Codex Alimentarius Commission Procedural Manual PDF

C O D E X A L I M E N T A R I U S CODEX ALIMENTARIUS COMMISSION...

C O D E X A L I M E N T A R I U S CODEX ALIMENTARIUS COMMISSION ISSN 2520-243X (online) ISSN 1020-8070 (Print) www.codexalimentarius.org 25 Joint FAO/WHO Food Standards Programme 2016 Procedural Manual - Twenty-fifth edition CODEX ALIMENTARIUS COMMISSION 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 PROCEDURAL MANUAL Procedure, procedures for the elaboration of Codex standards and related texts, basic definitions and guidelines for the operation of Codex committees. Twenty-seventh edition It also gives the membership of the Codex Alimentarius Commission. FAO/WHO For 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): [email protected] Web site: www.codexalimentarius.org 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-seventh edition WORLD HEALTH ORGANIZATION FOOD AND AGRICULTURAL ORGANIZATION OF THE UNITED NATIONS Rome, 2019 Required citation: FAO and WHO. 2019. Codex Alimentarius Commission – Procedural Manual twenty-seventh edition. Rome. 254 pp. Licence: CC BY-NC-SA 3.0 IGO. 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Queries regarding rights and licensing should be submitted to: [email protected]. 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............................................................................................ 27 Procedures for the Elaboration of Codex Standards and Related Texts...................................................................................... 29 Criteria for the Establishment of Subsidiary Bodies of the Codex Alimentarius Commission..................................................... 41 Criteria for the Establishment of Work Priorities........................................... 43 Guideline on the Application of the Criteria for the Establishment of Work Priorities..................................................... 45 Relations Between Commodity Committees and General Subject Committees................................................................................................. 48 Format for Codex Commodity Standards..................................................... 55 Guidelines for the Inclusion of Specific Provisions in Codex Standards and Related Texts.........................................................61 Procedures for Consideration of the Entry and Review of Food Additive Provisions In the General Standard for Food Additives................................ 61 Guidelines on the Elaboration and/or Revision of Codes of Hygienic Practice for Specific Commodities................................................................ 69 Procedure for the Inclusion of Additional Species in Codex Standards for Fish and Fishery Products.................................................. 70 Principles for the Establishment of Codex Methods of Analysis............... 75 Principles for the Establishment or Selection of Codex Sampling Procedures.................................................................................................... 90 The Use of Analytical Results: Sampling Plans, Relationship Between the Analytical Results, the Measurement Uncertainty,Recovery Factors and Provisions in Codex Standards...................................................................................... 93 Provisions on the Use of Proprietary Methods in Codex standards.................................................................................. 95 iii SECTION III: GUIDELINES FOR SUBSIDIARY BODIES............................. 97 Guidelines to Host Governments of Codex Committees and Ad Hoc Intergovernmental Task Forces............................................. 98 Guidelines on the Conduct of Meetings of Codex Committees and Ad Hoc Intergovernmental Task Forces............................................ 104 Guidelines to Chairpersons of Codex Committees and Ad Hoc Intergovernmental Task Forces.............................................. 107 Guidelines on Physical Working Groups..................................................... 112 Guidelines on Electronic Working Groups.................................................. 116 SECTION IV: RISK ANALYSIS..................................................................... 120 Working Principles for Risk Analysis for Application the Codex Alimentarius...................................................... 121 Definitions of Risk Analysis Terms Related to Food Safety........................ 128 Risk Analysis Principles Applied by the Codex Committee on Food Additives........................................................................................131 Risk Analysis Principles Applied by the Codex Committee on Contaminants in Foods............................................................................... 136 Policy of the Codex Committee on Contaminants in Foods for Exposure Assessment of Contaminants and Toxins in Foods or Food Groups.............................................................................142 Risk Analysis Principles Applied by the Codex Committee on Residues of Veterinary Drugs In Foods................................................. 146 Risk Assessment Policy for Residues of Veterinary Drugs In Foods........................................................................................... 157 Risk Analysis Principles Applied by the Codex Committee on Pesticide Residues................................................................................ 160 Nutritional Risk Analysis Principles and Guidelines for Application to the Work of the Committee on Nutrition and Foods for Special Dietary Uses..............................................189 Risk Analysis Principles and Procedures Applied by the Codex Committee on Food Hygiene.................................................................... 198 iv SECTION V: SUBSIDIARY BODIES OF THE CODEX ALIMENTARIUS COMMISSION................................................................................................. 205 Table of Committees, document references and terms of reference.................................................................................... 206 Commission and Executive Committee....................................................... 206 General Subject Committees....................................................................... 206 Commodity Committees (Active)................................................................. 210 Commodity Committees (Adjourned Sine Die)............................................ 212 Commodity Committees (Abolished)........................................................... 214 Ad Hoc Intergovernmental Task Forces (Active)......................................... 215 Ad Hoc Intergovernmental Task Forces (Dissolved)................................... 216 FAO/WHO Coordinating Committees.......................................................... 219 Committee Established Under Rule Xi.1(A) (Renamed and re-established)................................................................................... 221 Joint Meetings with other Organizations (Abolished)................................... 221 SECTION VI: MEMBERSHIP........................................................................ 223 Membership of the Codex Alimentarius Commission................................. 224 Core Functions of Codex Contact Points.................................................... 232 SECTION VII: RELATIONS WITH OTHER ORGANIZATIONS.................... 233 Guidelines on Cooperation between the Codex Alimentarius Commission and International Intergovernmental Organizations in the Elaboration of Standards and Related Texts.............................................. 234 Principles Concerning the Participation of International Non-Governmental Organizations in the Work of the Codex Alimentarius Commission...................................................... 237 APPENDIX: GENERAL DECISIONS OF THE COMMISSION..................... 244 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.......................................................... 245 Statements of Principle Relating to the Role of Food Safety Risk Assessment................................................................................................ 247 Measures to Facilitate Consensus.............................................................. 248 v INTRODUCTION The Procedural Manual of the Codex Alimentarius Commission describes the legal foundations and practical functioning of the Commission and its subsidiary bodies. 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.  Section III: Guidelines for Subsidiary Bodies contains guidelines for the smooth and transparent operation of Codex Committees, ad hoc Task Forces and physical and electronic working groups  Section IV: Risk Analysis – contains general and specific texts on risk analysis for application in the framework of the Codex Alimentarius Commission and its subsidiary bodies dealing with the protection of consumers’ health and to the joint FAO/WHO expert bodies and consultations.  Section V: Subsidiary Bodies of the Codex Alimentarius Commission, lists the Commission’s subsidiary bodies with their Terms of Reference.  Section VI: Membership, includes the membership list of the Commission (with year of accession where available) as well as the Core Functions of the Codex Contact Points.  Section VII: Relations with other Organizations outlines the Principles and Guidelines governing the relations between the Codex Alimentarius Commission and international intergovernmental and non- governmental organizations. 