The substance types listed below may fall outside the scope of the Regulation (EC) No 470/2009, and thus be exempt from an MRL evaluation:
For these substance types, applicants must notify EMA so that an assessment is conducted.
For more information, see:
Biological substances other than active principles of biological origin used in immunological veterinary medicines can be either 'chemical-like' or 'chemical-unlike'.
Chemical-like substances present similar concerns to chemical substances and are subject to a full MRL assessment.
Chemical-unlike substances are more complex and may contain multiple chemical types. Their residues can be cells, amino acids, lipids, carbohydrates, nucleic acids and their breakdown products. The CVMP decides on a case-by-case basis whether chemical-unlike substances require a full MRL assessment.
For full details, see Annex I.6 to Commission Regulation (EU) 2018/782.
Applicants who consider that a biological substance is chemical-unlike should notify EMA of their intention to submit an application at least two months in advance, via Service Now. They can do so by selecting Veterinary Regulatory > Pre-Submission-Vets > Intention to submit an MRL application > Biological substances not requiring an MRL evaluation.
The submission and the evaluation will follow the timetable for variations requiring assessment (standard timetable). Refer to the recommended submission dates available below.
The CVMP assesses whether a ‘No MRL required’ classification is appropriate without the need to conduct a full MRL evaluation.
To support this, the application should include a report and supporting information explaining the scientific basis for the request. It should address the points outlined in Annex I.7 to Commission Regulation (EU) 2018/782, as amended by Commission Regulation (EU) 2025/1101, which is available below.
Relevant information is also provided in the 'Guideline on determination of the need for an MRL evaluation for chemical-unlike biological substances'.
EMA charges a fee for evaluating the application. It invoices the fee to the applicant's address after it has validated the application.
Note: the former list of chemical-unlike substances considered as not requiring an MRL evaluation as per Regulation (EU) No. 2018/782, which was published by EMA, has been repealed. These substances are now included in Table 1 of the Annex to Commission Regulation (EU) No 37/2010 as per Commission Regulation (EU) 2025/1102.
For more information, see:
Non-active ingredients considered not have any effect on the body, also described as not exerting pharmacological effects, fall outside the scope of the MRL Regulation. This includes many excipients, for example.
The CVMP determines on a case-by-case basis whether a non-active ingredient exhibits pharmacological effects and poses a risk to the consumer. If the CVMP concludes that no MRL evaluation is required, EMA includes the substance in the following list:
Applicants who consider that a component of their product is not pharmacologically active should notify EMA via Service Now. They can do so by selecting Veterinary Regulatory > Pre-Submission-Vets to have the substance included in the above list.
Select the expandable panel below to find further guidance.
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The tracking of updates begins in April 2026.
8 April 2026
Page first published. Content transferred from the Maximum residue limits (MRL) page.