SECTION I

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, after acceptance by governments, publishing them in a Codex Alimentarius either as regional or world wide standards, together with international standards already finalized by other bodies under (b) above, wherever this is practicable;

(e) amending published standards, after appropriate survey 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.

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.

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.

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.

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 6 of Rule V, 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.

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 but after having served two consecutive terms shall be ineligible to hold such office for the next succeeding term.

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. (a) The Commission may appoint a Coordinator from among the Members of the Commission for any of the geographic locations enumerated in Rule IV.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.

(b) 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. Coordinators shall hold office from the end of the session of the Commission at which they were appointed until not later than the end of the third succeeding regular session, the precise term being determined by the Commission in each instance. After having served two consecutive terms, the Coordinators shall be ineligible to hold such office for the next succeeding term.

(c) The functions of the Coordinators shall be:

(i) to assist and coordinate the work of the Codex Committees set up under Rule X.1(b)(ii) in their region or group of countries in the preparation of draft standards, guidelines and other recommendations for submission to the Commission;

(ii) to assist the Executive Committee and the Commission, as required, by advising them of the views of countries and recognized regional intergovernmental and non-governmental organizations in their respective regions on matters under discussion or of interest.

(d) In order to carry out their functions, Coordinators shall participate in the Executive Committee as Observers.

5. The Commission may appoint one or more rapporteurs from among the delegates of the Members of the Commission.

6. 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.

RULE IV EXECUTIVE COMMITTEE

1. The Executive Committee shall consist of the Chairperson and Vice-Chairpersons of the Commission 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; it being understood that 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, but after having served two consecutive terms shall be ineligible to hold such office for the next succeeding term.

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 the general orientation and programme of work of the Commission, study special problems and help implement the programme as approved by the Commission. The Executive Committee may also exercise, when it shall deem it to be essential and subject to confirmation by the next session of the Commission, the Commission's powers under Rule X.1(b)(i), Rule X.5 insofar as it refers to bodies established under Rule X.1(b)(i), and Rule X.10, insofar as it refers to the designation of the Members who shall be responsible for appointing Chairpersons to subsidiary bodies established under Rule X.1(b)(i).

3. The Chairperson and Vice-Chairpersons of the Commission shall be respectively the Chairperson and Vice-Chairpersons of the Executive Committee.

4. 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.

5. The Executive Committee shall report to the Commission.

RULE V 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. Meetings of the Commission shall be held in public, unless the Commission decides otherwise.

6. 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 XIV.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.

RULE VI 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 VII 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.

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 XI, 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 VII of the present Rules.

RULE VIII 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.

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 Rule VIII.5 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 international 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 international organizations; such relations shall be handled by the Director-General of FAO or of WHO as appropriate.

RULE IX 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.

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 X 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 world-wide 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 X.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, except where otherwise provided in these Rules.

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 X.1(a), in consultation with the Chairperson of the Commission;

(b) in the case of bodies established under Rule X.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 X.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 X.1(a) and Rule X.1(b)(ii) after consultation, where appropriate, with the host country concerned and, in the case of bodies established under Rule X.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 X.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 X.1(a) and Rule X.1(b)(ii) shall be subject to the availability of the necessary funds, as shall the establishment of subsidiary bodies under Rule X.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 X.1(b)(i) and Rule X.1(b)(ii) shall be designated at each session by the Commission, except where otherwise provided in these Rules, 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.

RULE XI 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 world-wide 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 XII 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 X.1(a) and X.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 operating costs of subsidiary bodies established under Rule X.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.

4. Expenses incurred in connection with attendance at sessions of the Commission and its subsidiary bodies and travel of delegations of the Members of the Commission and of observers referred to in Rule VIII, shall be borne by the governments or organizations concerned. 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 XIII LANGUAGES

1. The languages of the Commission and of its subsidiary bodies set up under Rule X.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 X.1(b) shall include at least two of the languages of the Commission.

RULE XIV 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.

2. The Rules of the Commission, other than Rule I, Rule III.1, 2, 3 and 6, Rule IV, Rule V.2 and 6, Rule VI.1, 4 and 6, Rule VII.1, 2 and 3, Rule VIII, Rule IX.3 and 4, Rule X.5, 7 and 9, Rule XII, Rule XIV and Rule XV, 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 XV 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.

PROCEDURES FOR THE ELABORATION OF CODEX STANDARDS AND RELATED TEXTS

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.

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 authorise, 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 are published and governments are invited to notify the Commission's Secretariat of the status or use of the Codex standard in accordance with their established legal and administrative procedures. They are also sent to international organizations to which competence in the matter has been transferred by their Member States (See Part 5 of this document). Details of notifications are published periodically by the Commission's Secretariat.

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.

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;

• 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 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;

• 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 Additives^[3], the General Standard on Contaminants and Toxins in Foods^[4], 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 ad hoc 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;

• 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

Steps 1, 2 and 3

(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.

(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).

(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 standard^[5]. 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.

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 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

Steps 1, 2 and 3

(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.^[6] 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.

(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).

(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 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 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.

PART 5. SUBSEQUENT PROCEDURE CONCERNING PUBLICATION AND ACCEPTANCE 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. Members of the Commission and international organizations to which competence in the matter has been transferred by their Member States notify the Secretariat of the status or use of the Codex standard in accordance with the notification acceptance procedure set out in paragraph 4, paragraph 5 or paragraph 6 of the General Principles of the Codex Alimentarius, whichever is appropriate. Member States and Associate Members of FAO and/or WHO that are not Members of the Commission are also invited to notify the Secretariat if they wish to accept the Codex standard.

The Secretariat publishes periodically details of notifications received from governments and from international organizations to which competence in the matter has been transferred by their Member States with respect to the acceptance or otherwise of Codex standards and in addition to this information an appendix for each Codex standard (a) listing the countries in which products conforming with such standard may be freely distributed, and (b) where applicable, stating in detail all specified deviations which may have been declared in respect to acceptance.

The above mentioned publications will constitute the Codex Alimentarius.

The Secretariat examines deviations notified by governments and reports periodically to the Codex Alimentarius Commission concerning possible amendments to standards which might be considered by the Commission in accordance with the Procedure for the Revision and Amendment of Recommended Codex Standards.

SUBSEQUENT PROCEDURE CONCERNING PUBLICATION, ACCEPTANCE 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. Members of the region or group of countries concerned notify the Secretariat of the status and use the Codex Regional Standard in accordance with the notification procedure set out in Section 4 of the General Principles of the Codex Alimentarius. Other Members of the Commission may likewise notify the Secretariat of their use of the standard or of any other measures they propose to adopt with respect thereto, and also submit any observations as to its application. Member States and Associate Members of FAO and/or WHO that are not Members of the Commission are invited to notify the Secretariat of the status or use of the Codex standard.

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 World-wide Codex Standard in the light of all notifications received.

GUIDE TO THE CONSIDERATION OF STANDARDS AT STEP 8 OF THE PROCEDURE FOR THE ELABORATION OF CODEX STANDARDS INCLUDING CONSIDERATION OF ANY STATEMENTS RELATING TO ECONOMIC IMPACT

1. In order:

(a) to ensure that the work of the Codex committee concerned is not made less valuable by the passage of an insufficiently considered amendment in the Commission;

(b) at the same time to provide scope for significant amendments to be raised and considered in the Commission;

(c) to prevent, as far as practicable, lengthy discussion in the Commission on points that have been thoroughly argued in the Codex committee concerned;

(d) to ensure, as far as practicable, that delegations are given sufficient warning of amendments so that they may brief themselves adequately,

amendments to Codex standards at Step 8 should, as far as practicable, be submitted in writing, although amendments proposed in the Commission would not be excluded entirely, and the following procedure should be employed:

2. When Codex standards are distributed to Member Countries prior to their consideration by the Commission at Step 8, the Secretariat will indicate the date by which proposed amendments must be received; this date will be fixed so as to allow sufficient time for such amendments to be in the hands of governments not less than one month before the session of the Commission.

3. Governments should submit amendments in writing by the date indicated and should state that they had been previously submitted to the appropriate Codex committee with details of the submission of the amendment or should give the reason why the amendment had not been proposed earlier, as the case may be.

4. When amendments are proposed during a session of the Commission, without prior notice, to a standard which is at Step 8, the Chairperson of the Commission, after consultation with the chairperson of the appropriate committee, or, if the chairperson is not present, with the delegate of the chairing country, or, in the case of subsidiary bodies which do not have a chairing country, with other appropriate persons, shall rule whether such amendments are substantive.

5. If an amendment ruled as substantive is agreed to by the Commission, it shall be referred to the appropriate Codex committee for its comments and, until such comments have been received and considered by the Commission, the standard shall not be advanced beyond Step 8 of the Procedure.

6. It will be open to any Member of the Commission to draw to the attention of the Commission any matter concerning the possible implications of a draft standard for its economic interests, including any such matter which has not, in that Member's opinion, been satisfactorily resolved at an earlier step in the Procedure for the Elaboration of Codex Standards. All the information pertaining to the matter, including the outcome of any previous consideration by the Commission or a subsidiary body thereof should be presented in writing to the Commission, together with any draft amendments to the standard which would in the opinion of the country concerned, take into account the economic implications. In considering statements concerning economic implications the Commission should have due regard to the purposes of the Codex Alimentarius concerning the protection of the health of consumers and the ensuring of fair practices in the food trade, as set forth in the General Principles of the Codex Alimentarius, as well as the economic interests of the Member concerned. It will be open to the Commission to take any appropriate action including referring the matter to the appropriate Codex committee for its comments.

GUIDE TO THE PROCEDURE FOR THE REVISION AND AMENDMENT OF CODEX STANDARDS

1. Proposals for the amendment or revision of Codex standards should be submitted to the Commission's Secretariat in good time (not less than three months) before the session of the Commission at which they are to be considered. The proposer of an amendment should indicate the reasons for the proposed amendment and should also state whether the proposed amendment had been previously submitted to and considered by the Codex committee concerned and/or the Commission. If the proposed amendment has already been considered by the Codex committee and/or Commission, the outcome of the consideration of the proposed amendment should be stated.

2. Taking into account such information regarding the proposed amendment, as may be supplied in accordance with paragraph 1 above, and the outcome of the on-going critical review conducted by the Executive Committee, the Commission will decide whether the amendment or revision of a standard is necessary. If the Commission decides in the affirmative, and the proposer of the amendment is other than a Codex committee, the proposed amendment will be referred for consideration to the appropriate Codex committee, if such committee is still in existence. If such committee is not in existence, the Commission will determine how best to deal with the proposed amendment. If the proposer of the amendment is a Codex committee, it would be open to the Commission to decide that the proposed amendment be circulated to governments for comments prior to further consideration by the sponsoring Codex Committee. In the case of an amendment proposed by a Codex Committee, it will also be open to the Commission to adopt the amendment at Step 5 or Step 8 as appropriate, where in its opinion the amendment is either of an editorial nature or of a substantive nature but consequential to provisions in similar standards adopted by it at Step 8.

3. The procedure for amending or revising a Codex standard would be as laid down in paragraphs 5 and 6 of the Introduction to the Procedure for the Elaboration of Codex Standards (see page 19 above).

4. When the Commission has decided to amend or revise a standard, the unrevised standard will remain the applicable Codex standard until the revised standard has been adopted by the Commission.

ARRANGEMENTS FOR THE AMENDMENT OF CODEX STANDARDS ELABORATED BY CODEX COMMITTEES WHICH HAVE ADJOURNED SINE DIE

1. The need to consider amending or revising adopted Codex standards arises from time to time for a variety of reasons amongst which can be:

(a) changes in the evaluation of food additives, pesticides and contaminants;

(b) finalization of methods of analysis;

(c) editorial amendments of guidelines or other texts adopted by the Commission and related to all or a group of Codex standards e.g. "Guidelines on Date Marking", "Guidelines on Labelling of Non-retail Containers", "Carry-over Principle";

(d) consequential amendments to earlier Codex standards arising from Commission decisions on currently adopted standards of the same type of products;

(e) consequential and other amendments arising from either revised or newly elaborated Codex standards and other texts of general applicability which have been referenced in other Codex standards (Revision of General Principles of Food Hygiene, Codex Standard for the Labelling of Prepackaged Foods);

(f) technological developments or economic considerations e.g. provisions concerning styles, packaging media or other factors related to composition and essential quality criteria and consequential changes in labelling provisions;

(g) modifications of standards being proposed following an examination of government notifications of acceptances and specified deviations by the Secretariat as required in accordance with the Procedure for the Elaboration of Codex standards i.e. "Subsequent Procedure concerning Publication and Acceptance of Codex Standards", page 19.

2. The "Guide to the Procedure for the Revision and Amendment of Codex Standards" (see page 21) covers sufficiently amendments to Codex standards which have been elaborated by still active Codex Committees and those mentioned under paragraph 1 (g) above. In the case of amendments proposed to Codex standards elaborated by Codex Committees which have adjourned sine die, the procedure places an obligation on the Commission to "determine how best to deal with the proposed amendment". In order to facilitate consideration of such amendments, in particular, those of the type mentioned in para. 1 (a), (b), (c), (d), (e) and (f), the Commission has established more detailed guidance within the existing procedure for the amendment and revision of Codex standards.

