, question 20.
(40) See replies to Q1 – questionnaire to competitors, question 27; see replies to Q2 – questionnaire to customers, question 21.
(41) See replies to Q1 – questionnaire to competitors, question 31; see replies to Q2 – questionnaire to customers, question 25; see replies to Q3 – questionnaire to vendors, question 26.
(42) See replies to Q1 – questionnaire to competitors, question 21; see replies to Q3 – questionnaire to vendors, question 19.
(43) See replies to Q1 – questionnaire to competitors, question 25; see replies to Q2 – questionnaire to customers, question 19. Of the competitors who provided a meaningful response to this question, a majority considers that the Parties compete head-to-head. However, at the same time a majority of customers stated that the Parties do not compete head-to-head for the supply of IT products to customers.
(44) See replies to Q1 – questionnaire to competitors, question 35; see replies to Q2 – questionnaire to customers, question 29; see replies to Q3 – questionnaire to vendors, question 30.
(45) See replies to Q1 – questionnaire to competitors, question s 3 4.1-34.4 ; see replies to Q2 – questionnaire to customers, question s 28.1-28.4 ; see replies to Q3 – questionnaire to vendors, question 29.1-29.4 .
(46) See replies to Q1 – questionnaire to competitors, questions 34.1-34. 6 ; see replies to Q2 – questionnaire to customers, questions 28.1-28. 6 .
(47) See replies to Q1 – questionnaire to competitors, question 34.6; see replies to Q2 – questionnaire to customers, question 28.6.
(48) T he Parties submit that IDC’s estimate of the indirect channel segment size for high-end and midrange servers in Ireland is too small, resulting in an overstatement of the Parties’ presence in this segment. Likewise, the Parties’ best estimates of competitors’ sales by value in this segment would together represent more than 100% of the indirect channel based on the IDC estimate.
(49) In Portugal, Tech Data’s market share is [ 3 0-40 ] % and Avnet’s is [ 0 -5] %. In Spain, Tech Data’s market share is [ 1 0-20 ] % and Avnet’s share is [0-5] %.
(50) Form CO, Annex 8.
</note> | ENG | 32017M8248 |
<table><col/><col/><col/><tbody><tr><td><img/></td><td><p>Official Journal<br/>of the European Union</p></td><td><p>EN</p><p>Series L</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>2024/199</p></td><td><p>4.1.2024</p></td></tr></tbody></table>
COUNCIL DECISION (EU) 2024/199
of 13 November 2023
on the signing, on behalf of the Union, and provisional application of the Agreement between the European Union and the Principality of Liechtenstein on supplementary rules in relation to the Instrument for Financial Support for Border Management and Visa Policy, as part of the Integrated Border Management Fund, for the period 2021 to 2027
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 77(2), in conjunction with Article 218(5) thereof,
Having regard to the proposal from the European Commission,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>On 21 February 2022, the Council authorised the Commission, by Council Decision (EU) 2022/442 <a>(<span>1</span>)</a>, to open negotiations with Iceland, the Kingdom of Norway, the Swiss Confederation and the Principality of Liechtenstein for the arrangements on the financial contributions of those countries and the supplementary rules necessary for their participation, including provisions ensuring the protection of the Union’s financial interests and the powers of audit of the Court of Auditors, to be concluded pursuant to Regulation (EU) 2021/1148 of the European Parliament and of the Council <a>(<span>2</span>)</a>. The negotiations with the Principality of Liechtenstein were successfully concluded by the initialling of an Agreement on 16 June 2023.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Decision and is not bound by it or subject to its application.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>This Decision constitutes a development of the provisions of the Schengen<span>acquis</span> in which Ireland does not take part, in accordance with Council Decision 2002/192/EC <a>(<span>3</span>)</a>. Ireland is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The Agreement between the European Union and the Principality of Liechtenstein on supplementary rules in relation to the Instrument for Financial Support for Border Management and Visa Policy, as part of the Integrated Border Management Fund, for the period 2021 to 2027 should be signed on behalf of the Union. Certain provisions of that Agreement should be applied on a provisional basis, pending the completion of the procedures necessary for its entry into force,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
The signing on behalf of the Union of the Agreement between the European Union and the Principality of Liechtenstein on supplementary rules in relation to the Instrument for Financial Support for Border Management and Visa Policy, as part of the Integrated Border Management Fund, for the period 2021 to 2027 (the ‘Agreement’) is hereby authorised, subject to the conclusion of the Agreement ( 4 ) .
Article 2
The President of the Council is hereby authorised to designate the person(s) empowered to sign the Agreement on behalf of the Union.
Article 3
The Agreement, with the exception of its Article 5, shall be applied on a provisional basis in accordance with its Article 13(6) as from the day following its signature, pending the completion of the procedures necessary for its entry into force.
Article 4
This Decision shall enter into force on the day of its adoption.
Done at Brussels, 13 November 2023.
For the Council
The President
J. BORRELL FONTELLES
( 1 ) Council Decision (EU) 2022/442 of 21 February 2022 authorising the opening of negotiations with Iceland, the Kingdom of Norway, the Swiss Confederation and the Principality of Liechtenstein with a view to concluding agreements between the European Union and those countries on supplementary rules in relation to the Instrument for Financial Support for Border Management and Visa Policy, as part of the Integrated Border Management Fund ( OJ L 90, 18.3.2022, p. 116 ).
( 2 ) Regulation (EU) 2021/1148 of the European Parliament and of the Council of 7 July 2021 establishing, as part of the Integrated Border Management Fund, the Instrument for Financial Support for Border Management and Visa Policy ( OJ L 251, 15.7.2021, p. 48 ).
( 3 ) Council Decision 2002/192/EC of 28 February 2002 concerning Ireland’s request to take part in some of the provisions of the Schengen acquis ( OJ L 64, 7.3.2002, p. 20 ).
( 4 ) The text of the Agreement is published in OJ L, 2024/200, 4.1.2024, ELI: http://data.europa.eu/eli/agree_internation/2024/200/oj
ELI: http://data.europa.eu/eli/dec/2024/199/oj
ISSN 1977-0677 (electronic edition) | ENG | 32024D0199 |
<table><col/><col/><col/><col/><tbody><tr><td><p>20.3.2023   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>C 103/1</p></td></tr></tbody></table>
COMMISSION RECOMMENDATION
of 14 March 2023
on Energy Storage – Underpinning a decarbonised and secure EU energy system
(2023/C 103/01)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The Commission has put forward the European Green Deal, the strategy aiming at achieving climate neutrality by 2050, among others <a>(<span>1</span>)</a>. In this context, the Fit for 55 package <a>(<span>2</span>)</a> aims at reducing net greenhouse gas emissions by at least 55 % by 2030. Moreover, and against the background of Russia’s unprovoked invasion of Ukraine and weaponisation of its energy supply, the REPowerEU Communication <a>(<span>3</span>)</a> and plan <a>(<span>4</span>)</a> propose measures to rapidly end the dependence on Russian fossil fuels and tackle the energy crisis by accelerating the clean energy transition and joining forces to achieve a more resilient energy system.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Given that the production and use of energy account for more than 75 % of the Union’s greenhouse gas emissions, decarbonising the energy system is crucial to reaching those targets. To achieve the Union’s climate and energy targets, the energy system is undergoing a profound transformation characterised by improved energy efficiency, the massive and rapid deployment of variable renewable energy generation, more players, more decentralised, digitalised and interconnected systems and increased electrification of the economy. Such a system transformation requires more flexibility, understood as the energy system’s ability to adapt to changing needs of the grid and manage variability and uncertainty of demand and supply across all relevant timescales. Models <a>(<span>5</span>)</a> show a direct relationship, sometimes exponential, between the need for flexibility (daily, weekly and monthly) and renewable generation deployment. As a result, the need for flexibility will be particularly relevant in the coming years as the share of renewable energy in the electricity system is expected to reach 69 % by 2030.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>New operational challenges also call for additional services in the future electricity system (e.g. for balancing and non-frequency ancillary services <a>(<span>6</span>)</a>) to ensure stability and reliability and ultimately security of electricity supply.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Different technologies can provide the energy system with the necessary flexibility, such as energy storage, demand response, supply-side flexibility and interconnections. In particular, different energy storage technologies (e.g. mechanical, thermal, electrical, electro-chemical and chemical) can provide diverse services on different scales and at different timeframes. For example, thermal storage, in particular large thermal storage in district heating systems, can provide flexibility and balancing services to the electricity grid and therefore provides a cost-saving system integration solution by absorbing variable renewable electricity production (e.g. wind and solar energy). In addition, energy storage technologies can be a technical solution to provide stability and reliability.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Energy storage in the electricity system is defined in Article 2(59) of Directive (EU) 2019/944 of the European Parliament and of the Council <a>(<span>7</span>)</a> covering different technologies. Directive (EU) 2019/944 addresses the participation of energy storage in the electricity market, including the provision of flexibility services on a level playing field with other energy resources.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Beyond the electricity system, the storage of energy, such as thermal storage, can contribute to the energy system in multiple ways. For example, energy storage that complements renewable heating and cooling generators as part of individual and district heating systems allows a higher proportion of heating demand to be covered by variable and low-temperature renewable sources, such as shallow geothermal, solar thermal and ambient energy. Promoting these renewable heating systems is essential to shift away from fossil fuel-based heating systems, in particular in buildings.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Energy storage can play a crucial role in decarbonising the energy system, contributing to energy system integration and security of supply. A decarbonised energy system will require significant investment in storage capacity of all forms. Energy storage technologies can facilitate the electrification of different economic sectors, notably buildings and transport. For example, through the uptake of electric vehicles and their participation in the balancing of the electricity grid via demand response (e.g. by absorbing excess electricity in times of high renewable generation and low demand). The energy stored in electric vehicle batteries can also be effectively used to power homes and help stabilise the grid.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Energy storage, in particular ‘behind the meter’, can help consumers, both households and industries, to maximise self-consumption of self-produced renewable energy, making it possible for these consumers to reduce their energy bills.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>For energy systems that are less or not interconnected, such as islands, remote areas or the EU’s outermost regions flexibility resources, notably energy storage, can significantly help to move away from imported fossil fuels and manage high levels of short-term and seasonal variability in renewable energy supply.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>Energy storage faces a number of challenges that can affect its deployment to the levels necessary to significantly support the energy transition. Some of these challenges are related to a need for long-term visibility and predictability of revenues to facilitate access to finance.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>The Union electricity market is designed to already allow energy storage to participate in all electricity markets. This provides a basis to combine different revenue streams (revenue stacking) in order to support the viability of the storage business model and allow the maximum added value of energy storage for the energy system.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>The Guidelines on State aid for climate, environmental protection and energy <a>(<span>8</span>)</a> encourage Member States to introduce additional criteria or features in their security of supply measures to promote the participation of greener technologies (or reduce the participation of polluting technologies) necessary to support the delivery of the EU’s environmental protection objectives. Such criteria or features are expected to increase the proportion of storage benefitting from security of supply measures.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>Transmission system operators are required to take into account the potential for the use of energy storage facilities in their 10-year network development plan <a>(<span>9</span>)</a>. However, the typical operation pattern of energy storage – injecting electricity into the grid when generation levels are low and consuming electricity when they are high – can be further exploited when planning networks. Consumption from the grid during peak hours can be reduced through well-designed network charges and tariff schemes that strengthen the use of flexibility tools such as energy storage.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>The sharing of stored electricity has the potential to deliver wider benefits to the system through demand response, when final customers are exposed to appropriate price signals or are allowed to participate in flexibility schemes. As provided in Directive (EU) 2019/944, jointly acting final customers should not be exposed to double charges when providing flexibility services to system operators using front-of-the-meter storage facilities.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>The update of the national energy and climate plans for 2021-2030 as provided for in Article 14 of Regulation (EU) 2018/1999 on the governance of the Energy Union and Climate Action <a>(<span>10</span>)</a> should include greater ambition to speed up the green transition and increase energy security in line with the European Green Deal Package <a>(<span>11</span>)</a> and REPowerEU. The update of the national energy and climate plans should also include national objectives to increase system flexibility pursuant to Article 4(d)(3) of that Regulation.. Those updated national plans should also table relevant policies and measures to support investment needs identified under the REPowerEU as well as the key priority of protecting EU competitiveness and attractiveness with regard to global partners, while taking into account environmental impacts, particularly on habitats and ecosystems <a>(<span>12</span>)</a>. The national energy and climate plans are the opportunity to explore synergies across the five dimensions of the Energy Union <a>(<span>13</span>)</a>, in particular as regards benefits of electricity storage,</p></td></tr></tbody></table>
RECOMMENDS:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><span>Member States take into account the double role (generator-consumer) of energy storage when defining the applicable regulatory framework and procedures, in particular when implementing the Union legislation concerning the electricity market, in order to remove existing barriers. This includes preventing double taxation and facilitating permit-granting procedures <a>(<span>14</span>)</a>. National regulatory authorities should also consider such a role when setting network charges and tariff schemes, in compliance with Union legislation.</span></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><span>Member States identify the flexibility needs of their energy systems in the short, medium and long term, and in their updates of the national energy and climate plans strengthen the objectives and related policies and measures that aim to cost effectively promote the deployment of energy storage, both utility-scale and behind-the-meter storage, demand response and flexibility. Member States should also assess manufacturing capacity needs for the relevant energy storage technologies.</span></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><span>Member States, in particular their national regulatory authorities, ensure that energy system operators further assess the flexibility needs of their energy systems when planning transmission and distribution networks, including the potential of energy storage (short- and long-term duration) and whether energy storage can be a more cost effective alternative to grid investments. They should also consider the full potential of flexibility sources, in particular energy storage, when assessing their connection capacity (e.g. considering flexible connection contracts) and operating the system.</span></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><span>Member States identify potential financing gaps for short-, medium- and long-term energy storage, including behind-the-meter (thermal and using electricity) and other flexibility instruments, and if a need for additional flexible resources to achieve security of supply and environmental objectives is identified, consider the potential need for financing instruments that provide visibility and predictability of revenues.</span></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><span>Member States explore whether energy storage services - in particular the use of flexibility in distribution networks and the provision of non-frequency ancillary services - are sufficiently remunerated, and whether operators can add up the remuneration of several services.</span></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><span>Member States to consider competitive bidding processes if necessary to reach a sufficient level of deployment of flexibility sources to achieve transparent security of supply and environmental objectives, in line with State Aid rules. Potential improvements should be explored in the design of capacity mechanisms to facilitate the participation of flexibility sources including energy storage, e.g. by ensuring de-rating factors are appropriate in light of the security of supply objective pursued, reducing minimum eligible capacity and minimum bid size, facilitating aggregation, lowering the CO<span>2</span> emission limits, or prioritising greener technologies, in line with the Guidelines on State aid for climate, environmental protection and energy.</span></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><span>Member States identify any specific actions, regulatory and non-regulatory, necessary to remove barriers to the deployment of demand response and behind-the-meter storage, e.g. linked to the uptake of electrification of end use sectors based on renewable energy sources, the deployment of individual or collective self-consumption and to bidirectional charging through the use of electric vehicle batteries.</span></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><span>Member States accelerate the deployment of storage facilities and other flexibility tools in islands, remote areas and the EU’s outermost regions areas with insufficient grid capacity and unstable or long-distance connections to the main grid, for example through support schemes for low carbon flexible resources, including storage, and revise the network connection criteria to promote hybrid energy projects (i.e. renewable generation and storage).</span></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><span>Member States and national regulatory authorities publish detailed data on network congestion, renewable energy curtailment, market prices, renewable energy and greenhouse gas emission content in real time, as well as installed energy storage facilities, to facilitate investment decisions on new energy storage facilities.</span></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><span>Member States continue to support research and innovation in energy storage, in particular long-term energy storage and storage solutions coupling electricity with other energy carriers, and to optimise existing solutions (e.g. efficiency, capacity, duration, minimal climate and environmental footprint). Consideration should be given to de-risking instruments, such as technology accelerator programmes and dedicated support schemes that guide innovative energy storage technologies through to the commercialisation stage.</span></td></tr></tbody></table>
Done at Brussels, 14 March 2023.
For the Commission
Kadri SIMSON
Member of the Commission
<note>
( 1 ) COM(2019) 640 final. The European Green Deal also includes objectives beyond climate neutrality, such as halting biodiversity loss, reducing and eliminating pollution, and decoupling economic growth from resource use through circular economy approaches.
( 2 ) COM(2021) 550 final
( 3 ) COM(2022) 108 final.
( 4 ) COM(2022) 230 final.
( 5 ) See section 2.2 of the SWD(2023) 57
( 6 ) As defined in Article 2(45) and 2(49) of Directive (EU) 2019/944 ( OJ L 158, 14.6.2019, p. 125 ).
( 7 ) Directive (EU) 2019/944 of the European Parliament and of the Council of 5 June 2019 on common rules for the internal market for electricity and amending Directive 2012/27/EU ( OJ L158, 14.6.2019, p.125 ).
( 8 ) Communication from the Commission – Guidelines on State aid for climate, environmental protection and energy 2022, C/2022/481 ( OJ C 80, 18.2.2022, p. 1 ).
( 9 ) Regulation (EU) No 347/2013 of the European Parliament and of the Council of 17 April 2013 on guidelines for trans-European energy infrastructure, ( OJ L 115, 25.4.2013, p. 39 ).
( 10 ) OJ L 328, 21.12.2018, p. 1 .
( 11 ) https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/european-green-deal/delivering-european-green-deal_en#documents
( 12 ) In order to achieve the European Green Deal’s goals and respect the ‘do no harm’ principle, it is also necessary to take into account broader environmental trade-offs of energy storage and provide solutions to their mitigation or neutralisation.
( 13 ) COM(2015) 80.
( 14 ) See also Commission Recommendation (EU) 2022/822 of 18 May 2022 on speeding up permit-granting procedures for renewable energy projects and facilitating Power Purchase Agreements ( OJ L 146, 25.5.2022, p. 132 ), and Council Regulation (EU) 2022/2577 of 22 December 2022 laying down a framework to accelerate the deployment of renewable energy ( OJ L 335, 29.12.2022, p. 36 ).
</note> | ENG | 32023H0320(01) |
<table><col/><col/><col/><col/><tbody><tr><td><p>13.12.2021   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>LI 445/7</p></td></tr></tbody></table>
COUNCIL IMPLEMENTING REGULATION (EU) 2021/2194
of 13 December 2021
implementing Regulation (EU) No 36/2012 concerning restrictive measures in view of the situation in Syria
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EU) No 36/2012 of 18 January 2012 concerning restrictive measures in view of the situation in Syria and repealing Regulation (EU) No 442/2011 ( 1 ) , and in particular Article 32(1) thereof,
Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>On 18 January 2012, the Council adopted Regulation (EU) No 36/2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The Council remains deeply concerned about the situation in Syria.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The Wagner Group, a Russia-based unincorporated private military entity, provides a crucial contribution to Bashar al-Assad’s war efforts in Syria, in particular by training and directing Syrian forces and regime-affiliated militias.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The Council considers that two persons involved in the military operations of the Wagner group in Syria, as well as three companies benefiting from and supporting the Syrian regime should be added to the list of natural and legal persons, entities or bodies subject to restrictive measures in Annex II to Regulation (EU) No 36/2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Regulation (EU) No 36/2012 should therefore be amended accordingly,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Annex II to Regulation (EU) No 36/2012 is amended as set out in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the date of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 December 2021.
For the Council
The President
J. BORRELL FONTELLES
( 1 ) OJ L 16, 19.1.2012, p. 1 .
ANNEX
Annex II to Regulation (EU) No 36/2012 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The following entries are added to the list set out in Section A (Persons):</p><table><col/><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Name</p></td><td><p>Identifying information</p></td><td><p>Reasons</p></td><td><p>Date of listing</p></td></tr><tr><td><p>‘316.</p></td><td><p>Andrey Nikolaevich TROSHEV</p><p>(a.k.a. Andrei Mykolayvych TROSHEV)</p><p>Андрей Николаевич ТРОШЕВ</p></td><td><p>Position(s): Retired colonel, Founding member and Executive Director (Chief of Staff) of the Wagner Group;</p><p>Rank: Retired Colonel;</p><p>Call sign: Siedoy;</p><p>Date of birth: 5.4.1953;</p><p>Place of birth: Leningrad, former USSR (now Russian Federation);</p><p>Nationality: Russian;</p><p>Relatives/Associates: Dimitriy Utkin (Wagner Group Founder); Andrey Bogatov (Head of the 4th Attack and Reconnaissance Company of the Wagner Group), Aleksandr Sergeevich Kuznetsov (Commander of the 1st Attack and Reconnaissance Company of the Wagner Group);</p><p>Gender: male</p></td><td><p>Executive Director (Chief of Staff) of the Wagner Group, which operates in Syria and trains and directs Syrian forces. The Wagner Group also supports the Assad regime and fights alongside regime-affiliated militias and the Syrian army.</p><p>Andrey Troshev is directly involved in the military operations of the Wagner Group in Syria. He was particularly involved in the area of Deir ez-Zor. As such, he provides a crucial contribution to Bashar al-Assad’s war effort and therefore supports and benefits from the Syrian regime.</p></td><td><p>13.12.2021</p></td></tr><tr><td><p>317.</p></td><td><p>Andrey Mikhailovich BOGATOV</p><p>(a.k.a. Andrei Mychailovych BOGATOV)</p><p>Андрей Михайлович БОГАТОВ</p></td><td><p>Position(s): Head of the 4th Attack and Reconnaissance Company of the Wagner Group;</p><p>Call sign: Brodiaga;</p><p>Wagner group ID: M-1601;</p><p>Date of birth: 14.6.1964;</p><p>Place of birth: Stary Oskol , Belgorod region , former USSR (now Russian Federation);</p><p>Nationality: Russian;</p><p>Relatives/Associates: Dimitriy Utkin (Wagner Group Founder); Andrey Nikolaevich Troshev (Founding member and Executive Director (Chief of Staff) of the Wagner Group), Aleksandr Sergeevich Kuznetsov (Commander of the 1st Attack and Reconnaissance Company of the Wagner Group);</p><p>Gender: male</p></td><td><p>Head of the 4th Attack and Reconnaissance Company of the Wagner Group, which operates in Syria and trains and directs Syrian forces. The Wagner Group also supports the Assad regime and fights alongside regime-affiliated militias and the Syrian army.</p><p>Andrey Bogatov commands the operations of the Wagner Group and is directly involved in the military operations of the Wagner Group in Syria. He was particularly involved in the battle of Palmyra. As such, he provides a crucial contribution to Bashar al-Assad’s war effort and therefore supports and benefits from the Syrian regime.</p></td><td><p>13.12.2021’;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The following entries are added to the list set out in Section B (entities):</p><table><col/><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Name</p></td><td><p>Identifying information</p></td><td><p>Reasons</p></td><td><p>Date of listing</p></td></tr><tr><td><p>‘79.</p></td><td><p>Velada LLC</p><p>OOO Велада</p></td><td><p>Address: Ochakovskoye Shosse, Dom 28, Building 2, Local 3, Room 8, Moscow, 119530, Russian Federation;</p><p>Date of creation: 29.6.2015</p></td><td><p>Velada LLC is a private company that is involved in the oil and gas sector in Syria.</p><p>In December 2019, the Syrian parliament approved a contract granting Velada LLC the right to develop oil and gas in Syria, including in oilfields in the regime-controlled areas in Northeast Syria and a gas field north of Damascus. Thus, it benefits from or supports the Syrian regime.</p></td><td><p>13.12.2021</p></td></tr><tr><td><p>80.</p></td><td><p>Mercury LLC</p><p>OOO Меркурий</p></td><td><p>Address: Leninsky Prospekt, Dom 137, Building 1, Local 2, Room 5, Moscow, Russian Federation</p></td><td><p>Mercury LLC is a private company involved in the oil and gas sector in Syria.</p><p>In December 2019, the Syrian parliament approved a contract granting Mercury LLC the right to develop oil and gas in Syria, including in oilfields in the regime-controlled areas in Northeast Syria and a gas field in the north of Damascus. Thus, it benefits from or supports the Syrian regime.</p></td><td><p>13.12.2021</p></td></tr><tr><td><p>81.</p></td><td><p>Evro Polis LLC</p><p>OOO Евро Полис</p></td><td><p>Address: Ulitsa BratevGozozankinykh, Dom 2B, Pomeshchenie 3.1., Krasnogorsk, 143409, Russian Federation;</p><p>Relatives/Associates: General Petroleum Corp.</p></td><td><p>Evro Polis LLC is a private company linked to the Wagner Group in Syria, involved in the mining, oil and gas sectors in Syria.</p><p>Evro Polis LLC is used as a front for the Wagner Group in Syria. It has signed a number of contracts with the Syrian regime, through the state-owned General Petroleum Corp., under which it receives 25 % of the proceeds from the production of oil and gas in fields captured by the Wagner Group. Thus, it benefits from or supports the Syrian regime.</p></td><td><p>13.12.2021’.</p></td></tr></tbody></table></td></tr></tbody></table> | ENG | 32021R2194 |
<table><col/><col/><col/><col/><tbody><tr><td><p>24.7.2019   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 196/6</p></td></tr></tbody></table>
COMMISSION DIRECTIVE (EU) 2019/1258
of 23 July 2019
amending, for the purpose of its adaptation to technical progress, the Annex to Council Directive 80/181/EEC as regards the definitions of SI base units
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2009/34/EC of the European Parliament and of the Council of 23 April 2009 relating to common provisions for both measuring instruments and methods of metrological control ( 1 ) , in particular Article 16 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Council Directive 80/181/EEC <a>(<span>2</span>)</a> defines the units of measurement to be used in the Union thus enabling to express measurements and indications of quantity in line with the International System of Units (SI), adopted by the General Conference on Weights and Measures (CGPM) set up by the Metre Convention signed in Paris on 20 May 1875.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Directive 2009/34/EC sets out the general framework for the adoption of separate Directives concerning, amongst others, measuring instruments and their technical requirements, units of measurement and the harmonisation of methods of measurement and metrological control. Article 16 of that Directive envisages that the Commission may amend the annexes to the separate Directives referred to in its Article 1 for the purpose of adaptation to technical progress, including Chapter I of the Annex to Directive 80/181/EEC.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The CGPM decided, at its 24th meeting in 2011, on a new way of defining the SI based on a set of seven defining constants drawn from the fundamental constants of physics and other constants of nature. This decision was confirmed at the 25<span>th</span> meeting of the CGPM in 2014.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>On the 26th meeting of the CGPM in 2018, new definitions of the SI base units were adopted. The new definitions are based on the new principle of fixed numerical values of the defining constants and will be effective as from 20 May 2019. The new definitions are expected to improve the long-term stability and reliability of the SI base units as well as the accuracy and clarity of measurements.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The new definitions adopted by the CGPM reflect the latest developments in measurement science and standards. In order to adapt the definitions of the SI base units set out in Directive 80/181/EEC to technical progress and thus contribute to the uniform implementation of the SI, it is necessary to align them with the new definitions.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Directive 80/181/EEC should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>It is necessary to ensure that the new legislation applies as from the same date for all Member States, independently of the date of transposition, so that uniform implementation of Directive 80/181/EEC is in place.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The measures provided for in this Directive are in accordance with the opinion of the Committee for Adjustment to Technical Progress of the Directives referred to in Article 16 of Directive 2009/34/EC,</p></td></tr></tbody></table>
HAS ADOPTED THIS DIRECTIVE:
Article 1
Amendment
The Annex to Directive 80/181/EEC is amended in accordance with the Annex to this Directive.
Article 2
Transposition
1. Member States shall adopt and publish, by 13 May 2020 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
They shall apply those provisions from 13 June 2020.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3
Entry into force
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Directive is addressed to the Member States.
Done at Brussels, 23 July 2019.
For the Commission
The President
Jean-Claude JUNCKER
( 1 ) OJ L 106, 28.4.2009, p. 7 .
( 2 ) Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC ( OJ L 39, 15.2.1980, p. 40 ).
ANNEX
In the Annex, Chapter I, Section 1.1 is replaced by the following:
‘1.1. SI base units
<table><col/><col/><col/><tbody><tr><td><p>Quantity</p></td><td><p>Unit</p></td></tr><tr><td><p>Name</p></td><td><p>Symbol</p></td></tr><tr><td><p>Time</p></td><td><p>second</p></td><td><p>s</p></td></tr><tr><td><p>Length</p></td><td><p>metre</p></td><td><p>m</p></td></tr><tr><td><p>Mass</p></td><td><p>kilogram</p></td><td><p>kg</p></td></tr><tr><td><p>Electric current</p></td><td><p>ampere</p></td><td><p>A</p></td></tr><tr><td><p>Thermodynamic temperature</p></td><td><p>kelvin</p></td><td><p>K</p></td></tr><tr><td><p>Amount of substance</p></td><td><p>mole</p></td><td><p>mol</p></td></tr><tr><td><p>Luminous intensity</p></td><td><p>candela</p></td><td><p>cd</p></td></tr></tbody></table>
Definitions of SI base units:
<table><col/><col/><tbody><tr><td><p> </p></td><td><p><span>Unit of time</span></p><p>The second, symbol s, is the SI unit of time. It is defined by taking the fixed numerical value of the caesium frequency Δ<span>ν</span><span>Cs</span>, the unperturbed ground-state hyperfine transition frequency of the caesium 133 atom, to be 9 192 631 770 when expressed in the unit Hz, which is equal to s<span>– 1</span>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p> </p></td><td><p><span>Unit of length</span></p><p>The metre, symbol m, is the SI unit of length. It is defined by taking the fixed numerical value of the speed of light in vacuum<span>c</span> to be 299 792 458 when expressed in the unit m/s, where the second is defined in terms of Δ<span>ν</span><span>Cs</span>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p> </p></td><td><p><span>Unit of mass</span></p><p>The kilogram, symbol kg, is the SI unit of mass. It is defined by taking the fixed numerical value of the Planck constant<span>h</span> to be 6,626 070 15 × 10<span>– 34</span> when expressed in the unit J s, which is equal to kg m<span>2</span> s<span>– 1</span>, where the metre and the second are defined in terms of<span>c</span> and Δ<span>ν</span><span>Cs</span>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p> </p></td><td><p><span>Unit of electric current</span></p><p>The ampere, symbol A, is the SI unit of electric current. It is defined by taking the fixed numerical value of the elementary charge<span>e</span> to be 1,602 176 634 × 10<span>– 19</span> when expressed in the unit C, which is equal to A s, where the second is defined in terms of Δ<span>ν</span><span>Cs</span>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p> </p></td><td><p><span>Unit of thermodynamic temperature</span></p><p>The kelvin, symbol K, is the SI unit of thermodynamic temperature. It is defined by taking the fixed numerical value of the Boltzmann constant<span>k</span> to be 1,380 649 × 10<span>– 23</span> when expressed in the unit J K<span>– 1</span>, which is equal to kg m<span>2</span> s<span>– 2</span> K<span>– 1</span>, where the kilogram, metre and second are defined in terms of<span>h</span>,<span>c</span> and Δ<span>ν</span><span>Cs</span>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p> </p></td><td><p><span>Unit of amount of substance</span></p><p>The mole, symbol mol, is the SI unit of amount of substance. One mole contains exactly 6,022 140 76 × 10<span>23</span> elementary entities. This number is the fixed numerical value of the Avogadro constant,<span>N</span><span>A,</span> when expressed in the unit mol<span>– 1</span> and is called the Avogadro number.</p><p>The amount of substance, symbol<span>n</span>, of a system is a measure of the number of specified elementary entities. An elementary entity may be an atom, a molecule, an ion, an electron, any other particle or specified group of particles.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p> </p></td><td><p><span>Unit of luminous intensity</span></p><p>The candela, symbol cd, is the SI unit of luminous intensity in a given direction. It is defined by taking the fixed numerical value of the luminous efficacy of monochromatic radiation of frequency 540 × 10<span>12</span> Hz,<span>K</span><span>cd</span>, to be 683 when expressed in the unit lm W<span>– 1</span>, which is equal to cd sr W<span>– 1</span>, or cd sr kg<span>– 1</span> m<span>– 2</span> s<span>3</span>, where the kilogram, metre and second are defined in terms of<span>h</span>,<span>c</span> and Δ<span>ν</span><span>Cs</span>.</p></td></tr></tbody></table>
1.1.1. Special name and symbol of the SI derived unit of temperature for expressing Celsius temperature
<table><col/><col/><col/><tbody><tr><td><p>Quantity</p></td><td><p>Unit</p></td></tr><tr><td><p>Name</p></td><td><p>Symbol</p></td></tr><tr><td><p>Celsius temperature</p></td><td><p>degree Celsius</p></td><td><p>°C</p></td></tr></tbody></table>
Celsius temperature t is defined as the difference t = T – T 0 between the two thermodynamic temperatures T and T 0 where T 0 = 273,15 K. An interval or difference of temperature may be expressed either in kelvins or in degrees Celsius. The unit “degree Celsius” is equal to the unit “kelvin”.’ | ENG | 32019L1258 |
<table><col/><col/><col/><col/><tbody><tr><td><p>31.3.2021   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>C 114/129</p></td></tr></tbody></table>
Statement of revenue and expenditure of the Innovation and Networks Executive Agency for the financial year 2021
(2021/C 114/23)
REVENUE
<table><col/><col/><col/><col/><col/><tbody><tr><td><p>Title</p><p>Chapter</p></td><td><p>Heading</p></td><td><p>Financial year 2021</p></td><td><p>Financial year 2020</p></td><td><p>Financial year 2019</p></td></tr><tr><td><p><span>1</span></p></td><td><p><span>EUROPEAN UNION CONTRIBUTION</span></p></td></tr><tr><td><p>1 0</p></td><td><p>EUROPEAN UNION CONTRIBUTION</p></td><td><p>21 952 000</p></td><td><p>30 382 852</p></td><td><p>28 522 048 ,—</p></td></tr><tr><td><p> </p></td><td><p><span>Title 1 — Total</span></p></td><td><p><span>21 952 000</span></p></td><td><p><span>30 382 852</span></p></td><td><p><span>28 522 048 ,—</span></p></td></tr><tr><td><p><span>2</span></p></td><td><p><span>PARTICIPATION OF THIRD COUNTRIES</span></p></td></tr><tr><td><p>2 0</p></td><td><p>PARTICIPATION OF THIRD COUNTRIES</p></td><td><p>4 960 000</p></td><td><p>603 148</p></td><td><p>0 ,—</p></td></tr><tr><td><p> </p></td><td><p><span>Title 2 — Total</span></p></td><td><p><span>4 960 000</span></p></td><td><p><span>603 148</span></p></td><td><p><span>0 ,—</span></p></td></tr><tr/><tr/><tr><td><p> </p></td><td><p><span>GRAND TOTAL</span></p></td><td><p><span>26 912 000</span></p></td><td><p><span>30 986 000</span></p></td><td><p><span>28 522 048 ,—</span></p></td></tr></tbody></table>
EXPENDITURE
<table><col/><col/><col/><col/><col/><tbody><tr><td><p>Title</p><p>Chapter</p></td><td><p>Heading</p></td><td><p>Financial year 2021</p></td><td><p>Financial year 2020</p></td><td><p>Financial year 2019</p></td></tr><tr><td><p><span>1</span></p></td><td><p><span>STAFF EXPENDITURES</span></p></td></tr><tr><td><p>1 1</p></td><td><p>REMUNERATIONS, ALLOWANCES AND CHARGES</p></td><td><p>23 385 900</p></td><td><p>24 346 247</p></td><td><p>22 504 895 ,—</p></td></tr><tr><td><p>1 2</p></td><td><p>SOCIOMEDICAL AND TRAINING EXPENDITURE</p></td><td><p>869 400</p></td><td><p>1 442 003</p></td><td><p>1 189 233 ,—</p></td></tr><tr><td><p> </p></td><td><p><span>Title 1 — Total</span></p></td><td><p><span>24 255 300</span></p></td><td><p><span>25 788 250</span></p></td><td><p><span>23 694 128 ,—</span></p></td></tr><tr><td><p><span>2</span></p></td><td><p><span>INFRASTRUCTURE AND OPERATING EXPENDITURE</span></p></td></tr><tr><td><p>2 1</p></td><td><p>BUILDING EXPENDITURE</p></td><td><p>1 263 215</p></td><td><p>3 067 952</p></td><td><p>3 047 447 ,—</p></td></tr><tr><td><p>2 2</p></td><td><p>ICT</p></td><td><p>606 535</p></td><td><p>1 123 718</p></td><td><p>646 863 ,—</p></td></tr><tr><td><p>2 3</p></td><td><p>MOVABLE PROPERTY AND CURRENT OPERATING EXPENDITURE</p></td><td><p>50 250</p></td><td><p>175 512</p></td><td><p>113 893 ,—</p></td></tr><tr><td><p> </p></td><td><p><span>Title 2 — Total</span></p></td><td><p><span>1 920 000</span></p></td><td><p><span>4 367 182</span></p></td><td><p><span>3 808 203 ,—</span></p></td></tr><tr><td><p><span>3</span></p></td><td><p><span>PROGRAMME SUPPORT EXPENDITURE</span></p></td></tr><tr><td><p>3 1</p></td><td><p>PROGRAMME SUPPORT EXPENDITURE</p></td><td><p>736 700</p></td><td><p>830 568</p></td><td><p>1 019 717 ,—</p></td></tr><tr><td><p> </p></td><td><p><span>Title 3 — Total</span></p></td><td><p><span>736 700</span></p></td><td><p><span>830 568</span></p></td><td><p><span>1 019 717 ,—</span></p></td></tr><tr/><tr/><tr><td><p> </p></td><td><p><span>GRAND TOTAL</span></p></td><td><p><span>26 912 000</span></p></td><td><p><span>30 986 000</span></p></td><td><p><span>28 522 048 ,—</span></p></td></tr></tbody></table>
Establishment plan 1
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Function group and grade<a> (<span>1</span>)</a></p></td><td><p> </p></td></tr><tr><td><p>2021</p></td><td><p>2020</p></td></tr><tr><td><p>Authorized under the Union budget</p></td><td><p>Actually filled as at 31 December 2019</p></td><td><p>Authorized under the Union budget</p></td></tr><tr><td><p>Permanent posts</p></td><td><p>Temporary posts</p></td><td><p>Permanent posts</p></td><td><p>Temporary posts</p></td><td><p>Permanent posts</p></td><td><p>Temporary posts</p></td></tr><tr/><tr/><tr><td><p>AD 16</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AD 15</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AD 14</p></td><td><p>—</p></td><td><p>7</p></td><td><p>—</p></td><td><p>7</p></td><td><p>—</p></td><td><p>7</p></td></tr><tr><td><p>AD 13</p></td><td><p>—</p></td><td><p>9</p></td><td><p>—</p></td><td><p>9</p></td><td><p>—</p></td><td><p>9</p></td></tr><tr><td><p>AD 12</p></td><td><p>—</p></td><td><p>5</p></td><td><p>—</p></td><td><p>5</p></td><td><p>—</p></td><td><p>5</p></td></tr><tr><td><p>AD 11</p></td><td><p>—</p></td><td><p>5</p></td><td><p>—</p></td><td><p>5</p></td><td><p>—</p></td><td><p>5</p></td></tr><tr><td><p>AD 10</p></td><td><p>—</p></td><td><p>5</p></td><td><p>—</p></td><td><p>5</p></td><td><p>—</p></td><td><p>5</p></td></tr><tr><td><p>AD 9</p></td><td><p>—</p></td><td><p>9</p></td><td><p>—</p></td><td><p>7</p></td><td><p>—</p></td><td><p>9</p></td></tr><tr><td><p>AD 8</p></td><td><p>—</p></td><td><p>12</p></td><td><p>—</p></td><td><p>10</p></td><td><p>—</p></td><td><p>12</p></td></tr><tr><td><p>AD 7</p></td><td><p>—</p></td><td><p>10</p></td><td><p>—</p></td><td><p>10</p></td><td><p>—</p></td><td><p>10</p></td></tr><tr><td><p>AD 6</p></td><td><p>—</p></td><td><p>2</p></td><td><p>—</p></td><td><p>2</p></td><td><p>—</p></td><td><p>2</p></td></tr><tr><td><p>AD 5</p></td><td><p>—</p></td><td><p>3</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>3</p></td></tr><tr><td><p>Subtotal AD</p></td><td><p>—</p></td><td><p>67</p></td><td><p>—</p></td><td><p>60</p></td><td><p>—</p></td><td><p>67</p></td></tr><tr/><tr/><tr><td><p>AST 11</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST 10</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST 9</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST 8</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST 7</p></td><td><p>—</p></td><td><p>1</p></td><td><p>—</p></td><td><p>1</p></td><td><p>—</p></td><td><p>1</p></td></tr><tr><td><p>AST 6</p></td><td><p>—</p></td><td><p>2</p></td><td><p>—</p></td><td><p>2</p></td><td><p>—</p></td><td><p>2</p></td></tr><tr><td><p>AST 5</p></td><td><p>—</p></td><td><p>3</p></td><td><p>—</p></td><td><p>3</p></td><td><p>—</p></td><td><p>3</p></td></tr><tr><td><p>AST 4</p></td><td><p>—</p></td><td><p>3</p></td><td><p>—</p></td><td><p>3</p></td><td><p>—</p></td><td><p>3</p></td></tr><tr><td><p>AST 3</p></td><td><p>—</p></td><td><p>2</p></td><td><p>—</p></td><td><p>1</p></td><td><p>—</p></td><td><p>2</p></td></tr><tr><td><p>AST 2</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST 1</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>Subtotal AST</p></td><td><p>—</p></td><td><p>11</p></td><td><p>—</p></td><td><p>10</p></td><td><p>—</p></td><td><p>11</p></td></tr><tr/><tr/><tr><td><p>AST/SC 6</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST/SC 5</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST/SC 4</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST/SC 3</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST/SC 2</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST/SC 1</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>Subtotal AST/SC</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr/><tr/><tr><td><p><span>Total</span></p></td><td><p><span>—</span></p></td><td><p><span>78</span></p></td><td><p><span>—</span></p></td><td><p><span>70</span></p></td><td><p><span>—</span></p></td><td><p><span>78</span></p></td></tr><tr><td><p><span>Grand Total</span></p></td><td><p><span>78</span></p></td><td><p><span>70</span></p></td><td><p><span>78</span></p></td></tr><tr><td><p><a> (<span>1</span>)</a></p></td></tr></tbody></table>
Estimate of number of contract staff (expressed in full-time equivalents) and seconded national experts (includes current vacancies)
<table><col/><col/><col/><tbody><tr><td><p>Contract staff posts</p></td><td><p>2021</p></td><td><p>2020</p></td></tr><tr/><tr/><tr><td><p>FG IV</p></td><td><p>163</p></td><td><p>144</p></td></tr><tr><td><p>FG III</p></td><td><p>74</p></td><td><p>72</p></td></tr><tr><td><p>FG II</p></td><td><p>33</p></td><td><p>33</p></td></tr><tr><td><p>FG I</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>Total</p></td><td><p>270</p></td><td><p>249</p></td></tr></tbody></table>
<note>
( 1 ) Pending the finalisation of the delegation process to the executive agencies of operational programmes for the period 2021-2027, the delegation related to the completion of the legacy programmes prior to 2021 will continue in 2021. Therefore, until this finalisation this establishment plan, which reflects a staffing level corresponding to the authorized level of 2020, continues to apply.
</note> | ENG | 32021B0331(23) |
<table><col/><col/><col/><col/><tbody><tr><td><p>5.9.2019   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>C 301/101</p></td></tr></tbody></table>
COUNCIL RECOMMENDATION
of 9 July 2019
on the 2019 National Reform Programme of Hungary and delivering a Council opinion on the 2019 Convergence Programme of Hungary
(2019/C 301/17)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 121(2) and 148(4) thereof,
Having regard to Council Regulation (EC) No 1466/97 of 7 July 1997 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies ( 1 ) , and in particular Article 9(2) thereof,
Having regard to the recommendation of the European Commission,
Having regard to the resolutions of the European Parliament,
Having regard to the conclusions of the European Council,
Having regard to the opinion of the Employment Committee,
Having regard to the opinion of the Economic and Financial Committee,
Having regard to the opinion of the Social Protection Committee,
Having regard to the opinion of the Economic Policy Committee,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>On 21 November 2018, the Commission adopted the Annual Growth Survey, marking the start of the 2019 European Semester for economic policy coordination. It took due account of the European Pillar of Social Rights, proclaimed by the European Parliament, the Council and the Commission on 17 November 2017. The priorities of the Annual Growth Survey were endorsed by the European Council on 21 March 2019. On 21 November 2018, on the basis of Regulation (EU) No 1176/2011 of the European Parliament and of the Council <a>(<span>2</span>)</a>, the Commission also adopted the Alert Mechanism Report, in which it did not identify Hungary as one of the Member States for which an in-depth review would be carried out.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The 2019 country report for Hungary was published on 27 February 2019. It assessed Hungary’s progress in addressing the country-specific recommendations adopted by the Council on 13 July 2018 <a>(<span>3</span>)</a>, the follow-up given to the country-specific recommendations adopted in previous years and Hungary’s progress towards its national Europe 2020 targets</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>On 30 April 2019, Hungary submitted its 2019 National Reform Programme and its 2019 Convergence Programme. In order to take account of their interlinkages, the two programmes have been assessed at the same time.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Relevant country-specific recommendations have been addressed in the programming of the European Structural and Investment Funds (‘ESI Funds’) for 2014-2020. As provided for in Article 23 of Regulation (EU) No 1303/2013 of the European Parliament and of the Council <a>(<span>4</span>)</a>, where it is necessary to support the implementation of relevant Council recommendations, the Commission may request a Member State to review and propose amendments to its Partnership Agreement and relevant programmes. The Commission has provided further details on how it would make use of that provision in guidelines on the application of the measures linking the effectiveness of the ESI Funds to sound economic governance.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Hungary is currently in the preventive arm of the Stability and Growth Pact and subject to the debt rule. In its 2019 Convergence Programme, the government plans an improvement of the headline deficit to 1,8 % of gross domestic product (GDP) in 2019 from 2,2 % in 2018. The deficit is planned to continue gradually improving thereafter to 1,2 % in 2021 and to reach a balanced budgetary position in 2023. Based on the recalculated structural balance <a>(<span>5</span>)</a>, Hungary would be close to its medium-term budgetary objective — which has been changed from a structural deficit of 1,5 % of GDP in 2019 to 1,0 % of GDP as of 2020 — in 2022 and would achieve it in the following year. According to the Convergence Programme, the general government debt-to-GDP ratio is expected to decline gradually to below 60 % by the end of 2022. The macroeconomic scenario underpinning those budgetary projections is plausible for 2019 and markedly favourable from 2020, which poses risks to the implementation of the deficit targets. At the same time, the measures needed to support the planned deficit targets from 2020 onwards have not been sufficiently specified.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>On 22 June 2018, the Council found in accordance with Article 121(4) of the Treaty on the Functioning of the European Union that a significant observed deviation from the adjustment path towards the medium-term budgetary objective occurred in Hungary in 2017. In view of the established significant deviation, on 22 June 2018 the Council issued a Recommendation <a>(<span>6</span>)</a>, recommending that Hungary take the necessary measures to ensure that the nominal growth rate of net primary government expenditure <a>(<span>7</span>)</a> did not exceed 2,8 % in 2018, corresponding to an annual structural adjustment of 1,0 % of GDP. On 4 December 2018, the Council adopted Decision (EU) 2018/2028 <a>(<span>8</span>)</a>, establishing that Hungary had not taken effective action in response to its Recommendation of 22 June 2018, and issued a revised Recommendation <a>(<span>9</span>)</a>. In the Recommendation of 4 December 2018, the Council asked Hungary to take the necessary measures to ensure that the nominal growth rate of net primary government expenditure does not exceed 3,3 % in 2019, corresponding to an annual structural adjustment of 1,0 % of GDP. On 14 June 2019, the Council adopted Decision (EU) 2019/1003 <a>(<span>10</span>)</a>, establishing that Hungary had not taken effective action in response to the Council Recommendation of 4 December 2018. Moreover, based on 2018 outturn data, Hungary was found to be in significant deviation from the recommended adjustment in 2018.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>In line with Article 121(4) of the Treaty and Article 10(2) of Regulation (EC) No 1466/97, the Commission issued a warning to Hungary on 5 June 2019 that a significant deviation from the adjustment path towards the medium-term budgetary objective was observed in 2018. On 14 June 2019, the Council adopted a subsequent Recommendation <a>(<span>11</span>)</a> confirming the need for Hungary to take the necessary measures to ensure that the nominal growth rate of net primary government expenditure does not exceed 3,3 % in 2019, corresponding to an annual structural adjustment of 1,0 % of GDP. Based on the Commission 2019 spring forecast, there is a risk of a deviation from that Recommendation in 2019.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>In its Recommendation of 14 June 2019, the Council recommended Hungary to take the measures necessary to ensure that the nominal growth rate of net primary government expenditure does not exceed 4,7 % in 2020, corresponding to an annual structural adjustment of 0,75 % of GDP. This would put Hungary on an appropriate adjustment path towards the medium-term budgetary objective. Based on the Commission 2019 spring forecast under unchanged policies, there is a risk of a deviation from that requirement in 2020. Overall, the Council is of the opinion that significant further measures will be needed as of 2019 to comply with the provisions of the Stability and Growth Pact, in line with the Council Recommendation of 14 June 2019, with a view to correcting the significant observed deviation from the adjustment path towards the medium-term budgetary objective.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>The overall employment rate has improved significantly amid strong economic expansion but has not benefited all groups equally. The gaps in employment and wages between skills groups and men and women remain wide in comparison with the Union average. The gender employment gap is wide partly due to the limited supply of good quality childcare. Labour market outcomes for various vulnerable groups, including Roma and people with disabilities, are weak. Despite its reduction, the Public Works Scheme, which is not effective in leading participants to the jobs in the primary labour market, remains sizeable. Other policies to help unemployed or inactive people find work or training are insufficiently targeted. Developing digital skills could help improve employability. Recent measures are designed to get more retired workers back into jobs and to increase their number over time. Hungary’s overall poverty situation has been improving since 2013. The duration of unemployment benefits is the shortest in the Union, at a maximum of three months, which is well below the average amount of time needed to find a job.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>The share of people at risk of poverty and social exclusion is falling. There has been a clear shift from social benefits towards work-related family support and in-kind benefits, which are however not sufficiently targeted to the poor. While home-ownership subsidies have expanded, there has been no improvement in the supply of social housing.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>Education outcomes are below the Union average and show wide territorial disparities. Early school leaving is higher and the tertiary education attainment rate lower than the Union average. The education system hinders social mobility. Pupils are streamed early into different types of schools, with wide gaps in education outcomes and employment paths. The proportion of primary schools with majority Roma participation increased from 10 % in 2008 to 15 % in 2017. The impact of recent measures targeting the even distribution of disadvantaged pupils across schools is limited by the exemption of non-state schools from the requirement to take disadvantaged pupils. Disadvantaged children tend to be concentrated in vocational secondary schools where poorer levels of basic skills, higher dropout rates and lower pay and career prospects are more prevalent. The low participation of disadvantaged groups, in particular Roma, in quality education is a missed opportunity to build up human capital. The shortage of teachers also remains a challenge. Teachers’ salaries have risen in recent years but are still relatively low, compared to other tertiary education graduates. The low number of students participating in higher education is not in line with the strong demand for highly skilled workers and the wage premium of tertiary graduates, which is the highest in the Union. Hungarian higher education institutions have the lowest financial autonomy in the Union. In addition, the April 2017 amendment of the Higher Education Act, which set additional requirements for international universities to operate in Hungary, raised further concerns over academic freedom. In 2018, the internationally highest ranked Hungarian university signalled its intention to leave the country because of the regulatory uncertainty created by this amendment.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>Health outcomes lag behind most other Member States, reflecting both unhealthy lifestyles and the limited effectiveness of healthcare provision. The prevalence of smoking, alcohol use disorder and obesity is one of the highest in the Union. Hungarians are among the most likely in the Union to suffer premature death due to bad air quality. The number of avoidable deaths is one of the highest in the Union, partly due to inadequate screening and primary care management. There are significant socioeconomic disparities in access to quality care. Public spending on healthcare is below the Union average, and citizens rely on out-of-pocket payments to access quality care, which risks further widening the socioeconomic health divide. The system remains strongly hospital-centred, with weaknesses in primary care, in particular early detection and prevention of chronic diseases. A sizeable shortage of healthcare staff, in particular general practitioners and nurses, thwarts access to care in poorer areas.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>Increasing research and innovation capacities could improve Hungary’s modest innovation performance and increase productivity. The low level of intellectual asset accumulation is reflected in the low number of patent, trademark and design applications, the small number of innovative businesses and the low level of internationalisation by small and medium-sized enterprises. Smaller firms are especially reluctant to innovate, hindering their involvement in global value chains. Business R & D is concentrated in a few large, mainly foreign-owned companies and benefits from generous government support. Supporting science-business cooperation would contribute to better innovation performance and technology transfer. The quality of public science is suffering from inefficient R & D policies and underfunding as public sector R & D expenditure is well below the Union average. Recent policy measures aiming to cut the funding and limiting the independence of academic and research fora are creating uncertainty in those fora, which may result in the emigration of top research talent and risk a persistent decline in research quality.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>Weak local public transport connectivity and high commuting costs are contributing to unemployment in disadvantaged areas. The poor condition of the road and rail networks hampers mobility and reduces travel safety, with more than half of the road network in bad condition, especially in disadvantaged regions. Transport networks are centred on Budapest, while local networks and transversal connections through the country are not well developed. Road congestion is a growing challenge and a barrier to productivity in Hungary’s urban areas. Moreover, greenhouse gas emissions from road transport have increased strongly in the last 5 years.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>Energy efficiency in the residential sector remains weak. The electricity network needs to be prepared for the growing role of decentralised renewable electricity generation. Half of Hungary’s territory is significantly exposed to climate change risks including drought and floods, which create the need for investment in water management on the main rivers. Air pollution and water quality remain a concern. The main sources of pollution are residential solid fuel combustion, agriculture and transport emissions. The circular economy is still in an initial phase, recycling of municipal waste is underdeveloped and economic instruments are insufficient to address Hungarian environmental challenges.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(16)</p></td><td><p>Concerns remain over the prevention and prosecution of corruption. Several indicators suggest that Hungary’s exposure to corruption has increased in recent years. Corruption risks and favouritism distort the allocation of resources as these are not channelled to the most productive firms. The functioning of the prosecution service is of crucial importance to fighting corruption. While measures to fight low-level corruption appear to have been applied with some success, there are still no signs of determined action to prosecute corruption involving high-level officials or their immediate circle when serious allegations arise. Accountability for decisions to close investigations is a matter of concern, as there are no effective remedies to contest such decisions. The prevention of corruption is further hindered by public institutions applying restrictions, including dissuasive fees for access to information.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(17)</p></td><td><p>The independence, efficiency and quality of the justice system are crucial to attracting business and enabling economic growth. Checks and balances, which are crucial to ensuring judicial independence, are seen to be under further pressure within the ordinary courts system. The National Judicial Council faces increasing challenges in counter-balancing the powers of the President of the National Office for the Judiciary. Questions have been raised regarding the consequences of this for judicial independence. With regard to the Administrative Courts Law, it is noted that the government tabled a bill withdrawing the Act on the entry into force and transitional rules for the administrative courts on 30 May 2019.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(18)</p></td><td><p>The public procurement framework has improved in recent years but obstacles to competition remain. These include the use of procedures with limited publicity and systemic irregularities in the tendering processes, in particular related to inadequate selection and award criteria and unequal treatment of tenderers. While some indicators show improvements, the number of procedures with a single bidder are still high. The effective use of e-procurement could further increase efficiency and transparency.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(19)</p></td><td><p>Hungary’s social dialogue structures and processes remain underdeveloped and do not allow for meaningful involvement of the social partners in policy design and implementation. The deficiencies in stakeholder engagement and limited transparency undermine the evidence base for, and the quality of, policymaking. This results in frequent and unpredictable changes in regulations and discourages high-value-added investments.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(20)</p></td><td><p>Measures have been taken to further improve the tax system but some challenges remain. The tax burden on labour has decreased but remains high for low-income earners. Sector-specific taxes and a large number of small taxes complicate the tax system and raise compliance costs, in particular for smaller firms.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(21)</p></td><td><p>Regulatory barriers and State involvement in product markets hinder the selection of efficient enterprises and limit competition. The authorities continue to entrust certain services to State-owned firms or private firms specifically created for these purposes. Certain tailor-made legislation and measures and ad hoc exemptions from competition scrutiny hinder the functioning of the market and hamper investment. The unpredictability of the legal framework is a further problem, especially in the retail sector, which in recent years has faced frequent changes to regulations. Legislation imposing an additional special authorisation for modifications to the use or design of retail premises has been introduced in the past year. Regulation of professions also remains restrictive. The lack of competition in these sectors may become detrimental to innovation and efficiency.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(22)</p></td><td><p>The fight against aggressive tax planning is essential in making tax systems more efficient and fairer. Spillover effects of taxpayers’ aggressive tax-planning strategies between Member States call for a coordinated action of national policies to complement Union legislation. Hungary has taken measures against aggressive tax planning, but records relatively high capital inflows and outflows through special-purpose entities, which have no or little effect on the real economy. The absence of withholding taxes on outbound (i.e. from Union residents to third-country residents) dividend, interest and royalty payments made by companies based in Hungary may lead to those payments escaping tax altogether, if they are also not subject to tax in the recipient jurisdiction.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(23)</p></td><td><p>The programming of Union funds for the period 2021-2027 could help address some of the gaps identified in the recommendations, in particular in the areas covered by Annex D to the 2019 country report. This would allow Hungary to make the best use of those funds in respect of the identified sectors, taking into account regional disparities.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(24)</p></td><td><p>In the context of the 2019 European Semester, the Commission has carried out a comprehensive analysis of Hungary’s economic policy and published it in the 2019 country report. It has also assessed the 2019 Convergence Programme, the 2019 National Reform Programme and the follow-up given to the recommendations addressed to Hungary in previous years. The Commission has taken into account not only their relevance for sustainable fiscal and socioeconomic policy in Hungary, but also their compliance with Union rules and guidance, given the need to strengthen the Union’s overall economic governance by providing Union-level input into future national decisions.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(25)</p></td><td><p>In the light of this assessment, the Council has examined the 2019 Convergence Programme and its opinion <a>(<span>12</span>)</a> is reflected in particular in recommendation (1) below,</p></td></tr></tbody></table>
HEREBY RECOMMENDS that Hungary take action in 2019 and 2020 to:
1. Ensure compliance with the Council Recommendation of 14 June 2019 with a view to correcting the significant deviation from the adjustment path towards the medium-term budgetary objective.
2. Continue the labour market integration of the most vulnerable groups, in particular through upskilling, and improve the adequacy of social assistance and unemployment benefits. Improve education outcomes and increase the participation of disadvantaged groups, in particular Roma in quality mainstream education. Improve health outcomes by supporting preventive health measures and strengthening primary healthcare.
3. Focus investment-related economic policy on research and innovation, low-carbon energy, transport infrastructure, and waste management and energy and resource efficiency, taking into account regional disparities. Improve competition in public procurement.
4. Reinforce the anti-corruption framework, including by improving prosecutorial efforts and access to public information, and strengthen judicial independence. Improve the quality and transparency of the decision-making process through effective social dialogue and engagement with other stakeholders and through regular, appropriate impact assessments. Continue simplifying the tax system, while strengthening it against the risk of aggressive tax planning. Improve competition and regulatory predictability in the services sector.
Done at Brussels, 9 July 2019.
For the Council
The President
M. LINTILÄ
<note>
( 1 ) OJ L 209, 2.8.1997, p. 1 .
( 2 ) Regulation (EU) No 1176/2011 of the European Parliament and of the Council of 16 November 2011 on the prevention and correction of macroeconomic imbalances ( OJ L 306, 23.11.2011, p. 25 ).
( 3 ) OJ C 320, 10.9.2018, p. 72 .
( 4 ) Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006 ( OJ L 347, 20.12.2013, p. 320 ).
( 5 ) Cyclically adjusted balance net of one-off and temporary measures, recalculated by the Commission using the commonly agreed methodology.
( 6 ) Council Recommendation of 22 June 2018 with a view to correcting the significant observed deviation from the adjustment path toward the medium-term budgetary objective in Hungary ( OJ C 223, 27.6.2018, p. 1 ).
( 7 ) Net primary government expenditure comprises total government expenditure excluding interest expenditure, expenditure on Union programmes fully matched by Union funds revenue and non-discretionary changes in unemployment benefit expenditure. Nationally financed gross fixed capital formation is smoothed over a four-year period. Discretionary revenue measures or revenue increases mandated by law are factored in. One-off measures on both the revenue and expenditure sides are netted out.
( 8 ) Council Decision (EU) 2018/2028 of 4 December 2018 establishing that no effective action has been taken by Hungary in response to the Council Recommendation of 22 June 2018 ( OJ L 325, 20.12.2018, p. 29 ).
( 9 ) Council Recommendation of 4 December 2018 with a view to correcting the significant observed deviation from the adjustment path toward the medium-term budgetary objective in Hungary ( OJ C 460, 21.12.2018, p. 4 ).
( 10 ) Council Decision (EU) 2019/1003 of 14 June 2019 establishing that no effective action has been taken by Hungary in response to the Council Recommendation of 4 December 2018 ( OJ L 163, 20.6.2019, p. 64 ).
( 11 ) Council Recommendation of 14 June 2019 with a view to correcting the significant observed deviation from the adjustment path towards the medium-term budgetary objective in Hungary ( OJ C 210, 21.6.2019, p. 4 ).
( 12 ) Under Article 9(2) of Regulation (EC) No 1466/97.
</note> | ENG | 32019H0905(17) |
<table><col/><col/><col/><col/><tbody><tr><td><p>3.10.2018   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 248/215</p></td></tr></tbody></table>
DECISION (EU) 2018/1367 OF THE EUROPEAN PARLIAMENT
of 18 April 2018
on discharge in respect of the implementation of the budget of the European Chemicals Agency for the financial year 2016
THE EUROPEAN PARLIAMENT,
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the final annual accounts of the European Chemicals Agency for the financial year 2016,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the Court of Auditors’ report on the annual accounts of the European Chemicals Agency for the financial year 2016, together with the Agency’s reply <a>(<span>1</span>)</a>,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the statement of assurance <a>(<span>2</span>)</a> as to the reliability of the accounts and the legality and regularity of the underlying transactions provided by the Court of Auditors for the financial year 2016, pursuant to Article 287 of the Treaty on the Functioning of the European Union,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the Council’s recommendation of 20 February 2018 on discharge to be given to the Agency in respect of the implementation of the budget for the financial year 2016 (05941/2018 — C8-0077/2018),</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Article 319 of the Treaty on the Functioning of the European Union,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 <a>(<span>3</span>)</a>, and in particular Article 208 thereof,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC <a>(<span>4</span>)</a>, and in particular Article 97 thereof,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Commission Delegated Regulation (EU) No 1271/2013 of 30 September 2013 on the framework financial regulation for the bodies referred to in Article 208 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council <a>(<span>5</span>)</a>, and in particular Article 108 thereof,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Rule 94 of and Annex IV to its Rules of Procedure,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A8-0086/2018),</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>1.</p></td><td><span>Grants the Executive Director of the European Chemicals Agency discharge in respect of the implementation of the Agency’s budget for the financial year 2016;</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>2.</p></td><td><span>Sets out its observations in the resolution below;</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>3.</p></td><td><span>Instructs its President to forward this decision, and the resolution forming an integral part of it, to the Executive Director of the European Chemicals Agency, the Council, the Commission and the Court of Auditors, and to arrange for their publication in the<span>Official Journal of the European Union</span> (L series).</span></td></tr></tbody></table>
The President
Antonio TAJANI
The Secretary-General
Klaus WELLE
<note>
( 1 ) OJ C 417, 6.12.2017, p. 98 .
( 2 ) See footnote 1.
( 3 ) OJ L 298, 26.10.2012, p. 1 .
( 4 ) OJ L 396, 30.12.2006, p. 1 .
( 5 ) OJ L 328, 7.12.2013, p. 42 .
</note> | ENG | 32018B1367 |
<table><col/><col/><col/><col/><tbody><tr><td><p>18.2.2015   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 43/9</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2015/256
of 13 February 2015
approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (Comté (PDO))
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs ( 1 ) , and in particular Article 52(2) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined France's application for the approval of amendments to the specification for the protected designation of origin ‘Comté’ registered under Commission Regulation (EC) No 1107/96<a> (<span>2</span>)</a>, as amended by Regulation (EC) No 828/2003<a> (<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the<span>Official Journal of the European Union</span><a> (<span>4</span>)</a> as required by Article 50(2)(a) of that Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Comté’ (PDO) are hereby approved.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 February 2015.
For the Commission,
On behalf of the President,
Phil HOGAN
Member of the Commission
<note>
( 1 ) OJ L 343, 14.12.2012, p. 1 .
( 2 ) Commission Regulation (EC) No 1107/96 of 12 June 1996 on the registration of geographical indications and designations of origin under the procedure laid down in Article 17 of Council Regulation (EEC) No 2081/92 ( OJ L 148, 21.6.1996, p. 1 ).
( 3 ) Commission Regulation (EC) No 828/2003 of 14 May 2003 amending the specification of 16 names appearing in the Annex to Regulation (EC) No 1107/96 on the registration of geographical indications and designations of origin under the procedure laid down in Article 17 of Council Regulation (EEC) No 2081/92 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (Danablu, Monti Iblei, Lesbos, Beaufort, Salers, Reblochon or Reblochon de Savoie, Laguiole, Mont d'Or or Vacherin du Haut-Doubs, Comté, Roquefort, Epoisses de Bourgogne, Brocciu corse or Brocciu, Sainte-Maure de Touraine, Ossau-Iraty, Dinde de Bresse, Huile essentielle de lavande de Haute-Provence) ( OJ L 120, 15.5.2003, p. 3 ).
( 4 ) OJ C 356, 9.10.2014, p. 54 .
</note> | ENG | 32015R0256 |
02012R1247 — EN — 10.02.2017 — 001.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
<table><col/><col/><tr><td><p><a>►B</a></p></td><td><p>COMMISSION IMPLEMENTING REGULATION (EU) No 1247/2012</p><p>of 19 December 2012</p><p>laying down implementing technical standards with regard to the format and frequency of trade reports to trade repositories according to Regulation (EU) No 648/2012 of the European Parliament and of the Council on OTC derivatives, central counterparties and trade repositories</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 352 21.12.2012, p. 20)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p> </p></td><td><p> </p></td><td><p>Official Journal</p></td></tr><tr><td><p>  No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>►M1</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2017/105 of 19 October 2016</a></p></td><td><p>  L 17</p></td><td><p>17</p></td><td><p>21.1.2017</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) No 1247/2012
of 19 December 2012
laying down implementing technical standards with regard to the format and frequency of trade reports to trade repositories according to Regulation (EU) No 648/2012 of the European Parliament and of the Council on OTC derivatives, central counterparties and trade repositories
(Text with EEA relevance)
Article 1
Format of derivative contract reports
The information contained in a report under Article 9 of Regulation (EU) No 648/2012 shall be provided in the format specified in the Annex to this Regulation.
Article 2
Frequency of derivative contract reports
Where provided for in Article 11(2) of Regulation (EU) No 648/2012, mark to market or mark to model valuations of contracts reported to a trade repository shall be done on a daily basis. Any other reporting elements as provided for in the Annex to this Regulation and the Annex to the delegated act with regard to regulatory technical standards specifying the minimum details of the data to be reported to trade repositories pursuant to Article 9(5) of Regulation (EU) No 648/2012 shall be reported as they occur and taking into account the time limit foreseen under Article 9 of Regulation (EU) No 648/2012, notably as regards the conclusion, modification or termination of a contract.
Article 3
Identification of counterparties and other entities
1. A report shall use a legal entity identifier to identify:
(a) a beneficiary which is a legal person;
(b) a broking entity;
(c) a CCP;
(d) a clearing member which is a legal person;
(e) a counterparty which is a legal entity;
(f) a submitting entity.
2. Where a legal entity identifier is not available, the report shall include an interim entity identifier as defined at the Union level which is:
(a) unique;
(b) neutral;
(c) reliable;
(d) open source;
(e) scalable;
(f) accessible;
(g) available at a reasonable cost basis;
(h) subject to an appropriate governance framework.
3. Where neither a legal entity identifier nor an interim entity identifier is available, a report shall use a Business Identifier Code in accordance with ISO 9362 where available.
Article 4
Identification of Derivatives
1. A report shall identify a derivative contract using a unique product identifier which is:
(a) unique;
(b) neutral;
(c) reliable
(d) open source;
(e) scalable;
(f) accessible;
(g) available at a reasonable cost basis;
(h) subject to an appropriate governance framework.
2. Where a unique product identifier does not exist, a report shall identify a derivative contract by using the combination of the assigned ISO 6166 ISIN code or Alternative Instrument Identifier code with the corresponding ISO 10962 CFI code.
3. Where the combination referred to in paragraph 2 is not available, the type of derivative shall be identified on the following basis:
(a) the derivative class shall be identified as one of the following:
(i) commodities;
(ii) credit;
(iii) foreign exchange;
(iv) equity;
(v) interest rate;
(vi) other.
(b) the derivative type shall be identified as one of the following:
(i) contracts for difference;
(ii) forward rate agreements
(iii) forwards;
(iv) futures;
(v) options;
(vi) swaps;
(vii) other.
(c) in the case of derivatives not falling into a specific derivative class or derivative type, the report shall be made on the basis of the derivative class or derivative type that the counterparties agree the derivative contract most closely resembles.
Article 5
Reporting start date
1. Credit derivative and interest rate derivative contracts shall be reported:
(a) by 1 July 2013, where a trade repository for that particular derivative class has been registered under Article 55 of Regulation (EU) No 648/2012 before 1 April 2013;
(b) 90 days after the registration of a trade repository for a particular derivative class under Article 55 of Regulation (EU) No 648/2012, where there is no trade repository registered for that particular derivative class before or on 1 April 2013,;
(c) by 1 July 2015, where there is no trade repository registered for that particular derivative class under Article 55 of Regulation (EU) No 648/2012 by 1 July 2015. The reporting obligation shall commence on this date and contracts shall be reported to ESMA in accordance with Article 9(3) of that Regulation until a trade repository is registered for that particular derivative class.
2. Derivative contracts not referred to in paragraph 1 shall be reported:
(a) by 1 January 2014, where a trade repository for that particular derivative class has been registered under Article 55 of Regulation (EU) No 648/2012 before 1 October 2013;
(b) 90 days after the registration of a trade repository for a particular derivative class under Article 55 of Regulation (EU) No 648/2012, where there is no trade repository registered for that particular derivative class before or on 1 October 2013;
(c) by 1 July 2015, where there is no trade repository registered for that particular derivative class under Article 55 of Regulation (EU) No 648/2012 by 1 July 2015. The reporting obligation shall commence on this date and contracts shall be reported to ESMA in accordance with Article 9(3) of that Regulation until a trade repository is registered for that particular derivative class.
3. Those derivative contracts which were outstanding on 16 August 2012 and are still outstanding on the reporting start date shall be reported to a trade repository within 90 days of the reporting start date for a particular derivative class.
4. The following derivative contracts which are not outstanding on the commencement date for reporting for a particular derivative class shall be reported to a trade repository within five years of that date:
(a) derivative contracts that were entered into before 16 August 2012 and were still outstanding on 16 August 2012;
(b) derivative contracts that were entered into on or after 16 August 2012.
5. The reporting start date shall be extended by 180 days for the reporting of information referred to in Article 3 of the delegated act with regard to regulatory technical standards specifying the minimum details of the data to be reported to trade repositories pursuant to Article 9(5) of Regulation (EU) No 648/2012.
Article 6
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
Table 1
Counterparty Data
<table><col/><col/><col/><tbody><tr><td><p> </p><div/></td><td><p>Field</p></td><td><p>Format</p></td></tr><tr><td><p> </p><div/></td><td><p>Parties to the contract</p></td><td><p> </p><div/></td></tr><tr><td><p>1</p></td><td><p>Reporting timestamp</p></td><td><p>ISO 8601 date format / UTC time format.</p></td></tr><tr><td><p>2</p></td><td><p>Counterparty ID</p></td><td><p>Legal Entity Identifier (LEI) (20 alphanumerical digits), interim entity identifier (20 alphanumerical digits), BIC (11 alphanumerical digits) or a client code (50 alphanumerical digits).</p></td></tr><tr><td><p>3</p></td><td><p>ID of the other Counterparty</p></td><td><p>Legal Entity Identifier (LEI) (20 alphanumerical digits),</p><p>interim entity identifier (20 alphanumerical digits),</p><p>BIC (11 alphanumerical digits) or a</p><p>client code (50 alphanumerical digits).</p></td></tr><tr><td><p>4</p></td><td><p>Name of the counterparty</p></td><td><p>100 alphanumerical digits or blank in case of coverage by Legal Entity Identifier (LEI).</p></td></tr><tr><td><p>5</p></td><td><p>Domicile of the counterparty</p></td><td><p>500 alphanumerical digits or blank in case of coverage by Legal Entity Identifier (LEI).</p></td></tr><tr><td><p>6</p></td><td><p>Corporate sector of the counterparty</p></td><td><p>Taxonomy:</p><p>A = Assurance undertaking authorised in accordance with Directive 2002/83/EC;</p><p>C = Credit institution authorised in accordance with Directive 2006/48/EC;</p><p>F = Investment firm in accordance with Directive 2004/39/EC;</p><p>I = Insurance undertaking authorised in accordance with Directive 73/239/EEC;</p><p>L = Alternative investment fund managed by AIFMs authorised or registered in accordance with Directive 2011/61/EU;</p><p>O = Institution for occupational retirement provision within the meaning of Article 6(a) of Directive 2003/41/EC;</p><p>R = Reinsurance undertaking authorised in accordance with Directive 2005/68/EC;</p><p>U = UCITS and its management company, authorised in accordance with Directive 2009/65/EC; or</p><p>blank in case of coverage by Legal Entity Identifier (LEI) or in case of non-financial counterparties.</p></td></tr><tr><td><p>7</p></td><td><p>Financial or non-financial nature of the counterparty</p></td><td><p>F=Financial Counterparty, N=Non-Financial Counterparty.</p></td></tr><tr><td><p>8</p></td><td><p>Broker ID</p></td><td><p>Legal Entity Identifier (LEI) (20 alphanumerical digits),</p><p>interim entity identifier (20 alphanumerical digits),</p><p>BIC (11 alphanumerical digits) or a client code (50 alphanumerical digits).</p></td></tr><tr><td><p>9</p></td><td><p>Reporting entity ID</p></td><td><p>Legal Entity Identifier (LEI) (20 alphanumerical digits),</p><p>interim entity identifier (20 alphanumerical digits),</p><p>BIC (11 alphanumerical digits) or a</p><p>client code (50 alphanumerical digits).</p></td></tr><tr><td><p>10</p></td><td><p>Clearing member ID</p></td><td><p>Legal Entity Identifier (LEI) (20 alphanumerical digits),</p><p>interim entity identifier (20 alphanumerical digits),</p><p>BIC (11 alphanumerical digits) or a</p><p>client code (50 alphanumerical digits).</p></td></tr><tr><td><p>11</p></td><td><p>Beneficiary ID</p></td><td><p>Legal Entity Identifier (LEI) (20 alphanumerical digits),</p><p>interim entity identifier (20 alphanumerical digits),</p><p>BIC (11 alphanumerical digits) or a</p><p>client code (50 alphanumerical digits).</p></td></tr><tr><td><p>12</p></td><td><p>Trading capacity</p></td><td><p>P=Principal, A=Agent.</p></td></tr><tr><td><p>13</p></td><td><p>Counterparty side</p></td><td><p>B=Buyer, S=Seller.</p></td></tr><tr><td><p>14</p></td><td><p>Trade with non-EEA counterparty</p></td><td><p>Y=Yes, N=No.</p></td></tr><tr><td><p>15</p></td><td><p>Directly linked to commercial activity or treasury financing</p></td><td><p>Y=Yes, N=No.</p></td></tr><tr><td><p>16</p></td><td><p>Clearing threshold</p></td><td><p>Y=Above, N=Below.</p></td></tr><tr><td><p>17</p></td><td><p>Mark to market value of contract</p></td><td><p>Up to 20 numerical digits in the format xxxx,yyyyy.</p></td></tr><tr><td><p>18</p></td><td><p>Currency of mark to market value of the contract</p></td><td><p>ISO 4217 Currency Code, 3 alphabetical digits.</p></td></tr><tr><td><p>19</p></td><td><p>Valuation date</p></td><td><p>ISO 8601 date format.</p></td></tr><tr><td><p>20</p></td><td><p>Valuation time</p></td><td><p>UTC time format.</p></td></tr><tr><td><p>21</p></td><td><p>Valuation type</p></td><td><p>M=mark to market / O=mark to model.</p></td></tr><tr><td><p>22</p></td><td><p>Collateralisation</p></td><td><p>U=uncollateralised, PC= partially collateralised, OC=one way collateralised or FC=fully collateralised.</p></td></tr><tr><td><p>23</p></td><td><p>Collateral portfolio</p></td><td><p>Y=Yes, N=No.</p></td></tr><tr><td><p>24</p></td><td><p>Collateral portfolio code</p></td><td><p>Up to 10 numerical digits.</p></td></tr><tr><td><p>25</p></td><td><p>Value of the collateral</p></td><td><p>Specify the value the total amount of collateral posted; up to 20 numerical digits in the format xxxx,yyyyy.</p></td></tr><tr><td><p>26</p></td><td><p>Currency of the collateral value</p></td><td><p>Specify the currency of field 25; ISO 4217 Currency Code, 3 alphabetical digits.</p></td></tr></tbody></table>
Table 2
Common Data
<table><col/><col/><col/><col/><tbody><tr><td><p> </p><div/></td><td><p>Field</p></td><td><p>Format</p></td><td><p>Applicable types of derivative contract</p></td></tr><tr><td><p> </p><div/></td><td><p>Section 2a - Contract type</p></td><td><p> </p><div/></td><td><p>All contracts</p></td></tr><tr><td><p>1</p></td><td><p>Taxonomy used</p></td><td><p>Identify the taxonomy used:</p><p>U = Product Identifier [endorsed in Europe]</p><p><img/></p><p>E = Interim taxonomy</p></td><td><p> </p><div/></td></tr><tr><td><p>2</p></td><td><p>Product ID 1</p></td><td><p>For taxonomy = U:</p><p>Product Identifier (UPI), to be defined</p><p>For taxonomy = I:</p><p>ISIN or AII,</p><p>12 digits alphanumerical code</p><p>For taxonomy = E:</p><p>Derivative class:</p><p>CO = Commodity</p><p>CR = Credit</p><p>CU = Currency</p><p>EQ = Equity</p><p>IR = Interest Rate</p><p>OT = Other</p></td><td><p> </p><div/></td></tr><tr><td><p>3</p></td><td><p>Product ID 2</p></td><td><p>For taxonomy = U</p><p>Blank</p><p>For taxonomy = I</p><p>CFI, 6 characters alphabetical code</p><p>For taxonomy = E:</p><p>Derivative type:</p><p>CD = Contracts for difference</p><p>FR = Forward rate agreements</p><p>FU = Futures</p><p>FW = Forwards</p><p>OP = Option</p><p>SW = Swap</p><p>OT = Other</p></td><td><p> </p><div/></td></tr><tr><td><p>4</p></td><td><p>Underlying</p></td><td><p>ISIN (12 alphanumerical digits);</p><p>LEI (20 alphanumerical digits);</p><p>Interim entity identifier (20 alphanumerical digits);</p><p>UPI (to be defined);</p><p>B = Basket;</p><p>I = Index.</p></td><td><p> </p><div/></td></tr><tr><td><p>5</p></td><td><p>Notional currency 1</p></td><td><p>ISO 4217 Currency Code, 3 alphabetical digits.</p></td><td><p> </p><div/></td></tr><tr><td><p>6</p></td><td><p>Notional currency 2</p></td><td><p>ISO 4217 Currency Code, 3 alphabetical digits.</p></td><td><p> </p><div/></td></tr><tr><td><p>7</p></td><td><p>Deliverable currency</p></td><td><p>ISO 4217 Currency Code, 3 alphabetical digits.</p></td><td><p> </p><div/></td></tr><tr><td><p> </p><div/></td><td><p>Section 2b - Details on the transaction</p></td><td><p> </p><div/></td><td><p>All contracts</p></td></tr><tr><td><p>8</p></td><td><p>Trade ID</p></td><td><p>Up to 52 alphanumerical digits.</p></td><td><p> </p><div/></td></tr><tr><td><p>9</p></td><td><p>Transaction reference number</p></td><td><p>An alphanumeric field up to 40 characters</p></td><td><p> </p><div/></td></tr><tr><td><p>10</p></td><td><p>Venue of execution</p></td><td><p>ISO 10383 Market Identifier Code (MIC), 4 digits alphabetical.</p><p>Where relevant, XOFF for listed derivatives that are traded off-exchange or XXXX for OTC derivatives.</p></td><td><p> </p><div/></td></tr><tr><td><p>11</p></td><td><p>Compression</p></td><td><p>Y = if the contract results from compression; N= if the contract does not result from compression.</p></td><td><p> </p><div/></td></tr><tr><td><p>12</p></td><td><p>Price / rate</p></td><td><p>Up to 20 numerical digits in the format xxxx,yyyyy.</p></td><td><p> </p><div/></td></tr><tr><td><p>13</p></td><td><p>Price notation</p></td><td><p>E.g. ISO 4217 Currency Code, 3 alphabetical digits, percentage.</p></td><td><p> </p><div/></td></tr><tr><td><p>14</p></td><td><p>Notional amount</p></td><td><p>Up to 20 numerical digits in the format xxxx,yyyyy.</p></td><td><p> </p><div/></td></tr><tr><td><p>15</p></td><td><p>Price multiplier</p></td><td><p>Up to 10 numerical digits.</p></td><td><p> </p><div/></td></tr><tr><td><p>16</p></td><td><p>Quantity</p></td><td><p>Up to 10 numerical digits.</p></td><td><p> </p><div/></td></tr><tr><td><p>17</p></td><td><p>Up-front payment</p></td><td><p>Up to 10 numerical digits in the format xxxx,yyyyy for payments made by the reporting counterparty and in the format xxxx,yyyyy for payments received by the reporting counterparty.</p></td><td><p> </p><div/></td></tr><tr><td><p>18</p></td><td><p>Delivery type</p></td><td><p>C=Cash, P=Physical, O=Optional for counterparty.</p></td><td><p> </p><div/></td></tr><tr><td><p>19</p></td><td><p>Execution timestamp</p></td><td><p>ISO 8601 date format / UTC time format.</p></td><td><p> </p><div/></td></tr><tr><td><p>20</p></td><td><p>Effective date</p></td><td><p>ISO 8601 date format.</p></td><td><p> </p><div/></td></tr><tr><td><p>21</p></td><td><p>Maturity date</p></td><td><p>ISO 8601 date format.</p></td><td><p> </p><div/></td></tr><tr><td><p>22</p></td><td><p>Termination date</p></td><td><p>ISO 8601 date format.</p></td><td><p> </p><div/></td></tr><tr><td><p>23</p></td><td><p>Settlement date</p></td><td><p>ISO 8601 date format.</p></td><td><p> </p><div/></td></tr><tr><td><p>24</p></td><td><p>Master Agreement type</p></td><td><p>Free Text, field of up to 50 characters, identifying the name of the Master Agreement used, if any.</p></td><td><p> </p><div/></td></tr><tr><td><p>25</p></td><td><p>Master Agreement version</p></td><td><p>Year, xxxx.</p></td><td><p> </p><div/></td></tr><tr><td><p> </p><div/></td><td><p>Section 2c - Risk mitigation / Reporting</p></td><td><p> </p><div/></td><td><p>All contracts</p></td></tr><tr><td><p>26</p></td><td><p>Confirmation timestamp</p></td><td><p>ISO 8601 date format, UTC time format.</p></td><td><p> </p><div/></td></tr><tr><td><p>27</p></td><td><p>Confirmation means</p></td><td><p>Y=Non-electronically confirmed, N=Non-confirmed, E=Electronically confirmed.</p></td><td><p> </p><div/></td></tr><tr><td><p> </p><div/></td><td><p>Section 2d - Clearing</p></td><td><p> </p><div/></td><td><p>All contracts</p></td></tr><tr><td><p>28</p></td><td><p>Clearing obligation</p></td><td><p>Y=Yes, N=No.</p></td><td><p> </p><div/></td></tr><tr><td><p>29</p></td><td><p>Cleared</p></td><td><p>Y=Yes, N=No.</p></td><td><p> </p><div/></td></tr><tr><td><p>30</p></td><td><p>Clearing timestamp</p></td><td><p>ISO 8601 date format / UTC time format.</p></td><td><p> </p><div/></td></tr><tr><td><p>31</p></td><td><p>CCP ID</p></td><td><p>Legal Entity Identifier (LEI) (20 alphanumerical digits) or, if not available, interim entity identifier (20 alphanumerical digits) or, if not available, BIC (11 alphanumerical digits).</p></td><td><p> </p><div/></td></tr><tr><td><p>32</p></td><td><p>Intragroup</p></td><td><p>Y=Yes, N=No.</p></td><td><p> </p><div/></td></tr><tr><td><p> </p><div/></td><td><p>Section 2e - Interest Rates</p></td><td><p> </p><div/></td><td><p>Interest rate derivatives</p></td></tr><tr><td><p>33</p></td><td><p>Fixed rate of leg 1</p></td><td><p>Numerical digits in the format xxxx,yyyyy.</p></td><td><p> </p><div/></td></tr><tr><td><p>34</p></td><td><p>Fixed rate of leg 2</p></td><td><p>Numerical digits in the format xxxx,yyyyy.</p></td><td><p> </p><div/></td></tr><tr><td><p>35</p></td><td><p>Fixed rate day count</p></td><td><p>Actual/365, 30B/360 or Other.</p></td><td><p> </p><div/></td></tr><tr><td><p>36</p></td><td><p>Fixed leg payment frequency</p></td><td><p>An integer multiplier of a time period describing how often the counterparties exchange payments, e.g. 10D, 3M, 5Y.</p></td><td><p> </p><div/></td></tr><tr><td><p>37</p></td><td><p>Floating rate payment frequency</p></td><td><p>An integer multiplier of a time period describing how often the counterparties exchange payments, e.g. 10D, 3M, 5Y.</p></td><td><p> </p><div/></td></tr><tr><td><p>38</p></td><td><p>Floating rate reset frequency</p></td><td><p>D = An integer multiplier of a time period describing how often the counterparties exchange payments, e.g. 10D, 3M, 5Y.</p></td><td><p> </p><div/></td></tr><tr><td><p>39</p></td><td><p>Floating rate of leg 1</p></td><td><p>The name of the floating rate index, e.g. 3M Euribor.</p></td><td><p> </p><div/></td></tr><tr><td><p>40</p></td><td><p>Floating rate of leg 2</p></td><td><p>The name of the floating rate index, e.g. 3M Euribor.</p></td><td><p> </p><div/></td></tr><tr><td><p> </p><div/></td><td><p>Section 2f – Foreign Exchange</p></td><td><p> </p><div/></td><td><p>Currency derivatives</p></td></tr><tr><td><p>41</p></td><td><p>Currency 2</p></td><td><p>ISO 4217 Currency Code, 3 alphabetical digits.</p></td><td><p> </p><div/></td></tr><tr><td><p>42</p></td><td><p>Exchange rate 1</p></td><td><p>Up to 10 numerical digits in the format xxxx,yyyyy.</p></td><td><p> </p><div/></td></tr><tr><td><p>43</p></td><td><p>Forward exchange rate</p></td><td><p>Up to 10 numerical digits in the format xxxx,yyyyy.</p></td><td><p> </p><div/></td></tr><tr><td><p>44</p></td><td><p>Exchange rate basis</p></td><td><p>E.g. EUR/USD or USD/EUR.</p></td><td><p> </p><div/></td></tr><tr><td><p> </p><div/></td><td><p>Section 2g - Commodities</p></td><td><p>If a UPI is reported and contains all the information below, this is not required unless to be reported according to Regulation (EU) No 1227/2011.</p></td><td><p>Commodity derivatives</p></td></tr><tr><td><p>General</p></td></tr><tr><td><p>45</p></td><td><p>Commodity base</p></td><td><p>AG = Agricultural</p><p>EN = Energy</p><p>FR = Freights</p><p>ME = Metals</p><p>IN = Index</p><p>EV = Environmental</p><p>EX = Exotic</p></td><td><p> </p><div/></td></tr><tr><td><p>46</p></td><td><p>Commodity details</p></td><td><p><span>Agricultural</span></p><p>GO = Grains oilseeds</p><p>DA = Dairy</p><p>LI = Livestock</p><p>FO = Forestry</p><p>SO = Softs</p><p><span>Energy</span></p><p>OI = Oil</p><p>NG = Natural gas</p><p>CO = Coal</p><p>EL = Electricity</p><p>IE = Inter-energy</p><p><span>Metals</span></p><p>PR = Precious</p><p>NP = Non-precious</p><p><span>Environmental</span></p><p>WE = Weather</p><p>EM = Emissions</p></td><td><p> </p><div/></td></tr><tr><td><p>Energy</p></td></tr><tr><td><p>47</p></td><td><p>Delivery point or zone</p></td><td><p>EIC code, 16 character alphanumeric code.</p></td><td><p> </p><div/></td></tr><tr><td><p>48</p></td><td><p>Interconnection Point</p></td><td><p>Free text, field of up to 50 characters.</p></td><td><p> </p><div/></td></tr><tr><td><p>49</p></td><td><p>Load type</p></td><td><p>Repeatable section of fields 50-54 to identify the product delivery profile which correspond to the delivery periods of a day;</p><p>BL = Base Load</p><p>PL = Peak Load</p><p>OP = Off-Peak</p><p>BH = Block Hours</p><p>OT = Other</p></td><td><p> </p><div/></td></tr><tr><td><p>50</p></td><td><p>Delivery start date and time</p></td><td><p>ISO 8601 date format / UTC time format.</p></td><td><p> </p><div/></td></tr><tr><td><p>51</p></td><td><p>Delivery end date and time</p></td><td><p>ISO 8601 date format / UTC time format.</p></td><td><p> </p><div/></td></tr><tr><td><p>52</p></td><td><p>Contract capacity</p></td><td><p>Free text, field of up to 50 characters.</p></td><td><p> </p><div/></td></tr><tr><td><p>53</p></td><td><p>Quantity Unit</p></td><td><p>10 numerical digits in the format xxxx,yyyyy.</p></td><td><p> </p><div/></td></tr><tr><td><p>54</p></td><td><p>Price/time interval quantities</p></td><td><p>10 numerical digits in the format xxxx,yyyyy.</p></td><td><p> </p><div/></td></tr><tr><td><p> </p><div/></td><td><p>Section 2h - Options</p></td><td><p> </p><div/></td><td><p>Contracts that contain an option</p></td></tr><tr><td><p>55</p></td><td><p>Option type</p></td><td><p>P=Put, C=Call.</p></td><td><p> </p><div/></td></tr><tr><td><p>56</p></td><td><p>Option style (exercise)</p></td><td><p>A=American, B=Bermudan, E=European, S=Asian.</p></td><td><p> </p><div/></td></tr><tr><td><p>57</p></td><td><p>Strike price (cap/floor rate)</p></td><td><p>Up to 10 Numerical digits in the format xxxx,yyyyy.</p></td><td><p> </p><div/></td></tr><tr><td><p> </p><div/></td><td><p>Section 2i - Modifications to the contract</p></td><td><p> </p><div/></td><td><p>All contracts</p></td></tr><tr><td><p>58</p></td><td><p>Action type</p></td><td><p>N = New</p><p>M = Modify</p><p>E = Error,</p><p>C = Cancel,</p><p>Z = Compression,</p><p>V = Valuation update,</p><p>O = Other.</p></td><td><p> </p><div/></td></tr><tr><td><p>59</p></td><td><p>Details of action type</p></td><td><p>Free text, field of up to 50 characters.</p></td><td><p> </p><div/></td></tr></tbody></table> | ENG | 02012R1247-20170210 |
<table><col/><col/><col/><col/><tbody><tr><td><p>11.2.2019   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 39/11</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING DECISION (EU) 2019/240
of 6 February 2019
amending Implementing Decisions 2013/648/EU and 2013/650/EU as regards the representative of the authorisation holders
(notified under document C(2019) 747)
(Only the Dutch, French and English texts are authentic)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed ( 1 ) , and in particular to Article 9(2) and Article 21(2) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Dow AgroSciences Ltd, based in the United Kingdom, is representative in the Union of Dow AgroSciences LLC, based in the United States, pursuant to Commission Implementing Decisions 2013/648/EU <a>(<span>2</span>)</a> and 2013/650/EU <a>(<span>3</span>)</a> for genetically modified food and feed in accordance with Regulation (EC) No 1829/2003. For the authorisations under those decisions, Monsanto Europe S.A., based in Belgium, is representative in the Union of Monsanto Company, based in the United States.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>By letter dated 13 September 2018, Dow AgroSciences Ltd requested the Commission, in the context of the withdrawal of the United Kingdom from the European Union, that the authorisations for genetically modified food and feed for which Dow AgroSciences Ltd is representative of Dow AgroSciences LLC, should be transferred to Dow AgroSciences Distribution S.A.S., based in France. By letter dated 7 September 2018, Dow AgroSciences Distribution S.A.S confirmed its agreement with the transfer of representative.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>By letter dated 27 August 2018, the representative in the Union of Monsanto Company for those authorisations, Monsanto Europe S.A., informed the Commission that it converted its legal form and changed its name to Bayer Agriculture BVBA, Belgium. By letter dated 4 September 2018 the Commission informed Monsanto Europe S.A. that the authorisations concerned would need to be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The requested changes are purely administrative in nature and therefore do not entail a new assessment of the products concerned. The same applies as regards the addressees of the authorisations Decisions concerned, which should also be adapted accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Implementing Decisions 2013/648/EU and 2013/650/EU should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
Amendments to Implementing Decision 2013/648/EU
Implementing Decision 2013/648/EU is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>the text of point (a) of Article 6(1) is replaced by the following: ‘Dow AgroSciences Distribution S.A.S., France, representing DowAgroSciences LLC, United States; and’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>the text of point (b) of Article 6(1) is replaced by the following: ‘Bayer Agriculture BVBA, Belgium, representing Monsanto Company, United States’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>the text of point (a) of Article 8 is replaced by the following: ‘Dow AgroSciences Distribution S.A.S., 6, rue Jean Pierre Timbaud, 78180 Montigny-le-Bretonneux, France; and’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>the text of point (b) of Article 8 is replaced by the following: ‘Bayer Agriculture BVBA, Scheldelaan 460, 2040 Antwerp, Belgium’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>point (a) of the Annex is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the name ‘Dow AgroSciences Ltd’ is replaced by the terms ‘Dow AgroSciences Distribution S.A.S.’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the address ‘European Development Centre, 3B Park Square, Milton Park, Abingdon, Oxon OX14 4RN, United Kingdom’ is replaced by the terms ‘6, rue Jean Pierre Timbaud, 78180 Montigny-le-Bretonneux, France’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the name ‘Monsanto Europe S.A.’ is replaced by the terms ‘Bayer Agriculture BVBA’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the address ‘Avenue de Tervuren 270-272, 1150 Brussels, Belgium’ is replaced by the terms ‘Scheldelaan 460, 2040 Antwerp, Belgium’.</p></td></tr></tbody></table></td></tr></tbody></table>
Article 2
Amendments to Implementing Decision 2013/650/EU
Implementing Decision 2013/650/EU is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>the text of point (a) of Article 6(1) is replaced by the following: ‘Dow AgroSciences Distribution S.A.S., France, representing DowAgroSciences LLC, United States; and’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>the text of point (b) of Article 6(1) is replaced by the following: ‘Bayer Agriculture BVBA, Belgium, representing Monsanto Company, United States’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>the text of point (a) of Article 8 is replaced by the following: ‘Dow AgroSciences Distribution S.A.S., 6, rue Jean Pierre Timbaud, 78180 Montigny-le-Bretonneux, France; and’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>the text of point (b) of Article 8 is replaced by the following: ‘Bayer Agriculture BVBA, Scheldelaan 460, 2040 Antwerp, Belgium’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>point (a) of the Annex is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the name ‘Dow AgroSciences Ltd’ is replaced by ‘Dow AgroSciences Distribution S.A.S.’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the address ‘European Development Centre, 3B Park Square, Milton Park, Abingdon, Oxon OX14 4RN, United Kingdom’ is replaced by ‘6, rue Jean Pierre Timbaud, 78180 Montigny-le-Bretonneux, France’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the name ‘Monsanto Europe S.A.’ is replaced by the terms ‘Bayer Agriculture BVBA’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the address ‘Avenue de Tervuren 270-272, 1150 Brussels, Belgium’ is replaced by the terms ‘Scheldelaan 460, 2040 Antwerp, Belgium’.</p></td></tr></tbody></table></td></tr></tbody></table>
Article 3
Addressee
This Decision is addressed to:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>Dow AgroSciences Distribution S.A.S., 6, rue Jean Pierre Timbaud, 78180 Montigny le Bretonneux, France; and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>Bayer Agriculture BVBA, Scheldelaan 460, 2040 Antwerp, Belgium.</p></td></tr></tbody></table>
Done at Brussels, 6 February 2019.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
<note>
( 1 ) OJ L 268, 18.10.2003, p. 1 .
( 2 ) Commission Implementing Decision 2013/648/EU of 6 November 2013 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON89034 × 1507 × NK603 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council ( OJ L 302, 13.11.2013, p. 38 ).
( 3 ) Commission Implementing Decision 2013/650/EU of 6 November 2013 authorising the placing on the market of products containing, consisting of, or produced from genetically modified (GM) maize MON 89034 × 1507 × MON88017 × 59122 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7), four related GM maizes combining three different single GM events (MON89034 × 1507 × MON88017 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3), MON89034 × 1507 × 59122 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × DAS-59122-7), MON89034 × MON88017 × 59122 (MON-89Ø34-3 × MON-88Ø17-3 × DAS-59122-7), 1507 × MON 88017 × 59122 (DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7)) and four related GM maizes combining two different single GM events (MON89034 × 1507 (MON-89Ø34-3 × DAS-Ø15Ø7-1), MON89034 × 59122 (MON-89Ø34-3 × DAS-59122-7), 1507 × MON88017 (DAS-Ø15Ø7-1 × MON-88Ø17-3), MON 88017 × 59122 (MON-88Ø17-3 × DAS-59122-7)) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council ( OJ L 302, 13.11.2013, p. 47 ).
</note> | ENG | 32019D0240 |
<table><col/><col/><col/><col/><tbody><tr><td><p>16.11.2021   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 405/20</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING DECISION (EU) 2021/1993
of 15 November 2021
establishing the equivalence, for the purpose of facilitating the right of free movement within the Union, of COVID-19 certificates issued by New Zealand to the certificates issued in accordance with Regulation (EU) 2021/953 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2021/953 of the European Parliament and of the Council of 14 June 2021 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) to facilitate free movement during the COVID-19 pandemic ( 1 ) , and in particular Article 8(2) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Regulation (EU) 2021/953 lays down a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (‘EU Digital COVID Certificate’) for the purpose of facilitating the holders’ exercise of their right to free movement during the COVID-19 pandemic. It is also to contribute to facilitating the gradual lifting of restrictions to free movement put in place by Member States, in accordance with Union law, to limit the spread of SARS-CoV-2, in a coordinated manner.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Regulation (EU) 2021/953 allows for the acceptance of COVID-19 certificates issued by third countries to Union citizens and their family members where the Commission finds that those COVID-19 certificates are issued in accordance with standards that are to be considered as equivalent to those established pursuant to that Regulation. Furthermore, in accordance with Regulation (EU) 2021/954 of the European Parliament and of the Council <a>(<span>2</span>)</a>, Member States have to apply the rules laid down in Regulation (EU) 2021/953 to third-country nationals who do not fall within the scope of that Regulation, but who are legally staying or residing in their territory and who are entitled to travel to other Member States in accordance with Union law. Therefore, any equivalence findings laid down in this Decision should apply to COVID-19 vaccination and test certificates issued by New Zealand to Union citizens and their family members. Similarly, on the basis of Regulation (EU) 2021/954, such equivalence findings should also apply to COVID-19 vaccination and test certificates issued by New Zealand to third-country nationals legally staying or residing in the territory of the Member States under the conditions laid down in that Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>On 2 September 2021, New Zealand provided the Commission with detailed information on the issuance of interoperable COVID-19 vaccination and test certificates under the system entitled ‘My Covid Record’. New Zealand informed the Commission that it considered that its COVID-19 certificates are being issued in accordance with a standard and a technological system that are interoperable with the trust framework established by Regulation (EU) 2021/953 and that allow for the verification of the authenticity, validity and integrity of the certificates. In this regard, New Zealand informed the Commission that COVID-19 certificates issued by New Zealand in accordance with the ‘My Covid Record’ system contain the data set out in the Annex to Regulation (EU) 2021/953.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>New Zealand also informed the Commission that it accepts vaccination and test certificates issued by the Member States and EEA countries in accordance with Regulation (EU) 2021/953.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>On 19 October 2021, following a request by New Zealand, the Commission carried out technical tests that demonstrated that the COVID-19 vaccination and test certificates are issued by New Zealand in accordance with a system, the ‘My Covid Record’, that is interoperable with the trust framework established by Regulation (EU) 2021/953, and allows for the verification of the authenticity, validity and integrity of the certificates. The Commission also confirmed that the COVID-19 vaccination and test certificates issued by New Zealand in accordance with the ‘My Covid Record’ system contain the necessary data.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>In addition, New Zealand informed the Commission that it issues interoperable vaccination certificates for COVID-19 vaccines. These currently include Pfizer/BioNTech COMIRNATY and Pfizer New Zealand Limited (NZBN: 9429040634296).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>New Zealand also informed the Commission that it issues interoperable test certificates for nucleic acid amplification tests and rapid antigen tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Furthermore, New Zealand informed the Commission that it does not issue interoperable certificates of recovery.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>In addition, New Zealand informed the Commission that when verifiers in New Zealand verify certificates, the personal data included in them will be processed only to verify and confirm the holder’s vaccination or test result and will not be retained afterwards.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>The necessary elements for establishing that COVID-19 certificates issued by New Zealand in accordance with the ‘My Covid Record’ system are to be considered as equivalent to those issued in accordance with Regulation (EU) 2021/953 and are thus fulfilled.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>Therefore, COVID-19 certificates issued by New Zealand in accordance with the ‘My Covid Record’ system should be accepted under the conditions referred to in Article 5(5) and Article 6(5) of Regulation (EU) 2021/953.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>In order for this Decision to be operational, New Zealand should be connected to the EU Digital COVID Certificate trust framework established by Regulation (EU) 2021/953.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>In order to protect the Union’s interests, in particular in the area of public health, the Commission may use its powers to suspend application of this Decision or repeal it, if the conditions of Article 8(2) of Regulation (EU) 2021/953 are no longer met.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>In the light of the need to connect New Zealand to the EU Digital COVID Certificate trust framework established by Regulation (EU) 2021/953 as rapidly as possible, this Decision should enter into force on the day of its publication in the<span>Official Journal of the European Union</span>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 14 of Regulation (EU) 2021/953,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
COVID-19 vaccination and test certificates issued by New Zealand in accordance with the ‘My Covid Record’ system shall, for the purpose of facilitating the right of free movement within the Union, be considered as equivalent to those issued in accordance with Regulation (EU) 2021/953.
Article 2
New Zealand shall be connected to the EU Digital COVID Certificate trust framework established by Regulation (EU) 2021/953.
Article 3
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .
Done at Brussels, 15 November 2021.
For the Commission
The President
Ursula VON DER LEYEN
<note>
( 1 ) OJ L 211, 15.6.2021, p. 1 .
( 2 ) Regulation (EU) 2021/954 of the European Parliament and of the Council of 14 June 2021 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) with regard to third country nationals legally staying or residing in the territories of Member States during the COVID-19 pandemic ( OJ L 211, 15.6.2021, p. 24 ).
</note> | ENG | 32021D1993 |
<table><col/><col/><col/><col/><tbody><tr><td><p>23.3.2018   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 81/83</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING DECISION (EU) 2018/496
of 22 March 2018
on the establishment of the 2018 annual priority list for the development of network codes and guidelines
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 714/2009 of the European Parliament and of the Council of 13 July 2009 on conditions for access to the network for cross-border exchanges in electricity and repealing Regulation (EC) No 1228/2003 ( 1 ) , and in particular Article 6(1) thereof,
Having regard to Regulation (EC) No 715/2009 of the European Parliament and of the Council of 13 July 2009 on conditions for access to natural gas transmission networks and repealing Regulation (EC) No 1775/2005 ( 2 ) , and in particular Article 6(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The development and implementation of network codes and guidelines are essential in order to achieve full integration of the internal energy market. The Third Energy Package<a> (<span>3</span>)</a> has created an institutional framework for the development of network codes with a view to harmonising, where necessary, the technical, operational and market rules governing the electricity and gas grids. For that purpose, the Agency for the Cooperation of Energy Regulators (‘ACER’), the European Networks of Transmission System Operators (‘ENTSOs’) and the Commission work in close cooperation with all relevant stakeholders.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The areas in which network codes can be developed are set out in Articles 8(6) of Regulation (EC) No 714/2009 and Regulation (EC) No 715/2009. Besides the possibility to develop network codes, the Commission can also decide to develop guidelines in the areas set out in Article 18(1), (2) and (3) of Regulation (EC) No 714/2009 and Article 23(1) of Regulation (EC) No 715/2009. In accordance with Article 6(1) of Regulation (EC) No 714/2009 and Article 6(1) of Regulation (EC) No 715/2009, the Commission should first establish an annual priority list identifying the areas to be included in the development of network codes.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>During the public consultation<a> (<span>4</span>)</a>, the majority of stakeholders supported the prioritisation of the ongoing work and emphasised the importance of a proper and well-coordinated implementation of adopted network codes and guidelines whereby a structured involvement of stakeholders is ensured. A few respondents signalled that in the future it could be necessary to consider amending the adopted network codes and guidelines.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Acknowledging the responses of stakeholders and having regard to the future legislative initiatives in the context of the market design initiative, the various actions needed to ensure the full integration of the internal energy market and the fact that the implementation of network codes and guidelines will require significant resources from all relevant parties including the European Commission, ACER, ENTSOs and stakeholders, no new areas have been added to the annual priority lists,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
It is hereby established that no new areas have been identified for the development, in 2018, of network codes and guidelines for electricity and gas.
Article 2
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Done at Brussels, 22 March 2018.
For the Commission
The President
Jean-Claude JUNCKER
<note>
( 1 ) OJ L 211, 14.8.2009, p. 15 .
( 2 ) OJ L 211, 14.8.2009, p. 36 .
( 3 ) The Third Energy Package consists of Directive 2009/72/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in electricity and repealing Directive 2003/54/EC ( OJ L 211, 14.8.2009, p. 55 ), Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas and repealing Directive 2003/55/EC ( OJ L 211, 14.8.2009, p. 94 ), Regulations (EC) No 714/2009 and (EC) No 715/2009, and Regulation (EC) No 713/2009 of the European Parliament and of the Council of 13 July 2009 establishing an Agency for the Cooperation of Energy Regulators ( OJ L 211, 14.8.2009, p. 1 ).
( 4 ) The responses are published under: https://ec.europa.eu/info/consultations/public-consultation-priorities-network-codes-and-guidelines-2018-based-article-6-1-regulation-ec-no-714-2009-and-regulation-ec-no-715-2009_en
</note> | ENG | 32018D0496 |
<table><col/><col/><col/><col/><tbody><tr><td><p>8.2.2019   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 37/120</p></td></tr></tbody></table>
COUNCIL DECISION (EU) 2019/233
of 6 November 2018
on the position to be taken on behalf of the European Union in the relevant Committees of the United Nations Economic Commission for Europe as regards the proposals for modifications to UN Regulations Nos 3, 4, 6, 7, 11, 14, 16, 17, 19, 23, 24, 27, 29, 34, 37, 38, 43, 44, 46, 48, 50, 53, 60, 67, 69, 70, 74, 77, 83, 86, 87, 91, 94, 95, 98, 99, 100, 101, 104, 105, 110, 112, 113, 119, 121, 123, 128, 129, 132 and 137 and to UN Global Technical Regulation No 9, and as regards the proposals for three new UN Regulations
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114, in conjunction with Article 218(9) thereof,
Having regard to the proposal from the European Commission,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>By Council Decision 97/836/EC <a>(<span>1</span>)</a>, the Union acceded to the Agreement of the United Nations Economic Commission for Europe (UNECE) concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted to and/or be used on wheeled vehicles and the conditions for reciprocal recognition of approvals granted on the basis of those prescriptions (the ‘Revised 1958 Agreement’).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>By Council Decision 2000/125/EC <a>(<span>2</span>)</a>, the Union acceded to the Agreement concerning the establishing of global technical regulations for wheeled vehicles, equipment and parts which can be fitted and/or be used on wheeled vehicles (the ‘Parallel Agreement’).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Directive 2007/46/EC of the European Parliament and of the Council <a>(<span>3</span>)</a> replaced the approval systems of the Member States with a Union approval procedure and established a harmonised framework containing administrative provisions and general technical requirements for all new vehicles, systems, components and separate technical units. That Directive incorporated regulations adopted under the Revised 1958 Agreement (‘UN Regulations’) in the EU type-approval system, either as requirements for type-approval or as alternatives to Union legislation. Since the adoption of Directive 2007/46/EC, UN regulations have been increasingly incorporated into Union legislation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>In the light of experience and technical developments, the requirements relating to certain elements or features covered by UN Regulations Nos 3, 4, 6, 7, 11, 14, 16, 17, 19, 23, 24, 27, 29, 34, 37, 38, 43, 44, 46, 48, 50, 53, 60, 67, 69, 70, 74, 77, 83, 86, 87, 91, 94, 95, 98, 99, 100, 101, 104, 105, 110, 112, 113, 119, 121, 123, 128, 129, 132 and 137, as well as by UN Global Technical Regulation 9 need to be modified.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>In order to clarify and consolidate the component-related requirements currently contained in several UN Regulations, three new UN Regulations on light-signalling devices (LSD), road illumination devices (RID) and retro-reflective devices (RRD) need to be adopted. They will replace and repeal UN Regulations Nos 3, 4, 6, 7, 19, 23, 27, 38, 50, 69, 70, 77, 87, 91, 98, 104, 112, 113, 119 and 123 without changing any of the detailed technical requirements already in force to date.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>It is appropriate to establish the position to be taken on the Union's behalf in the Administrative Committee of the Revised 1958 Agreement and in the Executive Committee of the Parallel Agreement as regards the adoption of those modifications and those new UN Regulations, as the Regulations will be binding on the Union and capable of decisively influencing the content of Union law in the field of vehicle type-approval.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>In those Committees, the Union is to be represented by the Commission in accordance with Article 17(1) of the Treaty on European Union,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
The position to be taken on the Union's behalf in the Administrative Committee of the Revised 1958 Agreement and the Executive Committee of the Parallel Agreement during the period from 12 to 16 November 2018 shall be to vote in favour of the proposals listed in the Annex to this Decision.
Article 2
This Decision is addressed to the Commission.
Done at Brussels, 6 November 2018.
For the Council
The President
H. LÖGER
( 1 ) Council Decision 97/836/EC of 27 November 1997 with a view to accession by the European Community to the Agreement of the United Nations Economic Commission for Europe concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted to and/or be used on wheeled vehicles and the conditions for reciprocal recognition of approvals granted on the basis of these prescriptions (‘Revised 1958 Agreement’) ( OJ L 346, 17.12.1997, p. 78 ).
( 2 ) Council Decision 2000/125/EC of 31 January 2000 concerning the conclusion of the Agreement concerning the establishing of global technical regulations for wheeled vehicles, equipment and parts which can be fitted and/or be used on wheeled vehicles (‘Parallel Agreement’) ( OJ L 35, 10.2.2000, p. 12 ).
( 3 ) Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) ( OJ L 263, 9.10.2007, p. 1 ).
ANNEX
<table><col/><col/><col/><tbody><tr><td><p>Regulation No</p></td><td><p>Agenda item title</p></td><td><p>Document reference<a> (<span>1</span>)</a></p></td></tr><tr><td><p>3</p></td><td><p>Proposal for the 03 series of amendments to UN Regulation No 3 (Retro-reflecting devices)</p></td><td><p>ECE/TRANS/WP.29/2018/91</p></td></tr><tr><td><p>4</p></td><td><p>Proposal for the 01 series of amendments to UN Regulation No 4 (Illumination of rear registration plates)</p></td><td><p>ECE/TRANS/WP.29/2018/92</p></td></tr><tr><td><p>6</p></td><td><p>Proposal for the 02 series of amendments to UN Regulation No 6 (Direction indicators)</p></td><td><p>ECE/TRANS/WP.29/2018/93</p></td></tr><tr><td><p>7</p></td><td><p>Proposal for the 03 series of amendments to UN Regulation No 7 (Position, stop and end-outline lamps)</p></td><td><p>ECE/TRANS/WP.29/2018/94</p></td></tr><tr><td><p>11</p></td><td><p>Proposal for Supplement 2 to the 04 series of amendments to UN Regulation No 11 (Door latches and hinges)</p></td><td><p>ECE/TRANS/WP.29/2018/127</p></td></tr><tr><td><p>11</p></td><td><p>Proposal for Corrigendum 1 to the 04 series of amendments to UN Regulation No 11 (Door latches and hinges)</p></td><td><p>ECE/TRANS/WP.29/2018/155</p></td></tr><tr><td><p>14</p></td><td><p>Proposal for Corrigendum 2 to Revision 5 to UN Regulation No 14 (Safety-belt anchorages)</p></td><td><p>ECE/TRANS/WP.29/2018/156</p></td></tr><tr><td><p>16</p></td><td><p>Proposal for Supplement 11 to the 06 series of amendments to UN Regulation No 16 (Safety-belts)</p></td><td><p>ECE/TRANS/WP.29/2018/128</p></td></tr><tr><td><p>16</p></td><td><p>Proposal for Supplement 4 to the 07 series of amendments to UN Regulation No 16 (Safety-belts)</p></td><td><p>ECE/TRANS/WP.29/2018/129</p></td></tr><tr><td><p>16</p></td><td><p>Proposal for the 08 series of amendments to UN Regulation No 16 (Safety-belts)</p></td><td><p>ECE/TRANS/WP.29/2018/141</p></td></tr><tr><td><p>17</p></td><td><p>Proposal for the 09 series of amendments to UN Regulation No 17 (Strength of seats)</p></td><td><p>ECE/TRANS/WP.29/2018/142</p></td></tr><tr><td><p>19</p></td><td><p>Proposal for the 05 series of amendments to UN Regulation No 19 (Front fog lamps)</p></td><td><p>ECE/TRANS/WP.29/2018/95</p></td></tr><tr><td><p>23</p></td><td><p>Proposal for the 01 series of amendments to UN Regulation No 23 (Reversing lamps)</p></td><td><p>ECE/TRANS/WP.29/2018/96</p></td></tr><tr><td><p>24</p></td><td><p>Proposal for Supplement 4 to the 03 series of amendments to UN Regulation No 24 (Visible pollutants, measurement of power of Compression Ignition engine (Diesel smoke))</p></td><td><p>ECE/TRANS/WP.29/2018/143</p></td></tr><tr><td><p>27</p></td><td><p>Proposal for the 05 series of amendments to UN Regulation No 27 (Advance warning triangles)</p></td><td><p>ECE/TRANS/WP.29/2018/97</p></td></tr><tr><td><p>29</p></td><td><p>Proposal for Supplement 4 to the 03 series of amendments to UN Regulation No 29 (Cabs of commercial vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/130</p></td></tr><tr><td><p>34</p></td><td><p>Proposal for Supplement 6 to the 02 series of amendments to UN Regulation No 34 (Prevention of fire risks)</p></td><td><p>ECE/TRANS/WP.29/2018/120</p></td></tr><tr><td><p>34</p></td><td><p>Proposal for Supplement 2 to the 03 series of amendments to UN Regulation No 34 (Prevention of fire risks)</p></td><td><p>ECE/TRANS/WP.29/2018/121</p></td></tr><tr><td><p>37</p></td><td><p>Proposal for Supplement 47 to the 03 series of amendments to UN Regulation No 37 (Filament light sources)</p></td><td><p>ECE/TRANS/WP.29/2018/83</p></td></tr><tr><td><p>38</p></td><td><p>Proposal for the 01 series of amendments to UN Regulation No 38 (Rear fog lamps)</p></td><td><p>ECE/TRANS/WP.29/2018/98</p></td></tr><tr><td><p>43</p></td><td><p>Proposal for Supplement 8 to the 01 series of amendments to UN Regulation No 43 (Safety glazing)</p></td><td><p>ECE/TRANS/WP.29/2018/122</p></td></tr><tr><td><p>44</p></td><td><p>Proposal Supplement 15 to the 04 series of amendments to UN Regulation No 44 (Child restraint systems)</p></td><td><p>ECE/TRANS/WP.29/2018/131</p></td></tr><tr><td><p>46</p></td><td><p>Proposal for Supplement 6 to the 04 series of amendments to UN Regulation No 46 (Devices for indirect vision)</p></td><td><p>ECE/TRANS/WP.29/2018/123</p></td></tr><tr><td><p>48</p></td><td><p>Proposal for Supplement 11 to the 06 series of amendments to UN Regulation No 48 (Installation of lighting and light-signalling devices)</p></td><td><p>ECE/TRANS/WP.29/2018/84</p></td></tr><tr><td><p>48</p></td><td><p>Proposal for Supplement 12 to the 05 series of amendments to UN Regulation No 48 (Installation of lighting and light-signalling devices)</p></td><td><p>ECE/TRANS/WP.29/2018/85</p></td></tr><tr><td><p>48</p></td><td><p>Proposal for Supplement 11 to the 06 series of amendments to UN Regulation No 48 (Installation of lighting and light-signalling devices)</p></td><td><p>ECE/TRANS/WP.29/2018/99/Rev.1</p></td></tr><tr><td><p>48</p></td><td><p>Proposal for Supplement 12 to the 05 series of amendments to UN Regulation No 48 (Installation of lighting and light-signalling devices)</p></td><td><p>ECE/TRANS/WP.29/2018/100</p></td></tr><tr><td><p>48</p></td><td><p>Proposal for Supplement 18 to the 04 series of amendments to UN Regulation No 48 (Installation of lighting and light-signalling devices)</p></td><td><p>ECE/TRANS/WP.29/2018/101</p></td></tr><tr><td><p>48</p></td><td><p>Proposal for Supplement 6 to the 03 series of amendments to UN Regulation No 48 (Installation of lighting and light-signalling devices)</p></td><td><p>ECE/TRANS/WP.29/2018/102</p></td></tr><tr><td><p>50</p></td><td><p>Proposal for the 01 series of amendments to UN Regulation No 50 (Position, stop, direction indicator lamps for mopeds and motorcycles)</p></td><td><p>ECE/TRANS/WP.29/2018/103</p></td></tr><tr><td><p>53</p></td><td><p>Proposal for Supplement 2 to the 02 series of amendments to UN Regulation No 53 (Installation of lighting and light-signalling devices for L<span>3</span> vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/86</p></td></tr><tr><td><p>53</p></td><td><p>Proposal for Supplement 20 to the 01 series of amendments to UN Regulation No 53 (Installation of lighting and light-signalling devices for L<span>3</span> vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/87</p></td></tr><tr><td><p>53</p></td><td><p>Proposal for Supplement 2 to the 02 series of amendments to UN Regulation No 53 (Installation of lighting and light-signalling devices for L<span>3</span> vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/104/Rev.1</p></td></tr><tr><td><p>53</p></td><td><p>Proposal for Supplement 20 to the 01 series of amendments to UN Regulation No 53 (Installation of lighting and light-signalling devices for L<span>3</span> vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/105</p></td></tr><tr><td><p>60</p></td><td><p>Proposal for Corrigendum 1 to Revision 1 to UN Regulation No 60 (Driver operated controls for mopeds/motorcycles)</p></td><td><p>ECE/TRANS/WP.29/2018/152</p></td></tr><tr><td><p>67</p></td><td><p>Proposal for the 02 series of amendments to UN Regulation No 67 (LPG vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/124</p></td></tr><tr><td><p>69</p></td><td><p>Proposal for the 02 series of amendments to UN Regulation No 69 (Rear-marking plates for slow moving vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/106</p></td></tr><tr><td><p>70</p></td><td><p>Proposal for the 02 series of amendments to UN Regulation No 70 (Rear-marking plates for heavy and long vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/107</p></td></tr><tr><td><p>74</p></td><td><p>Proposal for Supplement 10 to the 01 series of amendments to UN Regulation No 74 (Installation of lighting and light-signalling devices for mopeds)</p></td><td><p>ECE/TRANS/WP.29/2018/88</p></td></tr><tr><td><p>74</p></td><td><p>Proposal for Supplement 10 to the 01 series of amendments to UN Regulation No 74 (Installation of lighting and light-signalling devices for mopeds)</p></td><td><p>ECE/TRANS/WP.29/2018/108/Rev.1</p></td></tr><tr><td><p>77</p></td><td><p>Proposal for the 01 series of amendments to UN Regulation No 77 (Parking lamps)</p></td><td><p>ECE/TRANS/WP.29/2018/109</p></td></tr><tr><td><p>83</p></td><td><p>Proposal for Supplement 2 to the 03 series of amendments to UN Regulation No 83 (Emissions of M<span>1</span> and N<span>1</span> vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/144</p></td></tr><tr><td><p>83</p></td><td><p>Proposal for Supplement 1 to the 04 series of amendments to UN Regulation No 83 (Emissions of M<span>1</span> and N<span>1</span> vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/145</p></td></tr><tr><td><p>83</p></td><td><p>Proposal for Supplement 12 to the 05 series of amendments to UN Regulation No 83 (Emissions of M<span>1</span> and N<span>1</span> vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/146</p></td></tr><tr><td><p>83</p></td><td><p>Proposal for Supplement 12 to the 06 series of amendments to UN Regulation No 83 (Emissions of M<span>1</span> and N<span>1</span> vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/147</p></td></tr><tr><td><p>83</p></td><td><p>Proposal for Supplement 18 to the 07 series of amendments to UN Regulation No 83 (Emissions of M<span>1</span> and N<span>1</span> vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/148</p></td></tr><tr><td><p>86</p></td><td><p>Proposal for Supplement 1 to the 01 series of amendments to UN Regulation No 86 (Installation of lighting and light-signalling devices for agricultural vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/110/Rev.1</p></td></tr><tr><td><p>86</p></td><td><p>Proposal for Supplement 7 to UN Regulation No 86 (Installation of lighting and light-signalling devices for agricultural vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/111</p></td></tr><tr><td><p>87</p></td><td><p>Proposal for the 01 series of amendments to UN Regulation No 87 (Daytime running lamps)</p></td><td><p>ECE/TRANS/WP.29/2018/112</p></td></tr><tr><td><p>91</p></td><td><p>Proposal for the 01 series of amendments to UN Regulation No 91 (Side marker lamps)</p></td><td><p>ECE/TRANS/WP.29/2018/113</p></td></tr><tr><td><p>94</p></td><td><p>Proposal Supplement 1 to the 03 series of amendments to UN Regulation No 94 (Frontal collision)</p></td><td><p>ECE/TRANS/WP.29/2018/132</p></td></tr><tr><td><p>95</p></td><td><p>Proposal for Supplement 7 to the 03 series of amendments to UN Regulation No 95 (Lateral collision)</p></td><td><p>ECE/TRANS/WP.29/2018/133</p></td></tr><tr><td><p>98</p></td><td><p>Proposal for the 02 series of amendments to UN Regulation No 98 (Headlamps with gas-discharge light sources)</p></td><td><p>ECE/TRANS/WP.29/2018/114</p></td></tr><tr><td><p>99</p></td><td><p>Proposal for Supplement 14 to the 03 series of amendments to UN Regulation No 99 (Gas-discharge light sources)</p></td><td><p>ECE/TRANS/WP.29/2018/89</p></td></tr><tr><td><p>100</p></td><td><p>Proposal for Supplement 5 to the 01 series of amendments to UN Regulation No 100 (Electric power trained vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/134 +</p><p>WP.29-176-03</p></td></tr><tr><td><p>100</p></td><td><p>Proposal for Supplement 4 to the 02 series of amendments to UN Regulation No 100 (Electric power trained vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/135</p></td></tr><tr><td><p>101</p></td><td><p>Proposal for Supplement 10 to UN Regulation No 101 (CO<span>2</span> emission/fuel consumption)</p></td><td><p>ECE/TRANS/WP.29/2018/149</p></td></tr><tr><td><p>101</p></td><td><p>Proposal for Supplement 8 to 01 series of amendments to UN Regulation No 101 (CO<span>2</span> emission/fuel consumption)</p></td><td><p>ECE/TRANS/WP.29/2018/150</p></td></tr><tr><td><p>104</p></td><td><p>Proposal for the 01 series of amendments to UN Regulation No 104 (Retro-reflective markings)</p></td><td><p>ECE/TRANS/WP.29/2018/115</p></td></tr><tr><td><p>105</p></td><td><p>Proposal for Supplement 1 to the 06 series of amendments to UN Regulation No 105 (ADR vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/126</p></td></tr><tr><td><p>110</p></td><td><p>Proposal for Supplement 1 to the 03 series of amendments to UN Regulation No 110 (CNG and LNG vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/125</p></td></tr><tr><td><p>110</p></td><td><p>Proposal for Corrigendum 1 to Revision 3 to UN Regulation No 110 (CNG and LNG vehicles)</p></td><td><p>ECE/TRANS/WP.29/2018/153</p></td></tr><tr><td><p>112</p></td><td><p>Proposal for the 02 series of amendments to UN Regulation No 112 (Headlamps emitting an asymmetrical passing-beam)</p></td><td><p>ECE/TRANS/WP.29/2018/116</p></td></tr><tr><td><p>113</p></td><td><p>Proposal for the 03 series of amendments to UN Regulation No 113 (Headlamps emitting a symmetrical passing-beam)</p></td><td><p>ECE/TRANS/WP.29/2018/117</p></td></tr><tr><td><p>119</p></td><td><p>Proposal for the 02 series of amendments to UN Regulation No 119 (Cornering lamps)</p></td><td><p>ECE/TRANS/WP.29/2018/118</p></td></tr><tr><td><p>121</p></td><td><p>Proposal for Corrigendum 1 to Revision 2 to UN Regulation No 121 (Identification of controls, tell-tales and indicators)</p></td><td><p>ECE/TRANS/WP.29/2018/154</p></td></tr><tr><td><p>123</p></td><td><p>Proposal for the 02 series of amendments to UN Regulation No 123 (Adaptive front lighting systems (AFS))</p></td><td><p>ECE/TRANS/WP.29/2018/119</p></td></tr><tr><td><p>128</p></td><td><p>Proposal for Supplement 8 to the original version of UN Regulation No 128 (LED light sources)</p></td><td><p>ECE/TRANS/WP.29/2018/90</p></td></tr><tr><td><p>129</p></td><td><p>Proposal for Supplement 8 to UN Regulation No 129 (Enhanced Child Restraint Systems)</p></td><td><p>ECE/TRANS/WP.29/2018/136</p></td></tr><tr><td><p>129</p></td><td><p>Proposal for Supplement 5 to the 01 series of amendments to UN Regulation No 129 (Enhanced Child Restraint Systems)</p></td><td><p>ECE/TRANS/WP.29/2018/137</p></td></tr><tr><td><p>129</p></td><td><p>Proposal for Supplement 4 to the 02 series of amendments to UN Regulation No 129 (Enhanced Child Restraint Systems)</p></td><td><p>ECE/TRANS/WP.29/2018/138</p></td></tr><tr><td><p>129</p></td><td><p>Proposal for Supplement 1 to the 03 series of amendments to UN Regulation No 129 (Enhanced Child Restraint Systems)</p></td><td><p>ECE/TRANS/WP.29/2018/139</p></td></tr><tr><td><p>132</p></td><td><p>Proposal for Supplement 1 to 01 series of amendments to UN Regulation No 132 (Retrofit Emissions Control devices (REC))</p></td><td><p>ECE/TRANS/WP.29/2018/151</p></td></tr><tr><td><p>137</p></td><td><p>Proposal for Supplement 2 to the 01 series of amendments to UN Regulation No 137. (Frontal impact with focus on restraint systems)</p></td><td><p>ECE/TRANS/WP.29/2018/140</p></td></tr><tr><td><p>New UN Reg</p></td><td><p>Proposal for a new UN Regulation on Light-Signalling Devices (LSD)</p></td><td><p>ECE/TRANS/WP.29/2018/157</p></td></tr><tr><td><p>New UN Reg</p></td><td><p>Proposal for a new UN Regulation on Road Illumination Devices (RID)</p></td><td><p>ECE/TRANS/WP.29/2018/158</p></td></tr><tr><td><p>New UN Reg</p></td><td><p>Proposal for a new UN Regulation on Retro-Reflective Devices (RRD)</p></td><td><p>ECE/TRANS/WP.29/2018/159</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>GTR No</p></td><td><p>Agenda item title</p></td><td><p>Document reference</p></td></tr><tr><td><p>UN GTR 9</p></td><td><p>Proposal for Amendment 2 to UN GTR No 9 (Pedestrian safety)</p></td><td><p>ECE/TRANS/WP.29/2018/160 & 161</p></td></tr></tbody></table>
<note>
( 1 ) All documents referenced in the table are publicly available at: http://www.unece.org/trans/main/wp29/wp29wgs/wp29gen/gen2018.html
</note> | ENG | 32019D0233 |
<table><col/><col/><col/><col/><tbody><tr><td><p>10.7.2014   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 201/7</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) No 746/2014
of 9 July 2014
fixing the allocation coefficient to be applied to import licence applications lodged from 27 June 2014 to 4 July 2014 under the tariff quota for maize opened by Regulation (EC) No 969/2006
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) , and in particular Article 188(1) and (3) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Commission Regulation (EC) No 969/2006<a> (<span>2</span>)</a> opened an annual import tariff quota of 277 988 tonnes of maize (order number 09.4131).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Article 2(1) of Regulation (EC) No 969/2006 fixes a quantity of 138 994 tonnes for subperiod 2 from 1 July to 31 December 2014.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The notification made in accordance with Article 4(3) of Regulation (EC) No 969/2006 shows that the applications lodged from 13:00 on 27 June 2014 to 13.00 (Brussels time) on 4 July 2014 in accordance with Article 4(1) of that Regulation exceed the quantities available. The extent to which import licences may be issued should therefore be determined by establishing the allocation coefficient to be applied to the quantities requested, calculated in accordance with Article 7(2) of Commission Regulation (EC) No 1301/2006<a> (<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Import licences should no longer be issued under Regulation (EC) No 969/2006 for the current quota period.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>In order to ensure sound management of the procedure of issuing import licences, the present Regulation should enter into force immediately after its publication,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
1. Each import licence application for maize under the quota referred to in Article 2(1) of Regulation (EC) No 969/2006 and lodged from 13:00 on 27 June 2014 to 13.00 (Brussels time) on 4 July 2014 shall give rise to the issue of a licence for the quantities applied for, multiplied by an allocation coefficient of 7,692996 %.
2. The issuing of licences for the quantities applied for from 13.00 (Brussels time) on 4 July 2014 is hereby suspended for the current quota period.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 9 July 2014.
For the Commission
On behalf of the President,
Jerzy PLEWA
Director-General for Agriculture and Rural Development
<note>
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) Commission Regulation (EC) No 969/2006 of 29 June 2006 opening and providing for the administration of a Community tariff quota for imports of maize from third countries ( OJ L 176, 30.6.2006, p. 44 ).
( 3 ) Commission Regulation (EC) No 1301/2006 of 31 August 2006 laying down common rules for the administration of import tariff quotas for agricultural products managed by a system of import licences ( OJ L 238, 1.9.2006, p. 13 ).
</note> | ENG | 32014R0746 |
<table><col/><col/><col/><col/><tbody><tr><td><p>19.4.2016   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 103/1</p></td></tr></tbody></table>
COUNCIL DECISION (EU) 2016/590
of 11 April 2016
on the signing, on behalf of the European Union, of the Paris Agreement adopted under the United Nations Framework Convention on Climate Change
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1), in conjunction with Article 218(5) thereof,
Having regard to the proposal from the European Commission,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>At the 21st Conference of the Parties of the United Nations Framework Convention on Climate Change (COP 21), which took place in Paris from 30 November to 12 December 2015, the text of an agreement was adopted concerning the strengthening of the global response to the threat of climate change. The Paris Agreement will enter into force on the 30th day after the date on which at least 55 parties to the Convention accounting in total for at least an estimated 55 % of total greenhouse gas emissions, have deposited their instruments of ratification, acceptance, approval or accession. Parties to the Convention include the Union and its Member States.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The Agreement, inter alia, sets out a long-term goal in line with the objective to keep the global temperature increase well below 2 °C above pre-industrial levels and to pursue efforts to keep it to 1,5 °C above pre-industrial levels. In order to achieve this goal, the Parties will prepare, communicate and maintain successive nationally determined contributions.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>On 6 March 2015, the Union and its Member States communicated their intended nationally determined contribution, which provides for a commitment to a binding target of at least a 40 % domestic reduction in greenhouse gas emissions by 2030 compared to 1990, as set out in the conclusions of the European Council of 23 October 2014 on the 2030 climate and energy policy framework.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The Agreement is open for signature at the United Nations Headquarters in New York from 22 April 2016 to 21 April 2017.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The Agreement is in conformity with the environmental objectives of the Union as referred to in Article 191 of the Treaty, namely preserving, protecting and improving the quality of the environment; protecting human health; and promoting measures at international level to deal with regional or worldwide environmental problems, and in particular combating climate change.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>There exists legislation in the Union implementing some of these objectives. Part of this existing Union legislation will have to be revised in order to implement certain provisions of the Agreement.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Therefore, the Agreement should be signed on behalf of the Union, subject to its conclusion at a later date,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
The signing on behalf of the Union of the Paris Agreement to the United Nations Framework Convention on Climate Change ( 1 ) is hereby authorised.
The signing shall take place in New York on 22 April 2016, or as soon as possible thereafter.
Article 2
The President of the Council is hereby authorised to designate the person(s) empowered to sign the Agreement on behalf of the Union.
Article 3
This Decision shall enter into force on the date of its adoption.
Done at Luxembourg, 11 April 2016.
For the Council
The President
M.H.P. VAN DAM
<note>
( 1 ) The text of the Agreement will be published together with the Decision on its conclusion.
</note> | ENG | 32016D0590 |
<table><col/><col/><col/><col/><tbody><tr><td><p>3.12.2018   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 307/1</p></td></tr></tbody></table>
COUNCIL REGULATION (EU) 2018/1877
of 26 November 2018
on the financial regulation applicable to the 11th European Development Fund, and repealing Regulation (EU) 2015/323
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on European Union and the Treaty on the Functioning of the European Union,
Having regard to the Partnership Agreement between the members of the African, Caribbean and Pacific Group of States of the one part, and the European Community and its Member States, of the other part, ( 1 ) as last amended (‘ACP-EU Partnership Agreement’),
Having regard to the Internal Agreement between the Representatives of the Governments of the Member States of the European Union, meeting within the Council, on the financing of European Union aid under the multiannual financial framework for the period 2014 to 2020, in accordance with the ACP-EU Partnership Agreement, and on the allocation of financial assistance for the Overseas Countries and Territories to which Part Four of the Treaty on the Functioning of the European Union applies ( 2 ) (‘the Internal Agreement’), and in particular Article 10(2) thereof,
Having regard to the proposal from the European Commission,
Having regard to the opinion of the Court of Auditors ( 3 ) ,
Having regard to the opinion of the European Investment Bank,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Council Regulation (EU) 2015/323 <a>(<span>4</span>)</a> determines detailed rules for the financial implementation of the 11th European Development Fund (‘11th EDF’). Those rules concern, inter alia: the applicable principles; the constitution of the 11th EDF resources; the financial actors and entities entrusted with budget-implementation tasks; the financing decisions, commitments and payments; the funding instruments, including procurement, grants, financial instruments and Union trust funds; the presentation of the accounts and accounting; the external audit by the Court of Auditors and discharge by the European Parliament; and the Investment Facility managed by the European Investment Bank (EIB).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>For the sake of simplification and coherence, Regulation (EU) 2015/323 was aligned, as much as possible, with Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council <a>(<span>5</span>)</a> and Commission Delegated Regulation (EU) No 1268/2012 <a>(<span>6</span>)</a>. That alignment was achieved by means of direct references to those Regulations and has, on the one hand, allowed for the easy identification of specificities in the financial implementation of the 11th EDF and, on the other hand, reduced the diversity of Union funding rules in the area of external action that creates an unnecessary burden for the recipients, the Commission and other actors involved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Regulation (EU, Euratom) No 966/2012 and Delegated Regulation (EU) No 1268/2012 have been merged and replaced by a single legal act, Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council <a>(<span>7</span>)</a>, which introduced significant changes and improvements and simplified the financial rules applicable to the general budget of the Union. In the interest of simplification, the financial regulation applicable to the 11th EDF should be aligned as much as possible with that Regulation. For reasons of legal clarity and taking into consideration the significant number of amendments required for that alignment, Regulation (EU) 2015/323 should be repealed and replaced by this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>It is necessary to recall that the framework for the financial implementation of the 11th EDF is constituted by, in addition to this Regulation, the ACP-EU Partnership Agreement, in particular Annex IV thereto, by the Internal Agreement, by Council Decision 2013/755/EU <a>(<span>8</span>)</a> and by Council Regulation (EU) 2015/322 <a>(<span>9</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The financial implementation of the 11th EDF should be guided by the principles of unity and budgetary accuracy, unit of account, specification, sound financial management and transparency. Having regard to the multiannual set-up of the 11th EDF, the budgetary principle of annuality should not apply to the 11th EDF.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>It is necessary to determine the detailed rules for the payment of the contributions by the Member States to the 11th EDF and for the country allocation of financial assistance for the overseas countries and territories (‘OCTs’) to which Part IV of the Treaty on the Functioning of the European Union (TFEU) applies.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The rules concerning the financial actors, i.e. the authorising and accounting officers, the delegation of their tasks as well as their liability should be aligned with Regulation (EU, Euratom) 2018/1046, as those actors act within the framework of the Commission when it implements the 11th EDF under this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>It is necessary to establish the detailed rules in accordance with which the authorising officer by delegation establishes the necessary arrangements to ensure the proper execution of operations, in close cooperation with the national, regional, intra-ACP or territorial authorising officer.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>The rules on methods of implementation, i.e. on the entrustment of budget-implementation tasks and on its conditions and limits, should be aligned with Regulation (EU, Euratom) 2018/1046. In addition, a provision on further entrustment of budget-implementation tasks mirroring that in Regulation (EU) No 236/2014 of the European Parliament and of the Council <a>(<span>10</span>)</a> should be included in order to ensure the coherent implementation of the funding of external action. This Regulation should nonetheless contain specific provisions on temporary acting in the place of the national authorising officer, on entrustment by the ACP States and OCTs to a service provider and on strengthening the protection of the financial interests of the Union in the case of indirect management with ACP States and OCTs.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>The provisions on financing decisions should be aligned with those of Regulation (EU, Euratom) 2018/1046 where the Commission implements the 11th EDF under this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>The rules on commitments should be aligned with those set out in Regulation (EU, Euratom) 2018/1046 with the exception of provisional commitments. In addition, an extension of deadlines should be provided for where it is necessary for actions carried out in indirect management by ACP States or OCTs.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>The time limits for payments should be aligned with those set out in Regulation (EU, Euratom) 2018/1046. Special provisions should be laid down where ACP States and OCTs are not entrusted with carrying out payments under indirect management and where, consequently, the Commission continues to carry out payments to recipients.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>Various implementation provisions concerning the internal auditor, good administration and redress, the IT system, electronic transmission, e-government, and the administrative and financial penalties and the use of the central exclusion database should be aligned with those of Regulation (EU, Euratom) 2018/1046. In addition, the protection of the financial interests of the Union through the imposition of penalties should be strengthened where the 11th EDF is implemented in indirect management with ACP States and OCTs.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>The rules on procurement, grants, prizes and experts should be aligned with those set out in Regulation (EU, Euratom) 2018/1046. The rules on financial instruments and Union trust funds should be aligned with adjustments due to the nature of the 11th EDF. Budget support to OCTs should take the institutional links with the Member State concerned into account.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>The rules on the presentation of accounts and accounting and on external audit and discharge should mirror those set out in Regulation (EU, Euratom) 2018/1046.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(16)</p></td><td><p>It is necessary to lay down the conditions in accordance with which the Court of Auditors should exercise its powers in respect of the 11th EDF.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(17)</p></td><td><p>It is necessary to lay down the conditions in accordance with which the EIB should manage the 11th EDF resources.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(18)</p></td><td><p>The provisions concerning scrutiny by the Court of Auditors of the 11th EDF resources managed by the EIB should comply with the tripartite agreement concluded between the Court of Auditors, the EIB and the Commission provided for in Article 287(3) TFEU.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(19)</p></td><td><p>The transitional provisions should lay down the rules on treating balances and revenue from the 8th, 9th and 10th European Development Funds (‘previous EDFs’) as well as the application of this Regulation to residual operations under those EDFs.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(20)</p></td><td><p>The interpretation of this Regulation should aim to ensure consistency with Regulation (EU, Euratom) 2018/1046 unless such an interpretation would be incompatible with the specificities of the 11th EDF as provided for in the ACP-EU Partnership Agreement, the Internal Agreement, Decision 2013/755/EU or Regulation (EU) 2015/322,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
PART ONE
MAIN PROVISIONS
TITLE I
Subject matter, scope and general provisions
Article 1
Subject matter
This Regulation lays down rules on the financial implementation of the resources of the 11th EDF and on the presentation and auditing of the accounts.
Article 2
Relation to Regulation (EU, Euratom) 2018/1046
1. For the purposes of this Regulation, references to the applicable provisions of Regulation (EU, Euratom) 2018/1046 shall not include procedural provisions which are not relevant to the 11th EDF.
2. Internal references in Regulation (EU, Euratom) 2018/1046 shall not render the provisions referred to indirectly applicable to the 11th EDF.
3. Specific references in this Regulation to the provisions of Regulation (EU, Euratom) 2018/1046 are understood to be dynamic references, which include the subsequent amendments to those provisions.
4. The Commission Decision on the Internal Rules on the implementation of the general budget of the European Union (European Commission section) for the attention of the Commission departments shall apply to the 11th EDF mutatis mutandis .
Article 3
General provisions
1. The definitions set out in Article 2 of Regulation (EU, Euratom) 2018/1046 shall apply.
2. For the purposes of this Regulation, the following terms in Regulation (EU, Euratom) 2018/1046 shall be construed as follows:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>‘appropriations’ or ‘operational appropriations’ means ‘11th EDF resources’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>‘basic act’ means, according to the relevant context, the Internal Agreement, Decision 2013/755/EU or Regulation (EU) 2015/322;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>‘budget’ or ‘budgetary’ means ‘11th EDF’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>‘budgetary commitment’ means ‘financial commitment’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>‘budget line’ means ‘allocation’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>‘third country’ means any partner country or territory covered by the geographical scope of the 11th EDF.</p></td></tr></tbody></table>
3. Articles 4 and 5 of Regulation (EU, Euratom) 2018/1046 shall apply.
TITLE II
Financial principles
Article 4
Financial principles
The 11th EDF resources shall be implemented in compliance with the following principles:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>unity and budgetary accuracy;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>unit of account;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>universality;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>specification;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>sound financial management and performance;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>transparency.</p></td></tr></tbody></table>
The financial year shall run from 1 January to 31 December.
Article 5
Principles of unity and budgetary accuracy
No revenue shall be collected and no expenditure shall be effected unless booked to the 11th EDF.
Article 8(2), (3) and (4) of Regulation (EU, Euratom) 2018/1046 shall apply.
Article 6
Principle of unit of account
Article 19 of Regulation (EU, Euratom) 2018/1046 shall apply.
Article 7
Principle of universality
1. Article 20 of Regulation (EU, Euratom) 2018/1046 shall apply. Without prejudice to Article 8 of this Regulation, total revenue shall cover total estimated payments.
2. The revenue referred to in point (c) of Article 8(2) of this Regulation shall automatically decrease payments made against the commitment from which it was generated.
3. The Union may not raise loans within the framework of the 11th EDF.
Article 8
Assigned revenue
1. Assigned revenue shall be earmarked to finance-specific items of expenditure.
2. The following shall constitute assigned revenue:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>financial contributions from Member States and third countries, including in both cases their public agencies, entities or natural persons, and from international organisations to certain external aid projects or programmes financed by the Union and managed by the Commission or the EIB on their behalf in accordance with Article 10 of Regulation (EU) 2015/322;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>revenue earmarked for a specific purpose, such as income from foundations, subsidies, gifts and bequests;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>revenue arising from the repayment, following recovery, of amounts wrongly paid;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>repayments and revenues generated by financial instruments or budgetary guarantees pursuant to Article 209(3) of Regulation (EU, Euratom) 2018/1046;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>revenue arising from the subsequent reimbursement of taxes pursuant to point (b) of the first subparagraph of Article 27(3) of Regulation (EU, Euratom) 2018/1046.</p></td></tr></tbody></table>
3. Assigned revenue referred to in points (a) and (b) of paragraph 2 shall finance such items of expenditure as determined by the donor, provided that it is accepted by the Commission.
Assigned revenue referred to in points (d) and (e) of paragraph 2 shall finance items of expenditure similar to those from which it was generated.
4. Articles 25, 26 and 27 of Regulation (EU, Euratom) 2018/1046 shall apply. Acceptance of a donation shall be subject to the authorisation of the Council.
5. The 11th EDF resources corresponding to assigned revenue shall be made available automatically when that revenue has been received by the Commission. However, an estimate of amounts receivable shall have the effect of making 11th EDF resources available in the case of assigned revenue referred to in point (a) of paragraph 2 where the agreement with the Member State is expressed in euros; in such cases, payments may be carried out against such revenue only when it has been received.
Article 9
Principle of specification
1. 11th EDF resources shall be earmarked for specific purposes per ACP State or OCTs and in accordance with the main instruments of cooperation.
2. In respect of the ACP States, the main instruments of cooperation are laid down by the financial protocol set out in Annex Ic to the ACP-EU Partnership Agreement. The earmarking of resources (indicative allocations) shall also be based on the Internal Agreement and Regulation (EU) 2015/322 and shall take account of the resources reserved for support expenditure linked to programming and implementation under Article 6 of the Internal Agreement.
3. In respect of the OCTs, the main instruments of cooperation are laid down in Part Four of Decision 2013/755/EU and Annex II thereto. The earmarking of those resources shall also take into account the non-allocated reserve provided for in Article 3(3) of that Annex and the resources for studies or technical assistance measures under point (c) of Article 1(1) thereof.
Article 10
Principle of sound financial management and performance, and internal control
Article 33(1), points (a) and (b) of Article 33(2), Article 33(3), and Articles 34 and 36 of Regulation (EU, Euratom) 2018/1046 shall apply.
Article 11
Principle of transparency
1. Article 37(1) and Article 38 of Regulation (EU, Euratom) 2018/1046 shall apply.
2. The annual statement of the commitments, payments and the annual amount of calls for contributions under Article 7 of the Internal Agreement shall be published in the Official Journal of the European Union .
3. For the purpose of Article 38(2) of Regulation (EU, Euratom) 2018/1046, the term ‘locality’ shall mean, where necessary, the equivalent to the region on NUTS 2 level when the recipient is a natural person.
TITLE III
11th EDF resources and implementation
Article 12
Sources of 11th EDF resources
The 11th EDF resources shall consist of the ceiling referred to in Article 1(2), (4) and (6) of the Internal Agreement, the funds referred to in Article 1(9) thereof and other assigned revenue referred to in Article 8 of this Regulation.
Article 13
Structure of the 11th EDF
The 11th EDF revenue and expenditure shall be classified according to their type or the use to which they are assigned.
Article 14
Implementation of the 11th EDF in accordance with the principle of sound financial management and performance
1. Article 57, Article 59(2) and (3) and Articles 60 and 61 of Regulation (EU, Euratom) 2018/1046 shall apply.
2. The Commission shall assume the responsibilities of the Union as referred to in Article 57 of the ACP-EU Partnership Agreement and in Decision 2013/755/EU. To that end, it shall implement the revenue and expenditure of the 11th EDF in accordance with the provisions of this Part and Part Three of this Regulation, under its own responsibility and within the limits of the 11th EDF resources.
3. The Member States shall cooperate with the Commission so that the 11th EDF resources are used in accordance with the principle of sound financial management and performance.
Article 15
Methods of implementation
Points (a) and (c) of the first subparagraph of Article 62(1), the first and third subparagraphs of Article 62(2), and Article 62(3) of Regulation (EU, Euratom) 2018/1046 shall apply.
TITLE IV
Financial actors
Article 16
General provisions on financial actors and their liability
1. Articles 72 to 76 of Regulation (EU, Euratom) 2018/1046 shall apply.
2. Articles 90 to 95 of Regulation (EU, Euratom) 2018/1046 concerning the liability of the financial actors shall apply.
Article 17
Authorising officer
1. The annual activity report referred to in Article 74(9) of Regulation (EU, Euratom) 2018/1046 shall include, in an annex, tables showing by allocation, country, territory, region or sub-region, the total commitments, assigned funds and payments effected during the financial year and aggregate totals since the opening of the respective EDF.
2. Where the responsible authorising officer of the Commission becomes aware of problems in carrying out procedures relating to the management of 11th EDF resources, he or she shall, in conjunction with the appointed national, regional, intra-ACP or territorial authorising officer, make all contacts necessary to remedy the situation and take any steps that are necessary. In cases where the national, regional, intra-ACP or territorial authorising officer does not or is unable to perform the duties incumbent on him or her under the ACP-EU Partnership Agreement or Decision 2013/755/EU, the responsible authorising officer of the Commission may temporarily take the former's place and act in the name and on behalf of the former in indirect management. In such a case, the Commission may receive, from the resources allocated to the ACP State or OCTs in question, financial compensation for the additional administrative workload incurred.
Article 18
Accounting officer
1. The accounting officer of the Commission shall be the accounting officer of the 11th EDF.
2. Points (a) and (c) to (f) of the first subparagraph of Article 77(1), Article 78(3) and (4), Article 79, Article 80(1), (2) and (3), Article 81, Article 82(2) to (10), and Articles 84, 85 and 86 of Regulation (EU, Euratom) 2018/1046 shall apply.
3. The accounting rules referred to in Article 80(1), (2) and (3) of Regulation (EU, Euratom) 2018/1046 shall apply to the 11th EDF resources managed by the Commission. Those rules shall be applied to the 11th EDF while taking into account the specific nature of its activities.
4. The accounting officer shall prepare and, after consulting the responsible authorising officer, adopt the chart of accounts to be applied to the 11th EDF's operations.
TITLE V
Revenue operations
Article 19
Annual contribution and its instalments
1. In accordance with Article 7 of the Internal Agreement, the ceiling for the annual amount of the contribution for the year n + 2 and the annual amount of the contribution for the year n + 1, as well as its payment in three instalments, shall be determined in accordance with the procedure set out in paragraphs 2 to 7 of this Article.
The instalments to be paid by each Member State shall be set in such a way as to be in proportion to the Member State's contributions to the 11th EDF as set out in Article 1(2) of the Internal Agreement.
2. The Commission shall present a proposal by 15 October of the year n, setting out:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the ceiling for the annual amount of the contribution for the year n + 2;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the annual amount of the contribution for the year n + 1;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the amount of the first instalment of the contribution for the year n + 1;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>an indicative, non-binding forecast based on a statistical approach for the expected annual amounts of contributions for the years n + 3 and n + 4.</p></td></tr></tbody></table>
The Council shall decide on that proposal by 15 November of the year n.
The Member States shall pay the first instalment of the contribution for the year n + 1 at the latest by 21 January of the year n + 1.
3. The Commission shall present a proposal by 15 June of the year n + 1, setting out:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the amount of the second instalment of the contribution for the year n + 1;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a revised annual amount of the contribution for the year n + 1 in line with actual needs, in cases where, in accordance with Article 7(3) of the Internal Agreement, the annual amount deviates from actual needs.</p></td></tr></tbody></table>
The Council shall decide on that proposal at the latest 21 calendar days following the presentation by the Commission of its proposal.
The Member States shall pay the second instalment at the latest 21 calendar days following the adoption of the Council decision.
4. By 15 June of the year n + 1, the Commission, taking into account the EIB's forecasts concerning the management and operation of the Investment Facility, including those interest rates subsidies which are implemented by the EIB, shall establish and communicate to the Council a statement of the commitments, payments, and the annual amount of the calls for contributions made in the year n and to be made in the years n + 1 and n + 2. The Commission shall provide the annual amounts of the contributions by Member State, as well as the amount still to be paid by the EDF, distinguishing between the shares of the EIB and of the Commission. The amounts for the years n + 1 and n + 2 shall be based on the capacity to deliver effectively the proposed level of resources while endeavouring to avoid significant variations between the different years, as well as significant end-of-year balances.
5. The Commission shall present a proposal by 10 October of the year n + 1, setting out:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the amount of the third instalment of the contribution for the year n + 1;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a revised annual amount of the contribution for the year n + 1 in line with actual needs, in cases where in accordance with Article 7(3) of the Internal Agreement the annual amount deviates from actual needs.</p></td></tr></tbody></table>
The Council shall decide on that proposal at the latest 21 calendar days following the presentation by the Commission of its proposal.
The Member States shall pay the third instalment at the latest 21 calendar days following the adoption of the Council decision.
6. The sum of the instalments relating to a certain year shall not exceed the annual amount of the contribution determined for that year. The annual amount of the contribution shall not exceed the ceiling determined for that year. The ceiling shall not be increased except in accordance with Article 7(4) of the Internal Agreement. A possible increase of the ceiling shall be made part of the proposals referred to in paragraphs 2, 3 and 5 of this Article.
7. The ceiling for the annual amount of the contribution to be paid by each Member State for the year n + 2, the annual amount of the contribution for the year n + 1 and the instalments of the contributions shall specify:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the amount managed by the Commission; and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the amount managed by the EIB, including the interest rates subsidies managed by it.</p></td></tr></tbody></table>
Article 20
Payment of the instalments
1. Calls for contributions shall first use up the amounts laid down for previous EDFs, one after the other.
2. The contributions of the Member States shall be expressed in euros and shall be paid in euros.
3. The contribution referred to in point (a) of Article 19(7) shall be credited by each Member State to a special account entitled ‘European Commission — European Development Fund’ opened with the central bank of the relevant Member State or the financial institution designated by it. The amount of such contributions shall remain in those special accounts until the payments need to be made.
4. The account referred to in paragraph 3 shall be kept free of any charge and interest.
5. Where negative interest is applied to the account referred to in paragraph 3 of this Article, the Member State concerned shall, at the latest on the date of payment of each instalment referred to in Article 19, credit the account with an amount corresponding to the amount of such negative interest applied until the first day of the month preceding the payment of the instalment.
6. Without prejudice to paragraph 7 of this Article, the Commission shall endeavour to make any withdrawals from the special accounts in such a way as to maintain a distribution of assets in those accounts that corresponds to the contribution key pursuant to point (a) of Article 1(2) of the Internal Agreement.
7. When covering the 11th EDF cash resource requirements in accordance with paragraph 3, the Commission shall aim to reduce the impact of the obligation on Member States to credit amounts of negative interest pursuant to paragraph 5 by drawing with priority on the sums credited to the accounts concerned.
8. The contribution referred to in point (b) of Article 19(7) shall be credited by each Member State in accordance with Article 47(1).
Article 21
Interest for unpaid contribution amounts
1. On the expiry of the time limits laid down in Article 19(2), (3) and (5), the Member State concerned shall be obliged to pay interest in accordance with the following conditions:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the interest rate shall be the rate applied by the European Central Bank to its principal refinancing operations, as published in the C series of the<span>Official Journal of the European Union</span>, in force on the first calendar day of the month in which the time limit expires, increased by two percentage points. That rate shall be increased by a quarter of a percentage point for each month of delay;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the interest shall be payable for the period elapsing from the calendar day following expiry of the time limit for payment up to the day of payment.</p></td></tr></tbody></table>
2. In respect of the contribution referred to in point (a) of Article 19(7) of this Regulation, the interest shall be credited to one of the accounts provided for in Article 1(6) of the Internal Agreement
In respect of the contribution referred to in in point (b) of Article 19(7) of this Regulation, the interest shall be credited to the Investment Facility in accordance with Article 47(1) of this Regulation.
Article 22
Calling on unpaid contributions
Upon expiry of the financial protocol set out in Annex Ic to the ACP-EU Partnership Agreement, the part of the contributions which the Member States remain obliged to pay in accordance with Article 19 of this Regulation shall be called on by the Commission and the EIB, as required, in accordance with the conditions laid down in this Regulation.
Article 23
Other revenue operations
1. Articles 97, 98 and 99, Article 100(1), the first subparagraph of Article 100(2), Article 101(1) to (6), and Articles 102 to 107 and 109 of Regulation (EU, Euratom) 2018/1046 shall apply. Recovery may be done by way of a Commission decision enforceable pursuant to Article 299 TFEU.
2. With regard to Article 97(3) of Regulation (EU, Euratom) 2018/1046, the reference to own resources shall be understood as reference to the Member States' contributions referred to in Article 19 of this Regulation.
3. Article 99(2) of Regulation (EU, Euratom) 2018/1046 shall apply to recoveries established in euro. For recoveries in local currency, it shall apply using the rate of the central bank of the country issuing the currency in force on the first calendar day of the month in which the recovery order is established.
TITLE VI
Expenditure operations
Article 24
Rules applicable to commitments and financing decisions
1. The commitment of expenditure shall be preceded by a financing decision adopted by the Commission.
2. Article 110(2) to (5), Article 111, points (a) and (b) of the first subparagraph of Article 112(1), Article 112(2) to (5), and Articles 114, 115 and 116 of Regulation (EU, Euratom) 2018/1046 shall apply.
3. With regard to the application of the third and fourth subparagraphs of Article 114(2) of Regulation (EU, Euratom) 2018/1046, the period within which to enter into legal commitments which implement the action may be extended beyond three years following the date of the conclusion of the financing agreement with ACP States and OCTs.
4. Where the 11th EDF resources are implemented in indirect management with ACP States or OCTs, the responsible authorising officer may, upon accepting justification, extend the two-year period referred to in Article 114(6) of Regulation (EU, Euratom) 2018/1046 and the three-year period referred to in the third subparagraph of Article 114(2) thereof.
5. At the end of the extended periods referred to in paragraph 3 and 4, the unused balances shall be, as applicable, decommitted.
6. Where measures are adopted under Articles 96 and 97 of the ACP-EU Partnership Agreement, the running of the periods referred to in this Article may be suspended.
7. For the purposes of the third subparagraph of paragraph 1 of Article 111 of Regulation (EU, Euratom) 2018/1046, compliance shall be assessed against the relevant provisions, in particular the Treaties, the ACP-EU Partnership Agreement, Decision 2013/755/EU, the Internal Agreement, this Regulation, and all acts adopted in implementation of those provisions.
Article 25
Time limits for payment
1. Subject to the conditions set out in paragraph 2 of this Article, Article 116 of Regulation (EU, Euratom) 2018/1046 shall apply to payments carried out by the Commission.
2. Where 11th EDF resources are applied under indirect management with ACP States or OCTs and the Commission executes payments on their behalf, the time limit referred to in point (b) of Article 116(1) of Regulation (EU, Euratom) 2018/1046 shall apply to all payments not referred to in point (a) thereof. The financing agreement shall contain the necessary provisions to ensure the timely collaboration of the contracting authority.
3. With regard to Article 116(5) of Regulation (EU, Euratom) 2018/1046, payments for which the Commission is responsible shall be charged to the same allocation as the corresponding contract. If the remaining funds are not sufficient, it will be charged to the account or accounts provided for in Article 1(6) of the Internal Agreement.
TITLE VII
Internal auditor
Article 26
Internal auditor
The internal auditor of the Commission shall be the internal auditor of the 11th EDF, and the internal audit progress committee of the Commission referred to in Article 123 of Regulation (EU, Euratom) 2018/1046 shall also carry out its role with regard to EDF resources managed by the Commission. Articles 118 to 122 of Regulation (EU, Euratom) 2018/1046 shall apply.
TITLE VIII
Various implementation provisions
Article 27
Common rules
Articles 124 to 146, Article 147(1), Article 148, Article 149(1) and (3) to(7), and Articles 150 to 153 of Regulation (EU, Euratom) 2018/1046 shall apply.
Article 28
Administrative arrangements with the European External Action Service
Detailed arrangements may be agreed between the European External Action Service and the Commission services in order to facilitate the implementation by Union delegations of the resources foreseen for support expenditure linked to the 11th EDF under Article 6 of the Internal Agreement.
TITLE IX
Funding instruments
Article 29
General provisions on funding instruments
1. For the purpose of providing financial assistance under this Title, cooperation between the Union, the ACP States and OCTs may take the form, inter alia, of:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>triangular arrangements by which the Union coordinates with any third country its assistance to an ACP State, OCTs or region;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>administrative cooperation measures such as twinning between the public institutions, local authorities, national public bodies or private law entities entrusted with public service tasks of a Member State or an outermost region, and those of an ACP State or OCTs or their region, as well as cooperation measures involving public-sector experts dispatched from the Member States and their regional and local authorities;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>expert facilities for targeted capacity building in the ACP State, OCTs or their region and short-term technical assistance and advice to them, as well as support of sustainable centres of knowledge and excellence on governance and reform in the public sector;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>contributions to the costs necessary to set up and administer a public-private partnership;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>sector policy support programmes, by which the Union provides support to an ACP State's or OCTs' sector programme;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>interest rate subsidies.</p></td></tr></tbody></table>
2. In addition to the types of financing provided for in Articles 30 to 37, financial assistance may also be provided through the following:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>debt relief, under internationally agreed debt relief programmes;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in exceptional cases, sectoral and general import programmes, which may take the form of:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>sectoral import programmes in kind,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>sectoral import programmes providing foreign exchange to finance imports for the sector in question, or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>general import programmes providing foreign exchange to finance general imports of a wide range of products.</p></td></tr></tbody></table></td></tr></tbody></table>
3. Financial assistance may also be provided through contributions to international, regional or national funds, such as those established or managed by the EIB, Member States or by ACP States or OCTs and regions or by international organisations, for attracting joint financing from a number of donors, or to funds set up by one or more donors for the purpose of the joint implementation of projects.
Reciprocal access by Union financial institutions to financial instruments set up by other organisations shall be promoted, as appropriate.
4. Actions financed under the 11th EDF may be implemented with parallel or joint co-financing.
In the case of parallel co-financing, an action is to be split into a number of clearly identifiable components which are each financed by the different partners providing co-financing in such a way that the end-use of the financing can always be identified.
In the case of joint co-financing, the total cost of an action is to be shared between the partners providing the co-financing and the resources are to be pooled in such a way that it is no longer possible to identify the source of financing for any given activity undertaken as part of the action.
5. In implementing its support to transition and reform in ACP States and OCTs, the Union shall draw on and share the experiences of Member States and lessons learned.
Article 30
Indirect management
1. Subject to the conditions set out in paragraphs 2 and 3 of this Article, Articles 154 to 159 of Regulation (EU, Euratom) 2018/1046 shall apply. For the purposes of Article 158 of that Regulation, indirect management with third countries may also take the form of a financing agreement concluded with the relevant organisation or body at regional or intra-ACP level.
2. Entities implementing 11th EDF funds shall ensure consistency with the Union's external policy and may entrust budget-implementation tasks to other entities under conditions equivalent to those applying to the Commission. They shall fulfil their obligations under Article 155(1) of Regulation (EU, Euratom) 2018/1046 annually. The audit opinion shall be submitted within one month of the report and management declaration, to be taken into account in providing assurance for the Commission.
International organisations as referred to in point (c)(ii) of the first subparagraph of Article 62(1) of Regulation (EU, Euratom) 2018/1046 and bodies of the Member States as referred to in points (c)(v) and (vi) of the first subparagraph of Article 62(1) of that Regulation which have been entrusted budget-implementation tasks by the Commission may also entrust budget-implementation tasks to non-profit organisations possessing the appropriate operational and financial capacity, under conditions equivalent to those applying to the Commission.
ACP States and OCTs may implement the 11th EDF funds through their departments and bodies governed by private law on the basis of a service contract. Those bodies shall be selected on the basis of open, transparent, proportionate and non-discriminatory procedures, avoiding conflict of interests. The financing agreement shall stipulate the terms of the service contract.
3. Where the 11th EDF is applied in indirect management with ACP States, OCTs or their regional organisations, without prejudice to the responsibilities of the contracting authorities, the Commission:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>shall, where necessary, recover amounts due from the contracting authorities' recipients in accordance with Articles 101 to 106 of Regulation (EU, Euratom) 2018/1046, with the exception of Article 101(7) to (9) thereof, including by means of a decision enforceable under the same conditions as those laid down in Article 299 TFEU;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>may, where the circumstances so require, impose administrative or financial penalties, or both, upon the contracting authority's participants or recipients, as well as upon other entities or persons who are, vis-à-vis the contracting authority, in one of the situations referred to in Article 136(1) of Regulation (EU, Euratom) 2018/1046, under the same conditions as those laid down in Articles 135 to 143 of that Regulation.</p></td></tr></tbody></table>
The financing agreement shall contain provisions to that end.
Article 31
Procurement
Articles 160 to 172, Article 173(1), the first and second subparagraphs of Article 173(2), Article 173(3) and (4), and Articles 174 to 179 of Regulation (EU, Euratom) 2018/1046 shall apply.
Article 32
Grants
Articles 180 to 205 of Regulation (EU, Euratom) 2018/1046 shall apply.
Article 33
Prizes
Articles 206 and 207 of Regulation (EU, Euratom) 2018/1046 shall apply.
Article 34
Financial instruments
1. Article 208(4) and (5), Article 209(1), (2) and (4), Article 210(1), Article 214, Article 215(2) to (7) and Article 216 of Regulation (EU, Euratom) 2018/1046 shall apply.
2. Financial instruments may be established under the 11th EDF. Member States or other parties may contribute to such instruments.
3. The 11th EDF shall be authorised to contribute to financial instruments or to the provisioning of budgetary guarantees set up by the Union budget.
4. Financial instruments may be established in the financing decisions referred to in Article 24. They shall be, whenever possible, under the lead of the EIB, a multilateral European financial institution such as the European Bank for Reconstruction and Development, or a bilateral European financial institution such as a bilateral development bank, and may be pooled with additional grants from other sources.
Article 35
Union trust funds
1. Articles 234, 235 and 252 of Regulation (EU, Euratom) 2018/1046 shall apply.
2. With regard to Article 234(2) of Regulation (EU, Euratom) 2018/1046, references to the competent committee shall be the understood as to the European Development Fund Committee referred to in Article 8 of the Internal Agreement.
Article 36
Budget support
1. Article 236 of Regulation (EU, Euratom) 2018/1046 shall apply.
2. Union general or sector budget support shall be based on mutual accountability and shared commitments to universal values, and shall aim at strengthening contractual partnerships between Union and ACP States or OCTs in order to promote democracy, human rights and the rule of law, to support sustainable and inclusive economic growth and to eradicate poverty.
3. Any decision to provide budget support shall be based on budget support policies agreed by the Union, a clear set of eligibility criteria and a careful assessment of the risks and benefits.
One of the key determinants of such a decision shall be an assessment of the commitment, record and progress of ACP States and OCTs with regard to democracy, human rights and the rule of law. Budget support shall be differentiated to better respond to the political, economic and social context of the ACP States and OCTs, taking into account situations of fragility.
4. When providing budget support, the Commission shall clearly define and monitor its conditionality, and shall also support the development of parliamentary control and audit capacities and increase transparency and public access to information.
5. Disbursement of budget support shall be conditional on satisfactory progress towards achieving the objectives agreed with the ACP States and OCTs.
6. When providing budget support to OCTs, their institutional links to the Member State concerned shall be taken into account.
Article 37
Experts and payment of subscriptions
Article 237(1) to (4), and Articles 238 and 239 of Regulation (EU, Euratom) 2018/1046 shall apply.
TITLE X
Annual accounts and other financial reporting
Article 38
11th EDF accounts
1. The annual accounts of the 11th EDF shall be prepared for each financial year, which shall run from 1 January to 31 December. Those accounts shall comprise:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the financial statements;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the report on financial implementation.</p></td></tr></tbody></table>
The financial statements shall be accompanied by the information supplied by the EIB in accordance with Article 51 of this Regulation.
Article 243 of Regulation (EU, Euratom) 2018/1046 shall apply.
2. The accounting officer shall send, via electronic means, the provisional accounts to the Court of Auditors by 31 March of the following year.
The Court of Auditors shall, by 15 June of the following year, make its observations on the provisional accounts as regards the part of the 11th EDF resources for the financial management of which the Commission is responsible, so that the Commission can make the corrections deemed necessary for drawing up the final accounts
3. The Commission shall approve the final accounts and send them, via electronic means, to the European Parliament, to the Council and to the Court of Auditors by 31 July of the following year.
By the same date, the accounting officer shall transmit a representation letter covering the final accounts to the Court of Auditors.
The second subparagraph of Article 246(3) of Regulation (EU, Euratom) 2018/1046 shall apply.
The final accounts shall be published in the Official Journal of the European Union together with the statement of assurance given by the Court of Auditors in accordance with Article 43 of this Regulation by 15 November of the following year.
Article 39
Report on financial implementation
1. The report on financial implementation shall be prepared by the responsible authorising officer and transmitted to the accounting officer by 15 March for inclusion in the 11th EDF accounts. It shall present a true and fair view of the revenue and expenditure operations from 11th EDF resources. It shall be presented in millions of euros and shall comprise:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the financial outturn account, which sets out all financial operations for the year in terms of revenue and expenditure;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the annex to the financial outturn account, which shall supplement and comment on the information given in that account.</p></td></tr></tbody></table>
2. The financial outturn account shall contain the following:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>a table describing changes over the preceding financial year in the allocations;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a table showing by allocation the total commitments, assigned funds and payments effected during the financial year and aggregate totals since the opening of the 11th EDF.</p></td></tr></tbody></table>
Article 40
Monitoring and reporting by the Commission and the EIB
1. The Commission and the EIB shall monitor, each to the extent to which it is concerned, the use of 11th EDF assistance by the ACP States, the OCTs or any other beneficiary, and the implementation of projects financed by the 11th EDF, having particular regard to the objectives referred to in Articles 55 and 56 of the ACP-EU Partnership Agreement and in the corresponding provisions of Decision 2013/755/EU.
2. The EIB shall periodically inform the Commission regarding the implementation of projects financed by the 11th EDF resources it administers, following the procedures set out in the operational guidelines of the Investment Facility.
3. The Commission and the EIB shall provide the Member States with information on the operational implementation of 11th EDF resources as foreseen in Article 18 of Regulation (EU) 2015/322. The Commission shall send that information to the Court of Auditors.
Article 41
Budgetary accounting
1. The budgetary accounts shall provide a detailed record of the financial implementation of the 11th EDF resources.
2. The budgetary accounts shall show all:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>allocations and the corresponding 11th EDF resources;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>financial commitments;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>payments; and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>established debts and collection operations for the financial year, in full and without any adjustment against each other.</p></td></tr></tbody></table>
3. When commitments, payments and debts are expressed in national currencies, the accounting system shall make it possible, where necessary, for them to be recorded in national currencies as well as in euros.
4. Global financial commitments shall be recorded in euros for the value of the financing decisions taken by the Commission. Individual financial commitments shall be recorded in euros at the equivalent of the value of the legal commitments. That value shall include, where appropriate:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>provision for the payment of reimbursable expenses on presentation of supporting documents;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>provision for the revision of prices, for the increase in quantities, and for contingencies as defined in contracts funded by the 11th EDF;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>financial provision for exchange rate fluctuations.</p></td></tr></tbody></table>
5. All accounting records referring to the fulfilment of a commitment shall be kept for a period of five years from the date of the decision giving discharge in respect of the financial implementation of 11th EDF resources, referred to in Article 44, concerning the financial year during which the commitment was closed for accounting purposes.
TITLE XI
External audit and discharge
Article 42
External audit of and discharge to the Commission
1. Regarding the operations financed from 11th EDF resources managed by the Commission in accordance with Article 14, the Court of Auditors shall exercise its powers in accordance with this Article and Article 43.
2. Articles 255, 256 and 257, Article 258(1) and (2), the second sentence of Article 258(3), Article 258(4) and Article 259 of Regulation (EU, Euratom) 2018/1046 shall apply.
