Establishment of maximum residue limits as a prerequisite for authorization

To apply for a marketing authorization for veterinary medicinal products for use in food-producing animals, all pharmacologically active substances must have been previously evaluated at the European Medicines Agency (EMA) regarding possible residues in meat, milk, eggs or honey according to Regulations (EC) No 470/2009 and (EU) 2018/782 and, if applicable, maximum residue limits (MRLs) shall be established. Under certain conditions the rules laid down in Regulation (EU) 2017/880 may be applied within this procedure, i.e. existing MRLs may be extrapolated to other animal species or further foodstuffs of animal origin.

Substances that have already been assessed are listed in the Annex to Regulation (EU) No 37/2010. Table 1 shows the permitted substances including numerical maximum residue limits and further provisions. The substances prohibited for use in food-producing animals are listed in table 2.

Substances without pharmacological activity as well as substances of biological origin classified as non-chemical-like may, upon application, be included in specific lists of the EMA without setting maximum residue limits so that they may be used in veterinary medicinal products for food-producing animals.

If a marketing authorization is to be applied for a veterinary medicinal product whose pharmacologically active substances have not yet been evaluated in accordance with Regulations (EC) No 470/2009 and Regulation (EU) 2018/782, it must be certified that a valid application for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 has been submitted to the EMA.

Advice concerning the need to establish maximum residue limits according to Regulation (EC) No 470/2009 may be requested on a case by case basis from the EMA.

Use of animals from clinical and residue studies for food production

For the authorization of a veterinary medicinal product, generally clinical and/or residue studies in target species are required. Clinical studies and/or residue studies must be approved in accordance with § 10 TAMG before they are conducted. In addition, a withdrawal period for the test preparation to be used can be applied for in accordance with § 10 TAMG, if food is to be produced from the animals treated in the course of clinical or residue studies.

Information on how maximum residue limits and withdrawal periods are established can be found here.

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