25.4.2013 Official Journal of the European Union L 113/5 II (Non-legislative acts) REGULATIONS COMMISSION IMPLEMENTING REGULATION (EU) No 378/2013 of 24 April 2013 approving the active substance Paecilomyces fumosoroseus strain FE 9901, 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 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 of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 29 March 2007. Union, (4)  The draft assessment report was reviewed by the Member ) i States and the European Food Safety Authority (here- Having regar‘_i to Regulation (EC) No 1107/2009 of the inafter ‘the Authorit)g). The Authorit}}fl presentedy to the European Parliament and of the Council of 21 October 2009 Commission its conclusion on the review of the pesticid . . . pesticide concerning_ the plac.lng of plapt protection products on the risk assessment of the active substance Paecilomyces fumo- market and repealing Council Directives 79/117/EEC and soroseus strain FE 9901 (%) on 20 August 2012, The draft 91/414[EEC (1), and in particular Articles 13(2) and 78(2) '8 ' . assessment report and the conclusion of the Authority thereof, were reviewed by the Member States and the Commission within the Standing Committee on the Whereas: Food Chain and Animal Health and the draft assessment report was finalised on 15 March 2013 in the format of ) ) ) the Commission review report for Paecilomyces fumoso- (1) In accordance with Article 80(1)(a) of Regulation (EC) No roseus strain FE 9901, 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 (5) It has appeared from the various examinations made that been adopted in accordance with Article 6(3) of that plant protection products containing Paecilomyces fumoso- Directive before 14 June 2011. For Paecilomyces fumoso- roseus strain FE 9901 may be expected to satisfy, in roseus strain FE 9901 the conditions of Article 80(1)(a) of general, the requirements laid down in Article 5(1)(a) Regulation (EC) No 1107/2009 are fulfilled by and (b) and Article 5(3) of Directive 91/414/EEC, in Commission Decision 2008/565/EC (3). particular with regard to the uses which were examined and detailed in the Commission review report. It is ) ) o therefore appropriate to approve Paecilomyces fumosoroseus (2)  In accordance with Article 6(2) of Directive 91/414/EEC strain FE 9901. Belgium received on 4 February 2004 an application from FuturEco S.L. for the inclusion of the active substance Paecilomyces fumosoroseus strain FE 9901 in (6) A reasonable period should be allowed to elapse before Annex I to Directive 91/414/EEC. Decision 2008/565(EC approval in order to permit Member States and the confirmed that the dossier was ‘complete’ in the sense interested parties to prepare themselves to meet the that it could be considered as satisfying, in principle, the new requirements resulting from the approval. data and information requirements of Annexes Il and III to Directive 91/414/EEC. (7)  Without prejudice to the obligations provided for in 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) 309, 24.11.2009, p. 1. 0J L 0] L 230, 19.8.1991, p. 1. 0J L 181, 10.7.2008, p. 49. Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a (*) EFSA Journal 2012; 10(9):2869. Available online: www.efsa.europa.