EN
29.3.2022
Official Journal of the European Union
L 101/1
II (Non-legislative acts)
REGULATIONS COMMISSION IMPLEMENTING REGULATION (EU) 2022/496 of 28 March 2022 approving the low-risk active substance Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV), isolate BV-0004 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 13(2) in conjunction with Article 22(1) thereof, Whereas: (1)
On 8 May 2018, Spain received an application pursuant to Article 7(1) of Regulation (EC) No 1107/2009 from Andermatt Biocontrol Suisse AG for the approval of the active substance Spodoptera exigua multicapsid nucleopoly­ hedrovirus (SeMNPV), isolate BV-0004.
(2)
In accordance with Article 9(3) of that Regulation, Spain, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority‘) on 24 September 2018 of the admissibility of the application.
(3)
On 24 March 2020, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
(4)
The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009.
In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority.
The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the form of an updated draft assessment report on 5 May 2021.
(5)
On 17 September 2021, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV), isolate BV-0004 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
The Authority made its conclusion available to the public.
(6)
The Commission presented a review report and a draft of this Regulation regarding Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV), isolate BV-0004 to the Standing Committee on Plants, Animals, Food and Feed on 22 October 2021 and 2 December 2021, respectively.
(7)
The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 13(1) of Regulation (EC) No 1107/2009, on the review report.
The applicant submitted its comments, which have been carefully examined.
(1) OJ L 309, 24.11.2009, p. 1.
(2) EFSA (European Food Safety Authority), 2021.
Peer review of the pesticide risk assessment of the active substance Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV) EFSA Journal 2021;19(10):6848