AI-assisted research summary: This Regulation authorises use of Enterococcus faecium (NCIMB 11181) as a feed additive for calves and piglets, subject to the Annex conditions.
21.7.2004 | EN | Official Journal of the European Union | L 247/11 ---|---|---|--- * * * COMMISSION REGULATION (EC) No 1333/2004 of 20 July 2004 concerning the permanent authorisation of certain additive in feedingstuffs (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), and in particular Articles 3 and 9d(1) thereof, Whereas: (1) | Directive 70/524/EEC provides for the authorisation of additives to be used in the Community. The additives referred to in Part II of Annex C to that Directive may be authorised without a time limit subject to certain conditions being satisfied. ---|--- (2) | The use of the microorganism preparation of Enterococcus faecium (NCIMB 11181) was provisionally authorised, for the first time, for calves and piglets by Commission Regulation (EC) No 2690/1999 (2). ---|--- (3) | New data were submitted in support of the application for authorisation without a time limit of that microorganism. The assessment shows that the conditions laid down in Directive 70/524/EEC for such an authorisation have been satisfied. ---|--- (4) | Accordingly, the use of that microorganism for calves and piglets, as specified in the Annex, should be authorised without a time limit. ---|--- (5) | The assessment of the applications shows that certain procedures should be required to protect workers from exposure to the additive set out in the Annex to this Regulation. Such protection should be assured by the application of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (3). ---|--- (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, ---|--- HAS ADOPTED THIS REGULATION: Article 1 The preparation of Enterococcus faecium (NCIMB 11181), as set out in the Annex, is authorised for use without a time limit as additive in animal nutrition under the conditions laid down in that Annex. Article 2 This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Communities. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 July 2004. For the Commission David BYRNE Member of the Commission * * * (1) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Regulation (EC) No 1756/2002 (OJ L 265, 3.10.2002, p. 1). (2) OJ L 326, 18.12.1999, p. 33. (3) OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). * * * ANNEX EC No | Additive | Chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation ---|---|---|---|---|---|---|---|--- CFU/kg of complete feedingstuff Micro-organisms E 1708 | Enterococcus faecium NCIMB 11181 | Preparation of Enterococcus faecium containing a minimum of | | Powder form: | | 4 × 1011 CFU/g additive ---|--- | Coated form: | | 5 × 1010 CFU/g additive ---|--- Calves | 6 months | 5 × 108 | 2 × 1010 | In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. | Without a time limit Piglets | — | 5 × 108 | 2 × 1010 | For piglets until approximately 35 kg. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. | Without a time limit * * *