Prioritising veterinary drug residues for monitoring in animal products

Abstract

Regulation (EU) 2017/625 prescribes that each EU member state should apply a risk-based monitoring program. In order to determine which substances and animal products have a higher priority to be included in the National Residue Control Plan (NRCP), decision trees have been drafted in an earlier project (van Asselt et al., 2018a;van Asselt et al., 2018b). These decision trees were used previously to prioritise antibiotics, antiparasitics, carbamates and NSAIDs into low, medium and high priority to include in the NRCP (van Asselt et al., , 2020.The current report describes the prioritisation of the remaining groups of substances included in the draft Annex of Regulation (EU) 2017/625 (i.e. 2.0 SANTE 2017 11987 Annex rev5) for bovine, milk, porcine, horse, goat, sheep, poultry and egg. This Annex has a different categorization than in the former Directive 96/23/EC and distinguishes between unauthorised (group A) and authorised (group B) substances, which were evaluated using two separate decision trees. For each substance (either in group A or group B), monitoring data (EFSA reports, RASFF notifications and results from the NRCP)were used to answer the questions related to monitoring in the decision trees. In case no noncompliances were found or monitoring data were limited, additional questions related to the likelihood of using the substance in the animal species were answered. For the group A substances, approvals outside the EU were used as well as EU registrations for companion animals and their online availability (e.g. on alibaba.com or ebay.com). Group A substances for which non-compliances were found, or for which there were indications of use, were evaluated on human health risks due to possible residues in animal products. Based on this outcome, the substances were classified as medium or high priority to include in the NRCP. For the group B substances, both EU registrations and sales data in the Netherlands were used to get an indication of potential use in the animal species. In case potential use was evaluated to be likely, the withdrawal periods of the veterinary medicinal products (VMPs) then determined whether the substances were classified as medium or low priority to include in the NRCP.Within group A, the unauthorised substances, stilbenes (group A1a), antithyroid agents (group A1b), steroids (group A1c), resorcylic acid lactones (group A1d) and beta-agonists (group A1e) were evaluated as well as prohibited substances (group A2, formerly group A6) as listed in Table 2 of the Annex to Regulation (EU) 37/2010. Finally, unauthorised pesticides and biocides (group A3b), unauthorised antimicrobials (group A3c), unauthorised coccidiostats and histomonostats (group A3d), unauthorised protein and peptide hormones (group A3e), and unauthorised sedatives (group A3f) were evaluated. Within group B, insecticides (group B1b), sedatives (B1c), and other pharmacologically active substances (group B1e) listed in Table 1 of the Annex to Regulation (EU) 37/2010 were evaluated as well as authorised coccidiostats a...