3. In the case where Codex committees have adjourned sine die:

(a) the Secretariat keeps under review all Codex standards originating from Codex Committees adjourned sine die and to determine the need for any amendments arising from decisions of the Commission, in particular amendments of the type mentioned in para. 1(a), (b), (c), (d) and those of (e) if of an editorial nature. If a need to amend the standard appears appropriate then the Secretariat should prepare a text for adoption in the Commission;

(b) amendments of the type in para (f) and those of (e) of a substantive nature, the Secretariat in cooperation with the national secretariat of the adjourned Committee and, if possible, the Chairperson of that Committee, should agree on the need for such an amendment and prepare a working paper containing the wording of a proposed amendment and the reasons for proposing such amendment, and request comments from Member Governments: (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 Member Governments 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 with a request to approve the amendment of the standard concerned. 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.

GENERAL PRINCIPLES OF THE CODEX ALIMENTARIUS

PURPOSE OF THE CODEX ALIMENTARIUS

1. The Codex Alimentarius is a collection of internationally adopted food standards presented in a uniform manner. These food standards aim at protecting consumers' health and ensuring fair practices in the food trade. The Codex Alimentarius also includes provisions of an advisory nature in the form of codes of practice, guidelines and other recommended measures intended to assist in achieving the purposes of the Codex Alimentarius. 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, pesticide residues, contaminants, labelling and presentation, methods of analysis and sampling. It also includes provisions of an advisory nature in the form of codes of practice, guidelines and other recommended measures.

NATURE OF CODEX STANDARDS

3. Codex standards contain requirements for food aimed at ensuring for the consumer a sound, 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 criteria listed therein.

ACCEPTANCE OF CODEX COMMODITY STANDARDS

4.A. A Codex standard may be accepted by a country in accordance with its established legal and administrative procedures in respect of distribution of the product concerned, whether imported or home produced, within its territorial jurisdiction in the following ways:

(i) Full acceptance

(a) Full acceptance means that the country concerned will ensure that a product to which the standard applies will be permitted to be distributed freely, in accordance with (c) below, within its territorial jurisdiction under the name and description laid down in the standard, provided that it complies with all the relevant requirements of the standard.

(b) The country will also ensure that products not complying with the standard will not be permitted to be distributed under the name and description laid down in the standard.

(c) The distribution of any sound products conforming with the standard will not be hindered by any legal or administrative provisions in the country concerned relating to the health of the consumer or to other food standard matters except for considerations of human, plant or animal health which are not specifically dealt with in the standard.

(ii) Acceptance with specified deviations

Acceptance with specified deviations means that the country concerned gives acceptance, as defined in paragraph 4.A(i), to the standard with the exception of such deviations as are specified in detail in its declaration of acceptance; it being understood that a product complying with the standard as qualified by these deviations will be permitted to be distributed freely within the territorial jurisdiction of the country concerned. The country concerned will further include in its declaration of acceptance a statement of the reasons for these deviations, and also indicate:

(a) whether products fully conforming to the standard may be distributed freely within its territorial jurisdiction in accordance with paragraph 4.A(i);

(b) whether it expects to be able to give full acceptance to the standard and, if so, when.

(iii) Free distribution

A declaration of free distribution means that the country concerned undertakes that products conforming with a Codex commodity standard may be distributed freely within its territorial jurisdiction insofar as matters covered by the Codex commodity standard are concerned.

B. A country which considers that it cannot accept the standard in any of the ways mentioned above should indicate:

(i) whether products conforming to the standard may be distributed freely within its territorial jurisdiction;

(ii) in what ways its present or proposed requirements differ from the standard, and, if possible the reasons for these differences.

C. (i) A country which accepts a Codex standard according to one of the provisions of 4.A is responsible for the uniform and impartial application of the provisions of the standard as accepted, in respect of all home-produced and imported products distributed within its territorial jurisdiction. In addition, the country should be prepared to offer advice and guidance to exporters and processors of products for export to promote understanding of and compliance with the requirements of importing countries which have accepted a Codex standard according to one of the provisions of 4.A.

(ii) Where, in an importing country, a product claimed to be in compliance with a Codex standard is found not to be in compliance with that standard, whether in respect of the label accompanying the product or otherwise, the importing country should inform the competent authorities in the exporting country of all the relevant facts and in particular the details of the origin of the product in question (name and address of the exporter), if it is thought that a person in the exporting country is responsible for such non-compliance.

ACCEPTANCE OF CODEX GENERAL STANDARDS

5.A. A Codex general standard may be accepted by a country in accordance with its established legal and administrative procedures in respect of the distribution of products to which the general standard applies, whether imported or home-produced, within its territorial jurisdiction in the following ways:

(i) Full acceptance

Full acceptance of a general standard means that the country concerned will ensure, within its territorial jurisdiction, that a product to which the general standard applies will comply with all the relevant requirements of the general standard except as otherwise provided in a Codex commodity standard. It also means that the distribution of any sound products conforming with the standard will not be hindered by any legal or administrative provisions in the country concerned, which relate to the health of the consumer or to other food standard matters and which are covered by the requirements of the general standard.

