L 312/28 Official Journal of the European Union 21.11.2013 COMMISSION IMPLEMENTING REGULATION (EU) No 1177/2013 of 20 November 2013 approving the active substance spirotetramat, 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: (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 spirotetramat the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2007/560/EC (). (2 In accordance with Article 6(2) of Directive 91/414/EEC Austria received on 9 October 2006 an application from Bayer CropScience AG for the inclusion of the active substance spirotetramat in Annex [ to Directive 91/414/EEC. Decision 2007/560/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 I 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) of Directive 91/414/EEC, for the uses proposed by the () 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 2007/560/EC of 2 August 2007 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of chlorantraniliprole, heptamaloxyglucan, spirotetramat and Helicoverpa armigera nucleo- polyhedrovirus in Annex I to Council Directive 91/414/EEC (O] L 213, 15.8.2007, p. 29). applicant. The designated rapporteur Member State submitted a draft assessment report on 5 May 2008. (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 spirotetramat (*) on 27 May 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 spirotetramat. (5) It has appeared from the various examinations made that plant protection products containing spirotetramat 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 use which was examined and detailed in the Commission review report. It is therefore appropriate to approve spirotetramat. (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. (8)  Without prejudice to the obligations provided for in 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 period of six months after approval to review authori- sations of plant protection products containing spirotet- ramat. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided (%) EFSA Journal (2013) 11(6):3243. Available online: www.efsa.europa. ceu.