SECTION II

GUIDELINES FOR CODEX COMMITTEES AND AD HOC INTERGOVERNMENTAL TASK FORCES

GUIDELINES TO HOST GOVERNMENTS OF CODEX COMMITTEES AND AD HOC INTERGOVERNMENTAL TASK FORCES

INTRODUCTION

By virtue of Article 7 of the Statutes of the Codex Alimentarius Commission and Rule X.1(b) of its Rules of Procedure, the Commission has established a number of Codex Committees and ad hoc Intergovernmental Task Forces to prepare standards in accordance with the Procedure for the Elaboration of Codex Standards and Coordinating Committees to exercise general coordination of its work in specific regions or groups of countries. The Rules of Procedure of the Commission shall apply, mutatis mutandis, to Codex Committees, Coordinating Committees and ad hoc Intergovernmental Task Forces. The Guidelines applying to Codex Committees, as described in this Section, apply also to Coordinating Committees and to Codex ad hoc Intergovernmental Task Forces.

COMPOSITION OF CODEX COMMITTEES

MEMBERSHIP

Membership of Codex Committees is open to Members of the Commission who have notified the Director-General of FAO or WHO of their desire to be considered as members thereof or to selected members designated by the Commission. Membership of Regional Coordinating Committees is open only to Members of the Commission belonging to the region or group of countries concerned.

OBSERVERS

Any other Member of the Commission or any Member or Associate Member of FAO or WHO which has not become a Member of the Commission may participate as an observer at any Codex Committee if it has notified the Director-General of FAO or WHO of its wish to do so. Such countries may participate fully in the discussions of the Committee and shall be provided with the same opportunities as other Members to express their point of view (including the submission of memoranda), but without the right to vote or to move motions either of substance or of procedure. International organizations which have formal relations with either FAO or WHO should also be invited to attend in an observer capacity sessions of those Codex Committees which are of interest to them.

ORGANIZATION AND DUTIES

CHAIRPERSON

The Codex Alimentarius Commission will designate a member country of the Commission, which has indicated its willingness to accept financial and all other responsibility, as having responsibility for appointing a chairperson of the Committee. The member country concerned is responsible for appointing the chairperson of the Committee from among its own nationals. Should this person for any reason be unable to take the chair, the member country concerned shall designate another person to perform the functions of the chairperson for as long as the chairperson is unable to do so. A Committee may appoint at any session one or more rapporteurs from among the delegates present.

SECRETARIAT

A member country to which a Codex Committee has been assigned is responsible for providing all conference services including the secretariat. The secretariat should have adequate administrative support staff able to work easily in the languages used at the session and should have at its disposal adequate word processing and document reproducing equipment. Interpretation, preferably simultaneous, should be provided from and into all languages used at the session, and if the report of the session is to be adopted in more than one of the working languages of the Committee, then the services of a translator should be available. The Committee secretariat and the Joint FAO/WHO (Codex) Secretariat are charged with the preparation of the draft report in consultation with the rapporteurs, if any.

DUTIES AND TERMS OF REFERENCE

The duties of a Codex Committee shall include:

(a) the drawing up of a list of priorities as appropriate, among the subjects and products within its terms of reference,

(b) consideration of the types of safety and quality elements (or recommendations) to be covered, whether in standards for general application or in reference to specific food products,

(c) consideration of the types of product to be covered by standards, e.g., whether materials for further processing into food should be covered,

(d) preparation of draft Codex standards within its terms of reference,

(e) reporting to each session of the Commission on the progress of its work and, where necessary, on any difficulties caused by its terms of reference, together with suggestions for their amendment.

(f) the review and, as necessary, revision of existing standards and related texts on a scheduled, periodic basis to ensure that the standards and related texts within its terms of reference are consistent with current scientific knowledge and other relevant information.

SESSIONS

DATE AND PLACE

A member country to which a Codex Committee has been assigned is consulted by the Directors-general of FAO and WHO before they determine when and where a session of this Committee shall be convened.

The member country should consider arrangements for holding Codex sessions in developing countries.

INVITATIONS AND PROVISIONAL AGENDA

Sessions of Codex Committees and Coordinating Committees will be convened by the Directors-General of FAO and WHO in consultation with the chairperson of the respective Codex Committee. The letter of invitation and provisional agenda shall be prepared by the Secretary, Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme, FAO, Rome, in consultation with the chairperson of the Committee for issue by the Directors-General to all Members and Associate Members of FAO and WHO or, in the case of Coordinating Committees, to the countries of the region or group of countries concerned, Codex Contact Points and interested international organizations in accordance with the official mailing lists of FAO and WHO. Chairpersons should, before finalizing the drafts, inform and consult with the national Codex Contact Point where one has been established, and, if necessary, obtain clearance from the national authorities concerned (Ministry of Foreign Affairs, Ministry of Agriculture, Ministry of Health, or as the case may be). The invitation and Provisional Agenda will be translated and distributed by FAO/WHO in the working languages of the Commission at least four months before the date of the meeting.

