Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

New provisions for the Regulation on Maximum Residue Limits ***

Dr. Marcus Riehl (Abschlußjahr: 2009)

Language: English

The main objective of the European Union (EU) legislation governing the licensing and marketing of veterinary medicines is to protect human and animal health. Veterinary medicinal products for food-producing animals can be authorised only if the foodstuffs produced will be harmless to consumers and do not contain residues of the medicine or its metabolites above the MRL (Maximum Residue Limit).

Since January 2000 it is not allowed to use any active substances in veterinary medicinal products for food-producing animals unless the MRLs for the substances concerned have been included in Annex I, II or III of Regulation (EEC) No 2377/90, as amended. The setting of MRLs ensures that consumers do not ingest potentially harmful residues. When establishing a MRL, consideration is also given to residues that occur in food of plant origin and/or come from the environment. The MRL is the basis for the determination of the withdrawal period which is required before animals can be sent for slaughter and used for human consumption.

The current regulation is a complex system which on the one hand has increased the consumer protection, animal health and animal welfare but on the other hand resulted in numerous difficulties such as strict limitations on the flexibility allowed to veterinary surgeons in using or prescribing veterinary medicines and problems related to the control of residues in foods of animal origin. The main problem is the strong impact on the availability of veterinary medicinal products, especially for food producing animals.

To overcome this problems, on 17 April 2007 the European Commission adopted the “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” which is reflecting the consultation on possible changes launched in 2004 by the Commission. The current regulation will be modified, but the principle of the MRL assessment will be retained.

The new proposal of the Commission has 4 main objectives:

1. To improve the availability of veterinary medicinal products for food producing animals in order to ensure animal health and welfare and avoid illegal use of substances

2. To simplify the existing legislation by enhancing readability of the provisions on established MRLs for the end-users (i.e. animal health professionals, control competent authorities in Member States and third countries)

3. To provide 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'

4. To clarify the Community procedures establishing MRLs by ensuring consistency with international standards

The European Parliament adopted a legislative resolution approving unamended, under the second reading of the codecision procedure of 2 April 2009 and it is planned by the Commission to have the final draft adopted by late 2009.

The thesis describes the current regulation and the problems associated with it, as well as the new proposal, which will replace the current regulation. It is discussed, to which extend the new proposal provides changes to overcome the existing problems and which further approaches could help to improve the current situation.

Pages: 42