Establishing maximum residue limits for veterinary medicines

Establishing maximum residue limits for veterinary medicines Maximum residue limits (MRLs) set safe limits for veterinary medicine residues in food consumed in the European Union (EU). Veterinary Regulatory and procedural guidance Maximum residue limit The maximum residue limit (MRL) is the highest concentration of residue accepted by the European Union (EU) in a food product obtained from an animal treated with a veterinary medicine. EMA's Committee for Veterinary Medicinal Products (CVMP) classifies the residues and establishes MRLs based on scientific risk assessments with defined criteria. The CVMP evaluates the safety of its pharmacologically active substances and their residues . It also recommends MRLs before a veterinary medicine intended for food-producing animals is authorised in the EU. This evaluation is based on human dietary exposure assessments. In addition, the CVMP is responsible for establishing MRLs for pharmacologically active substances in biocidal products used to kills or control germs or pests affecting animals. While the same principles and guidelines apply to establishing MRLs for pharmacologically active substances in medicines and biocides, EMA has published additional guidance on the risk characterisation and assessment of MRLs for biocides. In line with Regulation (EC) No 470/2009 , the following substances may not require a full MRL assessment: Active principles of biological origin used in immunological veterinary medicines Biological substances other than active principles of biological origin used in immunological veterinary medicines Non-active substances, i.e. substances considered not to have any effect on the body, also described as not exerting pharmacological effects For more information, see: Maximum residue limits Assessment criteria and extrapolation As of 19 June 2018, Commission Regulation (EU) 2018/782 describes the methodology to be used in the scientific risk assessment and establishment of risk management recommendations relevant to MRL applications. These rules replace previous guidance on MRLs, as outlined in volume 8 of 'the rules governing medicinal products in the European Union'. As of June 2017, Commission Regulation (EU) 2017/880 sets out the principles and minimum criteria for the extrapolation of an MRL to either another foodstuff from the same species or to the same foodstuff from another species. When finalising an MRL evaluation, the CVMP routinely considers if its conclusions can be extrapolated to additional species and foodstuffs, regardless of whether the applicant has specifically requested this. This aims to increase the availability of veterinary medicines. The CVMP uses the same criteria when evaluating extension applications . For more information, see: Commission Regulation (EU) 2018/782 Volume 8 of 'The rules governing medicinal products in the European Union ' Commission Regulation (EU) 2017/880 Post assessment EMA sends the CVMP opinion on the MRL application to the European Commission. It then confirms the classification of the substance by including it in the annex to Commission Regulation (EU) No 37/2010. Allowed substances which may be used in veterinary medicines for food-producing species or biocidal products for use in animal husbandry are listed in table 1 of the annex. The following information is included: Definitive MRL to be applied to each food commodity A provisional MRL, alternatively, to be applied to each food commodity - this classification is established for a defined period 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, alternatively - for substances where residues at the predicted levels do not pose a hazard to the health of the consumer Prohibited substances which are considered to represent a hazard to the health of the consumer at any level are included in table 2 of the annex. These substances must not be used in veterinary medicines for food-producing animals or in biocidal products for use in animal husbandry. For more information, see: Commission Regulation (EU) No 37/2010 Page update history An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes. The tracking of updates begins in April 2026. See update history 8 April 2026 Page first published. Content transferred from the Maximum residue limits (MRL) page. Related content Committee for Veterinary Medicinal Products (CVMP) Human dietary exposure assessments Biocides for use in animal husbandry: guidelines Maximum residue limits (MRLs): Questions and answers Substances exempt from maximum residue limit evaluation Related EU legislation Regulation (EC) No 470/2009 Commission Regulation (EU) 2018/782 Commission Regulation (EU) 2017/880 Commission Regulation (EU) No 37/2010 Volume 8 of 'The rules governing medicinal products in the European Union Share this page