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.
Before a veterinary medicine 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.
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 active substances for which consumer exposure represents a particular concern. Residues of these substances must be evaluated.
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 medicines are applied directly to the animal, biocidal products may not be.
For both types of substance, it must be included as an 'allowed substance' in table 1 of the annex to Commission Regulation (EU) No 37/2010 before the product can be authorised.
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, the substances that may be used 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 MRL assessments by the CVMP as follows:
- A brief statement concerning the MRL recommendation in the press release of the meeting when the opinion is adopted by the CVMP.
- A summary opinion following the opinion's adoption of the opinion. This is without prejudice to the final Commission Regulation.
- More detailed information as a European public MRL assessment report (EPMAR) following the publication of the Commission Regulation.
|Document(s)||Language||Status||First published||Last updated||Effective Date|
|Procedural announcement by the European Medicines Agency : Revised application form for the establishment of maximum residue limits (MRLs)||(English only)||2012-04-26|
|Application for the establishment of maximum residue limits for an active substance to be used in veterinary medicinal products in accordance with Regulation (EC) No. 470/2009||(English only)||2012-04-26||2015-06-30|
|Recommended submission dates for centralised and maximum-residue-limit procedures||(English only)||2009-07-01||2016-12-01|
|Substances considered as not falling within the scope of Regulation (EC) no 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin||(English only)||adopted||2009-09-23||2016-04-22|