3. For the purposes of this Title, the Court of Auditors shall have regard to the Treaties, the ACP-EU Partnership Agreement, Decision 2013/755/EU, the Internal Agreement, this Regulation and all other acts adopted pursuant to those instruments.
4. The Court of Auditors shall be informed of the internal rules referred to in Article 60(1) of Regulation (EU, Euratom) 2018/1046, including the appointment of authorising officers, as well as of the instrument of delegation referred to in Article 79 of that Regulation.
5. The national audit authorities of the ACP States and the OCTs shall be encouraged to cooperate with the Court of Auditors at its invitation.
6. The Court of Auditors may, at the request of one of the Union institutions, issue opinions on matters relating to the 11th EDF.
Article 43
Statement of assurance
At the same time as the annual report referred to in Article 258 of Regulation (EU, Euratom) 2018/1046, the Court of Auditors shall provide the European Parliament and the Council with a statement of assurance as to the reliability of the accounts and the legality and regularity of the underlying transactions, which shall be published in the Official Journal of the European Union .
Article 44
Discharge
1. Subject to paragraph 2 of this Article, Articles 260 to 263 of Regulation (EU, Euratom) 2018/1046 shall apply.
2. The discharge decision shall cover the accounts referred to in Article 38 of this Regulation, except the part thereof provided by the EIB in accordance with Article 51 thereof. The discharge referred to in Article 260(1) of Regulation (EU, Euratom) 2018/1046 shall be given in respect of those 11th EDF resources that are managed by the Commission in accordance with Article 14(2) of this Regulation for year n.
3. The discharge decision shall be published in the Official Journal of the European Union .
PART TWO
INVESTMENT FACILITY
Article 45
Role of the EIB
1. The EIB shall manage the Investment Facility and conduct operations thereunder, including interest rate subsidies and technical assistance, on behalf of the Union in accordance with this Part.
2. In addition, the EIB shall undertake the financial implementation of other operations carried out by means of financing from its own resources in accordance with Article 4 of the Internal Agreement, where applicable combined with interest rate subsidies drawn from the 11th EDF resources.
3. The implementation of this Part shall not give rise to any obligations or liabilities on the part of the Commission.
Article 46
Estimates of commitments and payments of the Investment Facility
Before 1 September of each year, the EIB shall send, in accordance with the Internal Agreement, the Commission its estimates of commitments and payments, which are necessary for drawing up the statement referred to in Article 7(1) of the Internal Agreement, in respect of the operations of the Investment Facility, including those interest rate subsidies that it implements. The EIB shall send the Commission updated estimates of commitments and payments when deemed necessary. Modalities for those estimates shall be laid down in the management agreement referred to in Article 49(4) of this Regulation.
Article 47
Management of contributions to the Investment Facility
1. The contributions referred to in point (b) of Article 19(7) and adopted by the Council shall be paid without cost for the beneficiary by the Member States to the EIB via a special account opened by the EIB in the name of the Investment Facility in accordance with detailed rules laid down in the management agreement referred to in Article 49(4).
2. The date referred to in Article 1(5) of the Internal Agreement shall be 31 December 2030.
3. Save where the Council decides otherwise regarding the remuneration of the EIB, in accordance with Article 5 of the Internal Agreement, proceeds received by the EIB via the credit balance of the special accounts referred to in paragraph 1 of this Article shall supplement the Investment Facility and shall be taken into consideration for the calls for contribution referred to in Article 19 of this Regulation and shall be used to meet any financial obligation after 31 December 2030.
4. The EIB shall undertake the treasury management of the amounts referred to in paragraph 1 of this Article in accordance with the detailed rules laid down in the management agreement referred to in Article 49(4).
5. The Investment Facility shall be managed in accordance with the conditions laid down in the ACP-EU Partnership Agreement, Decision 2013/755/EU, the Internal Agreement and this Part.
Article 48
Remuneration of the EIB
The EIB shall be remunerated on a full indemnity basis for the management of the Investment Facility operations. The Council shall decide on the resources and mechanisms for remuneration of the EIB in accordance with Article 5(4) of the Internal Agreement. The measures implementing that decision shall be incorporated in the management agreement referred to in Article 49(4) of this Regulation.
Article 49
Implementation of the Investment Facility
1. The EIB's own rules shall apply to instruments financed by the 11th EDF resources which it manages.
2. Where programmes or projects are co-financed by the Member States or their implementing bodies, and correspond to the priorities which are laid down in the Country Cooperation Strategies and Programming Documents provided for in Regulation (EU) 2015/322 and laid down in the second and third subparagraphs of Article 10(1) of the Internal Agreement and in Article 74 of Decision 2013/755/EU, the EIB may entrust tasks relating to the implementation of the Investment Facility to Member States or their implementing bodies.
3. The names of the recipients of financial support under the Investment Facility shall be published by the EIB, unless such disclosure risks harming the commercial interests of the recipients, while duly observing of the requirements of confidentiality and security, in particular the protection of personal data. The criteria for disclosure and the level of detail published shall take into account specificities of the sector and the nature of the Investment Facility.
4. The detailed rules for implementing this Part shall be the subject of a management agreement between the Commission, acting on behalf of the Union, and the EIB.
Article 50
Reporting under the Investment Facility
The EIB shall regularly inform the Commission of the operations carried out under the Investment Facility, including interest rate subsidies, the use made of each call for contributions paid to the EIB, and, in particular, of the total quarterly amounts of commitments, contracts and payments, in accordance with the detailed rules laid down in the management agreement referred to in Article 49(4).
Article 51
Accounting and financial statements of the Investment Facility
1. The EIB shall keep the accounts of the Investment Facility, including those interest rate subsidies that are implemented by it and financed by the 11th EDF, to provide a trail for the full circuit of the funds, from receipt to disbursement and then to the revenue to which they give rise and any subsequent recoveries. The EIB shall draw up the relevant accounting rules and methods which are guided by international accounting standards and inform the Commission and the Member States accordingly.
2. Each year the EIB shall send the Council and the Commission a report on the implementation of operations financed from 11th EDF resources under its management, including the financial statements drawn up in accordance with the rules and methods referred to in paragraph 1 of this Article and the information referred to in Article 39(2).
3. Those documents shall be submitted in draft form no later than 28 February and in their final version no later than 30 June of the financial year following the financial year which they concern, so that they can be used by the Commission in preparing the accounts referred to in Article 38 of this Regulation in accordance with Article 11(4) of the Internal Agreement. The report on the financial management of the resources managed by the EIB shall be submitted by the latter to the Commission by 31 March.
Article 52
External audit and discharge relating to EIB operations
The operations financed from 11th EDF resources managed by the EIB in accordance with this Part shall be subject to the audit and discharge procedures that the EIB applies for third party mandate accounts. Detailed rules for auditing by the Court of Auditors shall be set out in a tripartite agreement between the EIB, the Commission and the Court of Auditors.
PART THREE
TRANSITIONAL AND FINAL PROVISIONS
TITLE I
Transitional provisions
Article 53
Transfer of balances remaining from previous EDFs
Transfers to the 11th EDF of the balances remaining from resources constituted under the Internal Agreements relating to the previous EDFs shall be made in accordance with point (b) of Article 1(2), (3) and (4) of the Internal Agreement.
Article 54
Revenue from interest on resources of previous EDFs
The balance of revenue accruing from interest on the resources of previous EDFs shall be transferred to the 11th EDF and allocated for the same purposes as the revenue provided for in Article 1(6) of the Internal Agreement. The same shall apply to miscellaneous revenue of previous EDFs comprising, for example, default interest received in the event of late payment of contributions to those EDFs by Member States. The interest generated by the previous EDF resources managed by the EIB shall supplement the Investment Facility.
Article 55
Reduction of contributions by remaining balances
The amounts from projects under the 10th EDF or from other previous EDFs not committed according to Article 1(3) of the Internal Agreement, or decommitted according to Article 1(4) of the Internal Agreement, unless decided otherwise by the Council unanimously, shall reduce that part of Member States' contributions stated in point (a) of Article 1(2) of the Internal Agreement.
The impact on the contribution of each Member State shall be calculated in proportion to the contribution of each Member State to the 9th and 10th EDF. The impact shall be calculated annually.
Article 56
Application of this Regulation to operations under previous EDFs
This Regulation shall apply to operations financed from previous EDFs without prejudice to existing legal commitments. This Regulation shall not apply to the Investment Facility under previous EDFs.
Article 57
Commencement of contribution procedures
The procedure concerning Member States' contributions laid down in Articles 19 to 22 shall apply for the first time with regard to the contributions of the year n + 2, provided that the Internal Agreement enters into force between 1 October of year n and 30 September of year n + 1.
TITLE II
Final provisions
Article 58
Repeal
Regulation (EU) 2015/323 is hereby repealed.
References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in the Annex.
Article 59
Entry into force and application
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 26 November 2018.
For the Council
The President
F. MOGHERINI
( 1 ) OJ L 317, 15.12.2000, p. 3 .
( 2 ) OJ L 210, 6.8.2013, p. 1 .
( 3 ) OJ C 396, 31.10.2018, p. 1 .
( 4 ) Council Regulation (EU) 2015/323 of 2 March 2015 on the financial regulation applicable to the 11th European Development Fund ( OJ L 58, 3.3.2015, p. 17 ).
( 5 ) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 ( OJ L 298, 26.10.2012, p. 1 ).
( 6 ) Commission Delegated Regulation (EU) No 1268/2012 of 29 October 2012 on the rules of application of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council on the financial rules applicable to the general budget of the Union ( OJ L 362, 31.12.2012, p. 1 ).
( 7 ) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 ( OJ L 193, 30.7.2018, p. 1 ).
( 8 ) Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union (‘Overseas Association Decision’) ( OJ L 344, 19.12.2013, p. 1 ).
( 9 ) Council Regulation (EU) 2015/322 of 2 March 2015 on the implementation of the 11th European Development Fund ( OJ L 58, 3.3.2015, p. 1 ).
( 10 ) Regulation (EU) No 236/2014 of the European Parliament and of the Council of 11 March 2014 laying down common rules and procedures for the implementation of the Union's instruments for financing external action ( OJ L 77, 15.3.2014, p. 95 ).
ANNEX
CORRELATION TABLE
<table><col/><col/><tbody><tr><td><p>Regulation (EU) 2015/323</p></td><td><p>This Regulation</p></td></tr><tr><td><p>Article 1</p></td><td><p>Article 1</p></td></tr><tr><td><p>Article 2(1)</p></td><td><p>—</p></td></tr><tr><td><p>Article 2(2)</p></td><td><p>Article 2(1)</p></td></tr><tr><td><p>Article 2(3)</p></td><td><p>Article 2(2)</p></td></tr><tr><td><p>Article 2(4)</p></td><td><p>Article 3(1) and (2)</p></td></tr><tr><td><p>Article 2(5)</p></td><td><p>Article 2(4)</p></td></tr><tr><td><p>Article 3</p></td><td><p>Article 3(2)</p></td></tr><tr><td><p>Article 4</p></td><td><p>Article 3(2)</p></td></tr><tr><td><p>Article 5</p></td><td><p>Article 4</p></td></tr><tr><td><p>Article 6</p></td><td><p>Article 5</p></td></tr><tr><td><p>Article 7</p></td><td><p>Article 6</p></td></tr><tr><td><p>Article 8</p></td><td><p>Article 7</p></td></tr><tr><td><p>Article 9(1)</p></td><td><p>Article 8(1)</p></td></tr><tr><td><p>Article 9(2)</p></td><td><p>Article 8(2)</p></td></tr><tr><td><p>Article 9(2)(a)</p></td><td><p>Article 8(2)(a)</p></td></tr><tr><td><p>Article 9(2)(b)</p></td><td><p>Article 8(2)(b)</p></td></tr><tr><td><p>Article 9(2)(c)</p></td><td><p>Article 8(2)(c)</p></td></tr><tr><td><p>Article 9(2)(d)</p></td><td><p>—</p></td></tr><tr><td><p>Article 9(2)(e)</p></td><td><p>Article 8(2)(d)</p></td></tr><tr><td><p>Article 9(2)(f)</p></td><td><p>Article 8(2)(e)</p></td></tr><tr><td><p>Article 9(3)</p></td><td><p>Article 8(3)</p></td></tr><tr><td><p>Article 9(4)</p></td><td><p>—</p></td></tr><tr><td><p>Article 9(5)</p></td><td><p>Article 8(4)</p></td></tr><tr><td><p>Article 9(6)</p></td><td><p>Article 8(5)</p></td></tr><tr><td><p>Article 10</p></td><td><p>Article 9</p></td></tr><tr><td><p>Article 11(1)</p></td><td><p>Article 10</p></td></tr><tr><td><p>Article 11(2)</p></td><td><p>—</p></td></tr><tr><td><p>Article 11(3)</p></td><td><p>—</p></td></tr><tr><td><p>Article 11(4)</p></td><td><p>—</p></td></tr><tr><td><p>Article 12</p></td><td><p>—</p></td></tr><tr><td><p>Article 13(1)</p></td><td><p>Article 11(1)</p></td></tr><tr><td><p>Article 13(2)</p></td><td><p>Article 11(2)</p></td></tr><tr><td><p>Article 13(3)</p></td><td><p>Article 11(3)</p></td></tr><tr><td><p>Article 13(4)</p></td><td><p>Article 29(4)</p></td></tr><tr><td><p>Article 13(5)</p></td><td><p>Article 30</p></td></tr><tr><td><p>Article 14</p></td><td><p>Article 12</p></td></tr><tr><td><p>Article 15</p></td><td><p>Article 13</p></td></tr><tr><td><p>Article 16</p></td><td><p>Article 14</p></td></tr><tr><td><p>Article 17(1)</p></td><td><p>Article 14(1)</p></td></tr><tr><td><p>Article 17(2)</p></td><td><p>Article 15(1)</p></td></tr><tr><td><p>Article 17(3)</p></td><td><p>Article 30(2)</p></td></tr><tr><td><p>Article 17(4)</p></td><td><p>Article 30(3)</p></td></tr><tr><td><p>Article 17(5)</p></td><td><p>Article 29(3)</p></td></tr><tr><td><p>Article 18(1)</p></td><td><p>—</p></td></tr><tr><td><p>Article 18(2)</p></td><td><p>Article 16(1)</p></td></tr><tr><td><p>Article 18(3)</p></td><td><p>Article 16(2)</p></td></tr><tr><td><p>Article 19(1), first subparagraph</p></td><td><p>Article 18(2)</p></td></tr><tr><td><p>Article 19(1), second subparagraph</p></td><td><p>Article 17(1)</p></td></tr><tr><td><p>Article 19(2)</p></td><td><p>Article 17(2)</p></td></tr><tr><td><p>Article 20(1)</p></td><td><p>Article 18(1)</p></td></tr><tr><td><p>Article 20(2)</p></td><td><p>Article 18(2)</p></td></tr><tr><td><p>Article 21</p></td><td><p>Article 19</p></td></tr><tr><td><p>Article 22</p></td><td><p>Article 20</p></td></tr><tr><td><p>Article 23</p></td><td><p>Article 21</p></td></tr><tr><td><p>Article 24</p></td><td><p>Article 22</p></td></tr><tr><td><p>Article 25(1)</p></td><td><p>Article 23(1)</p></td></tr><tr><td><p>Article 25(2)</p></td><td><p>Article 23(2)</p></td></tr><tr><td><p>Article 25(3)</p></td><td><p>Article 23(3)</p></td></tr><tr><td><p>Article 25(4)</p></td><td><p>—</p></td></tr><tr><td><p>Article 25(5)</p></td><td><p>—</p></td></tr><tr><td><p>Article 26</p></td><td><p>Article 24(1)(2)</p></td></tr><tr><td><p>Article 27(1)</p></td><td><p>Article 24(2)</p></td></tr><tr><td><p>Article 27(2)</p></td><td><p>Article 24(3)</p></td></tr><tr><td><p>Article 27(3)</p></td><td><p>Article 24(4)</p></td></tr><tr><td><p>Article 27(4)</p></td><td><p>Article 24(5)</p></td></tr><tr><td><p>Article 27(5)</p></td><td><p>Article 24(6)</p></td></tr><tr><td><p>Article 27(6)</p></td><td><p>Article 24(7)</p></td></tr><tr><td><p>Article 27(7)</p></td><td><p>Articles 27, 42</p></td></tr><tr><td><p>Article 28</p></td><td><p>Article 26</p></td></tr><tr><td><p>Article 29</p></td><td><p>Article 25</p></td></tr><tr><td><p>Article 30</p></td><td><p>Article 26</p></td></tr><tr><td><p>Article 31</p></td><td><p>Article 27</p></td></tr><tr><td><p>Article 32</p></td><td><p>Article 27</p></td></tr><tr><td><p>Article 33</p></td><td><p>Article 27</p></td></tr><tr><td><p>Article 34</p></td><td><p>Article 28</p></td></tr><tr><td><p>Article 35(1)</p></td><td><p>Article 29(1)</p></td></tr><tr><td><p>Article 35(2)</p></td><td><p>Article 29(2)</p></td></tr><tr><td><p>Article 35(3)</p></td><td><p>Article 29(3)</p></td></tr><tr><td><p>Article 35(4)</p></td><td><p>Article 29(5)</p></td></tr><tr><td><p>—</p></td><td><p>Article 30(1)</p></td></tr><tr><td><p>Article 36</p></td><td><p>Article 31</p></td></tr><tr><td><p>Article 37</p></td><td><p>Article 32</p></td></tr><tr><td><p>Article 38</p></td><td><p>Article 33</p></td></tr><tr><td><p>Article 39</p></td><td><p>Article 36</p></td></tr><tr><td><p>Article 40</p></td><td><p>Article 34</p></td></tr><tr><td><p>Article 41</p></td><td><p>Article 37</p></td></tr><tr><td><p>Article 42</p></td><td><p>Article 35</p></td></tr><tr><td><p>Article 43(1), first and second subparagraphs</p></td><td><p>Article 38(1), first and second subparagraphs</p></td></tr><tr><td><p>Article 43(2)</p></td><td><p>Article 38(2), first subparagraph</p></td></tr><tr><td><p>Article 43(3)</p></td><td><p>Article 38(2), second subparagraph</p></td></tr><tr><td><p>Article 43(4)</p></td><td><p>Article 38(3), first and second subparagraphs</p></td></tr><tr><td><p>Article 43(5)</p></td><td><p>Article 38(3), third subparagraph</p></td></tr><tr><td><p>Article 43(6)</p></td><td><p>Article 38(3), fourth subparagraph</p></td></tr><tr><td><p>Article 43(7)</p></td><td><p>Article 38(2), first subparagraph, and Article 38(3), first and second subparagraphs</p></td></tr><tr><td><p>Article 44(1)</p></td><td><p>Article 38(1), third subparagraph</p></td></tr><tr><td><p>Article 44(2)</p></td><td><p>Article 39(1)</p></td></tr><tr><td><p>Article 44(3)</p></td><td><p>Article 39(2)</p></td></tr><tr><td><p>Article 45</p></td><td><p>Article 40</p></td></tr><tr><td><p>Article 46</p></td><td><p>Article 18(3) and (4)</p></td></tr><tr><td><p>Article 47</p></td><td><p>Article 41</p></td></tr><tr><td><p>Article 48(1)</p></td><td><p>Article 42(1)</p></td></tr><tr><td><p>Article 48(2)</p></td><td><p>Article 42(2)</p></td></tr><tr><td><p>Article 48(3)</p></td><td><p>Article 42(3)</p></td></tr><tr><td><p>Article 48(4)</p></td><td><p>Article 42(2)</p></td></tr><tr><td><p>Article 48(5)</p></td><td><p>Article 42(4)</p></td></tr><tr><td><p>Article 48(6)</p></td><td><p>Article 42(5)</p></td></tr><tr><td><p>Article 48(7)</p></td><td><p>Article 42(6)</p></td></tr><tr><td><p>Article 49</p></td><td><p>Article 43</p></td></tr><tr><td><p>Article 50(1)</p></td><td><p>Article 44(2)</p></td></tr><tr><td><p>Article 50(2)</p></td><td><p>Article 44(3)</p></td></tr><tr><td><p>Article 50(3)</p></td><td><p>Article 44(1)</p></td></tr><tr><td><p>Article 51</p></td><td><p>Article 45</p></td></tr><tr><td><p>Article 52</p></td><td><p>Article 46</p></td></tr><tr><td><p>Article 53</p></td><td><p>Article 47</p></td></tr><tr><td><p>Article 54</p></td><td><p>Article 48</p></td></tr><tr><td><p>Article 55</p></td><td><p>Article 49</p></td></tr><tr><td><p>Article 56</p></td><td><p>Article 50</p></td></tr><tr><td><p>Article 57(1)</p></td><td><p>Article 51(1)</p></td></tr><tr><td><p>Article 57(2)</p></td><td><p>Article 51(2) and (3)</p></td></tr><tr><td><p>Article 58</p></td><td><p>Article 52</p></td></tr><tr><td><p>Article 59</p></td><td><p>Article 53</p></td></tr><tr><td><p>Article 60</p></td><td><p>Article 54</p></td></tr><tr><td><p>Article 61</p></td><td><p>Article 55</p></td></tr><tr><td><p>Article 62</p></td><td><p>Article 56</p></td></tr><tr><td><p>Article 63</p></td><td><p>Article 57</p></td></tr><tr><td><p>—</p></td><td><p>Article 58</p></td></tr><tr><td><p>Article 64</p></td><td><p>Article 59</p></td></tr></tbody></table> | ENG | 32018R1877 |
<table><col/><col/><col/><col/><tbody><tr><td><p>13.4.2022   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>LI 115/1</p></td></tr></tbody></table>
COMMISSION DELEGATED REGULATION (EU) 2022/629
of 12 January 2022
amending the regulatory technical standards laid down in Delegated Regulation (EU) 2017/583 as regards adjustment the liquidity thresholds and trade percentile used to determine the size specific to the instrument applicable to certain non-equity instruments
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 ( 1 ) , and in particular Article 9(5), third subparagraph thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Commission Delegated Regulation (EU) 2017/583 <a>(<span>2</span>)</a> sets out the transparency requirements applicable to bonds, structured finance products, emission allowances and derivatives. In order to ensure a smooth implementation of those requirements, that Delegated Regulation has introduced an annual phase-in of application of certain transparency thresholds over the course of 4 years, starting from 2019. That phase-in allows gradual broadening of the application of corresponding transparency obligations. This concerns, in particular, the ‘average daily number of trades’ criterion used for the determination of bonds for which there is a liquid market and as the trade percentiles used for the determination of the size specific to the instrument (SSTI) which allows for pre-trade transparency obligations to be waived.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Under that phased-in approach, moving to the next stage is not automatic. The European Securities and Markets Authority (ESMA) is required to submit to the Commission its annual assessment of the appropriateness of the move to the next stage. The ESMA’s assessment has to analyse the evolution of trading volumes for the concerned financial instruments under the current stage and to anticipate the possible impact a move to the next stage could have on both available liquidity and market participants. If appropriate, ESMA is required to submit, together with its report, a revised regulatory standard adjusting the threshold to the next stage.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>ESMA submitted its assessment and revised regulatory standards to the Commission on 22 July 2021. ESMA concludes that between 1,57 % and 2,58 % of bonds traded between the first and the fourth quarter of 2020 were considered liquid following the criteria that apply in stage S2. Moving to stage S3 means an increase of approximately 40 %.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>With regard to the SSTI, ESMA concludes that moving from stage S2 to S3 will mostly affect trading in sovereign bonds and other public bonds, since for those instruments the increase will be the largest. Those instruments, however, typically are traded in the range of EUR 3 million to EUR 6 million. ESMA considers therefore that a move to stage S3 would keep the pre-trade SSTI sufficiently low to protect liquidity providers from market impact stemming from large orders, while ensuring that more liquid bonds would be subject to pre-trade transparency.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Taking into account the assessment undertaken by ESMA and the limited level of transparency in the bond markets, the limited effects to competition in the market and the fact that the threshold would still be sufficiently low to protect liquidity providers from potential market impact stemming from large orders, it is appropriate to move to stage S3 for bonds for which there is a liquid market and for the SSTI for bonds. The move to stage S3 should increase the level of transparency available in the bond market without a negative impact on liquidity.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Delegated Regulation (EU) 2017/583 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>This Regulation is based on the draft regulatory technical standards submitted to the Commission by ESMA.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>ESMA has conducted open public consultations on the draft regulatory technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the advice of the Securities and Markets Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council <a>(<span>3</span>)</a>,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Amendments to Delegated Regulation (EU) 2017/583
Article 17 of Delegated Regulation (EU) 2017/583 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>paragraph 1 is replaced by the following:</p><div><p>‘1.   For determining the bonds for which there is not a liquid market for the purposes of Article 6 and according to the methodology specified in Article 13(1), point (b), the approach for the liquidity criterion “average daily number of trades” shall be taken applying the “average daily number of trades” corresponding to stage S3 (7 daily trades).’;</p></div></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>paragraph 3 is replaced by the following:</p><div><p>‘3.   For determining the size specific to the financial instrument for the purposes of Article 5 and according to the methodology specified under Article 13(2), point (b)(i), the approach for the trade percentile to be applied shall be used applying the trade percentile corresponding to the stage S3 (50th percentile).</p><p>For determining the size specific to the financial instrument for the purposes of Article 5 and according to the methodology specified under Article 13(2), points (b)(ii) to (iv), the approach for the trade percentile to be applied shall be used applying the trade percentile corresponding to the stage S1 (30th percentile).’.</p></div></td></tr></tbody></table>
Article 2
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 January 2022.
For the Commission
The President
Ursula VON DER LEYEN
<note>
( 1 ) OJ L 173, 12.6.2014, p. 84 .
( 2 ) Commission Delegated Regulation (EU) 2017/583 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on transparency requirements for trading venues and investment firms in respect of bonds, structured finance products, emission allowances and derivatives ( OJ L 87, 31.3.2017, p. 229 ).
( 3 ) Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC ( OJ L 331, 15.12.2010, p. 84 ).
</note> | ENG | 32022R0629 |
<table><col/><col/><col/><tbody><tr><td><img/></td><td><p>Official Journal<br/>of the European Union</p></td><td><p>EN</p><p>Series L</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>2023/2918</p></td><td><p>28.12.2023</p></td></tr></tbody></table>
COMMISSION DELEGATED REGULATION (EU) 2023/2918
of 22 August 2023
supplementing Regulation (EU) No 1380/2013 of the European Parliament and of the Council as regards the establishment of a de minimis exemption to the landing obligation for certain demersal fisheries in the Adriatic and south-eastern Mediterranean Sea
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC ( 1 ) , and in particular Article 15(7) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Commission Delegated Regulation (EU) 2017/86 <a>(<span>2</span>)</a> established a temporary discard plan for certain demersal fisheries in the Mediterranean Sea applicable from 1 January 2017 until 31 December 2019. Commission Delegated Regulation (EU) 2020/4 <a>(<span>3</span>)</a> subsequently extended the period of application of the temporary discard plan until 31 December 2021.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>A<span>de minimis</span> exemption was subsequently established by Commission Delegated Regulation (EU) 2021/2064 <a>(<span>4</span>)</a>. That exemption was established for demersal species until 31 December 2023, whereas for by-catches of small pelagic made in demersal fisheries the exemption was established only until 31 December 2022. Commission Delegated Regulation (EU) 2022/2564 <a>(<span>5</span>)</a> subsequently extended the application of the<span>de minimis</span> exemptions for by-catches of small pelagic species until 31 December 2023.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Croatia, Italy and Slovenia (‘Adriatica High-Level Group’) and Greece, Italy, Cyprus and Malta (‘Sudestmed High-Level Group’) have a direct fisheries management interest in the Adriatic Sea and south-eastern Mediterranean Sea respectively. On 2 May 2023, the Adriatica High-Level Group and the Sudestmed High-Level Group submitted initial joint recommendations requesting the extension of the<span>de minimis</span> exemptions laid down in Delegated Regulation (EU) 2021/2064.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>On 15 June 2023, the Scientific, Technical and Economic Committee for Fisheries (‘STECF’) assessed the scientific evidence supporting the initial joint recommendations <a>(<span>6</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>First, the STECF noted that while the combined<span>de minimis</span> approach included in the scientific evidence covers a broad group of species with a wide range of discard rates, such broad coverage is a valid approach, given the complexity of the fisheries in the Adriatic Sea and south-eastern Mediterranean Sea.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Second, the STECF considered that individual<span>de minimis</span> exemptions covering a single species would likely result in many separate exemptions that would be equally challenging to monitor.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Third, discard rates have a very high heterogeneity both among geographical subareas (GSAs) and among pooled species (especially for species caught with bottom trawls) and reducing the level of unwanted catches through the use of selective gears or marine protected areas should be prioritised.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Fourth, regarding specifically the scientific evidence provided by the Adriatica High-Level group on disproportionate costs of handling unwanted catches, the STECF noted that several research projects and studies are ongoing or will be developed and that solid arguments were provided to justify the difficulty to improve selectivity and avoid all unwanted catches, in a short-term period. The STECF also welcomed the effort done to conduct disproportionate costs and selectivity studies and that new projects will be implemented by the relevant Member States.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>Fifth, regarding specifically the scientific evidence provided by the Sudestmed High-Level Group on disproportionate costs of handling unwanted catches, the STECF noted the effort and work done to provide evidence regarding the disproportionate costs of handling unwanted catches in south-eastern Mediterranean fisheries by means of an exhaustive Multicriteria Performance Matrix analysis. The STECF also welcomed the effort done to conduct selectivity studies and that new projects will be implemented by Member States.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>On 27 June 2023, the Sudestmed High-Level Group, and on 28 June 2023, the Adriatica High-Level Group submitted respectively updated joint recommendations.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>Under Article 18 of Regulation (EU) No 1380/2013 of the European Parliament and of the Council <a>(<span>7</span>)</a>, the Commission has considered the updated joint recommendations of Adriatica and SudestMed High-Level Groups in light of the STECF’s assessment of the initial joint recommendation to ensure that the updated joint recommendation is compatible with the relevant Union conservation measures, including the landing obligation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>The Commission has also taken into account that: (i) the upcoming evaluation of the landing obligation <a>(<span>8</span>)</a> is expected to provide more information on the effectiveness, efficiency, coherence, relevance and added value of landing obligation; and (ii) the Scientific, Technical and Economic Committee for Fisheries (STECF) has noted <a>(<span>9</span>)</a> that the current process of evaluating joint recommendations is inefficient, that further reflection is necessary as to how it can be further improved and that such reflection would allow discussion on data issues and on finding new ways to improve the implementation of the landing obligation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>The Commission also notes that, in the Adriatic Sea and south-eastern Mediterranean Sea, species are caught at the same time, at highly varying quantities, making a single stock approach challenging. Those species are furthermore caught by small-scale fishing vessels and landed in many different landing points spread out geographically along the coast. This results in disproportionate costs of handling unwanted catches.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>Moreover, in their updated joint recommendations, Member States renewed their commitment to undertake new studies with a roadmap and to increase the selectivity of the fishing gears in accordance with the results of current research programmes in order to reduce and limit unwanted catches and particularly catches below minimum conservation reference sizes. Member States also committed to identify further closure areas in order to reduce juvenile mortality.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>In addition, considering the high number of different species caught at the same time in demersal fishing operations using hooks, lines, gillnets and trammel nets in the Adriatic and south-eastern Mediterranean Sea, in their updated joint recommendations, Member States have proposed<span>de minimis</span> thresholds that are proportionate to the species frequency of capture.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(16)</p></td><td><p>For the reasons set out in recitals 3 to 15 above, the Commission therefore considers that the exemptions should be granted from 1 January 2024 to 31 December 2027.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(17)</p></td><td><p>Since the measures provided for in this Regulation impact directly on the planning of the fishing season of Union vessels and on related economic activities and for reasons of legal certainty this Regulation should apply from 1 January 2024,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Implementation of the landing obligation
The landing obligation provided for in Article 15(1) of Regulation (EU) No 1380/2013 shall apply in Union waters of the Adriatic and south-eastern Mediterranean Sea to demersal fisheries in accordance with this Regulation.
Article 2
Definitions
For the purposes of this Regulation, the following definitions shall apply:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>‘GFCM Geographical Sub-areas’ (‘GSAs’) means General Fisheries Commission for the Mediterranean (‘GFCM’) Geographical Sub-Areas as defined in the Annex I to Regulation (EU) No 1343/2011 of the European Parliament and of the Council <a>(<span>10</span>)</a>;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>‘Adriatic Sea’ means GFCM Geographical Sub-Areas 17 and 18;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>‘South-eastern Mediterranean Sea’ means GFCM Geographical Sub-Areas 14, 15, 16, 19, 20, 21, 22, 23, 24, 25, 26 and 27.</p></td></tr></tbody></table>
Article 3
De minimis exemption
1. By way of derogation from Article 15(1) of Regulation (EU) No 1380/2013, the following quantities of species may be discarded pursuant to Article 15(4), point (c), of Regulation (EU) No 1380/2013:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>in the Adriatic Sea:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>for hake<span>(Merluccius merluccius)</span> and mullets<span>(Mullus</span> spp.), up to a maximum of 5 % of the total annual catches of those species caught by vessels using bottom trawls;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>for hake<span>(Merluccius merluccius)</span> and mullets<span>(Mullus</span> spp.), up to a maximum of 1 % of the total annual catches of those species caught by vessels using gillnets and trammel nets (GSN, GN, GND, GNC, GTN, GTR, GEN);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>for hake<span>(Merluccius merluccius)</span> and mullets<span>(Mullus</span> spp.), up to a maximum of 1 % of the total annual catches of those species caught by vessels using rapido (TBB);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>for common sole<span>(Solea solea),</span> up to 3 % of total annual catches of those species caught by vessels using bottom trawls;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><p>for European seabass<span>(Dicentrarchus labrax)</span>, annular seabream<span>(Diplodus annularis),</span> sharpsnout seabream<span>(Diplodus puntazzo</span>), white seabream<span>(Diplodus sargus</span>), two-banded seabream<span>(Diplodus vulgaris)</span>, groupers<span>(Epinephelus</span> spp.) striped seabream<span>(Lithognathus mormyrus)</span>, Spanish seabream<span>(Pagellus acarne),</span> red seabream (<span>Pagellus bogaraveo</span>), common pandora (<span>Pagellus erythrinus</span>), common seabream<span>(Pagrus pagrus)</span>, wreckfish<span>(Polyprion americanus),</span> gilthead seabream<span>(Sparus aurata)</span> and deep-water rose shrimp<span>(Parapenaeus longirostris),</span> up to a maximum of 5 % of the total annual catches of those species caught by vessels using bottom trawls;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(vi)</p></td><td><p>for European seabass (<span>Dicentrarchus labrax</span>), annular seabream (<span>Diplodus annularis</span>), sharpsnout seabream (<span>Diplodus puntazzo</span>), white seabream (<span>Diplodus sargus</span>), two-banded seabream (<span>Diplodus vulgaris</span>), groupers (<span>Epinephelus</span> spp.), striped seabream (<span>Lithognathus mormyrus</span>), Spanish seabream (<span>Pagellus acarne</span>), red seabream (<span>Pagellus bogaraveo</span>), common pandora (<span>Pagellus erythrinus</span>), common seabream (<span>Pagrus pagrus</span>), wreckfish (<span>Polyprion americanus</span>), common sole (<span>Solea solea</span>) and gilthead seabream (<span>Sparus aurata</span>), up to a maximum of 2 % of the total annual catches of those species caught by vessels using gillnets and trammel nets (GNS, GN, GND, GNC, GTN, GTR, GEN);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(vii)</p></td><td><p>for European seabass (<span>Dicentrarchus labrax</span>), annular seabream (<span>Diplodus annularis</span>), sharpsnout seabream (<span>Diplodus puntazzo</span>), white seabream (<span>Diplodus sargus</span>), two-banded seabream (<span>Diplodus vulgaris</span>), groupers (<span>Epinephelus</span> spp.), striped seabream (<span>Lithognathus mormyrus</span>), Spanish seabream (<span>Pagellus acarne</span>), common pandora (<span>Pagellus erythrinus</span>), common seabream (<span>Pagrus pagrus</span>), wreckfish<span>(Polyprion americanus</span>), common sole (<span>Solea solea</span>) and gilthead seabream<span>(Sparus aurata</span>), up to a maximum of 1 % of the total annual catches of those species caught by vessels using hooks and lines (LHP, LHM, LLS, LLD, LL, LTL, LX);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(viii)</p></td><td><p>for anchovy (<span>Engraulis encrasicolus</span>), sardine (<span>Sardina pilchardus</span>), mackerel (<span>Scomber</span> spp.) and horse mackerel (<span>Trachurus</span> spp.), up to a maximum of 5 % of the total annual by-catches of those species caught by vessels using bottom trawls;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ix)</p></td><td><p>for Norway lobster (<span>Nephrops norvegicus</span>), up to a maximum of 1 % of the total annual catches of this specie caught by vessels using pots and traps;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in the south-eastern Mediterranean Sea:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>for hake (<span>Merluccius merluccius</span>) and mullets (<span>Mullus</span> spp.), up to a maximum of 5 % of the total annual catches of those species caught by vessels using bottom trawls;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>for hake (<span>Merluccius merluccius</span>) and mullets (<span>Mullus</span> spp.), up to a maximum of 1 % of the total annual catches of those species caught by vessels using gillnets and trammel nets (GNS, GN, GND, GNC, GTN, GTR, GEN);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>for deep-water rose shrimp (<span>Parapenaeaus longirostris</span>), up to a maximum of 5 % of the total annual catches of that species caught by vessels using bottom trawls;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>for European seabass (<span>Dicentrarchus labrax</span>), annular seabream (<span>Diplodus annularis</span>), sharpsnout seabream (<span>Diplodus puntazzo</span>), white seabream (<span>Diplodus sargus</span>), two-banded seabream (<span>Diplodus vulgaris</span>), groupers (<span>Epinephelus</span> spp.), striped seabream (<span>Lithognathus mormyrus</span>), Spanish seabream (<span>Pagellus acarne</span>), blackspot seabream (<span>Pagellus bogaraveo</span>), common pandora (<span>Pagellus erythrinus</span>), common seabream (<span>Pagrus pagrus</span>), wreckfish (<span>Polyprion americanus</span>) gilthead seabream (<span>Sparus aurata</span>) Norway Lobster (<span>Nephrops norvegicus</span>) and common sole (<span>Solea solea</span>), up to a maximum of 5 % of the total annual catches of those species caught by vessels using bottom trawls;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><p>for European seabass (<span>Dicentrarchus labrax</span>), annular seabream (<span>Diplodus annularis</span>), sharpsnout seabream (<span>Diplodus puntazzo</span>), white seabream (<span>Diplodus sargus</span>), two-banded seabream (<span>Diplodus vulgaris</span>), groupers (<span>Epinephelus</span> spp.), striped seabream (<span>Lithognathus mormyrus</span>), Spanish seabream (<span>Pagellus acarne</span>), blackspot seabream (<span>Pagellus bogaraveo</span>), common pandora (<span>Pagellus erythrinus</span>), common seabream (<span>Pagrus pagrus</span>), wreckfish (<span>Polyprion americanus</span>) gilthead seabream (<span>Sparus aurata</span>), common sole (<span>Solea solea</span>), lobster (<span>Homarus gammarus</span>) and crawfish (<span>Palinuridae</span>), up to a maximum of 3 % of total annual catches of those species caught by vessels using gillnets and trammel nets (GNS, GN, GND, GNC, GTN, GTR, GEN). In case landings of those species are less than 25 % of the total landings of the fisheries, the quantities to be discarded may be up to a maximum of 5 % of the total annual catches of those species;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(vi)</p></td><td><p>for European seabass (<span>Dicentrarchus labrax</span>), annular seabream (<span>Diplodus annularis</span>), sharpsnout seabream (<span>Diplodus puntazzo</span>), white seabream (<span>Diplodus sargus</span>), two-banded seabream (<span>Diplodus vulgaris</span>), groupers (<span>Epinephelus</span> spp.), striped seabream (<span>Lithognathus mormyrus</span>), blackspot seabream (<span>Pagellus bogaraveo</span>), Spanish seabream (<span>Pagellus acarne</span>), common pandora (<span>Pagellus erythrinus</span>), common seabream (<span>Pagrus pagrus</span>), wreckfish (<span>Polyprion americanus</span>), gilthead seabream (<span>Sparus aurata</span>), hake (<span>Merluccius merluccius</span>) up to a maximum of 1 % of the total annual catches of those species caught by vessels using hooks and lines (LHP, LHM, LLS, LLD, LL, LTL, LX). In case landings of those species are less than 25 % of the total landings of the fisheries, the quantities to be discarded may be up to a maximum of 3 % of the total annual catches of those species;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(vii)</p></td><td><p>for anchovy (<span>Engraulis encrasicolus</span>), sardine (<span>Sardina pilchardus</span>), mackerel (<span>Scomber</span> spp.) and horse mackerel (<span>Trachurus</span> spp.), up to a maximum of 5 % of the total annual by-catches of those species caught by vessels using bottom trawls.</p></td></tr></tbody></table></td></tr></tbody></table>
2. By 1 May 2027, the Member States having a direct management interest in the fisheries in the Adriatic and south-Eastern Mediterranean Sea shall submit to the Commission additional discard data and the results of the research, projects and studies supporting the exemption laid down in paragraph 1. The STECF shall assess the data and information submitted by 31 July 2027 at the latest.
Article 4
Entry into force and application
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union .
It shall apply from 1 January 2024 until 31 December 2027.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 August 2023.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 354, 28.12.2013, p. 22 .
( 2 ) Commission Delegated Regulation (EU) 2017/86 of 20 October 2016 establishing a discard plan for certain demersal fisheries in the Mediterranean Sea ( OJ L 14, 18.1.2017, p. 4 ).
( 3 ) Commission Delegated Regulation (EU) 2020/4 of 29 August 2019 amending Delegated Regulation (EU) 2017/86 establishing a discard plan for certain demersal fisheries in the Mediterranean Sea ( OJ L 2, 6.1.2020, p. 5 ).
( 4 ) Commission Delegated Regulation (EU) 2021/2064 of 25 August 2021 supplementing Regulation (EU) No 1380/2013 of the European Parliament and of the Council as regards the establishment of a de minimis exemption to the landing obligation for certain demersal fisheries in the Adriatic and south eastern Mediterranean Sea ( OJ L 421, 26.11.2021, p. 9 ).
( 5 ) Commission Delegated Regulation (EU) 2022/2564 of 16 August 2022 amending Delegated Regulation (EU) 2021/2064 supplementing Regulation (EU) No 1380/2013 of the European Parliament and of the Council as regards the establishment of a de minimis exemption to the landing obligation for certain fisheries in the Atlantic and south-eastern Mediterranean ( OJ L 330, 23.12.2022, p. 126 ).
( 6 ) Scientific, Technical and Economic Committee for Fisheries (STECF) – Evaluation of Joint Recommendations on the landing obligation and on Technical Measures Regulation (STECF-23-04 & 23-06).
( 7 ) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC ( OJ L 354, 28.12.2013, p. 22 ).
( 8 ) COM(2023) 103 final.
( 9 ) https://stecf.jrc.ec.europa.eu/documents/43805/61703874/STECF+23-0406+-+Ev+JRs+LO.pdf/5cf75911-6a7f-4aa5-be7d-3f371440b2bd
( 10 ) Regulation (EU) No 1343/2011 of the European Parliament and of the Council of 13 December 2011 on certain provisions for fishing in the GFCM (General Fisheries Commission for the Mediterranean) Agreement area and amending Council Regulation (EC) No 1967/2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea ( OJ L 347, 30.12.2011, p. 44 ).
ELI: http://data.europa.eu/eli/reg_del/2023/2918/oj
ISSN 1977-0677 (electronic edition) | ENG | 32023R2918 |
<table><col/><col/><col/><col/><tbody><tr><td><p>3.8.2023   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 195/1</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2023/1588
of 27 July 2023
approving non-minor amendments to the product specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Ogulinski kiseli kupus / Ogulinsko kiselo zelje’ (PDO))
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs ( 1 ) , and in particular Article 52(2) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Croatia’s application for the approval of amendments to the product specification for the protected designation of origin ‘Ogulinski kiseli kupus / Ogulinsko kiselo zelje’, registered under Commission Implementing Regulation (EU) 2015/1413 <a>(<span>2</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the<span>Official Journal of the European Union</span> <a>(<span>3</span>)</a> as required by Article 50(2)(a) of that Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the product specification should be approved,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The amendments to the product specification published in the Official Journal of the European Union regarding the name ‘Ogulinski kiseli kupus / Ogulinsko kiselo zelje’ (PDO) are hereby approved.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 July 2023.
For the Commission,
On behalf of the President,
Janusz WOJCIECHOWSKI
Member of the Commission
<note>
( 1 ) OJ L 343, 14.12.2012, p. 1 .
( 2 ) Commission Implementing Regulation (EU) 2015/1413 of 10 August 2015 entering a name in the register of protected designations of origin and protected geographical indications (Ogulinski kiseli kupus/Ogulinsko kiselo zelje (PDO)) ( OJ L 220, 21.8.2015, p. 1 ).
( 3 ) OJ C 128, 12.4.2023, p. 11 .
</note> | ENG | 32023R1588 |
<table><col/><col/><col/><tbody><tr><td><img/></td><td><p>Official Journal<br/>of the European Union</p></td><td><p>EN</p><p>Series L</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>2023/2686</p></td><td><p>28.11.2023</p></td></tr></tbody></table>
COUNCIL DECISION (CFSP) 2023/2686
of 27 November 2023
amending certain Council Decisions concerning restrictive measures in order to insert provisions on humanitarian exceptions
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on European Union, and in particular Article 29 thereof,
Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>In its conclusions of 20 May 2021‘on the Communication from the Commission to the European Parliament and the Council on the EU’s humanitarian action: new challenges, same principles’, the Council reaffirmed its commitment to avoid and, where unavoidable, mitigate to the maximum extent any potential unintended negative impacts of Union restrictive measures on principled humanitarian action. The Council reiterated that Union restrictive measures comply with all obligations under international law, in particular international human rights law, international humanitarian law and international refugee law. It underlined the importance of fully adhering to humanitarian principles and international humanitarian law in Union sanctions policy, including through the consistent inclusion of humanitarian exceptions in Union restrictive measures regimes where relevant, and by ensuring that an effective framework is in place for the use of such exceptions by humanitarian organisations.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>On 9 December 2022, the United Nations Security Council (UNSC) adopted United Nations Security Council Resolution (UNSCR) 2664 (2022), recalling its previous resolutions imposing sanctions measures in response to threats to international peace and security, and emphasising that measures taken by United Nations Member States to implement sanctions comply with their obligations under international law and are not intended to have adverse humanitarian consequences for civilian populations or adverse consequences for humanitarian activities or those carrying them out. The UNSC decided in paragraph 1 of UNSCR 2664 (2022) that the provision, processing or payment of funds, other financial assets or economic resources or the provision of goods and services necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs by certain actors are permitted and are not a violation of the asset freezes imposed by the UNSC or its Sanctions Committees.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>On 14 February 2023, the Council adopted Decision (CFSP) 2023/338 <a>(<span>1</span>)</a>, which introduced the humanitarian exemption pursuant to UNSCR 2664 (2022) in the Union restrictive measures regimes that give effect to measures decided upon by the UNSC or its Sanctions Committees. On 31 March 2023, the Council adopted Decision (CFSP) 2023/726 <a>(<span>2</span>)</a>, which introduced the humanitarian exemption pursuant to UNSCR 2664 (2022) in the Union restrictive measures regimes that give effect to measures decided upon by the UNSC or its Sanctions Committees and in complementary measures decided upon by the Council.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>In order to increase consistency and coherence across Union restrictive measures regimes and with those adopted by the UNSC or its Sanctions Committees, and to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs, the Council considers that an exemption to asset freeze measures applicable to, and to the restrictions on making funds and economic resources available to, designated natural or legal persons and entities, for the benefit of actors referred to in UNSCR 2664 (2022), organisations and agencies to which the Union has granted the Humanitarian Partnership Certificate, organisations and agencies which are certified or recognised by a Member State, or Member States’ specialised agencies should be introduced in certain Union restrictive measures regimes. Furthermore, the Council considers that a derogation mechanism should be introduced, or an existing derogation mechanism amended, for those organisations and actors involved in humanitarian activities that cannot benefit from that exemption. The Council also considers that review clauses related to those exceptions should be introduced. In addition, the Council considers that review clauses related to the existing provisions on humanitarian exceptions should be introduced in certain other Union restrictive measures regimes.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>It is therefore necessary to amend Council Decisions 2010/638/CFSP <a>(<span>3</span>)</a>, 2011/72/CFSP <a>(<span>4</span>)</a>, 2011/101/CFSP <a>(<span>5</span>)</a>, 2011/173/CFSP <a>(<span>6</span>)</a>, 2012/642/CFSP <a>(<span>7</span>)</a>, 2013/184/CFSP <a>(<span>8</span>)</a>, 2014/145/CFSP <a>(<span>9</span>)</a>, (CFSP) 2015/1763 <a>(<span>10</span>)</a>, (CFSP) 2017/2074 <a>(<span>11</span>)</a>, (CFSP) 2019/797 <a>(<span>12</span>)</a>, (CFSP) 2019/1720 <a>(<span>13</span>)</a>, (CFSP) 2021/1277 <a>(<span>14</span>)</a>, (CFSP) 2023/891 <a>(<span>15</span>)</a> and (CFSP) 2023/1532 <a>(<span>16</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Further action by the Union is necessary to implement certain measures in this Decision,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
Decision 2010/638/CFSP is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Article 4, the following paragraphs are added:</p><div><p>‘6.   Paragraphs 1 and 2 shall not apply to the making available of funds or economic resources necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs where such assistance and other activities are carried out by:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the United Nations (UN), including its programmes, funds and other entities and bodies, as well as its specialised agencies and related organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>international organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>humanitarian organisations having observer status with the UN General Assembly and members of those humanitarian organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>bilaterally or multilaterally funded non-governmental organisations participating in the UN Humanitarian Response Plans, UN Refugee Response Plans, other UN appeals or humanitarian clusters coordinated by the UN Office for the Coordination of Humanitarian Affairs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>organisations and agencies to which the Union has granted the Humanitarian Partnership Certificate or which are certified or recognised by a Member State in accordance with national procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>Member States’ specialised agencies; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>the employees, grantees, subsidiaries or implementing partners of the entities referred to in points (a) to (f) while and to the extent that they are acting in those capacities.</p></td></tr></tbody></table></div><div><p>7.   Without prejudice to paragraph 6, and by way of derogation from paragraphs 1 and 2, the competent authorities of a Member State may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as they deem appropriate, after having determined that the provision of such funds or economic resources is necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs.</p></div><div><p>8.   In the absence of a negative decision, a request for information or a notification for additional time from the relevant competent authority within five working days of the date of receipt of a request for authorisation under paragraph 7, that authorisation shall be considered granted.</p></div><div><p>9.   The Member State concerned shall inform the other Member States and the Commission of any authorisations granted under paragraphs 7 and 8 within four weeks of such authorisation.’</p></div>;</td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in Article 8, the following paragraph is added:</p><div><p>‘3.   The exceptions referred to in Article 4(6) and (7) as regards Article 4(1) and (2) shall be reviewed at regular intervals, and at least every 12 months, or at the urgent request of any Member State, the High Representative or the Commission following a fundamental change in circumstances.’</p></div>.</td></tr></tbody></table>
Article 2
Decision 2011/72/CFSP is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Article 1, the following paragraphs are added:</p><div><p>‘6.   Paragraphs 1 and 2 shall not apply to the provision, processing or payment of funds, other financial assets or economic resources or to the provision of goods and services which are necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs where such assistance and other activities are carried out by:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the United Nations (UN), including its programmes, funds and other entities and bodies, as well as its specialised agencies and related organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>international organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>humanitarian organisations having observer status with the UN General Assembly and members of those humanitarian organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>bilaterally or multilaterally funded non-governmental organisations participating in the UN Humanitarian Response Plans, UN Refugee Response Plans, other UN appeals or humanitarian clusters coordinated by the UN Office for the Coordination of Humanitarian Affairs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>organisations and agencies to which the Union has granted the Humanitarian Partnership Certificate or which are certified or recognised by a Member State in accordance with national procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>Member States’ specialised agencies; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>the employees, grantees, subsidiaries or implementing partners of the entities referred to in points (a) to (f) while and to the extent that they are acting in those capacities.</p></td></tr></tbody></table></div><div><p>7.   Without prejudice to paragraph 6, and by way of derogation from paragraphs 1 and 2, the competent authorities of a Member State may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as they deem appropriate, after having determined that the provision of such funds or economic resources is necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs.</p></div><div><p>8.   In the absence of a negative decision, a request for information or a notification for additional time from the relevant competent authority within five working days of the date of receipt of a request for authorisation under paragraph 7, that authorisation shall be considered granted.</p></div><div><p>9.   The Member State concerned shall inform the other Member States and the Commission of any authorisations granted under paragraphs 7 and 8 within four weeks of such authorisation.’</p></div>;</td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in Article 5, the following paragraph is added:</p><div><p>‘3.   The exceptions referred to in Article 1(6) and (7) as regards Article 1(1) and (2) shall be reviewed at regular intervals, and at least every 12 months, or at the urgent request of any Member State, the High Representative or the Commission following a fundamental change in circumstances.’</p></div>.</td></tr></tbody></table>
Article 3
Decision 2011/101/CFSP is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Article 5, the following paragraphs are added:</p><div><p>‘5.   Paragraphs 1 and 2 shall not apply to the provision, processing or payment of funds, other financial assets or economic resources or to the provision of goods and services which are necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs where such assistance and other activities are carried out by:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the United Nations (UN), including its programmes, funds and other entities and bodies, as well as its specialised agencies and related organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>international organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>humanitarian organisations having observer status with the UN General Assembly and members of those humanitarian organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>bilaterally or multilaterally funded non-governmental organisations participating in the UN Humanitarian Response Plans, UN Refugee Response Plans, other UN appeals or humanitarian clusters coordinated by the UN Office for the Coordination of Humanitarian Affairs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>organisations and agencies to which the Union has granted the Humanitarian Partnership Certificate or which are certified or recognised by a Member State in accordance with national procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>Member States’ specialised agencies; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>the employees, grantees, subsidiaries or implementing partners of the entities referred to in points (a) to (f) while and to the extent that they are acting in those capacities.</p></td></tr></tbody></table></div><div><p>6.   Without prejudice to paragraph 5, and by way of derogation from paragraphs 1 and 2, the competent authorities of a Member State may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as they deem appropriate, after having determined that the provision of such funds or economic resources is necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs.</p></div><div><p>7.   In the absence of a negative decision, a request for information or a notification for additional time from the relevant competent authority within five working days of the date of receipt of a request for authorisation under paragraph 6, that authorisation shall be considered granted.</p></div><div><p>8.   The Member State concerned shall inform the other Member States and the Commission of any authorisations granted under paragraphs 6 and 7 within four weeks of such authorisation.’</p></div>;</td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in Article 10, the following paragraph is added:</p><div><p>‘4.   The exceptions referred to in Article 5(5) and (6) as regards Article 5(1) and (2) shall be reviewed at regular intervals, and at least every 12 months, or at the urgent request of any Member State, the High Representative or the Commission following a fundamental change in circumstances.’</p></div>.</td></tr></tbody></table>
Article 4
Decision 2011/173/CFSP is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Article 2, the following paragraphs are added:</p><div><p>‘7.   Paragraphs 1 and 2 shall not apply to the making available of funds or economic resources necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs where such assistance and other activities are carried out by:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the United Nations (UN), including its programmes, funds and other entities and bodies, as well as its specialised agencies and related organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>international organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>humanitarian organisations having observer status with the UN General Assembly and members of those humanitarian organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>bilaterally or multilaterally funded non-governmental organisations participating in the UN Humanitarian Response Plans, UN Refugee Response Plans, other UN appeals or humanitarian clusters coordinated by the UN Office for the Coordination of Humanitarian Affairs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>organisations and agencies to which the Union has granted the Humanitarian Partnership Certificate or which are certified or recognised by a Member State in accordance with national procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>Member States’ specialised agencies; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>the employees, grantees, subsidiaries or implementing partners of the entities referred to in points (a) to (f) while and to the extent that they are acting in those capacities.</p></td></tr></tbody></table></div><div><p>8.   Without prejudice to paragraph 7, and by way of derogation from paragraphs 1 and 2, the competent authorities of a Member State may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as they deem appropriate, after having determined that the provision of such funds or economic resources is necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs.</p></div><div><p>9.   In the absence of a negative decision, a request for information or a notification for additional time from the relevant competent authority within five working days of the date of receipt of a request for authorisation under paragraph 8, that authorisation shall be considered granted.</p></div><div><p>10.   The Member State concerned shall inform the other Member States and the Commission of any authorisations granted under paragraphs 8 and 9 within four weeks of such authorisation.’</p></div>;</td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in Article 6, the following paragraph is added:</p><p> ‘The exceptions referred to in Article 2(7) and (8) as regards Article 2(1) and (2) shall be reviewed at regular intervals, and at least every 12 months, or at the urgent request of any Member State, the High Representative or the Commission following a fundamental change in circumstances.’.</p></td></tr></tbody></table>
Article 5
In Article 8 of Decision 2012/642/CFSP, the following paragraph is added:
‘3. The exception referred to in Article 5(1)(f)(i) as regards Article 4(1) and (2) shall be reviewed at regular intervals, and at least every 12 months, or at the urgent request of any Member State, the High Representative or the Commission following a fundamental change in circumstances.’
. Article 6
Decision 2013/184/CFSP is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Article 6, the following paragraph is added:</p><div><p>‘7.   Paragraphs 1 and 2 shall not apply to the making available of funds or economic resources necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs where such assistance and other activities are carried out by:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the United Nations (UN), including its programmes, funds and other entities and bodies, as well as its specialised agencies and related organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>international organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>humanitarian organisations having observer status with the UN General Assembly and members of those humanitarian organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>bilaterally or multilaterally funded non-governmental organisations participating in the UN Humanitarian Response Plans, UN Refugee Response Plans, other UN appeals or humanitarian clusters coordinated by the UN Office for the Coordination of Humanitarian Affairs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>organisations and agencies to which the Union has granted the Humanitarian Partnership Certificate or which are certified or recognised by a Member State in accordance with national procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>Member States’ specialised agencies; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>the employees, grantees, subsidiaries or implementing partners of the entities referred to in points (a) to (f) while and to the extent that they are acting in those capacities.’</p></td></tr></tbody></table></div>;</td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Article 6a is replaced by the following:</p><div><p>‘Article 6a</p><div><p>1.   Without prejudice to Article 6(7), and by way of derogation from Article 6(1) and (2), the competent authorities of a Member State may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as they deem appropriate, after having determined that the provision of such funds or economic resources is necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs.</p></div><div><p>2.   In the absence of a negative decision, a request for information or a notification for additional time from the relevant competent authority within five working days of the date of receipt of a request for authorisation under this Article, that authorisation shall be considered granted.</p></div><div><p>3.   The Member State concerned shall inform the other Member States and the Commission of any authorisations granted under this Article within four weeks of such authorisation.’</p></div></div>;</td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>in Article 12, the following paragraph is added:</p><p> ‘The exceptions referred to in Articles 6(7) and 6a(1) as regards Article 6(1) and (2) shall be reviewed at regular intervals, and at least every 12 months, or at the urgent request of any Member State, the High Representative or the Commission following a fundamental change in circumstances’.</p></td></tr></tbody></table>
Article 7
In Article 6 of Decision 2014/145/CFSP, the following paragraph is added:
‘The exceptions referred to in Article 2(11), as regards Article 2(2), and in Article 2(12), as regards Article 2(1) and (2), shall be reviewed at regular intervals, and at least every 12 months, or at the urgent request of any Member State, the High Representative or the Commission following a fundamental change in circumstances.’.
Article 8
Decision (CFSP) 2015/1763 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Article 2, the following paragraphs are added:</p><div><p>‘7.   Paragraphs 1 and 2 shall not apply to the making available of funds or economic resources necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs where such assistance and other activities are carried out by:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the United Nations (UN), including its programmes, funds and other entities and bodies, as well as its specialised agencies and related organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>international organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>humanitarian organisations having observer status with the UN General Assembly and members of those humanitarian organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>bilaterally or multilaterally funded non-governmental organisations participating in the UN Humanitarian Response Plans, UN Refugee Response Plans, other UN appeals or humanitarian clusters coordinated by the UN Office for the Coordination of Humanitarian Affairs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>organisations and agencies to which the Union has granted the Humanitarian Partnership Certificate or which are certified or recognised by a Member State in accordance with national procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>Member States’ specialised agencies; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>the employees, grantees, subsidiaries or implementing partners of the entities referred to in points (a) to (f) while and to the extent that they are acting in those capacities.</p></td></tr></tbody></table></div><div><p>8.   Without prejudice to paragraph 7, and by way of derogation from paragraphs 1 and 2, the competent authorities of a Member State may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as they deem appropriate, after having determined that the provision of such funds or economic resources is necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs.</p></div><div><p>9.   In the absence of a negative decision, a request for information or a notification for additional time from the relevant competent authority within five working days of the date of receipt of a request for authorisation under paragraph 8, that authorisation shall be considered granted.</p></div><div><p>10.   The Member State concerned shall inform the other Member States and the Commission of any authorisations granted under paragraphs 8 and 9 within four weeks of such authorisation.’</p></div>;</td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in Article 6, the following paragraph is added:</p><p> ‘The exceptions referred to in Article 2(7) and (8) as regards Article 2(1) and (2) shall be reviewed at regular intervals, and at least every 12 months, or at the urgent request of any Member State, the High Representative or the Commission following a fundamental change in circumstances.’.</p></td></tr></tbody></table>
Article 9
Decision (CFSP) 2017/2074 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Article 7, the following paragraphs are added:</p><div><p>‘8.   Paragraphs 1, 2 and 3 shall not apply to the provision, processing or payment of funds, other financial assets or economic resources or to the provision of goods and services which are necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs where such assistance and other activities are carried out by:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the United Nations (UN), including its programmes, funds and other entities and bodies, as well as its specialised agencies and related organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>international organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>humanitarian organisations having observer status with the UN General Assembly and members of those humanitarian organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>bilaterally or multilaterally funded non-governmental organisations participating in the UN Humanitarian Response Plans, UN Refugee Response Plans, other UN appeals or humanitarian clusters coordinated by the UN Office for the Coordination of Humanitarian Affairs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>organisations and agencies to which the Union has granted the Humanitarian Partnership Certificate or which are certified or recognised by a Member State in accordance with national procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>Member States’ specialised agencies; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>the employees, grantees, subsidiaries or implementing partners of the entities referred to in points (a) to (f) while and to the extent that they are acting in those capacities.</p></td></tr></tbody></table></div><div><p>9.   Without prejudice to paragraph 8, and by way of derogation from paragraphs 1, 2 and 3, the competent authorities of a Member State may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as they deem appropriate, after having determined that the provision of such funds or economic resources is necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs.</p></div><div><p>10.   In the absence of a negative decision, a request for information or a notification for additional time from the relevant competent authority within five working days of the date of receipt of a request for authorisation under paragraph 9, that authorisation shall be considered granted.</p></div><div><p>11.   The Member State concerned shall inform the other Member States and the Commission of any authorisations granted under paragraphs 9 and 10 within four weeks of such authorisation.’</p></div>;</td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in Article 13, the following paragraph is added:</p><p> ‘The exceptions referred to in Article 7(8) and (9) as regards Article 7(1), (2) and (3) shall be reviewed at regular intervals, and at least every 12 months, or at the urgent request of any Member State, the High Representative or the Commission following a fundamental change in circumstances.’.</p></td></tr></tbody></table>
Article 10
Decision (CFSP) 2019/797 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Article 5, the following paragraphs are added:</p><div><p>‘7.   Paragraphs 1 and 2 shall not apply to the making available of funds or economic resources necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs where such assistance and other activities are carried out by:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the United Nations (UN), including its programmes, funds and other entities and bodies, as well as its specialised agencies and related organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>international organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>humanitarian organisations having observer status with the UN General Assembly and members of those humanitarian organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>bilaterally or multilaterally funded non-governmental organisations participating in the UN Humanitarian Response Plans, UN Refugee Response Plans, other UN appeals or humanitarian clusters coordinated by the UN Office for the Coordination of Humanitarian Affairs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>organisations and agencies to which the Union has granted the Humanitarian Partnership Certificate or which are certified or recognised by a Member State in accordance with national procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>Member States’ specialised agencies; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>the employees, grantees, subsidiaries or implementing partners of the entities referred to in points (a) to (f) while and to the extent that they are acting in those capacities.</p></td></tr></tbody></table></div><div><p>8.   Without prejudice to paragraph 7, and by way of derogation from paragraphs 1 and 2, the competent authorities of the Member States may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as they deem appropriate, after having determined that the provision of such funds or economic resources is necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs.</p></div><div><p>9.   In the absence of a negative decision, a request for information or a notification for additional time from the relevant competent authority within five working days of the date of receipt of a request for authorisation under paragraph 8, that authorisation shall be considered granted.</p></div><div><p>10.   The Member State concerned shall inform the other Member States and the Commission of any authorisations granted under paragraphs 8 and 9 within four weeks of such authorisation.’</p></div>;</td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in Article 10, the following paragraph is added:</p><p> ‘The exceptions referred to in Article 5(7) and (8) as regards Article 5(1) and (2) shall be reviewed at regular intervals, and at least every 12 months, or at the urgent request of any Member State, the High Representative or the Commission following a fundamental change in circumstances.’.</p></td></tr></tbody></table>
Article 11
Decision (CFSP) 2019/1720 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Article 2, the following paragraph is added:</p><div><p>‘7.   Paragraph 1 and 2 shall not apply to the making available of funds or economic resources necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs where such assistance and other activities are carried out by:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the United Nations (UN), including its programmes, funds and other entities and bodies, as well as its specialised agencies and related organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>international organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>humanitarian organisations having observer status with the UN General Assembly and members of those humanitarian organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>bilaterally or multilaterally funded non-governmental organisations participating in the UN Humanitarian Response Plans, UN Refugee Response Plans, other UN appeals or humanitarian clusters coordinated by the UN Office for the Coordination of Humanitarian Affairs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>organisations and agencies to which the Union has granted the Humanitarian Partnership Certificate or which are certified or recognised by a Member State in accordance with national procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>Member States’ specialised agencies; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>the employees, grantees, subsidiaries or implementing partners of the entities referred to in points (a) to (f) while and to the extent that they are acting in those capacities.’</p></td></tr></tbody></table></div>;</td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Article 3 is replaced by the following:</p><div><p>‘Article 3</p><div><p>1.   Without prejudice to Article 2(7), and by way of derogation from Article 2(1) and (2), the competent authorities of a Member State may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as they deem appropriate, after having determined that the provision of such funds or economic resources is necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs.</p></div><div><p>2.   In the absence of a negative decision, a request for information or a notification for additional time from the relevant competent authority within five working days of the date of receipt of a request for authorisation under this Article, that authorisation shall be considered granted.</p></div><div><p>3.   The Member State concerned shall inform the other Member States and the Commission of any authorisations granted under this Article within four weeks of such authorisation.’</p></div></div>;</td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>in Article 9, the following paragraph is added:</p><p> ‘The exceptions referred to in Article 2(7) and Article 3 as regards Article 2(1) and (2) shall be reviewed at regular intervals, and at least every 12 months, or at the urgent request of any Member State, the High Representative or the Commission following a fundamental change in circumstances.’.</p></td></tr></tbody></table>
Article 12
Decision (CFSP) 2021/1277 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Article 2, the following paragraph is added:</p><div><p>‘7.   Paragraphs 1 and 2 shall not apply to the making available of funds or economic resources necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs where such assistance and other activities are carried out by:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the United Nations (UN), including its programmes, funds and other entities and bodies, as well as its specialised agencies and related organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>international organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>humanitarian organisations having observer status with the UN General Assembly and members of those humanitarian organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>bilaterally or multilaterally funded non-governmental organisations participating in the UN Humanitarian Response Plans, UN Refugee Response Plans, other UN appeals or humanitarian clusters coordinated by the UN Office for the Coordination of Humanitarian Affairs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>organisations and agencies to which the Union has granted the Humanitarian Partnership Certificate or which are certified or recognised by a Member State in accordance with national procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>Member States’ specialised agencies; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>the employees, grantees, subsidiaries or implementing partners of the entities referred to in points (a) to (f) while and to the extent that they are acting in those capacities.’</p></td></tr></tbody></table></div>;</td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Article 3 is replaced by the following:</p><div><p>‘Article 3</p><div><p>1.   Without prejudice to Article 2(7), and by way of derogation from Article 2(1) and (2), the competent authorities of the Member States may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as they deem appropriate, after having determined that the provision of such funds or economic resources is necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs.</p></div><div><p>2.   In the absence of a negative decision, a request for information or a notification for additional time from the relevant competent authority within five working days of the date of receipt of a request for authorisation under this Article, that authorisation shall be considered granted.</p></div><div><p>3.   The Member State concerned shall inform the other Member States and the Commission of any authorisations granted under this Article within four weeks of such authorisation.’</p></div></div>;</td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>in Article 9, the following paragraph is added:</p><p> ‘The exceptions referred to in Article 2(7) and Article 3 as regards Article 2(1) and (2) shall be reviewed at regular intervals, and at least every 12 months, or at the urgent request of any Member State, the High Representative or the Commission following a fundamental change in circumstances.’.</p></td></tr></tbody></table>
Article 13
In Article 8 of Decision (CFSP) 2023/891, the following paragraph is added:
‘The exceptions referred to in Article 2(7) and (8) as regards Article 2(1) and (2) shall be reviewed at regular intervals, and at least every 12 months, or at the urgent request of any Member State, the High Representative or the Commission following a fundamental change in circumstances.’.
Article 14
In Decision (CFSP) 2023/1532, Article 10 is replaced by the following:
‘Article 10
This Decision shall apply until 27 July 2024 and shall be kept under constant review. It shall be renewed, or amended as appropriate, if the Council deems that its objectives have not been met.
The exceptions referred to in Article 3(7) and (8) as regards Article 3(1) and (2) shall be reviewed at regular intervals, and at least every 12 months, or at the urgent request of any Member State, the High Representative or the Commission following a fundamental change in circumstances.’
. Article 15
This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union .
Done at Brussels, 27 November 2023.
For the Council
The President
Y. DÍAZ PÉREZ
( 1 ) Council Decision (CFSP) 2023/338 of 14 February 2023 amending certain Council decisions and common positions concerning restrictive measures in order to insert provisions on a humanitarian exemption ( OJ L 47, 15.2.2023, p. 50 ).
( 2 ) Council Decision (CFSP) 2023/726 of 31 March 2023 amending certain Council Decisions concerning restrictive measures in order to insert provisions on a humanitarian exemption ( OJ L 94, 3.4.2023, p. 48 ).
( 3 ) Council Decision 2010/638/CFSP of 25 October 2010 concerning restrictive measures in view of the situation in Guinea ( OJ L 280, 26.10.2010, p. 10 ).
( 4 ) Council Decision 2011/72/CFSP of 31 January 2011 concerning restrictive measures directed against certain persons and entities in view of the situation in Tunisia ( OJ L 28, 2.2.2011, p. 62 ).
( 5 ) Council Decision 2011/101/CFSP of 15 February 2011 concerning restrictive measures in view of the situation in Zimbabwe ( OJ L 42, 16.2.2011, p. 6 ).
( 6 ) Council Decision 2011/173/CFSP of 21 March 2011 concerning restrictive measures in view of the situation in Bosnia and Herzegovina ( OJ L 76, 22.3.2011, p. 68 ).
( 7 ) Council Decision 2012/642/CFSP of 15 October 2012 concerning restrictive measures in view of the situation in Belarus and the involvement of Belarus in the Russian aggression against Ukraine ( OJ L 285, 17.10.2012, p. 1 ).
( 8 ) Council Decision 2013/184/CFSP of 22 April 2013 concerning restrictive measures in view of the situation in Myanmar/Burma and repealing Decision 2010/232/CFSP ( OJ L 111, 23.4.2013, p. 75 ).
( 9 ) Council Decision 2014/145/CFSP of 17 March 2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine ( OJ L 78, 17.3.2014, p. 16 ).
( 10 ) Council Decision (CFSP) 2015/1763 of 1 October 2015 concerning restrictive measures in view of the situation in Burundi ( OJ L 257, 2.10.2015, p. 37 ).
( 11 ) Council Decision (CFSP) 2017/2074 of 13 November 2017 concerning restrictive measures in view of the situation in Venezuela ( OJ L 295, 14.11.2017, p. 60 ).
( 12 ) Council Decision (CFSP) 2019/797 of 17 May 2019 concerning restrictive measures against cyber-attacks threatening the Union or its Member States ( OJ L 129 I, 17.5.2019, p. 13 ).
( 13 ) Council Decision (CFSP) 2019/1720 of 14 October 2019 concerning restrictive measures in view of the situation in Nicaragua ( OJ L 262, 15.10.2019, p. 58 ).
( 14 ) Council Decision (CFSP) 2021/1277 of 30 July 2021 concerning restrictive measures in view of the situation in Lebanon ( OJ L 277 I, 2.8.2021, p. 16 ).
( 15 ) Council Decision (CFSP) 2023/891 of 28 April 2023 concerning restrictive measures in view of actions destabilising the Republic of Moldova ( OJ L 114, 2.5.2023, p. 15 ).
( 16 ) Council Decision (CFSP) 2023/1532 of 20 July 2023 concerning restrictive measures in view of Iran’s military support to Russia’s war of aggression against Ukraine ( OJ L 186, 25.7.2023, p. 20 ).
ELI: http://data.europa.eu/eli/dec/2023/2686/oj
ISSN 1977-0677 (electronic edition) | ENG | 32023D2686 |
<table><col/><col/><col/><col/><tbody><tr><td><p>31.7.2018   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 194/27</p></td></tr></tbody></table>
COUNCIL IMPLEMENTING REGULATION (EU) 2018/1072
of 30 July 2018
implementing Regulation (EU) No 269/2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EU) No 269/2014 of 17 March 2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine ( 1 ) , and in particular Article 14(1) thereof,
Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>On 17 March 2014, the Council adopted Regulation (EU) No 269/2014.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>As part of the Union's non-recognition policy of the illegal annexation of Crimea and Sevastopol, the Council regards the construction of the Kerch Bridge as a further action undermining the territorial integrity, sovereignty and independence of Ukraine.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The construction of this bridge and its official opening, on 15 May 2018, are key symbolic steps in consolidating the Russian Federation's control over the illegally annexed Crimea and Sevastopol and further isolating the peninsula from Ukraine.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>In view of the above, additional entities should be added to the list of persons, entities and bodies subject to restrictive measures as set out in Annex I to Regulation (EU) No 269/2014.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Annex I to Regulation (EU) No 269/2014 should therefore be amended accordingly,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The entities listed in the Annex to this Regulation shall be added to the list of entities set out in Annex I to Regulation (EU) No 269/2014.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 30 July 2018.
For the Council
The President
G. BLÜMEL
( 1 ) OJ L 78, 17.3.2014, p. 6 .
ANNEX
List of entities referred to in Article 1:
<table><col/><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Name</p></td><td><p>Identifying information</p></td><td><p>Reasons</p></td><td><p>Date of Listing</p></td></tr><tr><td><p>‘42.</p></td><td><p>AO “Institute Giprostroymost — Saint-Petersburg”</p><p>АО Институт Гипростроймост – Санкт-Петербург</p></td><td><p>Address:</p><table><col/><tbody><tr><td><p>7 Yablochkova street,</p></td></tr><tr><td><p>St. Petersburg,</p></td></tr><tr><td><p>197198 Russia</p></td></tr><tr><td><p>Website: http://gpsm.ru</p></td></tr><tr><td><p>Email: office@gpsm.ru</p></td></tr></tbody></table></td><td><p>AO “Institute Giprostroymost — Saint-Petersburg” participated in the construction of the Kerch Bridge through its design of the Bridge, connecting Russia to the illegally annexed Crimean peninsula. Therefore it is supporting the consolidation of the illegally annexed Crimean peninsula into the Russian Federation, which in turn further undermines the territorial integrity, sovereignty and independence of Ukraine.</p></td><td><p>31.7.2018</p></td></tr><tr><td><p>43.</p></td><td><p>PJSC Mostotrest</p><p>ПАО Мостотрест</p></td><td><p>Address:</p><table><col/><tbody><tr><td><p>6 Barklaya street,</p></td></tr><tr><td><p>Bld. 5 Moscow,</p></td></tr><tr><td><p>121087 Russia</p></td></tr></tbody></table></td><td><p>PJSC Mostotrest actively participated in the construction of the Kerch Bridge through its state contract for the maintenance of the bridge, connecting Russia to the illegally annexed Crimean peninsula. Furthermore it is owned by an individual (Arkady Rotenberg) that is already designated for his actions undermining Ukrainian sovereignty (person No 92 in this Annex). Therefore the company is supporting the consolidation of the illegally annexed Crimean peninsula into the Russian Federation, which in turn further undermines the territorial integrity, sovereignty and independence of Ukraine.</p></td><td><p>31.7.2018</p></td></tr><tr><td><p>44.</p></td><td><p>JSC Zaliv Shipyard</p><p>Судостроительный завод “Залив”</p></td><td><p>Address:</p><table><col/><tbody><tr><td><p>4 Tankistov street,</p></td></tr><tr><td><p>298310 Kerch,</p></td></tr><tr><td><p>Crimea</p></td></tr><tr><td><p>Website: http://zalivkerch.com</p></td></tr></tbody></table></td><td><p>JSC Zaliv Shipyard actively participated in the construction of new railway to the Kerch Bridge, connecting Russia to the illegally annexed Crimean peninsula. Therefore it is supporting the consolidation of the illegally annexed Crimean peninsula into the Russian Federation, which in turn further undermines the territorial integrity, sovereignty and independence of Ukraine.</p></td><td><p>31.7.2018</p></td></tr><tr><td><p>45.</p></td><td><p>Stroygazmontazh Corporation (SGM Group)</p><p>ООО Стройгазмонтаж</p><p>(груп СГМ)</p></td><td><p>Address:</p><table><col/><tbody><tr><td><p>Prospect Vernadskogo 53</p></td></tr><tr><td><p>Moscow,</p></td></tr><tr><td><p>119415 Russia</p></td></tr><tr><td><p>Website: www.ooosgm.com</p></td></tr></tbody></table></td><td><p>Stroygazmontazh Corporation (SGM Group) actively participated in the construction of the Kerch Bridge through its state contract for the construction of the bridge connecting Russia to the illegally annexed Crimean peninsula.</p><p>Furthermore it is owned by an individual (Arkady Rotenberg) that is already designated for his actions undermining Ukrainian sovereignty (person No 92 in this Annex). Therefore the company is supporting the consolidation of the illegally annexed Crimean peninsula into the Russian Federation, which in turn further undermines the territorial integrity, sovereignty and independence of Ukraine.</p></td><td><p>31.7.2018</p></td></tr><tr><td><p>46.</p></td><td><p>Stroygazmontazh Most OOO</p><p>OOO Стройгазмонтаж-Мост</p></td><td><p>Address:</p><table><col/><tbody><tr><td><p>Barklaya street 6, building 7</p></td></tr><tr><td><p>Moscow,</p></td></tr><tr><td><p>121087 Russia</p></td></tr></tbody></table><p>Registration ID: 1157746088170</p><p>Tax ID No: 7730018980</p><p>Website: http://kerch-most.ru/tag/sgam-most</p><p>Email: kerch-most@yandex.ru</p></td><td><p>Stroygazmontazh Most OOO is a subsidiary of lead contractor Stroygazmontazh that manages the construction project of the bridge over the Kerch Strait. Furthermore it is owned by an individual (Arkady Rotenberg) that is already designated for his actions undermining Ukrainian sovereignty (person No 92 in this Annex). Therefore the company is supporting the consolidation of the illegally annexed Crimean peninsula into the Russian Federation, which in turn further undermines the territorial integrity, sovereignty and independence of Ukraine.</p></td><td><p>31.7.2018</p></td></tr><tr><td><p>47.</p></td><td><p>CJSC VAD</p><p>AKTSIONERNOE OBSHCHESTVO VAD</p><p>АО «ВАД»</p></td><td><p>Address:</p><p>133 Chernyshevskogo street, Vologda, Vologodskaya Oblast, 160019 Russia</p><p>122, Grazhdanskiy Prospect, suite 5, Liter A, St. Petersburg, 195267 Russia</p><p>Registration ID: 1037804006811 (Russia)</p><p>Tax ID No: 7802059185</p><p>Website: www.zaovad.com</p><p>Email: office@zaovad.com</p></td><td><p>CJSC VAD is the main contractor for the construction of the Tavrida Highway in Crimea, the road over the Kerch Bridge and the access roads to it. Tavrida Highway will provide transportation access to Crimea through a system of newly constructed roadways that serve as a primary connection to the Kerch Bridge. Therefore CJSC VAD is supporting the consolidation of the illegally annexed Crimean peninsula into the Russian Federation, which in turn further undermines the territorial integrity, sovereignty and independence of Ukraine.</p></td><td><p>31.7.2018’</p></td></tr></tbody></table> | ENG | 32018R1072 |
<table><col/><col/><col/><col/><tbody><tr><td><p>31.3.2020   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>C 107/229</p></td></tr></tbody></table>
Statement of revenue and expenditure of the European Maritime Safety Agency for the financial year 2019 – amending budget No 2
(2020/C 107/45)
REVENUE
<table><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Title</p><p>Chapter</p></td><td><p>Heading</p></td><td><p>Budget 2019</p></td><td><p>Amending budget No 2</p></td><td><p>New amount</p></td></tr><tr><td><p>Commitments</p></td><td><p>Payments</p></td><td><p>Commitments</p></td><td><p>Payments</p></td><td><p>Commitments</p></td><td><p>Payments</p></td></tr><tr><td><p><span>2</span></p></td><td><p><span>SUBSIDY FROM THE COMMISSION</span></p></td></tr><tr><td><p>2 0</p></td><td><p>SUBSIDY FROM THE COMMISSION</p></td><td><p>80 511 842</p></td><td><p>79 265 391</p></td><td><p> </p></td><td><p> </p></td><td><p>80 511 842</p></td><td><p>79 265 391</p></td></tr><tr><td><p>2 1</p></td><td><p>OPERATIONAL INCOME</p></td><td><p>7 398 256,16</p></td><td><p>7 398 256,16</p></td><td><p>8 881 928,66</p></td><td><p>8 882 428,66</p></td><td><p>16 280 184,82</p></td><td><p>16 280 684,82</p></td></tr><tr><td><p> </p></td><td><p><span>Title 2 — Total</span></p></td><td><p><span>87 910 098,16</span></p></td><td><p><span>86 663 647,16</span></p></td><td><p><span>8 881 928,66</span></p></td><td><p><span>8 882 428,66</span></p></td><td><p><span>96 792 026,82</span></p></td><td><p><span>95 546 075,82</span></p></td></tr><tr><td><p> </p></td><td><p><span>GRAND TOTAL</span></p></td><td><p><span>87 910 098,16</span></p></td><td><p><span>86 663 647,16</span></p></td><td><p><span>8 881 928,66</span></p></td><td><p><span>8 882 428,66</span></p></td><td><p><span>96 792 026,82</span></p></td><td><p><span>95 546 075,82</span></p></td></tr></tbody></table>
EXPENDITURE
<table><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Title</p><p>Chapter</p></td><td><p>Heading</p></td><td><p>Appropriations 2019</p></td><td><p>Amending budget No 2</p></td><td><p>New amount</p></td></tr><tr><td><p>Commitments</p></td><td><p>Payments</p></td><td><p>Commitments</p></td><td><p>Payments</p></td><td><p>Commitments</p></td><td><p>Payments</p></td></tr><tr><td><p><span>1</span></p></td><td><p><span>STAFF</span></p></td></tr><tr><td><p>1 1</p></td><td><p>STAFF IN ACTIVE EMPLOYMENT</p></td><td><p>24 670 261</p></td><td><p>24 670 261</p></td><td><p> </p></td><td><p> </p></td><td><p>24 670 261</p></td><td><p>24 670 261</p></td></tr><tr><td><p>1 2</p></td><td><p>MISCELLANEOUS EXPENDITURE ON STAFF RECRUITMENT AND TRANSFER</p></td><td><p>330 000</p></td><td><p>330 000</p></td><td><p> </p></td><td><p> </p></td><td><p>330 000</p></td><td><p>330 000</p></td></tr><tr><td><p>1 3</p></td><td><p>MISSIONS AND DUTY TRAVEL</p></td><td><p>90 000</p></td><td><p>90 000</p></td><td><p> </p></td><td><p> </p></td><td><p>90 000</p></td><td><p>90 000</p></td></tr><tr><td><p>1 4</p></td><td><p>SOCIOMEDICAL STRUCTURE</p></td><td><p>35 000</p></td><td><p>35 000</p></td><td><p> </p></td><td><p> </p></td><td><p>35 000</p></td><td><p>35 000</p></td></tr><tr><td><p>1 5</p></td><td><p>TRAINING</p></td><td><p>230 000</p></td><td><p>230 000</p></td><td><p> </p></td><td><p> </p></td><td><p>230 000</p></td><td><p>230 000</p></td></tr><tr><td><p>1 6</p></td><td><p>SOCIAL MEASURES</p></td><td><p>670 000</p></td><td><p>670 000</p></td><td><p> </p></td><td><p> </p></td><td><p>670 000</p></td><td><p>670 000</p></td></tr><tr><td><p>1 7</p></td><td><p>ENTERTAINMENT AND REPRESENTATION</p></td><td><p>22 000</p></td><td><p>22 000</p></td><td><p> </p></td><td><p> </p></td><td><p>22 000</p></td><td><p>22 000</p></td></tr><tr><td><p> </p></td><td><p><span>Title 1 — Total</span></p></td><td><p><span>26 047 261</span></p></td><td><p><span>26 047 261</span></p></td><td><p> </p></td><td><p> </p></td><td><p><span>26 047 261</span></p></td><td><p><span>26 047 261</span></p></td></tr><tr><td><p><span>2</span></p></td><td><p><span>BUILDINGS, EQUIPMENT AND MISCELLANEOUS OPERATING EXPENDITURE</span></p></td></tr><tr><td><p>2 0</p></td><td><p>RENTAL OF BUILDINGS AND ASSOCIATED COSTS</p></td><td><p>3 429 481</p></td><td><p>3 429 481</p></td><td><p>48 627,31</p></td><td><p>48 627,31</p></td><td><p>3 478 108,31</p></td><td><p>3 478 108,31</p></td></tr><tr><td><p>2 1</p></td><td><p>INFORMATION TECHNOLOGY PURCHASES</p></td><td><p>455 000</p></td><td><p>455 000</p></td><td><p>13 136,61</p></td><td><p>13 136,61</p></td><td><p>468 136,61</p></td><td><p>468 136,61</p></td></tr><tr><td><p>2 2</p></td><td><p>MOVABLE PROPERTY AND ASSOCIATED COSTS</p></td><td><p>28 000</p></td><td><p>28 000</p></td><td><p> </p></td><td><p> </p></td><td><p>28 000</p></td><td><p>28 000</p></td></tr><tr><td><p>2 3</p></td><td><p>CURRENT ADMINISTRATIVE EXPENDITURE</p></td><td><p>101 500</p></td><td><p>101 500</p></td><td><p> </p></td><td><p> </p></td><td><p>101 500</p></td><td><p>101 500</p></td></tr><tr><td><p>2 4</p></td><td><p>POSTAGE AND TELECOMMUNICATIONS</p></td><td><p>80 000</p></td><td><p>80 000</p></td><td><p>39,28</p></td><td><p>39,28</p></td><td><p>80 039,28</p></td><td><p>80 039,28</p></td></tr><tr><td><p>2 5</p></td><td><p>EXPENDITURE ON FORMAL AND OTHER MEETINGS</p></td><td><p>125 000</p></td><td><p>125 000</p></td><td><p> </p></td><td><p> </p></td><td><p>125 000</p></td><td><p>125 000</p></td></tr><tr><td><p> </p></td><td><p><span>Title 2 — Total</span></p></td><td><p><span>4 218 981</span></p></td><td><p><span>4 218 981</span></p></td><td><p><span>61 803,20</span></p></td><td><p><span>61 803,20</span></p></td><td><p><span>4 280 784,20</span></p></td><td><p><span>4 280 784,20</span></p></td></tr><tr><td><p><span>3</span></p></td><td><p><span>OPERATIONAL EXPENDITURE</span></p></td></tr><tr><td><p>3 1</p></td><td><p>INFORMATION SERVICES AND DATABASES</p></td><td><p>4 394 131</p></td><td><p>5 566 899</p></td><td><p> </p></td><td><p> </p></td><td><p>4 394 131</p></td><td><p>5 566 899</p></td></tr><tr><td><p>3 2</p></td><td><p>INFORMATION AND COMMUNICATION</p></td><td><p>145 000</p></td><td><p>145 000</p></td><td><p> </p></td><td><p> </p></td><td><p>145 000</p></td><td><p>145 000</p></td></tr><tr><td><p>3 3</p></td><td><p>OPERATIONAL WORKSHOPS AND TRAINING</p></td><td><p>1 255 060</p></td><td><p>1 080 000</p></td><td><p> </p></td><td><p> </p></td><td><p>1 255 060</p></td><td><p>1 080 000</p></td></tr><tr><td><p>3 5</p></td><td><p>STUDIES</p></td><td><p>423 070</p></td><td><p>452 910</p></td><td><p> </p></td><td><p> </p></td><td><p>423 070</p></td><td><p>452 910</p></td></tr><tr><td><p>3 6</p></td><td><p>MISSION EXPENSES LINKED TO MARITIME AFFAIRS</p></td><td><p>664 000</p></td><td><p>558 000</p></td><td><p> </p></td><td><p> </p></td><td><p>664 000</p></td><td><p>558 000</p></td></tr><tr><td><p>3 7</p></td><td><p>LONG-RANGE IDENTIFICATION AND TRACKING DATA (LRIT)</p></td><td><p>1 576 000</p></td><td><p>1 575 000</p></td><td><p>–8 828,74</p></td><td><p>–8 828,74</p></td><td><p>1 567 171,26</p></td><td><p>1 566 171,26</p></td></tr><tr><td><p>3 9</p></td><td><p>COOPERATION ON COAST GUARD FUNCTIONS</p></td><td><p>12 942 339</p></td><td><p>16 182 340</p></td><td><p> </p></td><td><p> </p></td><td><p>12 942 339</p></td><td><p>16 182 340</p></td></tr><tr><td><p> </p></td><td><p><span>Title 3 — Total</span></p></td><td><p><span>21 399 600</span></p></td><td><p><span>25 560 149</span></p></td><td><p><span>–8 828,74</span></p></td><td><p><span>–8 828,74</span></p></td><td><p><span>21 390 771,26</span></p></td><td><p><span>25 551 320,26</span></p></td></tr><tr><td><p><span>4</span></p></td><td><p><span>ANTI-POLLUTION MEASURES</span></p></td></tr><tr><td><p>4 1</p></td><td><p>POLLUTION RESPONSE SERVICES</p></td><td><p>21 800 084</p></td><td><p>15 138 193,96</p></td><td><p>312,29</p></td><td><p>312,29</p></td><td><p>21 800 396,29</p></td><td><p>15 138 506,25</p></td></tr><tr><td><p>4 2</p></td><td><p>CLEANSEANET</p></td><td><p>6 696 172,16</p></td><td><p>7 907 562,20</p></td><td><p> </p></td><td><p> </p></td><td><p>6 696 172,16</p></td><td><p>7 907 562,20</p></td></tr><tr><td><p>4 3</p></td><td><p>CO-OPERATION, CO-ORDINATION AND INFORMATION</p></td><td><p>750 000</p></td><td><p>793 500</p></td><td><p> </p></td><td><p> </p></td><td><p>750 000</p></td><td><p>793 500</p></td></tr><tr><td><p> </p></td><td><p><span>Title 4 — Total</span></p></td><td><p><span>29 246 256,16</span></p></td><td><p><span>23 839 256,16</span></p></td><td><p><span>312,29</span></p></td><td><p><span>312,29</span></p></td><td><p><span>29 246 568,45</span></p></td><td><p><span>23 839 568,45</span></p></td></tr><tr><td><p><span>5</span></p></td><td><p><span>PROJECT FINANCED ACTIONS</span></p></td></tr><tr><td><p>5 1</p></td><td><p>MARITIME INFORMATION SERVICES</p></td><td><p>2 000 000</p></td><td><p>2 000 000</p></td><td><p> </p></td><td><p> </p></td><td><p>2 000 000</p></td><td><p>2 000 000</p></td></tr><tr><td><p>5 2</p></td><td><p>ASSISTANCE TO CANDIDATE AND ENP COUNTRIES</p></td><td><p>p.m.</p></td><td><p>p.m.</p></td><td><p>1 990 662,90</p></td><td><p>1 991 162,90</p></td><td><p>1 990 662,90</p></td><td><p>1 991 162,90</p></td></tr><tr><td><p>5 3</p></td><td><p>SURVEILLANCE SERVICE LEVEL AGREEMENTS</p></td><td><p>p.m.</p></td><td><p>p.m.</p></td><td><p>1 832 013,47</p></td><td><p>1 832 013,47</p></td><td><p>1 832 013,47</p></td><td><p>1 832 013,47</p></td></tr><tr><td><p>5 4</p></td><td><p>CLEANSEANET SERVICES TO THIRD PARTIES</p></td><td><p>p.m.</p></td><td><p>p.m.</p></td><td><p> </p></td><td><p> </p></td><td><p>p.m.</p></td><td><p>p.m.</p></td></tr><tr><td><p>5 5</p></td><td><p>COPERNICUS</p></td><td><p>4 698 000</p></td><td><p>4 698 000</p></td><td><p>4 948 000</p></td><td><p>4 948 000</p></td><td><p>9 646 000</p></td><td><p>9 646 000</p></td></tr><tr><td><p>5 6</p></td><td><p>EQUASIS</p></td><td><p>300 000</p></td><td><p>300 000</p></td><td><p>200 000</p></td><td><p>200 000</p></td><td><p>500 000</p></td><td><p>500 000</p></td></tr><tr><td><p>5 7</p></td><td><p>THETIS MODULES</p></td><td><p>p.m.</p></td><td><p>p.m.</p></td><td><p>–18 451,91</p></td><td><p>–18 451,91</p></td><td><p>–18 451,91</p></td><td><p>–18 451,91</p></td></tr><tr><td><p>5 9</p></td><td><p>MISCELLANEOUS</p></td><td><p>p.m.</p></td><td><p>p.m.</p></td><td><p>– 123 582,55</p></td><td><p>– 123 582,55</p></td><td><p>– 123 582,55</p></td><td><p>– 123 582,55</p></td></tr><tr><td><p> </p></td><td><p><span>Title 5 — Total</span></p></td><td><p><span>6 998 000</span></p></td><td><p><span>6 998 000</span></p></td><td><p><span>8 828 641,91</span></p></td><td><p><span>8 829 141,91</span></p></td><td><p><span>15 826 641,91</span></p></td><td><p><span>15 827 141,91</span></p></td></tr><tr><td><p> </p></td><td><p><span>GRAND TOTAL</span></p></td><td><p><span>87 910 098,16</span></p></td><td><p><span>86 663 647,16</span></p></td><td><p><span>8 881 928,66</span></p></td><td><p><span>8 882 428,66</span></p></td><td><p><span>96 792 026,82</span></p></td><td><p><span>95 546 075,82</span></p></td></tr></tbody></table> | ENG | 32020B0331(45) |
<table><col/><col/><col/><col/><tbody><tr><td><p>19.9.2018   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 235/21</p></td></tr></tbody></table>
COUNCIL IMPLEMENTING DECISION (CFSP) 2018/1250
of 18 September 2018
implementing Decision (CFSP) 2015/1333 concerning restrictive measures in view of the situation in Libya
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on European Union, and in particular Article 31(2) thereof,
Having regard to Council Decision (CFSP) 2015/1333 of 31 July 2015 concerning restrictive measures in view of the situation in Libya, and repealing Decision 2011/137/CFSP ( 1 ) , and in particular Article 12(1) thereof,
Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>On 31 July 2015 the Council adopted Decision (CFSP) 2015/1333.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>On 11 September 2018 the United Nations Security Council (‘UNSC’) Committee established pursuant to UNSC Resolution 1970 (2011) added one person to the list of persons and entities subject to restrictive measures.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Annexes I and III to Decision (CFSP) 2015/1333 should therefore be amended accordingly,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
Annexes I and III to Decision (CFSP) 2015/1333 are amended as set out in the Annex to this Decision.
Article 2
This Decision shall enter into force on the date of its publication in the Official Journal of the European Union .
Done at Brussels, 18 September 2018.
For the Council
The President
G. BLÜMEL
( 1 ) OJ L 206, 1.8.2015, p. 34 .
ANNEX
The following person is added to the list in Annex I to Decision (CFSP) 2015/1333:
<table><col/><col/><tbody><tr><td><p>‘27.</p></td><td><span><span>Name:</span> 1: Ibrahim 2: Saeed 3: Salim 4: Jadhran</span><p><span>Title:</span> na<span>Designation:</span> Leader of armed militias<span>DOB:</span> 1982<span>POB:</span> na<span>Good quality a.k.a.:</span> na<span>Low quality a.k.a.:</span> na<span>Nationality:</span> Libya<span>Passport no:</span> na<span>National identification no:</span> na<span>Address:</span> na<span>Listed on: 11 Sept. 2018. Other information:</span> name of mother Salma Abdula Younis.Listed pursuant to paragraphs 15 and 17 of resolution 1970 (Travel Ban, Asset Freeze). INTERPOL-UN Security Council Special Notice web link: www.interpol.int/en/notice/search/un/xxxx.</p><p>Listed pursuant to paragraphs 11 (b), 11 (c) and 11 (d) of resolution 2213 (2015); paragraph 11 of resolution 2362 (2017).</p><p>Additional information:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Libya's Attorney General's Office has issued an arrest warrant against the person concerned accusing him of perpetrating a number of crimes.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The person concerned carried out armed actions and attacks against oil installations located in the oil crescent region that caused its destruction, the latest of which was on 14 June 2018.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The attacks on the crescent oil region resulted in many casualties among the inhabitants of the region and endangered the lives of civilians.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The attacks intermittently halted Libyan oil exports from 2013 to 2018, which led to significant losses for the Libyan economy.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The person concerned attempted to export oil illegally.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The person concerned recruits foreign fighters for his repeated attacks against “oil crescent” region.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The person concerned, through his actions, is working against the stability of Libya, and constitutes an obstacle in the way of the Libyan parties to resolve the political crisis and implement the United Nations Plan of Action.’</p></td></tr></tbody></table></td></tr></tbody></table>
The following person is added to the list in Annex III to Decision (CFSP) 2015/1333:
<table><col/><col/><tbody><tr><td><p>‘27.</p></td><td><span><span>Name:</span> 1: Ibrahim 2: Saeed 3: Salim 4: Jadhran</span><p><span>Title:</span> na<span>Designation:</span> Leader of armed militias<span>DOB:</span> 1982<span>POB:</span> na<span>Good quality a.k.a.:</span> na<span>Low quality a.k.a.:</span> na<span>Nationality:</span> Libya<span>Passport no:</span> na<span>National identification no:</span> na<span>Address:</span> na<span>Listed on: 11 Sept. 2018. Other information:</span> name of mother Salma Abdula Younis.Listed pursuant to paragraphs 15 and 17 of resolution 1970 (Travel Ban, Asset Freeze). INTERPOL-UN Security Council Special Notice web link: www.interpol.int/en/notice/search/un/xxxx.</p><p>Listed pursuant to paragraphs 11 (b), 11 (c) and 11 (d) of resolution 2213 (2015); paragraph 11 of resolution 2362 (2017).</p><p>Additional information:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Libya's Attorney General's Office has issued an arrest warrant against the person concerned accusing him of perpetrating a number of crimes.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The person concerned carried out armed actions and attacks against oil installations located in the oil crescent region that caused its destruction, the latest of which was on 14 June 2018.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The attacks on the crescent oil region resulted in many casualties among the inhabitants of the region and endangered the lives of civilians.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The attacks intermittently halted Libyan oil exports from 2013 to 2018, which led to significant losses for the Libyan economy.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The person concerned attempted to export oil illegally.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The person concerned recruits foreign fighters for his repeated attacks against “oil crescent” region.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The person concerned, through his actions, is working against the stability of Libya, and constitutes an obstacle in the way of the Libyan parties to resolve the political crisis and implement the United Nations Plan of Action.’</p></td></tr></tbody></table></td></tr></tbody></table> | ENG | 32018D1250 |
<table><col/><col/><col/><col/><tbody><tr><td><p>12.4.2022   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 114/179</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING DECISION (EU) 2022/601
of 8 April 2022
on the recognition of the ‘Better Biomass’ voluntary scheme for demonstrating compliance with the requirements set in Directive (EU) 2018/2001 of the European Parliament and of the Council for biofuels, bioliquids, biomass fuels, renewable liquid and gaseous fuels of non-biological origin and recycled carbon fuels
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources ( 1 ) , and in particular Article 30(4) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Directive (EU) 2018/2001 establishes requirements for certain fuels, namely biofuels, bioliquids, biomass fuels, renewable liquid and gaseous fuels of non-biological origin and recycled carbon fuels, in order to ensure that they can only be counted towards the targets set in the Directive if they have been sustainably produced and save significant greenhouse gas emissions in comparison to fossil fuels. First, Article 29 of the Directive lays down sustainability and greenhouse gas emissions saving criteria for biofuels, bioliquids, and biomass fuels, and Article 26 of the Directive and Commission Delegated Regulation (EU) 2019/807 <a>(<span>2</span>)</a> establish the criteria to determine which feedstock for biofuels, bioliquids or biomass fuels has high indirect land-use change risk, on the one hand, and which high indirect land-use change-risk biofuels, bioliquids or biomass fuels that meet certain conditions can be certified as having low indirect land-use change risk, on the other hand. Second, Article 25(2) of the Directive lays down greenhouse gas emissions saving criteria for renewable liquid and gaseous fuels of non-biological origin and recycled carbon fuels used in transport. Third, Article 28(2) of the Directive requires economic operators to enter information in a Union database on the transactions made and the sustainability characteristics of renewable fuels (biofuels, biogas and renewable liquid and gaseous fuels of non-biological origin) and recycled carbon fuels used in transport.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The Directive also provides for rules on how to calculate the contribution of renewable electricity to the transport targets. In particular, Article 27(3) of the Directive provides rules to make such calculation, both when the electricity is directly used to power electric vehicles and when is used to produce renewable liquid and gaseous fuels of non-biological origin that are used in transport.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>In order to check that compliance with the rules for biofuels, bioliquids, biomass fuels, renewable liquid and gaseous fuels of non-biological origin and recycled carbon fuels is achieved, Member States may use voluntary schemes. Voluntary schemes have played an important role in providing evidence of compliance with the sustainability and greenhouse gas emissions saving criteria for biofuels and bioliquids under Directive 2009/28/EC of the European Parliament and of the Council <a>(<span>3</span>)</a>. Under Directive (EU) 2018/2001, the role of voluntary schemes has been expanded. First, they can now serve to certify compliance of all fuels produced from biomass, including gaseous and solid fuels, with the sustainability criteria set in Directive (EU) 2018/2001, and provide accurate data on their greenhouse gas emissions saving. Second, they can serve to certify compliance of renewable liquid and gaseous transport fuels of non-biological origin and recycled carbon fuels with their greenhouse gas emissions saving criteria. Third, they can serve to prove compliance with the rules, which Article 27(3) of Directive (EU) 2018/2001 establishes to calculate renewable electricity in transport. Fourth, they can serve to prove that economic operators enter accurate information into the Union or national database on renewable fuels and recycled carbon fuels used in transport in accordance with Article 28(4) of Directive (EU) 2018/2001. Fifth, they can be used to certify biofuels, bioliquids and biomass fuels with low indirect land-use change-risk. The Commission may decide that voluntary national or international schemes can serve all or some of these purposes.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Where an economic operator provides proof of or data on compliance with the sustainability and greenhouse gas emissions saving criteria, obtained in accordance with a voluntary scheme that has been recognised by the Commission, to the extent covered by the recognition decision, a Member State should not require the supplier to provide further evidence.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The request to the Commission for recognition under Article 30(4) of the Directive from the ‘Better Biomass’ voluntary scheme was first submitted to the Commission on 19 December 2020. This request led to an assessment of the scheme by the Commission, in which some issues requiring modification were identified. In its resubmission of 2 July 2021, the scheme correctly addressed these issues. The scheme covers all feedstocks, including wastes and residues and the entire chain of custody.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>In assessing the ‘Better Biomass’ voluntary scheme, the Commission found that it covers adequately the sustainability criteria laid down in Article 29(2) to (5) while it also contains accurate data on greenhouse gas emission savings for the purpose of Article 29(10) of Directive (EU) 2018/2001 and applies a mass balance methodology in accordance with the requirements of Article 30(1) and (2) of Directive (EU) 2018/2001. This assessment does not take into account the forthcoming implementing act to be adopted in accordance with article 30(8) of Directive (EU) 2018/2001, on rules to verify sustainability and greenhouse gas emissions saving criteria and low indirect land-use change-risk criteria as well as the delegated acts to be adopted in accordance with article 28(5) of Directive (EU) 2018/2001. The ‘Better Biomass’ voluntary scheme will therefore be re-assessed when such implementing and delegated acts will be adopted.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The assessment of the ‘Better Biomass’ voluntary scheme, found that it meets adequate standards of reliability, transparency and independent auditing and also complies with the methodological requirements set out in Annexes V and VI to Directive (EU) 2018/2001.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The recognised scheme should be made available in the section devoted to voluntary schemes on the Commission’s EUROPA website.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>The measures provided for in this Decision are in accordance with the opinion of the Committee on the Sustainability of Biofuels, Bioliquids and Biomass fuels,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
The ‘Better Biomass’ voluntary scheme (‘the scheme’), submitted for recognition to the Commission on 2 July 2021, demonstrates, for the fuels audited under the scheme, the following elements:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>compliance of the consignments of biofuels, bioliquids and biomass fuels with the sustainability criteria laid down in Article 29(2) to (5) and (10) of Directive (EU) 2018/2001;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>compliance of economic operators with the obligation to enter accurate information into the Union or national database on renewable fuels and recycled carbon fuels used in transport in accordance with Article 28(4) of Directive (EU) 2018/2001.</p></td></tr></tbody></table>
The scheme also contains accurate data on greenhouse gas emission savings for the purpose of Article 29(10) of Directive (EU) 2018/2001 in as far as it ensures that all relevant information from economic operators upstream the chain of custody is transferred to the economic operators downstream the chain of custody.
Article 2
The Decision is valid for a period of 5 years after it enters into force. In the event that the contents of the scheme, as submitted for recognition to the Commission on 2 July 2021, change in a way that might affect the basis of this Decision, such changes shall be notified to the Commission without delay. The Commission shall assess the notified changes with a view to establishing whether the scheme still adequately covers the sustainability criteria for which it is recognised.
Article 3
The Commission may repeal this Decision, inter alia, under the following circumstances:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>if it has been clearly demonstrated that the scheme has not implemented elements considered to be important for this Decision or if severe and structural breach of those elements has occurred;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>if the scheme fails to submit annual reports to the Commission pursuant to Article 30(5) of Directive (EU) 2018/2001;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>if the scheme fails to implement standards of independent auditing and other requirements specified in implementing acts referred to in Article 30(8) of Directive (EU) 2018/2001 or improvements to other elements of the scheme considered to be important for a continued recognition.</p></td></tr></tbody></table>
Article 4
This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union .
Done at Brussels, 8 April 2022.
For the Commission
The President
Ursula VON DER LEYEN
<note>
( 1 ) OJ L 328, 21.12.2018, p. 82 .
( 2 ) Commission Delegated Regulation (EU) 2019/807 of 13 March 2019 supplementing Directive (EU) 2018/2001 of the European Parliament and of the Council as regards the determination of high indirect land-use change-risk feedstock for which a significant expansion of the production area into land with high carbon stock is observed and the certification of low indirect land-use change-risk biofuels, bioliquids and biomass fuels ( OJ L 133, 21.5.2019, p. 1 ).
( 3 ) Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC ( OJ L 140, 5.6.2009, p. 16 ).
</note> | ENG | 32022D0601 |
<table><col/><col/><col/><col/><tbody><tr><td><p>11.12.2020   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 417/164</p></td></tr></tbody></table>
DECISION (EU) 2020/1885 OF THE EUROPEAN PARLIAMENT
of 13 May 2020
on discharge in respect of the implementation of the general budget of the European Union for the financial year 2018, Section IX — European Data Protection Supervisor
THE EUROPEAN PARLIAMENT,
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the general budget of the European Union for the financial year 2018 <a>(<span>1</span>)</a>,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the consolidated annual accounts of the European Union for the financial year 2018 (COM(2019) 316 — C9-0058/2019) <a>(<span>2</span>)</a>,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the European Data Protection Supervisor’s annual report to the discharge authority on internal audits carried out in 2018,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the Court of Auditors’ annual report on the implementation of the budget concerning the financial year 2018, together with the institutions’ replies <a>(<span>3</span>)</a>,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the statement of assurance <a>(<span>4</span>)</a> as to the reliability of the accounts and the legality and regularity of the underlying transactions provided by the Court of Auditors for the financial year 2018, pursuant to Article 287 of the Treaty on the Functioning of the European Union,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Article 314(10) and Articles 317, 318 and 319 of the Treaty on the Functioning of the European Union,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 <a>(<span>5</span>)</a>, and in particular Articles 55, 99, 164, 165 and 166 thereof,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 <a>(<span>6</span>)</a>, and in particular Articles 59, 118, 260, 261 and 262 thereof,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Rule 100 of and Annex V to its Rules of Procedure,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the opinion of the Committee on Civil Liberties, Justice and Home Affairs,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the report of the Committee on Budgetary Control (A9-0029/2020),</p></td></tr></tbody></table>
1. Grants the European Data Protection Supervisor discharge in respect of the implementation of the budget of the European Data Protection Supervisor for the financial year 2018;
2. Sets out its observations in the resolution below;
3. Instructs its President to forward this decision and the resolution forming an integral part of it to the European Data Protection Supervisor, the European Council, the Council, the Commission, the Court of Justice of the European Union, the Court of Auditors, the European Ombudsman and the European External Action Service, and to arrange for their publication in the Official Journal of the European Union (L series).
The President
David Maria SASSOLI
The Secretary-General
Klaus WELLE
<note>
( 1 ) OJ L 57, 28.2.2018 .
( 2 ) OJ C 327, 30.9.2019, p. 1 .
( 3 ) OJ C 340, 8.10.2019, p. 1 .
( 4 ) OJ C 340, 8.10.2019, p. 9 .
( 5 ) OJ L 298, 26.10.2012, p. 1 .
( 6 ) OJ L 193, 30.7.2018, p. 1 .
</note> | ENG | 32020B1885 |
<table><col/><col/><col/><col/><tbody><tr><td><p>29.10.2014   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 308/114</p></td></tr></tbody></table>
COMMISSION DECISION
of 27 October 2014
determining, pursuant to Directive 2003/87/EC of the European Parliament and of the Council, a list of sectors and subsectors which are deemed to be exposed to a significant risk of carbon leakage, for the period 2015 to 2019
(notified under document C(2014) 7809)
(Text with EEA relevance)
(2014/746/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC ( 1 ) , and in particular Article 10a(13) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Directive 2003/87/EC provides that auctioning should be the basic principle for allocation of greenhouse gas emission allowances to operators of installations within the scope of the Emission Trading System of the Union (‘EU ETS’) from 2013 onwards. However, eligible operators continue to receive free allowances between 2013 and 2020 in accordance with the rules set out in Directive 2003/87/EC and Commission Decision 2011/278/EU<a> (<span>2</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The absence of an ambitious international agreement on climate change aiming to limit the global temperature increase to 2 °C could undermine the benefit of actions carried out by the Union. The absence of binding action at the international level could lead to an increase in greenhouse gas emissions in third countries where industry is not subject to comparable carbon constraints (‘carbon leakage’). To address this risk of carbon leakage, Directive 2003/87/EC provides that, subject to the outcome of the international negotiations, the Commission is to determine a list of sectors and subsectors deemed to be exposed to a significant risk of carbon leakage (‘list of sectors and subsectors’). Those sectors and subsectors should receive free allowances at 100 % of the quantity determined on the basis of Directive 2003/87/EC and Decision 2011/278/EU, subject to the cross-sectoral correction factor referred to in Article 10a(5) of Directive 2003/87/EC and set out in Annex II to Commission Decision 2013/448/EU<a> (<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>In this respect, the Commission analysed the extent to which third countries representing a decisive share of global production of products in sectors and subsectors on the carbon leakage list firmly commit to reducing greenhouse gas emissions in those relevant sectors, and whether those commitments are comparable with those of the Union and are carried out within the same time-frame. In addition, the extent to which the efficiency of the installations located in those countries is comparable to the installations located in the Union was also examined. The Commission concluded that no sufficient comparability can be established on the commitment to reduce greenhouse gas emissions, and therefore the comparability of carbon efficiency is not relevant.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The first list of sectors and subsectors deemed to be exposed to a significant risk of carbon leakage was established for 2013 and 2014 by Commission Decision 2010/2/EU<a> (<span>4</span>)</a> in 2009.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The assessment should be based on a number of quantitative and qualitative criteria, and based on data from the three most recent years. In this regard, the Commission used data from the years 2009, 2010 and 2011, since data from 2012 were available for only some of the parameters.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>In order to establish the list of sectors and subsectors, the Commission assessed the risk of carbon leakage of sectors and subsectors at NACE-4 level of the Statistical classification of economic activities in the Union in accordance with Regulation (EC) No 1893/2006 of the European Parliament and of the Council<a> (<span>5</span>)</a>. NACE-4 is the level with optimal data availability defining sectors precisely. A sector is denoted at a 4-digit level of the NACE classification, and a subsector is denoted at CPA (6-digit) or Prodcom (8-digit) level, that is, the classification of goods used for statistics on industrial production in the Union, following directly from the NACE classification.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The sectors were first assessed on the basis of the quantitative criteria set out in Article 10a(15) and (16) of Directive 2003/87/EC. To apply those quantitative criteria, the Commission had to determine the sum of direct and indirect additional costs induced by the implementation of Directive 2003/87/EC.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The direct additional costs, induced by the quantity of allowances that a sector would need to purchase if not deemed to be exposed to a significant risk of carbon leakage, were calculated on the basis of the data on direct CO<span>2</span> emissions at sectoral level. The data in the European Union Transaction Log (‘EUTL’) are considered to be the most accurate and transparent source of CO<span>2</span> emissions data at installation level and have therefore been used to calculate the direct cost for sectors. For sectors and greenhouse gases only covered by the EU ETS from 1 January 2013, there are no emissions data in the EUTL available. Therefore, the Commission used the data on direct CO<span>2</span> emissions provided by Member States in the National Implementation Measures (NIMs) pursuant to Decision 2011/278/EU in those cases.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>In order to determine the indirect additional costs, the Commission collected data on electricity consumption at sectoral level from Member States, ensuring that no double counting of electricity consumed occurred between different NACE codes. To determine the emissions related to the production of electricity consumed by the different sectors for the list of sectors and subsectors in Decision 2010/2/EU, the Commission used the average emission factor derived from the total fuel mix for electricity production as it was considered to be based on the most accurate data. The same average emission factor has been used for the assessments underlying this Decision.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>Furthermore, to determine the direct and indirect additional costs, the Commission had to estimate the average carbon price. In order to establish the first list of sectors and subsectors an assumed carbon price of EUR 30 per tonne of CO<span>2</span> equivalent was used for the assessments. In the period of application of Decision 2010/2/EU, there has been a substantial difference between the carbon price assumed for the assessments and the actual carbon price, the latter one being considerably lower. However, the Commission has in its Communication entitled ‘A policy framework for the climate and energy in the period from 2020 to 2030’<a> (<span>6</span>)</a> proposed a 40 % unconditional greenhouse gas emission reduction target by 2030 as compared to 1990 and a corresponding renewable energy sources target. The Commission has also proposed to establish a market stability reserve in the EU ETS. Under those circumstances, it is expected that the carbon price will in the future be more strongly driven by mid- and long-term emission reductions. It is therefore considered justified to continue using an assumed carbon price of EUR 30 per tonne of CO<span>2</span> equivalent for the assessments underlying this Decision.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>The direct and indirect additional costs should be calculated as a share of gross value added. Regarding the estimation of gross value added at sectoral level, data from the Eurostat Structural Business Statistics have been used.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>Furthermore, the Commission assessed the trade intensity for each sector and subsector on the basis of data obtained from the Eurostat Comext database.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>In total, the Commission assessed 245 industrial sectors and 24 subsectors classified under the ‘Mining and quarrying’ and ‘Manufacturing’ divisions of the NACE classification. The sectors and subsectors listed in point 1 of the Annex to this Decision meet the criteria set out in Article 10a(15) and (16) of Directive 2003/87/EC and should be deemed as exposed to a significant risk of carbon leakage.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>Assessments based on the qualitative criteria set out in Article 10a(17) of Directive 2003/87/EC have been carried out on a number of sectors that were not deemed to be exposed to the risk of carbon leakage based on the quantitative criteria set out in Article 10a(15) and (16). The qualitative assessment was carried out in cases which met the qualitative criteria in the context of the determination of the previous list, in cases of sectors considered to be borderline, and on request by industry representatives.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>In the case of the sectors ‘Finishing of textiles’ (NACE code 1330), ‘Manufacture of bricks, tiles and construction products, in baked clay’ (NACE code 2332), ‘Manufacture of plaster products for construction purposes’ (NACE code 2362), ‘Casting of iron’ (NACE code 2451) and ‘Casting of light metals’ (2453), the qualitative assessments carried out in the context of the determination of the previous list of sectors and subsectors, valid for 2013 and 2014, have been updated. It was concluded that the circumstances justifying the addition of those sectors to the list of sectors and subsectors still prevail. Therefore, those sectors should be deemed as exposed to a significant risk of carbon leakage also for the period 2015 to 2019.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(16)</p></td><td><p>A qualitative assessment was carried out for the sector ‘Manufacture of malt’ (NACE code 1106), as this sector represented a borderline case with regard to Article 10a(16b) of Directive 2003/87/EC. Taking into account the increased cost resulting from the implementation of Directive 2003/87/EC, the assessment demonstrated high trade intensity and a significant drop in the profitability of the sector in the Union. The low profit margins limit the capacity of installations to invest and reduce emissions. Based on the combined impact of those factors, the sector should be deemed as exposed to a significant risk of carbon leakage.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(17)</p></td><td><p>The sectors listed in point 2 of the Annex should be deemed as exposed to a significant risk of carbon leakage on the basis of the qualitative criteria.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(18)</p></td><td><p>As the list of sectors and subsectors which are deemed to be exposed to a significant risk of carbon leakage to be laid down in the Annex is to be valid for the period from 2015 to 2019, this Decision should apply from 1 January 2015.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(19)</p></td><td><p>For reasons of legal certainty and clarity, Decision 2010/2/EU should be repealed with effect from 1 January 2015.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(20)</p></td><td><p>The measures provided for in this Decision are in accordance with the opinion of the Climate Change Committee,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
The sectors and subsectors listed in the Annex shall be deemed to be exposed to a significant risk of carbon leakage.
Article 2
Decision 2010/2/EU is repealed with effect from 1 January 2015.
Article 3
This Decision shall apply from 1 January 2015.
Article 4
This Decision is addressed to the Member States.
Done at Brussels, 27 October 2014.
For the Commission
Connie HEDEGAARD
Member of the Commission
( 1 ) OJ L 275, 25.10.2013, p. 32 .
( 2 ) Commission Decision 2011/278/EU of 27 April 2011 determining transitional Union-wide rules for harmonised free allocation of emission allowances pursuant to Article 10a of Directive 2003/87/EC of the European Parliament and of the Council ( OJ L 130, 17.5.2011, p. 1 ).
( 3 ) Commission Decision 2013/448/EU of 5 September 2013 concerning national implementation measures for the transitional free allocation of greenhouse gas emission allowances in accordance with Article 11(3) of Directive 2003/87/EC of the European Parliament and of the Council ( OJ L 240, 7.9.2013, p. 27 ).
( 4 ) Commission Decision 2010/2/EU of 24 December 2009 determining, pursuant to Directive 2003/87/EC of the European Parliament and of the Council, a list of sectors and subsectors which are deemed to be exposed to a significant risk of carbon leakage ( OJ L 1, 5.1.2010, p. 10 ).
( 5 ) Regulation (EC) No 1893/2006 of the European Parliament and of the Council of 20 December 2006 establishing the statistical classification of economic activities NACE Revision 2 and amending Council Regulation (EEC) No 3037/90 as well as certain EC Regulations on specific statistical domains ( OJ L 393, 30.12.2006, p. 1 ).
( 6 ) COM(2014)15 final/2 of 28 January 2014.
ANNEX
Sectors and subsectors which, pursuant to Article 10a(13) of Directive 2003/87/EC, are deemed to be exposed to a significant risk of carbon leakage
1. BASED ON THE CRITERIA SET OUT IN ARTICLE 10a(15) AND (16) OF DIRECTIVE 2003/87/EC
1.1. At the NACE-4 level
<table><col/><col/><col/><tbody><tr><td><p>NACE Code</p></td><td><p>Description</p></td><td><p>Criteria met</p></td></tr><tr><td><p>0510</p></td><td><p>Mining of hard coal</p></td><td><p>C</p></td></tr><tr><td><p>0610</p></td><td><p>Extraction of crude petroleum</p></td><td><p>C</p></td></tr><tr><td><p>0620</p></td><td><p>Extraction of natural gas</p></td><td><p>C</p></td></tr><tr><td><p>0710</p></td><td><p>Mining of iron ores</p></td><td><p>C</p></td></tr><tr><td><p>0729</p></td><td><p>Mining of other non-ferrous metal ores</p></td><td><p>C</p></td></tr><tr><td><p>0891</p></td><td><p>Mining of chemical and fertiliser minerals</p></td><td><p>C</p></td></tr><tr><td><p>0893</p></td><td><p>Extraction of salt</p></td><td><p>A</p></td></tr><tr><td><p>0899</p></td><td><p>Other mining and quarrying n.e.c.</p></td><td><p>A, C</p></td></tr><tr><td><p>1020</p></td><td><p>Processing and preserving of fish, crustaceans and molluscs</p></td><td><p>C</p></td></tr><tr><td><p>1041</p></td><td><p>Manufacture of oils and fats</p></td><td><p>C</p></td></tr><tr><td><p>1062</p></td><td><p>Manufacture of starches and starch products</p></td><td><p>A</p></td></tr><tr><td><p>1081</p></td><td><p>Manufacture of sugar</p></td><td><p>A</p></td></tr><tr><td><p>1086</p></td><td><p>Manufacture of homogenised food preparations and dietetic food</p></td><td><p>C</p></td></tr><tr><td><p>1101</p></td><td><p>Distilling, rectifying and blending of spirits</p></td><td><p>C</p></td></tr><tr><td><p>1102</p></td><td><p>Manufacture of wine from grape</p></td><td><p>C</p></td></tr><tr><td><p>1104</p></td><td><p>Manufacture of other non-distilled fermented beverages</p></td><td><p>A</p></td></tr><tr><td><p>1310</p></td><td><p>Preparation and spinning of textile fibres</p></td><td><p>C</p></td></tr><tr><td><p>1320</p></td><td><p>Weaving of textiles</p></td><td><p>C</p></td></tr><tr><td><p>1391</p></td><td><p>Manufacture of knitted and crocheted fabrics</p></td><td><p>C</p></td></tr><tr><td><p>1392</p></td><td><p>Manufacture of made-up textile articles, except apparel</p></td><td><p>C</p></td></tr><tr><td><p>1393</p></td><td><p>Manufacture of carpets and rugs</p></td><td><p>C</p></td></tr><tr><td><p>1394</p></td><td><p>Manufacture of cordage, rope, twine and netting</p></td><td><p>C</p></td></tr><tr><td><p>1395</p></td><td><p>Manufacture of non-wovens and articles made from non-wovens, except apparel</p></td><td><p>C</p></td></tr><tr><td><p>1396</p></td><td><p>Manufacture of other technical and industrial textiles</p></td><td><p>C</p></td></tr><tr><td><p>1399</p></td><td><p>Manufacture of other textiles n.e.c.</p></td><td><p>C</p></td></tr><tr><td><p>1411</p></td><td><p>Manufacture of leather clothes</p></td><td><p>C</p></td></tr><tr><td><p>1412</p></td><td><p>Manufacture of workwear</p></td><td><p>C</p></td></tr><tr><td><p>1413</p></td><td><p>Manufacture of other outerwear</p></td><td><p>C</p></td></tr><tr><td><p>1414</p></td><td><p>Manufacture of underwear</p></td><td><p>C</p></td></tr><tr><td><p>1419</p></td><td><p>Manufacture of other wearing apparel and accessories</p></td><td><p>C</p></td></tr><tr><td><p>1420</p></td><td><p>Manufacture of articles of fur</p></td><td><p>C</p></td></tr><tr><td><p>1431</p></td><td><p>Manufacture of knitted and crocheted hosiery</p></td><td><p>C</p></td></tr><tr><td><p>1439</p></td><td><p>Manufacture of other knitted and crocheted apparel</p></td><td><p>C</p></td></tr><tr><td><p>1511</p></td><td><p>Tanning and dressing of leather; dressing and dyeing of fur</p></td><td><p>C</p></td></tr><tr><td><p>1512</p></td><td><p>Manufacture of luggage, handbags and the like, saddlery and harness</p></td><td><p>C</p></td></tr><tr><td><p>1520</p></td><td><p>Manufacture of footwear</p></td><td><p>C</p></td></tr><tr><td><p>1622</p></td><td><p>Manufacture of assembled parquet floors</p></td><td><p>C</p></td></tr><tr><td><p>1629</p></td><td><p>Manufacture of other products of wood; manufacture of articles of cork, straw and plaiting materials</p></td><td><p>C</p></td></tr><tr><td><p>1711</p></td><td><p>Manufacture of pulp</p></td><td><p>A, C</p></td></tr><tr><td><p>1712</p></td><td><p>Manufacture of paper and paperboard</p></td><td><p>A</p></td></tr><tr><td><p>1724</p></td><td><p>Manufacture of wallpaper</p></td><td><p>C</p></td></tr><tr><td><p>1910</p></td><td><p>Manufacture of coke oven products</p></td><td><p>A, C</p></td></tr><tr><td><p>1920</p></td><td><p>Manufacture of refined petroleum products</p></td><td><p>A</p></td></tr><tr><td><p>2012</p></td><td><p>Manufacture of dyes and pigments</p></td><td><p>C</p></td></tr><tr><td><p>2013</p></td><td><p>Manufacture of other inorganic basic chemicals</p></td><td><p>A, C</p></td></tr><tr><td><p>2014</p></td><td><p>Manufacture of other organic basic chemicals</p></td><td><p>A, C</p></td></tr><tr><td><p>2015</p></td><td><p>Manufacture of fertilisers and nitrogen compounds</p></td><td><p>A, B</p></td></tr><tr><td><p>2016</p></td><td><p>Manufacture of plastics in primary forms</p></td><td><p>C</p></td></tr><tr><td><p>2017</p></td><td><p>Manufacture of synthetic rubber in primary forms</p></td><td><p>C</p></td></tr><tr><td><p>2020</p></td><td><p>Manufacture of pesticides and other agrochemical products</p></td><td><p>C</p></td></tr><tr><td><p>2042</p></td><td><p>Manufacture of perfumes and toilet preparations</p></td><td><p>C</p></td></tr><tr><td><p>2053</p></td><td><p>Manufacture of essential oils</p></td><td><p>C</p></td></tr><tr><td><p>2059</p></td><td><p>Manufacture of other chemical products n.e.c.</p></td><td><p>C</p></td></tr><tr><td><p>2060</p></td><td><p>Manufacture of man-made fibres</p></td><td><p>C</p></td></tr><tr><td><p>2110</p></td><td><p>Manufacture of basic pharmaceutical products</p></td><td><p>C</p></td></tr><tr><td><p>2120</p></td><td><p>Manufacture of pharmaceutical preparations</p></td><td><p>C</p></td></tr><tr><td><p>2211</p></td><td><p>Manufacture of rubber tyres and tubes; retreading and rebuilding of rubber tyres</p></td><td><p>C</p></td></tr><tr><td><p>2219</p></td><td><p>Manufacture of other rubber products</p></td><td><p>C</p></td></tr><tr><td><p>2311</p></td><td><p>Manufacture of flat glass</p></td><td><p>A</p></td></tr><tr><td><p>2313</p></td><td><p>Manufacture of hollow glass</p></td><td><p>A</p></td></tr><tr><td><p>2314</p></td><td><p>Manufacture of glass fibres</p></td><td><p>A/C<a> (<span>1</span>)</a></p></td></tr><tr><td><p>2319</p></td><td><p>Manufacture and processing of other glass, including technical glassware</p></td><td><p>C</p></td></tr><tr><td><p>2320</p></td><td><p>Manufacture of refractory products</p></td><td><p>C</p></td></tr><tr><td><p>2331</p></td><td><p>Manufacture of ceramic tiles and flags</p></td><td><p>A, C</p></td></tr><tr><td><p>2341</p></td><td><p>Manufacture of ceramic household and ornamental articles</p></td><td><p>C</p></td></tr><tr><td><p>2342</p></td><td><p>Manufacture of ceramic sanitary fixtures</p></td><td><p>C</p></td></tr><tr><td><p>2343</p></td><td><p>Manufacture of ceramic insulators and insulating fittings</p></td><td><p>C</p></td></tr><tr><td><p>2344</p></td><td><p>Manufacture of other technical ceramic products</p></td><td><p>C</p></td></tr><tr><td><p>2349</p></td><td><p>Manufacture of other ceramic products</p></td><td><p>C</p></td></tr><tr><td><p>2351</p></td><td><p>Manufacture of cement</p></td><td><p>B</p></td></tr><tr><td><p>2352</p></td><td><p>Manufacture of lime and plaster</p></td><td><p>B</p></td></tr><tr><td><p>2370</p></td><td><p>Cutting, shaping and finishing of stone</p></td><td><p>C</p></td></tr><tr><td><p>2391</p></td><td><p>Production of abrasive products</p></td><td><p>C</p></td></tr><tr><td><p>2410</p></td><td><p>Manufacture of basic iron and steel and of ferro-alloys</p></td><td><p>A</p></td></tr><tr><td><p>2420</p></td><td><p>Manufacture of tubes, pipes, hollow profiles and related fittings, of steel</p></td><td><p>C</p></td></tr><tr><td><p>2431</p></td><td><p>Cold drawing of bars</p></td><td><p>C</p></td></tr><tr><td><p>2441</p></td><td><p>Precious metals production</p></td><td><p>C</p></td></tr><tr><td><p>2442</p></td><td><p>Aluminium production</p></td><td><p>A, C</p></td></tr><tr><td><p>2443</p></td><td><p>Lead, zinc and tin production</p></td><td><p>A</p></td></tr><tr><td><p>2444</p></td><td><p>Copper production</p></td><td><p>C</p></td></tr><tr><td><p>2445</p></td><td><p>Other non-ferrous metal production</p></td><td><p>C</p></td></tr><tr><td><p>2446</p></td><td><p>Processing of nuclear fuel</p></td><td><p>A, C</p></td></tr><tr><td><p>2540</p></td><td><p>Manufacture of weapons and ammunition</p></td><td><p>C</p></td></tr><tr><td><p>2571</p></td><td><p>Manufacture of cutlery</p></td><td><p>C</p></td></tr><tr><td><p>2572</p></td><td><p>Manufacture of locks and hinges</p></td><td><p>C</p></td></tr><tr><td><p>2573</p></td><td><p>Manufacture of tools</p></td><td><p>C</p></td></tr><tr><td><p>2594</p></td><td><p>Manufacture of fasteners and screw machine products</p></td><td><p>C</p></td></tr><tr><td><p>2599</p></td><td><p>Manufacture of other fabricated metal products n.e.c.</p></td><td><p>C</p></td></tr><tr><td><p>2611</p></td><td><p>Manufacture of electronic components</p></td><td><p>C</p></td></tr><tr><td><p>2612</p></td><td><p>Manufacture of loaded electronic boards</p></td><td><p>C</p></td></tr><tr><td><p>2620</p></td><td><p>Manufacture of computers and peripheral equipment</p></td><td><p>C</p></td></tr><tr><td><p>2630</p></td><td><p>Manufacture of communication equipment</p></td><td><p>C</p></td></tr><tr><td><p>2640</p></td><td><p>Manufacture of consumer electronics</p></td><td><p>C</p></td></tr><tr><td><p>2651</p></td><td><p>Manufacture of instruments and appliances for measuring, testing and navigation</p></td><td><p>C</p></td></tr><tr><td><p>2652</p></td><td><p>Manufacture of watches and clocks</p></td><td><p>C</p></td></tr><tr><td><p>2660</p></td><td><p>Manufacture of irradiation, electromedical and electrotherapeutic equipment</p></td><td><p>C</p></td></tr><tr><td><p>2670</p></td><td><p>Manufacture of optical instruments and photographic equipment</p></td><td><p>C</p></td></tr><tr><td><p>2680</p></td><td><p>Manufacture of magnetic and optical media</p></td><td><p>C</p></td></tr><tr><td><p>2711</p></td><td><p>Manufacture of electric motors, generators and transformers</p></td><td><p>C</p></td></tr><tr><td><p>2712</p></td><td><p>Manufacture of electricity distribution and control apparatus</p></td><td><p>C</p></td></tr><tr><td><p>2720</p></td><td><p>Manufacture of batteries and accumulators</p></td><td><p>C</p></td></tr><tr><td><p>2731</p></td><td><p>Manufacture of fibre optic cables</p></td><td><p>C</p></td></tr><tr><td><p>2732</p></td><td><p>Manufacture of other electronic and electric wires and cables</p></td><td><p>C</p></td></tr><tr><td><p>2733</p></td><td><p>Manufacture of wiring devices</p></td><td><p>C</p></td></tr><tr><td><p>2740</p></td><td><p>Manufacture of electric lighting equipment</p></td><td><p>C</p></td></tr><tr><td><p>2751</p></td><td><p>Manufacture of electric domestic appliances</p></td><td><p>C</p></td></tr><tr><td><p>2752</p></td><td><p>Manufacture of non-electric domestic appliances</p></td><td><p>C</p></td></tr><tr><td><p>2790</p></td><td><p>Manufacture of other electrical equipment</p></td><td><p>C</p></td></tr><tr><td><p>2811</p></td><td><p>Manufacture of engines and turbines, except aircraft, vehicle and cycle engines</p></td><td><p>C</p></td></tr><tr><td><p>2812</p></td><td><p>Manufacture of fluid power equipment</p></td><td><p>C</p></td></tr><tr><td><p>2813</p></td><td><p>Manufacture of other pumps and compressors</p></td><td><p>C</p></td></tr><tr><td><p>2814</p></td><td><p>Manufacture of other taps and valves</p></td><td><p>C</p></td></tr><tr><td><p>2815</p></td><td><p>Manufacture of bearings, gears, gearing and driving elements</p></td><td><p>C</p></td></tr><tr><td><p>2821</p></td><td><p>Manufacture of ovens, furnaces and furnace burners</p></td><td><p>C</p></td></tr><tr><td><p>2822</p></td><td><p>Manufacture of lifting and handling equipment</p></td><td><p>C</p></td></tr><tr><td><p>2823</p></td><td><p>Manufacture of office machinery and equipment (except computers and peripheral equipment)</p></td><td><p>C</p></td></tr><tr><td><p>2824</p></td><td><p>Manufacture of power-driven hand tools</p></td><td><p>C</p></td></tr><tr><td><p>2825</p></td><td><p>Manufacture of non-domestic cooling and ventilation equipment</p></td><td><p>C</p></td></tr><tr><td><p>2829</p></td><td><p>Manufacture of other general-purpose machinery n.e.c.</p></td><td><p>C</p></td></tr><tr><td><p>2830</p></td><td><p>Manufacture of agricultural and forestry machinery</p></td><td><p>C</p></td></tr><tr><td><p>2841</p></td><td><p>Manufacture of metal forming machinery</p></td><td><p>C</p></td></tr><tr><td><p>2849</p></td><td><p>Manufacture of other machine tools</p></td><td><p>C</p></td></tr><tr><td><p>2891</p></td><td><p>Manufacture of machinery for metallurgy</p></td><td><p>C</p></td></tr><tr><td><p>2892</p></td><td><p>Manufacture of machinery for mining, quarrying and construction</p></td><td><p>C</p></td></tr><tr><td><p>2893</p></td><td><p>Manufacture of machinery for food, beverage and tobacco processing</p></td><td><p>C</p></td></tr><tr><td><p>2894</p></td><td><p>Manufacture of machinery for textile, apparel and leather production</p></td><td><p>C</p></td></tr><tr><td><p>2895</p></td><td><p>Manufacture of machinery for paper and paperboard production</p></td><td><p>C</p></td></tr><tr><td><p>2896</p></td><td><p>Manufacture of plastic and rubber machinery</p></td><td><p>C</p></td></tr><tr><td><p>2899</p></td><td><p>Manufacture of other special-purpose machinery n.e.c.</p></td><td><p>C</p></td></tr><tr><td><p>2910</p></td><td><p>Manufacture of motor vehicles</p></td><td><p>C</p></td></tr><tr><td><p>2931</p></td><td><p>Manufacture of electrical and electronic equipment for motor vehicles</p></td><td><p>C</p></td></tr><tr><td><p>3011</p></td><td><p>Building of ships and floating structures</p></td><td><p>C</p></td></tr><tr><td><p>3012</p></td><td><p>Building of pleasure and sporting boats</p></td><td><p>C</p></td></tr><tr><td><p>3030</p></td><td><p>Manufacture of air and spacecraft and related machinery</p></td><td><p>C</p></td></tr><tr><td><p>3091</p></td><td><p>Manufacture of motorcycles</p></td><td><p>C</p></td></tr><tr><td><p>3092</p></td><td><p>Manufacture of bicycles and invalid carriages</p></td><td><p>C</p></td></tr><tr><td><p>3099</p></td><td><p>Manufacture of other transport equipment n.e.c.</p></td><td><p>C</p></td></tr><tr><td><p>3109</p></td><td><p>Manufacture of other furniture</p></td><td><p>C</p></td></tr><tr><td><p>3211</p></td><td><p>Striking of coins</p></td><td><p>C</p></td></tr><tr><td><p>3212</p></td><td><p>Manufacture of jewellery and related articles</p></td><td><p>C</p></td></tr><tr><td><p>3213</p></td><td><p>Manufacture of imitation jewellery and related articles</p></td><td><p>C</p></td></tr><tr><td><p>3220</p></td><td><p>Manufacture of musical instruments</p></td><td><p>C</p></td></tr><tr><td><p>3230</p></td><td><p>Manufacture of sports goods</p></td><td><p>C</p></td></tr><tr><td><p>3240</p></td><td><p>Manufacture of games and toys</p></td><td><p>C</p></td></tr><tr><td><p>3250</p></td><td><p>Manufacture of medical and dental instruments and supplies</p></td><td><p>C</p></td></tr><tr><td><p>3291</p></td><td><p>Manufacture of brooms and brushes</p></td><td><p>C</p></td></tr><tr><td><p>3299</p></td><td><p>Other manufacturing n.e.c.</p></td><td><p>C</p></td></tr></tbody></table>
1.2. At the CPA or Prodcom level
<table><col/><col/><col/><tbody><tr><td><p>CPA or Prodcom</p></td><td><p>Description</p></td><td><p>Criteria met</p></td></tr><tr><td><p>081221</p></td><td><p>Kaolin and other kaolinic clays</p></td><td><p>C</p></td></tr><tr><td><p>08122250</p></td><td><p>Common clays and shales for construction use (excluding bentonite, fireclay, expanded clays, kaolin and kaolinic clays); andalusite, kyanite and sillimanite; mullite; chamotte or dinas earths</p></td><td><p>C</p></td></tr><tr><td><p>10311130</p></td><td><p>Frozen potatoes, prepared or preserved (including potatoes cooked or partly cooked in oil and then frozen; excluding by vinegar or acetic acid)</p></td><td><p>A</p></td></tr><tr><td><p>10311300</p></td><td><p>Dried potatoes in the form of flour, meal, flakes, granules and pellets</p></td><td><p>A</p></td></tr><tr><td><p>10391725</p></td><td><p>Concentrated tomato puree and paste</p></td><td><p>C</p></td></tr><tr><td><p>105121</p></td><td><p>Skimmed milk powder</p></td><td><p>C</p></td></tr><tr><td><p>105122</p></td><td><p>Whole milk powder</p></td><td><p>C</p></td></tr><tr><td><p>105153</p></td><td><p>Casein</p></td><td><p>C</p></td></tr><tr><td><p>105154</p></td><td><p>Lactose and lactose syrup</p></td><td><p>C</p></td></tr><tr><td><p>10515530</p></td><td><p>Whey and modified whey in powder, granules or other solid forms, whether or not concentrated or containing added sweetening matter</p></td><td><p>A, C</p></td></tr><tr><td><p>108211</p></td><td><p>Cocoa paste, whether or not defatted</p></td><td><p>C</p></td></tr><tr><td><p>108212</p></td><td><p>Cocoa butter, fat and oil</p></td><td><p>C</p></td></tr><tr><td><p>108213</p></td><td><p>Cocoa powder, not containing added sugar or other sweetening matter</p></td><td><p>C</p></td></tr><tr><td><p>10891334</p></td><td><p>Bakers' yeast</p></td><td><p>C</p></td></tr><tr><td><p>20111150</p></td><td><p>Hydrogen</p></td><td><p>B</p></td></tr><tr><td><p>20111160</p></td><td><p>Nitrogen</p></td><td><p>B</p></td></tr><tr><td><p>20111170</p></td><td><p>Oxygen</p></td><td><p>B</p></td></tr><tr><td><p>203021</p></td><td><p>Prepared pigments, opacifiers and colours, vitrifiable enamels and glazes, engobes, liquid lustres and the like; glass frit</p></td><td><p>C</p></td></tr><tr><td><p>239914</p></td><td><p>Artificial graphite; colloidal or semi-colloidal graphite; preparations based on graphite or other carbon in the form of semi-manufactures</p></td><td><p>C</p></td></tr><tr><td><p>23991910</p></td><td><p>Slag wool, rock wool and similar mineral wools and mixtures thereof, in bulk, sheets or rolls</p></td><td><p>A</p></td></tr><tr><td><p>23991920</p></td><td><p>Exfoliated vermiculite, expanded clays, foamed slag and similar expanded mineral materials and mixtures thereof</p></td><td><p>A</p></td></tr><tr><td><p>25501134</p></td><td><p>Open die forged ferrous parts for transmission shafts, camshafts, crankshafts and cranks etc.</p></td><td><p>A, C</p></td></tr></tbody></table>
The criteria based on which a sector is deemed to be exposed to a significant risk of carbon leakage are the following:
<table><col/><col/><col/><tbody><tr><td><p>A</p></td><td><p>:</p></td><td><p>criterion set out in Article 10a(15) of Directive 2003/87/EC;</p></td></tr><tr><td><p>B</p></td><td><p>:</p></td><td><p>criterion set out in Article 10a(16)(a) of Directive 2003/87/EC;</p></td></tr><tr><td><p>C</p></td><td><p>:</p></td><td><p>criterion set out in Article 10a(16)(b) of Directive 2003/87/EC.</p></td></tr></tbody></table>
2. BASED ON THE CRITERIA SET OUT IN ARTICLE 10a(17) OF DIRECTIVE 2003/87/EC
<table><col/><col/><tbody><tr><td><p>NACE Code</p></td><td><p>Description</p></td></tr><tr><td><p>1106</p></td><td><p>Manufacture of malt</p></td></tr><tr><td><p>1330</p></td><td><p>Finishing of textiles</p></td></tr><tr><td><p>2332</p></td><td><p>Manufacture of bricks, tiles and construction products, in baked clay</p></td></tr><tr><td><p>2362</p></td><td><p>Manufacture of plaster products for construction purposes</p></td></tr><tr><td><p>2451</p></td><td><p>Casting of iron</p></td></tr><tr><td><p>2453</p></td><td><p>Casting of light metals</p></td></tr></tbody></table>
<note>
( 1 ) The sector ‘Manufacture of glass fibres’ is described by two CPA codes: ‘231411 Slivers, rovings, yarn and chopped strands, of glass fibre’ and ‘231412 Voiles, webs, mats, mattresses, boards and other articles of glass fibres, except woven fabrics’. Assessed at the NACE-4 level, the sector does not meet the criteria set out in Article 10a(15) and (16) of Directive 2003/87/EC. However, subsector 231411 meets the criterion set out in Article 10a(16)(b), and subsector 231412 meets the criterion set out in Article 10a(15). As the two CPA codes cover the entire sector ‘Manufacture of glass fibres’, the sector is added to the list at NACE-4 level for ease of reference.
</note> | ENG | 32014D0746 |
02000L0054 — EN — 24.06.2020 — 002.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
<table><col/><col/><tr><td><p><a>►B</a></p></td><td><p> DIRECTIVE 2000/54/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL</p><p>of 18 September 2000</p><p>on the protection of workers from risks related to exposure to biological agents at work</p><p><a>(seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)</a></p><p>(OJ L 262 17.10.2000, p. 21)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p> </p></td><td><p> </p></td><td><p>Official Journal</p></td></tr><tr><td><p>  No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>►M1</a></p></td><td><p><a> COMMISSION DIRECTIVE (EU) 2019/1833 of 24 October 2019</a></p></td><td><p>  L 279</p></td><td><p>54</p></td><td><p>31.10.2019</p></td></tr><tr><td><p><a>►M2</a></p></td><td><p><a> COMMISSION DIRECTIVE (EU) 2020/739 of 3 June 2020</a></p></td><td><p>  L 175</p></td><td><p>11</p></td><td><p>4.6.2020</p></td></tr></table>
DIRECTIVE 2000/54/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 18 September 2000
on the protection of workers from risks related to exposure to biological agents at work
(seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)
CHAPTER I
GENERAL PROVISIONS
Article 1
Objective
1. This Directive has as its aim the protection of workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to biological agents at work.
It lays down particular minimum provisions in this area.
2. Directive 89/391/EEC shall apply fully to the whole area referred to in paragraph 1, without prejudice to more stringent and/or specific provisions contained in this Directive.
3. This Directive shall apply without prejudice to the provisions of Council Directive 90/219/EEC ( 1 ) and of Council Directive 90/220/EEC ( 2 ).
Article 2
Definitions
For the purpose of this Directive:
(a) 'biological agents' shall mean micro-organisms, including those which have been genetically modified, cell cultures and human endoparasites, which may be able to provoke any infection, allergy or toxicity;
(b) 'micro-organism' shall mean a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material;
(c) 'cell culture' shall mean the in-vitro growth of cells derived from multicellular organisms.
'Biological agents' shall be classified into four risk groups, according to their level of risk of infection:
1. group 1 biological agent means one that is unlikely to cause human disease:
2. group 2 biological agent means one that can cause human disease and might be a hazard to workers; it is unlikely to spread to the community; there is usually effective prophylaxis or treatment available;
3. group 3 biological agent means one that can cause severe human disease and present a serious hazard to workers; it may present a risk of spreading to the community, but there is usually effective prophylaxis or treatment available;
4. group 4 biological agent means one that causes severe human disease and is a serious hazard to workers; it may present a high risk of spreading to the community; there is usually no effective prophylaxis or treatment available.
Article 3
Scope — Determination and assessment of risks
1. This Directive shall apply to activities in which workers are or are potentially exposed to biological agents as a result of their work.
2. In the case of any activity likely to involve a risk of exposure to biological agents, the nature, degree and duration of workers' exposure must be determined in order to make it possible to assess any risk to the workers' health or safety and to lay down the measures to be taken.
In the case of activities involving exposure to several groups of biological agents, the risk shall be assessed on the basis of the danger presented by all hazardous biological agents present.
The assessment must be renewed regularly and in any event when any change occurs in the conditions which may affect workers' exposure to biological agents.
The employer must supply the competent authorities, at their request, with the information used for making the assessment.
3. The assessment referred to in paragraph 2 shall be conducted on the basis of all available information including:
(a) classification of biological agents which are or may be a hazard to human health, as referred to in Article 18;
(b) recommendations from a competent authority which indicate that the biological agent should be controlled in order to protect workers' health when workers are or may be exposed to such a biological agent as a result of their work;
(c) information on diseases which may be contracted as a result of the work of the workers;
(d) potential allergenic or toxigenic effects as a result of the work of the workers;
(e) knowledge of a disease from which a worker is found to be suffering and which has a direct connection with his work.
Article 4
Application of the various Articles in relation to assessment of risks
1. If the results of the assessment referred to in Article 3 show that the exposure and/or potential exposure is to a group 1 biological agent, with no identifiable health risk to workers, Articles 5 to 17 and Article 19 shall not apply.
However, point 1 of Annex VI should be observed.
2. If the results of the assessment referred to in Article 3 show that the activity does not involve a deliberate intention to work with or use a biological agent but may result in the workers' being exposed to a biological agent, as in the course of the activities for which an indicative list is given in Annex I, Articles 5, 7, 8, 10, 11, 12, 13 and 14 shall apply unless the results of the assessment referred to in Article 3 show them to be unnecessary.
CHAPTER II
EMPLOYERS' OBLIGATIONS
Article 5
Replacement
The employer shall avoid the use of a harmful biological agent if the nature of the activity so permits, by replacing it with a biological agent which, under its conditions of use, is not dangerous or is less dangerous to workers' health, as the case may be, in the present state of knowledge.
Article 6
Reduction of risks
1. Where the results of the assessment referred to in Article 3 reveal a risk to workers' health or safety, workers' exposure must be prevented.
2. Where this is not technically practicable, having regard to the activity and the risk assessment referred to in Article 3, the risk of exposure must be reduced to as low a level as necessary in order to protect adequately the health and safety of the workers concerned, in particular by the following measures which are to be applied in the light of the results of the assessment referred to in Article 3:
(a) keeping as low as possible the number of workers exposed or likely to be exposed;
(b) design of work processes and engineering control measures so as to avoid or minimise the release of biological agents into the place of work;
(c) collective protection measures and/or, where exposure cannot be avoided by other means, individual protection measures;
(d) hygiene measures compatible with the aim of the prevention or reduction of the accidental transfer or release of a biological agent from the workplace;
(e) use of the biohazard sign depicted in Annex II and other relevant warning signs;
(f) drawing up plans to deal with accidents involving biological agents;
(g) testing, where it is necessary and technically possible, for the presence, outside the primary physical confinement, of biological agents used at work;
(h) means for safe collection, storage and disposal of waste by workers including the use of secure and identifiable containers, after suitable treatment where appropriate;
(i) arrangements for the safe handling and transport of biological agents within the workplace.
Article 7
Information for the competent authority
1. Where the results of the assessment referred to in Article 3 reveal risk to workers' health or safety, employers shall, when requested, make available to the competent authority appropriate information on:
(a) the results of the assessment;
(b) the activities in which workers have been exposed or may have been exposed to biological agents;
(c) the number of workers exposed;
(d) the name and capabilities of the person responsible for safety and health at work;
(e) the protective and preventive measures taken, including working procedures and methods;
(f) an emergency plan for the protection of workers from exposure to group 3 or a group 4 biological agent which might result from a loss of physical containment.
2. Employers shall inform forthwith the competent authority of any accident or incident which may have resulted in the release of a biological agent and which could cause severe human infection and/or illness.
3. The list referred to in Article 11 and the medical record referred to in Article 14 shall be made available to the competent authority in cases where the undertaking ceases activity, in accordance with national laws and/or practice.
Article 8
Hygiene and individual protection
1. Employers shall be obliged, in the case of all activities for which there is a risk to the health or safety of workers due to work with biological agents, to take appropriate measures to ensure that:
(a) workers do not eat or drink in working areas where there is a risk of contamination by biological agents;
(b) workers are provided with appropriate protective clothing or other appropriate special clothing;
(c) workers are provided with appropriate and adequate washing and toilet facilities, which may include eye washes and/or skin antiseptics;
(d) any necessary protective equipment is:
— properly stored in a well-defined place,
— checked and cleaned if possible before, and in any case after, each use,
— is repaired, where defective, or is replaced before further use;
(e) procedures are specified for taking, handling and processing samples of human or animal origin.
2. Working clothes and protective equipment, including protective clothing referred to in paragraph 1, which may be contaminated by biological agents, must be removed on leaving the working area and, before taking the measures referred to in the second subparagraph, kept separately from other clothing.
The employer must ensure that such clothing and protective equipment is decontaminated and cleaned or, if necessary, destroyed.
3. Workers may not be charged for the cost of the measures referred to in paragraphs 1 and 2.
Article 9
Information and training of workers
1. Appropriate measures shall be taken by the employer to ensure that workers and/or any workers' representatives in the undertaking or establishment receive sufficient and appropriate training, on the basis of all available information, in particular in the form of information and instructions, concerning:
(a) potential risks to health;
(b) precautions to be taken to prevent exposure;
(c) hygiene requirements;
(d) wearing and use of protective equipment and clothing;
(e) steps to be taken by workers in the case of incidents and to prevent incidents.
2. The training shall be:
(a) given at the beginning of work involving contact with biological agents,
(b) adapted to take account of new or changed risks, and
(c) repeated periodically if necessary.
Article 10
Worker information in particular cases
1. Employers shall provide written instructions at the workplace and, if appropriate, display notices which shall, as a minimum, include the procedure to be followed in the case of:
(a) a serious accident or incident involving the handling of a biological agent;
(b) handling a group 4 biological agent.
2. Workers shall immediately report any accident or incident involving the handling of a biological agent to the person in charge, or to the person responsible for safety and health at work.
3. Employers shall inform forthwith the workers and/or any workers' representatives of any accident or incident which may have resulted in the release of a biological agent and which could cause severe human infection and/or illness.
In addition, employers shall inform the workers and/or any workers' representatives in the undertaking or establishment as quickly as possible when a serious accident or incident occurs, of the causes thereof and of the measures taken or to be taken to rectify the situation.
4. Each worker shall have access to the information on the list referred to in Article 11 which relates to him personally.
5. Workers and/or any workers' representatives in the undertaking or establishment shall have access to anonymous collective information.
6. Employers shall provide workers and/or their representatives, at their requst, with the information provided for in Article 7(1).
Article 11
List of exposed workers
1. Employers shall keep a list of workers exposed to group 3 and/or group 4 biological agents, indicating the type of work done and, whenever possible, the biological agent to which they have been exposed, as well as records of exposures, accidents and incidents, as appropriate.
2. The list referred to in paragraph 1 shall be kept for at least 10 years following the end of exposure, in accordance with national laws and/or practice.
In the case of those exposures which may result in infections:
(a) with biological agents known to be capable of establishing persistent or latent infections;
(b) that, in the light of present knowledge, are undiagnosable until illness develops many years later;
(c) that have particularly long incubation periods before illness develops;
(d) that result in illnesses which recrudesce at times over a long period despite treatment, or
(e) that may have serious long-term sequelae, the list shall be kept for an appropriately longer time up to 40 years following the last known exposure.
3. The doctor referred to in Article 14 and/or the competent authority for health and safety at work, and any other person responsible for health and safety at work, shall have access to the list referred to in paragraph 1.
Article 12
Consultation and participation of workers
Consultation and participation of workers and/or their representatives in connection with matters covered by this Directive shall take place in accordance with Article 11 of Directive 89/391/EEC.
Article 13
Notification to the competent authority
1. Prior notification shall be made to the competent authority of the use for the first time of:
(a) group 2 biological agents;
(b) group 3 biological agents;
(c) group 4 biological agents.
The notification shall be made at least 30 days before the commencement of the work.
Subject to paragraph 2, prior notification shall also be made of the use for the first time of each subsequent group 4 biological agent and of any subsequent new group 3 biological agent where the employer himself provisionally classifies that biological agent.
2. Laboratories providing a diagnostic service in relation to group 4 biological agents shall be required only to make an initial notification of their intention.
3. Renotification must take place in any case where there are substantial changes of importance to safety or health at work to processes and/or procedures which render the notification out of date.
4. The notification referred to in paragraphs 1, 2 and 3 shall include:
(a) the name and address of the undertaking and/or establishment;
(b) the name and capabilities of the person responsible for safety and health at work;
(c) the results of the assessment referred to in Article 3;
(d) the species of the biological agent;
(e) the protection and preventive measures that are envisaged.
CHAPTER III
MISCELLANEOUS PROVISIONS
Article 14
Health surveillance
1. The Member States shall establish, in accordance with national laws and practice, arrangements for carrying out relevant health surveillance of workers for whom the results of the assessment referred to in Article 3 reveal a risk to health or safety.
2. The arrangements referred to in paragraph 1 shall be such that each worker shall be able to undergo, if appropriate, relevant health surveillance:
(a) prior to exposure;
(b) at regular intervals thereafter.
Those arrangements shall be such that it is directly possible to implement individual and occupational hygiene measures.
3. The assessment referred to in Article 3 should identify those workers for whom special protective measures may be required.
When necessary, effective vaccines should be made available for those workers who are not already immune to the biological agent to which they are exposed or are likely to be exposed.
When employers make vaccines available, they should take account of the recommended code of practice set out in Annex VII.
If a worker is found to be suffering from an infection and/or illness which is suspected to be the result of exposure, the doctor or authority responsible for health surveillance of workers shall offer such surveillance to other workers who have been similarly exposed.
In that event, a reassessment of the risk of exposure shall be carried out in accordance with Article 3.
4. In cases where health surveillance is carried out, an individual medical record shall be kept for at least 10 years following the end of exposure, in accordance with national laws and practice.
In the special cases referred to in Article 11(2) second subparagraph, an individual medical record shall be kept for an appropriately longer time up to 40 years following the last known exposure.
5. The doctor or authority responsible for health surveillance shall propose any protective or preventive measures to be taken in respect of any individual worker.
6. Information and advice must be given to workers regarding any health surveillance which they may undergo following the end of exposure.
7. In accordance with national laws and/or practice:
(a) workers shall have access to the results of the health surveillance which concern them, and
(b) the workers concerned or the employer may request a review of the results of the health surveillance.
8. Practical recommendations for the health surveillance of workers are given in Annex IV.
9. All cases of diseases or death identified in accordance with national laws and/or practice as resulting from occupational exposure to biological agents shall be notified to the competent authority.
Article 15
Health and veterinary care facilities other than diagnostic laboratories
1. For the purpose of the assessment referred to in Article 3, particular attention should be paid to:
(a) uncertainties about the presence of biological agents in human patients or animals and the materials and speciments taken from them;
(b) the hazard represented by biological agents known or suspected to be present in human patients or animals and materials and specimens taken from them;
(c) the risks posed by the nature of the work.
2. Appropriate measures shall be taken in health and veterinary care facilities in order to protect the health and safety of the workers concerned.
The measures to be taken shall include in particular:
(a) specifying appropriate decontamination and disinfection procedures, and
(b) implementing procedures enabling contaminated waste to be handled and disposed of without risk.
3. In isolation facilities where there are human patients or animals who are, or who are suspected of being, infected with group 3 or group 4 biological agents, containment measures shall be selected from those in Annex V column A, in order to minimise the risk of infection.
Article 16
Special measures for industrial processes, laboratories and animal rooms
1. The following measures must be taken in laboratories, including diagnostic laboratories, and in rooms for laboratory animals which have been deliberately infected with group 2, 3 or 4 biological agents or which are or are suspected to be carriers of such agents.
(a) Laboratories carrying out work which involves the handling of group 2, 3 or 4 biological agents for research, development, teaching or diagnostic purposes shall determine the containment measures in accordance with Annex V, in order to minimise the risk of infection.
(b) Following the assessment referred to in Article 3, measures shall be determined in accordance with Annex V, after fixing the physical containment level required for the biological agents according to the degree of risk.
Activities involving the handling of a biological agent must be carried out:
— only in working areas corresponding to at least containment level 2, for a group 2 biological agent,
— only in working areas corresponding to at least containment level 3, for a group 3 biological agent,
— only in working areas corresponding to at least containment level 4, for a group 4 biological agent.
(c) Laboratories handling materials in respect of which there exist uncertainties about the presence of biological agents which may cause human disease but which do not have as their aim working with biological agents as such (i.e. cultivating or concentrating them) should adopt containment level 2 at least. Containment levels 3 or 4 must be used, when appropriate, where it is known or it is suspected that they are necessary, except where guidelines provided by the competent national authorities show that, in certain cases, a lower containment level is appropriate.
2. The following measures concerning industrial processes using group 2, 3 or 4 biological agents must be taken:
(a) The containment principles set out in the second subparagraph of paragraph 1(b) should also apply to industrial processes on the basis of the practical measures and appropriate procedures given in Annex VI.
(b) In accordance with the assessment of the risk linked to the use of group 2, 3 or 4 biological agents, the competent authorities may decide on appropriate measures which must be applied to the industrial use of such biological agents.
3. For all activities covered by paragraphs 1 and 2 where it has not been possible to carry out a conclusive assessment of a biological agent but concerning which it appears that the use envisaged might involve a serious health risk for workers, activities may only be carried out in workplaces where the containment level corresponds at least to level 3.
Article 17
Use of data
The Commission shall have access to the use made by the competent national authorities of the information referred to in Article 14(9).
Article 18
Classification of biological agents
1. Community classification shall be on the basis of the definitions in the second paragraph of Article 2, points 2 to 4 (groups 2 to 4).
2. Pending Community classification Member States shall classify biologial agents that are or may be a hazard to human health on the basis of the definition in the second paragraph of Article 2, points 2 to 4 (groups 2 to 4).
3. If the biological agent tobe assessed cannot be classified clearly in one of the groups defined in the second paragraph of Article 2, it must be classified in the highest risk group among the alternatives.
Article 19
Annexes
Purely technical adjustments to the Annexes in the light of technical progress, changes in international regulations or specifications and new findings in the field of biological agents shall be adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC.
Article 20
Notifying the Commission
Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive.
Article 21
Repeal
Directive 90/679/EEC, amended by the Directives referred to in Annex VIII, part A is repealed, without prejudice to the obligations of the Member States in respect of the deadlines for transposition laid down in Annex VIII, part B.
References to the repealed Directive shall be construed as references to this Directive and shall be correlated in accordance with the correlation table set out in Annex IX.
Article 22
Entry into force
This Directive enters into force on the twentieth day following its publication in the Official Journal of the European Communities.
Article 23
Addresses
This Directive is addressed to the Member States.
ANNEX I
INDICATIVE LIST OF ACTIVITIES
(Article 4(2))
Preliminary note
Where the result of the risk assessment, carried out in accordance with Article 3 and Article 4(2) of this Directive, shows an unintentional exposure to biological agents, there may be other work activities, not included in this Annex, which should be considered.
1. Work in food production plants.
2. Work in agriculture.
3. Work activities where there is contact with animals and/or products of animal origin.
4. Work in healthcare, including isolation and post-mortem units.
5. Work in clinical, veterinary and diagnostic laboratories, excluding diagnostic microbiological laboratories.
6. Work in refuse disposal plants.
7. Work in sewage purification installations.
ANNEX II
BIOHAZARD SIGN
(Article 6(2)(e))
ANNEX III
COMMUNITY CLASSIFICATION
Article 2, second paragraph, and Article 18
INTRODUCTORY NOTES
1. In line with the scope of the Directive, only agents which are known to infect humans are to be included in the classified list.
Where appropriate, indicators are given of the toxic and allergic potential of these agents.
Animal and plant pathogens which are known not to affect man are excluded.
In drawing up this list of classified biological agents consideration has not been given to genetically modified micro-organisms.
2. The list of classified agents is based on the effect of those agents on healthy workers.
No specific account is taken of particular effects on those whose susceptibility may be affected for one or other reason such as pre-existing disease, medication, compromised immunity, pregnancy or breast feeding.
Additional risk to such workers should be considered as part of the risk assessment required by the Directive.
In certain industrial processes, certain laboratory work or certain work with animals involving actual or potential exposure to biological agents of groups 3 or 4, any technical precautions taken must comply with Article 16 of the Directive.
3. Biological agents which have not been classified for inclusion in groups 2 to 4 of the list are not implicitly classified in group 1.
For genera where more than one species is known to be pathogenic to man, the list will include those species which are known to be the most frequently responsible for diseases, together with a more general reference to the fact that other species of the same genus may affect health.
When a whole genus is mentioned in the classified list of biological agents, it is implicit that the species and strains known to be non-pathogenic are excluded.
4. Where a strain is attenuated or has lost known virulence genes, then the containment required by the classification of its parent strain need not necessarily apply, subject to assessment appropriate for risk in the workplace.
This is the case, for example, when such a strain is to be used as a product or part of a product for prophylactic or therapeutic purposes.
5. The nomenclature of classified agents used to establish this list reflects and is in conformity with the latest international agreements of the taxonomy and nomenclature of agents at the time the list was prepared.
6. The list of classified biological agents reflects the state of knowledge at the time that it was devised.
It will be updated as soon as it no longer reflects the latest state of knowledge.
7. Member States are to ensure that all viruses which have already been isolated in humans and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
8. Certain biological agents classified in group 3 which are indicated in the appended list by two asterisks (**), may present a limited risk of infection for workers because they are not normally infectious by the airborne route.
Member States shall assess the containment measures to be applied to such agents, taking account of the nature of specific activities in question and of the quantity of the agent involved, with a view to determining whether, in particular circumstances, some of these measures may be dispensed with.
9. The requirements as to containment consequent on the classification of parasites apply only to stages in the life cycle of the parasite in which it is liable to be infectious to humans at the workplace.
10. This list also gives a separate indication in cases where the biological agents are likely to cause allergic or toxic reactions, where an effective vaccine is available, or where it is advisable to keep a list of exposed workers for more than 10 years.
These indications are shown by the following letters:
A: Possible allergic effects
D: List of workers exposed to this biological agent to be kept for more than 10 years after the end of last known exposure
T: Toxin production
V: Effective vaccine available and registered within the EU
The application of preventive vaccination should take account of the code of practice given in Annex VII.
BACTERIA
and similar organisms
NB: For biological agents appearing on this list, the entry of the whole genus with the addition of ‘spp.’ refers to other species belonging to this genus that have not specifically been included in the list, but which are known pathogens in humans. See introductory note 3 for further details.
<table><col/><col/><col/><tbody><tr><td><p>Biological agent</p></td><td><p>Classification</p></td><td><p>Notes</p></td></tr><tr><td><p><span>Actinomadura madurae</span></p></td><td><p>W</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Actinomadura pelletieri</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Actinomyces gerencseriae</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Actinomyces israelii</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Actinomyces</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Aggregatibacter actinomycetemcomitans (Actinobacillus actinomycetemcomitans)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Anaplasma</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Arcanobacterium haemolyticum (Corynebacterium haenolyticum)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Arcobacter butzleri</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Bacillus anthracis</span></p></td><td><p>3</p></td><td><p>T</p></td></tr><tr><td><p><span>Bacteroides fragilis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Bacteroides</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Bartonella bacilliformis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Bartonella quintana (Rochalimaea quintana)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Bartonella (Rochalimaea)</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Bordetella bronchiseptica</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Bordetella parapertussis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Bordetella pertussis</span></p></td><td><p>2</p></td><td><p>T, V</p></td></tr><tr><td><p><span>Bordetella</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Borrelia burgdorferi</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Borrelia duttonii</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Borrelia recurrentis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Borrelia</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Brachyspira</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Brucella abortus</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Brucella canis</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Brucella inopinata</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Brucella melitensis</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Brucella suis</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Burkholderia cepacia</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Burkholderia mallei (Pseudomonas mallei)</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Burkholderia pseudomallei (Pseudomonas pseudomallei)</span></p></td><td><p>3</p></td><td><p>D</p></td></tr><tr><td><p><span>Campylobacter fetus</span> subsp.<span>fetus</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Campylobacter fetus</span> subsp.<span>venerealis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Campylobacter jejuni</span> subsp.<span>doylei</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Campylobacter jejuni</span> subsp.<span>jejuni</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Campylobacter</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Cardiobacterium hominis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Cardiobacterium valvarum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Chlamydia abortus (Chlamydophila abortus)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Chlamydia caviae (Chlamydophila caviae)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Chlamydia felis (Chlamydophila felis)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Chlamydia pneumoniae (Chlamydophila pneumoniae)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Chlamydia psittaci (Chlamydophila psittaci)</span> (avian strains)</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Chlamydia psittaci (Chlamydophila psittaci)</span> (other strains)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Chlamydia trachomatis (Chlamydophila trachomatis)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Clostridium botulinum</span></p></td><td><p>2</p></td><td><p>T</p></td></tr><tr><td><p><span>Clostridium difficile</span></p></td><td><p>2</p></td><td><p>T</p></td></tr><tr><td><p><span>Clostridium perfringens</span></p></td><td><p>2</p></td><td><p>T</p></td></tr><tr><td><p><span>Clostridium tetani</span></p></td><td><p>2</p></td><td><p>T, V</p></td></tr><tr><td><p><span>Clostridium</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Corynebacterium diphtheriae</span></p></td><td><p>2</p></td><td><p>T, V</p></td></tr><tr><td><p><span>Corynebacterium minutissimum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Corynebacterium pseudotuberculosis</span></p></td><td><p>2</p></td><td><p>T</p></td></tr><tr><td><p><span>Corynebacterium ulcerans</span></p></td><td><p>2</p></td><td><p>T</p></td></tr><tr><td><p><span>Corynebacterium</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Coxiella burnetii</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Edwardsiella tarda</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Ehrlichia</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Eikenella corrodens</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Elizabethkingia meningoseptica (Flavobacterium meningosepticum)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Enterobacter aerogenes (Klebsiella mobilis)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Enterobacter cloacae</span> subsp.<span>cloacae (Enterobacter cloacae)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Enterobacter</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Enterococcus</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Erysipelothrix rhusiopathiae</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Escherichia coli</span> (with the exception of non-pathogenic strains)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Escherichia coli, verocytotoxigenic strains</span> (e.g. O157:H7 or O103)</p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p>T</p></td></tr><tr><td><p><span>Fluoribacter bozemanae (Legionella)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Francisella hispaniensis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Francisella tularensis</span> subsp.<span>holarctica</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Francisella tularensis</span> subsp.<span>mediasiatica</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Francisella tularensis</span> subsp.<span>novicida</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Francisella tularensis</span> subsp.<span>tularensis</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Fusobacterium necrophorum</span> subsp.<span>funduliforme</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Fusobacterium necrophorum</span> subsp.<span>necrophorum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Gardnerella vaginalis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Haemophilus ducreyi</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Haemophilus influenzae</span></p></td><td><p>2</p></td><td><p>V</p></td></tr><tr><td><p><span>Haemophilus</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Helicobacter pylori</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Helicobacter</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Klebsiella oxytoca</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Klebsiella pneumoniae</span> subsp.<span>ozaenae</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Klebsiella pneumoniae</span> subsp.<span>pneumoniae</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Klebsiella pneumoniae</span> subsp.<span>rhinoscleromatis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Klebsiella</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Legionella pneumophila</span> subsp.<span>fraseri</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Legionella pneumophila</span> subsp.<span>pascullei</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Legionella pneumophila</span> subsp.<span>pneumophila</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Legionella</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Leptospira interrogans</span> (all serovars)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Leptospira interrogans</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Listeria monocytogenes</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Listeria ivanovii</span> subsp.<span>ivanovii</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Listeria invanovii</span> subsp.<span>londoniensis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Morganella morganii</span> subsp.<span>morganii (Proteus morganii)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Morganella morganii</span> subsp.<span>sibonii</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium abscessus</span> subsp.<span>abscessus</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium africanum</span></p></td><td><p>3</p></td><td><p>V</p></td></tr><tr><td><p><span>Mycobacterium avium</span> subsp.<span>avium (Mycobacterium avium)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium avium</span> subsp.<span>paratuberculosis (Mycobacterium paratuberculosis)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium avium</span> subsp.<span>silvaticum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium bovis</span></p></td><td><p>3</p></td><td><p>V</p></td></tr><tr><td><p><span>Mycobacterium caprae (Mycobacterium tuberculosis</span> subsp.<span>caprae)</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium chelonae</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium chimaera</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium fortuitum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium intracellulare</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium kansasii</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium leprae</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium malmoense</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium marinum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium microti</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium pinnipedii</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium scrofulaceum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium simiae</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium szulgai</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium tuberculosis</span></p></td><td><p>3</p></td><td><p>V</p></td></tr><tr><td><p><span>Mycobacterium ulcerans</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycobacterium xenopi</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycoplasma hominis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycoplasma pneumoniae</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mycoplasma</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Neisseria gonorrhoeae</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Neisseria meningitidis</span></p></td><td><p>2</p></td><td><p>V</p></td></tr><tr><td><p><span>Neorickettsia sennetsu (Rickettsia sennetsu, Ehrlichia sennetsu)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Nocardia asteroides</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Nocardia brasiliensis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Nocardia farcinica</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Nocardia nova</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Nocardia otitidiscaviarum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Nocardia</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Orientia tsutsugamushi (Rickettsia tsutsugamushi)</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Pasteurella multocida</span> subsp.<span>gallicida (Pasteurella gallicida)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Pasteurella multocida</span> subsp.<span>multocida</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Pasteurella multocida</span> subsp.<span>septica</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Pasteurella</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Peptostreptococcus anaerobius</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Plesiomonas shigelloides</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Porphyromonas</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Prevotella</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Proteus mirabilis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Proteus penneri</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Proteus vulgaris</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Providencia alcalifaciens (Proteus inconstans)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Providencia rettgeri (Proteus rettgeri)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Providencia</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Pseudomonas aeruginosa</span></p></td><td><p>2</p></td><td><p>T</p></td></tr><tr><td><p><span>Rhodococcus hoagii (Corynebacterium equii)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Rickettsia africae</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Rickettsia akari</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Rickettsia australis</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Rickettsia canadensis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Rickettsia conorii</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Rickettsia heilongjiangensis</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Rickettsia japonica</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Rickettsia montanensis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Rickettsia typhi</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Rickettsia prowazekii</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Rickettsia rickettsii</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Rickettsia sibirica</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Rickettsia</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Salmonella enterica (choleraesuis)</span> subsp.<span>arizonae</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Salmonella Enteritidis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Salmonella Paratyphi A, B, C</span></p></td><td><p>2</p></td><td><p>V</p></td></tr><tr><td><p><span>Salmonella Typhi</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p>V</p></td></tr><tr><td><p><span>Salmonella Typhimurium</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Salmonella</span> (other serovars)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Shigella boydii</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Shigella dysenteriae</span> (Type 1)</p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p>T</p></td></tr><tr><td><p><span>Shigella dysenteriae,</span> other than Type 1</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Shigella flexneri</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Shigella sonnei</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Staphylococcus aureus</span></p></td><td><p>2</p></td><td><p>T</p></td></tr><tr><td><p><span>Streptobacillus moniliformis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Streptococcus agalactiae</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Streptococcus dysgalactiae</span> subsp.<span>equisimilis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Streptococcus pneumoniae</span></p></td><td><p>2</p></td><td><p>T, V</p></td></tr><tr><td><p><span>Streptococcus pyogenes</span></p></td><td><p>2</p></td><td><p>T</p></td></tr><tr><td><p><span>Streptococcus suis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Streptococcus</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Treponema carateum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Treponema pallidum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Treponema pertenue</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Treponema</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Trueperella pyogenes</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Ureaplasma parvum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Ureaplasma urealyticum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Vibrio cholerae</span> (including El Tor)</p></td><td><p>2</p></td><td><p>T, V</p></td></tr><tr><td><p><span>Vibrio parahaemolyticus (Benecka parahaemolytica)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Vibrio</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Yersinia enterocolitica</span> subsp.<span>enterolitica</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Yersinia enterocolitica</span> subsp.<span>palearctica</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Yersinia pestis</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Yersinia pseudotuberculosis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Yersinia</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><div><a>(<span>*1</span>)   </a><p>See paragraph 8 of the introductory notes.</p></div></td></tr></tbody></table>
VIRUSES (*)
(*) See paragraph 7 of the introductory notes.
