Commission Regulation (EC) No 1333/2004 of 20 July 2004 concerning the permanent authorisation of certain additive in feedingstuffs (Text with EEA relevance)
Grade B
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Address https://gelex.eu/eli/EU/regulation/2004/1333@2004-07-20/en
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, 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.
(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.
(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
ANNEX
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 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
Powder form:
4 × 1011 CFU/g additive
Coated form:
5 × 1010 CFU/g additive
Versions
Cited by
- Commission Implementing Regulation (EU) No 797/2013 of 21 August 2013 concerning the authorisation of a preparation of Enterococcus faecium NCIMB 11181 as a feed additive for calves for rearing and for fattening and weaned piglets (holder of authorisation Chr. Hansen A/S) and repealing Regulation (EC) No 1333/2004 (Text with EEA relevance) Regulation · Grade B
A preparation of Enterococcus faecium NCIMB 11181 was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use on calves for rearing and for fattening and weaned piglets by Commission Regulation (EC) No 1333/2004. That preparation was subsequently entered in the European Union Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.
- Commission Implementing Regulation (EU) No 797/2013 of 21 August 2013 concerning the authorisation of a preparation of Enterococcus faecium NCIMB 11181 as a feed additive for calves for rearing and for fattening and weaned piglets (holder of authorisation Chr. Hansen A/S) and repealing Regulation (EC) No 1333/2004 (Text with EEA relevance) Regulation · Grade B
As a new authorisation is granted in accordance with Regulation (EC) No 1831/2003, Regulation (EC) No 1333/2004 should be repealed.
- Commission Implementing Regulation (EU) No 797/2013 of 21 August 2013 concerning the authorisation of a preparation of Enterococcus faecium NCIMB 11181 as a feed additive for calves for rearing and for fattening and weaned piglets (holder of authorisation Chr. Hansen A/S) and repealing Regulation (EC) No 1333/2004 (Text with EEA relevance) Regulation · Grade B
Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for the disposal of existing stocks of the additive, pre-mixtures and compound feed containing it, as authorised by Regulation (EC) No 1333/2004.
- Commission Implementing Regulation (EU) No 797/2013 of 21 August 2013 concerning the authorisation of a preparation of Enterococcus faecium NCIMB 11181 as a feed additive for calves for rearing and for fattening and weaned piglets (holder of authorisation Chr. Hansen A/S) and repealing Regulation (EC) No 1333/2004 (Text with EEA relevance) Regulation · Grade B
Regulation (EC) No 1333/2004 is repealed.
- Commission Regulation (EC) No 1810/2005 of 4 November 2005 concerning a new authorisation for 10 years of an additive in feedingstuffs, the permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of new uses of certain additives already authorised in feedingstuffs (Text with EEA relevance) Regulation · Grade B
The use of the micro-organism preparation of Enterococcus faecium (NCIMB 11181) was authorised without a time-limit for calves and for piglets by Commission Regulation (EC) No 1333/2004. New data were submitted in support of an application to extend the authorisation of the use of that micro-organism preparation to chickens for fattening. The European Food Safety Authority (EFSA) delivered a favourable opinion on 13 April 2005 on the safety of that additive when used in the animal category chickens for fattening, under the conditions of use set out in Annex IV to this Regulation. The assessmen