C M MY CY CMY K CODEX ALIMENTARIUS COMMISSION

1 The Procedural Manual of the CODEX ALIMENTARIUS COMMISSION is intended to help Member Governments participate effectively in the work of the joint FAO/WHO Food Standards Programme. The manual is particularly useful for national delegations attending CODEX meetings and for international organizations attending as observers. It sets out the basic Rules of Procedure, procedures for the elaboration of CODEX standards and related texts, basic definitions and guidelines for the operation of CODEX also gives the membership of the CODEX ALIMENTARIUS MANUALCODEX ALIMENTARIUS COMMISSIONISSN 1020-8070C O D E X A L I M E N T A R I U SJoint FAO/WHO Food Standards Programme212013 CODEX ALIMENTARIUS COMMISSIONP rocedural Manual - Twenty-first editionFAO/WHOT wenty-first 978-92-5-107570-89789251 1 23/04/2013 11:18.

2 05 For further information on the activities of the CODEX ALIMENTARIUS COMMISSION ,please contact:Secretariat of the CODEX ALIMENTARIUS CommissionJoint FAO/WHO Food Standards ProgrammeFood and Agriculture Organization of the United NationsViale delle Terme di Caracalla00153 Rome, ItalyE-mail (Internet): site: publications may be obtained through the worldwide Sales Agents of FAO or by writing to:Sales and Marketing GroupFood and Agriculture Organization of the United NationsViale delle Terme di Caracalla00153 Rome, ItalyFax: +39 06 57053360 Email: by the Secretariat of the joint FAO/WHO Food Standards Programme, FAO, 1 08/05/2013 16:21.

3 06 WORLD HEALTH ORGANIZATIONFOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONSRome, 2013 CODEX ALIMENTARIUS COMMISSIONPROCEDURAL MANUALT wenty-first editionJoint FAO/WHO Food Standards ProgrammeThe 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.

4 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. 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 978-92-5-107570-8 (print)E-ISBN 978-92-5-107571-5 (PDF) FAO/WHO 2013 FAO and WHO encourage the use, reproduction and dissemination of material in this information product.

5 Except where otherwise indicated, material may be copied, downloaded and printed for private study, research and teaching purposes, or for use in non-commercial products or services, provided that appropriate acknowledgement of FAO as the source and copyright holder is given and that FAO s endorsement of users views, products or services is not implied in any requests for translation and adaptation rights, and for resale and other commercial use rights should be made via or addressed to information products are available on the FAO website ( ) and can be purchased through OF CONTENTSTABLE OF CONTENTS.

6 IiiINTRODUCTION .. 1 SECTION I: BASIC TEXTS AND DEFINITIONS .. 3 Statutes of the CODEX ALIMENTARIUS 4 Rules of Procedure of the CODEX ALIMENTARIUS COMMISSION .. 7 General Principles of the CODEX ALIMENTARIUS .. 20 Definitions for the Purposes of the CODEX ALIMENTARIUS .. 22 SECTION II: ELABORATION OF CODEX STANDARDS ANDRELATED TEXTS .. 26 Procedures for the Elaboration of CODEX Standards and Related Texts .. 27 Criteria for the Establishment of Subsidiary Bodies of the CODEX ALIMENTARIUS 38 Criteria for the Establishment of Work Priorities .. 40 Guideline on the Application of the Criteria for the Establishment of Work 41 Relations Between Commodity Committees and General Subject 44 Format for CODEX Commodity Standards.

7 50 Guidelines for the Inclusion of Specific Provisions in CODEX Standardsand Related 55 Procedures for Consideration of the Entry and Review of Food Additive Provisions In the General Standard for Food Additives ..55 Guidelines on the Elaboration and/or Revision of Codes of Hygienic Practice for Specific Commodities ..62 Principles for the Establishment of CODEX Methods of Analysis ..63 Principles for the Establishment or Selection of CODEX Sampling Use of Analytical Results: Sampling Plans, Relationship Between the Analytical Results, the Measurement Uncertainty, Recovery Factors and Provisions In CODEX on the use of proprietary methods in CODEX III: GUIDELINES FOR SUBSIDIARY BODIES.

8 85 Guidelines to Host Governments of CODEX Committees and Ad HocIntergovernmental Task Forces .. 86 Guidelines on the Conduct of Meetings of CODEX Committees and Ad HocIntergovernmental Task Forces .. 92 Guidelines to Chairpersons of CODEX Committees and Ad HocIntergovernmental Task Forces .. 95iv Guidelines on Physical Working Groups .. 97 Guidelines on Electronic Working Groups .. 103 SECTION IV: RISK ANALYSIS .. 106 Working Principles for Risk Analysis for Application In the Framework of the CODEX 107 Definitions of Risk Analysis Terms Related to Food 114 Risk Analysis Principles Applied by the CODEX Committee on Food Additives.

9 116 Risk Analysis Principles Applied by the Committee on Contaminants in Policy of the CODEX Committee on Contaminants in Foods for Exposure Assessment of Contaminants and Toxins in Foods or Food Groups .. 125 Risk Analysis Principles Applied by the CODEX Committee on Residues of Veterinary Drugs In Foods .. 129 Risk Assessment Policy for the Setting of Maximum Limits for Residues of Veterinary Drugs In Foods .. 136 Risk Analysis Principles Applied by the CODEX Committee on Pesticide Residues .. 138 Annex: List of Risk Management Policies Used by CCPR .. 142 Criteria for the Prioritization Process of Compounds for Evaluation by JMPR.

10 149 Nutritional Risk Analysis Principles and Guidelines for Application to the Work of the Committee on Nutrition and Foods for Special Dietary Uses .. 153 Risk Analysis Principles and Procedures Applied by the CODEX Committee on Food Hygiene ..162 SECTION V: SUBSIDIARY BODIES OF THE CODEX ALIMENTARIUS COMMISION .. 168 Table of Committees, document references and terms of reference .. 169 COMMISSION and Executive Committee .. 169 General Subject Committees .. 169 Commodity Committees (Active) .. 173 Commodity Committees (Adjourned Sine Die) .. 174 Commodity Committees (Abolished).