ДОПОЛНИТЕЛЬНЫЕ МАТЕРИАЛЫ
Ниже перечислены все справочные материалы, упомянутые в руководствах, включенных в инструментарий JECFA, а также дополнительные ресурсы.
Справочные материалы
Dick, M. 2019. Total residue depletion and metabolism study of 14C-Halquinol after oral administration to growing pigs at 24 mg/kg per day for 5 consecutive days. Study Number ELA1800653. Sponsor submitted.
FAO (Food and Agriculture Organization of the United Nations) & WHO (World Health Organization). 2016. Residue Evaluation of Certain Veterinary Drugs. Joint FAO/WHO Expert Committee on Food Additives. 81st Meeting 2015. Joint FAO/WHO Expert Committee on Food Additives (JECFA) Monographs No. 18. Rome. FAO & WHO. 2018. FAO/WHO Chronic individual food consumption database – Summary statistics https://apps.who.int/foscollab/Download/DownloadConso
FAO & WHO. 2020. Residue evaluation of certain veterinary drugs. Joint FAO/WHO Expert Committee on Food Additives. 88th Meeting 2019. Joint FAO/WHO Expert Committee on Food Additives (JECFA) Monographs No. 24. Rome. https://doi.org/10.4060/ca9167en
FAO & WHO. 2023. Maximum Residue Limits (MRLs) and Risk Management Recommendations (RMRs) for Residues of Veterinary Drugs in Foods. CX/MRL 2-2023. Codex Alimentarius International Food Standards. https://www.fao.org/fao-who-codexalimentarius/codex-texts/maximum-residue-limits/en/
FAO & WHO. 2025. Codex Alimentarius Commission Procedural Manual – Thirtieth edition. Rome. https://openknowledge.fao.org/handle/20.500.14283/cd4216en
Gallo-Torres, H.E. 1977. Methodology for the determination of bioavailability of labeled residues. J Toxicol Environ Health, 2(4): 827-845. https://doi.org/10.1080/15287397709529482
Hall, C. 2017. Marker residue depletion following oral administration of Quixalud in Feed (Halquinol 700 ppm) to swine for 10 consecutive days. Study Number NAH-16-067. Sponsor submitted.
Piñeiro, S.A. & Cerniglia, C.E. 2021. Antimicrobial drug residues in animal-derived foods: Potential impact on the human intestinal microbiome. J vet Pharmacol Ther; 44: 215–222. https://doi.org/10.1111/jvp.12892
Salleras, L., Domínguez, A., Mata, E., Taberber, J.L., Moro, I. & Salvà, P. 1995. Epidemiologic study of an outbreak of clenbuterol poisoning in Catalonia, Spain. Public Health Rep, 110(3): 338–342. PMID: 7610227.
VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2004a. Studies to evaluate the safety of residues of veterinary drugs in human food: Developmental toxicity testing. VICH GL32. (Safety: Developmental Toxicity), October 2002 - For implementation in October 2003 (Except EU: later date) - Revision 1 of May 2004. https://vichsec.org/wp-content/uploads/2024/10/GL32_st7-Rev.pdf
VICH. 2004b. Studies to evaluate the safety of residues of veterinary drug in human food: carcinogenicity testing (Revision at Step 9). VICH GL28. (Safety: Carcinogenicity), October 2004 – Implemented in March 2006. https://vichsec.org/wp-content/uploads/2024/10/Gl28_st7F.pdf
VICH. 2011. Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Metabolism study to determine the quantity and identify the nature of residues. VICH GL46 (MRK). February 2011 – Implemented in February 2012. https://vichsec.org/wp-content/uploads/2025/11/GL46-st7.pdf
VICH. 2015a. Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker residue depletion studies to establish product withdrawal periods. VICH GL48(R) (MRK). February 2015 – Implemented in January 2016. https://vichsec.org/wp-content/uploads/2024/10/GL48R-st7-corr.pdf
VICH. 2015b. Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Validation of analytical methods used in residue depletion studies. VICH GL49(R) (MRK). January 2015 – Implemented in January 2016. https://vichsec.org/wp-content/uploads/2024/10/GL49R-st7.pdf
VICH. 2016. Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish an acute reference dose (ARfD). VICH GL54. (Safety) November 2016, For implementation by November 2017. https://vichsec.org/wp-content/uploads/2024/10/GL54-st7.pdf
VICH. 2019. Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI. VICH GL36(R2). (Safety: microbiological ADI), February 2019 – Released for implementation at Step 7 in the regions by August 2019. https://vichsec.org/wp-content/uploads/2024/10/GL36R2-st7.pdf
VICH. 2025a. Studies to evaluate the safety of residues of veterinary drugs in human food: Reproduction testing (Revision 1). VICH GL 22(R). (Safety) - August 2025 - For implementation at Step 7 in the regions by August 2026. https://vichsec.org/wp-content/uploads/2025/08/GL22-R-st7.pdf
VICH. 2025b. Studies to evaluate the safety of residues of veterinary drugs in human food: Genotoxicity testing (Revision 2). VICH GL23(R2) (Safety) - August 2025 - For implementation at Step 7 in the regions by August 2026. https://vichsec.org/wp-content/uploads/2025/08/GL23R2-st7.pdf
WHO & FAO. 2009. Principles and methods for the risk assessment of chemicals in food. Environmental Health Criteria 240. Geneva, World Health Organization. https://www.who.int/publications/i/item/9789241572408
WHO. 2021. WHO Human Health Risk Assessment Toolkit: Chemical Hazards, second edition. Geneva, World Health Organization. https://www.who.int/publications/i/item/9789240035720
Additional reading
VICH. Guidelines - Toxicology
VICH. Guidelines - Antimicrobial safety
VICH. Guidelines - Metabolism and residue kinetics
Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF). Glossary of terms and definitions (Residues of Veterinary Drugs in Foods)