Codex Alimentarius Commission. Procedural Manual: 24th Edition

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2016Procedural Manual - Twenty-fourth editionThe Procedural Manual of the Codex Alimentarius Commission is intended tohelp Member Governments participate effectively in the work of the jointFAO/WHO Food Standards Programme. The manual is particularly useful fornational delegations attending Codex meetings and for internationalorganizations attending as observers. It sets out the basic Rules ofProcedure, procedures for the elaboration of Codex standards and relatedtexts, basic definitions and guidelines for the operation of Codex committees.It also gives the membership of the Codex Alimentarius Commission.24A L I M E N T A R I U SISSN 1020-8070CODEX ALIMENTARIUS COMMISSIONwww.codexalimentarius.orgC O D E XJoint FAO/WHO Food Standards ProgrammeCODEX ALIMENTARIUS COMMISSIONPROCEDURAL MANUALTwenty-fourth editionFAO/WHO

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):Web site:Codex@fao.orgwww.codexalimentarius.orgIssued by the Secretariat of theJoint FAO/WHO Food Standards Programme, FAO, Rome

Joint FAO/WHO Food Standards ProgrammeCODEX ALIMENTARIUSCOMMISSIONPROCEDURAL MANUALTwenty-fourth editionWORLD HEALTH ORGANIZATIONFOOD AND AGRICULTURAL ORGANIZATION OF THE UNITED NATIONSRome, 2015

The designations employed and the presentation of material in this publication do notimply the expression of any opinion whatsoever on the part of the Food and AgricultureOrganization 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, orconcerning the delimitation of its frontiers or boundaries. Dotted lines on maps representapproximate border lines for which there may not yet be full agreement. The mention ofspecific 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 WHOin preference to others of a similar nature that are not mentioned. Errors and omissionsexcepted, the names of proprietary products are distinguished by initial capital letters. Allreasonable precautions have been taken by FAO and WHO to verify the information containedin this publication. However, the published material is being distributed without warranty ofany kind, either expressed or implied. The responsibility for the interpretation and use of thematerial lies with the reader. In no event shall FAO and WHO be liable for damages arisingfrom its use.The views expressed herein are those of the authors and do not necessarily represent those ofFAO or WHO.ISBN 978-92-5-108928-6 WHO and FAO, 2015All rights reserved. WHO and FAO encourage the use, reproduction and dissemination ofmaterial in this information product. Except where otherwise indicated, material may becopied, downloaded and printed for private study, research and teaching purposes, providedthat appropriate acknowledgement of WHO and FAO as the source and copyright holderis given and that WHO and FAO’s endorsement of users’ views, products or services is notimplied in any way.Publications of the World Health Organization are available on the WHO web site (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211Geneva 27, Switzerland (tel.: 41 22 791 3264; fax: 41 22 791 4857; e-mail: bookorders@who.int). Requests for permission to reproduce or translate WHO publications – whether forsale or for noncommercial distribution – should be addressed to WHO Press through the WHOweb site (http://www.who.int/about/licensing/copyright form/en/index.html).All requests for translation and adaptation rights, and for resale and other commercial userights should be made via www.fao.org/contact-us/licence-request or addressed to copyright@fao.org.FAO information products are available on the FAO website (www.fao.org/publications) andcan be purchased through publications-sales@fao.org

TABLE OF CONTENTSTABLE OF CONTENTS . iiiINTRODUCTION . 1SECTION I: BASIC TEXTS AND DEFINITIONS . 3Statutes of the Codex Alimentarius Commission. 4Rules of Procedure of the Codex Alimentarius Commission . 7General Principles of the Codex Alimentarius . 21Definitions for the Purposes of the Codex Alimentarius . 23SECTION II: ELABORATION OF CODEX STANDARDS ANDRELATED TEXTS . 27Procedures for the Elaboration of Codex Standardsand Related Texts. 28Criteria for the Establishment of Subsidiary Bodiesof the Codex Alimentarius Commission . 40Criteria for the Establishment of Work Priorities . 42Guideline on the Application of the Criteriafor the Establishment of Work Priorities. 44Relations Between Commodity Committees and General SubjectCommittees. 47Format for Codex Commodity Standards . 53Guidelines for the Inclusion of Specific Provisions in Codex Standardsand Related Texts. 58Procedures for Consideration of the Entry and Review of FoodAdditive Provisions In the General Standard for Food Additives . 58Guidelines on the Elaboration and/or Revision of Codes of HygienicPractice for Specific Commodities . 66Procedure for the Inclusion of Additional Species in CodexStandards for Fish and Fishery Products . 67Principles for the Establishment of Codex Methods of Analysis . 72Principles for the Establishment or Selection of Codex SamplingProcedures . 85The Use of Analytical Results: Sampling Plans, RelationshipBetween the Analytical Results, the Measurement Uncertainty,Recovery Factors and Provisions in Codex Standards . 88Provisions on the Use of Proprietary Methods in Codex standards . 90iii

