This Regulation establishes that residues of veterinary medicinal products are all 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, and that maximum residue limits means the maximum concentration of residue resulting from the use of a veterinary medicinal product which may be accepted by the Community to be legally permitted in or on a food. This Regulation is based on the type and amount of residue considered being without any toxicological hazard for human health.
This Regulation shall not apply to active principles of biological origin intended to produce or to diagnose active or passive immunity used in immunological veterinary medicinal products. Where it appears a maximum residue limit the administration of the substances listed in Annex IV to food-producing animals shall be prohibited throughout the Community. Where a Member State considers that a urgent amendment of a provision contained in Annexes I to IV is necessary in order to protect human or animal health that Member State may temporarily suspend the operation of the provision concerned in its own territory. (16 articles and 5 Annexes)