Veterinary medicinal product residues in foodstuffs of animal origin

The rules on residues of veterinary medicinal products administered to food-producing animals are in line with the need to protect public health. Accordingly, this Regulation classifies pharmacologically active substances used in veterinary medicinal products on the basis of their public health implications. More specifically, it stipulates the level which is or is not permitted in foodstuffs of animal origin. In other words it establishes maximum limits for residues of veterinary medicinal products in such foodstuffs.

ACT

Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin [Official Journal L 224 of 18.08.1990]. [See amending acts].

SUMMARY

Owing to the effects which substances contained in veterinary medicinal products for food-producing animals can have, this Regulation classifies these substances and above all identifies the residues of veterinary medicinal products * which may or may not be permitted in foodstuffs of animal origin, and the level of such residues if they are permitted. In short, it lays down maximum limits for residues in foodstuffs of animal origin.

Accordingly, the pharmacologically active substances used in veterinary medicinal products are classified in four categories, in accordance with the need to protect public health, as follows:

• substances for which maximum residue limits (MRLs) * have been established (Annex I);
• substances for which an MRL is not necessary (Annex II);
• substances for which a provisional MRL may be established (Annex III);
• substances for which an MRL cannot be established, as they constitute a risk to consumer health (Annex IV).

The inclusion in Annexes I, II or III of a pharmacologically active substance used in veterinary medicinal products intended for food-producing animals must be the subject of an application for the establishing of a residue limit to the European Medicines Agency (the 'Agency'). This application must contain the safety information referred to in Annex V to the Regulation.

A Member State may temporarily suspend the application of a provision contained in the annexes in its territory where it considers that the provision must be amended owing to new information concerning a potential risk to human or animal health. The other Member States and the Commission must be informed of any such decision and the reasons for it.

The Commission must examine the reasons given by the Member State, draw up an opinion after consulting the Committee on Veterinary Medicinal Products and take appropriate action. It must notify the Council and the other Member States of the action taken. Any Member State may refer the action taken by the Commission to the Council within 15 days of such notification. The Council must give its opinion within 30 days of such referral.

However, the Commission may initiate the procedure to amend the annexes to the Regulation on the basis of the need to protect human health. Following each amendment, the Commission must publish a summary of the assessment of the safety of the substances concerned.

However, the Member States may not prohibit or impede the putting into circulation within their territories of foodstuffs of animal origin from other Member States on the grounds that they contain residues of veterinary medicinal products if the quantity of residue does not exceed the MRL provided for in Annexes I or III or if the substance concerned is listed in Annex II.

Furthermore, since 1 January 1997 the administration to food-producing animals of veterinary medicinal products containing pharmacologically active substances not listed in Annexes I, II or III has been prohibited in principle. However, the deadline has been postponed for certain substances which were still permitted when this Regulation entered into force and for which applications for the establishing of limits were made before 1 January 1996 (1 January 1998 for pyrazolinones, nitroimidazoles and arsenic acid , and 1 January 2000 for other substances).

RELATED ACTS

Proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, and repealing Regulation (EEC) No 2377/90 ([COM(2007) 194 final - Not published in the Official Journal].

The aim of this proposal is to improve and simplify the existing legal framework concerning maximum residue limits (MRLs). In particular it attempts to make the provisions on MRLs more comprehensible for final users (competent monitoring authorities in the Member States and third countries, etc.), create a clear reference tool for monitoring residues of pharmacologically active substances in foodstuffs in order to better protect public health, and, finally, to ensure consistency with international standards and clarify Community procedures establishing MRLs. It also aims to increase the availability of veterinary medicinal products and prevent the illegal use of substances, while limiting exposure of consumers to pharmacologically active substances used in these veterinary medicinal products.

Last updated: 21.05.2008