SECTION III: GUIDELINES FOR SUBSIDIARY BODIES . 92Guidelines to Host Governments of Codex Committeesand Ad Hoc Intergovernmental Task Forces . 93Guidelines on the Conduct of Meetings of Codex Committeesand Ad Hoc Intergovernmental Task Forces . 99Guidelines to Chairpersons of Codex Committeesand Ad Hoc Intergovernmental Task Forces . 102Guidelines on Physical Working Groups . 106Guidelines on Electronic Working Groups . 109SECTION IV: RISK ANALYSIS. 112Working Principles for Risk Analysis for Application In the Frameworkof the Codex Alimentarius. 113Definitions of Risk Analysis Terms Related to Food Safety. 120Risk Analysis Principles Applied by the Codex Committee on FoodAdditives . 122Risk Analysis Principles Applied by the Codex Committee onContaminants in Foods . . .127Policy of the Codex Committee on Contaminants in Foodsfor Exposure Assessment of Contaminants and Toxins in Foodsor Food Groups. 132Risk Analysis Principles Applied by the Codex Committeeon Residues of Veterinary Drugs In Foods . 136Risk Assessment Policy for Residues of Veterinary Drugs In Foods . 145Risk Analysis Principles Applied by the Codex Committeeon Pesticide Residues . 148Nutritional Risk Analysis Principles and Guidelines for Applicationto the Work of the Committee on Nutrition and Foods for SpecialDietary Uses . 176Risk Analysis Principles and Procedures Applied by the CodexCommittee on Food Hygiene . 185SECTION V: SUBSIDIARY BODIES OF THE CODEX ALIMENTARIUSCOMMISSION . 191Table of Committees, document references and terms of reference . 192Commission and Executive Committee . 192General Subject Committees . 192Commodity Committees (Active) . 196Commodity Committees (Adjourned Sine Die) . 198Commodity Committees (Abolished) . 199Ad Hoc Intergovernmental Task Forces (Active) . 200Ad Hoc Codex Intergovernmental Task Forces (Dissolved) . 200FAO/WHO Coordinating Committees . 203iv

Committee Established Under Rule Xi.1(A) (Renamedand re-established) . 205Joint Meetings with other Organizations (Abolished). 205SECTION VI: MEMBERSHIP . 207Membership of the Codex Alimentarius Commission . 208Core Functions of Codex Contact Points. 215SECTION VII: RELATIONS WITH OTHER ORGANIZATIONS . 216Guidelines on Cooperation between the Codex AlimentariusCommission and International Intergovernmental Organizationsin the Elaboration of Standards and Related Texts . 217Principles Concerning the Participation of InternationalNon-Governmental Organizations in the Workof the Codex Alimentarius Commission . 219APPENDIX: GENERAL DECISIONS OF THE COMMISSION . 227Statements of Principle Concerning the Role of Science in the CodexDecision-Making Process and the Extent to which other Factorsare taken into Account . 228Statements of Principle Relating to the Role of Food Safety RiskAssessment . 230Measures to Facilitate Consensus. 231v

INTRODUCTIONThe Procedural Manual of the Codex Alimentarius Commission describesthe legal foundations and practical functioning of the Commission and itssubsidiary bodies. Knowledge of the contents of this Manual is essential forCodex members and observers to participate effectively in the work of theCommission. The Manual has been organized into seven sections and oneappendix as follows: Section I: Basic Texts and Definitions sets out the Commission’sStatutes, Rules of Procedure and the General Principles of the CodexAlimentarius, as well as definitions of terms for the Purpose of the CodexAlimentarius which assist in the uniform interpretation of these texts. Section II: Elaboration of Codex Standards and Related Textscontains the Uniform Procedure for the Elaboration of Codex Standardsand Related Texts, the criteria for the establishment of work priorities andsubsidiary bodies, guidance on relations between CommodityCommittees and General Committees, a format for Codex Commoditystandards, procedures for consideration of food additive provisions,guidelines on the elaboration or revision of codes of hygienic practice andprinciples for selection of methods of analysis and sampling procedures. Section III: Guidelines for Subsidiary Bodies contains guidelinesfor the smooth and transparent operation of Codex Committees, ad hocTask Forces and physical and electronic working groups Section IV: Risk Analysis – contains general and specific texts onrisk analysis for application in the framework of the Codex AlimentariusCommission and its subsidiary bodies dealing with the protection ofconsumers’ health and to the joint FAO/WHO expert bodies andconsultations. Section V: Subsidiary bodies of the Codex AlimentariusCommission, lists the Commission’s subsidiary bodies with their Termsof Reference. Section VI: Membership, includes the membership list of theCommission (with year of accession where available) as well as the CoreFunctions of the Codex Contact Points. Section VII: Relations with other Organizations outlines thePrinciples and Guidelines governing the relations between the CodexAlimentarius Commission and international intergovernmental and nongovernmental organizations.1

Appendix: General Decisions of the Commission contains theStatements of Principle concerning the Role of Science in the Codexdecision-making process and the extent to which other factors are takeninto account, the Statements of Principle relating to the Role of FoodSafety Risk Assessment and the Measures to facilitate consensus.This 24th Edition of the Procedural Manual was prepared by the Secretariatfollowing the Thirty-eight Session of the Codex Alimentarius Commission,Rome, 2015. Further information concerning the Codex AlimentariusCommission and its Subsidiary Bodies can be obtained from the Secretariat,Codex Alimentarius Commission, Joint FAO/WHO Food StandardsProgramme, FAO, 00153 Rome, Italy, and from the website at:www.codexalimentarius.org2

Section I: Basic Texts and DefinitionsSECTION IBASIC TEXTS AND DEFINITIONS Statutes of the Codex Alimentarius Commission (Adopted in 1961by the 11th Session of the FAO Conference and in 1963 by the 16thSession of the World Health Assembly. Revised in 1966 and 2006) Rules of Procedure of the Codex Alimentarius Commission(Adopted in 1963 at the first session of the Commission. Amendedin 1964, 1965, 1966, 1968, 1969, 1970, 1999, 2003, 2005, 2006and 2007) General Principles of the Codex Alimentarius (Adopted in 1965.Amended in 1966, 1969, 1993, 1995 and 2007) Definitions3

Section I: Basic Texts and DefinitionsSTATUTES OF THE CODEX ALIMENTARIUS COMMISSIONArticle 1The Codex Alimentarius Commission shall, subject to Article 5 below, beresponsible for making proposals to, and shall be consulted by, theDirectors-General of the Food and Agriculture Organization (FAO) and theWorld Health Organization (WHO) on all matters pertaining to theimplementation of the Joint FAO/WHO Food Standards Programme, thepurpose of which is:(a)protecting the health of the consumers and ensuring fairpractices in the food trade;(b)promoting coordination of all food standards work undertaken byinternational governmental and non governmental organizations;(c)determining priorities and initiating and guiding the preparation ofdraft standards through and with the aid of appropriateorganizations;(d)finalizing standards elaborated under (c) above and publishingthem in a Codex Alimentarius either as regional or worldwidestandards, together with international standards already finalizedby other bodies under (b) above, wherever this is practicable;(e)amending published standards, as appropriate, in the light ofdevelopments.Article 2Membership of the Commission is open to all Member Nations andAssociate Members of FAO and WHO which are interested in internationalfood standards. Membership shall comprise such of these nations as havenotified the Director-General of FAO or of WHO of their desire to beconsidered as Members.Article 3Any Member Nation or Associate Member of FAO or WHO which is not aMember of the Commission but has a special interest in the work of theCommission, may, upon request communicated to the Director-General ofFAO or WHO, as appropriate, attend sessions of the Commission and of itssubsidiary bodies and ad hoc meetings as observers.4

Section I: Basic Texts and DefinitionsArticle 4Nations which, while not Member Nations or Associate Members of FAO orWHO, are members of the United Nations, may be invited on their request toattend meetings of the Commission as observers in accordance with theprovisions of FAO and WHO relating to the grant of observer status tonations.Article 5The Commission shall report and make recommendations to the Conferenceof FAO and the appropriate body of WHO through their respective DirectorsGeneral. Copies ofreports, including any conclusions andrecommendations, will be circulated to interested Member Nations andinternational organizations for their information as soon as they becomeavailable.Article 6The Commission shall establish an Executive Committee whose compositionshould ensure an adequate representation of the various geographical areasof the world to which the Members of the Commission belong. Betweensessions, the Executive Committee shall act as the Executive organ of theCommission.Article 7The Commission may establish such other subsidiary bodies as it deemsnecessary for the accomplishment of its task, subject to the availability of thenecessary funds.Article 8The Commission may adopt and amend its own Rules of Procedure whichshall come into force upon approval by the Directors-General of FAO andWHO, subject to such confirmation as may be prescribed by the proceduresof these Organizations.5

Section I: Basic Texts and DefinitionsArticle 9The operating expenses of the Commission and of its subsidiary bodies,other than those for which a Member has accepted the Chair, shall be borneby the budget of the Joint FAO/WHO Food Standards Programme whichshall be administered by FAO on behalf of the two Organizations inaccordance with the financial regulations of FAO. The Directors-General ofFAO and WHO shall jointly determine the respective portion of the costs ofthe Programme to be borne by each Organization and prepare thecorresponding annual expenditure estimates for inclusion in the RegularBudgets of the two Organizations for approval by the appropriate governingbodies.Article 10All expenses (including those relating to meetings, documents andinterpretation) involved in preparatory work on draft standards undertaken byMembers of the Commission, either independently or upon recommendationof the Commission, shall be defrayed by the government concerned. Withinthe approved budgetary estimates, the Commission may, however,recommend that a specified part of the costs of the preparatory workundertaken by the government on behalf of the Commission be recognizedas operating expenses of the Commission.6

Section I: Basic Texts and DefinitionsRULES OF PROCEDURE OF THE CODEX ALIMENTARIUSCOMMISSIONRule I Membership1.Membership of the Joint FAO/WHO Codex Alimentarius Commissionhereinafter referred to as “the Commission”, is open to all Member Nationsand Associate Members of FAO and/or WHO.2.Membership shall comprise such eligible nations as have notified theDirector-General of FAO or of WHO of their desire to be consideredMembers of the Commission.3.Membership shall also comprise regional economic integrationorganizations members of either FAO or WHO that notify the DirectorGeneral of FAO or WHO of their desire to be considered Members of theCommission.4.Each Member of the Commission shall communicate to the DirectorGeneral of FAO or of WHO the names of its representative and wherepossible other members of its delegation before the opening of each sessionof the Commission.Rule II Member Organizations1.A Member Organization shall exercise membership rights on analternative basis with its Member States that are Members of theCommission in the areas of their respective competence.2.A Member Organization shall have the right to participate in matterswithin its competence in any meetings of the Commission or its subsidiarybodies in which any of its Member States is entitled to participate. This iswithout prejudice to the possibility for the Member States to develop orsupport the position of the Member Organization in areas within itscompetence.3.A Member Organization may exercise on matters within itscompetence, in any meetings of the Commission or any subsidiary body ofthe Commission in which it is entitled to participate in accordance withparagraph 2, a number of votes equal to the number of its Member Stateswhich are entitled to vote in such meetings and present at the time the voteis taken. Whenever a Member Organization exercises its right to vote, itsMember States shall not exercise theirs, and conversely.4.A Member Organization shall not be eligible for election ordesignation, nor to hold office in the Commission or any subsidiary body. AMember Organization shall not participate in voting for any elective places inthe Commission and its subsidiary bodies.7

Section I: Basic Texts and Definitions5.Before any meeting of the Commission or a subsidiary body of theCommission in which a Member Organization is entitled to participate, theMember Organization or its Member States shall indicate in writing which, asbetween the Member Organization and its Member States, has competencein respect of any specific question to be considered in the meeting andwhich, as between the Member Organization and its Member States, shallexercise the right to vote in respect of each particular agenda item. Nothingin this paragraph shall prevent a Member Organization or its Member Statesfrom making a single declaration in the Commission and each subsidiarybody in which a Member Organization is entitled to participate for thepurposes of this paragraph, which declaration shall remain in force forquestions and agenda items to be considered at all subsequent meetings,subject to such exceptions or modifications as may be indicated before anyindividual meeting.6.Any Member of the Commission may request a Member Organizationor its Member States to provide information as to which, as between theMember Organization and its Member States, has competence in respect ofany specific question. The Member Organization or the Member Statesconcerned shall provide this information on such request.7.In cases where an agenda item covers both matters in respect ofwhich competence has been transferred to the Member Organization andmatters which lie within the competence of its Member States, both theMember Organization and its Member States may participate in thediscussions. In such cases the meeting, in arriving at its decisions, 1 shalltake into account only the intervention of the party which has the right tovote. 28.For the purpose of determining a quorum, as specified in paragraph 7of Rule VI, the delegation of a Member Organization shall be counted for anumber equal to the number of its Member States which are entitled toparticipate in the meeting and are present at the time the quorum is sought,to the extent that it is entitled to vote under the relevant agenda item.1The word ‘decisions’ should be understood to mean both voting and situations where a decision istaken by consensus.The above is without prejudice to the question of whether or not the views of the party not havingthe right to vote shall be reflected in the report of the meeting. Where the views of the party not havingthe right to vote are reflected in the report, the fact that they are the views of the party not having theright to vote shall also be reflected in the report.28

Section I: Basic Texts and DefinitionsRule III Officers1.The Commission shall elect a Chairperson and three ViceChairpersons from among the representatives, alternates and advisers(hereinafter referred to as “delegates”) of the Members of the Commission; itbeing understood that no delegate shall be eligible without the concurrenceof the head of his delegation. They shall be elected at each session andshall hold office from the end of the session at which they were elected untilthe end of the following regular session. The Chairperson and ViceChairpersons may remain in office only with the continuing endorsement ofthe respective Member of the Commission of which they were a delegate atthe time of election. The Directors-General of FAO and WHO shall declare aposition vacant when advised by the Member of the Commission that suchendorsement has ceased. The Chairperson and Vice-Chairpersons shall beeligible for re-election twice, provided that by the end of their second term ofoffice they have not served for a period of more than two years.2.The Chairperson, or in his absence a Vice-Chairperson, shall presideat meetings of the Commission and exercise such other function as may berequired to facilitate the work of the Commission. A Vice-Chairperson actingas Chairperson shall have the same powers and duties as the Chairperson.3.When neither the Chairperson nor the Vice-Chairperson are able toserve and, on the request of the outgoing Chairperson, during elections forthe Chairperson, the Directors-General of FAO and WHO shall appoint astaff member to act as Chairperson, until either a temporary Chairperson ora new Chairperson has been elected. Any temporary Chairperson so electedshall hold office until the Chairperson or one of the Vice-Chairpersons is ableto serve again.4.The Commission may appoint one or more rapporteurs from amongthe delegates of the Members of the Commission.5.The Directors-General of FAO and WHO shall be requested to appointfrom the staffs of their organizations a Secretary of the Commission andsuch other officials, likewise responsible to them, as may be necessary toassist the officers and the Secretary in performing all duties that the work ofthe Commission may require.9

Section I: Basic Texts and DefinitionsRule IV Coordinators1.The Commission may appoint a Coordinator from among theMembers of the Commission for any of the geographic locations enumeratedin Rule V.1 (hereinafter referred to as “regions”) or for any group of countriesspecifically enumerated by the Commission (hereinafter referred to as‘groups of countries’), whenever it may find, on the basis of a proposal of amajority of the Members of the Commission which constitute the region orgroup, that work for the Codex Alimentarius in the countries concerned sorequires.2.Appointment of Coordinators shall be made exclusively on theproposal of a majority of the Members of the Commission which constitutethe region or group of countries concerned. In principle, they shall benominated at each session of the relevant Coordinating Committeeestablished under Rule XI.1(b)(ii), and appointed at the following regularsession of the Commission. They shall hold office from the end of thissession. Coordinators may be reappointed for a second term. TheCommission shall make such arrangements as may be necessary in order toensure continuity in the functions of the Coordinators.3.10The functions of the Coordinators shall be:(a)to appoint the Chairperson of the Coordinating Committee wheresuch committee has been set up under Rule XI.1(b)(ii) for theregion or group of countries concerned;(b)to assist and coordinate the work of the Codex Committees setup under Rule XI.1(b)(i) in their region or group of countries inthe preparation of draft standards, guidelines and otherrecommendations for submission to the Commission;(c)to assist the Executive Committee and the Commission, asrequired, by advising them of the views of countries andrecognized regional intergovernmental and non-governmentorganizations in their respective regions on matters underdiscussion or of interest.

Section I: Basic Texts and DefinitionsRule V Executive Committee1.The Executive Committee shall consist of the Chairperson and theVice-Chairpersons of the Commission, and the Coordinators appointed onthe basis of Rule IV together with seven further Members elected by theCommission at regular sessions from among the Members of theCommission, one each coming from the following geographic locations:Africa, Asia, Europe, Latin America and the Caribbean, Near East, NorthAmerica, South-West Pacific. Not more than one delegate from any onecountry shall be a member of the Executive Committee. Members elected ona geographic basis shall hold office from the end of the session of theCommission at which they were elected until the end of the secondsucceeding regular session and shall be eligible for re-election if they havenot served for more than two years in their current term, but after havingserved two consecutive terms shall be ineligible to hold such office for thenext succeeding term. Members elected on a geographic basis are expectedto act within the Executive Committee in the interest of the Commission as awhole.2.The Executive Committee shall, between sessions of the Commission,act on behalf of the Commission as its executive organ. In particular, theExecutive Committee may make proposals to the Commission regardinggeneral orientation, strategic planning, and programming of the work of theCommission, study special problems and shall assist in the management ofthe

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