(ii) Acceptance with specified deviations

Acceptance with specified deviations means that the country concerned gives acceptance, as defined in paragraph 5.A(i), to the general standard with the exception of such deviations as are specified in detail in its declaration of acceptance. The country concerned will further include in its declaration of acceptance a statement of the reasons for these deviations, and also indicate whether it expects to be able to give full acceptance to the general standard and, if so, when.

(iii) Free distribution

A declaration of free distribution means that the country concerned undertakes that products conforming with the relevant requirements of a Codex general standard may be distributed freely within its territorial jurisdiction insofar as matters covered by the Codex general standard are concerned.

B. A country which considers that it cannot accept the general standard in any of the ways mentioned above should indicate in what ways its present or proposed requirements differ from the general standard, and if possible, the reasons for these differences.

C. (i) A country which accepts a general standard according to one of the provisions of paragraph 5.A is responsible for the uniform and impartial application of the provisions of the standard as accepted, in respect of all home produced and imported products distributed within its territorial jurisdiction. In addition, the country should be prepared to offer advice and guidance to exporters and processors of products for export to promote understanding of and compliance with the requirements of importing countries which have accepted a general standard according to one of the provisions of paragraph 5.A.

(ii) Where, in an importing country, a product claimed to be in compliance with a general standard is found not to be in compliance with that standard, whether in respect of the label accompanying the product or otherwise, the importing country should inform the competent authorities in the exporting country of all the relevant facts and in particular the details of the origin of the product in question (name and address of the exporter), if it is thought that a person in the exporting country is responsible for such non-compliance.

ACCEPTANCE OF CODEX MAXIMUM LIMITS FOR RESIDUES OF PESTICIDES AND VETERINARY DRUGS IN FOOD

6.A. A Codex maximum limit for residues of pesticides or veterinary drugs in food may be accepted by a country in accordance with its established legal and administrative procedures in respect of the distribution within its territorial jurisdiction of (a) home-produced and imported food or (b) imported food only, to which the Codex maximum limit applies in the ways set forth below. In addition, where a Codex maximum limit applies to a group of foods not individually named, a country accepting such Codex maximum limit in respect of other than the group of foods, shall specify the foods in respect of which the Codex maximum limit is accepted.

(i) Full acceptance

Full acceptance of a Codex maximum limit for residues of pesticides or veterinary drugs in food means that the country concerned will ensure, within its territorial jurisdiction, that a food, whether home-produced or imported, to which the Codex maximum limit applies, will comply with that limit. It also means that the distribution of a food conforming with the Codex maximum limit will not be hindered by any legal or administrative provisions in the country concerned which relate to matters covered by the Codex maximum limit.

(ii) Free distribution

A declaration of free distribution means that the country concerned undertakes that products conforming with the Codex maximum limit for residues of pesticides or veterinary drugs in food may be distributed freely within its territorial jurisdiction insofar as matters covered by the Codex maximum limit are concerned.

B. A country which considers that it cannot accept the Codex maximum limit for residues of pesticides or veterinary drugs in foods in any of the ways mentioned above should indicate in what ways its present or proposed requirements differ from the Codex maximum limit and, if possible, the reasons for these differences.

C. A country which accepts a Codex maximum limit for residues of pesticides or veterinary drugs in food according to one of the provisions of paragraph 6.A should be prepared to offer advice and guidance to exporters and processors of food for export to promote understanding of and compliance with the requirements of importing countries which have accepted a Codex maximum limit according to one of the provisions of paragraph 6.A.

D. Where, in an importing country, a food claimed to be in compliance with a Codex maximum limit is found not to be in compliance with the Codex maximum limit, the importing country should inform the competent authorities in the exporting country of all the relevant facts and, in particular, the details of the origin of the food in question (name and address of the exporter), if it is thought that a person in the exporting country is responsible for such non-compliance.

WITHDRAWAL OR AMENDMENT OF ACCEPTANCE

7. The withdrawal or amendment of acceptance of a Codex standard or a Codex maximum limit for residues of pesticides or veterinary drugs in food by a country shall be notified in writing to the Codex Alimentarius Commission's Secretariat who will inform all Member States and Associate Members of FAO and WHO of the notification and its date of receipt. The country concerned should provide the information required under paragraphs 4.A(iii), 5.A(iii), 4.B, 5.B or 6.B above, whichever is appropriate. It should also give as long a notice of the withdrawal or amendment as is practicable.

