title: The role of validated analytical methods in JECFA drug assessments and evaluation for recommending MRLs.
abstract: The Joint Food and Agriculture Organization and World Health Organization (FAO/WHO) Expert Committee on Food Additives (JECFA) is one of three Codex committees tasked with applying risk analysis and relying on independent scientific advice provided by expert bodies organized by FAO/WHO when developing standards. While not officially part of the Codex Alimentarius Commission structure, JECFA provides independent scientific advice to the Commission and its specialist committees such as the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) in setting maximum residue limits (MRLs) for veterinary drugs. Codex methods of analysis (Types I, II, III, and IV) are defined in the Codex Procedural Manual as are criteria to be used for selecting methods of analysis. However, if a method is to be used under a single laboratory condition to support regulatory work, it must be validated according to an internationally recognized protocol and the use of the method must be embedded in a quality assurance system in compliance with ISO/IEC 17025:2005. This paper examines the attributes of the methods used to generate residue depletion data for drug registration and/or licensing and for supporting regulatory enforcement initiatives that experts consider to be useful and appropriate in their assessment of methods of analysis. Copyright © 2016 Her Majesty the Queen in Right of Canada. Drug Testing and Analysis © 2016 John Wiley & Sons, Ltd.
authors.affiliation: Centre for Veterinary Drug Residues (CVDR), Canadian Food Inspection Agency, 116 Veterinary Road, Saskatoon, SK, S7N 2R3, Canada.
authors.forename: Joe O
authors.initials: JO
authors.lastname: Boison
mesh_terms: D000818:Animals; D002623:Chemistry Techniques, Analytical / Q000379:methods*; D004350:Drug Residues / Q000032:analysis*; D005506:Food Contamination / Q000032:analysis*; D064088:Hazard Analysis and Critical Control Points / Q000379:methods*; D006801:Humans; D018570:Risk Assessment; D054928:Validation Studies as Topic; D019155:Veterinary Drugs / Q000032:analysis*; D014944:World Health Organization
chemical_list: D019155:Veterinary Drugs
keywords: Codex Alimentarius Commission; Codex Committee on Residues of Veterinary Drugs in Foods; Joint WHO/FAO Expert Committee on Food Additives; depletion study; food safety; maximum residue limits; method validation