6.10.2001 Official Journal of the European Communities L 267/1 (Acts whose publication is obligatory) 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 Com- munity, Having regard to Council Directive 70/524/EEC of 23 Novem- ber 1970 concerning additives in feedingstuffs(l), as last amended by Directive 2001/46/EC of the European Parliament and of the Council (3), 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 (%), as last amended by Directive 95/11/EC (%), 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 resist- ance. The guidelines for additives other than micro- organisms and enzymes should therefore be sup- plemented by the establishment of a requirement for the dossier to include an assessment of the risk of the selection of andfor 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. () OJL 270, 14.12.1970, p. 1. (2) OJ L 234, 1.9.2001, p. 55. () OJL 64,7.3.1987,p. 19. (4) OJL 106, 11.5.1995, p. 23. (3) (6) 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. 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. The guidelines should be supplemented by more infor- mation on how workers and users can be exposed by the additive. An exposure assessment should be provided in order to take adequate measures. Confidence in the quality and objectivity of dossiers would be improved if they were supplemented by a critical appraisal of an independent person acknowl- edged to be an expert in the relevant field. The matters to be assessed in this report should be established in the guidelines. Experience has demonstrated that the guidelines should be supplemented by more specific criteria concerning the efficacy trials.