1  Appendix: General Decisions of the Commission contains the 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, the Statements of Principle relating to the Role of Food Safety Risk Assessment and the Measures to facilitate consensus. This 27th Edition of the Procedural Manual was prepared by the Secretariat following the Forty-first Session of the Codex Alimentarius Commission, Rome, 2018. Further information concerning the Codex Alimentarius Commission and its Subsidiary Bodies can be obtained from the Secretariat, Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme, FAO, 00153 Rome, Italy, and from the website at: www.codexalimentarius.org 2  Section I: Basic texts and definitions SECTION I BASIC TEXTS AND DEFINITIONS   Statutes of the Codex Alimentarius Commission (Adopted in 1961 by the 11th Session of the FAO Conference and in 1963 by the 16th Session 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. Amended in 1964, 1965, 1966, 1968, 1969, 1970, 1999, 2003, 2005, 2006 and 2007)  General Principles of the Codex Alimentarius (Adopted in 1965. Amended in 1966, 1969, 1993, 1995 and 2007)  Definitions 3 Section I: Basic texts and definitions STATUTES OF THE CODEX ALIMENTARIUS COMMISSION Article 1 The Codex Alimentarius Commission shall, subject to Article 5 below, be responsible for making proposals to, and shall be consulted by, the Directors- General of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) on all matters pertaining to the implementation of the Joint FAO/WHO Food Standards Programme, the purpose of which is: (a) protecting the health of the consumers and ensuring fair practices in the food trade; (b) promoting coordination of all food standards work undertaken by international governmental and non governmental organizations; (c) determining priorities and initiating and guiding the preparation of draft standards through and with the aid of appropriate organizations; (d) finalizing standards elaborated under (c) above and publishing them in a Codex Alimentarius either as regional or worldwide standards, together with international standards already finalized by other bodies under (b) above, wherever this is practicable; (e) amending published standards, as appropriate, in the light of developments. Article 2 Membership of the Commission is open to all Member Nations and Associate Members of FAO and WHO which are interested in international food standards. Membership shall comprise such of these nations as have notified the Director-General of FAO or of WHO of their desire to be considered as Members. Article 3 Any Member Nation or Associate Member of FAO or WHO which is not a Member of the Commission but has a special interest in the work of the Commission, may, upon request communicated to the Director-General of FAO or WHO, as appropriate, attend sessions of the Commission and of its subsidiary bodies and ad hoc meetings as observers. 4  Section I: Basic texts and definitions Article 4 Nations which, while not Member Nations or Associate Members of FAO or WHO, are members of the United Nations, may be invited on their request to attend meetings of the Commission as observers in accordance with the provisions of FAO and WHO relating to the grant of observer status to nations. Article 5 The Commission shall report and make recommendations to the Conference of FAO and the appropriate body of WHO through their respective Directors- General. Copies of reports, including any conclusions and recommendations, will be circulated to interested Member Nations and international organizations for their information as soon as they become available. Article 6 The Commission shall establish an Executive Committee whose composition should ensure an adequate representation of the various geographical areas of the world to which the Members of the Commission belong. Between sessions, the Executive Committee shall act as the Executive organ of the Commission. Article 7 The Commission may establish such other subsidiary bodies as it deems necessary for the accomplishment of its task, subject to the availability of the necessary funds. Article 8 The Commission may adopt and amend its own Rules of Procedure which shall come into force upon approval by the Directors-General of FAO and WHO, subject to such confirmation as may be prescribed by the procedures of these Organizations. 5 Section I: Basic texts and definitions Article 9 The operating expenses of the Commission and of its subsidiary bodies, other than those for which a Member has accepted the Chair, shall be borne by the budget of the Joint FAO/WHO Food Standards Programme which shall be administered by FAO on behalf of the two Organizations in accordance with the financial regulations of FAO. The Directors-General of FAO and WHO shall jointly determine the respective portion of the costs of the Programme to be borne by each Organization and prepare the corresponding annual expenditure estimates for inclusion in the Regular Budgets of the two Organizations for approval by the appropriate governing bodies. Article 10 All expenses (including those relating to meetings, documents and interpretation) involved in preparatory work on draft standards undertaken by Members of the Commission, either independently or upon recommendation of the Commission, shall be defrayed by the government concerned. Within the approved budgetary estimates, the Commission may, however, recommend that a specified part of the costs of the preparatory work undertaken by the government on behalf of the Commission be recognized as operating expenses of the Commission. 6  Section I: Basic texts and definitions RULES OF PROCEDURE OF THE CODEX ALIMENTARIUS COMMISSION Rule I Membership 1. Membership of the Joint FAO/WHO Codex Alimentarius Commission hereinafter referred to as “the Commission”, is open to all Member Nations and Associate Members of FAO and/or WHO. 2. Membership shall comprise such eligible nations as have notified the Director-General of FAO or of WHO of their desire to be considered Members of the Commission. 3. Membership shall also comprise regional economic integration organizations members of either FAO or WHO that notify the Director- General of FAO or WHO of their desire to be considered Members of the Commission. 4. Each Member of the Commission shall communicate to the Director- General of FAO or of WHO the names of its representative and where possible other members of its delegation before the opening of each session of the Commission. Rule II Member Organizations 1. A Member Organization shall exercise membership rights on an alternative basis with its Member States that are Members of the Commission in the areas of their respective competence. 2. A Member Organization shall have the right to participate in matters within its competence in any meetings of the Commission or its subsidiary bodies in which any of its Member States is entitled to participate. This is without prejudice to the possibility for the Member States to develop or support the position of the Member Organization in areas within its competence. 3. A Member Organization may exercise on matters within its competence, in any meetings of the Commission or any subsidiary body of the Commission in which it is entitled to participate in accordance with paragraph 2, a number of votes equal to the number of its Member States which are entitled to vote in such meetings and present at the time the vote is taken. Whenever a Member Organization exercises its right to vote, its Member States shall not exercise theirs, and conversely. 7 Section I: Basic texts and definitions 4. A Member Organization shall not be eligible for election or designation, nor to hold office in the Commission or any subsidiary body. A Member Organization shall not participate in voting for any elective places in the Commission and its subsidiary bodies. 5. Before any meeting of the Commission or a subsidiary body of the Commission in which a Member Organization is entitled to participate, the Member Organization or its Member States shall indicate in writing which, as between the Member Organization and its Member States, has competence in respect of any specific question to be considered in the meeting and which, as between the Member Organization and its Member States, shall exercise the right to vote in respect of each particular agenda item. Nothing in this paragraph shall prevent a Member Organization or its Member States from making a single declaration in the Commission and each subsidiary body in which a Member Organization is entitled to participate for the purposes of this paragraph, which declaration shall remain in force for questions and agenda items to be considered at all subsequent meetings, subject to such exceptions or modifications as may be indicated before any individual meeting. 6. Any Member of the Commission may request a Member Organization or its Member States to provide information as to which, as between the Member Organization and its Member States, has competence in respect of any specific question. The Member Organization or the Member States concerned shall provide this information on such request. 7. In cases where an agenda item covers both matters in respect of which competence has been transferred to the Member Organization and matters which lie within the competence of its Member States, both the Member Organization and its Member States may participate in the discussions. In such cases the meeting, in arriving at its decisions,1 shall take into account only the intervention of the party which has the right to vote. 2 8. For the purpose of determining a quorum, as specified in paragraph 7 of Rule VI, the delegation of a Member Organization shall be counted for a number equal to the number of its Member States which are entitled to participate 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. 1 The word ‘decisions’ should be understood to mean both voting and situations where a decision is taken by consensus. 2 The above is without prejudice to the question of whether or not the views of the party not having the right to vote shall be reflected in the report of the meeting. Where the views of the party not having the right to vote are reflected in the report, the fact that they are the views of the party not having the right to vote shall also be reflected in the report. 8  Section I: Basic texts and definitions Rule III Officers 1. The Commission shall elect a Chairperson and three Vice- Chairpersons from among the representatives, alternates and advisers (hereinafter referred to as “delegates”) of the Members of the Commission; it being understood that no delegate shall be eligible without the concurrence of the head of his delegation. They shall be elected at each session and shall hold office from the end of the session at which they were elected until the end of the following regular session. The Chairperson and Vice- Chairpersons may remain in office only with the continuing endorsement of the respective Member of the Commission of which they were a delegate at the time of election. The Directors-General of FAO and WHO shall declare a position vacant when advised by the Member of the Commission that such endorsement has ceased. The Chairperson and Vice-Chairpersons shall be eligible for re-election twice, provided that by the end of their second term of office they have not served for a period of more than two years. 