L 219/22 Official Journal of the European Union 15.8.2013 COMMISSION IMPLEMENTING REGULATION (EU) No 781/2013 of 14 August 2013 amending Implementing Regulation (EU) No 540/2011, as regards the conditions of approval of the active substance fipronil, and prohibiting the use and sale of seeds treated with plant protection products containing this 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 the first alternative of Article 21(3), Article 49(2) and Article 78(2) thereof, Whereas: (1) The active substance fipronil was included in Annex I to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3 by Commission Directive 2007/52[EC (). Commission Directive 2010/21/EU (*) amended Annex I to Directive 91/414/EEC as regards the specific provisions relating to fipronil. Active substances included in Annex I to Directive 91/414[EEC are deemed to be approved under Regu- lation (EC) No 11072009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (°). Based on new information received from Italy concerning risks to honeybees caused by coated maize seeds treated with plant protection products containing fipronil, the Commission decided to review the approval of that active substance. The Commission, in accordance with Article 21(2) of Regulation (EC) No 1107/2009, asked the European Food Safety Authority, hereinafter ‘the Authority’, for scientific and technical assistance to assess this new information and to review the risk assessment of fipronil as regards its impact on bees. 309, 24.11.2009, p. 1. 230, 19.8.1991, p. 1. 65, 13.3.2010, p. 27. 153, 11.6.2011, p. 1. () O] L () O] L () OJ L 214, 17.8.2007, p. 3. () O] L () O L ©) (10) (11) The Authority presented its conclusion on the risk assessment of fipronil as regards bees on 27 May 2013 (9). The Authority identified for the use as seed treatment in maize, high acute risks for bees from plant protection products containing the active substance fipronil. The Authority identified, in particular, a high acute risk for bees resulting from dust. In addition, unacceptable risks due to acute or chronic effects on colony survival and development could not be excluded for several crops. Furthermore, the Authority identified some missing information for each of the evaluated uses, in particular as regards long term risk to honeybees from dust exposure, from potential exposure to residues in pollen and nectar, from potential exposure to guttation fluid and from exposure to residues in succeding crops, weeds and soil. In the light of the new scientific and technical knowledge, the Commission considered that there are indications that some approved uses of fipronil do not satisfy the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 with respect to the impact on bees and that the high risk for bees could not be excluded except by imposing further restrictions. The Commission invited the notifier to submit comments. The conclusion of the Authority was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 16 July 2013 in the format of an addendum to the review report for fipronil. The Commission has come to the conclusion that a high risk for bees cannot be excluded except by imposing further restrictions. It is confirmed that the active substance fipronil is deemed to have been approved under Regulation (EC) No 1107/2009. In order to minimise the exposure of bees, it is, however, appropriate to restrict the use of (%) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment for bees for the active substance fipronil. EFSA Journal 2013;11(5):3158. [51 pp.] doi:10.2903/ j.efsa.2013.3158. Available online: www.efsa.europa.eu/efsajournal