Commission Regulation (EC) No 1444/2006 of 29 September 2006 concerning the authorisation of Bacillus subtilis C-3102 (Calsporin) as a feed additive (Text with EEA relevance)
Modified by
Commission Regulation (EC) No 164/2008of 22 February 2008amending Regulation (EC) No 1444/2006 as regards the minimum content of the feed additive Bacillus subtilis C-3102 (Calsporin)(Text with EEA relevance), 308R0164, February 23, 2008
Commission Regulation (EC) No 1444/2006of 29 September 2006concerning the authorisation of Bacillus subtilis C-3102 (Calsporin) as a feed additive(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,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. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8)., 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.(2)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation set out in the Annex. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.(3)The application concerns authorisation of the preparation Bacillus subtilis C-3102 (Calsporin) a feed additive for chickens for fattening, to be classified in the additive category "zootechnical additives".(4)The method of analysis included in the application for authorisation in accordance with Article 7(3)(c) of Regulation (EC) No 1831/2003 concerns the determination of the active substance of the feed additive in feed. The method of analysis referred to in the Annex to this Regulation is therefore not to be understood as a Community method of analysis within the meaning of Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rulesOJ L 165, 30.4.2004, as corrected by OJ L 191, 28.5.2004, p. 1. Regulation as amended by Commission Regulation (EC) No 776/2006 (OJ L 136, 24.5.2006, p. 3)..(5)The European Food Safety Authority (the Authority) concluded in its opinion of 8 March 2006 that Bacillus subtilis C-3102 (Calsporin) does not have an adverse effect on animal health, human health or the environmentOpinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the product Calsporin a preparation of Bacillus subtilis C-3102, as a feed additive for chickens for fattening in accordance with Regulation (EC) No 1831/2003. Adopted on 8 March 2006. The EFSA Journal (2006) 336, p. 1 to 15.. It further concluded that Bacillus subtilis C-3102 (Calsporin) does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. According to that opinion, the use of that preparation can improve the zootechnical parameters in chickens for fattening. It does not consider that there is a need for specific requirements of post market monitoring. The opinion of the Authority recommends appropriate measures for user safety. This opinion also verifies 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. The assessment of that preparation shows that the conditions for authorisation, 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)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: