COMMISSION IMPLEMENTING REGULATION (EU) 2021/79

of 27 January 2021

concerning the non-approval of the active substance topramezone, 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

(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) thereof,

Whereas:

(1) According to Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) applies to the procedure and the conditions for approval of active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive, before 14 June 2011. On 9 December 2003, the Commission adopted Decision 2003/850/EC (3) on the active substance topramezone (formerly BAS 670H) in accordance with Article 6(3) of Directive 91/414/EEC.

(2) On 12 May 2003, BASF Aktiengesellschaft (now BASF SE) submitted an application for the inclusion of topramezone in Annex I to Directive 91/414/EEC to France in accordance with Article 6(2) of that Directive. Decision 2003/850/EC confirmed that the dossier satisfied, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

(3) The assessment of the effects of topramezone on human and animal health and the environment for the uses proposed by the applicant has been carried out in accordance with the procedure provided in Article 6(2) and (4) of Directive 91/414/EEC. France submitted a draft assessment report to the Commission and the European Food Safety Authority (‘the Authority’) on 21 July 2006.

(4) The draft assessment report was reviewed by the Member States and the Authority. The Authority presented to the Commission its conclusion (4) on the pesticide risk assessment of the active substance topramezone on 13 January 2014.

(5) By letter of 29 June 2020, BASF SE withdrew the application for the approval of topramezone.

(6) Due to the withdrawal of the application, topramezone should not be approved.

(7) This Regulation does not prevent the submission of a further application for the active substance topramezone pursuant to Article 7 of Regulation (EC) No 1107/2009.

(8) 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:

Article 1 Non-approval of active substance The active substance topramezone is not approved.

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, 27 January 2021. For the Commission The President Ursula VON DER LEYEN

(1) OJ L 309, 24.11.2009, p. 1.

(2) 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).

(3) Commission Decision 2003/850/EC of 4 December 2003 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of BAS 670H and silver thiosulphate in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 322, 9.12.2003, p. 28).

(4) European Food Safety Authority, 2014. Conclusion on the peer review of the pesticide risk assessment of the active substance topramezone. EFSA Journal 2014;12(2):3540, 82 pp. doi:10.2903/j.efsa.2014.3540.