30.9.2006 EN Official Journal of the European Union L 271/25
COMMISSION REGULATION (EC) No 1446/2006
of 29 September 2006
concerning the authorisation of Enterococcus faecium (Biomin IMB52) 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 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. 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 Enterococcus faecium (Biomin IMB52) 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 rules (2).
(5) The use of the preparation Enterococcus faecium DSM 3530 was already authorised for calves up to six months of age by Commission Regulation (EC) No 418/2001 of 1 March 2001 concerning the authorisation of new additives and uses of additives in feedingstuffs (3). New data were submitted in support of an application for authorisation for chickens for fattening. In its assessment, the European Food Safety Authority (the Authority) concludes that the safety of this additive for the consumer, the user and the environment have already been established and will not be changed by the proposed new use. It further concludes that the use of the preparation does not have an adverse effect on this additional animal category and that 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,
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.