Human dietary exposure assessments
Table of contents
EMA and the European Food and Safety Authority (EFSA) have recommended a common approach on assessing consumer exposure to residues in food from animal origin. The residues can come from veterinary medicines, feed additives or pesticides. To ensure the safety of EU consumers, EMA and EFSA assess and establish their acceptable levels. Human dietary exposure assessments are an important part of this type of evaluation.
Food of animal origin (e.g. meat, eggs, cheese, honey) can include residues of veterinary medicines used to treat animals. In addition, it can contain residues from feed additives and from pesticides.
European Union (EU) countries monitor the levels of those residues to ensure the safety of consumers.
Residues are regulated under different legislation, including:
- Regulation (EC) No 470/2009 for the veterinary medicines;
- Regulation (EC) No 1831/2003 for feed additives;
- Regulation (EC) No 396/2005 for pesticides.
EMA establishes maximum residue limits (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.
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 MRLs.
EMA and EFSA carry out these assessments separately, using similar but independent methods and approaches. This can result in inconsistencies for substances with more than one use, for instance as a veterinary medicine and as 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.
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.
The European Commission is currently reviewing it and may issue follow-up actions.