Maximum residue limits
The maximum residue limit (MRL) is the maximum allowed concentration of substance 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 European Union (EU) requires by law that foodstuffs such as meat, milk or eggs must not contain any residue that might represent a hazard to the health of the consumer.
Regulation (EC) 470/2009 describes the rules and procedures for the establishment of MRLs. There are certain substances outside the scope of the Regulation:
- 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
This section of the website provides information for companies or individuals wishing to establish MRLs and submit an application to the Agency.
|Research and development||Marketing authorisation|
|Scientific guidelines: establishment of MRLs|
|Risk characterisation and assessment of MRLs for biocides|
Before a veterinary medicine intended for food-producing animals is authorised in the EU, the Committee for Medicinal Products for Veterinary Use (CVMP) evaluates the safety of its pharmacologically active substances and their residues. The Agency has published scientific guidance on the establishment of MRLs for veterinary medicines.
Similarly, the CVMP evaluates those active substances and residues in biocidal products for use in animal husbandry for which consumer exposure represents a particular concern. There is also available guidance on the risk characterisation and assessment of MRLs for biocides.
Submission of an MRL application
Applicants need to submit an MRL application to the European Medicines Agency (EMA) to have an MRL established for a new substance, or to have an existing MRL extended to a new animal species.
They should notify the Agency in writing of the name of the substance, the intended use and target species at least 3 months before the intended submission of the MRL application. The MRL application should be made at least 6 months before the marketing authorisation application.
Below are the MRL application form and recommended submission dates:
- Revised application form for the establishment of maximum residue limits (MRLs) , to be used pending the revision of Volume 8 of the Rules Governing Medicinal Products in the European Union.
- Recommended submission dates for centralised and maximum residue limit procedures
The submission procedure for an application to establish an MRL is defined in Article 8 of Regulation (EC) 470/2009 and further explained in Volume 8 of the Rules Governing Medicinal Products in the European Union.
More practical aspects on the submission of the application are explained in the following EMA standard operating procedure:
- Evaluation procedure for applications and requests for the establishment of maximum residue limits (MRLs) under articles 3, 9, 10 or 15 of Regulation (EC) 470/2009.
The submission of an MRL application requires the payment of a fee. The Agency may grant a total or partial fee exemption in the case of veterinary medicines for the treatment of rare diseases affecting minor animal species or for extensions of existing MRLs to additional animal species.
More detailed pre-submission guidance on the MRL application procedure is available in a Questions and Answer document.
Applicants can request further clarification in writing and/or a pre-submission meeting by writing to email@example.com. For pre-submission meetings, applicants should indicate details of the intended application, such as:
- substance and species
- nature of the application i.e. full application / extension / modification / extrapolation
- preferred dates for pre-submission meeting
- names and affiliation of participants
- specific questions they would like to discuss.
The Agency sends the CVMP opinion on the MRL application to the European Commision, who adopts a Commission Regulation confirming the classification of the substance. Substances that may be used are listed in table 1 (allowed substances) annex to Commission Regulation (EU) No 37/2010 with the following information:
- the definitive MRL to be applied to each food commodity, or
- 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; or
- a statement that no MRL is required - for substances where residues at the predicted levels do not pose a hazard to the health of the consumer.
Substances considered to represent a hazard to the health of the consumer at any level are included in table 2 (prohibited substances) of the annex to Commission Regulation (EU) No 37/2010. These substances must not be used in veterinary medicines for food producing animals or in biocidal products for use in animal husbandry.
Publication of information on MRLs
The Agency publishes information on MRL assessments as follows:
- A brief statement on the adoption of an opinion recommending the establishment of an MRL in the corresponding monthly CVMP press release.
- A summary opinion of the CVMP on the MRL.
- The CVMP MRL opinion for substances evaluated after the entry into force of Regulation (EC) No 470/2009 on 6 July 2009.
- A European public MRL assessment report (EPMAR) containing more detailed information following the publication of the Commission Regulation.