2. The Chairperson, or in his absence a Vice-Chairperson, shall preside at meetings of the Commission and exercise such other function as may be required to facilitate the work of the Commission. A Vice-Chairperson acting as Chairperson shall have the same powers and duties as the Chairperson. 3. When neither the Chairperson nor the Vice-Chairperson are able to serve and, on the request of the outgoing Chairperson, during elections for the Chairperson, the Directors-General of FAO and WHO shall appoint a staff member to act as Chairperson, until either a temporary Chairperson or a new Chairperson has been elected. Any temporary Chairperson so elected shall hold office until the Chairperson or one of the Vice-Chairpersons is able to serve again. 4. The Commission may appoint one or more rapporteurs from among the delegates of the Members of the Commission. 5. The Directors-General of FAO and WHO shall be requested to appoint from the staffs of their organizations a Secretary of the Commission and such other officials, likewise responsible to them, as may be necessary to assist the officers and the Secretary in performing all duties that the work of the Commission may require. 9 Section I: Basic texts and definitions Rule IV Coordinators 1. The Commission may appoint a Coordinator from among the Members of the Commission for any of the geographic locations enumerated in Rule V.1 (hereinafter referred to as “regions”) or for any group of countries specifically enumerated by the Commission (hereinafter referred to as ‘groups of countries’), whenever it may find, on the basis of a proposal of a majority of the Members of the Commission which constitute the region or group, that work for the Codex Alimentarius in the countries concerned so requires. 2. Appointment of Coordinators shall be made exclusively on the proposal of a majority of the Members of the Commission which constitute the region or group of countries concerned. In principle, they shall be nominated at each session of the relevant Coordinating Committee established under Rule XI.1(b)(ii), and appointed at the following regular session of the Commission. They shall hold office from the end of this session. Coordinators may be reappointed for a second term. The Commission shall make such arrangements as may be necessary in order to ensure continuity in the functions of the Coordinators. 3. The functions of the Coordinators shall be: (a) to appoint the Chairperson of the Coordinating Committee where such committee has been set up under Rule XI.1(b)(ii) for the region or group of countries concerned; (b) to assist and coordinate the work of the Codex Committees set up under Rule XI.1(b)(i) in their region or group of countries in the preparation of draft standards, guidelines and other recommendations for submission to the Commission; (c) to assist the Executive Committee and the Commission, as required, by advising them of the views of countries and recognized regional intergovernmental and non-government organizations in their respective regions on matters under discussion or of interest. 10  Section I: Basic texts and definitions Rule V Executive Committee 1. The Executive Committee shall consist of the Chairperson and the Vice-Chairpersons of the Commission, and the Coordinators appointed on the basis of Rule IV together with seven further Members elected by the Commission at regular sessions from among the Members of the Commission, one each coming from the following geographic locations: Africa, Asia, Europe, Latin America and the Caribbean, Near East, North America, South-West Pacific. Not more than one delegate from any one country shall be a member of the Executive Committee. Members elected on a geographic basis shall hold office from the end of the session of the Commission at which they were elected until the end of the second succeeding regular session and shall be eligible for re-election if they have not served for more than two years in their current term, but after having served two consecutive terms shall be ineligible to hold such office for the next succeeding term. Members elected on a geographic basis are expected to act within the Executive Committee in the interest of the Commission as a whole. 2. The Executive Committee shall, between sessions of the Commission, act on behalf of the Commission as its executive organ. In particular, the Executive Committee may make proposals to the Commission regarding general orientation, strategic planning, and programming of the work of the Commission, study special problems and shall assist in the management of the Commission’s programme of standards development, namely by conducting a critical review of proposals to undertake work and monitoring the progress of standards development. 3. The Executive Committee shall consider specific matters referred to it by the Directors-General of FAO and WHO as well as the estimate of expenditure for the Commission’s proposed programme of work as described in Rule XIII.1. 4. The Executive Committee may establish such sub-committees from among its Members as it may deem necessary to enable it to exercise its functions as effectively as possible. Such sub-committees should be limited in numbers, carry out preparatory work and report to the Executive Committee. The Executive Committee shall appoint one of the Vice- Chairpersons of the Commission to serve as chairpersons of any such sub- committee. Consideration should be given to an appropriate geographical balance in the membership of sub-committees. 5. The Chairperson and Vice-Chairpersons of the Commission shall be respectively the Chairperson and Vice-Chairpersons of the Executive Committee. 11 Section I: Basic texts and definitions 6. Sessions of the Executive Committee may be convened as often as necessary by the Directors-General of FAO and WHO, in consultation with the Chairperson. The Executive Committee shall normally meet immediately prior to each session of the Commission. 7. The Executive Committee shall report to the Commission. Rule VI Sessions 1. The Commission shall in principle hold one regular session each year at the Headquarters of either FAO or WHO. Additional sessions shall be held as considered necessary by the Directors-General of FAO and WHO after consultation, with the Chairperson of the Executive Committee. 2. Sessions of the Commission shall be convened and the place of the meeting shall be determined by the Directors-General of FAO and WHO after consultation, where appropriate, with the authorities of the host country. 3. Notice of the date and place of each session of the Commission shall be communicated to all Members of the Commission at least two months before the session. 4. Each Member of the Commission shall have one representative, who may be accompanied by one or more alternates and advisers. 5. In plenary meetings of the Commission, the representative of a Member may designate an alternate who shall have the right to speak and vote in the name of his or her delegation on any question. Moreover, upon the request of the representative or any alternate so designated, the Chairperson may allow an adviser to speak on any particular point. 6. Meetings of the Commission shall be held in public, unless the Commission decides otherwise. 7. The majority of the Members of the Commission shall constitute a quorum for the purposes of making recommendations for amendments to the Statutes of the Commission and of adopting amendments of, or additions to, the present Rules in accordance with Rule XV.1. For all other purposes the majority of the Members of the Commission attending the session shall constitute a quorum, provided that such a majority shall be not less than 20 percent of the total membership of the Commission, nor less than 25 Members. In addition, in the case of amendment or adoption of a proposed standard for a given region or group of countries, the quorum of the Commission shall include one third of the Members belonging to the region or group of countries concerned. 12  Section I: Basic texts and definitions Rule VII Agenda 1. The Directors-General of FAO and WHO, after consultation with the Chairperson of the Commission or with the Executive Committee, shall prepare a Provisional Agenda for each session of the Commission. 2. The first item on the Provisional Agenda shall be the adoption of the Agenda. 3. Any Member of the Commission may request the Directors-General of FAO or WHO to include specific items in the Provisional Agenda. 4. The Provisional Agenda shall be circulated by the Directors-General of FAO or WHO to all Members of the Commission at least two months before the opening of the session. 5. Any Member of the Commission, and the Directors-General of FAO and WHO, may, after the dispatch of the Provisional Agenda, propose the inclusion of specific items in the Agenda with respect to matters of an urgent nature. These items shall be placed on a supplementary list, which, if time permits before the opening of the session, shall be dispatched by the Directors-General of FAO and WHO to all Members of the Commission, failing which the supplementary list shall be communicated to the Chairperson for submission to the Commission. 6. No items included in the Agenda by the governing bodies or the Directors-General of FAO and WHO shall be deleted therefrom. After the Agenda has been adopted, the Commission may, by a two-thirds majority of the votes cast, amend the Agenda by the deletion, addition or modification of any other item. 7. Documents to be submitted to the Commission at any session shall be furnished by the Directors-General of FAO and WHO to all Members of the Commission, to the other eligible Nations attending the session as observers and to the non-member nations and international organizations invited as observers thereto, in principle at least two months prior to the session at which they are to be discussed. Rule VIII Voting and Procedures 1. Subject to the provisions of paragraph 3 of this Rule, each Member of the Commission shall have one vote. An alternate or adviser shall not have the right to vote except where substituting for the representative. 2. Except as otherwise provided in these rules, decisions of the Commission shall be taken by a majority of the votes cast. 13 Section I: Basic texts and definitions 3. At the request of a majority of the Members of the Commission constituting a given region or a group of countries that a standard be elaborated, the standard concerned shall be elaborated as a standard primarily intended for that region or group of countries. When a vote is taken on the elaboration, amendment or adoption of a draft standard primarily intended for a region or group of countries, only Members belonging to that region or group of countries may take part in the voting. The adoption of the standard may, however, take place only after submission of the draft text to all Members of the Commission for comments. The provisions of this paragraph shall not prejudice the elaboration or adoption of a corresponding standard with a different territorial scope. 4. Subject to the provisions of paragraph 5 of this Rule and paragraph 2 of Rule XII, any Member of the Commission may request a roll-call vote, in which case the vote of each Member shall be recorded. 5. Elections shall be decided by secret ballot, except that, where the number of candidates does not exceed the number of vacancies, the Chairperson may submit to the Commission that the election be decided by clear general consent. Any other matter shall be decided by secret ballot if the Commission so determines. 6. Formal proposals relating to items of the Agenda and amendments thereto shall be introduced in writing and handed to the Chairperson, who shall circulate them to representatives of Members of the Commission. 7. The provisions of Rule XII of the General Rules of FAO shall apply mutatis mutandis to all matters which are not specifically dealt with under Rule VIII of the present Rules. Rule IX Observers 1. Any Member Nation and any Associate Member of FAO or WHO which is not a Member of the Commission but has a special interest in the work of the Commission, may, upon request communicated to the Director- General of FAO or WHO, attend sessions of the Commission and of its subsidiary bodies as an observer. It may submit memoranda and participate without vote in the discussion. 2. Nations which, while not Member Nations or Associate Members of FAO or WHO, are Members of the United Nations, may, upon their request and subject to the provisions relating to the granting of observer status to nations adopted by the Conference of FAO and the World Health Assembly, be invited to attend in an observer capacity sessions of the Commission and of its subsidiary bodies. The status of nations invited to such sessions shall be governed by the relevant provisions adopted by the Conference of FAO. 14  Section I: Basic texts and definitions 3. Any Member of the Commission may attend as an observer the sessions of the subsidiary bodies and may submit memoranda and participate without vote in the discussions. 4. Subject to the provisions of paragraphs 5 and 6 of this Rule, the Directors-General of FAO or WHO may invite intergovernmental and international non-governmental organizations to attend as observers sessions of the Commission and of its subsidiary bodies. 5. Participation of intergovernmental organizations in the work of the Commission and the relations between the Commission and such organizations shall be governed by the relevant provisions of the Constitutions of FAO or WHO, as well as by the applicable regulations of FAO or WHO on relations with intergovernmental organizations; such relations shall be handled by the Director-General of FAO or WHO, as appropriate. 6. Participation of international non-governmental organizations in the work of the Commission and the relations between the Commission and such organizations shall be governed by the relevant provisions of the Constitution of FAO or WHO, as well as by applicable regulations of FAO or WHO on relations with international non-governmental organizations. Such relations shall be handled by the Director-General of FAO or WHO, as appropriate, on the advice of the Executive Committee. The Commission shall develop and keep under review principles and criteria concerning the participation of international non-governmental organizations in its work, consistent with the applicable regulations of FAO or WHO. Rule X Records and Reports 1. At each session the Commission shall approve a report embodying its views, recommendations and conclusions, including when requested a statement of minority views. Such other records for its own use as the Commission may on occasion decide shall also be maintained. 2. The report of the Commission shall be transmitted to the Directors- General of FAO and WHO at the close of each session, who shall circulate it to the Members of the Commission, to other countries and to organizations that were represented at the session, for their information, and upon request to other Member Nations and Associate Members of FAO and WHO. 3. Recommendations of the Commission having policy, programme or financial implications for FAO and/or WHO shall be brought by the Directors- General to the attention of the governing bodies of FAO and/or WHO for appropriate action. 15 Section I: Basic texts and definitions 4. Subject to the provisions of the preceding paragraph, the Directors- General of FAO and WHO may request Members of the Commission to supply the Commission with information on action taken on the basis of recommendations made by the Commission. Rule XI Subsidiary Bodies 1. The Commission may establish the following types of subsidiary bodies: (a) subsidiary bodies which it deems necessary for the accomplishment of its work in the finalization of draft standards; (b) subsidiary bodies in the form of: (i) Codex Committees for the preparation of draft standards for submission to the Commission, whether intended for worldwide use, for a given region or for a group of countries specifically enumerated by the Commission. (ii) Coordinating Committees for regions or groups of countries which shall exercise general coordination in the preparation of standards relating to such regions or groups of countries and such other functions as may be entrusted to them. 2. Subject to paragraph 3 below, membership in these subsidiary bodies shall consist, as may be determined by the Commission, either of such Members of the Commission as have notified the Directors-General of FAO or WHO of their desire to be considered as Members thereof, or of selected Members designated by the Commission. 3. Membership of subsidiary bodies established under Rule XI.1(b)(i) for the preparation of draft standards intended primarily for a region or group of countries, shall be open only to Members of the Commission belonging to such a region or group of countries. 4. Representatives of members of subsidiary bodies shall, insofar as possible, serve in a continuing capacity and shall be specialists active in the fields of the respective subsidiary bodies. 5. Subsidiary bodies may only be established by the Commission except where otherwise provided in these Rules. Their terms of reference and reporting procedures shall be determined by the Commission. 16  Section I: Basic texts and definitions 6. Sessions of subsidiary bodies shall be convened by the Directors- General of FAO and WHO: (a) in the case of bodies established under Rule XI.1(a), in consultation with the Chairperson of the Commission; (b) in the case of bodies established under Rule XI.1(b)(i) (Codex Committees), in consultation with the chairperson of the respective Codex Committee and also, in the case of Codex Committees for the preparation of draft standards for a given region or group of countries, with the Coordinator, if a Coordinator has been appointed for the region or group of countries concerned; (c) in the case of bodies established under Rule XI.1(b)(ii) (Coordinating Committees), in consultation with the Chairperson of the Coordinating Committee. 7. The Directors-General of FAO and WHO shall determine the place of meeting of bodies established under Rule XI.1(a) and Rule XI.1(b)(ii) after consultation, where appropriate, with the host country concerned and, in the case of bodies established under Rule XI.1(b)(ii), after consultation with the Coordinator for the region or group of countries concerned, if any. 8. Notice of the date and place of each session of bodies established under Rule XI.1(a) shall be communicated to all Members of the Commission at least two months before the session. 9. The establishment of subsidiary bodies under Rule XI.1(a) and Rule XI.1(b)(ii) shall be subject to the availability of the necessary funds, as shall the establishment of subsidiary bodies under Rule XI.1(b)(i) when any of their expenses are proposed to be recognized as operating expenses within the budget of the Commission in accordance with Article 10 of the Statutes of the Commission. Before taking any decision involving expenditure in connection with the establishment of such subsidiary bodies, the Commission shall have before it a report from the Director-General of FAO and/or WHO, as appropriate, on the administrative and financial implications thereof. 10. The Members who shall be responsible for appointing Chairpersons of subsidiary bodies established under Rule XI.1(b)(i) shall be designated at each session by the Commission and shall be eligible for re-designation. All other officers of subsidiary bodies shall be elected by the body concerned and shall be eligible for re-election. 11. The Rules of Procedure of the Commission shall apply mutatis mutandis to its subsidiary bodies. 17 Section I: Basic texts and definitions Rule XII Elaboration and Adoption of Standards 1. Subject to the provisions of these Rules of Procedure, the Commission may establish the procedures for the elaboration of worldwide standards and of standards for a given region or group of countries, and, when necessary, amend such procedures. 2. The Commission shall make every effort to reach agreement on the adoption or amendment of standards by consensus. Decisions to adopt or amend standards may be taken by voting only if such efforts to reach consensus have failed. Rule XIII Budget and Expenses 1. The Directors-General of FAO and WHO shall prepare for consideration by the Commission at its regular sessions an estimate of expenditure based on the proposed programme of work of the Commission and its subsidiary bodies, together with information concerning expenditures for the previous financial period. This estimate, with such modifications as may be considered appropriate by the Directors-General in the light of recommendations made by the Commission, shall subsequently be incorporated in the Regular Budgets of the two Organizations for approval by the appropriate governing bodies. 