Commission Directive 2001/79/EC
of 17 September 2001
amending Council Directive 87/153/EEC fixing guidelines for the assessment of additives in animal nutrition
(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 Directive 2001/46/EC of the European Parliament and of the Council(2), and in particular Article 5 thereof,
Whereas:
(1) Council Directive 87/153/EEC of 16 February 1987 fixing guidelines for the assessment of additives in animal nutrition(3), as last amended by Directive 95/11/EC(4), should be amended in the light of advances in scientific and technical knowledge.
(2) It has become apparent that the increasing prevalence of antibiotic-resistant bacteria is of major concern to public health. Resistance caused by the use of antibiotics as feed additives contributes to the overall levels of resistance. The guidelines for additives other than micro-organisms and enzymes should therefore be supplemented by the establishment of a requirement for the dossier to include an assessment of the risk of the selection of and/or transfer of resistance to antibiotics and of any increased persistence and shedding of enteropathogens in order to ensure the safety of the use of those additives. For this purpose, the data required for the risk assessment and methodology to be applied should also be established.
(3) They should be supplemented by the establishment of criteria for the assessment of the risk to the consumer which could result from the consumption of food containing residues of the additive or its metabolites. Based on the residue studies maximum residue limits (MRL's) and withdrawal periods should be established, where appropriate.
(4) The environmental impact of feed additives is important since the additives are normally used over a long period, and the abovementioned guidelines should therefore be supplemented by the establishment of criteria for the assessment of the risk of the additive having an adverse effect on the environment, either directly and or as a result of the effect of products derived from it, whether directly or excreted by the animals into the environment. For the determination of this impact a stepwise approach should be followed based on a first and second phase of studies.
(5) The guidelines should be supplemented by more information on how workers and users can be exposed by the additive. An exposure assessment should be provided in order to take adequate measures.
(6) Confidence in the quality and objectivity of dossiers would be improved if they were supplemented by a critical appraisal of an independent person acknowledged to be an expert in the relevant field. The matters to be assessed in this report should be established in the guidelines.
(7) Experience has demonstrated that the guidelines should be supplemented by more specific criteria concerning the efficacy trials.
(8) Article 9b(1) of Council Directive 70/524/EEC provides that an additive referred to in Article 2(aaa) of that Directive shall initially be authorised for 10 years, after which time, the person holding the authorisation for it may seek renewal of the authorisation for a further period of 10 years. It is necessary to establish guidelines indicating the information which must be included in such an application for renewal and its accompanying dossier.
(9) Article 9c(3) of Council Directive 70/524/EEC provides that 10 years after a substance has first been authorised, the findings of all or part of the evaluation of data and information contained in the dossier supplied for initial authorisation may be used for the benefit of other persons seeking authorisation to put that substance into circulation. It is therefore necessary to establish guidelines indicating the information which must nonetheless be included in an application and accompanying dossier.
(10) Scientific and technical knowledge should be taken into account.
(11) For clarity reasons, it is appropriate to divide the guidelines into those applicable to additives other than micro-organisms and enzymes and those applicable to micro-organisms and enzymes.
(12) These guidelines have been established on the basis of the Report of the Scientific Committee on Animal Nutrition on the revision of the guidelines for the assessment of additives in animal nutrition (adopted on 22 October 1999).
(13) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee for feedingstuffs,
HAS ADOPTED THIS DIRECTIVE:
Article 1
The Annex to Directive 87/153/EEC is amended as follows:
After its title the text set out in the Annex to this Directive shall be inserted.
Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2002 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 3
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 17 September 2001.