New Regulation on Maximum Residue Limits

On July 6 the new Regulation (EG) No. 470/2009 of the European Parliament came into force. The new provisions laid down in the new Regulation are expected to stimulate innovation and improve availability of veterinary medicinal products. At the same time the repealing Council Regulation (EEC) No. 2377/90 and amending Directive 2001/82/EC entered into force. The new Regulation on maximum residue limits aims at simplifying existing provisions for establishing the maximum amount of residues of veterinary medicinal products legally accepted in foodstuffs.
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 the exposure to residues of veterinary medicinal products present in foodstuffs. Due to the Commission the existing rules are too complex and while succeeding in guaranteeing a high level of public health protection, they have contributed to a decrease in 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 international trade.
Therefore the new Regulation aims to simplify the existing legislation, to improve the availability of veterinary medicinal products for food producing animals, to provide clear references for the control of residues of pharmacologically active substances in foodstuffs and to clarify the Community procedures establishing maximum residue limits (MRLs).
In order to ensure food safety, the regulation lays down the rules and procedures to establish:
The maximum residue concentration of a pharmacologically active substance (expressed in mg/kg or μg/kg on a fresh weight basis) which may be permitted in food of animal origin ("MRL"); and The residue level of a pharmacologically active substance established for control reasons in case of certain substances for which a MRL has not been laid down in the regulation (reference point for action).

Details

If a pharmacologically active substance is intendd for use in the Community in veterinary medicinal products an application to the European Medicine Agency (EMEA) has to be submitted. The EMEA will be responsible for giving a scientific opinion on the maximum residue limit (consisting of a scientific risk assessment and risk management recommendations). The final approval will be given by the European Commission.
The European Commission shall classify the pharmacologically active substances, and include a list of the substances and the therapeutic classes to which they belong. This classification shall also establish, for each of the substances and specific foodstuffs or species, one of the following:

• A maximum residue limit;
• A provisional maximum residue limit, where scientific data is incomplete but it is supposed there is no danger for humans;
• The absence of the need to establish a maximum residue limit (when there is no risk for human health); or
• A prohibition on the administration of a substance, where any presence or residue of the pharmacologically active substance may pose a danger to human health or when no final conclusion can be drawn as to the potential effects of the substance in question.

The Commission may also establish reference action points for residues of strong pharmacologically active substances not subject to a classification mentioned above, when it is deemed necessary in order to ensure the functioning of controls for foods of animal origin imported or placed on the market in accordance with regulation (EC) No 882/2004.
Only pharmacologically active substances, which are classified (see above), may be administered to food-producing animals within the Community. Besides, foods of animal origin which contain residues of pharmacologically active substances exceeding the maximum residue limit established, or exceeding the reference points set for the unclassified substances, shall not be imported or placed on the market in the EU.