2. The estimate of expenditure shall make provisions for the operating expenses of the Commission and the subsidiary bodies of the Commission established under Rule XI.1(a) and XI.1(b)(ii) and for the expenses relating to staff assigned to the Programme and other expenditures incurred in connection with the servicing of the latter. 3. The estimate of expenditure shall make provision for the travel expenses (including a daily subsistence allowance) of members of the Executive Committee from developing countries for the purpose of participating in meetings of the Executive Committee. 4. The operating costs of subsidiary bodies established under Rule XI.1(b)(i) (Codex Committees) shall be borne by each Member accepting the Chair of such a body. The estimate of expenditure may include a provision for such costs involved in preparatory work as may be recognized as operating expenses of the Commission in accordance with the provisions of Article 10 of the Statutes of the Commission. 18  Section I: Basic texts and definitions 5. Except as provided for in Rule XIII.3, the estimate of expenditure shall make no provision for expenses, including travel, incurred by delegations of the Members of the Commission or of observers referred to in Rule IX, in connection with their attendance at sessions of the Commission or its subsidiary bodies. Should experts be invited by the Directors-General of FAO or WHO to attend sessions of the Commission and its subsidiary bodies in their individual capacity, their expenses shall be borne out of the regular budgetary funds available for the work of the Commission. Rule XIV Languages 1. The languages of the Commission and of its subsidiary bodies set up under Rule XI.1(a) shall be not less than three of the working languages, as shall be determined by the Commission, which are working languages both of FAO and of the Health Assembly of WHO. 2. Notwithstanding the provisions of paragraph 1 above, other languages which are working languages either of FAO or of the Health Assembly of WHO may be added by the Commission if: (a) the Commission has before it a report from the Directors-General of FAO and WHO on the policy, financial and administrative implications of the addition of such languages; and (b) the addition of such languages has the approval of the Directors- General of FAO and WHO. 3. Where a representative wishes to use a language other than a language of the Commission he shall himself provide the necessary interpretation and/or translation into one of the languages of the Commission. 4. Without prejudice to the provisions of paragraph 3 of this Rule, the languages of subsidiary bodies set up under Rule XI.1(b) shall include at least two of the languages of the Commission. Rule XV Amendments and Suspension of Rules 1. Amendments of or additions to these Rules may be adopted by a two thirds majority of the votes cast, provided that 24 hours’ notice of the proposal for the amendment or addition has been given. Amendments of or additions to these Rules shall come into force upon approval by the Directors-General of FAO and WHO, subject to such confirmation as may be prescribed by the procedures of the two Organizations. 19 Section I: Basic texts and definitions 2. The Rules of the Commission, other than Rule I, Rule III.1, 2, 3 and 5, Rule V, Rule VI.2 and 7, Rule VII.1, 4 and 6, Rule VIII.1, 2 and 3, Rule IX, Rule X.3 and 4, Rule XI.5, 7 and 9, Rule XIII, Rule XV and Rule XVI, may be suspended by the Commission by a two thirds majority of the votes cast, provided that 24 hours’ notice of the proposal for suspension has been given. Such notice may be waived if no representative of the Members of the Commission objects. Rule XVI Entry into Force 1. In accordance with Article 8 of the Statutes of the Commission, these Rules of Procedure shall come into force upon approval by the Directors- General of FAO and WHO, subject to such confirmation as may be prescribed by the procedures of the two Organizations. Pending the coming into force of these Rules, they shall apply provisionally. 20  Section I: Basic texts and definitions GENERAL PRINCIPLES OF THE CODEX ALIMENTARIUS Purpose of the Codex Alimentarius 1. The Codex Alimentarius is a collection of internationally adopted food standards and related texts3 presented in a uniform manner. These food standards and related texts aim at protecting consumers’ health and ensuring fair practices in the food trade. The publication of the Codex Alimentarius is intended to guide and promote the elaboration and establishment of definitions and requirements for foods to assist in their harmonization and in doing so to facilitate international trade. Scope of the Codex Alimentarius 2. The Codex Alimentarius includes standards for all the principle foods, whether processed, semi-processed or raw, for distribution to the consumer. Materials for further processing into foods should be included to the extent necessary to achieve the purposes of the Codex Alimentarius as defined. The Codex Alimentarius includes provisions in respect of food hygiene, food additives, residues of pesticides and veterinary drugs, contaminants, labelling and presentation, methods of analysis and sampling, and import and export inspection and certification Nature of Codex Standards 3. Codex standards and related texts are not a substitute for, or alternative to national legislation. Every country’s laws and administrative procedures contain provisions with which it is essential to comply. 4. Codex standards and related texts contain requirements for food aimed at ensuring for the consumer a safe, wholesome food product free from adulteration, correctly labelled and presented. A Codex standard for any food or foods should be drawn up in accordance with the Format for Codex Commodity Standards and contain, as appropriate, the sections listed therein. 3 These include codes of practice, guidelines and other recommendations. 21 Section I: Basic texts and definitions Revision of Codex Standards 5. The Codex Alimentarius Commission and its subsidiary bodies are committed to revision as necessary of Codex standards and related texts to ensure that they are consistent with and reflect current scientific knowledge and other relevant information. When required, a standard or related text shall be revised or removed in accordance with the Procedures for the Elaboration of Codex Standards and Related Texts. Each member of the Codex Alimentarius Commission is responsible for identifying, and presenting to the appropriate committee, any new scientific and other relevant information which may warrant revision of any existing Codex standards or related texts. 22  Section I: Basic texts and definitions DEFINITIONS FOR THE PURPOSES OF THE CODEX ALIMENTARIUS  For the purposes of the Codex Alimentarius: Food means any substance, whether processed, semi-processed or raw, which is intended for human consumption, and includes drink, chewing gum and any substance which has been used in the manufacture, preparation or treatment of “food” but does not include cosmetics or tobacco or substances used only as drugs. Food Hygiene comprises conditions and measures necessary for the production, processing, storage and distribution of food designed to ensure a safe, sound, wholesome product fit for human consumption. Food Additive means any substance not normally consumed as a food by itself and not normally used as a typical ingredient of the food, whether or not it has nutritive value, the intentional addition of which to food for a technological (including organoleptic) purpose in the manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food results, or may be reasonably expected to result, (directly or indirectly) in it or its by-products becoming a component of or otherwise affecting the characteristics of such foods. The term does not include “contaminants” or substances added to food for maintaining or improving nutritional qualities. Good Manufacturing Practice in the use of Food Additives means that:  the quantity of the additive added to food does not exceed the amount reasonably required to accomplish its intended physical nutritional or other technical effect in food;  the quantity of the additive that becomes a component of food as a result of its use in the manufacturing, processing or packaging of a food and which is not intended to accomplish any physical, or other technological effect in the food itself, is reduced to the extent reasonably possible;  the additive is of appropriate food grade quality and is prepared and handled in the same way as a food ingredient. Food grade quality is achieved by compliance with the specifications as a whole and not merely with individual criteria in terms of safety. 23 Section I: Basic texts and definitions Processing Aid means any substance or material, not including apparatus or utensils, and not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, foods or its ingredients, to fulfil a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product. Contaminant means any substance not intentionally added to food or feed for food producing animals, which is present in such food or feed as a result of the production (including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food or feed, or as a result of environmental contamination. The term does not include insect fragments, rodent hairs and other extraneous matter. Codex Maximum Level for a Contaminant in a Food or Feed Commodity is the maximum concentration of that substance recommended by the Codex Alimentarius Commission to be legally permitted in that commodity. Pesticide means any substance intended for preventing, destroying, attracting, repelling, or controlling any pest including unwanted species of plants or animals during the production, storage, transport, distribution and processing of food, agricultural commodities, or animal feeds or which may be administered to animals for the control of ectoparasites. The term includes substances intended for use as a plant growth regulator, defoliant, desiccant, fruit thinning agent, or sprouting inhibitor and substances applied to crops either before or after harvest to protect the commodity from deterioration during storage and transport. The term normally excludes fertilizers, plant and animal nutrients, food additives, and animal drugs. Pesticide Residue means any specified substance in food, agricultural commodities, or animal feed resulting from the use of a pesticide. The term includes any derivatives of a pesticide, such as conversion products, metabolites, reaction products, and impurities considered to be of toxicological significance. Codex Maximum Limit for Pesticide Residues (MRL) is the maximum concentration of a pesticide residue (expressed as mg/kg), recommended by the Codex Alimentarius Commission to be legally permitted in or on food commodities and animal feeds. MRLs are based on GAP data and foods derived from commodities that comply with the respective MRLs are intended to be toxicologically acceptable. 