CODEX ALIMENTARIUS COMMISSION - Food and Agriculture ...

1 C O D E X A L I M E N T A R I U SJoint FAO/WHO Food Standards Programme252016 CODEX ALIMENTARIUS COMMISSION PROCEDURAL MANUALT wenty-sixth editionFor further information on the activities of the CODEX ALIMENTARIUS COMMISSION , please contact: Secretariat of the CODEX ALIMENTARIUS COMMISSION Joint FAO/WHO Food Standards Programme Food and Agriculture Organization of the United Nations Viale delle Terme di Caracalla 00153 Rome, Italy E-mail (Internet): Web site: Issued by the Secretariat of the Joint FAO/WHO Food Standards Programme, FAO, Rome Joint FAO/WHO Food Standards Programme CODEX ALIMENTARIUS COMMISSION PROCEDURAL MANUAL Twenty-Sixth edition WORLD HEALTH ORGANIZATION FOOD AND AGRICULTURAL ORGANIZATION OF THE UNITED NATIONS Rome, 2018 ISSN 1020-8070 (Print)ISSN 2520-243X (Online)The designations employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of the Food and Agriculture Organization of the United Nations (FAO) or of the World Health Organization (WHO) concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.

2 Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or products of manufacturers, whether or not these have been patented, does not imply that these are or have been endorsed or recommended by FAO or WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by FAO and WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall FAO and WHO be liable for damages arising from its use.

3 The views expressed herein are those of the authors and do not necessarily represent those of FAO or WHO. ISBN 978-92-5-130341-2 WHO and FAO, 2018 All rights reserved. WHO and FAO encourage the use, reproduction and dissemination of material in this information product. Except where otherwise indicated, material may be copied, downloaded and printed for private study, research and teaching purposes, provided that appropriate acknowledgement of WHO and FAO as the source and copyright holder is given and that WHO and FAO s endorsement of users views, products or services is not implied in any way. Publications of the World Health Organization are available on the WHO web site ( ) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.)

4 : +41 22 791 3264; fax: +41 22 791 4857; e-mail: Requests for permission to reproduce or translate WHO publications whether for sale or for noncommercial distribution should be addressed to WHO Press through the WHO web site: All requests for translation and adaptation rights, and for resale and other commercial use rights should be made via or addressed to FAO information products are available on the FAO website ( ) and can be purchased through iii CONTENTS INTRODUCTION .. 1 SECTION I: BASIC TEXTS AND DEFINITIONS .. 3 Statutes of the CODEX ALIMENTARIUS COMMISSION .. 4 Rules of Procedure of the CODEX ALIMENTARIUS COMMISSION .. 7 General Principles of the CODEX ALIMENTARIUS .. 21 Definitions for the Purposes of the CODEX ALIMENTARIUS .. 23 SECTION II: ELABORATION OF CODEX STANDARDS AND RELATED TEXTS.

5 27 Procedures for the Elaboration of CODEX Standards and Related Texts .. 29 Criteria for the Establishment of Subsidiary Bodies of the CODEX ALIMENTARIUS COMMISSION .. 42 Criteria for the Establishment of Work Priorities .. 44 Guideline on the Application of the Criteria for the Establishment of Work Priorities .. 46 Relations Between Commodity Committees and General Subject Committees .. 49 Format for CODEX Commodity Standards .. 56 Guidelines for the Inclusion of Specific Provisions in CODEX Standards and Related Texts .. 62 Procedures for Consideration of the Entry and Review of Food Additive Provisions In the General Standard for Food Additives .. 62 Guidelines on the Elaboration and/or Revision of Codes of Hygienic Practice for Specific Commodities .. 71 Procedure for the Inclusion of Additional Species in CODEX Standards for Fish and Fishery Products.

6 72 Principles for the Establishment of CODEX Methods of Analysis .. 77 Principles for the Establishment or Selection of CODEX sampling 92 The Use of Analytical Results: sampling Plans, Relationship Between the Analytical Results, the measurement uncertainty ,Recovery Factors and Provisions in CODEX Standards .. 95 Provisions on the Use of Proprietary Methods in CODEX standards .. 9 7 iv SECTION III: GUIDELINES FOR SUBSIDIARY BODIES .. 99 Guidelines to Host Governments of CODEX Committees and Ad Hoc Intergovernmental Task Forces .. 100 Guidelines on the Conduct of Meetings of CODEX Committees and Ad Hoc Intergovernmental Task Forces .. 107 Guidelines to Chairpersons of CODEX Committees and Ad Hoc Intergovernmental Task Forces .. 110 Guidelines on Physical Working 115 Guidelines on Electronic Working Groups.

7 119 SECTION IV: RISK ANALYSIS .. 123 Working Principles for Risk Analysis for Application In the Framework of the CODEX ALIMENTARIUS .. 124 Definitions of Risk Analysis Terms Related to Food Safety .. 131 Risk Analysis Principles Applied by the CODEX Committee on Food Additives .. 134 Risk Analysis Principles Applied by the CODEX Committee on Contaminants in Foods .. 139 Policy of the CODEX Committee on Contaminants in Foods for Exposure Assessment of Contaminants and Toxins in Foods or Food 145 Risk Analysis Principles Applied by the CODEX Committee on Residues of Veterinary Drugs In Foods .. 149 Risk Assessment Policy for Residues of Veterinary Drugs In Foods .. 160 Risk Analysis Principles Applied by the CODEX Committee on Pesticide Residues .. 163 Nutritional Risk Analysis Principles and Guidelines for Application to the Work of the Committee on Nutrition and Foods for Special Dietary Uses.

8 193 Risk Analysis Principles and Procedures Applied by the CODEX Committee on Food Hygiene .. 202 SECTION V: SUBSIDIARY BODIES OF THE CODEX ALIMENTARIUS COMMISSION .. 209 Table of Committees, document references and terms of reference .. 210 COMMISSION and Executive Committee .. 210 General Subject Committees .. 210 Commodity Committees (Active) .. 214 Commodity Committees (Adjourned Sine Die) .. 216 Commodity Committees (Abolished) .. 218 Ad Hoc Intergovernmental Task Forces (Active) .. 219 v Ad Hoc Intergovernmental Task Forces (Dissolved) .. 220 FAO/WHO Coordinating Committees .. 223 Committee Established Under Rule (A) (Renamed and re-established) .. 225 Joint Meetings with other Organizations (Abolished) .. 2 25 SECTION VI: MEMBERSHIP .. 227 Membership of the CODEX ALIMENTARIUS COMMISSION .. 2 28 Core Functions of CODEX Contact Points.

9 236 SECTION VII: RELATIONS WITH OTHER ORGANIZATIONS .. 237 Guidelines on Cooperation between the CODEX ALIMENTARIUS COMMISSION and International Intergovernmental Organizations in the Elaboration of Standards and Related Texts .. 238 Principles Concerning the Participation of International Non-Governmental Organizations in the Work of the CODEX ALIMENTARIUS COMMISSION .. 241 APPENDIX: GENERAL DECISIONS OF THE COMMISSION .. 2 49 Statements of Principle Concerning the Role of Science in the CODEX Decision-Making Process and the Extent to which other Factors are taken into Account .. 2 50 Statements of Principle Relating to the Role of Food Safety Risk Assessment .. 2 52 Measures to Facilitate Consensus .. 2 53 1 INTRODUCTION The Procedural Manual of the CODEX ALIMENTARIUS COMMISSION describes the legal foundations and practical functioning of the COMMISSION and its subsidiary bodies.

10 Knowledge of the contents of this Manual is essential for CODEX members and observers to participate effectively in the work of the COMMISSION . The Manual has been organized into seven sections and one appendix as follows: Section I: Basic Texts and Definitions sets out the COMMISSION s Statutes, Rules of Procedure and the General Principles of the CODEX ALIMENTARIUS , as well as definitions of terms for the Purpose of the CODEX ALIMENTARIUS which assist in the uniform interpretation of these texts. Section II: Elaboration of CODEX Standards and Related Texts contains the Uniform Procedure for the Elaboration of CODEX Standards and Related Texts, the criteria for the establishment of work priorities and subsidiary bodies, guidance on relations between Commodity Committees and General Committees, a format for CODEX Commodity standards, procedures for consideration of food additive provisions, guidelines on the elaboration or revision of codes of hygienic practice and principles for selection of methods of analysis and sampling procedures.