Commission Regulation (EC) No 2200/2001
of 17 October 2001
concerning provisional authorisations of additives 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), as last amended by European Parliament and Council Directive 2001/46/EC(2), and in particular Articles 3, 9e and 9i thereof,
Whereas:
(1) Articles 9e(1) and 9i(1) of the Directive provide that a provisional authorisation of a new additive or a new use of an additive may be given for a specific period.
(2) Article 4 of the Directive establishes the procedure for such authorisation.
(3) The current provisional authorisations of many additives expire on 30 September 2001, and it is appropriate to extend these to the maximum extent permitted under Directive 70/524/EEC, which is until the fourth anniversary of initial provisional authorisation in the case of substances provisionally authorised pursuant to Article 9e(1) of Directive 70/524/EEC, and until the fifth anniversary in the case of substances included in Annex II to Directive 70/524/EEC before 1 April 1998.
(4) Provisional authorisations under this Regulation are granted for a specified period, but without prejudice to the possibility that they may be withdrawn at any time in accordance with Articles 9m and 11 of the Directive.
(5) Further, authorisations for the use of antibiotics as additives in feedingstuffs are currently under review in the light of major concerns relating to the potential effect of the use of antibiotics as feed additives on the efficacy of antibiotics for therapeutic use in humans, a concern reflected by the fact that the Kingdom of Sweden has prohibited the use on its territory of all antibiotics as additives in feedingstuffs on the basis of Article 11 of the Directive, and in the light of the opinions adopted on 28 May 1999 and 10 and 11 May 2001 by the Scientific Steering Committee on anti-microbial resistance.
(6) The extension of the period of the provisional authorisations must be considered as a purely administrative measure involving no new evaluation of the concerned additives.
(7) For readability and coherence reasons, all the provisional authorisations of additives in feedingstuffs, for which the duration may not exceed four or five years, are consolidated in this Regulation.
(8) This Commission Regulation replaces Commission Regulation (EC) No 2697/2000 of 27 November 2000 concerning the provisional authorisations of additives in feedingstuffs(3); therefore it is necessary to repeal Regulation (EC) No 2697/2000.
(9) The provisional authorisations for most of the additives expire on 30 September 2001; therefore it is necessary to apply this Regulation from 1 October 2001.
(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Feedingstuffs,
The additives referred to in the Annex to this Regulation are authorised provisionally in accordance with Directive 70/524/EEC under the conditions laid down in this Annex.
Regulation (EC) No 2697/2000 is hereby repealed.
This Regulation shall enter into force on the day following its publication in the Official Journal of the European Communities.
It shall apply from 1 October 2001.
This Regulation shall be binding in its entirety and directly applicable in all Member States.