Rome, 20 to 28 February 2024
List of substances scheduled for evaluation and request for data
Attached is the list of substances (Annex 1) scheduled for evaluation or re-evaluation at the Ninety-eight meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). This list has been prepared by the Joint FAO/WHO Secretariat of the Committee and is based on recommendations of the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) and previous provisional decisions of JECFA.
Submission of data
Annex 1 lists the veterinary drugs to be considered at the meeting. Governments, interested organizations, producers of these compounds, and individuals are invited to submit data for the toxicological evaluations, for the residue evaluations and for estimating the intake of the chemicals that are listed. The submitted data may be published or unpublished and should contain detailed reports of laboratory studies, including individual animal data. Reference to relevant published studies should also be provided, where applicable. Summaries in the form of monographs are helpful, but they are not in themselves sufficient for evaluation.
Unpublished confidential studies that are submitted will be safeguarded and will be used only for evaluation purposes by JECFA. Summaries of the studies will be published by FAO and WHO after the meetings in the form of residue and toxicological monographs.
Should you wish for your data submission to be made available to other Joint FAO/WHO scientific committees than JECFA, please state this explicitly in a cover letter accompanying your submission with a clear indication of the extent to which the data package can be shared.
Data should be submitted in electronic format and should be presented preferably using standard word processing or document formats and need to include a “Table of contents” using fully descriptive file names. For large-volume submissions or for any questions related to data submissions please contact the Secretariat. Key material can be stored up to five years and will then be destroyed. For substances that are being re-evaluated, the FAO and WHO Secretariats of JECFA encourage the sponsor to contact them before submission of data to determine whether documents and data reviewed at previous meetings of the Committee should be re-submitted.
Date for submission
The submission of data on those compounds listed in Annex 1 is requested before
30 September 2023
Toxicological data
Data relevant to the toxicological evaluations of the substances on the agenda include the results of studies on:
- Biochemical data: pharmacokinetic, metabolic, and pharmacodynamic studies in experimental and food-producing animals, and in humans when available, effects on enzymes and other biochemical parameters;
- Toxicological studies: acute toxicity, short-term toxicity, long-term toxicity/carcinogenicity, reproductive toxicity and developmental toxicity studies in experimental animals and genotoxicity studies;
- Studies providing relevant data on the exposure to the compound by humans, including studies of effects observed after occupational exposure and epidemiological data following use in humans;
- Special studies designed to investigate specific effects of the compound, such as neurotoxicity, immune responses, mechanism of toxicity, or macromolecular binding;
- Data, studies or reasoned argument to determine the toxicological relevance of metabolites and degradatesa;
- Studies designed to evaluate the possibility that residues of the compound might have an adverse effect on the microbial ecology of the human intestinal tract and/or an increase in anti-bacterial resistance (AMR);
- Information on registration status and existing assessments of the compound.
This information needs to be submitted electronically (preferred) to the following e-mail address: jecfa@who.int, or by sending it on a USB stick to:
Attention: Mr Soren Madsen
Department of Nutrition and Food Safety
World Health Organization
Avenue Appia
1211 Geneva 27
Switzerland
E-mail: jecfa@who.int
Data relevant to recommending MRLs
Data relevant to the evaluation of residues in food products of animal origin, including:
- Chemical identity and properties of the drug;
- Drug use and dosage range;
- Pharmacokinetic and metabolic studies in experimental animals, target animals, and humans if available (information required by both FAO and WHO);
- Residue-depletion studies with radiolabelled drugs in target animals from zero withdrawal time to periods extending beyond the recommended withdrawal time (these studies should provide information on total residues, including free and bound residues, and major residue components to permit selection of marker residue and target tissues);
- Residue-depletion studies with unlabelled drugs for the analysis of marker residue in target animals and in eggs, milk, and honey (these should include studies with appropriate formulations, routes of application, and species, at doses up to the maximum recommended);
- A description of the analytical procedures used by the sponsor for the detection and determination of parent drug residues with information on validation and performance characteristics;
- A review of routine analytical methods that may be used by regulatory authorities for the detection of residues in target tissue, including information on quality assurance systems and sampling procedures recommended; and
- Information on registration status of veterinary drugs and on approved conditions of use.
The information needs to be submitted electronically to jecfa@fao.org. If electronic submission is not possible, please contact us for alternative deliveries:
Dr Markus Lipp
Food Systems and Food Safety Division
Telephone: +39 06 5705 3283
E-mail: jecfa@fao.org
Presentation of data
Please note that the above lists are not meant to be all-inclusive since it is recognized that other studies may, in some instances, assist in the evaluation.
Procedures for the evaluation of chemicals in food were updated and published by FAO and WHO (Principles and methods for the risk assessment of chemicals in food – Environmental Health Criteria No. 240), available at https://www.who.int/publications/i/item/9789241572408.
Specific guidance on the evaluation of and data needs for food additives are also available from FAO and WHO (see https://www.fao.org/food-safety/scientific-advice/jecfa/jecfa-guidelines/en/ and https://www.who.int/groups/joint-fao-who-expert-committee-on-food-additives-(jecfa)/procedural-guidance).
All relevant data, both positive and negative, should be submitted. Data should be presented, summarized and referenced in a clear and concise manner.
This call for data is available at both the FAO and WHO web sites:
https://www.fao.org/food-safety/scientific-advice/calls-for-data-and-experts-expert-rosters/en/
https://www.who.int/groups/joint-fao-who-expert-committee-on-food-additives-(jecfa)/calls-for-data