17.12.2014 Official Journal of the European Union L 360/1 II (Non-legislative acts) REGULATIONS COMMISSION IMPLEMENTING REGULATION (EU) No 1334/2014 of 16 December 2014 approving the active substance gamma-cyhalotrin, 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 and allowing Member States to extend provisional authorisations granted for that active substance (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 Articles 13(2) and 78(2) thereof, Whereas: (1)  In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414EEC () 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 gamma-cyhalothrin the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2004/686/EC (). (2)  In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 4 November 2003 an application from Cheminova A[S for the inclusion of the active substance gamma-cyhalothrin in Annex I to Dir- ective 91/414/EEC. Decision 2004/686EC 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 IIl 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 applicant. The designated rapporteur Member State, the United Kingdom, submitted a draft assessment report on 25 January 2008. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (%) additional information was requested from the applicant. The evaluation of the additional data by the United Kingdom was submitted in the format of addenda to the draft assessment report on 13 September 2012. () OJL309,24.11.2009,p. 1. (*) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, 1), ¢) FC)ommission Decision 2004/686EC of 29 September 2004 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of proquinazid, IKI-220 (flonicamid) and gamma-cyhalothrin in Annex I to Council Directive 91/414/EEC (OJ L 313, 12.10.2004, p. 21). (*) 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 noti- fication of that Directive (OJ L 53, 26.2.2011, p. 51).