REVISION OF CODEX STANDARDS

8. 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 using the same procedures as followed for the elaboration of a new standard. 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.

GUIDELINES FOR THE ACCEPTANCE PROCEDURE FOR CODEX STANDARDS

THE IMPORTANCE OF A RESPONSE TO EVERY NOTIFICATION

1. The Codex Alimentarius is the record of Codex Standards and of acceptances or other notifications by Member Countries or international organizations to which competence in the matter has been transferred by their Member States. It is revised regularly to take account of the issue of new or amended standards and the receipt of notifications. It is important that governments respond to every issue of new or amended standards. Governments should aim at giving formal acceptance to the standards. If acceptance or free circulation cannot be given unconditionally, the deviations or conditions, and the reasons, can be included in the response. Early and regular responses will ensure that the Codex Alimentarius can be kept up to date so as to serve as an indispensable reference for governments and international traders.

2. Governments should ensure that the information in the Codex Alimentarius reflects the up to date position. When changing national laws or practices the need for a notification to the Codex Secretariat should always be kept in mind.

3. The Codex procedure for elaboration of standards enables governments to participate at all stages. Governments should be able to make an early response to the issue of a Codex standard and should do their utmost to be ready to do so.

THE CODEX ALIMENTARIUS: NOT A SUBSTITUTE FOR, OR ALTERNATIVE TO, REFERRING TO NATIONAL LEGISLATION

4. Every country's laws and administrative procedures contain provisions which it is essential to understand and comply with. It is usually the practice to take steps to obtain copies of relevant legislation and/or to obtain professional advice about compliance. The Codex Alimentarius is a comparative record of the substantive similarities and differences between Codex Standards and corresponding national legislation. The Codex Standard will not normally deal with general matters of human, plant or animal health or with trade marks. The language which is required on labels will be a matter for national legislation and so will import licences and other administrative procedures.

5. The responses by governments should show clearly which provisions of the Codex Standard are identical to, similar to or different from, the related national requirements. General statements that national laws must be complied with should be avoided or accompanied by details of national provisions which require attention. Judgement will sometimes be required where the national law is in a different form or where it has different provisions.

OBLIGATIONS UNDER THE ACCEPTANCE PROCEDURE

6. The obligations which a country undertakes under the acceptance procedure are included in paragraph 4 of the General Principles. Paragraph 4.A(i)(a) provides for free distribution of conforming products, 4.A(i)(b) with the need to ensure that products which do not conform may not be distributed "under the name and description laid down". Paragraph 4.A(i)(c) is a general requirement not to hinder the distribution of sound products, except for matters relating to human, plant or animal health, not specifically dealt with in the standard. Similar provisions are included in Acceptance with Specified Deviations.

7. The essential difference between acceptances and notifications of free distribution is that a country which accepts, undertakes to enforce the Codex standard and to accept all the obligations set out in the General Principles subject to any specified deviations.

8. The Codex Committee on General Principles (CCGP) and the Commission (CAC) have reviewed the acceptance procedure and notifications by governments on a number of occasions. While recognizing that difficulties can arise from time to time in reconciling the obligations of the acceptance procedure with the laws and administrative procedures of a Member Country, the CCGP and the CAC have determined that the obligations are essential to the work and status of the CAC and that they should not be weakened in any way. The purpose of these guidelines therefore is to assist governments when they are considering how, in the light of the objectives of the acceptance procedure, to respond to Codex Standards.

THE RETURN OF THE RESPONSE

9. The principal decision which is required is whether to notify an acceptance according to one of the methods prescribed, or non acceptance as provided for in 4.B. Free distribution (4.A(iii)) does not carry with it the obligation to prevent non conforming products from being circulated, and it may be useful in cases where there is no corresponding national standard and no intention to introduce one.

THE NEED FOR AN INFORMED, RESPONSIBLE JUDGEMENT WHEN COMPARING THE CODEX STANDARD WITH NATIONAL LAWS

10. There will be some occasions when the detail in the Codex Standard is identical with national laws. Difficulties will arise however when national laws are in a different form, contain different figures or no figures at all, or in cases where there may be no standard in the country which corresponds in substance to the Codex Standard. The authority responsible for notifying the response to the CAC is urged to do its best to overcome any such difficulties by the exercise of its best endeavours and to respond, after such consultations as may be appropriate with the national organizations. The grounds on which the judgement has been based can be made clear in the notification. It may well be that they will not be such as to justify an acceptance, because of the obligations to stop the distribution of non conforming products, but a statement of free circulation should be possible on the basis of the facts and practices of each case. If there was a court decision or change in the law or practice subsequently, an amending response should be made.

