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:
(1) Commission Implementing Directive 2011/44/EU(2) included azadirachtin as an active substance in Annex I to Council Directive 91/414/EEC(3).
(2) In accordance with Regulation (EC) No 1107/2009, active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under that Regulation and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011(4).
(3) The approval of the active substance azadirachtin, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, was restricted to the use as insecticide.
(4) In accordance with Article 7(1) of Regulation (EC) No 1107/2009, on 27 February 2012 Trifolio-M GmbH, one of the producers of the active substance, submitted an application to the designated Rapporteur Member State, Germany, seeking an amendment to the conditions of approval of azadirachtin in order to allow its use as acaricide. The application was found to be admissible by the designated Rapporteur Member State.
(5) The designated Rapporteur Member State assessed the new use of the active substance azadirachtin in relation to the potential effects on human and animal health and the environment in accordance with the provisions of Article 4 of Regulation (EC) No 1107/2009, and prepared an addendum to the draft assessment report and additional report which was submitted to the European Food Safety Authority (‘the Authority’) and the Commission on 10 January 2013.
(6) In accordance with Article 12(1) of Regulation (EC) No 1107/2009, the Authority circulated the addendum to the draft assessment report and additional report to the applicant and to the Member States for comments and made it available to the public. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, additional information was requested from the applicant. Germany evaluated the additional information and submitted a revised addendum to the draft assessment report and additional report to the Commission and to the Authority on 19 September 2017.
(7) On 14 September 2018, the Authority communicated to the Commission its conclusion(5) on whether the new use of the active substance azadirachtin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft addendum to the review report for azadirachtin and a draft Regulation to the Standing Committee on Plants, Animals, Food and Feed on 19 May 2020.
(8) The applicant was invited to submit comments on the addendum to the review report.
(9) It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that, when the plant protection product is used as an acaricide, the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to withdraw the restriction for the use of azadiracthin as an insecticide only.
(10) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(11) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
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, 15 September 2020.
For the Commission
The President
Ursula von der Leyen
The column ‘Specific provisions’ of row 343, azadirachtin, of Part A of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:
‘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 azadirachtin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 and of the addendum to the review report on azadirachtin, and in particular Appendices I and II thereto, as finalised by the Standing Committee on Plants, Animals, Food and Feed on 17 July 2020 shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;
the protection of non-target arthropods and aquatic organisms.
Conditions of use shall include risk mitigation measures, where appropriate.’
Commission Implementing Directive 2011/44/EU of 13 April 2011 amending Council Directive 91/414/EEC to include azadirachtin as active substance and amending Commission Decision 2008/941/EC (OJ L 100, 14.4.2011, p. 43).
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).
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).
European Food Safety Authority; Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract). EFSA Journal 2018;16(9):5234. Doi: 10.2903/j.efsa.2018.5234.