26.3.2013 Official Journal of the European Union L 86/15 COMMISSION IMPLEMENTING REGULATION (EU) No 288/2013 of 25 March 2013 concerning the suspension of the authorisations of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM 1-1012) as provided for by Regulations (EC) No 256/2002, (EC) No 1453/2004, (EC) No 255/2005, (EC) No 1200/2005, (EC) No 166/2008 and (EC) No 378/2009 (Text with EEA relevance) THE EUROPEAN COMMISSION, (4) 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 nutrition (), and in particular Article 13(2) thereof, Whereas: (1) Regulation (EC) No 1831/2003 provides for the auth- orisation of additives for use in animal nutrition and for the grounds and procedures for granting, denying or suspending such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (?). (2)  The preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM 1-1012) was authorised without a time limit in accordance with Directive 70/524[EEC as a feed additive for use for piglets under two months and sows by Commission Regulation (EC) No 256/2002 (%), for piglets from two to four months and pigs for (6) fattening by Commission Regulation (EC) No 1453/2004 (%), for cattle for fattening by Commission Regulation (EC) No 255/2005 (°) and for rabbits for fattening and chickens for fattening by Commission Regulation (EC) No 1200/2005 (°). The preparation was subsequently entered in the European Union Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. (3)  That preparation was also authorised in accordance with Regulation (EC) No 1831/2003 for 10 years for turkeys for fattening by Commission Regulation (EC) No 166/2008 () and for rabbit breeding does by Commission Regulation (EC) No 378/2009 (3). 268, 18.10.2003, p. 29. 270, 14.12.1970, p. 1. 41, 13.2.2002, p. 6. 8) 269, 17.8.2004, p. 3. 45, 16.2.2005, p. 3. 195, 27.7.2005, p. 6. 50, 23.2.2008, p. 11. T R2TeTS ) o000 L000 PN/ RN/ RN BN e/ RN/ R} | il onlll onll ol el i anl ol 5 o~ O In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM 1-1012) as a feed additive for cattle for fattening, rabbits for fattening, chickens for fattening, piglets (weaned), pigs for fattening and sows for repro- duction and, in accordance with Article 7 of that Regu- lation, an application was submitted for a new use of that preparation for calves for rearing, both applications requesting the additive to be classified in the additive category ‘zootechnical additives. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The European Food Safety Authority (the Authority) concluded in its opinion of 16 October 2012 (°) that the strain of Bacillus cereus harbours resistance deter- minants to two antibiotics used in human and veterinary medicine, one of which at least can now be ascribed to an acquired resistance. It was also determined that, because of the presence of genes having the same organi- sation as pathogenic Bacillus cereus strains, it has to be assumed that the Bacillus cereus strain contained in the preparation subject to the application has the capacity to elaborate functional toxins involved in foodborne diseases. The information available does not allow one to exclude the risk that the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM 1-1012) may spread resistance to those antibiotics to other micro-organisms and may expose to the risk of the toxins those handling the additive or consumers. Consequently, it has not been established that that preparation does not have an adverse effect on animal health or on human health, when used under the proposed conditions. The conclusions from the Authority concerning the safety of the preparation apply to its use for all the animal species for which an authorisation has been granted, including for turkeys for fattening and for rabbit breeding does, as authorised by Regulations (EC) No 166/2008 and (EC) No 378/2009. Those authorisations therefore no longer meet the conditions set out by Article 5 of Regulation (EC) No 1831/2003. 116, 9.5.2009, p. 3. (%) EFSA Journal 2012; 10(10):2924.