NB : Viruses have been listed according to their order (O), family (F) and genus (G).
<table><col/><col/><col/><tbody><tr><td><p>Biological agent</p><p>(virus species or indicated taxonomy order)</p></td><td><p>Classification</p></td><td><p>Notes</p></td></tr><tr><td><p>Bunyavirales (O)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p><span>Hantaviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Orthohantavirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Andes orthohantavirus (Hantavirus species causing Hantavirus Pulmonary Syndrome [HPS])</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Bayou orthohantavirus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Black Creek Canal orthohantavirus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Cano Delgadito orthohantavirus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Choclo orthohantavirus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Dobrava-Belgrade orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS])</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>El Moro Canyon orthohantavirus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Hantaan orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS])</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Laguna Negra orthohantavirus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Prospect Hill orthohantavirus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Puumala orthohantavirus (Hantavirus species causing Nephropathia Epidemica [NE])</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Seoul orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS])</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Sin Nombre orthohantavirus (Hantavirus species causing Hantavirus Pulmonary Syndrome [HPS])</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Other hantaviruses known to be pathogenic</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Nairoviridae (F)</span></p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Orthonairovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Crimean-Congo haemorrhagic fever orthonairovirus</p></td><td><p>4</p></td><td><p> </p><div/></td></tr><tr><td><p>Dugbe orthonairovirus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Hazara orthonairovirus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Nairobi sheep disease orthonairovirus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Other nairoviruses known to be pathogenic</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Peribunyaviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Orthobunyavirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Bunyamwera orthobunyavirus (Germiston virus)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>California encephalitis orthobunyavirus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Oropouche orthobunyavirus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Other orthobunyaviruses known to be pathogenic</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Phenuiviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Phlebovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Bhanja phlebovirus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Punta Toro phlebovirus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Rift Valley fever phlebovirus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Sandfly fever Naples phlebovirus (Toscana Virus)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>SFTS phlebovirus (Severe Fever with Thrombocytopenia Syndrome-Virus)</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Other phleboviruses known to be pathogenic</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Herpesvirales (O)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p><span>Herpesviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Cytomegalovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Human betaherpesvirus 5 (Cytomegalovirus)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Lymphocryptovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Human gammaherpesvirus 4 (Epstein-Barr virus)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Rhadinoovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Human gammaherpesvirus 8</p></td><td><p>2</p></td><td><p>D</p></td></tr><tr><td><p>Roseolovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Human betaherpesvirus 6A (Human B-lymphotropic virus)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Human betaherpesvirus 6B</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Human betaherpesvirus 7</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Simplexvirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Macacine alphaherpesvirus 1 (Herpesvirus simiae, Herpes B virus)</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Human alphaherpesvirus 1 (Human herpesvirus 1, Herpes simplex virus type 1)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Human alphaherpesvirus 2 (Human herpesvirus 2, Herpes simplex virus type 2)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Varicellovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Human alphaherpesvirus 3 (Herpesvirus varicella-zoster)</p></td><td><p>2</p></td><td><p>V</p></td></tr><tr><td><p>Mononegavirales (O)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p><span>Filoviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Ebolavirus (G)</p></td><td><p>4</p></td><td><p> </p><div/></td></tr><tr><td><p>Marburgvirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Marburg marburgvirus</p></td><td><p>4</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Paramyxoviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Avulavirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Newcastle disease virus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Henipavirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Hendra henipavirus</p></td><td><p>4</p></td><td><p> </p><div/></td></tr><tr><td><p>Nipah henipavirus</p></td><td><p>4</p></td><td><p> </p><div/></td></tr><tr><td><p>Morbillivirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Measles morbillivirus</p></td><td><p>2</p></td><td><p>V</p></td></tr><tr><td><p>Respirovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Human respirovirus 1 (Parainfluenza virus 1)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Human respirovirus 3 (Parainfluenza virus 3)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Rubulavirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Mumps rubulavirus</p></td><td><p>2</p></td><td><p>V</p></td></tr><tr><td><p>Human rubulavirus 2 (Parainfluenza virus 2)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Human rubulavirus 4 (Parainfluenza virus 4)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Pneumoviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Metapneumovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Orthopneumovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Human orthopneumovirus (Respiratory syncytial virus)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Rhabdoviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Lyssavirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Australian bat lyssavirus</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p>V</p></td></tr><tr><td><p>Duvenhage lyssavirus</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p>V</p></td></tr><tr><td><p>European bat lyssavirus 1</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p>V</p></td></tr><tr><td><p>European bat lyssavirus 2</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p>V</p></td></tr><tr><td><p>Lagos bat lyssavirus</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p>Mokola lyssavirus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Rabies lyssavirus</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p>V</p></td></tr><tr><td><p>Vesiculovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Vesicular stomatitis virus, Alagoas vesiculovirus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Vesicular stomatitis virus, Indiana vesiculovirus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Vesicular stomatitis virus, New Jersey vesiculovirus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Piry vesiculovirus (Piry virus)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Nidovirales (O)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p><span>Coronaviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Betacoronavirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Severe acute respiratory syndrome-related coronavirus (SARS-virus)</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><a>▼M2</a></p></td></tr><tr><td><p>Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) <a>(<span>10</span>)</a></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><a>▼M1</a></p></td></tr><tr><td><p>Middle East respiratory syndrome coronavirus (MERS-virus)</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Other<span>Coronaviridae</span> known to be pathogenic</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Picornavirales (O)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p><span>Picornaviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Cardiovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Saffold virus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Cosavirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Cosavirus A</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Enterovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Enterovirus A</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Enterovirus B</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Enterovirus C</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Enterovirus D, Human Enterovirus type 70 (Acute haemorrhagic conjunctivitis virus)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Rhinoviruses</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Poliovirus, type 1 and 3</p></td><td><p>2</p></td><td><p>V</p></td></tr><tr><td><p>Poliovirus, type 2 <a>(<span>1</span>)</a></p></td><td><p>3</p></td><td><p>V</p></td></tr><tr><td><p>Hepatovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Hepatovirus A (Hepatitis A virus, Human Enterovirus type 72)</p></td><td><p>2</p></td><td><p>V</p></td></tr><tr><td><p>Kobuvirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Aichivirus A (Aichi virus 1)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Parechovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Parechoviruses A</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Parechoviruses B (Ljungan virus)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Other<span>Picornaviridae</span> known to be pathogenic</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Unassigned (O)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p><span>Adenoviridae</span> (F)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Astroviridae</span> (F)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Arenaviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Mammarenavirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Brazilian mammarenavirus</p></td><td><p>4</p></td><td><p> </p><div/></td></tr><tr><td><p>Chapare mammarenavirus</p></td><td><p>4</p></td><td><p> </p><div/></td></tr><tr><td><p>Flexal mammarenavirus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Guanarito mammarenavirus</p></td><td><p>4</p></td><td><p> </p><div/></td></tr><tr><td><p>Junín mammarenavirus</p></td><td><p>4</p></td><td><p> </p><div/></td></tr><tr><td><p>Lassa mammarenavirus</p></td><td><p>4</p></td><td><p> </p><div/></td></tr><tr><td><p>Lujo mammarenavirus</p></td><td><p>4</p></td><td><p> </p><div/></td></tr><tr><td><p>Lymphocytic choriomeningitis mammarenavirus, neurotropic strains</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Lymphocytic choriomeningitis mammarenavirus (other strains)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Machupo mammarenavirus</p></td><td><p>4</p></td><td><p> </p><div/></td></tr><tr><td><p>Mobala mammarenavirus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Mopeia mammarenavirus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Tacaribe mammarenavirus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Whitewater Arroyo mammarenavirus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Caliciviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Norovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Norovirus (Norwalk virus)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Other<span>Caliciviridae</span> known to be pathogenic</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Hepadnaviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Orthohepadnavirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Hepatitis B virus</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p>V, D</p></td></tr><tr><td><p><span>Hepeviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Orthohepevirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Orthohepevirus A (Hepatitis E virus)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Flaviviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Flavivirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Dengue virus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Japanese encephalitis virus</p></td><td><p>3</p></td><td><p>V</p></td></tr><tr><td><p>Kyasanur Forest disease virus</p></td><td><p>3</p></td><td><p>V</p></td></tr><tr><td><p>Louping ill virus</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p>Murray Valley encephalitis virus (Australia encephalitis virus)</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Omsk haemorrhagic fever virus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Powassan virus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Rocio virus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>St. Louis encephalitis virus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Tick-borne encephalitis virus</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Absettarov virus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Hanzalova virus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Hypr virus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Kumlinge virus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Negishi virus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Russian spring-summer encephalitis <a>(<span/>)</a></p></td><td><p>3</p></td><td><p>V</p></td></tr><tr><td><p>Tick-borne encephalitis virus Central European subtype</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p>V</p></td></tr><tr><td><p>Tick-borne encephalitis virus Far Eastern Subtype</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Tick-borne encephalitis virus Siberian subtype</p></td><td><p>3</p></td><td><p>V</p></td></tr><tr><td><p>Wesselsbron virus</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p>West Nile fever virus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Yellow fever virus</p></td><td><p>3</p></td><td><p>V</p></td></tr><tr><td><p>Zika virus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Other flaviviruses known to be pathogenic</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Hepacivirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Hepacivirus C (Hepatitis C virus)</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p>D</p></td></tr><tr><td><p><span>Orthomyxoviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Gammainfluenzavirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Influenza C virus</p></td><td><p>2</p></td><td><p>V <a>(<span/>)</a></p></td></tr><tr><td><p>Influenzavirus A (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Highly Pathogenic Avian Influenza Viruses HPAIV (H5), e.g. H5N1</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Highly Pathogenic Avian Influenza Viruses HPAIV (H7), e.g. H7N7, H7N9</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Influenza A virus</p></td><td><p>2</p></td><td><p>V <a>(<span/>)</a></p></td></tr><tr><td><p>Influenza A virus A/New York/1/18 (H1N1) (Spanish flu 1918)</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Influenza A virus A/Singapore/1/57 (H2N2)</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Low Pathogenic Avian Influenza Virus (LPAI) H7N9</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Influenzavirus B (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Influenza B virus</p></td><td><p>2</p></td><td><p>V <a>(<span/>)</a></p></td></tr><tr><td><p>Thogoto virus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Dhori virus (Tick-borne<span>orthomyxoviridae</span>: Dhori)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Thogoto virus (Tick-borne<span>orthomyxoviridae</span>: Thogoto)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Papillomaviridae</span> (F)</p></td><td><p>2</p></td><td><p>D <a>(<span/>)</a></p></td></tr><tr><td><p><span>Parvoviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Erythroparvovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Primate erythroparvovirus 1 (Human parvovirus, B 19 virus)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Polyomaviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Betapolyomavirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Human polyomavirus 1 (BK virus)</p></td><td><p>2</p></td><td><p>D <a>(<span/>)</a></p></td></tr><tr><td><p>Human polyomavirus 2 (JC virus)</p></td><td><p>2</p></td><td><p>D <a>(<span/>)</a></p></td></tr><tr><td><p><span>Poxviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Molluscipoxvirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Molluscum contagiosum virus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Orthopoxvirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Cowpox virus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Monkeypox virus</p></td><td><p>3</p></td><td><p>V</p></td></tr><tr><td><p>Vaccinia virus (incl. Buffalopox virus <a>(<span/>)</a>, Elephantpox virus <a>(<span/>)</a>, Rabbitpox virus <a>(<span/>)</a>)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Variola (major and minor) virus</p></td><td><p>4</p></td><td><p>V</p></td></tr><tr><td><p>Parapoxvirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Orf virus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Pseudocowpox virus (Milkers’ node virus, parapoxvirus bovis)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Yatapoxvirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Tanapox virus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Yaba monkey tumor virus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Reoviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Seadornavirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Banna virus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Coltivirus (G)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Rotavirus<span>es</span> (G)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Orbivirus (G)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Retroviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Deltaretrovirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Primate T-lymphotropic virus 1 (Human T-cell lymphotropic virus, type 1)</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p>D</p></td></tr><tr><td><p>Primate T-lymphotropic virus 2 (Human T-cell lymphotropic virus, type 2)</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p>D</p></td></tr><tr><td><p>Lentivirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Human immunodeficiency virus 1</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p>D</p></td></tr><tr><td><p>Human immunodeficiency virus 2</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p>D</p></td></tr><tr><td><p>Simian Immunodeficiency Virus (SIV) <a>(<span/>)</a></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Togaviridae</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Alphavirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Cabassouvirus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Eastern equine encephalomyelitis virus</p></td><td><p>3</p></td><td><p>V</p></td></tr><tr><td><p>Bebaru virus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Chikungunya virus</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p>Everglades virus</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p>Mayaro virus</p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p>Mucambo virus</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p>Ndumu virus</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p>O’nyong-nyong virus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Ross River virus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Semliki Forest virus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Sindbis virus</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Tonate virus</p></td><td><p>3 <a>(<span>*2</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p>Venezuelan equine encephalomyelitis virus</p></td><td><p>3</p></td><td><p>V</p></td></tr><tr><td><p>Western equine encephalomyelitis virus</p></td><td><p>3</p></td><td><p>V</p></td></tr><tr><td><p>Other alphaviruses known to be pathogenic</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p>Rubivirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Rubella virus</p></td><td><p>2</p></td><td><p>V</p></td></tr><tr><td><p><span>Unassigned</span> (F)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Deltavirus (G)</p></td><td><p> </p><div/></td><td><p> </p><div/></td></tr><tr><td><p>Hepatitis delta virus <a>(<span/>)</a></p></td><td><p>2</p></td><td><p>V, D</p></td></tr><tr><td><div><a>(<span>*1</span>)   </a><p>See paragraph 7 of the introductory notes.</p></div><div><a>(<span>1</span>)   </a><p>Classification according to WHO Global Action Plan to minimize poliovirus facility-associated risk after type-specific eradication of wild polioviruses and sequential cessation of oral polio vaccine use.</p></div><div><a>(<span>*2</span>)   </a><p>See paragraph 8 of the introductory notes.</p></div><div><a>(<span>2</span>)   </a><p>Tick-borne encephalitis.</p></div><div><a>(<span>3</span>)   </a><p>Hepatitis delta virus is pathogenic in workers only in the presence of simultaneous or secondary infection caused by hepatitis B virus. Vaccination against hepatitis B virus will therefore protect workers who are not affected by hepatitis B virus against hepatitis delta virus.</p></div><div><a>(<span>4</span>)   </a><p>Only for types A and B.</p></div><div><a>(<span>5</span>)   </a><p>Recommended for work involving direct contact with these agents.</p></div><div><a>(<span>6</span>)   </a><p>Two viruses are identified: one a buffalopox type and the other a variant of the Vaccinia virus.</p></div><div><a>(<span>7</span>)   </a><p>Variant of cowpox virus.</p></div><div><a>(<span>8</span>)   </a><p>Variant of Vaccinia.</p></div><div><a>(<span>9</span>)   </a><p>At present there is no evidence of disease in humans caused by the other retroviruses of simian origin. As a precaution containment level 3 is recommended for work with them.</p></div><div><span><a><span>►M2</span></a></span> <a>(<span>10</span>)   </a><p>In line with Article 16(1)(c), non-propagative diagnostic laboratory work involving SARS-CoV-2 should be conducted at a facility using procedures equivalent to at least containment level 2. Propagative work involving SARS-CoV-2 should be conducted at a containment level 3 laboratory with air pressure negative to atmosphere.</p><span> ◄</span></div></td></tr></tbody></table>
PRION DISEASE AGENTS
<table><col/><col/><col/><tbody><tr><td><p>Biological agent</p></td><td><p>Classification</p></td><td><p>Notes</p></td></tr><tr><td><p>Agent of Creutzfeldt-Jakob disease</p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p>D <a>(<span/>)</a></p></td></tr><tr><td><p>Variant Agent of Creutzfeldt-Jakob disease</p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p>D <a>(<span/>)</a></p></td></tr><tr><td><p>Agent of Bovine Spongiform Encephalopathy (BSE) and other related animal TSEs</p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p>D <a>(<span/>)</a></p></td></tr><tr><td><p>Agent of Gerstmann-Sträussler-Scheinker syndrome</p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p>D <a>(<span/>)</a></p></td></tr><tr><td><p>Agent of Kuru</p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p>D <a>(<span/>)</a></p></td></tr><tr><td><p>Agent of Scrapie</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><div><a>(<span>*1</span>)   </a><p>See paragraph 8 of the introductory notes.</p></div><div><a>(<span>1</span>)   </a><p>Recommended for work involving direct contact with these agents.</p></div></td></tr></tbody></table>
PARASITES
NB: For biological agents appearing on this list, the entry of the whole genus with the addition of ‘spp.’ refers to other species belonging to this genus that have not specifically been included in the list, but which are known pathogens in humans. See introductory note 3 for further details.
<table><col/><col/><col/><tbody><tr><td><p>Biological agent</p></td><td><p>Classification</p></td><td><p>Notes</p></td></tr><tr><td><p><span>Acanthamoeba castellani</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Ancylostoma duodenale</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Angiostrongylus cantonensis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Angiostrongylus costaricensis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Anisakis simplex</span></p></td><td><p>2</p></td><td><p>A</p></td></tr><tr><td><p><span>Ascaris lumbricoides</span></p></td><td><p>2</p></td><td><p>A</p></td></tr><tr><td><p><span>Ascaris suum</span></p></td><td><p>2</p></td><td><p>A</p></td></tr><tr><td><p><span>Babesia divergens</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Babesia microti</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Balamuthia mandrillaris</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Balantidium coli</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Brugia malayi</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Brugia pahangi</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Brugia timori</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Capillaria philippinensis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Capillaria</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Clonorchis sinensis (Opisthorchis sinensis)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Clonorchis viverrini (Opisthirchis viverrini)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Cryptosporidium hominis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Cryptosporidium parvum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Cyclospora cayetanensis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Dicrocoelium dentriticum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Dipetalonema streptocerca</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Diphyllobothrium latum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Dracunculus medinensis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Echinococcus granulosus</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Echinococcus multilocularis</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Echinococcus oligarthrus</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Echinococcus vogeli</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Entamoeba histolytica</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Enterobius vermicularis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Enterocytozoon bieneusi</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Fasciola gigantica</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Fasciola hepatica</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Fasciolopsis buski</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Giardia lamblia (Giardia duodenalis, Giardia intestinalis)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Heterophyes</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Hymenolepis diminuta</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Hymenolepis nana</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Leishmania aethiopica</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Leishmania braziliensis</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Leishmania donovani</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Leishmania guyanensis (Viannia guyanensis)</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Leishmania infantum (Leishmania chagasi)</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Leishmania major</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Leishmania mexicana</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Leishmania panamensis (Viannia panamensis)</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Leishmania peruviana</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Leishmania tropica</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Leishmania</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Loa loa</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mansonella ozzardi</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mansonella perstans</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Mansonella streptocerca</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Metagonimus</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Naegleria fowleri</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Necator americanus</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Onchocerca volvulus</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Opisthorchis felineus</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Opisthorchis</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Paragonimus westermani</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Paragonimus</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Plasmodium falciparum</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Plasmodium knowlesi</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Plasmodium</span> spp. (human and simian)</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Sarcocystis suihominis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Schistosoma haematobium</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Schistosoma intercalatum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Schistosoma japonicum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Schistosoma mansoni</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Schistosoma mekongi</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Strongyloides stercoralis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Strongyloides</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Taenia saginata</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Taenia solium</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Toxocara canis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Toxocara cati</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Toxoplasma gondii</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Trichinella nativa</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Trichinella nelsoni</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Trichinella pseudospiralis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Trichinella spiralis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Trichomonas vaginalis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Trichostrongylus orientalis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Trichostrongylus</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Trichuris trichiura</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Trypanosoma brucei brucei</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Trypanosoma brucei gambiense</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Trypanosoma brucei rhodesiense</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Trypanosoma cruzi</span></p></td><td><p>3 <a>(<span>*1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p><span>Wuchereria bancrofti</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><div><a>(<span>*1</span>)   </a><p>See paragraph 8 of the introductory notes.</p></div></td></tr></tbody></table>
FUNGI
NB: For biological agents appearing on this list, the entry of the whole genus with the addition of ‘spp.’ refers to other species belonging to this genus that have not specifically been included in the list, but which are known pathogens in humans. See introductory note 3 for further details.
<table><col/><col/><col/><tbody><tr><td><p>Biological agent</p></td><td><p>Classification</p></td><td><p>Notes</p></td></tr><tr><td><p><span>Aspergillus flavus</span></p></td><td><p>2</p></td><td><p>A</p></td></tr><tr><td><p><span>Aspergillus fumigatus</span></p></td><td><p>2</p></td><td><p>A</p></td></tr><tr><td><p><span>Aspergillus</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Blastomyces dermatitidis (Ajellomyces dermatitidis)</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Blastomyces gilchristii</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Candida albicans</span></p></td><td><p>2</p></td><td><p>A</p></td></tr><tr><td><p><span>Candida dubliniensis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Candida glabrata</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Candida parapsilosis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Candida tropicalis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Cladophialophora bantiana (Xylohypha bantiana, Cladosporium bantianum,</span><span>trichoides)</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Cladophialophora modesta</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Cladophialophora</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Coccidioides immitis</span></p></td><td><p>3</p></td><td><p>A</p></td></tr><tr><td><p><span>Coccidioides posadasii</span></p></td><td><p>3</p></td><td><p>A</p></td></tr><tr><td><p><span>Cryptococcus gattii (Filobasidiella neoformans var. bacillispora)</span></p></td><td><p>2</p></td><td><p>A</p></td></tr><tr><td><p><span>Cryptococcus neoformans (Filobasidiella neoformans var. neoformans)</span></p></td><td><p>2</p></td><td><p>A</p></td></tr><tr><td><p><span>Emmonsia parva</span> var<span>. parva</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Emmonsia parva</span> var<span>. crescens</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Epidermophyton floccosum</span></p></td><td><p>2</p></td><td><p>A</p></td></tr><tr><td><p><span>Epidermophyton</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Fonsecaea pedrosoi</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Histoplasma capsulatum</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Histoplasma capsulatum var. farciminosum</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Histoplasma duboisii</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Madurella grisea</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Madurella mycetomatis</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Microsporum</span> spp.</p></td><td><p>2</p></td><td><p>A</p></td></tr><tr><td><p><span>Nannizzia</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Neotestudina rosatii</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Paracoccidioides brasiliensis</span></p></td><td><p>3</p></td><td><p>A</p></td></tr><tr><td><p><span>Paracoccidioides lutzii</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Paraphyton</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Rhinocladiella mackenziei</span></p></td><td><p>3</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Scedosporium apiospermum</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Scedosporium prolificans (inflatum)</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Sporothrix schenckii</span></p></td><td><p>2</p></td><td><p> </p><div/></td></tr><tr><td><p><span>Talaromyces marneffei (Penicillium marneffei)</span></p></td><td><p>2</p></td><td><p>A</p></td></tr><tr><td><p><span>Trichophyton rubrum</span></p></td><td><p>2</p></td><td><p>A</p></td></tr><tr><td><p><span>Trichophyton tonsurans</span></p></td><td><p>2</p></td><td><p>A</p></td></tr><tr><td><p><span>Trichophyton</span> spp.</p></td><td><p>2</p></td><td><p> </p><div/></td></tr></tbody></table>
ANNEX IV
PRACTICAL RECOMMENDATIONS FOR THE HEALTH SURVEILLANCE OF WORKERS
(Article 14(8))
<table><col/><col/><tr><td><p>1.</p></td><td><p>The doctor and/or the authority responsible for the health surveillance of workers exposed to biological agents must be familiar with the exposure conditions or circumstances of each worker.</p></td></tr></table>
<table><col/><col/><tr><td><p>2.</p></td><td><p>Health surveillance of workers must be carried out in accordance with the principles and practices of occupational medicine: it must include at least the following measures:</p><div><div><span>— </span></div><div><div>keeping records of a worker's medical and occupational history,</div></div></div><div><div><span>— </span></div><div><div>a personalised assessment of the worker's state of health.</div></div></div><div><div><span>— </span></div><div><div>where appropriate, biological monitoring, as well as detection of early and reversible effects.</div></div></div><p>Further tests may be decided on for each worker when he is the subject of health surveillance, in the light of the most recent knowledge available to occupational medicine.</p></td></tr></table>
ANNEX V
INDICATIONS CONCERNING CONTAINMENT MEASURES AND CONTAINMENT LEVELS
(Articles 15(3) and 16(1)(a) and (b))
Preliminary note
The measures contained in this Annex shall be applied according to the nature of the activities, the assessment of risk to workers, and the nature of the biological agent concerned.
In the table, ‘Recommended’ means that the measures should in principle be applied, unless the results of the assessment referred to in Article 3(2) indicate otherwise.
<table><col/><col/><col/><col/><tbody><tr><td><p>A. Containment measures</p></td><td><p>B. Containment levels</p></td></tr><tr><td><p>2</p></td><td><p>3</p></td><td><p>4</p></td></tr><tr><td><p>Workplace</p></td></tr><tr><td><p>1. The workplace is to be separated from any other activities in the same building</p></td><td><p>No</p></td><td><p>Recommended</p></td><td><p>Yes</p></td></tr><tr><td><p>2. The workplace is to be sealable to permit fumigation</p></td><td><p>No</p></td><td><p>Recommended</p></td><td><p>Yes</p></td></tr><tr><td><p>Facilities</p></td></tr><tr><td><p>3. Infected material including any animal is to be handled in a safety cabinet or isolation or other suitable containment</p></td><td><p>Where appropriate</p></td><td><p>Yes, where infection is by airborne route</p></td><td><p>Yes</p></td></tr><tr><td><p>Equipment</p></td></tr><tr><td><p>4. Input air and extract air to the workplace are to be filtered using (HEPA <a>(<span>1</span>)</a>) or likewise</p></td><td><p>No</p></td><td><p>Yes, on extract air</p></td><td><p>Yes, on input and extract air</p></td></tr><tr><td><p>5. The workplace is to be maintained at an air pressure negative to atmosphere</p></td><td><p>No</p></td><td><p>Recommended</p></td><td><p>Yes</p></td></tr><tr><td><p>6. Surfaces impervious to water and easy to clean</p></td><td><p>Yes, for bench and floor</p></td><td><p>Yes, for bench, floor and other surfaces determined by risk assessment</p></td><td><p>Yes, for bench, walls, floor and ceiling</p></td></tr><tr><td><p>7. Surfaces resistant to acids, alkalis, solvents, disinfectants</p></td><td><p>Recommended</p></td><td><p>Yes</p></td><td><p>Yes</p></td></tr><tr><td><p>System of work</p></td></tr><tr><td><p>8. Access is to be restricted to nominated workers only</p></td><td><p>Recommended</p></td><td><p>Yes</p></td><td><p>Yes, via airlock <a>(<span>2</span>)</a></p></td></tr><tr><td><p>9. Efficient vector control, for example rodents and insects</p></td><td><p>Recommended</p></td><td><p>Yes</p></td><td><p>Yes</p></td></tr><tr><td><p>10. Specified disinfection procedures</p></td><td><p>Yes</p></td><td><p>Yes</p></td><td><p>Yes</p></td></tr><tr><td><p>11. Safe storage of a biological agent</p></td><td><p>Yes</p></td><td><p>Yes</p></td><td><p>Yes, secure storage</p></td></tr><tr><td><p>12. Personnel should shower before leaving the contained area</p></td><td><p>No</p></td><td><p>Recommended</p></td><td><p>Recommended</p></td></tr><tr><td><p>Waste</p></td></tr><tr><td><p>13. Validated inactivation process for the safe disposal of animal carcases</p></td><td><p>Recommended</p></td><td><p>Yes, on or off site</p></td><td><p>Yes, on site</p></td></tr><tr><td><p>Other measures</p></td></tr><tr><td><p>14. A laboratory is to contain its own equipment</p></td><td><p>No</p></td><td><p>Recommended</p></td><td><p>Yes</p></td></tr><tr><td><p>15. An observation window, or, alternative, is to be present, so that occupants can be seen</p></td><td><p>Recommended</p></td><td><p>Recommended</p></td><td><p>Yes</p></td></tr><tr><td><div><a>(<span>1</span>)   </a><p>HEPA: High efficiency particulate air</p></div><div><a>(<span>2</span>)   </a><p>Airlock: Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors.</p></div></td></tr></tbody></table>
ANNEX VI
CONTAINMENT FOR INDUSTRIAL PROCESSES
(Article 4(1) and Article 16(2)(a))
Preliminary note
In the table, ‘Recommended’ means that the measures should in principle be applied, unless the results of the assessment referred to in Article 3(2) indicate otherwise.
Group 1 biological agents
For work with group 1 biological agents including live attenuated vaccines, the principles of good occupational safety and hygiene should be observed.
Groups 2, 3 and 4 biological agents
It may be appropriate to select and combine containment requirements from different categories below on the basis of a risk assessment related to any particular process or part of a process.
<table><col/><col/><col/><col/><tbody><tr><td><p>A. Containment measures</p></td><td><p>B. Containment levels</p></td></tr><tr><td><p>2</p></td><td><p>3</p></td><td><p>4</p></td></tr><tr><td><p>General</p></td></tr><tr><td><p>1. Viable organisms should be handled in a system which physically separates the process from the environment</p></td><td><p>Yes</p></td><td><p>Yes</p></td><td><p>Yes</p></td></tr><tr><td><p>2. Exhaust gases from the closed system should be treated so as to:</p></td><td><p>Minimise release</p></td><td><p>Prevent release</p></td><td><p>Prevent release</p></td></tr><tr><td><p>3. Sample collection, addition of materials to a closed system and transfer of viable organisms to another closed system, should be performed so as to:</p></td><td><p>Minimise release</p></td><td><p>Prevent release</p></td><td><p>Prevent release</p></td></tr><tr><td><p>4. Bulk culture fluids should not be removed from the closed system unless the viable organisms have been:</p></td><td><p>Inactivated by validated chemical or physical means</p></td><td><p>Inactivated by validated chemical or physical means</p></td><td><p>Inactivated by validated chemical or physical means</p></td></tr><tr><td><p>5. Seals should be designed so as to:</p></td><td><p>Minimise release</p></td><td><p>Prevent release</p></td><td><p>Prevent release</p></td></tr><tr><td><p>6. The controlled area should be designed to contain spillage of the entire contents of the closed system</p></td><td><p>No</p></td><td><p>Recommended</p></td><td><p>Yes</p></td></tr><tr><td><p>7. The controlled area should be sealable to permit fumigation</p></td><td><p>No</p></td><td><p>Recommended</p></td><td><p>Yes</p></td></tr><tr><td><p>Facilities</p></td></tr><tr><td><p>8. Decontamination and washing facilities should be provided for personnel</p></td><td><p>Yes</p></td><td><p>Yes</p></td><td><p>Yes</p></td></tr><tr><td><p>Equipment</p></td></tr><tr><td><p>9. Input air and extract air to the controlled area should be HEPA <a>(<span>1</span>)</a> filtered</p></td><td><p>No</p></td><td><p>Recommended</p></td><td><p>Yes</p></td></tr><tr><td><p>10. The controlled area should be maintained at an air pressure negative to atmosphere</p></td><td><p>No</p></td><td><p>Recommended</p></td><td><p>Yes</p></td></tr><tr><td><p>11. The controlled area should be adequately ventilated to minimise air contamination</p></td><td><p>Recommended</p></td><td><p>Recommended</p></td><td><p>Yes</p></td></tr><tr><td><p>System of work</p></td></tr><tr><td><p>12. Closed systems <a>(<span>2</span>)</a> should be located within a controlled area</p></td><td><p>Recommended</p></td><td><p>Recommended</p></td><td><p>Yes, and purpose-built</p></td></tr><tr><td><p>13. Biohazard signs should be posted</p></td><td><p>Recommended</p></td><td><p>Yes</p></td><td><p>Yes</p></td></tr><tr><td><p>14. Access should be restricted to nominated personnel only</p></td><td><p>Recommended</p></td><td><p>Yes</p></td><td><p>Yes, via an airlock <a>(<span>3</span>)</a></p></td></tr><tr><td><p>15. Personnel should shower before leaving the controlled area</p></td><td><p>No</p></td><td><p>Recommended</p></td><td><p>Yes</p></td></tr><tr><td><p>16. Personnel should wear protective clothing</p></td><td><p>Yes, work clothing</p></td><td><p>Yes</p></td><td><p>Yes, complete change</p></td></tr><tr><td><p>Waste</p></td></tr><tr><td><p>17. Effluent from sinks and showers should be collected and inactivated before release</p></td><td><p>No</p></td><td><p>Recommended</p></td><td><p>Yes</p></td></tr><tr><td><p>18. Effluent treatment before final discharge</p></td><td><p>Inactivated by validated chemical or physical means</p></td><td><p>Inactivated by validated chemical or physical means</p></td><td><p>Inactivated by validated chemical or physical means</p></td></tr><tr><td><div><a>(<span>1</span>)   </a><p>HEPA: High efficiency particulate air</p></div><div><a>(<span>2</span>)   </a><p>Closed system: A system that physically separates the process from the environment (e.g. incubator vats, tanks, etc.).</p></div><div><a>(<span>3</span>)   </a><p>Airlock: Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors.</p></div></td></tr></tbody></table>
ANNEX VII
RECOMMENDED CODE OF PRACTICE ON VACCINATION
(Article 14(3))
<table><col/><col/><tr><td><p>1.</p></td><td><p>If the assessment referred to in Article 3(2) reveals that there is a risk to the health and safety of workers due to their exposure to biological agents for which effective vaccines exist, their employers should offer them vaccination.</p></td></tr></table>
<table><col/><col/><tr><td><p>2.</p></td><td><p>Vaccination should be carried out in accordance with national law and/or practice.</p><p>Workers should be informed of the benefits and drawbacks of both vaccination and non-vaccination.</p></td></tr></table>
<table><col/><col/><tr><td><p>3.</p></td><td><p>Vaccination must be offered free of charge to workers.</p></td></tr></table>
<table><col/><col/><tr><td><p>4.</p></td><td><p>A vaccination certificate may be drawn up which should be made available to the worker concerned and, on request, to the competent authorities.</p></td></tr></table>
ANNEX VIII
PART A
Repealed Directive with its successive amendments
(referred to in Article 21)
Council Directive 90/679/EEC (OJ L 374, 31.12.1990, p. 1)
Council Directive 93/88/EEC (OJ L 268, 29.10.1993, p. 71)
Commission Directive 95/30/EC (OJ L 155, 6.7.1995, p. 41)
Commission Directive 97/59/EC (OJ L 282, 15.10.1997, p. 33)
Commission Directive 97/65/EC (OJ L 335, 6.12.1997, p. 17)
PART B
Deadlines for transposition into national law
(referred to in Article 21)
<table><col/><col/><tbody><tr><td><p>Directive</p></td><td><p>Deadline for transposition</p></td></tr><tr><td><p>90/679/EEC</p></td><td><p>28 November 1993</p></td></tr><tr><td><p>93/88/EEC</p></td><td><p>30 April 1994</p></td></tr><tr><td><p>95/30/EC</p></td><td><p>30 November 1996</p></td></tr><tr><td><p>97/59/EC</p></td><td><p>31 March 1998</p></td></tr><tr><td><p>97/65/EC</p></td><td><p>30 June 1998</p></td></tr></tbody></table>
ANNEX IX
CORRELATION TABLE
<table><col/><col/><tbody><tr><td><p>Directive 90/679/EEC</p></td><td><p>This Directive</p></td></tr><tr><td><p>Article 1</p></td><td><p>Article 1</p></td></tr><tr><td><p>Article 2, point (a)</p></td><td><p>Article 2, first paragraph, point (a)</p></td></tr><tr><td><p>Article 2, point (b)</p></td><td><p>Article 2, first paragraph, point (b)</p></td></tr><tr><td><p>Article 2, point (c)</p></td><td><p>Article 2, first paragraph, point (c)</p></td></tr><tr><td><p>Article 2, point (d)</p></td><td><p>Article 2, second paragraph</p></td></tr><tr><td><p>Article 3(1)</p></td><td><p>Article 3(1)</p></td></tr><tr><td><p>Article 3(2)(a)</p></td><td><p>Article 3(2), first subparagraph</p></td></tr><tr><td><p>Article 3(2)(b)</p></td><td><p>Article 3(2), second subparagraph</p></td></tr><tr><td><p>Article 3(2)(c)</p></td><td><p>Article 3(2), third subparagraph</p></td></tr><tr><td><p>Article 3(2)(d)</p></td><td><p>Article 3(2), fourth subparagraph</p></td></tr><tr><td><p>Article 3(3), first indent</p></td><td><p>Article 3(3)(a)</p></td></tr><tr><td><p>Article 3(3), second indent</p></td><td><p>Article 3(3)(b)</p></td></tr><tr><td><p>Article 3(3), third indent</p></td><td><p>Article 3(3)(c)</p></td></tr><tr><td><p>Article 3(3), fourth indent</p></td><td><p>Article 3(3)(d)</p></td></tr><tr><td><p>Article 3(3), fifth indent</p></td><td><p>Article 3(3)(e)</p></td></tr><tr><td><p>Article 4</p></td><td><p>Article 4</p></td></tr><tr><td><p>Article 5</p></td><td><p>Article 5</p></td></tr><tr><td><p>Article 6</p></td><td><p>Article 6</p></td></tr><tr><td><p>Article 7(1), first indent</p></td><td><p>Article 7(1)(a)</p></td></tr><tr><td><p>Article 7(1), second indent</p></td><td><p>Article 7(1)(b)</p></td></tr><tr><td><p>Article 7(1), third indent</p></td><td><p>Article 7(1)(c)</p></td></tr><tr><td><p>Article 7(1), fourth indent</p></td><td><p>Article 7(1)(d)</p></td></tr><tr><td><p>Article 7(1), fifth indent</p></td><td><p>Article 7(1)(e)</p></td></tr><tr><td><p>Article 7(1), sixth indent</p></td><td><p>Article 7(1)(f)</p></td></tr><tr><td><p>Article 7(2)</p></td><td><p>Article 7(2)</p></td></tr><tr><td><p>Article 7(3)</p></td><td><p>Article 7(3)</p></td></tr><tr><td><p>Article 8(1)(a) to (e)</p></td><td><p>Article 8(1)(a) to (e)</p></td></tr><tr><td><p>Article 8(2)(a)</p></td><td><p>Article 8(2), first subparagraph</p></td></tr><tr><td><p>Article 8(2)(b)</p></td><td><p>Article 8(2), second subparagraph</p></td></tr><tr><td><p>Article 8(3)</p></td><td><p>Article 8(3)</p></td></tr><tr><td><p>Article 9(1)(a) to (e)</p></td><td><p>Article 9(1)(a) to (e)</p></td></tr><tr><td><p>Article 9(2), first indent</p></td><td><p>Article 9(2)(a)</p></td></tr><tr><td><p>Article 9(2), second indent</p></td><td><p>Article 9(2)(b)</p></td></tr><tr><td><p>Article 9(2), third indent</p></td><td><p>Article 9(2)(c)</p></td></tr><tr><td><p>Article 10(1), first indent</p></td><td><p>Article 10(1)(a)</p></td></tr><tr><td><p>Article 10(1), second indent</p></td><td><p>Article 10(1)(b)</p></td></tr><tr><td><p>Article 10(2) to (6)</p></td><td><p>Article 10(2) to (6)</p></td></tr><tr><td><p>Article 11(1)</p></td><td><p>Article 11(1)</p></td></tr><tr><td><p>Article 11(2), second subparagraph, first indent</p></td><td><p>Article 11(2), second subparagraph, (a)</p></td></tr><tr><td><p>Article 11(2), second subparagraph, second indent</p></td><td><p>Article 11(2), second subparagraph, (b)</p></td></tr><tr><td><p>Article 11(2), second subparagraph, third indent</p></td><td><p>Article 11(2), second subparagraph, (c)</p></td></tr><tr><td><p>Article 11(2), second subparagraph, fourth indent</p></td><td><p>Article 11(2), second subparagraph, (d)</p></td></tr><tr><td><p>Article 11(2), second subparagraph, fifth indent</p></td><td><p>Article 11(2), second subparagraph, (e)</p></td></tr><tr><td><p>Article 11(3)</p></td><td><p>Article 11(3)</p></td></tr><tr><td><p>Article 12</p></td><td><p>Article 12</p></td></tr><tr><td><p>Article 13(1), first indent</p></td><td><p>Article 13(1)(a)</p></td></tr><tr><td><p>Article 13(1), second indent</p></td><td><p>Article 13(1)(b)</p></td></tr><tr><td><p>Article 13(1), third indent</p></td><td><p>Article 13(1)(c)</p></td></tr><tr><td><p>Article 13(2) to (4)</p></td><td><p>Article 13(2) to (4)</p></td></tr><tr><td><p>Article 14(1)</p></td><td><p>Article 14(1)</p></td></tr><tr><td><p>Article 14(2), first indent</p></td><td><p>Article 14(2)(a)</p></td></tr><tr><td><p>Article 14(2), second indent</p></td><td><p>Article 14(2)(b)</p></td></tr><tr><td><p>Article 14(3) to (6)</p></td><td><p>Article 14(3) to (6)</p></td></tr><tr><td><p>Article 14(7), first indent</p></td><td><p>Article 14(7)(a)</p></td></tr><tr><td><p>Article 14(7), second indent</p></td><td><p>Article 14(7)(b)</p></td></tr><tr><td><p>Article 14(8)</p></td><td><p>Article 14(8)</p></td></tr><tr><td><p>Article 14(9)</p></td><td><p>Article 14(9)</p></td></tr><tr><td><p>Article 15</p></td><td><p>Article 15</p></td></tr><tr><td><p>Article 16(1)</p></td><td><p>Article 16(1)</p></td></tr><tr><td><p>Article 16(2)(a)</p></td><td><p>Article 16(2)(a)</p></td></tr><tr><td><p>Article 16(2)(b)</p></td><td><p>Article 16(2)(b)</p></td></tr><tr><td><p>Article 16(2)(c)</p></td><td><p>Article 16(3)</p></td></tr><tr><td><p>Article 17</p></td><td><p>Article 17</p></td></tr><tr><td><p>Article 18(1)</p></td><td><p>—</p></td></tr><tr><td><p>Article 18(2)</p></td><td><p>Article 18(1)</p></td></tr><tr><td><p>Article 18(3)</p></td><td><p>Article 18(2)</p></td></tr><tr><td><p>Article 18(4)</p></td><td><p>Article 18(3)</p></td></tr><tr><td><p>Article 19</p></td><td><p>Article 19</p></td></tr><tr><td><p>Article 20(1)</p></td><td><p>—</p></td></tr><tr><td><p>Article 20(2)</p></td><td><p>Article 20</p></td></tr><tr><td><p>—</p></td><td><p>Article 21</p></td></tr><tr><td><p>—</p></td><td><p>Article 22</p></td></tr><tr><td><p>—</p></td><td><p>Article 23</p></td></tr><tr><td><p>Annex I</p></td><td><p>Annex I</p></td></tr><tr><td><p>Annex II</p></td><td><p>Annex II</p></td></tr><tr><td><p>Annex III</p></td><td><p>Annex III</p></td></tr><tr><td><p>Annex IV</p></td><td><p>Annex IV</p></td></tr><tr><td><p>Annex V</p></td><td><p>Annex V</p></td></tr><tr><td><p>Annex VI</p></td><td><p>Annex VI</p></td></tr><tr><td><p>Annex VII</p></td><td><p>Annex VII</p></td></tr><tr><td><p>—</p></td><td><p>Annex VIII</p></td></tr><tr><td><p>—</p></td><td><p>Annex IX</p></td></tr></tbody></table>
<note>
( 1 ) Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms (OJ L 117, 8.5.1990, p. 1). Directive as last amended by Directive 98/81/EC (OJ L 330, 5.12.1998, p. 13).
( 2 ) Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (OJ L 117, 8.5.1990, p. 15). Directive as last amended by Directive 97/ 35/EC (OJ L 169, 27.6.1997, p. 72).
</note> | ENG | 02000L0054-20200624 |
<table><col/><col/><col/><col/><tbody><tr><td><p>3.11.2022   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 283/13</p></td></tr></tbody></table>
COUNCIL DECISION (EU) 2022/2103
of 13 October 2022
on the position to be taken on behalf of the European Union within the Council of Members of the International Olive Council as regards the elimination of the category ordinary virgin olive oil from Annex B of the International Agreement on Olive Oil and Table Olives, 2015
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207(4), first subparagraph, in conjunction with Article 218(9) thereof,
Having regard to the proposal from the European Commission,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The International Agreement on Olive Oil and Table Olives, 2015 (‘the Agreement’) was signed on behalf of the Union in accordance with Council Decision (EU) 2016/1892 <a>(<span>1</span>)</a> on 18 November 2016, subject to its conclusion at a later date. The Agreement entered into force provisionally on 1 January 2017 in accordance with Article 31(2) thereof.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The Agreement was concluded on 17 May 2019 by Council Decision (EU) 2019/848 <a>(<span>2</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Pursuant to Article 7(1) of the Agreement, the Council of Members of the International Olive Council (‘the Council of Members’) is to adopt decisions that modify the Agreement.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>During its 116<span>th</span> session to be held between 28 November and 2 December 2022, or within the framework of a procedure for adoption of decisions by the Council of Members by exchange of correspondence, the Council of Members is to adopt a decision eliminating the category ‘ordinary virgin olive oil’ from Annex B of the Agreement.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The decision will become binding under international law in accordance with Article 20(1) of the Agreement. It is therefore appropriate to establish the position to be taken on the Union’s behalf in the Council of Members, as the decision to be adopted will have legal effects on the Union.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>As the ‘ordinary virgin olive oil’ category does not exist in Regulation (EU) No 1308/2013 of the European Parliament and of the Council <a>(<span>3</span>)</a>, the decision of the Council of Members should be supported.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The position set out in this Decision should be taken on behalf of the Union at the 116<span>th</span> session of the Council of Members, or within the framework of a procedure for adoption of decisions by the Council of Members by exchange of correspondence, pursuant to Article 10(6) of the Agreement. The procedure for adoption by exchange of correspondence should be initiated before the next regular session of the Council of Members in November 2022,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
The position to be taken on the Union’s behalf within the Council of Members of the International Olive Council during its 116 th session to be held between 28 November and 2 December 2022, or within the framework of a procedure for adoption of decisions by the Council of Members by an exchange of correspondence to be initiated before its next regular session in November 2022, is to support the elimination of the category ‘ordinary virgin olive oil’ from Annex B of the International Agreement on Olive Oil and Table Olives as from 1 January 2026.
Article 2
This Decision shall enter into force on the date of its adoption.
Done at Luxembourg, 13 October 2022.
For the Council
The President
P. BLAŽEK
<note>
( 1 ) Council Decision (EU) 2016/1892 of 10 October 2016 on the signing, on behalf of the European Union, and provisional application of the International Agreement on Olive Oil and Table Olives, 2015 ( OJ L 293, 28.10.2016, p. 2 ).
( 2 ) Council Decision (EU) 2019/848 of 17 May 2019 on the conclusion on behalf of the European Union of the International Agreement on Olive Oil and Table Olives, 2015 ( OJ L 139, 27.5.2019, p. 1 ).
( 3 ) Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( OJ L 347, 20.12.2013, p. 671 ).
</note> | ENG | 32022D2103 |
<table><col/><col/><col/><col/><tbody><tr><td><p>23.12.2016   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 352/55</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2016/2379
of 22 December 2016
establishing the standard import values for determining the entry price of certain fruit and vegetables
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) ,
Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors ( 2 ) , and in particular Article 136(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the<span>Official Journal of the European Union</span>,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 December 2016.
For the Commission,
On behalf of the President,
Jerzy PLEWA
Director-General
Directorate-General for Agriculture and Rural Development
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) OJ L 157, 15.6.2011, p. 1 .
ANNEX
Standard import values for determining the entry price of certain fruit and vegetables
<table><col/><col/><col/><tbody><tr><td><p>(EUR/100 kg)</p></td></tr><tr><td><p>CN code</p></td><td><p>Third country code<a> (<span>1</span>)</a></p></td><td><p>Standard import value</p></td></tr><tr><td><p>0702 00 00</p></td><td><p>MA</p></td><td><p>99,1</p></td></tr><tr><td><p>TN</p></td><td><p>262,8</p></td></tr><tr><td><p>TR</p></td><td><p>115,2</p></td></tr><tr><td><p>ZZ</p></td><td><p>159,0</p></td></tr><tr><td><p>0707 00 05</p></td><td><p>MA</p></td><td><p>79,2</p></td></tr><tr><td><p>TR</p></td><td><p>156,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>117,9</p></td></tr><tr><td><p>0709 93 10</p></td><td><p>MA</p></td><td><p>230,7</p></td></tr><tr><td><p>TR</p></td><td><p>176,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>203,7</p></td></tr><tr><td><p>0805 10 20</p></td><td><p>TR</p></td><td><p>81,7</p></td></tr><tr><td><p>ZA</p></td><td><p>70,9</p></td></tr><tr><td><p>ZZ</p></td><td><p>76,3</p></td></tr><tr><td><p>0805 20 10</p></td><td><p>MA</p></td><td><p>67,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>67,6</p></td></tr><tr><td><p>0805 20 30 , 0805 20 50 , 0805 20 70 , 0805 20 90</p></td><td><p>IL</p></td><td><p>163,3</p></td></tr><tr><td><p>JM</p></td><td><p>129,1</p></td></tr><tr><td><p>TR</p></td><td><p>77,1</p></td></tr><tr><td><p>ZZ</p></td><td><p>123,2</p></td></tr><tr><td><p>0805 50 10</p></td><td><p>AR</p></td><td><p>76,7</p></td></tr><tr><td><p>TR</p></td><td><p>79,2</p></td></tr><tr><td><p>ZZ</p></td><td><p>78,0</p></td></tr><tr><td><p>0808 10 80</p></td><td><p>US</p></td><td><p>132,4</p></td></tr><tr><td><p>ZZ</p></td><td><p>132,4</p></td></tr><tr><td><p>0808 30 90</p></td><td><p>CN</p></td><td><p>87,8</p></td></tr><tr><td><p>ZZ</p></td><td><p>87,8</p></td></tr></tbody></table>
<note>
( 1 ) Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories ( OJ L 328, 28.11.2012, p. 7 ). Code ‘ZZ’ stands for ‘of other origin’.
</note> | ENG | 32016R2379 |
<table><col/><col/><col/><col/><tbody><tr><td><p>23.12.2020   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 434/3</p></td></tr></tbody></table>
COMMISSION DELEGATED REGULATION (EU) 2020/2190
of 29 October 2020
amending Delegated Regulation (EU) 2019/2124 as regards official controls at the border control post where goods leave the Union and certain provisions on transit and transhipment
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) ( 1 ) , and in particular points (b) and (d) of Article 51(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Commission Delegated Regulation (EU) 2019/2124 <a>(<span>2</span>)</a> establishes rules for the performance of official controls by the competent authorities of the Member States <a>(<span>3</span>)</a> on consignments of animals and goods in transit, transhipment and onward transportation through the Union.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Since several operators are involved during transit and transhipment, including importers, transporters, customs agents and traders, it is necessary to indicate that operators responsible for consignments should comply with the rules in Delegated Regulation (EU) 2019/2124.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>In order to ensure traceability of consignments until they leave the Union territory, the official certificate issued in accordance with Commission Implementing Regulation (EU) 2019/2128 <a>(<span>4</span>)</a> is to accompany the consignments from the approved warehouses to the border control posts where the goods leave the Union territory.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>In accordance with Implementing Regulation (EU) 2019/2128, official certificates may be issued in paper format. As a consequence, competent authorities responsible for official controls at NATO or US military bases, competent authorities at the border control posts where goods leave the Union and the representative of the master of a vessel or the operator responsible for delivery of consignments to a vessel leaving the Union territory should also be allowed the possibility of countersigning official certificates that are issued in paper format and returning such official certificates within 15 days from the date when transit was authorised.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>With a view to protecting human and animal health, consignments of products of animal origin, germinal products, animal by-products, derived products, hay and straw and composite products in transit from one third country to another third country may be authorised to pass through the Union territory provided they meet certain conditions. Such conditions should include the proper monitoring of consignments during transit and their due presentation for official controls at the border control post where they leave the Union territory.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>To ensure human and animal health protection, products of animal origin should be added to the commodities to be checked at the border control post where goods leave the Union.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Delegated Regulation (EU) 2019/2124 lays down the specific requirements for transit of animals, products of animal origin, germinal products, animal by-products, derived products, hay and straw and composite products from one part of the Union territory to another part of the Union territory, passing through the territory of a third country.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>After the transition period, which was agreed as part of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (Withdrawal Agreement), products of animal origin, germinal products, animal by-products, derived products, hay and straw and composite products that are moved from one part of the Union territory to another part of the Union territory, passing through the United Kingdom, excluding Northern Ireland, are to be presented for official controls at the border control post of re-introduction into the Union. The notion ‘Union territory’ includes Northern Ireland for the purposes of the application of this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>On the basis of prior notification of arrival of the consignment and documentary checks, the competent authorities of the border control post of re-introduction into the Union should be able to assess whether the consignment in transit may be readmitted into the Union or is to be presented for further controls. This prior notification should be effected by the operator responsible for the consignment. Prior notification and documentary checks should be performed through the information management system for official controls (IMSOC).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>However, several Member States have highlighted practical problems and the considerable administrative burden of using the IMSOC for prior notification and documentary checks in the specific case of transit through the United Kingdom, excluding Northern Ireland.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>In order to avoid any delay resulting from the administrative burden of complying with documentary formalities for the re-introduction of products of animal origin, germinal products, animal by-products, derived products, hay and straw and composite products into the Union, the possibility should be provided for Member States of using an alternative information system that achieves the same objectives as the IMSOC for prior notification and recording of the results of documentary checks at the border control post of re-introduction into the Union after transit through the United Kingdom, excluding Northern Ireland.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>Delegated Regulation (EU) 2019/2124 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>In order to ensure that the measures provided for in this Regulation are effective after the transition period in the Withdrawal Agreement ends, this Regulation should apply from 1 January 2021,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Delegated Regulation (EU) 2019/2124 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Article 2, point (7) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(7)</p></td><td><p>“border control post of introduction into the Union” means the border control post where animals and goods are presented for official controls and through which they enter the Union for subsequent placing on the market or for transit through the Union territory<a> (<span>*</span>)</a> and which may be the border control post of first arrival into the Union;</p></td></tr></tbody></table><p><a>(<span>*</span>)</a>  The notion “Union territory” includes Northern Ireland for the purposes of the application of this Regulation.’;"</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Article 14 is replaced by the following:</p><div><p>‘Article 14</p><p>Storage of transhipped consignments of products of animal origin, germinal products, animal by-products, derived products, hay and straw and composite products</p><p>The operator responsible for consignments of products of animal origin, germinal products, animal by-products, derived products, hay and straw and composite products shall ensure that those consignments are only stored during the transhipment period either in:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the customs or free zone area of the same port or airport in sealed containers; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>commercial storage facilities under the control of the same border control post, in compliance with the conditions laid down in Article 3(11) and (12) of Commission Implementing Regulation (EU) 2019/1014<a> (<span>**</span>)</a>.</p></td></tr></tbody></table></div><p><a>(<span>**</span>)</a>  Commission Implementing Regulation (EU) 2019/1014 of 12 June 2019 to lay down detailed rules on minimum requirements for border control posts, including inspection centres, and for the format, categories and abbreviations to use for listing border control posts and control points (<a>OJ L 165, 21.6.2019, p. 10</a>).’;"</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>in Article 29, point (c) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(c)</p></td><td><p>the operator responsible for the consignment ensures that an official certificate in accordance with the model set out in the Annex to Implementing Regulation (EU) 2019/2128 accompanies the consignment to its place of destination or to the border control post where the goods leave the Union territory;’;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Article 31 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>paragraph 2 is replaced by the following:</p><div><p>‘2.   The operator responsible for the consignments of goods referred to in paragraph 1 may unload those consignments at the port of destination before the delivery of the consignments to the vessel leaving the Union territory provided that the operation is authorised and supervised by the customs authority, and the conditions of delivery indicated in the notification referred to in paragraph 1 are met.’;</p></div></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>paragraph 4 is replaced by the following:</p><div><p>‘4.   The representative referred to in paragraph 3 or the operator responsible for the delivery of the consignments to the vessel leaving the Union territory shall return to the competent authorities of the border control post of introduction into the Union or of the warehouse, within a period of 15 days from the date on which transit was authorised at the border control post of introduction into the Union or at the warehouse, the countersigned official certificate referred to in point (a) of paragraph 3.’;</p></div></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Article 32 is replaced by the following:</p><div><p>‘Article 32</p><p>Operator’s obligations to present goods leaving the Union territory for official controls</p><div><p>1.   The operator responsible for consignments of products of animal origin, germinal products, animal by-products, derived products, hay and straw and composite products that leave the Union territory to be transported to a third country shall present those consignments for official controls to the competent authorities of the border control post indicated in the CHED, at a location indicated by those competent authorities.</p></div><div><p>2.   The operator responsible for the consignments of goods referred to in paragraph 1 that leave the Union territory to be dispatched to a NATO or US military base located in a third country shall present those consignments for official controls to the competent authorities of the border control post indicated in the official certificate issued in accordance with the model set out in the Annex to Implementing Regulation (EU) 2019/2128.’;</p></div></div></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Article 33 is replaced by the following:</p><div><p>‘Article 33</p><p>Official controls at the border control post where goods leave the Union territory</p><div><p>1.   The competent authorities of the border control post where products of animal origin, germinal products, animal by-products, derived products, hay and straw and composite products leave the Union territory shall perform an identity check to ensure that the consignment presented corresponds to the consignment referred to in the CHED or in the official certificate issued in accordance with the model set out in the Annex to Implementing Regulation (EU) 2019/2128 accompanying the consignment. In particular, they shall verify that the seals fixed on the vehicles or transport containers in accordance with point (d) of Article 19, point (d) of Article 28 or point (e) of Article 29 are still intact.</p></div><div><p>2.   The competent authorities of the border control post where goods referred to in paragraph 1 leave the Union territory shall record the outcome of official controls in part III of the CHED or part III of the official certificate issued in accordance with the model set out in the Annex to Implementing Regulation (EU) 2019/2128.</p></div><div><p>3.   The competent authorities of the border control post responsible for the checks referred to in paragraph 1 shall confirm to the competent authorities of the border control post of introduction into Union or of the warehouse, within a period of 15 days from the date on which transit was authorised at the border control post of introduction into the Union or at the warehouse, the arrival and compliance of the consignment with this Regulation, either by:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>entering the relevant information in the IMSOC; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>countersigning the official certificate issued in accordance with the model set out in the Annex to Implementing Regulation (EU) 2019/2128 and returning to the competent authorities of the warehouse the original certificate or transmitting a copy thereof.’;</p></td></tr></tbody></table></div></div></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Article 35 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>paragraph 2 is replaced by the following:</p><div><p>‘2.   The competent authorities responsible for controls at the NATO or US military base at the place of destination shall perform an identity check to confirm that the consignment corresponds to the one covered by the CHED or by the accompanying official certificate issued in accordance with the model set out in the Annex to Implementing Regulation (EU) 2019/2128. In particular, they shall verify that the seals fixed on the vehicles or transport containers in accordance with point (d) of Article 19 and point (e) of Article 29 are still intact.’;</p></div></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the following paragraph 3 is added:</p><div><p>‘3.   The competent authorities responsible for controls at the NATO or US military base at the place of destination shall confirm to the competent authorities of the border control post of introduction into the Union or of the warehouse, within a period of 15 days from the date on which transit was authorised at the border control post of introduction into the Union or at the warehouse, the arrival and compliance of the consignment with this Regulation, either by:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>entering the relevant information in the IMSOC; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>countersigning the official certificate issued in accordance with the model set out in the Annex to Implementing Regulation (EU) 2019/2128 and returning to the competent authorities of the warehouse the original certificate or transmitting a copy thereof.’;</p></td></tr></tbody></table></div></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>in Article 36, paragraph 3 is replaced by the following:</p><div><p>‘3.   The operator responsible for the consignment of goods referred to in paragraph 1 shall directly transport the consignment to one of the following destinations:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the border control post which authorised transit through the Union; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the warehouse where it was stored before refusal by a third country.’;</p></td></tr></tbody></table></div></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>Article 37 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the following paragraph 4a is inserted:</p><div><p>‘4a.   For the consignments of goods referred to in paragraph 1 of this Article that are not subject to animal health requirements for entry into the Union in accordance with the rules referred to in points (d) and (e) of Article 1(2) of Regulation (EU) 2017/625 and that are moved from one part of the Union territory to another part of the Union territory, passing through the United Kingdom, excluding Northern Ireland, the operators referred to in paragraph 2 of this Article may give prior notification of arrival of those consignments to the competent authorities of the border control post of re-introduction into the Union through an information system or a combination of information systems other than the IMSOC, provided such system or combination of systems:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>has been designated by the competent authorities;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>allows the operators to provide the following information:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the description of the goods in transit;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>the identification of the means of transport;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>the estimated time of arrival;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>the origin and destination of the consignments; and</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>allows the competent authorities of the border control post of re-introduction into the Union to:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>assess the information provided by the operators;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>inform the operators if the consignments must be presented for the additional checks provided for in paragraph 4.’;</p></td></tr></tbody></table></td></tr></tbody></table></div></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>paragraph 5 is replaced by the following:</p><div><p>‘5.   The operators responsible for consignments of animals that are moved from one part of the Union territory to another part of the Union territory, passing through the territory of a third country, shall present those consignments for official controls at the exit point from the Union territory.’.</p></div></td></tr></tbody></table></td></tr></tbody></table>
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
It shall apply from 1 January 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 October 2020.
For the Commission
The President
Ursula VON DER LEYEN
<note>
( 1 ) OJ L 95, 7.4.2017, p. 1 .
( 2 ) Commission Delegated Regulation (EU) 2019/2124 of 10 October 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards rules for official controls of consignments of animals and goods in transit, transhipment and onward transportation through the Union, and amending Commission Regulations (EC) No 798/2008, (EC) No 1251/2008, (EC) No 119/2009, (EU) No 206/2010, (EU) No 605/2010, (EU) No 142/2011, (EU) No 28/2012, Commission Implementing Regulation (EU) 2016/759 and Commission Decision 2007/777/EC ( OJ L 321, 12.12.2019, p. 73 ).
( 3 ) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, this Regulation applies to and in the United Kingdom in respect of Northern Ireland.
( 4 ) Commission Implementing Regulation (EU) 2019/2128 of 12 November 2019 establishing the model official certificate and rules for issuing official certificates for goods which are delivered to vessels leaving the Union and intended for ship supply or consumption by the crew and passengers, or to NATO or a United States’ military base ( OJ L 321, 12.12.2019, p. 114 ).
</note> | ENG | 32020R2190 |
<table><col/><col/><col/><col/><tbody><tr><td><p>22.4.2022   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 121/12</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2022/664
of 21 April 2022
amending Implementing Regulation (EU) 2019/159 imposing a definitive safeguard measure against imports of certain steel products
THE EUROPEAN COMMISSION,
Having regard to Regulation (EU) 2015/478 of the European Parliament and of the Council of 11 March 2015 on common rules for imports ( 1 ) and in particular Articles 16 and 20 thereof,
Having regard to Regulation (EU) 2015/755 of the European Parliament and of the Council of 29 April 2015 on common rules for imports from certain third countries ( 2 ) , and in particular Articles 13 and 16 thereof,
Whereas:
1. BACKGROUND
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>By Commission Implementing Regulation (EU) 2018/1013 <a>(<span>3</span>)</a> the European Commission (‘the Commission’) imposed a provisional safeguard measure on certain steel products (‘the provisional measure’).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>By Commission Implementing Regulation (EU) 2018/1712 <a>(<span>4</span>)</a> and in application of the provisions of the Economic Partnership Agreement (‘EPA’) between the Southern African Development Community (‘SADC’) and the European Union <a>(<span>5</span>)</a>, the Commission excluded these countries from the application of the safeguard measure.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>By Commission Implementing Regulation (EU) 2019/159 <a>(<span>6</span>)</a>, the Commission imposed a definitive safeguard measure on certain steel products (‘the definitive safeguard measure’), which consists of tariff-rate quotas (‘TRQs’) with respect to certain steel products (‘the product concerned’) encompassing 26 product categories, set at levels preserving traditional trade flows on a per-product-category basis. A 25 % tariff duty applies only if the quantitative thresholds of these TRQs are exceeded.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>By Commission Implementing Regulation (EU) 2021/1029 <a>(<span>7</span>)</a>, the Commission prolonged the duration of the safeguard measure until 30 June 2024.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>By Commission Implementing Regulation (EU) 2022/434 <a>(<span>8</span>)</a> the Commission adjusted the distribution of quota volumes in certain product categories following the imposition of an import ban on products from Russia and Belarus.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Certain countries with which the Union has signed an Economic Partnership Agreement (‘certain EPA countries’) <a>(<span>9</span>)</a> were excluded from the application of the definitive measure, and its subsequent amendments, including its prolongation. The exclusion of certain EPA countries from the definitive safeguard measure was justified by the provisions of Article 33 of the EPA. However, the exclusion provided for in the EPA was limited in time and it has now expired as regards certain EPA countries. Accordingly, and in order to respect the Most Favoured Nation (‘MFN’) obligation under WTO rules, certain EPA countries <a>(<span>10</span>)</a> should be brought within the scope of application of the safeguard measure <a>(<span>11</span>)</a>.</p></td></tr></tbody></table>
2. ANALYSIS
2.1. Increased imports
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The import data of certain EPA countries was not part of the finding of increased imports made by the Commission in the Definitive Safeguard Regulation <a>(<span>12</span>)</a>. This was in application of the principle of parallelism <a>(<span>13</span>)</a>, whereby the investigating authority cannot consider in its analysis of whether imports had increased imports from those origins excluded from the application of the measure.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Since imports from certain EPA countries can no longer benefit from the exclusion under the EPA, the Commission needs to reassess the original finding of increased imports by incorporating the import data from certain EPA countries.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>The evolution of imports in the period considered in the Definitive Safeguard Regulation, updated by including certain EPA countries import volumes, is shown in the following tables: first, for the product concerned (Table 1); and then, as a supplementary analysis, on a per product family basis (Table 2).</p><p><span>Table 1</span></p><p><span>Import volume (after inclusion of certain EPA countries) and market share</span></p><table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>2013</p></td><td><p>2014</p></td><td><p>2015</p></td><td><p>2016</p></td><td><p>2017</p></td><td><p>MRP</p></td></tr><tr><td><p>Imports (000 tonnes)</p></td><td><p>18 454</p></td><td><p>22 012</p></td><td><p>26 693</p></td><td><p>29 283</p></td><td><p>30 271</p></td><td><p>31 476</p></td></tr><tr><td><p><span>Index 2013=100</span></p></td><td><p><span>100</span></p></td><td><p><span>119</span></p></td><td><p><span>145</span></p></td><td><p><span>159</span></p></td><td><p><span>164</span></p></td><td><p><span>171</span></p></td></tr><tr><td><p>Market share</p></td><td><p>12,78 %</p></td><td><p>14,48 %</p></td><td><p>16,97 %</p></td><td><p>17,97 %</p></td><td><p>18,19 %</p></td><td><p>18,88 %</p></td></tr><tr><td><p><span>Source:</span> Eurostat and 2018 Union Industry questionnaire replies.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>Imports increased in absolute terms by 71 % during the period of analysis, and in relative terms with market shares increasing from 12,78 % to 18,88 % from 2013 to MRP.</p><p><span>Table 2</span></p><p><span>Import volume (after inclusion of certain EPA countries) and market share – per product family</span></p><table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>2013</p></td><td><p>2014</p></td><td><p>2015</p></td><td><p>2016</p></td><td><p>2017</p></td><td><p>MRP</p></td></tr><tr><td><p><span>Flat products</span></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Imports (000 tonnes)</p></td><td><p>12 405</p></td><td><p>14 301</p></td><td><p>18 509</p></td><td><p>20 405</p></td><td><p>20 457</p></td><td><p>20 342</p></td></tr><tr><td><p><span>Index 2013=100</span></p></td><td><p><span>100</span></p></td><td><p><span>115</span></p></td><td><p><span>149</span></p></td><td><p><span>165</span></p></td><td><p><span>165</span></p></td><td><p><span>164</span></p></td></tr><tr><td><p>Market share</p></td><td><p>14,28  %</p></td><td><p>15,88  %</p></td><td><p>19,50  %</p></td><td><p>20,80  %</p></td><td><p>21,03  %</p></td><td><p>21,01  %</p></td></tr><tr><td><p><span>Long products</span></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Imports (000 tonnes)</p></td><td><p>4 039</p></td><td><p>5 308</p></td><td><p>6 042</p></td><td><p>6 560</p></td><td><p>6 474</p></td><td><p>7 913</p></td></tr><tr><td><p><span>Index 2013=100</span></p></td><td><p><span>100</span></p></td><td><p><span>131</span></p></td><td><p><span>150</span></p></td><td><p><span>162</span></p></td><td><p><span>160</span></p></td><td><p><span>196</span></p></td></tr><tr><td><p>Market share</p></td><td><p>8,67  %</p></td><td><p>10,69  %</p></td><td><p>11,82  %</p></td><td><p>12,42  %</p></td><td><p>11,82  %</p></td><td><p>14,02  %</p></td></tr><tr><td><p><span>Tubes</span></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Imports (000 tonnes)</p></td><td><p>2 010</p></td><td><p>2 403</p></td><td><p>2 142</p></td><td><p>2 317</p></td><td><p>3 339</p></td><td><p>3 221</p></td></tr><tr><td><p><span>Index 2013=100</span></p></td><td><p><span>100</span></p></td><td><p><span>120</span></p></td><td><p><span>107</span></p></td><td><p><span>115</span></p></td><td><p><span>166</span></p></td><td><p><span>160</span></p></td></tr><tr><td><p>Market share</p></td><td><p>20,47  %</p></td><td><p>20,85  %</p></td><td><p>19,96  %</p></td><td><p>20,15  %</p></td><td><p>25,35  %</p></td><td><p>25,75  %</p></td></tr><tr><td><p><span>Source:</span> Eurostat and 2018 Union Industry questionnaire replies.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>Imports increased in all three product families (flat products, long products and tubes) in absolute terms by respectively 64 %, 96 % and 60 % during 2013-MRP. In the same period, imports also increased in relative terms with market shares increasing respectively from 14,28 % to 21,01 %, 8,67 % to 14,02 % and 20,47 % to 25,75 %.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>Therefore, the Commission confirmed that, after the inclusion of imports from certain EPA countries, there had been an increase of imports, both in absolute and relative terms for the product concerned in the period considered. In fact, this increase in imports is even larger than the one established by the Commission in the Definitive Safeguard Regulation. Thus, the Commission confirmed the findings of the definitive measure that an increase in imports of the product concerned took place, and that finding was further corroborated by the supplementary analysis undertaken at the level of each of the three product families.</p></td></tr></tbody></table>
2.2. Unforeseen developments
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>In recitals (48) to (62) of the Definitive Safeguard Regulation <a>(<span>14</span>)</a>, the Commission described in detail the unforeseen developments it had identified which had led to the increase in imports.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>The nature of those unforeseen developments encompasses a wide array of actions, developments and measures affecting the steel market on a worldwide scale. The addition into the analysis of certain EPA countries, which represent a minor share in the overall level of world steel production capacity <a>(<span>15</span>)</a> can therefore not change the findings made by the Commission in the Definitive Safeguard Regulation in this respect.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>Therefore, the findings regarding unforeseen developments of the Definitive Safeguard Regulation are confirmed.</p></td></tr></tbody></table>
2.3. Threat of serious injury, causation and Union interest
<table><col/><col/><tbody><tr><td><p>(16)</p></td><td><p>The addition of certain EPA countries’ imports into the analysis in any event has shown that the level of increased imports was even larger than in their absence. Therefore, the findings with regard to threat of serious injury, causation and Union interest made in the Definitive Safeguard Regulation remain valid.</p></td></tr></tbody></table>
2.4. Conclusion
<table><col/><col/><tbody><tr><td><p>(17)</p></td><td><p>In view of the above findings, the Commission confirmed that after the inclusion in the analysis of the imports from certain EPA countries, the original findings with regard to increase in imports, unforeseen developments, threat of serious injury, causation and Union interest remain valid.</p></td></tr></tbody></table>
3. UPDATE OF LIST OF DEVELOPING COUNTRIES SUBJECT TO MEASURES
<table><col/><col/><tbody><tr><td><p>(18)</p></td><td><p>The Commission calculated whether, in application of Article 18 of Regulation (EU) 2015/478 regarding developing countries member of the WTO, any of the certain EPA countries exceeded the relevant threshold of imports in each product category. The Commission based its calculation on the data concerning the year 2019 imports dataset in order to ensure consistency with the approach used for the measure currently in place.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(19)</p></td><td><p>The changes to the developing country exclusions are as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>South Africa is included under the measure in product categories 8, 9 and 10.</p></td></tr></tbody></table></td></tr></tbody></table>
4. LEVEL AND ALLOCATION OF TRQS
<table><col/><col/><tbody><tr><td><p>(20)</p></td><td><p>By including imports from certain EPA countries under the measure, the level of TRQs for each product category and allocation of TRQs (where appropriate) needs to be revised in line with the principle of parallelism, so that the volumes of quotas available correspond to the historical volumes of imports <a>(<span>16</span>)</a> from the countries subject to the measure.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(21)</p></td><td><p>In terms of the methodology used, the Commission followed the same approach underpinning the calculation and allocation of quotas in the Definitive Safeguard Regulation, only updating the figures resulting from the addition of imports from certain EPA countries.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(22)</p></td><td><p>The baseline to calculate the TRQ volume was based on the reference period (namely average imports in the period 2015-2017). Therefore, the Commission recalculated the average volume of imports in the reference period <a>(<span>17</span>)</a>, per product category, including where appropriate imports from certain EPA countries <a>(<span>18</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(23)</p></td><td><p>The Commission recalculated the volume of TRQs by adding to the average volume of imports in the reference period the subsequent increases of quota that have taken place since the imposition of the definitive safeguard measure <a>(<span>19</span>)</a>. The Commission also took into account the changes in quota introduced by Regulation (EU) 2022/434.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(24)</p></td><td><p>For the periods as of 1 July 2022 onwards, the Commission added, where applicable, the quota volumes corresponding to certain EPA countries’ imports.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(25)</p></td><td><p>For the quarter April-June 2022, which was ongoing when this Regulation entered into force, the Commission recalculated proportionally the amount of quota that will be added, where applicable, to the quota volumes initially available in the ongoing quarter <a>(<span>20</span>)</a> from the day this Regulation is applicable (1 May 2022) until 30 June 2022, when the current safeguard period <a>(<span>21</span>)</a> will conclude.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(26)</p></td><td><p>Regarding the allocation of quotas, and in order to determine whether any of the certain EPA countries qualified for a country-specific quota <a>(<span>22</span>)</a> the Commission assessed, for each of these countries <a>(<span>23</span>)</a>, whether their level of imports was least 5% of total imports in the reference period (in each product category).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(27)</p></td><td><p>As explained in recital (20) above, only South Africa exceeds the relevant thresholds of Article 18 of Regulation (EU) 2015/478 and it is therefore not benefitting from the developing country exemption. The Commission thus assessed the situation of South Africa in the three product categories where it is subject to the measure. The result is as follows:</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(28)</p></td><td><p>Category 8 is administered globally. Therefore, South Africa will be part of the global quota. The proportional share of its historical import volumes will be added to the global quota volumes in this category. For categories 9 and 10, South Africa will receive country-specific quotas in line with its historical import volumes.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(29)</p></td><td><p>An Implementing Regulation to be published once the ongoing functioning review investigation initiated on 17 December 2021 ends, will update the TRQ volumes in the Annex for the period starting on 1 July 2022. This Regulation will apply as of 1 May 2022 in order to provide sufficient notice to all economic operators.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(30)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Committee on Safeguards established under Article 3(3) of Regulation (EU) 2015/478 and Article 22(3) of Regulation (EU) 2015/755 respectively,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EU) 2019/159 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>point III.2 in Annex III is replaced by Annex I to this Regulation;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Annex IV is replaced by Annex II to this Regulation;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>the text in Article 6, paragraph 2, is replaced by ‘Mozambique shall also not be subject to the measures set out in Article 1.’.</p></td></tr></tbody></table>
Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union .
It shall apply as of 1 May 2022.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 21 April 2022.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) Regulation (EU) 2015/478 of the European Parliament and of the Council of 11 March 2015 on common rules for imports ( OJ L 83, 27.3.2015, p. 16 ).
( 2 ) Regulation (EU) 2015/755 of the European Parliament and of the Council of 29 April 2015 on common rules for imports from certain third countries ( OJ L 123, 19.5.2015, p. 33 ).
( 3 ) Commission Implementing Regulation (EU) 2018/1013of 17 July 2018 imposing provisional safeguard measures with regard to imports of certain steel products ( OJ L 181, 18.7.2018, p. 39 ).
( 4 ) Commission Implementing Regulation (EU) 2018/1712 of 13 November 2018 amending Implementing Regulation (EU) 2018/1013 imposing provisional safeguard measures with regard to imports of certain steel products ( OJ L 286, 14.11.2018, p. 17 ).
( 5 ) OJ L 250, 16.9.2016, p. 3 .
( 6 ) Commission Implementing Regulation (EU) 2019/159 of 31 January 2019 imposing a definitive safeguard measure against imports of certain steel products ( OJ L 31, 1.2.2019, p. 27 ) (‘Definitive Safeguard Regulation’).
( 7 ) Commission Implementing Regulation (EU) 2021/1029 of 24 June 2021 amending Commission Implementing Regulation (EU) 2019/159 to prolong the safeguard measure on imports of certain steel products ( OJ L 225 I, 25.6.2021, p. 1 ).
( 8 ) Commission Implementing Regulation (EU) 2022/434 of 15 March 2022 amending Regulation (EU) 2019/159 imposing a definitive safeguard measure against imports of certain steel products ( OJ L 88, 16.3.2022, p. 181 ).
( 9 ) Botswana, Cameroon, Eswatini, Fiji, Ghana, Ivory Coast, Lesotho, Namibia and South Africa.
( 10 ) Certain EPA countries are developing countries and WTO members, therefore they can benefit from ‘developing country’ exclusions, when the relevant conditions are met, in line with EU and WTO rules.
( 11 ) This does not apply to Mozambique as the EPA entered into provisional application for Mozambique on 4 February 2018. Thus, the exemption under the EPA remains in force.
( 12 ) See recitals (27) to (47) of Commission Implementing Regulation (EU) 2019/159.
( 13 ) Appellate Body Report, Argentine – Safeguard Measures on Imports of Footwear (WT/DS121/AB/R), 14 December 1999, para. 113.
( 14 ) As well as the findings in recitals (30) to (36) of the provisional measure.
( 15 ) See, as an example, ‘OECD: Latest Developments in Steelmaking Capacity, 2021’, Table 6. Available at: https://www.oecd.org/industry/ind/latest-developments-in-steelmaking-capacity-2021.pdf
( 16 ) In addition to liberalisation and other changes to the quotas that may have taken place.
( 17 ) See recital (146) of Definitive Safeguard Regulation.
( 18 ) The Commission only updated the volumes of those categories that registered imports from SADC countries in the reference period. If in the reference period there were no imports from these countries in a given category, then the TRQ volumes for such category remain unchanged.
( 19 ) The level of quotas was topped-up by 5 % upon entry into force of the definitive safeguard measure, and it was subsequently increased by 3 % every 1 July as a result of progressive liberalisation.
( 20 ) The quota volumes initially available in this quarter were defined last by Commission Implementing Regulation (EU) 2022/434.
( 21 ) The current safeguard period refers to the period 1 July 2021 – 30 June 2022.
( 22 ) See recital (147) of the Definitive Safeguard Regulation.
( 23 ) Where they were not below the threshold for developing country exclusions as per Article 18 Regulation (EU) 2015/478.
ANNEX I
‘III.2 — List of product categories originating in developing countries to which the definitive measures apply
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Country / Product group</p></td><td><p>1</p></td><td><p>2</p></td><td><p>3A</p></td><td><p>3B</p></td><td><p>4A</p></td><td><p>4B</p></td><td><p>5</p></td><td><p>6</p></td><td><p>7</p></td><td><p>8</p></td><td><p>9</p></td><td><p>10</p></td><td><p>12</p></td><td><p>13</p></td><td><p>14</p></td><td><p>15</p></td><td><p>16</p></td><td><p>17</p></td><td><p>18</p></td><td><p>19</p></td><td><p>20</p></td><td><p>21</p></td><td><p>22</p></td><td><p>24</p></td><td><p>25A</p></td><td><p>25B</p></td><td><p>26</p></td><td><p>27</p></td><td><p>28</p></td></tr><tr><td><p>Brazil</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>China</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td></tr><tr><td><p>India</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Indonesia</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Malaysia</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Mexico</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Moldova</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>North Macedonia</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>South Africa</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Thailand</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Tunisia</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Turkey</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td></tr><tr><td><p>Ukraine</p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td></tr><tr><td><p>United Arab Emirates</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Vietnam</p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>All other developing countries</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X’</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr></tbody></table>
ANNEX II
‘ANNEX IV
IV.1 – Volumes of tariff–rate quotas
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Product Number</p></td><td><p>Product category</p></td><td><p>CN Codes</p></td><td><p>Allocation by country (Where Applicable)</p></td><td><p>Year 1</p></td><td><p>Year 2</p></td><td><p>Year 3</p></td><td><p>Additional duty rate</p></td><td><p>Order numbers</p></td></tr><tr><td><p>From 1.7.2021 to 30.9.2021</p></td><td><p>From 1.10.2021 to 31.12.2021</p></td><td><p>From 1.1.2022 to 31.3.2022</p></td><td><p>From 1.4.2022 to 30.6.2022</p></td><td><p>From 1.7.2022 to 30.9.2022</p></td><td><p>From 1.10.2022 to 31.12.2022</p></td><td><p>From 1.1.2023 to 31.3.2023</p></td><td><p>From 1.4.2023 to 30.6.2023</p></td><td><p>From 1.7.2023 to 30.9.2023</p></td><td><p>From 1.10.2023 to 31.12.2023</p></td><td><p>From 1.1.2024 to 31.3.2024</p></td><td><p>From 1.4.2024 to 30.6.2024</p></td></tr><tr><td><p>Volume of tariff quota (net tonnes)</p></td><td><p>Volume of tariff quota (net tonnes)</p></td><td><p>Volume of tariff quota (net tonnes)</p></td></tr><tr><td><p>1</p></td><td><p>y and Other Alloy Hot Rolled Sheets and Strips</p></td><td><p>7208 10 00 , 7208 25 00 , 7208 26 00 , 7208 27 00 , 7208 36 00 , 7208 37 00 , 7208 38 00 , 7208 39 00 , 7208 40 00 , 7208 52 99 , 7208 53 90 , 7208 54 00 , 7211 14 00 , 7211 19 00 , 7212 60 00 , 7225 19 10 , 7225 30 10 , 7225 30 30 , 7225 30 90 , 7225 40 15 , 7225 40 90 , 7226 19 10 , 7226 91 20 , 7226 91 91 , 7226 91 99</p></td><td><p>Russian Federation</p></td><td><p>416 848,18</p></td><td><p>416 848,18</p></td><td><p>407 786,27</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8966</p></td></tr><tr><td><p>Turkey</p></td><td><p>330 387,67</p></td><td><p>330 387,67</p></td><td><p>323 205,33</p></td><td><p>430 246,90</p></td><td><p>448 024,13</p></td><td><p>448 024,13</p></td><td><p>438 284,48</p></td><td><p>443 154,30</p></td><td><p>461 464,85</p></td><td><p>461 464,85</p></td><td><p>451 433,01</p></td><td><p>456 448,93</p></td><td><p>25 %</p></td><td><p>09.8967</p></td></tr><tr><td><p>India</p></td><td><p>169 717,08</p></td><td><p>169 717,08</p></td><td><p>166 027,58</p></td><td><p>273 178,15</p></td><td><p>284 465,51</p></td><td><p>284 465,51</p></td><td><p>278 281,48</p></td><td><p>281 373,50</p></td><td><p>292 999,48</p></td><td><p>292 999,48</p></td><td><p>286 629,92</p></td><td><p>289 814,70</p></td><td><p>25 %</p></td><td><p>09.8968</p></td></tr><tr><td><p>Korea, Republic of</p></td><td><p>135 867,52</p></td><td><p>135 867,52</p></td><td><p>132 913,87</p></td><td><p>170 592,15</p></td><td><p>177 640,79</p></td><td><p>177 640,79</p></td><td><p>173 779,03</p></td><td><p>175 709,91</p></td><td><p>182 970,01</p></td><td><p>182 970,01</p></td><td><p>178 992,40</p></td><td><p>180 981,21</p></td><td><p>25 %</p></td><td><p>09.8969</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>120 514,16</p></td><td><p>120 514,16</p></td><td><p>117 894,29</p></td><td><p>142 706,31</p></td><td><p>148 602,75</p></td><td><p>148 602,75</p></td><td><p>145 372,25</p></td><td><p>146 987,50</p></td><td><p>153 060,83</p></td><td><p>153 060,83</p></td><td><p>149 733,42</p></td><td><p>151 397,12</p></td><td><p>25 %</p></td><td><p>09.8976</p></td></tr><tr><td><p>Serbia</p></td><td><p>119 634,36</p></td><td><p>119 634,36</p></td><td><p>117 033,62</p></td><td><p>151 443,06</p></td><td><p>157 700,49</p></td><td><p>157 700,49</p></td><td><p>154 272,22</p></td><td><p>155 986,36</p></td><td><p>162 431,51</p></td><td><p>162 431,51</p></td><td><p>158 900,39</p></td><td><p>160 665,95</p></td><td><p>25 %</p></td><td><p>09.8970</p></td></tr><tr><td><p>Other countries</p></td><td><p>1 020 975,90</p></td><td><p>1 020 975,90</p></td><td><p>998 780,77</p></td><td><p>1 120 627,94</p></td><td><p>1 166 931,42</p></td><td><p>1 166 931,42</p></td><td><p>1 141 563,34</p></td><td><p>1 154 247,38</p></td><td><p>1 201 939,35</p></td><td><p>1 201 939,35</p></td><td><p>1 175 810,26</p></td><td><p>1 188 874,80</p></td><td><p>25 %</p></td><td><p><a> (<span>1</span>)</a></p></td></tr><tr><td><p>2</p></td><td><p>Non Alloy and Other Alloy Cold Rolled Sheets</p></td><td><p>7209 15 00 , 7209 16 90 , 7209 17 90 , 7209 18 91 , 7209 25 00 , 7209 26 90 , 7209 27 90 , 7209 28 90 , 7209 90 20 , 7209 90 80 , 7211 23 20 , 7211 23 30 , 7211 23 80 , 7211 29 00 , 7211 90 20 , 7211 90 80 , 7225 50 20 , 7225 50 80 , 7226 20 00 , 7226 92 00</p></td><td><p>India</p></td><td><p>150 937,31</p></td><td><p>150 937,31</p></td><td><p>147 656,06</p></td><td><p>149 296,69</p></td><td><p>155 465,43</p></td><td><p>155 465,43</p></td><td><p>152 085,74</p></td><td><p>153 775,59</p></td><td><p>160 129,39</p></td><td><p>160 129,39</p></td><td><p>156 648,32</p></td><td><p>158 388,85</p></td><td><p>25 %</p></td><td><p>09.8801</p></td></tr><tr><td><p>Korea, Republic of</p></td><td><p>87 540,62</p></td><td><p>87 540,62</p></td><td><p>85 637,56</p></td><td><p>86 589,09</p></td><td><p>90 166,83</p></td><td><p>90 166,83</p></td><td><p>88 206,69</p></td><td><p>89 186,76</p></td><td><p>92 871,84</p></td><td><p>92 871,84</p></td><td><p>90 852,89</p></td><td><p>91 862,36</p></td><td><p>25 %</p></td><td><p>09.8802</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>80 906,72</p></td><td><p>80 906,72</p></td><td><p>79 147,88</p></td><td><p>80 027,30</p></td><td><p>83 333,92</p></td><td><p>83 333,92</p></td><td><p>81 522,32</p></td><td><p>82 428,12</p></td><td><p>85 833,94</p></td><td><p>85 833,94</p></td><td><p>83 967,99</p></td><td><p>84 900,96</p></td><td><p>25 %</p></td><td><p>09.8977</p></td></tr><tr><td><p>Ukraine</p></td><td><p>67 209,91</p></td><td><p>67 209,91</p></td><td><p>65 748,82</p></td><td><p>66 479,37</p></td><td><p>69 226,21</p></td><td><p>69 226,21</p></td><td><p>67 721,29</p></td><td><p>68 473,75</p></td><td><p>71 302,99</p></td><td><p>71 302,99</p></td><td><p>69 752,93</p></td><td><p>70 527,96</p></td><td><p>25 %</p></td><td><p>09.8803</p></td></tr><tr><td><p>Brazil</p></td><td><p>43 002,88</p></td><td><p>43 002,88</p></td><td><p>42 068,04</p></td><td><p>42 535,46</p></td><td><p>44 292,97</p></td><td><p>44 292,97</p></td><td><p>43 330,08</p></td><td><p>43 811,52</p></td><td><p>45 621,76</p></td><td><p>45 621,76</p></td><td><p>44 629,98</p></td><td><p>45 125,87</p></td><td><p>25 %</p></td><td><p>09.8804</p></td></tr><tr><td><p>Serbia</p></td><td><p>38 107,42</p></td><td><p>38 107,42</p></td><td><p>37 279,00</p></td><td><p>37 693,21</p></td><td><p>39 250,64</p></td><td><p>39 250,64</p></td><td><p>38 397,37</p></td><td><p>38 824,00</p></td><td><p>40 428,16</p></td><td><p>40 428,16</p></td><td><p>39 549,29</p></td><td><p>39 988,72</p></td><td><p>25 %</p></td><td><p>09.8805</p></td></tr><tr><td><p>Other countries</p></td><td><p>265 739,79</p></td><td><p>265 739,79</p></td><td><p>259 962,84</p></td><td><p>263 318,03</p></td><td><p>274 436,99</p></td><td><p>274 436,99</p></td><td><p>268 470,97</p></td><td><p>271 453,98</p></td><td><p>282 668,06</p></td><td><p>282 668,06</p></td><td><p>276 531,20</p></td><td><p>279 595,58</p></td><td><p>25 %</p></td><td><p><a> (<span>2</span>)</a></p></td></tr><tr><td><p>3.A</p></td><td><p>Electrical Sheets (other than GOES)</p></td><td><p>7209 16 10 , 7209 17 10 , 7209 18 10 , 7209 26 10 , 7209 27 10 , 7209 28 10</p></td><td><p>Russian Federation</p></td><td><p>350,64</p></td><td><p>350,64</p></td><td><p>343,02</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8808</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>300,46</p></td><td><p>300,46</p></td><td><p>293,93</p></td><td><p>506,54</p></td><td><p>527,47</p></td><td><p>527,47</p></td><td><p>516,00</p></td><td><p>521,74</p></td><td><p>543,29</p></td><td><p>543,29</p></td><td><p>531,48</p></td><td><p>537,39</p></td><td><p>25 %</p></td><td><p>09.8978</p></td></tr><tr><td><p>Iran, Islamic Republic of</p></td><td><p>153,51</p></td><td><p>153,51</p></td><td><p>150,17</p></td><td><p>151,91</p></td><td><p>158,18</p></td><td><p>158,18</p></td><td><p>154,75</p></td><td><p>156,46</p></td><td><p>162,93</p></td><td><p>162,93</p></td><td><p>159,39</p></td><td><p>161,16</p></td><td><p>25 %</p></td><td><p>09.8809</p></td></tr><tr><td><p>Korea, Republic of</p></td><td><p>124,95</p></td><td><p>124,95</p></td><td><p>122,24</p></td><td><p>232,64</p></td><td><p>242,25</p></td><td><p>242,25</p></td><td><p>236,98</p></td><td><p>239,62</p></td><td><p>249,52</p></td><td><p>249,52</p></td><td><p>244,09</p></td><td><p>246,81</p></td><td><p>25 %</p></td><td><p>09.8806</p></td></tr><tr><td><p>Other countries</p></td><td><p>757,52</p></td><td><p>757,52</p></td><td><p>741,05</p></td><td><p>777,65</p></td><td><p>809,79</p></td><td><p>809,79</p></td><td><p>792,18</p></td><td><p>800,98</p></td><td><p>834,08</p></td><td><p>834,08</p></td><td><p>815,95</p></td><td><p>825,01</p></td><td><p>25 %</p></td><td><p><a> (<span>3</span>)</a></p></td></tr><tr><td><p>3.B</p></td><td><p>7225 19 90 , 7226 19 80</p></td><td><p>Russian Federation</p></td><td><p>35 467,36</p></td><td><p>35 467,36</p></td><td><p>34 696,33</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8811</p></td></tr><tr><td><p>Korea, Republic of</p></td><td><p>21 197,70</p></td><td><p>21 197,70</p></td><td><p>20 736,88</p></td><td><p>32 204,00</p></td><td><p>33 534,63</p></td><td><p>33 534,63</p></td><td><p>32 805,62</p></td><td><p>33 170,12</p></td><td><p>34 540,67</p></td><td><p>34 540,67</p></td><td><p>33 789,78</p></td><td><p>34 165,23</p></td><td><p>25 %</p></td><td><p>09.8812</p></td></tr><tr><td><p>China</p></td><td><p>16 317,74</p></td><td><p>16 317,74</p></td><td><p>15 963,01</p></td><td><p>28 320,79</p></td><td><p>29 490,97</p></td><td><p>29 490,97</p></td><td><p>28 849,86</p></td><td><p>29 170,42</p></td><td><p>30 375,70</p></td><td><p>30 375,70</p></td><td><p>29 715,36</p></td><td><p>30 045,53</p></td><td><p>25 %</p></td><td><p>09.8813</p></td></tr><tr><td><p>Taiwan</p></td><td><p>12 242,39</p></td><td><p>12 242,39</p></td><td><p>11 976,25</p></td><td><p>22 149,74</p></td><td><p>23 064,94</p></td><td><p>23 064,94</p></td><td><p>22 563,53</p></td><td><p>22 814,23</p></td><td><p>23 756,89</p></td><td><p>23 756,89</p></td><td><p>23 240,43</p></td><td><p>23 498,66</p></td><td><p>25 %</p></td><td><p>09.8814</p></td></tr><tr><td><p>Other countries</p></td><td><p>6 343,40</p></td><td><p>6 343,40</p></td><td><p>6 205,50</p></td><td><p>7 898,74</p></td><td><p>8 225,11</p></td><td><p>8 225,11</p></td><td><p>8 046,30</p></td><td><p>8 135,71</p></td><td><p>8 471,86</p></td><td><p>8 471,86</p></td><td><p>8 287,69</p></td><td><p>8 379,78</p></td><td><p>25 %</p></td><td><p><a> (<span>4</span>)</a></p></td></tr><tr><td><p>4.A</p></td><td><p>Metallic Coated Sheets</p></td><td><p>TARIC Codes: 7210410020 , 7210490020 , 7210610020 , 7210690020 , 7212300020 , 7212506120 , 7212506920 , 7225920020 , 7225990011 , 7225990022 , 7225990040 , 7225990091 , 7225990092 , 7226993010 , 7226997011 , 7226997091 , 7226997094</p></td><td><p>Korea (Republic of)</p></td><td><p>34 726,32</p></td><td><p>34 726,32</p></td><td><p>33 971,40</p></td><td><p>34 348,86</p></td><td><p>35 768,11</p></td><td><p>35 768,11</p></td><td><p>34 990,54</p></td><td><p>35 379,32</p></td><td><p>36 841,15</p></td><td><p>36 841,15</p></td><td><p>36 040,26</p></td><td><p>36 440,70</p></td><td><p>25 %</p></td><td><p>09.8816</p></td></tr><tr><td><p>India</p></td><td><p>49 638,36</p></td><td><p>49 638,36</p></td><td><p>48 559,27</p></td><td><p>49 098,82</p></td><td><p>51 127,51</p></td><td><p>51 127,51</p></td><td><p>50 016,05</p></td><td><p>50 571,78</p></td><td><p>52 661,34</p></td><td><p>52 661,34</p></td><td><p>51 516,53</p></td><td><p>52 088,93</p></td><td><p>25 %</p></td><td><p>09.8817</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>32 719,56</p></td><td><p>32 719,56</p></td><td><p>32 008,27</p></td><td><p>32 363,92</p></td><td><p>33 701,15</p></td><td><p>33 701,15</p></td><td><p>32 968,52</p></td><td><p>33 334,83</p></td><td><p>34 712,19</p></td><td><p>34 712,19</p></td><td><p>33 957,57</p></td><td><p>34 334,88</p></td><td><p>25 %</p></td><td><p>09.8979</p></td></tr><tr><td><p>Other countries</p></td><td><p>439 629,02</p></td><td><p>439 629,02</p></td><td><p>430 071,87</p></td><td><p>435 187,30</p></td><td><p>453 341,17</p></td><td><p>453 341,17</p></td><td><p>443 485,93</p></td><td><p>448 413,55</p></td><td><p>466 939,93</p></td><td><p>466 939,93</p></td><td><p>456 794,90</p></td><td><p>461 864,50</p></td><td><p>25 %</p></td><td><p><a> (<span>5</span>)</a></p></td></tr><tr><td><p>4.B</p></td><td><p>CN Codes: 7210 20 00 , 7210 30 00 , 7210 90 80 , 7212 20 00 , 7212 50 20 , 7212 50 30 , 7212 50 40 , 7212 50 90 , 7225 91 00 , 7226 99 10 TARIC codes: 7210410080 , 7210490080 , 7210610080 , 7210690080 , 7212300080 , 7212506180 , 7212506980 , 7225920080 , 7225990025 , 7225990095 , 7226993090 , 7226997019 , 7226997096</p></td><td><p>China</p></td><td><p>118 662,79</p></td><td><p>118 662,79</p></td><td><p>116 083,16</p></td><td><p>117 372,98</p></td><td><p>122 222,67</p></td><td><p>122 222,67</p></td><td><p>119 565,66</p></td><td><p>120 894,17</p></td><td><p>125 889,35</p></td><td><p>125 889,35</p></td><td><p>123 152,63</p></td><td><p>124 520,99</p></td><td><p>25 %</p></td><td><p>09.8821</p></td></tr><tr><td><p>Korea (Republic of)</p></td><td><p>154 003,68</p></td><td><p>154 003,68</p></td><td><p>150 655,77</p></td><td><p>152 329,73</p></td><td><p>158 623,79</p></td><td><p>158 623,79</p></td><td><p>155 175,45</p></td><td><p>156 899,62</p></td><td><p>163 382,50</p></td><td><p>163 382,50</p></td><td><p>159 830,71</p></td><td><p>161 606,61</p></td><td><p>25 %</p></td><td><p>09.8822</p></td></tr><tr><td><p>India</p></td><td><p>70 874,00</p></td><td><p>70 874,00</p></td><td><p>69 333,27</p></td><td><p>70 103,64</p></td><td><p>73 000,22</p></td><td><p>73 000,22</p></td><td><p>71 413,26</p></td><td><p>72 206,74</p></td><td><p>75 190,23</p></td><td><p>75 190,23</p></td><td><p>73 555,66</p></td><td><p>74 372,95</p></td><td><p>25 %</p></td><td><p>09.8823</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>32 719,56</p></td><td><p>32 719,56</p></td><td><p>32 008,27</p></td><td><p>32 363,92</p></td><td><p>33 701,15</p></td><td><p>33 701,15</p></td><td><p>32 968,52</p></td><td><p>33 334,83</p></td><td><p>34 712,19</p></td><td><p>34 712,19</p></td><td><p>33 957,57</p></td><td><p>34 334,88</p></td><td><p>25 %</p></td><td><p>09.8980</p></td></tr><tr><td><p>Other countries</p></td><td><p>99 301,05</p></td><td><p>99 301,05</p></td><td><p>97 142,33</p></td><td><p>98 535,77</p></td><td><p>102 767,99</p></td><td><p>102 767,99</p></td><td><p>100 533,90</p></td><td><p>101 650,95</p></td><td><p>105 849,65</p></td><td><p>105 849,65</p></td><td><p>103 554,03</p></td><td><p>104 699,12</p></td><td><p>25 %</p></td><td><p><a> (<span>6</span>)</a></p></td></tr><tr><td><p>5</p></td><td><p>Organic Coated Sheets</p></td><td><p>7210 70 80 , 7212 40 80</p></td><td><p>India</p></td><td><p>72 733,52</p></td><td><p>72 733,52</p></td><td><p>71 152,36</p></td><td><p>71 942,94</p></td><td><p>74 915,53</p></td><td><p>74 915,53</p></td><td><p>73 286,93</p></td><td><p>74 101,23</p></td><td><p>77 162,99</p></td><td><p>77 162,99</p></td><td><p>75 485,54</p></td><td><p>76 324,26</p></td><td><p>25 %</p></td><td><p>09.8826</p></td></tr><tr><td><p>Korea, Republic of</p></td><td><p>65 734,04</p></td><td><p>65 734,04</p></td><td><p>64 305,04</p></td><td><p>65 019,54</p></td><td><p>67 706,06</p></td><td><p>67 706,06</p></td><td><p>66 234,19</p></td><td><p>66 970,13</p></td><td><p>69 737,25</p></td><td><p>69 737,25</p></td><td><p>68 221,22</p></td><td><p>68 979,23</p></td><td><p>25 %</p></td><td><p>09.8827</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>32 273,02</p></td><td><p>32 273,02</p></td><td><p>31 571,43</p></td><td><p>31 922,23</p></td><td><p>33 241,21</p></td><td><p>33 241,21</p></td><td><p>32 518,58</p></td><td><p>32 879,90</p></td><td><p>34 238,45</p></td><td><p>34 238,45</p></td><td><p>33 494,13</p></td><td><p>33 866,29</p></td><td><p>25 %</p></td><td><p>09.8981</p></td></tr><tr><td><p>Taiwan</p></td><td><p>21 067,46</p></td><td><p>21 067,46</p></td><td><p>20 609,47</p></td><td><p>20 838,47</p></td><td><p>21 699,48</p></td><td><p>21 699,48</p></td><td><p>21 227,76</p></td><td><p>21 463,62</p></td><td><p>22 350,47</p></td><td><p>22 350,47</p></td><td><p>21 864,59</p></td><td><p>22 107,53</p></td><td><p>25 %</p></td><td><p>09.8828</p></td></tr><tr><td><p>Turkey</p></td><td><p>14 544,98</p></td><td><p>14 544,98</p></td><td><p>14 228,79</p></td><td><p>14 386,89</p></td><td><p>14 981,33</p></td><td><p>14 981,33</p></td><td><p>14 655,65</p></td><td><p>14 818,49</p></td><td><p>15 430,77</p></td><td><p>15 430,77</p></td><td><p>15 095,32</p></td><td><p>15 263,05</p></td><td><p>25 %</p></td><td><p>09.8829</p></td></tr><tr><td><p>Other countries</p></td><td><p>39 845,48</p></td><td><p>39 845,48</p></td><td><p>38 979,27</p></td><td><p>39 412,50</p></td><td><p>41 041,04</p></td><td><p>41 041,04</p></td><td><p>40 148,84</p></td><td><p>40 594,94</p></td><td><p>42 272,27</p></td><td><p>42 272,27</p></td><td><p>41 353,31</p></td><td><p>41 812,79</p></td><td><p>25 %</p></td><td><p><a> (<span>7</span>)</a></p></td></tr><tr><td><p>6</p></td><td><p>Tin Mill products</p></td><td><p>7209 18 99 , 7210 11 00 , 7210 12 20 , 7210 12 80 , 7210 50 00 , 7210 70 10 , 7210 90 40 , 7212 10 10 , 7212 10 90 , 7212 40 20</p></td><td><p>China</p></td><td><p>102 651,92</p></td><td><p>102 651,92</p></td><td><p>100 420,36</p></td><td><p>101 536,14</p></td><td><p>105 731,48</p></td><td><p>105 731,48</p></td><td><p>103 432,97</p></td><td><p>104 582,22</p></td><td><p>108 903,42</p></td><td><p>108 903,42</p></td><td><p>106 535,96</p></td><td><p>107 719,69</p></td><td><p>25 %</p></td><td><p>09.8831</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>37 442,67</p></td><td><p>37 442,67</p></td><td><p>36 628,69</p></td><td><p>37 035,68</p></td><td><p>38 565,95</p></td><td><p>38 565,95</p></td><td><p>37 727,56</p></td><td><p>38 146,75</p></td><td><p>39 722,92</p></td><td><p>39 722,92</p></td><td><p>38 859,38</p></td><td><p>39 291,15</p></td><td><p>25 %</p></td><td><p>09.8982</p></td></tr><tr><td><p>Serbia</p></td><td><p>20 605,18</p></td><td><p>20 605,18</p></td><td><p>20 157,24</p></td><td><p>20 381,21</p></td><td><p>21 223,33</p></td><td><p>21 223,33</p></td><td><p>20 761,95</p></td><td><p>20 992,64</p></td><td><p>21 860,03</p></td><td><p>21 860,03</p></td><td><p>21 384,81</p></td><td><p>21 622,42</p></td><td><p>25 %</p></td><td><p>09.8832</p></td></tr><tr><td><p>Korea, Republic of</p></td><td><p>14 904,85</p></td><td><p>14 904,85</p></td><td><p>14 580,83</p></td><td><p>14 742,84</p></td><td><p>15 352,00</p></td><td><p>15 352,00</p></td><td><p>15 018,26</p></td><td><p>15 185,13</p></td><td><p>15 812,56</p></td><td><p>15 812,56</p></td><td><p>15 468,81</p></td><td><p>15 640,68</p></td><td><p>25 %</p></td><td><p>09.8833</p></td></tr><tr><td><p>Taiwan</p></td><td><p>12 392,30</p></td><td><p>12 392,30</p></td><td><p>12 122,90</p></td><td><p>12 257,60</p></td><td><p>12 764,07</p></td><td><p>12 764,07</p></td><td><p>12 486,59</p></td><td><p>12 625,33</p></td><td><p>13 146,99</p></td><td><p>13 146,99</p></td><td><p>12 861,18</p></td><td><p>13 004,09</p></td><td><p>25 %</p></td><td><p>09.8834</p></td></tr><tr><td><p>Other countries</p></td><td><p>34 348,50</p></td><td><p>34 348,50</p></td><td><p>33 601,80</p></td><td><p>33 975,69</p></td><td><p>35 379,80</p></td><td><p>35 379,80</p></td><td><p>34 610,67</p></td><td><p>34 995,23</p></td><td><p>36 441,19</p></td><td><p>36 441,19</p></td><td><p>35 649,00</p></td><td><p>36 045,09</p></td><td><p>25 %</p></td><td><p><a> (<span>8</span>)</a></p></td></tr><tr><td><p>7</p></td><td><p>Non Alloy and Other Alloy Quarto Plates</p></td><td><p>7208 51 20 , 7208 51 91 , 7208 51 98 , 7208 52 91 , 7208 90 20 , 7208 90 80 , 7210 90 30 , 7225 40 12 , 7225 40 40 , 7225 40 60 , 7225 99 00</p></td><td><p>Ukraine</p></td><td><p>220 959,54</p></td><td><p>220 959,54</p></td><td><p>216 156,07</p></td><td><p>256 810,19</p></td><td><p>267 421,24</p></td><td><p>267 421,24</p></td><td><p>261 607,74</p></td><td><p>264 514,49</p></td><td><p>275 443,88</p></td><td><p>275 443,88</p></td><td><p>269 455,97</p></td><td><p>272 449,93</p></td><td><p>25 %</p></td><td><p>09.8836</p></td></tr><tr><td><p>Korea, Republic of</p></td><td><p>90 484,11</p></td><td><p>90 484,11</p></td><td><p>88 517,06</p></td><td><p>96 106,51</p></td><td><p>100 077,50</p></td><td><p>100 077,50</p></td><td><p>97 901,90</p></td><td><p>98 989,70</p></td><td><p>103 079,83</p></td><td><p>103 079,83</p></td><td><p>100 838,96</p></td><td><p>101 959,39</p></td><td><p>25 %</p></td><td><p>09.8837</p></td></tr><tr><td><p>Russian Federation</p></td><td><p>76 413,23</p></td><td><p>76 413,23</p></td><td><p>74 752,08</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8838</p></td></tr><tr><td><p>India</p></td><td><p>50 218,77</p></td><td><p>50 218,77</p></td><td><p>49 127,06</p></td><td><p>60 949,84</p></td><td><p>63 468,21</p></td><td><p>63 468,21</p></td><td><p>62 088,47</p></td><td><p>62 778,34</p></td><td><p>65 372,26</p></td><td><p>65 372,26</p></td><td><p>63 951,12</p></td><td><p>64 661,69</p></td><td><p>25 %</p></td><td><p>09.8839</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>50 201,69</p></td><td><p>50 201,69</p></td><td><p>49 110,35</p></td><td><p>53 246,19</p></td><td><p>55 446,25</p></td><td><p>55 446,25</p></td><td><p>54 240,90</p></td><td><p>54 843,58</p></td><td><p>57 109,64</p></td><td><p>57 109,64</p></td><td><p>55 868,13</p></td><td><p>56 488,88</p></td><td><p>25 %</p></td><td><p>09.8983</p></td></tr><tr><td><p>Other countries</p></td><td><p>304 534,67</p></td><td><p>304 534,67</p></td><td><p>297 914,36</p></td><td><p>317 122,78</p></td><td><p>330 246,89</p></td><td><p>330 246,89</p></td><td><p>323 067,60</p></td><td><p>326 657,25</p></td><td><p>340 154,11</p></td><td><p>340 154,11</p></td><td><p>332 760,17</p></td><td><p>336 456,78</p></td><td><p>25 %</p></td><td><p><a> (<span>9</span>)</a></p></td></tr><tr><td><p>8</p></td><td><p>Stainless Hot Rolled Sheets and Strips</p></td><td><p>7219 11 00 , 7219 12 10 , 7219 12 90 , 7219 13 10 , 7219 13 90 , 7219 14 10 , 7219 14 90 , 7219 22 10 , 7219 22 90 , 7219 23 00 , 7219 24 00 , 7220 11 00 , 7220 12 00</p></td><td><p>Other countries</p></td><td><p>95 423,22</p></td><td><p>95 423,22</p></td><td><p>93 348,80</p></td><td><p>98 429,19</p></td><td><p>104 566,77</p></td><td><p>104 566,77</p></td><td><p>102 293,58</p></td><td><p>103 430,17</p></td><td><p>107 686,09</p></td><td><p>107 686,09</p></td><td><p>105 415,22</p></td><td><p>106 515,59</p></td><td><p>25 %</p></td><td><p><a> (<span>10</span>)</a></p></td></tr><tr><td><p>9</p></td><td><p>Stainless Cold Rolled Sheets and Strips</p></td><td><p>7219 31 00 , 7219 32 10 , 7219 32 90 , 7219 33 10 , 7219 33 90 , 7219 34 10 , 7219 34 90 , 7219 35 10 , 7219 35 90 , 7219 90 20 , 7219 90 80 , 7220 20 21 , 7220 20 29 , 7220 20 41 , 7220 20 49 , 7220 20 81 , 7220 20 89 , 7220 90 20 , 7220 90 80</p></td><td><p>Korea, Republic of</p></td><td><p>45 936,49</p></td><td><p>45 936,49</p></td><td><p>44 937,87</p></td><td><p>45 437,18</p></td><td><p>47 314,59</p></td><td><p>47 314,59</p></td><td><p>46 286,01</p></td><td><p>46 800,30</p></td><td><p>48 734,02</p></td><td><p>48 734,02</p></td><td><p>47 674,59</p></td><td><p>48 204,31</p></td><td><p>25 %</p></td><td><p>09.8846</p></td></tr><tr><td><p>Taiwan</p></td><td><p>42 598,45</p></td><td><p>42 598,45</p></td><td><p>41 672,39</p></td><td><p>42 135,42</p></td><td><p>43 876,40</p></td><td><p>43 876,40</p></td><td><p>42 922,57</p></td><td><p>43 399,48</p></td><td><p>45 192,69</p></td><td><p>45 192,69</p></td><td><p>44 210,24</p></td><td><p>44 701,47</p></td><td><p>25 %</p></td><td><p>09.8847</p></td></tr><tr><td><p>India</p></td><td><p>28 471,37</p></td><td><p>28 471,37</p></td><td><p>27 852,43</p></td><td><p>28 161,90</p></td><td><p>29 325,51</p></td><td><p>29 325,51</p></td><td><p>28 688,00</p></td><td><p>29 006,76</p></td><td><p>30 205,28</p></td><td><p>30 205,28</p></td><td><p>29 548,64</p></td><td><p>29 876,96</p></td><td><p>25 %</p></td><td><p>09.8848</p></td></tr><tr><td><p>South Africa</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>16 426,70</p></td><td><p>25 517,94</p></td><td><p>25 517,94</p></td><td><p>24 963,20</p></td><td><p>25 240,57</p></td><td><p>26 211,66</p></td><td><p>26 211,66</p></td><td><p>25 926,75</p></td><td><p>25 926,75</p></td><td><p> </p></td><td><p>09.8853</p></td></tr><tr><td><p>United States</p></td><td><p>23 164,35</p></td><td><p>23 164,35</p></td><td><p>22 660,78</p></td><td><p>22 912,56</p></td><td><p>23 859,28</p></td><td><p>23 859,28</p></td><td><p>23 340,60</p></td><td><p>23 599,94</p></td><td><p>24 575,06</p></td><td><p>24 575,06</p></td><td><p>24 040,82</p></td><td><p>24 307,94</p></td><td><p>25 %</p></td><td><p>09.8849</p></td></tr><tr><td><p>Turkey</p></td><td><p>19 275,63</p></td><td><p>19 275,63</p></td><td><p>18 856,60</p></td><td><p>19 066,12</p></td><td><p>19 853,90</p></td><td><p>19 853,90</p></td><td><p>19 422,30</p></td><td><p>19 638,10</p></td><td><p>20 449,52</p></td><td><p>20 449,52</p></td><td><p>20 004,97</p></td><td><p>20 227,24</p></td><td><p>25 %</p></td><td><p>09.8850</p></td></tr><tr><td><p>Malaysia</p></td><td><p>12 211,97</p></td><td><p>12 211,97</p></td><td><p>11 946,49</p></td><td><p>12 079,23</p></td><td><p>12 578,33</p></td><td><p>12 578,33</p></td><td><p>12 304,89</p></td><td><p>12 441,61</p></td><td><p>12 955,68</p></td><td><p>12 955,68</p></td><td><p>12 674,04</p></td><td><p>12 814,86</p></td><td><p>25 %</p></td><td><p>09.8851</p></td></tr><tr><td><p>Other countries</p></td><td><p>48 986,92</p></td><td><p>48 986,92</p></td><td><p>47 921,98</p></td><td><p>48 454,45</p></td><td><p>50 456,53</p></td><td><p>50 456,53</p></td><td><p>49 359,64</p></td><td><p>49 908,08</p></td><td><p>51 970,22</p></td><td><p>51 970,22</p></td><td><p>50 840,43</p></td><td><p>51 405,33</p></td><td><p>25 %</p></td><td><p><a> (<span>11</span>)</a></p></td></tr><tr><td><p>10</p></td><td><p>Stainless Hot Rolled Quarto Plates</p></td><td><p>7219 21 10 , 7219 21 90</p></td><td><p>China</p></td><td><p>4 549,32</p></td><td><p>4 549,32</p></td><td><p>4 450,42</p></td><td><p>4 499,87</p></td><td><p>4 685,80</p></td><td><p>4 685,80</p></td><td><p>4 583,94</p></td><td><p>4 634,87</p></td><td><p>4 826,38</p></td><td><p>4 826,38</p></td><td><p>4 721,46</p></td><td><p>4 773,92</p></td><td><p>25 %</p></td><td><p>09.8856</p></td></tr><tr><td><p>India</p></td><td><p>1 929,86</p></td><td><p>1 929,86</p></td><td><p>1 887,91</p></td><td><p>1 908,88</p></td><td><p>1 987,76</p></td><td><p>1 987,76</p></td><td><p>1 944,54</p></td><td><p>1 966,15</p></td><td><p>2 047,39</p></td><td><p>2 047,39</p></td><td><p>2 002,88</p></td><td><p>2 025,13</p></td><td><p>25 %</p></td><td><p>09.8857</p></td></tr><tr><td><p>South Africa</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>876,19</p></td><td><p>1 361,11</p></td><td><p>1 361,11</p></td><td><p>1 331,52</p></td><td><p>1 346,31</p></td><td><p>1 398,11</p></td><td><p>1 398,11</p></td><td><p>1 382,91</p></td><td><p>1 382,91</p></td><td><p> </p></td><td><p>09.8859</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>796,12</p></td><td><p>796,12</p></td><td><p>778,81</p></td><td><p>787,46</p></td><td><p>820,00</p></td><td><p>820,00</p></td><td><p>802,17</p></td><td><p>811,09</p></td><td><p>844,60</p></td><td><p>844,60</p></td><td><p>826,24</p></td><td><p>835,42</p></td><td><p>25 %</p></td><td><p>09.8984</p></td></tr><tr><td><p>Taiwan</p></td><td><p>735,01</p></td><td><p>735,01</p></td><td><p>719,03</p></td><td><p>727,02</p></td><td><p>757,06</p></td><td><p>757,06</p></td><td><p>740,60</p></td><td><p>748,83</p></td><td><p>779,77</p></td><td><p>779,77</p></td><td><p>762,82</p></td><td><p>771,29</p></td><td><p>25 %</p></td><td><p>09.8858</p></td></tr><tr><td><p>Other countries</p></td><td><p>964,37</p></td><td><p>964,37</p></td><td><p>943,41</p></td><td><p>953,89</p></td><td><p>993,30</p></td><td><p>993,30</p></td><td><p>971,71</p></td><td><p>982,51</p></td><td><p>1 023,10</p></td><td><p>1 023,10</p></td><td><p>1 000,86</p></td><td><p>1 011,98</p></td><td><p>25 %</p></td><td><p><a> (<span>12</span>)</a></p></td></tr><tr><td><p>12</p></td><td><p>Non Alloy and Other Alloy Merchant Bars and Light Sections</p></td><td><p>7214 30 00 , 7214 91 10 , 7214 91 90 , 7214 99 31 , 7214 99 39 , 7214 99 50 , 7214 99 71 , 7214 99 79 , 7214 99 95 , 7215 90 00 , 7216 10 00 , 7216 21 00 , 7216 22 00 , 7216 40 10 , 7216 40 90 , 7216 50 10 , 7216 50 91 , 7216 50 99 , 7216 99 00 , 7228 10 20 , 7228 20 10 , 7228 20 91 , 7228 30 20 , 7228 30 41 , 7228 30 49 , 7228 30 61 , 7228 30 69 , 7228 30 70 , 7228 30 89 , 7228 60 20 , 7228 60 80 , 7228 70 10 , 7228 70 90 , 7228 80 00</p></td><td><p>China</p></td><td><p>109 081,26</p></td><td><p>109 081,26</p></td><td><p>106 709,93</p></td><td><p>128 399,98</p></td><td><p>133 705,30</p></td><td><p>133 705,30</p></td><td><p>130 798,66</p></td><td><p>132 251,98</p></td><td><p>137 716,46</p></td><td><p>137 716,46</p></td><td><p>134 722,62</p></td><td><p>136 219,54</p></td><td><p>25 %</p></td><td><p>09.8861</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>91 256,44</p></td><td><p>91 256,44</p></td><td><p>89 272,60</p></td><td><p>107 269,12</p></td><td><p>111 701,34</p></td><td><p>111 701,34</p></td><td><p>109 273,05</p></td><td><p>110 487,19</p></td><td><p>115 052,38</p></td><td><p>115 052,38</p></td><td><p>112 551,24</p></td><td><p>113 801,81</p></td><td><p>25 %</p></td><td><p>09.8985</p></td></tr><tr><td><p>Turkey</p></td><td><p>65 582,60</p></td><td><p>65 582,60</p></td><td><p>64 156,89</p></td><td><p>97 010,41</p></td><td><p>101 018,76</p></td><td><p>101 018,76</p></td><td><p>98 822,70</p></td><td><p>99 920,73</p></td><td><p>104 049,32</p></td><td><p>104 049,32</p></td><td><p>101 787,38</p></td><td><p>102 918,35</p></td><td><p>25 %</p></td><td><p>09.8862</p></td></tr><tr><td><p>Russian Federation</p></td><td><p>60 883,89</p></td><td><p>60 883,89</p></td><td><p>59 560,32</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8863</p></td></tr><tr><td><p>Switzerland</p></td><td><p>48 810,77</p></td><td><p>48 810,77</p></td><td><p>47 749,66</p></td><td><p>62 348,55</p></td><td><p>64 924,71</p></td><td><p>64 924,71</p></td><td><p>63 513,31</p></td><td><p>64 219,01</p></td><td><p>66 872,46</p></td><td><p>66 872,46</p></td><td><p>65 418,71</p></td><td><p>66 145,58</p></td><td><p>25 %</p></td><td><p>09.8864</p></td></tr><tr><td><p>Belarus</p></td><td><p>39 066,48</p></td><td><p>39 066,48</p></td><td><p>38 217,21</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8865</p></td></tr><tr><td><p>Other countries</p></td><td><p>49 635,42</p></td><td><p>49 635,42</p></td><td><p>48 556,39</p></td><td><p>64 249,10</p></td><td><p>66 907,49</p></td><td><p>66 907,49</p></td><td><p>65 452,98</p></td><td><p>66 180,24</p></td><td><p>68 914,69</p></td><td><p>68 914,69</p></td><td><p>67 416,67</p></td><td><p>68 165,61</p></td><td><p>25 %</p></td><td><p><a> (<span>13</span>)</a></p></td></tr><tr><td><p>13</p></td><td><p>Rebars</p></td><td><p>7214 20 00 , 7214 99 10</p></td><td><p>Turkey</p></td><td><p>61 938,03</p></td><td><p>61 938,03</p></td><td><p>60 591,55</p></td><td><p>86 412,84</p></td><td><p>89 983,30</p></td><td><p>89 983,30</p></td><td><p>88 027,14</p></td><td><p>89 005,22</p></td><td><p>92 682,80</p></td><td><p>92 682,80</p></td><td><p>90 667,96</p></td><td><p>91 675,38</p></td><td><p>25 %</p></td><td><p>09.8866</p></td></tr><tr><td><p>Russian Federation</p></td><td><p>59 963,19</p></td><td><p>59 963,19</p></td><td><p>58 659,65</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8867</p></td></tr><tr><td><p>Ukraine</p></td><td><p>30 321,98</p></td><td><p>30 321,98</p></td><td><p>29 662,81</p></td><td><p>40 229,55</p></td><td><p>41 891,78</p></td><td><p>41 891,78</p></td><td><p>40 981,09</p></td><td><p>41 436,43</p></td><td><p>43 148,53</p></td><td><p>43 148,53</p></td><td><p>42 210,52</p></td><td><p>42 679,53</p></td><td><p>25 %</p></td><td><p>09.8868</p></td></tr><tr><td><p>Bosnia and Herzegovina</p></td><td><p>26 553,72</p></td><td><p>26 553,72</p></td><td><p>25 976,46</p></td><td><p>31 087,11</p></td><td><p>32 371,59</p></td><td><p>32 371,59</p></td><td><p>31 667,86</p></td><td><p>32 019,72</p></td><td><p>33 342,74</p></td><td><p>33 342,74</p></td><td><p>32 617,89</p></td><td><p>32 980,31</p></td><td><p>25 %</p></td><td><p>09.8869</p></td></tr><tr><td><p>Moldova, Republic of</p></td><td><p>19 083,72</p></td><td><p>19 083,72</p></td><td><p>18 668,86</p></td><td><p>25 981,80</p></td><td><p>27 055,33</p></td><td><p>27 055,33</p></td><td><p>26 467,17</p></td><td><p>26 761,25</p></td><td><p>27 866,99</p></td><td><p>27 866,99</p></td><td><p>27 261,19</p></td><td><p>27 564,09</p></td><td><p>25 %</p></td><td><p>09.8870</p></td></tr><tr><td><p>Other countries</p></td><td><p>115 435,69</p></td><td><p>115 435,69</p></td><td><p>112 926,22</p></td><td><p>126 179,66</p></td><td><p>131 393,24</p></td><td><p>131 393,24</p></td><td><p>128 536,86</p></td><td><p>129 965,05</p></td><td><p>135 335,03</p></td><td><p>135 335,03</p></td><td><p>132 392,97</p></td><td><p>133 864,00</p></td><td><p>25 %</p></td><td><p><a> (<span>14</span>)</a></p></td></tr><tr><td><p>14</p></td><td><p>Stainless Bars and Light Sections</p></td><td><p>7222 11 11 , 7222 11 19 , 7222 11 81 , 7222 11 89 , 7222 19 10 , 7222 19 90 , 7222 20 11 , 7222 20 19 , 7222 20 21 , 7222 20 29 , 7222 20 31 , 7222 20 39 , 7222 20 81 , 7222 20 89 , 7222 30 51 , 7222 30 91 , 7222 30 97 , 7222 40 10 , 7222 40 50 , 7222 40 90</p></td><td><p>India</p></td><td><p>29 368,19</p></td><td><p>29 368,19</p></td><td><p>28 729,75</p></td><td><p>29 048,97</p></td><td><p>30 249,23</p></td><td><p>30 249,23</p></td><td><p>29 591,64</p></td><td><p>29 920,44</p></td><td><p>31 156,71</p></td><td><p>31 156,71</p></td><td><p>30 479,39</p></td><td><p>30 818,05</p></td><td><p>25 %</p></td><td><p>09.8871</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>4 291,80</p></td><td><p>4 291,80</p></td><td><p>4 198,50</p></td><td><p>4 245,15</p></td><td><p>4 420,56</p></td><td><p>4 420,56</p></td><td><p>4 324,46</p></td><td><p>4 372,51</p></td><td><p>4 553,17</p></td><td><p>4 553,17</p></td><td><p>4 454,19</p></td><td><p>4 503,68</p></td><td><p>25 %</p></td><td><p>09.8986</p></td></tr><tr><td><p>Switzerland</p></td><td><p>4 224,49</p></td><td><p>4 224,49</p></td><td><p>4 132,65</p></td><td><p>4 178,57</p></td><td><p>4 351,22</p></td><td><p>4 351,22</p></td><td><p>4 256,63</p></td><td><p>4 303,92</p></td><td><p>4 481,76</p></td><td><p>4 481,76</p></td><td><p>4 384,33</p></td><td><p>4 433,04</p></td><td><p>25 %</p></td><td><p>09.8872</p></td></tr><tr><td><p>Ukraine</p></td><td><p>3 262,79</p></td><td><p>3 262,79</p></td><td><p>3 191,86</p></td><td><p>3 227,33</p></td><td><p>3 360,68</p></td><td><p>3 360,68</p></td><td><p>3 287,62</p></td><td><p>3 324,15</p></td><td><p>3 461,50</p></td><td><p>3 461,50</p></td><td><p>3 386,25</p></td><td><p>3 423,87</p></td><td><p>25 %</p></td><td><p>09.8873</p></td></tr><tr><td><p>Other countries</p></td><td><p>4 760,96</p></td><td><p>4 760,96</p></td><td><p>4 657,46</p></td><td><p>4 712,47</p></td><td><p>4 908,85</p></td><td><p>4 908,85</p></td><td><p>4 802,13</p></td><td><p>4 855,49</p></td><td><p>5 056,10</p></td><td><p>5 056,10</p></td><td><p>4 946,24</p></td><td><p>5 001,14</p></td><td><p>25 %</p></td><td><p><a> (<span>15</span>)</a></p></td></tr><tr><td><p>15</p></td><td><p>Stainless Wire Rod</p></td><td><p>7221 00 10 , 7221 00 90</p></td><td><p>India</p></td><td><p>6 830,52</p></td><td><p>6 830,52</p></td><td><p>6 682,03</p></td><td><p>6 756,28</p></td><td><p>7 035,44</p></td><td><p>7 035,44</p></td><td><p>6 882,49</p></td><td><p>6 958,96</p></td><td><p>7 246,50</p></td><td><p>7 246,50</p></td><td><p>7 088,97</p></td><td><p>7 167,73</p></td><td><p>25 %</p></td><td><p>09.8876</p></td></tr><tr><td><p>Taiwan</p></td><td><p>4 404,05</p></td><td><p>4 404,05</p></td><td><p>4 308,31</p></td><td><p>4 356,18</p></td><td><p>4 536,17</p></td><td><p>4 536,17</p></td><td><p>4 437,56</p></td><td><p>4 486,86</p></td><td><p>4 672,26</p></td><td><p>4 672,26</p></td><td><p>4 570,68</p></td><td><p>4 621,47</p></td><td><p>25 %</p></td><td><p>09.8877</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>3 538,16</p></td><td><p>3 538,16</p></td><td><p>3 461,24</p></td><td><p>3 499,70</p></td><td><p>3 644,30</p></td><td><p>3 644,30</p></td><td><p>3 565,08</p></td><td><p>3 604,69</p></td><td><p>3 753,63</p></td><td><p>3 753,63</p></td><td><p>3 672,03</p></td><td><p>3 712,83</p></td><td><p>25 %</p></td><td><p>09.8987</p></td></tr><tr><td><p>Korea, Republic of</p></td><td><p>2 198,79</p></td><td><p>2 198,79</p></td><td><p>2 150,99</p></td><td><p>2 174,89</p></td><td><p>2 264,75</p></td><td><p>2 264,75</p></td><td><p>2 215,52</p></td><td><p>2 240,13</p></td><td><p>2 332,69</p></td><td><p>2 332,69</p></td><td><p>2 281,98</p></td><td><p>2 307,34</p></td><td><p>25 %</p></td><td><p>09.8878</p></td></tr><tr><td><p>China</p></td><td><p>1 489,17</p></td><td><p>1 489,17</p></td><td><p>1 456,80</p></td><td><p>1 472,98</p></td><td><p>1 533,84</p></td><td><p>1 533,84</p></td><td><p>1 500,50</p></td><td><p>1 517,17</p></td><td><p>1 579,86</p></td><td><p>1 579,86</p></td><td><p>1 545,52</p></td><td><p>1 562,69</p></td><td><p>25 %</p></td><td><p>09.8879</p></td></tr><tr><td><p>Japan</p></td><td><p>1 477,87</p></td><td><p>1 477,87</p></td><td><p>1 445,74</p></td><td><p>1 461,81</p></td><td><p>1 522,21</p></td><td><p>1 522,21</p></td><td><p>1 489,12</p></td><td><p>1 505,66</p></td><td><p>1 567,87</p></td><td><p>1 567,87</p></td><td><p>1 533,79</p></td><td><p>1 550,83</p></td><td><p>25 %</p></td><td><p>09.8880</p></td></tr><tr><td><p>Other countries</p></td><td><p>735,02</p></td><td><p>735,02</p></td><td><p>719,04</p></td><td><p>733,05</p></td><td><p>766,43</p></td><td><p>766,43</p></td><td><p>749,76</p></td><td><p>758,10</p></td><td><p>789,39</p></td><td><p>789,39</p></td><td><p>772,34</p></td><td><p>780,81</p></td><td><p>25 %</p></td><td><p><a> (<span>16</span>)</a></p></td></tr><tr><td><p>16</p></td><td><p>Non Alloy and Other Alloy Wire Rod</p></td><td><p>7213 10 00 , 7213 20 00 , 7213 91 10 , 7213 91 20 , 7213 91 41 , 7213 91 49 , 7213 91 70 , 7213 91 90 , 7213 99 10 , 7213 99 90 , 7227 10 00 , 7227 20 00 , 7227 90 10 , 7227 90 50 , 7227 90 95</p></td><td><p>United Kingdom</p></td><td><p>140 152,62</p></td><td><p>140 152,62</p></td><td><p>137 105,82</p></td><td><p>167 756,86</p></td><td><p>174 688,36</p></td><td><p>174 688,36</p></td><td><p>170 890,78</p></td><td><p>172 789,57</p></td><td><p>179 929,01</p></td><td><p>179 929,01</p></td><td><p>176 017,51</p></td><td><p>177 973,26</p></td><td><p>25 %</p></td><td><p>09.8988</p></td></tr><tr><td><p>Ukraine</p></td><td><p>98 057,92</p></td><td><p>98 057,92</p></td><td><p>95 926,23</p></td><td><p>112 798,35</p></td><td><p>117 459,03</p></td><td><p>117 459,03</p></td><td><p>114 905,57</p></td><td><p>116 182,30</p></td><td><p>120 982,80</p></td><td><p>120 982,80</p></td><td><p>118 352,74</p></td><td><p>119 667,77</p></td><td><p>25 %</p></td><td><p>09.8881</p></td></tr><tr><td><p>Switzerland</p></td><td><p>95 792,44</p></td><td><p>95 792,44</p></td><td><p>93 710,00</p></td><td><p>123 996,49</p></td><td><p>129 119,86</p></td><td><p>129 119,86</p></td><td><p>126 312,91</p></td><td><p>127 716,39</p></td><td><p>132 993,46</p></td><td><p>132 993,46</p></td><td><p>130 102,30</p></td><td><p>131 547,88</p></td><td><p>25 %</p></td><td><p>09.8882</p></td></tr><tr><td><p>Russian Federation</p></td><td><p>82 910,07</p></td><td><p>82 910,07</p></td><td><p>81 107,67</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8883</p></td></tr><tr><td><p>Turkey</p></td><td><p>80 401,71</p></td><td><p>80 401,71</p></td><td><p>78 653,85</p></td><td><p>107 758,51</p></td><td><p>112 210,95</p></td><td><p>112 210,95</p></td><td><p>109 771,59</p></td><td><p>110 991,27</p></td><td><p>115 577,28</p></td><td><p>115 577,28</p></td><td><p>113 064,73</p></td><td><p>114 321,01</p></td><td><p>25 %</p></td><td><p>09.8884</p></td></tr><tr><td><p>Belarus</p></td><td><p>65 740,76</p></td><td><p>65 740,76</p></td><td><p>64 311,61</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8885</p></td></tr><tr><td><p>Moldova, Republic of</p></td><td><p>49 274,74</p></td><td><p>49 274,74</p></td><td><p>48 203,55</p></td><td><p>63 325,02</p></td><td><p>65 941,53</p></td><td><p>65 941,53</p></td><td><p>64 508,02</p></td><td><p>65 224,77</p></td><td><p>67 919,77</p></td><td><p>67 919,77</p></td><td><p>66 443,26</p></td><td><p>67 181,51</p></td><td><p>25 %</p></td><td><p>09.8886</p></td></tr><tr><td><p>Other countries</p></td><td><p>82 000,79</p></td><td><p>82 000,79</p></td><td><p>80 218,16</p></td><td><p>111 148,75</p></td><td><p>115 741,27</p></td><td><p>115 741,27</p></td><td><p>113 225,16</p></td><td><p>114 483,21</p></td><td><p>119 213,51</p></td><td><p>119 213,51</p></td><td><p>116 621,91</p></td><td><p>117 917,71</p></td><td><p>25 %</p></td><td><p><a> (<span>17</span>)</a></p></td></tr><tr><td><p>17</p></td><td><p>Angles, Shapes and Sections of Iron or Non Alloy Steel</p></td><td><p>7216 31 10 , 7216 31 90 , 7216 32 11 , 7216 32 19 , 7216 32 91 , 7216 32 99 , 7216 33 10 , 7216 33 90</p></td><td><p>Ukraine</p></td><td><p>28 955,05</p></td><td><p>28 955,05</p></td><td><p>28 325,59</p></td><td><p>28 640,32</p></td><td><p>29 823,70</p></td><td><p>29 823,70</p></td><td><p>29 175,36</p></td><td><p>29 499,53</p></td><td><p>30 718,41</p></td><td><p>30 718,41</p></td><td><p>30 050,62</p></td><td><p>30 384,52</p></td><td><p>25 %</p></td><td><p>09.8891</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>25 154,41</p></td><td><p>25 154,41</p></td><td><p>24 607,58</p></td><td><p>24 880,99</p></td><td><p>25 909,04</p></td><td><p>25 909,04</p></td><td><p>25 345,80</p></td><td><p>25 627,42</p></td><td><p>26 686,32</p></td><td><p>26 686,32</p></td><td><p>26 106,18</p></td><td><p>26 396,25</p></td><td><p>25 %</p></td><td><p>09.8989</p></td></tr><tr><td><p>Turkey</p></td><td><p>20 934,69</p></td><td><p>20 934,69</p></td><td><p>20 479,59</p></td><td><p>20 707,14</p></td><td><p>21 562,73</p></td><td><p>21 562,73</p></td><td><p>21 093,97</p></td><td><p>21 328,35</p></td><td><p>22 209,61</p></td><td><p>22 209,61</p></td><td><p>21 726,79</p></td><td><p>21 968,20</p></td><td><p>25 %</p></td><td><p>09.8892</p></td></tr><tr><td><p>Korea, Republic of</p></td><td><p>4 878,93</p></td><td><p>4 878,93</p></td><td><p>4 772,87</p></td><td><p>4 825,90</p></td><td><p>5 025,30</p></td><td><p>5 025,30</p></td><td><p>4 916,05</p></td><td><p>4 970,68</p></td><td><p>5 176,06</p></td><td><p>5 176,06</p></td><td><p>5 063,54</p></td><td><p>5 119,80</p></td><td><p>25 %</p></td><td><p>09.8893</p></td></tr><tr><td><p>Other countries</p></td><td><p>11 481,79</p></td><td><p>11 481,79</p></td><td><p>11 232,18</p></td><td><p>11 357,01</p></td><td><p>11 826,28</p></td><td><p>11 826,28</p></td><td><p>11 569,19</p></td><td><p>11 697,73</p></td><td><p>12 181,07</p></td><td><p>12 181,07</p></td><td><p>11 916,26</p></td><td><p>12 048,66</p></td><td><p>25 %</p></td><td><p><a> (<span>18</span>)</a></p></td></tr><tr><td><p>18</p></td><td><p>Sheet Piling</p></td><td><p>7301 10 00</p></td><td><p>China</p></td><td><p>6 477,35</p></td><td><p>6 477,35</p></td><td><p>6 336,54</p></td><td><p>6 406,94</p></td><td><p>6 671,67</p></td><td><p>6 671,67</p></td><td><p>6 526,64</p></td><td><p>6 599,15</p></td><td><p>6 871,82</p></td><td><p>6 871,82</p></td><td><p>6 722,43</p></td><td><p>6 797,13</p></td><td><p>25 %</p></td><td><p>09.8901</p></td></tr><tr><td><p>United Arab Emirates</p></td><td><p>3 205,68</p></td><td><p>3 205,68</p></td><td><p>3 135,99</p></td><td><p>3 170,83</p></td><td><p>3 301,85</p></td><td><p>3 301,85</p></td><td><p>3 230,07</p></td><td><p>3 265,96</p></td><td><p>3 400,90</p></td><td><p>3 400,90</p></td><td><p>3 326,97</p></td><td><p>3 363,94</p></td><td><p>25 %</p></td><td><p>09.8902</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>831,30</p></td><td><p>831,30</p></td><td><p>813,23</p></td><td><p>822,27</p></td><td><p>856,24</p></td><td><p>856,24</p></td><td><p>837,63</p></td><td><p>846,93</p></td><td><p>881,93</p></td><td><p>881,93</p></td><td><p>862,75</p></td><td><p>872,34</p></td><td><p>25 %</p></td><td><p>09.8990</p></td></tr><tr><td><p>Other countries</p></td><td><p>235,91</p></td><td><p>235,91</p></td><td><p>230,78</p></td><td><p>251,89</p></td><td><p>271,80</p></td><td><p>271,80</p></td><td><p>265,89</p></td><td><p>268,84</p></td><td><p>279,87</p></td><td><p>279,87</p></td><td><p>274,11</p></td><td><p>276,83</p></td><td><p>25 %</p></td><td><p><a> (<span>19</span>)</a></p></td></tr><tr><td><p>19</p></td><td><p>Railway Material</p></td><td><p>7302 10 22 , 7302 10 28 , 7302 10 40 , 7302 10 50 , 7302 40 00</p></td><td><p>United Kingdom</p></td><td><p>3 989,09</p></td><td><p>3 989,09</p></td><td><p>3 902,37</p></td><td><p>4 676,40</p></td><td><p>4 869,62</p></td><td><p>4 869,62</p></td><td><p>4 763,76</p></td><td><p>4 816,69</p></td><td><p>5 015,71</p></td><td><p>5 015,71</p></td><td><p>4 906,68</p></td><td><p>4 961,19</p></td><td><p>25 %</p></td><td><p>09.8991</p></td></tr><tr><td><p>Russian Federation</p></td><td><p>1 448,72</p></td><td><p>1 448,72</p></td><td><p>1 417,23</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8906</p></td></tr><tr><td><p>Turkey</p></td><td><p>1 176,71</p></td><td><p>1 176,71</p></td><td><p>1 151,13</p></td><td><p>1 424,86</p></td><td><p>1 483,74</p></td><td><p>1 483,74</p></td><td><p>1 451,48</p></td><td><p>1 467,61</p></td><td><p>1 528,25</p></td><td><p>1 528,25</p></td><td><p>1 495,03</p></td><td><p>1 511,64</p></td><td><p>25 %</p></td><td><p>09.8908</p></td></tr><tr><td><p>China</p></td><td><p>1 042,28</p></td><td><p>1 042,28</p></td><td><p>1 019,62</p></td><td><p>1 378,30</p></td><td><p>1 435,25</p></td><td><p>1 435,25</p></td><td><p>1 404,05</p></td><td><p>1 419,65</p></td><td><p>1 478,31</p></td><td><p>1 478,31</p></td><td><p>1 446,17</p></td><td><p>1 462,24</p></td><td><p>25 %</p></td><td><p>09.8907</p></td></tr><tr><td><p>Other countries</p></td><td><p>1 078,85</p></td><td><p>1 078,85</p></td><td><p>1 055,39</p></td><td><p>1 161,13</p></td><td><p>1 209,11</p></td><td><p>1 209,11</p></td><td><p>1 182,82</p></td><td><p>1 195,97</p></td><td><p>1 245,38</p></td><td><p>1 245,38</p></td><td><p>1 218,31</p></td><td><p>1 231,85</p></td><td><p>25 %</p></td><td><p><a> (<span>20</span>)</a></p></td></tr><tr><td><p>20</p></td><td><p>Gas pipes</p></td><td><p>7306 30 41 , 7306 30 49 , 7306 30 72 , 7306 30 77</p></td><td><p>Turkey</p></td><td><p>45 748,21</p></td><td><p>45 748,21</p></td><td><p>44 753,69</p></td><td><p>45 250,95</p></td><td><p>47 120,66</p></td><td><p>47 120,66</p></td><td><p>46 096,30</p></td><td><p>46 608,48</p></td><td><p>48 534,28</p></td><td><p>48 534,28</p></td><td><p>47 479,19</p></td><td><p>48 006,73</p></td><td><p>25 %</p></td><td><p>09.8911</p></td></tr><tr><td><p>India</p></td><td><p>17 605,35</p></td><td><p>17 605,35</p></td><td><p>17 222,62</p></td><td><p>17 413,99</p></td><td><p>18 133,51</p></td><td><p>18 133,51</p></td><td><p>17 739,30</p></td><td><p>17 936,41</p></td><td><p>18 677,52</p></td><td><p>18 677,52</p></td><td><p>18 271,48</p></td><td><p>18 474,50</p></td><td><p>25 %</p></td><td><p>09.8912</p></td></tr><tr><td><p>North Macedonia</p></td><td><p>6 502,44</p></td><td><p>6 502,44</p></td><td><p>6 361,09</p></td><td><p>6 431,76</p></td><td><p>6 697,52</p></td><td><p>6 697,52</p></td><td><p>6 551,92</p></td><td><p>6 624,72</p></td><td><p>6 898,44</p></td><td><p>6 898,44</p></td><td><p>6 748,48</p></td><td><p>6 823,46</p></td><td><p>25 %</p></td><td><p>09.8913</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>6 185,53</p></td><td><p>6 185,53</p></td><td><p>6 051,06</p></td><td><p>6 118,30</p></td><td><p>6 371,10</p></td><td><p>6 371,10</p></td><td><p>6 232,59</p></td><td><p>6 301,85</p></td><td><p>6 562,23</p></td><td><p>6 562,23</p></td><td><p>6 419,57</p></td><td><p>6 490,90</p></td><td><p>25 %</p></td><td><p>09.8992</p></td></tr><tr><td><p>Other countries</p></td><td><p>13 303,52</p></td><td><p>13 303,52</p></td><td><p>13 014,32</p></td><td><p>13 159,25</p></td><td><p>13 703,14</p></td><td><p>13 703,14</p></td><td><p>13 405,24</p></td><td><p>13 554,19</p></td><td><p>14 114,23</p></td><td><p>14 114,23</p></td><td><p>13 807,41</p></td><td><p>13 960,82</p></td><td><p>25 %</p></td><td><p><a> (<span>21</span>)</a></p></td></tr><tr><td><p>21</p></td><td><p>Hollow sections</p></td><td><p>7306 61 10 , 7306 61 92 , 7306 61 99</p></td><td><p>Turkey</p></td><td><p>70 099,15</p></td><td><p>70 099,15</p></td><td><p>68 575,25</p></td><td><p>90 057,78</p></td><td><p>93 778,84</p></td><td><p>93 778,84</p></td><td><p>91 740,17</p></td><td><p>92 759,51</p></td><td><p>96 592,21</p></td><td><p>96 592,21</p></td><td><p>94 492,38</p></td><td><p>95 542,30</p></td><td><p>25 %</p></td><td><p>09.8916</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>42 117,25</p></td><td><p>42 117,25</p></td><td><p>41 201,66</p></td><td><p>48 031,84</p></td><td><p>50 016,45</p></td><td><p>50 016,45</p></td><td><p>48 929,14</p></td><td><p>49 472,79</p></td><td><p>51 516,94</p></td><td><p>51 516,94</p></td><td><p>50 397,01</p></td><td><p>50 956,98</p></td><td><p>25 %</p></td><td><p>09.8993</p></td></tr><tr><td><p>Russian Federation</p></td><td><p>23 863,04</p></td><td><p>23 863,04</p></td><td><p>23 344,27</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8917</p></td></tr><tr><td><p>North Macedonia</p></td><td><p>22 765,25</p></td><td><p>22 765,25</p></td><td><p>22 270,35</p></td><td><p>26 588,32</p></td><td><p>27 686,91</p></td><td><p>27 686,91</p></td><td><p>27 085,02</p></td><td><p>27 385,96</p></td><td><p>28 517,52</p></td><td><p>28 517,52</p></td><td><p>27 897,57</p></td><td><p>28 207,54</p></td><td><p>25 %</p></td><td><p>09.8918</p></td></tr><tr><td><p>Ukraine</p></td><td><p>17 030,03</p></td><td><p>17 030,03</p></td><td><p>16 659,81</p></td><td><p>19 664,99</p></td><td><p>20 477,52</p></td><td><p>20 477,52</p></td><td><p>20 032,36</p></td><td><p>20 254,94</p></td><td><p>21 091,85</p></td><td><p>21 091,85</p></td><td><p>20 633,33</p></td><td><p>20 862,59</p></td><td><p>25 %</p></td><td><p>09.8919</p></td></tr><tr><td><p>Switzerland</p></td><td><p>14 319,90</p></td><td><p>14 319,90</p></td><td><p>14 008,60</p></td><td><p>14 697,47</p></td><td><p>15 304,75</p></td><td><p>15 304,75</p></td><td><p>14 972,04</p></td><td><p>15 138,40</p></td><td><p>15 763,90</p></td><td><p>15 763,90</p></td><td><p>15 421,20</p></td><td><p>15 592,55</p></td><td><p>25 %</p></td><td><p>09.8920</p></td></tr><tr><td><p>Belarus</p></td><td><p>14 100,50</p></td><td><p>14 100,50</p></td><td><p>13 793,96</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8921</p></td></tr><tr><td><p>Other countries</p></td><td><p>16 035,94</p></td><td><p>16 035,94</p></td><td><p>15 687,33</p></td><td><p>18 898,37</p></td><td><p>19 680,57</p></td><td><p>19 680,57</p></td><td><p>19 252,73</p></td><td><p>19 466,65</p></td><td><p>20 270,98</p></td><td><p>20 270,98</p></td><td><p>19 830,35</p></td><td><p>20 050,64</p></td><td><p>25 %</p></td><td><p><a> (<span>22</span>)</a></p></td></tr><tr><td><p>22</p></td><td><p>Seamless Stainless Tubes and Pipes</p></td><td><p>7304 11 00 , 7304 22 00 , 7304 24 00 , 7304 41 00 , 7304 49 10 , 7304 49 93 , 7304 49 95 , 7304 49 99</p></td><td><p>India</p></td><td><p>5 442,11</p></td><td><p>5 442,11</p></td><td><p>5 323,80</p></td><td><p>5 382,95</p></td><td><p>5 605,37</p></td><td><p>5 605,37</p></td><td><p>5 483,51</p></td><td><p>5 544,44</p></td><td><p>5 773,53</p></td><td><p>5 773,53</p></td><td><p>5 648,02</p></td><td><p>5 710,78</p></td><td><p>25 %</p></td><td><p>09.8926</p></td></tr><tr><td><p>Ukraine</p></td><td><p>3 407,64</p></td><td><p>3 407,64</p></td><td><p>3 333,57</p></td><td><p>3 370,60</p></td><td><p>3 509,87</p></td><td><p>3 509,87</p></td><td><p>3 433,57</p></td><td><p>3 471,72</p></td><td><p>3 615,17</p></td><td><p>3 615,17</p></td><td><p>3 536,58</p></td><td><p>3 575,87</p></td><td><p>25 %</p></td><td><p>09.8927</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>1 729,72</p></td><td><p>1 729,72</p></td><td><p>1 692,11</p></td><td><p>1 710,91</p></td><td><p>1 781,61</p></td><td><p>1 781,61</p></td><td><p>1 742,88</p></td><td><p>1 762,24</p></td><td><p>1 835,05</p></td><td><p>1 835,05</p></td><td><p>1 795,16</p></td><td><p>1 815,11</p></td><td><p>25 %</p></td><td><p>09.8994</p></td></tr><tr><td><p>Korea, Republic of</p></td><td><p>1 071,22</p></td><td><p>1 071,22</p></td><td><p>1 047,93</p></td><td><p>1 059,58</p></td><td><p>1 103,36</p></td><td><p>1 103,36</p></td><td><p>1 079,37</p></td><td><p>1 091,36</p></td><td><p>1 136,46</p></td><td><p>1 136,46</p></td><td><p>1 111,75</p></td><td><p>1 124,10</p></td><td><p>25 %</p></td><td><p>09.8928</p></td></tr><tr><td><p>Japan</p></td><td><p>996,18</p></td><td><p>996,18</p></td><td><p>974,53</p></td><td><p>985,35</p></td><td><p>1 026,07</p></td><td><p>1 026,07</p></td><td><p>1 003,76</p></td><td><p>1 014,92</p></td><td><p>1 056,85</p></td><td><p>1 056,85</p></td><td><p>1 033,88</p></td><td><p>1 045,36</p></td><td><p>25 %</p></td><td><p>09.8929</p></td></tr><tr><td><p>China</p></td><td><p>854,71</p></td><td><p>854,71</p></td><td><p>836,13</p></td><td><p>845,42</p></td><td><p>880,35</p></td><td><p>880,35</p></td><td><p>861,21</p></td><td><p>870,78</p></td><td><p>906,76</p></td><td><p>906,76</p></td><td><p>887,05</p></td><td><p>896,90</p></td><td><p>25 %</p></td><td><p>09.8931</p></td></tr><tr><td><p>Other countries</p></td><td><p>2 485,71</p></td><td><p>2 485,71</p></td><td><p>2 431,67</p></td><td><p>2 459,42</p></td><td><p>2 561,41</p></td><td><p>2 561,41</p></td><td><p>2 505,73</p></td><td><p>2 533,57</p></td><td><p>2 638,25</p></td><td><p>2 638,25</p></td><td><p>2 580,91</p></td><td><p>2 609,57</p></td><td><p>25 %</p></td><td><p><a> (<span>23</span>)</a></p></td></tr><tr><td><p>24</p></td><td><p>Other Seamless Tubes</p></td><td><p>7304 19 10 , 7304 19 30 , 7304 19 90 , 7304 23 00 , 7304 29 10 , 7304 29 30 , 7304 29 90 , 7304 31 20 , 7304 31 80 , 7304 39 10 , 7304 39 52 , 7304 39 58 , 7304 39 92 , 7304 39 93 , 7304 39 98 , 7304 51 81 , 7304 51 89 , 7304 59 10 , 7304 59 92 , 7304 59 93 , 7304 59 99 , 7304 90 00</p></td><td><p>China</p></td><td><p>31 746,88</p></td><td><p>31 746,88</p></td><td><p>31 056,73</p></td><td><p>35 138,95</p></td><td><p>36 590,84</p></td><td><p>36 590,84</p></td><td><p>35 795,39</p></td><td><p>36 193,11</p></td><td><p>37 688,57</p></td><td><p>37 688,57</p></td><td><p>36 869,25</p></td><td><p>37 278,91</p></td><td><p>25 %</p></td><td><p>09.8936</p></td></tr><tr><td><p>Ukraine</p></td><td><p>24 786,28</p></td><td><p>24 786,28</p></td><td><p>24 247,45</p></td><td><p>29 370,29</p></td><td><p>30 583,83</p></td><td><p>30 583,83</p></td><td><p>29 918,97</p></td><td><p>30 251,40</p></td><td><p>31 501,35</p></td><td><p>31 501,35</p></td><td><p>30 816,54</p></td><td><p>31 158,94</p></td><td><p>25 %</p></td><td><p>09.8937</p></td></tr><tr><td><p>Belarus</p></td><td><p>13 261,51</p></td><td><p>13 261,51</p></td><td><p>12 973,22</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8938</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>10 062,86</p></td><td><p>10 062,86</p></td><td><p>9 844,10</p></td><td><p>10 716,91</p></td><td><p>11 159,72</p></td><td><p>11 159,72</p></td><td><p>10 917,12</p></td><td><p>11 038,42</p></td><td><p>11 494,51</p></td><td><p>11 494,51</p></td><td><p>11 244,63</p></td><td><p>11 369,57</p></td><td><p>25 %</p></td><td><p>09.8995</p></td></tr><tr><td><p>United States</p></td><td><p>7 069,32</p></td><td><p>7 069,32</p></td><td><p>6 915,64</p></td><td><p>7 713,94</p></td><td><p>8 032,67</p></td><td><p>8 032,67</p></td><td><p>7 858,04</p></td><td><p>7 945,35</p></td><td><p>8 273,64</p></td><td><p>8 273,64</p></td><td><p>8 093,78</p></td><td><p>8 183,71</p></td><td><p>25 %</p></td><td><p>09.8940</p></td></tr><tr><td><p>Other countries</p></td><td><p>37 336,95</p></td><td><p>37 336,95</p></td><td><p>36 525,28</p></td><td><p>41 065,51</p></td><td><p>43 321,77</p></td><td><p>43 321,77</p></td><td><p>42 380,00</p></td><td><p>42 850,88</p></td><td><p>44 616,65</p></td><td><p>44 616,65</p></td><td><p>43 665,67</p></td><td><p>44 131,69</p></td><td><p>25 %</p></td><td><p><a> (<span>24</span>)</a></p></td></tr><tr><td><p>25.A</p></td><td><p>Large welded tubes</p></td><td><p>7305 11 00 , 7305 12 00</p></td><td><p>Other countries</p></td><td><p>111 953,87</p></td><td><p>111 953,87</p></td><td><p>109 520,09</p></td><td><p>110 738,79</p></td><td><p>115 315,30</p></td><td><p>115 315,30</p></td><td><p>112 808,45</p></td><td><p>114 061,88</p></td><td><p>118 774,75</p></td><td><p>118 774,75</p></td><td><p>116 192,73</p></td><td><p>117 483,73</p></td><td><p>25 %</p></td><td><p><a> (<span>25</span>)</a></p></td></tr><tr><td><p>25.B</p></td><td><p>Large welded tubes</p></td><td><p>7305 19 00 , 7305 20 00 , 7305 31 00 , 7305 39 00 , 7305 90 00</p></td><td><p>Turkey</p></td><td><p>9 842,08</p></td><td><p>9 842,08</p></td><td><p>9 628,12</p></td><td><p>13 668,52</p></td><td><p>14 233,28</p></td><td><p>14 233,28</p></td><td><p>13 923,86</p></td><td><p>14 078,57</p></td><td><p>14 660,28</p></td><td><p>14 660,28</p></td><td><p>14 341,58</p></td><td><p>14 500,93</p></td><td><p>25 %</p></td><td><p>09.8971</p></td></tr><tr><td><p>China</p></td><td><p>6 657,70</p></td><td><p>6 657,70</p></td><td><p>6 512,97</p></td><td><p>7 736,73</p></td><td><p>8 056,40</p></td><td><p>8 056,40</p></td><td><p>7 881,26</p></td><td><p>7 968,83</p></td><td><p>8 298,09</p></td><td><p>8 298,09</p></td><td><p>8 117,70</p></td><td><p>8 207,89</p></td><td><p>25 %</p></td><td><p>09.8972</p></td></tr><tr><td><p>Russian Federation</p></td><td><p>6 610,11</p></td><td><p>6 610,11</p></td><td><p>6 466,41</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8973</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>4 473,70</p></td><td><p>4 473,70</p></td><td><p>4 376,44</p></td><td><p>5 615,03</p></td><td><p>5 847,04</p></td><td><p>5 847,04</p></td><td><p>5 719,93</p></td><td><p>5 783,49</p></td><td><p>6 022,45</p></td><td><p>6 022,45</p></td><td><p>5 891,53</p></td><td><p>5 956,99</p></td><td><p>25 %</p></td><td><p>09.8996</p></td></tr><tr><td><p>Korea, Republic of</p></td><td><p>2 620,00</p></td><td><p>2 620,00</p></td><td><p>2 563,05</p></td><td><p>2 645,14</p></td><td><p>2 754,43</p></td><td><p>2 754,43</p></td><td><p>2 694,55</p></td><td><p>2 724,49</p></td><td><p>2 837,06</p></td><td><p>2 837,06</p></td><td><p>2 775,39</p></td><td><p>2 806,23</p></td><td><p>25 %</p></td><td><p>09.8974</p></td></tr><tr><td><p>Other countries</p></td><td><p>6 076,79</p></td><td><p>6 076,79</p></td><td><p>5 944,69</p></td><td><p>6 225,60</p></td><td><p>6 485,38</p></td><td><p>6 485,38</p></td><td><p>6 344,39</p></td><td><p>6 414,89</p></td><td><p>6 679,92</p></td><td><p>6 679,92</p></td><td><p>6 534,79</p></td><td><p>6 607,31</p></td><td><p>25 %</p></td><td><p><a> (<span>26</span>)</a></p></td></tr><tr><td><p>26</p></td><td><p>Other Welded Pipes</p></td><td><p>7306 11 10 , 7306 11 90 , 7306 19 10 , 7306 19 90 , 7306 21 00 , 7306 29 00 , 7306 30 11 , 7306 30 19 , 7306 30 80 , 7306 40 20 , 7306 40 80 , 7306 50 20 , 7306 50 80 , 7306 69 10 , 7306 69 90 , 7306 90 00</p></td><td><p>Switzerland</p></td><td><p>42 818,92</p></td><td><p>42 818,92</p></td><td><p>41 888,08</p></td><td><p>44 011,88</p></td><td><p>45 830,39</p></td><td><p>45 830,39</p></td><td><p>44 834,08</p></td><td><p>45 332,23</p></td><td><p>47 205,30</p></td><td><p>47 205,30</p></td><td><p>46 179,10</p></td><td><p>46 692,20</p></td><td><p>25 %</p></td><td><p>09.8946</p></td></tr><tr><td><p>Turkey</p></td><td><p>32 772,41</p></td><td><p>32 772,41</p></td><td><p>32 059,97</p></td><td><p>34 857,41</p></td><td><p>36 297,67</p></td><td><p>36 297,67</p></td><td><p>35 508,59</p></td><td><p>35 903,13</p></td><td><p>37 386,60</p></td><td><p>37 386,60</p></td><td><p>36 573,85</p></td><td><p>36 980,23</p></td><td><p>25 %</p></td><td><p>09.8947</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>10 166,27</p></td><td><p>10 166,27</p></td><td><p>9 945,26</p></td><td><p>10 644,57</p></td><td><p>11 084,39</p></td><td><p>11 084,39</p></td><td><p>10 843,42</p></td><td><p>10 963,90</p></td><td><p>11 416,92</p></td><td><p>11 416,92</p></td><td><p>11 168,73</p></td><td><p>11 292,82</p></td><td><p>25 %</p></td><td><p>09.8997</p></td></tr><tr><td><p>Taiwan</p></td><td><p>7 907,35</p></td><td><p>7 907,35</p></td><td><p>7 735,45</p></td><td><p>8 247,50</p></td><td><p>8 588,27</p></td><td><p>8 588,27</p></td><td><p>8 401,57</p></td><td><p>8 494,92</p></td><td><p>8 845,92</p></td><td><p>8 845,92</p></td><td><p>8 653,62</p></td><td><p>8 749,77</p></td><td><p>25 %</p></td><td><p>09.8950</p></td></tr><tr><td><p>China</p></td><td><p>6 886,62</p></td><td><p>6 886,62</p></td><td><p>6 736,92</p></td><td><p>7 389,90</p></td><td><p>7 695,24</p></td><td><p>7 695,24</p></td><td><p>7 527,95</p></td><td><p>7 611,60</p></td><td><p>7 926,10</p></td><td><p>7 926,10</p></td><td><p>7 753,79</p></td><td><p>7 839,95</p></td><td><p>25 %</p></td><td><p>09.8949</p></td></tr><tr><td><p>Russian Federation</p></td><td><p>6 741,47</p></td><td><p>6 741,47</p></td><td><p>6 594,91</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8952</p></td></tr><tr><td><p>Other countries</p></td><td><p>21 951,80</p></td><td><p>21 951,80</p></td><td><p>21 474,59</p></td><td><p>22 697,85</p></td><td><p>23 640,36</p></td><td><p>23 640,36</p></td><td><p>23 126,44</p></td><td><p>23 383,40</p></td><td><p>24 349,53</p></td><td><p>24 349,53</p></td><td><p>23 820,35</p></td><td><p>24 084,87</p></td><td><p>25 %</p></td><td><p><a> (<span>27</span>)</a></p></td></tr><tr><td><p>27</p></td><td><p>Non-alloy and other alloy cold finished bars</p></td><td><p>7215 10 00 , 7215 50 11 , 7215 50 19 , 7215 50 80 , 7228 10 90 , 7228 20 99 , 7228 50 20 , 7228 50 40 , 7228 50 61 , 7228 50 69 , 7228 50 80</p></td><td><p>Russian Federation</p></td><td><p>78 539,32</p></td><td><p>78 539,32</p></td><td><p>76 831,94</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8956</p></td></tr><tr><td><p>Switzerland</p></td><td><p>18 320,25</p></td><td><p>18 320,25</p></td><td><p>17 921,98</p></td><td><p>38 599,05</p></td><td><p>40 193,91</p></td><td><p>40 193,91</p></td><td><p>39 320,13</p></td><td><p>39 757,02</p></td><td><p>41 399,73</p></td><td><p>41 399,73</p></td><td><p>40 499,73</p></td><td><p>40 949,73</p></td><td><p>25 %</p></td><td><p>09.8957</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>13 700,68</p></td><td><p>13 700,68</p></td><td><p>13 402,84</p></td><td><p>23 285,77</p></td><td><p>24 247,91</p></td><td><p>24 247,91</p></td><td><p>23 720,78</p></td><td><p>23 984,34</p></td><td><p>24 975,34</p></td><td><p>24 975,34</p></td><td><p>24 432,40</p></td><td><p>24 703,87</p></td><td><p>25 %</p></td><td><p>09.8998</p></td></tr><tr><td><p>China</p></td><td><p>13 225,35</p></td><td><p>13 225,35</p></td><td><p>12 937,85</p></td><td><p>24 633,45</p></td><td><p>25 651,27</p></td><td><p>25 651,27</p></td><td><p>25 093,64</p></td><td><p>25 372,46</p></td><td><p>26 420,81</p></td><td><p>26 420,81</p></td><td><p>25 846,45</p></td><td><p>26 133,63</p></td><td><p>25 %</p></td><td><p>09.8958</p></td></tr><tr><td><p>Ukraine</p></td><td><p>10 774,36</p></td><td><p>10 774,36</p></td><td><p>10 540,13</p></td><td><p>27 802,46</p></td><td><p>28 951,22</p></td><td><p>28 951,22</p></td><td><p>28 321,85</p></td><td><p>28 636,54</p></td><td><p>29 819,76</p></td><td><p>29 819,76</p></td><td><p>29 171,51</p></td><td><p>29 495,63</p></td><td><p>25 %</p></td><td><p>09.8959</p></td></tr><tr><td><p>Other countries</p></td><td><p>10 215,52</p></td><td><p>10 215,52</p></td><td><p>9 993,44</p></td><td><p>28 881,11</p></td><td><p>30 074,44</p></td><td><p>30 074,44</p></td><td><p>29 420,65</p></td><td><p>29 747,54</p></td><td><p>30 976,67</p></td><td><p>30 976,67</p></td><td><p>30 303,27</p></td><td><p>30 639,97</p></td><td><p>25 %</p></td><td><p><a> (<span>28</span>)</a></p></td></tr><tr><td><p>28</p></td><td><p>Non Alloy Wire</p></td><td><p>7217 10 10 , 7217 10 31 , 7217 10 39 , 7217 10 50 , 7217 10 90 , 7217 20 10 , 7217 20 30 , 7217 20 50 , 7217 20 90 , 7217 30 41 , 7217 30 49 , 7217 30 50 , 7217 30 90 , 7217 90 20 , 7217 90 50 , 7217 90 90</p></td><td><p>Belarus</p></td><td><p>59 572,65</p></td><td><p>59 572,65</p></td><td><p>58 277,59</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8961</p></td></tr><tr><td><p>China</p></td><td><p>41 943,92</p></td><td><p>41 943,92</p></td><td><p>41 032,10</p></td><td><p>72 279,33</p></td><td><p>75 265,82</p></td><td><p>75 265,82</p></td><td><p>73 629,60</p></td><td><p>74 447,71</p></td><td><p>77 523,79</p></td><td><p>77 523,79</p></td><td><p>75 838,49</p></td><td><p>76 681,14</p></td><td><p>25 %</p></td><td><p>09.8962</p></td></tr><tr><td><p>Russian Federation</p></td><td><p>28 067,23</p></td><td><p>28 067,23</p></td><td><p>27 457,07</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>not applicable</p></td><td><p>25 %</p></td><td><p>09.8963</p></td></tr><tr><td><p>Turkey</p></td><td><p>22 626,68</p></td><td><p>22 626,68</p></td><td><p>22 134,80</p></td><td><p>47 034,60</p></td><td><p>48 978,01</p></td><td><p>48 978,01</p></td><td><p>47 913,27</p></td><td><p>48 445,64</p></td><td><p>50 447,35</p></td><td><p>50 447,35</p></td><td><p>49 350,67</p></td><td><p>49 899,01</p></td><td><p>25 %</p></td><td><p>09.8964</p></td></tr><tr><td><p>Ukraine</p></td><td><p>18 051,77</p></td><td><p>18 051,77</p></td><td><p>17 659,34</p></td><td><p>35 470,40</p></td><td><p>36 936,00</p></td><td><p>36 936,00</p></td><td><p>36 133,04</p></td><td><p>36 534,52</p></td><td><p>38 044,08</p></td><td><p>38 044,08</p></td><td><p>37 217,03</p></td><td><p>37 630,55</p></td><td><p>25 %</p></td><td><p>09.8965</p></td></tr><tr><td><p>Other countries</p></td><td><p>31 324,59</p></td><td><p>31 324,59</p></td><td><p>30 643,62</p></td><td><p>45 019,53</p></td><td><p>47 088,72</p></td><td><p>47 088,72</p></td><td><p>46 065,05</p></td><td><p>46 576,89</p></td><td><p>48 499,60</p></td><td><p>48 499,60</p></td><td><p>47 452,34</p></td><td><p>47 972,43</p></td><td><p>25 %</p></td><td><p><a> (<span>29</span>)</a></p></td></tr></tbody></table>
IV.2 – Volumes of global and residual tariff–rate quotas per trimester
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Product Number</p></td><td><p>Allocation by country (Where Applicable)</p></td><td><p>Year 1</p></td><td><p>Year 2</p></td><td><p>Year 3</p></td></tr><tr><td><p>From 1.7.2021 to 30.9.2021</p></td><td><p>From 1.10.2021 to 31.12.2021</p></td><td><p>From 1.1.2022 to 31.3.2022</p></td><td><p>From 1.4.2022 to 30.6.2022</p></td><td><p>From 1.7.2022 to 30.9.2022</p></td><td><p>From 1.10.2022 to 31.12.2022</p></td><td><p>From 1.1.2023 to 31.3.2023</p></td><td><p>From 1.4.2023 to 30.6.2023</p></td><td><p>From 1.7.2023 to 30.9.2023</p></td><td><p>From 1.10.2023 to 31.12.2023</p></td><td><p>From 1.1.2024 to 31.3.2024</p></td><td><p>From 1.4.2024 to 30.6.2024</p></td></tr><tr><td><p>Volume of tariff quota (net tonnes)</p></td><td><p>Volume of tariff quota (net tonnes)</p></td><td><p>Volume of tariff quota (net tonnes)</p></td><td><p>Volume of tariff quota (net tonnes)</p></td><td><p>Volume of tariff quota (net tonnes)</p></td><td><p>Volume of tariff quota (net tonnes)</p></td><td><p>Volume of tariff quota (net tonnes)</p></td><td><p>Volume of tariff quota (net tonnes)</p></td><td><p>Volume of tariff quota (net tonnes)</p></td><td><p>Volume of tariff quota (net tonnes)</p></td><td><p>Volume of tariff quota (net tonnes)</p></td><td><p>Volume of tariff quota (net tonnes)</p></td></tr><tr><td><p>1</p></td><td><p>Other countries</p></td><td><p>1 020 975,90</p></td><td><p>1 020 975,90</p></td><td><p>998 780,77</p></td><td><p>1 120 627,94</p></td><td><p>1 166 931,42</p></td><td><p>1 166 931,42</p></td><td><p>1 141 563,34</p></td><td><p>1 154 247,38</p></td><td><p>1 201 939,35</p></td><td><p>1 201 939,35</p></td><td><p>1 175 810,26</p></td><td><p>1 188 874,80</p></td></tr><tr><td><p>2</p></td><td><p>Other countries</p></td><td><p>265 739,79</p></td><td><p>265 739,79</p></td><td><p>259 962,84</p></td><td><p>263 318,03</p></td><td><p>274 436,99</p></td><td><p>274 436,99</p></td><td><p>268 470,97</p></td><td><p>271 453,98</p></td><td><p>282 668,06</p></td><td><p>282 668,06</p></td><td><p>276 531,20</p></td><td><p>279 595,58</p></td></tr><tr><td><p>3A</p></td><td><p>Other countries</p></td><td><p>757,52</p></td><td><p>757,52</p></td><td><p>741,05</p></td><td><p>777,65</p></td><td><p>809,79</p></td><td><p>809,79</p></td><td><p>792,18</p></td><td><p>800,98</p></td><td><p>834,08</p></td><td><p>834,08</p></td><td><p>815,95</p></td><td><p>825,01</p></td></tr><tr><td><p>3B</p></td><td><p>Other countries</p></td><td><p>6 343,40</p></td><td><p>6 343,40</p></td><td><p>6 205,50</p></td><td><p>7 898,74</p></td><td><p>8 225,11</p></td><td><p>8 225,11</p></td><td><p>8 046,30</p></td><td><p>8 135,71</p></td><td><p>8 471,86</p></td><td><p>8 471,86</p></td><td><p>8 287,69</p></td><td><p>8 379,78</p></td></tr><tr><td><p>4A</p></td><td><p>Other countries</p></td><td><p>439 629,02</p></td><td><p>439 629,02</p></td><td><p>430 071,87</p></td><td><p>435 187,30</p></td><td><p>453 341,17</p></td><td><p>453 341,17</p></td><td><p>443 485,93</p></td><td><p>448 413,55</p></td><td><p>466 939,93</p></td><td><p>466 939,93</p></td><td><p>456 794,90</p></td><td><p>461 864,50</p></td></tr><tr><td><p>4B</p></td><td><p>Other countries</p></td><td><p>99 301,05</p></td><td><p>99 301,05</p></td><td><p>97 142,33</p></td><td><p>98 535,77</p></td><td><p>102 767,99</p></td><td><p>102 767,99</p></td><td><p>100 533,90</p></td><td><p>101 650,95</p></td><td><p>105 849,65</p></td><td><p>105 849,65</p></td><td><p>103 554,03</p></td><td><p>104 699,12</p></td></tr><tr><td><p>5</p></td><td><p>Other countries</p></td><td><p>39 845,48</p></td><td><p>39 845,48</p></td><td><p>38 979,27</p></td><td><p>39 412,50</p></td><td><p>41 041,04</p></td><td><p>41 041,04</p></td><td><p>40 148,84</p></td><td><p>40 594,94</p></td><td><p>42 272,27</p></td><td><p>42 272,27</p></td><td><p>41 353,31</p></td><td><p>41 812,79</p></td></tr><tr><td><p>6</p></td><td><p>Other countries</p></td><td><p>34 348,50</p></td><td><p>34 348,50</p></td><td><p>33 601,80</p></td><td><p>33 975,69</p></td><td><p>35 379,80</p></td><td><p>35 379,80</p></td><td><p>34 610,67</p></td><td><p>34 995,23</p></td><td><p>36 441,19</p></td><td><p>36 441,19</p></td><td><p>35 649,00</p></td><td><p>36 045,09</p></td></tr><tr><td><p>7</p></td><td><p>Other countries</p></td><td><p>304 534,67</p></td><td><p>304 534,67</p></td><td><p>297 914,36</p></td><td><p>317 122,78</p></td><td><p>330 246,89</p></td><td><p>330 246,89</p></td><td><p>323 067,60</p></td><td><p>326 657,25</p></td><td><p>340 154,11</p></td><td><p>340 154,11</p></td><td><p>332 760,17</p></td><td><p>336 456,78</p></td></tr><tr><td><p>8</p></td><td><p>Other countries</p></td><td><p>95 423,22</p></td><td><p>95 423,22</p></td><td><p>93 348,80</p></td><td><p>98 429,19</p></td><td><p>104 566,77</p></td><td><p>104 566,77</p></td><td><p>102 293,58</p></td><td><p>103 430,17</p></td><td><p>107 686,09</p></td><td><p>107 686,09</p></td><td><p>105 415,22</p></td><td><p>106 515,59</p></td></tr><tr><td><p>9</p></td><td><p>Other countries</p></td><td><p>48 986,92</p></td><td><p>48 986,92</p></td><td><p>47 921,98</p></td><td><p>48 454,45</p></td><td><p>50 456,53</p></td><td><p>50 456,53</p></td><td><p>49 359,64</p></td><td><p>49 908,08</p></td><td><p>51 970,22</p></td><td><p>51 970,22</p></td><td><p>50 840,43</p></td><td><p>51 405,33</p></td></tr><tr><td><p>10</p></td><td><p>Other countries</p></td><td><p>964,37</p></td><td><p>964,37</p></td><td><p>943,41</p></td><td><p>953,89</p></td><td><p>993,30</p></td><td><p>993,30</p></td><td><p>971,71</p></td><td><p>982,51</p></td><td><p>1 023,10</p></td><td><p>1 023,10</p></td><td><p>1 000,86</p></td><td><p>1 011,98</p></td></tr><tr><td><p>12</p></td><td><p>Other countries</p></td><td><p>49 635,42</p></td><td><p>49 635,42</p></td><td><p>48 556,39</p></td><td><p>64 249,10</p></td><td><p>66 907,49</p></td><td><p>66 907,49</p></td><td><p>65 452,98</p></td><td><p>66 180,24</p></td><td><p>68 914,69</p></td><td><p>68 914,69</p></td><td><p>67 416,67</p></td><td><p>68 165,61</p></td></tr><tr><td><p>13</p></td><td><p>Other countries</p></td><td><p>115 435,69</p></td><td><p>115 435,69</p></td><td><p>112 926,22</p></td><td><p>126 179,66</p></td><td><p>131 393,24</p></td><td><p>131 393,24</p></td><td><p>128 536,86</p></td><td><p>129 965,05</p></td><td><p>135 335,03</p></td><td><p>135 335,03</p></td><td><p>132 392,97</p></td><td><p>133 864,00</p></td></tr><tr><td><p>14</p></td><td><p>Other countries</p></td><td><p>4 760,96</p></td><td><p>4 760,96</p></td><td><p>4 657,46</p></td><td><p>4 712,47</p></td><td><p>4 908,85</p></td><td><p>4 908,85</p></td><td><p>4 802,13</p></td><td><p>4 855,49</p></td><td><p>5 056,10</p></td><td><p>5 056,10</p></td><td><p>4 946,24</p></td><td><p>5 001,14</p></td></tr><tr><td><p>15</p></td><td><p>Other countries</p></td><td><p>735,02</p></td><td><p>735,02</p></td><td><p>719,04</p></td><td><p>733,05</p></td><td><p>766,43</p></td><td><p>766,43</p></td><td><p>749,76</p></td><td><p>758,10</p></td><td><p>789,39</p></td><td><p>789,39</p></td><td><p>772,34</p></td><td><p>780,81</p></td></tr><tr><td><p>16</p></td><td><p>Other countries</p></td><td><p>82 000,79</p></td><td><p>82 000,79</p></td><td><p>80 218,16</p></td><td><p>111 148,75</p></td><td><p>115 741,27</p></td><td><p>115 741,27</p></td><td><p>113 225,16</p></td><td><p>114 483,21</p></td><td><p>119 213,51</p></td><td><p>119 213,51</p></td><td><p>116 621,91</p></td><td><p>117 917,71</p></td></tr><tr><td><p>17</p></td><td><p>Other countries</p></td><td><p>11 481,79</p></td><td><p>11 481,79</p></td><td><p>11 232,18</p></td><td><p>11 357,01</p></td><td><p>11 826,28</p></td><td><p>11 826,28</p></td><td><p>11 569,19</p></td><td><p>11 697,73</p></td><td><p>12 181,07</p></td><td><p>12 181,07</p></td><td><p>11 916,26</p></td><td><p>12 048,66</p></td></tr><tr><td><p>18</p></td><td><p>Other countries</p></td><td><p>235,91</p></td><td><p>235,91</p></td><td><p>230,78</p></td><td><p>251,89</p></td><td><p>271,80</p></td><td><p>271,80</p></td><td><p>265,89</p></td><td><p>268,84</p></td><td><p>279,87</p></td><td><p>279,87</p></td><td><p>274,11</p></td><td><p>276,83</p></td></tr><tr><td><p>19</p></td><td><p>Other countries</p></td><td><p>1 078,85</p></td><td><p>1 078,85</p></td><td><p>1 055,39</p></td><td><p>1 161,13</p></td><td><p>1 209,11</p></td><td><p>1 209,11</p></td><td><p>1 182,82</p></td><td><p>1 195,97</p></td><td><p>1 245,38</p></td><td><p>1 245,38</p></td><td><p>1 218,31</p></td><td><p>1 231,85</p></td></tr><tr><td><p>20</p></td><td><p>Other countries</p></td><td><p>13 303,52</p></td><td><p>13 303,52</p></td><td><p>13 014,32</p></td><td><p>13 159,25</p></td><td><p>13 703,14</p></td><td><p>13 703,14</p></td><td><p>13 405,24</p></td><td><p>13 554,19</p></td><td><p>14 114,23</p></td><td><p>14 114,23</p></td><td><p>13 807,41</p></td><td><p>13 960,82</p></td></tr><tr><td><p>21</p></td><td><p>Other countries</p></td><td><p>16 035,94</p></td><td><p>16 035,94</p></td><td><p>15 687,33</p></td><td><p>18 898,37</p></td><td><p>19 680,57</p></td><td><p>19 680,57</p></td><td><p>19 252,73</p></td><td><p>19 466,65</p></td><td><p>20 270,98</p></td><td><p>20 270,98</p></td><td><p>19 830,35</p></td><td><p>20 050,64</p></td></tr><tr><td><p>22</p></td><td><p>Other countries</p></td><td><p>2 485,71</p></td><td><p>2 485,71</p></td><td><p>2 431,67</p></td><td><p>2 459,42</p></td><td><p>2 561,41</p></td><td><p>2 561,41</p></td><td><p>2 505,73</p></td><td><p>2 533,57</p></td><td><p>2 638,25</p></td><td><p>2 638,25</p></td><td><p>2 580,91</p></td><td><p>2 609,57</p></td></tr><tr><td><p>24</p></td><td><p>Other countries</p></td><td><p>37 336,95</p></td><td><p>37 336,95</p></td><td><p>36 525,28</p></td><td><p>41 065,51</p></td><td><p>43 321,77</p></td><td><p>43 321,77</p></td><td><p>42 380,00</p></td><td><p>42 850,88</p></td><td><p>44 616,65</p></td><td><p>44 616,65</p></td><td><p>43 665,67</p></td><td><p>44 131,69</p></td></tr><tr><td><p>25A</p></td><td><p>Other countries</p></td><td><p>111 953,87</p></td><td><p>111 953,87</p></td><td><p>109 520,09</p></td><td><p>110 738,79</p></td><td><p>115 315,30</p></td><td><p>115 315,30</p></td><td><p>112 808,45</p></td><td><p>114 061,88</p></td><td><p>118 774,75</p></td><td><p>118 774,75</p></td><td><p>116 192,73</p></td><td><p>117 483,73</p></td></tr><tr><td><p>25B</p></td><td><p>Other countries</p></td><td><p>6 076,79</p></td><td><p>6 076,79</p></td><td><p>5 944,69</p></td><td><p>6 225,60</p></td><td><p>6 485,38</p></td><td><p>6 485,38</p></td><td><p>6 344,39</p></td><td><p>6 414,89</p></td><td><p>6 679,92</p></td><td><p>6 679,92</p></td><td><p>6 534,79</p></td><td><p>6 607,31</p></td></tr><tr><td><p>26</p></td><td><p>Other countries</p></td><td><p>21 951,80</p></td><td><p>21 951,80</p></td><td><p>21 474,59</p></td><td><p>22 697,85</p></td><td><p>23 640,36</p></td><td><p>23 640,36</p></td><td><p>23 126,44</p></td><td><p>23 383,40</p></td><td><p>24 349,53</p></td><td><p>24 349,53</p></td><td><p>23 820,35</p></td><td><p>24 084,87</p></td></tr><tr><td><p>27</p></td><td><p>Other countries</p></td><td><p>10 215,52</p></td><td><p>10 215,52</p></td><td><p>9 993,44</p></td><td><p>28 881,11</p></td><td><p>30 074,44</p></td><td><p>30 074,44</p></td><td><p>29 420,65</p></td><td><p>29 747,54</p></td><td><p>30 976,67</p></td><td><p>30 976,67</p></td><td><p>30 303,27</p></td><td><p>30 639,97</p></td></tr><tr><td><p>28</p></td><td><p>Other countries</p></td><td><p>31 324,59</p></td><td><p>31 324,59</p></td><td><p>30 643,62</p></td><td><p>45 019,53</p></td><td><p>47 088,72</p></td><td><p>47 088,72</p></td><td><p>46 065,05</p></td><td><p>46 576,89</p></td><td><p>48 499,60</p></td><td><p>48 499,60</p></td><td><p>47 452,34</p></td><td><p>47 972,43</p></td></tr></tbody></table>
IV.3 – Maximum volume of residual quota accessible in last quarters to countries with a country specific quota
<table><col/><col/><col/><col/><tbody><tr><td><p>Product category</p></td><td><p><span>New allocated quota in tonnes</span></p></td></tr><tr><td><p>From 1.4.2022 to 30.6.2022</p></td><td><p>From 1.4.2023 to 30.6.2023</p></td><td><p>From 1.4.2024 to 30.6.2024</p></td></tr><tr><td><p>1</p></td><td><p>Special regime</p></td><td><p>Special regime</p></td><td><p>Special regime</p></td></tr><tr><td><p>2</p></td><td><p>263 318,03</p></td><td><p>271 453,98</p></td><td><p>279 595,58</p></td></tr><tr><td><p>3.A</p></td><td><p>777,65</p></td><td><p>800,98</p></td><td><p>825,01</p></td></tr><tr><td><p>3.B</p></td><td><p>7 898,74</p></td><td><p>8 135,71</p></td><td><p>8 379,78</p></td></tr><tr><td><p>4.A</p></td><td><p>435 187,30</p></td><td><p>448 413,55</p></td><td><p>461 864,50</p></td></tr><tr><td><p>4.B</p></td><td><p>Special regime</p></td><td><p>Special regime</p></td><td><p>Special regime</p></td></tr><tr><td><p>5</p></td><td><p>No access to the residual quota in Q4</p></td><td><p>No access to the residual quota in Q4</p></td><td><p>No access to the residual quota in Q4</p></td></tr><tr><td><p>6</p></td><td><p>33 975,69</p></td><td><p>34 995,23</p></td><td><p>36 045,09</p></td></tr><tr><td><p>7</p></td><td><p>317 122,78</p></td><td><p>326 657,25</p></td><td><p>336 456,78</p></td></tr><tr><td><p>8</p></td><td><p>Not applicable</p></td><td><p>Not applicable</p></td><td><p>Not applicable</p></td></tr><tr><td><p>9</p></td><td><p>48 454,45</p></td><td><p>49 908,08</p></td><td><p>51 405,33</p></td></tr><tr><td><p>10</p></td><td><p>286,17</p></td><td><p>294,75</p></td><td><p>303,59</p></td></tr><tr><td><p>12</p></td><td><p>38 549,46</p></td><td><p>39 708,14</p></td><td><p>40 899,37</p></td></tr><tr><td><p>13</p></td><td><p>32 806,71</p></td><td><p>33 790,91</p></td><td><p>34 804,64</p></td></tr><tr><td><p>14</p></td><td><p>2 591,86</p></td><td><p>2 670,52</p></td><td><p>2 750,63</p></td></tr><tr><td><p>15</p></td><td><p>542,46</p></td><td><p>560,99</p></td><td><p>577,80</p></td></tr><tr><td><p>16</p></td><td><p>No access to the residual quota in Q4</p></td><td><p>No access to the residual quota in Q4</p></td><td><p>No access to the residual quota in Q4</p></td></tr><tr><td><p>17</p></td><td><p>11 357,01</p></td><td><p>11 697,73</p></td><td><p>12 048,66</p></td></tr><tr><td><p>18</p></td><td><p>251,89</p></td><td><p>268,84</p></td><td><p>276,83</p></td></tr><tr><td><p>19</p></td><td><p>1 161,13</p></td><td><p>1 195,97</p></td><td><p>1 231,85</p></td></tr><tr><td><p>20</p></td><td><p>No access to the residual quota in Q4</p></td><td><p>No access to the residual quota in Q4</p></td><td><p>No access to the residual quota in Q4</p></td></tr><tr><td><p>21</p></td><td><p>3 968,66</p></td><td><p>4 088,00</p></td><td><p>4 210,63</p></td></tr><tr><td><p>22</p></td><td><p>1 992,13</p></td><td><p>2 052,19</p></td><td><p>2 113,75</p></td></tr><tr><td><p>24</p></td><td><p>41 065,51</p></td><td><p>42 850,88</p></td><td><p>44 131,69</p></td></tr><tr><td><p>25.A</p></td><td><p>Not applicable</p></td><td><p>Not applicable</p></td><td><p>Not applicable</p></td></tr><tr><td><p>25.B</p></td><td><p>6 225,60</p></td><td><p>6 414,89</p></td><td><p>6 607,31</p></td></tr><tr><td><p>26</p></td><td><p>22 697,85</p></td><td><p>23 383,40</p></td><td><p>24 084,87</p></td></tr><tr><td><p>27</p></td><td><p>No access to the residual quota in Q4</p></td><td><p>No access to the residual quota in Q4</p></td><td><p>No access to the residual quota in Q4</p></td></tr><tr><td><p>28</p></td><td><p>31 963,87</p></td><td><p>33 069,59</p></td><td><p>34 060,42</p></td></tr></tbody></table>
’ ( 1 ) From 1.7 to 31.3: 09.8601
From 1.4 to 30.6: 09.8602
From 1.4 to 30.6: For Turkey*: 09.8572, for India*: 09.8573, for Korea (Republic of)*: 09.8574, for Serbia*: 09.8575 and for United Kingdom*: 09.8599 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 2 ) From 1.7 to 31.3: 09.8603
From 1.4 to 30.6: 09.8604
From 1.4 to 30.6: For India*, Korea (Republic of)*, Ukraine*, Brazil*, Serbia* and United Kingdom*: 09.8567 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 3 ) From 1.7 to 31.3: 09.8605
From 1.4 to 30.6: 09.8606
From 1.4 to 30.6: For Korea (Republic of)*, Iran (Islamic republic of)* and United Kingdom*: 09.8568 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 4 ) From 1.7 to 31.3: 09.8607
From 1.4 to 30.6: 09.8608
From 1.4 to 30.6: For Korea (Republic of)*, China* and Taiwan*: 09.8569 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 5 ) From 1.7 to 31.3: 09.8609
From 1.4 to 30.6: 09.8610
From 1.4 to 30.6: For India*, Korea (Republic of)* and United Kingdom*: 09.8570 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 6 ) From 1.7 to 31.3: 09.8611
From 1.4 to 30.6: 09.8612
From 1.4 to 30.6: For China*: 09.8581, for Korea (Republic of)*: 09.8582, for India*: 09.8583, for United Kingdom*: 09.8584 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 7 ) From 1.7 to 31.3: 09.8613
From 1.4 to 30.6: 09.8614
( 8 ) From 1.7 to 31.3: 09.8615
From 1.4 to 30.6: 09.8616
From 1.4 to 30.6: For China*, Korea (Republic of)*, Taiwan*, Serbia* and United Kingdom*: 09.8576 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 9 ) From 1.7 to 31.3: 09.8617
From 1.4 to 30.6: 09.8618
From 1.4 to 30.6: For Ukraine*, Korea (Republic of)*, India* and United Kingdom*: 09.8577 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 10 ) From 1.7 to 31.3: 09.8619
From 1.4 to 30.6: 09.8620
( 11 ) From 1.7 to 31.3: 09.8621
From 1.4 to 30.6: 09.8622
From 1.4 to 30.6: For Korea (Republic of)*, Taiwan*, India*, South Africa*, United States of America*, Turkey* and Malaysia*: 09.8578 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 12 ) From 1.7 to 31.3: 09.8623
From 1.4 to 30.6: 09.8624
From 1.4 to 30.6: For China*, India*, South Africa*, Taiwan* and United Kingdom*: 09.8591 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 13 ) From 1.7 to 31.3: 09.8625
From 1.4 to 30.6: 09.8626
From 1.4 to 30.6: For China*, Turkey*, Switzerland * and United Kingdom*: 09.8592 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 14 ) From 1.7 to 31.3: 09.8627
From 1.4 to 30.6: 09.8628
From 1.4 to 30.6: For Turkey*, Ukraine*, Bosnia and Herzegovina* and Moldova*: 09.8593 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 15 ) From 1.7 to 31.3: 09.8629
From 1.4 to 30.6: 09.8630
From 1.4 to 30.6: For India*, Switzerland*, Ukraine* and United Kingdom*: 09.8594 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 16 ) From 1.7 to 31.3: 09.8631
From 1.4 to 30.6: 09.8632
From 1.4 to 30.6: For India*, Taiwan*, Korea (Republic of)*, China*, Japan* and United Kingdom*: 09.8595 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 17 ) From 1.7 to 31.3: 09.8633
From 1.4 to 30.6: 09.8634
( 18 ) From 1.7 to 31.3: 09.8635
From 1.4 to 30.6: 09.8636
From 1.4 to 30.6: For Turkey*, Ukraine*, Korea (Republic of)* and United Kingdom*: 09.8579 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 19 ) From 1.7 to 31.3: 09.8637
From 1.4 to 30.6: 09.8638
From 1.4 to 30.6: For China*, United Arab Emirates* and United Kingdom*: 09.8580 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 20 ) From 1.7 to 31.3: 09.8639
From 1.4 to 30.6: 09.8640
From 1.4 to 30.6: For China*, Turkey* and United Kingdom*: 09.8585 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 21 ) From 1.7 to 31.3: 09.8641
From 1.4 to 30.6: 09.8642
( 22 ) From 1.7 to 31.3: 09.8643
From 1.4 to 30.6: 09.8644
From 1.4 to 30.6: For Turkey*, Ukraine*, North Macedonia*, Switzerland * and United Kingdom*: 09.8596 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 23 ) From 1.7 to 31.3: 09.8645
From 1.4 to 30.6: 09.8646
From 1.4 to 30.6: For India*, Ukraine*, Korea (Republic of)*, Japan*, China* and United Kingdom*: 09.8597 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 24 ) From 1.7 to 31.3: 09.8647
From 1.4 to 30.6: 09.8648
From 1.4 to 30.6: For China*, Ukraine*, United States of America* and United Kingdom*: 09.8586 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 25 ) From 1.7 to 31.3: 09.8657
From 1.4 to 30.6: 09.8658
( 26 ) From 1.7 to 31.3: 09.8659
From 1.4 to 30.6: 09.8660
From 1.4 to 30.6: For Turkey*, China*, Korea (Republic of)* and United Kingdom*: 09.8587 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 27 ) From 1.7 to 31.3: 09.8651
From 1.4 to 30.6: 09.8652
From 1.4 to 30.6: For Switzerland*, Turkey*, Taiwan*, China * and United Kingdom*: 09.8588 *In case of exhaustion of their specific quotas in accordance with Article 1.5
( 28 ) From 1.7 to 31.3: 09.8653
From 1.4 to 30.6: 09.8654
( 29 ) From 1.7 to 31.3: 09.8655
From 1.4 to 30.6: 09.8656
From 1.4 to 30.6: For Turkey*, Ukraine* and China *: 09.8598 *In case of exhaustion of their specific quotas in accordance with Article 1.5 | ENG | 32022R0664 |
<table><col/><col/><col/><col/><tbody><tr><td><p>13.12.2016   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 337/13</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2016/2237
of 12 December 2016
establishing the standard import values for determining the entry price of certain fruit and vegetables
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) ,
Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors ( 2 ) , and in particular Article 136(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the<span>Official Journal of the European Union</span>,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 December 2016.
For the Commission,
On behalf of the President,
Jerzy PLEWA
Director-General
Directorate-General for Agriculture and Rural Development
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) OJ L 157, 15.6.2011, p. 1 .
ANNEX
Standard import values for determining the entry price of certain fruit and vegetables
<table><col/><col/><col/><tbody><tr><td><p>(EUR/100 kg)</p></td></tr><tr><td><p>CN code</p></td><td><p>Third country code<a> (<span>1</span>)</a></p></td><td><p>Standard import value</p></td></tr><tr><td><p>0702 00 00</p></td><td><p>MA</p></td><td><p>106,0</p></td></tr><tr><td><p>TN</p></td><td><p>123,9</p></td></tr><tr><td><p>TR</p></td><td><p>109,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>113,2</p></td></tr><tr><td><p>0707 00 05</p></td><td><p>MA</p></td><td><p>77,0</p></td></tr><tr><td><p>TR</p></td><td><p>166,4</p></td></tr><tr><td><p>ZZ</p></td><td><p>121,7</p></td></tr><tr><td><p>0709 93 10</p></td><td><p>MA</p></td><td><p>144,0</p></td></tr><tr><td><p>TR</p></td><td><p>161,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>152,8</p></td></tr><tr><td><p>0805 10 20</p></td><td><p>TR</p></td><td><p>66,3</p></td></tr><tr><td><p>ZA</p></td><td><p>27,9</p></td></tr><tr><td><p>ZZ</p></td><td><p>47,1</p></td></tr><tr><td><p>0805 20 10</p></td><td><p>MA</p></td><td><p>68,8</p></td></tr><tr><td><p>ZZ</p></td><td><p>68,8</p></td></tr><tr><td><p>0805 20 30 , 0805 20 50 , 0805 20 70 , 0805 20 90</p></td><td><p>IL</p></td><td><p>112,8</p></td></tr><tr><td><p>JM</p></td><td><p>112,0</p></td></tr><tr><td><p>TR</p></td><td><p>81,5</p></td></tr><tr><td><p>ZZ</p></td><td><p>102,1</p></td></tr><tr><td><p>0805 50 10</p></td><td><p>TR</p></td><td><p>86,1</p></td></tr><tr><td><p>ZZ</p></td><td><p>86,1</p></td></tr><tr><td><p>0808 10 80</p></td><td><p>US</p></td><td><p>97,3</p></td></tr><tr><td><p>ZA</p></td><td><p>36,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>67,0</p></td></tr><tr><td><p>0808 30 90</p></td><td><p>CN</p></td><td><p>89,2</p></td></tr><tr><td><p>ZZ</p></td><td><p>89,2</p></td></tr></tbody></table>
<note>
( 1 ) Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories ( OJ L 328, 28.11.2012, p. 7 ). Code ‘ZZ’ stands for ‘of other origin’.
</note> | ENG | 32016R2237 |
<table><col/><col/><col/><col/><tbody><tr><td><p>15.12.2022   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 321/38</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING DECISION (EU) 2022/2461
of 14 December 2022
recognising the ‘KZR INiG’ scheme for demonstrating compliance with the requirements set out in Directive (EU) 2018/2001 of the European Parliament and of the Council as regards biofuels, bioliquids, biomass fuels, renewable liquid and gaseous fuels of non-biological origin and recycled carbon fuels and repealing Commission Implementing Decision (EU) 2022/603
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources ( 1 ) , and in particular Article 30(4) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Directive (EU) 2018/2001 lays down requirements for certain fuels, namely biofuels, bioliquids, biomass fuels, renewable liquid and gaseous fuels of non-biological origin and recycled carbon fuels. These requirements ensure that these fuels can only be counted towards the targets set in that Directive if they have been sustainably produced and save significant greenhouse gas emissions compared to fossil fuels. Article 29 of that Directive lays down sustainability and greenhouse gas emissions saving criteria for biofuels, bioliquids, and biomass fuels. Furthermore, Article 26 of the Directive and Commission Delegated Regulation (EU) 2019/807 <a>(<span>2</span>)</a> lay down the criteria to determine: (i) which feedstock for biofuels, bioliquids or biomass fuels has high indirect land-use change risk; and (ii) which high indirect land-use change-risk biofuels, bioliquids or biomass fuels that meet certain conditions can be certified as having low indirect land-use change risk. Article 25(2) of Directive (EU) 2018/2001 lays down greenhouse gas emissions saving criteria for renewable liquid and gaseous fuels of non-biological origin and recycled carbon fuels used in transport. Article 28(2) of that Directive requires economic operators to enter information in a Union database on the transactions made and the sustainability characteristics of some renewable fuels (biofuels, biogas and renewable liquid and gaseous fuels of non-biological origin) and recycled carbon fuels used in transport.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Directive (EU) 2018/2001 also lays down rules for calculating the contribution of renewable electricity to transport targets. In particular, Article 27(3) of that Directive sets out the rules on how to calculate this contribution when the electricity is directly used to power electric vehicles and when it is used to produce renewable liquid and gaseous fuels of non-biological origin that are used in transport.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Voluntary schemes have played a significant role in providing evidence of compliance with the sustainability and greenhouse gas emissions saving criteria for biofuels and bioliquids. Under Directive (EU) 2018/2001, voluntary schemes can be used to: (i) certify compliance of all fuels produced from biomass, including gaseous and solid fuels, with the sustainability criteria laid down in that Directive; (ii) provide accurate data on their greenhouse gas emissions savings; (iii) certify compliance of renewable liquid and gaseous transport fuels of non-biological origin and recycled carbon fuels with their greenhouse gas emissions saving criteria; and (iv) prove compliance with the provisions of Article 27(3) of that Directive on calculating the share of renewable electricity in transport. Voluntary schemes can also be used to prove that economic operators enter accurate information into the Union or national databases on some renewable fuels and recycled carbon fuels used in transport, in accordance with Article 28(4) of Directive (EU) 2018/2001. Furthermore, voluntary schemes can be used to certify biofuels, bioliquids and biomass fuels with low indirect land-use change risk. The Commission may decide that voluntary national or international schemes can serve all or some of these purposes.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Under Article 30(9) of Directive (EU) 2018/2001, where an economic operator provides proof of or data on compliance with the sustainability and greenhouse gas emissions saving criteria, obtained in accordance with a voluntary scheme that has been recognised by the Commission, to the extent covered by the recognition decision, a Member State is not to require the supplier to provide further evidence.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>On 28 August 2020, the ‘KZR INiG’ scheme submitted a request for recognition to the Commission under Article 30(4) of Directive (EU) 2018/2001. The request led to an assessment of that scheme by the Commission, and some issues which prevented the scheme being considered as compatible with the sustainability criteria, as laid down in Article 29 of Directive (EU) 2018/2001 were identified. In its resubmission of 25 June 2021, the scheme correctly addressed those issues. The Commission’s assessment concluded that the scheme: (i) covered adequately the sustainability criteria for agricultural biomass laid down in Article 29(2) to (5) of Directive (EU) 2018/2001; (ii) contained accurate data on greenhouse gas emission savings for the purpose of Article 29(10) of Directive (EU) 2018/2001; and (iii) applied a mass balance methodology in accordance with the requirements of Article 30(1) and (2) of Directive (EU) 2018/2001. However, the Commission did not consider the scheme to adequately cover the sustainability criteria for forest biomass, laid down in Article 29(6) and (7) of Directive (EU) 2018/2001. Therefore, the ‘KZR INiG’ scheme was only recognised for demonstrating compliance with the requirements set out in Article 29(2) to (5) and (10) of Directive (EU) 2018/2001 by Commission Implementing Decision (EU) 2022/603 <a>(<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>The ‘KZR INiG’ scheme made further modifications to ensure that the sustainability criteria for forest biomass, laid down in Article 29(6) and (7) of Directive (EU) 2018/2001, were also adequately covered. After further amendments, all the remaining issues, which had previously been identified, were adequately addressed in a resubmission of 23 September 2022.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The ‘KZR INiG’ scheme covers the following feedstocks: agricultural biomass, forest biomass, and wastes and residues. The scheme also covers all types of fuels. It has a global geographic coverage and includes the entire chain of custody (for biomethane up to the production unit). The Commission has reassessed the ‘KZR INiG’ scheme since the resubmission of 23 September 2022 and has found that it: (i) covers adequately the sustainability criteria laid down in Article 29(2) to (7) of Directive (EU) 2018/2001; (ii) contains accurate data on greenhouse gas emission savings for the purposes of Article 29(10) of that Directive; and (iii) applies a mass balance methodology in accordance with the requirements of Article 30(1) and (2) of that Directive.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The Commission’s assessment does not take into account the implementing act to be adopted in accordance with Article 29(8) of Directive (EU) 2018/2001 on providing guidance for demonstrating compliance with the sustainability criteria laid down in Article 29(6) and (7) of that Directive <a>(<span>4</span>)</a>. The ‘KZR INiG’ scheme will therefore be re-assessed in this regard.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>Commission Implementing Regulation (EU) 2022/996 <a>(<span>5</span>)</a> will only apply from 30 December 2023. The ‘KZR INiG’ scheme should be re-assessed in light of the new Implementing Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>In its assessment of the ‘KZR INiG’ scheme, the Commission found that it meets adequate standards of reliability, transparency and independent auditing and complies with the methodological requirements set out in Annex VI to Directive (EU) 2018/2001.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>For reasons of transparency and legal certainty, it is appropriate that a single Commission act sets out in a comprehensive manner all the sustainability and greenhouse gas emissions criteria that the ‘KZR INiG’ scheme is considered to adequately cover. Therefore, Implementing Decision (EU) 2022/603 should be replaced.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>The recognised ‘KZR INiG’ scheme should be made available in the section on voluntary schemes on Europa, the Commission’s website</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>The measures provided for in this Decision are in accordance with the opinion of the Committee on the Sustainability of Biofuels, Bioliquids and Biomass fuels,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
The ‘KZR INiG’ voluntary scheme (‘the scheme’), submitted for recognition to the Commission on 23 September 2022, demonstrates the following elements for the fuels audited under the scheme:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>compliance of the consignments of biofuels, bioliquids and biomass fuels with the sustainability criteria laid down in Article 29(2) to (7) and (10) of Directive (EU) 2018/2001;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>compliance of economic operators with the obligation to enter accurate information into the Union or national databases on renewable fuels and recycled carbon fuels used in transport in accordance with Article 28(4) of Directive (EU) 2018/2001.</p></td></tr></tbody></table>
The scheme also contains accurate data on greenhouse gas emission savings for the purpose of Article 29(10) of Directive (EU) 2018/2001 in as far as it ensures that all relevant information from economic operators upstream from the chain of custody is transferred to the economic operators downstream from the chain of custody.
Any changes to the contents of the ‘KZR INiG’ voluntary scheme, as submitted for recognition to the Commission on 23 September 2022, that might affect the basis of this Decision, shall be notified to the Commission without delay. The Commission shall assess the notified changes to determine whether the scheme still adequately complies with the sustainability criteria for which it is recognised.
Article 2
The Decision shall apply until 16 December 2027.
Article 3
This Decision shall be repealed, if:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>it has been clearly demonstrated that the ‘KZR INiG’ voluntary scheme has not implemented elements considered to be important for this Decision or if a severe and structural breach of those elements has occurred;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the ‘KZR INiG’ voluntary scheme fails to submit annual reports to the Commission pursuant to Article 30(5) of Directive (EU) 2018/2001;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the ‘KZR INiG’ voluntary scheme fails to implement standards of independent auditing and other requirements set out in implementing acts referred to in Article 29(8) or Article 30(8) of Directive (EU) 2018/2001 or improvements to other elements of the scheme considered to be important for continued recognition.</p></td></tr></tbody></table>
Article 4
Implementing Decision (EU) 2022/603 is repealed with effect from 16 December 2022.
Article 5
This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union .
Done at Brussels, 14 December 2022.
For the Commission
The President
Ursula VON DER LEYEN
<note>
( 1 ) OJ L 328, 21.12.2018, p. 82 .
( 2 ) Commission Delegated Regulation (EU) 2019/807 of 13 March 2019 supplementing Directive (EU) 2018/2001 of the European Parliament and of the Council as regards the determination of high indirect land-use change-risk feedstock for which a significant expansion of the production area into land with high carbon stock is observed and the certification of low indirect land-use change-risk biofuels, bioliquids and biomass fuels ( OJ L 133, 21.5.2019, p. 1 ).
( 3 ) Commission Implementing Decision (EU) 2022/603 of 8 April 2022 on the recognition of the ‘KZR INiG’ scheme for demonstrating compliance with the requirements set in Directive (EU) 2018/2001 of the European Parliament and of the Council for biofuels, bioliquids, biomass fuels, renewable liquid and gaseous fuels of non-biological origin and recycled carbon fuels ( OJ L 114, 12.4.2022, p. 185 ).
( 4 ) The Implementing Regulation on providing guidance for demonstrating compliance with the sustainability criteria laid down in Article 29(6) and (7) of Directive (EU) 2018/2001 has received a positive opinion from the Committee on the Sustainability of Biofuels, Bioliquids and Biomass Fuels on 14 September 2022 but has not been officially adopted yet.
( 5 ) Commission Implementing Regulation (EU) 2022/996 of 14 June 2022 on rules to verify sustainability and greenhouse gas emissions saving criteria and low indirect land-use change-risk criteria ( OJ L 168, 27.6.2022, p. 1 ).
</note> | ENG | 32022D2461 |
<table><col/><col/><col/><col/><tbody><tr><td><p>11.3.2019   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 69/1</p></td></tr></tbody></table>
COMMISSION DELEGATED REGULATION (EU) 2019/379
of 19 December 2018
amending Delegated Regulation (EU) 2015/2195 on supplementing Regulation (EU) No 1304/2013 of the European Parliament and of the Council on the European Social Fund, regarding the definition of standard scales of unit costs and lump sums for reimbursement of expenditure by the Commission to Member States
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1304/2013 of the European Parliament and of the Council of 17 December 2013 on the European Social Fund and repealing Council Regulation (EC) No 1081/2006 ( 1 ) , and in particular Article 14(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>With a view to simplifying the use of the European Social Fund ‘ESF’ and reducing the administrative burden for beneficiaries, it is appropriate to increase the scope of standard scales of unit costs and lump sums available for reimbursement to Member States. The standard scales of unit costs and lump sums for reimbursement to Member States should be established on the basis of data submitted by Member States or published by Eurostat and on the basis of methods commonly agreed, including the methods set out in Article 67(5) and Article 68b(1) of Regulation (EU) No 1303/2013 of the European Parliament and of the Council <a>(<span>2</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Taking into account the significant disparities between Member States regarding the level of costs for a particular type of operation, the definition and amounts of standard scales of unit costs and lump sums may differ according to the type of operation and the Member State concerned in order to reflect their specificities.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Bulgaria has submitted methods for defining standard scales of unit costs for reimbursement of expenditure by the Commission.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>France, the Czech Republic, Slovakia, Austria, Romania, Cyprus and Croatia have submitted methods for either, amending existing standard scales of unit costs, or defining additional standard scales of unit costs for reimbursement by the Commission concerning types of operation not yet covered by Commission Delegated Regulation (EU) 2015/2195 <a>(<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>For the SSUCs relating to operations supporting education and applicable to all Member States except Denmark, amounts for Greece should be added and the conditions for reimbursement for vocational education and training should be clarified and reduced to reflect specific situations.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Taking into account the objective of expanding the possibilities for Member States to seek reimbursement from the Commission on the basis of standard scales of unit costs or lump sums, the Commission has defined unit costs and amounts for each Member State on the basis of data published by Eurostat and as reported by national Public Employment Services for operations in the area of trainnig.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Delegated Regulation (EU) 2015/2195 should therefore be amended accordingly,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EU) 2015/2195 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Annex II to Delegated Regulation (EU) 2015/2195 is replaced by the text in Annex I to this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Annex III to Delegated Regulation (EU) 2015/2195 is replaced by the text in Annex II to this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Annex VII to Delegated Regulation (EU) 2015/2195 is replaced by the text in Annex III to this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Annex X to Delegated Regulation (EU) 2015/2195 is replaced by the text in Annex IV to this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Annex XIII to Delegated Regulation (EU) 2015/2195 is replaced by the text in Annex V to this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Annex XIV to Delegated Regulation (EU) 2015/2195 is replaced by the text in Annex VI to this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Annex XV to Delegated Regulation (EU) 2015/2195 is replaced by the text in Annex VII to this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Annex XVI to Delegated Regulation (EU) 2015/2195 is replaced by the text in Annex VIII to this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>The text in Annex IX to this Regulation is added as Annex XX to Delegated Regulation (EU) 2015/2195.</p></td></tr></tbody></table>
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 December 2018.
For the Commission
The President
Jean-Claude JUNCKER
( 1 ) OJ L 347, 20.12.2013, p. 470 .
( 2 ) Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006 ( OJ L 347, 20.12.2013, p. 320 ).
( 3 ) Commission Delegated Regulation (EU) 2015/2195 of 9 July 2015 on supplementing Regulation (EU) No 1304/2013 of the European Parliament and of the Council on the European Social Fund, regarding the definition of standard scales of unit costs and lump sums for reimbursement of expenditure by the Commission to Member States ( OJ L 313, 28.11.2015, p. 22 ).
ANNEX I
‘ANNEX II
Conditions for reimbursement of expenditure on the basis of standard scales of unit costs to France
1. Definition of standard scales of unit costs
<table><col/><col/><col/><tbody><tr><td><p>Type of operations</p></td><td><p>Indicator name</p></td><td><p>Category of costs</p></td><td><p>Measurement unit for the indicator</p></td><td><p>Amounts (in EUR)</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>“Garantie Jeunes” supported under priority axis 1 “Accompagner les jeunes NEET vers et dans l'emploi” of the operational programme “PROGRAMME OPÉRATIONNEL NATIONAL POUR LA MISE EN ŒUVRE DE L'INITIATIVE POUR L'EMPLOI DES JEUNES EN METROPOLE ET OUTRE-MER” (CCI-2014FR05M9OP001)</p></td></tr></tbody></table></td><td><p>Young NEET<a> (<span>1</span>)</a> with a positive result under “Garantie Jeunes” at the latest 12 months following the start of coaching</p></td><td><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>allowances paid to the participant;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>activation costs incurred by the “missions locales”</p></td></tr></tbody></table></td><td><p>Number of young NEETs who have one of the following results at the latest 12 months following the start of the coaching:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>entered vocational skills training leading to a certification, whether by:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>entering training in lifelong learning; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>entering basic training;</p></td></tr></tbody></table><p>or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>started a company; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>found a job; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>has spent at least 80 working days in a (paid or not) professional environment</p></td></tr></tbody></table></td><td><p>6 400</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Training for the unemployed provided by accredited training organisations and supported by the Operational Programme Ile-de-France (CCI 2014FR05M0OP001)</p></td></tr></tbody></table></td><td><p>Participants with a successful outcome following a training course.</p></td><td><p>All eligible costs of the operation.</p></td><td><p>Number of participants with one of the following outcomes following a training course:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>received a diploma or a confirmation of acquired competencies at the end of their training course;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>found a job of at least one month duration;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>inscribed in a further professional training course;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>re-inscribed in their previous school curriculum after an interruption; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>gained access to a formal validation process of their aquired competencies.</p></td></tr></tbody></table><p>If a participant achieves more than one succesful outcome following the training course, this shall only give rise to the reimbursement of one amount for that training.</p></td><td><p><tblcnt><table><col/><col/><col/><tbody><tr><td><p>Category</p></td><td><p>Sector</p></td><td><p>Amount</p></td></tr><tr><td><p>1</p></td><td><p>Healthcare</p></td><td><p>3 931</p></td></tr><tr><td><p>Safety of goods and people</p></td></tr><tr><td><p>2</p></td><td><p>Cultural, sports and leisure activities</p></td><td><p>4 556</p></td></tr><tr><td><p>Services to people</p></td></tr><tr><td><p>Handling of soft materials</p></td></tr><tr><td><p>Agri-food, cooking</p></td></tr><tr><td><p>Trade and sales</p></td></tr><tr><td><p>Hosting, hotel industry, catering</p></td></tr><tr><td><p>Health and safety at work</p></td></tr><tr><td><p>3</p></td><td><p>Secretarial and office automation training</p></td><td><p>5 695</p></td></tr><tr><td><p>Social work</p></td></tr><tr><td><p>Electronics</p></td></tr><tr><td><p>Hairdressing, beauty and wellness</p></td></tr><tr><td><p>Vehicle and equipment maintenance</p></td></tr><tr><td><p>Transport, handling, storing</p></td></tr><tr><td><p>4</p></td><td><p>Agriculture</p></td><td><p>7 054</p></td></tr><tr><td><p>Environment</p></td></tr><tr><td><p>Building and public works</p></td></tr><tr><td><p>Printing and publishing techniques</p></td></tr></tbody></table></tblcnt></p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>Training for the unemployed provided by accredited training organisations and supported by the following Operational Programmes:</p><table><col/><col/><tbody><tr><td><p> </p></td><td><p>Rhône-Alpes (CCI 2014FR16M2OP010)</p><p>and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p> </p></td><td><p>Auvergne (CCI 2014FR16M0OP002)</p></td></tr></tbody></table></td></tr></tbody></table></td><td><p>Participants with a successful outcome following a training course.</p></td><td><p>All eligible costs of the operation.</p></td><td><p>Number of participants with one of the following outcomes following a training course:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>received a diploma which is officially endorsed by a professional representation organisation or government office.;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>received a confirmation of acquired competencies at the end of their training course;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>found a job;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>inscribed in a further professional training course;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>re-inscribed in their previous school curriculum after an interruption; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>gained access to a formal validation process of their aquired competencies.</p></td></tr></tbody></table><p>For category 5, additionally, number of participants with a successful outcome as described above who are entitled to receive an allowance from the Region Auvergne-Rhône-Alpes<a> (<span>2</span>)</a>.</p><p>If a participant achieves more than one succesful outcome following the training course, this shall only give rise to the reimbursement of one amount for that training.</p></td><td><p><tblcnt><table><col/><col/><col/><tbody><tr><td><p>Category</p></td><td><p>Sector</p></td><td><p>Amount</p></td></tr><tr><td><p>1</p></td><td><p>Transport, logistics, and tourism</p></td><td><p>4 403</p></td></tr><tr><td><p>Banking, insurance</p></td></tr><tr><td><p>Management, business administration, creation of enterprises</p></td></tr><tr><td><p>Services for individuals and communities</p></td></tr><tr><td><p>2</p></td><td><p>Health and social work, recreational, cultural and sporting activities</p></td><td><p>5 214</p></td></tr><tr><td><p>Restaurant, hotel and food industries</p></td></tr><tr><td><p>Trade</p></td></tr><tr><td><p>Handling of soft materials and wood; graphic industries</p></td></tr><tr><td><p>3</p></td><td><p>Building and public works</p></td><td><p>7 853</p></td></tr><tr><td><p>Process industries</p></td></tr><tr><td><p>Mechanics, metal working</p></td></tr><tr><td><p>Agriculture, marine, fisheries</p></td></tr><tr><td><p>Communication, information, art and entertainment</p></td></tr><tr><td><p>4</p></td><td><p>Maintenance</p></td><td><p>9 605</p></td></tr><tr><td><p>Electricity, electronics</p></td></tr><tr><td><p>IT and telecommunication</p></td></tr><tr><td><p>5</p></td><td><p>Allowances</p></td><td><p>1 901</p></td></tr></tbody></table></tblcnt></p></td></tr></tbody></table>
2. Adjustment of amounts
The amount of unit cost 1. is based partly on a standard scale of unit cost funded entirely by France. Out of the 6 400 EUR, 1 600 EUR correspond to the standard scale of unit cost set out by the “instruction ministérielle du 11 octobre 2013 relative à l'expérimentation Garantie Jeunes prise pour l'application du décret 2013-80 du 1 er octobre 2013 ainsi que par l'instruction ministérielle du 20 mars 2014” to cover the costs borne by the Youth Public Employment Services “Missions Locales” to coach each NEET entering the “Garantie Jeunes”.
Unit cost 1. shall be updated by the Member State in line with adjustments under national rules to the standard scale of unit cost of 1 600 EUR mentioned in paragraph 1 above that covers the costs borne by the Youth Public Employment Services.
The amount of unit costs 2. and 3. are based on publicly procured prices for training hours in the respective fields and geographical areas. These amounts will be adjusted when the procurement process for the underlying training courses is repeated according to the following formula:
New price (excl. VAT) = Old price (excl. VAT) × (0,5 + 0,5 × Sr/So)
Sr is the index of employed persons INSEE (identifier 1567446) of the last monthly publication at the date of the adjustement
So is the index of employed persons INSEE (identifier 1567446) of the monthly publication at the date of submission of the tender for the first adjustment; then, for the following adjustements, it refers to the monthly publication of the anniversary date of the submission of the tender.
’ ( 1 ) Young person not in employment, education or training that participates in an operation supported by the “PROGRAMME OPÉRATIONNEL NATIONAL POUR LA MISE EN ŒUVRE DE L'INITIATIVE POUR L'EMPLOI DES JEUNES EN METROPOLE ET OUTRE-MER”.
( 2 ) The entitlement to receive an allowance is regulated in decree n°88-368 of 15 April 1988 modified by decree n°2002-1551 of 23 December 2002.
ANNEX II
‘ANNEX III
Conditions for reimbursement of expenditure on the basis of standard scales of unit costs to the Czech Republic
1. Definition of standard scales of unit costs
<table><col/><col/><tbody><tr><td><p>Type of operations</p></td><td><p>Indicator name</p></td><td><p>Category of costs<a> (<span>1</span>)</a></p></td><td><p>Measurement unit for the indicator</p></td><td><p>Amounts</p><p>(in national currency CZK unless otherwise mentioned)</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Establishment of a new childcare facility under Priority Axis 1 of Operational Programme Employment (2014CZ05M9OP001) and Priority Axis 4 of Operational Programme Prague Growth Pole (2014CZ16M2OP001)</p></td></tr></tbody></table></td><td><p>Newly created place in a new childcare facility</p></td><td><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>purchase of equipment for a childcare facility;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>management of project phase focused on creating the facility.</p></td></tr></tbody></table></td><td><p>Number of newly created places in a new childcare facility<a> (<span>2</span>)</a></p></td><td><p>20 053 incl. VAT, or 16 992 excl. VAT</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Transformation of an existing facility to a children's group under Priority Axis 1 of Operational Programme Employment (2014CZ05M9OP001) and Priority Axis 4 of Operational Programme Prague Growth Pole (2014CZ16M2OP001)</p></td></tr></tbody></table></td><td><p>Transformed place in a children's group<a> (<span>3</span>)</a></p></td><td><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>purchase of equipment for a transformed facility;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>purchase of teaching aids;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>management of project phase focused on transforming the facility</p></td></tr></tbody></table></td><td><p>Number of transformed places in a children's group<a> (<span>4</span>)</a></p></td><td><p>9 518 incl. VAT, or 8 279 excl. VAT</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>Operating a childcare facility under Priority Axis 1 of Operational Programme Employment (2014CZ05M9OP001) and Priority Axis 4 of Operational Programme Prague Growth Pole (2014CZ16M2OP001)</p></td></tr></tbody></table></td><td><p>Occupancy per place in a childcare facility</p></td><td><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>salaries of teaching and non-teaching staff,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>operation of the childcare facility,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>management of the operation</p></td></tr></tbody></table></td><td><p>Occupancy rate<a> (<span>5</span>)</a></p></td><td><p>628<a> (<span>6</span>)</a></p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.</p></td><td><p>Upskilling of caregivers under Priority Axis 1 of Operational Programme Employment (2014CZ05M9OP001) and Priority Axis 4 of Operational Programme Prague Growth Pole (2014CZ16M2OP001)</p></td></tr></tbody></table></td><td><p>Achievement of a qualification as caregiver in a childcare facility</p></td><td><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>training and examination for professional qualification</p></td></tr></tbody></table></td><td><p>Number of persons who obtain a certification of professional qualification as caregiver in a childcare facility</p></td><td><p>14 178</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>5.</p></td><td><p>Lease of premises for childcare facilities under Priority Axis 1 of Operational Programme Employment (2014CZ05M9OP001) and Priority Axis 4 of Operational Programme Prague Growth Pole (2014CZ16M2OP001)</p></td></tr></tbody></table></td><td><p>Occupancy per place in a childcare facility</p></td><td><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rent of the premises for a childcare facility</p></td></tr></tbody></table></td><td><p>Occupancy rate<a> (<span>7</span>)</a>.</p></td><td><p>56<a> (<span>8</span>)</a></p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>6.</p></td><td><p>Further external professional training of employees under Priority Axis 1 of Operational Programme Employment, (2014CZ05M9OP001)</p></td></tr></tbody></table></td><td><p>One hour (60 minutes) of participation of an employee in an external training course on general information technologies (IT)</p></td><td><p>All eligible costs, including:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Direct costs of providing training;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Indirect costs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Wages for participants.</p></td></tr></tbody></table></td><td><p>Number of completed hours per employee.</p></td><td><p>324</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>7.</p></td><td><p>Further external professional training of employees under Priority Axis 1 of Operational Programme Employment (2014CZ05M9OP001)</p></td></tr></tbody></table></td><td><p>One hour (60 minutes) of participation of an employee in an external training course on soft and managerial skills</p></td><td><p>All eligible costs, including:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Direct costs of providing training;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Indirect costs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Wages for participants.</p></td></tr></tbody></table></td><td><p>Number of completed hours per employee.</p></td><td><p>593</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>8.</p></td><td><p>Further external professional training of employees under Priority Axis 1 of Operational Programme Employment (2014CZ05M9OP001)</p></td></tr></tbody></table></td><td><p>A period (45 minutes) of participation of an employee in external language training courses</p></td><td><p>All eligible costs, including:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Direct costs of providing training;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Indirect costs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Wages for participants.</p></td></tr></tbody></table></td><td><p>Number of completed periods per employee</p></td><td><p>173</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>9.</p></td><td><p>Further external professional training of employees under Priority Axis 1 of Operational Programme Employment (2014CZ05M9OP001)</p></td></tr></tbody></table></td><td><p>One hour (60 minutes) of participation of an employee in a training course in specialised IT</p></td><td><p>All eligible costs, inlcuding:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Direct costs of providing training;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Indirect costs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Wages for participants.</p></td></tr></tbody></table></td><td><p>Number of completed hours per employee</p></td><td><p>609</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>10.</p></td><td><p>Further external professional training of employees under Priority Axis 1 of the Operational Programme Employment (2014CZ05M9OP001)</p></td></tr></tbody></table></td><td><p>One hour (60 minutes) of participation of an employee in an external training course in accountancy, economy and law</p></td><td><p>All eligible costs, including:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Direct costs of providing training;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Indirect costs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Wages for participants.</p></td></tr></tbody></table></td><td><p>Number of completed hours per employee</p></td><td><p>436</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>11.</p></td><td><p>Further external professional training of employees under Priority Axis 1 of Operational Programme Employment (2014CZ05M9OP001)</p></td></tr></tbody></table></td><td><p>One hour (60 minutes) of participation of an employee in external technical and other professional training</p></td><td><p>All eligible costs, including:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Direct costs of providing training;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Indirect costs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Wages for participants.</p></td></tr></tbody></table></td><td><p>Number of completed hours per employee</p></td><td><p>252</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>12.</p></td><td><p>Further internal<a> (<span>9</span>)</a> professional training of employees under Priority Axis 1 of Operational Programme Employment (2014CZ05M9OP001)</p></td></tr></tbody></table></td><td><p>One hour (60 minutes) of participation of an employee in a training course provided by an internal trainer in any of the following areas:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>general information technologies (IT)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>soft and managerial skills</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>languages</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>specialised IT</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>accountancy, economy and law</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>technical and other professional.</p></td></tr></tbody></table></td><td><p>All eligible costs, including:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Direct staff costs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Indirect costs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Wages for participants.</p></td></tr></tbody></table></td><td><p>Number of completed hours per employee</p></td><td><p>144</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>13.</p></td><td><p>Support provided by non-permanent personnel to school/educational facility under Priority axis 3 of Operational Programme Research, Development and Education (2014CZ05M2OP001)</p></td></tr></tbody></table></td><td><p>0,1 full-time equivalent (FTE) worked as a school psychologist and/or a specialised school pedagogue per month</p></td><td><p>All eligible costs, including, direct staff costs</p></td><td><p>Number of 0,1 FTE worked per month</p></td><td><p>5 871</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>14.</p></td><td><p>Support provided by non-permanent personnel to school/educational facility under Priority axis 3 of Operational Programme Research, Development and Education (2014CZ05M2OP001)</p></td></tr></tbody></table></td><td><p>0,1 FTE worked by a school assistant and/or social pedagogue per month.</p></td><td><p>All eligible costs, including direct staff costs</p></td><td><p>Number of 0,1 FTE worked per month</p></td><td><p>School assistant: 3 617</p><p>Social pedagogue: 4 849</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>15.</p></td><td><p>Support provided by non-permanent personnel to school/educational facility under Priority axis 3 of Operational Programme Research, Development and Education (2014CZ05M2OP001)</p></td></tr></tbody></table></td><td><p>0,1 FTE worked by a nanny per month</p></td><td><p>All eligible costs, including direct staff costs.</p></td><td><p>Number of 0,1 FTE worked per month</p></td><td><p>3 402</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>16.</p></td><td><p>Provision of extracurricular activity for children/pupils at risk of school failure under Priority axis 3 of Operational Programme Research, Development and Education (2014CZ05M2OP001) and Priority Axis 4 of Operational Programme Prague Growth Pole (2014CZ16M2OP001)</p></td></tr></tbody></table></td><td><p>Provision of a block of 16 lessons of extracurricular activities with a duration of 90 minutes per lesson provided to a group of at least 6 children/pupils of which 2 are at risk of school failure.</p></td><td><p>All eligible costs, including direct staff costs.</p></td><td><p>Number of completed blocks of 16 lessons with a duration of 90 minutes per lesson provided to a group of at least 6 children/pupils of which 2 are at risk of school failure.</p></td><td><p>17 833</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>17.</p></td><td><p>Supporting pupils at the risk of school failure through tutoring under Priority axis 3 of Operational Programme Research, Development and Education (2014CZ05M2OP001) and Priority Axis 4 of Operational Programme Prague Growth Pole (2014CZ16M2OP001)</p></td></tr></tbody></table></td><td><p>Provision of a block of 16 hours of tutoring to a group of at least 3 registered pupils at risk of school failure.</p></td><td><p>All eligible costs, including direct staff costs.</p></td><td><p>Number of completed blocks of 16 hours provided to a goup of at least 3 registered pupils at risk of school failure.</p></td><td><p>8 917</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>18.</p></td><td><p>Professional development of pedagogues through structured training courses under Priority axis 3 of Operational Programme Research, Development and Education (2014CZ05M2OP001) and Priority Axis 4 of Operational Programme Prague Growth Pole (2014CZ16M2OP001)</p></td></tr></tbody></table></td><td><p>Hours of professional training provided to pedagogues.</p></td><td><p>All eligible costs, including direct costs of providing training.</p></td><td><p>Number of completed hours of training per pedagogue</p></td><td><table><col/><col/><tbody><tr><td><p>1)</p></td><td><p><span>435</span> for training inside regular class time</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2)</p></td><td><p><span>170</span> for training outside regular class time</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>19.</p></td><td><p>Provision of information to parents through meetings under Priority axis 3 of Operational Programme Research, Development and Education (2014CZ05M2OP001) and Priority Axis 4 of Operational Programme Prague Growth Pole (2014CZ16M2OP001)</p></td></tr></tbody></table></td><td><p>Thematic meeting with a minimum of eight parents for a minimum duration of two hours (120 minutes).</p></td><td><p>All eligible costs, including direct staff costs.</p></td><td><p>Number of thematic meetings with a minimum of eight parents for a minimum duration of two hours (120 minutes)</p></td><td><p>3 872</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>20.</p></td><td><p>Professional development of pedagogues in schools and educational facilities under Priority axis 3 of Operational Programme Research, Development and Education (2014CZ05M2OP001)</p></td></tr></tbody></table></td><td><p>Block of 30 hours of external mentoring/coaching to a group of between 3 and 8 pedagogues.</p></td><td><p>All eligible costs, including direct staff costs.</p></td><td><p>Number of completed blocks of 30 hours mentoring/coaching to a group of between 3 and 8 pedagogues.</p></td><td><p>31 191</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>21.</p></td><td><p>Professional development of pedagogues in schools and educational facilities under Priority axis 3 of Operational Programme Research, Development and Education (2014CZ05M2OP001)</p></td></tr></tbody></table></td><td><p>Training cycle of 15 hours of structured job-shadowing by a pedagogue</p></td><td><p>All eligible costs, including direct staff costs.</p></td><td><p>Number of completed training cycles of 15 hours per pedagogue undertaking a structured visit to another pedagogue in another school.</p></td><td><p>4 505</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>22.</p></td><td><p>Professional development of pedagogues in schools and educational facilities under Priority axis 3 of Operational Programme Research, Development and Education (2014CZ05M2OP001)</p></td></tr></tbody></table></td><td><p>Cycle of 10 hours of training through mutual cooperation involving a group of at least 3 pedagogues.</p></td><td><p>All eligible costs, including direct staff costs.</p></td><td><p>Number of completed training cycles of 10 hours involving a group of at least 3 pedagogues.</p></td><td><p>8 456</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>23.</p></td><td><p>Professional development of teaching staff of school/educational facility under Priority axis 3 of Operational Programme Research, Development and Education (2014CZ05M2OP001)</p></td></tr></tbody></table></td><td><p>Tandem lesson<a> (<span>10</span>)</a> of 2,75 hours.</p></td><td><p>All eligible costs, including direct staff costs:</p></td><td><p>Number of completed tandem lessons</p></td><td><p>815</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>24.</p></td><td><p>Professional development of pedagogues of school/educational facility under Priority axis 3 of Operational Programme Research, Development and Education (2014CZ05M2OP001)</p></td></tr></tbody></table></td><td><p>Cycle of 19 hours of mutual cooperation and learning involving an expert and 2 pedagogues.</p></td><td><p>All eligible costs, including direct staff costs.</p></td><td><p>Number of completed cycles of 19 hours involving an expert and 2 other pedagogues.</p></td><td><p>5 637</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>25.</p></td><td><p>Career advice services in schools and cooperation between schools and employers under Priority axis 3 of Operational Programme Research, Development and Education (2014CZ05M2OP001)</p></td></tr></tbody></table></td><td><p>0,1 FTE worked per month by a career advisor and/or a coordinator of cooperation between a school and employers.</p></td><td><p>All eligible costs, including direct staff costs</p></td><td><p>Number of 0,1 FTE worked per month</p></td><td><p>4 942</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>26.</p></td><td><p>Professional development of pedagogues of school/educational facility under Priority axis 3 of Operational Programme Research, Development and Education (2014CZ05M2OP001)</p></td></tr></tbody></table></td><td><p>Training cycle of 8,5 hours involving structured job-shadowing by a pedagogue and a mentor.</p></td><td><p>All eligible costs, including direct staff costs</p></td><td><p>Number of completed training cycles of 8,5 hours per structured visit to an institution/company/facility.</p></td><td><p>2 395</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>27.</p></td><td><p>Professional competence development of pedagogues under Priority axis 3 of Operational Programme Research, Development and Education (2014CZ05M2OP001) and Priority Axis 4 of Operational Programme Prague Growth Pole (2014CZ16M2OP001).</p></td></tr></tbody></table></td><td><p>Cycle of 3,75 hours or 4 cycles of 3,75 hours of training involving a pedagogue and expert/ICT technician.</p></td><td><p>All eligible costs, including direct staff costs</p></td><td><p>Number of completed training cycles of 3,75 hours involving a pedagogue and expert/ICT technician.</p></td><td><p>One Cycle: 1 103</p><p>Four Cycles: 4 412</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>28.</p></td><td><p>Mobility of researchers under priority axis 2 of Operational Programme Research, Development and Education (2014CZ05M2OP001).</p></td></tr></tbody></table></td><td><p>Months in mobility per researcher.</p></td><td><p>All eligible costs of the operation.</p></td><td><p>Number of months in mobility per researcher.</p></td><td><p><tblcnt><table><col/><col/><tbody><tr><td><p>Components</p></td><td><p>Amount (<span>11</span>) (EUR)</p></td></tr><tr><td><p><span>Living Allowance (for incoming mobility to CZ)</span></p></td><td><p><span>Junior</span></p></td><td><p>2 674</p></td></tr><tr><td><p><span>Senior</span></p></td><td><p>3 990</p></td></tr><tr><td><p>The amounts of Living Allowance for outgoing mobility from CZ shall be calculated by multiplying the amounts for incoming mobility by the relevant correction co-efficient listed in point 3 below, depending on destination country.</p></td></tr><tr><td><p><span>Mobility allowance</span></p></td><td><p>600</p></td></tr><tr><td><p><span>Family allowance</span></p></td><td><p>500</p></td></tr><tr><td><p><span>Research, training and networking costs</span></p></td><td><p>800</p></td></tr><tr><td><p><span>Management and Indirect Costs</span></p></td><td><p>650</p></td></tr></tbody></table></tblcnt></p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>29.</p></td><td><p>Supporting pupils with different mother tongue, teachers or parents through the assistance of an Intercultural Worker or Bilingual Assistant under Priority Axis 4 of Operational Programme Prague Growth Pole (2014CZ16M2OP001).</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>1)</p></td><td><p>0,1 FTE worked per month by an Intercultural Worker<a> (<span>12</span>)</a> or Bilingual Assistant.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2)</p></td><td><p>One hour (60 minutes) worked by an Intercultural Worker<a> (<span>13</span>)</a>.</p></td></tr></tbody></table></td><td><p>All eligible costs of the operation.</p></td><td><table><col/><col/><tbody><tr><td><p>1)</p></td><td><p>Number of 0,1 FTE worked by an Intercultural Worker or Bilingual Assistant per month.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2)</p></td><td><p>Number of hours worked by an Intercultural Worker.</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>1)</p></td><td><p>Intercultural Worker: 5 373</p><p>Bilingual Assistant: 4 464</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2)</p></td><td><p>Intercultural Worker: 308</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>30.</p></td><td><p>Transnational mobility projects for the training of educational staff under Priority Axis 4 “Education and learning and support of Employment” of Operational Programme Prague Growth Pole (2014CZ16M2OP001).</p></td></tr></tbody></table></td><td><p>A 4-day traineeship for educational staff in a school in another European State consisting of at least 24 hours of educational activities.</p></td><td><p>All eligible costs of the operation, which are:</p><table><col/><col/><tbody><tr><td><p>1)</p></td><td><p>Salaries for participants;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2)</p></td><td><p>Costs associated with organising the traineeship in the host and sending school.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>3)</p></td><td><p>Travel and subsistence costs;</p></td></tr></tbody></table></td><td><p>Number of 4-day traineeships participated in by educational staff in a school in another European State.</p></td><td><table><col/><col/><tbody><tr><td><p>1)</p></td><td><p>5 087</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2)</p></td><td><p>EUR 350</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>3)</p></td><td><p>To these amounts for each 4-day traineeship may be added an amount per participant to cover travel and subsistence costs as follows:</p><table><col/><col/><tbody><tr><td><p> </p></td><td><p><span>Travel costs</span> depending on distance as follows<a> (<span>14</span>)</a>:</p><tblcnt><table><col/><col/><tbody><tr><td><p> </p></td><td><p><span>Amount</span></p></td></tr><tr><td><p>10 – 99 km:</p></td><td><p>EUR 20</p></td></tr><tr><td><p>100 – 499 km:</p></td><td><p>EUR 180</p></td></tr><tr><td><p>500 – 1 999 km:</p></td><td><p>EUR 275</p></td></tr><tr><td><p>2 000 – 2 999 km:</p></td><td><p>EUR 360</p></td></tr><tr><td><p>3 000 – 3 999 km:</p></td><td><p>EUR 530</p></td></tr><tr><td><p>4 000 – 7 999 km:</p></td><td><p>EUR 820</p></td></tr><tr><td><p>8 000 km and above:</p></td><td><p>EUR 1 300</p></td></tr></tbody></table></tblcnt></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p> </p></td><td><p><span>Subsistence costs,</span> depending on country as follows:</p><tblcnt><table><col/><col/><tbody><tr><td><p> </p></td><td><p><span>Amount</span></p></td></tr><tr><td><p>Denmark, Ireland, Norway, Sweden, United Kingdom</p></td><td><p>EUR 448</p></td></tr><tr><td><p>Belgium, Bulgaria, Greece, France, Italy, Cyprus, Luxembourg, Hungary, Austria, Poland, Romania, Finland,</p></td><td><p>EUR 392</p></td></tr><tr><td><p>Germany, Spain, Latvia, Malta, Portugal, Slovakia,</p></td><td><p>EUR 336</p></td></tr><tr><td><p>Estonia, Croatia, Lithuania, Slovenia.</p></td><td><p>EUR 280</p></td></tr></tbody></table></tblcnt></td></tr></tbody></table></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>31.</p></td><td><p>Developing information and communications technology (ICT) skills of pupils and staff in school/educational facilities under Priority axis 3 of Operational Programme Research, Development and Education (2014CZ05M2OP001)</p></td></tr></tbody></table></td><td><p>Lesson of 45 minutes using ICT tools, with a minimum of 10 pupils of which at least 3 are at risk of school failure.</p></td><td><p>All eligible costs of the operation, including direct ICT costs and direct staff costs</p></td><td><p>Number of lessons of 45 minutes with a minimum of 10 pupils of which at least 3 are at risk of school failure.</p></td><td><p>2 000</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>32.</p></td><td><p>Professional development of teaching staff under Priority Axis 3 of Operational Programme Research, Development and Education (2014CZ05M2OP001)</p></td></tr></tbody></table></td><td><p>Project day consisting of cooperative teaching by teaching staff</p></td><td><p>All eligible costs, including travel costs and direct staff costs</p></td><td><p>Number of project days of cooperative teaching, which meet the following requirements:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>consisting of 4 lessons of 45 minutes each of teaching outside the normal school environment</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>to a group of at least 10 students, of which at least 3 are at risk of school</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>are complemented by at least 60 minutes of joint preparation and reflection</p></td></tr></tbody></table></td><td><p>6 477</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>(<span>11</span>)</p></td><td><p>The total amount per participant will depend on the characteristics of each incidence of mobility and the applicability of each of the components set out.</p></td></tr></tbody></table></td></tr></tbody></table>
2. Adjustments of amounts.
The rate for unit costs 6-11 may be adjusted by replacing the initial minimum wage rate in the calculation method that consists of the minimum wage, the cost for provision of training and indirect costs.
The rate for unit cost 12 may be adjusted by replacing the initial direct staff costs, including social security and health contributions, and/or the wages for participants, including social security and health contributions in the calculation method that consists of direct staff costs, including social security and health contributions and/or the wages for participants, including social security and health contributions.
The rate for unit costs 13-17, 19-27, and 29 may be adjusted by replacing the initial direct staff costs, including social security and health contributions, in the calculation method that consists of direct staff costs, including social security and health contributions, plus indirect costs.
The rate for unit cost 18 may be adjusted by replacing the salaries for participants, including social security and health contributions in the calculation method that consists of the cost for provision of training plus salaries for participants, including social security and health contributions, plus indirect costs.
The rates for unit cost 28 may be adjusted by replacing the amounts for Living Allowance, Mobility allowance, Family allowance, Research, training and networking costs Management and Indirect Costs.
The rate for unit cost 30 may be adjusted by replacing the initial direct staff costs, including social security and health contributions, the costs associated with organising the traineeship in the host and sending school, and the travel and subsistence costs in the calculation method that consists of direct staff costs, including social security and health contributions, the costs associated with organising the traineeship in the host and sending school, and the travel and subsistence costs.
The rate for unit cost 32 may be adjusted by replacing the amount for travel in the calculation method that consists of direct costs for travel, plus direct staff costs, plus indirect costs.
Adjustments will be based on the updated data as follows:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>for the minimum wage, amendments to the minimum wage as set by government decree no. 567/2006 Coll;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>for social security contributions, amendments to employers' contributions to social security, defined in Act no. 589/1992 Coll. on social security; and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>for health contributions, amendments to employers' contributions to health insurance, defined in Act no. 592/1992 Coll. on premiums for health insurance.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For average salaries to determine wages/staff costs, changes to the latest annual published data for relevant categories from the average earnings informational system (www.ISPV.cz).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For Living Allowance, Mobility allowance, Family allowance, Research, training and networking costs Management and Indirect Costs, amendment to rates for the HORIZON 2020 — Marie Skłodowska-Curie Actions as published at https://ec.europa.eu/research/mariecurieactions/</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For travel, subsistence and organisational costs under unit cost 30, amendments to the amounts for travel and organisational costs as well as individual support set by the European Commission for Key Action 1 (mobility projects) under the Erasmus+ programme (http://ec.europa.eu/programmes/erasmus-plus/).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For travel under unit cost 32, amendments to the amounts for travel between 10 and 99 kilometres as set out in the “distance calculator” of the Erasmus+ programme (http://ec.europa.eu/programmes/erasmus-plus/resources/distance-calculator_en).</p></td></tr></tbody></table>
3. Table of Coefficients related to outgoing mobility of researchers
<table><col/><col/><col/><col/><col/><tbody><tr><td><p>Country</p></td><td><p>Correction coefficient</p></td><td><p> </p></td><td><p>Country</p></td><td><p>Correction coefficient</p></td></tr><tr><td><p>Albania</p></td><td><p>0,908</p></td><td><p> </p></td><td><p>Latvia</p></td><td><p>0,906</p></td></tr><tr><td><p>Argentina</p></td><td><p>0,698</p></td><td><p> </p></td><td><p>Luxembourg</p></td><td><p>1,193</p></td></tr><tr><td><p>Australia</p></td><td><p>1,253</p></td><td><p> </p></td><td><p>Hungary</p></td><td><p>0,909</p></td></tr><tr><td><p>Belgium</p></td><td><p>1,193</p></td><td><p> </p></td><td><p>The former Yugoslav Republic of Macedonia</p></td><td><p>0,816</p></td></tr><tr><td><p>Bosnia and Herzegovina</p></td><td><p>0,878</p></td><td><p> </p></td><td><p>Malta</p></td><td><p>1,069</p></td></tr><tr><td><p>Brazil</p></td><td><p>1,098</p></td><td><p> </p></td><td><p>Mexico</p></td><td><p>0,840</p></td></tr><tr><td><p>Bulgaria</p></td><td><p>0,853</p></td><td><p> </p></td><td><p>Republic of Moldova</p></td><td><p>0,729</p></td></tr><tr><td><p>Montenegro</p></td><td><p>0,798</p></td><td><p> </p></td><td><p>Germany</p></td><td><p>1,179</p></td></tr><tr><td><p>Czech Republic</p></td><td><p>1,000</p></td><td><p> </p></td><td><p>Netherlands</p></td><td><p>1,245</p></td></tr><tr><td><p>China</p></td><td><p>1,014</p></td><td><p> </p></td><td><p>Norway</p></td><td><p>1,574</p></td></tr><tr><td><p>Denmark</p></td><td><p>1,615</p></td><td><p> </p></td><td><p>Poland</p></td><td><p>0,912</p></td></tr><tr><td><p>Estonia</p></td><td><p>0,934</p></td><td><p> </p></td><td><p>Portugal</p></td><td><p>1,063</p></td></tr><tr><td><p>Faroe Islands</p></td><td><p>1,600</p></td><td><p> </p></td><td><p>Austria</p></td><td><p>1,251</p></td></tr><tr><td><p>Finland</p></td><td><p>1,391</p></td><td><p> </p></td><td><p>Serbia</p></td><td><p>0,801</p></td></tr><tr><td><p>France</p></td><td><p>1,325</p></td><td><p> </p></td><td><p>Romania</p></td><td><p>0,815</p></td></tr><tr><td><p>Croatia</p></td><td><p>1,163</p></td><td><p> </p></td><td><p>Russia</p></td><td><p>1,378</p></td></tr><tr><td><p>India</p></td><td><p>0,630</p></td><td><p> </p></td><td><p>Greece</p></td><td><p>1,106</p></td></tr><tr><td><p>Indonesia</p></td><td><p>0,899</p></td><td><p> </p></td><td><p>Slovakia</p></td><td><p>0,986</p></td></tr><tr><td><p>Ireland</p></td><td><p>1,354</p></td><td><p> </p></td><td><p>Slovenia</p></td><td><p>1,027</p></td></tr><tr><td><p>Italy</p></td><td><p>1,273</p></td><td><p> </p></td><td><p>Spain</p></td><td><p>1,165</p></td></tr><tr><td><p>Israel</p></td><td><p>1,297</p></td><td><p> </p></td><td><p>Sweden</p></td><td><p>1,333</p></td></tr><tr><td><p>Japan</p></td><td><p>1,383</p></td><td><p> </p></td><td><p>Switzerland</p></td><td><p>1,350</p></td></tr><tr><td><p>Republic of South Africa</p></td><td><p>0,666</p></td><td><p> </p></td><td><p>Turkey</p></td><td><p>1,033</p></td></tr><tr><td><p>South Korea</p></td><td><p>1,255</p></td><td><p> </p></td><td><p>Ukraine</p></td><td><p>1,101</p></td></tr><tr><td><p>Canada</p></td><td><p>1,031</p></td><td><p> </p></td><td><p>United States of America</p></td><td><p>1,186</p></td></tr><tr><td><p>Cyprus</p></td><td><p>1,095</p></td><td><p> </p></td><td><p>United Kingdom</p></td><td><p>1,436</p></td></tr><tr><td><p>Lithuania</p></td><td><p>0,872</p></td><td><p> </p></td><td><p>Vietnam</p></td><td><p>0,610</p></td></tr></tbody></table>
’ ( 1 ) For unit costs 1-5, the categories of costs mentioned cover all costs associated with that operation, except for types of operations 1 and 2, which may also include other categories of costs.
( 2 ) Meaning a new place which is included in the capacity of the new childcare facility as recorded by national regulations, and which has proof of equipment for each new place provided.
( 3 ) A children's group means it has been registered as a children's group pursuant to national legislation on the provision of childcare services in a children's group.
( 4 ) Meaning a place in an existing facility which is newly registered as a children's group in accordance with national legislation and inlcuded in the official capacity of that group, and which has proof of equipment for each place.
( 5 ) The occupancy rate is defined as the number of children attending the childcare facility per half day during 6 months divided by the maximum capacity of the facility per half day during 6 months, multiplied by 100.
( 6 ) This amount will be paid for each 1 % point of occupancy per place up to a maximum of 75 % points for a period of 6 months. If the occupancy rate is less than 20 % there will be no reimbursement.
( 7 ) The occupancy rate is defined as the number of children attending the childcare facility per half day during 6 months divided by the maximum capacity of the facility per half day during 6 months, multiplied by 100.
( 8 ) This amount will be paid for each 1 % point of occupancy per place up to a maximum of 75 % points for a period of 6 months. If the occupancy rate is less than 20 % there will be no reimbursement.
( 9 ) Internal training is training provided by an internal trainer.
( 10 ) Tandem lesson is to be understood as two pedagogues cooperating to mutually strengthen their professional development by jointly planning, implementing and reflecting on teaching methods in a class.
( 12 ) This indicator will be used for Intercultural Workers or bilingual assistants employed directly on a full-time or a part-time basis by the school.
( 13 ) This indicator will be used for external Intercultural Workers engaged by the school to provide services on an hourly basis.
( 14 ) Based on travel distance per participant. Travel distances shall be calculated using the distance calculator supported by the European Commission - http://ec.europa.eu/programmes/erasmus-plus/tools/distance_en.htm
ANNEX III
‘ANNEX VII
Conditions for reimbursement of expenditure on the basis of standard scales of unit costs to Slovakia
1. Definition of standard scales of unit costs
<table><col/><col/><tbody><tr><td><p>Type of operations</p></td><td><p>Indicator name</p></td><td><p>Category of costs</p></td><td><p>Measurement unit for the indicators</p></td><td><p>Amounts</p><p>(in EUR)</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Professional development of employees in foreign language skills under Priority Axes 2, 3 and 4 of the Operational Programme Human Resources (2014SK05M0OP001)</p></td></tr></tbody></table></td><td><p>45-minute period of foreign language training per employee</p></td><td><p>All eligible costs of the operation, including direct costs of providing training.</p></td><td><p>Number of completed 45-minute periods of foreign language training per employee.</p></td><td><p>8,53</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>European Computer Driving Licence (ECDL certification under Priority Axes 1, 2 and 3 of Operational Programme Human Resources (2014SK05M0OP001)</p></td></tr></tbody></table></td><td><p>ECDL certification</p></td><td><p>All eligible costs of the operation, including direct cost of sitting examination and issuing certificate</p></td><td><p>Number of ECDL certificates awarded, differentiated by profile and module<a> (<span>1</span>)</a></p></td><td><p><tblcnt><table><col/><col/><tbody><tr><td><p>Certificate Name</p></td><td><p>Price</p></td></tr><tr><td><p>ECDL Profile — 1 Base/Standard exam</p></td><td><p>31,50</p></td></tr><tr><td><p>ECDL Profile — 2 Base/Standard exams</p></td><td><p>59,00</p></td></tr><tr><td><p>ECDL Profile — 3 Base/Standard exams</p></td><td><p>76,50</p></td></tr><tr><td><p>ECDL Profile — 4 Base/Standard exams</p></td><td><p>92,00</p></td></tr><tr><td><p>ECDL Profile — 5 Base/Standard exams</p></td><td><p>111,50</p></td></tr><tr><td><p>ECDL Profile — 6 Base/Standard exams</p></td><td><p>127,00</p></td></tr><tr><td><p>ECDL Profile — 7 Base/Standard exams</p></td><td><p>142,50</p></td></tr><tr><td><p>ECDL Profile — 8 Base/Standard exams</p></td><td><p>163,00</p></td></tr><tr><td><p>ECDL Profile — 1 Advanced exam</p></td><td><p>39,10</p></td></tr><tr><td><p>ECDL Profile — 2 Advanced exams</p></td><td><p>74,30</p></td></tr><tr><td><p>ECDL Profile — 3 Advanced exams</p></td><td><p>99,40</p></td></tr><tr><td><p>ECDL Profile — 4 Advanced exams</p></td><td><p>122,50</p></td></tr></tbody></table></tblcnt></p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>Inclusion in elementary schools under Priority Axis Education of Operational Programme Human Resources (2014SK05M0OP001)</p></td></tr></tbody></table></td><td><p>Occupation of newly created posts in inclusive teams</p></td><td><p>Direct wage costs</p><p>Indirect costs</p></td><td><p>Number of months during which a newly created post in an inclusive team is occupied.</p></td><td><p>School psychologist — 1 235 per month</p><p>Special pedagogue/social pedagogue — 1 440 per month</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.</p></td><td><p>Inclusion in kindergartens and elementary schools under Priority Axis Education of Operational Programme Human Resources (2014SK05M0OP001)</p></td></tr></tbody></table></td><td><p>Occupation of newly created posts for pedagogical assistants</p></td><td><p>Direct wage costs</p><p>Indirect costs</p></td><td><p>Number of months during which a newly created post for a pedagogical assistant is occupied</p></td><td><p>1 005 per month</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>5.</p></td><td><p>Integration of pupils in kindergartens and schools under Priority Axis Education of Operational Programme Human Resources (2014SK05M0OP001)</p></td></tr></tbody></table></td><td><p>Occupation of a newly created teacher's assistant post</p></td><td><p>Direct wage costs</p><p>Indirect costs</p></td><td><p>Number of months during which a newly created post of teacher's assistant is occupied</p></td><td><p>966 per month</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>6.</p></td><td><p>Training of teaching and specialised staff under Priority Axis Education of Operational Programme Human Resources (2014SK05M0OP001)</p></td></tr></tbody></table></td><td><p>One hour of participation in training for teaching and specialised staff</p></td><td><p>Direct wage costs of the trainer and wages of the participant.</p><p>Indirect Costs</p></td><td><p>Number of completed hours per participant in training for teaching and specialised staff</p></td><td><p>Group of 20 participants: 10,10 per completed hour per participant</p><p>Group of 12 participants: 10,65 per completed hour per participant.</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>7.</p></td><td><p>Training of prospective teachers of higher education facilities under Priority Axis Education of Operational Programme Human Resources (2014SK05M0OP001)</p></td></tr></tbody></table></td><td><p>One hour of analysis by a training teacher of a student's direct teaching activity unit (school class) or direct education activity (school facility).</p></td><td><p>Direct wage costs.</p><p>Indirect costs.</p></td><td><p>Number of hours of direct analysis by a training teacher of students' direct teaching activity unit (school class) or direct education activity (school facility).</p></td><td><p>9,66 per hour</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>8.</p></td><td><p>Teaching clubs<a> (<span>2</span>)</a> under Priority Axis Education of Operational Programme Human Resources (2014SK05M0OP001)</p></td></tr></tbody></table></td><td><p>One hour of participation by teaching staff<a> (<span>3</span>)</a> in a teaching club</p></td><td><p>Direct wage costs. Indirect costs.</p></td><td><p>Number of hours of participation by teaching staff in a teaching club</p></td><td><p>10,60</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>9.</p></td><td><p>Teaching of additional school classes<a> (<span>4</span>)</a> under Priority Axis Education of Operational Programme Human Resources (2014SK05M0OP001)</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>One hour of teaching of an additonal school class by a primary school teacher</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>One hour of teaching of an additonal school class by a secondary school teacher</p></td></tr></tbody></table></td><td><p>Direct wage costs and indirect costs.</p></td><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Number of hours of teaching of additonal school classes by a primary school teacher</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Number of hours of teaching of additonal school classes by a secondary school teacher</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Teaching by a primary school teacher: 11,70</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Teaching by a secondary school teacher: 12,30</p></td></tr></tbody></table></td></tr></tbody></table>
2. Adjustment of amounts
The amout for unit cost 5 may be adjusted in line with changes to the normative allowance for teacher's assistants established in accordance with §9a section 3 of Governmental Regulation (EC) No 630/2008 of the Slovak Republic, laying down the details of the breakdown of funds from the state budget for schools and school facilities.
The amount for unit cost 7 may be adjusted in line with changes to the guidelines for allocation of subsidies from the state budget to public higher education institutions, in accordance with Act No 131/2002 on higher education institutions.
The amount for unit costs 8 and 9 may be adjusted by replacing the initial direct wage costs in the calculation method that consists of direct wage costs and a flat rate for indirect costs.
Adjustments will be based on change of salaries for primary and secondary school teachers established at national level in accordance with §28 section 1 of Act No 553/2003 on remuneration of some employees working in public interest.
’ ( 1 ) There are two possible modules — 1) Base/Standard and 2) Advanced.
( 2 ) A teaching club shall consist of minimum 3 and maximum 10 members and each club meeting shall last a maximum of 3 hours. Teaching clubs both with and without a written output can declare a maximum of 30 hours per semester for participation of each member at the club. Teaching clubs with a written output can each declare a maximum of 50 hours for production of their written output.
( 3 ) The participation at the teaching clubs is strictly limited to the following categories of teaching staff, as defined in §3 and §12 of Act No 317/2009: teachers, teaching assistants, educators and teachers/trainers of practical education.
( 4 ) Additional school classes are classes run by the school in addition to the classes normally financed by the state budget. An additional class lasts 60 minutes and consists of 45 minutes teaching plus 15 minutes of preparatory or follow-up activities. Additional classes can be provided up to a maximum, per school year and per school, of:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>12 classes weekly for primary schools — level I;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>15 classes weekly for primary schools — level II;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>33 classes weekly for secondary schools.</p></td></tr></tbody></table>
ANNEX IV
‘ANNEX X
Conditions for reimbursement of expenditure on the basis of standard scales of unit costs to Austria
1. Definition of standard scales of unit costs
<table><col/><col/><col/><tbody><tr><td><p>Type of operations</p></td><td><p>Indicator name</p></td><td><p>Category of costs</p></td><td><p>Measurement unit for the indicators</p></td><td><p>Amounts (in EUR)</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Measures to reduce the number of early school leavers.</p><p>Priority axis 3 of OP 2014AT05SFOP001</p></td></tr></tbody></table></td><td><p>Provision of teaching hours<a> (<span>1</span>)</a>.</p></td><td><p>Staff costs for teachers<a> (<span>2</span>)</a>.</p></td><td><p>Number of teaching hours per type of school.</p></td><td><p><tblcnt><table><col/><col/><col/><tbody><tr><td><p>Type of school (<span>3</span>)</p></td><td><p>Amount</p></td></tr><tr><td><p>3070</p></td><td><p>95,91</p></td></tr><tr><td><p>3080</p></td><td><p>89,98</p></td></tr><tr><td><p>3081</p></td><td><p>96,28</p></td></tr><tr><td><p>3082</p></td><td><p>107,09</p></td></tr><tr><td><p>3091</p></td><td><p>78,87</p></td></tr></tbody></table></tblcnt></p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Basic education courses under priority axis 1.1, 3.2. and 4 of OP 2014AT05SFOP001</p></td></tr></tbody></table></td><td><p>Hours of provision of basic education in five competency areas by one or two coaches and of provision of accompanying childcare services.</p></td><td><p>All costs of the operation.</p></td><td><p>Number of teaching hours<a> (<span>4</span>)</a> provided by:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>one or two coaches<a> (<span>5</span>)</a>;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>within or outside the main residency community of the beneficiary;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>with or without childcare services.</p></td></tr></tbody></table></td><td><p><tblcnt><table><col/><col/><col/><tbody><tr><td><p>Criteria</p></td><td><p>Amount per teaching hour</p></td></tr><tr><td><p>Courses with 1 coach</p></td><td><p>110</p></td></tr><tr><td><p>Courses with 2 coaches</p></td><td><p>150</p></td></tr><tr><td><p>Courses with 1 coach and provision of childcare facilities</p></td><td><p>150</p></td></tr><tr><td><p>Courses with 2 coaches and provision of childcare facilities</p></td><td><p>190</p></td></tr><tr><td><p>Courses with 1 coach outside the main residency community of the beneficiery</p></td><td><p>140</p></td></tr><tr><td><p>Courses with 2 coaches outside the main residency community of the beneficiery</p></td><td><p>180</p></td></tr><tr><td><p>Courses with 1 coach and provision of childcare facilities outside the main residency community of the beneficiery</p></td><td><p>180</p></td></tr></tbody></table></tblcnt></p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>Educational counselling under priority axis 3.2. and 4 of OP 2014AT05SFOP001</p></td></tr></tbody></table></td><td><p>Provision of face-to-face counselling services to individuals.</p></td><td><p>All costs of the operation.</p></td><td><p>Number of face-to-face couselling sessions provided.</p></td><td><p>338,43</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.</p></td><td><p>Management verifications of OP 2014AT05SFOP001 under priority axis 5 (technical assistance)</p></td></tr></tbody></table></td><td><p>Hours of provision of management verification services to the Managing Authority — support with the tasks of the first level control.</p></td><td><p>All costs of the operation.</p></td><td><p>Number of hours performing management verification tasks.</p></td><td><p>62,96</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>5.</p></td><td><p>All operations of OP 2014AT05SFOP001 with the exception of operations covered by unit costs 1-4 of this annex.</p></td></tr></tbody></table></td><td><p>Working hours of staff working directly on the operation.</p></td><td><p>Direct staff costs of the operation (column A).</p><p>All costs of the operation with the exception of salaries and allowances paid to participants (column B).</p></td><td><p>Number of actual working hours per category of staff<a> (<span>6</span>)</a>.</p></td><td><p><tblcnt><table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Amount per hour (A)</p></td><td><p>Amount per hour (b) (<span>7</span>)</p></td></tr><tr><td><p>Administrative staff</p></td><td><p>24,90</p></td><td><p>34,86</p></td></tr><tr><td><p>Key staff</p></td><td><p>30,09</p></td><td><p>42,13</p></td></tr><tr><td><p>Project leader</p></td><td><p>40,06</p></td><td><p>56,09</p></td></tr></tbody></table></tblcnt></p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>(<span>3</span>)</p></td><td><p>Type of school:</p><table><col/><col/><tbody><tr><td><p>3070</p></td><td><p>Secondary Academic Schools (AHS)</p></td></tr><tr><td><p>3080</p></td><td><p>Technical/industrial schools (TMHS)</p></td></tr><tr><td><p>3081</p></td><td><p>Secondary schools and colleges for tourism and for social and services-related occupations (HUM)</p></td></tr><tr><td><p>3082</p></td><td><p>Commercial academies and commercial schools (HAK/HAS)</p></td></tr><tr><td><p>3091</p></td><td><p>Secondary college for early childhood pedagogy/Secondary college for social pedagogy (BAfEP/BASOP).</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(<span>7</span>)</p></td><td><p>The total amount in this column is used to cover all costs of the operation with the exception of salaries and allowances paid to participants. This amount is based on the following method: amount per hour plus an amount resulting from the application of a 40 % flat rate over the amount per hour.</p></td></tr></tbody></table></td></tr></tbody></table>
2. Adjustment of amounts
The rates for unit cost 1 are adjusted annually in line with the WFA Financial Effects Regulation ( 3 ) . This regulation is published annually and contains specifications regarding the valorisation of personnel costs for the purpose of budget planning for the coming years. The rates will be adjusted for the first time on 1 September 2017 on the basis of the valorisation for 2017 laid down in that regulation.
The rate for unit cost 3 will be adjusted annually reflecting changes in the Consumer Price Index as published by Statistik Austria.
The rate for unit cost 4 will be adjusted annually in line with the legal basis for prices of these services as stipulated by the Ministry of Finance.
The rates for unit cost 5 will be adjusted annually reflecting changes in the collective agreements BABE and SWÖ.
’ ( 1 ) One teaching hour equals 50 minutes.
( 2 ) These are the only costs to be claimed for ESF reimbursement for the specified operations.
( 4 ) One teaching hour equals 50 minutes.
( 5 ) Two coaches are allowed for groups with a minimum of seven participants.
( 6 ) There is no obligation to establish a separate working time registration system for staff with a fixed percentage of time worked on the operation per month. The employer shall issue a document for each employee setting out the fixed percentage of time for working on the operation.
( 3 ) WFA Finanzielle-Auswirkungen-Verordnung, www.ris.bka.gv.at
ANNEX V
‘ANNEX XIII
Conditions for reimbursement of expenditure on the basis of standard scales of unit costs to Romania
1. Definition of standard scales of unit costs
<table><col/><col/><col/><col/><col/><tbody><tr><td><p>Type of operations</p></td><td><p>Indicator name</p></td><td><p>Category of costs</p></td><td><p>Measurement unit for the indicators</p></td><td><p>Amounts</p><p>(in LEI)</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Subsidies paid to employers for hiring specified categories of workers under Priority Axes 1. 2. 3. 4 and 5 of the Human Capital Operational Programme (2014RO05M9OP001)</p></td></tr></tbody></table></td><td><p>Monthly subsidy paid to an employer for each person employed on an open-ended contract.</p></td><td><p>All costs related to the employment subsidy</p></td><td><p>Number of months in employment</p></td><td><p>900 per month for up to 12 months for every employer who hires on an open ended contract for a minimum period of 18 months</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>a graduate of an education institution.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>an unemployed over 45 years old.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>a long term unemployed.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>a young NEET.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>unemployed who are single parents of mono-parental families</p></td></tr></tbody></table><p>900 lei/month for up to 18 months paid for every employer who hires a person with disabilities (except those hired under legal obligation) on an open ended contract for a minimum period of 18 months.</p><p>900 lei/month for up to 5 years for employers who hire with full-time contracts unemployed persons who within 5 years from the date of employment fulfil the conditions for requiring partial early retirement pension or old age pension</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Vocational training under priority axes 1, 2, 3, 4, 5 and 6 of the Human Capital Operational Programme (2014RO05M9OP001).</p></td></tr></tbody></table></td><td><p>A participant obtaining a professional qualification (level 2, 3 or 4).</p></td><td><p>All costs related to the training — including indirect costs — excluding participant related costs, such us transportation, accommodation, meals, subsidies, as well as the project management costs.</p></td><td><p>Number of persons obtaining a professional qualification certificate (level 2, 3 or 4)</p></td><td><table><col/><col/><tbody><tr><td><p>a)</p></td><td><p>1 324 per participant for level 2 qualification</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>b)</p></td><td><p>2 224 per participant for level 3 qualification</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>c)</p></td><td><p>4 101 per participant for level 4 qualification</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>Financial support for employers that employ persons in an apprenticeship program under priority axes 1, 2 and 3 of the Human Capital Operational Programme (2014RO05M9OP001).</p></td></tr></tbody></table></td><td><p>Monthly financial support paid to an employer for each person enrolled in a paid apprenticeship.</p></td><td><p>All costs related to the apprenticeship subsidy</p></td><td><p>Number of months in paid apprenticeship</p></td><td><p>1 125 per month</p><p>per apprentice for a maximum period of:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>12 months — for qualification level 2</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>24 months — for qualification level 3</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>36 months — for qualification level 4</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.</p></td><td><p>Financial support for employers that employ persons in an internship program under priority axes 1, 2 and 3 of the Human Capital Operational Programme (2014RO05M9OP001).</p></td></tr></tbody></table></td><td><p>Monthly financial support paid to an employer for each person with tertiary education enrolled in a paid internship programme</p></td><td><p>All costs related to the internship subsidy</p></td><td><p>Number of months of a person with tertirary education in a paid internship</p></td><td><p>1 350 per month</p><p>per tertiary education intern for a maximum period of 6 months.</p></td></tr></tbody></table>
2. Adjustment of amounts
The rates for unit cost 1 may be adjusted by any amendment of the rates set out by law no. 76/2002 on the unemployment insurance system and employment stimulation. Such changes will take effect on the same date as the revisions to the above-mentioned law come into force.
The amouts for unit cost 2 may be changed adjusted in line with the yearly inflation rate (RO National Statistical Institute inflation index).
The rates for unit costs 3 and 4 may be adjusted by any amendment of the rates set out by law no. 76/2002 on the unemployment insurance system and employment stimulation, including its subsequent amendments and law no. 279/2005 regarding apprenticeship programmes at the work place, including its subsequent amendments, and law no. 335/2013 regarding internships programme for higher education graduates, including its subsequent amendments. Such changes will take effect on the same date as the revisions to the above-mentioned law come into force.
Adjustment of the amounts pursuant to the paragraphs above shall apply to calls launched after entry into force of the amending legislative acts.
’ ANNEX VI
‘ANNEX XIV
Conditions for reimbursement of expenditure on the basis of standard scales of unit costs to all Member States specified.
1. Definition of standard scales of unit costs
<table><col/><col/><col/><col/><col/><tbody><tr><td><p>Type of operations<a> (<span>1</span>)</a></p></td><td><p>Indicator name</p></td><td><p>Category of costs</p></td><td><p>Measurement unit for the indicators</p></td><td><p>Amounts</p><p>(in EUR)</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Formal education operations (from early childhood education to tertiary level including formal vocational education) in all ESF operational programmes.</p></td></tr></tbody></table></td><td><p>Participants in an academic year of formal education.</p></td><td><p>All eligible costs directly related to providing core goods and services of education<a> (<span>2</span>)</a>.</p></td><td><p>Number of participants with verified attendance<a> (<span>3</span>)</a> in an academic year of formal education, differentiated by ISCED<a> (<span>4</span>)</a> classification.</p></td><td><p>See point 3.1<a> (<span>5</span>)</a></p><p>The amounts are for full-time participation in an academic year.</p><p>In case of part-time participation the amount shall be established on the basis of a pro rata reflecting the participation of the student.</p><p>In case the course lasts less than one academic year, the amount shall be established on the basis of a pro rata reflecting the duration of the course.</p><p>For vocational education and training (upper secondary level and non-tertiary post-secondary level), in case of courses with a reduced share of time spent in a formal education institute as compared to the courses reported for data collection during the reference year, the amount shall be proportionally reduced reflecting the time spent in the education institute.</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Any operations concerning training<a> (<span>6</span>)</a> of registered unemployed, job-seekers or inactive people, except types of operations for which other simplified cost options have been established in another annex to this Delegated Regulation.</p></td></tr></tbody></table></td><td><p>Participants who have successfully completed a training course<a> (<span>7</span>)</a>.</p></td><td><p>All eligible costs of the operation.</p></td><td><p>Number of participants who have successfully completed a training course.</p></td><td><p>See point 3.2.1</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For those Member States listed in point 3.3:</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>the amounts mentioned in point 3.2 shall be multiplied by the index for the relevant regional Operational Programme mentioned in point 3.3;</p></td></tr></tbody></table><p>where operational programmes cover more than one region, the amount to be reimbursed shall be in acordance with the region in which the operation or project is implemented.</p><p>The method used to calculate these amounts requires that where these amounts are claimed for a type of operation under an Operational Programme, the same amount is claimed for all similar types of operations under the same Operational Programme.</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>Any operations concerning the provision of employment-related counselling services<a> (<span>8</span>)</a> to registered unemployed, job-seekers or inactive people, except types of operations for which other simplified cost options have been established in another annex to this Delegated Regulation.</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Hourly rate for provision of counselling services</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Monthly rate for provision of counselling services</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>Annual rate for provision of counselling services</p></td></tr></tbody></table></td><td><p>All eligible costs of the operation, except allowances paid to participants</p></td><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Number of hours of counselling services provided<a> (<span>9</span>)</a></p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Number of months of counselling services provided</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>Number of years of counselling services provided</p></td></tr></tbody></table></td><td><p>See points 3.2.2, 3.2.3 and 3.2.4 below</p><p>For those Member States listed in point 3.3:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>the amounts mentioned in points 3.2 shall be multiplied by the index for the relevant regional Operational Programme mentioned in point 3.3;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>where operational programmes cover more than one region, the amount to be reimbursed shall be in acordance with the region in which the operation or project is implemented.</p></td></tr></tbody></table><p>The method used to calculate these amounts requires that where these amounts are claimed for a type of operation under an Operational Programme, the same amount is claimed for all similar types of operations under the same Operational Programme.</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.</p></td><td><p>Any operations concerning the provision of training to employed persons, except types of operations for which other simplified cost options have been established in another annex to this Delegated Regulation.</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Hourly rate of training provided to employed persons</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Hourly rate of salary paid to an employee while on a training course.</p></td></tr></tbody></table></td><td><p>All eligible costs of the operation.</p><p>Where the salary of the employee while on a training course is not an eligible cost, only unit cost 1 shall be reimbursed.</p><p>Where the salary of the employee while on training is considered as an eligible cost, the combined amount from unit costs 1 and 2 may be reimbursed.</p></td><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Number of completed hours<a> (<span>10</span>)</a> of training to employed persons per participant.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Number of hours of salary paid to employees while on a training course<a> (<span>11</span>)</a>.</p></td></tr></tbody></table></td><td><p>See points 3.2.5 and 3.2.6 below</p><p>For those Member States listed in point 3.3:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>the amounts mentioned in point 3.2 shall be multiplied by the index for the relevant regional Operational Programme mentioned in point 3.3;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>where operational programmes cover more than one region, the amount to be reimbursed shall be in acordance with the region in which the operation or project is implemented.</p></td></tr></tbody></table><p>The method used to calculate these amounts requires that where these amounts are claimed for a type of operation under an Operational Programme, the same amount is claimed for all similar types of operations under the same Operational Programme.</p></td></tr></tbody></table>
2. Adjustment of Amounts.
N/A 3.1 Amounts per participation in formal education (in EUR) ( 12 )
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p> </p></td><td><p>AT</p></td><td><p>BE</p></td><td><p>BG</p></td><td><p>CY</p></td><td><p>CZ</p></td><td><p>DE</p></td><td><p>EE</p></td><td><p>EL</p></td><td><p>ES</p></td><td><p>FI*</p></td><td><p>FR</p></td><td><p>HU</p></td><td><p>HR*</p></td></tr><tr><td><p>Early childhood education</p></td><td><p>ED0</p></td><td><p>6 453</p></td><td><p>n/a</p></td><td><p>1 388</p></td><td><p>2 183</p></td><td><p>2 059</p></td><td><p>6 965</p></td><td><p>3 023</p></td><td><p>n/a</p></td><td><p>3 393</p></td><td><p>10 026</p></td><td><p>5 364</p></td><td><p>2 439 *</p></td><td><p>2 198</p></td></tr><tr><td><p>Early childhood educational development</p></td><td><p>ED01</p></td><td><p>6 804</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>469</p></td><td><p>n/a</p></td><td><p>9 131</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>3 140</p></td><td><p>16 075</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td></tr><tr><td><p>Pre-primary education</p></td><td><p>ED02</p></td><td><p>6 385</p></td><td><p>6 000</p></td><td><p>1 388</p></td><td><p>2 626</p></td><td><p>2 059</p></td><td><p>6 197</p></td><td><p>n/a</p></td><td><p>2 825</p></td><td><p>3 474</p></td><td><p>8 595</p></td><td><p>5 364</p></td><td><p>n/a</p></td><td><p>2 716</p></td></tr><tr><td><p>Primary education</p></td><td><p>ED1</p></td><td><p>8 488</p></td><td><p>7 763</p></td><td><p>904</p></td><td><p>6 717</p></td><td><p>2 205</p></td><td><p>6 322</p></td><td><p>3 118</p></td><td><p>3 211</p></td><td><p>3 947</p></td><td><p>8 428</p></td><td><p>5 007</p></td><td><p>1 772</p></td><td><p>4 592</p></td></tr><tr><td><p>Primary and lower secondary education (levels 1 and 2)</p></td><td><p>ED1_2</p></td><td><p>10 003</p></td><td><p>8 321</p></td><td><p>1 007</p></td><td><p>7 097</p></td><td><p>2 804</p></td><td><p>7 207</p></td><td><p>3 200</p></td><td><p>3 461</p></td><td><p>4 329</p></td><td><p>10 047</p></td><td><p>5 876</p></td><td><p>1 708</p></td><td><p>2 181</p></td></tr><tr><td><p>Lower secondary education</p></td><td><p>ED2</p></td><td><p>11 527</p></td><td><p>9 510</p></td><td><p>1 131</p></td><td><p>7 860</p></td><td><p>3 680</p></td><td><p>7 781</p></td><td><p>3 376</p></td><td><p>3 972</p></td><td><p>5 066</p></td><td><p>13 297</p></td><td><p>6 977</p></td><td><p>1 643</p></td><td><p>n/a</p></td></tr><tr><td><p>Lower secondary education — general</p></td><td><p>ED24</p></td><td><p>11 527</p></td><td><p>n/a</p></td><td><p>1 162</p></td><td><p>7 860</p></td><td><p>3 687</p></td><td><p>7 781</p></td><td><p>3 358</p></td><td><p>3 972</p></td><td><p>5 066</p></td><td><p>13 297</p></td><td><p>6 977</p></td><td><p>1 612</p></td><td><p>n/a</p></td></tr><tr><td><p>Lower secondary education — vocational</p></td><td><p>ED25</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>2 215</p></td><td><p>n/a</p></td><td><p>4 553</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>5 070</p></td><td><p>n/a</p></td></tr><tr><td><p>Upper secondary education</p></td><td><p>ED3</p></td><td><p>11 045</p></td><td><p>n/a</p></td><td><p>1 034</p></td><td><p>8 113</p></td><td><p>3 414</p></td><td><p>7 877</p></td><td><p>3 493</p></td><td><p>3 578</p></td><td><p>5 071 *</p></td><td><p>7 644</p></td><td><p>9 267</p></td><td><p>2 708</p></td><td><p>1 995</p></td></tr><tr><td><p>Upper secondary and post-secondary non-tertiary education (levels 3 and 4)</p></td><td><p>ED3_4</p></td><td><p>10 390</p></td><td><p>10 219</p></td><td><p>1 038</p></td><td><p>8 023</p></td><td><p>3 331</p></td><td><p>7 001</p></td><td><p>3 540</p></td><td><p>n/a</p></td><td><p>5 339</p></td><td><p>7 644</p></td><td><p>9 180</p></td><td><p>3 024</p></td><td><p>1 995</p></td></tr><tr><td><p>Upper secondary education — general</p></td><td><p>ED34</p></td><td><p>9 629</p></td><td><p>n/a</p></td><td><p>947</p></td><td><p>7 371</p></td><td><p>3 066</p></td><td><p>8 151</p></td><td><p>3 304</p></td><td><p>3 024</p></td><td><p>4 742</p></td><td><p>7 625</p></td><td><p>9 047</p></td><td><p>2 314</p></td><td><p>n/a</p></td></tr><tr><td><p>Upper secondary and post-secondary non-tertiary education — general (levels 34 and 44)</p></td><td><p>ED34_44</p></td><td><p>9 629</p></td><td><p>10 022</p></td><td><p>947</p></td><td><p>7 371</p></td><td><p>2 844</p></td><td><p>8 081</p></td><td><p>3 304</p></td><td><p>3 024</p></td><td><p>4 742</p></td><td><p>7 625</p></td><td><p>9 029</p></td><td><p>2 314</p></td><td><p>n/a</p></td></tr><tr><td><p>Upper secondary education — vocational</p></td><td><p>ED35</p></td><td><p>11 978</p></td><td><p>n/a</p></td><td><p>1 119</p></td><td><p>11 881 *</p></td><td><p>3 538</p></td><td><p>7 596</p></td><td><p>3 812</p></td><td><p>4 957</p></td><td><p>6 188</p></td><td><p>7 651</p></td><td><p>9 651</p></td><td><p>4 010</p></td><td><p>2 826</p></td></tr><tr><td><p>Upper secondary and post-secondary non-tertiary education — vocational (levels 35 and 45)</p></td><td><p>ED35_45</p></td><td><p>10 836</p></td><td><p>10 353</p></td><td><p>1 127</p></td><td><p>11 244</p></td><td><p>3 521</p></td><td><p>6 236</p></td><td><p>3 782</p></td><td><p>n/a</p></td><td><p>6 569</p></td><td><p>7 651</p></td><td><p>9 429</p></td><td><p>3 922</p></td><td><p>2 826</p></td></tr><tr><td><p>Post-secondary non-tertiary education</p></td><td><p>ED4</p></td><td><p>1 661</p></td><td><p>n/a</p></td><td><p>2 459</p></td><td><p>n/a</p></td><td><p>730</p></td><td><p>3 895</p></td><td><p>3 756</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>5 917</p></td><td><p>5 058</p></td><td><p>n/a</p></td></tr><tr><td><p>Post-secondary non-tertiary education</p></td><td><p>ED44</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>712</p></td><td><p>6 652</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>6 744</p></td><td><p>n/a</p></td><td><p>n/a</p></td></tr><tr><td><p>Post-secondary non-tertiary education — vocational</p></td><td><p>ED45</p></td><td><p>1 661</p></td><td><p>n/a</p></td><td><p>2 459</p></td><td><p>n/a</p></td><td><p>783</p></td><td><p>3630</p></td><td><p>3756</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>5 733</p></td><td><p>5 058</p></td><td><p>n/a</p></td></tr><tr><td><p>Short cycle tertiary education</p></td><td><p>ED5</p></td><td><p>12 416</p></td><td><p>8 864</p></td><td><p>n/a</p></td><td><p>1 054</p></td><td><p>8 138</p></td><td><p>6 109</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>5 040</p></td><td><p>n/a</p></td><td><p>8 883</p></td><td><p>824</p></td><td><p>n/a</p></td></tr><tr><td><p>Tertiary education (levels 5-8)</p></td><td><p>ED5-8</p></td><td><p>9 493</p></td><td><p>7 934</p></td><td><p>913</p></td><td><p>3 625</p></td><td><p>1 986</p></td><td><p>6 267</p></td><td><p>2 979</p></td><td><p>1 294</p></td><td><p>3 678</p></td><td><p>9 414</p></td><td><p>6 297</p></td><td><p>1 645</p></td><td><p>3 258</p></td></tr><tr><td><p>Tertiary education excluding short-cycle tertiary education (levels 6-8)</p></td><td><p>ED6-8</p></td><td><p>8 938</p></td><td><p>7 899</p></td><td><p>913</p></td><td><p>3 894</p></td><td><p>1 970</p></td><td><p>6 267</p></td><td><p>2 979</p></td><td><p>1 294</p></td><td><p>3 337</p></td><td><p>9 414</p></td><td><p>5 464</p></td><td><p>1 829 *</p></td><td><p>n/a</p></td></tr></tbody></table>
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p> </p></td><td><p>IE*</p></td><td><p>IT</p></td><td><p>LV</p></td><td><p>LT</p></td><td><p>LU</p></td><td><p>MT</p></td><td><p>NL*</p></td><td><p>PL</p></td><td><p>PT</p></td><td><p>RO</p></td><td><p>SI</p></td><td><p>SK</p></td><td><p>SE</p></td><td><p>UK*</p></td></tr><tr><td><p>Early childhood education</p></td><td><p>ED0</p></td><td><p>n/a</p></td><td><p>3 709</p></td><td><p>2 548</p></td><td><p>1 971</p></td><td><p>17 395</p></td><td><p>4 138</p></td><td><p>6 065</p></td><td><p>1 810</p></td><td><p>2 689</p></td><td><p>1 009</p></td><td><p>4 433 *</p></td><td><p>2 084</p></td><td><p>13 267 *</p></td><td><p>3 978</p></td></tr><tr><td><p>Early childhood educational development</p></td><td><p>ED01</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>1 937</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>1 930</p></td><td><p>5 344 *</p></td><td><p>n/a</p></td><td><p>14 879 *</p></td><td><p>4 008</p></td></tr><tr><td><p>Pre-primary education</p></td><td><p>ED02</p></td><td><p>4 986</p></td><td><p>3 709</p></td><td><p>2 548</p></td><td><p>1 978</p></td><td><p>17 395</p></td><td><p>4 138</p></td><td><p>6 065</p></td><td><p>1 810</p></td><td><p>2 689</p></td><td><p>977</p></td><td><p>4 067 *</p></td><td><p>2 084</p></td><td><p>12 692 *</p></td><td><p>3 973</p></td></tr><tr><td><p>Primary education</p></td><td><p>ED1</p></td><td><p>6 471</p></td><td><p>5 428</p></td><td><p>3 225</p></td><td><p>2 292</p></td><td><p>17 433</p></td><td><p>4 080</p></td><td><p>6 681</p></td><td><p>2 703</p></td><td><p>3 828</p></td><td><p>701</p></td><td><p>4 985 *</p></td><td><p>2 766</p></td><td><p>9 217</p></td><td><p>8 777</p></td></tr><tr><td><p>Primary and lower secondary education (levels 1 and 2)</p></td><td><p>ED1_2</p></td><td><p>6 925</p></td><td><p>5 669</p></td><td><p>3 233</p></td><td><p>2 196</p></td><td><p>17 120</p></td><td><p>5 168</p></td><td><p>7 757</p></td><td><p>2 682</p></td><td><p>4 262</p></td><td><p>983</p></td><td><p>4 467</p></td><td><p>2 604</p></td><td><p>9 379</p></td><td><p>8 898</p></td></tr><tr><td><p>Lower secondary education</p></td><td><p>ED2</p></td><td><p>8 200</p></td><td><p>6 056</p></td><td><p>3 250</p></td><td><p>2 139</p></td><td><p>16 594</p></td><td><p>7 325</p></td><td><p>9 352</p></td><td><p>2 640</p></td><td><p>5 001</p></td><td><p>1 326</p></td><td><p>4 393 *</p></td><td><p>2 454</p></td><td><p>9 750</p></td><td><p>9 142</p></td></tr><tr><td><p>Lower secondary education — general</p></td><td><p>ED24</p></td><td><p>8 200</p></td><td><p>6 057</p></td><td><p>3 249</p></td><td><p>2 140</p></td><td><p>16 594</p></td><td><p>7 341</p></td><td><p>8 228</p></td><td><p>2 640</p></td><td><p>n/a</p></td><td><p>1 326</p></td><td><p>4 393 *</p></td><td><p>2 387</p></td><td><p>n/a</p></td><td><p>9 464</p></td></tr><tr><td><p>Lower secondary education — vocational</p></td><td><p>ED25</p></td><td><p>n/a</p></td><td><p>5 762</p></td><td><p>3 488</p></td><td><p>2 044</p></td><td><p>n/a</p></td><td><p>4 946</p></td><td><p>12 367</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>4 951</p></td><td><p>n/a</p></td><td><p>6 370</p></td></tr><tr><td><p>Upper secondary education</p></td><td><p>ED3</p></td><td><p>8 496</p></td><td><p>5 950</p></td><td><p>3 370</p></td><td><p>2 190</p></td><td><p>15 619</p></td><td><p>4 954</p></td><td><p>6 995</p></td><td><p>2 336 *</p></td><td><p>4 411 *</p></td><td><p>1 367</p></td><td><p>3 407</p></td><td><p>2 811</p></td><td><p>9 871</p></td><td><p>8 701</p></td></tr><tr><td><p>Upper secondary and post-secondary non-tertiary education (levels 3 and 4)</p></td><td><p>ED3_4</p></td><td><p>9 252</p></td><td><p>5 995 *</p></td><td><p>3 392</p></td><td><p>2 185</p></td><td><p>15 211</p></td><td><p>5 001</p></td><td><p>6 995</p></td><td><p>2 229</p></td><td><p>4 475</p></td><td><p>1 260</p></td><td><p>3 407</p></td><td><p>2 828</p></td><td><p>9 657</p></td><td><p>8 701</p></td></tr><tr><td><p>Upper secondary education — general</p></td><td><p>ED34</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>3 409</p></td><td><p>2 197</p></td><td><p>13 391</p></td><td><p>4 751</p></td><td><p>7 589</p></td><td><p>2 025</p></td><td><p>n/a</p></td><td><p>3 084</p></td><td><p>4 241 *</p></td><td><p>2 316</p></td><td><p>6 749</p></td><td><p>8 895</p></td></tr><tr><td><p>Upper secondary and post-secondary non-tertiary education — general (levels 34 and 44)</p></td><td><p>ED34_44</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>3 409</p></td><td><p>2 197</p></td><td><p>13 391</p></td><td><p>4 761</p></td><td><p>7 589</p></td><td><p>2 025</p></td><td><p>n/a</p></td><td><p>3 084</p></td><td><p>4 241 *</p></td><td><p>2 316</p></td><td><p>6 758</p></td><td><p>8 895</p></td></tr><tr><td><p>Upper secondary education — vocational</p></td><td><p>ED35</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>3 312</p></td><td><p>2 169</p></td><td><p>17 032</p></td><td><p>6 190</p></td><td><p>6 710</p></td><td><p>2 520 *</p></td><td><p>n/a</p></td><td><p>75</p></td><td><p>3 717 *</p></td><td><p>3 085</p></td><td><p>14 773 *</p></td><td><p>8 295</p></td></tr><tr><td><p>Upper secondary and post-secondary non-tertiary education — vocational (levels 35 and 45)</p></td><td><p>ED35_45</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>3 372</p></td><td><p>2 171</p></td><td><p>16 319</p></td><td><p>5 653</p></td><td><p>6 709</p></td><td><p>2 317 *</p></td><td><p>n/a</p></td><td><p>152</p></td><td><p>3 717 *</p></td><td><p>3 091</p></td><td><p>13 841</p></td><td><p>8 295</p></td></tr><tr><td><p>Post-secondary non-tertiary education</p></td><td><p>ED4</p></td><td><p>10 628</p></td><td><p>n/a</p></td><td><p>3 693</p></td><td><p>2 173</p></td><td><p>1 467</p></td><td><p>5 263</p></td><td><p>5 056</p></td><td><p>634</p></td><td><p>n/a</p></td><td><p>475</p></td><td><p>n/a</p></td><td><p>3 168</p></td><td><p>4 146 *</p></td><td><p>n/a</p></td></tr><tr><td><p>Post-secondary non-tertiary education</p></td><td><p>ED44</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>6 178</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>7 285</p></td><td><p>n/a</p></td></tr><tr><td><p>Post-secondary non-tertiary education — vocational</p></td><td><p>ED45</p></td><td><p>10 628</p></td><td><p>n/a</p></td><td><p>3 693</p></td><td><p>2 173</p></td><td><p>1 467</p></td><td><p>5 232</p></td><td><p>5 056</p></td><td><p>634</p></td><td><p>n/a</p></td><td><p>475</p></td><td><p>n/a</p></td><td><p>3 168</p></td><td><p>4 203</p></td><td><p>n/a</p></td></tr><tr><td><p>Short cycle tertiary education</p></td><td><p>ED5</p></td><td><p>n/a</p></td><td><p>2 718</p></td><td><p>3 570</p></td><td><p>n/a</p></td><td><p>20 587</p></td><td><p>6 463</p></td><td><p>6 205</p></td><td><p>3 575</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>1 725 *</p></td><td><p>3 417</p></td><td><p>6 483</p></td><td><p>1 731</p></td></tr><tr><td><p>Tertiary education (levels 5-8)</p></td><td><p>ED5-8</p></td><td><p>6 562</p></td><td><p>2 334</p></td><td><p>2 709</p></td><td><p>2 349</p></td><td><p>26 940</p></td><td><p>8 994</p></td><td><p>6 081</p></td><td><p>2 591</p></td><td><p>1 293 *</p></td><td><p>1 894</p></td><td><p>4 027</p></td><td><p>2 890</p></td><td><p>10 360</p></td><td><p>2 257</p></td></tr><tr><td><p>Tertiary education excluding short-cycle tertiary education (levels 6-8)</p></td><td><p>ED6-8</p></td><td><p>6 562</p></td><td><p>2 332</p></td><td><p>2 567</p></td><td><p>2 349</p></td><td><p>27 673</p></td><td><p>9 450</p></td><td><p>6 081</p></td><td><p>2 588</p></td><td><p>1 293 *</p></td><td><p>1 894</p></td><td><p>4 200 *</p></td><td><p>2 881</p></td><td><p>10 683</p></td><td><p>2 304</p></td></tr></tbody></table>
3.2 Amounts for training for the employed and unemployed, and employment services (in EUR)
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><table><col/><col/><tbody><tr><td><p>3.2.1</p></td><td><p>Amount per participant demonstrating successful completion of a training course</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>3.2.2</p></td><td><p>Hourly rate for provision of employment services</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>3.2.3</p></td><td><p>Monthly rate for provision of employment services</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>3.2.4</p></td><td><p>Annual amount for provision of employment services</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>3.2.5</p></td><td><p>Hourly rate for training of employed persons</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>3.2.6</p></td><td><p>Hourly rate for salary of employed person</p></td></tr></tbody></table></td></tr><tr><td><p>Austria</p></td><td><p>2 277</p></td><td><p>39</p></td><td><p>6 723</p></td><td><p>80 672</p></td><td><p>33,98</p></td><td><p>26,03</p></td></tr><tr><td><p>Belgium</p></td><td><p>3 351</p></td><td><p>42</p></td><td><p>7 010</p></td><td><p>84 112</p></td><td><p>22,97</p></td><td><p>31,08</p></td></tr><tr><td><p>Bulgaria</p></td><td><p>596</p></td><td><p>3</p></td><td><p>543</p></td><td><p>6 511</p></td><td><p>5,14</p></td><td><p>1,76</p></td></tr><tr><td><p>Cyprus</p></td><td><p>2 696</p></td><td><p>29</p></td><td><p>5 467</p></td><td><p>65 604</p></td><td><p>18,85</p></td><td><p>10,94</p></td></tr><tr><td><p>Czech Republic</p></td><td><p>521</p></td><td><p>11</p></td><td><p>1988</p></td><td><p>23 864</p></td><td><p>9,29</p></td><td><p>7,39</p></td></tr><tr><td><p>Germany</p></td><td><p>6 959</p></td><td><p>42</p></td><td><p>7 582</p></td><td><p>90 992</p></td><td><p>36,03</p></td><td><p>23,11</p></td></tr><tr><td><p>Denmark</p></td><td><p>5 803</p></td><td><p>55</p></td><td><p>9 496</p></td><td><p>113 956</p></td><td><p>39,67</p></td><td><p>32,02</p></td></tr><tr><td><p>Estonia</p></td><td><p>711</p></td><td><p>14</p></td><td><p>2 498</p></td><td><p>29 968</p></td><td><p>14,03</p></td><td><p>8,22</p></td></tr><tr><td><p>Greece</p></td><td><p>2 064</p></td><td><p>21</p></td><td><p>3 685</p></td><td><p>44 222</p></td><td><p>17,72</p></td><td><p>11,56</p></td></tr><tr><td><p>Spain</p></td><td><p>2 772</p></td><td><p>20</p></td><td><p>3 508</p></td><td><p>42 095</p></td><td><p>17,58</p></td><td><p>18,30</p></td></tr><tr><td><p>Finland</p></td><td><p>5 885</p></td><td><p>45</p></td><td><p>7 683</p></td><td><p>92 204</p></td><td><p>38,39</p></td><td><p>27,69</p></td></tr><tr><td><p>France</p></td><td><p>6 274</p></td><td><p>48</p></td><td><p>7 297</p></td><td><p>87 556</p></td><td><p>35,99</p></td><td><p>25,26</p></td></tr><tr><td><p>Croatia</p></td><td><p>689</p></td><td><p>10</p></td><td><p>1 620</p></td><td><p>19 440</p></td><td><p>10,52</p></td><td><p>5,90</p></td></tr><tr><td><p>Hungary</p></td><td><p>1818</p></td><td><p>10</p></td><td><p>1 816</p></td><td><p>21 790</p></td><td><p>15,67</p></td><td><p>5,02</p></td></tr><tr><td><p>Ireland</p></td><td><p>11 119</p></td><td><p>36</p></td><td><p>6 411</p></td><td><p>76 920</p></td><td><p>31,79</p></td><td><p>27,20</p></td></tr><tr><td><p>Italy</p></td><td><p>3 676</p></td><td><p>31</p></td><td><p>5 438</p></td><td><p>65 247</p></td><td><p>27,42</p></td><td><p>22,20</p></td></tr><tr><td><p>Lithuania</p></td><td><p>1 359</p></td><td><p>8</p></td><td><p>1 574</p></td><td><p>18 878</p></td><td><p>7,43</p></td><td><p>3,71</p></td></tr><tr><td><p>Luxembourg</p></td><td><p>19 302</p></td><td><p>34</p></td><td><p>5 908</p></td><td><p>70 890</p></td><td><p>29,87</p></td><td><p>23,30</p></td></tr><tr><td><p>Latvia</p></td><td><p>756</p></td><td><p>8</p></td><td><p>1 385</p></td><td><p>16 607</p></td><td><p>7,94</p></td><td><p>7,21</p></td></tr><tr><td><p>Malta</p></td><td><p>2 256</p></td><td><p>13</p></td><td><p>2 184</p></td><td><p>26 212</p></td><td><p>16,49</p></td><td><p>8,41</p></td></tr><tr><td><p>Netherlands</p></td><td><p>5 018</p></td><td><p>36</p></td><td><p>6 474</p></td><td><p>77 680</p></td><td><p>32,01</p></td><td><p>23,33</p></td></tr><tr><td><p>Poland</p></td><td><p>594</p></td><td><p>6</p></td><td><p>1 051</p></td><td><p>12 611</p></td><td><p>11,21</p></td><td><p>4,47</p></td></tr><tr><td><p>Portugal</p></td><td><p>994</p></td><td><p>21</p></td><td><p>3 648</p></td><td><p>43 784</p></td><td><p>8,33</p></td><td><p>10,63</p></td></tr><tr><td><p>Romania</p></td><td><p>583</p></td><td><p>8</p></td><td><p>1 555</p></td><td><p>18 656</p></td><td><p>0,27</p></td><td><p>2,56</p></td></tr><tr><td><p>Sweden</p></td><td><p>7 303</p></td><td><p>48</p></td><td><p>8 369</p></td><td><p>100 430</p></td><td><p>58,02</p></td><td><p>32,67</p></td></tr><tr><td><p>Slovenia</p></td><td><p>854</p></td><td><p>22</p></td><td><p>4 015</p></td><td><p>48 185</p></td><td><p>18,90</p></td><td><p>7,61</p></td></tr><tr><td><p>Slovakia</p></td><td><p>424</p></td><td><p>7</p></td><td><p>1 117</p></td><td><p>13 411</p></td><td><p>11,13</p></td><td><p>12,52</p></td></tr><tr><td><p>United Kingdom</p></td><td><p>5 863</p></td><td><p>25</p></td><td><p>4 690</p></td><td><p>56 286</p></td><td><p>36,07</p></td><td><p>15,16</p></td></tr></tbody></table>
3.3. Index to be applied for the amounts for stated regional operations programmes.
<table><col/><col/><col/><col/><col/><tbody><tr><td><p><span>Belgium</span></p></td><td><p>1,00</p></td><td><p> </p></td><td><p><span>France</span></p></td><td><p>1,00</p></td></tr><tr><td><p>Brussels Capital</p></td><td><p>1,26</p></td><td><p> </p></td><td><p>Île de France</p></td><td><p>1,32</p></td></tr><tr><td><p>Flanders</p></td><td><p>0,97</p></td><td><p> </p></td><td><p>Champagne-Ardenne</p></td><td><p>0,88</p></td></tr><tr><td><p>Wallonia</p></td><td><p>0,91</p></td><td><p> </p></td><td><p>Picardie</p></td><td><p>0,91</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>Haute-Normandie</p></td><td><p>0,96</p></td></tr><tr><td><p><span>Germany</span></p></td><td><p>1,00</p></td><td><p> </p></td><td><p>Centre</p></td><td><p>0,89</p></td></tr><tr><td><p>Baden-Württemberg</p></td><td><p>1,08</p></td><td><p> </p></td><td><p>Basse-Normandie</p></td><td><p>0,86</p></td></tr><tr><td><p>Bayern</p></td><td><p>1,05</p></td><td><p> </p></td><td><p>Bourgogne</p></td><td><p>0,87</p></td></tr><tr><td><p>Berlin</p></td><td><p>0,98</p></td><td><p> </p></td><td><p>Nord — Pas-de-Calais</p></td><td><p>0,95</p></td></tr><tr><td><p>Brandenburg</p></td><td><p>0,82</p></td><td><p> </p></td><td><p>Lorraine</p></td><td><p>0,90</p></td></tr><tr><td><p>Bremen</p></td><td><p>1,06</p></td><td><p> </p></td><td><p>Alsace</p></td><td><p>0,97</p></td></tr><tr><td><p>Hamburg</p></td><td><p>1,21</p></td><td><p> </p></td><td><p>Franche-Comté</p></td><td><p>0,89</p></td></tr><tr><td><p>Hessen</p></td><td><p>1,12</p></td><td><p> </p></td><td><p>Pays de la Loire</p></td><td><p>0,90</p></td></tr><tr><td><p>Mecklenburg-Vorpommern</p></td><td><p>0,79</p></td><td><p> </p></td><td><p>Bretagne</p></td><td><p>0,86</p></td></tr><tr><td><p>Niedersachsen</p></td><td><p>0,93</p></td><td><p> </p></td><td><p>Poitou-Charentes</p></td><td><p>0,83</p></td></tr><tr><td><p>Nordrhein-Westfalen</p></td><td><p>1,02</p></td><td><p> </p></td><td><p>Aquitaine</p></td><td><p>0,87</p></td></tr><tr><td><p>Rheinland-Pfalz</p></td><td><p>0,96</p></td><td><p> </p></td><td><p>Midi-Pyrénées</p></td><td><p>0,91</p></td></tr><tr><td><p>Saarland</p></td><td><p>0,98</p></td><td><p> </p></td><td><p>Limousin</p></td><td><p>0,84</p></td></tr><tr><td><p>Sachsen</p></td><td><p>0,81</p></td><td><p> </p></td><td><p>Rhône-Alpes</p></td><td><p>0,97</p></td></tr><tr><td><p>Sachsen-Anhalt</p></td><td><p>0,82</p></td><td><p> </p></td><td><p>Auvergne</p></td><td><p>0,86</p></td></tr><tr><td><p>Schleswig-Holstein</p></td><td><p>0,87</p></td><td><p> </p></td><td><p>Languedoc-Roussillon</p></td><td><p>0,84</p></td></tr><tr><td><p>Thüringen</p></td><td><p>0,82</p></td><td><p> </p></td><td><p>Provence-Alpes-Côte d'Azur</p></td><td><p>0,93</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>Corse</p></td><td><p>0,93</p></td></tr><tr><td><p><span>Greece</span></p></td><td><p>1,00</p></td><td><p> </p></td><td><p>Guadeloupe</p></td><td><p>1,01</p></td></tr><tr><td><p>Anatoliki Makedonia, Thraki</p></td><td><p>0,81</p></td><td><p> </p></td><td><p>Martinique</p></td><td><p>0,90</p></td></tr><tr><td><p>Kentriki Makedonia</p></td><td><p>0,88</p></td><td><p> </p></td><td><p>Guyane</p></td><td><p>0,99</p></td></tr><tr><td><p>Dytiki Makedonia</p></td><td><p>1,12</p></td><td><p> </p></td><td><p>La Réunion</p></td><td><p>0,83</p></td></tr><tr><td><p>Ipeiros</p></td><td><p>0,79</p></td><td><p> </p></td><td><p>Mayotte</p></td><td><p>0,64</p></td></tr><tr><td><p>Thessalia</p></td><td><p>0,83</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Ionia Nisia</p></td><td><p>0,82</p></td><td><p> </p></td><td><p><span>Italy</span></p></td><td><p>1,00</p></td></tr><tr><td><p>Dytiki Ellada</p></td><td><p>0,81</p></td><td><p> </p></td><td><p>Piemonte</p></td><td><p>1,04</p></td></tr><tr><td><p>Sterea Ellada</p></td><td><p>0,90</p></td><td><p> </p></td><td><p>Valle d'Aosta</p></td><td><p>1,00</p></td></tr><tr><td><p>Peloponnisos</p></td><td><p>0,79</p></td><td><p> </p></td><td><p>Liguria</p></td><td><p>1,01</p></td></tr><tr><td><p>Attiki</p></td><td><p>1,23</p></td><td><p> </p></td><td><p>Lombardia</p></td><td><p>1,16</p></td></tr><tr><td><p>Voreio Aigaio</p></td><td><p>0,90</p></td><td><p> </p></td><td><p>Provincia Autonoma di Bolzano/Bozen</p></td><td><p>1,15</p></td></tr><tr><td><p>Notio Aigaio</p></td><td><p>0,97</p></td><td><p> </p></td><td><p>Provincia Autonoma di Trento</p></td><td><p>1,04</p></td></tr><tr><td><p>Kriti</p></td><td><p>0,83</p></td><td><p> </p></td><td><p>Veneto</p></td><td><p>1,03</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>Friuli-Venezia Giulia</p></td><td><p>1,08</p></td></tr><tr><td><p><span>Spain</span></p></td><td><p>1,00</p></td><td><p> </p></td><td><p>Emilia-Romagna</p></td><td><p>1,06</p></td></tr><tr><td><p>Galicia</p></td><td><p>0,88</p></td><td><p> </p></td><td><p>Toscana</p></td><td><p>0,95</p></td></tr><tr><td><p>Principado de Asturias</p></td><td><p>0,98</p></td><td><p> </p></td><td><p>Umbria</p></td><td><p>0,87</p></td></tr><tr><td><p>Cantabria</p></td><td><p>0,96</p></td><td><p> </p></td><td><p>Marche</p></td><td><p>0,90</p></td></tr><tr><td><p>País Vasco</p></td><td><p>1,17</p></td><td><p> </p></td><td><p>Lazio</p></td><td><p>1,07</p></td></tr><tr><td><p>Comunidad Foral de Navarra</p></td><td><p>1,07</p></td><td><p> </p></td><td><p>Abruzzo</p></td><td><p>0,89</p></td></tr><tr><td><p>La Rioja</p></td><td><p>0,92</p></td><td><p> </p></td><td><p>Molise</p></td><td><p>0,82</p></td></tr><tr><td><p>Aragón</p></td><td><p>0,98</p></td><td><p> </p></td><td><p>Campania</p></td><td><p>0,84</p></td></tr><tr><td><p>Comunidad de Madrid</p></td><td><p>1,18</p></td><td><p> </p></td><td><p>Puglia</p></td><td><p>0,82</p></td></tr><tr><td><p>Castilla y León</p></td><td><p>0,91</p></td><td><p> </p></td><td><p>Basilicata</p></td><td><p>0,86</p></td></tr><tr><td><p>Castilla-la Mancha</p></td><td><p>0,88</p></td><td><p> </p></td><td><p>Calabria</p></td><td><p>0,75</p></td></tr><tr><td><p>Extremadura</p></td><td><p>0,84</p></td><td><p> </p></td><td><p>Sicilia</p></td><td><p>0,86</p></td></tr><tr><td><p>Cataluña</p></td><td><p>1,09</p></td><td><p> </p></td><td><p>Sardegna</p></td><td><p>0,84</p></td></tr><tr><td><p>Comunidad Valenciana</p></td><td><p>0,91</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Illes Balears</p></td><td><p>0,96</p></td><td><p> </p></td><td><p><span>Portugal</span></p></td><td><p>1,00</p></td></tr><tr><td><p>Andalucía</p></td><td><p>0,87</p></td><td><p> </p></td><td><p>Norte</p></td><td><p>0,86</p></td></tr><tr><td><p>Región de Murcia</p></td><td><p>0,84</p></td><td><p> </p></td><td><p>Algarve</p></td><td><p>0,87</p></td></tr><tr><td><p>Ciudad Autónoma de Ceuta</p></td><td><p>1,07</p></td><td><p> </p></td><td><p>Centro</p></td><td><p>0,84</p></td></tr><tr><td><p>Ciudad Autónoma de Melilla</p></td><td><p>1,04</p></td><td><p> </p></td><td><p>Área Metropolitana de Lisboa</p></td><td><p>1,33</p></td></tr><tr><td><p>Canarias</p></td><td><p>0,91</p></td><td><p> </p></td><td><p>Alentejo</p></td><td><p>0,91</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>Região Autónoma dos Açores</p></td><td><p>0,91</p></td></tr><tr><td><p><span>Poland</span></p></td><td><p>1,00</p></td><td><p> </p></td><td><p>Região Autónoma da Madeira</p></td><td><p>0,95</p></td></tr><tr><td><p>Lódzkie</p></td><td><p>0,75</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Mazowieckie</p></td><td><p>1,26</p></td><td><p> </p></td><td><p><span>United Kingdom</span></p></td><td><p>1,00</p></td></tr><tr><td><p>Malopolskie</p></td><td><p>1,05</p></td><td><p> </p></td><td><p>England</p></td><td><p>1,01</p></td></tr><tr><td><p>Slaskie</p></td><td><p>1,19</p></td><td><p> </p></td><td><p>Wales</p></td><td><p>0,83</p></td></tr><tr><td><p>Lubelskie</p></td><td><p>0,60</p></td><td><p> </p></td><td><p>Scotland</p></td><td><p>0,99</p></td></tr><tr><td><p>Podkarpackie</p></td><td><p>0,81</p></td><td><p> </p></td><td><p>Northern Ireland</p></td><td><p>0,83</p></td></tr><tr><td><p>Swietokrzyskie</p></td><td><p>0,63</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Podlaskie</p></td><td><p>0,73</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Wielkopolskie</p></td><td><p>1,16</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Zachodniopomorskie</p></td><td><p>1,06</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Lubuskie</p></td><td><p>0,88</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Dolnoslaskie</p></td><td><p>1,22</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Kujawsko-Pomorskie</p></td><td><p>0,91</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Warminsko-Mazurskie</p></td><td><p>0,83</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Pomorskie</p></td><td><p>0,78</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr></tbody></table>
’ ( 1 ) These unit costs cannot be used for types of operations for which other simplified cost options are established in another annex to this Delegated Regulation.
( 2 ) Other potential eligible costs of this type of operation, such as allowances, transport, accommodation or other type of support provided to students participating in these types of operations, are not covered by the unit cost.
( 3 ) Verified attendance means that proof of the attendance of the student in the formal education or training course is to be verified by national authorities on two or three occasions during the per academic year, in accordance with each Member State's normal practices and procedures for verifying attendance in formal education or training.
( 4 ) International Standard Classification of Education: http://ec.europa.eu/eurostat/statistics-explained/index.php/International_Standard_Classification_of_Education_(ISCED)
( 5 ) The table in point 3.1 sets out rates for all Member States with the exception of Denmark for which data is not currently available. For courses lasting at least one full academic year, these amounts can be reimbursed to the Member State on the following basis: 50 % for the first proof of attendance during the academic year (normally at the beginning of the academic year, in accordance with national rules and practices), 30 % for the second proof of attendance and 20 % for the third and final proof of attendance. For those Member States whose national systems provide for this information to be collected only twice per year, or for courses lasting less than one full academic year, it will be 50 % for the first proof of attendance and 50 % for the second and final proof of attendance.
( 6 ) The training courses can be primarily either institutional or workplace-based, but must be delivered at least partly in an institutional setting.
( 7 ) A training course will be considered as ‘successfully completed’ when there is a document demonstrating completion in accordance with national rules or practices. For example, this could be a certificate issued by the training provider or an equivalent document which is acceptable under national rules or practices.
The condition of successfully completing a training course shall not be regarded as being met where a participant successfully only completes some of the modules within a training course.
( 8 ) Employment-related counselling services can be provided in a one-on-one situation or as part of a group. They include all services and activities undertaken by the PES, together with services provided by other public agencies or any other bodies contracted under public finance, which facilitate the integration of unemployed and other jobseekers in the labour market or which assist employers in recruiting and selecting staff.
( 9 ) As demonstrated by a verifiable time management system.
( 10 ) As demonstrated by a verifiable time management system.
( 11 ) As demonstrated by a verifiable time management system.
( 12 ) N/A indicates that no data is available for that particular Member State and the indicated education level.
Reference year of data collection is 2015 apart from fields marked with a * (including all fields for FI, HR, IE, NL and UK) — reference year is 2014 for these fields.
ANNEX VII
‘ANNEX XV
Conditions for reimbursement of expenditure on the basis of standard scales of unit costs to Cyprus
1. Definition of standard scales of unit costs
<table><col/><col/><tbody><tr><td><p>Type of operations</p></td><td><p>Indicator name</p></td><td><p>Category of costs</p></td><td><p>Measurement unit for the indicators</p></td><td><p>Amounts</p><p>(in EUR)</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>“School and Social Inclusion Actions” under Priority Axis 3 of Operational Programme Employment, Human Resources and Social Cohesion (CCI 2014CY05M9OP001).</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>1)</p></td><td><p>Rate for one period of 45 minutes for teachers hired on contract.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2)</p></td><td><p>Daily rate for permanent and temporary teachers.</p></td></tr></tbody></table></td><td><p>All eligible costs including direct staff costs.</p></td><td><table><col/><col/><tbody><tr><td><p>1)</p></td><td><p>Number of hours worked.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2)</p></td><td><p>Number of days worked.</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>1)</p></td><td><p>21 per 45-minute period</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2)</p></td><td><p>300 per day</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>“Establishment and Functioning of a Central ADMINISTRATION of Welfare Benefits Service” under Priority Axis 3 of Operational Programme Employment, Human Resources and Social Cohesion (CCI 2014CY05M9OP001).</p></td></tr></tbody></table></td><td><p>Monthly rate for permanent and temporary government employees.</p></td><td><p>All eligible costs including direct staff costs.</p></td><td><p>Number of months worked differentiated by salary scale.</p></td><td><p><tblcnt><table><col/><col/><tbody><tr><td><p>Salary Scales</p></td><td><p>amounts</p></td></tr><tr><td><p>Α1</p></td><td><p>1 794</p></td></tr><tr><td><p>A2</p></td><td><p>1 857</p></td></tr><tr><td><p>A3</p></td><td><p>2 007</p></td></tr><tr><td><p>A4</p></td><td><p>2 154</p></td></tr><tr><td><p>A5</p></td><td><p>2 606</p></td></tr><tr><td><p>A6</p></td><td><p>3 037</p></td></tr><tr><td><p>A7</p></td><td><p>3 404</p></td></tr><tr><td><p>A8</p></td><td><p>3 733</p></td></tr><tr><td><p>A9</p></td><td><p>4 365</p></td></tr><tr><td><p>A10</p></td><td><p>4 912</p></td></tr><tr><td><p>A11</p></td><td><p>5 823</p></td></tr><tr><td><p>A12</p></td><td><p>6 475</p></td></tr><tr><td><p>A13</p></td><td><p>7 120</p></td></tr></tbody></table></tblcnt></p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>Disability and functionality assessments under Priority Axis 3 of Operational Programme Employment, Human Resources and Social Cohesion (CCI 2014CY05M9OP001).</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>1)</p></td><td><p>Provision of a disability assessment.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2)</p></td><td><p>Provision of a disability and functionality assessment.</p></td></tr></tbody></table></td><td><p>All categories of eligible costs.</p></td><td><p>Number of assessments carried out.</p></td><td><table><col/><col/><tbody><tr><td><p>1)</p></td><td><p>Disability assessment:190</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2)</p></td><td><p>Disability and functionality assessment: 303</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.</p></td><td><p>Reform of the vocational education and training system under under Priority Axis 3 of Operational Programme Employment, Human Resources and Social Cohesion (CCI 2014CY05M9OP001).</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>One day of work by a teacher</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>One month of work by a teacher</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>One hour of work by a teacher hired on contract</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>4.</p></td><td><p>One hour of work by a laboratory assistant hired on contract</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>5.</p></td><td><p>One minute of work by a psychologist hired on contract</p></td></tr></tbody></table></td><td><p>All categories of eligible costs</p></td><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Number of days of work by a teacher, differentiated by salary scale</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Number of months of work by a teacher, differentiated by salary scale</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>Number of teaching hours (45 min) of work by a teacher hired on contract</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>4.</p></td><td><p>Number of teaching hours (45 min) of work by a laboratory assistant hired on contract</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>5.</p></td><td><p>Number of minutes of work by a psychologist hired on contract</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>1)</p></td><td><p><tblcnt><table><col/><col/><tbody><tr><td><p>Salary scale</p></td><td><p>amounts</p></td></tr><tr><td><p>A8</p></td><td><p>277</p></td></tr><tr><td><p>A9</p></td><td><p>330</p></td></tr><tr><td><p>A10</p></td><td><p>371</p></td></tr><tr><td><p>A11</p></td><td><p>440</p></td></tr><tr><td><p>A12</p></td><td><p>488</p></td></tr></tbody></table></tblcnt></p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2)</p></td><td><p><tblcnt><table><col/><col/><tbody><tr><td><p>A8</p></td><td><p>4 554</p></td></tr><tr><td><p>A9</p></td><td><p>5 404</p></td></tr><tr><td><p>A10</p></td><td><p>6 082</p></td></tr><tr><td><p>A11</p></td><td><p>7 210</p></td></tr><tr><td><p>A12</p></td><td><p>8 005</p></td></tr><tr><td><p>A13</p></td><td><p>8 791</p></td></tr></tbody></table></tblcnt></p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>3)</p></td><td><p>34</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>4)</p></td><td><p>21</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>5)</p></td><td><p>0,63</p></td></tr></tbody></table></td></tr></tbody></table>
2. Adjustment of amounts
Not applicable.
’ ANNEX VIII
‘ANNEX XVI
Conditions for reimbursement of expenditure on the basis of standard scales of unit costs to Croatia
1. Definition of standard scales of unit costs
<table><col/><col/><col/><col/><col/><tbody><tr><td><p>Type of operations</p></td><td><p>Indicator name</p></td><td><p>Category of costs</p></td><td><p>Measurement unit for the indicators</p></td><td><p>Amounts</p><p>(in HRK)</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Improving access to education for disadvantaged students at pre-tertiary level by providing targeted professional support to students through teaching assistants under Priority Axis 3 “Education and Lifelong learning” of the Operational Programme “Efficient Human Resources” (2014HR05M9OP001)</p></td></tr></tbody></table></td><td><p>Months worked by a teaching assistant</p></td><td><p>All eligible costs of the operation</p></td><td><p>Number of months worked</p></td><td><p>4 530,18</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Occupational training under priority axis 1 “High employment and labour mobility” of the Operational Programme “Efficient Human Resources” (2014HR05M9OP001)</p></td></tr></tbody></table></td><td><p>Months of participation in occupational training</p></td><td><p>All eligible costs of the operation except travel costs for the participant, costs of participant's education and professional exam (if applicable)</p></td><td><p>Number of months of participation in occupational training</p></td><td><p>For participants without prior work experience:</p><p>3 318,81</p><p>For participants with prior work experience:</p><table><col/><col/><tbody><tr><td><p>a)</p></td><td><p>for first 12 months of participation in occupational training</p>3 791,19</td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>b)</p></td><td><p>for last 12 months of participation in occupational training</p>3 318,81</td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>Public works programmes supported under priority axis 1 “High employment and labour mobility” and priority axis 2 “Social inclusion” of the Operational Programme “Efficient Human Resources” (2014HR05M9OP001)</p></td></tr></tbody></table></td><td><p>Months during which an employment aid is paid for an employee in a public works programme</p></td><td><p>All eligible costs of the operation except travel costs for the participant, costs of participant's education and professional exam (if applicable)</p></td><td><p>Number of months' employment aid per employee</p></td><td><table><col/><col/><tbody><tr><td><p>a)</p></td><td><p>3 943,24</p><p>for full- time employment, 100 % employment aid intensity</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>b)</p></td><td><p>1 971,62</p><p>for full- time employment, 50 % employment aid intensity and half-time employment, 100 % aid intensity</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.</p></td><td><p>Active labour market measures supported under priority axis 1 “High employment and labour mobility” and priority axis 2 “Social inclusion” of the Operational Programme “Efficient Human Resources” (2014HR05M9OP001)</p></td></tr></tbody></table></td><td><p>Months during which the participant takes part in an active employment policy measure.</p></td><td><p>Travel costs</p></td><td><p>Number of months participated in an active employment measure.</p></td><td><p>452,16</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr></tbody></table>
2. Adjustment of amounts
Unit costs 2 shall be adjusted each calendar year by replacing the amount for financial aid and the contribution for compulsory insurance in the calculation method.
Adjustments will be based on:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>for financial aid, changes to the Statutory minimum wage according to the Minimum Wage Decree issued by Government, published on Official Gazette of Republic of Croatia (https://www.nn.hr)</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>for contributions for compulsory insurance, changes to the minimum monthly bases according to the Order on the bases for calculation of contributions for compulsory insurance issued by Minister of Finance, published on Official Gazette of Republic of Croatia (https://www.nn.hr).</p><p>In addition any changes of the Employment Promotion Act provisions regulating mechanisms for determining financial aid and compulsory insurance payments for Occupational training and/or any changes of the Act on Contributions (NN 84/08, 152/08, 94/09, 18/11, 22/12, 144/12, 148/13, 41/14, 143/14, 115/16) provisions regulating calculations for compulsory contributions may entail changes to the proposed calculation method.</p></td></tr></tbody></table>
The amount for unit costs 3 shall be adjusted each calendar year by replacing the amount for Statutory minimum wage and the annual sickleave rate in the calculation method.
Adjustments will be based on:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>changes to the Statutory minimum wage according to the Minimum Wage Decree issued by Government for a calendar year, published on Official Gazette of Republic of Croatia (https://www.nn.hr) according to the Article 7 of the Law on Minimum Wage (NN 39/13)</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>changes to the official annual sick leave rate in Croatia, published on the website of Croatian Health Insurance Fund (http://www.hzzo.hr/o-zavodu/izvjesca/). In addition any changes of the Act on Contributions (NN 84/08, 152/08, 94/09, 18/11, 22/12, 144/12, 148/13, 41/14, 143/14, 115/16) provisions regulating calculations for compulsory contributions may entail changes to the proposed calculation method.</p></td></tr></tbody></table>
’ ANNEX IX
‘ANNEX XX
Conditions for reimbursement of expenditure on the basis of standard scales of unit costs to Bulgaria
1. Definition of standard scales of unit costs
<table><col/><col/><col/><col/><col/><tbody><tr><td><p>Type of operations</p></td><td><p>Indicator name</p></td><td><p>Category of costs</p></td><td><p>Measurement unit for the indicators</p></td><td><p>Amounts</p></td></tr><tr><td><p>Vocational training under priority Axis 1 and 2 of OP 2014BG05M9OP001</p></td><td><p>Participants gaining qualification upon leaving vocational training.</p></td><td><p>All eligible costs of the operation.</p></td><td><p>Number of participants who have attended at least 80 % of the classes and have successfully completed vocational training courses and have received a corresponding certificate.</p></td><td><p>See table under point 3</p></td></tr></tbody></table>
2. Adjustment of amounts
Unit costs adjustment shall be linked to amendments in the national regulations — Council of Ministers Decree (CMD) No 280/2015 and the National Action Plan for Employment for implementation of the labour market's active policy for the respective year.
3. Amounts (in BGN) ( 1 )
<table><col/><col/><col/><col/><col/><tbody><tr><td><p>Training courses for acquisition of professional qualifications</p></td><td><p>Minimum duration in training hours</p></td><td><p>Amounts</p></td><td><p>Amounts including indirect costs for beneficiaries selected via a competitive grant awarding procedure</p></td><td><p>Amounts including indirect costs for beneficiaries selected via a direct grant awarding procedure</p></td></tr><tr><td><p>First degree courses</p></td><td><p>300</p></td><td><p>600</p></td><td><p>660</p></td><td><p>624</p></td></tr><tr><td><p>Second degree courses</p></td><td><p>660</p></td><td><p>1 200</p></td><td><p>1 320</p></td><td><p>1 248</p></td></tr><tr><td><p>Third degree courses</p></td><td><p>960</p></td><td><p>1 800</p></td><td><p>1 980</p></td><td><p>1 872</p></td></tr><tr><td><p>Part of a profession on first degree qualification<a> (<span>2</span>)</a></p></td><td><p>200</p></td><td><p>400</p></td><td><p>440</p></td><td><p>416</p></td></tr><tr><td><p>Part of a profession on second degree qualification</p></td><td><p>300</p></td><td><p>600</p></td><td><p>660</p></td><td><p>624</p></td></tr><tr><td><p>Part of a profession on third degree qualification</p></td><td><p>600</p></td><td><p>1 125</p></td><td><p>1 237,50</p></td><td><p>1 170</p></td></tr></tbody></table>
<table><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Training courses for acquisition of key competences</p></td><td><p>Minimum duration in training hours</p></td><td><p>Amounts</p></td><td><p>Amounts including indirect costs for beneficiaries selected via a competitive grant awarding procedure</p></td><td><p>Amounts including indirect costs for beneficiaries selected via a direct grant awarding procedure</p></td></tr><tr><td><p>for unemployed</p></td><td><p>for employed and self-employed</p></td><td><p>for unemployed</p></td><td><p>for employed and self-employed</p></td><td><p>for unemployed</p></td><td><p>for employed and self-employed</p></td></tr><tr><td><p>Key competence 2 — communication in foreign language</p></td><td><p>300</p></td><td><p>700</p></td><td><p>770</p></td><td><p>728</p></td></tr><tr><td><p>Key competence 3 — mathematics and basic knowledge of natural sciences and technologies</p></td><td><p>30</p></td><td><p>140</p></td><td><p>70</p></td><td><p>154</p></td><td><p>77</p></td><td><p>145,60</p></td><td><p>72,80</p></td></tr><tr><td><p>Key competence 4 — digital competence</p></td><td><p>45</p></td><td><p>250</p></td><td><p>275</p></td><td><p>260</p></td></tr><tr><td><p>Key competence 5 — skill for learning</p></td><td><p>30</p></td><td><p>140</p></td><td><p>70</p></td><td><p>154</p></td><td><p>77</p></td><td><p>145,60</p></td><td><p>72,80</p></td></tr><tr><td><p>Key competence 6 — social and civil competences</p></td><td><p>30</p></td><td><p>140</p></td><td><p>70</p></td><td><p>154</p></td><td><p>77</p></td><td><p>145,60</p></td><td><p>72,80</p></td></tr><tr><td><p>Key competence 7 — enterprise and entrepreneurship</p></td><td><p>30</p></td><td><p>140</p></td><td><p>70</p></td><td><p>154</p></td><td><p>77</p></td><td><p>145,60</p></td><td><p>72,80</p></td></tr></tbody></table>
’ ( 1 ) If participants are required to pay fees for the participation in the training, the amounts due need to be deducted from the unit cost.
<note>
( 2 ) Part of a profession is to be understood as training courses partly completed with the minimum hours as specified in above table (point (3).
</note> | ENG | 32019R0379 |
<table><col/><col/><col/><col/><tbody><tr><td><p>1.2.2019   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>C 39/1</p></td></tr></tbody></table>
RECOMMENDATION OF THE EUROPEAN SYSTEMIC RISK BOARD
of 5 December 2018
amending Recommendation ESRB/2015/2 on the assessment of cross-border effects of and voluntary reciprocity for macroprudential policy measures
(ESRB/2018/8)
(2019/C 39/01)
THE GENERAL BOARD OF THE EUROPEAN SYSTEMIC RISK BOARD,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1092/2010 of the European Parliament and of the Council of 24 November 2010 on European Union macro-prudential oversight of the financial system and establishing a European Systemic Risk Board ( 1 ) , and in particular Article 3 and Articles 16 to 18 thereof,
Having regard to Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 ( 2 ) , and in particular Article 458(8) thereof,
Having regard to Decision ESRB/2011/1 of the European Systemic Risk Board of 20 January 2011 adopting the Rules of Procedure of the European Systemic Risk Board ( 3 ) , and in particular Articles 18 to 20 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>In order to ensure effective and consistent national macroprudential policy measures, it is important to complement the mandatory reciprocity required under Union law with voluntary reciprocity.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The framework on voluntary reciprocity for macroprudential policy measures, set out in Recommendation ESRB/2015/2 of the European Systemic Risk Board <a>(<span>4</span>)</a>, aims to ensure that the same set of macroprudential requirements apply to the same type of risk exposures in a given Member State, irrespective of the legal status and location of the financial service provider.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Recommendation ESRB/2017/4 of the European Systemic Risk Board <a>(<span>5</span>)</a> recommends the relevant activating authority to propose a maximum materiality threshold when submitting a request for reciprocation to the European Systemic Risk Board (ESRB), below which an individual financial service provider’s exposure to the identified macroprudential risk in the jurisdiction where the macroprudential policy measure is applied by the activating authority can be considered non-material. The ESRB may recommend a different threshold if deemed necessary.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>As a general principle, in line with Article 458(3) of Regulation (EU) No 575/2013, the activating authority is expected to cooperate with the relevant authorities reciprocating the measure in order to ensure an efficient and effective implementation of the reciprocating measure.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>From 1 July 2018, French global systemically important institutions (G-SIIs) and other systemically important institutions (O-SIIs) at the highest level of consolidation of their banking prudential perimeter are subject, pursuant to Article 458(2)(d)(ii) of Regulation (EU) No 575/2013, to a large exposure limit of 5 per cent of their eligible capital in relation to highly-indebted large non-financial corporations having their registered office in France.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Following the request by the<span>Haut Conseil de stabilité financière</span> (High Council for financial stability) to the ESRB under Article 458(8) of Regulation (EU) No 575/2013, and in order to: (i) prevent the materialisation of negative cross-border effects in the form of leakages and regulatory arbitrage that could result from the implementation of the macroprudential policy measure applied in France in accordance with Article 458(2)(d)(ii) of Regulation (EU) No 575/2013; (ii) signal to other market participants the systemic risks associated with the increased leverage of large non-financial corporations having their registered office in France; and (iii) increase the resilience of systemically important institutions in other Member States, the General Board of the ESRB has decided to include this measure in the list of macroprudential policy measures which are recommended to be reciprocated under Recommendation ESRB/2015/2.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>As the measure activated by the<span>Haut Conseil de stabilité financière</span> is applied only at the highest level of consolidation, in line with the principle specified in sub-recommendation C(2) of Recommendation ESRB/2015/2 according to which the relevant authorities should implement the same macroprudential policy measure as the one that has been implemented by the activating authority, it should also be possible to reciprocate the measure at the same level of consolidation. In addition, applying the materiality threshold at an individual level could lead to the exemption of institutions which, at a consolidated level, have concentrated large exposures to highly-indebted non-financial corporations having their registered office in France, thereby creating an incentive for regulatory arbitrage. Consequently, the recommended materiality threshold should, in this exceptional case, be applied on a consolidated basis.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Therefore, Recommendation ESRB/2015/2 should be amended accordingly,</p></td></tr></tbody></table>
HAS ADOPTED THIS RECOMMENDATION:
AMENDMENTS
Recommendation ESRB/2015/2 is amended as follows:
<table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>in Section 1, sub-recommendation C(1) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘1.</p></td><td><p>The relevant authorities are recommended to reciprocate the macroprudential policy measures adopted by other relevant authorities and recommended for reciprocation by the ESRB. It is recommended that the following measures, as further described in the Annex, be reciprocated:</p><p>Estonia:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>a 1 per cent systemic risk buffer rate applied in accordance with Article 133 of Directive 2013/36/EU to the domestic exposures of all credit institutions authorised in Estonia;</p></td></tr></tbody></table><p>Finland:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>a 15 per cent floor for the average risk-weight on residential mortgage loans secured by a mortgage on housing units in Finland applied in accordance with Article 458(2)(d)(vi) of Regulation (EU) No 575/2013 to credit institutions authorised in Finland, using the Internal Ratings Based (IRB) Approach for calculating regulatory capital requirements;</p></td></tr></tbody></table><p>Belgium:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>a risk-weight add-on for retail exposures secured by residential immovable property located in Belgium, applied in accordance with Article 458(2)(d)(vi) of Regulation (EU) No 575/2013 to credit institutions authorised in Belgium, using the IRB Approach for calculating regulatory capital requirements and composed of:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>a flat risk-weight add-on of 5 percentage points; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a proportionate risk-weight add-on consisting of 33 per cent of the exposure-weighted average of the risk-weights applied to the portfolio of retail exposures secured by residential immovable property located in Belgium;</p></td></tr></tbody></table></td></tr></tbody></table><p>France:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>a tightening of the large exposure limit provided for in Article 395(1) of Regulation (EU) No 575/2013, applicable to exposures to highly-indebted large non-financial corporations having their registered office in France to 5 per cent of eligible capital, applied in accordance with Article 458(2)(d)(ii) of Regulation (EU) No 575/2013 to global systemically important institutions (G-SIIs) and other systemically important institutions (O-SIIs) at the highest level of consolidation of their banking prudential perimeter.’;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>The Annex is replaced by the Annex to this Recommendation.</p></td></tr></tbody></table>
Done at Frankfurt am Main, 5 December 2018.
Francesco MAZZAFERRO
The Head of the ESRB Secretariat
on behalf of the General Board of the ESRB
( 1 ) OJ L 331, 15.12.2010, p. 1 .
( 2 ) OJ L 176, 27.6.2013, p. 1 .
( 3 ) OJ C 58, 24.2.2011, p. 4 .
( 4 ) Recommendation ESRB/2015/2 of the European Systemic Risk Board of 15 December 2015 on the assessment of cross-border effects of and voluntary reciprocity for macroprudential policy measures ( OJ C 97, 12.3.2016, p. 9 ).
( 5 ) Recommendation ESRB/2017/4 of the European Systemic Risk Board of 20 October 2017 amending Recommendation ESRB/2015/2 on the assessment of cross-border effects of and voluntary reciprocity for macroprudential policy measures ( OJ C 431, 15.12.2017, p. 1 ).
ANNEX
The Annex to Recommendation ESRB/2015/2 is replaced by the following:
‘Annex
Estonia
1 per cent systemic risk buffer rate applied in accordance with Article 133 of Directive 2013/36/EU to the domestic exposures of all credit institutions authorised in Estonia
I. Description of the measure
<table><col/><col/><col/><tbody><tr><td/><td><p>1.</p></td><td><span>The Estonian measure constitutes a 1 per cent systemic risk buffer rate applied in accordance with Article 133 of Directive 2013/36/EU to the domestic exposures of all credit institutions authorised in Estonia.</span></td></tr></tbody></table>
II. Reciprocation
<table><col/><col/><col/><tbody><tr><td/><td><p>2.</p></td><td><span>Where Member States have implemented Article 134 of Directive 2013/36/EU in national law, relevant authorities are recommended to reciprocate the Estonian measure for exposures located in Estonia of domestically authorised institutions in accordance with Article 134(1) of Directive 2013/36/EU. For the purposes of this paragraph, the deadline specified in sub-recommendation C(3) applies.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>3.</p></td><td><span>Where Member States have not implemented Article 134 of Directive 2013/36/EU in national law, relevant authorities are recommended to reciprocate the Estonian measure for exposures located in Estonia of domestically authorised institutions in accordance with sub-recommendation C(2). Relevant authorities are recommended to adopt the equivalent measure within six months.</span></td></tr></tbody></table>
Finland
A credit institution-specific minimum level of 15 per cent for the average risk-weight on loans secured by a mortgage on housing units in Finland applicable to credit institutions using the Internal Ratings Based (IRB) Approach (hereinafter “IRB credit institutions”) under Article 458(2)(d)(vi) of Regulation (EU) No 575/2013.
I. Description of the measure
<table><col/><col/><col/><tbody><tr><td/><td><p>1.</p></td><td><span>The Finnish measure, applied in accordance with Article 458(2)(d)(vi) of Regulation (EU) No 575/2013, consists of a credit institution-specific average risk-weight floor of 15 per cent for IRB credit institutions, at the portfolio level, for residential mortgage loans secured by housing units in Finland.</span></td></tr></tbody></table>
II. Reciprocation
<table><col/><col/><col/><tbody><tr><td/><td><p>2.</p></td><td><span>In accordance with Article 458(5) of Regulation (EU) No 575/2013, relevant authorities of the Member States concerned are recommended to reciprocate the Finnish measure and apply it to IRB credit institutions' portfolios of retail mortgage loans secured by housing units in Finland issued by domestically authorised branches located in Finland. For the purposes of this paragraph, the deadline specified in sub-recommendation C(3) applies.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>3.</p></td><td><span>Relevant authorities are also recommended to reciprocate the Finnish measure and apply it to IRB credit institutions' portfolios of retail mortgage loans secured by housing units in Finland issued directly across borders by credit institutions established in their respective jurisdictions. For the purposes of this paragraph, the deadline specified in sub-recommendation C(3) applies.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>4.</p></td><td><span>In accordance with sub-recommendation C(2), the relevant authorities are recommended to apply, following consultation with the ESRB, a macroprudential policy measure available in their jurisdiction that has the effect most equivalent to the above measure recommended for reciprocation, including adopting supervisory measures and powers laid down in Title VII, Chapter 2, Section IV of Directive 2013/36/EU. The relevant authorities are recommended to adopt the equivalent measure within four months.</span></td></tr></tbody></table>
III. Materiality threshold
<table><col/><col/><col/><tbody><tr><td/><td><p>5.</p></td><td><span>The measure is complemented by a materiality threshold of EUR 1 billion exposure to the residential mortgage lending market in Finland to steer the potential application of the<span>de minimis</span> principle by the reciprocating Member States.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>6.</p></td><td><span>In line with Section 2.2.1 of Recommendation ESRB/2015/2, relevant authorities of the Member State concerned may exempt individual IRB credit institutions with non-material portfolios of retail mortgage loans secured by housing units in Finland below the materiality threshold of EUR 1 billion. In this case the relevant authorities should monitor the materiality of the exposures and are recommended to reciprocate when an IRB credit institution exceeds the threshold of EUR 1 billion.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>7.</p></td><td><span>Where there are no IRB credit institutions authorised in other Member States concerned with branches located in Finland or providing financial services directly in Finland that have exposures of EUR 1 billion or above to the Finnish mortgage market, relevant authorities of the Member States concerned may decide not to reciprocate as provided by Section 2.2.1 of Recommendation ESRB/2015/2. In this case the relevant authorities should monitor the materiality of the exposures and are recommended to reciprocate when an IRB credit institution exceeds the threshold of EUR 1 billion.</span></td></tr></tbody></table>
Belgium
A risk-weight add-on for retail exposures secured by residential immovable property located in Belgium, imposed on credit institutions authorised in Belgium using the IRB Approach and applied in accordance with Article 458(2)(d)(vi) of Regulation (EU) No 575/2013. The add-on is composed of two components:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p><span><span>a flat risk-weight add-on of 5 percentage points; and</span></span></p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p><span><span>a proportionate risk-weight add-on consisting of 33 per cent of the exposure-weighted average of the risk-weights applied to the portfolio of retail exposures secured by residential immovable property located in Belgium.</span></span></p></td></tr></tbody></table>
I. Description of the measure
<table><col/><col/><col/><tbody><tr><td/><td><p>1.</p></td><td><span>The Belgian measure, applied in accordance with Article 458(2)(d)(vi) of Regulation (EU) No 575/2013 and imposed on credit institutions authorised in Belgium using the IRB Approach, consists of a risk-weight add-on for retail exposures secured by residential immovable property located in Belgium, which is composed of two components:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>The first component consists of a 5 percentage point increase to the risk-weight for retail exposures secured by residential immovable property located in Belgium obtained after computing the second part of the risk-weight add-on in accordance with point (b).</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>The second component consists of a risk-weight increase of 33 per cent of the exposure-weighted average of the risk-weights applied to the portfolio of retail exposures secured by residential immovable property located in Belgium. The exposure-weighted average is the average of the risk-weights of the individual loans calculated in accordance with Article 154 of Regulation (EU) No 575/2013, weighted by the relevant exposure value.</p></td></tr></tbody></table></td></tr></tbody></table>
II. Reciprocation
<table><col/><col/><col/><tbody><tr><td/><td><p>2.</p></td><td><span>In accordance with Article 458(5) of Regulation (EU) No 575/2013, relevant authorities of the Member States concerned are recommended to reciprocate the Belgian measure by applying it to branches located in Belgium of domestically authorised credit institutions using the IRB Approach within the deadline specified in sub-recommendation C(3).</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>3.</p></td><td><span>Relevant authorities are recommended to reciprocate the Belgian measure by applying it to domestically authorised credit institutions using the IRB Approach that have direct retail exposures secured by residential immovable property located in Belgium. In accordance with sub-recommendation C(2), the relevant authorities are recommended to apply the same measure as the one that has been implemented in Belgium by the activating authority within the deadline specified in sub-recommendation C(3).</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>4.</p></td><td><span>If the same macroprudential policy measure is not available in their jurisdiction, the relevant authorities are recommended to apply, following consultation with the ESRB, a macroprudential policy measure available in their jurisdiction that has the most equivalent effect to the above measure recommended for reciprocation, including adopting supervisory measures and powers laid down in Title VII, Chapter 2, Section IV of Directive 2013/36/EU. Relevant authorities are recommended to adopt the equivalent measure by no later than four months following the publication of this Recommendation in the<span>Official Journal of the European Union</span>.</span></td></tr></tbody></table>
III. Materiality threshold
<table><col/><col/><col/><tbody><tr><td/><td><p>5.</p></td><td><span>The measure is complemented by an institution-specific materiality threshold of EUR 2 billion to steer the potential application of the<span>de minimis</span> principle by the relevant authorities reciprocating the measure.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>6.</p></td><td><span>In line with Section 2.2.1 of Recommendation ESRB/2015/2, relevant authorities of the Member State concerned may exempt individual domestically authorised credit institutions using the IRB Approach having non-material retail exposures secured by residential immovable property in Belgium which are below the materiality threshold of EUR 2 billion. When applying the materiality threshold, the relevant authorities should monitor the materiality of exposures and are recommended to apply the Belgian measure to previously exempted individual domestically authorised credit institutions when the materiality threshold of EUR 2 billion is breached.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>7.</p></td><td><span>Where there are no credit institutions authorised in the Member States concerned with branches located in Belgium or which have direct retail exposures secured by residential immovable property in Belgium, which use the IRB Approach and which have exposures of EUR 2 billion or above to the Belgian residential immovable property market, relevant authorities of the Member States concerned may, pursuant to Section 2.2.1 of Recommendation ESRB/2015/2, decide not to reciprocate the Belgian measure. In this case the relevant authorities should monitor the materiality of the exposures and are recommended to reciprocate the Belgian measure when a credit institution using the IRB Approach exceeds the threshold of EUR 2 billion.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>8.</p></td><td><span>In line with Section 2.2.1 of Recommendation ESRB/2015/2, the materiality threshold of EUR 2 billion is a recommended maximum threshold level. Reciprocating relevant authorities may therefore instead of applying the recommended threshold set a lower threshold for their jurisdictions where appropriate, or reciprocate the measure without any materiality threshold.</span></td></tr></tbody></table>
France
A tightening of the large exposure limit provided for in Article 395(1) of Regulation (EU) No 575/2013, applicable to exposures to highly-indebted large non-financial corporations having their registered office in France to 5 per cent of eligible capital, applied in accordance with Article 458(2)(d)(ii) of Regulation (EU) No 575/2013 to global systemically important institutions (G-SIIs) and other systemically important institutions (O-SIIs) at the highest level of consolidation of their banking prudential perimeter.
