L 312/18 Official Journal of the European Union 21.11.2013 COMMISSION IMPLEMENTING REGULATION (EU) No 1175/2013 of 20 November 2013 approving the active substance benalaxyl-M, 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 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 ('), 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 benalaxyl-M the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2003/35/EC (). In accordance with Article 6(2) of Directive 91/414/EEC Portugal received on 22 February 2002 an application from Isagro SpA for the inclusion of the active substance benalaxyl-M in Annex I to Directive 91/414/EEC. Decision 2003/35/EC 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 III to Directive 91/414/EEC. For that active substance, the effects on human and animal health and the environment have been assessed, () O] L 309, 24.11.2009, p. 1. (%) Council Directive 91/414[EEC of 15 July 1991 concerning the ) placing of plant protection products on the market (O] L 230, 19.8.1991, p. 1). Commission Decision 2003/35/EC of 10 January 2003 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of benalaxyl-M, benthiavalicarb, 1-methylcyclopropene, prothioconazole and fluox- astrobin in Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection products on the market (O] L 11, 16.1.2003, p. 52). ©) in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 21 November 2003. This draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority). The Authority presented to the Commission its conclusion (¥) on the pesticide risk assessment of the active substance benalaxyl-M on 28 July 2007. In its conclusion, the Authority did not take into account all information submitted by the applicant and assessed by the designated rapporteur Member State before that date. The Commission requested the Authority to revise its conclusion and to take into account all information submitted. The designated rapporteur Member State assessed all information submitted by the applicant and submitted an Addendum to the draft assessment report on 16 April 2012. The Addendum to the draft assessment report was reviewed by the Member States and the Authority. The Authority presented to the Commission a first version of its conclusion (°) on the pesticide risk assessment of the active substance benalaxyl-M on 21 March 2013 and an amended version on 25 March 2013. The updated draft assessment report and the 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 finalised on 3 October 2013 in the format of the Commission review report for benalaxyl-M. It has appeared from the various examinations made that plant protection products containing benalaxyl-M 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 benalaxyl-M. (*) EFSA Scientific Report (2007) 108, 1-86. (°) EFSA Journal 2013; 11(1):3052. Available online: www.efsa.europa.