30.8.2013 [ EN_| Official Journal of the European Union L 232/13 COMMISSION IMPLEMENTING REGULATION (EU) No 826/2013 of 29 August 2013 approving the active substance sedaxane, 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 the Annex to 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) and Article 78(2) thereof, Whereas: In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (?) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For sedaxane the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2011/123/EU (). In accordance with Article 6(2) of Directive 91/414/EEC France received on 14 June 2010 an application from Syngenta Crop Protection AG for the inclusion of the active substance sedaxane in Annex I to Directive 91/414/EEC. Decision 2011/123/EU confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and I to Directive 91/414/EEC. For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the 309, 24.11.2009, p. 1. 0J L 0] L 230, 19.8.1991, p. 1. 0J L 49, 24.2.2011, p. 40. applicant. The designated rapporteur Member State submitted a draft assessment report on 10 May 2011. The draft assessment report was reviewed by the Member States and the European Food Safety Authority (here- inafter ‘the Authority’). The Authority presented to the Commission its conclusion on the review of the pesticide risk assessment of the active substance sedaxane () on 6 July 2012. In November 2012, the Commission requested further toxicological assessment from the Authority. The rapporteur Member State submitted an addendum to its draft assessment report. The Authority updated its conclusion and undertook a final consultation with the Member States. The Authority presented to the Commission its updated conclusion on the review of the pesticide risk assessment of the active substance sedaxane (°) on 18 December 2012. The draft assessment report and the updated conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and the draft assessment report was finalised on 16 July 2013 in the format of the Commission review report for sedaxane. It has appeared from the various examinations made that plant protection products containing sedaxane may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414[EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve sedaxane. (*) EFSA Journal (2012); 10(7):2823. Available online: www.efsa. europa.eu (°) EFSA Journal (2012); 11(1):3057. Available online: www.efsa. europa.eu