24  Section I: Basic texts and definitions Codex MRLs, which are primarily intended to apply in international trade, are derived from estimations made by the JMPR following: (a) toxicological assessment of the pesticide and its residue; and (b) review of residue data from supervised trials and supervised uses including those reflecting national good agricultural practices. Data from supervised trials conducted at the highest nationally recommended, authorized or registered uses are included in the review. In order to accommodate variations in national pest control requirements, Codex MRLs take into account the higher levels shown to arise in such supervised trials, which are considered to represent effective pest control practices. Consideration of the various dietary residue intake estimates and determinations both at the national and international level in comparison with the ADI, should indicate that foods complying with Codex MRLs are safe for human consumption. Good Agricultural Practice in the Use of Pesticides (GAP) includes the nationally authorized safe uses of pesticides under actual conditions necessary for effective and reliable pest control. It encompasses a range of levels of pesticide applications up to the highest authorised use, applied in a manner which leaves a residue which is the smallest amount practicable. Authorized safe uses are determined at the national level and include nationally registered or recommended uses, which take into account public and occupational health and environmental safety considerations. Actual conditions include any stage in the production, storage, transport, distribution and processing of food commodities and animal feed. Veterinary Drug means any substance applied or administered to any food producing animal, such as meat or milk producing animals, poultry, fish or bees, whether used for therapeutic, prophylactic or diagnostic purposes or for modification of physiological functions or behaviour. Residues of Veterinary Drugs include the parent compounds and/or their metabolites in any edible portion of the animal product, and include residues of associated impurities of the veterinary drug concerned. Codex Maximum Limit for Residues of Veterinary Drugs (MRL) is the maximum concentration of residue resulting from the use of a veterinary drug (expressed in mg/kg or μg/kg on a fresh weight basis) that is recommended by the Codex Alimentarius Commission to be legally permitted or recognized as acceptable in or on a food. 25 Section I: Basic texts and definitions It is based on the type and amount of residue considered to be without any toxicological hazard for human health as expressed by the Acceptable Daily Intake (ADI), or on the basis of a temporary ADI that utilizes an additional safety factor. It also takes into account other relevant public health risks as well as food technological aspects. When establishing an MRL, consideration is also given to residues that occur in food of plant origin and/or the environment. Furthermore, the MRL may be reduced to be consistent with good practices in the use of veterinary drugs and to the extent that practical analytical methods are available. Good Practice in the Use of Veterinary Drugs is the official recommended or authorized usage including withdrawal periods, approved by national authorities, of veterinary drugs under practical conditions. Traceability/Product Tracing: the ability to follow the movement of a food through specified stage(s) of production, processing and distribution. 26  Section II: Elaboration of Codex texts SECTION II ELABORATION OF CODEX STANDARDS AND RELATED TEXTS  Procedures for the Elaboration of Codex Standards and Related Texts. (Adopted in 1965. Revised in 1993 and 2004. Amended in 1966, 1969, 1976, 1981, 2005, 2006, 2008, 2015)  Criteria for the Establishment of Subsidiary Bodies of the Codex Alimentarius Commission. (Adopted in 1969. Revised in 1999)  Criteria for the Establishment of Work Priorities. (Adopted in 1969. Revised in 1999, 2005 and 2010)  Guideline on the Application of the Criteria for the Establishment of Work Priorities (Criteria Applicable to Commodities). (Adopted in 2010)  Relations between Commodity Committees and General Committees. (Amended in 1995, 1997, 1999, 2001 and 2008)  Format for Codex Commodity Standards. (Adopted in 1969. Amended in 2007, 2008, 2010, 2011 and 2016)  Guidelines for the Inclusion of Specific Provisions in Codex Standards and Related Texts o Procedures for consideration of entry and review of Food Additive Provisions in the General Standard for Food Additives. (Adopted in 2007) o Guidelines on the Elaboration and/or Revision of Codes of Hygienic Practice for Specific Commodities. (Adopted in 1997) o Procedure for the Inclusion of Additional Species in Codex Standards for Fish and Fishery Products. (Adopted in 2013) o Principles for the Establishment of Codex Methods of Analysis. (Adopted in 1964. Amended in 1969, 1979, 2001, 2003, 2004, 2008, 2009, 2013 and 2017) o Principles for the Establishment or Selection of Codex Sampling Procedures. (Adopted in 1993. Amended 2007) 27 Section II: Elaboration of Codex texts o The use of Analytical Results: Sampling Plans, Relationship between the Analytical Results, the measurement uncertainty, recovery factors and provisions in Codex Standards. (Adopted in 2006) o Provisions on the use of proprietary methods in Codex standards (Adopted 2012) 28  Section II: Elaboration of Codex texts PROCEDURES FOR THE ELABORATION OF CODEX STANDARDS AND RELATED TEXTS Note: These procedures apply to the elaboration of Codex standards and related texts (e.g. codes of practice, guidelines) adopted by the Codex Alimentarius Commission as recommendations for governments. Introduction The full procedure for the elaboration of Codex standards is as follows: 1. The Commission shall implement a unified approach in the area of standards development by taking its decisions, based on a strategic planning process (“standards management”) (See Part 1 of this document). 2. An on-going critical review shall ensure that proposals for new work and draft standards submitted to the Commission for adoption continue to meet the strategic priorities of the Commission and can be developed within a reasonable period of time, taking into account the requirements and availability of scientific expert advice (See Part 2 of this document). 3. The Commission decides, taking into account the outcome of the on- going critical review conducted by the Executive Committee, that a standard should be elaborated and also which subsidiary body or other body should undertake the work. Decisions to elaborate standards may also be taken by subsidiary bodies of the Commission in accordance with the above- mentioned outcome subject to subsequent approval by the Commission at the earliest possible opportunity. The Secretariat arranges for the preparation of a “proposed draft standard” which is circulated to governments for comments and is then considered in the light of these by the subsidiary body concerned which may present the text to the Commission as a “draft standard”. If the Commission adopts the “draft standard” it is sent to governments for further comments and in the light of these and after further consideration by the subsidiary body concerned, the Commission reconsiders the draft and may adopt it as a “Codex standard”. The procedure is described in Part 3 of this document. 4. The Commission or any subsidiary body, subject to the confirmation of the Commission may decide that the urgency of elaborating a Codex standard is such that an accelerated elaboration procedure should be followed. While taking this decision, all appropriate matters shall be taken into consideration, including the likelihood of new scientific information becoming available in the immediate future. The accelerated elaboration procedure is described in Part 4 of this document. 29 Section II: Elaboration of Codex texts 5. The Commission or the subsidiary body or other body concerned may decide that the draft be returned for further work at any appropriate previous Step in the Procedure. The Commission may also decide that the draft be held at Step 8. 6. The Commission may authorize, on the basis of two-thirds majority of votes cast, the omission of Steps 6 and 7, where such an omission is recommended by the Codex Committee entrusted with the elaboration of the draft. Recommendations to omit steps shall be notified to Members and interested international organizations as soon as possible after the session of the Codex Committee concerned. When formulating recommendations to omit Steps 6 and 7, Codex Committees shall take all appropriate matters into consideration, including the need for urgency, and the likelihood of new scientific information becoming available in the immediate future. 7. The Commission may at any stage in the elaboration of a standard entrust any of the remaining Steps to a Codex Committee or other body different from that to which it was previously entrusted. 8. It will be for the Commission itself to keep under review the revision of “Codex standards”. The procedure for revision should, mutatis mutandis, be that laid down for the elaboration of Codex standards, except that the Commission may decide to omit any other step or steps of that Procedure where, in its opinion, an amendment proposed by a Codex Committee is either of an editorial nature or of a substantive nature but consequential to provisions in similar standards adopted by the Commission at Step 8. 9. Codex standards and related texts are published and are sent to governments as well as to international organizations to which competence in the matter has been transferred by their Member States (see Part 5 of this document). Part 1. Strategic Planning Process 1. Taking into account the “Criteria for the Establishment of Work Priorities”, the strategic plan shall state broad priorities against which individual proposals for standards (and revision of standards) can be evaluated during the critical review process. 2. The strategic plan shall cover a six-year period and shall be renewed every two years on a rolling basis. 