Invitations should include the following:

(a) title of the Codex Committee,

(b) time and date of opening and date of closing of the session,

(c) place of the session,

(d) languages to be used and arrangements for interpretation, i.e., whether simultaneous or not,

(e) if appropriate, information on hotel accommodation,

(f) request for the names of the chief delegate and other members of the delegation, and for information on whether the chief delegate of a government will be attending as a representative or in the capacity of an observer.

Replies to invitations will normally be requested to be sent to reach the chairperson as early as possible and in any case not less than 30 days before the session. A copy should be sent also to the Secretary, Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme, FAO, Rome. It is of the utmost importance that by the date requested a reply to invitations should be sent by all those governments and international organizations which intend to participate. The reply should specify the number of copies and the language of the documents required.

The Provisional Agenda should state the time, date and place of the meeting and should include the following items:

(a) adoption of the agenda,

(b) if considered necessary, election of rapporteurs,

(c) items relating to subject matter to be discussed, including, where appropriate, the step in the Commission's Procedure for the Elaboration of Standards at which the item is being dealt with at the session. There should also be reference to the Committee papers relevant to the item,

(d) any other business,

(e) consideration of date and place of next session,

(f) adoption of draft report.

The work of the Committee and the length of the meeting should be so arranged as to leave sufficient time at the end of the session for a report of the Committee's transactions to be agreed.

ORGANIZATION OF WORK

A Codex or Coordinating Committee may assign specific tasks to countries, groups of countries or to international organizations represented at meetings of the Committee and may ask member countries and international organizations for views on specific points.

Ad hoc working groups established to accomplish specific tasks shall be disbanded once the tasks have been accomplished as determined by the Committee.

A Codex or Coordinating Committee may not set up standing sub-committees, whether open to all Members of the Commission or not, without the specific approval of the Commission.

PREPARATION AND DISTRIBUTION OF PAPERS

Papers for a session should be sent by the chairperson of the Codex Committee concerned at least two months before the opening of the session to the following:

(i) all Codex Contact Points,

(ii) chief delegates of member countries, of observer countries and of international organizations, and

(iii) other participants on the basis of replies received. Twenty copies of all papers in each of the languages used in the Committee concerned should be sent to the Secretary, Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme, FAO, Rome.

Papers for a session prepared by participants must be drafted in one of the working languages of the Commission, which should, if possible, be one of the languages used in the Codex Committee concerned. These papers should be sent to the chairperson of the Committee, with a copy to the Secretary, Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme, FAO, Rome, in good time to be included in the distribution of papers for the session.

Documents circulated at a session of a Codex Committee other than draft documents prepared at the session and ultimately issued in a final form, should subsequently receive the same distribution as other papers prepared for the Committee.

Codex Contact Points will be responsible for ensuring that papers^[8] are circulated to those concerned within their own country and for ensuring that all necessary action is taken by the date specified.

Consecutive reference numbers in suitable series should be assigned to all documents of Codex Committees. The reference number should appear at the top right-hand corner of the first page together with a statement of the language in which the document was prepared and the date of its preparation. A clear statement should be made of the provenance (origin or author country) of the paper immediately under the title. The text should be divided into numbered paragraphs. At the end of these guidelines is a series of references for Codex documents adopted by the Codex Alimentarius Commission for its own sessions and those of its subsidiary bodies.

Members of the Codex Committees should advise the Committee chairperson through their Codex Contact Point of the number of copies of documents normally required.

Working papers of Codex Committees may be circulated freely to all those assisting a delegation in preparing for the business of the Committee; they should not, however, be published. There is, however, no objection to the publication of reports of the meetings of Committees or of completed draft standards.

GUIDELINES ON THE CONDUCT OF MEETINGS OF CODEX COMMITTEES AND AD HOC INTERGOVERNMENTAL TASK FORCES

INTRODUCTION

By virtue of Article 7 of the Statutes of the Codex Alimentarius Commission and Rule X.1(b) of its Rules of Procedure, the Commission has established a number of Codex Committees and ad hoc Intergovernmental Task Forces to prepare standards in accordance with the Procedure for the Elaboration of Codex Standards and Coordinating Committees to exercise general coordination of its work in specific regions or groups of countries. The Rules of Procedure of the Commission shall apply, mutatis mutandis, to Codex Committees, Coordinating Committees and ad hoc Intergovernmental Task Forces. The Guidelines applying to the conduct of meetings of Codex Committees as described in this Section apply also to those of Coordinating Committees and to those of Codex ad hoc Intergovernmental Task Forces.

