Joint FAO/WHO Expert Committee on Food Additives, 66th meeting, Rome, 22-28 February 2006

This volume of FAO JECFA Monographs contains residue evaluation of certain veterinary drugs prepared at the 85th Meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), held in Geneva, 17–26 October 2017. This was the twenty-fifth JECFA meeting specifically convened to consider residues of veterinary drugs in food. The Committee elaborated principles for evaluating the safety of residues of veterinary drugs in food, for establishing acceptable daily intakes (ADIs) and acute reference doses (ARfDs) and for recommending maximum residue limits (MRLs) for such residues when the drugs under consideration are administered to food-producing animals in accordance with good practice in the use of veterinary drugs (GVP). Furthermore, the committee evaluated the safety of residues of eight veterinary drugs and responded to specific concerns raised by the Codex Committee on Residues of Veterinary Drugs in Foods. The enclosed monographs provide the scientific basis for the recommendations of MRLs, including information on chemical identity and properties of the compounds, pharmacokinetics and metabolism, residue depletion studies and analytical methods validated and used for the detection and quantification of the compounds. This publication and other documents produced by JECFA contain information that is useful to all those who work with or are involved with recommending or controlling maximum residue limits for veterinary drugs in food.

This volume of FAO JECFA Monographs contains residue evaluation of certain veterinary drugs prepared at the 98th meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), held from 20 to 29 February 2024. This JECFA meeting was convened specifically to consider residues of veterinary drugs in food-producing animal species. The tasks for the Committee were to further elaborate principles for evaluating the safety of residues of veterinary drugs in food and for establishing acceptable daily intakes (ADIs) and/or acute reference doses (ARfDs), and to recommend maximum residue limits (MRLs) for substances when they are administered to food-producing animals in accordance with good veterinary practice (GVP) in the use of veterinary drugs. The present volume contains monographs on the evaluations of residue data of substances scheduled for evaluation at the request of the Codex Committee on Residues of Veterinary Drugs in Food. A summary of the recommendations on compounds is also presented in this report. The enclosed monographs provided the scientific basis for the recommendations of MRLs.

This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of residues of certain veterinary drugs in food and to recommend maximum levels for such residues in food. The first part of the report considers general principles regarding the evaluation of residues of veterinary drugs within the terms of reference of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) including MRLs for generic fish species acute reference doses (ARfDs) for veterinary drugs an approach for dietary exposure assessment of compounds used for multiple purposes (i.e. veterinary drugs and pesticides) dietary exposure assessment for less-than-lifetime exposure and the assessment of short-term (90-day and 12-month) studies in dogs. Summaries follow of the Committee's evaluations of toxicological and residue data on a variety of veterinary drugs: two insecticides (diflubenzuron and teflubenzuron) an antiparasitic agent (ivermectin) an ectoparasiticide (sisapronil) and a B2-adrenoceptor agonist (zilpaterol hydrochloride). In addition the Committee considered issues raised in concern forms from the Codex Committee on Residues of Veterinary Drugs in Foods on lasalocid sodium an antiparasitic agent. Annexed to the report is a summary of the Committee's recommendations on these drugs including acceptable daily intakes (ADIs) ARfDs and proposed MRLs.

This volume contains monographs prepared at the eighty-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), which met in Geneva, Switzerland, from 17 to 26 October 2017. [Author] The toxicological monographs in this volume summarize data on the veterinary drug residues that were evaluated toxicologically by the Committee: amoxicillin, ampicillin, ethion, flumethrin, halquinol and lufenuron. [Author] Annexed to the report is a summary of the Committee’s recommendations on these and other drugs discussed at the eighty-fifth meeting, including acceptable daily intakes (ADIs), acute reference doses (ARfDs) and proposed maximum residue limits (MRLs). [Author] This volume and others in the WHO Food Additives Series contain information that is useful to those who produce and use food additives and veterinary drugs and those involved with controlling contaminants in food, government and food regulatory officers, industrial testing laboratories, toxicological laboratories and universities. [Author]

This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of residues of certain veterinary drugs in food and to recommend maximum levels for such residues in food. The first part of the report considers general principles regarding the evaluation of veterinary drugs within the terms of reference of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), including a hypothesis-driven decision tree approach for the safety evaluation of residues of veterinary drugs; comments on the Committee for Veterinary Products for Medicinal Use reflection paper on the new approach developed by JECFA for exposure and maximum residue limit (MRL) assessment of residues; residues of veterinary drugs in honey and possible approaches to derive MRLs for this commodity; comments on a paper entitled "Risk-assessment policies: Differences among jurisdictions"; and the use of no-observed-effect level (NOEL) and no-observed-adverse-effect level (NOAEL) in JECFA assessments. Summaries follow of the Committee's evaluations of toxicological and residue data on a variety of veterinary drugs: three antimicrobial agents (avilamycin, tilmicosin, tylosin), one authentic (triclabendazole), one production aid (melengestrol acetate), two antimicrobial agents and production aids (monesin and narasin), a glucocorticosteroid (dexamethasone) and an antimicrobial agent ands contaminant (malachite green). Annexed to the report is a summary of the Committee's recommendations on these drugs, including acceptable daily intakes (ADI's) and proposed MRL's.

The report contains the monographs that were prepared at the eighty-eighth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), which took place at the headquarters of the Food and Agriculture Organization of the United Nations (FAO) in Rome on 22–31 October 2019. [Author] These monographs summarize the data on the safety of residues in food of selected veterinary drugs reviewed by the JECFA. [Author]

This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of residues of certain veterinary drugs in food and to recommend maximum levels for such residues in food. The first part of the report considers general principles regarding the evaluation of residues of veterinary drugs within the terms of reference of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). It covers topics such as the parallel review process; estimation of dietary exposure to veterinary drug residues; a risk-based decision tree approach for safety evaluation; assessment of the potential effects of residues on the human intestinal microbiome. Summaries follow the Committee’s evaluations of toxicological and residue data on a variety of veterinary drugs: two antiparasitic agents (imidacloprid, ivermectin) and one coccidiostat (nicarbazin). Additionally, further evaluation of the parasiticide selamectin is included as part of a pilot in support of the proposed parallel review process. Annexed to the report is a summary of the Committee’s recommendations on these drugs, including acceptable daily intakes and proposed maximum residue limits.