I. Description of the measure
<table><col/><col/><col/><tbody><tr><td/><td><p>1.</p></td><td><span>The French measure, applied in accordance with Article 458(2)(d)(ii) of Regulation (EU) No 575/2013 and imposed on G-SIIs and O-SIIs at the highest level of consolidation of their banking prudential perimeter (not at a sub-consolidated level), consists of a tightening of the large exposure limit to 5 per cent of their eligible capital, applicable to exposures to highly-indebted large non-financial corporations having their registered office in France.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>2.</p></td><td><span>A non-financial corporation is defined as a natural or legal person under private law having its registered office in France, and which, at its level and at the highest level of consolidation, belongs to the non-financial corporations sector as defined in point 2.45 of Annex A to Regulation (EU) No 549/2013 of the European Parliament and of the Council <a>(<span>1</span>)</a>.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>3.</p></td><td><span>The measure applies to exposures to non-financial corporations having their registered office in France and to exposures to groups of connected non-financial corporations as follows:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>For non-financial corporations which are part of a group of connected non-financial corporations having its registered office at the highest level of consolidation in France, the measure applies to the sum of the net exposures towards the group and all its connected entities within the meaning of point (39) of Article 4(1) of Regulation (EU) No 575/2013;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>For non-financial corporations which are part of a group of connected non-financial corporations having its registered office at the highest level of consolidation outside France, the measure applies to the sum of:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the exposures to those non-financial corporations having their registered office in France;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>the exposures to the entities in France or abroad over which the non-financial corporations referred to in (i) have direct or indirect control within the meaning of point (39) of Article 4(1) of Regulation (EU) No 575/2013; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>the exposures to the entities in France or abroad which are economically dependent on the non-financial corporations referred to in (i) within the meaning of point (39) of Article 4(1) of Regulation (EU) No 575/2013.</p></td></tr></tbody></table></td></tr></tbody></table><p>Non-financial corporations which do not have their registered office in France and which are not a subsidiary or an economically dependent entity of, and which are not directly or indirectly controlled by, a non-financial corporation having its registered office in France, therefore fall outside the scope of the measure.</p><p>In accordance with Article 395(1) of Regulation (EU) No 575/2013, the measure is applicable after taking into account the effect of the credit risk mitigation techniques and exemptions in accordance with Articles 399 to 403 of Regulation (EU) No 575/2013.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>4.</p></td><td><span>A G-SII or an O-SII must consider a non-financial corporation having its registered office in France as large if its original exposure to the non-financial corporation, or to the group of connected non-financial corporations within the meaning of paragraph 3, is equal to or larger than EUR 300 million. The original exposure value is calculated in accordance with Articles 389 and 390 of Regulation (EU) No 575/2013 before taking into account the effect of credit risk mitigation techniques and exemptions set out in Articles 399 to 403 of Regulation (EU) No 575/2013, as reported in accordance with Article 9 of Commission Implementing Regulation (EU) No 680/2014 <a>(<span>2</span>)</a>.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>5.</p></td><td><span>A non-financial corporation is considered highly-indebted if it has a leverage ratio that is greater than 100 per cent and a financial charges coverage ratio that is below three, calculated at the highest level of group consolidation as follows:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>The leverage ratio is the ratio between total debt net of cash and equity; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>The financial charges coverage ratio is the ratio between, on the one hand, the value added plus operating subsidies less: (i) payroll; (ii) operating taxes and duties; (iii) other net ordinary operating expenses excluding net interest and similar charges; and (iv) depreciation and amortisation, and, on the other hand, interest and similar charges.</p></td></tr></tbody></table><p>The ratios are calculated based on accounting aggregates defined in accordance with the applicable standards, as presented in the non-financial corporation's financial statements, certified where appropriate by a chartered accountant.</p></td></tr></tbody></table>
II. Reciprocation
<table><col/><col/><col/><tbody><tr><td/><td><p>6.</p></td><td><span>Relevant authorities are recommended to reciprocate the French measure by applying it to domestically authorised G-SIIs and O-SIIs at the highest level of consolidation within the jurisdiction of their banking prudential perimeter.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>7.</p></td><td><span>If the same macroprudential policy measure is not available in their jurisdiction, in line with sub-recommendation C(2), the relevant authorities are recommended to apply, following consultation with the ESRB, a macroprudential policy measure available in their jurisdiction that has the most equivalent effect to the above measure recommended for reciprocation. The relevant authorities are recommended to adopt the equivalent measure by no later than six months following the publication of this Recommendation in the<span>Official Journal of the European Union</span>.</span></td></tr></tbody></table>
III. Materiality threshold
<table><col/><col/><col/><tbody><tr><td/><td><p>8.</p></td><td><span>The measure is complemented by a combined materiality threshold to steer the potential application of the<span>de minimis</span> principle by the relevant authorities reciprocating the measure, which is composed of:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>A threshold of EUR 2 billion for the total original exposures of domestically authorised G-SIIs and O-SIIs at the highest level of consolidation of the banking prudential perimeter to the French non-financial corporations sector;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>A threshold of EUR 300 million applicable to domestically authorised G-SIIs and O-SIIs equalling or exceeding the threshold mentioned in (a) for:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>a single original exposure to a non-financial corporation having its registered office in France;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>the sum of original exposures to a group of connected non-financial corporations, which has its registered office at the highest level of consolidation in France, calculated in accordance with paragraph 3(a);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>the sum of original exposures to non-financial corporations having their registered office in France which are part of a group of connected non-financial corporations having its registered office at the highest level of consolidation outside France as reported in templates C 28.00 and C 29.00 of Annex VIII to Implementing Regulation (EU) No 680/2014;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>A threshold of 5 per cent of the G-SII's or O-SII's eligible capital at the highest level of consolidation, for exposures identified in (b) after taking into account the effect of the credit risk mitigation techniques and exemptions in accordance with Articles 399 to 403 of Regulation (EU) No 575/2013.</p></td></tr></tbody></table><p>The thresholds referred to in paragraphs (b) and (c) are to be applied irrespective of whether the relevant entity or non-financial corporation is highly-indebted or not.</p><p>The original exposure value referred to in paragraphs (a) and (b) is to be calculated in accordance with Articles 389 and 390 of Regulation (EU) No 575/2013 before taking into account the effect of credit risk mitigation techniques and exemptions set out in Articles 399 to 403 of Regulation (EU) No 575/2013 as reported in accordance with Article 9 of Implementing Regulation (EU) No 680/2014.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>9.</p></td><td><span>In line with Section 2.2.1 of Recommendation ESRB/2015/2, the relevant authorities of the Member State concerned may exempt domestically authorised G-SIIs or O-SIIs at the highest level of consolidation of their banking prudential perimeter which do not breach the combined materiality threshold referred to in paragraph 8. When applying the materiality threshold, the relevant authorities should monitor the materiality of the exposures of domestically authorised G-SIIs and O-SIIs to the French non-financial corporations sector as well as the exposure concentration of domestically authorised G-SIIs and O-SIIs to large non-financial corporations having their registered office in France, and are recommended to apply the French measure to previously exempted domestically authorised G-SIIs or O-SIIs at the highest level of consolidation of their banking prudential perimeter when the combined materiality threshold referred to in paragraph 8 is breached. Relevant authorities are also encouraged to signal the systemic risks associated with the increased leverage of large non-financial corporations having their registered office in France to other market participants in their jurisdiction.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>10.</p></td><td><span>Where there are no G-SIIs or O-SIIs at the highest level of consolidation of their banking prudential perimeter authorised in the Member States concerned and having exposures to the French non-financial corporations sector above the materiality threshold referred to in paragraph 8, the relevant authorities of the Member States concerned may, pursuant to Section 2.2.1 of Recommendation ESRB/2015/2, decide not to reciprocate the French measure. In this case the relevant authorities should monitor the materiality of the exposures of domestically authorised G-SIIs and O-SIIs to the French non-financial corporations sector as well as the exposure concentration of domestically authorised G-SIIs and O-SIIs to large non-financial corporations having their registered office in France, and are recommended to reciprocate the French measure when a G-SII or O-SII at the highest level of consolidation of its banking prudential perimeter exceeds the combined materiality threshold referred to in paragraph 8. Relevant authorities are also encouraged to signal the systemic risks associated with the increased leverage of large non-financial corporations having their registered office in France to other market participants in their jurisdiction.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>11.</p></td><td><span>In line with Section 2.2.1 of Recommendation ESRB/2015/2, the combined materiality threshold referred to in paragraph 8 is a recommended maximum threshold level. Reciprocating relevant authorities may therefore instead of applying the recommended threshold set a lower threshold for their jurisdictions where appropriate, or reciprocate the measure without any materiality threshold.</span></td></tr></tbody></table>
’ ( 1 ) Regulation (EU) No 549/2013 of the European Parliament and of the Council of 21 May 2013 on the European system of national and regional accounts in the European Union ( OJ L 174, 26.6.2013, p. 1 ).
<note>
( 2 ) Commission Implementing Regulation (EU) No 680/2014 of 16 April 2014 laying down implementing technical standards with regard to supervisory reporting of institutions according to Regulation (EU) No 575/2013 of the European Parliament and of the Council ( OJ L 191, 28.6.2014, p. 1 ).
</note> | ENG | 32019Y0201(01) |
<table><col/><col/><col/><col/><tbody><tr><td><p>16.7.2016   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 192/71</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2016/1161
of 15 July 2016
establishing the standard import values for determining the entry price of certain fruit and vegetables
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) ,
Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors ( 2 ) , and in particular Article 136(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the<span>Official Journal of the European Union</span>,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 July 2016.
For the Commission,
On behalf of the President,
Jerzy PLEWA
Director-General for Agriculture and Rural Development
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) OJ L 157, 15.6.2011, p. 1 .
ANNEX
Standard import values for determining the entry price of certain fruit and vegetables
<table><col/><col/><col/><tbody><tr><td><p>(EUR/100 kg)</p></td></tr><tr><td><p>CN code</p></td><td><p>Third country code<a> (<span>1</span>)</a></p></td><td><p>Standard import value</p></td></tr><tr><td><p>0702 00 00</p></td><td><p>MA</p></td><td><p>166,2</p></td></tr><tr><td><p>ZZ</p></td><td><p>166,2</p></td></tr><tr><td><p>0709 93 10</p></td><td><p>TR</p></td><td><p>136,9</p></td></tr><tr><td><p>ZZ</p></td><td><p>136,9</p></td></tr><tr><td><p>0805 50 10</p></td><td><p>AR</p></td><td><p>144,6</p></td></tr><tr><td><p>BO</p></td><td><p>217,8</p></td></tr><tr><td><p>CL</p></td><td><p>120,9</p></td></tr><tr><td><p>UY</p></td><td><p>200,2</p></td></tr><tr><td><p>ZA</p></td><td><p>176,3</p></td></tr><tr><td><p>ZZ</p></td><td><p>172,0</p></td></tr><tr><td><p>0808 10 80</p></td><td><p>AR</p></td><td><p>193,6</p></td></tr><tr><td><p>BR</p></td><td><p>92,6</p></td></tr><tr><td><p>CL</p></td><td><p>130,5</p></td></tr><tr><td><p>CN</p></td><td><p>102,6</p></td></tr><tr><td><p>NZ</p></td><td><p>147,2</p></td></tr><tr><td><p>US</p></td><td><p>117,0</p></td></tr><tr><td><p>ZA</p></td><td><p>111,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>127,9</p></td></tr><tr><td><p>0808 30 90</p></td><td><p>AR</p></td><td><p>182,6</p></td></tr><tr><td><p>CL</p></td><td><p>112,1</p></td></tr><tr><td><p>NZ</p></td><td><p>156,3</p></td></tr><tr><td><p>ZA</p></td><td><p>137,7</p></td></tr><tr><td><p>ZZ</p></td><td><p>147,2</p></td></tr><tr><td><p>0809 10 00</p></td><td><p>TR</p></td><td><p>191,2</p></td></tr><tr><td><p>ZZ</p></td><td><p>191,2</p></td></tr><tr><td><p>0809 29 00</p></td><td><p>TR</p></td><td><p>281,0</p></td></tr><tr><td><p>ZZ</p></td><td><p>281,0</p></td></tr></tbody></table>
<note>
( 1 ) Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories ( OJ L 328, 28.11.2012, p. 7 ). Code ‘ZZ’ stands for ‘of other origin’.
</note> | ENG | 32016R1161 |
<table><col/><col/><col/><col/><tbody><tr><td><p>30.11.2016   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 324/7</p></td></tr></tbody></table>
COUNCIL IMPLEMENTING DECISION (EU) 2016/2090
of 21 November 2016
amending Decision 2009/790/EC authorising the Republic of Poland to apply a measure derogating from Article 287 of Directive 2006/112/EC on the common system of value added tax
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax ( 1 ) , and in particular Article 395 thereof,
Having regard to the proposal from the European Commission,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Point (14) of Article 287 of Directive 2006/112/EC authorises the Republic of Poland (‘Poland’) to exempt from value added tax (VAT) taxable persons whose annual turnover is no higher than the equivalent in national currency of EUR 10 000 at the conversion rate on the day of its accession.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>By virtue of Council Decision 2009/790/EC<a> (<span>2</span>)</a>, Poland was authorised, until 31 December 2012 and as a derogation, to exempt from VAT taxable persons whose annual turnover is no higher than the equivalent in national currency of EUR 30 000 at the conversion rate on the day of its accession (‘the derogating measure’). The derogating measure was subsequently extended by Council Implementing Decision 2012/769/EU<a> (<span>3</span>)</a> until 31 December 2015 and by Council Implementing Decision (EU) 2015/1173<a> (<span>4</span>)</a> until 31 December 2018.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>In a letter registered with the Commission on 1 June 2016, Poland requested authorisation to increase that threshold from EUR 30 000 to EUR 40 000. By means of that increase, an additional number of very small businesses could be exempted from certain or all of the obligations in relation to VAT set out in Chapters 2 to 6 of Title XI of Directive 2006/112/EC. The burden on the tax authorities with regard to the auditing of very small businesses would therefore also be decreased.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>In accordance with the second subparagraph of Article 395(2) of Directive 2006/112/EC, the Commission informed the other Member States, by letters dated 22 September 2016, of the request made by Poland. By letter dated 23 September 2016, the Commission notified Poland that it had all the information necessary to consider the request.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The information provided by Poland indicates that potentially 24 000 additional taxable persons could make use of the derogating measure in order to reduce their VAT obligations. The budgetary impact in terms of VAT revenue has been estimated by Poland at PLN 300 million.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Given that an increased threshold will further reduce VAT obligations for very small businesses and that those businesses are still able to opt for the normal VAT arrangements in accordance with Article 290 of Directive 2006/112/EC, Poland should be authorised to apply the increased threshold for the remaining application period of Decision 2009/790/EC, which ends on 31 December 2018. However, Articles 281 to 294 of Directive 2006/112/EC on a special scheme for small enterprises are subject to review, and a directive amending those Articles might therefore enter into force before that date.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The derogation will have no impact on the Union's own resources accruing from VAT because Poland will carry out a compensation calculation in accordance with Article 6 of Council Regulation (EEC, Euratom) No 1553/89<a> (<span>5</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Decision 2009/790/EC should therefore be amended accordingly,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
Articles 1 and 2 of Decision 2009/790/EC are replaced by the following:
‘Article 1
By way of derogation from Article 287 of Directive 2006/112/EC, the Republic of Poland is authorised to exempt from VAT taxable persons whose annual turnover is no higher than the equivalent in national currency of EUR 40 000 at the conversion rate on the day of its accession.
Article 2
This Decision shall apply until the entry into force of a Directive amending Articles 281 to 294 of Directive 2006/112/EC on a special scheme for small enterprises, or until 31 December 2018, whichever is the earlier.’.
Article 2
This Decision is addressed to the Republic of Poland.
Done at Brussels, 21 November 2016.
For the Council
The President
P. PLAVČAN
<note>
( 1 ) OJ L 347, 11.12.2006, p. 1 .
( 2 ) Council Decision 2009/790/EC of 20 October 2009 authorising the Republic of Poland to apply a measure derogating from Article 287 of Directive 2006/112/EC on the common system of value added tax ( OJ L 283, 30.10.2009, p. 53 ).
( 3 ) Council Implementing Decision 2012/769/EU of 4 December 2012 amending Decision 2009/790/EC authorising the Republic of Poland to apply a measure derogating from Article 287 of Directive 2006/112/EC on the common system of value added tax ( OJ L 338, 12.12.2012, p. 27 ).
( 4 ) Council Implementing Decision (EU) 2015/1173 of 14 July 2015 amending Decision 2009/790/EC authorising the Republic of Poland to apply a measure derogating from Article 287 of Directive 2006/112/EC on the common system of value added tax ( OJ L 189, 17.7.2015, p. 36 ).
( 5 ) Council Regulation (EEC, Euratom) No 1553/89 of 29 May 1989 on the definitive uniform arrangements for the collection of own resources accruing from value added tax ( OJ L 155, 7.6.1989, p. 9 ).
</note> | ENG | 32016D2090 |
<table><col/><col/><col/><col/><tbody><tr><td><p>22.10.2021   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>CI 427/11</p></td></tr></tbody></table>
COUNCIL DECISION
of 19 October 2021
appointing one member and one alternate member of the Advisory Committee for the Coordination of Social Security Systems for Italy
(2021/C 427 I/03)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems ( 1 ) , and in particular Article 75 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>By Decision of 21 September 2020 <a>(<span>2</span>)</a>, the Council appointed the members and alternate members of the Advisory Committee for the Coordination of Social Security Systems for the period from 20 October 2020 to 19 October 2025.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The government of Italy has submitted nominations to the Council for two posts to be filled,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
The following persons are hereby appointed as member and alternate member of the Advisory Committee for the Coordination of Social Security Systems for the period 20 October 2020 to 19 October 2025:
<table><col/><col/><tbody><tr><td><p>I.</p></td><td><p>GOVERNMENT REPRESENTATIVES</p><table><col/><col/><col/><tbody><tr><td><p>Country</p></td><td><p>Members</p></td><td><p>Alternates</p></td></tr><tr><td><p>Italy</p></td><td><p>Mr Giovanni CALABRÒ</p></td><td><p>Ms Silvia BOLOGNINI</p></td></tr></tbody></table></td></tr></tbody></table>
Article 2
The Council shall appoint the members and alternate members not yet nominated at a later date.
Article 3
This Decision shall enter into force on the date of its adoption.
Done at Luxembourg, 19 October 2021.
For the Council
The President
G. DOVŽAN
<note>
( 1 ) OJ L 166, 30.4.2004, p. 1 .
( 2 ) Council Decision of 21 September 2020 appointing the members and alternate members of the Advisory Committee for the Coordination of Social Security Systems ( OJ C 315 I, 23.9.2020, p. 1 ).
</note> | ENG | 32021D1022(01) |
02013R1072 — EN — 01.01.2015 — 000.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
<table><col/><col/><tr><td><p><a>►B</a></p></td><td><p> REGULATION (EU) No 1072/2013 OF THE EUROPEAN CENTRAL BANK</p><p>of 24 September 2013</p><p>concerning statistics on interest rates applied by monetary financial institutions (recast)</p><p><a>(ECB/2013/34)</a></p><p>(OJ L 297 7.11.2013, p. 51)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p> </p></td><td><p> </p></td><td><p>Official Journal</p></td></tr><tr><td><p>  No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>►M1</a></p></td><td><p><a> REGULATION (EU) No 756/2014 OF THE EUROPEAN CENTRAL BANK  of 8 July 2014</a></p></td><td><p>  L 205</p></td><td><p>14</p></td><td><p>12.7.2014</p></td></tr></table>
REGULATION (EU) No 1072/2013 OF THE EUROPEAN CENTRAL BANK
of 24 September 2013
concerning statistics on interest rates applied by monetary financial institutions (recast)
(ECB/2013/34)
Article 1
Definitions
For the purpose of this Regulation:
1. the terms ‘reporting agents’, and ‘resident’ have the same meaning as defined in Article 1 of Regulation (EC) No 2533/98;
2. ‘households’ means, the household sector and the sector of non-profit institutions serving households (S.14 and S.15 combined) as set out in the revised European System of Accounts (hereinafter the ‘ESA 2010’) laid down by Regulation (EU) No 549/2013;
3. ‘non-financial corporations’ means the sector of non-financial corporations (S.11) as set out in ESA 2010;
4. ‘monetary financial institution’ (MFI) has the same meaning as defined in Article 1 of Regulation (EU) No 1071/2013 of the European Central Bank of 24 September 2013 concerning the balance sheet of the monetary financial institutions sector (ECB/2013/33) ( 5 );
5. ‘MFI interest rate statistics’ means statistics relating to those interest rates that are applied by resident MFIs except central banks and MMFs to euro-denominated deposits and loans vis-à-vis households and non-financial corporations resident in the euro area Member States. ‘MFI interest rate statistics’ include corresponding new business volumes of euro-denominated deposits and loans, as well as new business volumes of renegotiated loans;
6. ‘money market funds’(MMF) has the same meaning as defined in Article 1 of Regulation (EU) No 1171/2013 of the European Central Bank (ECB/2013/33);
7. ‘reference reporting population’ means resident MFIs except central banks and MMFs which take euro-denominated deposits from and/or grant euro-denominated loans to households and/or non-financial corporations resident in the euro area Member States;
8. ‘tail institution’ means a small MFI except a central bank or an MMFs that has been granted a derogation pursuant to Article 4.
Article 2
Actual reporting population
1. The actual reporting population shall consist of resident MFIs except central banks and MMFs drawn from the reference reporting population and selected by NCBs. NCBs shall select the actual reporting population either through a census or a sample.
2. In the case of a sample, the NCBs shall stratify the reference reporting population into homogeneous strata and then either select the actual reporting population at random from each stratum or select the largest institutions within each stratum.
3. In the case of random sampling selection, the minimum national sample size shall be such that the maximum random error at national level does not on average exceed 10 basis points at a confidence interval of 90 %. Where the largest institutions are selected, the minimum national sample size shall comply with a similar level of quality measure on the basis of a function of the estimated mean absolute value of the errors.
4. NCBs shall also apply the formulas and criteria for the selection of the actual reporting population set out in Guideline ECB/2007/9 of 1 August 2007 on monetary, financial institutions and market statistics ( 6 ).
5. Each NCB shall inform its resident reporting agents about their statistical reporting requirements following national procedures.
6. The Governing Council shall be entitled to check compliance with this Article.
Article 3
Statistical reporting requirements
1. For the purposes of the regular production of MFI interest rate statistics, the actual reporting population shall report monthly statistical information relating to new business and outstanding amounts to the NCB of the Member State in which the reporting agent is resident. The required statistical information is specified in Annex I.
2. The NCBs shall define and implement the reporting arrangements to be followed by the actual reporting population in accordance with national requirements. The NCBs shall ensure that these reporting arrangements provide the statistical information required and allow accurate checking of fulfilment of the minimum standards for transmission, accuracy, compliance with concepts and revisions as referred to in paragraph 3.
3. The required statistical information shall be reported in accordance with the minimum standards for transmission, accuracy, compliance with concepts and revisions as set out in Annex II.
4. The NCBs shall report the aggregated national monthly statistical information to the ECB by close of business on the 19th working day after the end of the reference month.
5. The ECB may impose sanctions on reporting agents which fail to comply with the statistical reporting requirements set out in this Regulation in accordance with Decision ECB/2010/10 of 19 August 2010 on non-compliance with statistical reporting requirements ( 7 ).
Article 4
Derogations
1. Where reporting agents are selected by a census, NCBs may grant derogations to small MFIs except central banks and MMFs in respect of reporting frequency, provided that the combined contribution of these reporting agents to the national MFI balance sheet in terms of outstanding amounts, as calculated in accordance with Regulation (EU) No 1071/2013 (ECB/2008/33), does not exceed 5 %. Instead of monthly reporting, tail institutions may report MFI interest rate statistics on a quarterly basis.
2. NCBs shall check the fulfilment of the conditions set out in paragraph 1 annually in a timely manner in order to grant or withdraw, if necessary, any derogation with effect from the start of each year.
3. Tail institutions may choose not to make use of the derogations and to fulfil the full statistical reporting requirements instead.
4. For grossing up to 100 % coverage, NCBs may choose the procedure for carrying forward the reported data into the missing periods by applying appropriate statistical estimation techniques to take into account trends in the data or seasonal patterns. NCBs shall monitor the number of tail institutions on an annual basis.
Article 5
Verification and compulsory collection
The NCBs shall exercise the right to verify or to collect compulsorily information which reporting agents are required to provide pursuant to this Regulation, without prejudice to the ECB’s right to exercise this right itself. In particular, the NCBs shall exercise this right when a reporting agent does not fulfil the minimum standards for transmission, accuracy, compliance with concepts and revisions specified in Annex II.
Article 6
First reporting
First reporting pursuant to this Regulation shall start with data for December 2014.
Article 7
Repeal
1. Regulation (EU) No 63/2002 (ECB/2001/18) is repealed with effect from 1 January 2015.
2. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex IV.
Article 8
Final provision
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union . It shall apply from 1 January 2015.
This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.
ANNEX I
REPORTING SCHEME FOR MONETARY FINANCIAL INSTITUTION INTEREST RATE STATISTICS
PART 1
Type of rate
I. Annualised agreed rate
General principle
1. The type of rate that reporting agents provide for all instrument categories of deposits and loans referring to new business and outstanding amounts is the annualised agreed rate (AAR). It is defined as the interest rate that is individually agreed between the reporting agent and the household or non-financial corporation for a deposit or loan, converted to an annual basis and quoted in percentages per annum. The AAR covers all interest payments on deposits and loans, but no other charges that may apply. Disagio, defined as the difference between the nominal amount of the loan and the amount received by the customer, is considered as an interest payment at the start of the contract (time t 0 ) and is therefore reflected in the AAR.
2. If interest payments agreed between the reporting agent and the household or non-financial corporation are capitalised at regular intervals within a year, for example per month or quarter rather than per annum, the agreed rate is annualised by means of the following formula to derive the annualised agreed rate:
with:
<table><col/><col/><tr><td><p>x</p></td><td><p>as the AAR,</p></td></tr></table>
<table><col/><col/><tr><td><p>r<span>ag</span></p></td><td><p>as the interest rate per annum that is agreed between the reporting agents and the household or non-financial corporation for a deposit or loan where the dates of the interest capitalisation of the deposit and all the payments and repayments of the loan are at regular intervals within the year, and</p></td></tr></table>
<table><col/><col/><tr><td><p>n</p></td><td><p>as the number of interest capitalisation periods for the deposit and (re)payment periods for the loan per year, i.e. 1 for yearly payments, 2 for semi-annual payments, 4 for quarterly payments and 12 for monthly payments.</p></td></tr></table>
3. National central banks (NCBs) may require their reporting agents to provide the narrowly defined effective rate (NDER) for all or some deposit and loan instruments referring to new business and outstanding amounts, instead of the AAR. The NDER is defined as the interest rate, on an annual basis, that equalises the present value of all commitments other than charges (deposits or loans, payments or repayments, interest payments), future or existing, agreed by the reporting agents and the household or non-financial corporation. The NDER is equivalent to the interest rate component of the annual percentage rate of charge (APRC) as defined in Article 3(i) of Directive 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on credit agreements for consumers and repealing Council Directive 87/102/EEC ( 8 ). The NDER uses successive approximation and can therefore be applied to any type of deposit or loan, whereas the AAR uses the algebraic formula defined in paragraph 2 and is therefore only applicable to deposits and loans with regular capitalisation of interest payments. All other requirements are identical, which means that references in the remainder of this Annex to the AAR also apply to the NDER.
Treatment of taxes, subsidies and regulatory arrangements
4. The interest payments covered in the AAR reflect what the reporting agent pays on deposits and receives for loans. Where the amount paid by one party and received by the other differs, the point of view of the reporting agent determines the interest rate reported for the purposes of MFI interest rate statistics.
5. Following this principle, interest rates are recorded on a gross basis before tax, since the pre-tax interest rates reflect what reporting agents pay on deposits and receive for loans.
6. Furthermore, subsidies granted to households or non-financial corporations by third parties are not taken into account when determining the interest payment, because the subsidies are not paid or received by the reporting agent.
7. Favourable rates that reporting agents apply to their employees are covered by MFI interest rate statistics.
8. Where regulatory arrangements affect interest payments, for example interest rate ceilings or the prohibition of remuneration of overnight deposits, these are reflected in MFI interest rate statistics. Any change in the rules determining regulatory arrangements, for example the level of administered interest rates or interest rate ceilings, is shown in MFI interest rate statistics as a change in the interest rate.
II. Annual percentage rate of charge
9. In addition to AARs, the reporting agents provide the APRC for new business in respect of consumer credit and loans to households for house purchases, i.e.:
— one APRC for new business consumer credit (see indicator 30 in Appendix 2), and
— one APRC for new business loans to households for house purchases (see indicator 31 in Appendix 2) ( 9 ).
10. The APRC covers the ‘total cost of the credit to the consumer’, as defined in Article 3(g) of Directive 2008/48/EC. These total costs comprise an interest rate component and a component of other (related) charges, such as the cost of inquiries, administration, preparation of the documents, guarantees, credit insurance, etc.
11. The composition of the component of other charges may vary across countries, because the definitions in Directive 2008/48/EC are applied differently, and because national financial systems and the procedure for securing credits differ.
III. Convention
12. Reporting agents apply a standard year of 365 days for the compilation of the AAR, i.e. the effect of an additional day in leap years is ignored.
PART 2
Business coverage
13. Reporting agents provide MFI interest rate statistics referring to outstanding amounts and to new business.
IV. Interest rates on outstanding amounts
14. Outstanding amounts are defined as the stock of all deposits placed by households and non-financial corporations with the reporting agent and the stock of all loans granted by the reporting agent to households and non-financial corporations.
15. An interest rate on outstanding amounts reflects the weighted average interest rate applied to the stock of deposits or loans in the relevant instrument category as at the time reference point as defined in paragraph 29. The weighted average interest rate is the sum of the AAR multiplied by the corresponding outstanding amounts and divided by the total outstanding amounts. It covers all outstanding balances on contracts that have been agreed in all the periods prior to the reference date.
V. New business on overnight deposits, deposits redeemable at notice, credit card debt and revolving loans and overdrafts
16. In the case of overnight deposits, deposits redeemable at notice, credit card debt and revolving loans and overdrafts as defined in paragraphs 46 to 49 and 55, the concept of new business is extended to the whole stock. Hence, the debit or credit balance, i.e. the amount outstanding at the time reference point as defined in paragraph 32, is used as an indicator for new business on overnight deposits, deposits redeemable at notice, credit card debt and revolving loans and overdrafts .
17. The interest rates for overnight deposits, deposits redeemable at notice, credit card debt and revolving loans and overdrafts reflect the weighted average interest rate applied to the stock on these accounts at the time reference point as defined in paragraph 32. They cover the current balance sheet positions of all outstanding contracts that have been agreed in all the periods prior to the reference date.
18. In order to calculate MFI interest rates on accounts that can either be a deposit or a loan, depending on their balance, reporting agents distinguish between the periods with a credit balance and the periods with a debit balance. The reporting agents report weighted average interest rates referring to the credit balances as overnight deposits and weighted average interest rates referring to the debit balances as overdrafts. They do not report weighted average interest rates combining (low) overnight deposit rates and (high) overdraft rates.
VI. New business in instrument categories other than overnight deposits, deposits redeemable at notice, credit card debt and revolving loans and overdrafts
19. The following paragraphs 20 to 27 refer to deposits with agreed maturity, repurchase agreements (repos) and all loans other than revolving loans and overdrafts and credit card debt as defined in paragraphs 46 to 49 and 55. Paragraphs 22 to 23 on renegotiated loans refer only to loans other than revolving loans, overdrafts and credit card debt.
20. New business is defined as any new agreement between the household or non-financial corporation and the reporting agent. New agreements comprise:
— all financial contracts, that specify for the first time the interest rate of the deposit or loan, and
— all renegotiations of existing deposit and loan contracts as defined in paragraph 21.
21. Renegotiation refers to the active involvement of the household or non-financial corporation in adjusting the terms and conditions of an existing deposit or loan contract, including the interest rate. Thus, extensions and other adjustments of the terms and conditions that are carried out automatically, i.e. without any active involvement of the household or non-financial corporation, are not renegotiations.
22. For the separate reporting of new business volumes of renegotiated loans to households and non-financial corporations in MFI interest rate statistics renegotiated loans comprise all new business loans, other than revolving loans and overdrafts and credit card debt, which have been granted but not yet repaid at the time they are renegotiated.
23. Loans for debt restructuring are not per se excluded from renegotiated loans. However, if the restructuring involves a renegotiation of the interest rate, and as a result, the loan is granted at a rate below market conditions as described in paragraph 28, it should not be included in renegotiated loans nor new business.
24. The new business rate reflects the weighted average interest rate applied to the deposits and loans in the relevant instrument category in respect of new agreements concluded between households or non-financial corporations and the reporting agent during the time reference period as defined in paragraph 35.
25. Changes in floating interest rates in the sense of automatic adjustments of the interest rate performed by the reporting agent are not new agreements and are therefore not considered as new business. For existing contracts, these changes in floating rates are therefore not captured in new business rates but only in the average rates on outstanding amounts.
26. A change from fixed to floating interest rates or vice versa (at time t 1 ) during the course of the contract, which has been agreed at the start of the contract (time t 0 ), is not a new agreement but part of the terms and conditions of the loan laid down at time t 0 . It is therefore not considered as new business.
27. A household or non-financial corporation is normally expected to take out a loan other than a revolving loan or overdraft in full at the start of the contract. It may, however, take out a loan in one or more tranches at times t 1 , t 2 , t 3, etc. instead of taking out the full amount at the start of the contract (time t 0 ). The fact that a loan is taken out in one or more tranches is irrelevant for MFI interest rate statistics. The agreement between the household or non-financial corporation and the reporting agent at time t 0 , which includes the interest rate and the full amount of the loan, is covered by MFI interest rate statistics on new business. If a renegotiation of the terms and conditions of the loan takes place after time t 0 , the full amount granted and not yet repaid by the time the renegotiation takes place should be reported under renegotiated loans.
VII. Treatment of bad loans and loans for debt restructuring below market conditions
28. Bad loans and loans for debt restructuring granted at rates below market conditions are not included in the weighted average interest rates or in the new business volumes. Bad loans are defined in accordance with Annex II to Regulation (EU) No 1071/2013 (ECB/2013/33), and the total amount of a loan partially or totally classified as a bad loan is excluded from MFI interest rates statistics. Loans for debt restructuring, i.e. restructuring in relation to financially distressed debtors, should be defined in accordance with existing national definitions.
PART 3
Time reference point
VIII. Time reference point for MFI interest rates on outstanding amounts
29. NCBs decide whether at national level the MFI interest rates on outstanding amounts, i.e. indicators 1 to 26 described in Appendix 1, are compiled as a snapshot of end-period observations or as implicit rates referring to period averages. The period covered is one month.
30. Interest rates on outstanding amounts as a snapshot of end-month observations are calculated as weighted averages of the interest rates applied to the stock of deposits and loans at a certain point in time on the last day of the month. At that point in time, the reporting agent collects the interest rates applicable and the amounts involved for all outstanding deposits and loans vis-à-vis households and non-financial corporations and compiles a weighted average interest rate for each instrument category. In contrast to monthly averages, MFI interest rates on outstanding amounts compiled as end-month observations only cover those contracts that are still outstanding at the time of the data collection.
31. Interest rates on outstanding amounts as implicit rates referring to the average of the month are calculated as quotients, with the accrued interest payable on deposits and receivable on loans during the reference month as the numerator, and the average stock during the month as the denominator. At the end of the reference month, the reporting agent reports the accrued interest payable or receivable during the month for each instrument category and the average stock of deposits and loans during the same month. In contrast to end-month observations, the MFI interest rates on outstanding amounts compiled as monthly averages also include contracts that were outstanding at some time during the month but are no longer outstanding at the end of the month. The average stock of deposits and loans during the reference month is ideally compiled as the average of daily stocks over the month. As a minimum standard, the average monthly stock is derived from daily balances for volatile instrument categories, i.e. at least overnight deposits, deposits redeemable at notice, extended credit card credit and revolving loans and overdrafts. For all other instrument categories, the average monthly stock is derived from weekly or more frequent balances.
IX. Time reference point for new business on overnight deposits, deposits redeemable at notice, extended credit card credit and revolving loans and overdrafts
32. NCBs decide whether at national level the MFI interest rates on overnight deposits, deposits redeemable at notice, extended credit card credit and revolving loans and overdrafts, i.e. indicators 1, 5, 6, 7, 12, 23, 32 and 36 described in Appendix 2, are compiled as a snapshot of end-period observations or as implicit rates referring to period averages. The period covered is one month.
33. Analogous to the compilation of the interest rates on outstanding amounts contained in Appendix 1, the interest rates on overnight deposits, deposits redeemable at notice, extended credit card credit and revolving loans and overdrafts are compiled in either of the following manners:
(a) a snapshot of end-month observations is calculated, i.e. weighted averages of the interest rates applied to the stock of these deposits and loans at a certain point in time on the last day of the month. At that time, the reporting agent collects the interest rates and the amounts involved for all overnight deposits, deposits redeemable at notice, extended credit card credit and revolving loans and overdrafts vis-à-vis households and non-financial corporations, and compile a weighted average interest rate for each instrument category. In contrast to monthly averages, MFI interest rates on outstanding amounts compiled as end-month observations only cover those contracts that are still outstanding at the time of data collection;
(b) implicit rates referring to the average of the month are calculated, i.e. quotients, with the accrued interest payable on deposits and receivable on loans as the numerator and the average daily stock as the denominator. At the end of the month, for overnight deposits, deposits redeemable at notice, extended credit card credit and revolving loans and overdrafts the reporting agent reports the accrued interest payable or receivable during the month and the average stock of deposits and loans during the same month. For overnight deposits, deposits redeemable at notice, extended credit card credit and revolving loans and overdrafts the average monthly stock is derived from daily balances. In contrast to end-month observations, the MFI interest rates on outstanding amounts compiled as monthly averages also include contracts that were outstanding at some time during the month, but are no longer outstanding at the end of the month.
34. Concerning accounts that can either be a deposit or a loan, depending on their balance, only the balance at a certain time on the last day of the month determines whether the account is an overnight deposit or an overdraft in that month, if MFI interest rates are compiled as a snapshot of end-month observations. If MFI interest rates are calculated as implicit rates referring to the average of the month, an assessment is made each day as to whether the account is a deposit or a loan. An average of the daily credit balances and the daily debit balances is then calculated to derive the average monthly stock for the denominator of the implicit rates. Furthermore, the flow in the numerator distinguishes between accrued interest payable on deposits and receivable on loans. Reporting agents do not report weighted average interest rates combining (low) overnight deposit rates and (high) overdraft rates.
X. Time reference point for new business (other than overnight deposits, deposit redeemable at notice, credit card debt and revolving loans and overdrafts)
35. MFI interest rates on new business other than overnight deposits, deposits redeemable at notice, credit card debt, and revolving loans and overdrafts, i.e. all of the indicators described in Appendix 2 except indicators 1, 5, 6, 7, 12, 23, 32 and 36 are calculated as period averages. The period covered is (the whole of) one month.
36. For each instrument category, the reporting agents calculate the new business rate as a weighted average of all interest rates on new business operations in the instrument category during the reference month. These interest rates referring to the average of the month are transmitted to the NCB of the Member State whose currency is the euro (hereinafter the ‘euro area Member State’) in which the reporting agent is resident, together with the amount of new business conducted during the reporting month for each instrument category. Reporting agents take into account the new business operations conducted during the entire month.
37. For the indicators referring to renegotiated loans to households and non-financial corporations, i.e. indicators 88 to 91 described in Appendix 2, only information on new business volumes is required. All renegotiations of existing deposit and loan contracts as defined in paragraphs 22 to 27 should be taken into account, even if the same contract is renegotiated more than once during the reference month.
PART 4
Instrument categories
XI. General provisions
38. Reporting agents provide MFI interest rate statistics on outstanding amounts for the instrument categories specified in Appendix 1 and on new business for the instrument categories specified in Appendix 2. As defined in paragraph 16, the interest rates on overnight deposits, deposits redeemable at notice, revolving loans and overdrafts and extended credit card credit are interest rates on new business, although the concept of new business is extended to the whole stock, and are therefore included in Appendix 2.
39. An instrument category specified in Appendices 1 and 2 is inapplicable at national level in some euro area Member States and therefore ignored if resident credit and other institutions do not offer any products belonging to this category to households and non-financial corporations at all. Data are provided if some business exists, however limited.
40. For each instrument category defined in Appendices 1 and 2, and applied in the banking business of resident credit and other institutions with households and non-financial corporations resident in the euro area Member States, the MFI interest rate statistics are compiled based on all of the interest rates applied to all of the products that fall within this instrument category. This means that NCBs may not define a set of national products within each instrument category on which MFI interest rate statistics are collected; instead, the rates on all products offered by each of the reporting agents are covered. As stated in Article 16 of Guideline ECB/2007/9 of 1 August 2007 on monetary, financial institutions and market statistics ( 10 ), NCBs do not need to cover in the sample each product that exists at national level. However, they must not exclude a whole instrument category on the grounds that the amounts involved are very small. Hence, if an instrument category is only offered by one institution, then this institution is represented in the sample. If an instrument category did not exist in a euro area Member State at the time of the initial drawing of the sample, but a new product belonging to this category is being introduced by one institution thereafter, this institution is included in the sample at the time of the next representativity check. If a new product is created within an existing instrument category at national level, the institutions in the sample cover it with the next reporting, as all reporting agents are required to report on all their products.
41. The exception to the principle of covering all interest rates applied to all products are interest rates on bad loans and loans for debt restructuring. As stated in paragraph 28, all bad loans, and loans for debt restructuring at rates below market conditions, i.e. applied to financially distressed debtors, are excluded from MFI interest rate statistics.
XII. Breakdown by currency
42. MFI interest rate statistics cover the interest rates applied by the reporting population. Data on deposits and loans in currencies other than euro shall not be required at the level of all euro area Member States. This is reflected in Appendices 1 and 2 where all indicators refer to deposits and loans denominated in euro.
XIII. Breakdown by sector
43. With the exception of repos, a sectoral breakdown shall be applied to all deposits and loans required for MFI interest rate statistics. Appendices 1 and 2 therefore distinguish between indicators vis-à-vis households (including non-profit institutions serving households) ( 11 ) and vis-à-vis non-financial corporations ( 12 ). In addition, separate data is reported for sole proprietors/partnerships without legal status as part of households, but only in respect of new business loans for ‘other purposes’. NCBs may waive the requirement of separate identification of loans to sole proprietors when such loans constitute less than 5 % of the euro area Member State’s total household lending in terms of outstanding amounts, as calculated in accordance with Regulation (EU) No 1071/2013 (ECB/2013/33).
44. Indicator 5 in Appendix 1 and indicator 11 in Appendix 2 refer to repos. Although the remuneration of repos is not independent of the holding sector in all euro area Member States, no sector breakdown by households and non-financial corporations is required for repos at the level of all euro area Member States. Furthermore, no maturity breakdown is required at the level of all euro area Member States, as repos are assumed to be predominantly very short-term. The MFI interest rate on repos refers without differentiation to both sectors.
45. Indicators 5 and 6 in Appendix 2 refer to deposits redeemable at notice held by households. The interest rate and the weight for deposits redeemable at notice, however, at the level of all euro area Member States refer to deposits redeemable at notice held by both households and non-financial corporations, i.e. both sectors are merged but allocated to households. At the level of all euro area Member States, no sector breakdown is required.
XIV. Breakdown by type of instrument
46. Unless otherwise stated in the following paragraphs 47 to 55, the instrument breakdown for MFI interest rates and the definitions of the types of instruments follow the asset and liabilities categories set out in Part 2 of Annex II to Regulation (EU) No 1071/2013 (ECB/2013/33).
47. MFI interest rates on overnight deposits, i.e. indicators 1 and 7 in Appendix 2, cover all overnight deposits, whether or not they are interest bearing. Zero-interest overnight deposits are therefore captured by MFI interest rate statistics.
48. For the purpose of MFI interest rate statistics, revolving loans and overdrafts, i.e. indicators 12 and 23 in Appendix 2, have the same meaning as defined in Part 2 of Annex II to Regulation (EU) No 1071/2013 (ECB/2013/33), regardless of their initial period of interest rate fixation. Penalties on overdrafts applied as component of other charges, for example in the form of special fees, are not covered by the AAR as defined in paragraph 1, because this type of rate only covers the interest rate on loans. Loans reported under this category are not reported under any other new business category.
49. For the purpose of MFI interest rate statistics, credit card debt has the same meaning as defined in Part 2 of Annex II to Regulation (EU) No 1071/2013 (ECB/2013/33). Data on the interest rate is reported only in respect of extended credit card credit, in indicators 32 and 36. The interest rate on convenience credit card credit is not reported separately, as it is by definition 0 %. However, the outstanding convenience credit card credit is included as part of the MFI interest rate statistics on outstanding amounts, together with the outstanding extended credit card credit. Neither extended nor convenience credit card credit is reported under any other new business indicator.
50. For the purpose of MFI interest rate statistics, new business loans to non-financial corporations (except revolving loans and overdrafts and credit card debt), i.e. indicators 37 to 54, 80, 82, 84 and 91 in Appendix 2, comprise all loans other than credit card debt and revolving loans and overdrafts to enterprises, regardless of their amount, while indicators 62 to 79, 81, 83 and 85 refer to secured loans as defined in paragraph 64. Loans to non-financial corporations in Appendix 1 referring to outstanding amounts have the same meaning as defined in Part 2 of Annex II to Regulation (EU) No 1071/2013 (ECB/2013/33) and cover revolving loans and overdrafts and credit card debt.
51. For the purpose of MFI interest rate statistics, new business loans to households for consumption, i.e. indicators 13 to 15, 30 and 88 in Appendix 2, are defined as loans, other than credit card debt or revolving loans and overdrafts, granted for the purpose of personal use in the consumption of goods and services, while indicators 55 to 57 refer to secured loans as defined in paragraph 64. Loans for consumption in Appendix 1 referring to outstanding amounts have the same meaning as defined in Part 2 of Annex II to Regulation (EU) No 1071/2013 (ECB/2013/33) and cover revolving loans and overdrafts and credit card debt.
52. For the purpose of MFI interest rate statistics, new business loans to households for house purchases, i.e. indicators 16 to 19, 31, and 89 in Appendix 2, are defined as credit other than revolving loans and overdrafts or credit card debt, extended for the purpose of investing in housing, including building, garages and home improvements (refurbishment), while indicators 58 to 61 refer to secured loans as defined in paragraph 64. Loans to households for house purchases in Appendix 1 referring to outstanding amounts have the same meaning as defined in Part 2 of Annex II to Regulation (EU) No 1071/2013 (ECB/2013/33) and cover revolving loans and overdrafts and credit card debt.
53. For the purpose of MFI interest rate statistics, new business loans to households for other purposes, i.e. indicators 20 to 22, 33 to 35 and 90 in Appendix 2, are defined as loans other than revolving loans and overdrafts or credit card debt, granted for purposes such as business, debt consolidation, education, etc. Other loans to households in Appendix 1 referring to outstanding amounts have the same meaning as defined in Part 2 of Annex II to Regulation (EU) No 1071/2013 (ECB/2013/33) and include revolving loans and overdrafts and credit card debt.
54. For MFI interest rates on outstanding amounts, loans for consumption, loans to households for house purchases and other loans to households for other purposes together cover all loans granted to households by resident credit and other institutions, including revolving loans and overdrafts and credit card debt.
55. For MFI interest rates on new business, extended credit card credit, revolving loans and overdrafts, loans to households for consumption, for house purchases and for other purposes cover all loans except convenience credit card credit granted to households by resident credit and other institutions. Convenience credit card credit is not separately reported in MFI interest rate statistics on new business, but is included as part of the corresponding outstanding amount items.
XV. Breakdown by amount category
56. For other loans to non-financial corporations, i.e. indicators 37 to 54 and 62 to 85 in Appendix 2, three categories of amounts are distinguished: (a) ‘up to and including EUR 0,25 million’; (b) ‘over EUR 0,25 million up to and including EUR 1 million’; and (c) ‘over EUR 1 million’. The amount refers to the single loan transaction considered as new business, rather than to all business between the non-financial corporation and the reporting agent.
XVI. Breakdown by original and residual maturity, notice and interest rate reset period or initial rate fixation
57. Depending on the type of instrument and on whether the MFI interest rate refers to outstanding amounts or to new business, the statistics provide a breakdown by original and residual maturity, periods of notice and interest rate reset and/or initial period of fixation of the rate. These breakdowns refer to time bands or ranges, for example an interest rate on a deposit with an agreed maturity of up to two years refers to an average rate across all deposits with an agreed original maturity between two days and a maximum of two years, weighted by size of the deposit.
58. The breakdown by original and residual maturity as well as periods of notice and interest rate reset follow the definitions set out in Part 2 of Annex II to Regulation (EU) No 1071/2013 (ECB/2013/33). A breakdown by original maturity is applied to all deposit categories other than repos referring to outstanding amounts and all lending categories referring to outstanding amounts as set out in Appendix 1. A breakdown by original maturity in combination with residual maturity and next interest rate reset is applied to indicators 15 to 26 as defined in Appendix 1. A breakdown by original maturity is also applied to new business on deposits with agreed maturity, and a breakdown by period of notice to new business on deposits redeemable at notice as set out in Appendix 2. Separate data on loans to non-financial corporations with an initial period of interest rate fixation up to one year in combination with original maturity above one year are reported for each size of loan band referred to in paragraph 56, as set out in Appendix 2.
59. The lending interest rates on new business, except for indicators 88 to 91 on renegotiated loans in Appendix 2, are broken down by the initial period of interest rate fixation contained in the contract. For the purpose of MFI interest rate statistics, the initial period of fixation is defined as a predetermined period of time at the start of a contract during which the value of the interest rate will not change. The initial period of fixation may be shorter than or equal to the original maturity of the loan. The value of the interest rate is only considered to be unchangeable if it is defined as an exact level, for example as 10 %, or as a differential to a reference rate at a fixed point in time, for example as 6-month EURIBOR plus 2 percentage points at a certain predetermined day and time. If at the start of the contract a procedure to calculate the lending rate is agreed between the household or non-financial corporation and the reporting agent for a certain period of time, for example 6-month EURIBOR plus 2 percentage points for three years, the initial rate fixation period is not considered to be three years, but six months, since the value of the interest rate may change every six months during the three years. The MFI interest rate statistics on new lending business only reflect the interest rate that is agreed for the initial period of fixation at the start of a contract or after renegotiation of the loan. If after this initial period of fixation the interest rate automatically changes to a floating rate, this is not reflected in the MFI interest rates on new business but only in those on outstanding amounts.
60. The following periods of initial rate fixation are distinguished for loans to households:
For loans to households for consumption and other purposes:
— floating rate and up to (and including) one year initial rate fixation,
— over one year and up to (and including) five years initial rate fixation, and
— over five years initial rate fixation.
For loans to households for house purchase:
— floating rate and up to (and including) one year initial rate fixation,
— over one and up to (and including) five years initial rate fixation,
— over five and up to (and including) 10 years initial rate fixation, and
— over 10 years initial rate fixation.
61. The following periods of initial rate fixation are distinguished for loans to non-financial corporations up to EUR 0,25 million, over EUR 0,25 million up to EUR 1 million and over EUR 1 million:
— floating rate and up to (and including) three months initial rate fixation,
— over three months and up to (and including) one year initial rate fixation,
— over one year and up to (and including) three years initial rate fixation,
— over three years and up to (and including) five years initial rate fixation,
— over five and up to (and including) ten years initial rate fixation, and
— over 10 years initial rate fixation.
62. For the purposes of MFI interest rate statistics, ‘floating rate’ is defined as the interest rate that is subject to interest revisions on a continuous basis, e.g. every day, or at the discretion of the MFI except central banks and MMFs.
XVII. Breakdown by secured loans with collateral and/or guarantees
63. Loans to households and non-financial corporations secured with collateral and/or guarantees are additionally separately reported for all MFI interest rate statistics new business categories except credit card debt, revolving loans and overdrafts, and lending for other purposes. Furthermore, no breakdown by collateral/guarantees is required for the indicators referring to new business volumes of renegotiated loans.
64. For the purpose of MFI interest rate statistics, the breakdown of loans according to collateral/guarantees includes the total amount of new business loans which are collateralised using the ‘funded credit protection’ technique as defined in Article 4(1)(58) and Articles 197 to 200 of Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms ( 13 ) and/or guaranteed using the ‘unfunded credit protection’ technique as defined in Article 4(1)(59) and Articles 201, 202 and 203 of Regulation (EU) No 575/2013, in such a way that the value of the collateral and/or guarantee is higher than or equal to the total amount of the loan. If an MFI except central banks and MMFs applies a system different from the ‘Standardised Approach’ as defined in Regulation (EU) No 575/2013 for supervisory purposes, it may also apply the same treatment in the reporting of loans included under this breakdown.
PART 5
Reporting obligations
65. In order to derive aggregates referring to all euro area Member States, three levels of aggregation are applied for each of the instrument categories listed in Appendices 1 and 2.
XVIII. Statistical information at the level of the reporting agents
66. The first level of aggregation is carried out by the reporting agents as defined in paragraphs 67 to 72. However, NCBs may also ask reporting agents to provide data at the level of individual deposits and loans. The data is reported to the NCB of the euro area Member State in which the reporting agent is resident.
67. If the interest rates on outstanding amounts, i.e. indicators 1 to 26 in Appendix 1, are compiled as a snapshot of end-month observations, then the reporting agents provide a weighted average interest rate referring to the last day of the month for each of the instrument categories.
68. If the interest rates on outstanding amounts, i.e. indicators 1 to 26 in Appendix 1, are compiled as implicit rates referring to the average of the month, reporting agents provide the accrued interest payable or receivable during the month and the average stock of deposits and loans during the same month for each of the instrument categories.
69. If the interest rates on overnight deposits, deposits redeemable at notice, extended credit card credit and revolving loans and overdrafts, i.e. indicators 1, 5, 6, 7, 12, 23, 32 and 36 in Appendix 2, are compiled as a snapshot of end-month observations, then the reporting agents provide a weighted average interest rate referring to the last day of the month for each of the instrument categories.
70. If the interest rates on overnight deposits, deposits redeemable at notice, extended credit card credit and revolving loans and overdrafts, i.e. indicators 1, 5, 6, 7, 12, 23, 32 and 36 in Appendix 2, are compiled as implicit rates referring to the average of the month, then the reporting agents provide the accrued interest payable or receivable during the month and the average stock of deposits and loans during the same month for each of the instrument categories.
71. For each of the instrument categories on new business, i.e. indicators 2 to 4, 8 to 11, 13 to 22, 30 to 31, 33 to 35 and 37 to 85 in Appendix 2, reporting agents provide a weighted average interest rate. In addition, reporting agents provide the amount of new business conducted in each instrument category during the month for each of indicators 2 to 4, 8 to 11, 13 to 22, 33 to 35 and 37 to 85 in Appendix 2. For the instrument categories referring to renegotiated loans to households and non-financial corporations (indicators 88 to 91 in Appendix 2), only information on new business volumes is required.
72. Credit and other institutions that are permitted by an NCB to report MFI interest rate statistics together as a group are considered as one reporting agent and provide the data referred to in paragraphs 67 to 71 referring to the group as a whole. In addition, these reporting agents provide every year the number of reporting institutions within the group and the variance of interest rates across these institutions for each instrument category. The number of reporting institutions within the group and the variance refer to the month of October and are transmitted with the October data.
XIX. National weighted average interest rates and Aggregated results for the euro area Member States
73. The second level of aggregation is carried out by the NCBs. They aggregate the interest rates and related amounts of business for all their national reporting agents to a national weighted average interest rate for each instrument category. The data are reported to the European Central Bank (ECB). The final level of aggregation of the instrument categories per euro area Member State to the level of all euro area Member States is carried out by the ECB.
Appendix 1
Instrument categories for rates on outstanding amounts
An AAR or NDER is reported on a monthly basis for each of the categories included in Table 1.
Table 1
<table><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p> </p><div/></td><td><p>Sector</p></td><td><p>Type of instrument</p></td><td><p>Original maturity</p></td><td><p>Residual maturity</p></td><td><p>Interest rate reset</p></td><td><p>Outstanding amount indicator</p></td><td><p>Reporting obligation</p></td></tr><tr><td><p>Deposits in EUR</p></td><td><p>From households</p></td><td><p>With agreed maturity</p></td><td><p>Up to 2 years</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>1</p></td><td><p>AAR</p></td></tr><tr><td><p>Over 2 years</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>2</p></td><td><p>AAR</p></td></tr><tr><td><p>From non-financial corporations</p></td><td><p>With agreed maturity</p></td><td><p>Up to 2 years</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>3</p></td><td><p>AAR</p></td></tr><tr><td><p>Over 2 years</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>4</p></td><td><p>AAR</p></td></tr><tr><td><p>Repos</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>5</p></td><td><p>AAR</p></td></tr><tr><td><p>Loans in EUR</p></td><td><p>To households</p></td><td><p>For house purchases</p></td><td><p>Up to 1 year</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>6</p></td><td><p>AAR</p></td></tr><tr><td><p>Over 1 and up to 5 years</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>7</p></td><td><p>AAR</p></td></tr><tr><td><p>Over 5 years</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>8</p></td><td><p>AAR</p></td></tr><tr><td><p>For consumption and other purposes</p></td><td><p>Up to 1 year</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>9</p></td><td><p>AAR</p></td></tr><tr><td><p>Over 1 and up to 5 years</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>10</p></td><td><p>AAR</p></td></tr><tr><td><p>Over 5 years</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>11</p></td><td><p>AAR</p></td></tr><tr><td><p>Total</p></td><td><p>Over 1 year</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>15</p></td><td><p>AAR</p></td></tr><tr><td><p>up to 1 year</p></td><td><p> </p><div/></td><td><p>16</p></td><td><p>AAR</p></td></tr><tr><td><p>over 1 year</p></td><td><p>in the next 12 months</p></td><td><p>17</p></td><td><p>AAR</p></td></tr><tr><td><p>Over 2 years</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>18</p></td><td><p>AAR</p></td></tr><tr><td><p>up to 2 years</p></td><td><p> </p><div/></td><td><p>19</p></td><td><p>AAR</p></td></tr><tr><td><p>over 2 years</p></td><td><p>in the next 24 months</p></td><td><p>20</p></td><td><p>AAR</p></td></tr><tr><td><p>To non-financial corporations</p></td><td><p>Up to 1 year</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>12</p></td><td><p>AAR</p></td></tr><tr><td><p>Over 1 and up to 5 years</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>13</p></td><td><p>AAR</p></td></tr><tr><td><p>Over 5 years</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>14</p></td><td><p>AAR</p></td></tr><tr><td><p>Over 1 year</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>21</p></td><td><p>AAR</p></td></tr><tr><td><p>up to 1 year</p></td><td><p> </p><div/></td><td><p>22</p></td><td><p>AAR</p></td></tr><tr><td><p>over 1 year</p></td><td><p>in the next 12 months</p></td><td><p>23</p></td><td><p>AAR</p></td></tr><tr><td><p>Over 2 years</p></td><td><p> </p><div/></td><td><p> </p><div/></td><td><p>24</p></td><td><p>AAR</p></td></tr><tr><td><p>up to 2 years</p></td><td><p> </p><div/></td><td><p>25</p></td><td><p>AAR</p></td></tr><tr><td><p>over 2 years</p></td><td><p>in the next 24 months</p></td><td><p>26</p></td><td><p>AAR</p></td></tr></tbody></table>
Appendix 2
Instrument categories for interest rates on new business
An AAR or NDER is reported on a monthly basis for the categories included in Tables 2, 3 and 4. The reporting of the AAR is accompanied by the related business volume if indicated in the tables by the word ‘amount’. For the categories referring to renegotiated loans in Table 6, only information on new business volumes is required.
Categories within Tables 2 (except indicators 33 to 35), 3, 5 and 6 are mutually exclusive within each table. Therefore, a loan reported under any indicator in Table 2 (except indicators 33 to 35) and/or in Table 3 and/or Table 5 and/or Table 6 is not reported again under any other indicator in the same table, except for loans reported in indicators 33 to 35, which are also to be reported under indicators 20 to 22.
All loans reported under any category in Table 3 must also appear in the corresponding categories of Tables 2. As for indicators in Table 4, these are sub-indicators of Tables 2, and, if secured, of Table 3; therefore any loan reported under Table 4 must also appear in Tables 2 and 3 as appropriate. The loans reported under any category in Table 6 must also appear in the appropriate category in Table 2, and, as appropriate, in Tables 3, and 4.
Table 5 refers only to APRC. Loans recorded in Table 5 are also be recorded in Tables 2, 3, 4 and 6 as appropriate, taking into account the different methodology of APRC as contained in paragraph 9.
The concept of new business is extended to the whole stock, i.e. to outstanding amounts in the case of overnight deposits, deposits redeemable at notice, revolving loans and overdrafts and extended credit card credit, i.e. indicators 1, 5, 6, 7, 12, 23, 32, 36.
Table 2
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p> </p><div/></td><td><p>Sector</p></td><td><p>Type of instrument</p></td><td><p>Original maturity, period of notice, initial period of interest rate fixation</p></td><td><p>New business indicator</p></td><td><p>Reporting obligation</p></td></tr><tr><td><p>Deposits in EUR</p></td><td><p>From households</p></td><td><p>Overnight</p></td><td><p>1</p></td><td><p>AAR</p></td></tr><tr><td><p>With agreed maturity</p></td><td><p>Up to 1 year maturity</p></td><td><p>2</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 1 and up to 2 years maturity</p></td><td><p>3</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 2 years maturity</p></td><td><p>4</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Redeemable at notice <a>(<span>*1</span>)</a></p></td><td><p>Up to 3 months’ notice</p></td><td><p>5</p></td><td><p>AAR</p></td></tr><tr><td><p>Over 3 months’ notice</p></td><td><p>6</p></td><td><p>AAR</p></td></tr><tr><td><p>From non-financial corporations</p></td><td><p>Overnight</p></td><td><p>7</p></td><td><p>AAR</p></td></tr><tr><td><p>With agreed maturity</p></td><td><p>Up to 1 year maturity</p></td><td><p>8</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 1 and up to 2 years maturity</p></td><td><p>9</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 2 years maturity</p></td><td><p>10</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Repos</p></td><td><p>11</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Loans in EUR</p></td><td><p>To households</p></td><td><p>Revolving loans and overdrafts</p></td><td><p>12</p></td><td><p>AAR</p></td></tr><tr><td><p>Extended credit card credit</p></td><td><p>32</p></td><td><p>AAR</p></td></tr><tr><td><p>For consumption</p></td><td><p>Floating rate and up to 1 year period of initial rate fixation</p></td><td><p>13</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 1 and up to 5 years period of initial rate fixation</p></td><td><p>14</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 5 years period of initial rate fixation</p></td><td><p>15</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>For house purchases</p></td><td><p>Floating rate and up to 1 year period of initial rate fixation</p></td><td><p>16</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 1 and up to 5 years period of initial rate fixation</p></td><td><p>17</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 5 and up to 10 years period of initial rate fixation</p></td><td><p>18</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 10 years period of initial rate fixation</p></td><td><p>19</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>For other purposes</p></td><td><p>Floating rate and up to 1 year period of initial rate fixation</p></td><td><p>20</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 1 and up to 5 years period of initial rate fixation</p></td><td><p>21</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 5 years period of initial rate fixation</p></td><td><p>22</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>For other purposes, of which: Sole proprietors</p></td><td><p>Floating rate and up to 1 year period of initial rate fixation</p></td><td><p>33</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 1 and up to 5 years period of initial rate fixation</p></td><td><p>34</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 5 years period of initial rate fixation</p></td><td><p>35</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Loans in EUR</p></td><td><p>To non-financial corporations</p></td><td><p>Revolving loans and overdrafts</p></td><td><p>23</p></td><td><p>AAR</p></td></tr><tr><td><p>Extended credit card credit</p></td><td><p>36</p></td><td><p>AAR</p></td></tr><tr><td><p>Loans up to an amount of EUR 0,25 mn</p></td><td><p>Floating rate and up to 3 months period of initial rate fixation</p></td><td><p>37</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 3 months and up to 1 year period of initial rate fixation</p></td><td><p>38</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 1 and up to 3 year period of initial rate fixation</p></td><td><p>39</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 3 and up to 5 years period of initial rate fixation</p></td><td><p>40</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 5 and up to 10 years period of initial rate fixation</p></td><td><p>41</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 10 years period of initial rate fixation</p></td><td><p>42</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Loans over an amount of EUR 0,25 mn and up to EUR 1 mn</p></td><td><p>Floating rate and up to 3 months period of initial rate fixation</p></td><td><p>43</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 3 months and up to 1 year period of initial rate fixation</p></td><td><p>44</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 1 and up to 3 years period of initial rate fixation</p></td><td><p>45</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 3 and up to 5 years period of initial rate fixation</p></td><td><p>46</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 5 and up to 10 years period of initial rate fixation</p></td><td><p>47</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 10 years period of initial rate fixation</p></td><td><p>48</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Loans over an amount of EUR 1 mn</p></td><td><p>Floating rate and up to 3 months period of initial rate fixation</p></td><td><p>49</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 3 month and up to 1 year period of initial rate fixation</p></td><td><p>50</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 1 and up to 3 years period of initial rate fixation</p></td><td><p>51</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 3 and up to 5 years period of initial rate fixation</p></td><td><p>52</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 5 and up to 10 years period of initial rate fixation</p></td><td><p>53</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 10 years period of initial rate fixation</p></td><td><p>54</p></td><td><p>AAR, amount</p></td></tr><tr><td><div><a>(<span>*1</span>)   </a><p>For this instrument category, households and non-financial corporations are merged and allocated to the household sector.</p></div></td></tr></tbody></table>
Table 3
New business loans with collateral and/or guarantees
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p> </p><div/></td><td><p>Sector</p></td><td><p>Type of instrument</p></td><td><p>Initial period of interest rate fixation</p></td><td><p>New business indicator</p></td><td><p>Reporting obligation</p></td></tr><tr><td><p>Loans in EUR</p></td><td><p>To households</p></td><td><p>For consumption</p></td><td><p>Floating rate and up to 1 year period of initial rate fixation</p></td><td><p>55</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 1 and up to 5 years period of initial rate fixation</p></td><td><p>56</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 5 years period of initial rate fixation</p></td><td><p>57</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>For house purchases</p></td><td><p>Floating rate and up to 1 year period of initial rate fixation</p></td><td><p>58</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 1 and up to 5 years period of initial rate fixation</p></td><td><p>59</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 5 and up to 10 years period of initial rate fixation</p></td><td><p>60</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 10 years period of initial rate fixation</p></td><td><p>61</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Loans in EUR</p></td><td><p>To non-financial corporations</p></td><td><p>Loans up to an amount of EUR 0,25 mn</p></td><td><p>Floating rate and up to 3 months’ period of initial rate fixation</p></td><td><p>62</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 3 months and up to 1 year period of initial rate fixation</p></td><td><p>63</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 1 and up to 3 years’ period of initial rate fixation</p></td><td><p>64</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 3 and up to 5 years’ period of initial rate fixation</p></td><td><p>65</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 5 and up to 10 years’ period of initial rate fixation</p></td><td><p>66</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 10 years’ period of initial rates fixation</p></td><td><p>67</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Loans over an amount of EUR 0,25 mn and up to EUR 1 mn</p></td><td><p>Floating rate and up to 3 months’ period of initial rate fixation</p></td><td><p>68</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 3 months and up to 1 year period of initial rate fixation</p></td><td><p>69</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 1 and up to 3 years’ period of initial rate fixation</p></td><td><p>70</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 3 and up to 5 years’ period of initial rate fixation</p></td><td><p>71</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 5 and up to 10 years’ period of initial rate fixation</p></td><td><p>72</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 10 years’ period of initial rate fixation</p></td><td><p>73</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Loans over an amount of EUR 1 mn</p></td><td><p>Floating rate and up to 3 months’ period of initial rate fixation</p></td><td><p>74</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 3 months and up to 1 year period of initial rate fixation</p></td><td><p>75</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 1 and up to 3 years’ period of initial rate fixation</p></td><td><p>76</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 3 and up to 5 years’ period of initial rate fixation</p></td><td><p>77</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 5 and up to 10 years’ period of initial rate fixation</p></td><td><p>78</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Over 10 years’ period of initial rate fixation</p></td><td><p>79</p></td><td><p>AAR, amount</p></td></tr></tbody></table>
Table 4
New business loans to non-financial corporations with period of initial rate fixation below 1 year and original maturity over 1 year
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p> </p><div/></td><td><p>Sector</p></td><td><p>Type of instrument</p></td><td><p>All loans / collateralised/guaranteed loans by original maturity</p></td><td><p>New business indicator</p></td><td><p>Reporting obligation</p></td></tr><tr><td><p>Loans in EUR</p></td><td><p>To non-financial corporations</p></td><td><p>Loans up to an amount of EUR 0,25 mn</p></td><td><p>Floating rate and up to 1 year period of initial rate fixation, with original maturity over 1 year</p></td><td><p>80</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Floating rate and up to 1 year period of initial rate fixation, with original maturity over 1 year, only collateralised/guaranteed loans</p></td><td><p>81</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Loans over an amount of EUR 0,25 mn and up to EUR 1 mn</p></td><td><p>Floating rate and up to 1 year period of initial rate fixation, with original maturity over 1 year</p></td><td><p>82</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Floating rate and up to 1 year period of initial rate fixation, with original maturity over 1 year, only collateralised/guaranteed loans</p></td><td><p>83</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Loans over an amount of EUR 1 mn</p></td><td><p>Floating rate and up to 1 year period of initial rate fixation, with original maturity over 1 year</p></td><td><p>84</p></td><td><p>AAR, amount</p></td></tr><tr><td><p>Floating rate and up to 1 year period of initial rate fixation, with original maturity over 1 year, only collateralised/guaranteed loans</p></td><td><p>85</p></td><td><p>AAR, amount</p></td></tr></tbody></table>
Table 5
New business loans to households
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p> </p><div/></td><td><p>Sector</p></td><td><p>Type of instrument</p></td><td><p>All loans</p></td><td><p>New business indicator</p></td><td><p>Reporting obligation</p></td></tr><tr><td><p>Loans in EUR</p></td><td><p>To households</p></td><td><p>For consumption</p></td><td><p>APRC</p></td><td><p>30</p></td><td><p>APRC</p></td></tr><tr><td><p>For house purchase</p></td><td><p>APRC</p></td><td><p>31</p></td><td><p>APRC</p></td></tr></tbody></table>
Table 6
New business renegotiated loans
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p> </p><div/></td><td><p>Sector</p></td><td><p>Type of instrument</p></td><td><p>Original maturity, period of notice, initial period of interest rate fixation</p></td><td><p>New business indicator</p></td><td><p>Reporting obligation</p></td></tr><tr><td><p>Loans in EUR</p></td><td><p>To households</p></td><td><p>For consumption</p></td><td><p>total</p></td><td><p>88</p></td><td><p>Amount</p></td></tr><tr><td><p>For house purchase</p></td><td><p>total</p></td><td><p>89</p></td><td><p>Amount</p></td></tr><tr><td><p>For other purposes</p></td><td><p>total</p></td><td><p>90</p></td><td><p>Amount</p></td></tr><tr><td><p>To non-financial corporations</p></td><td><p>total</p></td><td><p>91</p></td><td><p>Amount</p></td></tr></tbody></table>
ANNEX II
MINIMUM STANDARDS TO BE APPLIED BY THE ACTUAL REPORTING POPULATION
Reporting agents must fulfil the following minimum standards to meet the European Central Bank’s (ECB’s) statistical reporting requirements.
1. Minimum standards for transmission:
(a) reporting must be timely and within the deadlines set by the NCB of the euro area Member State in which the reporting agent is resident (hereinafter the ‘relevant NCB’);
(b) statistical reports must take their form and format from the technical reporting requirements set by the relevant NCB;
(c) the reporting agent must provide the details of one or more contact persons to the relevant NCB;
(d) the technical specifications for data transmission to the relevant NCB must be followed.
2. Minimum standards for accuracy:
(a) statistical information must be correct;
(b) reporting agents must be able to provide information on the developments implied by the transmitted data;
(c) statistical information must be complete and must not contain continuous and structural gaps; existing gaps should be acknowledged, explained to the relevant NCB and, where applicable, bridged as soon as possible;
(d) reporting agents must follow the dimensions, rounding policy and decimals set by the relevant NCB for the technical transmission of the data.
3. Minimum standards for compliance with concepts:
(a) statistical information must comply with the definitions and classifications contained in this Regulation;
(b) in the event of deviations from these definitions and classifications, reporting agents must monitor and quantify the difference between the measure used and the measure contained in this Regulation on a regular basis;
(c) reporting agents must be able to explain breaks in the transmitted data compared with the previous periods’ figures.
4. Minimum standards for revisions:
The revisions policy and procedures set by the ECB and the relevant NCB must be followed. Revisions deviating from regular revisions must be accompanied by explanatory notes.
ANNEX III
REPEALED REGULATION WITH LIST OF SUCCESSIVE AMENDMENTS
(referred to in Article 7)
Regulation (EC) No 63/2002 (ECB/2001/18)
(OJ L 10, 12.1.2002, p. 24)
Amended by:
Regulation (EC) No 2181/2004 (ECB/2004/21)
(OJ L 371, 18.12.2004, p. 42)
Regulation (EC) No 290/2009 (ECB/2009/7)
(OJ L 94, 8.4.2009, p. 75)
Regulation (EU) No 674/2010 (ECB/2010/7)
(OJ L 196, 28.7.2010, p. 23)
ANNEX IV
CORRELATION TABLE
<table><col/><col/><tbody><tr><td><p>Regulation (EC) No 63/2002 (ECB/2001/18)</p></td><td><p>This Regulation</p></td></tr><tr><td><p>Article 1</p></td><td><p>Article 1</p></td></tr><tr><td><p>Article 2(1)</p></td><td><p>Article 2(1)</p></td></tr><tr><td><p> </p><div/></td><td><p>Article 2(2)</p></td></tr><tr><td><p> </p><div/></td><td><p>Article 2(3)</p></td></tr><tr><td><p> </p><div/></td><td><p>Article 2(4)</p></td></tr><tr><td><p>Article 2(2)</p></td><td><p>Article 2(5)</p></td></tr><tr><td><p>Article 2(3)</p></td><td><p>Article 2(6)</p></td></tr><tr><td><p>Article 3</p></td><td><p>Article 3</p></td></tr><tr><td><p> </p><div/></td><td><p>Article 4</p></td></tr><tr><td><p>Article 4</p></td><td><p>Article 5</p></td></tr><tr><td><p>Article 5</p></td><td><p>Article 6</p></td></tr><tr><td><p>Article 6</p></td><td><p>Article 7</p></td></tr><tr><td><p> </p><div/></td><td><p>Article 8</p></td></tr><tr><td><p>Article 7</p></td><td><p>Article 9</p></td></tr><tr><td><p>Annex I <a>(<span>1</span>)</a></p></td><td><p> </p><div/></td></tr><tr><td><p>Annex II</p></td><td><p>Annex I</p></td></tr><tr><td><p>Annex III</p></td><td><p>Annex II</p></td></tr><tr><td><p> </p><div/></td><td><p>Annex III</p></td></tr><tr><td><p>Annex IV</p></td><td><p> </p><div/></td></tr><tr><td><div><a>(<span>1</span>)   </a><p>To be included in an ECB guideline recasting Guideline ECB/2007/9.</p></div></td></tr></tbody></table>
<note>
( 1 ) OJ L 318, 27.11.1998, p. 8.
( 2 ) OJ L 10, 12.1.2002, p. 24.
( 3 ) OJ L 174, 26.6.2013, p. 1.
( 4 ) OJ L 331, 15.12.2010, p. 162.
( 5 ) See page 1 of this Official Journal.
( 6 ) OJ L 341, 27.12.2007, p. 1.
( 7 ) OJ L 226, 28.8.2010, p. 48.
( 8 ) OJ L 133, 22.5.2008, p. 66.
( 9 ) NCBs may grant derogations for consumer credit and loans to households for house purchase vis-à-vis non-profit institutions serving households.
( 10 ) OJ L 341, 27.12.2007, p. 1.
( 11 ) S.14 and S.15 combined, as defined in the ESA 2010 laid down by Regulation (EU) No 549/2013 of the European Parliament and of the Council of 21 May 2013 on the European system of national and regional accounts in the European Union (OJ L 174, 26.6.2013, p. 1).
( 12 ) S.11 as defined in ESA 2010.
( 13 ) OJ L 176, 27.6.2013, p. 1.
</note> | ENG | 02013R1072-20150101 |
<table><col/><col/><col/><col/><tbody><tr><td><p>16.4.2015   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 99/4</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2015/592
of 14 April 2015
approving a non-minor amendment to the specification for a name entered in the register of protected designations of origin and protected geographical indications (Presunto de Barrancos/Paleta de Barrancos (PDO))
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs ( 1 ) , and in particular Article 52(2) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>In accordance with the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Portugal's application for the approval of an amendment to the specification for the protected designation of origin ‘Presunto de Barrancos’, registered under Commission Regulation (EC) No 2400/96<a> (<span>2</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Since the amendment in question is not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the<span>Official Journal of the European Union</span> as required by Article 50(2)(a) of that Regulation<a> (<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendment to the specification should be approved,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The amendment to the specification published in the Official Journal of the European Union regarding the name ‘Presunto de Barrancos’/‘Paleta de Barrancos’ (PDO) is hereby approved.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 April 2015.
For the Commission,
On behalf of the President,
Phil HOGAN
Member of the Commission
<note>
( 1 ) OJ L 343, 14.12.2012, p. 1 .
( 2 ) Commission Regulation (EC) No 2400/96 of 17 December 1996 on the entry of certain names in the ‘Register of protected designation of origin and protected geographical indications’ provided for in Council Regulation (EEC) No 2081/92 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs ( OJ L 327, 18.12.1996, p. 11 ).
( 3 ) OJ C 432, 2.12.2014, p. 16 .
</note> | ENG | 32015R0592 |
<table><col/><col/><col/><col/><tbody><tr><td><p>30.11.2021   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 427/120</p></td></tr></tbody></table>
COMMISSION DELEGATED REGULATION (EU) 2021/2086
of 5 July 2021
amending Annexes II and IV to Regulation (EU) 2019/1009 of the European Parliament and of the Council for the purpose of adding precipitated phosphate salts and derivates as a component material category in EU fertilising products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 ( 1 ) , and in particular Article 42(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Regulation (EU) 2019/1009 lays down rules on the making available on the market of EU fertilising products. EU fertilising products contain component materials of one or more of the categories listed in Annex II to that Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Article 42(2) of Regulation (EU) 2019/1009 read in conjunction with Article 42(1), first subparagraph, point (b), of that Regulation requires the Commission to assess struvite without undue delay after 15 July 2019, and to include it in Annex II to that Regulation if that assessment concludes that EU fertilising products containing that material do not present a risk to human, animal or plant health, to safety or to the environment, and ensure agronomic efficiency.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Struvite can be waste, and can in accordance with Article 19 of Regulation (EU) 2019/1009 cease to be waste if it is contained in a compliant EU fertilising product. Pursuant to Article 42(3) of that Regulation read in conjunction with Article 6 of Directive 2008/98/EC of the European Parliament and of the Council <a>(<span>2</span>)</a>, the Commission may therefore include struvite in Annex II to Regulation (EU) 2019/1009 only if recovery rules in that Annex ensure that the material is to be used for specific purposes, that a market or demand exists for it, and that its use will not lead to overall adverse environmental or human health impacts.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The Commission’s Joint Research Centre (‘JRC’) began its assessment of struvite in anticipation of the adoption of Regulation (EU) 2019/1009, and concluded it in 2019. Throughout the assessment, the scope was widened to include the broad spectrum of precipitated phosphate salts, as well as their derivates.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>JRC’s assessment report <a>(<span>3</span>)</a> concludes that precipitated phosphate salts and derivates, if produced following the recovery rules suggested in the report, provide plants with nutrients or improve their nutrition efficiency and therefore ensure agronomic efficiency.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>JRC’s assessment report furthermore concludes that there is an existing and growing market demand for precipitated phosphate salts and derivates, and that those materials are likely to be used to provide nutrient inputs to European agriculture. It further concludes that the use of precipitated phosphate salts and derivates produced following the recovery rules suggested in the report does not lead to overall adverse environmental or human health impacts.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The recovery rules suggested in JRC’s assessment report include measures to limit the risks of recycling or producing contaminants, such as creating an exhaustive list of eligible input materials and excluding, for example, mixed municipal waste, and laying down specific processing conditions and product quality requirements. That assessment report also concludes that the conformity assessment rules applicable to fertilising products containing precipitated phosphate salts and derivates should include a quality system assessed and approved by a notified body.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Based on the above, the Commission concludes that precipitated phosphate salts and derivates, if produced in accordance with the recovery rules suggested in JRC’s assessment report, ensure agronomic efficiency within the meaning of Article 42(1), first subparagraph, point (b)(ii), of Regulation (EU) 2019/1009. Furthermore, they comply with the criteria laid down in Article 6 of Directive 2008/98/EC. Finally, if compliant with the other requirements laid down in Regulation (EU) 2019/1009 in general and in Annex I to that Regulation in particular, they would not present a risk to human, animal or plant health, to safety or to the environment within the meaning of Article 42(1), first subparagraph, point (b)(i), of Regulation (EU) 2019/1009. Therefore, precipitated phosphate salts and derivates should be included in Annex II to Regulation (EU) 2019/1009 subject to those recovery rules.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>In particular, animal by-products or derived products within the meaning of Regulation (EC) No 1069/2009 of the European Parliament and of the Council <a>(<span>4</span>)</a> should only be allowed as input materials for precipitated phosphate salts and derivates governed by Regulation (EU) 2019/1009, if and when their end points in the manufacturing chain have been determined in accordance with Article 5(2), third subparagraph, of Regulation (EC) No 1069/2009 and will be reached at the latest by the end of the production process of the EU fertilising product containing the precipitated phosphate salts or derivates.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>Furthermore, given the fact that precipitated phosphate salt and derivates can be considered to be recovered waste or by-products within the meaning of Directive 2008/98/EC, such materials should be excluded from component material categories 1 and 11 of Annex II to Regulation (EU) 2019/1009 pursuant to Article 42(1), third subparagraph, of that Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>It is important to ensure that when fertilising products contain precipitated phosphate salts and derivates, they are subject to an appropriate conformity assessment procedure including a quality system assessed and approved by a notified body. Therefore, it is necessary to amend Annex IV to Regulation (EU) 2019/1009 to provide for a conformity assessment appropriate for such fertilising products.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>Given that the requirements set out in Annex II to Regulation (EU) 2019/1009 and the conformity assessment procedures set out in Annex IV to that Regulation are to apply as of 16 July 2022, it is necessary to defer the application of this Regulation to the same date,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EU) 2019/1009 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Annex II is amended in accordance with Annex I to this Regulation;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Annex IV is amended in accordance with Annex II to this Regulation.</p></td></tr></tbody></table>
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
It shall apply from 16 July 2022.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 July 2021.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 170, 25.6.2019, p. 1 .
( 2 ) Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives ( OJ L 312, 22.11.2008, p. 3 ).
( 3 ) Huygens D, Saveyn HGM, Tonini D, Eder P, Delgado Sancho L, Technical proposals for selected new fertilising materials under the Fertilising Products Regulation (Regulation (EU) 2019/1009) – Process and quality criteria, and assessment of environmental and market impacts for precipitated phosphate salts & derivates, thermal oxidation materials & derivates and pyrolysis & gasification materials, EUR 29841 EN, Publications Office of the European Union, Luxembourg, 2019, ISBN 978-92-76-09888-1, doi:10.2760/186684, JRC117856.
( 4 ) Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) ( OJ L 300, 14.11.2009, p. 1 ).
ANNEX I
Annex II to Regulation (EU) 2019/1009 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>In Part I, the following point is added:</p><p> "CMC 12: Precipitated phosphate salts and derivates".</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Part II is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>In CMC 1, point 1 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>in sub-point (g), “or” is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>in sub-point (h), “.” is replaced by “, or”;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>the following sub-point (i) is added:</p><table><col/><col/><tbody><tr><td><p>“(i)</p></td><td><p>precipitated phosphate salts or derivates, which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC,”.</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>In CMC 11, point 1 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>in sub-point (c), “or” is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>in sub-point (d), “.” is replaced by “, or”;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>the following sub-point (e) is added:</p><table><col/><col/><tbody><tr><td><p>“(e)</p></td><td><p>precipitated phosphate salts or derivates, which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC.”.</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>The following CMC 12 is added:</p><p> "CMC 12: PRECIPITATED PHOSPHATE SALTS AND DERIVATES</p><table><col/><col/><col/><tbody><tr><td/><td><p>1.</p></td><td><span>An EU fertilising product may contain precipitated phosphate salts obtained through precipitation exclusively from one or more of the following input materials:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>wastewaters and sewage sludge from municipal wastewater treatment plants, other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>wastewaters and sludge from processing of foods, beverages, pet foods, animal feeds, or dairy products, other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009, unless processing steps involved contact with biocidal products within the meaning of Article 3(1), point (a), of Regulation (EU) No 528/2012 of the European Parliament and of the Council<a> (<span>*1</span>)</a> other than those defined as product-type 4 of main group 1 of Annex V to that Regulation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>bio-waste within the meaning of Article 3, point 4, of Directive 2008/98/EC resulting from separate bio-waste collection at source, other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>processing residues within the meaning of Article 2, point (t), of Directive 2009/28/EC of the European Parliament and of the Council<a> (<span>*2</span>)</a> from the production of bioethanol and biodiesel derived from materials referred to in this point, sub-points (b), (c) and (e);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>living or dead organisms or parts thereof, which are unprocessed or processed only by manual, mechanical or gravitational means, dissolution in water, flotation, extraction with water, steam distillation or heating solely to remove water, or which are extracted from air by any means, except<a> (<span>*3</span>)</a>:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>materials originating from mixed municipal waste,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>sewage sludge, industrial sludge or dredging sludge,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>animal by-products or derived products within the scope of Regulation (EC) No 1069/2009;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>substances and mixtures, other than<a> (<span>*3</span>)</a>:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>those referred to in sub-points (a) to (e),</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>waste within the meaning of Article 3,point 1, of Directive 2008/98/EC,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>substances or mixtures which have ceased to be waste in one or more Member States by virtue of the national measures transposing Article 6 of Directive 2008/98/EC,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>substances formed from precursors which have ceased to be waste in one or more Member States by virtue of the national measures transposing Article 6 of Directive 2008/98/EC, or mixtures containing such substances,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>non-biodegradable polymers,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>animal by-products or derived products within the scope of Regulation (EC) No 1069/2009.</p></td></tr></tbody></table></td></tr></tbody></table><p>In addition, precipitated phosphate salts shall be obtained through precipitation from any input material referred to in sub-points (a) to (f), or a combination thereof, processed by manual, mechanical or gravitational means, solid-liquid fractionation using biodegradable polymers, dissolution in water, flotation, extraction with water, steam distillation or heating solely to remove water, thermal hydrolysis, anaerobic digestion or composting. The temperature under such processes shall not be raised above 275 °C.</p></td></tr></tbody></table><table><col/><col/><col/><tbody><tr><td/><td><p>2.</p></td><td><span>The precipitation process shall take place under controlled conditions in a reactor. In addition, only input materials, which are not contaminated with other material streams, or input materials, other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009, which have been unintentionally contaminated with other material streams in a one-off incident resulting only in trace levels of exogenous compounds shall be used.</span><p>In the plant where the precipitation takes place, physical contacts between input and output materials shall be avoided after the precipitation process, including during storage.</p></td></tr></tbody></table><table><col/><col/><col/><tbody><tr><td/><td><p>3.</p></td><td><span>The precipitated phosphate salts shall contain:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>a minimum phosphorus pentoxide (P<span>2</span>O<span>5</span>) content of 16 % of the dry matter content;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a maximum organic carbon (C<span>org</span>) content of 3 % of the dry matter content;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>no more than 3 g/kg dry matter of macroscopic impurities above 2 mm in any of the following forms: organic matter, glass, stones, metal and plastics;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>no more than 5 g/kg dry matter of the sum of the macroscopic impurities referred to in sub-point (c).</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><col/><tbody><tr><td/><td><p>4.</p></td><td><span>An EU fertilising product may contain derivates from precipitated phosphate salts produced through one or more chemical manufacturing steps that react the precipitated phosphate salts with materials referred to in sub-point 1(f) that are consumed in or used for chemical processing.</span><p>The derivate manufacturing process shall be executed so as to intentionally modify the chemical composition of the precipitated phosphate salts.</p></td></tr></tbody></table><table><col/><col/><col/><tbody><tr><td/><td><p>5.</p></td><td><span>The precipitated phosphate salts used for the derivates shall comply with points 1, 2 and 3.</span></td></tr></tbody></table><table><col/><col/><col/><tbody><tr><td/><td><p>6.</p></td><td><span>Notwithstanding point 1, an EU fertilising product may contain precipitated phosphate salts obtained through precipitation from Category 2 or Category 3 materials or derived products thereof, in accordance with the conditions set out in Article 32(1) and (2) of Regulation (EC) No 1069/2009 and in the measures referred to in Article 32(3) of that Regulation, alone or mixed with input materials referred to in point 1, provided that both of the following conditions are fulfilled:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the end point in the manufacturing chain has been determined in accordance with Article 5(2), third subparagraph, of Regulation (EC) No 1069/2009;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the conditions in points 2 and 3 are met.</p></td></tr></tbody></table><p>An EU fertilising product may also contain derivates from such precipitated phosphate salts, obtained in accordance with the conditions set out in point 4.</p></td></tr></tbody></table><table><col/><col/><col/><tbody><tr><td/><td><p>7.</p></td><td><span>In the plant where the precipitation takes place, the production lines for the processing of input materials allowed for the precipitated phosphate salts and derivates referred to in points 1, 4 and 6 shall be clearly separated from production lines for the processing of other input materials.</span></td></tr></tbody></table><table><col/><col/><col/><tbody><tr><td/><td><p>8.</p></td><td><span>Where for the PFC of an EU fertilising product containing or consisting of precipitated phosphate salts or derivates or both there are no requirements regarding<span>Salmonella</span> spp.,<span>Escherichia coli</span> or<span>Enterococcaceae</span> in Annex I, those pathogens shall not exceed the limits set out in the following table:</span><table><col/><col/><col/><col/><col/><tbody><tr><td><p>Micro-organisms to be tested</p></td><td><p>Sampling plans</p></td><td><p>Limit</p></td></tr><tr><td><p>n</p></td><td><p>c</p></td><td><p>m</p></td><td><p>M</p></td></tr><tr><td><p><span>Salmonella</span> spp.</p></td><td><p>5</p></td><td><p>0</p></td><td><p>0</p></td><td><p>Absence in 25 g or 25 ml</p></td></tr><tr><td><p><span>Escherichia coli</span></p><p>or</p><p><span>Enterococcaceae</span></p></td><td><p>5</p></td><td><p>5</p></td><td><p>0</p></td><td><p>1 000 in 1 g or 1 ml</p></td></tr></tbody></table><p>Where:</p><table><col/><col/><col/><tbody><tr><td><p>n</p></td><td><p>=</p></td><td><p>number of samples to be tested,</p></td></tr><tr><td><p>c</p></td><td><p>=</p></td><td><p>number of samples where the number of bacteria expressed in CFU is between m and M,</p></td></tr><tr><td><p>m</p></td><td><p>=</p></td><td><p>threshold value for the number of bacteria expressed in CFU that is considered satisfactory,</p></td></tr><tr><td><p>M</p></td><td><p>=</p></td><td><p>maximum value of the number of bacteria expressed in CFU.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><col/><tbody><tr><td/><td><p>9.</p></td><td><span>Pathogens in an EU fertilising product containing or consisting of precipitated phosphate salts obtained from materials referred to in sub-point 1(a) or derivates from such precipitated phosphate salts or both shall not exceed the limits set out in the following table:</span><table><col/><col/><col/><col/><col/><tbody><tr><td><p>Micro-organisms to be tested</p></td><td><p>Sampling plans</p></td><td><p>Limit</p></td></tr><tr><td><p>n</p></td><td><p>c</p></td><td><p>m</p></td><td><p>M</p></td></tr><tr><td><p><span>Clostridium perfringens</span></p></td><td><p>5</p></td><td><p>5</p></td><td><p>0</p></td><td><p>100 CFU in 1 g or 1 ml</p></td></tr><tr><td><p><span>Ascaris</span> sp. viable eggs</p></td><td><p>5</p></td><td><p>0</p></td><td><p>0</p></td><td><p>Absence in 25 g or 25 ml</p></td></tr></tbody></table><p>Where:</p><table><col/><col/><col/><tbody><tr><td><p>n</p></td><td><p>=</p></td><td><p>number of samples to be tested,</p></td></tr><tr><td><p>c</p></td><td><p>=</p></td><td><p>number of samples where the number of bacteria expressed in CFU is between m and M,</p></td></tr><tr><td><p>m</p></td><td><p>=</p></td><td><p>threshold value for the number of bacteria expressed in CFU that is considered satisfactory,</p></td></tr><tr><td><p>M</p></td><td><p>=</p></td><td><p>maximum value of the number of bacteria expressed in CFU.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><col/><tbody><tr><td/><td><p>10.</p></td><td><span>The requirements set out in points (8) and (9), as well as the requirements for<span>Salmonella</span> spp.,<span>Escherichia coli</span> or<span>Enterococcaceae</span> set in the corresponding PFC of an EU fertilising product consisting only of precipitated phosphate salts or derivates or both shall not apply when those precipitated phosphate salts or all of the biogenic input materials used in the precipitation process have undergone one of the following processes:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>pressure sterilisation through the heating to a core temperature of more than 133 °C for at least 20 minutes at an absolute pressure of at least 3 bars, whereby the pressure must be produced by the evacuation of all air in the sterilisation chamber and the replacement of the air by steam (‘saturated steam’);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>processing in a pasteurisation or hygienisation unit that reaches a temperature of 70 °C for at least one hour.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><col/><tbody><tr><td/><td><p>11.</p></td><td><span>Precipitated phosphate salts obtained from materials referred to in sub-point 1(a) and derivates obtained from such precipitated phosphate salts shall have no more than 6 mg/kg dry matter of PAH<span>16</span><a> (<span>*4</span>)</a></span></td></tr></tbody></table><table><col/><col/><col/><tbody><tr><td/><td><p>12.</p></td><td><span>The sum of aluminium (Al) and iron (Fe) in precipitated phosphate salts or derivates shall not exceed 10 % of the dry matter of the precipitated phosphate salts or the derivates.</span></td></tr></tbody></table><table><col/><col/><col/><tbody><tr><td/><td><p>13.</p></td><td><span>Precipitated phosphate salts or derivates shall have been registered pursuant to Regulation (EC) No 1907/2006 with a dossier containing:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the information provided for by Annexes VI, VII and VIII of Regulation (EC) No 1907/2006; and;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product, unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by points 6, 7, 8, or 9 of Annex V to that Regulation.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><col/><tbody><tr><td/><td><p>14.</p></td><td><span>For the purposes of points 3, 11 and 12, the dry matter of precipitated phosphate salts and derivates shall be measured using vacuum drying at 40 °C until constant weight to avoid the loss of crystal-bound water.</span></td></tr></tbody></table><p><a>(<span>*1</span>)</a>  Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (<a>OJ L 167, 27.6.2012, p. 1</a>)."</p><p><a>(<span>*2</span>)</a>  Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC (<a>OJ L 140 5.6.2009, p. 16</a>)."</p><p><a>(<span>*3</span>)</a>  The exclusion of an input material from a sub-point does not prevent it from being an eligible input material by virtue of another sub-point."</p><p><a>(<span>*3</span>)</a>  The exclusion of an input material from a sub-point does not prevent it from being an eligible input material by virtue of another sub-point."</p><p><a>(<span>*4</span>)</a>  Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, indeno[1,2,3-cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene.”."</p></td></tr></tbody></table></td></tr></tbody></table>
( *1 ) Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( OJ L 167, 27.6.2012, p. 1 ).
( *2 ) Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC ( OJ L 140 5.6.2009, p. 16 ).
( *3 ) The exclusion of an input material from a sub-point does not prevent it from being an eligible input material by virtue of another sub-point.
( *4 ) Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, indeno[1,2,3-cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene.”."
ANNEX II
In Annex IV, Part II, of Regulation (EU) 2019/1009, Module D1 (Quality assurance of the production process) is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>In point 2.2, sub-point (d) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>“(d)</p></td><td><p>drawings, schemes, descriptions and explanations necessary for the understanding of the manufacturing process of the EU fertilising product, and, in relation to materials belonging to CMCs 3, 5 and 12 as defined in Annex II, a written description and a diagram of the production process, where each treatment, storage vessel and area is clearly identified,”.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The introductory wording in point 5.1.1.1 is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>“5.1.1.1.</p></td><td><p>For materials belonging to CMCs 3, 5 and 12, as defined in Annex II, senior management of the manufacturer’s organisation shall:”.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Point 5.1.2.1 is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>“5.1.2.1.</p></td><td><p>For materials belonging to CMCs 3, 5 and 12, as defined in Annex II, the quality system shall ensure compliance with the requirements specified in that Annex.”.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Point 5.1.3.1 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>The introductory wording is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>“5.1.3.1.</p></td><td><p>For materials belonging to CMCs 3, 5 and 12, as defined in Annex II, the examinations and tests shall comprise the following elements:”.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>Sub-points (b) and (c) are replaced by the following:</p><table><col/><col/><tbody><tr><td><p>“(b)</p></td><td><p>Qualified staff shall carry out a visual inspection of each consignment of input materials and verify compatibility with the specifications of input materials in CMCs 3, 5 and 12 laid down in Annex II.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>The manufacturer shall refuse any consignment of any given input material where visual inspection raises any suspicion of any of the following:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>the presence of hazardous or damageable substances for the process or for the quality of the final EU fertilising product;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>incompatibility with the specifications of CMCs 3, 5 and 12 in Annex II, in particular by presence of plastics leading to exceedance of the limit value for macroscopic impurities.”.</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>Sub-point (e) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>“(e)</p></td><td><p>Samples shall be taken on output materials, to verify that they comply with the specifications laid down in CMCs 3, 5 and 12, as defined in Annex II, and that the properties of the output material do not jeopardise the EU fertilising product’s compliance with the relevant requirements laid down in Annex I.”.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>In subpoint (f), the introductory wording is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>“(f)</p></td><td><p>For materials belonging to CMCs 3 and 5, the output material samples shall be taken on a regular basis with at least the following frequency:”.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>The following sub-points are inserted:</p><table><col/><col/><tbody><tr><td><p>“(fa)</p></td><td><p>For materials belonging to CMC 12, the output material samples shall be taken with at least the following default frequency, or sooner than scheduled if triggered by any significant change that may affect the quality of the EU fertilising product:</p><table><col/><col/><tbody><tr><td><p><span>Annual output (tonnes)</span></p></td><td><p><span>Samples/year</span></p></td></tr><tr><td><p>≤ 3 000</p></td><td><p>4</p></td></tr><tr><td><p>3 001 – 10 000</p></td><td><p>8</p></td></tr><tr><td><p>10 001 – 20 000</p></td><td><p>12</p></td></tr><tr><td><p>20 001 – 40 000</p></td><td><p>16</p></td></tr><tr><td><p>40 001 – 60 000</p></td><td><p>20</p></td></tr><tr><td><p>60 001 – 80 000</p></td><td><p>24</p></td></tr><tr><td><p>80 001 – 100 000</p></td><td><p>28</p></td></tr><tr><td><p>100 001 – 120 000</p></td><td><p>32</p></td></tr><tr><td><p>120 001 – 140 000</p></td><td><p>36</p></td></tr><tr><td><p>140 001 – 160 000</p></td><td><p>40</p></td></tr><tr><td><p>160 001 – 180 000</p></td><td><p>44</p></td></tr><tr><td><p>> 180 000</p></td><td><p>48</p></td></tr></tbody></table></td></tr></tbody></table><p>Manufacturers may reduce the default frequency of testing for contaminants as indicated above by considering the distribution of historical samples. After a minimum monitoring period of one year and a minimum number of 10 samples showing compliance with the requirements in Annex I and II, the manufacturer may reduce the default sampling frequency for that parameter by a factor 2 in case the greatest contaminant level recorded from the last 10 samples is smaller than half of the limit value for that parameter laid down in Annexes I and II.</p><p>(fb) For materials belonging to CMC 12, each batch or portion of production shall be assigned a unique code for quality management purposes. At least one sample per 3 000 tonnes of these materials or one sample per two months, whichever occurs soonest, shall be stored in good condition for a period of at least 2 years.”.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>In sub-point (g) (iii), “.” is replaced by “,” and the following sub-point (iv) is added:</p><table><col/><col/><tbody><tr><td><p>“(iv)</p></td><td><p>for materials belonging to CMC 12, measure retainer samples referred to in sub-point (fb) and take the necessary corrective actions to prevent possible further transport and use of that material.”.</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>In point 5.1.4.1, the introductory wording is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>“5.1.4.1.</p></td><td><p>For materials belonging to CMCs 3, 5 and 12, as defined in Annex II, the quality records shall demonstrate effective control of input materials, production, storage and compliance of input and output materials with the relevant requirements of this Regulation. Each document shall be legible and available at its relevant place(s) of use, and any obsolete version shall be promptly removed from all places where it is used, or at least identified as obsolete. The quality management documentation shall contain at least the following information:”.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>In point 5.1.5.1, the introductory wording is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>“5.1.5.1.</p></td><td><p>For materials belonging to CMCs 3, 5 and 12, as defined in Annex II, the manufacturer shall establish an annual internal audit program in order to verify the compliance of the quality system, with the following components:”.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Point 6.3.2 is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>“6.3.2.</p></td><td><p>For materials belonging to CMCs 3, 5 and 12, as defined in Annex II, the notified body shall take and analyse output material samples during each audit, and those audits shall be carried out with the following frequency:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>during the notified body’s first year of surveillance of the plant in question: the same frequency as the sampling frequency indicated in the tables included in points 5.1.3.1(f) and, respectively, 5.1.3.1(fa); and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>during the following years of surveillance: half the sampling frequency indicated in the table included in point 5.1.3.1(f) and, respectively, 5.1.3.1(fa).”.</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table> | ENG | 32021R2086 |
<table><col/><col/><col/><col/><tbody><tr><td><p>16.11.2018   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>C 417/11</p></td></tr></tbody></table>
DECISION OF THE AUTHORITY FOR EUROPEAN POLITICAL PARTIES AND EUROPEAN POLITICAL FOUNDATIONS
of 13 September 2018
to remove Alliance for Peace and Freedom from the Register
(Only the Dutch, French and German texts are authentic)
(2018/C 417/06)
THE AUTHORITY FOR EUROPEAN POLITICAL PARTIES AND EUROPEAN POLITICAL FOUNDATIONS,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to the Treaty establishing the European Atomic Energy Community,
Having regard to Regulation (EU, Euratom) No 1141/2014 of the European Parliament and of the Council of 22 October 2014 on the statute and funding of European political parties and European political foundations ( 1 ) , in particular Article 40a thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>On 11 September 2017, the Authority for European Political Parties and European Political Foundations (‘Authority’) received an application for registration as a European political party under Article 8(1) of Regulation (EU, Euratom) No 1141/2014 from Alliance for Peace and Freedom (‘APF’).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>On 13 September 2017, the European Commission put forward a proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU, Euratom) No 1141/2014 on the statute and funding of European political parties and European political foundations <a>(<span>2</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>On 9 February 2018, the Authority adopted a decision to register APF as a European political party (the ‘decision to register’). The decision to register was published in the<span>Official Journal of the European Union</span> on 6 June 2018, and APF acquired European legal personality on that date.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>On 3 May 2018, the European Parliament and the Council adopted Regulation (EU, Euratom) 2018/673 <a>(<span>3</span>)</a> amending Regulation (EU, Euratom) No 1141/2014. Regulation (EU, Euratom) 2018/673 entered into force on the day of its publication in the<span>Official Journal of the European Union</span>, i.e., 4 May 2018, and amended, among other things, the conditions applicants must satisfy to obtain registration as a European political party.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Pursuant to Article 40a(3) of Regulation (EU, Euratom) No 1141/2014, European political parties registered before 4 May 2018 were required to submit documents proving that they satisfied the conditions laid down in points (b) and (ba) of Article 3(1) of Regulation (EU, Euratom) No 1141/2014 as amended (the ‘amended conditions for registration’) by 5 July 2018 at the latest.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>On 4 May 2018, the Authority addressed to all registered European political parties a letter informing them of the conclusion of the legislative process leading to the adoption of Regulation (EU, Euratom) 2018/673 (the ‘letter of 4 May 2018’). The letter of 4 May 2018 set out the implications of the new legal framework and reminded European political parties of their obligation to submit documents proving that they satisfied the amended conditions for registration by 5 July 2018.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>On 22 June 2018, the Authority received a submission from Kotleba — L’udová Strana Naše Slovensko (‘LSNS’) stating, among other things, that LSNS is a member party of APF and is represented in the national council of the Slovak Republic.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>On 2 July 2018, the Authority received a submission from Nationaldemokratische Partei Deutschlands (‘NPD’) stating, among other things, that NPD is a member party of APF and is represented in the European Parliament.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>The Authority has received no further documentation from either APF or national political parties on behalf of APF for the purpose of proving that APF satisfied the amended conditions for registration by 5 July 2018.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>On 10 August 2018, the Authority sent APF a preliminary assessment to provide it with an opportunity to be heard pursuant to Article 34 of Regulation (EU, Euratom) No 1141/2014 with respect to the amended conditions for registration and its failure to produce sufficient documents by 5 July 2018.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>APF did not submit any observations in response to the Authority’s preliminary assessment of 10 August 2018.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>The Authority takes the view that APF failed to prove within the time limit set by the European legislator that it satisfied the amended conditions for registration. This is because APF has submitted insufficient documentation by 5 July 2018, i.e., documents originating from LSNS (Slovakia) and NPD (Germany) only. Those two submissions are insufficient to prove that APF satisfied the amended conditions for registration in at least one quarter of the Member States.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>The Authority also considers that an analysis of the merits of the submissions of LSNS and NPD is not necessary because, even if those submissions were in principle suitable for proving that APF satisfied the amended conditions for registration in two Members States, that would not change the fact that APF has submitted insufficient documentation by 5 July 2018.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>Pursuant to Article 40a(4) of Regulation (EU, Euratom) No 1141/2014, the Authority considers that APF failed to prove that it satisfied the amended conditions for registration by 5 July 2018 and that APF must therefore be removed from the Register,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
Alliance for Peace and Freedom is hereby removed from the Register.
Article 2
This Decision is addressed to
<table><col/><tbody><tr><td><p>Alliance for Peace and Freedom</p></td></tr><tr><td><p>Sentier de Montigny 16</p></td></tr><tr><td><p>6060 Gilly</p></td></tr><tr><td><p>Belgium</p></td></tr></tbody></table>
Done at Brussels, 13 September 2018.
For the Authority for European Political Parties and European Political Foundations
The Director
M. ADAM
<note>
( 1 ) OJ L 317, 4.11.2014, p. 1 .
( 2 ) COM/2017/0481 final — 2017/0219 (COD).
( 3 ) OJ L 114 I, 4.5.2018, p. 1 .
</note> | ENG | 32018D1116(02) |
02019R0816 — EN — 11.06.2019 — 001.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
<table><col/><col/><tr><td><p><a>►B</a></p></td><td><p>REGULATION (EU) 2019/816 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL</p><p>of 17 April 2019</p><p><a>establishing a centralised system for the identification of Member States holding conviction information on third-country nationals and stateless persons (ECRIS-TCN) to supplement the European Criminal Records Information System and amending Regulation (EU) 2018/1726</a></p><p>(OJ L 135 22.5.2019, p. 1)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p> </p></td><td><p> </p></td><td><p>Official Journal</p></td></tr><tr><td><p>  No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>►M1</a></p></td><td><p><a>REGULATION (EU) 2019/818 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 May 2019</a></p></td><td><p>  L 135</p></td><td><p>85</p></td><td><p>22.5.2019</p></td></tr></table>
REGULATION (EU) 2019/816 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 17 April 2019
establishing a centralised system for the identification of Member States holding conviction information on third-country nationals and stateless persons (ECRIS-TCN) to supplement the European Criminal Records Information System and amending Regulation (EU) 2018/1726
CHAPTER I
General provisions
Article 1
Subject matter
This Regulation establishes:
(a) a system to identify the Member States holding information on previous convictions of third-country nationals (‘ECRIS-TCN’);
(b) the conditions under which ECRIS-TCN shall be used by the central authorities in order to obtain information on such previous convictions through the European Criminal Records Information System (ECRIS) established by Decision 2009/316/JHA, as well as the conditions under which Eurojust, Europol and the EPPO shall use ECRIS-TCN;
(c) the conditions under which ECRIS-TCN contributes to facilitating and assisting in the correct identification of persons registered in ECRIS-TCN under the conditions and for the purposes of Article 20 of Regulation (EU) 2019/818 of the European Parliament and of the Council ( 1 ), by storing identity data, travel document data and biometric data in the CIR.
Article 2
Scope
This Regulation applies to the processing of identity information of third-country nationals who have been subject to convictions in the Member States for the purpose of identifying the Member States where such convictions were handed down. With the exception of point (b)(ii) of Article 5(1), the provisions of this Regulation that apply to third-country nationals also apply to citizens of the Union who also hold the nationality of a third country and who have been subject to convictions in the Member States. This Regulation also facilitates and assists in the correct identification of persons in accordance with this Regulation and with Regulation (EU) 2019/818.
Article 3
Definitions
For the purposes of this Regulation, the following definitions apply:
(1) ‘conviction’ means any final decision of a criminal court against a natural person in respect of a criminal offence, to the extent that the decision is entered in the criminal records of the convicting Member State;
(2) ‘criminal proceedings’ means the pre-trial stage, the trial stage and the execution of the conviction;
(3) ‘criminal record’ means the national register or registers recording convictions in accordance with national law;
(4) ‘convicting Member State’ means the Member State in which a conviction is handed down;
(5) ‘central authority’ means an authority designated in accordance with Article 3(1) of Framework Decision 2009/315/JHA;
(6) ‘competent authorities’ means the central authorities and Eurojust, Europol and the EPPO, which are competent to access or query ECRIS-TCN in accordance with this Regulation;
(7) ‘third-country national’ means a person who is not a citizen of the Union within the meaning of Article 20(1) TFEU, or who is a stateless person or a person whose nationality is unknown;
—————
(9) ‘interface software’ means the software hosted by the competent authorities allowing them to access the central system through the communication infrastructure referred to in point (d) of Article 4(1);
(10) ‘identity information’ means alphanumeric data, fingerprint data and facial images that are used to establish a connection between these data and a natural person;
(11) ‘alphanumeric data’ means data represented by letters, digits, special characters, spaces and punctuation marks;
(12) ‘fingerprint data’ means the data relating to plain and rolled impressions of the fingerprints of each of a person's fingers;
(13) ‘facial image’ means a digital image of a person's face;
(14) ‘hit’ means a match or matches established by comparison between identity information recorded in the central system and the identity information used for a search;
(15) ‘national central access point’ means the national connection point to the communication infrastructure referred to in point (d) of Article 4(1);
(16) ‘ECRIS reference implementation’ means the software developed by the Commission and made available to the Member States for the exchange of criminal records information through ECRIS;
(17) ‘national supervisory authority’ means an independent public authority which is established by a Member State pursuant to applicable Union data protection rules;
(18) ‘supervisory authorities’ means the European Data Protection Supervisor and the national supervisory authorities;
(19) ‘CIR’ means the common identity repository established by Article 17(1) of Regulation (EU) 2019/818;
(20) ‘ECRIS-TCN data’ means all data stored in the central system and in the CIR in accordance with Article 5;
(21) ‘ESP’ means the European search portal established by Article 6(1) of Regulation (EU) 2019/818.
Article 4
Technical architecture of ECRIS-TCN
1. ECRIS-TCN shall be composed of:
(a) a central system;
(aa) the CIR;
(b) a national central access point in each Member State;
(c) interface software enabling the connection of the competent authorities to the central system via the national central access points and the communication infrastructure referred to in point (d);
(d) a communication infrastructure between the central system and the national central access points;
(e) a communication infrastructure between the central system and the central infrastructures of the ESP and the CIR.
2. The central system shall be hosted by eu-LISA at its technical sites.
3. The interface software shall be integrated with the ECRIS reference implementation. The Member States shall use the ECRIS reference implementation or, in the situation and under the conditions set out in paragraphs 4 to 8, the national ECRIS implementation software to query ECRIS-TCN and to send subsequent requests for criminal records information.
4. The Member States which use their national ECRIS implementation software shall be responsible for ensuring that their national ECRIS implementation software allows their national criminal records authorities to use ECRIS-TCN, with the exception of the Interface Software, in accordance with this Regulation. For that purpose, they shall, before the date of start of operations of ECRIS-TCN in accordance with Article 35(4), ensure that their national ECRIS implementation software functions in accordance with the protocols and technical specifications established in the implementing acts referred to in Article 10, and with any further technical requirements established by eu-LISA pursuant to this Regulation based on those implementing acts.
5. For as long as they do not use the ECRIS reference implementation, Member States which use their national ECRIS implementation software shall also ensure the implementation of any subsequent technical adaptations to their national ECRIS implementation software required by any changes to the technical specifications established in the implementing acts referred to in Article 10, or changes to any further technical requirements established by eu-LISA pursuant to this Regulation based on those implementing acts, without undue delay.
6. The Member States which use their national ECRIS implementation software shall bear all the costs associated with the implementation, maintenance and further development of their national ECRIS implementation software and its interconnection with ECRIS-TCN, with the exception of the interface software.
7. If a Member State which uses its national ECRIS implementation software is unable to comply with its obligations under this Article, it shall be obliged to use the ECRIS reference implementation, including the integrated interface software, to make use of ECRIS-TCN.
8. In view of the assessment to be carried out by the Commission pursuant to point (b) of Article 36(10), the Member States concerned shall provide the Commission with all necessary information.
CHAPTER II
Entry and use of data by central authorities
Article 5
Data entry in ECRIS-TCN
1. For each convicted third-country national, the central authority of the convicting Member State shall create a data record in ECRIS-TCN. The data record shall include:
(a) as concerns alphanumeric data:
(i) information to be included unless, in individual cases, such information is not known to the central authority (obligatory information):
— surname (family name),
— first names (given names),
— date of birth,
— place of birth (town and country),
— nationality or nationalities,
— gender,
— previous names, if applicable,
— the code of the convicting Member State,
(ii) information to be included if it has been entered in the criminal record (optional information):
— parents' names,
(iii) information to be included if it is available to the central authority (additional information):
— identity number, or the type and number of the person's identification documents, as well as the name of the issuing authority,
— pseudonyms or aliases;
(b) as concerns fingerprint data:
(i) fingerprint data that have been collected in accordance with national law during criminal proceedings;
(ii) as a minimum, fingerprint data collected on the basis of either of the following criteria:
— where the third-country national has received a custodial sentence of at least 6 months;
— or — where the third-country national has been convicted of a criminal offence which is punishable under the law of the Member State by a custodial sentence of a maximum period of at least 12 months.
1a. The CIR shall contain the data referred to in point (b) of paragraph 1 and the following data of point (a) of paragraph 1: surname (family name), first names (given names), date of birth, place of birth (town and country), nationality or nationalities, gender, previous names, if applicable, where available pseudonyms or aliases, where available, the type and number of the person's travel documents, as well as the name of the issuing authority. The CIR may contain the data referred to in paragraph 3. The remaining ECRIS-TCN data shall be stored in the central system.
2. The fingerprint data referred to in point (b) of paragraph 1 of this Article shall have the technical specifications for the quality, resolution and processing of fingerprint data provided for in the implementing act referred to in point (b) of Article 10(1). The reference number of the fingerprint data of the convicted person shall include the code of the convicting Member State.
3. The data record may also contain facial images of the convicted third-country national, if the law of the convicting Member State allows for the collection and storage of facial images of convicted persons.
4. The convicting Member State shall create the data record automatically, where possible, and without undue delay after the conviction has been entered into the criminal records.
5. The convicting Member States shall also create data records for convictions handed down prior to the date of start of entry of data in accordance with Article 35(1) to the extent that data related to convicted persons are stored in their national databases. In those cases, fingerprint data shall be included only where they have been collected during criminal proceedings in accordance with national law, and where they can be clearly matched with other identity information in criminal records.
6. In order to comply with the obligations set out in points (b)(i) and (ii) of paragraph 1, and in paragraph 5, Member States may use fingerprint data collected for purposes other than criminal proceedings, where such use is permitted under national law.
Article 6
Facial images
1. Until the entry into force of the delegated act provided for in paragraph 2, facial images may be used only to confirm the identity of a third-country national who has been identified as a result of an alphanumeric search or a search using fingerprint data.
2. The Commission is empowered to adopt delegated acts in accordance with Article 37 supplementing this Regulation concerning the use of facial images for the purpose of identifying third-country nationals in order to identify the Member States holding information on previous convictions concerning such persons, when it becomes technically possible. Before exercising this empowerment, the Commission, taking into account necessity and proportionality, as well as technical developments in the field of facial recognition software, shall assess the availability and readiness of the required technology.
Article 7
Use of ECRIS-TCN for identifying the Member States holding criminal records information
1. The central authorities shall use ECRIS-TCN to identify the Member States holding criminal records information on a third-country national in order to obtain information on previous convictions through ECRIS, when criminal records information on that person is requested in the Member State concerned for the purposes of criminal proceedings against that person, or for any of the following purposes, if provided for under and in accordance with national law:
— checking a person's own criminal record at his or her request,
— security clearance,
— obtaining a licence or permit,
— employment vetting,
— vetting for voluntary activities involving direct and regular contacts with children or vulnerable persons,
— visa, acquisition of citizenship and migration procedures, including asylum procedures, and
— checks in relation with public contracts and public examinations.
However, in specific cases other than those in which a third-country national asks the central authority for information on his or her own criminal record, or where the request is made in order to obtain criminal records information pursuant to Article 10(2) of Directive 2011/93/EU, the authority requesting criminal records information may decide that such use of ECRIS-TCN is not appropriate.
2. Any Member State which decides, if provided for under and in accordance with national law, to use ECRIS-TCN for purposes other than those set out in paragraph 1 in order to obtain information on previous convictions through ECRIS, shall, by the date of start of operations as referred to in Article 35(4), or any time thereafter, notify the Commission of such other purposes and any changes to such purposes. The Commission shall publish such notifications in the Official Journal of the European Union within 30 days of receipt of the notifications.
3. Eurojust, Europol and the EPPO are entitled to query ECRIS-TCN to identify the Member States holding criminal records information on a third-country national in accordance with Articles 14 to 18. However, they shall not enter, rectify or erase any data in ECRIS-TCN.
4. For the purposes referred to in paragraphs 1, 2 and 3, the competent authorities may also query ECRIS-TCN to verify whether, in respect of a citizen of the Union, any Member State holds criminal records information concerning this person as a third-country national.
5. When querying ECRIS-TCN, the competent authorities may use all or only some of the data referred to in Article 5(1). The minimum set of data that is required to query the system shall be specified in an implementing act adopted in accordance with point (g) of Article 10(1).
6. The competent authorities may also query ECRIS-TCN using facial images, provided that such functionality has been implemented in accordance with Article 6(2).
7. In the event of a hit, the central system shall automatically provide the competent authority with information on the Member States holding criminal records information on the third-country national, along with the associated reference numbers and any corresponding identity information. Such identity information shall only be used for the purpose of verifying the identity of the third-country national concerned. The result of a search in the central system may only be used for the purpose of making a request according to Article 6 of Framework Decision 2009/315/JHA or a request referred to in Article 17(3) of this Regulation.
8. In the event that there is no hit, the central system shall automatically inform the competent authority.
CHAPTER III
Retention and modification of the data
Article 8
Retention period for data storage
1. Each data record shall be stored in the central system and the CIR for as long as the data related to the convictions of the person concerned are stored in the criminal records.
2. Upon expiry of the retention period referred to in paragraph 1, the central authority of the convicting Member State shall erase the data record, including any fingerprint data or facial images, from the central system and the CIR. The erasure shall be done automatically, where possible, and in any event no later than one month after the expiry of the retention period.
Article 9
Modification and erasure of data
1. The Member States may modify or erase the data which they have entered into the central system and the CIR .
2. Any modification of the information in the criminal records which led to the creation of a data record in accordance with Article 5 shall include identical modification of the information stored in that data record in the central system and the CIR by the convicting Member State without undue delay.
3. If a convicting Member State has reason to believe that the data it has recorded in the central system and the CIR are inaccurate or that data were processed in the central system and the CIR in contravention of this Regulation, it shall:
(a) immediately launch a procedure for checking the accuracy of the data concerned or the lawfulness of its processing, as appropriate;
(b) if necessary, rectify the data or erase them from the central system and the CIR without undue delay.
4. If a Member State other than the convicting Member State which entered the data has reason to believe that data recorded in the central system and the CIR are inaccurate or that data were processed in the central system and the CIR in contravention of this Regulation, it shall contact the central authority of the convicting Member State without undue delay.
The convicting Member State shall:
(a) immediately launch a procedure for checking the accuracy of the data concerned or the lawfulness of its processing, as appropriate;
(b) if necessary, rectify the data or erase them from the central system and the CIR without undue delay;
(c) inform the other Member State that the data have been rectified or erased, or of the reasons why the data have not been rectified or erased, without undue delay.
CHAPTER IV
Development, operation and responsibilities
Article 10
Adoption of implementing acts by the Commission
1. The Commission shall adopt the implementing acts necessary for the technical development and implementation of ECRIS-TCN as soon as possible, and in particular acts concerning:
(a) the technical specifications for the processing of the alphanumeric data;
(b) the technical specifications for the quality, resolution and processing of fingerprint data;
(c) the technical specifications of the interface software;
(d) the technical specifications for the quality, resolution and processing of facial images for the purposes of and under the conditions set out in Article 6;
(e) data quality, including a mechanism for and procedures to carry out data quality checks;
(f) entering the data in accordance with Article 5;
(g) accessing and querying ECRIS-TCN in accordance with Article 7;
(h) modifying and erasing the data in accordance with Articles 8 and 9;
(i) keeping and accessing logs in accordance with Article 31;
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(k) providing statistics in accordance with Article 32;
(l) performance and availability requirements of ECRIS-TCN, including minimal specifications and requirements on the biometric performance of ECRIS-TCN in particular in terms of the required false positive identification rate and false negative identification rate.
2. The implementing acts referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in Article 38(2).
Article 11
Development and operational management of ECRIS — TCN
1. eu-LISA shall be responsible for the development of ECRIS-TCN in accordance with the principle of data protection by design and by default. In addition, eu-LISA shall be responsible for the operational management of ECRIS-TCN. The development shall consist of the elaboration and implementation of the technical specifications, testing and overall project coordination.
2. eu-LISA shall also be responsible for the further development and maintenance of the ECRIS reference implementation.
3. eu-LISA shall define the design of the physical architecture of ECRIS-TCN including its technical specifications and evolution as regards the central system, the national central access point and the interface software. That design shall be adopted by its Management Board, subject to a favourable opinion of the Commission.
4. eu-LISA shall develop and implement ECRIS-TCN as soon as possible after the entry into force of this Regulation and following the adoption by the Commission of the implementing acts provided for in Article 10.
5. Prior to the design and development phase of ECRIS-TCN, the Management Board of eu-LISA shall establish a Programme Management Board composed of ten members.
The Programme Management Board shall be composed of eight members appointed by the Management Board, the Chair of the Advisory Group referred to in Article 39 and one member appointed by the Commission. The members appointed by the Management Board shall be elected only from those Member States which are fully bound under Union law by the legislative instruments governing ECRIS and which will participate in ECRIS-TCN. The Management Board shall ensure that the members it appoints to the Programme Management Board have the necessary experience and expertise in the development and management of IT systems supporting judicial and criminal records authorities.
eu-LISA shall participate in the work of the Programme Management Board. To that end, representatives of eu-LISA shall attend the meetings of the Programme Management Board in order to report on work regarding the design and development of ECRIS-TCN and on any other related work and activities.
The Programme Management Board shall meet at least once every three months, and more often when necessary. It shall ensure the adequate management of the design and development phase of ECRIS-TCN and shall ensure consistency between central and national ECRIS-TCN projects, and national ECRIS implementation software. The Programme Management Board shall submit written reports regularly and if possible every month to the Management Board of eu-LISA on the progress of the project. The Programme Management Board shall have no decision-making power nor any mandate to represent the members of the Management Board.
6. The Programme Management Board shall establish its rules of procedure which shall include in particular rules on:
(a) chairmanship;
(b) meeting venues;
(c) preparation of meetings;
(d) admission of experts to the meetings;
(e) communication plans ensuring that non-participating Members of the Management Board are kept fully informed.
7. The chairmanship of the Programme Management Board shall be held by a Member State which is fully bound under Union law by the legislative instruments governing ECRIS and the legislative instruments governing the development, establishment, operation and use of all the large-scale IT systems managed by eu-LISA.
8. All travel and subsistence expenses incurred by the members of the Programme Management Board shall be paid by eu-LISA. Article 10 of the eu-LISA Rules of Procedure shall apply mutatis mutandis . The Programme Management Board's secretariat shall be ensured by eu-LISA.
9. During the design and development phase, the Advisory Group referred to in Article 39 shall be composed of the national ECRIS-TCN project managers and chaired by eu-LISA. During the design and development phase it shall meet regularly, if possible at least once a month, until the start of operations of ECRIS-TCN. It shall report after each meeting to the Programme Management Board. It shall provide the technical expertise to support the tasks of the Programme Management Board and shall follow up on the state of preparation of the Member States.
10. In order to ensure the confidentiality and integrity of data stored in ECRIS-TCN at all times, eu-LISA shall, in cooperation with the Member States, provide for appropriate technical and organisational measures, taking into account the state of the art, the cost of implementation and the risks posed by the processing.
11. eu-LISA shall be responsible for the following tasks related to the communication infrastructure referred to in point (d) of Article 4(1):
(a) supervision;
(b) security;
(c) the coordination of relations between the Member States and the provider of the communication infrastructure.
12. The Commission shall be responsible for all other tasks relating to the communication infrastructure referred to in point (d) of Article 4(1), in particular:
(a) tasks relating to the implementation of the budget;
(b) acquisition and renewal;
(c) contractual matters.
13. eu-LISA shall develop and maintain a mechanism and procedures for carrying out quality checks on the data stored in ECRIS-TCN and shall provide regular reports to the Member States. eu-LISA shall provide regular reports to the Commission covering the issues encountered and the Member States concerned.
14. The operational management of ECRIS-TCN shall consist of all the tasks necessary to keep ECRIS-TCN operational in accordance with this Regulation, and in particular the maintenance work and technical developments necessary to ensure that ECRIS-TCN functions at a satisfactory level in accordance with the technical specifications.
15. eu-LISA shall perform tasks related to providing training on the technical use of ECRIS-TCN and the ECRIS reference implementation.
16. Without prejudice to Article 17 of the Staff Regulations of Officials of the European Union, laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 ( 2 ), eu-LISA shall apply appropriate rules of professional secrecy or other equivalent duties of confidentiality to its entire staff required to work with data registered in the central system. That obligation shall also apply after such staff leave office or employment or after the termination of their activities.
Article 12
Responsibilities of the Member States
1. Each Member State shall be responsible for:
(a) ensuring a secure connection between its national criminal records and fingerprints databases and the national central access point;
(b) the development, operation and maintenance of the connection referred to in point (a);
(c) ensuring a connection between its national systems and the ECRIS reference implementation;
(d) the management of and arrangements for access of duly authorised staff of the central authorities to ECRIS-TCN in accordance with this Regulation and for establishing and regularly updating a list of such staff and the profiles referred to in point (g) of Article 19(3).
2. Each Member State shall give the staff of its central authority who have a right to access ECRIS-TCN appropriate training covering, in particular, data security and data protection rules and applicable fundamental rights, before authorising them to process data stored in the the central system and the CIR .
Article 13
Responsibility for the use of data
1. In accordance with applicable Union data protection rules, each Member State shall ensure that the data recorded in ECRIS-TCN are processed lawfully, and in particular that:
(a) only duly authorised staff have access to the data for the performance of their tasks;
(b) the data are collected lawfully in a manner that fully respects the human dignity and fundamental rights of the third-country national;
(c) the data are entered into ECRIS-TCN lawfully;
(d) the data are accurate and up-to-date when they are entered into ECRIS-TCN.
2. eu-LISA shall ensure that ECRIS-TCN is operated in accordance with this Regulation, with the delegated act referred to in Article 6(2) and with the implementing acts referred to in Article 10, as well as in accordance with Regulation (EU) 2018/1725. In particular, eu-LISA shall take the necessary measures to ensure the security of the central system, the CIR and the communication infrastructure referred to in point (d) of Article 4(1), without prejudice to the responsibilities of each Member State.
3. eu-LISA shall inform the European Parliament, the Council and the Commission as well as the European Data Protection Supervisor as soon as possible of the measures it takes pursuant to paragraph 2 in view of the start of operations of ECRIS-TCN.
4. The Commission shall make the information referred to in paragraph 3 available to the Member States and to the public through a regularly updated public website.
Article 14
Access for Eurojust, Europol, and the EPPO
1. Eurojust shall have direct access to ECRIS-TCN for the purpose of the implementation of Article 17, as well as for fulfilling its tasks under Article 2 of Regulation (EU) 2018/1727, in order to identify the Member States holding information on previous convictions of third-country nationals.
2. Europol shall have direct access to ECRIS-TCN for the purpose of fulfilling its tasks under points (a) to (e) and (h) of Article 4(1) of Regulation (EU) 2016/794, in order to identify the Member States holding information on previous convictions of third-country nationals.
3. The EPPO shall have direct access to ECRIS-TCN for the purpose of fulfilling its tasks under Article 4 of Regulation (EU) 2017/1939, in order to identify the Member States holding information on previous convictions of third-country nationals.
4. Following a hit indicating the Member States holding criminal records information on a third-country national, Eurojust, Europol, and the EPPO may use their respective contacts with the national authorities of those Member States to request the criminal records information in the manner provided for in their respective founding acts.
Article 15
Access by authorised staff of Eurojust, Europol and the EPPO
Eurojust, Europol and the EPPO shall be responsible for the management of and arrangements for access of duly authorised staff to ECRIS-TCN in accordance with this Regulation and for establishing and regularly updating a list of such staff and their profiles.
Article 16
Responsibilities of Eurojust, Europol and the EPPO
Eurojust, Europol and the EPPO shall:
(a) establish the technical means to connect to ECRIS-TCN and be responsible for maintaining that connection;
(b) provide appropriate training covering, in particular, data security and data protection rules and applicable fundamental rights to those members of their staff who have a right to access ECRIS-TCN before authorising them to process data stored in the central system;
(c) ensure that the personal data processed by them under this Regulation is protected in accordance with the applicable data protection rules.
Article 17
Contact point for third countries and international organisations
1. Third countries and international organisations may, for the purposes of criminal proceedings, address requests for information on which Member States, if any, hold criminal records information on a third-country national to Eurojust. To that end, they shall use the standard form set out in the Annex to this Regulation.
2. When Eurojust receives a request under paragraph 1, it shall use ECRIS-TCN to identify which Member States, if any, hold criminal records information on the third-country national concerned.
3. If there is a hit, Eurojust shall ask the Member State that holds criminal records information on the third-country national concerned whether it consents to Eurojust informing the third country or the international organisation of the name of the Member State concerned. Where that Member State gives its consent, Eurojust shall inform the third country or the international organisation of the name of that Member State, and of how it can introduce a request for extracts from the criminal records with that Member State in accordance with the applicable procedures.
4. In cases where there is no hit or where Eurojust cannot provide an answer in accordance with paragraph 3 to requests made under this Article, it shall inform the third country or international organisation concerned that it has completed the procedure, without providing any indication of whether criminal records information on the person concerned is held by one of the Member States.
Article 18
Providing information to a third country, international organisation or private party
Neither Eurojust, Europol, the EPPO nor any central authority shall transfer or make available to a third country, an international organisation or a private party information obtained from ECRIS-TCN concerning a third-country national. This Article shall be without prejudice to Article 17(3).
Article 19
Data Security
1. eu-LISA shall take the necessary measures to ensure the security of ECRIS-TCN, without prejudice to the responsibilities of each Member State, taking the security measures specified in paragraph 3 into consideration.
2. As regards the operation of ECRIS-TCN, eu-LISA shall take the necessary measures in order to achieve the objectives set out in paragraph 3, including the adoption of a security plan and a business continuity and disaster recovery plan, and to ensure that installed systems may, in case of interruption, be restored.
3. The Member States shall ensure the security of the data before and during the transmission to and receipt from the national central access point. In particular, each Member State shall:
(a) physically protect data, including by making contingency plans for the protection of infrastructure;
(b) deny unauthorised persons access to national installations in which the Member State carries out operations related to ECRIS-TCN;
(c) prevent the unauthorised reading, copying, modification or removal of data media;
(d) prevent the unauthorised input of data and the unauthorised inspection, modification or erasure of stored personal data;
(e) prevent the unauthorised processing of data in ECRIS-TCN and any unauthorised modification or erasure of data processed in ECRIS-TCN;
(f) ensure that persons authorised to access ECRIS-TCN have access only to the data covered by their access authorisation, by means of individual user identities and confidential access modes only;
(g) ensure that all authorities with a right of access to ECRIS-TCN create profiles describing the functions and responsibilities of persons who are authorised to enter, rectify, erase, consult and search the data and make their profiles available to the national supervisory authorities without undue delay at their request;
(h) ensure that it is possible to verify and establish to which Union bodies, offices and agencies personal data may be transmitted using data communication equipment;
(i) ensure that it is possible to verify and establish what data have been processed in ECRIS-TCN, when, by whom and for what purpose;
(j) prevent the unauthorised reading, copying, modification or erasure of personal data during the transmission of personal data to or from ECRIS-TCN or during the transport of data media, in particular by means of appropriate encryption techniques;
(k) monitor the effectiveness of the security measures referred to in this paragraph and take the necessary organisational measures related to self-monitoring and supervision to ensure compliance with this Regulation.
4. eu-LISA and the Member States shall cooperate in order to ensure a coherent data security approach based on a security risk management process encompassing the entire ECRIS-TCN.
Article 20
Liability
1. Any person who, or any Member State which, has suffered material or non-material damage as a result of an unlawful processing operation or any other act incompatible with this Regulation shall be entitled to receive compensation from:
(a) the Member State which is responsible for the damage suffered; or
(b) eu-LISA, where eu-LISA has not complied with its obligations set out in this Regulation or in Regulation (EU) 2018/1725.
The Member State which is responsible for the damage suffered or eu-LISA, respectively, shall be exempted from liability, in whole or in part, if it proves that it is not responsible for the event which gave rise to the damage.
2. If any failure of a Member State, Eurojust, Europol, or the EPPO to comply with its obligations under this Regulation causes damage to ECRIS-TCN, that Member State, Eurojust, Europol, or the EPPO, respectively, shall be held liable for such damage, unless and insofar as eu-LISA or another Member State participating in ECRIS-TCN failed to take reasonable measures to prevent the damage from occurring or to minimise its impact.
3. Claims for compensation against a Member State for the damage referred to in paragraphs 1 and 2 shall be governed by the law of the defendant Member State. Claims for compensation against eu-LISA, Eurojust, Europol and the EPPO for the damage referred to in paragraphs 1 and 2 shall be governed by their respective founding acts.
Article 21
Self-monitoring
Member States shall ensure that each central authority takes the measures necessary to comply with this Regulation and cooperates, where necessary, with the supervisory authorities.
Article 22
Penalties
Any misuse of data entered in ECRIS-TCN shall be subject to penalties or disciplinary measures, in accordance with national or Union law, that are effective, proportionate and dissuasive.
CHAPTER V
Data protection rights and supervision
Article 23
Data controller and data processor
1. Each central authority is to be considered as data controller in accordance with applicable Union data protection rules for the processing of the personal data by that central authority's Member State under this Regulation.
2. eu-LISA shall be considered as data processor in accordance with Regulation (EU) 2018/1725 as regards the personal data entered into the central system and the CIR by the Member States.
Article 24
Purpose of the processing of personal data
1. The data entered into the central system and the CIR shall only be processed for the purposes of the identification of the Member States holding the criminal records information of third-country nationals. The data entered into the CIR shall also be processed in accordance with Regulation (EU) 2019/818 for facilitating and assisting in the correct identification of persons registered in the ECRIS-TCN in accordance with this Regulation.
2. With the exception of duly authorised staff of Eurojust, Europol and the EPPO who have access to ECRIS-TCN for the purposes of this Regulation, access to ECRIS-TCN shall be reserved exclusively to duly authorised staff of the central authorities. Access shall be limited to the extent needed for the performance of the tasks in accordance with the purpose referred to in paragraph 1, and to what is necessary and proportionate to the objectives pursued.
3. Without prejudice to paragraph 2, access for the purposes of consulting the data stored in the CIR shall also be reserved for the duly authorised staff of the national authorities of each Member State and for the duly authorised staff of the Union agencies that are competent for the purposes laid down in Articles 20 and 21 of Regulation (EU) 2019/818. Such access shall be limited according to the extent that the data are required for the performance of their tasks for those purposes, and proportionate to the objectives pursued.
Article 25
Right of access, rectification, erasure and restriction of processing
1. The requests of third-country nationals concerning the rights of access to personal data, to rectification and erasure and to restriction of processing of personal data which are set out in the applicable Union data protection rules may be addressed to the central authority of any Member State.
2. Where a request is made to a Member State other than the convicting Member State, the Member State to which the request has been made shall forward it to the convicting Member State without undue delay and in any event within 10 working days of receiving the request. Upon receipt of the request, the convicting Member State shall:
(a) immediately launch a procedure for checking the accuracy of the data concerned and the lawfulness of its processing in ECRIS-TCN; and
(b) respond to the Member State that forwarded the request without undue delay.
3. In the event that data recorded in ECRIS-TCN are inaccurate or have been processed unlawfully, the convicting Member State shall rectify or erase the data in accordance with Article 9. The convicting Member State or, where applicable, the Member State to which the request has been made shall confirm in writing to the person concerned without undue delay that action has been taken to rectify or erase data relating to that person. The convicting Member State shall also without undue delay inform any other Member State which has been a recipient of conviction information obtained as a result of a query of ECRIS-TCN of what action has been taken.
4. If the convicting Member State does not agree that data recorded in ECRIS-TCN are inaccurate or have been processed unlawfully, that Member State shall adopt an administrative or judicial decision explaining in writing to the person concerned why it is not prepared to rectify or erase data relating to him or her. Such cases may, where appropriate, be communicated to the national supervisory authority.
5. The Member State which has adopted the decision pursuant to paragraph 4 shall also provide the person concerned with information explaining the steps which that person can take if the explanation given pursuant to paragraph 4 is not acceptable to him or her. This shall include information on how to bring an action or a complaint before the competent authorities or courts of that Member State and any assistance, including from the national supervisory authorities, that is available in accordance with the national law of that Member State.
6. Any request made pursuant to paragraph 1 shall contain the information necessary to identify the person concerned. That information shall be used exclusively to enable the exercise of the rights referred to in paragraph 1 and shall be erased immediately afterwards.
7. Where paragraph 2 applies, the central authority to whom the request was addressed shall keep a written record that such a request was made and of how it was addressed and to which authority it was forwarded. Upon request from the national supervisory authority, the central authority shall make that record available to that national supervisory authority without delay. The central authority and the national supervisory authority shall erase such records three years after their creation.
Article 26
Cooperation to ensure respect for data protection rights
1. The central authorities shall cooperate with each other in order to ensure respect for the rights laid down in Article 25.
2. In each Member State, the national supervisory authority shall, upon request, provide information to the person concerned on how to exercise his or her right to rectify or erase data relating to him or to her, in accordance with the applicable Union data protection rules.
3. For the purposes of this Article, the national supervisory authority of the Member State which transmitted the data and the national supervisory authority of the Member State to which the request has been made shall cooperate with each other.
Article 27
Remedies
Any person shall have the right to lodge a complaint and the right to a legal remedy in the convicting Member State which refused the right of access to or the right of rectification or erasure of data relating to him or to her, referred to in Article 25 in accordance with national or Union law.
Article 28
Supervision by the national supervisory authorities
1. Each Member State shall ensure that the national supervisory authorities designated pursuant to applicable Union data protection rules shall monitor the lawfulness of the processing of personal data referred to in Articles 5 and 6 by the Member State concerned, including their transmission to and from ECRIS-TCN.
2. The national supervisory authority shall ensure that an audit of the data processing operations in the national criminal records and fingerprints databases related to the data exchange between those systems and ECRIS-TCN is carried out in accordance with relevant international auditing standards at least every three years from the date of the start of operations of ECRIS-TCN.
3. Member States shall ensure that their national supervisory authorities have sufficient resources to fulfil the tasks entrusted to them under this Regulation.
4. Each Member State shall supply any information requested by its national supervisory authorities and shall, in particular, provide them with information on the activities carried out in accordance with Articles 12, 13 and 19. Each Member State shall grant its national supervisory authorities access to its records pursuant to Article 25(7) and to its logs pursuant to Article 31(6) and allow them access at all times to all its ECRIS-TCN related premises.
Article 29
Supervision by the European Data Protection Supervisor
1. The European Data Protection Supervisor shall monitor that the personal data processing activities of eu-LISA concerning ECRIS-TCN are carried out in accordance with this Regulation.
2. The European Data Protection Supervisor shall ensure that an audit of eu-LISA's personal data processing activities is carried out in accordance with relevant international auditing standards at least every three years. A report of that audit shall be sent to the European Parliament, the Council, the Commission, eu-LISA and the supervisory authorities. eu-LISA shall be given an opportunity to make comments before the report is adopted.
3. eu-LISA shall supply information requested by the European Data Protection Supervisor, give him or her access to all documents and to its logs referred to in Article 31 and allow him or her access to all of its premises at any time.
Article 30
Cooperation among national supervisory authorities and the European Data Protection Supervisor
Coordinated supervision of ECRIS-TCN shall be ensured in accordance with Article 62 of Regulation (EU) 2018/1725.
Article 31
Keeping of logs
1. eu-LISA and the competent authorities shall ensure, in accordance with their respective responsibilities, that all data processing operations in ECRIS-TCN are logged in accordance with paragraph 2 for the purposes of checking the admissibility of requests, monitoring data integrity and security and the lawfulness of the data processing as well as for the purposes of self-monitoring.
2. The log shall show:
(a) the purpose of the request for access to ECRIS-TCN data;
(b) the data transmitted as referred to in Article 5;
(c) the national file reference;
(d) the date and exact time of the operation;
(e) the data used for a query;
(f) the identifying mark of the official who carried out the search.
3. The log of consultations and disclosures shall make it possible to establish the justification of such operations.
4. Logs shall be used only for monitoring the lawfulness of data processing and for ensuring data integrity and security. Only logs containing non-personal data may be used for the monitoring and evaluation referred to in Article 36. Those logs shall be protected by appropriate measures against unauthorised access and erased after three years, if they are no longer required for monitoring procedures which have already begun.
5. On request, eu-LISA shall make the logs of its processing operations available to the central authorities without undue delay.
6. The competent national supervisory authorities responsible for checking the admissibility of the requests and monitoring the lawfulness of the data processing and data integrity and security shall have access to logs at their request for the purpose of fulfilling their duties. On request, the central authorities shall make the logs of their processing operations available to the competent national supervisory authorities without undue delay.
CHAPTER VI
Final provisions
Article 32
Use of data for reporting and statistics
1. The duly authorised staff of eu-LISA, of the competent authorities and of the Commission shall have access to the data processed within ECRIS-TCN solely for the purposes of reporting and providing statistics, without allowing for individual identification.
2. For the purpose of paragraph 1 of this Article, eu-LISA shall store the data referred to in that paragraph in the central repository for reporting and statistics referred to in Article 39 of Regulation (EU) 2019/818.
3. The procedures put in place by eu-LISA to monitor the functioning of ECRIS-TCN referred to in Article 36 as well as the ECRIS reference implementation shall include the possibility to produce regular statistics for monitoring purposes.
Every month eu-LISA shall submit to the Commission statistics relating to the recording, storage and exchange of information extracted from criminal records through ECRIS-TCN and the ECRIS reference implementation. eu-LISA shall ensure that it is not possible to identify individuals on the basis of those statistics. At the request of the Commission, eu-LISA shall provide it with statistics on specific aspects related to the implementation of this Regulation.
4. The Member States shall provide eu-LISA with the statistics necessary to fulfil its obligations referred to in this Article. They shall provide the Commission with statistics on the number of convicted third-country nationals, as well as the number of convictions of third-country nationals on their territory.
Article 33
Costs
1. The costs incurred in connection with the establishment and operation of the central system, the CIR and , the communication infrastructure referred to in point (d) of Article 4(1), the interface software and the ECRIS reference implementation shall be borne by the general budget of the Union.
2. The costs of connection of Eurojust, Europol and the EPPO to ECRIS-TCN shall be borne by their respective budgets.
3. Other costs shall be borne by the Member States, specifically the costs incurred by the connection of the existing national criminal records registers, fingerprints databases and the central authorities to ECRIS-TCN, as well as the costs of hosting the ECRIS reference implementation.
Article 34
Notifications
1. Each Member State shall notify eu-LISA of its central authority, or authorities, that has access to enter, rectify, erase, consult or search data, as well as of any change in this respect.
2. eu-LISA shall ensure publication of the list of central authorities notified by the Member States, both in the Official Journal of the European Union and on its website. When eu-LISA receives notification of a change to a Member State's central authority, it shall update the list without undue delay.
Article 35
Entry of data and start of operations
1. Once the Commission is satisfied that the following conditions are met, it shall determine the date from which the Member States shall start entering the data referred to in Article 5 into ECRIS-TCN:
(a) the relevant implementing acts referred to in Article 10 have been adopted;
(b) the Member States have validated the technical and legal arrangements to collect and transmit the data referred to in Article 5 to ECRIS-TCN and have notified them to the Commission;
(c) eu-LISA has carried out a comprehensive test of ECRIS-TCN, in cooperation with the Member States, using anonymous test data.
2. When the Commission has determined the date of start of entry of data in accordance with paragraph 1, it shall communicate that date to the Member States. Within a period of two months following that date, the Member States shall enter the data referred to in Article 5 into ECRIS-TCN, taking account of Article 41(2).
3. After the end of the period referred to in paragraph 2, eu-LISA shall carry out a final test of ECRIS-TCN, in cooperation with the Member States.
4. When the test referred to in paragraph 3 has been successfully completed and eu-LISA considers that ECRIS-TCN is ready to start operations, it shall notify the Commission. The Commission shall inform the European Parliament and the Council of the results of the test and shall decide on the date on which ECRIS-TCN is to start operations.
5. The decision of the Commission on the date of the start of operations of ECRIS-TCN, as referred to in paragraph 4, shall be published in the Official Journal of the European Union .
6. The Member States shall start using ECRIS-TCN from the date determined by the Commission in accordance with paragraph 4.
7. When taking the decisions referred to in this Article, the Commission may specify different dates for the entry into ECRIS-TCN of alphanumeric data and fingerprint data as referred to in Article 5, as well as for the start of operations with respect to those different categories of data.
Article 36
Monitoring and evaluation
1. eu-LISA shall ensure that procedures are in place to monitor the development of ECRIS-TCN in light of objectives relating to planning and costs and to monitor the functioning of ECRIS-TCN and the ECRIS reference implementation in light of objectives relating to the technical output, cost-effectiveness, security and quality of service.
2. For the purposes of monitoring the functioning of ECRIS-TCN and its technical maintenance, eu-LISA shall have access to the necessary information relating to the data processing operations performed in ECRIS-TCN and in the ECRIS reference implementation.
3. By 12 December 2019 and every six months thereafter during the design and development phase, eu-LISA shall submit a report to the European Parliament and the Council on the state of play of the development of ECRIS-TCN and of the ECRIS reference implementation.
4. The report referred to in paragraph 3 shall include an overview of the current costs and the progress of the project, a financial impact assessment, and information on any technical problems and risks that may impact the overall costs of ECRIS-TCN to be borne by the general budget of the Union in accordance with Article 33.
5. In the event of substantial delays in the development process, eu-LISA shall inform the European Parliament and the Council as soon as possible of the reasons for these delays and of their impact in terms of time and finances.
6. Once the development of ECRIS-TCN and of the ECRIS reference implementation is finalised, eu-LISA shall submit a report to the European Parliament and to the Council explaining how the objectives, in particular relating to planning and costs, were achieved and justifying any divergences.
7. In the event of a technical upgrade of ECRIS-TCN which could result in substantial costs, eu-LISA shall inform the European Parliament and the Council.
8. Two years after the start of operations of ECRIS-TCN and every year thereafter, eu-LISA shall submit to the Commission a report on the technical functioning of ECRIS-TCN and of the ECRIS reference implementation, including their security, based in particular on the statistics on the functioning and use of ECRIS-TCN and on the exchange, through the ECRIS reference implementation, of information extracted from the criminal records.
9. Four years after the start of operations of ECRIS-TCN and every four years thereafter, the Commission shall conduct an overall evaluation of ECRIS-TCN and of the ECRIS reference implementation. The overall evaluation report established on this basis shall include an assessment of the application of this Regulation and an examination of results that have been achieved relative to the objectives that were set and of the impact on fundamental rights. The report shall also include an assessment of whether the underlying rationale for operating ECRIS-TCN continues to hold, of the appropriateness of the use of biometric data for the purposes of ECRIS-TCN, of the security of ECRIS-TCN and of any security implications for future operations. The evaluation shall include any necessary recommendations. The Commission shall transmit the report to the European Parliament, the Council, the European Data Protection Supervisor and the European Union Agency for Fundamental Rights.
10. In addition, the first overall evaluation as referred to in paragraph 9 shall include an assessment of:
(a) the extent to which, on the basis of relevant statistical data and further information from the Member States, the inclusion in ECRIS-TCN of identity information of citizens of the Union who also hold the nationality of a third country has contributed to the achievement of the objectives of this Regulation;
(b) the possibility, for some Member States, to continue the use of national ECRIS implementation software, as referred to in Article 4;
(c) the entry of fingerprint data into ECRIS-TCN, in particular the application of the minimum criteria as referred to in point (b)(ii) of Article 5(1);
(d) the impact of ECRIS and of ECRIS-TCN on the protection of personal data.
The assessment may be accompanied, if necessary, by legislative proposals. Subsequent overall evaluations may include an assessment of any or all of those aspects.
11. The Member States, Eurojust, Europol and the EPPO shall provide eu-LISA and the Commission with the information necessary to draft the reports referred to in paragraphs 3, 8 and 9 according to the quantitative indicators predefined by the Commission or eu-LISA or both. That information shall not jeopardise working methods or include information that reveals sources, staff members or investigations.
12. Where relevant, the supervisory authorities shall provide eu-LISA and the Commission with the information necessary to draft the reports referred to in paragraph 9 according to the quantitative indicators predefined by the Commission or eu-LISA or both. That information shall not jeopardise working methods or include information that reveals sources, staff members or investigations.
13. eu-LISA shall provide the Commission with the information necessary to produce the overall evaluations referred to in paragraph 9.
Article 37
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 6(2) shall be conferred on the Commission for an indeterminate period of time from 11 June 2019.
3. The delegation of power referred to in Article 6(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. A delegated act adopted pursuant to Article 6(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 38
Committee procedure
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Article 39
Advisory Group
eu-LISA shall establish an Advisory Group in order to obtain expertise related to ECRIS-TCN and the ECRIS reference implementation, in particular in the context of preparation of its annual work programme and its annual activity report. During the design and development phase, Article 11(9) shall apply.
Article 40
Amendments to Regulation (EU) 2018/1726
Regulation (EU) 2018/1726 is amended as follows:
(1) In Article 1, paragraph 4 is replaced by the following:
‘4. The Agency shall be responsible for the preparation, development or operational management of the Entry/Exit System (EES), DubliNet, the European Travel Information and Authorisation System (ETIAS), ECRIS-TCN and the ECRIS reference implementation.’;
(2) The following Article is inserted:
‘Article 8a
Tasks related to ECRIS-TCN and the ECRIS reference implementation
In relation to ECRIS-TCN and the ECRIS reference implementation, the Agency shall perform:
(a) the tasks conferred on it by Regulation (EU) 2019/816 of the European Parliament and of the Council ( *1 );
(b) tasks relating to training on the technical use of ECRIS-TCN and the ECRIS reference implementation.
(3) In Article 14, paragraph 1 is replaced by the following:
‘1. The Agency shall monitor developments in research relevant for the operational management of SIS II, VIS, Eurodac, the EES, ETIAS, DubliNet, ECRIS-TCN and other large-scale IT systems as referred to in Article 1(5).’;
(4) In Article 19, paragraph 1 is amended as follows:
(a) point (ee) is replaced by the following:
‘(ee) adopt the reports on the development of the EES pursuant to Article 72(2) of Regulation (EU) 2017/2226, the reports on the development of ETIAS pursuant to Article 92(2) of Regulation (EU) 2018/1240 and the reports on the development of ECRIS-TCN and of the ECRIS reference implementation pursuant to Article 36(3) of Regulation (EU) 2019/816;’;
(b) point (ff) is replaced by the following:
‘(ff) adopt the reports on the technical functioning of SIS II pursuant to Article 50(4) of Regulation (EC) No 1987/2006 and Article 66(4) of Decision 2007/533/JHA respectively, of VIS pursuant to Article 50(3) of Regulation (EC) No 767/2008 and Article 17(3) of Decision 2008/633/JHA, of the EES pursuant to Article 72(4) of Regulation (EU) 2017/2226, of ETIAS pursuant to Article 92(4) of Regulation (EU) 2018/1240, and of ECRIS-TCN and of the ECRIS reference implementation pursuant to Article 36(8) of Regulation (EU) 2019/816;’;
(c) point (hh) is replaced by the following:
‘(hh) adopt formal comments on the European Data Protection Supervisor's reports on the audits carried out pursuant to Article 45(2) of Regulation (EC) No 1987/2006, Article 42(2) of Regulation (EC) No 767/2008 and Article 31(2) of Regulation (EU) No 603/2013, Article 56(2) of Regulation (EU) 2017/2226, Article 67 of Regulation (EU) 2018/1240 and to Article 29(2) of Regulation (EU) 2019/816 and ensure appropriate follow-up of those audits;’;
(d) the following point is inserted:
‘(lla) submit to the Commission statistics related to ECRIS-TCN and to the ECRIS reference implementation pursuant to the second subparagraph of Article 32(3) of Regulation (EU) 2019/816;’;
(e) point (mm) is replaced by the following:
‘(mm) ensure annual publication of the list of competent authorities authorised to search directly the data contained in SIS II pursuant to Article 31(8) of Regulation (EC) No 1987/2006 and Article 46(8) of Decision 2007/533/JHA, together with the list of Offices of the national systems of SIS II (N.SIS II Offices) and SIRENE Bureaux pursuant to Article 7(3) of Regulation (EC) No 1987/2006 and Article 7(3) of Decision 2007/533/JHA respectively as well as the list of competent authorities pursuant to Article 65(2) of Regulation (EU) 2017/2226, the list of competent authorities pursuant to Article 87(2) of Regulation (EU) 2018/1240 and the list of central authorities pursuant to Article 34(2) of Regulation (EU) 2019/816;’;
(5) In Article 22(4), the following subparagraph is inserted after the third subparagraph:
‘Eurojust, Europol and the EPPO may attend the meetings of the Management Board as observers when a question concerning ECRIS-TCN in relation to the application of Regulation (EU) 2019/816 is on the agenda.’;
(6) In Article 24(3), point (p) is replaced by the following:
‘(p) establishing, without prejudice to Article 17 of the Staff Regulations of Officials, confidentiality requirements in order to comply with Article 17 of Regulation (EC) No 1987/2006, Article 17 of Decision 2007/533/JHA, Article 26(9) of Regulation (EC) No 767/2008, Article 4(4) of Regulation (EU) No 603/2013, Article 37(4) of Regulation (EU) 2017/2226, Article 74(2) of Regulation (EU) No 2018/1240 and Article 11(16) of Regulation (EU) 2019/816;’;
(7) In Article 27(1), the following point is inserted:
‘(da) ECRIS-TCN Advisory Group;’.
Article 41
Implementation and transitional provisions
1. Member States shall take the necessary measures to comply with this Regulation as soon as possible so as to ensure the proper functioning of ECRIS-TCN.
2. For convictions handed down prior to the date of start of entry of data in accordance with Article 35(1), the central authorities shall create the individual data records in the central system and the CIR as follows:
(a) alphanumeric data to be entered into the central system and the CIR by the end of the period referred to in Article 35(2);
(b) fingerprint data to be entered into the CIR within two years after the start of operations in accordance with Article 35(4).
Article 42
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.
ANNEX
STANDARD INFORMATION REQUEST FORM AS REFERRED TO IN ARTICLE 17(1) OF REGULATION (EU) 2019/816 IN ORDER TO OBTAIN INFORMATION ON WHICH MEMBER STATE, IF ANY, HOLDS CRIMINAL RECORDS INFORMATION OF A THIRD-COUNTRY NATIONAL
<note>
( 1 ) Regulation (EU) 2019/818 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of police and judicial cooperation, asylum and migration and amending Regulations (EU) 2018/1726, (EU) 2018/1862 and (EU) 2019/816 (OJ L 135, 22.5.2019, p. 85).
( 2 ) OJ L 56, 4.3.1968, p. 1.
( *1 ) Regulation (EU) 2019/816 of the European Parliament and of the Council of 17 April 2019 establishing a centralised system for the identification of Member States holding conviction information on third-country nationals and stateless persons (ECRIS-TCN) to supplement the European Criminal Records Information System) and amending Regulation (EU) 2018/1726 (OJ L 135, 22.5.2019, p. 1).’;
</note> | ENG | 02019R0816-20190611 |
<table><col/><col/><col/><col/><tbody><tr><td><p>20.12.2018   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 326/1</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2018/1974
of 14 December 2018
amending Regulation (EU) No 1178/2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EU) 2018/1139 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulation (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 ( 1 ) , and in particular Article 23 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Commission Regulation (EU) No 1178/2011 <a>(<span>2</span>)</a> lays down technical requirements for the certification of flight simulation training devices, the certification of pilots involved in the operation of certain aircraft, and the certification of persons and organisations involved in the pilot training, testing and checking.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Since the last decade, aeroplane upset or loss of control have been identified among the major risk factors that could lead to fatal accidents in commercial air transport operations and its prevention became a strategic priority in Europe <a>(<span>3</span>)</a> and at a global level. This included new training requirements to better prepare pilots for adverse situations of aircraft upset and loss of control.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>By Commission Regulation (EU) 2015/445 <a>(<span>4</span>)</a>, the existing training requirements for commercial pilots were updated to include upset prevention and recovery training (UPRT) as a mandatory constituent of the theoretical knowledge of pilots. Further detailed training elements and training objectives are needed to improve pilot competencies for both prevention of and recovery from aeroplane upsets that can lead to a loss of control and, eventually, to a fatal accident.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>UPRT needs to be integrated at various stages of a professional pilot's career and should be reflected in the privileges stated in the individual pilot licence. A well-developed and well-maintained competence of professional pilots in upset prevention and recovery should be ensured. UPRT should become a mandatory part of the multi-crew pilot licence (MPL) training course and the integrated training course for airline transport pilots for aeroplanes (ATP(A)) and a training course for a commercial pilot licence for aeroplanes (CPL(A)) as well as for class and type-ratings for single-pilot aeroplanes operated in multi-pilot operations, single-pilot non-high-performance complex, high-performance complex aeroplanes and multi-pilot aeroplanes ratings. In order to allow pilots to develop advanced competencies in upset prevention and recovery, the relevant training course should include related air exercises in an aeroplane.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Further to the introduction of the new course related to the development of advanced pilot competencies in upset prevention and recovery, the requirements for instructor certificates should be revised in order to ensure that persons instructing on this course are appropriately qualified.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>This Regulation reflects the provisions adopted by the International Civil Aviation Organisation (ICAO) in 2014 on UPRT for multi-crew pilot licences and for multi-pilot aeroplane type ratings through the amendment to Annex 1 to the Chicago Convention on Personnel Licensing.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>It is in the interest of aviation safety that the new UPRT elements should be implemented as soon as possible. Transitional provisions should be put in place to allow training courses that have started before these UPRT-related amendments to the requirements on pilot training become effective, to be completed without any further adaptation. In this context, it should be considered that pilots flying for commercial air operators in accordance with Commission Regulation (EU) No 965/2012 <a>(<span>5</span>)</a> need to undergo regular operator training which already today contains UPRT elements. Additionally, pilot training organisations should be given a transitional period to adapt their training programmes to comply with the new UPRT requirements. At the end of that transitional period, all relevant training courses should be conducted in accordance with the new UPRT requirements.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Negotiations between the Union and certain third countries are currently still ongoing, including on the conversion of pilot licences and associated medical certificates. In order to ensure that Member States may continue to recognise third country licences and medical certificates for an interim period in light of those negotiations, it is necessary to prolong the period during which Member States may decide not to apply the provisions of Regulation (EU) No 1178/2011 in their territory to pilots holding a licence and associated medical certificate issued by a third country involved in the non-commercial operation of certain aircraft.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>The European Union Aviation Safety Agency submitted draft implementing rules to the European Commission together with its Opinion No 06/2017.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 127 of Regulation (EU) 2018/1139,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EU) No 1178/2011 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>after Article 4a, the following Article 4b is inserted:</p><div><p>‘Article 4b</p><p>Upset prevention and recovery training</p><div><p>1.   Upset prevention and recovery training shall become a mandatory part of a training course for a multi-crew pilot licence (MPL), an integrated training course for airline transport pilots for aeroplanes (ATP(A)), a training course for a commercial pilot licence for aeroplanes (CPL(A)) and training courses for a class or type rating for:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>single-pilot aeroplanes operated in multi-pilot operations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>single-pilot non-high-performance complex aeroplanes;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>single-pilot high-performance complex aeroplanes; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>multi-pilot aeroplanes;</p></td></tr></tbody></table><p>in accordance with Annex I (Part-FCL).</p></div><div><p>2.   For training courses referred to in paragraph 1 that commence before 20 December 2019 at an approved training organisation (ATO), upset prevention and recovery training shall not be mandatory provided that:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>CPL(A), ATP(A) or MPL training course is otherwise completed in accordance with Annex I (Part-FCL) and the skill test is completed in compliance with points FCL.320 (CPL), FCL.620 (IR) or FCL.415.A (MPL) of Annex I (Part-FCL) by 20 December 2021 at the latest; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>class or type rating training course for the aeroplanes is otherwise completed in accordance with Annex I (Part-FCL) and the skill test is completed in compliance with the second subparagraph of paragraph (c) of point FCL.725 of Annex I (Part-FCL) to this Regulation by 20 December 2021 at the latest.</p></td></tr></tbody></table><p>For the purpose of paragraph 1, the competent authority may on its own assessment and pursuant to a recommendation from an ATO give credit for any upset prevention and recovery training completed before 20 December 2019 under national training requirements.’;</p></div></div></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in Article 12, paragraph 4 is replaced by the following:</p><div><p>‘4.   By way of derogation from paragraph 1, Member States may decide not to apply the provisions of this Regulation until 20 June 2020, to pilots holding a licence and associated medical certificate issued by a third country involved in the non-commercial operation of aircraft as specified in Article 2(1)(b), points (i) or (ii), of Regulation (EU) 2018/1139. Member States shall make those decisions publicly available.’;</p></div></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Article 12, paragraph 8, is replaced by the following:</p><div><p>‘8.   By way of derogation from paragraph 1, point FCL.315.A, the second sentence of paragraph (a) of point FCL.410.A and paragraph (c) of point FCL.725.A of Annex I (Part-FCL) shall apply from 20 December 2019.’;</p></div></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Annex I to Regulation (EU) No 1178/2011 is amended in accordance with the Annex to this Regulation.</p></td></tr></tbody></table>
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
However:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>Article 1(1) shall apply from 20 December 2019.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>Article 1(4) shall apply from 20 December 2019.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>Notwithstanding point (b) above, points (2), (4), (5) and (12) of the Annex to this Regulation shall apply from 31 January 2022.</p></td></tr></tbody></table>
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 December 2018.
For the Commission
Violeta BULC
Member of the Commission
( 1 ) Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 ( OJ L 212, 22.8.2018, p. 1 ).
( 2 ) Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council ( OJ L 311, 25.11.2011, p. 1 ).
( 3 ) European Plan for Aviation Safety 2018-2022, pt. 5.3.1, p. 33.
( 4 ) Commission Regulation (EU) 2015/445 of 17 March 2015 amending Regulation (EU) No 1178/2011 as regards technical requirements and administrative procedures related to civil aviation aircrew ( OJ L 74, 18.3.2015, p. 1 ).
( 5 ) Commission Regulation (EU) No 965/2012 of 5 October 2012 laying down technical requirements and administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council ( OJ L 296, 25.10.2012, p. 1 ).