PRESUMPTIVE STANDARDS

11. A presumptive standard is one which is assumed to be the standard in the absence of any other. (A presumption in law is the assumption of the truth of anything until the contrary is proved.) Some countries have said that a Codex MRL is the presumptive limit for a pesticide residue. Countries may be able and willing to regard a Codex Standard as the presumptive standard in cases where there is no corresponding standard, code of practice or other accepted expression of the "nature, substance or quality" of the food. A country need not apply the presumption to all the provisions of the standard if the details of its additives, contaminants, hygiene or labelling rules are different from those in the standard. In such a case the provisions in the Codex Standard defining the description, essential composition and quality factors relating to the specified name and description could still be the presumptive standard for those matters.

12. The justification for regarding the Codex Standard as a presumptive standard is the fact that it is the minimum standard for a food elaborated in the CAC "so as to ensure a sound, wholesome product free from adulteration, correctly labelled and presented". (General Principles, Paragraph 3.) The word minimum does not have any pejorative connotations: it simply means the level of quality and soundness of a product judged by consensus to be appropriate for trade internationally and nationally.

13. Whether a presumptive standard would merit an acceptance would depend on whether the country concerned could say that non conforming products could not be distributed under the same name and description laid down in the standard. However it would enable a declaration of free circulation to be made and countries are asked to give the idea serious consideration.

FORMAT AND CONTENT OF CODEX STANDARDS

SCOPE

14. This section, together with the name of the standard and the name and description laid down in the labelling section, should be examined in order to assess whether the obligations of the acceptance procedure can properly be accepted.

DESCRIPTION, ESSENTIAL COMPOSITION AND QUALITY FACTORS

15. These sections will define the minimum standard for the food. They will be the most difficult to address unless by chance the details are virtually identical (i.e. ignoring significant matters of editorial expression or format). However, a country which has taken part in the elaboration of the standard either by attending the meetings or by sending comments under the Step Procedure has, no doubt, consulted national organizations on the extent to which the draft provisions in the standard would be acceptable nationally. This factual information needs to be turned into a formal response when the standard is sent out for acceptance. Countries are asked to do their best to exercise an informal judgement on lines discussed in Paragraph 7 above. Some of the quality criteria e.g. allowances for defects may represent good manufacturing practice or be left to trade contracts. This will have to be taken into account. A free distribution response ought to be possible in most cases.

FOOD ADDITIVES

16. The food additives included in the standard have been assessed and cleared by JECFA. The Commodity Committee and the CCFAC have assessed technological need and safety in use. If national laws are different, all the detailed differences should be reported. It should be borne in mind, however, that the aim of international food standardization work is to harmonize policies and attitudes as much as possible. Therefore every effort should be made to keep deviations to the minimum.

CONTAMINANTS

17. If national limits apply they should be quoted if not the same as those laid down in the Codex Standard. Where general laws about safety, health or nature of the food apply, the limits quoted in the standard could properly be regarded as representing those which are unavoidable in practice and within safety limits.

HYGIENE AND WEIGHTS AND MEASURES

18. If national requirements are different they should be reported.

LABELLING

19. The General Standard for the Labelling of Prepackaged Foods represents the international consensus on information to be included on the labels of all foods.

20. Governments are exhorted to use the General Standard as a basis for their national legislation and to keep differences to an absolute minimum especially those of detail or minutiae. Governments should observe the footnote to the Scope section and should ensure that all compulsory provisions relating to presentation of information which are additional to, and different from, those in the standard should be notified. Any other compulsory provisions in national legislation should also be notified if they are not provided for in the Codex standard. The labelling provisions in Codex standards include sections of the revised General Standard by reference. When accepting a Codex commodity standard, a country which has already accepted and responded to the General Standard can then refer to the terms of that acceptance in any subsequent responses. As much specific information as is relevant and helpful should be given. In particular, this should include the name and description relating to the food, the interpretation of any special requirements relating to the law or custom of the country, any additional details about presentation of the mandatory information and detailed differences if any in the labelling requirements e.g. in relation to class names, declaration of added water, declaration of origin. It will be assumed that the language(s) in which the particulars should be given will be as indicated by national legislation or custom.

METHODS OF ANALYSIS AND SAMPLING

21. The obligations which a country assumes in accepting the following Codex Defining Methods of Analysis included in Codex standards are as follows^[7]:

(a) Codex Defining Methods of Analysis (Type I) are subject to acceptance by governments just as are the provisions which they define and which form part of Codex standards.

