Skip to main content
European Commission logo
enen
Food, Farming, Fisheries
Food Safety

Consumer Protection through Maximum Residue Limits

What is the issue

Pharmacologically active substances administered to food-producing animals may leave residues harmful to human health in foodstuffs of animal origin. Therefore, the safety of the residues of veterinary medicinal products remaining post-treatment in foodstuffs of animal origin has to be scientifically assessed in accordance with the procedure laid down in Regulation (EC) No 470/2009.

About the limits

Regulation (EC) No 470/2009 sets out the Union rules for the establishment of maximum residue limits (MRLs) in foodstuffs of animal origin of pharmacologically active substances included in veterinary medicinal products intended for food-producing animals or in biocidal products used in animal husbandry.

It provides the basis for a number of legislative implementation measures carried out by the Commission:

The substances allowed for use in veterinary medicinal products intended for food-producing species are listed in Table 1 of the Annex. Their MRLs are fixed for each applicable target species and relevant target tissues.

Pharmacologically active substances listed in Table 2 of the Annex are considered hazardous to the health of the consumer when present in foodstuffs obtained from treated animals. Therefore, it is not possible to authorise veterinary medicinal products containing those substances for administration to food-producing animals.

The regulation is updated each time a maximum residue limit is established or changed.

  • Commission Implementing Regulation (EU) 2017/12 sets out the form and content of the applications and requests for the establishment of maximum residue limits.
  • Commission Regulation (EU) 2017/880 provides rules on the use of a maximum residue limit established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species and a maximum residue limit established for a pharmacologically active substance in one or more species for other species (so called 'extrapolation of MRLs').
  • Commission Implementing Regulation (EU) 2018/470 provides rules on the maximum residue limit to be considered for control purposes for foodstuffs derived from animals which have been treated in the EU under Article 11 of Directive 2001/82/EC (so called 'cascade MRLs').
  • Commission Regulation (EU) 2018/782 lays down the methodology to be used in the scientific risk assessment and the establishment of risk management recommendations relevant to MRL applications.

List of substances considered as not falling within the scope of Regulation (EC) No 470/2009

Certain excipients used in veterinary medicines for use in food-producing animals or in biocidal products for use in animal husbandry fall outside the scope of the MRL Regulation.

Such excipients, although not included in Table 1 of the Annex to Commission Regulation (EU) No 37/2010, can still be used in veterinary medicinal products intended for administration to food-producing animals, if they are included in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009 managed by the European Medicines Agency.

Related links