Residues of Pharmacological substances and Contaminations from animal foods

The consumer is entitled to foods which do not contain any harmful residues from feedstuffs and the medical treatment of animals.

The responsible handling of animals involves sensibly combating animal diseases and treating sick animals, if necessary, with medical substances. If these animals are used for the production of food, there is a possibility that low amounts of the substances used in treatment may reach the food chain of humans (so-called "residues"). Hence, medicinal products may only be used in food-producing animals under controlled conditions. As far as possible it must be excluded that humans who consume foods from treated animals take in residues of veterinary medicinal products which damage their health.

Maximum levels for residues apply when undertaking assessments in conjunction with the control of foods for illegal residues of pharmacological substances. They are regulated throughout the EU by Regulation (EEC) No. 2377/90 of the Council "For the creation of a Community procedure for the laying down of maximum levels for veterinary medicinal products in foods of animal origin".

Before a veterinary medicinal product is approved, extensive scientific studies are carried out to determine whether and which residues could occur in the food obtained from the animal and in what concentrations such residues can be tolerated, provided that no health risk is apparent. The maximum tolerable concentration of residues in a foodstuff is called a maximum residue limit (MRL). A substance in a veterinary medicinal product for food-producing animals can only be authorised if the consumer risk from residues has been adequately assessed.

In the European Community, there is a standardised procedure for setting maximum residue levels for veterinary medicinal products, which was established by Regulation (EC) No. 470/2009 of the European Parliament and of the Council of 6 May 2009 ‘laying down Community procedures for the establishment of residue limits of pharmacologically in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council.

In this procedure, a comprehensive catalogue of criteria is taken into account, according to which the most diverse potential biological effects of a substance are examined, such as pharmacological activity, possible acute and chronic toxic ity (toxicity), possible damage to genetic material (mutagenicity), possible damage to embryos/foetuses (teratogenicity) and also tumour-producing potential (carcinogenicity). On the basis of all these investigations and considerations, it is determined whether there is a harmless dose of the substance that can be ingested daily in food without risk to health, even over the course of a lifetime (‘Acceptable Daily Intake’, ADIshort forAcceptable Daily Intake). If such a dose can be determined, the maximum permissible concentrations of the substance in question in individual foodstuffs such as meat, milk, eggs or honey are specified (maximum levels) so that the tolerable daily intake is not exceeded even if all of these products are eaten in relatively large quantities. Substances that are critical in food in any concentration, no matter how small, and for which no ADIshort forAcceptable Daily Intake can therefore be set, may not be used in food-producing animals.

On the one hand, the maximum levels form the basis for determining withdrawal periods when authorising veterinary medicinal products: the withdrawal periods define the period of time that must be taken into account after the administration of the medicinal product before ‘safe’ food can be obtained from the animal again (through milking, collecting eggs or slaughtering) due to the extensive excretion of the active substance. On the other hand, the maximum levels are legally binding assessment values for the control of food for unauthorised residues of pharmacologically active substances.