Document ID: 32022R0800
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>23.5.2022&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 143/4</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2022/800
of 20 May 2022
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3
(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 13(2)(c) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Council Directive 2009/116/EC&#160;<a>(<span>2</span>)</a> included paraffin oils CAS No&#160;64742-46-7, CAS No&#160;72623-86-0 and CAS No&#160;97862-82-3 as active substances in Annex I to Council Directive 91/414/EEC&#160;<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&#160;1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No&#160;540/2011&#160;<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 substances paraffin oils CAS No&#160;64742-46-7, CAS No&#160;72623-86-0 and CAS No&#160;97862-82-3, as set out in Part A of the Annex to Implementing Regulation (EU) No&#160;540/2011, allows for their use as an insecticide and acaricide only.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>In accordance with Article&#160;7(1) of Regulation (EC) No&#160;1107/2009, on 30&#160;September 2014, Total Fluids submitted an application to Greece, the rapporteur Member State, seeking an amendment to the conditions of approval of paraffin oils CAS No&#160;64742-46-7, CAS No&#160;72623-86-0 and CAS No&#160;97862-82-3 in order to allow for their use as a fungicide. The application was found to be admissible by the rapporteur Member State.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The rapporteur Member State assessed the new use of paraffin oils CAS No&#160;64742-46-7, CAS No&#160;72623-86-0 and CAS No&#160;97862-82-3 applied for in&#160;2014 in relation to the potential effects on human and animal health and the environment in accordance with Article&#160;4 of Regulation (EC) No&#160;1107/2009, and prepared a draft assessment report which was submitted to the European Food Safety Authority (&#8216;the Authority&#8217;) and the Commission on 6&#160;February 2018.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>In accordance with Article&#160;12(1) of Regulation (EC) No&#160;1107/2009, the Authority circulated the revised assessment report to the applicant and to the Member States for comments and made it available to the public. In accordance with Article&#160;12(3) of Regulation (EC) No&#160;1107/2009, additional information was requested from the applicant.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>On 23&#160;September 2021, the Authority communicated to the Commission its conclusion&#160;<a>(<span>5</span>)</a> on whether the new use of paraffin oils CAS No&#160;64742-46-7, CAS No&#160;72623-86-0 and CAS No&#160;97862-82-3 can be expected to meet the approval criteria provided for in Article&#160;4 of Regulation (EC) No&#160;1107/2009.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The Commission presented an addendum to the review report for paraffin oils CAS No&#160;64742-46-7, CAS No&#160;72623-86-0 and CAS No&#160;97862-82-3 and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 27&#160;January 2022.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>The Commission invited the applicant to submit comments on the addendum to the review report, which have been carefully examined.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>It has been established with respect to one or more representative uses of at least one plant protection product containing paraffin oils CAS No&#160;64742-46-7, CAS-No-72623-86-0 and CAS No&#160;97862-82-3 that, when used as a fungicide, the approval criteria provided for in Article&#160;4 of Regulation (EC) No&#160;1107/2009 are satisfied. It is therefore appropriate to amend the specific provisions as laid down in the approval of paraffin oils CAS No&#160;64742-46-7, CAS No&#160;72623-86-0 and CAS-No-97862-82-3 to include the use as a fungicide in addition to the uses as an insecticide and acaricide.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>Implementing Regulation (EU) No&#160;540/2011 should therefore be amended accordingly.</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
Amendment to Implementing Regulation (EU) No 540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
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, 20 May 2022.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 309, 24.11.2009, p. 1 .
( 2 ) Council Directive 2009/116/EC of 25 June 2009 amending Directive 91/414/EEC to include paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 as active substances ( OJ L 237, 9.9.2009, p. 7 ).
( 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 ) EFSA (European Food Safety Authority), 2021.
Peer review of the efficacy as a fungicide of the active substances paraffin oils (CAS 64742-46-7 chain lengths C11–C25, CAS 72623-86-0 chain lengths C15–C30 and CAS 97862-82-3 chain lengths C11–C30); EFSA Journal 2021;19(10)6876doi: 10.2903/j.efsa.2021.6876.
ANNEX
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, the entry in the column ‘Specific provisions’ of row 294, paraffin oils CAS No 64742-46-7, CAS-No-72623-86-0 and CAS No 97862-82-3, is replaced by the following:
‘Part A
Only uses as insecticide, acaricide and fungicide may be authorised.
Part B
For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3, including its addendum, and in particular Appendices I and II thereof, shall be taken into account.
Conditions of use shall include risk mitigation measures, where appropriate.’