Assessment of human dietary exposure to residues of veterinary medicines in the EU

EMA and the European Food Safety Authority (EFSA) have published a joint report on the development of a harmonised approach to the assessment of dietary exposure of people to residues of veterinary medicines, feed additives and pesticides in food of animal origin in the European Union (EU).

Veterinary medicines may leave residues in food derived from animal farming. Food can also contain residues of feed additives and pesticides to which animals have been exposed. In the EU, the presence of these residues is regulated to ensure the safety of consumers with legally binding maximum residue limits (MRLs) established. The establishment of MRLs relies on evaluations carried out by EFSA and EMA, which include an assessment of human dietary exposure performed by modelling the level of residues to which people may be exposed.

However, different approaches are used in the assessments depending on whether the residues originate from veterinary medicines, feed additives or pesticides. While the methodologies are based on common principles, differences in the scientific approaches and practices can result in different outcomes.

To advance harmonisation, the European Commission (EC) mandated EFSA and EMA in 2020 to develop a common approach to the assessments. The Agencies set up a joint working group, composed of specialists with relevant expertise. The working group developed a set of recommendations for each element of the exposure assessment, which were finalised after a public consultation that took place between June and September 2022. After that, the final report was adopted by EMA’s Committee for Veterinary Medicinal Products (CVMP), endorsed by EFSA’s Scientific Committee, and forwarded to the EC in December 2022.

The final report represents an important step towards harmonisation. If the recommendations are supported by the EC, their implementation in the different sectors will require a number of follow-up actions over the coming years. For veterinary medicines in particular, implementation of the recommendations will represent a very significant change to the way dietary exposure is assessed.