Maximum residue limits

The maximum residue limit (MRL) is the maximum concentration of residue accepted by the European Union (EU) in a food product obtained from an animal that has received a veterinary medicine or that has been exposed to a biocidal product for use in animal husbandry.

The EU requires by law that foodstuffs, such as meat, milk or eggs, obtained from animals treated with veterinary medicines or exposed to biocidal products used in animal husbandry must not contain any residue that might represent a hazard to the health of the consumer.

Background to MRLs

Before a veterinary medicinal product intended for food-producing animals can be authorised in the EU, the safety of its pharmacologically active substances and their residues must first be evaluated and included in table 1 (allowed substances) of the Annex to Commission Regulation (EU) No 37/2010.

Similarly, a safety assessment is undertaken for the active substances included in biocidal products for use in animal husbandry, but an evaluation of the residues and the setting of MRLs is only considered for those active substances for which consumer exposure represents a particular concern. Residues of these substances, like residues of active substances used in veterinary medicinal products for use in food-producing animals, must be evaluated and included as an allowed substance in table 1 of the Annex to Commission Regulation (EU) No 37/2010 before a biocidal product intended for use in animal husbandry and containing a relevant active substance can be authorised.

The difference in approach between these two types of MRL is justified by the different types of exposure that the animals will receive in each case: while veterinary medicinal products are applied directly to the animal biocidal products may not be.

MRL procedure

The assessment of the safety of residues is carried out by the by the Committee for Medicinal Products for Veterinary Use (CVMP).

Once the substances have been assessed and following the adoption of a Commission Regulation confirming the classification of the substances, those substances that may be used in veterinary medicinal products and in biocidal products for use in animal husbandry are listed in table 1 of the Annex to Commission Regulation (EU) No 37/2010.

For each substance the table includes one of the following:

• the definitive MRL to be applied for each food commodity;
• a provisional MRL to be applied to each food commodity. This classification is established for a defined period of time and only in those cases where there are no grounds for supposing that residues of the substance at the level proposed will present a hazard to the health of the consumer but where further information is still required in order to finalise the evaluation of the substance;
• a statement that no MRL is required. This classification is established in those cases where residues at the predicted levels do not pose a hazard to the health of the consumer.

Some substances are considered to represent a hazard to the safety of the consumer at any level. These substances must not be used in veterinary medicines for use in food producing animals or in biocidal products for use in animal husbandry, and are included in table 2 (prohibited substances) of the annex to Commission Regulation (EU) No 37/2010.

Publication of information on MRLs

The European Medicines Agency publishes information on the MRL assessments by the CVMP as follows:

1. A brief statement concerning the MRL recommendation in the press release of the meeting at which the opinion is adopted by the CVMP.
2. A summary opinion following the opinion's adoption of the opinion. This is without prejudice to the final Commission Regulation.
3. More detailed information as a European public MRL assessment report (EPMAR) following the publication of the Commission Regulation.

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