CONDUCT OF MEETINGS

Meetings of Codex and Coordinating Committees shall be held in public unless the Committee decides otherwise. Member countries responsible for Codex and Coordinating Committees shall decide who should open meetings on their behalf.

Meetings should be conducted in accordance with the Rules of Procedure of the Codex Alimentarius Commission.

Only the chief delegates of members, or of observer countries or of international organizations have the right to speak unless they authorize other members of their delegations to do so.

The representative of a regional economic integration organization shall provide the chairperson of the Committee, before the beginning of each session, with a written statement outlining where the competence lies between this organization and its members for each item, or subparts thereof, as appropriate, of the provisional agenda, pursuant to the Declaration of Competence submitted according to Rule II of the Rules of Procedure of the Codex Alimentarius Commission by this organization. In areas of shared ("mixed") competence between this organization and its members, this statement shall make clear which party has the voting right.

Delegations and delegations from observer countries who wish their opposition to a decision of the Committee to be recorded may do so, whether the decision has been taken by a vote or not, by asking for a statement of their position to be contained in the report of the Committee. This statement should not merely use a phrase such as: "The delegation of X reserved its position" but should make clear the extent of the delegation's opposition to a particular decision of the Committee and state whether they were simply opposed to the decision or wished for a further opportunity to consider the question.

REPORTS

In preparing reports, the following points shall be borne in mind:

(a) decisions should be clearly stated; action taken in regard to economic impact statements should be fully recorded; all decisions on draft standards should be accompanied by an indication of the step in the Procedure that the standards have reached;

(b) if action has to be taken before the next meeting of the Committee, the nature of the action, who is to take it and when the action must be completed should be clearly stated;

(c) where matters require attention by other Codex Committees, this should be clearly stated;

(d) if the report is of any length, summaries of points agreed and the action to be taken should be included at the end of the report, and in any case, a section should be included at the end of the report showing clearly in summary form:

- standards considered at the session and the steps they have reached;

- standards at any step of the Procedure, the consideration of which has been postponed or which are held in abeyance and the steps which they have reached;

- new standards proposed for consideration, the probable time of their consideration at Step 2 and the responsibility for drawing up the first draft.

The following appendices should be attached to the report:

(a) list of participants with full postal addresses,
(b) draft standards with an indication of the step in the Procedure which has been reached.

The Joint FAO/WHO Secretariat should ensure that, as soon as possible and in any event not later than one month after the end of the session, copies of the final report, as adopted in the languages of the Committee, are sent to all participants, and all Codex Contact Points.

DRAWING UP OF CODEX STANDARDS

A Codex Committee, in drawing up standards and related texts, should bear in mind the following:

(a) the guidance given in the General Principles of the Codex Alimentarius;

(b) that all standards and related texts should have a preface containing the following information:

- the description of the standard or related text,

- a brief description of the scope and purpose(s) of the standard or related text,

- references including the step which the standard or related text has reached in the Commission's Procedures for the Elaboration of Standards, together with the date on which the draft was approved,

- matters in the draft standard or related text requiring endorsement or action by other Codex Committees.

(c) that for standards or any related text for a product which includes a number of sub-categories, the Committee should give preference to the development of a general standard or related text with specific provisions as necessary for sub-categories.

GUIDELINES TO CHAIRPERSONS OF CODEX COMMITTEES AND AD HOC INTERGOVERNMENTAL TASK FORCES

INTRODUCTION

By virtue of Article 7 of the Statutes of the Codex Alimentarius Commission and Rule X.1(b) of its Rules of Procedure, the Commission has established a number of Codex Committees and ad hoc Intergovernmental Task Forces to prepare standards in accordance with the Procedure for the Elaboration of Codex Standards and Coordinating Committees to exercise general coordination of its work in specific regions or groups of countries. The Rules of Procedure of the Commission shall apply, mutatis mutandis, to Codex Committees, Coordinating Committees and ad hoc Intergovernmental Task Forces. The Guidelines applying to the Chairpersons of Codex Committees as described in this Section apply also to those of Coordinating Committees and to those of Codex ad hoc Intergovernmental Task Forces.

DESIGNATION

The Codex Alimentarius Commission will designate a member country of the Commission, which has indicated its willingness to accept financial and all other responsibility, as having responsibility for appointing a chairperson of the Committee. The member country concerned is responsible for appointing the chairperson of the Committee from among its own nationals. Should this person for any reason be unable to take the chair, the member country concerned shall designate another person to perform the functions of the chairperson for as long as the chairperson is unable to do so.

