Commission Implementing Regulation (EU) No 888/2011 of 5 September 2011 concerning the authorisation of diclazuril as a feed additive for turkeys for fattening (holder of authorisation Janssen Pharmaceutica N.V.) and amending Regulation (EC) No 2430/1999 Text with EEA relevance
Modified by
Commission Implementing Regulation (EU) No 160/2013of 21 February 2013amending Regulations (EC) No 162/2003, (EC) No 971/2008, (EU) No 1118/2010 and (EU) No 169/2011 and Implementing Regulation (EU) No 888/2011 as regards the name of the holder of the authorisation of diclazuril in animal feed(Text with EEA relevance), 32013R0160, February 22, 2013
Commission Implementing Regulation (EU) No 888/2011of 5 September 2011concerning the authorisation of diclazuril as a feed additive for turkeys for fattening (holder of authorisation Janssen Pharmaceutica N.V.) and amending Regulation (EC) No 2430/1999(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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutritionOJ L 268, 18.10.2003, p. 29., and in particular Article 9(2) thereof,Whereas:(1)Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EECOJ L 270, 14.12.1970, p. 1..(2)Diclazuril, CAS number 101831-37-2, was authorised for 10 years in accordance with Directive 70/524/EEC as a feed additive for use on chickens for fattening, chickens reared for laying up to 16 weeks and turkeys up to 12 weeks by Commission Regulation (EC) No 2430/1999OJ L 296, 17.11.1999, p. 3.. The additive was subsequently entered in the Community Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. Its use has further been authorised for 10 years for chickens for fattening by Commission Regulation (EU) No 1118/2010OJ L 317, 3.12.2010, p. 5., for guinea fowls by Commission Regulation (EU) No 169/2011OJ L 49, 24.2.2011, p. 6. and for rabbits by Commission Regulation (EC) No 971/2008OJ L 265, 4.10.2008, p. 3..(3)In accordance with Article 10(2) in conjunction with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the re-evaluation of diclazuril as a feed additive for turkeys for fattening, requesting that additive be classified in the additive category "coccidiostats and histomonostats". That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.(4)The European Food Safety Authority (the Authority) concluded in its opinion of 16 March 2011EFSA Journal 2011; 9(4):2115. that, under the proposed conditions of use, diclazuril does not have an adverse effect on animal health, consumer health or the environment, and that it is effective in controlling coccidiosis in turkeys for fattening. It concluded that no safety concerns would arise for users provided that appropriate protective measures are taken. It also verified the report on the method of analysis of the feed additive in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003.(5)The assessment of diclazuril shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.(6)As a consequence of a new authorisation being granted by this Regulation, the entry in Regulation (EC) No 2430/1999 concerning diclazuril should be deleted.(7)Since the modifications to the conditions of authorisation are not related to safety reasons, it is appropriate to allow a transitional period for the disposal of existing stocks of premixtures and compound feed containing this preparation, as authorised by Regulation (EC) No 2430/1999 for use on turkeys up to 12 weeks.(8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,HAS ADOPTED THIS REGULATION: