Human dietary exposure assessments

EMA and the European Food Safety Authority (EFSA) promote a harmonised approach to assessing human dietary exposure to residues from veterinary medicines, feed additives and pesticides. They establish acceptable levels of these residues to ensure consumer safety in the European Union (EU).

Human dietary exposure assessments estimate the levels to which a certain population may be exposed to a substance. EMA and EFSA use this type of evaluation in their risk assessments to determine maximum residue limits (MRLs).

Food of animal origin (e.g. meat, eggs, cheese, honey) can include residues of veterinary medicines. In addition, it can contain residues from feed additives and from pesticides.

European Union (EU) countries monitor the levels of residues to ensure consumer safety.

For more information, see:

• Maximum residue limits (MRL)

Harmonising human dietary exposure assessments

EMA establishes MRLs for pharmacologically active substances of veterinary medicines and biocidal products in animal husbandry, while EFSA determines the acceptable limits for feed additives and for pesticides.

EMA and EFSA carry out human dietary exposure assessments separately. They use similar but independent methods and approaches. This can lead to differences when a substance is used for more than one purpose, such as both a veterinary medicine and a pesticide.

The European Commission mandated EFSA and EMA to develop a common approach to evaluate consumer exposure to residues in food from animal origin in 2020.

Relevant legislation includes:

• Regulation (EC) No 470/2009 for the veterinary medicines;
• Regulation (EC) No 1831/2003 for feed additives;
• Regulation (EC) No 396/2005 for pesticides.

Report on common approach for consumer exposure

EMA and EFSA have developed a joint report to help harmonise their approaches to the assessment of human exposure to residues of veterinary medicines, feed additives and pesticides in food of animal origin.

The report compares available models of consumer exposure and makes recommendations for their future use by EMA and EFSA in their routine assessments.

EMA and EFSA published the final report in January 2023.

The report takes the views of stakeholders into account, gathered in a public consultation between June and September 2022. An overview of the resulting comments is available.

EMA / EFSA report on development of a harmonised approach to human dietary exposure

Overview of comments received on draft EMA / EFSA report on development of a harmonised approach to human dietary exposure

Reference Number: EMA/CVMP/719874/2022

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31 March 2026

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