30  Section II: Elaboration of Codex texts Part 2. Critical Review Proposals to Undertake New Work or to Revise a Standard 1. Prior to approval for development, each proposal for new work or revision of a standard shall be accompanied by a project document, prepared by the Committee or Member proposing new work or revision of a standard, detailing:  the purposes and the scope of the standard;  its relevance and timeliness;  the main aspects to be covered;  an assessment against the Criteria for the Establishment of Work Priorities;  relevance to the Codex strategic objectives;  information on the relation between the proposal and other existing Codex documents as well as other ongoing work4;  identification of any requirement for and availability of expert scientific advice;  identification of any need for technical input to the standard from external bodies so that this can be planned for;  the proposed time-line for completion of the new work, including the start date, the proposed date for adoption at Step 5, and the proposed date for adoption by the Commission; the time frame for developing a standard should not normally exceed five years. 2. The decision to undertake new work or to revise standards shall be taken by the Commission taking into account a critical review conducted by the Executive Committee. 3. The critical review includes:  examination of proposals for development/revision of standards, taking into account the “Criteria for the Establishment of Work Priorities", the strategic plan of the Commission and the required supporting work of independent risk assessment;  identifying the standard setting needs of developing countries; 4 Countries could seek the assistance of the Codex Secretariat to provide information on other on-going work in Codex 31 Section II: Elaboration of Codex texts  advice on the need for coordination of work between relevant Codex subsidiary bodies  advice on establishment and dissolution of committees and task forces, including ad hoc cross-committee task forces (in areas where work falls within several committee mandates); and  preliminary assessment of the need for expert scientific advice and the availability of such advice from FAO, WHO or other relevant expert bodies, and the prioritisation of that advice. 4. The decision to undertake new work or revision of individual maximum residue limits for pesticides or veterinary drugs, or the maintenance of the General Standard on Food Additives5, the General Standard on Contaminants and Toxins in Food and Feed 6, the Food Categorisation System and the International Numbering System, shall follow the procedures established by the Committees concerned and endorsed by the Commission. Monitoring Progress of Standards Development 5. The Executive Committee shall review the status of development of draft standards against the time frame agreed by the Commission and shall report its findings to the Commission. 6. The Executive Committee may propose an extension of the time frame; cancellation of work; or propose that the work be undertaken by a Committee other than the one to which it was originally entrusted, including the establishment of a limited number of subsidiary bodies, if appropriate. 7. The critical review process shall ensure that progress in the development of standards is consistent with the envisaged time frame, that draft standards submitted to the Commission for adoption have been fully considered at Committee level. 8. Monitoring shall take place against the time-line deemed necessary and revisions in the coverage of the standard shall need to be specifically endorsed by the Commission. This shall therefore include:  monitoring of progress in developing standards and advising what corrective action should be taken; 5 Including related methods of analysis and sampling plans 6 Including related methods of analysis and sampling plans 32  Section II: Elaboration of Codex texts  examining proposed standards from Codex committees, before they are submitted to the Commission for adoption:  for consistency with the mandate of Codex, the decisions of the Commission, and existing Codex texts,  to ensure that the requirements of the endorsement procedure have been fulfilled, where appropriate,  for format and presentation, and  for linguistic consistency. Part 3. Uniform Procedure for the Elaboration of Codex Standards and Related Texts Step 1 The Commission decides, taking into account the outcome of the critical review conducted by the Executive Committee, to elaborate a World-wide Codex Standard and also decides which subsidiary body or other body should undertake the work. A decision to elaborate a World-wide Codex Standard may also be taken by subsidiary bodies of the Commission in accordance with the above mentioned outcome, subject to subsequent approval by the Commission at the earliest possible opportunity. In the case of Codex Regional Standards, the Commission shall base its decision on the proposal of the majority of Members belonging to a given region or group of countries submitted at a session of the Codex Alimentarius Commission. Step 2 The Secretariat arranges for the preparation of a proposed draft standard. In the case of Maximum Limits for Residues of Pesticides or Veterinary Drugs, the Secretariat distributes the recommendations for maximum limits, when available from the Joint Meetings of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group on Pesticide Residues (JMPR), or the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Any other relevant information regarding risk assessment work conducted by FAO and WHO should also be made available. In the cases of milk and milk products or individual standards for cheeses, the Secretariat distributes the recommendations of the International Dairy Federation (IDF). 33 Section II: Elaboration of Codex texts Step 3 The proposed draft standard is sent to Members of the Commission and interested international organizations for comment on all aspects including possible implications of the proposed draft standard for their economic interests. Step 4 The comments received are sent by the Secretariat to the subsidiary body or other body concerned which has the power to consider such comments and to amend the proposed draft standard. Step 5 The proposed draft standard is submitted through the Secretariat to the Executive Committee for critical review and to the Commission with a view to its adoption as a draft standard7. In taking any decision at this step, the Commission will give due consideration to the outcome of the critical review and to any comments that may be submitted by any of its Members regarding the implications which the proposed draft standard or any provisions thereof may have for their economic interests. In the case of Regional Standards, all Members of the Commission may present their comments, take part in the debate and propose amendments, but only the majority of the Members of the region or group of countries concerned attending the session can decide to amend or adopt the draft. In taking any decisions at this step, the Members of the region or group of countries concerned will give due consideration to any comments that may be submitted by any of the Members of the Commission regarding the implications which the proposed draft standard or any provisions thereof may have for their economic interests. Step 6 The draft standard is sent by the Secretariat to all Members and interested international organizations for comment on all aspects, including possible implications of the draft standard for their economic interests. 7 Without prejudice to the outcome of the critical review conducted by the Executive Committee and/or any decision that may be taken by the Commission at Step 5, the proposed draft standard may be sent by the Secretariat for government comments prior to its consideration at Step 5, when, in the opinion of the subsidiary body or other body concerned, the time between the relevant session of the Commission and the subsequent session of the subsidiary body or other body concerned requires such action in order to advance the work. 34  Section II: Elaboration of Codex texts Step 7 The comments received are sent by the Secretariat to the subsidiary body or other body concerned, which has the power to consider such comments and amend the draft standard. Step 8 The draft standard is submitted through the Secretariat to the Executive Committee for critical review and to the Commission, together with any written proposals received from Members and interested international organizations for amendments at Step 8, with a view to its adoption as a Codex standard. In taking any decision at this step, the Commission will give due consideration to the outcome of the critical review and to any comments that may be submitted by any of its Members regarding the implications which the draft standard or any provisions thereof may have for their economic interests. In the case of Regional standards, all Members and interested international organizations may present their comments, take part in the debate and propose amendments but only the majority of Members of the region or group of countries concerned attending the session can decide to amend and adopt the draft. Part 4. Uniform Accelerated Procedure for the Elaboration of Codex Standards and Related Texts Step 1 The Commission, on the basis of a two-thirds majority of votes cast, taking into account the outcome of the critical review conducted by the Executive Committee, shall identify those standards which shall be the subject of an accelerated elaboration process.8 The identification of such standards may also be made by subsidiary bodies of the Commission, on the basis of a two- thirds majority of votes cast, subject to confirmation at the earliest opportunity by the Commission. 8 Relevant considerations could include, but need not be limited to, matters concerning new scientific information; new technology(ies); urgent problems related to trade or public health; or the revision or up- dating of existing standards. 