28.11.2006 EN Official Journal of the European Union L 330/9
COMMISSION REGULATION (EC) No 1750/2006
of 27 November 2006
concerning the authorisation of selenomethionine 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 selenomethionine as a feed additive for all species, to be classified in the additive category ‘nutritional 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 European Food Safety Authority (the Authority) concluded in its opinion of 19 April 2006 that selenomethionine does not have an adverse effect on animal health, human health or the environment (3). It further concluded that selenomethionine 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 be considered as a source of bio available Se and fulfils the criteria of a nutritional additive for all species. The opinion of the Authority recommends appropriate measures for user safety. It does not consider that there is a need for specific requirements of post market monitoring. 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 ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, 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.