13.5.2014 Official Journal of the European Union L 138/65 COMMISSION IMPLEMENTING REGULATION (EU) No 485/2014 of 12 May 2014 approving the active substance Bacillus pumilus QST 2808, 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 Regu- lation (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 91/414EEC () 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 Bacillus pumilus QST 2808 the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Implementing Decision 2011/253/EU (). (2)  In accordance with Article 6(2) of Directive 91/414EEC the Netherlands received on 3 December 2010 an appli- cation from AgraQuest Inc., now Bayer CropScience, for the inclusion of the active substance Bacillus pumilus QST 2808 in Annex I to Directive 91/414/EEC. Implementing Decision 2011/253/EU 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. (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 submitted a draft assessment report on 8 May 2012. (4)  The draft assessment report was reviewed by the Member States and the European Food Safety Authority (herein- after ‘the Authority’). The Authority presented to the Commission its conclusion (*) on the pesticide risk assess- ment of the active substance Bacillus pumilus QST 2808 on 26 July 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 20 March 2014 in the format of the Commis- sion review report for Bacillus pumilus QST 2808. (5) It has appeared from the various examinations made that plant protection products containing Bacillus pumilus QST 2808 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 Bacillus pumilus QST 2808. (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. () OJL 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 (OJ L 230, 19.8.1991, p-1). (®) Commission Implementing Decision 2011/253/EU of 26 April 2011 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of metobromuron, S-Abscisic acid, Bacillus amyloliquefaciens subsp. plantarum D747, Bacillus pumilus QST 2808 and Streptomyces lydicus WYEC 108 in Annex I to Council Directive 91/414/EEC (OJ L 106, 27.4.2011, p.13). (*) EFSA Journal (2013) 11(8):3346. Available online: www.efsa.europa.eu.