"Full acceptance" of a Codex Defining Method means the acceptance that the value provided for in a Codex standard is defined by means of the Codex method. In determining compliance with the value in the Codex standard, governments undertake to use the Codex Defining Method, especially in cases of disputes involving the results of analysis.

"Non acceptance" of Codex Defining Method or acceptance of Codex standards with substantive deviations in the Codex Defining Methods means acceptance of the Codex standard with specified deviation.

(b) The "acceptance" of Codex standards containing Codex Reference Methods of Analysis (Type II) means the recognition that Codex Reference Methods are methods the reliability of which has been demonstrated on the basis of internationally acceptable criteria. They are, therefore, obligatory for use, i.e. subject to acceptance by governments, in disputes involving the results of analysis. "Non acceptance" of the Codex Reference Method or acceptance of Codex standards with substantive deviations in the Codex Reference Methods for use in disputes involving methods of analysis, should be taken to mean acceptance of the Codex standard with specified deviation.

(c) The "acceptance" of Codex standards containing Codex Alternative Approved Methods of Analysis (Type III) means the recognition that Codex Alternative Approved Methods are methods the reliability of which has been demonstrated in terms of internationally acceptable criteria. They are recommended for use in food control, inspection or for regulatory purposes.

"Non acceptance" of a Codex Alternative Approved Method does not constitute a deviation from the Codex standard.

(d) Since the reliability of the Tentative Methods (Type IV) has not yet been endorsed by the Codex Committee on Methods of Analysis and Sampling on the basis of the internationally accepted criteria, it follows that they cannot be regarded as final Codex methods. Type IV methods may, eventually become Type I, II or III methods with the resultant implications regarding the acceptance of Codex methods. Type IV methods are, therefore, not recommended as Codex methods until their reliability has been recognized by the CCMAS. They may be included in draft Codex standards or in Codex standards provided their non approved status is clearly indicated.

SUMMARY

22. Governments are urged to respond to every issue of Codex standards. The inclusion of responses in the Codex Alimentarius will enable the CAC and Member Governments to address the question of closer approximation of international and national requirements. Governments are urged to take the Codex standard fully into consideration when changing their national laws. The Codex Alimentarius will always be an invaluable reference for governments and for international traders although national legislation must always be consulted and complied with.

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.

Contaminant means any substance not intentionally added to food, which is present in such food 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 as a result of environmental contamination. The term does not include insect fragments, rodent hairs and other extraneous matter.

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.

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.

Codex maximum limit for pesticide residues (MRLP) 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.

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.

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 (MRLVD) is the maximum concentration of residue resulting from the use of a veterinary drug (expressed in mg/kg or ìg/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.

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 (GPVD) is the official recommended or authorized usage including withdrawal periods, approved by national authorities, of veterinary drugs under practical conditions.

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.

Traceability/Product Tracing: the ability to follow the movement of a food through specified stage(s) of production, processing and distribution.

DEFINITIONS OF RISK ANALYSIS TERMS RELATED TO FOOD SAFETY

Hazard: A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.

Risk: A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.

Risk Analysis: A process consisting of three components: risk assessment, risk management and risk communication.

Risk Assessment: A scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization.

Risk Management: The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.

Risk Communication: The interactive exchange of information and opinions throughout the risk analysis process concerning risk, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions.

Risk Assessment Policy: Documented guidelines on the choice of options and associated judgements for their application at appropriate decision points in the risk assessment such that the scientific integrity of the process is maintained.

Risk Profile: The description of the food safety problem and its context.

Risk Characterization: The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment.

Risk Estimate: The quantitative estimation of risk resulting from risk characterization.

Hazard Identification: The identification of biological, chemical, and physical agents capable of causing adverse health effects and which may be present in a particular food or group of foods.

Hazard Characterization: The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food. For chemical agents, a dose-response assessment should be performed. For biological or physical agents, a dose-response assessment should be performed if the data are obtainable.

Dose-Response Assessment: The determination of the relationship between the magnitude of exposure (dose) to a chemical, biological or physical agent and the severity and/or frequency of associated adverse health effects (response).

Exposure Assessment: The qualitative and/or quantitative evaluation of the likely intake of biological, chemical, and physical agents via food as well as exposures from other sources if relevant.

Food Safety Objective (FSO): The maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the appropriate level of protection (ALOP).

Performance Criterion (PC): The effect in frequency and/or concentration of a hazard in a food that must be achieved by the application of one or more control measures to provide or contribute to a PO or an FSO.

Performance Objective (PO): The maximum frequency and/or concentration of a hazard in a food at a specified step in the food chain before the time of consumption that provides or contributes to an FSO or ALOP, as applicable.