ANNEX
Annex I to Regulation (EU) No 1178/2011 (Part-FCL) is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Point FCL.010 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the introductory sentence is replaced by the following:</p><p>‘For the purposes of this Annex (Part-FCL), the following definitions shall apply:’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a new definition of ‘Accessible’ is inserted before the definition of ‘Aerobatic flight’ as follows:</p><p>‘“Accessible” means that a device can be used by:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>the approved training organisation (ATO) under whose approval a training course for a class or type rating is being conducted; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>the examiner conducting the assessment of competence, skill test or proficiency check for the purpose of assessing, testing or checking.’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the definition of ‘Aerobatic flight’ is replaced by the following:</p><p>‘“Aerobatic flight” means an intentional manoeuvre involving an abrupt change in an aircraft's attitude, an abnormal attitude, or abnormal acceleration, not necessary for normal flight or for instruction for licences, certificates, or ratings other than the aerobatic rating.’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>After the definition of ‘Aeroplane required to be operated with a co-pilot’, a new definition of ‘Aeroplane upset prevention and recovery training’ is inserted as follows:</p><p>‘“Aeroplane upset prevention and recovery training” (UPRT) means training consisting of:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>aeroplane upset prevention training: a combination of theoretical knowledge and flying training with the aim of providing flight crew with the required competencies to prevent aeroplane upsets; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>aeroplane upset recovery training: a combination of theoretical knowledge and flying training with the aim of providing flight crew with the required competencies to recover from aeroplane upsets.’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>After the definition of ‘Airship’, a new definition of ‘Available FSTD’ is inserted as follows:</p><p>‘‘Available FSTD’ means any flight simulation training device (FSTD) that is vacant for use of the FSTD operator or of the customer irrespective of any time considerations.’;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Point FCL.310 is replaced by the following:</p><p><span>‘FCL.310 CPL — Theoretical knowledge examinations</span></p><p>Applicants for the issue of a CPL shall demonstrate a level of knowledge appropriate to the privileges granted in the following subjects:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>air law;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>aircraft general knowledge — airframe/systems/power plant;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>aircraft general knowledge — instrumentation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>mass and balance;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>performance;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>flight planning and monitoring;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>human performance;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>meteorology;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>general navigation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(j)</p></td><td><p>radio navigation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(k)</p></td><td><p>operational procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(l)</p></td><td><p>principles of flight; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(m)</p></td><td><p>communications.’;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Point FCL.410.A is replaced by the following:</p><p><span>‘FCL.410.A MPL – Training course and theoretical knowledge examinations</span></p><p>(a)   Course</p><p>Applicants for the issue of an MPL shall have completed a training course of theoretical knowledge and flight instruction at an ATO in accordance with Appendix 5 to this Annex (Part-FCL).</p><p>(b)   Examination</p><p>Applicants for the issue of an MPL shall demonstrate a level of theoretical knowledge appropriate to the holders of an ATPL(A), in accordance with FCL.515, and to a multi-pilot type rating.’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Point FCL.515 is replaced by the following:</p><p><span>‘FCL.515 ATPL — Training course and theoretical knowledge examinations</span></p><p>(a)   Course</p><p>Applicants for an ATPL shall have completed a training course at an ATO. The course shall be either an integrated training course or a modular course, in accordance with Appendix 3 to this Annex (Part-FCL).</p><p>(b)   Examination</p><p>Applicants for the issue of an ATPL shall demonstrate a level of knowledge appropriate to the privileges granted in the following subjects:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>air law;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>aircraft general knowledge — airframe/systems/power plant;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>aircraft general knowledge — instrumentation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>mass and balance;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>performance;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>flight planning and monitoring;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>human performance;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>meteorology;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>general navigation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>radio navigation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>operational procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>principles of flight; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>communications.’;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Point FCL.615 is replaced by the following:</p><p><span>‘FCL.615 IR — Theoretical knowledge and flight instruction</span></p><p>(a)   Course</p><p>Applicants for an IR shall have completed a course of theoretical knowledge and flight instruction at an ATO. The course shall be:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>an integrated training course which includes training for the IR, in accordance with Appendix 3 to this Annex (Part-FCL); or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>a modular course in accordance with Appendix 6 to this Annex (Part-FCL).</p></td></tr></tbody></table><p>(b)   Examination</p><p>Applicants shall demonstrate a level of theoretical knowledge appropriate to the privileges granted in the following subjects:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>air law;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>aircraft general knowledge — instrumentation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>flight planning and monitoring;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>human performance;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>meteorology;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>radio navigation; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>communications.’;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Point FCL.725 paragraph (d) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(d)</p></td><td><span>An applicant who already holds a type rating for an aircraft type, with the privilege for either single-pilot or multi-pilot operations, shall be considered to have already fulfilled the theoretical requirements when applying to add the privilege for the other form of operation on the same aircraft type. Such an applicant shall complete additional flight training for the other form of operation at an ATO or an AOC holder specifically authorised for such training by the competent authority. The form of operation shall be entered in the licence.’</span></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Point FCL.720.A is replaced by the following:</p><p><span>‘FCL.720.A Experience requirements and prerequisites for the issue of class or type ratings — aeroplanes</span></p><p>Unless otherwise determined in the operational suitability data established in accordance with Annex I (Part-21) to Regulation (EU) No 748/2012 (OSD), applicants for the issue of a class or type rating shall comply with the following experience requirements and prerequisites for the issue of the relevant rating:</p><p>(a)   Single-pilot aeroplanes</p><p>Applicants for the issue of a first class or type rating on a single-pilot aeroplane seeking the privilege to operate the aeroplane in multi-pilot operations shall meet the requirements in points (b)(4) and (b)(5).</p><p>Additionally, for:</p><p>(1)   Single-pilot multi-engine aeroplanes</p><p>Applicants for the issue of a first class or type rating on a single-pilot multi-engine aeroplane shall have completed at least 70 hours as PIC in aeroplanes.</p><p>(2)   Single-pilot high-performance non-complex aeroplanes</p><p>Before starting flight training, applicants for the issue of a class or type rating for a single-pilot aeroplane classified as a high-performance aeroplane shall:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>have at least 200 hours of total flying experience, of which 70 hours as PIC in aeroplanes; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>comply with one of the following requirements:</p><table><col/><col/><tbody><tr><td><p>(A)</p></td><td><p>hold a certificate of satisfactory completion of a course for additional theoretical knowledge undertaken at an ATO; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(B)</p></td><td><p>have passed the ATPL(A) theoretical knowledge examinations in accordance with this Annex (Part-FCL); or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(C)</p></td><td><p>hold, in addition to a licence issued in accordance with this Annex (Part-FCL), an ATPL(A) or CPL(A)/IR with theoretical knowledge credit for ATPL(A), issued in accordance with Annex 1 to the Chicago Convention.</p></td></tr></tbody></table></td></tr></tbody></table><p>(3)   Single-pilot high-performance complex aeroplanes</p><p>Applicants for the issue of a type rating for a complex single-pilot aeroplane classified as a high-performance aeroplane shall, in addition to meeting the requirements in point (2), hold or have held a single- or multi-engine IR(A), as appropriate and as established in Subpart G and shall meet the requirements in point (b)(5).</p><p>(b)   Multi-pilot aeroplanes</p><p>Applicants for the issue of the first type rating course for a multi-pilot aeroplane shall be student pilots currently undergoing training on an MPL training course or comply with the following requirements:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>have at least 70 hours of flight experience as PIC in aeroplanes;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>hold or have held a multi-engine IR(A);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>have passed the ATPL(A) theoretical knowledge examinations in accordance with this Annex (Part-FCL);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>except when the type rating course is combined with an MCC course:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>hold a certificate of satisfactory completion of an MCC course in aeroplanes; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>hold a certificate of satisfactory completion of MCC in helicopters and have more than 100 hours of flight experience as pilots of multi-pilot helicopters; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>have at least 500 hours as pilots of multi-pilot helicopters; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>have at least 500 hours as pilots in multi-pilot operations on single-pilot multi-engine aeroplanes, in commercial air transport in accordance with the applicable air operations requirements; and</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>have completed the training course specified in FCL.745.A.</p></td></tr></tbody></table><p>(c)   Notwithstanding point (b), a Member State may issue a type rating with restricted privileges for a multi-pilot aeroplane that allows holders of such a rating to act as cruise relief co-pilots above Flight Level 200, provided that two other members of the crew have a type rating in accordance with point (b).</p><p>(d)   When so determined in the OSD, the exercise of the privileges of a type rating may be initially limited to flight under the supervision of an instructor. The flight hours under supervision shall be entered in the pilots' logbook or equivalent record and signed by the instructor. The limitation shall be removed when pilots demonstrate that the hours of flight under supervision required in the OSD have been completed.’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Point FCL.725.A is replaced by the following:</p><p><span>‘FCL.725.A Theoretical knowledge and flight instruction for the issue of class and type ratings — aeroplanes</span></p><p>Unless otherwise determined in in the operational suitability data established in accordance with Annex I (Part-21) to Regulation (EU) No 748/2012:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>for single-pilot multi-engine aeroplanes:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>the theoretical knowledge course for a single-pilot multi-engine class rating shall include at least 7 hours of instruction in multi-engine aeroplane operations; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>the flight training course for a single-pilot multi-engine class or type rating shall include at least 2 hours and 30 minutes of dual flight instruction under normal conditions of multi-engine aeroplane operations, and not less than 3 hours 30 minutes of dual flight instruction in engine failure procedures and asymmetric flight techniques.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>for single-pilot aeroplanes (sea):</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>the training course for single-pilot aeroplane (sea) ratings shall include theoretical knowledge and flight instruction; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>the flight training for a class or type rating (sea) for single-pilot aeroplanes (sea) shall include at least 8 hours of dual flight instruction if applicants hold the land version of the relevant class or type rating, or 10 hours if applicants do not hold such a rating; and</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>for single-pilot non-high-performance complex aeroplanes, single-pilot high-performance complex aeroplanes and multi-pilot aeroplanes, the training courses shall include UPRT theoretical knowledge and flight instruction related to the specificities of the relevant class or type.’;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>A new point FCL.745.A is inserted as follows:</p><p><span>‘FCL.745.A Advanced UPRT course — aeroplanes</span></p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>The advanced UPRT course shall be completed at an ATO and shall comprise at least:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>5 hours of theoretical knowledge instruction;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>preflight briefings and postflight debriefings; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>3 hours of dual flight instruction with a flight instructor for aeroplanes FI(A) qualified in accordance with point FCL.915 (e) and consisting of advanced UPRT in an aeroplane qualified for the training task.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>Upon completion of the UPRT course, applicants shall be issued with a certificate of completion by the ATO.’;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>Point (b)(1) of point FCL.900 is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(1)</p></td><td><span>The competent authority may issue a specific certificate granting privileges for flight instruction when compliance with the requirements established in this Subpart is not possible in the case of the introduction of:</span></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>new aircraft in the Member States or in an operator's fleet; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>new training courses in this Annex (Part-FCL).</p></td></tr></tbody></table><p>Such a certificate shall be limited to the training flights necessary for the introduction of the new type of aircraft or the new training course and its validity shall not, in any case, exceed 1 year.’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>Point FCL.915 is amended as follows:</p><p><span>‘FCL.915 General prerequisites and requirements for instructors</span></p><p>(a)   General</p><p>Applicants for the issue of an instructor certificate shall be at least 18 years of age.</p><p>(b)   Additional requirements for instructors providing flight instruction in aircraft</p><p>Applicants for the issue of or holders of an instructor certificate with privileges to conduct flight instruction in an aircraft shall:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>for licence training, hold at least the licence or, in the case of point FCL.900(c), the equivalent licence, for which flight instruction is to be given;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>for a rating training, hold the relevant rating or, in the case of point FCL.900(c), the equivalent rating, for which flight instruction is to be given;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>except in the case of flight test instructors (FTIs), have:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>completed at least 15 hours of flight time as pilots of the class or type of aircraft on which flight instruction is to be given, of which a maximum of 7 hours may be in an FSTD representing the class or type of aircraft, if applicable; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>passed an assessment of competence for the relevant category of instructor on that class or type of aircraft; and</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>be entitled to act as PIC in the aircraft during such flight instruction.</p></td></tr></tbody></table><p>(c)   Credit towards further ratings and for the purpose of revalidation</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Applicants for further instructor certificates may be credited with the teaching and learning skills already demonstrated for the instructor certificate held.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Hours flown as an examiner during skill tests or proficiency checks shall be credited in full towards revalidation requirements for all instructor certificates held.</p></td></tr></tbody></table><p>(d)   Credit for extension to further types shall take into account the relevant elements as defined in the operational suitability data established in accordance with Annex I (Part-21) to Regulation (EU) No 748/2012 (OSD).</p><p>(e)   Additional requirements for instructing in a training course in accordance with FCL.745.A:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>In addition to (b), before acting as instructors for a training course according to FCL.745.A, holders of an instructor certificate shall:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>have at least 500 hours of flight time as pilots of aeroplanes, including 200 hours of flight instruction;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>after complying with the experience requirements in point (e)(1)(i), have completed a UPRT instructor training course at an ATO, during which the competence of applicants shall have been assessed continuously; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>upon completion of the course, have been issued with a certificate of course completion by the ATO, whose Head of Training (HT) shall have entered the privileges specified in point (e)(1) in the logbook of the applicants.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The privileges referred to in point (e)(1) shall only be exercised if instructors have, during the last year, received refresher training at an ATO during which the competence required to instruct on a course in accordance with point FCL.745.A is assessed to the satisfaction of the HT.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Instructors holding the privileges specified in point (e)(1) may act as instructors for a course as specified in point (e)(1)(ii), provided that they:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>have 25 hours of flight instruction experience during training according to FCL745.A;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>have completed an assessment of competence for this privilege; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>comply with the recency requirements in point (e)(2).</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>These privileges shall be entered in the logbook of the instructors and signed by the examiner.’;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>Appendix 1 is replaced by the following:</p><div><div><p>‘Appendix 1</p><p><span>Crediting of theoretical knowledge</span></p><p><span>CREDITING OF THEORETICAL KNOWLEDGE IN THE SAME OR ANOTHER CATEGORY OF AIRCRAFT — BRIDGE INSTRUCTION AND EXAMINATION REQUIREMENTS</span></p><p>1.   <span>LAPL, PPL, BPL and SPL</span></p><p>1.1.   For the issue of an LAPL, holders of an LAPL in another category of aircraft shall be fully credited with theoretical knowledge on the common subjects established in FCL.120(a).</p><p>1.2.   Without prejudice to paragraph 1.1., for the issue of an LAPL, a PPL, a BPL or an SPL, holders of a licence in another category of aircraft shall receive theoretical knowledge instruction and pass theoretical knowledge examinations to the appropriate level in the following subjects:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>principles of flight;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>operational procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>flight performance and planning;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>aircraft general knowledge; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>navigation.</p></td></tr></tbody></table><p>1.3.   For the issue of a PPL, a BPL or an SPL, holders of an LAPL in the same category of aircraft shall be credited in full towards the theoretical knowledge instruction and examination requirements.</p><p>1.4.   Notwithstanding point 1.2, for the issue of an LAPL(A), holders of an LAPL(S) with TMG extension shall demonstrate an adequate level of theoretical knowledge for the SEP(land) class in accordance with FCL.135.A(a)(2).</p><p>2.   <span>CPL</span></p><p>2.1.   Applicants for the issue of a CPL holding a CPL in another category of aircraft shall have received theoretical knowledge bridge instruction at an ATO on an approved course according to the differences identified between the CPL syllabi for different aircraft categories.</p><p>2.2.   Applicants shall pass theoretical knowledge examinations as defined in this Annex (Part-FCL) for the following subjects in the appropriate aircraft category:</p><table><col/><tbody><tr><td><p>021 — Aircraft general knowledge: airframe and systems, electrics, power plant and emergency equipment;</p></td></tr></tbody></table><table><col/><tbody><tr><td><p>022 — Aircraft general knowledge: instrumentation;</p></td></tr></tbody></table><table><col/><tbody><tr><td><p>032/034 — Performance aeroplanes or helicopters, as applicable;</p></td></tr></tbody></table><table><col/><tbody><tr><td><p>070 — Operational procedures; and</p></td></tr></tbody></table><table><col/><tbody><tr><td><p>080 — Principles of flight.</p></td></tr></tbody></table><p>2.3.   Applicants for the issue of a CPL having passed the relevant theoretical knowledge examinations for an IR in the same category of aircraft are credited towards the theoretical knowledge requirements in human performance and meteorology unless they have completed the IR training course in accordance with Appendix 6, Section Aa, to this Annex (Part-FCL).</p><p>2.4.   Applicants for a CPL having passed the relevant theoretical knowledge examinations for an IR or EIR in the same category of aircraft are credited towards the theoretical knowledge requirements in the communications subject.</p><p>3.   <span>ATPL</span></p><p>3.1.   Applicants for the issue of an ATPL holding an ATPL in another category of aircraft shall have received theoretical knowledge bridge instruction at an ATO on an approved course according to the differences identified between the ATPL syllabi for different aircraft categories.</p><p>3.2.   Applicants shall pass theoretical knowledge examinations as defined in this Annex (Part-FCL) for the following subjects in the appropriate aircraft category:</p><table><col/><tbody><tr><td><p>021 — Aircraft general knowledge: airframe and systems, electrics, power plant and emergency equipment;</p></td></tr></tbody></table><table><col/><tbody><tr><td><p>022 — Aircraft general knowledge: instrumentation;</p></td></tr></tbody></table><table><col/><tbody><tr><td><p>032/034 — Performance aeroplanes or helicopters, as applicable;</p></td></tr></tbody></table><table><col/><tbody><tr><td><p>070 — Operational procedures; and</p></td></tr></tbody></table><table><col/><tbody><tr><td><p>080 — Principles of flight.</p></td></tr></tbody></table><p>3.3.   Applicants for the issue of an ATPL(A) having passed the relevant theoretical examination for a CPL(A) are credited towards the theoretical knowledge requirements in the subject ‘communications’.</p><p>3.4.   Applicants for the issue of an ATPL(H) having passed the relevant theoretical examinations for a CPL(H) are credited towards the theoretical knowledge requirements in the following subjects:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>air law;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>principles of flight (helicopter); and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>communications.</p></td></tr></tbody></table><p>3.5.   Applicants for the issue of an ATPL(A) having passed the relevant theoretical examination for an IR(A) are credited towards the theoretical knowledge requirements in the subject ‘communications’.</p><p>3.6.   Applicants for the issue of an ATPL(H) with an IR(H) having passed the relevant theoretical examinations for a CPL(H) are credited towards the theoretical knowledge requirements in the following subjects:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>principles of flight (helicopter); and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>communications.</p></td></tr></tbody></table><p>4.   <span>IR</span></p><p>4.1.   Applicants for the issue of an IR or an EIR having passed the relevant theoretical examinations for a CPL in the same aircraft category are credited towards the theoretical knowledge requirements in the following subjects:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>human performance;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>meteorology; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>communications.</p></td></tr></tbody></table><p>4.2.   Applicants for the issue of an IR(H) having passed the relevant theoretical examinations for an ATPL(H) VFR are required to pass the following examination subjects:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>air law;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>flight planning and flight monitoring; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>radio navigation.</p></td></tr></tbody></table></div></div>’;</td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>Appendix 3, Section A is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>point (4) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘4.</p></td><td><span>The course shall comprise:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>theoretical knowledge instruction to the ATPL(A) knowledge level;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>visual and instrument flying training;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>training in MCC for the operation of multi-pilot aeroplanes; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>UPRT in accordance with FCL.745.A unless applicants have already completed this training course before starting the ATP integrated course.’;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>point (5) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘5.</p></td><td><span>Applicants failing or being unable to complete the entire ATP(A) course may apply to the competent authority for the theoretical knowledge examination and skill test for a licence with lower privileges and an IR if the applicable requirements are met.’;</span></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>point 7 is renamed ‘7.1.’ and a new point (7.2.) is inserted as follows:</p><table><col/><col/><tbody><tr><td><p>‘7.2.</p></td><td><span>The theoretical knowledge instruction in UPRT shall be conducted in accordance with FCL.745.A.’;</span></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>point (9) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘9.</p></td><td><span>The flying training, not including type rating training, shall comprise a total of at least 195 hours, including all progress tests, of which up to 55 hours for the entire course may be instrument ground time. Within the total of 195 hours, applicants shall complete at least:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>95 hours of dual instruction, of which up to 55 hours may be instrument ground time;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>70 hours as PIC including VFR flight, and instrument flight time as SPIC. The instrument flight time as SPIC shall only be counted as PIC flight time up to a maximum of 20 hours;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>50 hours of cross-country flight as PIC, including one VFR cross-country flight of at least 540 km (300 NM), in the course of which full-stop landings at two aerodromes different from the aerodrome of departure shall be made; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>5 hours of flight time at night, comprising 3 hours of dual instruction, which shall include at least:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>1 hour of cross-country navigation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>five solo take-offs; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>five solo full-stop landings;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>UPRT flight instruction in accordance with FCL.745.A;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>115 hours of instrument time comprising, at least:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>20 hours as SPIC;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>15 hours of MCC, for which an FFS or an FNPT II may be used;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>50 hours of instrument flight instruction, of which up to:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>25 hours may be instrument ground time in an FNPT I; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>40 hours may be instrument ground time in an FNPT II, an FTD 2 or an FFS, of which up to 10 hours may be conducted in an FNPT I.</p></td></tr></tbody></table><p>Applicants holding a module completion certificate for the Basic Instrument Flight Module shall be credited with up to 10 hours towards the required instrument instruction time. Hours done in a BITD shall not be credited; and</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>5 hours in an aeroplane which:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>is certificated for the carriage of at least 4 persons; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>has a variable pitch propeller and retractable landing gear.’;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>Appendix 5 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>point (7) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘7.</p></td><td><span>An approved MPL theoretical knowledge course shall comprise at least 750 hours of instruction for the ATPL(A) knowledge level, as well as the hours required for:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>theoretical knowledge instruction for the relevant type rating, in accordance with Subpart H; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>UPRT theoretical knowledge instruction in accordance with FCL.745.A.’;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>point (8) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘8.</p></td><td><span>The flying training shall comprise a total of at least 240 hours, composed of hours as PF and PM, in actual and simulated flight, and covering the following four phases of training:</span><p>(a)   Phase 1 — Core flying skills</p><p>Specific basic single-pilot training in an aeroplane</p><p>(b)   Phase 2 — Basic</p><p>Introduction of multi-crew operations and instrument flight</p><p>(c)   Phase 3 — Intermediate</p><p>Application of multi-crew operations to a multi-engine turbine aeroplane certified as a high-performance aeroplane in accordance with Annex I (Part-21) to Regulation (EU) No 748/2012</p><p>(d)   Phase 4 — Advanced</p><p>Type rating training within an airline-oriented environment.</p><p>MCC requirements shall be incorporated into the relevant phases above.</p><p>Training in asymmetric flight shall be given either in an aeroplane or an FFS.’</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>a new point (8a) is inserted as follows:</p><table><col/><col/><tbody><tr><td><p>‘8a.</p></td><td><span>Flight experience in actual flight shall include:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>all the experience requirements of Subpart H;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>UPRT flight instruction in accordance with FCL.745.A;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>aeroplane UPRT exercises related to the specificities of the relevant type in accordance with FCL.725.A(c);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>night flying;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>flight solely by reference to instruments; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>the experience required to achieve the relevant airmanship.’;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>Appendix 9 is replaced by the following:</p><div><div><p>‘Appendix 9</p><p><span>Training, skill test and proficiency check for MPL, ATPL, type and class ratings, and proficiency check for IRs</span></p><p>A.   <span>General</span></p><p>1.   Applicants for a skill test shall have received instruction in the same class or type of aircraft to be used in the test.</p><p>The training for MPA and PL type ratings shall be conducted in an FFS or in a combination of FSTD(s) and FFS. The skill test or proficiency check for MPA and PL type ratings and the issue of an ATPL and an MPL, shall be conducted in an FFS, if available.</p><p>The training, skill test or proficiency check for class or type ratings for SPA and helicopters shall be conducted in:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>an available and accessible FFS, or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a combination of FSTD(s) and the aircraft if an FFS is not available or accessible; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the aircraft if no FSTD is available or accessible.</p></td></tr></tbody></table><p>If FSTDs are used during training, testing or checking, the suitability of the FSTDs used shall be verified against the applicable ‘Table of functions and subjective tests’ and the applicable ‘Table of FSTD validation tests’ contained in the primary reference document applicable for the device used. All restrictions and limitations indicated on the device's qualification certificate shall be considered.</p><p>2.   Failure to achieve a pass in all sections of the test in two attempts will require further training.</p><p>3.   There is no limit to the number of skill tests that may be attempted.</p><p>CONTENT OF THE TRAINING/SKILL TEST/PROFICIENCY CHECK</p><p>4.   Unless otherwise determined in the operational suitability data established in accordance with Annex I (Part-21) to Regulation (EU) No 748/2012 (OSD), the syllabus of flight instruction, the skill test and the proficiency check shall comply with this Appendix. The syllabus, skill test and proficiency check may be reduced to give credit for previous experience on similar aircraft types, as determined in the OSD.</p><p>5.   Except in the case of skill tests for the issue of an ATPL, when so defined in the OSD for the specific aircraft, credit may be given for skill test items common to other types or variants where the pilots are qualified.</p><p>CONDUCT OF THE TEST/CHECK</p><p>6.   The examiner may choose between different skill test or proficiency check scenarios containing simulated relevant operations. Full-flight simulators and other training devices shall be used, as established in this Annex (Part-FCL).</p><p>7.   During the proficiency check, the examiner shall verify that holders of the class or type rating maintain an adequate level of theoretical knowledge.</p><p>8.   Should applicants choose to terminate a skill test for reasons considered inadequate by the examiner, they shall retake the entire skill test. If the test is terminated for reasons considered adequate by the examiner, only those sections not completed shall be tested in a further flight.</p><p>9.   At the discretion of the examiner, any manoeuvre or procedure of the test may be repeated once by the applicants. The examiner may stop the test at any stage if it is considered that the applicants' demonstration of flying skill requires a complete retest.</p><p>10.   Applicants shall be required to fly the aircraft from a position where the PIC or co-pilot functions, as relevant, can be performed. Under single-pilot conditions, the test shall be performed as if there was no other crew member present.</p><p>11.   During preflight preparation for the test, applicants are required to determine power settings and speeds. Applicants shall indicate to the examiner the checks and duties carried out, including the identification of radio facilities. Checks shall be completed in accordance with the checklist for the aircraft on which the test is being taken and, if applicable, with the MCC concept. Performance data for take-off, approach and landing shall be calculated by applicants in compliance with the operations manual or flight manual for the aircraft used. Decision heights/altitudes, minimum descent heights/altitudes and missed approach point shall be agreed upon with the examiner.</p><p>12.   The examiner shall take no part in the operation of the aircraft except where intervention is necessary in the interests of safety or to avoid unacceptable delay to other traffic.</p><p>SPECIFIC REQUIREMENTS FOR THE SKILL TEST/PROFICIENCY CHECK FOR MULTI-PILOT AIRCRAFT TYPE RATINGS, FOR SINGLE-PILOT AEROPLANE TYPE RATINGS WHEN OPERATED IN MULTI-PILOT OPERATIONS, FOR MPL AND ATPL</p><p>13.   The skill test for a multi-pilot aircraft or a single-pilot aeroplane when operated in multi-pilot operations shall be performed in a multi-crew environment. Another applicant or another type rated qualified pilot may function as the second pilot. If an aircraft is used, the second pilot shall be the examiner or an instructor.</p><p>14.   Applicants shall operate as PF during all sections of the skill test, except for abnormal and emergency procedures, which may be conducted as PF or PM in accordance with MCC. Applicants for the initial issue of a multi-pilot aircraft type rating or ATPL shall also demonstrate the ability to act as PM. Applicants may choose either the left-hand or the right-hand seat for the skill test if all items can be executed from the selected seat.</p><p>15.   The following matters shall be specifically checked by the examiner for applicants for the ATPL or a type rating for multi-pilot aircraft or for multi-pilot operations in a single-pilot aeroplane extending to the duties of a PIC, irrespective of whether the applicants act as PF or PM:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>managing crew cooperation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>maintaining a general survey of the aircraft operation by appropriate supervision; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>setting priorities and making decisions in accordance with safety aspects and relevant rules and regulations appropriate to the operational situation, including emergencies.</p></td></tr></tbody></table><p>16.   The test or check should be accomplished under IFR, if the IR rating is included, and as far as possible be accomplished in a simulated commercial air transport environment. An essential element to be checked is the ability to plan and conduct the flight from routine briefing material.</p><p>17.   When the type rating course has included less than 2 hours of flight training in the aircraft, the skill test may be conducted in an FFS and may be completed before the flight training in the aircraft.</p><p>The approved flight training shall be performed by a qualified instructor under the responsibility of:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>an ATO; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>an organisation holding an AOC issued in accordance with Annex III (Part-ORO) to Regulation (EU) No 965/2012 and specifically approved for such training; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the instructor, in cases where no aircraft flight training for SP aircraft at an ATO or AOC holder is approved, and the aircraft flight training was approved by the applicants' competent authority.</p></td></tr></tbody></table><p>A certificate of completion of the type rating course including the flight training in the aircraft shall be forwarded to the competent authority before the new type rating is entered in the applicants' licence.</p><p>18.   For the upset recovery training, ‘stall event’ means either an approach-to-stall or a stall. An FFS can be used by the ATO to either train recovery from a stall or demonstrate the type-specific characteristics of a stall, or both, provided that:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the FFS has been qualified in accordance with the special evaluation requirements in CS-FSTD(A); and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the ATO has successfully demonstrated to the competent authority that any negative transfer of training is mitigated.</p></td></tr></tbody></table><p>B.   <span>Specific requirements for the aeroplane category</span></p><p>PASS MARKS</p><p>1.   In the case of single-pilot aeroplanes, with the exception of single-pilot high-performance complex aeroplanes, applicants shall pass all sections of the skill test or proficiency check. Failure in any item of a section will cause applicants to fail the entire section. If they fail only one section, they shall repeat only that section. Failure in more than one section will require applicants to repeat the entire test or check. Failure in any section in the case of a retest or recheck, including those sections that have been passed on a previous attempt, will require applicants to repeat the entire test or check again. For single-pilot multi-engine aeroplanes, Section 6 of the relevant test or check, addressing asymmetric flight, shall be passed.</p><p>2.   In the case of multi-pilot and single-pilot high-performance complex aeroplanes, applicants shall pass all sections of the skill test or proficiency check. Failure in more than five items will require applicants to take the entire test or check again. Applicants failing 5 or fewer items shall take the failed items again. Failure in any item on the retest or recheck, including those items that have been passed on a previous attempt, will require applicants to repeat the entire check or test again. Section 6 is not part of the ATPL or MPL skill test. If applicants only fail or do not take Section 6, the type rating will be issued without CAT II or CAT III privileges. To extend the type rating privileges to CAT II or CAT III, applicants shall pass the Section 6 on the appropriate type of aircraft.</p><p>FLIGHT TEST TOLERANCE</p><p>3.   Applicants shall demonstrate the ability to:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>operate the aeroplane within its limitations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>complete all manoeuvres with smoothness and accuracy;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>exercise good judgement and airmanship;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>apply aeronautical knowledge;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>maintain control of the aeroplane at all times in such a manner that the successful outcome of a procedure or manoeuvre is never in doubt;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>understand and apply crew coordination and incapacitation procedures, if applicable; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>communicate effectively with the other crew members, if applicable.</p></td></tr></tbody></table><p>4.   The following limits shall apply, corrected to make allowance for turbulent conditions and the handling qualities and performance of the aeroplane used:</p><table><col/><tbody><tr><td><p>Height</p><table><col/><col/><tbody><tr><td><p>Generally</p></td><td><p>± 100 ft</p></td></tr><tr><td><p>Starting a go-around at decision height/altitude</p></td><td><p>+ 50 ft/– 0 ft</p></td></tr><tr><td><p>Minimum descent height/MAPt/altitude</p></td><td><p>+ 50 ft/– 0 ft</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><tbody><tr><td><p>Tracking</p><table><col/><col/><tbody><tr><td><p>On radio aids</p></td><td><p>± 5°</p></td></tr><tr/><tr/><tr><td><p>For ‘angular’ deviations</p></td><td><p>Half-scale deflection, azimuth and glide path (e.g. LPV, ILS, MLS, GLS)</p></td></tr><tr><td><p>2D (LNAV) and 3D (LNAV/VNAV) ‘linear’ lateral deviations</p></td><td>cross-track error/deviation shall normally be limited to ±<p><img/></p> of the RNP value associated with the procedure. Brief deviations from this standard up to a maximum of one time the RNP value are allowable.</td></tr><tr><td><p>3D linear vertical deviations (e.g. RNP APCH (LNAV/VNAV) using BaroVNAV)</p></td><td><p>not more than – 75 ft below the vertical profile at any time, and not more than + 75 ft above the vertical profile at or below 1 000 ft above aerodrome level.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><tbody><tr><td><p>Heading</p><table><col/><col/><tbody><tr><td><p>all engines operating</p></td><td><p>± 5°</p></td></tr><tr><td><p>with simulated engine failure</p></td><td><p>± 10°</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><tbody><tr><td><p>Speed</p><table><col/><col/><tbody><tr><td><p>all engines operating</p></td><td><p>± 5 knots</p></td></tr><tr><td><p>with simulated engine failure</p></td><td><p>+ 10 knots/– 5 knots</p></td></tr></tbody></table></td></tr></tbody></table><p>CONTENT OF THE TRAINING/SKILL TEST/PROFICIENCY CHECK</p><p>5.   Single-pilot aeroplanes, except for high-performance complex aeroplanes</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>The following symbols mean:</p><table><col/><col/><tbody><tr><td><p>P =</p></td><td><p>Trained as PIC or co-pilot and as PF and PM</p></td></tr><tr><td><p>OTD =</p></td><td><p>Other training devices may be used for this exercise</p></td></tr><tr><td><p>X =</p></td><td><p>An FFS shall be used for this exercise; otherwise, an aeroplane shall be used if appropriate for the manoeuvre or procedure</p></td></tr><tr><td><p>P# =</p></td><td><p>The training shall be complemented by supervised aeroplane inspection</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>The practical training shall be conducted at least at the training equipment level shown as (P), or may be conducted on any higher level of equipment shown by the arrow (---->).</p><p>The following abbreviations are used to indicate the training equipment used:</p><table><col/><col/><tbody><tr><td><p>A =</p></td><td><p>aeroplane</p></td></tr><tr><td><p>FFS =</p></td><td><p>full-flight simulator</p></td></tr><tr><td><p>FSTD =</p></td><td><p>flight simulation training device</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>The starred (*) items of Section 3B and, for multi-engine, Section 6, shall be flown solely by reference to instruments if revalidation/renewal of an IR is included in the skill test or proficiency check. If the starred (*) items are not flown solely by reference to instruments during the skill test or proficiency check, and when there is no crediting of IR privileges, the class or type rating will be restricted to VFR only.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>Section 3A shall be completed to revalidate a type or multi-engine class rating, VFR only, where the required experience of 10 route sectors within the previous 12 months has not been completed. Section 3A is not required if Section 3B is completed.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>Where the letter ‘M’ appears in the skill test or proficiency check column, this will indicate a mandatory exercise or a choice where more than one exercise appears.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>An FSTD shall be used for practical training for type or ME class ratings if they form part of an approved class or type rating course. The following considerations will apply to the approval of the course:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the qualification of the FSTD as set out in the relevant requirements of Annex VI (Part-ARA) and Annex VII (Part-ORA);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>the qualifications of the instructors;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>the amount of FSTD training provided on the course; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>the qualifications and previous experience on similar types of the pilots under training.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>If privileges for multi-pilot operation are sought for the first time, pilots holding privileges for single-pilot operations shall:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>complete a bridge course containing manoeuvres and procedures including MCC as well as the exercises of Section 7 using tthreat and error management (TEM), CRM and human factors at an ATO; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>pass a proficiency check in multi-pilot operations.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>If privileges for single-pilot operations are sought for the first time, pilots holding privileges for multi-pilot operations shall be trained at an ATO and checked for the following additional manoeuvres and procedures in single-pilot operations:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>for SE aeroplanes, 1.6, 4.5, 4.6, 5.2 and, if applicable, one approach from Section 3.B;and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>for ME aeroplanes, 1.6, Section 6 and, if applicable, one approach from Section 3.B.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>Pilots holding privileges for both single-pilot and multi-pilot operations in accordance with points (g) and (h) may revalidate privileges for both types of operations by completing a proficiency check in multi-pilot operations in addition to the exercises referred to in points (h)(1) or (h)(2), as applicable, in single-pilot operations.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(j)</p></td><td><p>If a skill test or a proficiency check is completed in multi-pilot operations only, the type rating shall be restricted to multi-pilot operations. The restriction shall be removed when pilots comply with point (h).</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(k)</p></td><td><p>The training, testing and checking shall follow the table mentioned below.</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Training at an ATO, testing and checking requirements for single-pilot privileges</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Training at an ATO, testing and checking requirements for multi-pilot privileges</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Training at an ATO, testing and checking requirements for pilots holding single-pilot privileges seeking multi-pilot privileges for the first time (bridge course)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Training at an ATO, testing and checking requirements for pilots holding multi-pilot privileges seeking single-pilot privileges for the first time (bridge course)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Training at an ATO and checking requirements for combined revalidation and renewal of single and multi-pilot privileges</p><table><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>(1)</p></td><td><p>(2)</p></td><td><p>(3)</p></td><td><p>(4)</p></td><td><p>(5)</p></td></tr><tr><td><p>Type of operation</p></td><td><p>SP</p></td><td><p>MP</p></td><td><p>SP → MP (initial)</p></td><td><p>MP → SP (initial)</p></td><td><p>SP + MP</p></td></tr><tr><td><p> </p></td><td><p><span>Training</span></p></td><td><p><span>Testing/checking</span></p></td><td><p><span>Training</span></p></td><td><p><span>Testing/checking</span></p></td><td><p><span>Training</span></p></td><td><p><span>Testing/checking</span></p></td><td><p><span>Training, testing and checking (SE aeroplanes)</span></p></td><td><p><span>Training, testing and checking (ME aeroplanes)</span></p></td><td><p><span>SE aeroplanes</span></p></td><td><p><span>ME aeroplanes</span></p></td></tr><tr><td><p>Initial issue</p></td><td><p>Sections 1-6</p></td><td><p>Sections 1-6</p></td><td><p>Sections 1-7</p></td><td><p>Sections 1-7</p></td><td><p>MCC</p><p>CRM</p><p>Human factors</p><p>TEM</p><p>Section 7</p></td><td><p>Sections 1-7</p></td><td><p>1.6, 4.5, 4.6, 5.2 and, if applicable, one approach from Section 3.B</p></td><td><p>1.6, Section 6 and, if applicable, one approach from Section 3.B</p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SP complex</p></td><td><p>1-7</p></td><td><p>1-7</p></td></tr><tr><td><p>Revalidation</p></td><td><p>n/a</p></td><td><p>Sections 1–6</p></td><td><p>n/a</p></td><td><p>Sections 1–7</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>MPO:</p><p>Sections 1-7</p><p>SPO:</p><p>1.6, 4.5, 4.6, 5.2 and, if applicable, one approach from Section 3.B</p></td><td><p>MPO:</p><p>Sections 1-7</p><p>SPO:</p><p>1.6, Section 6 and, if applicable, one approach from Section 3.B</p></td></tr><tr><td><p>SP complex</p></td><td><p>1-7</p></td><td><p>1-7</p></td></tr><tr><td><p>Renewal</p></td><td><p>FCL.740</p></td><td><p>Sections 1-6</p></td><td><p>FCL.740</p></td><td><p>Sections 1-6</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>n/a</p></td><td><p>Training: FCL.740</p></td><td><p>Training: FCL.740</p></td></tr><tr><td><p>SP complex</p></td><td><p>1-7</p></td><td><p>1-7</p></td><td><p>Check: as for the revalidation</p></td><td><p>Check: as for the revalidation</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(l)</p></td><td><p>To establish or maintain PBN privileges, one approach shall be an RNP APCH. Where an RNP APCH is not practicable, it shall be performed in an appropriately equipped FSTD.</p><table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>TMGs AND SINGLE-PILOT AEROPLANES, EXCEPT FOR HIGH-PERFORMANCE COMPLEX AEROPLANES</p></td><td><p>PRACTICAL TRAINING</p></td><td><p>CLASS OR TYPE RATING SKILL TEST OR PROFICIENCY CHECK</p></td></tr><tr><td><p>Manoeuvres/procedures</p></td><td><p>FSTD</p></td><td><p>A</p></td><td><p>Instructor initials when training completed</p></td><td><p>Tested or checked in FSTD or A</p></td><td><p>Examiner initials when test or check completed</p></td></tr><tr><td><p>SECTION 1</p></td></tr><tr/><tr><td><p>1</p><p>1.1</p></td><td><p>Departure</p><p>Preflight including:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>documentation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>mass and balance;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>weather briefing; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>NOTAM.</p></td></tr></tbody></table></td><td><p>OTD</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>1.2</p></td><td><p>Pre-start checks</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>1.2.1</p></td><td><p>External</p></td><td><p>OTD</p><p>P#</p></td><td><p>P</p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>1.2.2</p></td><td><p>Internal</p></td><td><p>OTD</p><p>P#</p></td><td><p>P</p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>1.3</p></td><td><p>Engine starting:</p><p>normal malfunctions.</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>1.4</p></td><td><p>Taxiing</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>1.5</p></td><td><p>Pre-departure checks:</p><p>engine run-up (if applicable)</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>1.6</p></td><td><p>Take-off procedure:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>normal with flight manual flap settings; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>crosswind (if conditions are available).</p></td></tr></tbody></table></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>1.7</p></td><td><p>Climbing:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Vx/Vy;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>turns onto headings; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>level off.</p></td></tr></tbody></table></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>1.8</p></td><td><p>ATC liaison — compliance, R/T procedures</p></td><td><p>P----></p></td><td><p> </p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>SECTION 2</p></td></tr><tr/><tr><td><p>2</p><p>2.1</p></td><td><p>Airwork (visual meteorological conditions (VMC))</p><p>Straight and level flight at various airspeeds including flight at critically low airspeed with and without flaps (including approach to V V<span>mca</span> when applicable)</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2.2</p></td><td><p>Steep turns (360° left and right at 45° bank)</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.3</p></td><td><p>Stalls and recovery:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>clean stall;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>approach to stall in descending turn with bank with approach configuration and power;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>approach to stall in landing configuration and power; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>approach to stall, climbing turn with take-off flap and climb power (single-engine aeroplanes only)</p></td></tr></tbody></table></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.4</p></td><td><p>Handling using autopilot and flight director (may be conducted in Section 3), if applicable</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.5</p></td><td><p>ATC liaison — compliance, R/T procedures</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>SECTION 3A</p></td></tr><tr/><tr><td><p>3A</p><p>3A.1</p></td><td><p>En route procedures VFR</p><p>(see B.5 (c) and (d))</p><p>Flight plan, dead reckoning and map reading</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3A.2</p></td><td><p>Maintenance of altitude, heading and speed</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3A.3</p></td><td><p>Orientation, timing and revision of ETAs</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3A.4</p></td><td><p>Use of radio navigation aids (if applicable)</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3A.5</p></td><td><p>Flight management (flight log, routine checks including fuel, systems and icing)</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3A.6</p></td><td><p>ATC liaison — compliance, R/T procedures</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SECTION 3B</p></td></tr><tr/><tr><td><p>3B</p><p>3B.1*</p></td><td><p>Instrument flight</p><p>Departure IFR</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>3B.2*</p></td><td><p>En route IFR</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>3B.3*</p></td><td><p>Holding procedures</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>3B.4*</p></td><td><p>3D operations to decision height/altitude (DH/A) of 200 ft (60 m) or to higher minima if required by the approach procedure (autopilot may be used to the final approach segment vertical path intercept)</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>3B.5*</p></td><td><p>2D operations to minimum descent height/altitude (MDH/A)</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>3B.6*</p></td><td><p>Flight exercises including simulated failure of the compass and attitude indicator:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>rate 1 turns; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>recoveries from unusual attitudes.</p></td></tr></tbody></table></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>3B.7*</p></td><td><p>Failure of localiser or glideslope</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3B.8*</p></td><td><p>ATC liaison — compliance, R/T procedures</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Intentionally left blank</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SECTION 4</p></td></tr><tr/><tr><td><p>4</p><p>4.1</p></td><td><p>Arrival and landings</p><p>Aerodrome arrival procedure</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>4.2</p></td><td><p>Normal landing</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>4.3</p></td><td><p>Flapless landing</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>4.4</p></td><td><p>Crosswind landing (if suitable conditions)</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.5</p></td><td><p>Approach and landing with idle power from up to 2 000 ft above the runway (single-engine aeroplanes only)</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.6</p></td><td><p>Go-around from minimum height</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>4.7</p></td><td><p>Night go-around and landing (if applicable)</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.8</p></td><td><p>ATC liaison — compliance, R/T procedures</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>SECTION 5</p></td></tr><tr/><tr><td><p>5</p></td><td><p>Abnormal and emergency procedures (This section may be combined with Sections 1 through 4.)</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.1</p></td><td><p>Rejected take-off at a reasonable speed</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>5.2</p></td><td><p>Simulated engine failure after take-off (single-engine aeroplanes only)</p></td><td><p> </p></td><td><p>P</p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>5.3</p></td><td><p>Simulated forced landing without power (single-engine aeroplanes only)</p></td><td><p> </p></td><td><p>P</p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>5.4</p></td><td><p>Simulated emergencies:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>fire or smoke in flight; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>systems' malfunctions as appropriate</p></td></tr></tbody></table></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.5</p></td><td><p>ME aeroplanes and TMG training only: engine shutdown and restart (at a safe altitude if performed in the aircraft)</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.6</p></td><td><p>ATC liaison — compliance, R/T procedures</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SECTION 6</p></td></tr><tr/><tr><td><p>6</p><p>6.1*</p></td><td><p>Simulated asymmetric flight</p><p>(This section may be combined with Sections 1 through 5.)</p><p>Simulated engine failure during take-off (at a safe altitude unless carried out in an FFS or an FNPT II)</p></td><td><p>P----></p></td><td><p>--->X</p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>6.2*</p></td><td><p>Asymmetric approach and go-around</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>6.3*</p></td><td><p>Asymmetric approach and full-stop landing</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>6.4</p></td><td><p>ATC liaison — compliance, R/T procedures</p></td><td><p>P----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>SECTION 7</p></td></tr><tr/><tr><td><p>7</p></td><td><p>UPRT</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>7.1</p></td><td><p>Flight manoeuvres and procedures</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>7.1.1</p></td><td><p>Manual flight with and without flight directors</p><p>(no autopilot, no autothrust/autothrottle, and at different control laws, where applicable)</p></td><td><p>P-----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>7.1.1.1</p></td><td><p>At different speeds (including slow flight) and altitudes within the FSTD training envelope.</p></td><td><p>P-----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>7.1.1.2</p></td><td><p>Steep turns using 45° bank, 180° to 360° left and right</p></td><td><p>P-----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>7.1.1.3</p></td><td><p>Turns with and without spoilers</p></td><td><p>P-----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>7.1.1.4</p></td><td><p>Procedural instrument flying and manoeuvring including instrument departure and arrival, and visual approach</p></td><td><p>P-----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>7.2</p><p>7.2.1</p></td><td><p>Upset recovery training</p><p>Recovery from stall events in:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>take-off configuration;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>clean configuration at low altitude;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>clean configuration near maximum operating altitude; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>landing configuration</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>7.2.2</p></td><td><p>The following upset exercises:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>recovery from nose-high at various bank angles; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>recovery from nose-low at various bank angles.</p></td></tr></tbody></table></td><td><p>P</p><p>FFS qualified for the training task only</p></td><td><p>X</p><p>An aeroplane shall not be used for this exercise</p></td><td><p> </p></td><td><p>FFS only</p></td><td><p> </p></td></tr><tr><td><p>7.3</p></td><td><p>Go-around with all engines operating* from various stages during an instrument approach</p></td><td><p>P---></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>7.4</p></td><td><p>Rejected landing with all engines operating:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>from various heights below DH/MDH 15 m (50 ft) above the runway threshold</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>after touchdown (baulked landing)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In aeroplanes which are not certificated as transport category aeroplanes (JAR/FAR 25) or as commuter category aeroplanes (SFAR 23), the rejected landing with all engines operating shall be initiated below MDH/A or after touchdown.</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr></tbody></table></td></tr></tbody></table><p>6.   Multi-pilot aeroplanes and single-pilot high-performance complex aeroplanes</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>The following symbols mean:</p><table><col/><col/><tbody><tr><td><p>P =</p></td><td><p>Trained as PIC or co-pilot and as PF and PM for the issue of a type rating as applicable.</p></td></tr><tr><td><p>OTD =</p></td><td><p>Other training devices may be used for this exercise</p></td></tr><tr><td><p>X =</p></td><td><p>An FFS shall be used for this exercise; otherwise an aeroplane shall be used if appropriate for the manoeuvre or procedure</p></td></tr><tr><td><p>P# =</p></td><td><p>The training shall be complemented by supervised aeroplane inspection</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>The practical training shall be conducted at least at the training equipment level shown as (P), or may be conducted up to any higher equipment level shown by the arrow (----->).</p><p>The following abbreviations are used to indicate the training equipment used:</p><table><col/><col/><tbody><tr><td><p>A =</p></td><td><p>aeroplane</p></td></tr><tr><td><p>FFS =</p></td><td><p>full-flight simulator</p></td></tr><tr><td><p>FSTD =</p></td><td><p>flight simulation training device</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>The starred items (*) shall be flown solely by reference to instruments.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>Where the letter ‘M’ appears in the skill test or proficiency check column, this will indicate a mandatory exercise.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>An FFS shall be used for practical training and testing if the FFS forms part of an approved type rating course. The following considerations will apply to the approval of the course:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the qualifications of the instructors;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>the qualification and the amount of training provided on the course in an FSTD; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>the qualifications and previous experience on similar types of the pilots under training.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>Manoeuvres and procedures shall include MCC for multi-pilot aeroplane and for single-pilot high-performance complex aeroplanes in multi-pilot operations.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>Manoeuvres and procedures shall be conducted in single-pilot role for single-pilot high-performance complex aeroplanes in single-pilot operations.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>In the case of single-pilot high-performance complex aeroplanes, when a skill test or proficiency check is performed in multi-pilot operations, the type rating shall be restricted to multi-pilot operations. If privileges of single-pilot are sought, the manoeuvres/procedures in 2.5, 3.8.3.4, 4.4, 5.5 and at least one manoeuvre/procedure from Section 3.4 have to be completed in addition as single-pilot.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>In the case of a restricted type rating issued in accordance with FCL.720.A(e), applicants shall fulfil the same requirements as other applicants for the type rating except for the practical exercises relating to the take-off and landing phases.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(j)</p></td><td><p>To establish or maintain PBN privileges, one approach shall be an RNP APCH. Where an RNP APCH is not practicable, it shall be performed in an appropriately equipped FSTD.</p><table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>MULTI-PILOT AEROPLANES AND SINGLE-PILOT HIGH-PERFORMANCE COMPLEX AEROPLANES</p></td><td><p>PRACTICAL TRAINING</p></td><td><p>ATPL/MPL/TYPE RATING SKILL TEST OR PROF. CHECK</p></td></tr><tr><td><p>Manoeuvres/procedures</p></td><td><p>FSTD</p></td><td><p>A</p></td><td><p>Instructor initials when training completed</p></td><td><p>Tested or checked in FSTD or A</p></td><td><p>Examiner initials when test or check completed</p></td></tr><tr><td><p>SECTION 1</p></td></tr><tr/><tr><td><table><col/><col/><tbody><tr><td><p>1</p></td><td><p>Flight preparation</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>1.1.</p></td><td><p>Performance calculation</p></td></tr></tbody></table></td><td><p>OTD</p><p>P</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.2.</p></td><td><p>Aeroplane external visual inspection; location of each item and purpose of inspection</p></td></tr></tbody></table></td><td><p>OTD P#</p></td><td><p>P</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.3.</p></td><td><p>Cockpit inspection</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.4.</p></td><td><p>Use of checklist prior to starting engines, starting procedures, radio and navigation equipment check, selection and setting of navigation and communication frequencies</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.5.</p></td><td><p>Taxiing in compliance with ATC instructions or instructions of instructor</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.6.</p></td><td><p>Before take-off checks</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>SECTION 2</p></td></tr><tr/><tr><td><table><col/><col/><tbody><tr><td><p>2</p></td><td><p>Take-offs</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.1.</p></td><td><p>Normal take-offs with different flap settings, including expedited take-off</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.2*</p></td><td><p>Instrument take-off; transition to instrument flight is required during rotation or immediately after becoming airborne</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.3.</p></td><td><p>Crosswind take-off</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.4.</p></td><td><p>Take-off at maximum take-off mass (actual or simulated maximum take-off mass)</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.5.</p></td><td><p>Take-offs with simulated engine failure:</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.5.1*</p></td><td><p>shortly after reaching V2</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>(In aeroplanes which are not certificated as transport category or commuter category aeroplanes, the engine failure shall not be simulated until reaching a minimum height of 500 ft above the runway end. In aeroplanes having the same performance as a transport category aeroplane regarding take-off mass and density altitude, the instructor may simulate the engine failure shortly after reaching V2)</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.5.2*</p></td><td><p>between V1 and V2</p></td></tr></tbody></table></td><td><p>P</p></td><td><p>X</p></td><td><p> </p></td><td><p>M FFS only</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.6.</p></td><td><p>Rejected take-off at a reasonable speed before reaching V1</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>---->X</p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>SECTION 3</p></td></tr><tr/><tr><td><table><col/><col/><tbody><tr><td><p>3</p></td><td><p>Flight manoeuvres and procedures</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>3.1.</p></td><td><p>Manual flight with and without flight directors</p><p>(no autopilot, no autothrust/autothrottle, and at different control laws, where applicable)</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.1.1.</p></td><td><p>At different speeds (including slow flight) and altitudes within the FSTD training envelope</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.1.2.</p></td><td><p>Steep turns using 45° bank, 180° to 360° left and right</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.1.3.</p></td><td><p>Turns with and without spoilers</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.1.4.</p></td><td><p>Procedural instrument flying and manoeuvring including instrument departure and arrival, and visual approach</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.2.</p></td><td><p>Tuck under and Mach buffets (if applicable), and other specific flight characteristics of the aeroplane (e.g. Dutch Roll)</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>---->X</p><p>An aeroplane shall not be used for this exercise</p></td><td><p> </p></td><td><p>FFS only</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.3.</p></td><td><p>Normal operation of systems and controls engineer's panel (if applicable)</p></td></tr></tbody></table></td><td><p>OTD</p><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.4.</p></td><td><p>Normal and abnormal operations of following systems:</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>M</p></td><td><p>A mandatory minimum of 3 abnormal items shall be selected from 3.4.0 to 3.4.14 inclusive</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.4.0.</p></td><td><p>Engine (if necessary propeller)</p></td></tr></tbody></table></td><td><p>OTD</p><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.4.1.</p></td><td><p>Pressurisation and air conditioning</p></td></tr></tbody></table></td><td><p>OTD</p><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.4.2.</p></td><td><p>Pitot/static system</p></td></tr></tbody></table></td><td><p>OTD</p><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.4.3.</p></td><td><p>Fuel system</p></td></tr></tbody></table></td><td><p>OTD</p><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.4.4.</p></td><td><p>Electrical system</p></td></tr></tbody></table></td><td><p>OTD</p><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.4.5.</p></td><td><p>Hydraulic system</p></td></tr></tbody></table></td><td><p>OTD</p><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.4.6.</p></td><td><p>Flight control and trim system</p></td></tr></tbody></table></td><td><p>OTD</p><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.4.7.</p></td><td><p>Anti-icing/de-icing system, glare shield heating</p></td></tr></tbody></table></td><td><p>OTD</p><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.4.8.</p></td><td><p>Autopilot/flight director</p></td></tr></tbody></table></td><td><p>OTD</p><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p>M</p><p>(single pilot only)</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.4.9.</p></td><td><p>Stall warning devices or stall avoidance devices, and stability augmentation devices</p></td></tr></tbody></table></td><td><p>OTD</p><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.4.10.</p></td><td><p>Ground proximity warning system, weather radar, radio altimeter, transponder</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.4.11.</p></td><td><p>Radios, navigation equipment, instruments, FMS</p></td></tr></tbody></table></td><td><p>OTD</p><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.4.12.</p></td><td><p>Landing gear and brake</p></td></tr></tbody></table></td><td><p>OTD</p><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.4.13.</p></td><td><p>Slat and flap system</p></td></tr></tbody></table></td><td><p>OTD</p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.4.14.</p></td><td><p>Auxiliary power unit (APU)</p></td></tr></tbody></table></td><td><p>OTD</p><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Intentionally left blank</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.6.</p></td><td><p>Abnormal and emergency procedures:</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>M</p></td><td><p>A mandatory minimum of 3 items shall be selected from 3.6.1 to 3.6.9 inclusive</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.6.1.</p></td><td><p>Fire drills, e.g. engine, APU, cabin, cargo compartment, flight deck, wing and electrical fires including evacuation</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.6.2.</p></td><td><p>Smoke control and removal</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.6.3.</p></td><td><p>Engine failures, shutdown and restart at a safe height</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.6.4.</p></td><td><p>Fuel dumping (simulated)</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.6.5.</p></td><td><p>Wind shear at take-off/landing</p></td></tr></tbody></table></td><td><p>P</p></td><td><p>X</p></td><td><p> </p></td><td><p>FFS only</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.6.6.</p></td><td><p>Simulated cabin pressure failure/emergency descent</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.6.7.</p></td><td><p>Incapacitation of flight crew member</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.6.8.</p></td><td><p>Other emergency procedures as outlined in the appropriate aeroplane flight manual (AFM)</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.6.9.</p></td><td><p>TCAS event</p></td></tr></tbody></table></td><td><p>OTD</p><p>P-----></p></td><td><p>An aeroplane shall not be used</p></td><td><p> </p></td><td><p>FFS only</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.7.</p></td><td><p>Upset recovery training</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>3.7.1.</p></td><td><p>Recovery from stall events in:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>take-off configuration;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>clean configuration at low altitude;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>clean configuration near maximum operating altitude; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>landing configuration.</p></td></tr></tbody></table></td></tr></tbody></table></td><td><p>P</p><p>FFS qualified for the training task only</p></td><td><p>X</p><p>An aeroplane shall not be used for this exercise</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.7.2.</p></td><td><p>The following upset exercises:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>recovery from nose-high at various bank angles; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>recovery from nose-low at various bank angles</p></td></tr></tbody></table></td></tr></tbody></table></td><td><p>P</p><p>FFS qualified for the training task only</p></td><td><p>X</p><p>An aeroplane shall not be used for this exercise</p></td><td><p> </p></td><td><p>FFS only</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.8.</p></td><td><p>Instrument flight procedures</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.8.1*</p></td><td><p>Adherence to departure and arrival routes and ATC instructions</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.8.2*</p></td><td><p>Holding procedures</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.8.3*</p></td><td><p>3D operations to DH/A of 200 ft (60 m) or to higher minima if required by the approach procedure</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p><span>Note:</span> According to the AFM, RNP APCH procedures may require the use of autopilot or flight director. The procedure to be flown manually shall be chosen taking into account such limitations (for example, choose an ILS for 3.8.3.1 in the case of such AFM limitation).</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.8.3.1*</p></td><td><p>Manually, without flight director</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p>M</p><p>(skill test only)</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.8.3.2*</p></td><td><p>Manually, with flight director</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.8.3.3*</p></td><td><p>With autopilot</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.8.3.4*</p></td><td><p>Manually, with one engine simulated inoperative; engine failure has to be simulated during final approach before passing 1 000 ft above aerodrome level until touchdown or through the complete missed approach procedure. In aeroplanes which are not certificated as transport category aeroplanes (JAR/FAR 25) or as commuter category aeroplanes (SFAR 23), the approach with simulated engine failure and the ensuing go-around shall be initiated in conjunction with the non-precision approach as described in 3.8.4. The go-around shall be initiated when reaching the published obstacle clearance height/altitude (OCH/A); however, not later than reaching an MDH/A of 500 ft above the runway threshold elevation. In aeroplanes having the same performance as a transport category aeroplane regarding take-off mass and density altitude, the instructor may simulate the engine failure in accordance with 3.8.3.4.</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.8.3.5.*</p></td><td><p>Manually, with one engine simulated inoperative; engine failure has to be simulated during final approach after passing the outer marker (OM) within a distance of not more than 4 NM until touchdown or through the complete missed approach procedure</p><p>In aeroplanes which are not certificated as transport category aeroplanes (JAR/FAR 25) or as commuter category aeroplanes (SFAR 23), the approach with simulated engine failure and the ensuing go-around shall be initiated in conjunction with the non-precision approach as described in 3.8.4. The go-around shall be initiated when reaching the published OCH/A; however, not later than reaching an MDH/A of 500 ft above the runway threshold elevation. In aeroplanes having the same performance as a transport category aeroplane regarding take-off mass and density altitude, the instructor may simulate the engine failure in accordance with 3.8.3.4.</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.8.4*</p></td><td><p>2D operations down to the MDH/A</p></td></tr></tbody></table></td><td><p>P*---></p></td><td><p>-----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.8.5.</p></td><td><p>Circling approach under the following conditions:</p><table><col/><col/><tbody><tr><td><p>(a)*</p></td><td><p>approach to the authorised minimum circling approach altitude at the aerodrome in question in accordance with the local instrument approach facilities in simulated instrument flight conditions;</p><p>followed by:</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>circling approach to another runway at least 90° off centreline from the final approach used in item (a), at the authorised minimum circling approach altitude.</p></td></tr></tbody></table><p><span>Remark:</span> If (a) and (b) are not possible due to ATC reasons, a simulated low visibility pattern may be performed.</p></td></tr></tbody></table></td><td><p>P*---></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.8.6.</p></td><td><p>Visual approaches</p></td></tr></tbody></table></td><td><p>P----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SECTION 4</p></td></tr><tr/><tr><td><table><col/><col/><tbody><tr><td><p>4</p></td><td><p>Missed approach procedures</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.1.</p></td><td><p>Go-around with all engines operating* during a 3D operation on reaching decision height</p></td></tr></tbody></table></td><td><p>P*---></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.2.</p></td><td><p>Go-around with all engines operating* from various stages during an instrument approach</p></td></tr></tbody></table></td><td><p>P*---></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.3.</p></td><td><p>Other missed approach procedures</p></td></tr></tbody></table></td><td><p>P*---></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.4*</p></td><td><p>Manual go-around with the critical engine simulated inoperative after an instrument approach on reaching DH, MDH or MAPt</p></td></tr></tbody></table></td><td><p>P*-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.5.</p></td><td><p>Rejected landing with all engines operating:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>from various heights below DH/MDH;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>after touchdown (baulked landing)</p></td></tr></tbody></table><p>In aeroplanes which are not certificated as transport category aeroplanes (JAR/FAR 25) or as commuter category aeroplanes (SFAR 23), the rejected landing with all engines operating shall be initiated below MDH/A or after touchdown.</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SECTION 5</p></td></tr><tr/><tr><td><table><col/><col/><tbody><tr><td><p>5</p></td><td><p>Landings</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>5.1.</p></td><td><p>Normal landings* with visual reference established when reaching DA/H following an instrument approach operation</p></td></tr></tbody></table></td><td><p>P</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>5.2.</p></td><td><p>Landing with simulated jammed horizontal stabiliser in any out-of-trim position</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>An aeroplane shall not be used for this exercise</p></td><td><p> </p></td><td><p>FFS only</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>5.3.</p></td><td><p>Crosswind landings (aircraft, if practicable)</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>5.4.</p></td><td><p>Traffic pattern and landing without extended or with partly extended flaps and slats</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>5.5.</p></td><td><p>Landing with critical engine simulated inoperative</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>5.6.</p></td><td><p>Landing with two engines inoperative:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>aeroplanes with three engines: the centre engine and one outboard engine as far as practicable according to data of the AFM; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>aeroplanes with four engines: two engines at one side</p></td></tr></tbody></table></td></tr></tbody></table></td><td><p>P</p></td><td><p>X</p></td><td><p> </p></td><td><p>M</p><p>FFS only</p><p>(skill test only)</p></td><td><p> </p></td></tr><tr><td><p><span>General remarks:</span></p><p>Special requirements for the extension of a type rating for instrument approaches down to a decision height of less than 200 ft (60 m), i.e. CAT II/III operations.</p></td></tr><tr><td><p>SECTION 6</p></td></tr><tr/><tr><td><p>Additional authorisation on a type rating for instrument approaches down to a DH of less than 60 m (200 ft) (CAT II/III)</p><p>The following manoeuvres and procedures are the minimum training requirements to permit instrument approaches down to a DH of less than 60 m (200 ft). During the following instrument approaches and missed approach procedures, all aeroplane equipment required for type certification of instrument approaches down to a DH of less than 60 m (200 ft) shall be used.</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>6.1*</p></td><td><p>Rejected take-off at minimum authorised runway visual range (RVR)</p></td></tr></tbody></table></td><td><p>P*-----></p></td><td><p>---->X</p><p>An aeroplane shall not be used for this exercise</p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>6.2*</p></td><td><p>CAT II/III approaches:</p><p>in simulated instrument flight conditions down to the applicable DH, using flight guidance system. Standard procedures of crew coordination (task sharing, call-out procedures, mutual surveillance, information exchange and support) shall be observed.</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>6.3*</p></td><td><p>Go-around:</p><p>after approaches as indicated in 6.2 on reaching DH.</p><p>The training shall also include a go-around due to (simulated) insufficient RVR, wind shear, aeroplane deviation in excess of approach limits for a successful approach, ground/airborne equipment failure prior to reaching DH, and go-around with simulated airborne equipment failure.</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>6.4*</p></td><td><p>Landing(s):</p><p>with visual reference established at DH following an instrument approach. Depending on the specific flight guidance system, an automatic landing shall be performed.</p></td></tr></tbody></table></td><td><p>P-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr></tbody></table><p><span>NOTE:</span> CAT II/III operations shall be performed in accordance with the applicable air operations requirements.</p></td></tr></tbody></table><p>7.   Class ratings — sea</p><p>Section 6 shall be completed to revalidate a multi-engine class rating sea, VFR only, where the required experience of 10 route sectors within the previous 12 months has not been completed.</p><table><col/><col/><col/><col/><tbody><tr><td><p>CLASS RATING SEA</p></td><td><p>PRACTICAL TRAINING</p></td><td><p>CLASS RATING SKILL TEST OR PROFICIENCY CHECK</p></td></tr><tr><td><p>Manoeuvres/procedures</p></td><td><p>Instructor's initials when training completed</p></td><td><p>Examiner's initials when test completed</p></td></tr><tr><td><p>SECTION 1</p></td></tr><tr/><tr><td><table><col/><col/><tbody><tr><td><p>1</p></td><td><span>Departure</span></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>1.1.</p></td><td><p>Preflight including:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>documentation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>mass and balance;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>weather briefing; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>NOTAM.</p></td></tr></tbody></table></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.2.</p></td><td><p>Pre-start checks</p><p>External/internal</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.3.</p></td><td><p>Engine start-up and shutdown</p><p>Normal malfunctions</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.4.</p></td><td><p>Taxiing</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.5.</p></td><td><p>Step taxiing</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.6.</p></td><td><p>Mooring:</p></td></tr></tbody></table></td><td><p>Beach</p><p>Jetty pier</p><p>Buoy</p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.7.</p></td><td><p>Engine-off sailing</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.8.</p></td><td><p>Pre-departure checks:</p><p>Engine run-up (if applicable)</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.9.</p></td><td><p>Take-off procedure:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>normal with flight manual flap settings; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>crosswind (if conditions are available).</p></td></tr></tbody></table></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.10.</p></td><td><p>Climbing:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>turns onto headings</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>level off</p></td></tr></tbody></table></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.11.</p></td><td><p>ATC liaison — compliance, R/T procedures</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SECTION 2</p></td></tr><tr/><tr><td><table><col/><col/><tbody><tr><td><p>2</p></td><td><span>Airwork (VFR)</span></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.1.</p></td><td><p>Straight and level flight at various airspeeds including flight at critically low airspeed with and without flaps (including approach to VMCA when applicable)</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.2.</p></td><td><p>Steep turns (360° left and right at 45° bank)</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.3.</p></td><td><p>Stalls and recovery:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>clean stall;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>approach to stall in descending turn with bank with approach configuration and power;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>approach to stall in landing configuration and power; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>approach to stall, climbing turn with take-off flap and climb power (single-engine aeroplanes only).</p></td></tr></tbody></table></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.4.</p></td><td><p>ATC liaison — compliance, R/T procedures</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SECTION 3</p></td></tr><tr/><tr><td><table><col/><col/><tbody><tr><td><p>3</p></td><td><span>En route procedures VFR</span></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>3.1.</p></td><td><p>Flight plan, dead reckoning and map reading</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.2.</p></td><td><p>Maintenance of altitude, heading and speed</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.3.</p></td><td><p>Orientation, timing and revision of ETAs</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.4.</p></td><td><p>Use of radio navigation aids (if applicable)</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.5.</p></td><td><p>Flight management (flight log, routine checks including fuel, systems and icing)</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.6.</p></td><td><p>ATC liaison — compliance, R/T procedures</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SECTION 4</p></td></tr><tr/><tr><td><table><col/><col/><tbody><tr><td><p>4</p></td><td><span>Arrivals and landings</span></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>4.1.</p></td><td><p>Aerodrome arrival procedure (amphibians only)</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.2.</p></td><td><p>Normal landing</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.3.</p></td><td><p>Flapless landing</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.4.</p></td><td><p>Crosswind landing (if suitable conditions)</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.5.</p></td><td><p>Approach and landing with idle power from up to 2 000 ′ above the water (single-engine aeroplanes only)</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.6.</p></td><td><p>Go-around from minimum height</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.7.</p></td><td><p>Glassy water landing</p><p>Rough water landing</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.8.</p></td><td><p>ATC liaison — compliance, R/T procedures</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SECTION 5</p></td></tr><tr/><tr><td><table><col/><col/><tbody><tr><td><p>5</p></td><td><span>Abnormal and emergency procedures</span><p>(This section may be combined with Sections 1 through 4.)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>5.1.</p></td><td><p>Rejected take-off at a reasonable speed</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>5.2.</p></td><td><p>Simulated engine failure after take-off (single-engine aeroplanes only)</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>5.3.</p></td><td><p>Simulated forced landing without power (single-engine aeroplanes only)</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>5.4.</p></td><td><p>Simulated emergencies:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>fire or smoke in flight; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>systems' malfunctions as appropriate.</p></td></tr></tbody></table></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>5.5.</p></td><td><p>ATC liaison — compliance, R/T procedures</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SECTION 6</p></td></tr><tr/><tr><td><table><col/><col/><tbody><tr><td><p>6</p></td><td><span>Simulated asymmetric flight</span><p>(This section may be combined with Sections 1 through 5.)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>6.1.</p></td><td><p>Simulated engine failure during take-off (at a safe altitude unless carried out in an FFS and an FNPT II)</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>6.2.</p></td><td><p>Engine shutdown and restart (ME skill test only)</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>6.3.</p></td><td><p>Asymmetric approach and go-around</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>6.4.</p></td><td><p>Asymmetric approach and full-stop landing</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>6.5.</p></td><td><p>ATC liaison — compliance, R/T procedures</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td></tr></tbody></table><p>C.   <span>Specific requirements for the helicopter category</span></p><p>1.   In the case of skill test or proficiency check for type ratings and the ATPL, applicants shall pass Sections 1 to 4 and 6 (as applicable) of the skill test or proficiency check. Failure in more than five items will require applicants to repeat the entire test or check. Applicants failing not more than five items shall repeat the failed items. Failure in any item in the case of a retest or a recheck or failure in any other items already passed will require the applicants to repeat the entire test or check again. All sections of the skill test or proficiency check shall be completed within 6 months.</p><p>2.   In the case of proficiency check for an IR, applicants shall pass Section 5 of the proficiency check. Failure in more than 3 items will require applicants to repeat the entire Section 5. Applicants failing not more than 3 items shall repeat the failed items. Failure in any item in the case of a recheck or failure in any other items of Section 5 already passed will require applicants to repeat the entire check.</p><p>FLIGHT TEST TOLERANCE</p><p>3.   Applicants shall demonstrate the ability to:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>operate the helicopter within its limitations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>complete all manoeuvres with smoothness and accuracy;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>exercise good judgement and airmanship;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>apply aeronautical knowledge;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>maintain control of the helicopter at all times in such a manner that the successful outcome of a procedure or manoeuvre is never in doubt;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>understand and apply crew coordination and incapacitation procedures, if applicable; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>communicate effectively with the other crew members, if applicable.</p></td></tr></tbody></table><p>4.   The following limits shall apply, corrected to make allowance for turbulent conditions and the handling qualities and performance of the helicopter used.</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>IFR flight limits</p><table><col/><tbody><tr><td><p>Height</p><table><col/><col/><tbody><tr><td><p>Generally</p></td><td><p>± 100 ft</p></td></tr><tr><td><p>Starting a go-around at decision height/altitude</p></td><td><p>+ 50 ft/– 0 ft</p></td></tr><tr><td><p>Minimum descent height/MAPt/altitude</p></td><td><p>+ 50 ft/– 0 ft</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><tbody><tr><td><p>Tracking</p><table><col/><col/><tbody><tr/><tr/><tr><td><p>On radio aids</p></td><td><p>± 5°</p></td></tr><tr><td><p>For ‘angular’ deviations</p></td><td><p>Half-scale deflection, azimuth and glide path (e.g. LPV, ILS, MLS, GLS)</p></td></tr><tr><td><p>2D (LNAV) and 3D (LNAV/VNAV) ‘linear’ lateral deviations</p></td><td>cross-track error/deviation shall normally be limited to ±<p><img/></p> of the RNP value associated with the procedure. Brief deviations from this standard up to a maximum of one time the RNP value are allowable.</td></tr><tr><td><p>3D linear vertical deviations (e.g. RNP APCH (LNAV/VNAV) using BaroVNAV)</p></td><td><p>not more than – 75 ft below the vertical profile at any time, and not more than + 75 ft above the vertical profile at or below 1 000 ft above aerodrome level.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><tbody><tr><td><p>Heading</p><table><col/><col/><tbody><tr><td><p>all engines operating</p></td><td><p>± 5°</p></td></tr><tr><td><p>with simulated engine failure</p></td><td><p>± 10°</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><tbody><tr><td><p>Speed</p><table><col/><col/><tbody><tr><td><p>all engines operating</p></td><td><p>± 5 knots</p></td></tr><tr><td><p>with simulated engine failure</p></td><td><p>+ 10 knots/– 5 knots</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>VFR flight limits</p><table><col/><col/><tbody><tr/><tr/><tr><td><p>Height</p></td><td><p> </p></td></tr><tr><td><p>Generally</p></td><td><p>± 100 ft</p></td></tr><tr/><tr/><tr><td><p>Heading</p></td><td><p> </p></td></tr><tr><td><p>Normal operations</p></td><td><p>± 5°</p></td></tr><tr><td><p>Abnormal operations/emergencies</p></td><td><p>± 10°</p></td></tr><tr/><tr/><tr><td><p>Speed</p></td><td><p> </p></td></tr><tr><td><p>Generally</p></td><td><p>± 10 knots</p></td></tr><tr><td><p>With simulated engine failure</p></td><td><p>+ 10 knots/– 5 knots</p></td></tr><tr/><tr/><tr><td><p>Ground drift</p></td><td><p> </p></td></tr><tr><td><p>T.O. hover I.G.E.</p></td><td><p>± 3 ft</p></td></tr><tr><td><p>Landing</p></td><td><p>± 2 ft (with 0 ft rearward or lateral flight)</p></td></tr></tbody></table></td></tr></tbody></table><p>CONTENT OF THE TRAINING/SKILL TEST/PROFICIENCY CHECK</p><p>GENERAL</p><p>5.   The following symbol means:</p><table><col/><col/><col/><tbody><tr><td><p>P</p></td><td><p>=</p></td><td><p>Trained as PIC for the issue of a type rating for single-pilot helicopters (SPH) or trained as PIC or co-pilot and as PF and PM for the issue of a type rating for multi pilot helicopters (MPH).</p></td></tr></tbody></table><p>6.   The practical training shall be conducted at least at the training equipment level shown as (P), or may be conducted up to any higher equipment level shown by the arrow (---->).</p><p>The following abbreviations are used to indicate the training equipment used:</p><table><col/><col/><tbody><tr><td><p>FFS =</p></td><td><p>full-flight simulator</p></td></tr><tr><td><p>FTD =</p></td><td><p>flight training device</p></td></tr><tr><td><p>H =</p></td><td><p>helicopter</p></td></tr></tbody></table><p>7.   The starred items (*) shall be flown in actual or simulated IMC, only by applicants wishing to renew or revalidate an IR(H) or extend the privileges of that rating to another type.</p><p>8.   Instrument flight procedures (Section 5) shall be performed only by applicants wishing to renew or revalidate an IR(H) or extend the privileges of that rating to another type. An FFS or an FTD 2/3 may be used for this purpose.</p><p>9.   Where the letter ‘M’ appears in the skill test or proficiency check column, this will indicate a mandatory exercise.</p><p>10.   An FSTD shall be used for practical training and testing if the FSTD forms part of a type rating course. The following considerations will apply to the course:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the qualification of the FSTD as set out in the relevant requirements of Annex VI (Part-ARA) and Annex VII (Part-ORA);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the qualifications of the instructor and examiner;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the amount of FSTD training provided on the course;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the qualifications and previous experience in similar types of the pilots under training; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>the amount of supervised flying experience provided after the issue of the new type rating.</p></td></tr></tbody></table><p>MULTI-PILOT HELICOPTERS</p><p>11.   Applicants for the skill test for the issue of the multi-pilot helicopter type rating and ATPL(H) shall pass only Sections 1 to 4 and, if applicable, Section 6.</p><p>12.   Applicants for the revalidation or renewal of the multi-pilot helicopter type rating proficiency check shall pass only Sections 1 to 4 and, if applicable, Section 6.</p><table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>SINGLE/MULTI-PILOT HELICOPTERS</p></td><td><p>PRACTICAL TRAINING</p></td><td><p>SKILL TEST OR PROFICIENCY CHECK</p></td></tr><tr><td><p>Manoeuvres/procedures</p></td><td><p>FSTD</p></td><td><p>H</p></td><td><p>Instructor initials when training completed</p></td><td><p>Checked in FSTD or H</p></td><td><p>Examiner initials when test completed</p></td></tr><tr><td><p>SECTION 1 — Preflight preparations and checks</p></td></tr><tr/><tr><td><p>1.1</p></td><td><p>Helicopter exterior visual inspection; location of each item and purpose of inspection</p></td><td><p> </p></td><td><p>P</p></td><td><p> </p></td><td><p>M (if performed in the helicopter)</p></td><td><p> </p></td></tr><tr><td><p>1.2</p></td><td><p>Cockpit inspection</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>1.3</p></td><td><p>Starting procedures, radio and navigation equipment check, selection and setting of navigation and communication frequencies</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>1.4</p></td><td><p>Taxiing/air taxiing in compliance with ATC instructions or with instructions of an instructor</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>1.5</p></td><td><p>Pre-take-off procedures and checks</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>SECTION 2 — Flight manoeuvres and procedures</p></td></tr><tr/><tr><td><p>2.1</p></td><td><p>Take-offs (various profiles)</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.2</p></td><td><p>Sloping ground or crosswind take-offs & landings</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2.3</p></td><td><p>Take-off at maximum take-off mass (actual or simulated maximum take-off mass)</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2.4</p></td><td><p>Take-off with simulated engine failure shortly before reaching TDP or DPATO</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.4.1</p></td><td><p>Take-off with simulated engine failure shortly after reaching TDP or DPATO</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.5</p></td><td><p>Climbing and descending turns to specified headings</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.5.1</p></td><td><p>Turns with 30° bank, 180° to 360° left and right, by sole reference to instruments</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.6</p></td><td><p>Autorotative descent</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.6.1</p></td><td><p>For single-engine helicopters (SEH) autorotative landing or for multi-engine helicopters (MEH) power recovery</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.7</p></td><td><p>Landings, various profiles</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.7.1</p></td><td><p>Go-around or landing following simulated engine failure before LDP or DPBL</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.7.2</p></td><td><p>Landing following simulated engine failure after LDP or DPBL</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>SECTION 3 — Normal and abnormal operations of the following systems and procedures</p></td></tr><tr/><tr><td><p>3</p></td><td><p>Normal and abnormal operations of the following systems and procedures:</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>M</p></td><td><p>A mandatory minimum of 3 items shall be selected from this section</p></td></tr><tr><td><p>3.1</p></td><td><p>Engine</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.2</p></td><td><p>Air conditioning (heating, ventilation)</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.3</p></td><td><p>Pitot/static system</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.4</p></td><td><p>Fuel system</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.5</p></td><td><p>Electrical system</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.6</p></td><td><p>Hydraulic system</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.7</p></td><td><p>Flight control and trim system</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.8</p></td><td><p>Anti-icing and de-icing system</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.9</p></td><td><p>Autopilot/flight director</p></td><td><p>P</p></td><td><p>---></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.10</p></td><td><p>Stability augmentation devices</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.11</p></td><td><p>Weather radar, radio altimeter, transponder</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.12</p></td><td><p>Area navigation system</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.13</p></td><td><p>Landing gear system</p></td><td><p>P</p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.14</p></td><td><p>APU</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.15</p></td><td><p>Radio, navigation equipment, instruments and FMS</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SECTION 4 — Abnormal and emergency procedures</p></td></tr><tr/><tr><td><p>4</p></td><td><p>Abnormal and emergency procedures</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>M</p></td><td><p>A mandatory minimum of 3 items shall be selected from this section</p></td></tr><tr><td><p>4.1</p></td><td><p>Fire drills (including evacuation if applicable)</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.2</p></td><td><p>Smoke control and removal</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.3</p></td><td><p>Engine failures, shutdown and restart at a safe height</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.4</p></td><td><p>Fuel dumping (simulated)</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.5</p></td><td><p>Tail rotor control failure (if applicable)</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.5.1</p></td><td><p>Tail rotor loss (if applicable)</p></td><td><p>P</p></td><td><p>A helicopter shall not be used for this exercise</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.6</p></td><td><p>Incapacitation of crew member — MPH only</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.7</p></td><td><p>Transmission malfunctions</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.8</p></td><td><p>Other emergency procedures as outlined in the appropriate flight manual</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SECTION 5 — Instrument flight procedures (to be performed in IMC or simulated IMC)</p></td></tr><tr/><tr><td><p>5.1</p></td><td><p>Instrument take-off: transition to instrument flight is required as soon as possible after becoming airborne</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.1.1</p></td><td><p>Simulated engine failure during departure</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.2</p></td><td><p>Adherence to departure and arrival routes and ATC instructions</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.3</p></td><td><p>Holding procedures</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.4</p></td><td><p>3D operations to DH/A of 200 ft (60 m) or to higher minima if required by the approach procedure</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.4.1</p></td><td><p>Manually, without flight director.</p><p>Note: According to the AFM, RNP APCH procedures may require the use of autopilot or flight director. The procedure to be flown manually shall be chosen taken into account such limitations (for example, choose an ILS for 5.4.1 in the case of such AFM limitation).</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.4.2</p></td><td><p>Manually, with flight director</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.4.3</p></td><td><p>With coupled autopilot</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.4.4</p></td><td><p>Manually, with one engine simulated inoperative; engine failure has to be simulated during final approach before passing 1 000 ft above aerodrome level until touchdown or until completion of the missed approach procedure</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.5</p></td><td><p>2D operations down to the MDA/H</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.6</p></td><td><p>Go-around with all engines operating on reaching DA/H or MDA/MDH</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.6.1</p></td><td><p>Other missed approach procedures</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.6.2</p></td><td><p>Go-around with one engine simulated inoperative on reaching DA/H or MDA/MDH</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.7</p></td><td><p>IMC autorotation with power recovery</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.8</p></td><td><p>Recovery from unusual attitudes</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>SECTION 6 — Use of optional equipment</p></td></tr><tr/><tr><td><p>6</p></td><td><p>Use of optional equipment</p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr></tbody></table><p>D.   <span>Specific requirements for the powered-lift aircraft category</span></p><p>1.   In the case of skill tests or proficiency checks for powered-lift aircraft type ratings, applicants shall pass Sections 1 to 5 and 6 (as applicable) of the skill test or proficiency check. Failure in more than five items will require applicants to repeat the entire test or check. Applicants failing not more than five items shall repeat the failed items. Failure in any item in the case of a retest or a recheck or failure in any other items already passed will require applicants to repeat the entire test or check. All sections of the skill test or proficiency check shall be completed within 6 months.</p><p>FLIGHT TEST TOLERANCE</p><p>2.   Applicants shall demonstrate the ability to:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>operate the powered-lift aircraft within its limitations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>complete all manoeuvres with smoothness and accuracy;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>exercise good judgement and airmanship;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>apply aeronautical knowledge;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>maintain control of the powered-lift aircraft at all times in such a manner that the successful outcome of a procedure or manoeuvre is never in doubt;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>understand and apply crew coordination and incapacitation procedures; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>communicate effectively with the other crew members.</p></td></tr></tbody></table><p>3.   The following limits shall apply, corrected to make allowance for turbulent conditions and the handling qualities and performance of the powered-lift aircraft used.</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p><span>IFR flight limits</span></p><table><col/><col/><tbody><tr/><tr/><tr><td><p>Height</p></td><td><p> </p></td></tr><tr><td><p>Generally</p></td><td><p>± 100 ft</p></td></tr><tr><td><p>Starting a go-around at decision height/altitude</p></td><td><p>+ 50 ft/– 0 ft</p></td></tr><tr><td><p>Minimum descent height/altitude</p></td><td><p>+ 50 ft/– 0 ft</p></td></tr><tr/><tr/><tr><td><p>Tracking</p></td><td><p> </p></td></tr><tr><td><p>On radio aids</p></td><td><p>± 5°</p></td></tr><tr><td><p>Precision approach</p></td><td><p>half-scale deflection, azimuth and glide path</p></td></tr></tbody></table><table><col/><col/><tbody><tr/><tr/><tr><td><p>Heading</p></td><td><p> </p></td></tr><tr><td><p>Normal operations</p></td><td><p>± 5°</p></td></tr><tr><td><p>Abnormal operations/emergencies</p></td><td><p>± 10°</p></td></tr><tr/><tr/><tr><td><p>Speed</p></td><td><p> </p></td></tr><tr><td><p>Generally</p></td><td><p>± 10 knots</p></td></tr><tr><td><p>With simulated engine failure</p></td><td><p>+ 10 knots/– 5 knots</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>VFR flight limits:</p><table><col/><col/><tbody><tr/><tr/><tr><td><p>Height</p></td><td><p> </p></td></tr><tr><td><p>Generally</p></td><td><p>± 100 ft</p></td></tr><tr/><tr/><tr><td><p>Heading</p></td><td><p> </p></td></tr><tr><td><p>Normal operations</p></td><td><p>± 5°</p></td></tr><tr><td><p>Abnormal operations/emergencies</p></td><td><p>± 10°</p></td></tr><tr/><tr/><tr><td><p>Speed</p></td><td><p> </p></td></tr><tr><td><p>Generally</p></td><td><p>± 10 knots</p></td></tr><tr><td><p>With simulated engine failure</p></td><td><p>+ 10 knots/– 5 knots</p></td></tr><tr/><tr/><tr><td><p>Ground drift</p></td><td><p> </p></td></tr><tr><td><p>T.O. hover I.G.E.</p></td><td><p>± 3 ft</p></td></tr><tr><td><p>Landing</p></td><td><p>± 2 ft (with 0 ft rearward or lateral flight)</p></td></tr></tbody></table></td></tr></tbody></table><p>CONTENT OF THE TRAINING/SKILL TEST/PROFICIENCY CHECK</p><p>4.   The following symbol means:</p><table><col/><col/><col/><tbody><tr><td><p>P</p></td><td><p>=</p></td><td><p>Trained as PIC or co-pilot and as PF and PM for the issue of a type rating as applicable</p></td></tr></tbody></table><p>5.   The practical training shall be conducted at least at the training equipment level shown as (P), or may be conducted up to any higher equipment level shown by the arrow (---->).</p><p>6.   The following abbreviations are used to indicate the training equipment used:</p><table><col/><col/><tbody><tr><td><p>FFS =</p></td><td><p>full-flight simulator</p></td></tr><tr><td><p>FTD =</p></td><td><p>flight training device</p></td></tr><tr><td><p>OTD =</p></td><td><p>other training device</p></td></tr><tr><td><p>PL =</p></td><td><p>powered-lift aircraft</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>Applicants for the skill test for the issue of the powered-lift aircraft type rating shall pass Sections 1 to 5 and, if applicable, Section 6.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>Applicants for the revalidation or renewal of the powered-lift aircraft type rating proficiency check shall pass Sections 1 to 5 and, if applicable, Section 6 and/or Section 7.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>The starred items (*) shall be flown solely by reference to instruments. If this condition is not met during the skill test or proficiency check, the type rating will be restricted to VFR only.</p></td></tr></tbody></table><p>7.   Where the letter ‘M’ appears in the skill test or proficiency check column, this will indicate a mandatory exercise.</p><p>8.   FSTDs shall be used for practical training and testing if they form part of an approved type rating course. The following considerations will apply to the approval of the course:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the qualification of the FSTDs as set out in the relevant requirements of Annex VI (Part-ARA) and Annex VII (Part-ORA); and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the qualifications of the instructor.</p><table><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>POWERED-LIFT AIRCRAFT CATEGORY</p></td><td><p>PRACTICAL TRAINING</p></td><td><p>SKILL TEST OR PROFICIENCY CHECK</p></td></tr><tr><td><p>Manoeuvres/procedures</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>Instructor's initials when training completed</p></td><td><p>Checked in FFS PL</p></td><td><p>Examiner's initials when test completed</p></td></tr><tr><td><p>OTD</p></td><td><p>FTD</p></td><td><p>FFS</p></td><td><p>PL</p></td></tr><tr><td><p>SECTION 1 — Preflight preparations and checks</p></td></tr><tr/><tr><td><p>1.1</p></td><td><p>Powered-lift aircraft exterior visual inspection;</p><p>location of each item and purpose of inspection</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>P</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>1.2</p></td><td><p>Cockpit inspection</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>1.3</p></td><td><p>Starting procedures, radio and navigation equipment check, selection and setting of navigation and communication frequencies</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>1.4</p></td><td><p>Taxiing in compliance with ATC instructions or with instructions of an instructor</p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>1.5</p></td><td><p>Pre-take-off procedures and checks including power check</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>SECTION 2 — Flight manoeuvres and procedures</p></td></tr><tr/><tr><td><p>2.1</p></td><td><p>Normal VFR take-off profiles:</p><table><col/><col/><tbody><tr><td><p> </p></td><td><p>Runway operations (short take-off and landing (STOL) and vertical take-off and landing (VTOL)) including crosswind</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p> </p></td><td><p>Elevated heliports</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p> </p></td><td><p>Ground level heliports</p></td></tr></tbody></table></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.2</p></td><td><p>Take-off at maximum take-off mass (actual or simulated maximum take-off mass)</p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2.3.1</p></td><td><p>Rejected take-off:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>during runway operations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>during elevated heliport operations; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>during ground level operations.</p></td></tr></tbody></table></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.3.2</p></td><td><p>Take-off with simulated engine failure after passing decision point:</p><table><col/><col/><tbody><tr><td><p> </p></td><td><p>during runway operations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p> </p></td><td><p>during elevated heliport operations; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p> </p></td><td><p>during ground level operations.</p></td></tr></tbody></table></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.4</p></td><td><p>Autorotative descent in helicopter mode to ground (an aircraft shall not be used for this exercise)</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p>M</p><p>FFS</p><p>only</p></td><td><p> </p></td></tr><tr><td><p>2.4.1</p></td><td><p>Windmill descent in aeroplane mode (an aircraft shall not be used for this exercise)</p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p>M</p><p>FFS</p><p>only</p></td><td><p> </p></td></tr><tr><td><p>2.5</p></td><td><p>Normal VFR landing profiles:</p><table><col/><col/><tbody><tr><td><p> </p></td><td><p>runway operations (STOL and VTOL)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p> </p></td><td><p>elevated heliports</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p> </p></td><td><p>ground level heliports</p></td></tr></tbody></table></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.5.1</p></td><td><p>Landing with simulated engine failure after reaching decision point:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>during runway operations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>during elevated heliport operations; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>during ground level operations.</p></td></tr></tbody></table></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2.6</p></td><td><p>Go-around or landing following simulated engine failure before decision point</p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>SECTION 3 — Normal and abnormal operations of the following systems and procedures:</p></td></tr><tr/><tr><td><p>3</p></td><td><p>Normal and abnormal operations of the following systems and procedures (may be completed in an FSTD if qualified for the exercise):</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>M</p></td><td><p>A mandatory minimum of 3 items shall be selected from this section</p></td></tr><tr><td><p>3.1</p></td><td><p>Engine</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.2</p></td><td><p>Pressurisation and air conditioning (heating, ventilation)</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.3</p></td><td><p>Pitot/static system</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.4</p></td><td><p>Fuel system</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.5</p></td><td><p>Electrical system</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.6</p></td><td><p>Hydraulic system</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.7</p></td><td><p>Flight control and trim system</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.8</p></td><td><p>Anti-icing and de-icing system, glare shield heating (if fitted)</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.9</p></td><td><p>Autopilot/flight director</p></td><td><p>P</p></td><td><p>---></p></td><td><p>---></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.10</p></td><td><p>Stall warning devices or stall avoidance devices and stability augmentation devices</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.11</p></td><td><p>Weather radar, radio altimeter, transponder, ground proximity warning system (if fitted)</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.12</p></td><td><p>Landing gear system</p></td><td><p>P</p></td><td><p>-----></p></td><td><p>-----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.13</p></td><td><p>APU</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.14</p></td><td><p>Radio, navigation equipment, instruments and FMS</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.15</p></td><td><p>Flap system</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SECTION 4 — Abnormal and emergency procedures</p></td></tr><tr/><tr><td><p>4</p></td><td><p>Abnormal and emergency procedures</p><p>(may be completed in an FSTD if qualified for the exercise)</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>M</p></td><td><p>A mandatory minimum of 3 items shall be selected from this section</p></td></tr><tr><td><p>4.1</p></td><td><p>Fire drills, engine, APU, cargo compartment, flight deck and electrical fires including evacuation if applicable</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.2</p></td><td><p>Smoke control and removal</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.3</p></td><td><p>Engine failures, shutdown and restart</p><p>(an aircraft shall not be used for this exercise) including one engine inoperative conversion from helicopter to aeroplane modes and vice versa</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p>FFS</p><p>only</p></td><td><p> </p></td></tr><tr><td><p>4.4</p></td><td><p>Fuel dumping (simulated, if fitted)</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.5</p></td><td><p>Wind shear at take-off and landing (an aircraft shall not be used for this exercise)</p></td><td><p> </p></td><td><p> </p></td><td><p>P</p></td><td><p> </p></td><td><p> </p></td><td><p>FFS</p><p>only</p></td><td><p> </p></td></tr><tr><td><p>4.6</p></td><td><p>Simulated cabin pressure failure/emergency descent (an aircraft shall not be used for this exercise)</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p>FFS</p><p>only</p></td><td><p> </p></td></tr><tr><td><p>4.7</p></td><td><p>ACAS event</p><p>(an aircraft shall not be used for this exercise)</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p>FFS</p><p>only</p></td><td><p> </p></td></tr><tr><td><p>4.8</p></td><td><p>Incapacitation of crew member</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.9</p></td><td><p>Transmission malfunctions</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p>FFS</p><p>only</p></td><td><p> </p></td></tr><tr><td><p>4.10</p></td><td><p>Recovery from a full stall (power on and off) or after activation of stall warning devices in climb, cruise and approach configurations (an aircraft shall not be used for this exercise)</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p>FFS</p><p>only</p></td><td><p> </p></td></tr><tr><td><p>4.11</p></td><td><p>Other emergency procedures as detailed in the appropriate flight manual</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SECTION 5 — Instrument flight procedures (to be performed in IMC or simulated IMC)</p></td></tr><tr/><tr><td><p>5.1</p></td><td><p>Instrument take-off: transition to instrument flight is required as soon as possible after becoming airborne</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.1.1</p></td><td><p>Simulated engine failure during departure after decision point</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.2</p></td><td><p>Adherence to departure and arrival routes and ATC instructions</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.3</p></td><td><p>Holding procedures</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.4</p></td><td><p>Precision approach down to a decision height not less than 60 m (200 ft)</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.4.1</p></td><td><p>Manually, without flight director</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p>M* (Skill test only)</p></td><td><p> </p></td></tr><tr><td><p>5.4.2</p></td><td><p>Manually, with flight director</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.4.3</p></td><td><p>With use of autopilot</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.4.4</p></td><td><p>Manually, with one engine simulated inoperative; engine failure has to be simulated during final approach before passing the OM and continued either to touchdown or until completion of the missed approach procedure</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.5</p></td><td><p>Non-precision approach down to the MDA/H</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.6</p></td><td><p>Go-around with all engines operating on reaching DA/H or MDA/MDH</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.6.1</p></td><td><p>Other missed approach procedures</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.6.2</p></td><td><p>Go-around with one engine simulated inoperative on reaching DA/H or MDA/MDH</p></td><td><p>P*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.7</p></td><td><p>IMC autorotation with power recovery to land on runway in helicopter mode only (an aircraft shall not be used for this exercise)</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p>M*</p><p>FFS only</p></td><td><p> </p></td></tr><tr><td><p>5.8</p></td><td><p>Recovery from unusual attitudes (this one depends on the quality of the FFS)</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>SECTION 6 — Additional authorisation on a type rating for instrument approaches down to a decision height of less than 60 m (200 ft) (CAT II/III)</p></td></tr><tr/><tr><td><p>6</p></td><td><p>Additional authorisation on a type rating for instrument approaches down to a decision height of less than 60 m (CAT II/III).</p><p>The following manoeuvres and procedures are the minimum training requirements to permit instrument approaches down to a DH of less than 60 m (200 ft). During the following instrument approaches and missed approach procedures, all powered-lift aircraft equipment required for the type certification of instrument approaches down to a DH of less than 60 m (200 ft) shall be used.</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>6.1</p></td><td><p>Rejected take-off at minimum authorised RVR</p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>6.2</p></td><td><p>ILS approaches:</p><p>in simulated instrument flight conditions down to the applicable DH, using flight guidance system. Standard operating procedures (SOPs) of crew coordination shall be observed.</p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>6.3</p></td><td><p>Go-around:</p><p>after approaches as indicated in 6.2 on reaching DH. The training shall also include a go-around due to (simulated) insufficient RVR, wind shear, aircraft deviation in excess of approach limits for a successful approach, ground/airborne equipment failure prior to reaching DH, and go-around with simulated airborne equipment failure.</p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>6.4</p></td><td><p>Landing(s):</p><p>with visual reference established at DH following an instrument approach. Depending on the specific flight guidance system, an automatic landing shall be performed.</p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>SECTION 7 — Optional equipment</p></td></tr><tr/><tr><td><p>7</p></td><td><p>Use of optional equipment</p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr></tbody></table></td></tr></tbody></table><p>E.   <span>Specific requirements for the airship category</span></p><p>1.   In the case of skill tests or proficiency checks for airship type ratings, applicants shall pass Sections 1 to 5 and 6 (as applicable) of the skill test or proficiency check. Failure in more than five items will require applicants to repeat the entire test or check. Applicants failing not more than five items shall take the failed items again. Failure in any item in the case of a retest or a recheck, or failure in any other items already passed will require applicants to repeat the entire test or check again. All sections of the skill test or proficiency check shall be completed within 6 months.</p><p>FLIGHT TEST TOLERANCE</p><p>2.   Applicants shall demonstrate the ability to:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>operate the airship within its limitations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>complete all manoeuvres with smoothness and accuracy;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>exercise good judgement and airmanship;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>apply aeronautical knowledge;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>maintain control of the airship at all times in such a manner that the successful outcome of a procedure or manoeuvre is never in doubt;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>understand and apply crew coordination and incapacitation procedures; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>communicate effectively with the other crew members.</p></td></tr></tbody></table><p>3.   The following limits shall apply, corrected to make allowance for turbulent conditions and the handling qualities and performance of the airship used.</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p><span>IFR flight limits:</span></p><table><col/><col/><tbody><tr/><tr/><tr><td><p>Height</p></td><td><p> </p></td></tr><tr><td><p>Generally</p></td><td><p>± 100 ft</p></td></tr><tr><td><p>Starting a go-around at decision height/altitude</p></td><td><p>+ 50 ft/– 0 ft</p></td></tr><tr><td><p>Minimum descent height/altitude</p></td><td><p>+ 50 ft/– 0 ft</p></td></tr><tr/><tr/><tr><td><p>Tracking</p></td><td><p> </p></td></tr><tr><td><p>On radio aids</p></td><td><p>± 5°</p></td></tr><tr><td><p>Precision approach</p></td><td><p>half-scale deflection, azimuth and glide path</p></td></tr><tr/><tr/><tr><td><p>Heading</p></td><td><p> </p></td></tr><tr><td><p>Normal operations</p></td><td><p>± 5°</p></td></tr><tr><td><p>Abnormal operations/emergencies</p></td><td><p>± 10°</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>VFR flight limits:</p><table><col/><col/><tbody><tr/><tr/><tr><td><p>Height</p></td><td><p> </p></td></tr><tr><td><p>Generally</p></td><td><p>± 100 ft</p></td></tr><tr/><tr/><tr><td><p>Heading</p></td><td><p> </p></td></tr><tr><td><p>Normal operations</p></td><td><p>± 5°</p></td></tr><tr><td><p>Abnormal operations/emergencies</p></td><td><p>± 10°</p></td></tr></tbody></table></td></tr></tbody></table><p>CONTENT OF THE TRAINING/SKILL TEST/PROFICIENCY CHECK</p><p>4.   The following symbol means:</p><table><col/><col/><col/><tbody><tr><td><p>P</p></td><td><p>=</p></td><td><p>Trained as PIC or co-pilot and as PF and PM for the issue of a type rating as applicable.</p></td></tr></tbody></table><p>5.   The practical training shall be conducted at least at the training equipment level shown as (P), or may be conducted up to any higher equipment level shown by the arrow (---->).</p><p>6.   The following abbreviations are used to indicate the training equipment used:</p><table><col/><col/><tbody><tr><td><p>FFS =</p></td><td><p>full-flight simulator</p></td></tr><tr><td><p>FTD =</p></td><td><p>flight training device</p></td></tr><tr><td><p>OTD =</p></td><td><p>other training device</p></td></tr><tr><td><p>As =</p></td><td><p>airship</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>Applicants for the skill test for the issue of the airship shall pass Sections 1 to 5 and, if applicable, Section 6.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>Applicants for the revalidation or renewal of the airship type rating proficiency check shall pass Sections 1 to 5 and, if applicable Section 6.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>The starred items (*) shall be flown solely by reference to instruments. If this condition is not met during the skill test or proficiency check, the type rating will be restricted to VFR only.</p></td></tr></tbody></table><p>7.   Where the letter ‘M’ appears in the skill test or proficiency check column, this will indicate a mandatory exercise.</p><p>8.   FSTDs shall be used for practical training and testing if they form part of a type rating course. The following considerations will apply to the course:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the qualification of the FSTDs as set out in the relevant requirements of Annex VI (Part-ARA) and Annex VII (Part-ORA); and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the qualifications of the instructor.</p><table><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>AIRSHIP CATEGORY</p></td><td><p>PRACTICAL TRAINING</p></td><td><p>SKILL TEST OR PROFICIENCY CHECK</p></td></tr><tr><td><p>Manoeuvres/procedures</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>Instructor's initials when training completed</p></td><td><p>Checked in</p></td><td><p>Examiner's initials when test completed</p></td></tr><tr><td><p>OTD</p></td><td><p>FTD</p></td><td><p>FFS</p></td><td><p>As</p></td><td><p>FFS As</p></td></tr><tr><td><p>SECTION 1 — Preflight preparations and checks</p></td></tr><tr/><tr><td><p>1.1</p></td><td><p>Preflight inspection</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>P</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>1.2</p></td><td><p>Cockpit inspection</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>1.3</p></td><td><p>Starting procedures, radio and navigation equipment check, selection and setting of navigation and communication frequencies</p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>1.4</p></td><td><p>Off-mast procedure and ground manoeuvring</p></td><td><p> </p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>1.5</p></td><td><p>Pre-take-off procedures and checks</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>SECTION 2 — Flight manoeuvres and procedures</p></td></tr><tr/><tr><td><p>2.1</p></td><td><p>Normal VFR take-off profile</p></td><td><p> </p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.2</p></td><td><p>Take-off with simulated engine failure</p></td><td><p> </p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.3</p></td><td><p>Take-off with heaviness > 0 (Heavy T/O)</p></td><td><p> </p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2.4</p></td><td><p>Take-off with heaviness < 0 (Light/TO)</p></td><td><p> </p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2.5</p></td><td><p>Normal climb procedure</p></td><td><p> </p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2.6</p></td><td><p>Climb to pressure height</p></td><td><p> </p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2.7</p></td><td><p>Recognising of pressure height</p></td><td><p> </p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2.8</p></td><td><p>Flight at or close to pressure height</p></td><td><p> </p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.9</p></td><td><p>Normal descent and approach</p></td><td><p> </p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2.10</p></td><td><p>Normal VFR landing profile</p></td><td><p> </p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.11</p></td><td><p>Landing with heaviness > 0 (Heavy Ldg.)</p></td><td><p> </p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p>2.12</p></td><td><p>Landing with heaviness < 0 (Light Ldg.)</p></td><td><p> </p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p>M</p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Intentionally left blank</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SECTION 3 — Normal and abnormal operations of the following systems and procedures</p></td></tr><tr/><tr><td><p>3</p></td><td><p>Normal and abnormal operations of the following systems and procedures (may be completed in an FSTD if qualified for the exercise):</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>M</p></td><td><p>A mandatory minimum of 3 items shall be selected from this section</p></td></tr><tr><td><p>3.1</p></td><td><p>Engine</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.2</p></td><td><p>Envelope pressurisation</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.3</p></td><td><p>Pitot/static system</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.4</p></td><td><p>Fuel system</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.5</p></td><td><p>Electrical system</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.6</p></td><td><p>Hydraulic system</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.7</p></td><td><p>Flight control and trim system</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.8</p></td><td><p>Ballonet system</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.9</p></td><td><p>Autopilot/flight director</p></td><td><p>P</p></td><td><p>---></p></td><td><p>---></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.10</p></td><td><p>Stability augmentation devices</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.11</p></td><td><p>Weather radar, radio altimeter, transponder, ground proximity warning system (if fitted)</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.12</p></td><td><p>Landing gear system</p></td><td><p>P</p></td><td><p>-----></p></td><td><p>-----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.13</p></td><td><p>APU</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>3.14</p></td><td><p>Radio, navigation equipment, instruments and FMS</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Intentionally left blank</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SECTION 4 — Abnormal and emergency procedures</p></td></tr><tr/><tr><td><p>4</p></td><td><p>Abnormal and emergency procedures</p><p>(may be completed in an FSTD if qualified for the exercise)</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>M</p></td><td><p>A mandatory minimum of three items shall be selected from this section</p></td></tr><tr><td><p>4.1</p></td><td><p>Fire drills, engine, APU, cargo compartment, flight deck and electrical fires, including evacuation if applicable</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.2</p></td><td><p>Smoke control and removal</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.3</p></td><td><p>Engine failures, shutdown and restart:</p><p>in particular phases of flight, inclusive multiple engine failure</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.4</p></td><td><p>Incapacitation of crew member</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>4.5</p></td><td><p>Transmission/gearbox malfunctions</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p>FFS only</p></td><td><p> </p></td></tr><tr><td><p>4.6</p></td><td><p>Other emergency procedures as outlined in the appropriate flight manual</p></td><td><p>P</p></td><td><p>----></p></td><td><p>----></p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>SECTION 5 — Instrument Flight Procedures (to be performed in IMC or simulated IMC)</p></td></tr><tr/><tr><td><p>5.1</p></td><td><p>Instrument take-off: transition to instrument flight is required as soon as possible after becoming airborne</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.1.1</p></td><td><p>Simulated engine failure during departure</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.2</p></td><td><p>Adherence to departure and arrival routes and ATC instructions</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.3</p></td><td><p>Holding procedures</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.4</p></td><td><p>Precision approach down to a decision height not less than 60 m (200 ft)</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.4.1</p></td><td><p>Manually, without flight director</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p>M*</p><p>(Skill test only)</p></td><td><p> </p></td></tr><tr><td><p>5.4.2</p></td><td><p>Manually, with flight director</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.4.3</p></td><td><p>With use of autopilot</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.4.4</p></td><td><p>Manually, with one engine simulated inoperative; engine failure has to be simulated during final approach before passing the OM and continued to touchdown or until completion of the missed approach procedure</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.5</p></td><td><p>Non-precision approach down to the MDA/H</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.6</p></td><td><p>Go-around with all engines operating on reaching DA/H or MDA/MDH</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.6.1</p></td><td><p>Other missed approach procedures</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>5.6.2</p></td><td><p>Go-around with one engine simulated inoperative on reaching DA/H or MDA/MDH</p></td><td><p>P*</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>5.7</p></td><td><p>Recovery from unusual attitudes</p><p>(this one depends on the quality of the FFS)</p></td><td><p>P*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p>---->*</p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>SECTION 6 — Additional authorisation on a type rating for instrument approaches down to a decision height of less than 60 m (200 ft) (CAT II/III)</p></td></tr><tr/><tr><td><p>6</p></td><td><p>Additional authorisation on a type rating for instrument approaches down to a decision height of less than 60 m (200 ft) (CAT II/III).</p><p>The following manoeuvres and procedures are the minimum training requirements to permit instrument approaches down to a DH of less than 60 m (200 ft). During the following instrument approaches and missed approach procedures, all airship equipment required for the type certification of instrument approaches down to a DH of less than 60 m (200 ft) shall be used.</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>6.1</p></td><td><p>Rejected take-off at minimum authorised RVR</p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>6.2</p></td><td><p>ILS approaches:</p><p>in simulated instrument flight conditions down to the applicable DH, using flight guidance system. SOPs of crew coordination shall be observed.</p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>6.3</p></td><td><p>Go-around</p><p>After approaches as indicated in 6.2 on reaching DH.</p><p>The training shall also include a go-around due to (simulated) insufficient RVR, wind shear, aircraft deviation in excess of approach limits for a successful approach, ground/airborne equipment failure prior to reaching DH and, go-around with simulated airborne equipment failure.</p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>6.4</p></td><td><p>Landing(s):</p><p>with visual reference established at DH following an instrument approach. Depending on the specific flight guidance system, an automatic landing shall be performed</p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p>M*</p></td><td><p> </p></td></tr><tr><td><p>SECTION 7 — Optional equipment</p></td></tr><tr/><tr><td><p>7</p></td><td><p>Use of optional equipment</p></td><td><p> </p></td><td><p>P</p></td><td><p>----></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr></tbody></table></td></tr></tbody></table></div></div>’</td></tr></tbody></table> | ENG | 32018R1974 |
<table><col/><col/><col/><col/><tbody><tr><td><p>6.5.2014   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 133/53</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) No 461/2014
of 5 May 2014
establishing the standard import values for determining the entry price of certain fruit and vegetables
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) ( 1 ) ,
Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors ( 2 ) , and in particular Article 136(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the<span>Official Journal of the European Union</span>,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 May 2014.
For the Commission ,
On behalf of the President ,
Jerzy PLEWA
Director-General for Agriculture and Rural Development
( 1 ) OJ L 299, 16.11.2007, p. 1 .
( 2 ) OJ L 157, 15.6.2011, p. 1 .
ANNEX
Standard import values for determining the entry price of certain fruit and vegetables
<table><col/><col/><col/><tbody><tr><td><p>(EUR/100 kg)</p></td></tr><tr><td><p>CN code</p></td><td><p>Third country code<a> (<span>1</span>)</a></p></td><td><p>Standard import value</p></td></tr><tr><td><p>0702 00 00</p></td><td><p>MA</p></td><td><p>35,3</p></td></tr><tr><td><p>MK</p></td><td><p>96,5</p></td></tr><tr><td><p>TN</p></td><td><p>109,1</p></td></tr><tr><td><p>TR</p></td><td><p>97,3</p></td></tr><tr><td><p>ZZ</p></td><td><p>84,6</p></td></tr><tr><td><p>0707 00 05</p></td><td><p>MA</p></td><td><p>35,6</p></td></tr><tr><td><p>MK</p></td><td><p>51,1</p></td></tr><tr><td><p>TR</p></td><td><p>133,0</p></td></tr><tr><td><p>ZZ</p></td><td><p>73,2</p></td></tr><tr><td><p>0709 93 10</p></td><td><p>MA</p></td><td><p>70,8</p></td></tr><tr><td><p>TR</p></td><td><p>113,2</p></td></tr><tr><td><p>ZA</p></td><td><p>31,4</p></td></tr><tr><td><p>ZZ</p></td><td><p>71,8</p></td></tr><tr><td><p>0805 10 20</p></td><td><p>EG</p></td><td><p>54,5</p></td></tr><tr><td><p>IL</p></td><td><p>74,0</p></td></tr><tr><td><p>MA</p></td><td><p>55,5</p></td></tr><tr><td><p>TN</p></td><td><p>68,6</p></td></tr><tr><td><p>TR</p></td><td><p>63,3</p></td></tr><tr><td><p>ZZ</p></td><td><p>63,2</p></td></tr><tr><td><p>0805 50 10</p></td><td><p>MA</p></td><td><p>35,6</p></td></tr><tr><td><p>TR</p></td><td><p>95,1</p></td></tr><tr><td><p>ZZ</p></td><td><p>65,4</p></td></tr><tr><td><p>0808 10 80</p></td><td><p>AR</p></td><td><p>95,2</p></td></tr><tr><td><p>BR</p></td><td><p>89,6</p></td></tr><tr><td><p>CL</p></td><td><p>100,5</p></td></tr><tr><td><p>CN</p></td><td><p>98,6</p></td></tr><tr><td><p>MK</p></td><td><p>30,8</p></td></tr><tr><td><p>NZ</p></td><td><p>137,8</p></td></tr><tr><td><p>US</p></td><td><p>158,7</p></td></tr><tr><td><p>ZA</p></td><td><p>110,2</p></td></tr><tr><td><p>ZZ</p></td><td><p>102,7</p></td></tr></tbody></table>
<note>
( 1 ) Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 ( OJ L 354, 14.12.2006, p. 19 ). Code ‘ZZ’ stands for ‘of other origin’.
</note> | ENG | 32014R0461 |
<table><col/><col/><col/><col/><tbody><tr><td><p>25.11.2016   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>C 439/1</p></td></tr></tbody></table>
This text updates the recommendations to national courts and tribunals adopted following the entry into force on 1 November 2012 of the new Rules of Procedure of the Court of Justice ( OJ C 338, 6.11.2012, p. 1 ). Based on experience gained in implementing those rules ( 1 ) , and on the latest case-law, the present recommendations serve as a reminder of the essential characteristics of the preliminary ruling procedure and to provide courts and tribunals making references to the Court for a preliminary ruling with all the practical information required in order for the Court to be in a position to give a useful reply to the questions referred.
RECOMMENDATIONS
to national courts and tribunals, in relation to the initiation of preliminary ruling proceedings
(2016/C 439/01)
Introduction
<table><col/><col/><col/><tbody><tr><td/><td><p>1.</p></td><td><p>The reference for a preliminary ruling, provided for in Article 19(3)(b) of the Treaty on European Union (‘TEU’) and Article 267 of the Treaty on the Functioning of the European Union (‘TFEU’), is a fundamental mechanism of EU law. It is designed to ensure the uniform interpretation and application of that law within the European Union, by offering the courts and tribunals of the Member States a means of bringing before the Court of Justice of the European Union (‘the Court’) for a preliminary ruling questions concerning the interpretation of EU law or the validity of acts adopted by the institutions, bodies, offices or agencies of the Union.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>2.</p></td><td><p>The preliminary ruling procedure is based on close cooperation between the Court and the courts and tribunals of the Member States. In order to ensure that that procedure is fully effective, it is necessary to recall its essential characteristics and to provide further information to clarify the provisions of the rules of procedure relating, in particular, to the originator and scope of a request for a preliminary ruling, as well as to the form and content of such a request. That information — which applies to all requests for a preliminary ruling (I) — is supplemented by the provisions that apply to requests for a preliminary ruling requiring particularly expeditious handling (II) and by an annex which summarises the essential elements of any request for a preliminary ruling.</p></td></tr></tbody></table>
I. Provisions which apply to all requests for a preliminary ruling
The originator of the request for a preliminary ruling
<table><col/><col/><col/><tbody><tr><td/><td><p>3.</p></td><td><p>The jurisdiction of the Court to give a preliminary ruling on the interpretation or validity of EU law is exercised exclusively on the initiative of the national courts and tribunals, whether or not the parties to the main proceedings have expressed the wish that a question be referred to the Court. In so far as it is called upon to assume responsibility for the subsequent judicial decision, it is for the national court or tribunal before which a dispute has been brought — and for that court or tribunal alone — to determine, in the light of the particular circumstances of each case, both the need for a request for a preliminary ruling in order to enable it to deliver judgment and the relevance of the questions which it submits to the Court.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>4.</p></td><td><p>Status as a court or tribunal is interpreted by the Court as a self-standing concept of EU law, the Court taking account of a number of factors such as whether the body making the reference is established by law, whether it is permanent, whether its jurisdiction is compulsory, whether its procedure is<span>inter partes</span>, whether it applies rules of law and whether it is independent.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>5.</p></td><td><p>The courts and tribunals of the Member States may refer a question to the Court on the interpretation or validity of EU law where they consider that a decision of the Court on the question is necessary to enable them to give judgment (see second paragraph of Article 267 TFEU). A reference for a preliminary ruling may, inter alia, prove particularly useful when a question of interpretation is raised before the national court or tribunal that is new and of general interest for the uniform application of EU law, or where the existing case-law does not appear to provide the necessary guidance in a new legal context or set of facts.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>6.</p></td><td><p>Where a question is raised in the context of a case that is pending before a court or tribunal against whose decisions there is no judicial remedy under national law, that court or tribunal is nonetheless required to bring a request for a preliminary ruling before the Court (see third paragraph of Article 267 TFEU), unless there is already well-established case-law on the point or unless the correct interpretation of the rule of law in question admits of no reasonable doubt.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>7.</p></td><td><p>It follows, moreover, from settled case-law that although national courts and tribunals may reject pleas raised before them challenging the validity of acts of an institution, body, office or agency of the Union, the Court has exclusive jurisdiction to declare such acts invalid. When it has doubts about the validity of such an act, a court or tribunal of a Member State must therefore refer the matter to the Court, stating the reasons for which it considers that the act is invalid.</p></td></tr></tbody></table>
The subject matter and scope of the request for a preliminary ruling
<table><col/><col/><col/><tbody><tr><td/><td><p>8.</p></td><td><p>A request for a preliminary ruling must concern the interpretation or validity of EU law, not the interpretation of rules of national law or issues of fact raised in the main proceedings.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>9.</p></td><td><p>The Court can give a preliminary ruling only if EU law applies to the case in the main proceedings. It is essential, in that respect, that the referring court or tribunal set out all the relevant matters of fact and of law that have prompted it to consider that any provisions of EU law may be applicable in the case.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>10.</p></td><td><p>With regard to references for a preliminary ruling concerning the interpretation of the Charter of Fundamental Rights of the European Union, it must be noted that, under Article 51(1) of the Charter, the provisions of the Charter are addressed to the Member States only when they are implementing EU law. While the circumstances of such implementation can vary, it must nevertheless be clearly and unequivocally apparent from the request for a preliminary ruling that a rule of EU law other than the Charter is applicable to the case in the main proceedings. Since the Court has no jurisdiction to give a preliminary ruling where a legal situation does not come within the scope of EU law, any provisions of the Charter that may be relied upon by the referring court or tribunal cannot, of themselves, form the basis for such jurisdiction.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>11.</p></td><td><p>Lastly, although, in order to deliver its decision, the Court necessarily takes into account the legal and factual context of the dispute in the main proceedings, as defined by the referring court or tribunal in its request for a preliminary ruling, it does not itself apply EU law to that dispute. When ruling on the interpretation or validity of EU law, the Court makes every effort to give a reply which will be of assistance in resolving the dispute in the main proceedings, but it is for the referring court or tribunal to draw case-specific conclusions, if necessary by disapplying the rule of national law held incompatible with EU law.</p></td></tr></tbody></table>
The appropriate stage at which to make a reference for a preliminary ruling
<table><col/><col/><col/><tbody><tr><td/><td><p>12.</p></td><td><p>A national court or tribunal may submit a request for a preliminary ruling to the Court as soon as it finds that a ruling on the interpretation or validity of EU law is necessary to enable it to give judgment. It is that court or tribunal which is in fact in the best position to decide at what stage of the proceedings such a request should be made.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>13.</p></td><td><p>Since, however, that request will serve as the basis of the proceedings before the Court and the Court must therefore have available to it all the information that will enable it both to assess whether it has jurisdiction to give a reply to the questions raised and, if so, to give a useful reply to those questions, it is necessary that a decision to make a reference for a preliminary ruling be taken when the national proceedings have reached a stage at which the referring court or tribunal is able to define, in sufficient detail, the legal and factual context of the case in the main proceedings, and the legal issues which it raises. In the interests of the proper administration of justice, it may also be desirable for the reference to be made only after both sides have been heard.</p></td></tr></tbody></table>
The form and content of the request for a preliminary ruling
<table><col/><col/><col/><tbody><tr><td/><td><p>14.</p></td><td><p>The request for a preliminary ruling may be in any form allowed by national law in respect of procedural issues, but it should be borne in mind that that request serves as the basis of the proceedings before the Court and is served on all the interested persons referred to in Article 23 of the Statute of the Court (‘the Statute’) and, in particular, on all the Member States, with a view to obtaining any observations they may wish to make. Owing to the consequential need to translate it into all the official languages of the European Union, the request for a preliminary ruling should therefore be drafted simply, clearly and precisely by the referring court or tribunal, avoiding superfluous detail. As experience has shown, about 10 pages are often sufficient to set out adequately the legal and factual context of a request for a preliminary ruling.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>15.</p></td><td><p>The content of any request for a preliminary ruling is prescribed by Article 94 of the Rules of Procedure of the Court and is summarised in the annex hereto. In addition to the text of the questions referred to the Court for a preliminary ruling, the request for a preliminary ruling must contain:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>a summary of the subject matter of the dispute and the relevant findings of fact as determined by the referring court or tribunal, or, at the very least, an account of the facts on which the questions referred are based,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>the tenor of any national provisions applicable in the case and, where appropriate, the relevant national case-law, and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>a statement of the reasons which prompted the referring court or tribunal to inquire about the interpretation or validity of certain provisions of EU law, and the relationship between those provisions and the national legislation applicable to the main proceedings.</p></td></tr></tbody></table><p>In the absence of one or more of the above, the Court may have to decline jurisdiction to give a preliminary ruling on the questions referred or dismiss the request for a preliminary ruling as inadmissible.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>16.</p></td><td><p>In its request for a preliminary ruling, the referring court or tribunal must provide precise references for the national provisions applicable to the facts of the dispute in the main proceedings, and accurately identify the provisions of EU law whose interpretation is sought or whose validity is challenged. The request should include, if need be, a brief summary of the relevant arguments of the parties to the main proceedings. It is helpful to bear in mind in that context that it is only the request for a preliminary ruling that will be translated, not any annexes to that request.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>17.</p></td><td><p>The referring court or tribunal may also briefly state its view on the answer to be given to the questions referred for a preliminary ruling. That information may be useful to the Court, particularly where it is called upon to give a preliminary ruling in an expedited or urgent procedure.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>18.</p></td><td><p>Lastly, the questions referred to the Court for a preliminary ruling must appear in a separate and clearly identified section of the order for reference, preferably at the beginning or the end. It must be possible to understand them on their own terms, without it being necessary to refer to the statement of the grounds for the request.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>19.</p></td><td><p>In order to make the request for a preliminary ruling easier to read, it is essential that the Court receive it in typewritten form and that the pages and paragraphs of the order for reference be numbered.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>20.</p></td><td><p>The request for a preliminary ruling must be dated and signed, then sent, by registered post, to the Court Registry at the following address: Rue du Fort Niedergrünewald, 2925 Luxembourg, LUXEMBOURG. The request must be accompanied by any relevant documents and, in particular, precise contact details for the parties to the main proceedings and their representatives, if any, as well as the file of the case in the main proceedings or a copy of it. The file (or copy file) will be retained at the Registry throughout the proceedings where, unless otherwise indicated by the referring court or tribunal, it may be consulted by the interested persons referred to in Article 23 of the Statute.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>21.</p></td><td><p>Under the preliminary ruling procedure, the Court will, as a rule, use the information contained in the order for reference, including nominative or personal data. It is therefore for the referring court or tribunal itself, if it considers it necessary, to redact certain details in its request for a preliminary ruling or to render anonymous one or more persons or entities concerned by the dispute in the main proceedings.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>22.</p></td><td><p>After the request for a preliminary ruling has been lodged, the Court may also render such persons or entities anonymous of its own motion, or at the request of the referring court or tribunal or of a party to the main proceedings. In order to maintain its effectiveness, such a request for anonymity must, however, be made at the earliest possible stage of the proceedings, and in any event prior to publication in the<span>Official Journal of the European Union</span> of the notice relating to the case concerned, and to service of the request for a preliminary ruling on the interested persons referred to in Article 23 of the Statute, which generally takes place about one month after the request for a preliminary ruling has been lodged. Given the increasing use of new information and communication technologies, any anonymisation after such publication and service would be devoid of practical purpose.</p></td></tr></tbody></table>
Interaction between the reference for a preliminary ruling and the national proceedings
<table><col/><col/><col/><tbody><tr><td/><td><p>23.</p></td><td><p>Although the referring court or tribunal may still order protective measures, particularly in connection with a reference on determination of validity, the lodging of a request for a preliminary ruling nevertheless calls for the national proceedings to be stayed until the Court has given its ruling.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>24.</p></td><td><p>While the Court, in principle, remains seised of a request for a preliminary ruling for so long as that request is not withdrawn, it must nevertheless be borne in mind that the Court's role in the preliminary ruling procedure is to contribute to the effective administration of justice in the Member States and not to give opinions on general or hypothetical questions. Since the preliminary ruling procedure is predicated on there being proceedings actually pending before the referring court or tribunal, it is incumbent on that court or tribunal to inform the Court of any procedural step that may affect the referral and, in particular, of any discontinuance or withdrawal, amicable settlement or other event leading to the termination of the proceedings. The referring court or tribunal must also inform the Court of any decision delivered in the context of an appeal against the order for reference and of the consequences of that decision for the request for a preliminary ruling.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>25.</p></td><td><p>In the interests of the proper conduct of the preliminary ruling proceedings before the Court and in order to maintain their effectiveness, it is important, however, that such information is communicated to the Court with the minimum of delay. The national courts and tribunals should also note that the withdrawal of a request for a preliminary ruling may have an impact on the management of similar cases (or of a series of cases) by the referring court or tribunal. Where the outcome of a number of cases pending before the referring court or tribunal depends on the reply to be given by the Court to the questions submitted by that court or tribunal, it may be appropriate for that court or tribunal to join those cases in the request for a preliminary ruling in order to enable the Court to reply to the questions referred notwithstanding any withdrawal of one or more cases.</p></td></tr></tbody></table>
Costs and legal aid
<table><col/><col/><col/><tbody><tr><td/><td><p>26.</p></td><td><p>Preliminary ruling proceedings before the Court are free of charge and the Court does not rule on the costs of the parties to the proceedings pending before the referring court or tribunal; it is for the referring court or tribunal to rule on those costs.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>27.</p></td><td><p>If a party to the main proceedings has insufficient means and where it is possible under national rules, the referring court or tribunal may grant that party legal aid to cover the costs, including those of lawyers' fees, which it incurs before the Court. The Court itself may also grant legal aid where the party in question is not already in receipt of aid under national rules or to the extent to which that aid does not cover, or covers only partly, costs incurred before the Court.</p></td></tr></tbody></table>
Communication between the Court and the national court or tribunal
<table><col/><col/><col/><tbody><tr><td/><td><p>28.</p></td><td><p>The Court Registry will remain in contact with the referring court or tribunal throughout the proceedings, and will send it copies of all procedural documents and any requests for information or clarification deemed necessary in order for a useful reply to be given to the questions referred by that court or tribunal.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>29.</p></td><td><p>At the end of the proceedings, the Registry will send the Court's decision to the referring court or tribunal, which is invited to inform the Court of the action taken upon that decision in the case in the main proceedings and to communicate to the Court its final decision in that case.</p></td></tr></tbody></table>
II. Provisions applicable to requests for a preliminary ruling requiring particularly expeditious handling
<table><col/><col/><col/><tbody><tr><td/><td><p>30.</p></td><td><p>As provided in Article 23a of the Statute and Articles 105 to 114 of the Rules of Procedure, a reference for a preliminary ruling may, in certain circumstances, be determined pursuant to an expedited procedure or an urgent procedure. The Court will decide whether these procedures are to be applied, either on submission by the referring court or tribunal of a duly reasoned request setting out the matters of fact or of law which justify the application of such procedure(s), or, exceptionally, of its own motion, where that appears to be required by the nature or the particular circumstances of the case.</p></td></tr></tbody></table>
Conditions for the application of the expedited and urgent procedures
<table><col/><col/><col/><tbody><tr><td/><td><p>31.</p></td><td><p>Article 105 of the Rules of Procedure provides that a reference for a preliminary ruling may thus be determined pursuant to an expedited procedure derogating from the provisions of those rules where the nature of the case requires that it be dealt with within a short time. Since that procedure imposes significant constraints on all those involved in it, and, in particular, on all the Member States called upon to lodge observations, whether written or oral, within much shorter time limits than would ordinarily apply, its application must be sought only in particular circumstances that warrant the Court giving its ruling quickly on the questions referred. According to settled case-law, the large number of persons or legal situations potentially affected by the decision that the referring court or tribunal has to deliver after bringing the matter before the Court for a preliminary ruling does not, in itself, constitute an exceptional circumstance that would justify the use of the expedited procedure.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>32.</p></td><td><p>The same applies<span>a fortiori</span> to the urgent preliminary ruling procedure, provided for in Article 107 of the Rules of Procedure. That procedure, which applies only in the areas covered by Title V of Part Three of the TFEU, relating to the area of freedom, security and justice, imposes even greater constraints on those concerned, since it limits the number of parties authorised to lodge written observations and, in cases of extreme urgency, allows the written part of the procedure before the Court to be omitted altogether. The application of the urgent procedure must therefore be requested only where it is absolutely necessary for the Court to give its ruling very quickly on the questions submitted by the referring court or tribunal.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>33.</p></td><td><p>Although it is not possible to provide an exhaustive list of such circumstances, particularly because of the varied and evolving nature of the rules of EU law governing the area of freedom, security and justice, a national court or tribunal may, for example, consider submitting a request for the urgent preliminary ruling procedure to be applied in the case, referred to in the fourth paragraph of Article 267 TFEU, of a person in custody or deprived of his liberty, where the answer to the question raised is decisive as to the assessment of that person's legal situation, or in proceedings concerning parental authority or custody of young children, where the identity of the court having jurisdiction under EU law depends on the answer to the question referred for a preliminary ruling.</p></td></tr></tbody></table>
The request for application of the expedited procedure or the urgent procedure
<table><col/><col/><col/><tbody><tr><td/><td><p>34.</p></td><td><p>To enable the Court to decide quickly whether the expedited procedure or the urgent preliminary ruling procedure should be applied, the request must set out precisely the matters of fact and law which establish the urgency and, in particular, the risks involved in following the ordinary procedure. In so far as it is possible to do so, the referring court or tribunal must also briefly state its view on the answer to be given to the questions referred. Such a statement makes it easier for the parties to the main proceedings and the other interested persons participating in the procedure to define their positions, and therefore contributes to the rapidity of the procedure.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>35.</p></td><td><p>The request for the application of the expedited procedure or the urgent procedure must in any event be submitted in an unambiguous form that enables the Registry to establish immediately that the file has to be dealt with in a particular way. Accordingly, the referring court or tribunal is requested to specify which of the two procedures is required in the particular case, and to mention in its request the relevant article of the Rules of Procedure (Article 105 for the expedited procedure or Article 107 for the urgent procedure). That mention must be included in a clearly identifiable place in its order for reference (for example, at the head of the page or in a separate judicial document). Where appropriate, it may be helpful for a covering letter from the referring court or tribunal to refer to that request.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>36.</p></td><td><p>As regards the order for reference itself, it is particularly important that it should be concise where the matter is urgent, as this will help to ensure the rapidity of the procedure.</p></td></tr></tbody></table>
Communication between the Court, the referring court or tribunal and the parties to the main proceedings
<table><col/><col/><col/><tbody><tr><td/><td><p>37.</p></td><td><p>In order to expedite and facilitate communication with the referring court or tribunal and the parties to the main proceedings, a court or tribunal submitting a request for the expedited procedure or the urgent procedure to be applied is requested to state the email address and any fax number which may be used by the Court, together with the email addresses and any fax numbers of the representatives of the parties to the proceedings.</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>38.</p></td><td><p>A copy of the signed order for reference together with a request for the expedited procedure or the urgent procedure to be applied can initially be sent to the Court by email (ECJ-Registry@curia.europa.eu) or by fax (+352 433766). Processing of the reference and of the request can then begin upon receipt of the emailed or faxed copy. The originals of those documents must, however, be sent to the Court Registry as soon as possible.</p></td></tr></tbody></table>
( 1 ) OJ L 265, 29.9.2012, p. 1 .
ANNEX
The essential elements of a request for a preliminary ruling
1. The referring court or tribunal
A request for a preliminary ruling must specify the referring court or tribunal and, where appropriate, the chamber or formation of the court or tribunal making the reference, and must include full contact details for that court or tribunal, in order to facilitate subsequent contact between that court or tribunal and the Court of Justice.
2. The parties to the main proceedings and their representatives
After specifying the referring court or tribunal, the request for a preliminary ruling should state the names of the parties to the main proceedings and anyone representing them before that court or tribunal. Those particulars must be as comprehensive as possible and must notably include, in the order for reference or in the covering letter, the exact postal address of the persons concerned, their telephone or fax number and, in so far as they have one, their email address.
The attention of the national courts and tribunals is here drawn to Article 95 of the Rules of Procedure of the Court, and to points 21 and 22 of these recommendations. If the referring court or tribunal considers it necessary, it must itself redact certain names or details in its request for a preliminary ruling, or send an anonymised version of that request in addition to the full request for a preliminary ruling, which will serve as the basis of the proceedings before the Court.
3. The subject matter of the dispute in the main proceedings and the relevant facts
The referring court or tribunal must briefly describe the subject matter of the dispute in the main proceedings and the relevant findings of fact, as determined by that court or tribunal.
4. The relevant legal provisions
The request for a preliminary ruling must contain precise references to the national provisions applicable to the facts of the dispute in the main proceedings, including any relevant case-law, and the provisions of EU law whose interpretation is sought or whose validity is challenged. Those references must be comprehensive and must include the precise title of and citations for the provisions concerned, as well as their publication references. As far as possible, case-law citations, whether national or European, should also include the ECLI number (‘European Case Law Identifier’) of the decision concerned.
5. The grounds for the reference
The Court can rule on the request for a preliminary ruling only if EU law is applicable to the case in the main proceedings. The referring court or tribunal must therefore set out the reasons which prompted it to inquire about the interpretation or validity of provisions of EU law, and the relationship between those provisions and the national legislation applicable to the main proceedings. If it considers it helpful for the purposes of understanding the case, the referring court or tribunal may set out here the arguments of the parties in that regard.
6. The questions referred for a preliminary ruling
The referring court or tribunal should set out, clearly and distinctly, the questions it is submitting to the Court for a preliminary ruling. It must be possible to understand those questions on their own terms, without the need to refer to the statement of the grounds for the request for a preliminary ruling.
In so far as it is able to do so, the referring court or tribunal should also briefly state its view on the answer to be given to the questions referred for a preliminary ruling.
7. Possible need for specific treatment
Lastly, where the referring court or tribunal considers that the request it is submitting to the Court has to be dealt with in a particular way, both as regards the need to preserve the anonymity of the persons concerned by the dispute in the main proceedings and as regards the rapidity with which the request may have to be dealt with by the Court, the reasons for such treatment must be set out in detail in the request for a preliminary ruling and in any covering letter.
Formal aspects of the request for a preliminary ruling
Requests for a preliminary ruling must be submitted in a form that facilitates electronic processing by the Court and, in particular, that enables them to be scanned and optical character recognition to be applied. To that end:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>the request should be typed on white, unlined, A4-size paper,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>the text should be in a commonly used font (such as Times New Roman, Courier or Arial), in at least 12 point in the body of the text and at least 10 point in any footnotes, with 1,5 line spacing and horizontal and vertical margins of at least 2,5 cm (above, below, at the left and at the right of the page), and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>all the pages of the request, and the paragraphs they contain, should be numbered consecutively.</p></td></tr></tbody></table>
The request for a preliminary ruling must be dated and signed. It should be sent by registered post, together with the file of the case in the main proceedings, to the Registry of the Court of Justice, Rue du Fort Niedergrünewald, 2925 Luxembourg, LUXEMBOURG.
In the event of a request for the expedited procedure or the urgent procedure to be applied, it is recommended that a signed copy of the request for a preliminary ruling is first sent by email (ECJ-Registry@curia.europa.eu) or by fax (+352 433766), and that the original of that request is then sent by post. | ENG | 32016H1125(01) |
<table><col/><col/><col/><col/><tbody><tr><td><p>6.12.2022   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 314/88</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2022/2375
of 29 November 2022
approving Union amendments to the specification for a Protected Designation of Origin or a Protected Geographical Indication (‘Bianco di Custoza’/‘Custoza’ (PDO))
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Commission Delegated Regulation (EU) 2019/33 of 17 October 2018 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards applications for protection of designations of origin, geographical indications and traditional terms in the wine sector, the objection procedure, restrictions of use, amendments to product specifications, cancellation of protection, and labelling and presentation ( 1 ) , and in particular Article 15(2) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The Commission has examined the application for the approval of Union amendments to the product specification for the Protected Designation of Origin ‘Bianco di Custoza’/‘Custoza’, forwarded by Italy in accordance with Article 105 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council <a>(<span>2</span>)</a> in conjunction with Article 15 of Delegated Regulation (EU) 2019/33. The changes include a change of name from ‘Bianco di Custoza’/‘Custoza’ to ‘Custoza’.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The Commission has published the application for the approval of the Union amendments to the product specification in the<span>Official Journal of the European Union</span> <a>(<span>3</span>)</a>, as required by Article 97(3) of Regulation (EU) No 1308/2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The Union amendments to the product specification should therefore be approved in accordance with Article 99 of Regulation (EU) No 1308/2013 in conjunction with Article 15(2) of Delegated Regulation (EU) 2019/33,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The amendments to the product specification published in the Official Journal of the European Union regarding the name ‘Bianco di Custoza’/‘Custoza’ (PDO) are hereby approved.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 November 2022.
For the Commission,
On behalf of the President,
Janusz WOJCIECHOWSKI
Member of the Commission
<note>
( 1 ) OJ L 9, 11.1.2019, p. 2 .
( 2 ) Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( OJ L 347, 20.12.2013, p. 671 ).
( 3 ) OJ C 295, 2.8.2022, p. 5 .
</note> | ENG | 32022R2375 |
<table><col/><col/><col/><col/><tbody><tr><td><p>27.6.2023   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 161/44</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2023/1301
of 26 June 2023
amending Commission Implementing Regulation (EU) 2019/159 imposing a definitive safeguard measure on imports of certain steel products
THE EUROPEAN COMMISSION,
Having regard to Regulation (EU) 2015/478 of the European Parliament and of the Council of 11 March 2015 on common rules for imports ( 1 ) and in particular Articles 16 and 20 thereof,
Having regard to Regulation (EU) 2015/755 of the European Parliament and of the Council of 29 April 2015 on common rules for imports from certain third countries ( 2 ) , and in particular Articles 13 and 16 thereof,
Whereas:
1. BACKGROUND
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>By Commission Implementing Regulation (EU) 2019/159 (‘the Definitive Regulation’) <a>(<span>3</span>)</a>, the European Commission imposed a definitive safeguard measure on certain steel products (‘the safeguard measure’), which consists of tariff-rate quotas (‘TRQs’) with respect to certain steel products (‘the product concerned’) encompassing 26 steel product categories, set at levels preserving traditional trade flows on a per-product-category basis. A 25 % tariff duty applies only if the quantitative thresholds of these TRQs, which increase (currently by 4%) annually as a result of liberalisation, are exceeded. The safeguard measure was imposed for an initial period of three years, that is to say, until 30 June 2021.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>By Commission Implementing Regulation (EU) 2021/1029 <a>(<span>4</span>)</a> (‘the Prolongation Review Regulation’), the Commission prolonged the safeguard measure until 30 June 2024.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The Commission made technical adjustments to the measure as a result of different functioning review investigations, by means of Commission Implementing Regulation (EU) 2019/1590 <a>(<span>5</span>)</a> (‘First functioning review regulation’), Commission Implementing Regulation (EU) 2020/894 <a>(<span>6</span>)</a> (‘Second functioning review regulation’), and Commission Implementing Regulation (EU) 2022/978 <a>(<span>7</span>)</a> (‘Third functioning review regulation’) respectively. The Commission also reviewed the measure following the withdrawal of the United Kingdom from the Union <a>(<span>8</span>)</a>. The Commission adjusted the measure following certain events, in particular the imposition of an import ban on steel from Russia and Belarus in the context of Russia's unprovoked and unjustified military aggression against Ukraine <a>(<span>9</span>)</a>, and the expiration of certain provisions in a bilateral agreement with preferential trading partners <a>(<span>10</span>)</a>.</p></td></tr></tbody></table>
2. SCOPE OF THE INVESTIGATION
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Recital (85) of the Prolongation Review Regulation stated that “with a view to guaranteeing that the safeguard measure remains in place only to the extent that it is necessary, the Commission will carry out a review to determine whether, on the basis of the circumstances at that time, the safeguard measure should be terminated by 30 June 2023 namely after two years of prolongation”.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>In the Prolongation Review Regulation, the Commission further noted that, in addition to assessing the possible termination of the measure by 30 June 2023 in view of the circumstances present at that time, it may also use this review, in case of no early termination of the measure, to update the list of developing countries subject to and excluded from the measure based on 2022 import data and to assess whether the level of liberalisation continued to be appropriate.</p></td></tr></tbody></table>
3. PROCEDURE
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>The Commission thus initiated a review investigation by means of a Notice of Initiation (‘the Notice’) published in the Official Journal of the European Union on 2 December 2022 <a>(<span>11</span>)</a>. The Notice invited interested parties to provide evidence and data to determine whether it would be justified to terminate the measure by 30 June 2023.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The Commission sought specific information from Union producers and users via questionnaires, which were made available to interested parties on the public file (‘TRON’) <a>(<span>12</span>)</a> as well as on the European Commission’s (DG TRADE) website <a>(<span>13</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>As in previous review investigations, the Commission devised a two-stage written procedure. First, parties had the possibility to send their submissions and where applicable, a reply to the questionnaires by 13 January 2023. The Commission made this information available on the public file and interested parties had the possibility to make comments (rebuttals phase). The Commission subsequently made the rebuttals available in TRON.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>At a later stage of the proceeding the Commission uploaded on TRON the updated set of questionnaire replies from Union producers to include the most recent data available, namely economic indicators of the last quarter of 2022. Interested parties were given the opportunity to comment on the updated information.</p></td></tr></tbody></table>
4. FINDINGS OF THE INVESTIGATION
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>As per the Prolongation Review Regulation, the safeguard measure was set to be in place until 30 June 2024. At that time, the Commission concluded that an increase in the volume of imports should the measure be terminated as originally expected, could undermine significantly any meaningful economic recovery and the efforts being made by the Union steel industry in its process of adjustment to a higher level of imports. Therefore, the measure could be terminated on 30 June 2023 only if the Commission concluded in view of the circumstances following the Prolongation review, and on the basis of the evidence available (including the submissions and rebuttals received from interested parties in the ongoing review investigation) that such early termination would be justified. Conversely, in the absence of positive evidence justifying an early termination, the measure would automatically continue to be in place until 30 June 2024.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>In order to carry out its assessment, the Commission examined the comments and evidence received from interested parties, including the questionnaire replies, and where necessary crosschecked the information against any other available sources that it gathered through its own research as part of the investigation. As will be explained below, the Commission concluded that, under current circumstances, the early termination of the safeguard measure would not be justified.</p></td></tr></tbody></table>
4.1. Assessment of the claims requesting the termination of the measure
4.1.1. Alleged insufficiency of steel for users due to quick exhaustion of some TRQs
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>Some interested parties claimed that the fact that some TRQs (be them country-specific or residual) were exhausted before the end of a given quarter would show that the existing volume of free-of-duty steel available from imports is insufficient. Accordingly, parties claimed that this situation resulted in users not being able to source the steel required for their businesses.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>The Commission observed that, like it had been the case since the imposition of the definitive safeguard measure in February 2019, certain origins exhausted TRQs in some product categories in the early days of a quarter also in the period assessed in this review investigation. However, as confirmed in previous investigations <a>(<span>14</span>)</a>, this fact cannot lead to the conclusion that the safeguard measure creates a shortage of steel for users in general. In this respect, the Commission noted that the claims by some interested parties referred to the exhaustion of some specific TRQs in isolation, without referring to the overall availability of steel outside a specific origin that may have exhausted its country-specific TRQ quickly. Thus, the Commission confirmed that, whilst some specific origins were exhausted at a given moment in time in certain product categories, in general terms access to other origins remained largely available for those product categories.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>In this respect, the Commission assessed the overall TRQ use in the ongoing safeguard year (July 22-June 23) based on the data available at the time of making the determination, namely, the complete set of data of the first three quarters of the period (July 22 – March 23). This data showed the following TRQ use evolution:</p><p><span>Table 1</span></p><p><span>TRQ use evolution</span>  <a>(<span>15</span>)</a></p><p><figure><img/></figure></p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>The Commission also assessed the TRQ use and availability on a per product category basis to confirm the overall trend displayed in Table 1. The combined assessment unequivocally showed that Union users had the possibility to source free-of-duty steel from several sources quarter after quarter across virtually all product categories, and that the available free-of-duty volumes were increasing (in some cases substantially) quarter after quarter.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(16)</p></td><td><p>In view of these facts, the Commission concluded that the claims regarding shortage of imported steel <a>(<span>16</span>)</a> did not correspond to the data assessed. The analysis also showed an increasing volume of TRQs unused across categories. Relevant data regarding the evolution of the market, e.g. consumption in the Union market, showed a progressive slowing down in the second half of 2022 (See Section 4.2.2). Moreover, no evidence was provided showing that, with respect to the products under those exhausted TRQs, there was insufficient supply from Union producers.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(17)</p></td><td><p>For these reasons, the Commission disagreed with the claims that the quick exhaustion of some TRQs (from some origins) in certain categories would have led to a shortage of steel in the Union market.</p></td></tr></tbody></table>
4.1.2. Alleged reduced risk of trade diversion due to changes in the US Section 232 measure
<table><col/><col/><tbody><tr><td><p>(18)</p></td><td><p>Some interested parties argued that, because of some changes in the US Section 232 measure, the risk of trade diversion would have been allegedly reduced to the point that the safeguard measure would no longer be necessary on these grounds.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(19)</p></td><td><p>The Commission had assessed the evolution of the US Section 232 measure in previous reviews and concluded that the changes in the US Section 232 measure did not alter the basis underpinning the assessment regarding the risk of trade diversion. <a>(<span>17</span>)</a> In the context of this investigation, the Commission looked into the latest developments of the US measure. In the first place, the Commission observed that the US Administration did not appear to have intentions to remove the measure in the near future, noting that “[t]he Biden Administration is committed to preserving U.S. national security by ensuring the long-term viability of our steel and aluminum industries, and we do not intend to remove the Section 232 duties as a result of these disputes” <a>(<span>18</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(20)</p></td><td><p>Secondly, in light of the information presented by interested parties and its own analysis, the Commission established that the following changes to the US 232 measure had taken place since the Commission last assessed this argument in the Third Review Regulation of June 2022 <a>(<span>19</span>)</a>: first, as of 1 June 2022, the US established a TRQ for the UK whereby certain volume of in-quota imports are exempted from the measure, while out-of-quota imports remain subject to the additional 25% duty. Second, as of 1 June 2022, the US suspended the measure for Ukraine temporarily.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(21)</p></td><td><p>The analysis showed that the scope of the US Section 232 measure barely changed since the Commission last assessed it in the Third Review Regulation, which showed that the US market continues to be heavily shielded from steel imports.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(22)</p></td><td><p>The Commission further assessed the evolution of imports into the US market <a>(<span>20</span>)</a>, and confirmed that in overall terms, they had gone down by -10% in 2022 as compared to 2017, the year prior to the imposition of the US Section 232 measure <a>(<span>21</span>)</a>. As regards imports into the US market from those countries that are the main steel supplying countries into the Union, the trend is much steeper, as their combined imports fell by -27%, representing a reduction of over 2 million tonnes.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(23)</p></td><td><p>Therefore, the Commission confirmed that imports into the US market continued to be significantly below pre-Section 232 measure levels. With the US market still affected by the Section 232 measures, the Union market remains the largest steel importing market worldwide.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(24)</p></td><td><p>The Commission also noted that interested parties did not provide any evidence in this investigation that would put into question the Commission’s findings in previous investigations and thus, did not alter the findings of those investigations with regard to the risk of trade diversion into the Union market stemming from the US Section 232 measure.</p></td></tr></tbody></table>
4.1.3. Alleged risk of shortage of supply due to Union producers idling certain facilities in 2022 amidst high energy prices
<table><col/><col/><tbody><tr><td><p>(25)</p></td><td><p>Some interested parties observed that some Union producers had temporarily stopped or reduced production in some of their production sites due to the surge of costs associated to energy. In this respect, these parties argued that as a result there was a risk of shortage of supply in the market, and of increased prices due to reduced supply from the Union producers’ side.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(26)</p></td><td><p>The Commission’s analysis showed that indeed, amid a spike in energy prices in the Union <a>(<span>22</span>)</a>, several Union producers temporarily idled some production facilities to mitigate the impact on their economic performance <a>(<span>23</span>)</a>. However, such measures were of temporary nature and the evidence available indicates that Union producers had either brought back most of the capacity into operation or were in the process of doing so <a>(<span>24</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(27)</p></td><td><p>Therefore, the Commission concluded that the temporary idling of certain production facilities that took place mostly in the second half of 2022 was a temporary situation and it has been largely reversed by restarting previously idled production during the first months of 2023.</p></td></tr></tbody></table>
4.1.4. Alleged obstacles posed by the safeguard to imports that are necessary to satisfy demand
<table><col/><col/><tbody><tr><td><p>(28)</p></td><td><p>In connection to the above argument, some interested parties also argued that imports from a variety of third countries are necessary to satisfy demand and that the safeguard measure constitutes an obstacle for sourcing without restrictions from specific origins at any given point in time. Some interested parties also made general claims concerning longer delivery times from Union producers and increased steel prices.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(29)</p></td><td><p>In this regard the Commission noted that the safeguard measure was designed in a way to ensure that historical trade flows would continue to enter the Union market free-of-duty. Such historical volumes have furthermore been progressively liberalised year after year. The Commission, in previous reviews of the measure, explained that interested parties active in the steel sector needed to adapt to the existing regulatory framework (in this case, the existence of a safeguard measure) when conducting their business. As shown in recital (14), the data analysed in this review clearly showed that there has been an increasing volume of TRQs unused quarter after quarter across product categories and that Union producers had generally additional capacity available. Therefore, the fact that imports from one specific origin in a given category may have exhausted the relevant TRQ before the end of a quarter, does not mean that the safeguard measure has unduly restricted the ability of interested parties to source steel free-of-duty from other sources, including other third countries or the Union.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(30)</p></td><td><p>Regarding delivery times, the Commission noted that the views among some interested parties appeared to differ regarding whether the Union delivery times were standard or whether they were abnormally long. In view of the contradictory claims on this subject among users, and the fact that no evidence was received showing that longer than usual delivery times was currently a common phenomenon in the Union, the Commission considered that delivery times could not be currently regarded as a supply issue.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(31)</p></td><td><p>Regarding steel prices, the Commission assessed the evolution of prices in the Union and in other major steel markets and noted that in the first quarter of 2023 prices had drastically decreased when compared to the peak reached in 2022. Such a decrease in prices took place in a context of increasing energy costs for, among others, Union steel producers. The Commission considered that the evolution of prices in the Union market could thus not be directly linked to the safeguard measure, as a comparable trend which also coincided in time was observed in other major steel markets. In addition, the Commission noted that the availability of free-of-duty TRQs throughout the period ensured that users had generally alternative options to paying the 25% duty or sourcing from Union producers, thus not preventing relevant additional free-of-duty imports from entering the Union market.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(32)</p></td><td><p>Therefore, the Commission concluded that the evolution of prices was showing a downwards trend towards the end of 2022, and that they had substantially decreased when compared to their peak earlier in 2022. Moreover, the Commission confirmed that these trends were also observed in other major steel markets, thus indicating that this was a rather global phenomenon not linked to the Union market and the safeguard measure.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(33)</p></td><td><p>In view of the above elements, the Commission considered that interested parties did not demonstrate that the safeguard measure would have overall limited their ability to source steel free-of-duty in light of existing demand, nor have they shown how in the future that would be the case if the measure continued to be in place in light of forecasted demand and future TRQ levels (see Section 6).</p></td></tr></tbody></table>
4.1.5. Alleged lack of import pressure due to low TRQ use
<table><col/><col/><tbody><tr><td><p>(34)</p></td><td><p>Some interested parties argued that because overall, TRQs across product categories were not being used, and in some cases showing a very low use level, the measure would no longer be necessary and therefore the Commission should terminate the safeguard measure.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(35)</p></td><td><p>While Table 1 shows that the rate of TRQ use has undeniably gone down quarter on quarter, the Commission considered that conclusions cannot be drawn by assessing this fact in isolation. This fact should be put into a context of decreasing consumption. In this respect, the Commission assessed in further detail the extent of import pressure by looking at the total volume of imports and their share over total consumption in the same period, and by focusing on the TRQ use, notably those instances where country-specific TRQs by some origins were rapidly exhausted.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(36)</p></td><td><p>First, regarding the overall volume of imports, the Commission noted that despite a slowdown in Union consumption notably in the second half of 2022, which impacted the level of TRQ use, imports in the year 2022 totalled 31.1 million tonnes. This constitutes the third highest level of imports in the last decade. In terms of market share, imports reached 19%, with an upwards increase towards the end of 2022 (reaching 21% in the last quarter of 2022). This is the second highest market share achieved by imports in the last decade <a>(<span>25</span>)</a>, only exceeded by the share of imports in the year 2018, which also constituted the peak volume of imports in the last decade. Therefore, despite a reduction in the level of TRQ use in a situation of lower consumption, data shows that import pressure increased and remained, in terms of market share, close to the historically high levels reached just before the adoption of a definitive safeguard measure in early 2019.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(37)</p></td><td><p>Secondly, in every quarter there were several country-specific TRQs which indeed were fully used in the early stages of a quarter. This phenomenon, which was addressed by the Commission in previous regulations <a>(<span>26</span>)</a>, showed that there continued to be import pressure from certain origins in some product categories despite the overall availability of TRQ volumes, thus contributing to the increase in market share of imports in a context of decreasing demand.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(38)</p></td><td><p>Lastly, and although interested parties arguing in favour of termination did not generally refer to it, the Commission considers that the assessment regarding existing and future import pressure on the Union market cannot be done in isolation, e.g., by looking only at the TRQ use. Rather, it needs to be done by looking at the several existing parameters in the sector, also including the evolution of overcapacity. In this regard, the Commission observed that global overcapacity in the steel sector had further increased.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(39)</p></td><td><p>The most recent estimates by the OECD point to additional global capacity being added. The OECD noted in February 2023: ‘<span>The risk of a global excess capacity crisis has increased. Despite declining steel demand, and a weak outlook, capacity expansions continue at a robust pace, often in pursuit of export markets. The gap between global capacity and crude steel production surged to 632.0 mmt in 2022 from 516.9 mmt in 2021. The recent rise in excess capacity poses risks for the long-term health and viability of the steel industry, and its ability to enable economic growth and prosperity</span>.’ <a>(<span>27</span>)</a></p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(40)</p></td><td><p>The OECD further added: ’In 2022 alone, global steelmaking capacity increased by 32.0 million metric tonnes (mmt) to 2 463,4 mmt. To give a sense of the actual magnitudes involved, the increases seen in global capacity are larger than the existing capacity levels of some large steel-producing economies’. <a>(<span>28</span>)</a></p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(41)</p></td><td><p>Therefore, the Commission considers that the lower use of TRQs does not necessarily imply a reduction in the import pressure which could justify the termination of the measure by 30 June 2023.</p></td></tr></tbody></table>
4.1.6. Allegation that market outlooks support an early termination
<table><col/><col/><tbody><tr><td><p>(42)</p></td><td><p>Some interested parties relied on some market outlooks to support the argument of a termination of the measure by 30 June 2023. In their view, some forecasts would suggest that the situation in the Union steel market was expected to improve towards the end of 2023 and therefore the Commission should remove the safeguard measure to ensure that downstream industries are not constrained by the measure and can benefit fully from these alleged improving market conditions.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(43)</p></td><td><p>The Commission analysed multiple sources to obtain a good understanding of the market outlooks. All sources analysed presented a rather gloomy forecast for the global steel sector, including the Union market, for 2023-24, pointing to high uncertainty, in particular triggered by Russia's unprovoked and unjustified military aggression against Ukraine, inflation, the increased energy prices <a>(<span>29</span>)</a>, and an economic slowdown, among other factors. Most of the forecasts analysed also highlight a likely worse situation for the Union market.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(44)</p></td><td><p>The OECD, in December 2022 <a>(<span>30</span>)</a>, noted “<span>The outlook for global steel markets has deteriorated sharply. (…) Steel consumption is expected to decline by 2.3% in 2022 and to rebound by 1% in 2023. Energy and commodity price increases, inflationary pressure, lower demand from China and political instability have worsened steel demand trends globally</span>”.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(45)</p></td><td><p>The OECD, in February 2023 <a>(<span>31</span>)</a>, observed “<span>A fragile and subdued economic recovery has been derailed by higher than anticipated inflation (…). Russia’s war of aggression against Ukraine has further contributed to pushing up prices, especially for energy, and is having an unequal impact among jurisdictions, with Europe being hit the hardest. The uncertainty about the outlook is high, and the risks are skewed to the downside due to a potential for inflation to become more entrenched and erode households’ purchasing power further, as well as to the risk of an escalation of the war</span>”.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(46)</p></td><td><p>In its Global Steel Outlook for 2023 <a>(<span>32</span>)</a>, Fitch Ratings noted “<span>The global steel sector will not fully recover in 2023 from the supply-demand shift in favour of end-markets caused by reduced consumption in second half of 2022. We expect materially lower earnings for steelmakers as the global economic slowdown has ended the period of exceptionally high prices supported by post-pandemic pent-up demand. Prospects for steel companies remain gloomy in Europe due to high and volatile energy costs, the looming recession, waning consumer confidence, and the greater need to re-design supply chains for the steel sector and possibly its end-markets</span>”.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(47)</p></td><td><p>Standard and Poor’s Platts also noted the uncertain market outlook and the increased prices of steelmaking materials and energy. <a>(<span>33</span>)</a></p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(48)</p></td><td><p>The World Steel Association, in its Short Range Outlook of October 2022 stated “<span>Steel demand recovery in developed economies saw a major setback in 2022 due to sustained inflation and lasting supply side bottlenecks. The war in Ukraine has provided further impetus to inflation and supply chain issues. In particular, the EU is facing dire economic conditions with high inflation and the energy crisis. Sentiment is dwindling and industrial activities are cooling sharply toward a decline as high energy prices are forcing factory shutdowns</span>.” <a>(<span>34</span>)</a> In its latest outlook of April 2023, the World Steel Association noted that “<span>while the EU economy grew by 3.5% in 2022, avoiding recession, industrial activities suffered significantly from high energy costs that led to a sizable contraction in steel demand in 2022. In 2023, the EU steel industry will continue to feel the impact of war, other supply chain-related issues, and continued monetary tightening. In 2024, demand is expected to see a visible rebound as the impact of the Ukraine war and supply chain disruptions are expected to dissipate. However, the outlook is subject to persisting uncertainty</span>” <a>(<span>35</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(49)</p></td><td><p>Therefore, the Commission did not consider that the current outlooks for the Union steel market could justify the termination of the measure by 30 June 2023.</p></td></tr></tbody></table>
4.1.7. Product/country specific claims
<table><col/><col/><tbody><tr><td><p>(50)</p></td><td><p>Some interested parties made several types of claims that were specific either to a given product category, or to the circumstances of a given country. Some parties sometimes also requested the Commission to perform different kinds of technical adjustments to the measure.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(51)</p></td><td><p>The Commission observed that the scope of the measure, and more specifically of this review investigation, did not cover the specific developments in a particular product category or related to a specific third country as the measure applies<span>erga omnes</span> and it covers a product concerned which comprises by twenty-six product categories. Therefore, neither country or product specific exclusion, nor specific adjustments to the functioning of the measure were possible <a>(<span>36</span>)</a>. Rather, as announced in the Notice of Initiation and as recalled in Section 2 of this Regulation, the scope of this investigation was to assess whether a termination of the measure by 30 June 2023 was justified.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(52)</p></td><td><p>Therefore, the Commission disregarded these claims as they fell outside the scope of the investigation.</p></td></tr></tbody></table>
4.1.8. Allegation that trade defence measures other than a safeguard are more appropriate for the steel sector
<table><col/><col/><tbody><tr><td><p>(53)</p></td><td><p>Some interested parties argued that other trade defence measures, namely anti-dumping and anti-subsidy instruments, are more appropriate to deal with any import-related problem faced by the Union steel industry, and that their combination with a safeguard measure creates a situation of overprotection for the Union industry. In addition, some parties noted that the Union steel industry is already sufficiently protected by means of numerous anti-dumping and countervailing measures on a wide range of products.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(54)</p></td><td><p>The Commission recalled, as it did in previous review investigations, and in reaction to similar claims <a>(<span>37</span>)</a>, that the safeguard instrument is compatible with the application of other Trade Defence Instruments such as anti-dumping and anti-subsidy. Furthermore, the Commission recalls that the EU legal framework allows for the imposition of anti-dumping and countervailing measures simultaneously to safeguards <a>(<span>38</span>)</a>. Therefore, this claim was dismissed.</p></td></tr></tbody></table>
4.1.9. Allegation that findings of WTO Dispute Settlement Body in dispute DS595 require the Commission to terminate the measure
<table><col/><col/><tbody><tr><td><p>(55)</p></td><td><p>Some interested parties referred to the Dispute Settlement Body (‘DSB’) Report of 29 April 2022 <a>(<span>39</span>)</a> in the dispute<span>DS595 European Union – Safeguard measures on certain steel products</span>, claiming that the Commission should have automatically terminated the measure as it was inconsistent with certain provisions of the WTO Agreement on Safeguards and the General Agreement on Trade and Tariffs (‘GATT’).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(56)</p></td><td><p>In this respect the Commission referred to the Implementing Regulation (EU) 2023/104 of 13 January 2023 <a>(<span>40</span>)</a> whereby it implemented the DSB ruling, thus bringing the steel safeguard measure into conformity with WTO rules in the few aspects where the Panel had identified inconsistencies.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(57)</p></td><td><p>Therefore, the claims pertaining to that dispute are not pertinent in the context of the ongoing review as they were already addressed by means of a separate legal act. In any event, and as it stemmed from the logic behind Regulation (EU) 2023/104, the Commission disagreed with the claims that the findings of the Panel in that dispute would have required it to terminate the measure.</p></td></tr></tbody></table>
4.1.10. The import ban on Russia and Belarus introduced due to Russia's unprovoked and unjustified military aggression against Ukraine has a negative impact on the market
<table><col/><col/><tbody><tr><td><p>(58)</p></td><td><p>Some interested parties referred to Russia's unprovoked and unjustified military aggression against Ukraine and to the import ban on Russia and Belarus due to Union sanctions against these countries, arguing that generally these events were causing important disruptions on the Union steel market.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(59)</p></td><td><p>The Commission does not dispute that these events have an effect, among many other areas of the economy, on the Union steel market. However, limiting the assessment to the steel safeguard measure, the Commission recalled the redistribution of the country-specific quotas of Russia and Belarus in March 2022.This redistribution sought to minimise the effects of the import ban imposed on steel products originating in both countries, and to ensure that users would continue to be able to access the same volumes from multiple sources.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(60)</p></td><td><p>The Commission also noted that the duration of Russia's unprovoked and unjustified military aggression against Ukraine and its consequences on the steel market, including the import ban on Russia and Belarus, cannot be predicted at this stage.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(61)</p></td><td><p>In this respect, the Commission thus did not consider that these events could justify a termination of the measure by 30 June 2023.</p></td></tr></tbody></table>
4.1.11. Allegation that the improved performance of the Union industry requires the termination of the measure
<table><col/><col/><tbody><tr><td><p>(62)</p></td><td><p>Some interested parties claimed that the situation of the Union industry had improved to an extent that it would make the safeguard measure unnecessary.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(63)</p></td><td><p>The Commission addressed these claims in the context of its analysis of the situation of the Union industry in Section 4.2.2 below. In particular, the Commission noted that, whilst certain economic factors improved in 2021, the situation of the Union industry deteriorated in 2022, notably in view of the instability of the market due to the Russia's unprovoked and unjustified military aggression against Ukraine as well as a peak in energy prices.</p></td></tr></tbody></table>
4.1.12. Allegation that changes in third country TDI measures should lead to the termination of the safeguard
<table><col/><col/><tbody><tr><td><p>(64)</p></td><td><p>Some interested parties claimed that some of the TDI measures in place against steel products in different jurisdictions had expired or they had been terminated recently. Accordingly, some parties argued, the Commission should take this development into consideration when assessing the potential termination of the measure by 30 June 2023.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(65)</p></td><td><p>In this regard, the Commission did not contest the claim that certain TDI measures on steel may have expired or been terminated recently. However, the Commission considered that such developments cannot be assessed in isolation. In the investigation the Commission confirmed that a number of new TDI measures had also been imposed recently on a variety of products and origins by several jurisdictions. Therefore, the expiry or termination of certain measures took place in a period where other new TDI measures were introduced <a>(<span>41</span>)</a>. The Commission noted that it has not received any substantial analysis or evidence that would render invalid its previous findings <a>(<span>42</span>)</a> regarding the detailed scope of TDI measures in third countries.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(66)</p></td><td><p>Therefore, the Commission considered that the claims received by interested parties did not put into question its findings in previous investigations on this matter, <a>(<span>43</span>)</a> and as such, did not support a termination of the measure by 30 June 2023.</p></td></tr></tbody></table>
4.2. Analysis of questionnaire replies
4.2.1. Questionnaire replies from Union users
<table><col/><col/><tbody><tr><td><p>(67)</p></td><td><p>To establish a balanced and comprehensive picture of the market situation, the Commission sought proactively input from users and their associations. To this end, the Commission sent specific questionnaires to 154 Union steel users and 19 user associations that had participated in previous reviews of the measure and were thus registered in the case file. Other users and associations also had the possibility to respond to these questionnaires which were available on the European Commission’s (DG TRADE) website.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(68)</p></td><td><p>Despite the specific proactive outreach, the Commission received responses from only around 30 users, including some Union users’ associations such as automotive, home appliance, processors of Wire Rod, and Cold Rolled, Galvanized and Coated Coil Manufacturers, in addition to several individual users across different steel-using sectors. The main complaints of users have been summarised and rebutted in Section 4.1.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(69)</p></td><td><p>Regarding the analysis of the information supplied in the questionnaires, the Commission, as a first remark, noted that, despite the proactive reach out, including to industry associations, it received a rather low number of questionnaire replies received from the user side (around 30 replies from over 160 known users).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(70)</p></td><td><p>In any event, the Commission also analysed the users’ questionnaire replies in light of other key parameters, notably the TRQ use and the market outlook. As can be seen from the respective analyses on these topics (see e.g. Section 4.1.1), users are benefitting from an ever-increasing level of duty-free TRQs (+20% increase of TRQ volumes since 2019) which remain consistently unused across product categories. Furthermore, as of 1 July 2023 the TRQs will be further increased by 4% (in compliance with WTO obligations to liberalize the measure progressively), thus benefitting those users who want to increase further their volume of imports from specific origins.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(71)</p></td><td><p>In this regard, users have not provided any evidence that the volume of TRQs (including the increased volumes due to liberalisation that will be added to the TRQs as of 1 July 2023) together with the availability of Union-produced steel would not be adequate to fulfil their needs in light of existing and forecasted demand.</p></td></tr></tbody></table>
4.2.2. Questionnaire replies from Union producers
<table><col/><col/><tbody><tr><td><p>(72)</p></td><td><p>In the investigation the Commission also sought to assess the evolution of the economic situation of the Union steel producers through questionnaires. The Commission received questionnaire replies from the three main Union steel producer associations (EUROFER, ESTA and CTA) <a>(<span>44</span>)</a> in addition to a few additional individual replies from Union producers. The period for which data was provided comprised the years 2021 and 2022.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(73)</p></td><td><p>Some interested parties claimed that the economic situation of the Union industry had improved, notably in the year 2021, recording high levels of profitability in a context of very high steel prices, and that the situation would have continued into the year 2022. In view of such alleged improved performance, some parties argued that the safeguard measure would no longer be necessary and, therefore, it should be terminated by 30 June 2023.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(74)</p></td><td><p>The questionnaire replies from Union producers showed that the Union industry experienced an overall positive situation in 2021, driven notably by the post-COVID rebound in demand and abnormally high steel prices. The situation continued to be overall very positive in early 2022.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(75)</p></td><td><p>However, throughout the rest of 2022 the economic performance of the Union industry deteriorated rapidly. This was due to several factors. In particular, the breakout of Russia's unprovoked and unjustified military aggression against Ukraine lead to disruptions in several sectors, also affecting the steel market. Moreover, a spike in energy prices led to higher costs of production for steelmakers, but in a context of slowing down in demand where steel prices decreased to face an import pressure which remained at high levels in several important product categories.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(76)</p></td><td><p>The evolution of injury indicators showed that Union steel consumption in 2022 (166.1 million tonnes) decreased by more than 20 million tonnes (-11.4%) when compared to 2021 (187.4 million tonnes).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(77)</p></td><td><p>For its part, production of the Union industry decreased by 10.8% from 2021 (167.7 million tonnes) to 2022 (149.6 million tonnes). The level of production went down in particular in the second half of 2022 compared to the first half of 2022 (-20.8%).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(78)</p></td><td><p>Moreover, production capacity utilisation was at 76% in 2021 and it remained almost the same (75%) in the Q1 (January-March) of 2022. However, as of Q2 (April-June) 2022 it started to decrease, reaching a very low figure of 58% in Q4 (October-December) 2022. Overall, production capacity utilisation decreased by 10 percentage points from 2021 to 2022, standing at 65.6%.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(79)</p></td><td><p>Furthermore, the volume of sales of Union producers in the Union market followed a decreasing trend from 2021 continuously until the last quarter (October-December) of 2022. The volume of sales decreased year-on-year by 6.4% from 68.4 million tonnes in 2021 to 64.1 million tonnes. In relative terms, the Union producers’ market share dropped from 81,9% in 2021 to 81,3% in 2022.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(80)</p></td><td><p>Lastly, profitability of those sales was at 9% in 2021 and it kept increasing until 14.2% in Q2 (April-June) of 2022. However, this positive trend reversed as of Q3 (July-September) 2022, dropping to 3.9% and subsequently reaching a loss-making situation of -0.2% in Q4 (October-December) of 2022. In 2022, overall the Union industry made less than 1% profit.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(81)</p></td><td><p>Consequently, the situation of the Union industry worsened towards the end of the period considered, in particular due to some factors which took place in 2022, together with the remaining import pressure, which led the Union industry to lower its prices, and reduce its market share to remain breakeven.</p></td></tr></tbody></table>
4.3. Forward looking analysis
<table><col/><col/><tbody><tr><td><p>(82)</p></td><td><p>Having assessed the comments from interested parties and having described the questionnaire replies from users and producers, including the evolution of the Union producers’ economic indicators, the Commission complemented this analysis with a forward-looking assessment of the likely developments of some elements, should the measure be terminated by 30 June 2023. In particular, the Commission examined whether an increase in the volume of imports could be expected, should the measure be terminated before as originally expected.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(83)</p></td><td><p>In the first place, the Commission assessed whether, as it had found in previous review investigations, the Union market continued to be attractive. The information assessed by the Commission showed that the Union continued to be the largest steel importing market worldwide. In fact, its share over total world imports in 2022 increased by more than three percentage points when compared to the year 2021 <a>(<span>45</span>)</a>. This demonstrated that not only in overall terms the Union market continued to be the largest importing market but also that its leading position strengthened further in 2022.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(84)</p></td><td><p>The Commission then assessed the attractiveness of the Union market in terms of prices. The assessment showed that in terms of price levels, import prices into the Union from its main supplying countries were consistently higher than their export prices to other third markets for a large majority of their steel exports (in 50% to 81% of the total customs codes subject to the measure the export values to the Union were higher than to other third markets; on average, 69% of the customs codes concerned were sold at a higher price in the Union than on other third markets) <a>(<span>46</span>)</a>. Furthermore, the assessment revealed that the Union market constituted an important relevant exporting market for these countries <a>(<span>47</span>)</a>. The main steel supplying countries to the Union were those predominantly exhausting TRQs.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(85)</p></td><td><p>Therefore, the Commission concluded that the Union market continued to be attractive for exporting countries both in terms of volume and prices.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(86)</p></td><td><p>Then, the Commission noted that the volume of imports into the Union remained at high levels when compared to historical figures (last decade). The share of imports was also high when compared to previous levels, and close to the peak reached in 2018 prior to the imposition of a definitive safeguard measure <a>(<span>48</span>)</a>. Furthermore, when compared to the consumption in the Union market in the period 2021-2022, which decreased by -11% (-21.3 million tonnes), imports went down by -8% (from 33.8 million tonnes to 31.1 million tonnes), while domestic sales also went down but at a higher pace, -12%. Therefore, the market share of imports increased despite a double-digit decrease in consumption in the Union market. The Commission therefore concluded that the level of import penetration in the Union market continued to be at high levels and that it even increased in 2022 when compared to 2021 despite a reduction in consumption.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(87)</p></td><td><p>The Commission also confirmed that<span>,</span> as noted in recitals (39) and (40), the situation in 2022 regarding global overcapacity in the steel sector continued to follow the same upwards trend. Therefore, and also in the absence of any evidence from interested parties that would demonstrate the contrary, the Commission concluded that its previous findings with regards to the effects of overcapacity on the market and performance of steel producers remain valid.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(88)</p></td><td><p>Likewise, the Commission concluded that in overall terms, exporting countries had not been able to find other outlets to compensate for the trade volumes lost in the US and Union market since 2018. In fact, their total exports to other markets were generally lower than they were in 2018.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(89)</p></td><td><p>In light of the above, the Commission concluded that imports into the Union would increase if the safeguard measure was terminated by 30 June 2023. Indeed, the evolution of imports, TRQ used and imports’ market share in the recent period considered confirmed the attractiveness of the Union market and the willingness of the largest steel exporters to obtain better access to the Union market, especially on some product categories.</p></td></tr></tbody></table>
4.4. Conclusion
<table><col/><col/><tbody><tr><td><p>(90)</p></td><td><p>Based on a careful analysis of the submissions and rebuttals received from interested parties requesting the termination of the safeguard measure by 30 June 2023 (Section 4.1) as well as of the questionnaire replies (Section 4.2), as well as the conclusion reached in its forward-looking assessment (Section 4.3) the Commission concluded that on the basis of the current circumstances and information available the termination of the measure by 30 June 2023 is not justified. Should the measure be terminated at this stage, the likely increased in the volume of imports could undermine the situation of the Union industry. As a result of this conclusion, and since the measure is set to continue in place until 30 June 2024, the Commission then assessed, as foreseen by the Notice of Initiation, the list of developing countries which should be subject to and excluded from the measure based on updated import data (Section 5). It also assessed whether the current level of liberalisation of 4% remained appropriate (Section 6).</p></td></tr></tbody></table>
5. UPDATE OF THE LIST OF DEVELOPING COUNTRIES SUBJECT TO THE MEASURE
<table><col/><col/><tbody><tr><td><p>(91)</p></td><td><p>Any developing country member of the WTO was excluded from the application of the definitive measure for as long as its share of imports into the EU remains below 3% of the total imports for each product category. Also, if in a given category the collective share of imports from developing countries (whose individual share is below 3%) exceeds 9%, then all developing countries will be subject to the measure in that product category. <a>(<span>49</span>)</a> The Commission committed to monitor the development of imports after the adoption of the measure and to review the list of excluded countries on a regular basis.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(92)</p></td><td><p>The last update took place in the framework of the latest functioning review investigation of June 2022, and it was based on import data from 2021. Thus, to adapt the list of developing countries subject to, and excluded from, the measure the Commission updated the calculations based on the most recently available consolidated import data, i.e., year 2022 import statistics. <a>(<span>50</span>)</a></p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(93)</p></td><td><p>The changes resulting from this update are the following (the updated table is available in the Annex to this Regulation).</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>All developing countries are included in categories 4B, 5, 25B and 28 because the sum of all import shares in 2022 that were below 3% is higher than 9% <a>(<span>51</span>)</a>;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Brazil is included in categories 1and 2, and excluded in category 6;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>China is included in categories 7 and 25A;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Egypt is included in categories 13 and16;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>India is included in categories 3B, 12, 16 and 17;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Indonesia is included in category 16;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Malaysia is included in categories 9 and 16;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Moldova is excluded in category 12;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>North Macedonia is included in category 26;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Oman is included in category 13;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>South Africa is included in category 4A;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Türkiye is included in categories 3A and 25A;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>United Arab Emirates are excluded in category 16;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Viet Nam is included in category 26, and excluded in category 3A.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(94)</p></td><td><p>Regarding this adjustment, some interested parties claimed that the Commission, in updating its list of developing countries, should not automatically include those developing countries currently excluded from the measure, and whose imports would have compensated for the volumes formerly imported from Russia and Belarus before the import ban. These parties argued that the methodology used by the Commission of calculating the share of imports on the basis of the thresholds set by the EU basic safeguard regulation would not be appropriate in light of the exceptional political situation arising from Russia's unprovoked and unjustified military aggression against Ukraine. In other words, these parties requested that the Commission changed the denominator used to calculate the import share of developing countries by removing certain origins in some product categories.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(95)</p></td><td><p>The Commission noted that the rules regarding developing country exclusions are set out in Article 9.1 of the WTO Agreement on Safeguards and Article 18 of the EU basic safeguard regulation. Therefore, in the Commission’s reading of these provisions there is no room for an exclusion of certain imports from the calculation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(96)</p></td><td><p>In fact, and irrespective of the specific reasons alleged, the Commission was of the view that if an investigating authority was allowed to pick and choose what imports it included for the relevant calculation of thresholds under these provisions, that would inevitably risk leading to potentially discriminatory treatment among interested parties.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(97)</p></td><td><p>Therefore, the Commission could not accept the interpretation of the relevant provisions for calculating the thresholds for developing country exclusions made by some interested parties.</p></td></tr></tbody></table>
6. LEVEL OF LIBERALISATION
<table><col/><col/><tbody><tr><td><p>(98)</p></td><td><p>The current liberalisation rate of the safeguard was set at an annual rate of 4% <a>(<span>52</span>)</a>. The Commission assessed in this investigation whether this level of liberalisation continued to be appropriate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(99)</p></td><td><p>Some interested parties requested that the level of liberalisation be increased to e.g. 5%. On the other hand, other interested parties rejected the requests for a further increase of the liberalisation rate as unjustified.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(100)</p></td><td><p>In view of the recent negative trends in the Union steel market, the uncertainty surrounding the economic forecasts for the near future in particular for the Union, and the fact that there were TRQs generally available throughout the period across product categories, the Commission considered that an increase in the level of liberalisation beyond its current rate was not justified.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(101)</p></td><td><p>Therefore, the TRQs will continue to increase by 4% as of 1 July 2023 for all product categories. The specific volumes for the period 1 July 2023 – 30 June 2024 (on a quarterly basis) are set out in Annex II of the Third Review Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(102)</p></td><td><p>Finally, the present review amending the safeguard measure also complies with the obligations arising from the bilateral Agreements signed with certain third countries.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(103)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Committee on Safeguards established under Article 3(3) of Regulation (EU) 2015/478 and Article 22(3) of Regulation (EU) 2015/755 respectively,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EU) 2019/159 is amended as follows:
<table><col/><col/><tbody><tr><td><p> </p></td><td><p>Annex III.2 in Annex III is replaced by Annex I to this Regulation.</p></td></tr></tbody></table>
Parts of the table concerning product number 9 in Part IV.1 and in IV.2 of Annex IV is replaced by tables in Annex II to this Regulation.
Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union . It shall apply as of 1 July 2023.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 26 June 2023.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) Regulation (EU) 2015/478 of the European Parliament and of the Council of 11 March 2015 on common rules for imports, ( OJ L 83, 27.3.2015, p. 16 ).
( 2 ) Regulation (EU) 2015/755 of the European Parliament and of the Council of 29 April 2015 on common rules or imports from certain third countries, ( OJ L 123, 19.5.2015, p. 33 ).
( 3 ) Commission Implementing Regulation (EU) 2019/159 of 31 January 2019 imposing definitive safeguard measures against imports of certain steel products, ( OJ L 31, 1.2.2019, p. 27 (“Definitive Safeguard Regulation”).
( 4 ) Commission Implementing Regulation (EU) 2021/1029 of 24 June 2021 amending Commission Implementing Regulation (EU) 2019/159 to prolong the safeguard measure on imports of certain steel products, ( OJ L 225 I, 25.6.2021, p.1 ).
( 5 ) Commission Implementing Regulation (EU) 2019/1590 of 26 September 2019 amending Implementing Regulation (EU) 2019/159 imposing definitive safeguard measures against imports of certain steel products, ( OJ L 248, 27.9.2019, p. 28 ).
( 6 ) Commission Implementing Regulation (EU) 2020/894 of 29 June 2020 amending Implementing Regulation (EU) 2019/159 imposing definitive safeguard measures against imports of certain steel products, ( OJ L 206, 30.6.2020, p. 27 ).
( 7 ) Commission Implementing Regulation (EU) 2022/978 of 23 June 2022 amending Implementing Regulation (EU) 2019/159 imposing a definitive safeguard measure on imports of certain steel products, ( OJ L 167, 24.6.2022, p.58 ).
( 8 ) Commission Implementing Regulation (EU) 2020/2037 of 10 December 2020 amending Implementing Regulation (EU) 2019/159 imposing definitive safeguard measures against imports of certain steel products, ( OJ L 416, 11.12.2020, p.32 ).
( 9 ) Commission Implementing Regulation (EU) 2022/434 of 15 March 2022 amending Regulation (EU) 2019/159 imposing a definitive safeguard measure against imports of certain steel products, ( OJ L 88, 15.3.2022, p.181 ).
( 10 ) Commission Implementing Regulation (EU) 2022/664 of 21 April 2022 amending Implementing Regulation (EU) 2019/159 imposing a definitive safeguard measure against imports of certain steel product, ( OJ L 121, 22.4.2022, p.12 ).
( 11 ) OJ C 459, 2.12.2022, p.6 .
( 12 ) https://tron.trade.ec.europa.eu/tron/TDI
( 13 ) https://tron.trade.ec.europa.eu/investigations/case-history?caseId=2645
( 14 ) See, inter alia, Section 3.2.1. of Second Review Regulation, recitals (27) and (28) of the Prolongation Review Regulation and recital (56) of Third Review Regulation.
( 15 ) Source: European Commission based on the information regarding TRQ daily use available at: https://ec.europa.eu/taxation_customs/dds2/taric/quota_consultation.jsp
( 16 ) In addition to free-of-duty steel available from other third country sources Union users may have had the possibility, at least in some situations, of resorting also to steel available from Union producers.
( 17 ) See, for instance, Section 3.5 of the Third Review Regulation.
( 18 ) See Statement from USTR Spokesperson Adam Hodge of 9 December 2022: https://ustr.gov/about-us/policy-offices/press-office/press-releases/2022/december/statement-ustr-spokesperson-adam-hodge
( 19 ) See recitals (54) to (59) of Commission Implementing Regulation (EU) 2022/978 of 23 June 2022 amending Implementing Regulation (EU) 2019/159 imposing a definitive safeguard measure on imports of certain steel products; OJ L 167, 24.6.2022, p. 58 .
( 20 ) Source : https://dataweb.usitc.gov/
( 21 ) This calculation does not take into account imports into the US from the EU, as the analysis under this section is focused on assessing the possible trade diversion from third countries into the Union market.
( 22 ) S&P Global: Current gas, electricity prices threaten European steelmaking viability: https://www.spglobal.com/commodityinsights/en/market-insights/latest-news/metals/090922-current-gas-electricity-prices-threaten-european-steelmaking-viability-eurofer (9 September 2022); Steel makers fear deepening crisis from energy crunch as output halted: https://www.reuters.com/business/energy/steel-makers-fear-deepening-crisis-energy-crunch-output-halted-2022-09-23/ (Reuters, 23 September 2022). To see the evolution of natural gas prices in the Union, see, for instance, Trading Economics: https://tradingeconomics.com/commodity/eu-natural-gas (last accessed 30 April 2023).
( 23 ) See, as an example: ArcelorMittal To Idle Parts of Three Plants as Energy Costs Bite: https://www.bloomberg.com/news/articles/2022-09-02/arcelormittal-to-idle-parts-of-three-plants-as-energy-costs-bite#xj4y7vzkg (Bloomberg, 2 September 2022); Steel Plants Across Europe Cut Production as Power Prices Soar: https://www.bloomberg.com/news/articles/2022-03-09/spanish-steel-production-curbed-as-power-costs-soar-to-a-record#xj4y7vzkg (Bloomberg, 9 March 2022);
( 24 ) S&P Global: Back in action: European mills restart idled blast furnaces on higher flat steel prices, 13 March 2023: https://www.spglobal.com/commodityinsights/en/market-insights/blogs/metals/031323-back-in-action-european- mills-restart-idled-blast-furnaces-on-higher-flat-steel-prices. See also: Eurometal: Flat steel producer Acciaierie d'Italia to boost production in 2023, 2024: Flat steel producer Acciaierie d'Italia to boost production in 2023, 2024 - EUROMETAL; GMK: US Steel Kosice resumed operation of the blast furnace after a month and a half of downtime: https://gmk.center/en/news/us-steel-kosice-resumed-operation-of-the-blast-furnace-after-a-month-and-a-half-ofdowntime/
( 25 ) For import share in the period 2013-2017 see Table 2 of Definitive Regulation. For import share in the period 2018-2020, see Table 10 of Prolongation Regulation. The share of imports in 2021 was 18.1%.
Source: Eurostat for imports, and industry data and questionnaire replies for consumption.
( 26 ) See references included in footnote 14 to recital (13) of this Regulation.
( 27 ) OECD, Latest Developments in Steelmaking Capacity (17 February 2023).
( 28 ) Ibid
( 29 ) Regarding the evolution of energy prices and their expected price levels in the Union compared with historical data, see Economist Intelligence Unit: Commodities Outlook 2023, page 3 (available upon subscription); and Trading Economics: https://tradingeconomics.com/commodity/eu-natural-gas. Both sources show that the current energy prices in the Union, while far below the peak reached in 2022, continue to be at a substantially higher level than in previous years.
( 30 ) OECD, Steel Market developments: Q4 2022 (16 December 2022).
( 31 ) OECD, Steel Market developments, Q2 2023 (21 February 2023).
( 32 ) Fitch Ratings: Global Steel Outlook 2023 (12 December 2022): https://www.fitchratings.com/research/corporate-finance/global-steel-outlook-2023-13-12-2022#:~:text=We%20forecast%20global%20steel%20consumption,tonnes%20(mt)%20in%202022.
( 33 ) S&P Platts Global: Steel Price Forecast and Steel Market Outlook 2023 (available upon subscription).
( 34 ) World Steel Association: Short Range Outlook, October 2022.
( 35 ) World Steel Association: Short Range Outlook, April 2023.
( 36 ) See, in connection to similar claims raised in previous investigations, the Commission’s findings in Section 4.5 of the Third functioning review regulation, Section 7.6 of the Prolongation review regulation, recital (123) of the Second functioning review regulation, recital (159) and (163) of the First functioning review regulation.
( 37 ) See Section 7.10 of the Prolongation Regulation
( 38 ) Regulation (EU) 2015/477 of the European Parliament and of the Council of 11 March 2015 on measures that the Union may take in relation to the combined effect of anti-dumping or anti-subsidy measures with safeguard measures; OJ L 83, 27.3.2015, p. 11 .
( 39 ) WT/DS595/R European Union – Safeguard Measures on Certain Steel Products , 29 April 2022.
( 40 ) Commission Implementing Regulation (EU) 2023/104 of 12 January 2023 amending Implementing Regulation (EU) 2019/159 imposing a definitive safeguard measure on imports of certain steel products following a report adopted by the World Trade Organization’s Dispute Settlement Body; OJ L 12, 13.1.2023, p. 7 .
( 41 ) See OECD - Steel trade and trade policy developments - 2021-22 (16.12.22), Table B.1, p.47.
( 42 ) See Section 1.1.2. of Commission Implementing Regulation (EU) 2023/104.
( 43 ) See recitals (47) and (48) of the Prolongation Regulation.
( 44 ) The questionnaire replies from these associations also included the individual questionnaire replies of their members participating in the proceeding. Both sets of data were available in the case file (TRON).
( 45 ) See OECD Steel Market Developments, Q4 (December 2022), p. 22, table 4. Available at: https://www.oecd.org/industry/ind/steel-market-developments-Q4-2022.pdf
( 46 ) Source of raw data: Global Trade Atlas ‘GTA’. https://www.gtis.com/gta/. Figures pertaining to the year 2022, for exports from the main steel exporting countries to the Union, namely China, India, South Korea, Taiwan, Türkiye (their combined exports of steel to the Union in 2022 represented 52% of total imports). Figures from Russia, formerly the second largest steel exporting country to the Union, have not been considered since its steel exports to certain jurisdictions, including the Union market, are currently banned as a result of sanctions imposed because of its unprovoked and unjustified military aggression against Ukraine.
( 47 ) For most of these origins the Union market represented a double-digit share of its total exports, reaching up to 27%.
( 48 ) Imports into the Union went down by -9% in 2022 when compared to the peak reached in 2018, representing a reduction of – 3,2 million tonnes.
( 49 ) In line with Article 18 of the Regulation (EU) 2015/478 and Article 9.1 of the WTO Agreement on Safeguards.
( 50 ) Source: Eurostat
( 51 ) Until this review investigation, all developing countries members of the WTO were subject to the measure in category 24 as the 9% was exceeded. Since such threshold is no longer met in 2022, then only those developing countries members of the WTO exceeding the 3% threshold will be subject to the measure.
( 52 ) See recital (42) of Third functioning review regulation.
ANNEX I
“ANNEX III.2
List of product categories originating in developing countries to which the definitive measures apply
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p><span>Country / Product group</span></p></td><td><p><span>1</span></p></td><td><p><span>2</span></p></td><td><p><span>3A</span></p></td><td><p><span>3B</span></p></td><td><p><span>4A</span></p></td><td><p><span>4B</span></p></td><td><p><span>5</span></p></td><td><p><span>6</span></p></td><td><p><span>7</span></p></td><td><p><span>8</span></p></td><td><p><span>9</span></p></td><td><p><span>10</span></p></td><td><p><span>12</span></p></td><td><p><span>13</span></p></td><td><p><span>14</span></p></td><td><p><span>15</span></p></td><td><p><span>16</span></p></td><td><p><span>17</span></p></td><td><p><span>18</span></p></td><td><p><span>19</span></p></td><td><p><span>20</span></p></td><td><p><span>21</span></p></td><td><p><span>22</span></p></td><td><p><span>24</span></p></td><td><p><span>25A</span></p></td><td><p><span>25B</span></p></td><td><p><span>26</span></p></td><td><p><span>27</span></p></td><td><p><span>28</span></p></td></tr><tr><td><p>Argentina</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td></tr><tr><td><p>Brazil</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td></tr><tr><td><p>China</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td></tr><tr><td><p>Egypt</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td></tr><tr><td><p>India</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td></tr><tr><td><p>Indonesia</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td></tr><tr><td><p>Kazakhstan</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td></tr><tr><td><p>Malaysia</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td></tr><tr><td><p>Mexico</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td></tr><tr><td><p>Moldova</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td></tr><tr><td><p>North Macedonia</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td></tr><tr><td><p>Oman</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td></tr><tr><td><p>South Africa</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td></tr><tr><td><p>Türkiye</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td></tr><tr><td><p>Ukraine</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td></tr><tr><td><p>United Arab Emirates</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td></tr><tr><td><p>Vietnam</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p>X</p></td></tr><tr><td><p>All other developing countries</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td><td><p> </p></td><td><p> </p></td><td><p>X</p></td></tr></tbody></table>
” ANNEX II
“ANNEX IV
IV.1 – Volumes of tariff–rate quotas
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Product Number</p></td><td><p>Product category</p></td><td><p>CN Codes</p></td><td><p>Allocation by country (Where Applicable)</p></td><td><p>Year 6</p></td><td><p>Additional duty rate</p></td><td><p>Order numbers</p></td></tr><tr><td><p>From 1.7.2023 to 30.9.2023</p></td><td><p>From 1.10.2023 to 31.12.2023</p></td><td><p>From 1.1.2024 to 31.3.2024</p></td><td><p>From 1.4.2024 to 30.6.2024</p></td></tr><tr><td><p>Volume of tariff quota (net tonnes)</p></td></tr><tr><td><p>9</p></td><td><p>Stainless Cold Rolled Sheets and Strips</p></td><td><p>7219 31 00 , 7219 32 10 , 7219 32 90 , 7219 33 10 , 7219 33 90 , 7219 34 10 , 7219 34 90 , 7219 35 10 , 7219 35 90 , 7219 90 20 , 7219 90 80 , 7220 20 21 , 7220 20 29 , 7220 20 41 , 7220 20 49 , 7220 20 81 , 7220 20 89 , 7220 90 20 , 7220 90 80</p></td><td><p>Korea, Republic of</p></td><td><p>49 549,16</p></td><td><p>49 549,16</p></td><td><p>49 010,58</p></td><td><p>49 010,58</p></td><td><p>25 %</p></td><td><p>09.8846</p></td></tr><tr><td><p>Taiwan</p></td><td><p>45 948,59</p></td><td><p>45 948,59</p></td><td><p>45 449,15</p></td><td><p>45 449,15</p></td><td><p>25 %</p></td><td><p>09.8847</p></td></tr><tr><td><p>India</p></td><td><p>30 710,50</p></td><td><p>30 710,50</p></td><td><p>30 376,69</p></td><td><p>30 376,69</p></td><td><p>25 %</p></td><td><p>09.8848</p></td></tr><tr><td><p>South Africa</p></td><td><p>26 723,10</p></td><td><p>26 723,10</p></td><td><p>26 432,63</p></td><td><p>26 432,63</p></td><td><p>25 %</p></td><td><p>09.8853</p></td></tr><tr><td><p>United States</p></td><td><p>24 986,11</p></td><td><p>24 986,11</p></td><td><p>24 714,52</p></td><td><p>24 714,52</p></td><td><p>25 %</p></td><td><p>09.8849</p></td></tr><tr><td><p>Türkiye</p></td><td><p>20 791,56</p></td><td><p>20 791,56</p></td><td><p>20 565,57</p></td><td><p>20 565,57</p></td><td><p>25 %</p></td><td><p>09.8850</p></td></tr><tr><td><p>Malaysia</p></td><td><p>13 172,38</p></td><td><p>13 172,38</p></td><td><p>13 029,20</p></td><td><p>13 029,20</p></td><td><p>25 %</p></td><td><p>09.8851</p></td></tr><tr><td><p>Other countries</p></td><td><p>52 837,87</p></td><td><p>52 837,87</p></td><td><p>52 263,55</p></td><td><p>52 263,55</p></td><td><p>25 %</p></td><td><p><a> (<span>1</span>)</a></p></td></tr></tbody></table>
IV.2 – Volumes of global and residual tariff–rate quotas per trimester
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Product Number</p></td><td><p>Allocation by country (Where Applicable)</p></td><td><p>Year 3</p></td></tr><tr><td><p>From 1.7.2023 to 30.9.2023</p></td><td><p>From 1.10.2023 to 31.12.2023</p></td><td><p>From 1.1.2024 to 31.3.2024</p></td><td><p>From 1.4.2024 to 30.6.2024</p></td></tr><tr><td><p>Volume of tariff quota (net tonnes)</p></td><td><p>Volume of tariff quota (net tonnes)</p></td><td><p>Volume of tariff quota (net tonnes)</p></td><td><p>Volume of tariff quota (net tonnes)</p></td></tr><tr><td><p>9</p></td><td><p>Other countries</p></td><td><p>52 837,87</p></td><td><p>52 837,87</p></td><td><p>52 263,55</p></td><td><p>52 263,55</p></td></tr></tbody></table>
” ( 1 ) From 1.7 to 31.3: 09.8621
From 1.4 to 30.6: 09.8622
From 1.4 to 30.6: For Korea (Republic of)*, Taiwan*, India*, South Africa*, United States of America*, Türkiye* and Malaysia*: 09.8578 *In case of exhaustion of their specific quotas in accordance with Article 1.5 | ENG | 32023R1301 |
<table><col/><col/><col/><col/><tbody><tr><td><p>8.11.2021   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 393/9</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2021/1926
of 5 November 2021
approving the checks on conformity to marketing standards for fruit and vegetables carried out by the United Kingdom and amending Implementing Regulation (EU) No 543/2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) , and in particular Article 91, point (f), thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>According to Article 15(1) of Commission Implementing Regulation (EU) No 543/2011 <a>(<span>2</span>)</a>, the Commission may, at the request of a third country, approve checks on conformity to marketing standards carried out by that third country prior to import into the Union.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Following the withdrawal of the United Kingdom from the Union on 1 February 2020 and in view of the end of the transition period provided for in the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (Withdrawal Agreement) on 31 December 2020, the United Kingdom had sent the Commission a request to approve checks on conformity to specific marketing standards carried out by the United Kingdom prior to import into the Union. In particular, the United Kingdom had undertaken to comply with the requirements set for the marketing of fruit and vegetables after the end of the transition period and had indicated the official authority and the inspection bodies referred to in Article 15(2), second subparagraph, of Implementing Regulation (EU) No 543/2011.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>On that basis, Commission Implementing Regulation (EU) 2020/2102 <a>(<span>3</span>)</a> approved checks on conformity to marketing standards for fruit and vegetables carried out by the United Kingdom, specified the official authority under the responsibility of which those checks are carried out, as well as the inspection bodies in charge of the proper checks in Great Britain and listed the United Kingdom in Annex IV to Implementing Regulation (EU) No 543/2011 with a footnote.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Although in accordance with Articles 6(3) and 7(1) of the Withdrawal Agreement and Articles 5(4) and 13(1) of the Protocol on Ireland/Northern Ireland to that Agreement in conjunction with Annex 2 to that Protocol, Implementing Regulation (EU) No 543/2011 applies to and in the United Kingdom in respect of Northern Ireland, Article 7(3), first subparagraph, of that Protocol provides that in respect of the recognition in one Member State of technical regulations, assessments, registrations, certificates, approvals and authorisations issued or carried out by the authorities of another Member State, or by a body established in another Member State, references to Member States in provisions of Union law made applicable by that Protocol are not to be read as including the United Kingdom in respect of Northern Ireland as regards technical regulations, assessments, registrations, certificates, approvals and authorisations issued or carried out by the authorities of the United Kingdom or by bodies established in the United Kingdom. Consequently, checks on conformity to marketing standards carried out by the inspection body for Northern Ireland should be considered as carried out by a third country, without prejudice to Article 7(3), fourth subparagraph, of that Protocol.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Therefore, the Commission should also specify the inspection body in charge of the proper checks for Northern Ireland, as notified by the United Kingdom on 9 April 2020, and clarify the entry of the United Kingdom in Annex IV to Implementing Regulation (EU) No 543/2011.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Implementing Regulation (EU) No 543/2011 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>In the interest of clarity and legal certainty, Implementing Regulation (EU) 2020/2102 should be repealed.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Approval of conformity checks
The checks on conformity to marketing standards for fruit and vegetables carried out by the United Kingdom prior to import into the Union are approved.
Article 2
Official authority and inspection bodies
1. The Secretary of State for the Department for Environment, Food & Rural Affairs is the official authority of the United Kingdom referred to in Article 15(2), second subparagraph, of Implementing Regulation (EU) No 543/2011 under the responsibility of which the checks referred to in Article 1 of this Regulation are carried out.
2. The Horticulture Marketing Inspectorate for England and Wales, the Scottish Government’s Horticulture and Marketing Unit for Scotland and the Department of Agriculture, Environment and Rural Affairs for Northern Ireland are the inspection bodies of the United Kingdom in charge of the proper checks within the meaning of Article 15(2), second subparagraph, of Implementing Regulation (EU) No 543/2011.
Article 3
Amendment of Implementing Regulation (EU) No 543/2011
Annex IV to Implementing Regulation (EU) No 543/2011 is replaced by the text in the Annex to this Regulation.
Article 4
Repeal
Implementing Regulation (EU) 2020/2102 is repealed.
Article 5
Entry into force
This Regulation shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 November 2021.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors ( OJ L 157, 15.6.2011, p. 1 ).
( 3 ) Commission Implementing Regulation (EU) 2020/2102 of 15 December 2020 approving the checks on conformity to marketing standards for fruit and vegetables carried out by the United Kingdom and amending Implementing Regulation (EU) No 543/2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors ( OJ L 425, 16.12.2020, p. 84 ).
ANNEX
‘ANNEX IV
Third countries where the conformity checks have been approved under Article 15 and the products concerned
<table><col/><col/><tbody><tr><td><p>Country</p></td><td><p>Products</p></td></tr><tr><td><p>Switzerland</p></td><td><p>Fresh fruit and vegetables</p></td></tr><tr><td><p>Morocco</p></td><td><p>Fresh fruit and vegetables</p></td></tr><tr><td><p>South Africa</p></td><td><p>Fresh fruit and vegetables</p></td></tr><tr><td><p>Israel<a> (<span>*1</span>)</a></p></td><td><p>Fresh fruit and vegetables</p></td></tr><tr><td><p>India</p></td><td><p>Fresh fruit and vegetables</p></td></tr><tr><td><p>New Zealand</p></td><td><p>Apples, pears and kiwi fruit</p></td></tr><tr><td><p>Senegal</p></td><td><p>Fresh fruit and vegetables</p></td></tr><tr><td><p>Kenya</p></td><td><p>Fresh fruit and vegetables</p></td></tr><tr><td><p>Turkey</p></td><td><p>Fresh fruit and vegetables</p></td></tr><tr><td><p>United Kingdom:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Great Britain</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Northern Ireland<a> (<span>*2</span>)</a></p></td></tr></tbody></table></td><td><p>Fresh fruit and vegetables</p></td></tr></tbody></table>
’ ( *1 ) The Commission’s approval under Article 15 is given to fruit and vegetables originating within the State of Israel, excluding the territories under Israeli administration since June 1967, namely the Golan Heights, the Gaza Strip, East Jerusalem and the rest of the West Bank.
<note>
( *2 ) In accordance with Articles 6(3) and 7(1) of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community and Articles 5(4) and 13(1) of the Protocol on Ireland/Northern Ireland to that Agreement in conjunction with Annex 2 to that Protocol, for the purposes of this Regulation references to Member States include the United Kingdom in respect of Northern Ireland. However, in accordance with Article 7(3) of that Protocol, in respect of the recognition in one Member State of technical regulations, assessments, registrations, certificates, approvals and authorisations issued or carried out by the authorities of another Member State, or by a body established in another Member State, references to Member States in provisions of Union law made applicable by that Protocol are not to be read as including the United Kingdom in respect of Northern Ireland as regards technical regulations, assessments, registrations, certificates, approvals and authorisations issued or carried out by the authorities of the United Kingdom or by bodies established in the United Kingdom.
</note> | ENG | 32021R1926 |
<table><col/><col/><col/><col/><tbody><tr><td><p>4.11.2014   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 316/62</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) No 1185/2014
of 3 November 2014
establishing the standard import values for determining the entry price of certain fruit and vegetables
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) ,
Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors ( 2 ) , and in particular Article 136(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the<span>Official Journal of the European Union</span>,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 November 2014.
For the Commission,
On behalf of the President,
Jerzy PLEWA
Director-General for Agriculture and Rural Development
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) OJ L 157, 15.6.2011, p. 1 .
ANNEX
Standard import values for determining the entry price of certain fruit and vegetables
<table><col/><col/><col/><tbody><tr><td><p>(EUR/100 kg)</p></td></tr><tr><td><p>CN code</p></td><td><p>Third country code<a> (<span>1</span>)</a></p></td><td><p>Standard import value</p></td></tr><tr><td><p>0702 00 00</p></td><td><p>AL</p></td><td><p>55,3</p></td></tr><tr><td><p>MA</p></td><td><p>90,6</p></td></tr><tr><td><p>MK</p></td><td><p>57,9</p></td></tr><tr><td><p>ZZ</p></td><td><p>67,9</p></td></tr><tr><td><p>0707 00 05</p></td><td><p>AL</p></td><td><p>71,2</p></td></tr><tr><td><p>JO</p></td><td><p>193,6</p></td></tr><tr><td><p>TR</p></td><td><p>126,5</p></td></tr><tr><td><p>ZZ</p></td><td><p>130,4</p></td></tr><tr><td><p>0709 93 10</p></td><td><p>MA</p></td><td><p>43,5</p></td></tr><tr><td><p>TR</p></td><td><p>137,0</p></td></tr><tr><td><p>ZZ</p></td><td><p>90,3</p></td></tr><tr><td><p>0805 50 10</p></td><td><p>AR</p></td><td><p>72,8</p></td></tr><tr><td><p>TR</p></td><td><p>86,7</p></td></tr><tr><td><p>UY</p></td><td><p>29,5</p></td></tr><tr><td><p>ZZ</p></td><td><p>63,0</p></td></tr><tr><td><p>0806 10 10</p></td><td><p>BR</p></td><td><p>292,5</p></td></tr><tr><td><p>LB</p></td><td><p>283,5</p></td></tr><tr><td><p>MD</p></td><td><p>36,9</p></td></tr><tr><td><p>PE</p></td><td><p>351,3</p></td></tr><tr><td><p>TR</p></td><td><p>146,2</p></td></tr><tr><td><p>US</p></td><td><p>400,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>251,8</p></td></tr><tr><td><p>0808 10 80</p></td><td><p>BA</p></td><td><p>34,8</p></td></tr><tr><td><p>BR</p></td><td><p>51,7</p></td></tr><tr><td><p>CA</p></td><td><p>88,6</p></td></tr><tr><td><p>CL</p></td><td><p>86,8</p></td></tr><tr><td><p>NZ</p></td><td><p>145,5</p></td></tr><tr><td><p>US</p></td><td><p>231,6</p></td></tr><tr><td><p>ZA</p></td><td><p>139,5</p></td></tr><tr><td><p>ZZ</p></td><td><p>111,2</p></td></tr><tr><td><p>0808 30 90</p></td><td><p>CN</p></td><td><p>75,3</p></td></tr><tr><td><p>TR</p></td><td><p>99,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>87,5</p></td></tr></tbody></table>
<note>
( 1 ) Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories ( OJ L 328, 28.11.2012, p. 7 ). Code ‘ZZ’ stands for ‘of other origin’.
</note> | ENG | 32014R1185 |
<table><col/><col/><col/><tbody><tr><td><img/></td><td><p>Official Journal<br/>of the European Union</p></td><td><p>EN</p><p>Series L</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>2023/2767</p></td><td><p>14.12.2023</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2023/2767
of 13 December 2023
establishing a procedure for the approval and certification of innovative technologies for reducing CO 2 emissions from passenger cars and light commercial vehicles pursuant to Regulation (EU) 2019/631 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2019/631 of the European Parliament and of the Council of 17 April 2019 setting CO 2 emission performance standards for new passenger cars and for new light commercial vehicles, and repealing Regulations (EC) No 443/2009 and (EU) No 510/2011 ( 1 ) , and in particular Article 11(2) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>To promote the development of new and advanced vehicle technologies reducing CO<span>2</span> emissions, Article 11 of Regulation (EU) 2019/631 provides for the possibility to consider CO<span>2</span> savings that are achieved through the use of such innovative technologies in passenger cars or light commercial vehicles, but which cannot be fully quantified using the Worldwide Harmonised Light Vehicles Test Procedure (WLTP).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Commission Implementing Regulations (EU) No 725/2011 <a>(<span>2</span>)</a> and (EU) No 427/2014 <a>(<span>3</span>)</a> establish procedures for the approval and certification of innovative technologies for reducing CO<span>2</span> emissions respectively from passenger cars and light commercial vehicles. While the scope of those Regulations differs, they are almost identical in content.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The scopes of Implementing Regulations (EU) No 725/2011 and (EU) No 427/2014 provide that efficiency improvements for air conditioning systems are not eligible as eco-innovations whereas Article 11 of Regulation (EU) 2019/631 provides that such efficiency improvements will become eligible as from 1 January 2025. It is therefore necessary to amend Implementing Regulations (EU) No 725/2011 and (EU) No 427/2014 to align them with Regulation (EU) 2019/631 and ensure that applications may be submitted ahead of 2025 so that vehicle manufacturers may benefit from CO<span>2</span> emissions savings from 2025 onwards.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>It is appropriate to merge Implementing Regulations (EU) No 725/2011 and (EU) No 427/2014 into one Regulation, carrying over most of their provisions while introducing new provisions under Article 11 of Regulation (EU) 2019/631 and, where necessary, bringing improvements based on the experience gained in applying Implementing Regulations (EU) No 725/2011 and (EU) No 427/2014. It is therefore appropriate to repeal those Implementing Regulations and replace them by one Implementing Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Manufacturers or suppliers may submit applications proposing an innovative technology as an eco-innovation. Such applications should propose a methodology containing all elements necessary to accurately determine the CO<span>2</span> emission savings achieved, considering notably the identification of an appropriate baseline, the specific testing conditions and the real-world usage of the innovative technology. Such application should also include a verification report drawn up by an independent and certified body proving the eligibility and qualifications of the innovative technology.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>In order to simplify the certification of CO<span>2</span> savings, it should be possible for the applicant to propose, in addition to a detailed testing methodology for determining the savings, a simplified evaluation method or pre-defined CO<span>2</span> savings in the application for the approval of an innovative technology as an eco-innovation. Where such simplified methods or pre-defined CO<span>2</span> savings are used, the savings certified by approval authorities should be determined in a conservative way reflecting the lowest level of savings demonstrated.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Following the submission of an application by a manufacturer or supplier, the Commission should assess the completeness and content of the application and decide within 9 months as to whether or not it can approve the eco-innovation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Vehicle manufacturers wishing to use eco-innovations to benefit from a reduction of the average specific CO<span>2</span> emissions of their fleet should determine the CO<span>2</span> savings for the purpose of type-approval on the basis of the approval decisions. To limit the eco-innovations mechanism to the technologies with a more significant impact on CO<span>2</span> emissions, a minimum threshold of 0,5 g/km of savings per innovation should be set.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>Where a vehicle is equipped with more than one eco-innovation, the interaction between those technologies could cause their combined CO<span>2</span> savings to be less than the sum of the individual savings. Any form of such interaction should be assessed at both the application and type-approval stages in order to ensure an accurate recording of the CO<span>2</span> savings.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>The Commission should have the possibility to review the eco-innovation CO<span>2</span> savings attributed to individual vehicles to ensure the proper implementation of the approval decisions issued in accordance with this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Climate Change Committee,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Subject matter
This Regulation sets out the procedure to be followed for the approval of innovative technologies in accordance with Article 11 of Regulation (EU) 2019/631.
Article 2
Definitions
For the purposes of this Regulation, the definitions set out in Article 2 of Commission Regulation (EU) 2017/1151 ( 4 ) , in Article 3 of Regulation (EU) 2019/631, and in paragraph 3 of UN Regulation No 154 ( 5 ) , shall apply.
The following definitions shall also apply:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>‘innovative technology’ means a technology that has been fitted in 3 % or less of all new passenger cars registered in the Union in the year<span>n</span>-4 for applications related to passenger cars or in 3 % or less of all new light commercial vehicles registered in the Union in the year<span>n</span>-4 for applications related to light commercial vehicles, with<span>n</span> being the year of application, or a combination of such technologies with similar technical features and characteristics and for which the CO<span>2</span> savings can be demonstrated using one methodology;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>‘eco-innovation’ means an innovative technology accompanied by a testing methodology that has been approved by the Commission in accordance with this Regulation;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>‘supplier’ means the manufacturer of an innovative technology responsible for ensuring conformity of production, its authorised representative in the Union, or the importer;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>‘applicant’ means a manufacturer or supplier, or a group of manufacturers or suppliers, submitting an eco-innovation application;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>‘approval decision’ means a Commission Implementing Decision on the approval of an innovative technology as an eco-innovation;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>‘independent and certified body’ means a category A or B technical service referred to in Article 68(1), points (a) and (b), of Regulation (EU) 2018/858 of the European Parliament and of the Council <a>(<span>6</span>)</a> meeting the requirements set out in Articles 69 and 70 of that Regulation and that is not an in-house technical service of a manufacturer;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>‘specific test conditions’ means test conditions that are set out for the purpose of demonstrating the CO<span>2</span> savings of the innovative technology with strong statistical significance and that are not set out in Regulation (EU) 2017/1151;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>‘eco-innovation vehicle’ means a vehicle fitted with the innovative technology, or the innovative technology as a standalone component;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>‘baseline vehicle’ means a vehicle not fitted with the innovative technology but that is in all other aspects identical to the eco-innovation vehicle, or a baseline technology as a stand-alone component.</p></td></tr></tbody></table>
Article 3
Eco-innovation application
1. An applicant shall submit its application for the approval of an innovative technology as an eco-innovation (‘eco-innovation application’) to the Commission by email. If the supporting data cannot be sent by email, it shall be sent on an electronic data carrier or uploaded to a server accessible by the Commission.
2. An eco-innovation application shall include the following:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the contact details of the applicant;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a description of the innovative technology, the way it is fitted on a vehicle, the vehicle category (i.e. M1 or N1), propulsion type (i.e. pure ICE vehicle, NOVC-HEV or OVC-HEV), the type of fuel and the fuel mode covered;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>a proposal for a methodology to demonstrate the CO<span>2</span> savings of the innovative technology or, where such methodology is already set out in an existing approval decision, a reference to such methodology;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>a verification report.</p></td></tr></tbody></table>
3. Notwithstanding paragraph 2, point (c), the applicant may also include in its application a simplified methodology associated with the methodology referred to in paragraph 2, point (c), or pre-defined CO 2 savings values.
4. Where the applicant is a group of manufacturers or suppliers, and where required for reasons related to confidentiality or competition, several verification reports may be provided by the members of the applicant group for different sets of data supporting the same application.
Article 4
Methodology to demonstrate the CO 2 savings of the innovative technology
1. The methodology referred to in Article 3(2), point (c), and, where applicable, the associated simplified methodology referred to in Article 3(3), shall provide results in terms of CO 2 savings that are verifiable, repeatable and reproducible.
2. The methodology referred to in Article 3(2), point (c), of this Regulation shall:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>define specific test conditions;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>identify a baseline vehicle that is supported by statistical evidence on the basis of which verifiable assumptions about its appropriateness and representativeness can be made;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>set out how to determine the CO<span>2</span> emissions savings from the innovative technology, taking into account the specific test conditions referred to in point (a), the real-world usage of the innovative technology, supported by statistical evidence, and the extent to which the innovative technology is already covered by the Type 1 test which is set out in Annex XXI to Regulation (EU) 2017/1151;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>take account of any deterioration effect of the technology over time and to what extent it modifies the CO<span>2</span> emissions savings;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>where relevant, take account of the interaction with other eco-innovations and to what extent it modifies the CO<span>2</span> emissions savings.</p></td></tr></tbody></table>
3. The simplified methodology referred to in Article 3(3) shall provide results in terms of CO 2 savings that are lower or equal to those determined using the associated methodology referred to in Article 3(2), point (c), including any possible interactions with other approved eco-innovations.
4. In the case of pre-defined CO 2 savings values proposed in accordance with Article 3(3), those values shall be lower or equal to the CO 2 savings determined in accordance with the methodology referred to in Article 3(2), point (c).
Article 5
Verification report
1. In the verification report referred to in Article 3(2), point (d), of this Regulation, the independent and certified body shall:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>declare that it qualifies as an independent and certified body:</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>prove that the proposed technology or combination of technologies qualifies as an innovative technology;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>prove that the innovative technology fulfils the conditions set out in Article 11(2) of Regulation (EU) 2019/631;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>prove that the innovative technology relates to items intrinsic to the efficient operation of the vehicle or constitutes an efficiency improvement for air conditioning systems;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>prove that the methodologies referred to in Article 3 fulfil the requirements as provided for in Article 4;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>describe the interaction between the innovative technology and all eco-innovations covered by approval decisions that may be fitted to the same vehicle, and specify the impact of any such interaction on the total CO<span>2</span> savings.</p></td></tr></tbody></table>
2. Where the application concerns an innovative technology already covered by an existing approval decision, paragraph 1, points (b) to (f), may be substituted by references to such approval decision.
Article 6
Verification of the application’s completeness and approval decision
1. Within 10 working days from receiving an eco-innovation application, the Commission shall notify the applicant whether or not the application is considered complete. The Commission may invite the applicant to provide additional elements to complete its application and shall notify the applicant within 10 working days from receipt of such additional elements whether or not the application is considered complete.
2. If the applicant fails to provide the missing information within the deadline set by the Commission, the application shall be considered to have been withdrawn.
3. Once it has found an application to be complete, the Commission shall proceed with its assessment. Where the Commission finds that the methodologies referred to in Article 3 do not fulfil the requirements as set out in Article 4, it may adjust the methodologies or propose other methodologies than the ones proposed by the applicant. In such cases, the applicant shall be consulted.
4. Within 9 months from receipt of a complete eco-innovation application, the Commission shall issue an approval decision if it concludes that the verification report referred to in Article 3(2), point (d), fulfils the requirements set out in Article 5. If it does not so conclude, the Commission shall notify the applicant of the refusal of the application and provide justifications.
5. The 9-month period referred to in paragraph 4 may be extended by up to 5 months where the Commission finds that, because of the complexity of the innovative technology or the accompanying methodology, the eco-innovation application cannot be appropriately assessed within 9 months.
In this case, the Commission shall, within 30 working days from receipt of the complete eco-innovation application, notify the applicant of the extended deadline.
6. The approval decision shall specify the information required for the determination of the CO 2 savings in accordance with Article 7.
7. The Commission may, at any time, amend an approval decision on its own initiative, in particular to take into account technical progress.
Article 7
Certified CO 2 savings from eco-innovations
1. A manufacturer wishing to benefit from a reduction of its average specific CO 2 emissions by means of the CO 2 savings from an eco-innovation shall proceed in accordance with Annex XII to Regulation (EU) 2017/1151 and refer to the approval decision.
2. The approval authority referred to in Annex XII to Regulation (EU) 2017/1151 shall determine the CO 2 savings of the eco-innovation in accordance with Article 30 of Regulation (EU) 2018/858, using a methodology set out in the approval decision.
3. Where the CO 2 savings for an individual vehicle are less than 0,5 g/km, the CO 2 savings shall not be considered for the purpose of type-approval and their value shall not be indicated in the Certificate of Conformity.
4. Where vehicles are fitted with several eco-innovations, the manufacturer shall declare in the application for an EC type-approval in accordance with Annex XII to Regulation (EU) 2017/1151, whether or not interactions between the eco-innovations may affect their total CO 2 savings.
If the eco-innovations have no such interactions, the CO 2 savings shall be demonstrated separately for each eco-innovation and the total CO 2 savings for the purpose of the certification of the vehicles shall be the sum of the CO 2 savings of the individual eco-innovations.
If the eco-innovations have such interactions, the manufacturer shall provide a report from an independent and certified body on the impact of the interaction on the total savings of the eco-innovations in the vehicles, unless this impact is quantified in the approval decision.
Where, due to such interactions, the total CO 2 savings are less than 0,5 g CO 2 /km times the number of eco-innovations installed in the vehicle, the CO 2 savings shall not be considered for the purpose of type-approval and their value shall not be indicated in the Certificate of Conformity.
5. In the case of completed vehicles related to incomplete base vehicles as defined in Article 3 of Regulation (EU) 2018/858, only eco-innovations fitted to the base vehicle shall be considered for the certification of CO 2 savings from an eco-innovation.
Article 8
Review of CO 2 savings
1. The Commission may verify the CO 2 savings attributed to individual vehicles using a methodology laid out in the applicable approval decisions.
2. Where it finds that there is a difference between the certified CO 2 savings and the CO 2 savings it has verified, the Commission shall notify the manufacturer of its findings.
The Commission may also, where it finds, or is informed of, deviations or inconsistences in the methodology or in the innovative technology in comparison to the information it had received as part of the application, notify this to the manufacturer.
The manufacturer shall, within 40 working days of receipt of the notification, provide the Commission with evidence demonstrating the accuracy of the certified CO 2 savings.
3. Where the evidence referred to in paragraph 2 is not provided within the time period referred to in paragraph 2, third subparagraph, or where it finds that the evidence provided is not satisfactory, the Commission may decide not to take the certified CO 2 savings into account for the calculation of the average specific emissions of that manufacturer for all calendar years for which those certified CO 2 savings were accounted for.
Article 9
Repeal
Implementing Regulations (EU) No 725/2011 and (EU) No 427/2014 are repealed.
Article 10
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 December 2023.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 111, 25.4.2019, p. 13 .
( 2 ) Commission Implementing Regulation (EU) No 725/2011 of 25 July 2011 establishing a procedure for the approval and certification of innovative technologies for reducing CO 2 emissions from passenger cars pursuant to Regulation (EC) No 443/2009 of the European Parliament and of the Council ( OJ L 194, 26.7.2011, p. 19 ).
( 3 ) Commission Implementing Regulation (EU) No 427/2014 of 25 April 2014 establishing a procedure for the approval and certification of innovative technologies for reducing CO 2 emissions from light commercial vehicles pursuant to Regulation (EU) No 510/2011 of the European Parliament and of the Council ( OJ L 125, 26.4.2014, p. 57 ).
( 4 ) Commission Regulation (EU) 2017/1151 of 1 June 2017 supplementing Regulation (EC) No 715/2007 of the European Parliament and of the Council on type-approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information, amending Directive 2007/46/EC of the European Parliament and of the Council, Commission Regulation (EC) No 692/2008 and Commission Regulation (EU) No 1230/2012 and repealing Commission Regulation (EC) No 692/2008 ( OJ L 175, 7.7.2017, p. 1 ).
( 5 ) UN Regulation No 154 – Uniform provisions concerning the approval of light duty passenger and commercial vehicles with regards to criteria emissions, emissions of carbon dioxide and fuel consumption and/or the measurement of electric energy consumption and electric range (WLTP) [2022/2124] ( OJ L 290, 10.11.2022, p. 1 ).
( 6 ) Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC ( OJ L 151 14.6.2018, p. 1 ).
ELI: http://data.europa.eu/eli/reg_impl/2023/2767/oj
ISSN 1977-0677 (electronic edition) | ENG | 32023R2767 |
<table><col/><col/><col/><col/><tbody><tr><td><p>2.8.2016   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 208/46</p></td></tr></tbody></table>
COMMISSION RECOMMENDATION (EU) 2016/1318
of 29 July 2016
on guidelines for the promotion of nearly zero-energy buildings and best practices to ensure that, by 2020, all new buildings are nearly zero-energy buildings
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Buildings are central to the EU's energy efficiency policy, as they account for nearly 40 %<a> (<span>1</span>)</a> of final energy consumption.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The importance of the building sector for energy efficiency improvements was highlighted in the European Commission's Communication on energy efficiency and its contribution to energy security and the 2030 framework for climate and energy policy<a> (<span>2</span>)</a> and in its Communication on a framework strategy for a resilient energy union with a forward-looking climate change policy<a> (<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Full implementation and enforcement of existing energy legislation is recognised as the first priority in establishing the Energy Union.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The Directive on the energy performance of buildings is the main legal instrument addressing energy efficiency in buildings in the context of the 2020 energy efficiency targets.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Article 9 of the Directive sets a specific target that by the end of 2020 all new buildings must have nearly zero or very low energy needs. The nearly zero or very low amount of energy required should be covered to a very significant extent by energy from renewable sources.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>National legislation transposing the requirements of Article 9(1) is required to ensure that by 31 December 2020 all new buildings are nearly zero-energy buildings. The same nearly zero-energy target but with a shorter deadline of 31 December 2018 applies for new buildings occupied and owned by public authorities. This should create a transparent national legal framework for economic operators regarding requirements for the energy performance of new buildings as of the end of 2020.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>In parallel to requirements for new buildings, the Directive requires Member States to put in place support policies to stimulate the refurbishment of existing building stocks towards nearly zero-energy levels.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The Commission has issued a Report to the European Parliament and the Council on progress by Member States towards nearly zero-energy buildings<a> (<span>4</span>)</a>. Further information has been gathered from Member States as part of their reporting obligations on the subject matter.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>Progress by Member States has slowly improved but should be accelerated. Although measures to support the growth in nearly zero-energy buildings at national level have increased, Member States should step up their efforts to ensure that all new buildings are nearly zero-energy by the target dates in the Directive.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>The Directive on the energy performance of buildings is currently under review. Principles for nearly zero-energy buildings are one of the pillars of the current Directive and are set to become the norm for new buildings as of 2020. The review will assess whether additional measures will be needed for 2030. The development of new policies and approaches should be based on solid foundations. It is crucial that the nearly zero-energy buildings requirements for 2020 are fully implemented.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>This is further supported by Article 9(4) of the Directive, which provides that the Commission may issue a recommendation on nearly zero-energy buildings to Member States.</p></td></tr></tbody></table>
HAS ADOPTED THIS RECOMMENDATION:
<table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Member States should follow the guidelines provided in the Annex to this Recommendation. Following these guidelines will help to ensure that, by 31 December 2020, all new buildings are nearly zero-energy buildings, and will help Member States to develop national plans for increasing the number of nearly zero-energy buildings.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>The Recommendation shall be published in the<span>Official Journal of the European Union</span>.</p></td></tr></tbody></table>
Done at Brussels, 29 July 2016.
For the Commission
Miguel ARIAS CAÑETE
Member of the Commission
( 1 ) See ‘Energy, transport and environment indicators, 2012 edition’, European Commission. For the purpose of this estimate, the final energy consumption for the household and services sectors has been combined. This includes, for example, electricity consumption for appliances but excludes energy consumption in industrial buildings.
( 2 ) SWD(2014) 255 final.
( 3 ) Energy union package COM(2015) 80 final.
( 4 ) COM(2013) 483 final/2.
ANNEX
1. INTRODUCTION
Following the introduction of efficiency requirements in national building codes, new buildings today consume only half as much energy as typical buildings from the 1980s.
The Energy Performance of Buildings Directive (the ‘EPBD’ or ‘the Directive’) requires Member States to establish minimum requirements for the energy performance of newly constructed buildings and existing buildings undergoing major renovations. Further to these minimum requirements, the EPBD sets a clear requirement for all new buildings, by the end of the decade, to have nearly zero or very low energy needs and qualify as nearly zero-energy buildings (NZEB). However, the existing building stock is old and inefficient and is being renovated at a slow pace. In line with the EPBD, the stock of existing buildings should also be gradually transformed to similar standards.
Full implementation and enforcement of existing energy legislation is recognised as the first priority in establishing the Energy Union ( 1 ) . Ensuring that all new buildings are nearly zero-energy buildings by 31 December 2020 (two years earlier for public buildings), and supporting the transformation of existing building stocks towards NZEB standards, are two crucial requirements under the current legal framework.
2. CONTEXT: THE PROVISIONS OF THE EPBD ON NZEB
2.1. The concept of NZEB
According to Article 2(2) of the EPBD an NZEB ‘…means a building that has a very high energy performance, as determined in accordance with Annex I. The nearly zero or very low amount of energy required should be covered to a very significant extent by energy from renewable sources, including energy from renewable sources produced on-site or nearby’.
The first part of the definition establishes energy performance as the defining element that makes a building an ‘NZEB’. This energy performance has to be very high and determined in accordance with Annex I of the EPBD. The second part of the definition provides guiding principles to achieve this very high performance by covering the resulting low amount of energy to a very significant extent by energy from renewable sources.
The concept of NZEB reflects the fact that renewable energy and efficiency measures work together. When placed on-building, renewable energy will reduce net delivered energy. In many cases, on-site renewable energy will not be sufficient to bring energy needs close to zero, without further energy efficiency measures or a significant decrease of primary energy factors for off-site renewable energy sources. Therefore, higher and more demanding requirements for highly efficient NZEB will also drive an increased use of on-building renewables and should result in adaptation of primary energy factors for off-site energy carriers, taking their renewable energy content into account.
While the EPBD sets the framework definition of NZEBs, its detailed application in practice (e.g. what is a ‘very high energy performance’ and what would be the recommended significant contribution of ‘energy from renewable sources’) is the responsibility of the Member States when they transpose Article 9 of the Directive into their national legal systems.
2.1.1. What is the energy performance of a ‘nearly zero-energy’ building?
Energy performance is defined ( 2 ) as ‘…the amount of energy needed to meet the energy demand associated with a typical use of the building which includes, inter alia, energy used for heating, cooling, ventilation, hot water and lighting’. Commission Delegated Regulation (EU) No 244/2012 ( 3 ) and its accompanying guidelines ( 4 ) provide useful guidance on how to calculate the energy performance of a building ( 5 ) .
Under Annex I(3) to the Regulation, the calculation of energy performance starts with the calculation of final energy needs ( 6 ) for heating and cooling, and ends with the calculation of the net primary energy . The ‘direction’ of the calculation goes from the building's needs to the source (i.e. to the primary energy).
Under the EPBD, Member States can use their own national primary energy factors to transform the final delivered energy into primary energy and calculate building energy performance.
The primary energy use must be calculated using primary energy factors specific to each energy carrier (e.g. electricity, heating oil, biomass, district heating and cooling). The accompanying guidelines to the Delegated Regulation recommend using the same 2,5 primary energy factor for delivered and for exported electricity.
Energy produced on-site (used on-site or exported) reduces the primary energy needs associated with delivered energy.
The end objective of the energy performance calculation is to determine the annual overall energy use in net primary energy, which corresponds to energy use for heating, cooling, ventilation, hot water and lighting. This annual balancing is consistent with the current EPBD framework. However, studies suggest that there could be benefits in calculating energy balances at smaller time steps (e.g. to observe daily and seasonal effects) ( 7 ) .
In accordance with Article 4(1), minimum requirements must take account of general indoor climate conditions in order to avoid possible negative effects such as inadequate ventilation. To avoid deterioration of indoor air quality, comfort and health conditions in the European building stock ( 8 ) , the stepwise tightening of minimum energy performance requirements resulting from the implementation of NZEB across Europe should be done together with appropriate strategies dealing with indoor environment.
Similarly, studies ( 9 ) indicate that often new and renovated buildings do not reach the planned energy performance. Mechanisms should be put in place to calibrate the calculation of the energy performance with actual energy use.
2.1.2. Relationship between cost-optimal and NZEB levels
The EPBD establishes a benchmarking system (principle of ‘cost-optimality’) to guide Member States in setting energy performance requirements contained in national or regional building codes, and keeping them under regular review. Under the EPBD, cost-optimality ( 10 ) sets the minimum level of ambition for both building renovation and new buildings.
In line with the cost-optimal requirements under Article 5 of the Directive, national minimum energy performance requirements are to be reviewed every five years and strengthened if they are significantly less ambitious than the national cost-optimal levels.
The cost-optimal methodology allows Member States to define the range of NZEB requirements in 2020. This requires assessing and comparing different energy efficiency and renewable energy measures, both individually and in combination, as part of packages of measures to be applied to reference buildings.
Accordingly, to define and meet the NZEB level, Member States can use different combinations of measures concerning insulation or other energy efficiency measures, inclusion of highly-efficient technical building systems and use of on-site renewable energy sources ( 11 ) . As part of the cost-optimal calculations, Member States need to explore the contribution of each of these three types of measures.
Member States have to define primary energy factors per energy carrier. These primary energy factors can be based on national or regional average values, or on specific values. These factors should take into account the renewable energy content of the energy supplied to the building, including from nearby sources, in order to place on-site and off-site renewable energy sources on equal footing.
It is important to keep in mind that, for the bulk of new buildings, the nearly zero-energy buildings concept will apply as from January 2021 onwards (for new public buildings from January 2019 onwards). By then, technology costs are likely to be lower in reaction to more mature markets and larger volumes. It is therefore likely that the NZEB levels will correspond to the cost-optimum for 2020.
The evidence suggests that existing technologies related to energy savings, energy efficiency and renewable energies are sufficient to reach, in combination, a suitable target for nearly zero-energy buildings ( 12 ) . A technology gap that would need to be bridged by 2021 has not been identified. Analysis of the cost-optimal reports required under Article 5 of the EPBD indicates that a smooth transition between cost optimality and NZEB is achievable ( 13 ) .
Each five-year cost-optimality cycle presents an opportunity to lock energy efficiency gains into national building codes as new technologies are proven, and a chance to amend the building performance rules to close the gap to cost-optimal levels. After 2020, the principle of cost-optimality will allow continuous improvement of the level of ambition of NZEB requirements for new buildings, as part of the regular review of national building codes for new and for existing buildings.
2.1.3. How do renewable energy sources contribute?
A particular important objective has been the integration of renewable energy sources in national NZEB implementation. Directive 2009/28/EC of the European Parliament and of the Council ( 14 ) (hereafter the RES Directive) requires Member States to introduce in their building regulations and codes appropriate measures in order to increase the share of all kinds of energy from renewable sources in the building sector ( 15 ) .
Such measures are complementary to the NZEB requirements in the EPBD. The provisions of the EPBD naturally drive the use of renewable energy sources, notably on-site as the energy produced on-building reduces the primary energy associated with the delivered energy. In this way, on-site renewables are always part of the calculation of the energy performance of the building.
While several Member States require a renewable energy share of the primary energy used or a minimum renewable energy contribution in kWh/(m 2 .y), others use indirect requirement such as a low non-renewable primary energy use that can only be met if renewable energy is part of the building concept ( 16 ) . This flexibility allows adaptation to national circumstances and local conditions (building type, climate, costs for comparable renewable technologies and accessibility, optimal combination with demand side measures, building density, etc.). The most frequently applied renewable energy systems in NZEB are on-building solar thermal and PV systems. Other renewable energy sources used in these buildings are geothermal (from ground source heat pumps) and biomass.
For example, renewable energy technologies such as solar thermal and PV systems are more cost-effective in Mediterranean climates (characterised by higher solar radiation) than in other climates. Therefore, these technologies can have a higher relative contribution to tighter energy performance requirements.
As regards off-site renewable energy sources, including those nearby such as district heating and cooling ( 17 ) , the share of renewable energy in the energy carrier mix (for instance in the electricity network mix when electricity is the energy carrier) will affect the energy performance of the building through primary energy factors. Member States make use of this flexibility as significantly different primary energy factors for different energy carriers are observed in general, and for most renewable energy sources and technologies in particular ( 18 ) .
2.2. What do national applied definitions of NZEB need to cover?
The majority of Member States ( 19 ) already use a primary energy use indicator in kWh/(m 2 .y) in line with Annex I. In addition, Member States often include other parameters such as U-values of building envelope components, net and final energy for heating and cooling and CO 2 emissions.
Approximately 60 % of Member States have fixed their detailed application of the NZEB definition in a legal document (e.g. building regulations and energy decrees).
Member States' detailed application in practice of the definition of nearly zero-energy buildings needs to include a numerical indicator of primary energy use expressed in kWh/(m 2 .y) ( 20 ) . This detailed application is to be included in the national transposition measures or in the national plan for increasing the number of NZEB.
2.3. New buildings: timeline for NZEB targets
Article 9(1) of the EPBD requires Member States to
‘…ensure that:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>by 31 December 2020, all new buildings are nearly zero-energy buildings; and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>after 31 December 2018, new buildings occupied and owned by public authorities are nearly zero-energy buildings.’</p></td></tr></tbody></table>
National legislation transposing the requirements of Article 9(1) needs to contain provisions, measures or policies to ensure that by 31 December 2020 all new buildings are nearly-zero energy buildings. The same applies for new public occupied and owned buildings to be nearly-zero energy buildings by 31 December 2018.
With a view to preparing the implementation of Article 9(1), national plans for increasing the number of nearly zero-energy buildings had to include, inter alia, intermediate targets for improving the energy performance of new buildings by 2015. These targets could relate to the minimum percentage of new buildings to be nearly zero-energy buildings, by that date.
Member States must ensure that the requirements of Article 9(1)(a) are met by 31 December 2020 and 31 December 2018 for Article 9(1)(b). Although these dates are in the future, the deadline for transposition of Article 9 was 9 January 2013 ( 21 ) . By this date, all the NZEB provisions of Article 9 needed to be reflected in national transposition measures. Indeed, such a lengthy run-up is necessary given how long it takes to plan, have permission for and construct a building.
Having these targets set in national legislation creates transparency about the political goals and gives visibility to economic operators and other stakeholders concerning the future requirements for the energy performance of new buildings.
Furthermore, Article 9(1) requires Member States to ensure that by the relevant dates, ‘all new buildings are NZEBs’. As a result, citizens buying newly constructed buildings or apartments in 2021 would expect the market to have evolved in line with these targets, and buildings to be NZEBs.
Experience from the construction sector shows that the timing of the end of construction or completion of a building might be uncertain and may suffer delays. Member States would need to factor in the period of validity of building permits, the length of construction and completion of building works and the targets in Article 9(1) of the EPBD to avoid falling short of the obligation to ensure that ‘by January 2021 all new buildings are NZEBs’.
2.4. Policies and measures for the promotion of NZEB
Under Article 9(1), Member States must draw up national plans for increasing the number of NZEBs. The minimum elements to be included in the national plans are established in Article 9(3), as follows:
‘The national plans shall include, inter alia, the following elements:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the Member State's detailed application in practice of the definition of nearly zero-energy buildings, reflecting their national, regional or local conditions, and including a numerical indicator of primary energy use expressed in kWh/m<span>2</span> per year….;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>intermediate targets for improving the energy performance of new buildings, by 2015…;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>information on the policies and financial or other measures (…..) including details of energy from renewable sources in new buildings and existing buildings undergoing major renovation in the context of Article 13(4) of Directive 2009/28/EC and Articles 6 and 7 of this Directive.’</p></td></tr></tbody></table>
2.5. Supporting the transformation of existing buildings towards NZEB
The EPBD also includes NZEB obligations relating to existing buildings without target dates or an obligation to set minimum energy performance requirements. Article 9(2) of the EPBD requires Member States to, ‘following the leading example of the public sector, develop policies and take measures such as the setting of targets in order to stimulate the transformation of buildings that are refurbished into NZEBs, and inform the Commission thereof in their national plans…’.
Supporting the transformation of existing building stocks towards NZEBs under Article 9(2) of the EPBD should include as an element the increase of energy from renewable sources (Article 9(3)(c)). In addition Article 13(6) of the RES Directive requires that Member States promote the use of renewable energy heating and cooling in their building codes and regulations.
Article 9(2) aims therefore at increasing renovation depth by setting national support policies to refurbish existing buildings to deeper, NZEB levels. The obligation in Article 9(2) of the EPBD is complemented by national long term building strategies under Article 4 of Directive 2012/27/EU of the European Parliament and of the Council ( 22 ) (EED), which should result in increased renovation rates through mobilising finance and investments in building renovation. These long term renovation strategies bring together the above elements of the EED (renovation rate) and of the EPBD (renovation depth).
The framework definition of NZEB in the EPBD does not differentiate between new and existing buildings. Having such differentiation may be misleading towards consumers, as would be the case if there were separate Energy Performance Certification ratings for new and for existing buildings.
‘Refurbishment into NZEB’ therefore means a refurbishment of a magnitude that allows the energy performance requirements of a NZEB level to be met. This does not prevent having different timelines and financial support for existing buildings, in recognition of the longer period required for NZEB levels to be cost-optimal in the case of existing buildings.
3. PROGRESS BY MEMBER STATES TOWARDS NZEB
3.1. Applied national definitions of NZEB
Numerical indicators are not comparable across Member States because different energy performance calculation methodologies are used ( 23 ) . Some Member States have extended the scope of the numerical indicator by including non-mandatory energy uses, e.g. energy use in appliances. Evidence shows how inclusion of lighting and appliances can result in more optimal solutions, especially for electricity use ( 24 ) .
With this caveat, the available evidence ( 25 ) shows that where a numerical indicator has been set, the requirements range rather widely from 0 kWh/(m 2 .y) to 270 kWh/(m 2 .y) (which includes energy use in appliances) and are mainly given as primary energy use in kWh/m 2 /y. The higher values are mainly for hospitals or other specialised non-residential buildings.
For residential buildings, most Member States aim to have a primary energy use not higher than 50 kWh/(m 2 .y). The maximal primary energy use ranges between 20 kWh/(m 2 .y) in Denmark or 33 kWh/(m 2 .y) in Croatia (Littoral) and 95 kWh/(m 2 .y) in Latvia. Several countries (Belgium (Brussels), Estonia, France, Ireland, Slovakia, United Kingdom, Bulgaria, Denmark, Croatia (Continental), Malta, Slovenia) aim at 45 or 50 kWh/(m 2 .y) ( 26 ) .
As regards the share of renewable energy, the reporting is quite diverse, with only a few countries defining a specific minimum percentage and the majority making qualitative statements.
No Member State has yet reported any legislative regime for not applying the NZEB requirements in specific and justifiable cases where the cost benefit analysis over the economic life cycle of the building in question is negative, as permitted under Article 9(6) of the EPBD.
3.2. Policies and measures for the promotion of NZEB
An assessment of the state of play as of October 2014 ( 27 ) showed that Member States reported a wide range of policies and measures in support of the NZEB objectives in their national plans and National Energy Efficiency Action Plans, although it is often not clear to what extent these measures specifically target NZEB. Compared to the situation reported in the 2013 Commission progress report ( 28 ) , the number of policies and measures reported from the Member States has increased.
More than two thirds of the Member States have in place polices and measures in the categories of awareness raising and education, strengthening building regulation and energy performance certificates. Financial instruments and support measures, including e.g. incentive policies, loans with reduced interest rate, tax exemptions, energy bonuses for private individuals, grant schemes for installation of renewable energy, guidance and financing for at-risk populations and subsidised mortgage interest rates for energy efficient homes, are another focus to promote NZEB.
Most of the policies and measures reported by the Member States also apply to public buildings. The scope of measures for public buildings varies substantially between Member States ranging from central government buildings only to all publicly-owned buildings or all buildings used for public purposes. Some Member States also have specific measures for public buildings. These are mainly monitoring campaigns (e.g. ‘NRClick’ is an energy accounting system for the comparison of different municipalities in Belgium) and demonstration projects (e.g. in Germany the Zero-energy building for the Federal Environmental Agency (Umweltbundesamt)).
An EU wide overview of the status of national plans for NZEB was prepared in 2015 ( 29 ) . This recent analysis confirms sustained progress, both in the quantity and in the quality of national measures for the promotion of NZEB, including the detailed application of the definition, intermediate targets by 2015 and financial and other policies. This report identifies several exemplary or front-runner policy frameworks.
Some Member States have estimated the benefits of NZEB implementation. New full time jobs will be created: between 649 and 1 180 in Bulgaria, between 4 100 and 6 200 in Poland, between 1 390 and 2 203 in Romania. Bulgaria expects additional investments between EUR 38 and 69 million, Poland between EUR 240 and 365 million, and Romania between EUR 82 and 130 million. Minimum primary energy requirements are foreseen between 70 kWh/m 2 /y (Bulgaria and Poland) and 100 kWh/m 2 /y (Romania) in 2015, but they will become between 30 kWh/m 2 /y and 50 kWh/m 2 /y in 2020. The percentage of renewable energy will pass from 20 % in 2015 to 40 % in 2020. CO 2 emissions will pass from 8-10 kgCO 2 /m 2 /y to 3-7 kgCO 2 /m 2 /y in 2020.
Recent studies suggest that energy reductions of 80 % and more are economically feasible in new NZEB constructions in Europe, although the mix of selected measures varies strongly with climate. Results show how a broad approach to efficiency combined with renewable measures is feasible across the EU, at different costs ( 30 ) .
4. RECOMMENDATIONS
4.1. Application of the NZEB definition in practice: when is the ambition of a NZEB level of energy performance too low?
This section provides the general principles and factors that Member States are advised to take into account in developing the NZEB definition to be applied at national level, in line with the EPBD.
There cannot be a single level of ambition for NZEB across the EU. Flexibility is needed to account for the impact of climatic conditions on heating and cooling needs and on the cost-effectiveness of packages of energy efficiency and renewable energy sources measures.
Nevertheless, the terms ‘nearly zero’ or ‘very low amount’ of energy introduced by the EPBD provide indications as to the extent and limits of Member States' discretion. NZEB definitions should aim at a nearly equalised energy balance.
The NZEB level for new buildings cannot be below (less stringent) than the 2021 cost-optimal level that will be calculated in accordance with Article 5 of the Directive. The cost-optimal level is the minimum level of ambition for NZEB performance. The NZEB level of energy performance for new buildings will be determined by the best technology that is available and well introduced on the market at that time, financial aspects and legal and political considerations at national level.
The establishment of numeric benchmarks for NZEB primary energy use indicators, at EU level, is most useful when the values to be compared with these benchmarks result from transparent calculation methodologies. Standards ( 31 ) are currently under finalisation to allow for transparent comparison of national and regional calculation methodologies.
With these considerations in mind, benchmarks are usually provided in terms of energy needs . Underlying reasons are the fact that energy needs are the starting point for the calculation of primary energy and therefore a very low level of energy need for heating and cooling is a vital pre-condition for nearly zero primary energy buildings. Very low energy needs are also a precondition to achieve a significant share of energy from renewable energy sources and nearly zero primary energy.
Projecting the 2020 prices and technologies, benchmarks for the energy performance of NZEB are in the following ranges for the different EU climatic zones ( 32 ) :
<table><col/><col/><tbody><tr><td><p> </p></td><td><p>Mediterranean:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Offices: 20-30 kWh/(m<span>2</span>.y) of net primary energy with, typically, 80 — 90 kWh/(m<span>2</span>.y) of primary energy use covered by 60 kWh/(m<span>2</span>.y) of on-site renewable sources;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>New single family house: 0-15 kWh/m<span>2</span>.y) of net primary energy with, typically, 50-65 kWh/(m<span>2</span>.y) of primary energy use covered by 50 kWh/(m<span>2</span>.y) of on-site renewable sources;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p> </p></td><td><p>Oceanic:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Offices: 40-55 kWh/(m<span>2</span>.y) of net primary energy with, typically, 85-100 kWh/(m<span>2</span>.y) of primary energy use covered by 45 kWh/(m<span>2</span>.y) of on-site renewable sources;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>New single family house: 15-30 kWh/(m<span>2</span>.y) of net primary energy with, typically, 50-65 kWh/(m<span>2</span>.y) of primary energy use covered by 35 kWh/(m<span>2</span>.y) of on-site renewable sources; and</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p> </p></td><td><p>Continental:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Offices: 40-55 kWh/(m<span>2</span>.y) of net primary energy with, typically, 85-100 kWh/(m<span>2</span>.y) of primary energy use covered by 45 kWh/(m<span>2</span>.y) of on-site renewable sources;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>New single family house: 20-40 kWh/(m<span>2</span>.y) of net primary energy with, typically, 50-70 kWh/(m<span>2</span>.y) of primary energy use covered by 30 kWh/(m<span>2</span>.y) of on-site renewable sources;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p> </p></td><td><p>Nordic:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Offices: 55-70 kWh/(m<span>2</span>.y) of net primary energy with, typically, 85-100 kWh/(m<span>2</span>.y) of primary energy use covered by 30 kWh/(m<span>2</span>.y) of on-site renewable sources;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>New single family house: 40-65 kWh/(m<span>2</span>.y) of net primary energy with, typically, 65-90 kWh/(m<span>2</span>.y) of primary energy use covered by 25 kWh/(m<span>2</span>.y) of on-site renewable sources.</p></td></tr></tbody></table></td></tr></tbody></table>
Member States are advised to use renewable energy sources in an integrated design concept to cover the low energy requirements of buildings ( 33 ) .
Some Member States have chosen to link the NZEB level to one of the best energy performance classes (e.g. building class A++), as specified in an energy performance certificate. This approach, when accompanied by a clear energy performance indicator, is recommended to give clear information to investors and drive the market towards NZEB.
4.2. Meeting the obligation to ensure that new buildings are NZEB as of end of 2020
Preparing new buildings to deliver on the NZEB targets may require adaptation of existing practices. Minimum energy performance requirements and nearly-zero requirements would have to be assessed considering the deadlines in Article 9(1).
Furthermore, Member States need to ensure that if new constructions do not comply with the energy performance requirements, adequate sanction mechanisms are in place. This may require differentiated sanctions for new buildings after the NZEB deadlines have passed.
Member States are advised to assess these elements as soon as possible to make sure that the NZEB targets are achieved. It is equally recommended that Member States define the mechanism that will be used to monitor the fulfilment of the NZEB targets. This mechanism should also monitor the achievement of the intermediate 2015 targets in line with Article 9(1), as well as of possible additional milestones at national level up to 2020. This will strengthen the current NZEB roadmaps and contribute to monitoring mechanisms in the coming years.
4.3. Policies and measures for the promotion of NZEB
In most Member States a wide range of policies has been selected to increase the number of NZEBs (e.g., awareness raising and information, education and training, strengthening building regulations and energy performance certificates, chosen by: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Poland, Portugal, Sweden, Slovenia, United Kingdom). However, policies sometimes seem rather general and addressed to ‘all buildings’. Their specific support to NZEB is not always sufficiently clear, nor is to what extent they contribute in practice to achieving the NZEB target in a country. Therefore, a stronger connection between policies, measures and NZEB is recommended.
To facilitate the provision of this information, the Commission has made available to the Member States a non-obligatory template, whose use is recommended to facilitate the comparability and analysis of the NZEB plans ( 34 ) .
4.4. Supporting the transformation of existing buildings towards NZEB
Best practices to target the transformation of the existing building stock range from technology awareness ( 35 ) , incentive schemes to financial instruments, taxation mechanisms, economic instruments such as energy saving obligation schemes, market instruments like public private partnerships to stimulate building renovation or one stop solution centres giving advice on energy renovation ( 36 ) .
The approach followed in some Member States that links financial support for building renovation to the achievement of high energy classes equivalent to NZEB level can be considered a good practice to stimulate the transformation of national building stocks towards NZEB levels.
In the last decade most Member States introduced measures addressed to the existing building stock and new forward-looking perspectives have been recently defined within the national renovation strategies developed in accordance with Energy Efficiency Directive Article 4. Member States should design consistent mixtures of policy instruments (policy packages), depending only partially on public budgets.
Reliable data to monitor policy impacts, including actual energy performance and indoor environment, are required above all for building stock refurbishment. In some countries with limited solar renewable energy potential (e.g. northern Europe), policies that support alternative measures are needed (e.g. biomass). The adoption of roadmaps and indicators is also a good tool to address specific needs and monitor implementation. Member States are advised to further strengthen and evaluate the adopted measures in order to successfully stimulate cost-effective deep and NZEB renovations.
5. SUMMARY OF RECOMMENDATIONS
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Principles for NZEB are one of the pillars of the current Directive and are set to become the norm for new buildings as of 2020. Member States are advised to step up their efforts to fully implement and enforce the provisions of the EPBD to ensure that all new buildings become NZEB by the target dates in the Directive.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Member States are advised to set national definitions of NZEB at a sufficiently high level of ambition –not below the projected cost-optimal level of minimum requirements- and to use renewable energy sources in an integrated design concept to cover the low energy requirements of nearly-zero energy buildings. Recommended benchmarks are provided in Section 4.1. Proper indoor environment should be ensured to avoid deterioration of indoor air quality, comfort and health conditions in the European building stock.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>In ensuring that new buildings will be NZEB as of the end of 2020, Member States should assess as soon as possible whether adaptation of existing practices is needed. It is equally recommended that Member States define the mechanism that will be used to monitor the fulfilment of the NZEB targets and to consider the possibility to set up differentiated sanctions for new buildings after the NZEB deadlines have passed.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Policies and measures for the promotion of NZEB should be more specific in clarifying to what extent they contribute to achieving NZEB targets. A stronger connection between policies, measures and NZEBs is recommended. To facilitate the provision of this information, the Commission has made available to Member States a non-obligatory template, whose use is recommended to facilitate the comparability and analysis of the plans.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The Commission recommends that Member States accelerate progress in the development of support policies addressing specifically the refurbishment of existing building stocks towards NZEB levels. Member States should design consistent mixtures of policy instruments (policy packages) to provide the required long-term stability to investors in efficient buildings, including deep and NZEB renovations. Reliable data collection to monitor policy impacts is recommended to address specific needs and to monitor the implementation of building stock refurbishment.</p></td></tr></tbody></table>
( 1 ) COM(2015) 80 final.
( 2 ) Article 2(4).
( 3 ) Commission Delegated Regulation (EU) No 244/2012 of 16 January 2012 supplementing Directive 2010/31/EU of the European Parliament and of the Council on the energy performance of buildings by establishing a comparative methodology framework for calculating cost-optimal levels of minimum energy performance requirements for buildings and building elements ( OJ L 81, 21.3.2012, p. 18 ).
( 4 ) Guidelines establishing a methodology framework for calculating cost-optimal levels of minimum energy performance requirements ( OJ C 115, 19.4.2012, p. 1 ).
( 5 ) See table in page 10 of the guidelines.
( 6 ) ‘Energy need’, ‘delivered energy’ and ‘net primary energy’ should be read according to the definitions laid down in Delegated Regulation (EU) No 244/2012 and its accompanying Guidelines.
( 7 ) See for instance ‘Analysis of load match and grid interaction indicators in net zero energy buildings with simulated and monitored data’, Applied Energy, 31 December 2014, pp. 119-131.
( 8 ) JRC report on ‘Promoting healthy and energy efficient buildings in the European Union’, 2016.
( 9 ) See e.g. ‘Predicted vs. actual energy performance of non-domestic buildings: Using post-occupancy evaluation data to reduce the performance gap’, Anna Carolina Menezes, Andrew Cripps, Dino Bouchlaghem & Richard Buswell (2012), Applied Energy, Volume 97, pp. 355-364, http://www.sciencedirect.com/science/article/pii/S0306261911007811/
( 10 ) Meaning the level of energy performance which leads to the lowest cost during the estimated lifecycle of the building.
( 11 ) ‘Energy from renewable sources’ covers energy from renewable non-fossil sources namely wind, solar, aerothermal, geothermal, hydrothermal and ocean energy, hydropower, biomass, landfill gas, sewagetreatment plant gas and biogases.
( 12 ) ‘Towards nearly zero-energy buildings- Definition on common principles under the EPBD’ (http://ec.europa.eu/energy/sites/ener/files/documents/nzeb_full_report.pdf), carried out by Ecofys forthe European Commission, DG ENERGY.
( 13 ) Report of the Commission to the European Parliament and the Council on progress by Member States in reaching cost-optimal levels of minimum energy performance requirements.
( 14 ) Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC ( OJ L 140, 5.6.2009, p. 16 ).
( 15 ) See Article 13(4) of the RES Directive.
( 16 ) EPBD Concerted Action III book, 2016.
( 17 ) DHC systems in the EU have a level of market deployment of about 10-13 % of EU energy heating/cooling supply.
( 18 ) See footnote 12.
( 19 ) 23 Member States and one of the Belgian regions.
( 20 ) In accordance with Article 9(3)(a).
( 21 ) Article 28(1) second subparagraph.
( 22 ) Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC ( OJ L 315, 14.11.2012, p. 1 ).
( 23 ) On-going standardisation work and projects such as the GE 2 O project (http://www.geoclusters.eu/) try to overcome this limitation while acknowledging natural differences such as climate.
( 24 ) Modelling of optimal paths to reach NZEB for new constructions in Europe, presented by Delia D'Agostino at the WSED conference in February 2016 (http://www.wsed.at/en/programme/young-researchers-conference-energy-efficiency-biomass/).
( 25 ) http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52013DC0483R(01)&from=EN. This report includes information from all Member States except for Greece and Spain, which had notsent a national plan or consolidated template as of 18 September 2014. A more recent overview table ofnational definitions of NZEB is available here: http://ec.europa.eu/energy/en/topics/energy-efficiency/buildings/nearly-zero-energy-buildings.
( 26 ) See information included in the JRC synthesis report on national plans for NZEB, 2016, a BPIE factsheet of January 2015 (http://bpie.eu/uploads/lib/document/attachment/128/BPIE_factsheet_nZEB_definitions_across_Europe.pdf) and updated information published by the Commission in October 2014 (https://ec.europa.eu/energy/sites/ener/files/documents/Updated%20progress%20report%20NZEB.pdf)
( 27 ) https://ec.europa.eu/energy/sites/ener/files/documents/Updated%20progress%20report%20NZEB.pdf
( 28 ) http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52013DC0483R(01)&from=EN
( 29 ) JRC synthesis report on national plans for NZEB, 2016, available in the following website: http://iet.jrc.ec.europa.eu/energyefficiency/publications/all
( 30 ) See footnote 24.
( 31 ) Commission's mandate M/480 to CEN on the elaboration of EPBD standards.
( 32 ) In the study ‘Towards nearly zero-energy buildings- Definition on common principles under the EPBD’ (http://ec.europa.eu/energy/sites/ener/files/documents/nzeb_full_report.pdf), carried out by Ecofys for the European Commission, DG ENERGY:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Mediterranean is referred to as Zone 1: Catania (others: Athens, Larnaca, Luga, Seville, Palermo)</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Oceanic as Zone 4: Paris (others: Amsterdam, Berlin, Brussels, Copenhagen, Dublin, London, Macon, Nancy, Prague, Warszawa)</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Continental as Zone 3: Budapest (others: Bratislava, Ljubljana, Milan, Vienna)</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Nordic as Zone 5: Stockholm (Helsinki, Riga, Stockholm, Gdansk, Tovarene).</p></td></tr></tbody></table>
<note>
( 33 ) The integrated energy performance of a building corresponds to the amount of net primary energy needed to meet the different needs associated with its typical use and must reflect the heating energy needs and cooling energy needs, domestic hot water needs and built-in lighting. As a result, in addition to the quality of insulation of the building, an integrated performance considers heating installations, cooling installations, energy for ventilation, lighting installations, position and orientation of the building, heat recovery, active solar gains and other renewable energy sources.
( 34 ) The templates as filled in by the Member States are available from this website http://ec.europa.eu/energy/en/topics/energy-efficiency/buildings/nearly-zero-energy-buildings
( 35 ) The EU supports technology development under the H2020 programme — in particular through the Public Private Partnership on Energy efficient Buildings — https://ec.europa.eu/research/industrial_technologies/energy-efficient-buildings_en.html
( 36 ) See footnote 22.
</note> | ENG | 32016H1318 |
<table><col/><col/><col/><col/><tbody><tr><td><p>18.7.2018   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 182/40</p></td></tr></tbody></table>
COMMISSION DELEGATED REGULATION (EU) 2018/987
of 27 April 2018
amending and correcting Delegated Regulation (EU) 2017/655 supplementing Regulation (EU) 2016/1628 of the European Parliament and of the Council with regard to monitoring of gaseous pollutant emissions from in-service internal combustion engines installed in non-road mobile machinery
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC ( 1 ) , and in particular Article 19(2) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Commission Delegated Regulation (EU) 2017/655 <a>(<span>2</span>)</a> lays down, inter alia, the procedures for the monitoring of gaseous pollutant emissions from in-service internal combustion engines installed in non-road mobile machinery.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Pursuant to Table III-1 of Annex III to Regulation (EU) 2016/1628, the mandatory dates of application for EU type-approval and placing on the market of engines of sub-category NRE-v-5 is one year later than for engines of sub-category NRE-v-6.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Therefore, to facilitate manufacturers of these NRE-v-5 engines of lower power ranges to comply with the limit dates for submitting test results to the approval authorities set out in Delegated Regulation (EU) 2017/655, the required duration of accumulated service of in-service internal combustion engines installed in non-road mobile machinery and tested in the framework of monitoring of gaseous pollutant emissions should be reduced for that sub-category of engines.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>For the purpose of clarity, it should be stated in Appendix 5 of the Annex to Delegated Regulation (EU) 2017/655 that the reference work and reference CO<span>2</span> mass used by the manufacturer in the procedures for the calculation of gaseous pollutant emissions for an engine type, or any engine type within the same engine family, are those specified in the addendum of the EU type-approval certificate of the engine type, or the engine family, in accordance with the template set out in Annex IV to Commission Implementing Regulation (EU) 2017/656 <a>(<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>To avoid mistakes in the rounding of gaseous pollutant emissions calculations, it should be clarified that the applicable exhaust emissions limit values are set out in Article 18(2) of Regulation (EU) 2016/1628.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>To ensure the internal consistency of the Delegated Regulation (EU) 2017/655 and to align it with Commission Delegated Regulation (EU) 2017/654 <a>(<span>4</span>)</a>, certain measurement units should be revised.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Following the publication of Delegated Regulation (EU) 2017/655, errors of different types, including incorrect assignment of responsibilities and mistakes in certain equations, have been detected and need to be corrected.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Delegated Regulation (EU) 2017/655 should therefore be amended and corrected accordingly,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Amendments to Delegated Regulation (EU) 2017/655
Delegated Regulation (EU) 2017/655 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>the following Article 3a is inserted:</p><p>‘Article 3a</p><p>Transitional provisions</p><p>1.   Notwithstanding the application of the provisions of this Regulation, as amended by Commission Delegated Regulation (EU) 2018/987<a> (<span>*1</span>)</a>, approval authorities shall, until 31 December 2018, also continue to grant EU type-approvals to engine types or engine families in accordance with this Regulation, in its version applicable on 6 August 2018.’;</p><p>2.   Notwithstanding the application of the provisions of this Regulation, as amended by Delegated Regulation (EU) 2018/987, the Member States shall, until 30 June 2019, also permit the placing on the market of engines based on an engine type approved in accordance with this Regulation, in its version applicable on 6 August 2018.</p><p><a>(<span>*1</span>)</a>  Commission Delegated Regulation (EU) 2018/987 of 27 April 2018 amending and correcting Delegated Regulation (EU) 2017/655 supplementing Regulation (EU) 2016/1628 of the European Parliament and of the Council with regard to monitoring of gaseous pollutant emissions from in-service internal combustion engines installed in non-road mobile machinery (<a>OJ L 182, 18.7.2018, p. 40</a>).’;"</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>the Annex to Delegated Regulation (EU) 2017/655 is amended in accordance with Annex I to this Regulation.</p></td></tr></tbody></table>
Article 2
Corrections to Delegated Regulation (EU) 2017/655
The Annex to Delegated Regulation (EU) 2017/655 is corrected in accordance with Annex II to this Regulation.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 April 2018.
For the Commission
The President
Jean-Claude JUNCKER
( 1 ) OJ L 252, 16.9.2016, p. 53 .
( 2 ) Commission Delegated Regulation (EU) 2017/655 of 19 December 2016 supplementing Regulation (EU) 2016/1628 of the European Parliament and of the Council with regard to monitoring of gaseous pollutant emissions from in-service internal combustion engines installed in non-road mobile machinery ( OJ L 102, 13.4.2017, p. 334 ).
( 3 ) Commission Implementing Regulation (EU) 2017/656 of 19 December 2016 laying down the administrative requirements relating to emission limits and type-approval of internal combustion engines for non-road mobile machinery in accordance with Regulation (EU) 2016/1628 of the European Parliament and of the Council ( OJ L 102, 13.4.2017, p. 364 ).
( 4 ) Commission Delegated Regulation (EU) 2017/654 of 19 December 2016 supplementing Regulation (EU) 2016/1628 of the European Parliament and of the Council with regard to technical and general requirements relating to emission limits and type-approval for internal combustion engines for non-road mobile machinery ( OJ L 102, 13.4.2017, p. 1 ).
ANNEX I
The Annex to Delegated Regulation (EU) 2017/655 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>points 2.6.1.1 and 2.6.1.2 are replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘2.6.1.1.</p></td><td><p>Testing 9 engines with an accumulated service of less than<span>a</span> % of the EDP, in accordance with Table 1. Test results shall be submitted to the approval authority by 31 December 2022.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.6.1.2.</p></td><td><p>Testing 9 engines with an accumulated service higher than<span>b</span> % of the EDP, in accordance with Table 1. Test reports shall be submitted to the approval authority by 31 December 2024.’;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in point 2.6.1.3, the following Table 1 is added:</p><p>‘<span>Table 1</span></p><p><span>% of EDP values</span></p><table><col/><col/><col/><tbody><tr><td><p>Reference power of selected engine (kW)</p></td><td><p><span>a</span></p></td><td><p><span>b</span></p></td></tr><tr><td><p>56 ≤ P < 130</p></td><td><p>20</p></td><td><p>55</p></td></tr><tr><td><p>130 ≤ P ≤ 560</p></td><td><p>30</p></td><td><p>70’;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>point 2.6.2.1 is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘2.6.2.1.</p></td><td><span>The test results of the first nine engines shall be submitted not later than 12 months after the first engine was installed in a non-road mobile machinery and not later than 18 months after starting the production of the approved engine type or engine family.’;</span></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>point 3.1.1 is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘3.1.1.</p></td><td><span>The non-road mobile machinery's operator performing the in-service monitoring test may be other than the usual professional one if the manufacturer demonstrates to the approval authority that the designated operator has attained enough skills and training to operate the non-road mobile machine.’;</span></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>in Appendix 3, in point 4.1, the table is replaced by the following:</p><p>‘<span>Table</span></p><p><span>Tolerances</span></p><table><col/><col/><tbody><tr><td><p>Slope of the regression line, m</p></td><td><p>0,9 to 1,1 – Recommended</p></td></tr><tr><td><p>Coefficient of determination, r<span>2</span></p></td><td><p>min. 0,90 – Mandatory’;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Appendix 5 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the following point 2.1.5 is inserted before Figure 1:</p><table><col/><col/><tbody><tr><td><p>‘2.1.5.</p></td><td><span>The reference work and reference CO<span>2</span> mass of an engine type, or for all engine types within the same engine family, shall be those specified in points 11.3.1 and 11.3.2 of the addendum to the EU type approval certificate of the engine type or the engine family, as set out in Annex IV to Commission Implementing Regulation (EU) 2017/656<a> (<span>*1</span>)</a>.</span></td></tr></tbody></table><p><a>(<span>*1</span>)</a>  Commission Implementing Regulation (EU) 2017/656 of 19 December 2016 laying down the administrative requirements relating to emission limits and type-approval of internal combustion engines for non-road mobile machinery in accordance with Regulation (EU) 2016/1628 of the European Parliament and of the Council (<a>OJ L 102, 13.4.2017, p. 364</a>).’;"</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>point 3 is replaced by the following:</p><p>‘3.   <span>Rounding of gaseous pollutant emissions calculations</span></p><p>In accordance with Standard ASTM E 29-06b (Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications), the final test results shall be rounded in one step to the number of places to the right of the decimal point indicated by the applicable exhaust emissions limit values set out in Article 18(2) of Regulation (EU) 2016/1628 plus one additional significant figure.’.</p></td></tr></tbody></table></td></tr></tbody></table>
ANNEX II
The Annex to Delegated Regulation (EU) 2017/655 is corrected as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>point 5.1 is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘5.1.</p></td><td><span>The ECU shall provide data stream information to the measurement instruments or data logger of the Portable Emissions Measurement System (PEMS) in accordance with the requirements set out in Appendix 7.’;</span></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>points 6.1 to 6.4 are replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘6.1.</p></td><td><p>In-service monitoring tests shall be conducted using PEMS in accordance with Appendix 1.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>6.2.</p></td><td><p>Manufacturers shall comply with the test procedure set out in Appendix 2 with regard to the in-service monitoring of engines installed on non-road mobile machinery using a PEMS.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>6.3.</p></td><td><p>Manufacturers shall follow the procedures set out in Appendix 3 for the pre-processing of the data resulting of the in-service monitoring of engines installed on non-road mobile machinery using a PEMS.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>6.4.</p></td><td><p>Manufacturers shall follow the procedures set out in Appendix 4 for the determination of valid events during an in-service monitoring test of engines installed on non-road mobile machinery using a PEMS.’;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>point 8 is replaced by the following:</p><p>‘8.   <span>Calculations</span></p><p>Manufacturers shall follow the procedures set out in Appendix 5 for the gaseous pollutant emissions calculations for the in-service monitoring of engines installed on non-road mobile machinery using a PEMS.’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>in point 10.1, the first sentence is replaced by the following:</p><p>‘Manufacturers shall draft a test report of the in-service monitoring of engines installed on non-road mobile machinery using a PEMS for each engine tested.’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Appendix 5 is corrected as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>point 2.2.1 is replaced by the following:</p><p>‘2.2.1.   Calculations of the brake specific gaseous pollutant emissions</p><p>The brake-specific gaseous pollutant emissions<span>e</span><span>gas</span> (g/kWh) shall be calculated for each averaging window and each gaseous pollutant in the following way:</p><p><img/></p><p>Where:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>m<span>i</span></span> is the mass emission of the gaseous pollutant during the i<span>th</span> averaging window, g/averaging window,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>W</span>(<span>t</span><span>2,</span><span><span>i</span></span>) –<span>W</span>(<span>t</span><span>1,</span><span><span>i</span></span>) is the engine work during the i<span>th</span> averaging window, kWh.’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>point 2.2.3 is replaced by the following:</p><p>‘2.2.3.   Calculations of the conformity factors</p><p>The conformity factors shall be calculated for each individual valid averaging window and each individual gaseous pollutant in the following way:</p><p><img/></p><p>Where:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>e<span>gas</span></span> is the brake-specific emission of the gaseous pollutant, g/kWh;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>L</span> is the applicable limit, g/kWh.’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td>in point 2.3, in the legend for the first equation, the indents relating to<p><img/></p> and<p><img/></p> are replaced by the following:<table><col/><col/><tbody><tr><td><p>‘—</p></td><td><p><img/></p> is the CO<span>2</span> mass measured between the test start and time<span>t<span>j,i</span></span>, g;</td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><img/></p> is the CO<span>2</span> mass determined for the NRTC, g;’;</td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>in point 2.3.1, in the legend for the equation, the indent relating to<span>P</span><span>max</span> is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘—</p></td><td><p><span>P</span><span>max</span> is the maximum net power, as defined in Article 3(28) of Regulation (EU) 2016/1628, kW.’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>point 2.3.2 is replaced by the following:</p><p>‘2.3.2.   Calculations of the conformity factors</p><p>The conformity factors shall be calculated for each individual averaging window and each individual pollutant in the following way:</p><p><img/></p><p>With</p><table><col/><col/><tbody><tr><td><p> </p></td><td><p><img/> (in service ratio) and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p> </p></td><td><p><img/> (certification ratio)</p></td></tr></tbody></table><p>Where:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>m<span>i</span></span> is the mass emission of the gaseous pollutant during the i<span>th</span> averaging window, g/averaging window,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><img/> is the CO<span>2</span> mass during the i<span>th</span> averaging window, g;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><img/> is the engine CO<span>2</span> mass determined for the NRTC, g,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>m<span>L</span></span> is the mass emission of gaseous pollutant corresponding to the applicable limit on the NRTC, g.’;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>in Appendix 8, point 2.8 is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘2.8.</p></td><td><span>Engine total swept volume [cm<span>3</span>]’.</span></td></tr></tbody></table></td></tr></tbody></table> | ENG | 32018R0987 |
<table><col/><col/><col/><col/><tbody><tr><td><p>16.7.2021   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 253/11</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2021/1164
of 12 July 2021
conferring protection under Article 99 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council on the name ‘Willamette Valley’ (PGI)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) , and in particular Article 99 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>In accordance with Article 97(2) and (3) of Regulation (EU) No 1308/2013, the Commission has examined the application to register the name ‘Willamette Valley’ forwarded by Willamette Valley Wineries Association (United States of America) and has published it in the<span>Official Journal of the European Union</span> <a>(<span>2</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>In accordance with Article 99 of Regulation (EU) No 1308/2013, the name ‘Willamette Valley’ should be protected and entered in the register referred to in Article 104 of that Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The name ‘Willamette Valley’ (PGI) is hereby protected.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 July 2021.
For the Commission,
On behalf of the President,
Janusz WOJCIECHOWSKI
Member of the Commission
<note>
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) OJ C 58, 18.2.2021, p. 86 .
</note> | ENG | 32021R1164 |
<table><col/><col/><col/><col/><tbody><tr><td><p>19.4.2021   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>LI 132/1</p></td></tr></tbody></table>
COUNCIL IMPLEMENTING REGULATION (EU) 2021/638
of 19 April 2021
implementing Regulation (EU) No 401/2013 concerning restrictive measures in view of the situation in Myanmar/Burma
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EU) No 401/2013 concerning restrictive measures in view of the situation in Myanmar/Burma ( 1 ) , and in particular Article 4i thereof,
Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>On 2 May 2013, the Council adopted Regulation (EU) No 401/2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>On 22 March 2021, the Council adopted Regulation (EU) 2021/479 <a>(<span>2</span>)</a>, which extended the designation criteria to include activities undermining democracy and the rule of law in Myanmar/Burma, as well as the possibility to impose restrictive measures against the economic interests of the Myanmar Armed Forces (Tatmadaw).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>On 22 March 2021, the Council also adopted Regulation (EU) 2021/480 <a>(<span>3</span>)</a>, imposing restrictive measures against 11 persons in response to the military coup carried out on 1 February 2021 and to the serious human rights violations committed since then by the military and police forces in Myanmar/Burma.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>In view of the continuing grave situation in Myanmar/Burma, ten persons and two entities should be included in the list of natural and legal persons, entities and bodies subject to restrictive measures in Annex IV to Regulation (EU) No 401/2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Annex IV to Regulation (EU) No 401/2013 should therefore be amended accordingly,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Annex IV to Regulation (EU) No 401/2013 is amended as set out in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the date of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 April 2021.
For the Council
The President
A. P. ZACARIAS
( 1 ) Council Regulation (EU) No 401/2013 of 2 May 2013 concerning restrictive measures in view of the situation in Myanmar/Burma and repealing Regulation (EC) No 194/2008 ( OJ L 121, 3.5.2013, p. 1 ).
( 2 ) Council Regulation (EU) 2021/479 of 22 March 2021 amending Regulation (EU) No 401/2013 concerning restrictive measures in respect of Myanmar/Burma ( OJ L 99 I, 22.3.2021, p. 13 ).
( 3 ) Council Implementing Regulation (EU) 2021/480 of 22 March 2021 implementing Regulation (EU) No 401/2013 concerning restrictive measures in respect of Myanmar/Burma ( OJ L 99 I, 22.3.2021, p. 15 ).
ANNEX
Annex IV to Regulation (EU) No 401/2013 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>the following heading to the table is added:</p><table><col/><col/><tbody><tr><td><p>‘A.</p></td><td><p>Natural persons referred to in Article 4a’;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>the following natural persons are added:</p><table><col/><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Name</p></td><td><p>Identifying information</p></td><td><p>Reasons</p></td><td><p>Date of listing</p></td></tr><tr><td><p>‘26.</p></td><td><p>Mahn Nyein Maung (a.k.a. P'do, Phado Man Nyein Maung)</p></td><td><p>Member of State Administrative Council;</p></td><td><p>Mahn Nyein Maung is a member of the State Administrative Council (SAC).</p></td><td><p>19.4.2021</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p>Date of birth: c. 1947;</p><p>Nationality: Myanmar;</p><p>Gender: Male</p></td><td><p>On 1 February 2021, the Myanmar Armed Forces (Tatmadaw), led by Commander-in-Chief Min Aung Hlaing, staged a coup in Myanmar by setting aside the results of the elections held on 8 November 2020 and by overthrowing the democratically elected government. As part of the coup, Vice-President Myint Swe, functioning as Acting President, declared a state of emergency on 1 February and transferred the legislative, executive and judicial powers of the state to the Commander-in-Chief of Defence Services Senior General Min Aung Hlaing. On 2 February, the SAC was established to exercise those powers, preventing the democratically elected government from fulfilling its mandate.</p><p>As a member of the SAC, Mahn Nyein Maung has been directly involved in and responsible for decision making concerning state functions and is therefore responsible for undermining democracy and the rule of law in Myanmar/Burma.</p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>Additionally, the SAC adopted decisions restricting the rights to freedom of expression, including access to information, and peaceful assembly. The military forces and authorities operating under the control of the SAC have committed serious human rights violations since 1 February 2021, killing civilian and unarmed protestors, restricting freedom of assembly and of expression, including by restricting internet access, and through arbitrary arrests and detention of opposition leaders and opponents of the coup. Further, the SAC has imposed martial law in parts of the country allowing the military complete authority over the specified areas, including administrative, judicial and law enforcement functions. In the areas under martial law, civilians, including journalists and peaceful protesters, are prosecuted by military courts, effectively depriving them of the right to due process, including the right to appeal. Violent actions by military and police forces threatening peace, security and stability has increased significantly in areas where martial law has been declared.</p><p>As a member of the SAC, Mahn Nyein Maung is directly responsible for those repressive decisions and for serious human rights violations.</p></td><td><p> </p></td></tr><tr><td><p>27.</p></td><td><p>Thein Nyunt</p></td><td><p>Member of State Administrative Council; Chairman of New National Democracy Party (NNDP);</p><p>Date of birth: 26 December 1944;</p><p>Place of birth: Kawkareik (Karen State) Myanmar/Burma;</p><p>Nationality: Myanmar;</p><p>ID number: 12/THAGAKA(NAING)012432;</p><p>Gender: Male</p></td><td><p>Thein Nyunt is a member of the State Administrative Council (SAC).</p><p>On 1 February 2021, the Myanmar Armed Forces (Tatmadaw), led by Commander-in-Chief Min Aung Hlaing, staged a coup in Myanmar by setting aside the results of the elections held on 8 November 2020 and by overthrowing the democratically elected government. As part of the coup, Vice-President Myint Swe, functioning as Acting President, declared a state of emergency on 1 February and transferred the legislative, executive and judicial powers of the state to the Commander-in-Chief of Defence Services Senior General Min Aung Hlaing. On 2 February, the SAC was established to exercise those powers, preventing the democratically elected government from fulfilling its mandate.</p><p>As a member of the SAC, Thein Nyunt has been directly involved in and responsible for decision making concerning state functions and is therefore responsible for undermining democracy and the rule of law in Myanmar/Burma.</p></td><td><p>19.4.2021</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>Additionally, the SAC adopted decisions restricting the rights to freedom of expression, including access to information, and peaceful assembly. The military forces and authorities operating under the control of the SAC have committed serious human rights violations since 1 February 2021, killing civilian and unarmed protestors, restricting freedom of assembly and of expression, including by restricting internet access, and through arbitrary arrests and detention of opposition leaders and opponents of the coup. Further, the SAC has imposed martial law in parts of the country allowing the military complete authority over the specified areas, including administrative, judicial and law enforcement functions. In the areas under martial law, civilians, including journalists and peaceful protesters, are prosecuted by military courts, effectively depriving them of the right to due process, including the right to appeal. Violent actions by military and police forces threatening peace, security and stability has increased significantly in areas where martial law has been declared.</p><p>As a member of the SAC, Thein Nyunt is directly responsible for those repressive decisions and for serious human rights violations.</p></td><td><p> </p></td></tr><tr><td><p>28.</p></td><td><p>Khin Maung Swe</p></td><td><p>Member of State Administrative Council; Chairman of National Democratic Force party (NDF);</p><p>Date of birth: 24 July 1942;</p><p>Place of birth: Ngathaingchaung, Pathein District, Myanmar/Burma;</p><p>Nationality: Myanmar;</p><p>Gender: Male</p></td><td><p>Khin Maung Swe is a member of the State Administrative Council (SAC).</p><p>On 1 February 2021, the Myanmar Armed Forces (Tatmadaw), led by Commander-in-Chief Min Aung Hlaing, staged a coup in Myanmar by setting aside the results of the elections held on 8 November 2020 and by overthrowing the democratically elected government. As part of the coup, Vice-President Myint Swe, functioning as Acting President, declared a state of emergency on 1 February and transferred the legislative, executive and judicial powers of the state to the Commander-in-Chief of Defence Services Senior General Min Aung Hlaing. On 2 February, the SAC was established to exercise those powers, preventing the democratically elected government from fulfilling its mandate.</p><p>As a member of the SAC, Khin Maung Swe has been directly involved in and responsible for decision-making concerning state functions and is therefore responsible for undermining democracy and the rule of law in Myanmar/Burma.</p></td><td><p>19.4.2021</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>Additionally, the SAC adopted decisions restricting the rights to freedom of expression, including access to information, and peaceful assembly. The military forces and authorities operating under the control of the SAC have committed serious human rights violations since 1 February 2021, killing civilian and unarmed protestors, restricting freedom of assembly and of expression, including by restricting internet access, and through arbitrary arrests and detention of opposition leaders and opponents of the coup. Further, the SAC has imposed martial law in parts of the country allowing the military complete authority over the specified areas, including administrative, judicial and law enforcement functions. In the areas under martial law, civilians, including journalists and peaceful protesters, are prosecuted by military courts, effectively depriving them of the right to due process, including the right to appeal. Violent actions by military and police forces threatening peace, security and stability has increased significantly in areas where martial law has been declared.</p><p>As a member of the SAC, Khin Maung Swe is directly responsible for those repressive decisions and for serious human rights violations.</p></td><td><p> </p></td></tr><tr><td><p>29.</p></td><td><p>Aye Nu Sein</p></td><td><p>Member of State Administrative Council; Vice-chair of the Arakan National Party;</p><p>Date of birth: 24 March 1957;</p><p>Place of birth: Sittwe, Rakhine State, Myanmar/Burma;</p><p>Nationality: Myanmar;</p><p>Gender: Female</p></td><td><p>Aye Nu Sein is a member of the State Administrative Council (SAC).</p><p>On 1 February 2021, the Myanmar Armed Forces (Tatmadaw), led by Commander-in-Chief Min Aung Hlaing, staged a coup in Myanmar by setting aside the results of the elections held on 8 November 2020 and by overthrowing the democratically elected government. As part of the coup, Vice-President Myint Swe, functioning as Acting President, declared a state of emergency on 1 February and transferred the legislative, executive and judicial powers of the state to the Commander-in-Chief of Defence Services Senior General Min Aung Hlaing. On 2 February, the SAC was established to exercise those powers, preventing the democratically elected government from fulfilling its mandate.</p><p>As a member of the SAC, Aye Nu Sein has been directly involved in and responsible for decision-making concerning state functions and is therefore responsible for undermining democracy and the rule of law in Myanmar/Burma.</p></td><td><p>19.4.2021</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>Additionally, the SAC adopted decisions restricting the rights to freedom of expression, including access to information, and peaceful assembly. The military forces and authorities operating under the control of the SAC have committed serious human rights violations since 1 February 2021, killing civilian and unarmed protestors, restricting freedom of assembly and of expression, including by restricting internet access, and through arbitrary arrests and detention of opposition leaders and opponents of the coup. Further, the SAC has imposed martial law in parts of the country allowing the military complete authority over the specified areas, including administrative, judicial and law enforcement functions. In the areas under martial law, civilians, including journalists and peaceful protesters, are prosecuted by military courts, effectively depriving them of the right to due process, including the right to appeal. Violent actions by military and police forces threatening peace, security and stability has increased significantly in areas where martial law has been declared.</p><p>As a member of the SAC, Aye Nu Sein is directly responsible for those repressive decisions and for serious human rights violations.</p></td><td><p> </p></td></tr><tr><td><p>30.</p></td><td><p>Jeng Phang Naw Htaung</p></td><td><p>Member of State Administrative Council;</p><p>Nationality: Myanmar;</p><p>Gender: Male</p></td><td><p>Jeng Phang Naw Htaung is a member of the State Administrative Council (SAC).</p><p>On 1 February 2021, the Myanmar Armed Forces (Tatmadaw), led by Commander-in-Chief Min Aung Hlaing, staged a coup in Myanmar by setting aside the results of the elections held on 8 November 2020 and by overthrowing the democratically elected government. As part of the coup, Vice-President Myint Swe, functioning as Acting President, declared a state of emergency on 1 February and transferred the legislative, executive and judicial powers of the state to the Commander-in-Chief of Defence Services Senior General Min Aung Hlaing. On 2 February, the SAC was established to exercise those powers, preventing the democratically elected government from fulfilling its mandate.</p><p>As a member of the SAC, Jeng Phang Naw Htaung has been directly involved in and responsible for decision-making concerning state functions and is therefore responsible for undermining democracy and the rule of law in Myanmar/Burma.</p></td><td><p>19.4.2021</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>Additionally, the SAC adopted decisions restricting the rights to freedom of expression, including access to information, and peaceful assembly. The military forces and authorities operating under the control of the SAC have committed serious human rights violations since 1 February 2021, killing civilian and unarmed protestors, restricting freedom of assembly and of expression, including by restricting internet access, and through arbitrary arrests and detention of opposition leaders and opponents of the coup. Further, the SAC has imposed martial law in parts of the country allowing the military complete authority over the specified areas, including administrative, judicial and law enforcement functions. In the areas under martial law, civilians, including journalists and peaceful protesters, are prosecuted by military courts, effectively depriving them of the right to due process, including the right to appeal. Violent actions by military and police forces threatening peace, security and stability has increased significantly in areas where martial law has been declared.</p><p>As a amember of the SAC, Jeng Phang Naw Htaung is directly responsible for those repressive decisions and for serious human rights violations.</p></td><td><p> </p></td></tr><tr><td><p>31.</p></td><td><p>Maung Ha</p></td><td><p>Member of State Administrative Council;</p><p>Nationality: Myanmar;</p><p>Gender: Male</p></td><td><p>Maung Ha is a member of the State Administrative Council (SAC).</p><p>On 1 February 2021, the Myanmar Armed Forces (Tatmadaw), led by Commander-in-Chief Min Aung Hlaing, staged a coup in Myanmar by setting aside the results of the elections held on 8 November 2020 and by overthrowing the democratically elected government. As part of the coup, Vice-President Myint Swe, functioning as Acting President, declared a state of emergency on 1 February and transferred the legislative, executive and judicial powers of the state to the Commander-in-Chief of Defence Services Senior General Min Aung Hlaing. On 2 February, the SAC was established to exercise those powers, preventing the democratically elected government from fulfilling its mandate.</p><p>As a member of the SAC, Maung Ha has been directly involved in and responsible for decision-making concerning state functions and is therefore responsible for undermining democracy and the rule of law in Myanmar/Burma.</p></td><td><p>19.4.2021</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>Additionally, the SAC adopted decisions restricting the rights to freedom of expression, including access to information, and peaceful assembly. The military forces and authorities operating under the control of the SAC have committed serious human rights violations since 1 February 2021, killing civilian and unarmed protestors, restricting freedom of assembly and of expression, including by restricting internet access, and through arbitrary arrests and detention of opposition leaders and opponents of the coup. Further, the SAC has imposed martial law in parts of the country allowing the military complete authority over the specified areas, including administrative, judicial and law enforcement functions. In the areas under martial law, civilians, including journalists and peaceful protesters, are prosecuted by military courts, effectively depriving them of the right to due process, including the right to appeal. Violent actions by military and police forces threatening peace, security and stability has increased significantly in areas where martial law has been declared.</p><p>As a member of the SAC, Maung Ha is directly responsible for those repressive decisions and for serious human rights violations.</p></td><td><p> </p></td></tr><tr><td><p>32.</p></td><td><p>Sai Long Hseng</p></td><td><p>Member of State Administrative Council;</p><p>Date of birth: 18 April 1947;</p><p>Place of birth: Kengtung, Myanmar/Burma;</p><p>Nationality: Myanmar;</p><p>Citizenship verification card: Katana (Naing) 0052495;</p><p>NRC Number:</p><p>13/KATANA (N)-005249;</p><p>Gender: Male</p></td><td><p>Sai Long Hseng is a member of the State Administrative Council (SAC).</p><p>On 1 February 2021, the Myanmar Armed Forces (Tatmadaw), led by Commander-in-Chief Min Aung Hlaing, staged a coup in Myanmar by setting aside the results of the elections held on 8 November 2020 and by overthrowing the democratically elected government. As part of the coup, Vice-President Myint Swe, functioning as Acting President, declared a state of emergency on 1 February and transferred the legislative, executive and judicial powers of the state to the Commander-in-Chief of Defence Services Senior General Min Aung Hlaing. On 2 February, the SAC was established to exercise those powers, preventing the democratically elected government from fulfilling its mandate.</p><p>As a member of the SAC, Sai Long Hseng has been directly involved in and responsible for decision-making concerning state functions and is therefore responsible for undermining democracy and the rule of law in Myanmar/Burma.</p></td><td><p>19.4.2021</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>Additionally, the SAC adopted decisions restricting the rights to freedom of expression, including access to information, and peaceful assembly. The military forces and authorities operating under the control of the SAC have committed serious human rights violations since 1 February 2021, killing civilian and unarmed protestors, restricting freedom of assembly and of expression, including by restricting internet access, and through arbitrary arrests and detention of opposition leaders and opponents of the coup. Further, the SAC has imposed martial law in parts of the country allowing the military complete authority over the specified areas, including administrative, judicial and law enforcement functions. In the areas under martial law, civilians, including journalists and peaceful protesters, are prosecuted by military courts, effectively depriving them of the right to due process, including the right to appeal. Violent actions by military and police forces threatening peace, security and stability has increased significantly in areas where martial law has been declared.</p><p>As a member of the SAC, Sai Long Hseng is directly responsible for those repressive decisions and for serious human rights violations.</p></td><td><p> </p></td></tr><tr><td><p>33.</p></td><td><p>Saw Daniel</p></td><td><p>Member of State Administrative Council;</p><p>Date of birth: 25 November 1957;</p><p>Place of birth: Loikaw (Kayah State) Myanmar/Burma;</p><p>Nationality: Myanmar;</p><p>Gender: Male</p></td><td><p>Saw Daniel is a member of the State Administrative Council (SAC).</p><p>On 1 February 2021, the Myanmar Armed Forces (Tatmadaw), led by Commander-in-Chief Min Aung Hlaing, staged a coup in Myanmar by setting aside the results of the elections held on 8 November 2020 and by overthrowing the democratically elected government. As part of the coup, Vice-President Myint Swe, functioning as Acting President, declared a state of emergency on 1 February and transferred the legislative, executive and judicial powers of the state to the Commander-in-Chief of Defence Services Senior General Min Aung Hlaing. On 2 February, the SAC was established to exercise those powers, preventing the democratically elected government from fulfilling its mandate.</p><p>As a member of the SAC, Saw Daniel has been directly involved in and responsible for decision-making concerning state functions and is therefore responsible for undermining democracy and the rule of law in Myanmar/Burma.</p></td><td><p>19.4.2021</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>Additionally, the SAC adopted decisions restricting the rights to freedom of expression, including access to information, and peaceful assembly. The military forces and authorities operating under the control of the SAC have committed serious human rights violations since 1 February 2021, killing civilian and unarmed protestors, restricting freedom of assembly and of expression, including by restricting internet access, and through arbitrary arrests and detention of opposition leaders and opponents of the coup. Further, the SAC has imposed martial law in parts of the country allowing the military complete authority over the specified areas, including administrative, judicial and law enforcement functions. In the areas under martial law, civilians, including journalists and peaceful protesters, are prosecuted by military courts, effectively depriving them of the right to due process, including the right to appeal. Violent actions by military and police forces threatening peace, security and stability has increased significantly in areas where martial law has been declared.</p><p>As a member of the SAC, Saw Daniel is directly responsible for those repressive decisions and for serious human rights violations.</p></td><td><p> </p></td></tr><tr><td><p>34.</p></td><td><p>Dr Banyar Aung Moe</p></td><td><p>Member of State Administrative Council;</p><p>Nationality: Myanmar;</p><p>Gender: Male</p></td><td><p>Banyar Aung Moe is a member of the State Administrative Council (SAC).</p><p>On 1 February 2021, the Myanmar Armed Forces (Tatmadaw), led by Commander-in-Chief Min Aung Hlaing, staged a coup in Myanmar by setting aside the results of the elections held on 8 November 2020 and by overthrowing the democratically elected government. As part of the coup, Vice-President Myint Swe, functioning as Acting President, declared a state of emergency on 1 February and transferred the legislative, executive and judicial powers of the state to the Commander-in-Chief of Defence Services Senior General Min Aung Hlaing. On 2 February, the SAC was established to exercise those powers, preventing the democratically elected government from fulfilling its mandate.</p><p>As a member of the SAC, Banyar Aung Moe has been directly involved in and responsible for decision-making concerning state functions and is therefore responsible for undermining democracy and the rule of law in Myanmar/Burma.</p></td><td><p>19.4.2021</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p>Additionally, the SAC adopted decisions restricting the rights to freedom of expression, including access to information, and peaceful assembly. The military forces and authorities operating under the control of the SAC have committed serious human rights violations since 1 February 2021, killing civilian and unarmed protestors, restricting freedom of assembly and of expression, including by restricting internet access, and through arbitrary arrests and detention of opposition leaders and opponents of the coup. Further, the SAC has imposed martial law in parts of the country allowing the military complete authority over the specified areas, including administrative, judicial and law enforcement functions. In the areas under martial law, civilians, including journalists and peaceful protesters, are prosecuted by military courts, effectively depriving them of the right to due process, including the right to appeal. Violent actions by military and police forces threatening peace, security and stability has increased significantly in areas where martial law has been declared.</p><p>As a member of the SAC, Banyar Aung Moe is directly responsible for those repressive decisions and for serious human rights violations.</p></td><td><p> </p></td></tr><tr><td><p>35.</p></td><td><p>U Chit Naing (a.k.a.: Sate Pyin Nyar)</p></td><td><p>Minister for Information;</p><p>Date of birth: December 1948;</p><p>Place of birth: Kyee Nee Village, Chauk Township, Magway Region, Myanmar/Burma;</p><p>Nationality: Myanmar;</p><p>Address: No. 150, Yadanar Street, Yadanar Housing (near Tine Yin Thar Village), Tharkayta Township, Yangon, Myanmar;</p></td><td><p>U Chit Naing has been the Minister for Information since 2 February 2021. He was appointed by the Chairman of the State Administrative Council (SAC) that took over the legislative, executive and judicial powers of the State as of 2 February 2021.</p><p>As Minister for Information, he is responsible for state-owned media (MWD, MRTV, Myanmar Alin, Kyemon and Global New Light of Myanmar newspapers and the Myanmar News Agency (MNA) and Myanmar Digital News), and thus for broadcast and publication of official news. Since he took over the ministry, the newspapers have been filled with pro-military articles and he is therefore responsible for junta propaganda and spreading disinformation through state media that are not reporting accurately. He is directly responsible for decisions that led to the crackdown on Myanmar media. This includes directives, which ordered independent media not to use the words “coup”, “military regime” and “junta”, and which has seen five local news outlets banned in the country. He is therefore responsible for undermining democracy in Myanmar/Burma by limiting press freedom and access of information both on-line and off-line.</p></td><td><p>19.4.2021’</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p>Responsible for state-owned media (MWD, MRTV, Myanmar Alin, Kyemon and Global New Light of Myanmar newspapers and the Myanmar News Agency (MNA) and Myanmar Digital News.</p></td><td><p>In his statements, he publicly supported the military coup. As Minister of information, appointed by the Chairman of the SAC, U Chit Naing is responsible for actions and policies undermining democracy and the rule of law in Myanmar/Burma, as well as actions that threaten the peace, security and stability of Myanmar/Burma.</p></td><td><p> </p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>the following heading and table are added:</p><table><col/><col/><tbody><tr><td><p>‘B.</p></td><td><p>Legal persons, entities and bodies referred to in Article 4a</p><table><col/><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Name</p></td><td><p>Identifying information</p></td><td><p>Reasons</p></td><td><p>Date of listing</p></td></tr><tr><td><p>1.</p></td><td><p>Myanmar Economic Holdings Public Company Ltd</p></td><td><p>Address: 51 Mahabandoola road, 189/191 Botataung, Yangon region, Myanmar 11 161;</p><p>Type of entity: Public Company Limited by Shares;</p><p>Place of registration: Yangon, Myanmar/Burma;</p><p>Date of registration: 27 April 1990;</p></td><td><p>Myanmar Economic Holdings Public Company Ltd (MEHL) is a conglomerate owned and controlled by the Myanmar Armed Forces (Tatmadaw), having subsidiaries and affiliated companies in diverse sectors of the economy, including banking, insurance, construction, trade, transportation, mining, gem extraction, manufacturing and tourism. MEHL and its subsidiaries generate revenue for the Tatmadaw, therefore contributing to its capabilities to carry out activities undermining democracy and the rule of law and to serious human rights violations in Myanmar/Burma.</p><p>MEHL and its subsidiaries donated assets to the military in 2017 during the Tatmadaw’s fundraising ceremonies. Therefore, MEHL financially supported the Tatmadaw and thus contributed to its capability to carry out the “clearance operations” and serious human rights violations in 2017 against the Rohingya population.</p></td><td><p>19.4.2021</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p>Registration number: 156387282;</p><p>Principal place of business: Myanmar/Burma;</p><p>Associates: Board of directors: Lt. Gen Dwe Aung Lin: director (EU-designated); Lt. Gen Moe Myint Tun: director (EU-designated); Patron group: Commander-in-Chief Min Aung Hlaing: chairman (EU-designated);</p><p>Deputy-Commander-in-Chief Soe Win: Vice-chairman (EU-designated);</p><p>Phone number: 01-290843;</p><p>Website: http://www.mehl.com.mm/</p></td><td><p>MEHL’s board of directors is exclusively composed of senior officers (active or retired) of the Tatmadaw. Two members of the board of Directors (Lt. Gen. Dwe Aung Lin and Lt. Gen. Moe Myint Tun) are also members of the State Administration Council, the<span>ad hoc</span> body created after the 1 February coup, currently governing de facto Myanmar, and are listed under Council Decision 2013/184/CFSP and Council Regulation (EU) No 401/2013 concerning restrictive measures in view of the situation in Myanmar/Burma.</p><p>Commander-in-Chief Min Aung Hlaing and Deputy-Commander-in-Chief Soe Win lead the Patron Group of MEHL as Chairman and Vice Chairman, respectively.</p></td><td><p> </p></td></tr><tr><td><p>2.</p></td><td><p>Myanmar Economic Corporation Limited</p></td><td><p>Address: Corner of Ahlone road & Kannar road, Ahlone, Yangon, Myanmar;</p><p>Type of entity: Company limited by shares;</p><p>Place of registration: Yangon, Myanmar/Burma</p><p>Date of registration: Founded in 1997 as a State owned company, registered as a private company on 9 January 2019;</p><p>Registration number: 105444192;</p></td><td><p>Myanmar Economic Corporation (MEC) is a conglomerate owned and controlled by the Myanmar Armed Forces (Tatmadaw), having subsidiaries and affiliated companies in diverse sectors of the economy, including banking, insurance, construction, trade, transportation, mining, gem extraction, manufacturing and tourism. MEC and its subsidiaries generate revenue for the Tatmadaw, therefore contributing to its capabilities to carry out activities undermining democracy and the rule of law and to serious human rights violations in Myanmar/Burma.</p><p>MEC’s board of directors is exclusively composed of senior officers (active or retired) of the Tatmadaw.</p></td><td><p>19.4.2021’</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p>Place of business: Myanmar/Burma;</p><p>Phone number: 01-8221369;</p><p>Email address: mecadm.hq@gmail.com</p></td><td><p>MEC and its subsidiaries donated assets to the military in 2017 during the Tatmadaw’s fundraising ceremonies. Therefore MEC financially supported the Tatmadaw and thus contributed to its capability to carry out the “clearance operations” and serious human rights violations in 2017 against the Rohingya population.</p></td><td><p> </p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table> | ENG | 32021R0638 |
<table><col/><col/><col/><col/><tbody><tr><td><p>23.12.2020   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 434/59</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING DECISION (EU) 2020/2201
of 22 December 2020
on the appointment of certain members and their alternates of the Network Management Board and of the European Aviation Crisis Coordination Cell for the air traffic management network functions
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 551/2004 of the European Parliament and of the Council of 10 March 2004 on the organisation and use of the airspace in the single European sky (the airspace Regulation) ( 1 ) , and in particular Article 6(4) thereof,
Having regard to Commission Implementing Regulation (EU) 2019/123 of 24 January 2019 laying down detailed rules for the implementation of air traffic management (ATM) network functions ( 2 ) , and in particular Articles 18 and 19 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Implementing Regulation (EU) 2019/123 establishes a Network Management Board to monitor and steer the execution of the network functions of air traffic management. It also establishes a European Aviation Crisis Coordination Cell to ensure effective crisis management at network level.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The chairperson, vice-chairpersons, members of the Network Management Board and their alternates and the members of the European Aviation Crisis Coordination Cell and their alternates have been appointed for the period from 2020 to 2024 by Commission Implementing Decision (EU) 2019/2168 <a>(<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>In 2020, the Commission received a number of proposals for appointments for both the Network Management Board and the European Aviation Crisis Coordination Cell pursuant to Article 18 (7) and Article 19 (2) of Commission Implementing Regulation (EU) 2019/123.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The persons proposed should be appointed so as to succeed, as from 1 January 2021, to the persons that had been appointed by Implementing Decision (EU) 2019/2168.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>This decision should enter into force as a matter of urgency before the beginning of the period covered by the appointments in question.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>The measures provided for in this Decision are in accordance with the opinion of the Single Sky Committee,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
The persons listed in Annex I shall be appointed for the period from 1 January 2021 until 31 December 2024 as members and alternates of the Network Management Board, in the respective capacities referred to in that Annex. Where the Annex specifies a shorter time period, that time period shall apply. In respect of the positions concerned by these appointments, the mandates of the persons appointed in accordance with Implementing Decision (EU) 2019/2186 expire on 31 December 2020.
Article 2
The persons listed in Annex II shall be appointed for the period from 1 January 2021 until 31 December 2024 as the members and alternates of the European Aviation Crisis Coordination Cell, in the respective capacities referred to in that Annex. In respect of the positions concerned by these appointments, the mandates of the persons appointed in accordance with Implementing Decision (EU) 2019/2186 expire on 31 December 2020.
Article 3
This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union .
Done at Brussels, 22 December 2020.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 96, 31.3.2004, p. 20 .
( 2 ) Commission Implementing Regulation (EU) 2019/123 of 24 January 2019 laying down detailed rules for the implementation of air traffic management (ATM) network functions and repealing Commission Regulation (EU) No 677/2011 ( OJ L 28, 31.1.2019, p. 1 ).
( 3 ) Commission Implementing Decision (EU) 2019/2168 of 17 December 2019 on the appointment of the chairperson and the members and their alternates of the Network Management Board and of the members and their alternates of the European Aviation Crisis Coordination Cell for the air traffic management network functions for the third reference period 2020-2024 ( OJ L 328, 18.12.2019, p. 90 ).
ANNEX I
Appointments of voting and non-voting members and their alternates of the Network Management Board
<table><col/><col/><tbody><tr><td><p><span>Chairperson:</span></p></td><td><p>No new appointment</p></td></tr><tr><td><p><span>1st Vice Chairperson:</span></p></td><td><p>No new appointment</p></td></tr><tr><td><p><span>2nd Vice Chairperson</span>:</p></td><td><p>No new appointment</p></td></tr></tbody></table>
Airspace users:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Voting members</p></td><td><p>Alternates</p></td></tr><tr><td><p>AIRE/ERA</p></td><td><p>No new appointment</p></td><td><p>Mrs Montserrat Barriga, Director General European Regions Airline Association (ERA)</p></td></tr><tr><td><p>A4E</p></td><td><p>Mr Achim Baumann, Policy Director at A4E</p></td><td><p>Mr Matthew Krasa, Head Of Public Affairs</p><p>Ryanair</p></td></tr><tr><td><p>IATA</p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr><tr><td><p>EBAA/IAOPA/EAS</p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr></tbody></table>
Air navigation service providers per functional airspace block:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Voting members</p></td><td><p>Alternates</p></td></tr><tr><td><p>BALTIC</p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr><tr><td><p>BLUEMED</p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr><tr><td><p>DANUBE</p></td><td><p>No new appointment</p></td><td><p>Mr Valentin CIMPUIERU,</p><p>Director General</p><p>Romanian Air Traffic Services Administration (ROMATSA)</p></td></tr><tr><td><p>DK-SE</p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr><tr><td><p>FABCE</p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr><tr><td><p>FABEC</p></td><td><p>Mr Dirk MAHNS,</p><p>COO</p><p>Deutsche Flugsicherung GmbH (DFS)</p></td><td><p>No new appointment</p></td></tr><tr><td><p>NEFAB</p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr><tr><td><p>SOUTH-WEST</p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr><tr><td><p>IRELAND</p></td><td><p>No new appointment</p></td><td><p>Mr Joe RYAN,</p><p>Irish Aviation Authority</p></td></tr></tbody></table>
Airport operators:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Voting members</p></td><td><p>Alternates</p></td></tr><tr><td><p> </p></td><td><p>No new appointment</p></td><td><p>Mr Ivan BASSATO, Airport Management Director Aeroporti di Roma Via dell’Aeroporto di Fiumicino, 320 Aeroporto ‘Leonardo da Vinci’ 00054 Fiumicino (Roma)</p></td></tr><tr><td><p> </p></td><td><p>No new appointment</p></td><td><p>Ms Isabelle BAUMELLE, Chief Operating Officer & Airline Marketing Director Société Aéroports de la Côte d’Azur BP 3331 06206 Nice Cedex 3 France</p></td></tr></tbody></table>
Military:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Voting members</p></td><td><p>Alternates</p></td></tr><tr><td><p>Military Air Navigation Service Providers</p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr><tr><td><p>Military airspace users</p></td><td><p>No new appointment</p></td><td><p>Col. YANN Pichavant,</p><p>ATM Representative EU, NATO, EUROCONTROL</p><p>French MOD</p></td></tr></tbody></table>
Chairperson of the Network Management Board:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Non-voting member</p></td><td><p>Alternate</p></td></tr><tr><td><p> </p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr></tbody></table>
European Commission:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Non-voting member</p></td><td><p>Alternate</p></td></tr><tr><td><p> </p></td><td><p>Ms Christine BERG,</p><p>Head of Unit Single European Sky</p><p>DG MOVE European Commission</p></td><td><p>Mr Staffan EKWALL,</p><p>Policy officer,</p><p>DG MOVE European Commission</p></td></tr></tbody></table>
EFTA Surveillance Authority:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Non-voting member</p></td><td><p>Alternate</p></td></tr><tr><td><p> </p></td><td><p>No new appointment</p></td><td><p>Ms Valgerður Guðmundsdóttir, Deputy Director, Internal Market affairs , EFTA Surveillance Authority</p></td></tr></tbody></table>
Network Manager:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Non-voting member</p></td><td><p>Alternate</p></td></tr><tr><td><p> </p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr></tbody></table>
Chairperson of the working group on operations (NDOP):
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Non-voting member</p></td><td><p>Alternate</p></td></tr><tr><td><p> </p></td><td><p>No new appointment</p></td><td><p>Mr József BAKOS,</p><p>Head of ATS</p><p>HungaroControl</p></td></tr></tbody></table>
Representatives of Air Navigation Service providers of associated countries:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Non-voting members</p></td><td><p>Alternates</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>1 January 2021 - 31 December 2021</p></td><td><p>Mr Sitki Kagan ERTAS,</p><p>Air Navigation Service provider of Turkey (DHMI)</p></td><td><p>Ms Sevda TURHAN,</p><p>Air Navigation Service provider of Turkey (DHMI)</p></td></tr><tr><td><p> </p></td><td><p>Mr Maksim ET’HEMAJ,</p><p>Director of Technical Division</p><p>ALBCONTROL</p></td><td><p>Mr Dritan ISAKU,</p><p>Director of Operational Division</p><p>ALBCONTROL</p></td></tr></tbody></table>
Eurocontrol:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Non-voting member</p></td><td><p>Alternate</p></td></tr><tr><td><p> </p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr></tbody></table>
ANNEX II
APPOINTMENTS OF PERMANENT MEMBERS AND THEIR ALTERNATES OF THE EUROPEAN AVIATION COORDINATION CRISIS CELL
Member States :
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Member</p></td><td><p>Alternate</p></td></tr><tr><td><p> </p></td><td><p>No new appointment</p></td><td><p>no new appointment</p></td></tr></tbody></table>
EFTA States:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Member</p></td><td><p>Alternate</p></td></tr><tr><td><p> </p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr></tbody></table>
European Commission:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Member</p></td><td><p>Alternate</p></td></tr><tr><td><p> </p></td><td><p>Ms Christine BERG,</p><p>Head of Unit Single European Sky</p><p>DG MOVE European Commission</p></td><td><p>Mr Staffan EKWALL,</p><p>Policy officer,</p><p>DG MOVE European Commission</p></td></tr></tbody></table>
Agency:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Member</p></td><td><p>Alternate</p></td></tr><tr><td><p> </p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr></tbody></table>
Eurocontrol:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Member</p></td><td><p>Alternate</p></td></tr><tr><td><p> </p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr></tbody></table>
Network Manager:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Member</p></td><td><p>Alternate</p></td></tr><tr><td><p> </p></td><td><p>No new appointment</p></td><td><p>Mr Steven Moore,</p><p>EACCC Operations Manager</p><p>Directorate Network Manager</p><p>EUROCONTROL</p></td></tr></tbody></table>
Military:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Member</p></td><td><p>Alternate</p></td></tr><tr><td><p> </p></td><td><p>Lieutenant-Colonel Frank Josten,</p><p>German Military Aviation Authority</p></td><td><p>Colonel YANN Pichavant,</p><p>French Military Aviation Authority</p></td></tr></tbody></table>
Air Navigation Service providers:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Member</p></td><td><p>Alternate</p></td></tr><tr><td><p> </p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr></tbody></table>
Aiport operators:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Member</p></td><td><p>Alternate</p></td></tr><tr><td><p> </p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr></tbody></table>
Airspace users:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Member</p></td><td><p>Alternate</p></td></tr><tr><td><p> </p></td><td><p>No new appointment</p></td><td><p>No new appointment</p></td></tr></tbody></table> | ENG | 32020D2201 |
<table><col/><col/><col/><col/><tbody><tr><td><p>20.3.2015   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 76/56</p></td></tr></tbody></table>
DECISION (EU) 2015/470 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 11 March 2015
on the mobilisation of the European Globalisation Adjustment Fund in accordance with point 13 of the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (application EGF/2013/011 BE/Saint-Gobain Sekurit, from Belgium)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1927/2006 of the European Parliament and of the Council of 20 December 2006 establishing the European Globalisation Adjustment Fund ( 1 ) , and in particular Article 12(3) thereof,
Having regard to the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management ( 2 ) , and in particular point 13 thereof,
Having regard to the proposal from the European Commission,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The European Globalisation Adjustment Fund (EGF) was established to provide additional support for workers made redundant as a result of major structural changes in world trade patterns due to globalisation and to assist them with their reintegration into the labour market.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The EGF shall not exceed a maximum annual amount of EUR 150 million (2011 prices), as laid down in Article 12 of Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020<a> (<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Belgium submitted an application to mobilise the EGF, in respect of redundancies in the enterprise Saint-Gobain Sekurit Benelux SA, on 19 December 2013 and supplemented it by additional information up to 4 July 2014. This application complies with the requirements for determining the financial contributions as laid down in Article 10 of Regulation (EC) No 1927/2006. The Commission therefore proposes to mobilise an amount of EUR 1 339 928.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The EGF should therefore be mobilised in order to provide a financial contribution for the application submitted by Belgium,</p></td></tr></tbody></table>
HAVE ADOPTED THIS DECISION:
Article 1
For the general budget of the European Union for the financial year 2015, the European Globalisation Adjustment Fund shall be mobilised to provide the sum of EUR 1 339 928 in commitment and payment appropriations.
Article 2
This Decision shall be published in the Official Journal of the European Union .
Done at Strasbourg, 11 March 2015.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
Z. KALNIŅA-LUKAŠEVICA
<note>
( 1 ) OJ L 406, 30.12.2006, p. 1 .
( 2 ) OJ C 373, 20.12.2013, p. 1 .
( 3 ) OJ L 347, 20.12.2013, p. 884 .
</note> | ENG | 32015D0470 |
<table><col/><col/><col/><col/><tbody><tr><td><p>27.2.2015   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 56/33</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2015/311
of 26 February 2015
establishing the standard import values for determining the entry price of certain fruit and vegetables
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) ,
Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors ( 2 ) , and in particular Article 136(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the<span>Official Journal of the European Union</span>,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 26 February 2015.
For the Commission,
On behalf of the President,
Jerzy PLEWA
Director-General for Agriculture and Rural Development
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) OJ L 157, 15.6.2011, p. 1 .
ANNEX
Standard import values for determining the entry price of certain fruit and vegetables
<table><col/><col/><col/><tbody><tr><td><p>(EUR/100 kg)</p></td></tr><tr><td><p>CN code</p></td><td><p>Third country code<a> (<span>1</span>)</a></p></td><td><p>Standard import value</p></td></tr><tr><td><p>0702 00 00</p></td><td><p>EG</p></td><td><p>169,3</p></td></tr><tr><td><p>IL</p></td><td><p>81,7</p></td></tr><tr><td><p>MA</p></td><td><p>85,9</p></td></tr><tr><td><p>TR</p></td><td><p>92,8</p></td></tr><tr><td><p>ZZ</p></td><td><p>107,4</p></td></tr><tr><td><p>0707 00 05</p></td><td><p>TR</p></td><td><p>191,7</p></td></tr><tr><td><p>ZZ</p></td><td><p>191,7</p></td></tr><tr><td><p>0709 93 10</p></td><td><p>MA</p></td><td><p>98,0</p></td></tr><tr><td><p>TR</p></td><td><p>207,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>152,8</p></td></tr><tr><td><p>0805 10 20</p></td><td><p>EG</p></td><td><p>46,2</p></td></tr><tr><td><p>IL</p></td><td><p>69,5</p></td></tr><tr><td><p>MA</p></td><td><p>49,4</p></td></tr><tr><td><p>TN</p></td><td><p>61,9</p></td></tr><tr><td><p>TR</p></td><td><p>68,7</p></td></tr><tr><td><p>ZZ</p></td><td><p>59,1</p></td></tr><tr><td><p>0805 20 10</p></td><td><p>IL</p></td><td><p>133,4</p></td></tr><tr><td><p>MA</p></td><td><p>101,2</p></td></tr><tr><td><p>ZZ</p></td><td><p>117,3</p></td></tr><tr><td><p>0805 20 30, 0805 20 50, 0805 20 70, 0805 20 90</p></td><td><p>EG</p></td><td><p>97,5</p></td></tr><tr><td><p>IL</p></td><td><p>150,5</p></td></tr><tr><td><p>JM</p></td><td><p>118,2</p></td></tr><tr><td><p>MA</p></td><td><p>118,2</p></td></tr><tr><td><p>TR</p></td><td><p>84,7</p></td></tr><tr><td><p>US</p></td><td><p>131,2</p></td></tr><tr><td><p>ZZ</p></td><td><p>116,7</p></td></tr><tr><td><p>0805 50 10</p></td><td><p>EG</p></td><td><p>41,5</p></td></tr><tr><td><p>TR</p></td><td><p>51,4</p></td></tr><tr><td><p>ZZ</p></td><td><p>46,5</p></td></tr><tr><td><p>0808 10 80</p></td><td><p>BR</p></td><td><p>69,4</p></td></tr><tr><td><p>CL</p></td><td><p>94,9</p></td></tr><tr><td><p>MK</p></td><td><p>27,7</p></td></tr><tr><td><p>US</p></td><td><p>209,4</p></td></tr><tr><td><p>ZZ</p></td><td><p>100,4</p></td></tr><tr><td><p>0808 30 90</p></td><td><p>CL</p></td><td><p>143,4</p></td></tr><tr><td><p>CN</p></td><td><p>99,9</p></td></tr><tr><td><p>US</p></td><td><p>122,7</p></td></tr><tr><td><p>ZA</p></td><td><p>105,5</p></td></tr><tr><td><p>ZZ</p></td><td><p>117,9</p></td></tr></tbody></table>
<note>
( 1 ) Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories ( OJ L 328, 28.11.2012, p. 7 ). Code ‘ZZ’ stands for ‘of other origin’.
</note> | ENG | 32015R0311 |
<table><col/><col/><col/><col/><tbody><tr><td><p>2.8.2022   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 202/27</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2022/1345
of 1 August 2022
laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council with regard to registration and approval of establishments keeping terrestrial animals and collecting, producing, processing or storing germinal products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) ( 1 ) , and in particular Article 86(1) and (2) and Article 96(3) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Regulation (EU) 2016/429 lays down rules for animal diseases that are transmissible to animals or humans, including rules on the registration and approval by the competent authority of establishments keeping terrestrial animals and collecting, producing, processing or storing germinal products.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Commission Delegated Regulation (EU) 2019/2035 <a>(<span>2</span>)</a> supplements Regulation (EU) 2016/429 by laying down detailed rules concerning the registers to be kept by the competent authority of registered and approved establishments keeping terrestrial animals and collecting, producing, processing or storing germinal products registered with it or approved by it.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>More particularly, Article 18, point (d), of Delegated Regulation (EU) 2019/2035 provides that the competent authority is to include in its register of establishments of kept terrestrial animals and of hatcheries registered with it the address and geographical coordinates (latitude and longitude) of the location of the establishment. Furthermore, Article 18, point (h), of Delegated Regulation (EU) 2019/2035 provides that the competent authority is to include in that register information about the period during which animals or hatching eggs are kept on the establishment if it is not continuously occupied, including seasonal occupation or occupation during particular events. While Article 84(1), point (b), of Regulation (EU) 2016/429 provides that operators of establishments keeping terrestrial animals or collecting, producing, processing or storing germinal products are to provide the competent authority with certain information in order for their establishments to be registered, that information does not include all the detailed information required under Article 18, points (d) and (h), of Delegated Regulation (EU) 2019/2035. It is therefore appropriate to lay down a requirement for the operators of establishments of kept terrestrial animals and of hatcheries to provide such detailed information to the competent authority for the purpose of registration.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Similarly, Article 21, points (d) and (h), of Delegated Regulation (EU) 2019/2035 also provide that the competent authority is to include in its register of establishments approved by it the same detailed information required by Article 18, points (d) and (h), of that Delegated Regulation. While Article 96(1) of Regulation (EU) 2016/429 requires operators to provide the competent authority with certain information for the purposes of their application for approval of their establishment, that information does not include all the detailed information required under Article 21, points (d) and (h), of Delegated Regulation (EU) 2019/2035. It is therefore appropriate to lay down a requirement for the operators of establishments of kept terrestrial animals and of hatcheries to provide such detailed information to the competent authority for the purpose of approval.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>In addition, Article 85 of Regulation (EU) 2016/429 provides that Member States may, by way of derogation from Article 84(1) of that Regulation, exempt from the registration requirement certain categories of establishments posing an insignificant risk to animal or public health. Such exemptions may only be granted if those categories of establishments are of a type falling under the rules laid down in an implementing act adopted in accordance with Article 86(2) of that Regulation. Rules concerning the types of establishments posing an insignificant risk that may be exempted by the Member States from the registration requirement in accordance with Article 85 should therefore be laid down.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Certain establishments, in particular those keeping ungulates cannot be considered as posing an insignificant risk, as referred to in Article 85 of Regulation (EU) 2016/429, due to a number of listed diseases that may be transmitted by ungulates and which may affect the animal health status of establishments or zones in that respect. Similarly, dogs, cats and ferrets kept on an establishment for breeding purposes cannot be considered as posing an insignificant risk, especially from a human health perspective.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The movement of animals, germinal products and products of animal origin constitutes an important risk factor for animal and human health. Establishments where movements take place, involving in particular movements to or from other Member States or third countries, should therefore not be considered as posing an insignificant risk. However, establishments where animals, germinal products or products of animal origin are kept with a certain continuity and the primary purpose is not the movement of those animals, germinal products or products of animal origin to or out of the establishment, can be considered as posing an insignificant risk, even if such movements could occur on an occasional basis.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Operators often keep terrestrial animals of several species on the same establishment. If a Member State exempts from the registration requirement certain categories of establishments posing an insignificant risk, as provided for in Article 85 of Regulation (EU) 2016/429, it is not proportionate to the risk involved to require operators to provide the information referred to in Article 84(1), point (b)(iii), regarding kept terrestrial animals for which the establishment could be exempted from the registration requirement in accordance with Article 3 of this Regulation as if those animals were the only animals kept on that establishment.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Subject matter and scope
This Regulation lays down rules concerning:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the information to be provided by operators of establishments of kept terrestrial animals and of hatcheries for the purpose of the registration of their establishments, as provided for in Article 84(1) of Regulation (EU) 2016/429;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the types of establishments keeping terrestrial animals posing an insignificant risk that may be exempted by the Member States from the registration requirement in accordance with Article 85 of Regulation (EU) 2016/429;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the information to be provided by operators of establishments of kept terrestrial animals and of hatcheries in their application for approval of their establishment in accordance with Article 96(1) of Regulation (EU) 2016/429.</p></td></tr></tbody></table>
Article 2
Information to be provided by operators for the purpose of the registration of their establishment
1. Operators of establishments of kept terrestrial animals and of hatcheries referred to in Article 84(1) of Regulation (EU) 2016/429 shall, in addition to the information referred to in Article 84(1), point (b), of that Regulation, before they commence such activities, provide the competent authority with the following information:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the address and geographical coordinates (latitude and longitude) of the location of the establishment to be registered;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the period during which the kept terrestrial animals or hatching eggs are kept on the registered establishment if it is not continuously occupied, including seasonal occupation or occupation during particular events.</p></td></tr></tbody></table>
2. Operators of establishments of kept terrestrial animals referred to in Article 84(1) of Regulation (EU) 2016/429 shall not be obliged to provide the competent authority with the information referred to in Article 84(1), point (b)(iii), of that Regulation, regarding kept terrestrial animals falling within the derogation used by the Member State in accordance with Article 3 of this Regulation.
Article 3
Types of establishments keeping terrestrial animals that may be exempted by the Member States from the registration requirement
1. Member States may exempt from the registration requirement establishments keeping terrestrial animals posing an insignificant risk, as provided for in Article 85 of Regulation (EU) 2016/429, if the following criteria are fulfilled:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>no ungulates are kept on the establishment;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>no dogs, cats or ferrets are kept for breeding on the establishment;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the establishment is not involved in any movement of kept terrestrial animals, germinal products or products of animal origin to or from another Member State or third country;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the kept terrestrial animals, germinal products or products of animal origin on the establishment are not intended to be moved out of the establishment.</p></td></tr></tbody></table>
2. Member States that exempt establishments in accordance with paragraph 1 may lay down additional criteria regarding limitations on the number of kept terrestrial animals that may be kept on such establishments and restrict the geographical location of those establishments, in particular in relation to their proximity to establishments registered or approved by the competent authority.
Article 4
Information to be provided by operators in their application for approval of their establishment
Operators of establishments of kept terrestrial animals and of hatcheries shall, for the purposes of their application for approval of their establishment as provided for in Article 94(1) and Article 95, point (a), of Regulation (EU) 2016/429, in addition to the information referred to in Article 96(1) of that Regulation, provide the competent authority with the following information:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the address and geographical coordinates (latitude and longitude) of the location of the establishment to be approved;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the period during which animals or hatching eggs are kept on the approved establishment if it is not continuously occupied, including seasonal occupation or occupation during particular events.</p></td></tr></tbody></table>
Article 5
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 1 August 2022.
For the Commission
The President
Ursula VON DER LEYEN
<note>
( 1 ) OJ L 84, 31.3.2016, p. 1 .
( 2 ) Commission Delegated Regulation (EU) 2019/2035 of 28 June 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs ( OJ L 314, 5.12.2019, p. 115 ).
</note> | ENG | 32022R1345 |
<table><col/><col/><col/><col/><tbody><tr><td><p>14.3.2022   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 85/1</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2022/413
of 10 March 2022
amending for the 330th time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations ( 1 ) , and in particular Article 7(1)(a) and Article 7a(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>On 7 March 2022, the Sanctions Committee of the United Nations Security Council decided to add an entry to the list of persons, groups and entities to whom the freezing of funds and economic resources should apply.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Annex I to Regulation (EC) No 881/2002 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>In order to ensure that the measures provided for in this Regulation are effective it should enter into force immediately,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Annex I to Regulation (EC) No 881/2002 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 March 2022.
For the Commission
On behalf of the President
Director-General
Directorate-General for Financial Stability, Financial Services and Capital Markets Union
( 1 ) OJ L 139, 29.5.2002, p. 9 .
ANNEX
In Annex I to Regulation (EC) No 881/2002 the following entry is added under the heading ‘Legal persons, groups and entities’:
‘KHATIBA AL-TAWHID WAL-JIHAD (KTJ) (original script: Катиба ат-Таухид валь-Джихад); A.k.a.: a) JANNAT OSHIKLARI; b) Jama`at al-Tawhid wal-Jihad ; F.k.a.: JANNAT OSHIKLARI. Address: na. Other information: Khatiba al-Tawhid wal-Jihad (formerly known as Jannat Oshiklari) is a terrorist organization operating under the umbrella of the international terrorist organization Al-Nusrah Front for the People of the Levant. The group mainly operates in the provinces of Hama, Idlib and Ladhiqiyah, in the Syrian Arab Republic, and also conduct operations in Turkey, Kyrgyzstan, Uzbekistan, Russian Federation, Tajikistan, Kazakhstan, Egypt, Afghanistan, Ukraine. The number of fighters of KTJ is about 500. KTJ also cooperates with such terrorist organizations as Khatiba Imam al-Bukhari and the Islamic Jihad Group. Date of designation referred to in Article 7d(2)(i): 7.03.2022.’ | ENG | 32022R0413 |
<table><col/><col/><col/><col/><tbody><tr><td><p>16.12.2014   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 359/164</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING DECISION
of 12 December 2014
on a Union financial contribution for 2014 to cover expenditure incurred by Germany, Spain, France, Italy, the Netherlands and Austria for the purposes of combating organisms harmful to plants or plant products
(notified under document C(2014) 9478)
(Only the Dutch, French, German, Italian and Spanish texts are authentic)
(2014/910/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 652/2014 of the European Parliament and of the Council of 15 May 2014 laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material ( 1 ) , and in particular Article 45(3) thereof,
Having regard to Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 ( 2 ) , and in particular Article 84(2) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>In accordance with points (a) to (c) of Article 16(1) of Regulation (EU) No 652/2014, Union funding may be awarded to Member States to cover expenditure relating directly, as applicable, to measures adopted pursuant to Article 16(1) or Article 16(3) of Council Directive 2000/29/EC <a>(<span>3</span>)</a> concerning the eradication or containment of pests, or the prevention of their spread. As a transitional rule, Article 45(3) of that Regulation lays down that for applications of Member States for Union funding for the emergency measures referred to above and submitted to the Commission by 30 April 2014, Articles 22 to 24 of Directive 2000/29/EC shall continue to apply.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Germany submitted eight applications for Union funding. The first application was introduced on 12 December 2013 and relates to measures taken in 2012 to control<span>Anoplophora glabripennis</span> in Baden-Württemberg. The outbreak of that harmful organism was detected there in 2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The second application was introduced on 18 December 2013 and relates to measures taken in 2012 and 2013 to control<span>Diabrotica virgifera</span> in Saxony. The outbreak of that harmful organism was detected in 2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The third application was introduced on 19 December 2013 and relates to measures taken in 2012 and 2013 to control<span>Anoplophora glabripennis</span> in Bayern. The outbreak of that harmful organism was detected there in 2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The fourth application was introduced on 3 April 2014 and relates to measures taken in 2013 to control<span>Anoplophora glabripennis</span> in Baden-Württemberg. The outbreak of that harmful organism was detected there in 2012 (the same outbreak as referred to in point 2).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>The fifth application was introduced on 16 April 2014 and relates to measures taken in 2013 to control<span>Diabrotica virgifera</span> in Rhineland-Palatinate. The outbreaks of that harmful organism were detected in 2011 and 2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The sixth application was introduced on 16 April 2014 and relates to measures taken in 2013 to control<span>Diabrotica virgifera</span> in Baden-Württemberg. The outbreaks of that harmful organism were detected in different rural or city districts of that State in 2010, 2011, 2012 and 2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The seventh application was introduced on 28 April 2014 and relates to measures taken from August 2012 until August 2013 to control<span>Anoplophora glabripennis</span> in Nordrhein-Westfalen. The outbreak of that harmful organism was detected there in 2009.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>The eighth application was introduced on 30 April 2014 and relates to measures taken in 2012 and 2013 to control<span>Diabrotica virgifera</span> in Hessen. The outbreak of that harmful organism was detected in 2011.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>Spain submitted five applications for Union funding on 16 April 2014. The first application relates to measures of intensified inspections in the four Autonomous Communities bordering Portugal, taken in 2013 to control<span>Bursaphelenchus xylophilus.</span> Those inspections took place in view of the extended presence of that harmful organism in the neighbouring areas of Portugal, without being the result of a specific outbreak of that harmful organism in the territory of Spain.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>The second application relates to measures taken or planned for 2014 in Galicia to control<span>Bursaphelenchus xylophilus.</span> The outbreak of that harmful organism was detected in 2010 in the area of As Neves.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>The third application relates to measures taken or planned for 2014 in Catalonia to control<span>Pomacea insularum.</span> The outbreak of that harmful organism was detected in 2010.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>The fourth application relates to measures taken or planned for 2014 in Extremadura to control<span>Bursaphelenchus xylophilus.</span> The outbreak of that harmful organism was detected in 2012 in the area of Valverde del Fresno.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>The fifth application relates to measures taken or planned for 2014 in Castilla y León to control<span>Bursaphelenchus xylophilus.</span> The outbreak of that harmful organism was detected in 2013 in the area of Sancti-Spiritus.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>France introduced two applications for Union funding on 30 April 2014. The first application relates to measures taken or planned in 2014 to control<span>Anoplophora glabripennis</span> in Alsace. Measures were taken in France as a consequence of findings in July 2011 of that harmful organism in the bordering area of Germany.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(16)</p></td><td><p>The second application relates to measures taken or planned in 2013 and 2014 to control<span>Anoplophora glabripennis</span> in Corsica. The outbreak of that harmful organism was detected in 2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(17)</p></td><td><p>Italy submitted three applications for Union funding. The first application was introduced on 29 April 2014 and relates to measures taken or planned in 2014 to control<span>Anoplophora glabripennis</span> in Marche. The outbreak of that harmful organism was detected in 2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(18)</p></td><td><p>The second application was introduced on 29 April 2014 and relates to measures taken or planned in 2013 and 2014 to control<span>Xylella fastidiosa</span> in Puglia. The outbreak of that harmful organism was detected in 2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(19)</p></td><td><p>The third one was submitted on 30 April 2014 and relates to measures taken or planned from September 2014 to September 2015 to control citrus tristeza virus in Sicilia, where the appearance of a severe strain was confirmed in 2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(20)</p></td><td><p>The Netherlands submitted three applications for Union funding. The first application was introduced on 31 December 2013 and relates to measures taken in 2012 and 2013 in the area of Westland to control<span>Anthonomus eugenii.</span> The outbreak of that harmful organism was detected in 2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(21)</p></td><td><p>The second and the third applications were submitted on 30 April 2014. The second one relates to measures taken in 2013 and 2014 in the area of Winterswijk to control<span>Anoplophora glabripennis.</span> The outbreak of that harmful organism was detected in 2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(22)</p></td><td><p>The third one relates to measures taken in 2013 and 2014 in the area of South Holland to control potato spindle tuber viroid. The outbreak of that harmful organism was detected in 2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(23)</p></td><td><p>Austria submitted two applications for Union funding on 30 April 2014 relating to measures taken to control<span>Anoplophora glabripennis</span>. The first application relates to measures taken in 2012 and 2013 in the area of Sankt Georgen bei Obernberg am Inn, where the outbreak of that harmful organism was detected in 2012. That application includes updates of an application submitted in May 2013 concerning the measures taken in 2012 and planned, at that time, for 2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(24)</p></td><td><p>The second application relates to measures taken in 2013 and 2014 in the area of Gallspach, where the outbreak of that harmful organism was detected in 2013.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(25)</p></td><td><p>In their applications, Germany, Spain, France, Italy, the Netherlands and Austria have each established a programme of actions to eradicate or, where legally possible, contain the above harmful organisms introduced in their territories. These programmes specify the objectives to be achieved, the measures carried out, their duration and their cost.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(26)</p></td><td><p>All the above measures consist of a variety of plant health measures, including destruction of contaminated trees or crops, application of plant protection products, sanitation techniques, inspections and tests carried out officially or upon official request to monitor the presence or extent of contamination by the respective harmful organisms, and replacement of destroyed plants, within the meaning of Article 23(2)(a), (b) and (c) of Directive 2000/29/EC.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(27)</p></td><td><p>The technical information provided by Germany, Spain, France, Italy, the Netherlands and Austria has enabled the Commission to analyse the situation accurately and comprehensively. The Commission has concluded that the conditions for the granting of a Union funding, as laid down, in particular, in Article 23 of Directive 2000/29/EC, have been met. Accordingly, it is appropriate to provide a Union financial contribution to cover the expenditure on those requests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(28)</p></td><td><p>The measures and expenditure eligible for Union funding have been clarified by letter of the Commission, dated 25 May 2012, to the Chief Plant Health Officers of the Member States.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(29)</p></td><td><p>In accordance with the second subparagraph of Article 23(5) of Directive 2000/29/EC, the Union financial contribution may cover up to 50 % of eligible expenditure for measures that have been taken within a period of not more than two years after the date of detection of the appearance or that are planned for that period. However, in accordance with the third subparagraph of that Article, that period may be extended if it has been established that the objective of the measures will be achieved within a reasonable additional period, in which case the rate of the Union financial contribution shall be degressive over the years concerned.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(30)</p></td><td><p>Having regard to the conclusions of the Plant Health Evaluation Board of the Commission held from 30 June to 4 July 2014 on the evaluation of the respective requests, it is appropriate to extend the two-year period for the applications concerned to another two years, pursuant to point (b) of Article 1(2) of Commission Regulation (EC) No 1040/2002 <a>(<span>4</span>)</a>. However, and, in accordance with the principle of degressivity, it is appropriate to reduce the rate of the Union financial contribution for these measures to 45 % of eligible expenditure for the third year and to 40 % for the fourth year of these requests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(31)</p></td><td><p>The Union funding up to 50 % of eligible expenditure should therefore apply to the following applications: Germany, Baden-Württemberg,<span>Diabrotica virgifera,</span> rural districts of Alb-Donau-Kreis and Karlsruhe (2013), Germany, Baden-Württemberg,<span>Anoplophora glabripennis</span> (2012 and 2013), Germany, Bayern,<span>Anoplophora glabripennis</span> (2012 and 2013), Germany, Hessen,<span>Diabrotica virgifera</span> (2012), Germany, Rheinland-Pfalz,<span>Diabrotica virgifera</span> (2013), Germany, Saxony,<span>Diabrotica virgifera</span> (2012 and 2013), Spain, Castilla y León,<span>Bursaphelenchus xylophilus</span> (2014), France, Corse,<span>Anoplophora glabripennis</span> (2013 and 2014), Italy, Marche,<span>Anoplophora glabripennis</span> (2014), Italy, Sicilia, Citrus Tristeza Virus (2014 and 2015), Italy, Puglia,<span>Xylella fastidiosa</span> (2013 and 2014), the Netherlands, Winterswijk area,<span>Anoplophora glabripennis</span> (2013), the Netherlands, South Holland, Potato Spindle Tuber Viroid (2013 and 2014), the Netherlands, Westland,<span>Anthonomus eugenii</span> (2012 and 2013), Austria, Sankt Georgen bei Obernberg am Inn,<span>Anoplophora glabripennis</span> (2012 and 2013) and Austria, Gallspach,<span>Anoplophora glabripennis</span> (2013 and 2014).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(32)</p></td><td><p>The Union funding up to 45 % of eligible expenditure should therefore apply to the following requests: Germany, Baden-Württemberg,<span>Diabrotica virgifera,</span> rural districts of Rastatt (2013), Germany, Hessen,<span>Diabrotica virgifera</span> (2013), Spain, Extremadura, Valverde del Fresno,<span>Bursaphelenchus xylophilus</span> (2014), France, Alsace,<span>Anoplophora glabripennis</span> (2014) and the Netherlands, Winterswijk area,<span>Anoplophora glabripennis</span> (2014), as the measures concerned have already been the subject of a Union financial contribution under Commission Implementing Decision 2012/789/EU <a>(<span>5</span>)</a> (Germany, Spain and France) and Commission Implementing Decision 2013/800/EU <a>(<span>6</span>)</a> (Germany, Baden-Württemberg, Spain, France and the Netherlands), for the first two years of their implementation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(33)</p></td><td><p>Moreover, a funding up to 40 % should apply to the fourth year of the following requests: Germany, Baden-Württemberg,<span>Diabrotica virgifera,</span> rural districts of Breisgau-Hochschwarzwald (2013), Germany,<span>Anoplophora glabripennis</span>, Nordrhein-Westfalen (August 2012 to August 2013), Spain, Catalonia,<span>Pomacea insularum</span> (2014) and Spain, Galicia,<span>Bursaphelenchus xylophilus</span> (2014) as, for each of those four dossiers, the measures have been the subject of a Union financial contribution under Commission Implementing Decision 2011/868/EU <a>(<span>7</span>)</a>, Implementing Decision 2012/789/EU and Implementing Decision 2013/800/EU for the first three years of their implementation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(34)</p></td><td><p>Pursuant to subparagraphs 1 and 2 of Article 23(6) of Directive 2000/29/EC, further action may be implemented in the light of the development of the situation in the Union, and allocation of financial contribution from the Union for such further action may be decided. That action must be made subject to certain requirements or additional conditions, if these are necessary for the achievement of the objective in question. Moreover, pursuant to subparagraph 3 of Article 23(6), where such further action is essentially designed to protect Union territories, other than that of the Member State concerned, it may be decided that the Union financial allocation covers more than 50 % of the expenditure.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(35)</p></td><td><p>Spain has carried out intensive inspections for<span>Bursaphelenchus xylophilus</span> at the border area with Portugal, in the Autonomous Communities of Andalusia, Castilla y León, Extremadura and Galicia, and covering areas that are not demarcated for that harmful organism. Those inspections aim at intensive surveillance for early detection and eradication in the particular areas to protect the rest of the Union territory. Spain has already allocated significant resources to control three isolated outbreaks of<span>Bursaphelenchus xylophilus</span> in Castilla y León, Extremadura and Galicia. That action is considered essentially designed to protect the territory of Spain, as well as Union territories other than that of Spain, given the great relevance of<span>Bursaphelenchus xylophilus</span> for coniferous plants and wood, the rapidity with which that harmful organism spreads, and the possible impact of that spread on Union forestry and international wood trade. It is therefore relevant to allocate a higher rate of Union financial contribution to that request, and in particular a rate of 75 %.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(36)</p></td><td><p>In accordance with Article 84 of Regulation (EU, Euratom) No 966/2012, the commitment of expenditure from the Union budget shall be preceded by a financing decision setting out the essential elements of the action involving expenditure and adopted by the institution or the authorities to which powers have been delegated by the institution. Article 94 of Commission Delegated Regulation (EU) No 1268/2012 <a>(<span>8</span>)</a> establishes detailed rules on the financing decision.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(37)</p></td><td><p>The present decision constitutes a financing decision for the expenditure provided in the Union funding applications submitted by Member States.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(38)</p></td><td><p>For the application of this Decision, it is appropriate to define the term ‘substantial change’ within the meaning of Article 94(4) of Delegated Regulation (EU) No 1268/2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(39)</p></td><td><p>The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
Financial contribution
1. On the basis of the applications submitted by the Member States and analysed by the Commission, the allocation of Union funding for 2014 to cover expenditure incurred by Germany, Spain, France, Italy, the Netherlands and Austria relating to necessary measures as specified in Article 23(2)(a), (b) and (c) of Directive 2000/29/EC and taken for the purpose of combating the organisms concerned by the requests listed in Annex I to this Decision, is hereby approved.
On the basis of the application submitted by Spain and analysed by the Commission, the allocation of Union funding for 2014 to cover expenditure incurred by that Member State and relating to further actions, as specified in Article 23(6) of Directive 2000/29/EC, to control Bursaphelenchus xylophilus in the request listed in Annex II to this Decision, is hereby approved.
2. The total amount of the Union funding referred to in paragraph 1 is EUR 5 715 000 . The maximum amounts of the Union funding for each of the requests shall be as indicated in Annex I or II to this Decision, respectively.
3. Those Union fundings shall be financed from the following line of the general budget of the European Union for 2014: budget line 17 04 04.
4. This Decision and its Annexes constitute a financing decision within the meaning of Article 84 of Regulation (EU, Euratom) No 966/2012.
Article 2
Payment of Union contribution
1. The Union funding, as set out in Annexes I and II to this Decision, shall be granted provided that the Member States concerned:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>implement the measures in accordance with the relevant provisions of Union law, including rules on competition and on the award of public contracts;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>submit evidence of the measures in accordance with the provisions laid down in Regulation (EC) No 1040/2002;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>submit a request for payment to the Commission, in accordance with Article 5 of Regulation (EC) No 1040/2002, accompanied by a technical report for the measures implemented.</p></td></tr></tbody></table>
2. No payment of the Union funding may occur if the request of payment mentioned under point (c) of paragraph 1 is submitted later than 31 October 2015.
Article 3
Flexibility clause
Cumulated changes to the allocations to specific actions not exceeding 15 % of the maximum contribution set in Article 1 of this Decision shall not be considered to be substantial within the meaning of Article 94(4) of Delegated Regulation (EU) No 1268/2012, where those changes do not significantly affect the nature of the actions and objective of the programme. The increase of the maximum contribution set in Article 1 of this Decision shall not exceed 15 %.
The authorising officer responsible may adopt the changes referred to in the first paragraph in accordance with the principles of sound financial management and proportionality.
Article 4
Addressees
This Decision is addressed to the Federal Republic of Germany, the Kingdom of Spain, the French Republic, the Italian Republic, the Kingdom of the Netherlands and the Republic of Austria.
Done at Brussels, 12 December 2014.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
( 1 ) OJ L 189, 27.6.2014, p. 1 .
( 2 ) OJ L 298, 26.10.2012, p. 1 .
( 3 ) Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community ( OJ L 169, 10.7.2000, p. 1 ).
( 4 ) Commission Regulation (EC) No 1040/2002 of 14 June 2002 establishing detailed rules for the implementation of the provisions relating to the allocation of a financial contribution from the Community for plant-health control and repealing Regulation (EC) No 2051/97 ( OJ L 157, 15.6.2002, p. 38 ).
( 5 ) Commission Implementing Decision 2012/789/EU of 14 December 2012 on a Union financial contribution pursuant to Council Directive 2000/29/EC for 2012 to cover expenditure incurred by Germany, Spain, France, Italy, Cyprus, the Netherlands and Portugal for the purpose of combating organisms harmful to plants or plant products ( OJ L 348, 18.12.2012, p. 22 ).
( 6 ) Commission Implementing Decision 2013/800/EU of 18 December 2013 on a Union financial contribution for 2013 to cover expenditure incurred by Germany, Spain, France, the Netherlands and Portugal for the purposes of combating organisms harmful to plants or plant products ( OJ L 352, 24.12.2013, p. 58 ).
( 7 ) Commission Implementing Decision 2011/868/EU of 19 December 2011 on a Union financial contribution for 2011 to cover expenditure incurred by Germany, Spain, Italy, Cyprus, Malta, the Netherlands and Portugal for the purpose of combating organisms harmful to plants or plant products ( OJ L 341, 22.12.2011, p. 57 ).
( 8 ) Commission Delegated Regulation (EU) No 1268/2012 of 29 October 2012 on the rules of application of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council on the financial rules applicable to the general budget of the Union ( OJ L 362, 31.12.2012, p. 1 ).
ANNEX I
REQUESTS BASED ON ARTICLE 23(5) OF DIRECTIVE 2000/29/EC AND SUBJECT TO UNION FINANCIAL CONTRIBUTION
Section I
Requests whose Union financial contribution corresponds to 50 % of eligible expenditure
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Member State</p></td><td><p>Harmful organisms combated</p></td><td><p>Affected plants</p></td><td><p>Year</p></td><td><p>a</p></td><td><p>Maximum Union contribution (EUR )</p></td></tr><tr><td><p>Germany, Baden-Württemberg, rural districts of Alb —Donau — Kreis, and Karlsruhe</p></td><td><p><span>Diabrotica virgifera</span></p></td><td><p><span>Zea mays</span></p></td><td><p>2013</p></td><td><p>2</p></td><td><p>12 000</p></td></tr><tr><td><p>Germany, Baden-Württemberg,</p></td><td><p><span>Anoplophora glabripennis</span></p></td><td><p>Various tree species</p></td><td><p>2012 and 2013</p></td><td><p>1 and 2</p></td><td><p>79 000</p></td></tr><tr><td><p>Germany, Bayern</p></td><td><p><span>Anoplophora glabripennis</span></p></td><td><p>Various tree species</p></td><td><p>2012 and 2013</p></td><td><p>1 and 2</p></td><td><p>388 000</p></td></tr><tr><td><p>Germany, Hessen</p></td><td><p><span>Diabrotica virgifera</span></p></td><td><p><span>Zea mays</span></p></td><td><p>2012</p></td><td><p>2</p></td><td><p>11 500</p></td></tr><tr><td><p>Germany, Rhineland-Palatinate</p></td><td><p><span>Diabrotica virgifera</span></p></td><td><p><span>Zea mays</span></p></td><td><p>2013</p></td><td><p>2</p></td><td><p>31 000</p></td></tr><tr><td><p>Germany, Saxony</p></td><td><p><span>Diabrotica virgifera</span></p></td><td><p><span>Zea mays</span></p></td><td><p>2012 and 2013</p></td><td><p>1 and 2</p></td><td><p>27 000</p></td></tr><tr><td><p>Spain, Castilla y León, Sancti Spiritu</p></td><td><p><span>Bursaphelenchus xylophilus</span></p></td><td><p>Coniferous trees</p></td><td><p>2014</p></td><td><p>1</p></td><td><p>279 000</p></td></tr><tr><td><p>France, Corse</p></td><td><p><span>Anoplophora glabripennis</span></p></td><td><p>Various tree species</p></td><td><p>7.2013-7.2014</p></td><td><p>1</p></td><td><p>109 000</p></td></tr><tr><td><p>Italy, Marche</p></td><td><p><span>Anoplophora glabripennis</span></p></td><td><p>Various tree species</p></td><td><p>2014</p></td><td><p>1</p></td><td><p>178 000</p></td></tr><tr><td><p>Italy, Sicilia</p></td><td><p><span>Citrus tristeza virus</span></p></td><td><p>Citrus trees</p></td><td><p>9.2014-9.2015</p></td><td><p>1</p></td><td><p>891 000</p></td></tr><tr><td><p>Italy, Puglia</p></td><td><p><span>Xylella fastidiosa</span></p></td><td><p>Olive trees and other hosts</p></td><td><p>2013 and 2014</p></td><td><p>1 and 2</p></td><td><p>751 000</p></td></tr><tr><td><p>The Netherlands, Winterswijk municipality</p></td><td><p><span>Anoplophora glabripennis</span></p></td><td><p>Acer pseudoplatanus</p></td><td><p>2013</p></td><td><p>2</p></td><td><p>23 000</p></td></tr><tr><td><p>The Netherlands, South Holland</p></td><td><p><span>Potato Spindle Tuber Viroid</span></p></td><td><p><span>Dahlia</span> sp.</p></td><td><p>2013 and 2014</p></td><td><p>1 and 2</p></td><td><p>72 000</p></td></tr><tr><td><p>The Netherlands, Westland</p></td><td><p><span>Anthonomus eugenii</span></p></td><td><p><span>Capsicum annuum</span></p></td><td><p>2012 and 2013</p></td><td><p>1 and 2</p></td><td><p>280 000</p></td></tr><tr><td><p>Austria, Sankt Georgen bei Obernberg am Inn</p></td><td><p><span>Anoplophora glabripennis</span></p></td><td><p>Various tree species</p></td><td><p>2012 and 2013</p></td><td><p>1 and 2</p></td><td><p>80 000</p></td></tr><tr><td><p>Austria, Gallspach</p></td><td><p><span>Anoplophora glabripennis</span></p></td><td><p>Various tree species</p></td><td><p>2013 and 2014</p></td><td><p>1 and 2</p></td><td><p>60 000</p></td></tr><tr><td><p>Legend: a = year of implementation of the measures in the request</p></td></tr></tbody></table>
Section II
Requests whose Union financial contribution rates differ, in application of the principle of degressivity
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Member State</p></td><td><p>Harmful organisms combated</p></td><td><p>Affected plants</p></td><td><p>Year</p></td><td><p>a</p></td><td><p>Rate of cofinancing (%)</p></td><td><p>Maximum Union contribution (EUR )</p></td></tr><tr><td><p>Germany, Baden-Württemberg, rural district of Rastatt</p></td><td><p><span>Diabrotica virgifera</span></p></td><td><p><span>Zea mays</span></p></td><td><p>2013</p></td><td><p>3</p></td><td><p>45</p></td><td><p>5 000</p></td></tr><tr><td><p>Germany, Baden-Württemberg, rural district of Breisgau-Hochschwarzwald</p></td><td><p><span>Diabrotica virgifera</span></p></td><td><p><span>Zea mays</span></p></td><td><p>2013</p></td><td><p>4</p></td><td><p>40</p></td><td><p>33 000</p></td></tr><tr><td><p>Germany, Hessen</p></td><td><p><span>Diabrotica virgifera</span></p></td><td><p><span>Zea mays</span></p></td><td><p>2013</p></td><td><p>3</p></td><td><p>45</p></td><td><p>10 000</p></td></tr><tr><td><p>Germany, Nordrhein-Westfalen</p></td><td><p><span>Anoplophora glabripennis</span></p></td><td><p>Various tree species</p></td><td><p>8.2012-8.2013</p></td><td><p>4</p></td><td><p>40</p></td><td><p>108 000</p></td></tr><tr><td><p>Spain, Catalonia</p></td><td><p><span>Pomacea insularum</span></p></td><td><p><span>Oryza sativa</span></p></td><td><p>2014</p></td><td><p>4</p></td><td><p>40</p></td><td><p>235 000</p></td></tr><tr><td><p>Spain, Galicia, As Neves</p></td><td><p><span>Bursaphelenchus xylophilus</span></p></td><td><p>Coniferous trees</p></td><td><p>2014</p></td><td><p>4</p></td><td><p>40</p></td><td><p>1 186 000</p></td></tr><tr><td><p>Spain, Extremadura, Valverde del Fresno</p></td><td><p><span>Bursaphelenchus xylophilus</span></p></td><td><p>Coniferous trees</p></td><td><p>2014</p></td><td><p>3</p></td><td><p>45</p></td><td><p>397 000</p></td></tr><tr><td><p>France, Alsace</p></td><td><p><span>Anoplophora glabripennis</span></p></td><td><p>Various tree species</p></td><td><p>2014</p></td><td><p>3</p></td><td><p>45</p></td><td><p>75 000</p></td></tr><tr><td><p>The Netherlands, Winterswijk</p></td><td><p><span>Anoplophora glabripennis</span></p></td><td><p><span>Acer pseudoplatanus</span></p></td><td><p>2014</p></td><td><p>3</p></td><td><p>45</p></td><td><p>22 500</p></td></tr><tr><td><p>Legend: a = year of implementation of the measures in the request</p></td></tr></tbody></table>
ANNEX II
REQUESTS BASED ON ARTICLE 23(6) OF DIRECTIVE 2000/29/EC AND SUBJECT TO UNION FINANCIAL CONTRIBUTION
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Member State</p></td><td><p>Harmful organisms combated</p></td><td><p>Affected plants or plant products</p></td><td><p>Year</p></td><td><p>a</p></td><td><p>Rate of cofinancing (%)</p></td><td><p>Maximum Union contribution (EUR )</p></td></tr><tr><td><p>Spain, intensive inspection programme at the border with Portugal</p></td><td><p><span>Bursaphelenchus xylophilus</span></p></td><td><p>Coniferous trees</p></td><td><p>2013</p></td><td><p>2</p></td><td><p>75</p></td><td><p>372 000</p></td></tr><tr><td><p>Legend: a = year of implementation of the measures in the request.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p><span>Total Union contribution (EUR )</span></p></td><td><p><span>5 715 000</span></p></td></tr></tbody></table> | ENG | 32014D0910 |
<table><col/><col/><col/><col/><tbody><tr><td><p>13.9.2016   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>C 336/1</p></td></tr></tbody></table>
COUNCIL DECISION
of 12 September 2016
adopting the Council's position on the draft general budget of the European Union for the financial year 2017
(2016/C 336/01)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 314(3) thereof, in conjunction with the Treaty establishing the European Atomic Energy Community and in particular Article 106a thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>On 18 July 2016, the Commission submitted a proposal containing the draft general budget of the European Union for the financial year 2017<a> (<span>1</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The Council examined the Commission proposal with a view to defining a position consistent, on the revenue side, with Council Decision 2007/436/EC, Euratom of 7 June 2007 on the system of the European Communities' own resources<a> (<span>2</span>)</a>, and, on the expenditure side, with Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020<a> (<span>3</span>)</a>,</p></td></tr></tbody></table>
HAS DECIDED AS FOLLOWS:
Sole Article
The Council's position on the draft general budget of the European Union for the financial year 2017 was adopted by the Council on 12 September 2016.
