Human dietary exposure: EMA/EFSA joint report

EIPG news

Human health is constantly exposed to risk factors, including the residues of veterinary medicines, feed additives and pesticides in food of animal origin. The European Medicines Agency (EMA) and the European Food Safety Authority (EFSA) are among the main regulators involved in setting and verifying the legally binding maximum residue limits (MRLs) for chemical substances, together with the European Chemicals Agency (ECHA).

The European Commission has asked EMA and EFSA to develop a harmonized approach to the assessment of dietary exposure to residues of veterinary medicines in food of animal origin. The resulting recommendations have recently been published in the form of a joint report and, if adopted, may request the implementation of specific action targeted to the different sectors to reach a better harmonization.

Meanwhile, on 9 February 2023 the Commission implementing Regulation (EU) 2022/1255 designating antimicrobials reserved for treatment of certain infections in humans entered into force. The measure is part of the broader approach against antimicrobial resistance, and it aims to promote a more prudent and responsible use of antimicrobial medicinal products in animals, including very strict rules on their veterinary prescription for prophylactic and metaphylactic use.

The report initially discusses the different approaches and models currently in use by EMA, EFSA, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Joint Meeting on Pesticide Residues (JMPR). Sectorial legislations in the field of medicinal products, food and chemicals may greatly differ from one another in the approach and methodologies chosen to define exposure limits and to run risk assessments referred to residues of veterinary medicinal products, feed additives, pesticides and biocides. In general terms, exposure studies are usually run using radiolabeling to trace the fate of a substance and to characterize its metabolites and their concentration in edible tissues/food commodities from target animals.

A further level of complexity in the assessment has to be considered for substances with dual uses, such as veterinary medicines and pesticides.

The final goal of the exercise was to obtain a most realistic exposure assessment possible based on the available methodologies. The so identified “preferred methodology” focuses on data sources and models, includes also alternative proposals on a number of items, and it might represent the “blueprint” for a future harmonized methodology.

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