16.6.2009 Official Journal of the European Union L 152/11 REGULATION (EC) No 470/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 37 and Article 152(4)(b) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the procedure referred to in Article 251 of the Treaty (3), Whereas: As a result of scientific and technical progress it is possible to detect the presence of residues of veterinary medicinal products in foodstuffs at ever lower levels. In order to protect public health, maximum residue limits should be established in accordance with generally recognised principles of safety assessment, taking into account toxicological risks, environmental contamina- tion, as well as the microbiological and pharmacological effects of residues. Account should also be taken of other scientific assessments of the safety of substances concerned which may have been undertaken by inter- national organisations or scientific bodies established within the Community. () OJ C 10, 15.1.2008, p. 51. (%) Opinion of the European Parliament of 17 June 2008 (not yet published in the Official Journal), Council Common Position of 18 December 2008 (O] C 33 E, 10.2.2009, p. 30) and Position of the European Parliament of 2 April 2009 (not yet published in the Official Journal). G) ( ( ( ’) 9 ’) This Regulation directly concerns public health and is relevant to the functioning of the internal market in products of animal origin included in Annex I to the Treaty. It is therefore necessary to establish maximum residue limits for pharmacologically active substances in respect of various foodstuffs of animal origin, including meat, fish, milk, eggs and honey. Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the estab- lishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (?) introduced Community procedures to evaluate the safety of residues of pharmacologically active substances in accordance with human food safety requirements. A pharmacologically active substance may be used in food- producing animals only if evaluated favourably. Maximum residue limits are established for such substances where they are considered necessary for the protection of human health. Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to veterinary medicinal products (%) provides that veterinary medicinal products may be authorised or used in food-producing animals only if pharmacologically active substances contained therein have been assessed as safe according to Regulation (EEC) No 2377/90. Moreover that Directive contains rules concerning the documentation of use, re-desig- nation (off label use), prescription and distribution of veterinary medicinal products intended for use in food- producing animals. In the light of the European Parliament’s resolution of 3 May 2001 (°) on the availability of veterinary medicinal products, the Commission’s public consultation undertaken in 2004 and its assessment of the experience gained, it has proved necessary to modify the procedures for setting maximum residue limits while maintaining the overall system for setting such limits. 24, 18.8.1990, p. 1. o L2 0J L 311, 28.11.2001, p. 1. 0] C2 7 E, 31.1.2002, p. 80.