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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 that has received a veterinary medicine.
Applicants need to submit an application to EMA for:
EMA charges a fee for MRL applications.
It may grant a total or partial fee exemption for veterinary medicinal products classified as eligible for authorisation according to Article 23 of Regulation (EU) 2019/6, i.e. applications for limited markets.
For more information, see:
Applicants must submit the MRL application at least 6 months before the marketing authorisation application.
At least 6 months before the intended submission of the MRL application, applicants need to submit an MRL letter of intent via the Iris Portal with the following:
If the company has a valid micro, small and medium-sized enterprise (SME) status or a classification as eligible for authorisation according to Article 23 of Regulation (EU) 2019/6, they should include this information in the notification.
The data requirements and dossier structure are laid down in the Commission Implementing Regulation (EU) 2017/12.
For more information, see:
Applicants can request a pre-submission interaction meeting via Service Now. They can do so by selecting Veterinary Regulatory > Pre-Submission-Vet Requests > Queries on pre-submissions.
For pre-submission interactions, applicants should include details of the intended application, such as:
EMA provides more pre-submission guidance in the form of questions and answers.
Applicants should submit the MRL letter of intent through the IRIS Portal.
For MRL applications, applicants should use the MRL application form and consult the recommended submission dates available below in this section
The application submission process remains unchanged and will continue through the eSubmission Gateway / Web Client portal. The IRIS Portal serves as the platform for procedure management.
For guidance on how to register for the Veterinary eSubmission website and how to use IRIS, see:
The application and procedure are defined in Article 8 of Regulation (EC) 470/2009 and further described in Commission Implementing Regulation (EU) 2017/12.
For information on the practical aspects of how to submit the application and its evaluation, see the standard operating procedure available in the following link:
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.
27 October 2026
'Pre-submission guidance' and 'Submission of the application' sections revised.
8 April 2026
Page first published. Content transferred from the Maximum residue limits (MRL) page.