Maximum residue levels of veterinary medicines in relation to food safety: European Community legislation and ethical aspects

Residues of veterinary medicinal products, as defined by the European Union, are “pharmacologically active substances (whether active principles, excipients or degradation products) and their metabolites which remain in foodstuffs obtained from animals to which the veterinary medicinal product in question has been administered”. The policy for Maximum Residue Limit (MRL) setting is focused on a high protection level for the consumer. MRL can be set when risk assessment shows no risk for the consumer. An MRL is the maximum concentration of residue following administration of a veterinary medicine which is legally permitted or acceptable in food under the laws of the EU. The responsibility for keeping residues under the MRL lies with veterinarians and farmers, using licensed animal medicines. Violative residues of veterinary medicines can occur as a result of improper use of a licensed product or through the illegal use of an unlicensed substance. Consequently, it became clear that prudent use of not only antimicrobials used for treatment and prevention of disease but also those used for growth promotion (e.g. β-agonists or steroid hormones) in farm animals is an integral part of good veterinary practice. In the following an overview of the European Community legislation on the studies required for residues is given. Ethical aspects are also considered.