The use of veterinary medicinal products in animals kept for the production of meat, milk, eggs or honey may result in residues of pharmacologically active substances or their metabolites in these foodstuffs. Consumption of foodstuffs containing these residues must not pose a risk to the health of consumers.

Before a pharmacologically active substance can be authorised for use in food-producing animals, a comprehensive risk assessment concerning residues in food needs to be performed. Legal basis for the establishment of maximum residue limits (MRL) for pharmacologically active substances in animal derived food is Regulation (EC) No 470/2009. Within the MRL procedure possible risks for consumers are assessed and maximum residue limits for animal derived food are set. These values are effective in the EU member states as well as for import of food from third countries and must not be exceeded.

The risk assessment for establishing maximum residue limits  are carried out by the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) on request by an applicant. For the MRL procedure, the applicant submits a dossier covering the toxicological, pharmacological, and – if relevant – microbiological properties of the pharmacological active substance allowing for hazard identification and hazard characterisation according to the provisions of Regulation (EU) 2018/782. Based on this, the maximum dose is derived which does not yet cause any adverse health effects in the most sensitive species or in humans. Subsequently, uncertainty factors are introduced to account for e.g. differences between human and animal organism (interspecies variability) and the variability between humans (intraspecies variability). The resulting value is the Acceptable Daily Intake (ADI) which represents the maximum amount that can be ingested daily over a lifetime with no appreciable health risk.

The MRL for the individual food commodities such as meat, milk, eggs or honey is determined in a way that the sum of all possible residues in daily diet will be below the ADI with sufficient statistical certainty. Details of the procedure can be found here. Under the conditions laid down in Regulation (EU) 2017/880, MRLs may be extrapolated to another foodstuff or other animal species (e.g. species such as goats or rabbits which are less relevant for food production) within this procedure.

As a result of the MRL procedure numerical MRL values may be set, which are listed in Table 1 of the Annex to Commission Regulation (EU) No 37/2010. Substances for which the evaluation has shown that derivation of numerical MRLs is not necessary are also listed there. If an MRL procedure leads to the conclusion that no safe maximum residue limits can be set, the substance will be listed in Table 2 of the Annex leading to the prohibition of their use in food producing animals. New substances will be included with so called implementing Regulations. Therefore, it is recommended to use the latest consolidated version when searching for MRLs.

The principles of this concept are used for the risk assessment of residues relating to veterinary medicinal products as well as pesticides and chemical contaminants in foodstuff within the EU and international committees (e.g. EFSA, JECFA or JMPR).

For substances of biological origin that are classified by the EMA as non-chemical-like, an MRL procedure is usually not necessary. Upon submission of a scientific basis for the inclusion, they may be included by EMA in the separate list of biological substances considered as not requiring an MRL evaluation as per Regulation (EU) No 2018/782.

Substances that do not need to be assessed regarding their residues in foods of animal origin, because they are not subject to the provisions of Regulation (EC) No 479/2009, are included in a publicly available list of “Substances not within the scope of the MRL Regulation” (“Out-of-Scope” list) as far as applications for inclusion in this list have been made. The list can be retrieved at the EMA website.

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