35 Section II: Elaboration of Codex texts Step 2 The Secretariat arranges for the preparation of a proposed draft standard. In the case of Maximum Limits for Residues of Pesticides or Veterinary Drugs, the Secretariat distributes the recommendations for maximum limits, when available from the Joint Meetings of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group on Pesticide Residues (JMPR), or the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Any other relevant information regarding risk assessment work conducted by FAO and WHO should also be made available. In the cases of milk and milk products or individual standards for cheeses, the Secretariat distributes the recommendations of the International Dairy Federation (IDF). Step 3 The proposed draft standard is sent to Members of the Commission and interested international organizations for comment on all aspects including possible implications of the proposed draft standard for their economic interests. When standards are subject to an accelerated procedure, this fact shall be notified to the Members of the Commission and the interested international organizations. Step 4 The comments received are sent by the Secretariat to the subsidiary body or other body concerned which has the power to consider such comments and to amend the proposed draft standard. Step 5 In the case of standards identified as being subject to an accelerated elaboration procedure, the proposed draft standard is submitted through the Secretariat to the Executive Committee for critical review and to the Commission, together with any written proposals received from Members and interested international organizations for amendments, with a view to its adoption as a Codex standard. In taking any decision at this step, the Commission will give due consideration to the outcome of the critical review and to any comments that may be submitted by any of its Members regarding the implications which the proposed draft standard or any provisions thereof may have for their economic interests. In the case of Regional standards, all Members and interested international organizations may present their comments, take part in the debate and propose amendments but only the majority of Members of the region or group of countries concerned attending the session can decide to amend and adopt the proposed draft. 36  Section II: Elaboration of Codex texts Part 5. Subsequent Procedure Concerning Publication of Codex Standards The Codex standard is published and issued to all Member States and Associate Members of FAO and/or WHO and to the international organizations concerned. The above mentioned publications will constitute the Codex Alimentarius. Subsequent Procedure Concerning Publication and Possible Extension of Territorial Application of the Standard The Codex Regional Standard is published and issued to all Member States and Associate Members of FAO and/or WHO and to the international organizations concerned. It is open to the Commission to consider at any time the possible extension of the territorial application of a Codex Regional Standard or its conversion into a Worldwide Codex Standard. (a) A request to convert a regional standard into a worldwide standard may arise immediately after adoption of the regional standard at Step 8, or some time thereafter. (b) The conversion of a regional standard into a worldwide standard may contemplate the following situations as per status of the relevant commodity committee: (i) When the relevant commodity committee is active: Requests for conversion of a regional standard into a worldwide standard should preferably be made by the commodity committee concerned, substantiated by a Project Document. This Project Document will be reviewed by the Executive Committee in the framework of the Critical Review Process, taking into account the programme of work of the commodity committee concerned. If the Codex Alimentarius Commission approves the proposal, taking into account the outcome of the Critical Review by the Executive Committee, the regional standard usually enters the Uniform Accelerated Procedure at Step 3, for consideration at Step 4 at the subsequent session of the commodity committee concerned. (ii) When the relevant commodity committee is not active: When the commodity committee concerned is not active (i.e., not holding physical sessions), the proposal for conversion of a regional standard into a worldwide standard should preferably come through the originating coordinating committee, substantiated by a Project Document; it may also come from Codex members in 37 Section II: Elaboration of Codex texts the form of a Project Document for consideration by the Executive Committee in the framework of the Critical Review process. If the Codex Alimentarius Commission approves the proposal, taking into account the outcome of the Critical Review by the Executive Committee, the regional standard usually enters the Uniform Accelerated Procedure at Step 3, for consideration at Step 4 by the commodity committee concerned. In this case, the Executive Committee should give consideration to how to proceed with the work either by correspondence, or by reconvening the adjourned committee. In the latter situation, the Executive Committee should recommend to the Commission the reactivation of the committee adjourned sine die to undertake the new work. Guide to the Procedure for the Amendment and Revision of Codex Standards and Related Texts 1. The procedure for amending or revising a Codex standard is laid down in paragraph 8 of the Introduction to the Procedure for the Elaboration of Codex Standards and Related Texts. This Guide provides more detailed guidance on the existing procedure for the amendment and revision of Codex standards and related text. 2. When the Commission has decided to amend or revise a standard, the unrevised standard will remain the applicable Codex standard until the amendment to the standard or the revised standard has been adopted by the Commission. 3. For the purpose of this Guide: Amendment means any addition, change or deletion of text or numerical values in a Codex standard or related text, may be editorial or substantive, and concerns one or a limited number of articles in the Codex text. In particular, amendments of an editorial nature may include but are not limited to:  correction of an error;  insertion of an explanatory footnote; and  updating of references consequential to the adoption, amendment or revision of Codex standards and other texts of general applicability, including the provisions in the Procedural Manual. 38  Section II: Elaboration of Codex texts Finalization or updating of methods of analysis and sampling as well as alignment of provisions, for consistency, to those in similar standards or related texts adopted by the Commission may be handled by the Commission in the same manner as amendments of an editorial nature, as far as the procedure described in this Guide is concerned. Revision means any changes to a Codex standard or related text other than those covered under “amendment” as defined above. The Commission has the final authority to determine whether a proposal made constitutes an amendment or a revision, and whether an amendment proposed is of an editorial or substantive nature. 4. Proposals for the amendment or revision of Codex standards and related texts should be submitted to the Commission by the subsidiary body concerned, by the Secretariat, or a member of the Commission where the subsidiary body concerned is not in existence or has been adjourned sine die. In the latter case, proposals should be received by the Secretariat in good time (not less than three months) before the session of the Commission at which they are to be considered. The proposal should be accompanied by a project document (see Part 2 of the Elaboration Procedures) unless the Executive Committee or the Commission decides otherwise. However, if the amendment proposed is of an editorial nature, the preparation of a project document is not required. 5. Taking into account the outcome of the on-going critical review conducted by the Executive Committee, the Commission decides whether the amendment or revision of a standard is necessary. If the Commission decides in the affirmative, one of the following courses of action will be taken: (i) In the case of an amendment of an editorial nature, it will be open to the Commission to adopt the amendment at Step 8 of the Uniform Procedure (see Part 3 of the Elaboration Procedures). (ii) In the case of an amendment proposed and agreed upon by a subsidiary body, it will also be open to the Commission to adopt the amendment at Step 5 of the Uniform Procedure (see Part 3 of the Elaboration Procedures). (iii) In other cases, the Commission will approve the proposal as new work and the approved new work will be referred for consideration to the appropriate subsidiary body, if such body is still in existence. If such body is not in existence, the Commission will determine how best to deal with the new work. 39 Section II: Elaboration of Codex texts 6. Where Codex subsidiary bodies have been abolished or dissolved, or Codex committees have been adjourned sine die, the Secretariat keeps under review all Codex standards and related texts elaborated by these bodies and determines the need for any amendments, in particular those arising from decisions of the Commission If the need for amendments of an editorial nature is identified then the Secretariat should prepare proposed amendments for consideration and adoption by the Commission. If the need for amendments of a substantive nature is identified, the Secretariat, in cooperation with the national secretariat of the adjourned Committee if applicable, should prepare a working paper containing the reasons for proposing amendments and the wording of such amendments as appropriate, and request comments from members of the Commission: (a) on the need to proceed with such an amendment and (b) on the proposed amendment itself. If the majority of the replies received from members of the Commission is affirmative on both the need to amend the standard and the suitability of the proposed wording for the amendment or an alternative proposed wording, the proposal should be submitted to the Commission for consideration and adoption. In cases where replies do not appear to offer an uncontroversial solution then the Commission should be informed accordingly and it would be for the Commission to determine how best to proceed. 40  Section II: Elaboration of Codex texts CRITERIA FOR THE ESTABLISHMENT OF SUBSIDIARY BODIES OF THE CODEX ALIMENTARIUS COMMISSION When there is a proposal for the elaboration of a standard, code of practice or related text in an area not covered by the terms of reference of any existing subsidiary body9, or the revision of standards, codes of practice or other texts elaborated by subsidiary bodies adjourned sine die, such