The full text can be accessed for consultation or downloading on the Council's website: http://www.consilium.europa.eu/
Done at Brussels, 12 September 2016.
For the Council
The President
M. LAJČÁK
<note>
( 1 ) COM(2016) 300 final.
( 2 ) OJ L 163, 23.6.2007, p. 17 .
( 3 ) OJ L 347, 20.12.2013, p. 884 .
</note> | ENG | 32016D0913(01) |
02017D1212 — EN — 11.02.2019 — 001.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
<table><col/><col/><tr><td><p><a>►B</a></p></td><td><p>COMMISSION IMPLEMENTING DECISION (EU) 2017/1212</p><p>of 4 July 2017</p><p>authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize DAS-40278-9, pursuant to Regulation (EC) No 1829/2003 of the European parliament and of the Council on genetically modified food and feed</p><p><span><span>(notified under document C(2017) 4503)</span></span></p><p>(Only the English text is authentic)</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 173 6.7.2017, p. 43)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p> </p></td><td><p> </p></td><td><p>Official Journal</p></td></tr><tr><td><p>  No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>►M1</a></p></td><td><p><a>COMMISSION IMPLEMENTING DECISION (EU) 2019/239 Text with EEA relevance of 6 February 2019</a></p></td><td><p>  L 39</p></td><td><p>7</p></td><td><p>11.2.2019</p></td></tr></table>
COMMISSION IMPLEMENTING DECISION (EU) 2017/1212
of 4 July 2017
authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize DAS-40278-9, pursuant to Regulation (EC) No 1829/2003 of the European parliament and of the Council on genetically modified food and feed
(notified under document C(2017) 4503)
(Only the English text is authentic)
(Text with EEA relevance)
Article 1
Genetically modified organism and unique identifier
Genetically modified maize ( Zea mays L.) DAS-40278-9, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier DAS-4Ø278-9, in accordance with Regulation (EC) No 65/2004.
Article 2
Authorisation
The following products are authorised for the purposes of Article 4(2) and Article 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:
(a) foods and food ingredients containing, consisting of, or produced from the GMO referred to in Article 1;
(b) feed containing, consisting of, or produced from GMO referred to in Article 1;
(c) The GMO referred to in Article 1 in products containing it or consisting of it for any other use than those provided in points (a) and (b), with the exception of cultivation.
Article 3
Labelling
1. For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘maize’.
2. The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of the GMO referred to in Article 1, with the exception of products referred to in point (a) of Article 2.
Article 4
Monitoring for environmental effects
1. The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (g) of the Annex, is put in place and implemented.
2. The authorisation holder shall submit annual reports on the implementation and the results of the activities set out in the monitoring plan to the Commission in accordance with Decision 2009/770/EC.
Article 5
Community register
The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.
Article 6
Authorisation holder
The authorisation holder shall be Dow AgroSciences Distribution S.A.S., France.
Article 7
Validity
This Decision shall apply for a period of 10 years from the date of its notification.
Article 8
Addressee
This Decision is addressed to Dow AgroSciences Distribution S.A.S., 6, rue Jean Pierre Timbaud, 78180 Montigny-le-Bretonneux, France.
ANNEX
(a) Authorisation holder:
<table><col/><col/><col/><tr><td><p>Name</p></td><td><p>:</p></td><td><p>Dow AgroSciences Distribution S.A.S.</p></td></tr></table>
<table><col/><col/><col/><tr><td><p>Address</p></td><td><p>:</p></td><td><p>6, rue Jean Pierre Timbaud, 78180 Montigny-le-Bretonneux, France.</p></td></tr></table>
(b) Designation and specification of the products:
(1) foods and food ingredients containing, consisting of, or produced from maize DAS-40278-9;
(2) feed containing, consisting of, or produced from maize DAS-40278-9;
(3) Maize DAS-40278-9 in products containing it or consisting of it for any other use than those provided in points (1) and (2), with the exception of cultivation.
DAS4Ø278-9 maize expresses the AAD-1 protein which confers tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) herbicides.
(c) Labelling:
(1) For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘maize’;
(2) The words ‘not for cultivation’ shall appear on the label of and in the accompanying documents of the products containing or consisting of maize DAS-40278-9 with the exception of products referred to in point (a) of Article 2.
(d) Method for detection:
(1) Event specific real-time quantitative PCR based method for DAS-4Ø278-9 maize; the detection method is validated on the single-trait event using genomic DNA extracted from seeds of DAS-4Ø278-9 maize;
(2) Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx;
(3) Reference Material: ERM®-BF433 accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/.
(e) Unique identifier:
DAS-4Ø278-9;
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:
[Biosafety Clearing-House, Record ID number: published in the Community register of genetically modified food and feed when notified ].
(g) Monitoring plan for environmental effects:
Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
[Link: plan published in the Community register of genetically modified food and feed ]
(h) Post market monitoring requirements for the use of the food for human consumption
Not required.
Note: Links to relevant documents may need to be modified over the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed. | ENG | 02017D1212-20190211 |
<table><col/><col/><col/><col/><tbody><tr><td><p>9.2.2022   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 28/5</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2022/168
of 8 February 2022
authorising the placing on the market of pasteurised Akkermansia muciniphila as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 ( 1 ) , and in particular Article 12 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 <a>(<span>2</span>)</a> establishing a Union list of authorised novel foods was adopted.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>On 24 October 2019, the company A-Mansia Biotech S.A. (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place pasteurised<span>Akkermansia muciniphila</span> on the Union market as a novel food. The applicant requested for pasteurised<span>Akkermansia muciniphila</span> bacteria to be used as a novel food at levels not exceeding 5 × 10<span>10</span> cells per day in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council <a>(<span>3</span>)</a> and in foods for special medical purposes as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council <a>(<span>4</span>)</a>, intended for the adult population, excluding pregnant and lactating women.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>On 24 October 2019, the applicant also made a request to the Commission for the protection of proprietary data for a number of studies submitted in support of the application, namely, a bacterial reverse mutation test <a>(<span>5</span>)</a>, an<span>in vitro</span> mammalian cell micronucleus test <a>(<span>6</span>)</a>, a 14-day dose ranging oral toxicity study in rats <a>(<span>7</span>)</a>, a 90-day oral toxicity study in rats <a>(<span>8</span>)</a>, the published toxicity data <a>(<span>9</span>)</a>, a flow cytometry validation study <a>(<span>10</span>)</a>, and an antimicrobial resistance study <a>(<span>11</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>On 19 May 2020, the Commission requested, in accordance with Article 10(3) of Regulation (EU) 2015/2283, the European Food Safety Authority (‘the Authority’) to carry out an assessment of pasteurised<span>Akkermansia muciniphila</span> as a novel food.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>On 7 July 2021, the Authority adopted its scientific opinion on the safety of pasteurised<span>Akkermansia muciniphila</span> as a novel food pursuant to Regulation (EU) 2015/2283 <a>(<span>12</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>In its scientific opinion, the Authority concluded that pasteurised<span>Akkermansia muciniphila</span> is safe under the proposed conditions of use for the proposed target populations at levels not exceeding 3,4 × 10<span>10</span> cells/day. Therefore, that scientific opinion gives sufficient grounds to establish that pasteurised<span>Akkermansia muciniphila</span>, when used at levels not exceeding 3,4 × 10<span>10</span> cells/day in food supplements and in foods for special medical purposes intended for the adult population, excluding pregnant and lactating women, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>In its scientific opinion, the Authority noted that its conclusion on the safety of the novel food was based on the data from the bacterial reverse mutation test, the<span>in vitro</span> mammalian cell micronucleus test, the 14-day dose ranging oral toxicity study in rats, the 90-day oral toxicity study in rats, the method validation study for the formulation analysis for the 90-day oral toxicity study in rats, and the antimicrobial resistance study.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those data and to clarify their claim to an exclusive right of reference to them in accordance with Article 26(2)(b) of Regulation (EU) 2015/2283.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>The applicant declared that they held proprietary and exclusive rights of reference to the data from the bacterial reverse mutation test, the<span>in vitro</span> mammalian cell micronucleus test, the 14-day dose ranging oral toxicity study in rats, the 90-day oral toxicity study in rats, the published toxicity data, the flow cytometry validation study, and the antimicrobial resistance study at the time they submitted the application and therefore third parties could not lawfully have access to or use those studies.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the data from the bacterial reverse mutation test, the<span>in vitro</span> mammalian cell micronucleus test, the 14-day dose ranging oral toxicity study in rats, the 90-day oral toxicity study in rats, the published toxicity data, the flow cytometry validation study, and the antimicrobial resistance study contained in the applicant’s file on which the Authority based its conclusion on the safety of the novel food and without which it could have not assessed the novel food, should not be used by the Authority for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation. Accordingly, only the applicant should be authorised to place pasteurised<span>Akkermansia muciniphila</span> on the market within the Union during that period.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>However, restricting the authorisation of pasteurised<span>Akkermansia muciniphila</span> and the reference to the data contained in the applicant’s file for the sole use by the applicant does not prevent other applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such authorisation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>The Annex to Regulation (EU) 2017/2470 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
1. Pasteurised Akkermansia muciniphila as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
2. For a period of five years from the date of entry into force of this Regulation only the initial applicant:
<table><col/><col/><tbody><tr><td><p> </p></td><td><p>company: A-Mansia Biotech S.A.;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p> </p></td><td><p>address: rue Granbonpré, 11 Bâtiment H 1435 Mont-Saint-Guibert, Belgium,</p></td></tr></tbody></table>
is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for that novel food without reference to the data protected pursuant to Article 2 or with the agreement of A-Mansia Biotech S.A.
3. The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex.
Article 2
The scientific data contained in the application file on the basis of which the novel food referred to in Article 1 have been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of A-Mansia Biotech S.A.
Article 3
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 4
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 February 2022.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 327, 11.12.2015, p. 1 .
( 2 ) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods ( OJ L 351, 30.12.2017, p. 72 ).
( 3 ) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements ( OJ L 183, 12.7.2002, p. 51 ).
( 4 ) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 ( OJ L 181, 29.6.2013, p. 35 ).
( 5 ) Brient, 2019a (unpublished).
( 6 ) Brient, 2019b (unpublished).
( 7 ) Bracken, 2019a (unpublished).
( 8 ) Bracken, 2019b (unpublished).
( 9 ) Druart C., Plovier H., Van Hul M., Brient A., Phipps K.R., de Vos W.M., and Cani P.D., 2020. Toxicological Safety evaluation of pasteurized Akkermansia muciniphila . Journal of Applied Toxicology, 41:276-290.
( 10 ) Jensen, 2019 (unpublished).
( 11 ) Gueimonde, 2019 (unpublished).
( 12 ) Safety of pasteurised Akkermansia muciniphila as a novel food pursuant to Article 10 of Regulation (EU) 2015/2283; EFSA Journal 2021:19(9):6780.
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Table 1 (Authorised novel foods), the following entry is inserted:</p><table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Authorised novel food</p></td><td><p>Conditions under which the novel food may be used</p></td><td><p>Additional specific labelling requirements</p></td><td><p>Other requirements</p></td><td><p>Data Protection</p></td></tr><tr><td><p> </p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td></tr><tr><td><p>‘<span><span>Akkermansia muciniphila</span> (pasteurised)</span></p></td><td><p>Foods for special medical purposes as defined under Regulation (EU) No 609/2013 for the adult population, excluding pregnant and lactating women</p></td><td><p>3,4 × 10<span>10</span> cells/day</p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘pasteurised<span>Akkermansia muciniphila</span>’.</p></td><td><p> </p></td><td><p>Authorised on 1 March 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.</p><p>Applicant: A-Mansia Biotech S.A., rue Granbonpré, 11, Bâtiment H, 1435 Mont-Saint-Guibert. Belgium. During the period of data protection, the novel food pasteurised<span>Akkermansia muciniphila</span> is authorised for placing on the market within the Union only by A-Mansia Biotech S.A., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Mansia Biotech S.A..</p><p>End date of the data protection: 1 March 2027.’</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC for the adult population, excluding pregnant and lactating women</p></td><td><p>3,4 × 10<span>10</span> cells/day</p></td><td><p>The labelling of food supplements containing pasteurised<span>Akkermansia muciniphila</span> shall bear a statement that they should be consumed by adults only, excluding pregnant and lactating women.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in Table 2 (Specifications), the following entry is inserted:</p><table><col/><col/><tbody><tr><td><p>Authorised novel food</p></td><td><p>Specification</p></td></tr><tr><td><p>‘<span><span>Akkermansia muciniphila</span> (pasteurised)</span></p></td><td><p><span>Description:</span></p><p>Pasteurised<span>Akkermansia muciniphila</span> (strain ATCC BAA-835, CIP 107961) is produced by anaerobic growth of the bacteria followed by pasteurisation, concentration of the cells, cryopreservation, and freeze drying.</p><p><span>Characteristics/Composition:</span></p><p>Total<span>A. muciniphila</span> cell count (cells/g): 2,5 × 10<span>10</span> to 2,5 × 10<span>12</span></p><p>Viable<span>A. muciniphila</span> cell count (CFU/g): < 10 (LoD)(*)</p><p>Water activity: ≤ 0,43</p><p>Moisture (%): ≤ 12,0</p><p>Protein (%): ≤ 35,0</p><p>Fat (%): ≤ 4,0</p><p>Crude ash (%): ≤ 21,0</p><p>Carbohydrates (%): 36,0 – 86,0</p><p><span>Microbiological criteria:</span></p><p>Aerobic mesophilic total count: ≤ 500 CFU(**)/g</p><p>Sulphite reducing anaerobes: ≤ 50 CFU/g</p><p>Coagulase<span>+</span> Staphylococci: ≤ 10 CFU/g</p><p>Enterobacteriaceae: ≤ 10 CFU/g</p><p>Yeast: ≤ 10 CFU/g</p><p>Mould: ≤ 10 CFU/g</p><p><span>Bacillus cereus</span>: ≤ 100 CFU/g</p><p><span>Listeria</span> spp.: Absence in 25 g</p><p><span>Salmonella</span> spp.: Absence in 25 g</p><p><span>Escherichia coli</span>: Absence in 1 g</p><table><col/><col/><tbody><tr><td><p>(*)</p></td><td><p>LoD: Limit of Detection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(**)</p></td><td><p>Colony Forming Units.’</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table> | ENG | 32022R0168 |
<table><col/><col/><col/><col/><tbody><tr><td><p>12.7.2016   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>C 252/9</p></td></tr></tbody></table>
COMMISSION DECISION
of 6 July 2016
regarding the open source licensing of DG Maritime Affairs and Fisheries Integrated Fisheries Data Management software
(2016/C 252/03)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on European Union, the Treaty Establishing the European Atomic Energy Community and to the Treaty on the Functioning of the European Union,
Having regard to the Decision of the Commission of 19 September 2001 (PV1536) conferring to the Directors-General and Heads of Services the power to decide on the need to file an application for protection of intellectual property rights resulting from the activities or programmes for which they are responsible, the granting of licences related thereto, the acquisition, transfer or surrender or abandoning of rights, and to the Directors-General the power of administrative execution related thereto,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The Directorate-General for Maritime Affairs and Fisheries (DG Maritime Affairs and Fisheries) has developed several information systems belonging to the Integrated Fisheries Data Management (IFDM) software suite for electronic exchanges of fishing activities data based on the United Nations Centre for Trade Facilitation and Electronic Business (UN/CEFACT) FLUX standard.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The current IFDM suite (hereinafter referred to as the software) contains the following information systems: FLUX Transportation Layer for the exchange of electronic messages according to the UN/CEFACT standard, the Union Vessel Monitoring System (VMS) tool for the monitoring of vessel positions and for which DG Maritime Affairs and Fisheries has developed three modules (Spatial, reporting and USM) as well as the VMS ERS Viewer which extends Union VMS with functionality for the visualisation of electronic fishing logbooks in the UN/CEFACT format.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The open source licensing of the software could benefit the worldwide harmonisation of fisheries data exchanges and allow cost savings. Therefore, the distribution of the software tools should be made available to Member States, third countries, Regional Fisheries Monitoring Organisations as well as the Food and Agriculture Organisation of the United Nations.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>DG Maritime Affairs and Fisheries, as DG responsible for the development and maintenance of the software and — at the same time — entrusted service for the administrative execution of decisions in the field of Intellectual Property, considers the open source licensing of the software appropriate and opportune.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>In order to distribute and to promote the use of the software and to avoid its exclusive appropriation, the software will be released under an open source license,</p></td></tr></tbody></table>
HAS DECIDED AS FOLLOWS:
Article 1
Non-exclusive open source licence terms may be applied for the distribution of the software with a view to enable its use, reproduction, development, and further distribution.
Article 2
This Decision will apply to any future releases or new versions of this software.
Done at Brussels, 6 July 2016.
For the Commission
João AGUIAR MACHADO
Director-General | ENG | 32016D0712(01) |
<table><col/><col/><col/><col/><tbody><tr><td><p>2.4.2015   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>C 112/4</p></td></tr></tbody></table>
COMMISSION DECISION
of 27 March 2015
amending the Annex to the Monetary Agreement between the European Union and the Republic of San Marino
(2015/C 112/06)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to the Monetary Agreement of 27 March 2012 between the European Union and the Republic of San Marino, and in particular Article 8(5) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Article 8 of the Monetary Agreement between the European Union and the Republic of San Marino (hereinafter ‘the Monetary Agreement’) requires the Republic of San Marino to implement Union acts concerning the rules on euro banknotes and coins, banking and financial law, prevention of money laundering, prevention of fraud and counterfeiting of cash and non-cash means of payment, medals and tokens and statistical reporting requirements. Those acts are listed in the Annex to the Monetary Agreement.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The Annex needs to be amended by the Commission every year to take into account the new relevant legal acts and rules of the Union and the amendments to the existing ones.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Some legal acts and rules of the Union are not relevant anymore and should therefore be deleted from the Annex, while some new relevant legal acts and rules of the Union and some amendments to existing legal acts were adopted and have to be added to the Annex.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The Annex to the Monetary Agreement should therefore be amended accordingly,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
The Annex to the Monetary Agreement between the European Union and the Republic of San Marino is replaced by the Annex to this Decision.
Article 2
This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union .
Done at Brussels, 27 March 2015.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Legal provisions to be implemented</p></td><td><p>Deadline for implementing</p></td></tr><tr><td><p><span>Prevention of money laundering</span></p></td></tr><tr><td><p>1</p></td><td><p>Council Decision 2000/642/JHA of 17 October 2000 concerning arrangements for cooperation between financial intelligence units of the Member States in respect of exchanging information (<a>OJ L 271, 24.10.2000, p. 4</a>)</p></td><td><p>1 Sept 2013</p></td></tr><tr><td><p>2</p></td><td><p>Council Framework Decision 2005/212/JHA of 24 February 2005 on Confiscation of Crime-Related Proceeds, Instrumentalities and Property (<a>OJ L 68, 15.3.2005, p. 49</a>)</p></td><td><p>1 Oct 2014<a> (<span>1</span>)</a></p></td></tr><tr><td><p>3</p></td><td><p>Directive 2005/60/EC of the European Parliament and of the Council of 26 October 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing (<a>OJ L 309, 25.11.2005, p. 15</a>)</p></td><td><p>1 Sept 2013</p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>4</p></td><td><p>Directive 2007/64/EC of the European Parliament and of the Council of 13 November 2007 on payment services in the internal market amending Directives 97/7/EC, 2002/65/EC, 2005/60/EC and 2006/48/EC and repealing Directive 97/5/EC (<a>OJ L 319, 5.12.2007, p. 1</a>)</p></td><td><p> </p></td></tr><tr><td><p>5</p></td><td><p>Directive 2008/20/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2005/60/EC on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing, as regards the implementing powers conferred on the Commission (<a>OJ L 76, 19.3.2008, p. 46</a>)</p></td><td><p> </p></td></tr><tr><td><p>6</p></td><td><p>Directive 2009/110/EC of the European Parliament and of the Council of 16 September 2009 on the taking up, pursuit and prudential supervision of the business of electronic money institutions amending Directives 2005/60/EC and 2006/48/EC and repealing Directive 2000/46/EC (<a>OJ L 267, 10.10.2009, p. 7</a>)</p></td><td><p> </p></td></tr><tr><td><p>7</p></td><td><p>Directive 2010/78/EU of the European Parliament and of the Council of 24 November 2010 amending Directives 98/26/EC, 2002/87/EC, 2003/6/EC, 2003/41/EC, 2003/71/EC, 2004/39/EC, 2004/109/EC, 2005/60/EC, 2006/48/EC, 2006/49/EC and 2009/65/EC in respect of the powers of the European Supervisory Authority (European Banking Authority), the European Supervisory Authority (European Insurance and Occupational Pensions Authority) and the European Supervisory Authority (European Securities and Markets Authority) (<a>OJ L 331, 15.12.2010, p. 120</a>)</p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p><span>Supplemented by:</span></p></td><td><p> </p></td></tr><tr><td><p>8</p></td><td><p>Council Framework Decision 2001/500/JHA of 26 June 2001 on money laundering, the identification, tracing, freezing, seizing and confiscation of instrumentalities and the proceeds of crime (<a>OJ L 182, 5.7.2001, p. 1</a>)</p></td><td><p> </p></td></tr><tr><td><p>9</p></td><td><p>Regulation (EC) No 1889/2005 of the European Parliament and of the Council of 26 October 2005 on controls of cash entering or leaving the Community (<a>OJ L 309, 25.11.2005, p. 9</a>)</p></td><td><p> </p></td></tr><tr><td><p>10</p></td><td><p>Commission Directive 2006/70/EC of 1 August 2006 laying down implementing measures for Directive 2005/60/EC of the European Parliament and of the Council as regards the definition of politically exposed person and the technical criteria for simplified customer due diligence procedures and for exemption on grounds of a financial activity conducted on an occasional or very limited basis (<a>OJ L 214, 4.8.2006, p. 29</a>)</p></td><td><p> </p></td></tr><tr><td><p>11</p></td><td><p>Regulation (EC) No 1781/2006 of the European Parliament and of the Council of 15 November 2006 on information on the payer accompanying transfers of funds (<a>OJ L 345, 8.12.2006, p. 1</a>)</p></td><td><p> </p></td></tr><tr><td><p>12</p></td><td><p>Council Decision 2007/845/JHA of 6 December 2007 concerning cooperation between Asset Recovery Offices of the Member States in the field of tracing and identification of proceeds from, or other property related to, crime (<a>OJ L 332, 18.12.2007, p. 103</a>)</p></td><td><p> </p></td></tr><tr><td><p>13</p></td><td><p>Directive 2014/42/EU of the European Parliament and of the Council of 3 April 2014 on the freezing and confiscation of instrumentalities and proceeds of crime in the European Union (<a>OJ L 127, 29.4.2014, p. 39</a>)</p></td><td><p>1 Nov 2015<a> (<span>2</span>)</a></p></td></tr><tr><td><p><span>Prevention of fraud and counterfeiting</span></p></td></tr><tr><td><p>14</p></td><td><p>Council Framework Decision 2001/413/JHA of 28 May 2001 combating fraud and counterfeiting of non-cash means of payment (<a>OJ L 149, 2.6.2001, p. 1</a>)</p></td><td><p>1 Sept 2013</p></td></tr><tr><td><p>15</p></td><td><p>Council Regulation (EC) No 1338/2001 of 28 June 2001 laying down measures necessary for the protection of the euro against counterfeiting (<a>OJ L 181, 4.7.2001, p. 6</a>)</p></td><td><p>1 Sept 2013</p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>16</p></td><td><p>Council Regulation (EC) No 44/2009 of 18 December 2008 amending Regulation (EC) No 1338/2001 laying down measures necessary for the protection of the euro against counterfeiting (<a>OJ L 17, 22.1.2009, p. 1</a>)</p></td><td><p> </p></td></tr><tr><td><p>17</p></td><td><p>Council Decision 2001/887/JHA of 6 December 2001 on the protection of the euro against counterfeiting (<a>OJ L 329, 14.12.2001, p. 1</a>)</p></td><td><p>1 Sept 2013</p></td></tr><tr><td><p>18</p></td><td><p>Council Decision 2003/861/EC of 8 December 2003 concerning analysis and cooperation with regard to counterfeit euro coins (<a>OJ L 325, 12.12.2003, p. 44</a>)</p></td><td><p>1 Sept 2013</p></td></tr><tr><td><p>19</p></td><td><p>Council Regulation (EC) No 2182/2004 of 6 December 2004 concerning medals and tokens similar to euro coins (<a>OJ L 373, 21.12.2004, p. 1</a>)</p></td><td><p>1 Sept 2013</p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>20</p></td><td><p>Council Regulation (EC) No 46/2009 of 18 December 2008 amending Regulation (EC) No 2182/2004 concerning medals and tokens similar to euro coins (<a>OJ L 17, 22.1.2009, p. 5</a>)</p></td><td><p> </p></td></tr><tr><td><p>21</p></td><td><p>Directive 2014/62/EU of the European Parliament and of the Council of 15 May 2014 on the protection of the euro and other currencies against counterfeiting by criminal law, and replacing Council Framework Decision 2000/383/JHA (<a>OJ L 151, 21.5.2014, p. 1</a>)</p></td><td><p>1 July 2016<a> (<span>2</span>)</a></p></td></tr><tr><td><p><span>Rules on euro banknotes and coins</span></p></td></tr><tr><td><p>22</p></td><td><p>Council Regulation (EC) No 2532/98 of 23 November 1998 concerning the powers of the European Central Bank to impose sanctions (<a>OJ L 318, 27.11.1998, p. 4</a>)</p></td><td><p>1 Sept 2013</p></td></tr><tr><td><p>23</p></td><td><p>Council Conclusions of 23 November 1998 and of 5 November 2002 on collector coins</p></td><td><p>1 Sept 2013</p></td></tr><tr><td><p>24</p></td><td><p>Council Conclusions of 10 May 1999 on the quality management system for euro coins</p></td><td><p>1 Sept 2013</p></td></tr><tr><td><p>25</p></td><td><p>Communication from the Commission 2001/C 318/03 of 22 October 2001 on copyright protection of the common face design of the euro coins (C(2001) 600 final) (<a>OJ C 318, 13.11.2001, p. 3</a>)</p></td><td><p>1 Sept 2013</p></td></tr><tr><td><p>26</p></td><td><p>Guideline of the European Central Bank ECB/2003/5 of 20 March 2003 on the enforcement of measures to counter non-compliant reproductions of euro banknotes and on the exchange and withdrawal of euro banknotes (<a>OJ L 78, 25.3.2003, p. 20</a>)</p></td><td><p>1 Sept 2013</p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>27</p></td><td><p>Guideline ECB/2013/11 of the European Central Bank of 19 April 2013 amending Guideline ECB/2003/5 on the enforcement of measures to counter non-compliant reproductions of euro banknotes and on the exchange and withdrawal of euro banknotes (<a>OJ L 118, 30.4.2013, p. 43</a>)</p></td><td><p>1 Oct 2013<a> (<span>1</span>)</a></p></td></tr><tr><td><p>28</p></td><td><p>Commission Recommendation 2009/23/EC of 19 December 2008 on common guidelines for the national sides and the issuance of euro coins intended for circulation (C(2008) 8625) (<a>OJ L 9, 14.1.2009, p. 52</a>)</p></td><td><p>1 Sept 2013</p></td></tr><tr><td><p>29</p></td><td><p>Decision of the European Central Bank ECB/2010/14 of 16 September 2010 on the authenticity and fitness checking and recirculation of euro banknotes (<a>OJ L 267, 9.10.2010, p. 1</a>)</p></td><td><p>1 Sept 2013</p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>30</p></td><td><p>Decision of the European Central Bank ECB/2012/19 of 7 September 2012 amending Decision ECB/2010/14 on the authenticity and fitness checking and recirculation of euro banknotes (2012/507/EU) (<a>OJ L 253, 20.9.2012, p. 19</a>)</p></td><td><p>1 Oct 2013<a> (<span>1</span>)</a></p></td></tr><tr><td><p>31</p></td><td><p>Regulation (EU) No 1210/2010 of the European Parliament and of the Council of 15 December 2010 concerning authentication of euro coins and handling of euro coins unfit for circulation (<a>OJ L 339, 22.12.2010, p. 1</a>)</p></td><td><p>1 Sept 2013</p></td></tr><tr><td><p>32</p></td><td><p>Regulation (EU) No 1214/2011 of the European Parliament and of the Council of 16 November 2011 on the professional transport of euro cash by road between euro-area Member States (<a>OJ L 316, 29.11.2011, p. 1</a>)</p></td><td><p>1 Oct 2014<a> (<span>1</span>)</a></p></td></tr><tr><td><p>33</p></td><td><p>Regulation (EU) No 651/2012 of the European Parliament and of the Council of 4 July 2012 on the issuance of euro coins (<a>OJ L 201, 27.7.2012, p. 135</a>)</p></td><td><p>1 Oct 2013<a> (<span>1</span>)</a></p></td></tr><tr><td><p>34</p></td><td><p>Decision ECB/2013/10 of the European Central Bank of 19 April 2013 on the denominations, specifications, reproduction, exchange and withdrawal of euro banknotes (<a>OJ L 118, 30.4.2013, p. 37</a>)</p></td><td><p>1 Oct 2013<a> (<span>1</span>)</a></p></td></tr><tr><td><p>35</p></td><td><p>Council Regulation (EU) No 729/2014 of 24 June 2014 on denominations and technical specifications of euro coins intended for circulation (<a>OJ L 194, 2.7.2014, p. 1</a>)</p></td><td><p>1 Oct 2013</p></td></tr><tr><td><p><span>Banking and Financial Legislation</span></p></td></tr><tr><td><p>36</p></td><td><p>Council Directive 86/635/EEC of 8 December 1986 on the annual accounts and consolidated accounts of banks and other financial institutions (<a>OJ L 372, 31.12.1986, p. 1</a>)</p></td><td><p>1 Sept 2016</p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>37</p></td><td><p>Directive 2001/65/EC of the European Parliament and of the Council of 27 September 2001 amending Directives 78/660/EEC, 83/349/EEC and 86/635/EEC as regards the valuation rules for the annual and consolidated accounts of certain types of companies as well as of banks and other financial institutions (<a>OJ L 283, 27.10.2001, p. 28</a>)</p></td><td><p> </p></td></tr><tr><td><p>38</p></td><td><p>Directive 2003/51/EC of the European Parliament and of the Council of 18 June 2003 amending Directives 78/660/EEC, 83/349/EEC, 86/635/EEC and 91/674/EEC on the annual and consolidated accounts of certain types of companies, banks and other financial institutions and insurance undertakings (<a>OJ L 178, 17.7.2003, p. 16</a>)</p></td><td><p> </p></td></tr><tr><td><p>39</p></td><td><p>Directive 2006/46/EC of the European Parliament and of the Council of 14 June 2006 amending Council Directives 78/660/EEC on the annual accounts of certain types of companies, 83/349/EEC on consolidated accounts, 86/635/EEC on the annual accounts and consolidated accounts of banks and other financial institutions and 91/674/EEC on the annual accounts and consolidated accounts of insurance undertakings (<a>OJ L 224, 16.8.2006, p. 1</a>)</p></td><td><p> </p></td></tr><tr><td><p>40</p></td><td><p>Council Directive 89/117/EEC of 13 February 1989 on the obligations of branches established in a Member State of credit institutions and financial institutions having their head offices outside that Member State regarding the publication of annual accounting documents (<a>OJ L 44, 16.2.1989, p. 40</a>)</p></td><td><p>1 Sept 2018</p></td></tr><tr><td><p>41</p></td><td><p>Directive 97/9/EC of the European Parliament and of the Council of 3 March 1997 on investment compensation schemes (<a>OJ L 84, 26.3.1997, p. 22</a>)</p></td><td><p>1 Sept 2018</p></td></tr><tr><td><p>42</p></td><td><p>Commission Recommendation 97/489/EC of 30 July 1997 concerning transactions by electronic payment instruments and in particular the relationship between issuer and holder (<a>OJ L 208, 2.8.1997, p. 52</a>)</p></td><td><p>1 Sept 2018</p></td></tr><tr><td><p>43</p></td><td><p>Directive 98/26/EC of the European Parliament and of the Council of 19 May 1998 on settlement finality in payment and securities settlement systems (<a>OJ L 166, 11.6.1998, p. 45</a>)</p></td><td><p>1 Sept 2018</p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>44</p></td><td><p>Directive 2009/44/EC of the European Parliament and of the Council of 6 May 2009 amending Directive 98/26/EC on settlement finality in payment and securities settlement systems and Directive 2002/47/EC on financial collateral arrangements as regards linked systems and credit claims (<a>OJ L 146, 10.6.2009, p. 37</a>)</p></td><td><p> </p></td></tr><tr><td><p>45</p></td><td><p>Directive 2010/78/EU of the European Parliament and of the Council of 24 November 2010 amending Directives 98/26/EC, 2002/87/EC, 2003/6/EC, 2003/41/EC, 2003/71/EC, 2004/39/EC, 2004/109/EC, 2005/60/EC, 2006/48/EC, 2006/49/EC and 2009/65/EC in respect of the powers of the European Supervisory Authority (European Banking Authority), the European Supervisory Authority (European Insurance and Occupational Pensions Authority) and the European Supervisory Authority (European Securities and Markets Authority) (<a>OJ L 331, 15.12.2010, p. 120</a>)</p></td><td><p> </p></td></tr><tr><td><p>46</p></td><td><p>Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (<a>OJ L 201, 27.7.2012, p. 1</a>)</p></td><td><p> </p></td></tr><tr><td><p>47</p></td><td><p>Directive 2001/24/EC of the European Parliament and of the Council of 4 April 2001 on the reorganisation and winding up of credit institutions (<a>OJ L 125, 5.5.2001, p. 15</a>)</p></td><td><p>1 Sept 2018</p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>48</p></td><td><p>Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (<a>OJ L 173, 12.6.2014, p. 190</a>)</p></td><td><p> </p></td></tr><tr><td><p>49</p></td><td><p>Directive 2002/47/EC of the European Parliament and of the Council of 6 June 2002 on financial collateral arrangements (<a>OJ L 168, 27.6.2002, p. 43</a>)</p></td><td><p>1 Sept 2018</p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>50</p></td><td><p>Directive 2009/44/EC of the European Parliament and of the Council of 6 May 2009 amending Directive 98/26/EC on settlement finality in payment and securities settlement systems and Directive 2002/47/EC on financial collateral arrangements as regards linked systems and credit claims (<a>OJ L 146, 10.6.2009, p. 37</a>)</p></td><td><p> </p></td></tr><tr><td><p>51</p></td><td><p>Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (<a>OJ L 173, 12.6.2014, p. 190</a>)</p></td><td><p> </p></td></tr><tr><td><p>52</p></td><td><p>Directive 2002/87/EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate and amending Council Directives 73/239/EEC, 79/267/EEC, 92/49/EEC, 92/96/EEC, 93/6/EEC and 93/22/EEC, and Directives 98/78/EC and 2000/12/EC of the European Parliament and of the Council (<a>OJ L 35, 11.2.2003, p. 1</a>)</p></td><td><p>1 Sept 2018</p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>53</p></td><td><p>Directive 2005/1/EC of the European Parliament and of the Council of 9 March 2005 amending Council Directives 73/239/EEC, 85/611/EEC, 91/675/EEC, 92/49/EEC and 93/6/EEC and Directives 94/19/EC, 98/78/EC, 2000/12/EC, 2001/34/EC, 2002/83/EC and 2002/87/EC in order to establish a new organisational structure for financial services committees (<a>OJ L 79, 24.3.2005, p. 9</a>)</p></td><td><p> </p></td></tr><tr><td><p>54</p></td><td><p>Directive 2008/25/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2002/87/EC on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate, as regards the implementing powers conferred on the Commission (<a>OJ L 81, 20.3.2008, p. 40</a>)</p></td><td><p> </p></td></tr><tr><td><p>55</p></td><td><p>Directive 2010/78/EU of the European Parliament and of the Council of 24 November 2010 amending Directives 98/26/EC, 2002/87/EC, 2003/6/EC, 2003/41/EC, 2003/71/EC, 2004/39/EC, 2004/109/EC, 2005/60/EC, 2006/48/EC, 2006/49/EC and 2009/65/EC in respect of the powers of the European Supervisory Authority (European Banking Authority), the European Supervisory Authority (European Insurance and Occupational Pensions Authority) and the European Supervisory Authority (European Securities and Markets Authority) (<a>OJ L 331, 15.12.2010, p. 120</a>)</p></td><td><p> </p></td></tr><tr><td><p>56</p></td><td><p>Directive 2011/89/EU of the European Parliament and of the Council of 16 November 2011 amending Directives 98/78/EC, 2002/87/EC, 2006/48/EC and 2009/138/EC as regards the supplementary supervision of financial entities in a financial conglomerate (<a>OJ L 326, 8.12.2011, p. 113</a>)</p></td><td><p> </p></td></tr><tr><td><p>57</p></td><td><p>Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (<a>OJ L 176, 27.6.2013, p. 338</a>)</p></td><td><p> </p></td></tr><tr><td><p>58</p></td><td><p>Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments amending Council Directives 85/611/EEC and 93/6/EEC and Directive 2000/12/EC of the European Parliament and of the Council and repealing Council Directive 93/22/EEC (<a>OJ L 145, 30.4.2004, p. 1</a>)</p></td><td><p>1 Sept 2018</p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>59</p></td><td><p>Directive 2006/31/EC of the European Parliament and of the Council of 5 April 2006 amending directive 2004/39/EC on markets in financial instruments, as regards certain deadlines (<a>OJ L 114, 27.4.2006, p. 60</a>)</p></td><td><p> </p></td></tr><tr><td><p>60</p></td><td><p>Directive 2007/44/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 92/49/EEC and Directives 2002/83/EC, 2004/39/EC, 2005/68/EC and 2006/48/EC as regards procedural rules and evaluation criteria for the prudential assessment of acquisitions and increase of holdings in the financial sector (<a>OJ L 247, 21.9.2007, p. 1</a>)</p></td><td><p> </p></td></tr><tr><td><p>61</p></td><td><p>Directive 2008/10/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2004/39/EC on markets in financial instruments, as regards the implementing powers conferred on the Commission (<a>OJ L 76, 19.3.2008, p. 33</a>)</p></td><td><p> </p></td></tr><tr><td><p>62</p></td><td><p>Directive 2010/78/EU of the European Parliament and of the Council of 24 November 2010 amending Directives 98/26/EC, 2002/87/EC, 2003/6/EC, 2003/41/EC, 2003/71/EC, 2004/39/EC, 2004/109/EC, 2005/60/EC, 2006/48/EC, 2006/49/EC, and 2009/65/EC in respect of the powers of the European Supervisory Authority (European Banking Authority), the European Supervisory Authority (European Insurance and Occupational Pensions Authority) and the European Supervisory Authority (European Securities and Markets Authority) (<a>OJ L 331, 15.12.2010, p. 120</a>)</p></td><td><p> </p></td></tr><tr><td><p>63</p></td><td><p>Commission Regulation (EC) No 1287/2006 of 10 August 2006 implementing Directive 2004/39/EC of the European Parliament and of the Council as regards record-keeping obligations for investment firms, transaction reporting, market transparency, admission of financial instruments to trading, and defined terms for the purposes of that Directive (<a>OJ L 241, 2.9.2006, p. 1</a>)</p></td><td><p>1 Sept 2018</p></td></tr><tr><td><p>64</p></td><td><p>Commission Directive 2006/73/EC of 10 August 2006 implementing Directive 2004/39/EC of the European Parliament and of the Council as regards organisational requirements and operating conditions for investment firms and defined terms for the purposes of that Directive (<a>OJ L 241, 2.9.2006, p. 26</a>)</p></td><td><p>1 Sept 2018</p></td></tr><tr><td><p>65</p></td><td><p>Directive 2007/64/EC of the European Parliament and of the Council of 13 November 2007 on payment services in the internal market amending Directives 97/7/EC, 2002/65/EC, 2005/60/EC and 2006/48/EC and repealing Directive 97/5/EC (<a>OJ L 319, 5.12.2007, p. 1</a>)</p></td><td><p>1 Sept 2016</p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>66</p></td><td><p>Directive 2009/111/EC of the European Parliament and of the Council of 16 September 2009 amending Directives 2006/48/EC, 2006/49/EC and 2007/64/EC as regards banks affiliated to central institutions, certain own funds items, large exposures, supervisory arrangements, and crisis management (<a>OJ L 302, 17.11.2009, p. 97</a>)</p></td><td><p> </p></td></tr><tr><td><p>67</p></td><td><p>Regulation (EC) No 924/2009 of the European Parliament and of the Council of 16 September 2009 on cross-border payments in the Community and repealing Regulation (EC) No 2560/2001 (<a>OJ L 266, 9.10.2009, p. 11</a>)</p></td><td><p>1 Sept 2018</p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>68</p></td><td><p>Regulation (EU) No 260/2012 of the European Parliament and of the Council of 14 March 2012 establishing technical and business requirements for credit transfers and direct debits in euro and amending Regulation (EC) No 924/2009 (<a>OJ L 94, 30.3.2012, p. 22</a>)</p></td><td><p>1 Sept 2018<a> (<span>1</span>)</a></p></td></tr><tr><td><p>69</p></td><td><p>Directive 2009/110/EC of the European Parliament and of the Council of 16 September 2009 on the taking up, pursuit and prudential supervision of the business of electronic money institutions amending Directives 2005/60/EC and 2006/48/EC and repealing Directive 2000/46/EC (<a>OJ L 267, 10.10.2009, p. 7</a>)</p></td><td><p>1 Sept 2016</p></td></tr><tr><td><p>70</p></td><td><p>Council Regulation (EU) No 1096/2010 of 17 November 2010 conferring specific tasks upon the European Central Bank concerning the functioning of the European Systemic Risk Board (<a>OJ L 331, 15.12.2010, p. 162</a>)</p></td><td><p>1 Sept 2016</p></td></tr><tr><td><p>71</p></td><td><p>Regulation (EU) No 1092/2010 of the European Parliament and of the Council of 24 November 2010 on European Union macro-prudential oversight of the financial system and establishing a European Systemic Risk Board (<a>OJ L 331, 15.12.2010, p. 1</a>)</p></td><td><p>1 Sept 2016</p></td></tr><tr><td><p>72</p></td><td><p>Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (<a>OJ L 331, 15.12.2010, p. 12</a>)</p></td><td><p>1 Sept 2016</p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>73</p></td><td><p>Regulation (EU) No 1022/2013 of the European Parliament and of the Council of 22 October 2013 amending Regulation (EU) No 1093/2010 establishing a European Supervisory Authority (European Banking Authority) as regards the conferral of specific tasks on the European Central Bank pursuant to Council Regulation (EU) No 1024/2013 (<a>OJ L 287, 29.10.2013, p. 5</a>)</p></td><td><p> </p></td></tr><tr><td><p>74</p></td><td><p>Directive 2014/17/EU of the European Parliament and of the Council of 4 February 2014 on credit agreements for consumers relating to residential immovable property and amending Directives 2008/48/EC and 2013/36/EU and Regulation (EU) No 1093/2010 (<a>OJ L 60, 28.2.2014, p. 34</a>)</p></td><td><p> </p></td></tr><tr><td><p>75</p></td><td><p>Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (<a>OJ L 173, 12.6.2014, p. 190</a>)</p></td><td><p> </p></td></tr><tr><td><p>76</p></td><td><p>Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (<a>OJ L 331, 15.12.2010, p. 84</a>)</p></td><td><p>1 Sept 2016</p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>77</p></td><td><p>Directive 2011/61/EU of the European Parliament and of the Council of 8 June 2011 on Alternative Investment Fund Managers and amending Directives 2003/41/EC and 2009/65/EC and Regulations (EC) No 1060/2009 and (EU) No 1095/2010 (<a>OJ L 174, 1.7.2011, p. 1</a>)</p></td><td><p> </p></td></tr><tr><td><p>78</p></td><td><p>Regulation (EU) No 258/2014 of the European Parliament and of the Council of 3 April 2014 establishing a Union programme to support specific activities in the field of financial reporting and auditing for the period of 2014-20 and repealing Decision No 716/2009/EC (<a>OJ L 105, 8.4.2014, p. 1</a>)</p></td><td><p> </p></td></tr><tr><td><p>79</p></td><td><p>Directive 2014/51/EU of the European Parliament and of the Council of 16 April 2014 amending Directives 2003/71/EC and 2009/138/EC and Regulations (EC) No 1060/2009, (EU) No 1094/2010 and (EU) No 1095/2010 in respect of the powers of the European Supervisory Authority (European Insurance and Occupational Pensions Authority) and the European Supervisory Authority (European Securities and Markets Authority) (<a>OJ L 153, 22.5.2014, p. 1</a>)</p></td><td><p> </p></td></tr><tr><td><p>80</p></td><td><p>Directive 2010/78/EU of the European Parliament and of the Council of 24 November 2010 amending Directives 98/26/EC, 2002/87/EC, 2003/6/EC, 2003/41/EC, 2003/71/EC, 2004/39/EC, 2004/109/EC, 2005/60/EC, 2006/48/EC, 2006/49/EC, and 2009/65/EC in respect of the powers of the European Supervisory Authority (European Banking Authority), the European Supervisory Authority (European Insurance and Occupational Pensions Authority) and the European Supervisory Authority (European Securities and Markets Authority) (<a>OJ L 331, 15.12.2010, p. 120</a>)</p></td><td><p>1 Sept 2016</p></td></tr><tr><td><p>81</p></td><td><p>Regulation (EU) No 260/2012 of the European Parliament and of the Council of 14 March 2012 establishing technical and business requirements for credit transfers and direct debits in euro and amending Regulation (EC) No 924/2009 (<a>OJ L 94, 30.3.2012, p. 22</a>)</p></td><td><p>1 April 2018<a> (<span>2</span>)</a></p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>82</p></td><td><p>Regulation (EU) No 248/2014 of the European Parliament and of the Council of 26 February 2014 amending Regulation (EU) No 260/2012 as regards the migration to Union-wide credit transfers and direct debits (<a>OJ L 84, 20.3.2014, p. 1</a>)</p></td><td><p> </p></td></tr><tr><td><p>83</p></td><td><p>Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (<a>OJ L 201, 27.7.2012, p. 1</a>)</p></td><td><p>1 Oct 2017<a> (<span>1</span>)</a></p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>84</p></td><td><p>Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (<a>OJ L 176, 27.6.2013, p. 1</a>)</p></td><td><p> </p></td></tr><tr><td><p>85</p></td><td><p>Commission Delegated Regulation (EU) No 1002/2013 of 12 July 2013 amending Regulation (EU) No 648/2012 of the European Parliament and of the Council on OTC derivatives, central counterparties and trade repositories with regard to the list of exempted entities (<a>OJ L 279, 19.10.2013, p. 2</a>)</p></td><td><p> </p></td></tr><tr><td><p>86</p></td><td><p>Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (<a>OJ L 173, 12.6.2014, p. 190</a>)</p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p><span>Supplemented by:</span></p></td><td><p> </p></td></tr><tr><td><p>87</p></td><td><p>Commission Implementing Regulation (EU) No 1247/2012 of 19 December 2012 laying down implementing technical standards with regard to the format and frequency of trade reports to trade repositories according to Regulation (EU) No 648/2012 of the European Parliament and of the Council on OTC derivatives, central counterparties and trade repositories (<a>OJ L 352, 21.12.2012, p. 20</a>)</p></td><td><p> </p></td></tr><tr><td><p>88</p></td><td><p>Commission Implementing Regulation (EU) No 1248/2012 of 19 December 2012 laying down implementing technical standards with regard to the format of applications for registration of trade repositories according to Regulation (EU) No 648/2012 of the European Parliament and of the Council on OTC derivatives, central counterparties and trade repositories (<a>OJ L 352, 21.12.2012, p. 30</a>)</p></td><td><p> </p></td></tr><tr><td><p>89</p></td><td><p>Commission Implementing Regulation (EU) No 1249/2012 of 19 December 2012 laying down implementing technical standards with regard to the format of the records to be maintained by central counterparties according to Regulation (EU) No 648/2012 of the European Parliament and of the Council on OTC derivatives, central counterparties and trade repositories (<a>OJ L 352, 21.12.2012, p. 32</a>)</p></td><td><p> </p></td></tr><tr><td><p>90</p></td><td><p>Commission Delegated Regulation (EU) No 148/2013 of 19 December 2012 supplementing Regulation (EU) No 648/2012 of the European Parliament and of the Council on OTC derivatives, central counterparties and trade repositories with regard to regulatory technical standards on the minimum details of the data to be reported to trade repositories (<a>OJ L 52, 23.2.2013, p. 1</a>)</p></td><td><p> </p></td></tr><tr><td><p>91</p></td><td><p>Commission Delegated Regulation (EU) No 149/2013 of 19 December 2012 supplementing Regulation (EU) No 648/2012 of the European Parliament and of the Council with regard to regulatory technical standards on indirect clearing arrangements, the clearing obligation, the public register, access to a trading venue, non-financial counterparties, and risk mitigation techniques for OTC derivatives contracts not cleared by a CCP (<a>OJ L 52, 23.2.2013, p. 11</a>)</p></td><td><p> </p></td></tr><tr><td><p>92</p></td><td><p>Commission Delegated Regulation (EU) No 150/2013 of 19 December 2012 supplementing Regulation (EU) No 648/2012 of the European Parliament and of the Council on OTC derivatives, central counterparties and trade repositories with regard to regulatory technical standards specifying the details of the application for registration as a trade repository (<a>OJ L 52, 23.2.2013, p. 25</a>)</p></td><td><p> </p></td></tr><tr><td><p>93</p></td><td><p>Commission Delegated Regulation (EU) No 151/2013 of 19 December 2012 supplementing Regulation (EU) No 648/2012 of the European Parliament and of the Council on OTC derivatives, central counterparties and trade repositories, with regard to regulatory technical standards specifying the data to be published and made available by trade repositories and operational standards for aggregating, comparing and accessing the data (<a>OJ L 52, 23.2.2013, p. 33</a>)</p></td><td><p> </p></td></tr><tr><td><p>94</p></td><td><p>Commission Delegated Regulation (EU) No 152/2013 of 19 December 2012 supplementing Regulation (EU) No 648/2012 of the European Parliament and of the Council with regard to regulatory technical standards on capital requirements for central counterparties (<a>OJ L 52, 23.2.2013, p. 37</a>)</p></td><td><p> </p></td></tr><tr><td><p>95</p></td><td><p>Commission Delegated Regulation (EU) No 153/2013 of 19 December 2012 supplementing Regulation (EU) No 648/2012 of the European Parliament and of the Council with regard to regulatory technical standards on requirements for central counterparties (<a>OJ L 52, 23.2.2013, p. 41</a>)</p></td><td><p>1 Oct 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>96</p></td><td><p>Commission Delegated Regulation (EU) No 876/2013 of 28 May 2013 supplementing Regulation (EU) No 648/2012 of the European Parliament and of the Council with regard to regulatory technical standards on colleges for central counterparties (<a>OJ L 244, 13.9.2013, p. 19</a>)</p></td><td><p>1 Oct 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>97</p></td><td><p>Commission Delegated Regulation (EU) No 1003/2013 of 12 July 2013 supplementing Regulation (EU) No 648/2012 of the European Parliament and of the Council with regard to fees charged by the European Securities and Markets Authority to trade repositories (<a>OJ L 279, 19.10.2013, p. 4</a>)</p></td><td><p>1 Oct 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>98</p></td><td><p>Commission Delegated Regulation (EU) No 285/2014 of 13 February 2014 supplementing Regulation (EU) No 648/2012 of the European Parliament and of the Council with regard to regulatory technical standards on direct, substantial and foreseeable effect of contracts within the Union and to prevent the evasion of rules and obligations (<a>OJ L 85, 21.3.2014, p. 1</a>)</p></td><td><p>1 Oct 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>99</p></td><td><p>Commission Delegated Regulation (EU) No 667/2014 of 13 March 2014 supplementing Regulation (EU) No 648/2012 of the European Parliament and of the Council with regard to rules of procedure for penalties imposed on trade repositories by the European Securities and Markets Authority including rules on the right of defence and temporal provisions (<a>OJ L 179, 19.6.2014, p. 31</a>)</p></td><td><p>1 Oct 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>100</p></td><td><p>Commission Implementing Regulation (EU) No 484/2014 of 12 May 2014 laying down implementing technical standards with regard to the hypothetical capital of a central counterparty according to Regulation (EU) No 648/2012 of the European Parliament and of the Council (<a>OJ L 138, 13.5.2014, p. 57</a>)</p></td><td><p>1 Oct 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>101</p></td><td><p>Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (<a>OJ L 176, 27.6.2013, p. 1</a>)</p></td><td><p>1 Sept 2017<a> (<span>1</span>)</a></p></td></tr><tr><td><p> </p></td><td><p><span>Supplemented by:</span></p></td><td><p> </p></td></tr><tr><td><p>102</p></td><td><p>Commission Implementing Regulation (EU) No 1423/2013 of 20 December 2013 laying down implementing technical standards with regard to disclosure of own funds requirements for institutions according to Regulation (EU) No 575/2013 of the European Parliament and of the Council (<a>OJ L 355, 31.12.2013, p. 60</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>103</p></td><td><p>Commission Delegated Regulation (EU) No 183/2014 of 20 December 2013 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council on prudential requirements for credit institutions and investment firms, with regard to regulatory technical standards for specifying the calculation of specific and general credit risk adjustments (<a>OJ L 57, 27.2.2014, p. 3</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>104</p></td><td><p>Commission Delegated Regulation (EU) No 241/2014 of 7 January 2014 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards for Own Funds requirements for institutions (<a>OJ L 74, 14.3.2014, p. 8</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>105</p></td><td><p>Commission Delegated Regulation (EU) No 342/2014 of 21 January 2014 supplementing Directive 2002/87/EC of the European Parliament and of the Council and Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards for the application of the calculation methods of capital adequacy requirements for financial conglomerates (<a>OJ L 100, 3.4.2014, p. 1</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>106</p></td><td><p>Commission Delegated Regulation (EU) No 523/2014 of 12 March 2014 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards for determining what constitutes the close correspondence between the value of an institution's covered bonds and the value of the institution's assets (<a>OJ L 148, 20.5.2014, p. 4</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>107</p></td><td><p>Commission Delegated Regulation (EU) No 525/2014 of 12 March 2014 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards for the definition of market (<a>OJ L 148, 20.5.2014, p. 15</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>108</p></td><td><p>Commission Delegated Regulation (EU) No 526/2014 of 12 March 2014 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards for determining proxy spread and limited smaller portfolios for credit valuation adjustment risk (<a>OJ L 148, 20.5.2014, p. 17</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>109</p></td><td><p>Commission Delegated Regulation (EU) No 528/2014 of 12 March 2014 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards for non-delta risk of options in the standardised market risk approach (<a>OJ L 148, 20.5.2014, p. 29</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>110</p></td><td><p>Commission Delegated Regulation (EU) No 529/2014 of 12 March 2014 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards for assessing the materiality of extensions and changes of the Internal Ratings Based Approach and the Advanced Measurement Approach (<a>OJ L 148, 20.5.2014, p. 36</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>111</p></td><td><p>Commission Delegated Regulation (EU) No 625/2014 of 13 March 2014 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council by way of regulatory technical standards specifying the requirements for investor, sponsor, original lenders and originator institutions relating to exposures to transferred credit risk (<a>OJ L 174, 13.6.2014, p. 16</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>112</p></td><td><p>Commission Implementing Regulation (EU) No 680/2014 of 16 April 2014 laying down implementing technical standards with regard to supervisory reporting of institutions according to Regulation (EU) No 575/2013 of the European Parliament and of the Council (<a>OJ L 191, 28.6.2014, p. 1</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>113</p></td><td><p>Commission Implementing Regulation (EU) No 602/2014 of 4 June 2014 laying down implementing technical standards for facilitating the convergence of supervisory practices with regard to the implementation of additional risk weights according to Regulation (EU) No 575/2013 of the European Parliament and of the Council (<a>OJ L 166, 5.6.2014, p. 22</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>114</p></td><td><p>Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (<a>OJ L 176, 27.6.2013, p. 338</a>)</p></td><td><p>1 Sept 2017<a> (<span>1</span>)</a></p></td></tr><tr><td><p> </p></td><td><p><span>Amended by:</span></p></td><td><p> </p></td></tr><tr><td><p>115</p></td><td><p>Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (<a>OJ L 173, 12.6.2014, p. 190</a>)</p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p><span>Supplemented by:</span></p></td><td><p> </p></td></tr><tr><td><p>116</p></td><td><p>Commission Delegated Regulation (EU) No 604/2014 of 4 March 2014 supplementing Directive 2013/36/EU of the European Parliament and of the Council with regard to regulatory technical standards with respect to qualitative and appropriate quantitative criteria to identify categories of staff whose professional activities have a material impact on an institution's risk profile (<a>OJ L 167, 6.6.2014, p. 30</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>117</p></td><td><p>Commission Delegated Regulation (EU) No 524/2014 of 12 March 2014 supplementing Directive 2013/36/EU of the European Parliament and of the Council with regard to regulatory technical standards specifying the information that competent authorities of home and host Member States supply to one another (<a>OJ L 148, 20.5.2014, p. 6</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>118</p></td><td><p>Commission Delegated Regulation (EU) No 527/2014 of 12 March 2014 supplementing Directive (EU) No 2013/36/EU of the European Parliament and of the Council with regard to regulatory technical standards specifying the classes of instruments that adequately reflect the credit quality of an institution as a going concern and are appropriate to be used for the purposes of variable remuneration (<a>OJ L 148, 20.5.2014, p. 21</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>119</p></td><td><p>Commission Delegated Regulation (EU) No 530/2014 of 12 March 2014 supplementing Directive 2013/36/EU of the European Parliament and of the Council with regard to regulatory technical standards further defining material exposures and thresholds for internal approaches to specific risk in the trading book (<a>OJ L 148, 20.5.2014, p. 50</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>120</p></td><td><p>Commission Implementing Regulation (EU) No 620/2014 of 4 June 2014 laying down implementing technical standards with regard to information exchange between competent authorities of home and host Member States, according to Directive 2013/36/EU of the European Parliament and of the Council (<a>OJ L 172, 12.6.2014, p. 1</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>121</p></td><td><p>Commission Implementing Regulation (EU) No 650/2014 of 4 June 2014 laying down implementing technical standards with regard to the format, structure, contents list and annual publication date of the information to be disclosed by competent authorities in accordance with Directive 2013/36/EU of the European Parliament and of the Council (<a>OJ L 185, 25.6.2014, p. 1</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>122</p></td><td><p>Commission Implementing Regulation (EU) No 710/2014 of 23 June 2014 laying down implementing technical standards with regard to conditions of application of the joint decision process for institution-specific prudential requirements according to Directive 2013/36/EU of the European Parliament and of the Council (<a>OJ L 188, 27.6.2014, p. 19</a>)</p></td><td><p>1 Sept 2017<a> (<span>2</span>)</a></p></td></tr><tr><td><p>123</p></td><td><p>Directive 2014/49/EU of the European Parliament and of the Council of 16 April 2014 on deposit-guarantee schemes (<a>OJ L 173, 12.6.2014, p. 149</a>)</p></td><td><p>1 Sept 2016<a> (<span>2</span>)</a></p></td></tr><tr><td><p>124</p></td><td><p>Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (<a>OJ L 173, 12.6.2014, p. 190</a>)</p></td><td><p>1 Sept 2018<a> (<span>2</span>)</a></p></td></tr><tr><td><p><span>Legislation on collection of statistical information</span></p></td></tr><tr><td><p>125</p></td><td><p>Guideline of the European Central Bank of 25 July 2013 on the statistical reporting requirements of the European Central Bank in the field of quarterly financial accounts (ECB/2013/24) (<a>OJ L 2, 7.1.2014, p. 34</a>)</p></td><td><p>1 Sept 2016<a> (<span>2</span>)</a></p></td></tr><tr><td><p>126</p></td><td><p>Regulation (EU) No 1072/2013 of the European Central Bank of 24 September 2013 concerning statistics on interest rates applied by monetary financial institutions (ECB/2013/34) (<a>OJ L 297, 7.11.2013, p. 51</a>)</p></td><td><p>1 Sept 2016<a> (<span>2</span>)</a></p></td></tr></tbody></table>
<note>
( 1 ) The Joint Committee of 2013 agreed on these deadlines pursuant to Article 8(5) of the Monetary Agreement of 27 March 2012 between the European Union and the Republic of San Marino.
( 2 ) The Joint Committee of 2014 agreed on these deadlines pursuant to Article 8(5) of the Monetary Agreement of 27 March 2012 between the European Union and the Republic of San Marino.
</note> | ENG | 32015D0402(01) |
<table><col/><col/><col/><col/><tbody><tr><td><p>4.6.2015   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 137/8</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2015/862
of 3 June 2015
establishing the standard import values for determining the entry price of certain fruit and vegetables
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) ,
Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors ( 2 ) , and in particular Article 136(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the<span>Official Journal of the European Union</span>,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 June 2015.
For the Commission,
On behalf of the President,
Jerzy PLEWA
Director-General for Agriculture and Rural Development
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) OJ L 157, 15.6.2011, p. 1 .
ANNEX
Standard import values for determining the entry price of certain fruit and vegetables
<table><col/><col/><col/><tbody><tr><td><p>(EUR/100 kg)</p></td></tr><tr><td><p>CN code</p></td><td><p>Third country code<a> (<span>1</span>)</a></p></td><td><p>Standard import value</p></td></tr><tr><td><p>0702 00 00</p></td><td><p>AL</p></td><td><p>46,1</p></td></tr><tr><td><p>MA</p></td><td><p>77,9</p></td></tr><tr><td><p>MK</p></td><td><p>71,9</p></td></tr><tr><td><p>TN</p></td><td><p>138,3</p></td></tr><tr><td><p>TR</p></td><td><p>80,1</p></td></tr><tr><td><p>ZZ</p></td><td><p>82,9</p></td></tr><tr><td><p>0707 00 05</p></td><td><p>AL</p></td><td><p>34,4</p></td></tr><tr><td><p>MK</p></td><td><p>40,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>37,5</p></td></tr><tr><td><p>0709 93 10</p></td><td><p>TR</p></td><td><p>70,0</p></td></tr><tr><td><p>ZZ</p></td><td><p>70,0</p></td></tr><tr><td><p>0805 50 10</p></td><td><p>AR</p></td><td><p>109,6</p></td></tr><tr><td><p>BO</p></td><td><p>145,2</p></td></tr><tr><td><p>BR</p></td><td><p>107,1</p></td></tr><tr><td><p>TR</p></td><td><p>67,0</p></td></tr><tr><td><p>ZA</p></td><td><p>166,3</p></td></tr><tr><td><p>ZZ</p></td><td><p>119,0</p></td></tr><tr><td><p>0808 10 80</p></td><td><p>AR</p></td><td><p>93,1</p></td></tr><tr><td><p>BR</p></td><td><p>100,6</p></td></tr><tr><td><p>CL</p></td><td><p>138,8</p></td></tr><tr><td><p>NZ</p></td><td><p>131,1</p></td></tr><tr><td><p>US</p></td><td><p>219,4</p></td></tr><tr><td><p>ZA</p></td><td><p>132,9</p></td></tr><tr><td><p>ZZ</p></td><td><p>136,0</p></td></tr><tr><td><p>0809 10 00</p></td><td><p>TR</p></td><td><p>288,5</p></td></tr><tr><td><p>ZZ</p></td><td><p>288,5</p></td></tr><tr><td><p>0809 29 00</p></td><td><p>US</p></td><td><p>507,5</p></td></tr><tr><td><p>ZZ</p></td><td><p>507,5</p></td></tr></tbody></table>
<note>
( 1 ) Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories ( OJ L 328, 28.11.2012, p. 7 ). Code ‘ZZ’ stands for ‘of other origin’.
</note> | ENG | 32015R0862 |
<table><col/><col/><col/><col/><tbody><tr><td><p>1.9.2023   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>C 312/1</p></td></tr></tbody></table>
COUNCIL RECOMMENDATION
of 14 July 2023
on the 2023 National Reform Programme of Belgium and delivering a Council opinion on the 2023 Stability Programme of Belgium
(2023/C 312/01)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 121(2) and Article 148(4) thereof,
Having regard to Council Regulation (EC) No 1466/97 of 7 July 1997 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies ( 1 ) , and in particular Article 5(2) thereof,
Having regard to the recommendation of the European Commission,
Having regard to the resolutions of the European Parliament,
Having regard to the conclusions of the European Council,
Having regard to the opinion of the Employment Committee,
Having regard to the opinion of the Economic and Financial Committee,
Having regard to the opinion of the Social Protection Committee,
Having regard to the opinion of the Economic Policy Committee,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Regulation (EU) 2021/241 of the European Parliament and of the Council <a>(<span>2</span>)</a>, which established the Recovery and Resilience Facility (‘the Facility’), entered into force on 19 February 2021. The Facility provides financial support to the Member States for the implementation of reforms and investments, entailing a fiscal impulse financed by the Union. In line with the priorities of the European Semester, the Facility contributes to economic and inclusive recovery and to the implementation of sustainable and growth-enhancing reforms and investments, in particular reforms and investments to promote the green and digital transitions and to make the Member States’ economies more resilient. It also helps strengthen public finances and boost growth and job creation in the medium and long term, improve territorial cohesion within the Union and support the continued implementation of the European Pillar of Social Rights. The maximum financial contribution per Member State under the Facility was updated on 30 June 2022, in accordance with Article 11(2) of Regulation (EU) 2021/241.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>On 22 November 2022, the Commission adopted the 2023 Annual Sustainable Growth Survey, marking the start of the 2023 European Semester for economic policy coordination. On 23 March 2023, the European Council endorsed the priorities of the 2023 Annual Sustainable Growth Survey, which are centred around the four dimensions of competitive sustainability. On 22 November 2022, on the basis of Regulation (EU) No 1176/2011 of the European Parliament and of the Council <a>(<span>3</span>)</a>, the Commission also adopted the 2023 Alert Mechanism Report, in which it did not identify Belgium as one of the Member States that may be affected or may be at risk of being affected by imbalances. As such, an in-depth review would not be needed. On the same date, the Commission also adopted an opinion on Belgium’s 2023 draft budgetary plan. The Commission also adopted a recommendation for a Council recommendation on the economic policy of the euro area and a proposal for the 2023 Joint Employment Report, which analyses the implementation of the Employment Guidelines and the principles of the European Pillar of Social Rights. The Council adopted the Recommendation on the economic policy of the euro area <a>(<span>4</span>)</a> (‘2023 Recommendation on the euro area’) on 16 May 2023 and the Joint Employment Report on 13 March 2023.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>While the Union’s economies are showing remarkable resilience, the geopolitical context continues to have a negative impact. As the Union stands firmly with Ukraine, the Union’s economic and social policy agenda is focused on reducing the negative impact of energy shocks on both vulnerable households and firms in the short term, and on keeping up efforts to deliver on the green and digital transitions, support sustainable and inclusive growth, safeguard macroeconomic stability and increase resilience in the medium term. It also focuses heavily on increasing the Union’s competitiveness and productivity.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>On 1 February 2023, the Commission issued a communication entitled ‘A Green Deal Industrial Plan for the Net-Zero Age’ (‘the Green Deal Industrial Plan’). The aim of the Green Deal Industrial Plan is to boost the competitiveness of the Union’s net-zero industry and support the fast transition to climate neutrality. It complements ongoing efforts under the European Green Deal and REPowerEU. It also aims to provide a more supportive environment for scaling up the Union’s manufacturing capacity for the net-zero technologies and products required to meet the Union’s ambitious climate targets, and to ensure access to relevant critical raw materials, including by diversifying sourcing, properly exploiting geological resources in Member States and maximising the recycling of raw materials. The Green Deal Industrial Plan is based on four pillars: a predictable and simplified regulatory environment, faster access to finance, the enhancement of skills, and open trade for resilient supply chains. On 16 March 2023, the Commission issued a further communication entitled ‘Long-term competitiveness of the EU: looking beyond 2030’, structured along nine mutually reinforcing drivers with the objective of working towards a growth-enhancing regulatory framework. It sets policy priorities aimed at actively ensuring structural improvements, well-focused investments and regulatory measures for the long-term competitiveness of the Union and its Member States. The recommendations below help address those priorities.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>In 2023, the European Semester for economic policy coordination continues to evolve in line with the implementation of the Facility. The full implementation of the recovery and resilience plans remains essential for delivering the policy priorities under the European Semester, as the plans address all or a significant subset of the relevant country-specific recommendations issued in recent years. The 2019, 2020 and 2022 country-specific recommendations remain equally relevant for the recovery and resilience plans revised, updated or amended in accordance with Articles 14, 18 and 21 of Regulation (EU) 2021/241.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Regulation (EU) 2023/435 of the European Parliament and of the Council <a>(<span>5</span>)</a> (the ‘REPowerEU Regulation’), which was adopted on 27 February 2023, aims to rapidly phase out the Union’s dependence on Russian fossil-fuel imports. This will contribute to energy security and the diversification of the Union’s energy supply, while increasing the uptake of renewables, energy storage capacities and energy efficiency. The REPowerEU Regulation enables Member States to add a new REPowerEU chapter to their national recovery and resilience plans in order to finance key reforms and investments that will help achieve the REPowerEU objectives. Those reforms and investments will also help boost the competitiveness of the Union’s net-zero industry as outlined in the Green Deal Industrial Plan and address the energy-related country-specific recommendations issued to the Member States in 2022 and, where applicable, in 2023. The REPowerEU Regulation introduces a new category of non-repayable financial support, made available to Member States in order to finance new energy-related reforms and investments under their recovery and resilience plans.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>On 8 March 2023, the Commission adopted a communication providing fiscal policy guidance for 2024 (‘the communication of 8 March 2023’). It aims to support the preparation of Member States’ stability and convergence programmes and thereby strengthen policy coordination. The Commission recalled that the general escape clause of the Stability and Growth Pact will be deactivated at the end of 2023. It called for fiscal policies in 2023–2024 that ensure medium-term debt sustainability and raise potential growth in a sustainable manner and invited Member States to set out in their 2023 stability and convergence programmes how their fiscal plans will ensure that the Treaty reference value of 3 % of gross domestic product (GDP) is adhered to and ensure plausible and continuous debt reduction, or for debt to be kept at prudent levels in the medium term. The Commission also invited Member States to phase out national fiscal measures introduced to protect households and firms from the energy price shock, starting with the least targeted ones. It indicated that, if support measures needed to be extended because of renewed energy price pressures, Member States should better target such measures at vulnerable households and firms. The Commission stated that the fiscal recommendations would be quantified and differentiated. Moreover, as proposed in its communication of 9 November 2022 on orientations for a reform of the EU economic governance framework, the fiscal recommendations would be formulated on the basis of net primary expenditure. It recommended that all Member States continue to protect nationally financed investment and ensure the effective use of the Facility and other Union funds, in particular in light of the green and digital transitions and resilience objectives. The Commission indicated that it will propose to the Council to open deficit-based excessive deficit procedures in spring 2024 on the basis of the outturn data for 2023, in line with existing legal provisions.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>On 26 April 2023, the Commission presented legislative proposals to implement a comprehensive reform of the Union’s economic governance rules. The central objective of the proposals is to strengthen public debt sustainability and promote sustainable and inclusive growth in all Member States through reforms and investments. In its proposals, the Commission aims to improve national ownership, simplify the framework and move towards a greater medium-term focus, in combination with effective and more coherent enforcement. According to the Council conclusions of 14 March 2023 on orientations for a reform of the EU economic governance framework, the objective is to conclude the legislative work in 2023.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>On 30 April 2021, Belgium submitted its national recovery and resilience plan to the Commission, in accordance with Article 18(1) of Regulation (EU) 2021/241. Pursuant to Article 19 of Regulation (EU) 2021/241, the Commission assessed the relevance, effectiveness, efficiency and coherence of the recovery and resilience plan, in accordance with the assessment guidelines set out in Annex V to that Regulation. On 13 July 2021, the Council adopted its Implementing Decision on the approval of the assessment of the recovery and resilience plan for Belgium <a>(<span>6</span>)</a>. The release of instalments is conditional on the adoption of a decision by the Commission, in accordance with Article 24(5) of Regulation (EU) 2021/241, stating that Belgium has satisfactorily fulfilled the relevant milestones and targets set out in the Council Implementing Decision. Satisfactory fulfilment presupposes that the achievement of preceding milestones and targets has not been reversed.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>On 30 April 2023, Belgium submitted its 2023 National Reform Programme and its 2023 Stability Programme, in line with Article 4(1) of Regulation (EC) No 1466/97. To take account of their interlinkages, the two programmes have been assessed together. In accordance with Article 27 of Regulation (EU) 2021/241, the 2023 National Reform Programme also reflects Belgium’s biannual reporting on the progress made in achieving its recovery and resilience plan.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>On 24 May 2023, the Commission published the 2023 country report for Belgium. It assessed Belgium’s progress in addressing the relevant country-specific recommendations adopted by the Council between 2019 and 2022 and took stock of Belgium’s implementation of the recovery and resilience plan. On the basis of that analysis, the country report identified gaps with regard to those challenges that are not addressed or only partially addressed by the recovery and resilience plan, as well as new and emerging challenges. It also assessed Belgium’s progress in implementing the European Pillar of Social Rights and in achieving the Union headline targets on employment, skills and poverty reduction, as well as progress in achieving the United Nations Sustainable Development Goals.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>According to data validated by Eurostat, Belgium’s general government deficit decreased from 5,5 % of GDP in 2021 to 3,9 % in 2022, while general government debt fell from 109,1 % of GDP at the end of 2021 to 105,1 % at the end of 2022. On 24 May 2023, the Commission issued a report under Article 126(3) of the Treaty. That report discussed the budgetary situation of Belgium, as its general government deficit in 2022 exceeded the 3 %-of-GDP Treaty reference value. The report concluded that the deficit criterion was not fulfilled. In line with the communication of 8 March 2023, the Commission did not propose to open new excessive deficit procedures in spring 2023. The Commission subsequently stated that it would propose to the Council to open deficit-based excessive deficit procedures in spring 2024, on the basis of the outturn data for 2023. Belgium should take account of this in the execution of its 2023 budget and in preparing its draft budgetary plan for 2024.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>The general government balance has been impacted by the fiscal policy measures taken to mitigate the economic and social impact of the increase in energy prices. In 2022, such fiscal policy revenue-decreasing measures included a cut in excise duties on petrol fuel and VAT reductions on residential electricity and gas contracts, while such fiscal policy expenditure-increasing measures included extended coverage of the social tariff on electricity and natural gas for vulnerable households, across-the-board income transfers to households directly through their gas and electricity energy bills (‘the energy package’), earmarked lump sum transfers (for those households using heating oil, propane or pellet fuel), and direct support to help companies faced with rising energy costs. The cost of those measures was partly offset by new taxes on windfall profits of energy producers and suppliers, namely on the electricity and oil sectors. The Commission estimates the net budgetary cost of those measures at 0,9 % of GDP in 2022. The general government balance has also been impacted by the budgetary cost of offering temporary protection to displaced persons from Ukraine, which is estimated at 0,1 % of GDP in 2022. At the same time, the estimated cost of temporary emergency measures related to the COVID-19 crisis dropped to 0,5 % of GDP in 2022, from 3 % in 2021.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>On 18 June 2021, the Council recommended that in 2022 Belgium <a>(<span>7</span>)</a> use the Facility to finance additional investment in support of the recovery, while pursuing a prudent fiscal policy. Moreover, the Council recommended that Belgium preserve nationally-financed investment.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>According to the Commission estimates, the fiscal stance <a>(<span>8</span>)</a> in 2022 was supportive, at ‒ 2 % of GDP. As recommended by the Council, Belgium continued to support the recovery with investments to be financed by the Facility. Expenditure financed by grants under the Facility and other Union funds amounted to 0,2 % of GDP in 2022 (0,2 % of GDP in 2021). Nationally financed investment provided a neutral contribution to the fiscal stance <a>(<span>9</span>)</a>. Belgium therefore preserved nationally financed investment, as recommended by the Council. At the same time, the growth in nationally financed primary current expenditure (net of new revenue measures) provided an expansionary contribution of 1,9 percentage points to the fiscal stance. That significant expansionary contribution included the additional impact of fiscal policy measures taken to mitigate the economic and social impact of the increase in energy prices (additional net budgetary cost of 0,8 % of GDP compared to 2021), as well as the cost of offering temporary protection to displaced persons from Ukraine (0,1 % of GDP). At the same time, rising current expenditure, driven in particular by the automatic indexation of social benefits and public-sector wages and other structurally increasing current expenditure, reflecting, in particular demographic ageing, also contributed to the growth in net primary current expenditure. That significant expansionary contribution of nationally financed current expenditure was thus only partially due to the measures to address the economic and social impact of the increase in energy prices, as well as the cost of offering temporary protection to displaced persons from Ukraine. Belgium therefore did not sufficiently limit the growth in nationally financed current expenditure.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(16)</p></td><td><p>The macroeconomic scenario underpinning the budgetary projections in the 2023 Stability Programme is in line with the Commission’s 2023 spring forecast for 2023 and thereafter. The government projects real GDP to grow by 1 % in 2023 and 1,7 % in 2024. By comparison, the Commission’s 2023 spring forecast projects a real GDP growth of 1,2 % in 2023 and 1,4 % in 2024.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(17)</p></td><td><p>In its 2023 Stability Programme, the government expects that the general government deficit will increase to 5,1 % of GDP in 2023. The increase in 2023 mainly reflects increasing permanent current spending, notably due to the automatic indexation of social benefits and public-sector wages as well as to demographic ageing, the budgetary impact of a temporary decrease in firms’ social contributions during the first half of 2023, and a deficit-increasing reform of the taxation of residential energy products. According to the 2023 Stability Programme, the general government debt-to-GDP ratio is expected to increase from 105,1 % at the end of 2022 to 106,7 % at the end of 2023. The Commission’s 2023 spring forecast projects a government deficit of 5 % of GDP for 2023. This is in line with the deficit projected in the 2023 Stability Programme. The Commission’s 2023 spring forecast projects a slightly lower general government debt-to-GDP ratio of 106 % at the end of 2023. The difference is due to a somewhat higher projected nominal GDP in 2023 in the Commission’s 2023 spring forecast.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(18)</p></td><td><p>The general government balance in 2023 is expected to continue to be impacted by the fiscal measures taken to mitigate the economic and social impact of the increase in energy prices. They consist of measures extended from 2022, in particular a cut in excise duties on petrol fuel that ended on 31 March 2023, VAT reductions on electricity and gas residential contracts, an extension of the coverage of the social tariff on energy products, the energy package, earmarked lump sum transfers (for those households using heating sources other than gas and electricity), and direct support to help companies faced with rising energy costs. The cost of those measures continues to be partly offset by taxes on windfall profits of energy suppliers, namely by taxes on the electricity and oil sectors, that have been in place since 2022, and by a tax in 2023 on a gas international network system operator (Fluxys). Taking those revenues into account, the net budgetary cost of the support measures is projected in the Commission’s 2023 spring forecast at 0,4 % of GDP in 2023 <a>(<span>10</span>)</a>. Most measures in 2023 do not appear to be targeted at the most vulnerable households or firms, although many of them preserve the price signal to reduce energy demand and increase energy efficiency. As a result, the amount of targeted support measures, to be taken into account in the assessment of compliance with the Council Recommendation of 12 July 2022 <a>(<span>11</span>)</a>, is estimated in the Commission’s 2023 spring forecast at 0,1 % of GDP in 2023 (compared to 0,2 % of GDP in 2022). The budgetary cost of temporary protection to displaced persons from Ukraine is projected to remain stable compared to 2022. Finally, the general government balance in 2023 is expected to benefit from the phasing-out of temporary emergency measures related to the COVID-19 crisis, which have been estimated at 0,5 % of GDP.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(19)</p></td><td><p>In its Recommendation of 12 July 2022, the Council recommended that Belgium ensure in 2023 a prudent fiscal policy, in particular by limiting the growth of nationally financed primary current expenditure below medium-term potential output growth <a>(<span>12</span>)</a>, taking into account continued temporary and targeted support to households and firms most vulnerable to energy price hikes and to people fleeing Ukraine. At the same time, Belgium should stand ready to adjust current spending to the evolving situation. Belgium was also recommended to expand public investment for the green and digital transitions, and for energy security taking into account the REPowerEU initiative, including by making use of the Facility and other Union funds.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(20)</p></td><td><p>In 2023, the fiscal stance is projected in the Commission’s 2023 spring forecast to be expansionary (‒ 1,1 % of GDP), in a context of high inflation. This follows an expansionary fiscal stance in 2022 (‒ 2 % of GDP). The growth in nationally financed primary current expenditure (net of discretionary revenue measures) in 2023 is projected to provide an expansionary contribution of 0,7 % of GDP to the fiscal stance. This includes the reduced cost of the targeted support measures to households and firms most vulnerable to energy price hikes by 0,1 % of GDP. The growth of nationally financed primary current expenditure in excess of the medium-term potential output growth is therefore not due to the targeted support to households and firms most vulnerable to energy price hikes and to people fleeing Ukraine. The expansionary growth in nationally financed primary current expenditure (net of discretionary revenue measures) is also driven by permanent increases in public-sector wages and social benefits (due to the indexation of such wages and benefits), by structurally rising current expenditure resulting from demographic ageing, by a reform of residential energy contract taxation, and by a temporary decrease in firms’ social contributions during the first half of 2023. In sum, the projected growth of nationally financed primary current expenditure is not in line with the Council Recommendation of 12 July 2022. Expenditure financed by grants under the Facility and other Union funds is projected to amount to 0,3 % of GDP in 2023, while nationally financed investment is projected to provide an expansionary contribution to the fiscal stance of 0,1 percentage points <a>(<span>13</span>)</a>. Therefore, Belgium plans to finance additional investment through the Facility and other Union funds, and it also plans to preserve nationally-financed investment. It plans to finance public investment for the green and digital transitions, and for energy security, such as investment projects in the renovation of buildings, sustainable mobility and the decarbonisation of the energy sector, and key investments to accelerate the digital transition, including digitalising the public administration, promoting digital inclusion and reinforcing cyber security, which are funded by the Facility and other Union funds.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(21)</p></td><td><p>According to the 2023 Stability Programme the general government deficit is expected to decline to 4,2 % of GDP in 2024. The decrease in 2024 also reflects the withdrawal of temporary support measures that were adopted in the context of rising energy prices. According to the 2023 Stability Programme, the general government debt-to-GDP ratio is expected to increase to 107,1 % at the end of 2024. On the basis of policy measures known at the cut-off date of the forecast, the Commission’s 2023 spring forecast projects a government deficit of 4,7 % of GDP in 2024. This is higher than the deficit projected in the 2023 Stability Programme, mainly due to deficit-reducing measures not yet specified in the 2023 Stability Programme amounting to 0,2 % of GDP (therefore not taken into account in the Commission’s 2023 spring forecast) and to a less favourable projection of government revenue, in particular as regards corporate taxes. The Commission’s 2023 spring forecast projects a similar general government debt-to-GDP ratio of 107,3 % at the end of 2024.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(22)</p></td><td><p>The 2023 Stability Programme envisages the phasing-out of all of the energy support measures in 2024. The Commission also currently assumes the full phasing-out of energy support measures in 2024. This is based on the assumption of no renewed energy price increases.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(23)</p></td><td><p>Regulation (EC) No 1466/97 calls for an annual improvement in the structural budget balance toward the medium-term budgetary objective, with 0,5 % of GDP as a benchmark <a>(<span>14</span>)</a>. Taking into account fiscal sustainability considerations and the need to reduce the deficit to below the 3 %-of-GDP Treaty reference value, an improvement in the structural balance of at least 0,7 % of GDP for 2024 would be appropriate, according to the Commission. To ensure such an improvement, and in accordance with the Commission’s methodology, the growth in net nationally-financed primary expenditure <a>(<span>15</span>)</a> in 2024 should not exceed 2 %, as reflected in this Recommendation. At the same time, the remaining energy support measures (currently estimated by the Commission at 0,4 % of GDP in 2023) should be phased out, if energy-market developments so permit and starting with the least targeted measures, and the related savings should be used to reduce the government deficit. In addition, according to the Commission’s 2023 spring forecast, the growth in net nationally-financed primary current expenditure in 2023 is not in line with the Council Recommendation of 12 July 2022. If this is confirmed, lower growth in net primary expenditure in 2024 would be appropriate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(24)</p></td><td><p>Assuming unchanged policies, the Commission’s 2023 spring forecast projects the net nationally financed primary expenditure to grow by 2,7 % in 2024, which is above the recommended growth rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(25)</p></td><td><p>According to the 2023 Stability Programme, government investment is expected to increase from 2,9 % of GDP in 2023 to 3,1 % of GDP in 2024. The higher investment reflects higher nationally financed investment and investment financed by the Union, namely through the Facility. The 2023 Stability Programme refers to reforms and investments that are expected to contribute to fiscal sustainability and sustainable and inclusive growth. Those reforms and investments include a project for a fiscal reform of the tax and benefits system aimed at boosting employment and economic activity, thereby fostering the sustainability of public finances, and a pension reform (as foreseen in the recovery and resilience plan) to improve the financial sustainability of the pensions system. In addition, the recovery and resilience plan intends to step up efforts to bolster public investment with a view to speeding up the green and digital transitions, including through the implementation of the recovery and resilience plan.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(26)</p></td><td><p>The 2023 Stability Programme outlines a medium-term fiscal path until 2026. According to the 2023 Stability Programme, the general government deficit is expected to decline to 3,3 % of GDP in 2025 and to 2,9 % by 2026. Therefore, the general government deficit is planned to decrease below 3 % of GDP in 2026. According to the 2023 Stability Programme, the general government debt-to-GDP ratio is expected to increase from 107,1 % at the end of 2024 to 107,8 % by the end of 2026.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(27)</p></td><td><p>Belgium faces substantial fiscal sustainability challenges. Those challenges relate to both the high level of government debt and the expected worsening, under unchanged policies, of the impact of ageing-related expenditure on public finances in the face of a rapidly ageing population. In the Commission’s 2021 Ageing Report, ageing-related expenditure is projected to increase by 3,6 percentage points of GDP by 2040 and by 5,4 percentage points of GDP by 2070, mostly due to pension and long-term care expenditure. Pension expenditure is projected to increase by 3 percentage points of GDP over 2019–2070, compared to 0,1 percentage point of GDP on average in the euro area. In the case of Belgium, the bulk of the projected increase would already occur by 2040, when pension expenditure would increase by 2,7 percentage points of GDP to 14,9 % of GDP. Belgium’s recovery and resilience plan includes a pension reform that aims to help address this challenge, alongside other objectives such as improving the social sustainability of the system, incentivising people to remain active in the labour market after meeting early retirement conditions and ensuring greater convergence between and within pension systems. On long-term care, public spending amounted to 2,2 % of GDP in 2019 (Union average 1,7 %), which made Belgium one of the countries with the highest spending on long-term care in the Union. By 2070, long-term care expenditure is projected to increase further to 4,3 % of GDP in the baseline scenario. However, those costs could increase to 6,0 % of GDP in the most negative scenarios <a>(<span>16</span>)</a>. Evidence suggests a possible overuse of residential care and unnecessary or premature institutionalisation of older people. Available data suggest that the number of older people placed unnecessarily or at least prematurely in a residential care facility remains high, although it has been decreasing over the last decade. In particular, the data pointed out that the share of individuals affected by this issue was high in Brussels and Wallonia. Reforms to improve the cost-efficient use of the different care settings, in particular to avoid and delay unnecessary or premature institutionalisation, have been initiated by the federated entities, to which responsibility for long-term care has been devolved since 2019. However, they do not focus enough on addressing the fiscal sustainability challenge.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(28)</p></td><td><p>Despite recent reforms, the tax wedge (social security contributions and taxation of labour income) in Belgium remains well above the Union average at all wage levels, except for very low wage earners (50 % of the average), which may create disincentives to work. Some measures have been introduced to increase the net income of low wage earners, such as the job bonus (in Flanders) and in-work benefits for the long-term unemployed or for interregional mobility (at federal level). However, those measures also further increase the high marginal tax rate for lower-middle-income earners (‘low wage trap’), which may discourage investments in lifelong learning as well as increase the number of hours worked. Unemployment benefits are unlimited in time and not means-tested for the long-term unemployed. Moreover, several non-cash social benefits are linked to the unemployment status of beneficiaries, which may contribute to existing inactivity, unemployment and low wage traps. A broad review of the benefits system would improve transparency in terms of work incentives and could contribute to increase the effectiveness of activation policies.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(29)</p></td><td><p>The extensive use of tax expenditure, partly to counterbalance the high tax rates, creates inefficiencies and tends to favour certain types of remuneration and expenses. This leads to economic, social and environmental distortions. Special schemes like meal vouchers, commuting subsidies or withholding tax exemption for overtime, research and development work and night/shift work are costly for the budget and have been found to create inefficiencies. Some personal income tax deductions (e.g. deduction for service vouchers) disproportionally benefit high-income earners. There are still tax incentives for immovable property investments at federal level (cadastral values that underestimate actual rental income, interest deductibility for secondary housing loans) and at regional level (<span>chèque-habitat</span> in Wallonia). Those tax incentives distort resource allocation and potentially generate tax-induced overinvestment in certain types of assets. Tax-related environmentally harmful subsidies have increased. The reduction of the VAT rate on electricity and gas for residential contracts, while providing household support, continues to favour fossil fuels in the long term and discourages further diversification and energy savings. In the face of increasing traffic congestion and air pollution issues, transport taxes and pollution taxes still seem to be underused. The broader tax reform, which the government plans to phase in by 2024, is expected – if adopted and implemented – to reduce the tax burden on labour and reduce some of the distortions.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(30)</p></td><td><p>In accordance with Article 19(3), point (b), of Regulation (EU) 2021/241 and criterion 2.2 of Annex V to that Regulation, the recovery and resilience plan includes an extensive set of mutually reinforcing reforms and investments to be implemented by 2026. The implementation of Belgium’s recovery and resilience plan is underway, albeit with increasing risk of delays. Belgium has not yet submitted a payment request. An effective governance will be needed to allow for a swift and steady implementation. The recovery and resilience plan is expected to be revised in 2023, to include among others a REPowerEU chapter, while taking into account the downward revision of the Facility maximum grant allocation to Belgium. The swift inclusion of the new REPowerEU chapter in the recovery and resilience plan will allow additional reforms and investments to be financed in support of Belgium’s strategic objectives in the field of energy and the green transition. In accordance with Article 14(6) of Regulation (EU) 2021/241, on 31 March 2023, Belgium expressed its intention to request EUR 1 024 900 000 of additional loan support under the Facility. The systematic and effective involvement of local and regional authorities, social partners and other relevant stakeholders remains important for the successful implementation of the recovery and resilience plan, as well as other economic and employment policies going beyond that plan, in order to ensure broad ownership of the overall policy agenda.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(31)</p></td><td><p>The Commission approved all Belgium’s cohesion policy programming documents in 2022 apart from the European Regional Development Fund for the Brussels-Capital Region, which was adopted in 2023. Proceeding with the swift implementation of the cohesion policy programmes in complementarity and synergy with the recovery and resilience plan, including the REPowerEU chapter, is key to achieving the green and digital transitions, increasing economic and social resilience and achieving balanced territorial development in Belgium.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(32)</p></td><td><p>Beyond the economic and social challenges addressed by the recovery and resilience plan and cohesion policy programmes, Belgium faces a number of additional challenges related to its labour market, education system, energy policy and the green transition. The job vacancy rate in Belgium is currently one of the highest in the Union and employers are finding it increasingly difficult to hire employees with the right skills. Regional disparities in labour market participation, however, are significant. Labour shortages are high in both low- and high-skilled occupations with shortages in several sectors, including information and communication technologies, professional, technical and scientific jobs, hospitality and healthcare. The number of graduates, especially women, in science, technology, engineering and mathematics (STEM) remains low and their share is only slowly increasing, despite dedicated STEM action plans. Skills mismatches are also explained by low participation in adult learning. The current incentives for adult learning may not reach the low-educated, for whom upskilling could offer better employment opportunities. High-quality education and training systems that respond to changing labour market needs and targeted upskilling and reskilling measures are key to reducing skills shortages and promoting labour inclusion and reallocation. Addressing labour shortages and skills mismatches is a key lever for tackling the digital transformation and enabling the green transition, as well as for achieving the 2030 Union headline targets on employment and skills.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(33)</p></td><td><p>In addition to reducing work disincentives from the tax and benefits system, more effective and targeted activation measures could help unlock the large untapped labour potential and alleviate the growing labour and skills shortages. Disadvantaged groups, including people with low education attainment, a migrant background or with disabilities, are less integrated in the labour market. There is a low transition rate on average from unemployment or inactivity to employment. This suggests that there is still scope to strengthen the effectiveness of active labour market policies, in particular with more systematic evaluations and integrated pathways for jobseekers who face multiple barriers to finding a job. Pursuing policies to boost the reintegration of workers on long-term sick leave, in particular due to burnout and depression (25 % of cases), who now largely exceed the number of unemployed, will also be necessary to further increase the employment rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(34)</p></td><td><p>On labour shortages and skills mismatches, there are concerns about the performance, inclusiveness and equity of the education systems, also in light of high public spending on education. The gap in educational outcomes is closely linked to students’ socioeconomic and migrant background and is among the largest in the Union, leading to inequalities in education. Increasing the labour market relevance and attractiveness of vocational education and training will be key. Strengthening the teaching profession by providing better teacher training and continuous professional development, and by developing more flexible and attractive career paths, would help reduce a growing shortage of qualified teachers, which risks further increasing existing educational inequalities. Some steps have been recently taken or are planned to strengthen the teaching profession. It will be essential to continue and monitor the implementation of those measures and their impact.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(35)</p></td><td><p>Around 70 % of Belgium’s gross inland energy consumption is covered by fossil fuel imports. In 2021, oil provided 45 % of Belgium’s energy mix and natural gas 23 %. Belgium’s consumption of natural gas dropped by 15 % in the period between August 2022 and March 2023, compared with the average gas consumption over the same period in the preceding five years, in line with the 15 % reduction target laid down in Council Regulation (EU) 2022/1369 <a>(<span>17</span>)</a>. Belgium could keep pursuing efforts to temporarily reduce gas demand until 31 March 2024 pursuant to Council Regulation (EU) 2023/706 <a>(<span>18</span>)</a>. Renewable energy accounted for only 13 % of final energy consumption in 2021. Belgium will need to significantly increase its renewable energy target by 2030, which is currently 17,5 % and considered unambitious in the Commission’s 2020 assessment, to reflect the more ambitious Union objectives. To meet the planned reduction of nuclear energy and projected rise in electricity demand, energy efficiency and the share of electricity from renewable sources will need to significantly increase. The development of onshore wind projects and the related expansion of the power grid are, however, still severely hampered by low public acceptance and long delays related to permitting procedures, in particular due to repetitive and lengthy appeal procedures. Further steps can be taken to accelerate the deployment of onshore wind power and related grid reinforcement. Spatial planning and a review of the minimum distance rules of wind turbines from airports, radars and military zones could free up more space for wind energy. Furthermore, permitting could be made easier by granting wind and grid infrastructure projects the status of overriding public interest and processing appeals faster. The participation of municipalities and citizens in renewable energy generation projects could increase local acceptability.</p><p>The expansion of rooftop solar power (both small-scale and large-scale installations) could be further stimulated by adopting reforms that provide for binding requirements for large public and commercial buildings, incentives for landlords, and legal frameworks that facilitate energy sharing. In addition, self-consumption and demand-side flexibility could be promoted. The proactive development of more integrated and consistent ten-year electricity network investment plans could avoid delays in connecting new wind energy projects (and other renewable sources) as well as end users (heat pumps, charging points for electric cars), and should anticipate the expected surge in industrial electricity consumption.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(36)</p></td><td><p>Further policy reforms and additional investments to reduce greenhouse gas emissions in the energy, industry, building and transport sectors would help reduce Belgium’s high overall dependency on fossil fuel imports. Energy efficiency gains in industry could be incentivised by improving voluntary agreements, introducing energy savings and decarbonisation plans for the largest fossil fuel users, stimulating electrification and the deployment of industrial heat pumps and further embedding circular production methods. Belgium risks not reaching its renovation and energy efficiency targets for 2030. The challenge of reducing fossil fuel consumption in buildings is still considerable. The current investment efforts on energy renovations should therefore be stepped up and complemented with policy reforms such as a ban on fossil fuels in new buildings, mandatory energy-efficient renovations, phasing out fossil fuel-based heating and shifting incentives towards low carbon heating solutions such as heat pumps and heat networks supplied with recovered and renewable energy. This should be matched by adapting education and training to the relevant emerging green technical skills and ensuring sufficient and appropriately skilled technicians and construction workers. In transport, the high share of private car use accounts for a large part of oil consumption in Belgium. Promoting ‘soft mobility’ (for example, cycling and shared mobility) and the use of public transport would help reduce the use of private cars, together with road congestion costs. In 2022, cycling increased as a method of commuting to work, particularly in Flanders and Brussels, thanks to continuous investments in cycling infrastructure, promotion initiatives and targeted incentives. However, there is still scope to further encourage this form of soft mobility through investments in cycling infrastructure and in road safety for cyclists. The use of public transport has not yet fully recovered after the COVID-19 crisis and could be further promoted by improvements to suburban and intercity services, investments in fleet renewal and higher frequency of services.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(37)</p></td><td><p>Labour and skills shortages in sectors and occupations key for the green transition, including manufacturing, deployment and maintenance of net-zero technologies, are creating bottlenecks in the transition to a net-zero economy. High-quality education and training systems that respond to changing labour market needs and targeted upskilling and reskilling measures are key to reducing skills shortages and promoting labour inclusion and reallocation. To unlock untapped labour supply, those measures need to be accessible, in particular for individuals and in sectors and regions most affected by the green transition. In 2022, labour shortages were reported for several occupations that require specific skills or knowledge for the green transition, including civil engineering functions and power-plant operators.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(38)</p></td><td><p>In the light of the Commission’s assessment, the Council has examined the 2023 Stability Programme and its opinion <a>(<span>19</span>)</a> is reflected in recommendation (1).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(39)</p></td><td><p>In view of the close interlinkages between the economies of euro-area Member States and their collective contribution to the functioning of the economic and monetary union, the Council recommended that euro-area Member States take action, including through their recovery and resilience plans, to (i) preserve debt sustainability and refrain from broad-based support to aggregate demand in 2023, better target fiscal measures taken to mitigate the impact of high energy prices and reflect on appropriate ways to wind down support as energy price pressures diminish; (ii) sustain a high level of public investment and promote private investment to support the green and digital transitions; (iii) support wage developments that mitigate the loss in purchasing power while limiting second-round effects on inflation, further improve active labour-market policies and address skills shortages; (iv) improve the business environment and ensure that energy support to companies is cost-effective, temporary and targeted to viable firms and that it maintains incentives for the green transition; and (v) preserve macro-financial stability and monitor risks while continuing to work on completing the banking union. For Belgium, recommendations (1), (2), (3) and (4) contribute to the implementation of the first, second and third recommendations set out in the 2023 Recommendation on the euro area,</p></td></tr></tbody></table>
HEREBY RECOMMENDS that Belgium take action in 2023 and 2024 to:
1. Wind down the emergency energy support measures in force, using the related savings to reduce the government deficit, as soon as possible in 2023 and 2024. Should renewed energy price increases necessitate new or continued support measures, ensure that such support measures are targeted at protecting vulnerable households and firms, are fiscally affordable and preserve incentives for energy savings.
Ensure prudent fiscal policy, in particular by limiting the nominal increase in nationally financed net primary expenditure in 2024 to not more than 2 % ( 20 ) .
Preserve nationally financed public investment and ensure the effective absorption of grants under the Facility and of other Union funds, in particular to foster the green and digital transitions.
For the period beyond 2024, continue to pursue a medium-term fiscal strategy of gradual and sustainable consolidation, combined with investments and reforms conducive to higher sustainable growth, in order to achieve a prudent medium-term fiscal position.
Strengthen efforts to improve the efficiency of long-term care. Pursue the reform of the taxation and benefits system to reduce disincentives to work by shifting the tax burden away from labour and by simplifying the tax and benefits system. Review tax expenditures in order to reduce their economic, social and environmental harmful impact.
2. Ensure effective governance in order to allow for a swift and steady implementation of its recovery and resilience plan. Swiftly finalise the REPowerEU chapter with a view to rapidly starting the implementation thereof. Proceed with the speedy implementation of cohesion policy programmes, in close complementarity and synergy with the recovery and resilience plan.
3. Address labour shortages and skills mismatches, in particular by strengthening activation policies (including guidance) in order to integrate disadvantaged groups into the labour market. Improve the performance and equity of the education and training systems, and continue reforms to strengthen the teaching profession.
4. Reduce overall reliance on fossil fuels by stepping up energy efficiency improvements and the reduction of fossil fuel use in buildings, by further stimulating the decarbonisation of industry and by promoting the use and supply of public transport and soft mobility. Accelerate the deployment of renewable energies and related grid infrastructure by further streamlining permitting procedures, including by reducing the length of appeal procedures, and by adopting legal frameworks to further boost investments in renewable energy installations and facilitate energy sharing. Step up policy efforts aimed at the provision and acquisition of skills and competences needed for the green transition.
Done at Brussels, 14 July 2023.
For the Council
The President
N. CALVIÑO SANTAMARÍA
<note>
( 1 ) OJ L 209, 2.8.1997, p. 1 .
( 2 ) Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility ( OJ L 57, 18.2.2021, p. 17 ).
( 3 ) Regulation (EU) No 1176/2011 of the European Parliament and of the Council of 16 November 2011 on the prevention and correction of macroeconomic imbalances ( OJ L 306, 23.11.2011, p. 25 ).
( 4 ) Council Recommendation of 16 May 2023 on the economic policy of the euro area ( OJ C 180, 23.5.2023, p. 1 ).
( 5 ) Regulation (EU) 2023/435 of the European Parliament and of the Council of 27 February 2023 amending Regulation (EU) 2021/241 as regards REPowerEU chapters in recovery and resilience plans and amending Regulations (EU) No 1303/2013, (EU) 2021/1060 and (EU) 2021/1755, and Directive 2003/87/EC ( OJ L 63, 28.2.2023, p. 1 ).
( 6 ) ST 10161/21 INIT; ST 10161/21 ADD 1.
( 7 ) Council Recommendation of 18 June 2021 delivering a Council opinion on the 2021 Stability Programme of Belgium ( OJ C 304, 29.7.2021, p. 1 ).
( 8 ) The fiscal stance is measured as the change in primary expenditure (net of discretionary revenue measures), excluding temporary emergency measures related to the COVID-19 crisis but including expenditure financed by non-repayable support (grants) from the Facility and other Union funds, relative to medium-term potential growth. For more details see Box 1 in the Fiscal Statistical Tables.
( 9 ) Other nationally financed capital expenditure provided a neutral contribution of 0 percentage points of GDP.
( 10 ) That figure represents the level of annual budgetary cost of those measures, including current revenue and expenditure as well as, where relevant, capital expenditure measures.
( 11 ) Council Recommendation of 12 July 2022 on the 2022 National Reform Programme of Belgium and delivering a Council opinion on the 2022 Stability Programme of Belgium ( OJ C 334, 1.9.2022, p. 1 ).
( 12 ) On the basis of the Commission’s 2023 spring forecast, the medium-term (10-year average) potential output growth of Belgium is estimated at 5,4 % in nominal terms.
( 13 ) Other nationally financed capital expenditure is projected to provide an expansionary contribution of 0,1 percentage points of GDP.
( 14 ) Article 5 of Regulation (EC) No 1466/97 also requires an adjustment of more than 0,5 % of GDP for Member States with a government debt exceeding 60 % of GDP, or with more pronounced debt sustainability risks.
( 15 ) Net primary expenditure is defined as nationally financed expenditure net of discretionary revenues measures and excluding interest expenditure and cyclical unemployment expenditure.
( 16 ) European Commission, 2021 Ageing Report. Belgium long-term care spending is projected to reach 6 % of GDP in the cost convergence scenario and in the cost and coverage convergence scenario.
( 17 ) Council Regulation (EU) 2022/1369 of 5 August 2022 on coordinated demand-reduction measures for gas ( OJ L 206, 8.8.2022, p. 1 ).
( 18 ) Council Regulation (EU) 2023/706 of 30 March 2023 amending Regulation (EU) 2022/1369 as regards prolonging the demand-reduction period for demand-reduction measures for gas and reinforcing the reporting and monitoring of their implementation ( OJ L 93, 31.3.2023, p. 1 ).
( 19 ) Under Article 5(2) of Regulation (EC) No 1466/97.
( 20 ) Which is estimated to correspond to an annual improvement in the structural budget balance of at least 0,7 % of GDP for 2024, as described in recital 23.
</note> | ENG | 32023H0901(01) |
<table><col/><col/><col/><col/><tbody><tr><td><p>7.6.2019   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 149/53</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2019/935
of 16 April 2019
laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards analysis methods for determining the physical, chemical and organoleptic characteristics of grapevine products and notifications of Member States decisions concerning increases in natural alcoholic strength
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) and in particular Articles 80(5), 91(c) and (d) and 223(3) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Regulation (EU) No 1308/2013 repealed and replaced Council Regulation (EC) No 1234/2007 <a>(<span>2</span>)</a>. Section 1 of Chapter I of Title II of Part II of Regulation (EU) No 1308/2013 lays down rules on the categories of grapevine products, oenological practices and the applicable restrictions and empowers the Commission to adopt delegated and implementing acts in that respect. In order to ensure the smooth functioning of the wine market in the new legal framework, certain rules have to be adopted by means of such acts. Those acts should replace the provisions of Commission Regulation (EC) No 606/2009 <a>(<span>3</span>)</a> which is repealed by Commission Delegated Regulation (EU) 2019/934 <a>(<span>4</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Pursuant to Article 80(5) and Article 91(d) of Regulation (EU) No 1308/2013 the Commission shall, where necessary, lay down rules on the analysis methods for determining the physical, chemical and organoleptic characteristics of grapevine products. The methods shall be based on any relevant methods recommended and published by the International Organisation of Vine and Wine (OIV), unless they would be ineffective or inappropriate. Article 91(c) of Regulation (EU) No 1308/2013 moreover empowers the Commission to lay down rules for checking whether those products have been subjected to processes contrary to the authorised oenological practices in the Union.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The method of analysis for determining whether allyl isothiocyanate is present in the wine product is laid down in the Annex to this Regulation. As regards other methods for determining whether products have undergone processes contrary to the authorised oenological practices, the applicable rules should be those allowed by the Member States concerned.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Point 3 of Section A of Part I of Annex VIII to Regulation (EU) No 1308/2013 sets out an obligation for Member States to notify the Commission of any increase in the limits laid down in point 2 of that Section. Details concerning the submission of this information by Member States to the Commission should be laid down.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Scope
This Regulation lays down rules for the application of Title II, Chapter I of Regulation (EU) No 1308/2013, concerning analysis methods for determining the physical, chemical and organoleptic characteristics of grapevine products, and notifications of decisions by Member States allowing increases in natural alcoholic strength.
Article 2
Applicable Union analysis methods
The analysis methods referred to in point (d) of Article 75(5) of Regulation (EU) No 1308/2013 to be used for verification of the limits laid down by Union rules to the use of allyl isothiocyanate for the production of certain grapevine products are laid down in the Annex to this Regulation.
Article 3
Notification of Member States decisions allowing an increase in natural alcoholic strength
1. Member States allowing for an increase of the natural alcoholic strength by volume pursuant to point 3 of Section A of Part I of Annex VIII to Regulation (EU) No 1308/2013 shall notify the Commission of this within one month following the granting of the derogation. In the notification, the Member States shall specify the regions and the varieties concerned by the decision and they shall submit data and evidence indicating that the climatic conditions have been exceptionally unfavourable in the regions concerned.
2. The notification shall be made in accordance with Commission Delegated Regulation (EU) 2017/1183 ( 5 ) and Commission Implementing Regulation (EU) 2017/1185 ( 6 ) .
3. The Commission shall then inform the other Member States.
Article 4
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
It shall apply from 7 December 2019 .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 April 2019.
For the Commission
The President
Jean-Claude JUNCKER
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organization of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) ( OJ L 299, 16.11.2007, p. 1 ).
( 3 ) Commission Regulation (EC) No 606/2009 of 10 July 2009 laying down certain detailed rules for implementing Council Regulation (EC) No 479/2008 as regards the categories of grapevine products, oenological practices and the applicable restrictions ( OJ L 193, 24.7.2009, p. 1 ).
( 4 ) Commission Delegated Regulation (EU) 2019/934 of 12 March 2019 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards wine-growing areas where the alcoholic strength may be increased, authorised oenological practices and restrictions applicable to the production and conservation of grapevine products, the minimum percentage of alcohol for by-products and their disposal, and publication of OIV files (see page 1 of this Official Journal).
( 5 ) Commission Delegated Regulation (EU) 2017/1183 of 20 April 2017 on supplementing Regulations (EU) No 1307/2013 and (EU) No 1308/2013 of the European Parliament and of the Council with regard to the notifications to the Commission of information and documents ( OJ L 171, 4.7.2017, p. 100 ).
( 6 ) Commission Implementing Regulation (EU) 2017/1185 of 20 April 2017 laying down rules for the application of Regulations (EU) No 1307/2013 and (EU) No 1308/2013 of the European Parliament and of the Council as regards notifications to the Commission of information and documents and amending and repealing several Commission Regulations ( OJ L 171, 4.7.2017, p. 113 ).
ANNEX
SPECIAL UNION ANALYSIS METHODS
ALLYL ISOTHIOCYANATE
1. Principle of the method
Any allyl isothiocyanate present in the wine is collected by distillation and identified by gas chromatography.
2. Reagents
2.1. Ethanol, absolute.
2.2. Standard solution: solution of allyl isothiocyanate in absolute alcohol containing 15 mg of allyl isothiocyanate per litre.
2.3. Freezing mixture consisting of ethanol and dry ice (temperature – 60 °C).
3. Apparatus
3.1. Distillation apparatus as shown in the figure. A stream of nitrogen is passed continuously through the apparatus.
3.2. Heating mantle, thermostatically controlled.
3.3. Flowmeter.
3.4. Gas chromatograph fitted with a flame spectrophotometer detector equipped with a selective filter for sulphur compounds (wavelength = 394 nm) or any other suitable detector.
3.5. Stainless steel chromatograph column of internal diameter 3 mm and length 3 m filled with Carbowax 20M at 10 % on Chromosorb WHP, 80 to 100 mesh.
3.6. Microsyringe, 10μl.
4. Procedure
Put two litres of wine into the distillation flask, introduce a few millilitres of ethanol (point 2.1) into the two collecting tubes so that the porous parts of the gas dispersion rods are completely immersed. Cool the two tubes externally with the freezing mixture. Connect the flask to the collecting tubes and begin to flush the apparatus with nitrogen at a rate of three litres per hour. Heat the wine to 80 °C with the heating mantle, distil and collect 45 to 50 ml of the distillate.
Stabilize the chromatograph. It is recommended that the following conditions are used:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>injector temperature: 200 °C,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>column temperature: 130 °C,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>helium carrier gas flow rate: 20 ml per minute.</p></td></tr></tbody></table>
With the microsyringe, introduce a volume of the standard solution such that the peak corresponding to the allyl isothiocyanate can easily be identified on the gas chromatogram.
Similarly introduce an aliquot of the distillate into the chromatograph. Check that the retention time of the peak obtained corresponds with that of the peak of allyl isothiocyanate.
Under the conditions described above, compounds naturally present in the wine will not produce interfering peaks on the chromatogram of the sample solution.
Apparatus for distillation under a current of nitrogen | ENG | 32019R0935 |
<table><col/><col/><col/><col/><tbody><tr><td><p>27.9.2019   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 249/283</p></td></tr></tbody></table>
DECISION (EU, Euratom) 2019/1514 OF THE EUROPEAN PARLIAMENT
of 26 March 2019
on the closure of the accounts of the Euratom Supply Agency for the financial year 2017
THE EUROPEAN PARLIAMENT,
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the final annual accounts of the Euratom Supply Agency for the financial year 2017,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the Court of Auditors' report on the annual accounts of the Euratom Supply Agency for the financial year 2017, together with the Agency's reply <a>(<span>1</span>)</a>,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the statement of assurance <a>(<span>2</span>)</a> as to the reliability of the accounts and the legality and regularity of the underlying transactions provided by the Court of Auditors for the financial year 2017, pursuant to Article 287 of the Treaty on the Functioning of the European Union,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the Council's recommendation of 12 February 2019 on discharge to be given to the Agency in respect of the implementation of the budget for the financial year 2017 (05825/2019 — C8-0089/2019),</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Article 319 of the Treaty on the Functioning of the European Union,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Article 106a of the Treaty establishing the European Atomic Energy Community,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 <a>(<span>3</span>)</a>, and in particular Article 1(2) thereof,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 <a>(<span>4</span>)</a>, and in particular Article 68 thereof,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Council Decision 2008/114/EC, Euratom of 12 February 2008 establishing Statutes for the Euratom Supply Agency <a>(<span>5</span>)</a>, and in particular Article 8 thereof,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Rule 94 of and Annex IV to its Rules of Procedure,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the report of the Committee on Budgetary Control (A8-0132/2019),</p></td></tr></tbody></table>
1. Approves the closure of the accounts of the Euratom Supply Agency for the financial year 2017;
2. Instructs its President to forward this decision to the Acting Director-General of the Euratom Supply Agency, the Council, the Commission and the Court of Auditors, and to arrange for its publication in the Official Journal of the European Union (L series).
The President
Antonio TAJANI
The Secretary-General
Klaus WELLE
<note>
( 1 ) OJ C 434, 30.11.2018, p. 188 .
( 2 ) OJ C 434, 30.11.2018, p. 188 .
( 3 ) OJ L 298, 26.10.2012, p. 1 .
( 4 ) OJ L 193, 30.7.2018, p. 1 .
( 5 ) OJ L 41, 15.2.2008, p. 15 .
</note> | ENG | 32019B1514 |
01995R0297 — EN — 01.04.2023 — 018.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
<table><col/><col/><tr><td><p><a>►B</a></p></td><td><p> COUNCIL REGULATION (EC) No 297/95</p><p>of 10 February 1995</p><p><a>on fees payable to the European Agency for the Evaluation of Medicinal Products</a></p><p>(OJ L 035 15.2.1995, p. 1)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p> </p></td><td><p> </p></td><td><p>Official Journal</p></td></tr><tr><td><p>  No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>►M1</a></p></td><td><p><a> COUNCIL REGULATION (EC) No 2743/98 of 14 December 1998</a></p></td><td><p>  L 345</p></td><td><p>3</p></td><td><p>19.12.1998</p></td></tr><tr><td><p><a> M2</a></p></td><td><p><a> COMMISSION REGULATION (EC) No 494/2003 of 18 March 2003</a></p></td><td><p>  L 73</p></td><td><p>6</p></td><td><p>19.3.2003</p></td></tr><tr><td><p><a>►M3</a></p></td><td><p><a> COUNCIL REGULATION (EC) No 1905/2005 of 14 November 2005</a></p></td><td><p>  L 304</p></td><td><p>1</p></td><td><p>23.11.2005</p></td></tr><tr><td><p><a> M4</a></p></td><td><p><a> COMMISSION REGULATION (EC) No 312/2008 of 3 April 2008</a></p></td><td><p>  L 93</p></td><td><p>8</p></td><td><p>4.4.2008</p></td></tr><tr><td><p><a> M5</a></p></td><td><p><a> COMMISSION REGULATION (EC) No 249/2009 of 23 March 2009</a></p></td><td><p>  L 79</p></td><td><p>34</p></td><td><p>25.3.2009</p></td></tr><tr><td><p><a> M6</a></p></td><td><p><a> COMMISSION REGULATION (EU) No 261/2010 of 25 March 2010</a></p></td><td><p>  L 80</p></td><td><p>36</p></td><td><p>26.3.2010</p></td></tr><tr><td><p><a> M7</a></p></td><td><p><a> COMMISSION REGULATION (EU) No 301/2011 of 28 March 2011</a></p></td><td><p>  L 81</p></td><td><p>5</p></td><td><p>29.3.2011</p></td></tr><tr><td><p><a> M8</a></p></td><td><p><a> COMMISSION REGULATION (EU) No 273/2012 of 27 March 2012</a></p></td><td><p>  L 90</p></td><td><p>11</p></td><td><p>28.3.2012</p></td></tr><tr><td><p><a> M9</a></p></td><td><p><a> COMMISSION REGULATION (EU) No 220/2013 of 13 March 2013</a></p></td><td><p>  L 70</p></td><td><p>1</p></td><td><p>14.3.2013</p></td></tr><tr><td><p><a> M10</a></p></td><td><p><a> COMMISSION REGULATION (EU) No 272/2014 of 17 March 2014</a></p></td><td><p>  L 79</p></td><td><p>37</p></td><td><p>18.3.2014</p></td></tr><tr><td><p><a> M11</a></p></td><td><p><a> COMMISSION REGULATION (EU) 2015/490 of 23 March 2015</a></p></td><td><p>  L 78</p></td><td><p>9</p></td><td><p>24.3.2015</p></td></tr><tr><td><p><a> M12</a></p></td><td><p><a> COMMISSION REGULATION (EU) 2016/461 of 30 March 2016</a></p></td><td><p>  L 80</p></td><td><p>25</p></td><td><p>31.3.2016</p></td></tr><tr><td><p><a> M13</a></p></td><td><p><a> COMMISSION REGULATION (EU) 2017/612 of 30 March 2017</a></p></td><td><p>  L 86</p></td><td><p>7</p></td><td><p>31.3.2017</p></td></tr><tr><td><p><a> M14</a></p></td><td><p><a> COMMISSION REGULATION (EU) 2018/471 of 21 March 2018</a></p></td><td><p>  L 79</p></td><td><p>19</p></td><td><p>22.3.2018</p></td></tr><tr><td><p><a> M15</a></p></td><td><p><a> COMMISSION REGULATION (EU) 2019/480 of 22 March 2019</a></p></td><td><p>  L 82</p></td><td><p>15</p></td><td><p>25.3.2019</p></td></tr><tr><td><p><a> M16</a></p></td><td><p><a> COMMISSION REGULATION (EU) 2020/422 of 19 March 2020</a></p></td><td><p>  L 84</p></td><td><p>11</p></td><td><p>20.3.2020</p></td></tr><tr><td><p><a> M17</a></p></td><td><p><a> COMMISSION REGULATION (EU) 2022/510 of 29 March 2022</a></p></td><td><p>  L 103</p></td><td><p>3</p></td><td><p>31.3.2022</p></td></tr><tr><td><p><a>►M18</a></p></td><td><p><a> COMMISSION REGULATION (EU) 2023/699 of 29 March 2023</a></p></td><td><p>  L 92</p></td><td><p>1</p></td><td><p>30.3.2023</p></td></tr></table>
Corrected by:
<table><col/><col/><col/><col/><col/><tr><td><p><a> C1</a></p></td><td><p><a>Corrigendum, OJ L 075, 4.4.1995, p.  29  (297/1995)</a></p></td></tr></table>
<table><col/><tr><td><p>NB: This consolidated version contains references to the European unit of accout and/or the ecu, which from 1 January 1999 should be understood as references to the euro — Council Regulation (EEC) No 3308/80 (OJ L 345, 20.12.1980, p. 1) and Coundil Regulation (EC) No 1103/97 (OJ L 162, 19.6.1997, p. 1).</p></td></tr></table>
COUNCIL REGULATION (EC) No 297/95
of 10 February 1995
on fees payable to the European Agency for the Evaluation of Medicinal Products
Article 1
Scope
Fees for obtaining and maintaining a Community authorisation to market medicinal products for human and veterinary use and for other services supplied by the Agency shall be levied in accordance with this Regulation.
The amounts of these fees shall be laid down in euro.
Article 2
The Agency shall indicate in its annual estimate intended for the establishment of the preliminary draft budget of the Commission the estimates concerning the fees for the following financial year, and this shall be done separately from the estimating of the overall expenditure and the possible contribution by the Community.
Article 3
Medicinal products for human use covered by the procedures laid down in Regulation (EC) No 726/2004 ( 1 )
1. Authorisation to market a medicinal product
(a) Full fee
A full fee of EUR 345 800 shall apply for an application for a marketing authorisation supported by a full dossier. That fee shall cover a single strength associated with one pharmaceutical form and one presentation.
The fee shall be increased by EUR 34 800 for each additional strength and/or pharmaceutical form submitted at the same time as the initial application for authorisation. That increase shall cover one additional strength or pharmaceutical form and one presentation.
The fee shall be increased by EUR 8 600 for each additional presentation of the same strength and pharmaceutical form, submitted at the same time as the initial application for authorisation.
(b) Reduced fee
A reduced fee of EUR 134 100 shall apply to applications for a marketing authorisation pursuant to Article 10(1) and (3), and Article 10c of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( 2 ). That fee shall cover a single strength associated with one pharmaceutical form and one presentation.
A specific reduced fee of EUR 223 600 shall apply to applications for a marketing authorisation pursuant to Article 10(4) of Directive 2001/83/EC. That fee shall cover a single strength associated with one pharmaceutical form and one presentation.
The reduced fees referred to in the first and second subparagraph shall be increased by EUR 13 400 for each additional strength or pharmaceutical form submitted at the same time as the initial application for authorisation. That increase shall cover one additional strength or pharmaceutical form and one presentation.
The reduced fees referred to in the first and second subparagraph shall be increased by EUR 8 600 for each additional presentation of the same strength and pharmaceutical form, submitted at the same time as the initial application for authorisation.
(c) Extension fee
An extension fee of EUR 103 800 shall apply for each extension of a marketing authorisation within the meaning of Annex II to Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93 ( 3 ), which has already been granted.
By derogation from the first subparagraph, a reduced extension fee falling within the range of EUR 26 200 to EUR 77 900 shall apply for certain extensions. Those extensions shall be included in a list, which shall be drawn up in accordance with Article 11(2) of this Regulation.
The extension fee and the reduced extension fee shall be increased by EUR 8 600 for each additional presentation of the same extension submitted at the time of the extension application.
2. Variation
(a) Type I variation fee
A Type I variation fee shall apply for a minor variation to a marketing authorisation, as defined in Article 3(2) of Regulation (EC) No 1085/2003. For Type IA variations, the fee shall be EUR 3 900 . For Type IB variations, the fee shall be EUR 8 600 .
In the event of the same variation being introduced, this fee shall cover all authorised strengths, pharmaceutical forms and presentations.
(b) Type II variation fee
A Type II variation fee of EUR 103 800 shall apply for a major variation to a marketing authorisation, as defined in Article 3(3) of Regulation (EC) No 1085/2003.
By derogation from the first subparagraph, a reduced Type II variation fee falling within the range of EUR 26 200 to EUR 77 900 shall apply for certain variations. Those variations shall be included in a list, which shall be drawn up in accordance with Article 11(2) of this Regulation.
In the event of the same variation being introduced, this fee shall cover all authorised strengths, pharmaceutical forms and presentations.
3. Renewal fee
The fee for examininginformation available at the time of the five-yearly renewal of an authorisation to market a medicinal product shall be EUR 17 000 . It shall be charged for each strength associated with a pharmaceutical form.
4. Inspection fee
A fee of EUR 26 200 shall apply for any inspection within or outside the Community. For inspections outside the Community, travel expenses shall be charged extra on the basis of actual cost.
By derogation from the first subparagraph, a reduced inspection fee shall apply for certain inspections, according to the extent and nature of the inspection and on the basis of the conditions laid down in accordance with Article 11(2).
5. Transfer fee
The fee for a change in the holder of the marketing authorisations to which the transfer relates shall be EUR 8 600 . This covers all authorised presentations of a given medicinal product.
6. Annual fee
An annual fee of EUR 123 900 shall apply for each marketing authorisation of a medicinal product. That fee shall cover all authorised presentations of a given medicinal product.
By derogation from the first subparagraph, a reduced annual fee falling within the range of EUR 30 800 to EUR 92 800 shall apply for certain types of medicinal products. Those medicinal products shall be included in a list, which shall be drawn up in accordance with Article 11(2).
Article 4
Medicinal products for human use covered by the procedures laid down in Directive 2001/83/EC
Referral fee
A referral fee of EUR 86 000 shall apply where the procedures laid down in Article 30(1) and Article 31 of Directive 2001/83/EC are initiated by the applicant of a marketing authorisation or the holder of an existing marketing authorisation.
Where more than one applicant of marketing authorisations or holder of existing marketing authorisations are concerned by the procedures referred to in the first subparagraph, the applicants or holders may be grouped for the purpose of the payment of one single referral fee. If however, the same procedure concerns more than ten different applicants or holders, the fee shall be charged by the application of the abovementioned referral fee.
Article 5
Medicinal products for veterinary use covered by the procedures laid down in Regulation (EC) No 726/2004
1. Authorisation to market a medicinal product
(a) Full fee
A full fee of EUR 173 000 shall apply for an application for a marketing authorisation supported by a full dossier. That fee shall cover a single strength associated with one pharmaceutical form and one presentation.
The fee shall be increased by EUR 17 000 for each additional strength and/or pharmaceutical form submitted at the same time as the initial application for authorisation. That increase shall cover one additional strength or pharmaceutical form and one presentation.
The fee shall be increased by EUR 8 600 for each additional presentation of the same strength and pharmaceutical form, submitted at the same time as the initial application for authorisation.
In the case of immunological veterinary medicinal products, the full fee shall be reduced to EUR 86 000 , with each additional strength and/or pharmaceutical form and/or presentation entailing an increase of EUR 8 600 .
For the purposes of this point (a), the number of target species is irrelevant.
(b) Reduced fee
A reduced fee of EUR 86 000 shall apply to applications for a marketing authorisation pursuant to Article 13(1) and (3), and Article 13c of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products ( 4 ). That fee shall cover a single strength associated with one pharmaceutical form and one presentation.
A specific reduced fee of EUR 146 200 shall apply to applications for a marketing authorisation pursuant to Article 13(4) of Directive 2001/82/EC. That fee shall cover a single strength associated with one pharmaceutical form and one presentation.
The reduced fees referred to in the first and second subparagraph shall be increased by EUR 17 000 for each additional strength or pharmaceutical form submitted at the same time as the initial application for authorisation. That increase shall cover one additional strength or pharmaceutical form and one presentation.
The reduced fees referred to in the first and second subparagraph shall be increased by EUR 8 600 for each additional presentation of the same strength and pharmaceutical form, submitted at the same time as the initial application for authorisation.
In the case of immunological veterinary medicinal products, the fee shall be reduced to EUR 43 300 , with each additional strength and/or pharmaceutical form and/or presentation entailing an increase of EUR 8 600 .
For the purposes of this point, the number of target species is irrelevant.
(c) Extension fee
An extension fee of EUR 43 300 shall apply for each extension of a marketing authorisation within the meaning of Annex II to Regulation (EC) No 1085/2003, which has already been granted.
By derogation from the first subparagraph, a reduced extension fee falling withn the range of EUR 10 700 to EUR 32 600 shall apply for certain extensions. Those extensions shall be included in a list, which shall be drawn up in accordance with Article 11(2) of this Regulation.
The extension fee and the reduced extension fee shall be increased by EUR 8 600 for each additional presentation of the same extension submitted at the time of the extension application.
2. Variation
(a) Type I variation fee
A Type I variation fee shall apply for a minor variation to a marketing authorisation, as defined in Article 3(2) of Regulation (EC) No 1085/2003. For Type IA variations, the fee shall be EUR 3 900 . For Type IB variations, the fee shall be EUR 8 600 .
In the event of the same variation being introduced, this fee shall cover all authorised strengths, pharmaceutical forms and presentations.
(b) Type II variation fee
A Type II variation fee of EUR 51 800 shall apply for a major variation to a marketing authorisation, as defined in Article 3(3) of Regulation (EC) No 1085/2003.
By derogation from the first subparagraph, a reduced Type II variation fee falling within the range of EUR 13 000 to EUR 39 100 shall apply for certain variations. Those variations shall be included in a list, which shall be drawn up in accordance with Article 11(2) of this Regulation.
In the case of immunological veterinary medicinal products, the fee shall be EUR 8 600 .
In the event of the same variation being introduced, the fee referred to in the first, second and third subparagraph shall cover all authorised strengths, pharmaceutical forms and presentations.
3. Renewal fee
The fee for examining information available at the time of the five-yearly renewal of an authorisation to market a medicinal product shall be EUR 8 600 . It shall be charged for each strength associated with a pharmaceutical form.
4. Inspection fee
A fee of EUR 26 200 shall apply for any inspection within or outside the Community. For inspections outside the Community, travel expenses shall be charged extra on the basis of actual cost.
By derogation from the first subparagraph, a reduced inspection fee shall apply for certain inspections, according to the extent and nature of the inspection and on the basis of the conditions laid down in accordance with Article 11(2).
5. Transfer fee
The fee for a change in the holder of the marketing authorisations to which the transfer relates shall be EUR 8 600 . This covers all authorised presentations of a given medicinal product.
6. Annual fee
An annual fee of EUR 41 500 shall apply for each marketing authorisation of a medicinal product. That fee shall cover all authorised presentations of a given medicinal product.
By derogation from the first subparagraph, a reduced annual fee falling within the range of EUR 10 200 to EUR 30 800 shall apply for certain types of medicinal products. Those medicinal products shall be included in a list, which shall be drawn up in accordance with Article 11(2).
Article 6
Veterinary medicinal products covered by the procedures laid down in Directive 2001/82/EC
Referral fee
A referral fee of EUR 51 800 shall apply where the procedures laid down in Article 34(1) and Article 35 of Directive 2001/82/EC are initiated by the applicant of a marketing authorisation or the holder of an existing marketing authorisation.
Where more than one applicant of marketing authorisations or holder of existing marketing authorisations are concerned by the procedures referred to in the first subparagraph, the applicants or holders may be grouped for the purpose of the payment of one single referral fee. If however, the same procedure concerns more than ten different applicants or holders, the fee shall be charged by the application of the abovementioned referral fee.
Article 7
Establishment of maximum residue limits (MRL) for veterinary medicinal products in accordance with the procedures laid down in Regulation (EEC) No 2377/90 ( 5 )
1. Fees for establishing MRL
A full MRL fee of EUR 86 000 shall be charged for an application to set an initial MRL for a given substance.
An additional fee of EUR 26 200 shall apply for each application to modify an existing MRL, as included in one of the Annexes to Regulation (EEC) No 2377/90.
MRL fees shall be deducted from the fee payable for an application for marketing authorisation or an application to extend a marketing authorisation for the medicinal product containing the substance for which an MRL has been set where such applications are submitted by the same applicant. However, this deduction may total no more than one half of the fee to which it applies.
—————
Article 8
Various Fees
1. Fee for scientific advice
The scientific advice fee shall apply where an application is made for scientific advice concerning the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products.
When it concerns medicinal products for human use, the fee shall be EUR 103 800 .
When it concerns veterinary medicinal products, the fee shall be EUR 51 800 .
By derogation from the second subparagraph, a reduced scientific advice fee falling within the range of EUR 26 200 to EUR 77 900 shall apply for certain scientific advice concerning medicinal products for human use.
By derogation from the third subparagraph, a reduced scientific advice fee falling within the range of EUR 13 000 to EUR 39 100 shall apply for certain scientific advice concerning veterinary medicinal products.
The scientific advice referred to in the fourth and fifth subparagraph shall be included in a list, which shall be drawn up in accordance with Article 11(2).
2. Fee for scientific services not covered by Articles 3 to 7 or by Article 8(1)
A scientific service fee shall apply where an application is made for any scientific advice or opinion by a scientific Committee, which is not covered by Articles 3 to 7 or by Article 8(1). This includes any evaluation of traditional herbal medicinal products, any opinion on medicinal products for compassionate use, any consultation on ancillary substances, including blood derivatives, incorporated in medical devices, and any evaluation of plasma master files and vaccine antigen master files.
When it concerns medicinal products for human use, the fee shall be EUR 345 800 .
When it concerns veterinary medicinal products, the fee shall be EUR 173 000 .
Article 3 of this Regulation shall apply to any scientific opinion for the evaluation of medicinal products for human use intended exclusively for markets outside the Community pursuant to Article 58 of Regulation (EC) No 726/2004.
By derogation from the second subparagraph, a reduced scientific service fee falling within the range of EUR 3 900 to EUR 298 000 shall apply for certain scientific opinions or services concerning medicinal products for human use.
By derogation from the third subparagraph, a reduced scientific service fee falling within the range of EUR 3 900 to EUR 149 200 shall apply for certain scientific opinions or services concerning veterinary medicinal products.
The scientific opinions or services referred to in the fifth and sixth subparagraph shall be included in a list, which shall be drawn up in accordance with Article 11(2).
3. Fee for administrative services
A fee falling within the range of EUR 100 to EUR 8 600 shall apply for administrative services where documents or certificates are issued outside the framework of services covered by another fee provided for in this Regulation or where an application is rejected following the conclusion of the administrative validation of the related dossier or where the information required in the case of parallel distribution has to be checked.
A classification of the services and fees shall be included in a list, which shall be drawn up in accordance with Article 11(2).
Article 9
Possible fee reductions
Without prejudice to more specific provisions of Community law, in exceptional circumstances and for imperative reasons of public or animal health, fee reductions may be granted case by case by the Executive Director after consultation of the competent scientific committee. Any decision taken pursuant to this Article shall state the reasons on which it is based.
A total or partial exemption from payment of the fees laid down in this Regulation may be granted, in particular for medicinal products for treating rare diseases or diseases affecting minor animal species or for extension of existing MRL to additional animal species or for medicinal products available for compassionate use.
The detailed conditions for the application of the total or partial exemption shall be determined in accordance with Article 11(2).
The fee payable for an opinion on a medicinal product for compassionate use shall be deducted from the fee payable for an application for a marketing authorisation of the same medicinal product, where such application is submitted by the same applicant.
Article 10
Due date and deferral of the payment
1. Fees shall be due on the date of the administrative validation of the relevant application unless specific provisions stipulate otherwise. They shall be payable within 45 days of the date of the notification of the administrative validation to the applicant. They shall be paid in euro.
The annual fee shall be due on the first and each subsequent anniversary of the notification of the marketing authorisation decision. It shall be payable within 45 days of the due date. The annual fee shall relate to the preceding year.
The inspection fee shall be payable within 45 days from the date on which the inspection is carried out.
2. The payment of the fee for an application for a marketing authorisation of a medicinal product to be used in a human pandemic situation shall be deferred until the pandemic situation is duly recognised, either by the World Health Organisation or by the Community in the framework of Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community ( 6 ). Such deferral shall not exceed five years.
3. Where any fee payable under this Regulation remains unpaid at its due date and without prejudice to the Agency’s capacity to institute legal proceedings conferred on it by Article 71 of Regulation (EC) No 726/2004, the Executive Director may decide not to provide the requested services or to suspend all the services and procedures under way until the fee has been paid, including the relevant interest as provided for in Article 86 of Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed rules for the implementation of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities ( 7 ).
Article 11
Implementing rules
1. On a proposal from the Executive Director and following a favourable opinion from the Commission, the Agency's Management Board shall fix the rules for repaying a part of the resources deriving from the annual fees to the competent national authorities involved in Community market supervision.
2. Without prejudice to the provisions of Regulation (EC) No 726/2004, the Management Board of the Agency may, on a proposal from the Executive Director and following a favourable opinion from the Commission, specify any provision necessary for the application of this Regulation. Those provisions shall be made publicly available.
3. In the event of disagreement as to the classification of an application in one of the fee categories laid down in this Regulation, the Executive Director shall give a ruling after consultation of the competent scientific committee.
Article 12
Amendment
Any amendment to this Regulation shall be adopted by the Council acting by a qualified majority after consulting the European Parliament, on a proposal from the Commission.
However, amendments to the amounts of the fees established by this Regulation shall be adopted in accordance with the procedure laid down in Article 87(2) of Regulation (EC) No 726/2004, with exception of the updating provided for in the fifth paragraph of this Article.
By 24 November 2010, the Commission shall present a report on its implementation to the Council, this report shall contain an analysis of the need for including a dispute settlement procedure into this Regulation.
Any review of the fees shall be based on an evaluation of the Agency’s costs and on the basis of the related costs of the services provided for by the Member States. Those costs shall be calculated in accordance with generally accepted international costing methods, which shall be adopted in accordance with Article 11(2).
With effect from 1 April of each year, the Commission shall review the fees by reference to the inflation rate as published in the Official Journal of the European Union and update them.
Article 13
Entry into force and legal effect
This Regulation shall enter into force on the day following its publication in the Official Journal of the European Communities .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
<note>
( 1 ) OJ L 136, 30.4.2004, p. 1.
( 2 ) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p. 34).
( 3 ) OJ L 159, 27.6.2003, p. 24.
( 4 ) OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58).
( 5 ) OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 1518/2005 (OJ L 244, 20.9.2005, p. 11).
( 6 ) OJ L 268, 3.10.1998, p. 1. Decision as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).
( 7 ) OJ L 357, 31.12.2002, p. 1. Regulation as amended by Regulation (EC, Euratom) No 1261/2005 (OJ L 201, 2.8.2005, p. 3).
</note> | ENG | 01995R0297-20230401 |
<table><col/><col/><col/><col/><tbody><tr><td><p>16.4.2021   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 131/168</p></td></tr></tbody></table>
COUNCIL DECISION (EU) 2021/624
of 12 April 2021
on the position to be taken on behalf of the European Union within the Joint Committee established by the Convention between the European Economic Community, the Republic of Austria, the Republic of Finland, the Republic of Iceland, the Kingdom of Norway, the Kingdom of Sweden and the Swiss Confederation, on a common transit procedure as regards amendments of Appendices I and III to that Convention
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular the first subparagraph of Article 207(4) in conjunction with Article 218(9) thereof,
Having regard to the proposal from the European Commission,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The Convention between the European Economic Community, the Republic of Austria, the Republic of Finland, the Republic of Iceland, the Kingdom of Norway, the Kingdom of Sweden and the Swiss Confederation, on a common transit procedure <a>(<span>1</span>)</a> (‘the Convention’) was concluded on 20 May 1987 and entered into force on 1 January 1988.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Pursuant to Article 15(3), point (a), of the Convention, the Joint Committee established by the Convention is to adopt, by decision, amendments to the Appendices to the Convention.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>In early 2021, the Joint Committee is to adopt a decision on the amendments of Appendices I and III to the Convention.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Article 311 of Commission Implementing Regulation (EU) 2015/2447 <a>(<span>2</span>)</a> (the ‘Implementing Regulation’), on the request to transfer the recovery of the customs debt, has been amended by Commission Implementing Regulation (EU) 2019/1394 <a>(<span>3</span>)</a>. Therefore, Article 50 of Appendix I to the Convention, which mirrors Article 311 of the Implementing Regulation, should be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Annex 72-04 to the Implementing Regulation, on the business continuity procedure for Union transit, has been amended by Commission Implementing Regulation (EU) 2020/893 <a>(<span>4</span>)</a>. The validity of the paper-based comprehensive guarantee certificates and guarantee waiver certificates was prolonged in order to allow for more flexibility in the business continuity procedure in transit and reduce the formalities and costs incurred by customs authorities. Therefore, Article 79 of Appendix I to the Convention and point 19.3, Chapter III, Annex II to Appendix I to the Convention, which mirror point 19.3, Chapter III, Part I, Annex 72-04 to the Implementing Regulation, should be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>When the Union Customs Code ceases to apply to and in the United Kingdom, with the exception of Northern Ireland, the United Kingdom will accede to the Convention as a separate Contracting Party <a>(<span>5</span>)</a> and the Protocol on Ireland/Northern Ireland, which forms an integral part of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community <a>(<span>6</span>)</a>, will apply. The Convention contains references to the names of Member States of the European Union, common transit countries and the respective country codes. It is therefore necessary to amend Appendix III to the Convention in order to indicate that the United Kingdom is a common transit country and that the Union Customs Code, in particular as regards the provisions concerning guarantees, applies in Northern Ireland.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>It is appropriate to establish the position to be taken on the Union’s behalf in the Joint Committee, with regard to the amendments of Appendices I and III to the Convention, as those amendments will be binding on the Union.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The position of the Union within the Joint Committee should therefore be based on the draft Decision of the Joint Committee,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
The position to be taken on the Union’s behalf within the Joint Committee either during its 33 rd meeting or a subsequent meeting or by means of a written procedure, as regards the amendments to Appendices I and III to the Convention, shall be based on the draft Decision of the Joint Committee ( 7 ) .
Minor technical changes to the draft decision of the Joint Committee may be agreed to by the representatives of the Union in the Joint Committee, without further decision of the Council.
Article 2
This Decision shall enter into force on the date of its adoption.
Done at Brussels, 12 April 2021.
For the Council
The President
A. P. ZACARIAS
<note>
( 1 ) OJ L 226, 13.8.1987, p. 2 .
( 2 ) Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code ( OJ L 343, 29.12.2015, p. 558 ).
( 3 ) Commission Implementing Regulation (EU) 2019/1394 of 10 September 2019 amending and correcting Implementing Regulation (EU) 2015/2447 as regards certain rules on surveillance for release for free circulation and exit from the customs territory of the Union ( OJ L 234, 11.9.2019, p. 1 ).
( 4 ) Commission Implementing Regulation (EU) 2020/893 of 29 June 2020 amending Implementing Regulation (EU) 2015/2447 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code ( OJ L 206, 30.6.2020, p. 8 ).
( 5 ) Decision No 1/2018 of the EU-CTC Joint Committee of 4 December 2018 as regards an invitation to the United Kingdom to accede to the Convention on a common transit procedure (2018/1987) ( OJ L 317, 14.12.2018, p. 47 ).
( 6 ) OJ L 29, 31.1.2020, p. 7 .
( 7 ) See document ST 6126/21 onhttp://register.consilium.europa.eu
</note> | ENG | 32021D0624 |
<table><col/><col/><col/><col/><tbody><tr><td><p>16.12.2021   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 450/10</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2021/2236
of 15 December 2021
on the specific rules for implementing Regulation (EU) 2021/1529 of the European Parliament and of the Council establishing an Instrument for Pre-accession Assistance (IPA III)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2021/1529 of the European Parliament and of the Council of 15 September 2021 establishing an Instrument for Pre-accession Assistance (IPA III) ( 1 ) , and in particular Article 16 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Regulation (EU) 2021/947 of the European Parliament and of the Council <a>(<span>2</span>)</a> lays down rules and procedures for the implementation of assistance, which are applicable to IPA III assistance. Recital 52 and Article 16 of Regulation (EU) 2021/1529 empowers the Commission to set out specific rules establishing uniform conditions for the implementation of the Regulation. Specific rules should be laid down for addressing the specific situations in particular for indirect management with beneficiaries listed in Annex I to the Regulation (EU) 2021/1529 (the ‘IPA III beneficiaries’), for cross-border cooperation as defined in Article 2(b) of Regulation (EU) 2021/1529 and rural development assistance.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>In order to ensure that pre-accession assistance is implemented in all IPA III beneficiaries in a uniform manner and respecting the principle of sound financial management, the Commission and the IPA III beneficiaries should conclude arrangements in the form of financial framework partnership agreements and sectoral agreements laying down the principles for their cooperation under this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The Commission should support the IPA III beneficiaries in their efforts to develop their capacity to manage Union funds according to the principles and rules provided for in Union legislation. To this effect and where appropriate, the Commission should entrust budget implementation tasks to the IPA III beneficiaries.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>It is necessary to set out specific rules for entrusting budget implementation tasks to the IPA III beneficiaries in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council <a>(<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>It is necessary to set out detailed rules on monitoring and evaluation by the IPA III beneficiaries when implementing IPA III assistance under indirect management.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>It is necessary to set specific rules for reporting in order to further detail the reporting requirements to be complied with by the IPA III beneficiaries.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>IPA III will continue to support setting up and strengthening of sector coordination and monitoring systems proportionate to the responsibilities of the IPA beneficiary. The structures set up in the context of the sector approach under IPA and IPA II may continue to perform their duties and new sectoral monitoring committees should be established when the responsibilities of the IPA beneficiary so justify.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>It is necessary to set out specific rules for establishing financial correction and the procedure to be applied towards the IPA III beneficiaries when implementing IPA III assistance under indirect management.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>IPA III assistance should be used to promote cross-border cooperation between IPA III beneficiaries. Genuine cross-border cooperation between IPA III beneficiaries should include the joint development, implementation and financing of activities resulting in the intensification of neighbourly relations, sustainable partnerships for socio-economic development or the removal of obstacles to this development.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>It is therefore necessary to define uniform rules for the management of cross-border cooperation between IPA III beneficiaries, including the roles and responsibilities of the structures and authorities involved in the management of the cross border cooperation programmes.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>Cross-border cooperation between one or more Member States and one or more IPA III beneficiaries, as defined in Article 2(a) of Regulation (EU) 2021/1529 should not be covered by this Implementing Regulation, unless financing agreements concluded in accordance with Article 59 of Regulation (EU) 2021/1059 of the European Parliament and of the Council <a>(<span>4</span>)</a> refer to this Implementing Regulation, a given financial framework partnership agreement or a specific provision thereof.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>Rural development assistance under IPA III should increase competitiveness of the agri-food sector and promote a gradual alignment with the<span>acquis</span> on the Common Agricultural Policy of the Union. Specific rules are necessary to finance assistance of a similar nature to that under the European Agriculture Fund for Rural Development, through management and control systems respecting good governance principles and resembling structures with functions of a similar nature in the Member States.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>In order to allow for timely programming and implementation of the IPA III programmes for 2021, this Regulation should enter into force on the day following that of its publication in the<span>Official Journal of the European Union</span>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the IPA III committee,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
TITLE I
SUBJECT MATTER AND GENERAL FRAMEWORK FOR IMPLEMENTATION OF IPA ASSISTANCE
Article 1
Subject matter and scope
This Regulation lays down specific rules establishing uniform conditions for implementing Regulation (EU) 2021/1529 with regard to structures of implementation of IPA III assistance, indirect management with IPA III beneficiaries and specific rules for cross-border cooperation and agriculture and rural development assistance. Cross-border cooperation between one or more Member States and one or more IPA III beneficiaries, as defined in Article 2(a) of Regulation (EU) 2021/1529 is not covered by this implementing Regulation, unless financing agreements concluded in accordance with Article 59 of Regulation (EU) 2021/1059 refer to this Implementing Regulation, a given financial framework partnership agreement or a specific provision thereof.
Article 2
Definitions
For the purposes of this Regulation, the following definitions shall apply:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>‘IPA III beneficiary’ means one of the beneficiaries listed in the Annex I to Regulation (EU) 2021/1529;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>‘financial framework partnership agreement’ means an arrangement concluded between the Commission and an IPA III beneficiary laying down the principles of the financial cooperation between the IPA III beneficiary and the Commission under this Regulation;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>‘sectoral agreement’ means an arrangement concluded between the Commission and an IPA III beneficiary for implementing a specific IPA III programme, setting out the rules and procedures to be respected, which are not contained in the financial framework partnership agreement or financing agreements;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>‘financing agreement’ means an annual or multi-annual agreement concluded between the Commission and an IPA III beneficiary, for implementing the IPA III assistance;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>‘authority’ means a public entity or body of an IPA III beneficiary or a Member State at central, regional or local level;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>‘major project’ means a project comprising of a series of works, activities or services which is intended, in itself, to accomplish a definite and indivisible task of a precise economic or technical nature, which has clearly identified goals and whose total cost exceeds that which is specified in the financial framework partnership agreement;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>‘beneficiary’ means a public or private body, responsible for initiating and implementing operations within a cross-border cooperation programme;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>‘operation’ means a project, contract, action or group of projects selected by the contracting authority of the programme concerned, or under its responsibility, contributing to the objectives of the priority or priorities to which it relates;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>‘lead IPA III beneficiary’ means the IPA III beneficiary, which has been appointed as leader and therefore hosts the contracting authority for the cross-border programme.</p></td></tr></tbody></table>
Article 3
Principles of Union financing
IPA III assistance shall support the adoption and implementation of the IPA III beneficiaries’ reforms as referred to in Article 3 of Regulation (EU) 2021/1529. Specific programmes and stand-alone actions may require both IPA III beneficiary and Union financial contributions.
Article 4
Principle of ownership
1. The ownership of the programming and implementation of IPA III assistance shall lay primarily with the IPA III beneficiary.
2. The IPA III beneficiary shall appoint a National IPA Co-ordinator (NIPAC).
3. The NIPAC shall ensure a close link between the use of IPA III assistance and the general accession process.
4. The NIPAC shall be the main counterpart of the Commission for the overall process of coordination of programming in line with the objectives and thematic priorities of the IPA III programming framework referred to in Article 7 of Regulation (EU) 2021/1529 (the ‘IPA III programming framework’), monitoring of implementation, evaluation and reporting of IPA III assistance, including the coordination within the IPA III beneficiary’s administration and with other donors. The NIPAC shall also endeavour that the IPA III beneficiary’s administration takes all necessary steps to facilitate the implementation of the related programmes.
5. The NIPAC shall co-ordinate the participation of IPA III beneficiaries in the relevant territorial and cross-border cooperation programmes under Regulation (EU) 2021/1529 and Regulation (EU) 2021/1059. The NIPAC may delegate this coordination task to a structure established for the management of cross-border cooperation, as appropriate.
6. The NIPAC shall be a high-ranking representative of the government or the central administration of the IPA III beneficiary with the appropriate authority.
Article 5
Financial framework partnership agreement, sectoral agreements and financing agreement
1. The Commission and the IPA III beneficiary shall conclude a financial framework partnership agreement setting out specific arrangements for the management, control, supervision, monitoring, evaluation, reporting and audit of IPA III assistance committing the IPA III beneficiary to transpose into its legal order the relevant Union regulatory requirements. The financial framework partnership agreement may be complemented by sectoral agreements setting out specific provisions for the management and implementation of IPA III assistance in specific policy areas or programmes.
2. With the exception of duly justified cases, IPA III assistance shall only be granted to the IPA III beneficiary after the financial framework partnership agreement and, where relevant, the applicable sectoral agreement, have entered into force.
3. Financing agreements shall provide the terms on which the IPA III assistance shall be granted, including the applicable methods of implementation of IPA III assistance, implementation deadlines, as well as rules on the eligibility of expenditure.
4. Where programmes are implemented under indirect management by an IPA III beneficiary, the financial framework partnership agreement, sectoral agreement, where applicable, and the financing agreement taken as a whole shall comply with Article 129, Article 155(6) and Article 158 of Regulation (EU, Euratom) 2018/1046.
5. The financial framework partnership agreement shall apply to all financing agreements. Sectoral agreements, where relevant, shall apply to all financing agreements concluded in relation to the policy area or programme covered by the sectoral agreement.
6. In addition to the elements provided for in Article 130 of Regulation (EU, Euratom) 2018/1046, the financial framework partnership agreements and, where relevant, sectoral agreements shall lay down, in particular, detailed provisions concerning:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the structures and authorities needed for the management, control, supervision, monitoring, evaluation, reporting and audit of IPA III assistance, as well as their functions and responsibilities;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>conditions and control requirements for the establishment of the required structures and authorities by the IPA III beneficiary in order to allow for entrusting budget implementation tasks of IPA III assistance;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>rules on taxes, duties and charges in accordance with Article 27(9) and (10) of Regulation (EU) 2021/947;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>requirements for payments, examination and acceptance of accounts and financial corrections procedures, de-commitment of unused funds and closure of the programmes.</p></td></tr></tbody></table>
Article 6
Reporting
By 15 February of the following financial year, the NIPAC shall provide the Commission with an annual report on the implementation of financial assistance under IPA III. Other reporting requirements shall be set out in the financial framework partnership agreement.
Article 7
IPA monitoring committee
1. The Commission and the IPA III beneficiary shall have in place an IPA monitoring committee no later than six months after the entry into force of the first financing agreement. That committee shall also fulfil the responsibilities of the IPA monitoring committee under Council Regulation (EC) No 1085/2006 ( 5 ) and Regulation (EU) No 231/2014 of the European Parliament and of the Council ( 6 ) .
2. The IPA monitoring committee shall review the overall effectiveness, efficiency, quality, coherence, coordination and compliance of the implementation of all actions towards achieving the results set out in the financing agreements and in the IPA III programming framework. For that purpose, it shall base itself, where relevant, on the information provided by the sectoral monitoring committees referred to in Article 10 and other existing central coordination structures of the IPA III beneficiary.
3. The IPA monitoring committee shall be composed of representatives of the Commission, the NIPAC, of other relevant authorities and bodies of the IPA III beneficiary, as well as, where relevant, bilateral donors, international organisations, international financial institutions and other stakeholders, including civil society and private sector organisations.
4. A representative of the Commission and the NIPAC shall co-chair the IPA monitoring committee meetings.
5. The IPA monitoring committee shall adopt its rules of procedure.
6. The IPA monitoring committee shall meet at least once a year. Ad hoc meetings may be convened at the initiative of the Commission or of the IPA III beneficiary in particular on a thematic basis.
TITLE II
INDIRECT MANAGEMENT BY IPA III BENEFICIARIES
Article 8
Structures and authorities
1. In the event of indirect management by the IPA III beneficiary, the following structures and authorities shall be established by the IPA III beneficiary:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the National IPA Co-ordinator (NIPAC);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the National Authorising Officer (NAO);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the Management Structure composed of the NAO Support Office and the Accounting Body;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the Managing Authorities and Intermediate Bodies;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>the Audit Authority.</p></td></tr></tbody></table>
2. The roles and responsibilities of the structures referred to in paragraph 1 shall be defined in the financial framework partnership agreement.
3. The IPA III beneficiary shall ensure adequate segregation of duties between and within the structures and authorities referred to in paragraph 1.
Article 9
Indirect management with an IPA III beneficiary
1. The Commission may implement IPA III assistance in indirect management with an IPA III beneficiary by concluding a financing agreement in accordance with Articles 154 and 158 of Regulation (EU, Euratom) 2018/1046.
2. Prior to signing a financing agreement, the Commission shall obtain evidence that the conditions set out in Article 154(4), first subparagraph, points (a) to (f), of Regulation (EU, Euratom) 2018/1046 are fulfilled. The Commission shall also ensure that the structures and authorities referred to in Article 8 of this Regulation have been set up.
3. The NAO shall monitor the continued fulfilment by the structures and authorities referred to in Article 8 of the requirements referred to in paragraph 2 of this Article. In case of failure to satisfy those requirements, the NAO shall inform the Commission immediately, and shall take the appropriate safeguard measures regarding payments made or contracts signed.
4. Multiannual programmes covered by a financing agreement and making use of the provisions of Article 30(3), first subparagraph, of Regulation (EU) 2021/947 shall be implemented in indirect management with IPA III beneficiaries. Decisions adopting multi-annual action plans as referred to in Article 23 of Regulation (EU) 2021/947 shall, where appropriate, include an indicative list of major projects. The Commission shall apply Article 30(3), second and third subparagraph of Regulation (EU) 2021/947, unless an earlier deadline for the automatic decommitments has been specified in a sectoral or financing agreement.
5. The amount concerned by the de-commitment referred to in paragraph 4 shall be reduced by the amounts equivalent to that part of the budget commitment to which one of the following conditions applies:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the action is suspended by a legal proceeding or by an administrative appeal having suspensory effect;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>it has not been possible to make a payment request for reasons of<span>force majeure</span> seriously affecting implementation of all or part of the programme.</p></td></tr></tbody></table>
The IPA III beneficiary claiming force majeure shall demonstrate the direct consequences of the force majeure on the implementation of all or part of the programme.
6. The IPA III beneficiary shall send to the Commission information on the conditions referred to in paragraph 5, points (a) and (b) of this Article in the annual report referred to in Article 6.
Article 10
Sectoral monitoring committees
1. The IPA III beneficiary shall have in place IPA sectoral monitoring committees to monitor annual and multiannual programmes implemented in indirect management by the IPA III beneficiary, which are financed under Regulation (EC) No 1085/2006, Regulation (EU) No 231/2014 and Regulation (EU) 2021/1529 in a specific sector. Such committees shall be in place no later than six months after the entry into force of the first financing agreement in that sector.
2. In accordance with the principle of proportionality, in the case of annual programmes implemented in indirect management, the obligation of having in place an IPA sectoral monitoring committee may be waived in the financing agreement.
3. Where an IPA sectoral monitoring committee has been established, that committee may, in addition to the multiannual programmes implemented in indirect management, monitor other annual programmes financed by under Regulation (EC) No 1085/2006, Regulation (EU) No 231/2014 and Regulation (EU) 2021/1529 implemented in direct or indirect management in the same specific sector.
4. For cross-border cooperation programmes, the Joint Monitoring Committee referred to in Article 18 shall fulfil the functions of IPA sectoral monitoring committee.
5. Each IPA sectoral monitoring committee shall monitor the progress of programme implementation. It shall review the effectiveness, efficiency, quality, coherence, coordination and compliance of the implementation of the actions in the programme and their consistency with the relevant strategies.
6. Each IPA sectoral monitoring committee shall adopt its rules of procedure.
7. The IPA sectoral monitoring committee shall be composed of representatives of relevant IPA III beneficiary authorities and bodies, other stakeholders such as economic, social and environmental partners and international organisations, international financial institutions and civil society. The Commission shall participate in the work of the committee. A senior representative of the IPA III beneficiary shall chair the IPA sectoral monitoring committee meetings. Depending on the policy area or programme, the Commission may co-chair the committee meetings.
8. The IPA sectoral monitoring committees shall meet at least twice every twelve months.
Article 11
Evaluations by the IPA III beneficiary in indirect management
1. The IPA III beneficiary implementing IPA III assistance in indirect management shall be responsible for carrying out evaluations of the programmes it manages, in accordance with Article 34 of Regulation (EU, Euratom) 2018/1046, Article 42 of Regulation (EU) 2021/947 and applicable Commission guidelines.
2. The IPA III beneficiary shall, in consultation with the Commission, draw up an evaluation plan presenting the evaluation activities to be carried out.
Article 12
Financial corrections by the Commission
1. In order to ensure that the IPA III assistance has been used in accordance with the applicable rules, the Commission shall apply financial correction mechanisms.
2. A financial correction may arise from either of the following causes:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>identification of any error, irregularity, fraud, corruption;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>identification of a weakness or deficiency in the management and control systems of the IPA III beneficiary;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>failure to ensure achievement of results or the sustainability of the action, or both;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>follow-up by the Commission on the audit activity reports and opinions of the audit authority.</p></td></tr></tbody></table>
3. If the Commission finds that expenditure under the programmes covered by IPA III has been incurred and paid in a way that has infringed applicable rules, it shall decide what amounts are to be excluded from Union financing.
4. Financial corrections shall be made as appropriate by compensation, in the situations referred to in paragraph 2.
5. The Commission shall apply the financial corrections on the basis of identification of the amounts unduly spent and the financial implications for the budget. Where such amounts cannot be identified precisely in order to apply individual corrections, the Commission may apply flat-rate corrections or corrections based on an extrapolation of the findings. When deciding the amount of a correction, the Commission shall take into account the nature and gravity and/or the extent and financial implications of any situation referred to in paragraph 2.
Article 13
Examination and acceptance of accounts
The Commission shall satisfy itself that the accounts are complete, accurate and true by applying an examination and acceptance of accounts procedure specified in the financial framework partnership agreement, or in the sectoral agreement where applicable.
TITLE III
CROSS-BORDER COOPERATION BETWEEN IPA III BENEFICIARIES
Article 14
Thematic priorities and co-financing
1. The thematic priorities of IPA III assistance for cross-border cooperation shall be those defined in Annex III to Regulation (EU) 2021/1529.
2. The Union co-financing rate at the level of each thematic priority shall not be higher than 85 % of the eligible expenditure of a cross-border cooperation programme.
Article 15
Technical assistance
1. Each cross-border cooperation programme shall include a specific budget allocation for technical assistance support, which shall be limited to 10% of the Union contribution to the cross-border cooperation programme.
Technical assistance may support preparatory, management, monitoring, evaluation, information, communication, networking, dispute resolution, control and audit activities related to the implementation of the programme as well as activities to reinforce the administrative capacity for implementing the programme. The technical assistance may support in particular the financing of the Joint Technical Secretariat, activities for the reduction of the administrative burden for beneficiaries, including electronic data exchange systems, and actions to reinforce the capacity of, and exchange best practices between, authorities in the participating countries and of beneficiaries to manage IPA III assistance.
2. Technical assistance support may also concern the preceding and subsequent programming periods.
Article 16
Programming and selection of operations
1. Cross-border cooperation programmes shall be drawn up in accordance with the model programme provided by the Commission and shall be prepared jointly by the participating IPA III beneficiaries and submitted to the Commission by electronic means. The participating IPA III beneficiaries and the Commission shall agree on the list of eligible regions, which shall be included in the relevant cross-border cooperation programme.
2. Operations selected under a cross-border cooperation programme shall deliver clear cross-border impacts and benefits.
3. Operations under cross-border cooperation programmes shall be selected by the contracting authority through calls for proposals covering the whole eligible area.
4. Participating IPA III beneficiaries may also identify operations outside call for proposals. In that event, the operations shall be specifically mentioned in the cross-border cooperation programme referred to in paragraph 1.
5. Operations selected for cross-border cooperation shall involve beneficiaries from at least two participating IPA III beneficiaries. Beneficiaries shall cooperate in the development and implementation of operations. In addition, they shall cooperate in either the staffing or the financing of operations or both.
6. An operation may be implemented in a single participating IPA III beneficiary, provided that cross-border impacts and benefits are identified.
Article 17
Beneficiaries
1. The beneficiaries shall be established in an IPA III beneficiary participating in the programme.
2. The beneficiaries shall appoint one of them as lead beneficiary. The lead beneficiary shall ensure the implementation of the entire operation, monitor that the operation is implemented in accordance with the conditions set out in the contract and lay down the arrangements with other beneficiaries to guarantee the sound financial management of the funds allocated to the operation, including the arrangements for recovering amounts unduly paid.
Article 18
Structures and authorities
1. The following structures shall be involved in the management of cross-border cooperation programmes in the IPA III beneficiaries:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the NIPACs of the IPA III beneficiaries participating in the cross-border cooperation programme, which are jointly responsible for ensuring that the objectives set out in the proposed cross-border cooperation programmes are consistent with the objectives in the IPA III programming framework;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the NAO and the Management Structure, referred to in Article 8(1), point (c), of the lead IPA III beneficiary when the cross-border programme is implemented in indirect management;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the cross-border cooperation structures in all the participating IPA beneficiaries which shall cooperate closely in the programming and implementation of the relevant cross-border cooperation programme. In case of indirect management, the cross-border cooperation structure in the lead IPA III beneficiary shall perform the tasks of Managing Authority referred to in Article 8(1), point (d). The Managing Authority shall designate intermediate bodies;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the Audit Authority referred to in Article 8(1), point (e), when the cross-border programme is implemented in indirect management with the IPA III beneficiary. Where the Audit Authority does not have the authorisation to carry out its functions in the whole territory covered by a cross-border cooperation programme, it shall be assisted by a group of auditors comprising representatives of each country participating in the cross-border cooperation programme.</p></td></tr></tbody></table>
2. The roles and responsibilities of the structures referred to in paragraph 1 shall be further defined in the financial framework partnership agreement.
3. The participating IPA III beneficiaries shall establish for each cross-border cooperation programme a Joint Monitoring Committee (‘JMC’) which shall also fulfil the role of the sectoral monitoring committee referred to in Article 10.
4. A Joint Technical Secretariat (‘JTS’) shall be set up to assist the Commission as well as other structures and authorities including the JMC. The same JTS may assist in the preparation and implementation of more than one cross-border cooperation programmes.
5. In indirect management by IPA III beneficiary, the participating IPA III beneficiaries shall conclude a bilateral or multilateral arrangement setting out their respective responsibilities for implementing the relevant cross-border cooperation programme. The minimum requirements for such arrangement shall be defined in the financial framework partnership agreement.
Article 19
Specific financing provisions
Cross-border cooperation programmes under IPA III shall be implemented in direct or indirect management, through multiannual programmes.
TITLE IV
AGRICULTURE AND RURAL DEVELOPMENT
Article 20
Specific provisions of rural development assistance
1. Rural development assistance shall be subject to a multi-annual programme, which is a multiannual action plan in accordance with Articles 23 and 24 of Regulation (EU) 2021/947, to be drawn up at central level, prepared by the relevant authorities designated by the IPA III beneficiary and submitted to the Commission after consulting the appropriate stakeholders.
2. Rural development programmes shall be implemented by the IPA III beneficiaries in indirect management in accordance with Article 62(1), point (c) of Regulation (EU, Euratom) 2018/1046 and shall enable financing of selected types of actions as funded under the European Agricultural Fund for Rural Development.
3. For rural development programmes, the structures referred to in Article 8(1), point (d) shall consist of the IPA Rural Development (IPARD) Agency and the IPARD Managing Authority, which shall operate in close cooperation.
4. In determining the share of public expenditure as a percentage of total eligible cost of investment, account shall not be taken of national aid to facilitate access to loans granted without any Union contribution provided under Regulation (EU) 2021/1529.
5. Investment projects under rural development programmes shall remain eligible for Union financing provided they do not undergo a substantial modification within five years from the final payment.
6. For rural development programmes, the sectoral monitoring committee referred to in Article 10 shall be the sectoral IPARD monitoring committee.
TITLE V
FINAL PROVISION
Article 21
Entry into force and application
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union .
It shall apply from 1 January 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 December 2021.
For the Commission
The President
Ursula VON DER LEYEN
<note>
( 1 ) OJ L 330, 20.9.2021, p. 1 .
( 2 ) Regulation (EU) 2021/947 of the European Parliament and of the Council of 9 June 2021 establishing the Neighbourhood, Development and International Cooperation Instrument – Global Europe, amending and repealing Decision No 466/2014/EU and repealing Regulation (EU) 2017/1601 and Council Regulation (EC, Euratom) No 480/2009 ( OJ L 209, 14.6.2021, p. 1 ).
( 3 ) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 ( OJ L 193, 30.7.2018, p. 1 ).
( 4 ) Regulation (EU) 2021/1059 of the European Parliament and of the Council of 24 June 2021 on specific provisions for the European territorial cooperation goal (Interreg) supported by the European Regional Development Fund and external financing instruments ( OJ L 231, 30.6.2021, p. 94 ).
( 5 ) Council Regulation (EC) No 1085/2006 of 17 July 2006 establishing an Instrument for Pre-Accession Assistance (IPA) ( OJ L 210, 31.7.2006, p. 82 ).
( 6 ) Regulation (EU) No 231/2014 of the European Parliament and of the Council of 11 March 2014 establishing an Instrument for Pre-accession Assistance (IPA II) ( OJ L 77, 15.3.2014, p. 11 ).
</note> | ENG | 32021R2236 |
<table><col/><col/><col/><col/><tbody><tr><td><p>12.9.2022   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 235/35</p></td></tr></tbody></table>
COUNCIL IMPLEMENTING DECISION (CFSP) 2022/1509
of 9 September 2022
implementing Decision (CFSP) 2015/1333 concerning restrictive measures in view of the situation in Libya
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on European Union, and in particular Article 31(2) thereof,
Having regard to Council Decision (CFSP) 2015/1333 of 31 July 2015 concerning restrictive measures in view of the situation in Libya, and repealing Decision 2011/137/CFSP ( 1 ) , and in particular Article 12(1) thereof,
Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>On 31 July 2015, the Council adopted Decision (CFSP) 2015/1333.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>On 18 July 2022, the United Nations Security Council (‘UNSC’) Committee established pursuant to UNSC Resolution 1970 (2011) updated the information relating to one person subject to restrictive measures.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Annexes I and III to Decision (CFSP) 2015/1333 should therefore be amended accordingly,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
Annexes I and III to Decision (CFSP) 2015/1333 are hereby amended as set out in the Annex to this Decision.
Article 2
This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union .
Done at Brussels, 9 September 2022.
For the Council
The President
J. SÍKELA
( 1 ) OJ L 206, 1.8.2015, p. 34 .
ANNEX
In Annex I and Annex III to Decision (CFSP) 2015/1333, entry 6 is replaced by the following:
<table><col/><col/><tbody><tr><td><p>‘6.</p></td><td><p><span>Name: 1: ABU 2: ZAYD 3: UMAR 4: DORDA</span></p><p><span>Title:</span> n/a<span>Designation: a)</span> Director, External Security Organisation.<span>b)</span> Head of external intelligence agency.<span>DOB:</span> 4 Apr. 1944<span>POB:</span> Alrhaybat<span>Good quality a.k.a.: a)</span> Dorda Abuzed OE<span>b)</span> Abu Zayd Umar Hmeid Dorda<span>Low quality a.k.a.:</span> n/a<span>Nationality:</span> n/a<span>Passport no:</span> Libya number FK117RK0, issued on 25 Nov. 2018, issued in Tripoli (Date of expiration: 24 Nov. 2026)<span>National identification no:</span> n/a<span>Address:</span> Libya (Believed status/location: deceased)<span>Listed on:</span> 26 Feb. 2011 (amended on 27 Jun. 2014, 1 Apr. 2016, 25 Feb. 2020, 18 Jul. 2022)<span>Other information:</span> Listed pursuant to paragraph 15 of resolution 1970 (Travel Ban). Listed on 17 March 2011 pursuant to paragraph 17 of resolution 1970 (Asset Freeze).’</p></td></tr></tbody></table> | ENG | 32022D1509 |