21.11.2013 Official Journal of the European Union L 312/23 COMMISSION IMPLEMENTING REGULATION (EU) No 1176/2013 of 20 November 2013 approving the active substance pyroxsulam, 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 (1), and in particular Article 13(2) and Article 78(2) thereof, Whereas: (1) 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 pyroxsulam the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2007/277[EC (). (2)  In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 28 February 2006 an application from Dow AgroSciences GmbH for the inclusion of the active substance pyroxsulam in Annex [ to Directive 91/414/EEC. Decision 2007/277[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 Il and III to Directive 91/414/EEC. (3)  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) () OJ 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 2007/277[EC of 20 April 2007 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of pyroxsulam in Annex [ to Council Directive 91/414/EEC (O] L 116, 4.5.2007, p. 59). of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 20 March 2008. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (¥ additional information was requested from the applicant on 5 July 2012. The evaluation of the additional data by the United Kingdom was submitted in the format of an updated draft assessment report in November 2012. (4)  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 pesticide risk assessment of the active substance pyroxsulam (°) on 3 April 2013. The 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 pyroxsulam. (5) It has appeared from the various examinations made that plant protection products containing pyroxsulam 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 pyroxsulam. (6)  In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information. (7) A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval. (*) Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive (O] L 53, 26.2.2011, p. 51). (°) EFSA Journal 2013; 11(4):3182. Available online: www.efsa.europa. eu