26.2.2011 EN Official Journal of the European Union L 53/33
COMMISSION REGULATION (EU) No 184/2011
of 25 February 2011
concerning the authorisation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds (holder of authorisation Calpis Co. Ltd Japan, represented by Calpis Co. Ltd Europe Representative Office)
(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 nutrition (1), 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 to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) The application concerns the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens reared for laying, turkeys and minor avian species, to be classified in the additive category ‘zootechnical additives’.
(4) The use of Bacillus subtilis C-3102 (DSM 15544) has been authorised for 10 years for chickens for fattening by Commission Regulation (EC) No 1444/2006 (2) and for weaned piglets by Commission Regulation (EU) No 333/2010 (3).
(5) New data were submitted in support of the application for the authorisation of the preparation for chickens reared for laying, turkeys and minor avian species. The European Food Safety Authority (the Authority) concluded in its opinion of 5 October 2010 (4) that Bacillus subtilis C-3102 (DSM 15544), under the proposed conditions of use, does not have an adverse effect on animal health, human health or the environment, and that its use can improve the weight gain of the target species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. 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.
(6) The assessment of Bacillus subtilis C-3102 (DSM 15544) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.