Medicinal products for veterinary use

Maximum Residue Limits

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Major developments

General information

On 17 April 2007 the European Commission adopted a legal proposal to amend the Regulation on Maximum Residue Limits which aims at simplifying existing provisions for establishing the maximum amount of residues of veterinary medicinal products legally accepted in foodstuffs. The new provisions are expected to stimulate innovation and improve the availability of veterinary medicinal products.

The primary purpose of the legislation on pharmacologically active substances used in veterinary medicinal products is to ensure the protection of consumers against possible harmful effects resulting from exposure to residues of veterinary medicinal products present in foodstuffs. However, existing rules are too complex and while succeeding in guaranteeing a high level of public health protection, they have contributed to a decrease in the availability of medicines for food producing animals in the EU and have led to various problems related to the implementation and enforcement of the legislation, creating difficulties in the functioning of the single market and in international trade.

The new legislation is aimed at:

  • Improving the availability of veterinary medicinal products for food producing animals in order to ensure animal health and welfare and avoid illegal use of substances.
  • Providing clear references for the control of residues of pharmacologically active substances in foodstuffs to improve consumer health protection and the functioning of the Single Market.
  • Clarifying the Community procedures establishing Maximum Residue Limits (MRLs) by ensuring consistency with international standards.
  • Simplifying existing legislation by enhancing readability of the provisions on established MRLs for end users (i.e. animal health professionals, competent inspection authorities in Member States and third countries).

The Commission proposal was adopted by the European Parliament and Council under the co-decision procedure and published in the Official Journal of 16 June 2009. The new Regulation (Regulation (EC) No 470/2009) will enter into force on the twentieth day following its publication in the Official Journal.

More information on the establishment of maximum residue limits may be found under the EudraLex - Volume 8 - Notice to applicants (for veterinary medicinal products).

Additional information: