19.12.2008 EN Official Journal of the European Union L 340/38
COMMISSION REGULATION (EC) No 1293/2008
of 18 December 2008
concerning the authorisation of a new use of Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20 and Levucell SC10 ME) 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 the authorisation of a new use of the preparation of Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20, Levucell SC10 ME), as a feed additive for lambs, to be classified in the additive category ‘zootechnical additives’.
(4) The use of Saccharomyces cerevisiae CNCM I-1077 was authorised without a time limit for dairy cows and cattle for fattening by Commission Regulation (EC) No 1200/2005 (2) and, until 22 March 2017, for dairy goats and dairy sheep by Commission Regulation (EC) No 226/2007 (3).
(5) New data were submitted in support of an application for authorisation for lambs. The European Food Safety Authority (the Authority) concluded in its opinion of 16 July 2008 (4) that Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20/Levucell SC10 ME) does not have an adverse effect on animal health, human health or the environment. It further concluded that Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20/Levucell SC10 ME) 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 is safe for lambs. That opinion also states that that preparation can produce a beneficial effect on final weight and average daily gain. 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 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.
(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.