CRITERIA FOR THE APPOINTMENT OF CHAIRPERSONS

By virtue of Article 7 of its Statutes, the Commission may establish such subsidiary bodies as it deems necessary for the accomplishment of its task.

The Member countries who shall be designated, under Rule X.10, as responsible for appointing Chairpersons of subsidiary bodies established under Rule X.1(b)(i) and Rule X.1(b)(ii), shall retain the right to appoint a chairperson of their choice.

The following criteria may be considered during the selection of the appointee:

• to be a national of the member country responsible for appointing the chairperson of the Committee;

• to have a general knowledge in the fields of the subsidiary body concerned and to be able to understand and analyse technical issues;

• insofar as possible, to be able to serve in a continuing capacity;

• to be familiar with the system of Codex and its rules, and to have experience in the work of relevant international, governmental or non-governmental organizations;

• to be able to communicate clearly both orally and in writing in one of the working languages of the Commission;

• to have demonstrated ability in chairing meetings with objectivity and impartiality, and in facilitating consensus building;

• to exercise tact and sensitivity to issues of particular importance to members of the Commission;

• not to engage and/or not to have engaged in activities which could give rise to a conflict of interest on any item on the agenda of the Committee.

CONDUCT OF MEETINGS

The chairperson should invite observations from members of the Committee concerning the Provisional Agenda and in the light of such observations formally request the Committee to adopt the Provisional Agenda or the amended agenda.

Meetings should be conducted in accordance with the Rules of Procedure of the Codex Alimentarius Commission. Attention is particularly drawn to Rule VII.7 which reads: "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 XII of the General Rules of FAO, a copy of which will be supplied to all chairpersons of Codex and Coordinating Committees, gives full instructions on the procedures to be followed in dealing with voting, points of order, adjournment and suspension of meetings, adjournment and closure of discussions on a particular item, reconsideration of a subject already decided and the order in which amendments should be dealt with.

Chairpersons of Codex Committees should ensure that all questions are fully discussed, in particular statements concerning possible economic implications of standards under consideration at Steps 4 and 7.

Chairpersons should also ensure that the written comments, received in a timely manner, of members and observers not present at the session are considered by the Committee; that all issues are put clearly to the Committee. This can usually best be done by stating what appears to be the generally acceptable view and asking delegates whether they have any objection to its being adopted.

Chairpersons should use the statement submitted by the representatives of the regional economic integration organizations on the matters of respective competence between these organizations and their members in the conduct of meetings, including assessing of the situation with regard to the party which has the right to vote.

CONSENSUS^[9]

The chairpersons should always try to arrive at a consensus and should not ask the Committee to proceed to voting if agreement on the Committee's decision can be secured by consensus.

The Procedure for the Elaboration of Codex Standards and Related Texts allows for full discussion and exchange of views on the issue under consideration, in order to ensure the transparency of the process and arrive at compromises that would facilitate consensus.

Much of the responsibility for facilitating the achievement of consensus would lie in the hands of the Chairpersons.

When working out the means of progressing the work of a Committee, the chairperson should consider:

(a) the need for timely progress in developing standards;

(b) the need to achieve consensus among the members as to the content of, and justification for, proposed standards;

(c) the importance of achieving consensus at all stages of the elaboration of standards and that draft standards should, as a matter of principle, be submitted to the Commission for adoption only where consensus has been achieved at the technical level.

The chairperson should also consider implementing the following measures in order to facilitate consensus building in the elaboration of standards at the Committee stage:

(a) ensuring that: (i) the scientific basis is well established on current data including, wherever possible, scientific data and intake and exposure information from the developing countries; (ii) where data from developing countries are not available, an explicit request for collecting and making available such data is made; and (iii) where necessary, further studies are carried out in order to clarify controversial issues;

(b) ensuring that issues are thoroughly discussed at meetings of the Committees concerned;

(c) organizing informal meetings of the parties concerned where disagreements arise, provided that the objectives of any such meetings are clearly defined by the Committee concerned and that participation is open to all interested delegations and observers in order to preserve transparency;

(d) requesting the Commission, where possible, for a redefinition of the scope of the subject matter being considered for the elaboration of standards in order to cut out issues on which consensus cannot be reached;

(e) ensuring that matters are not progressed from step to step until all relevant concerns are taken into account and adequate compromises worked out^[10];

(f) facilitating increased involvement and participation of developing countries.

PRINCIPLES CONCERNING THE PARTICIPATION OF INTERNATIONAL NON-GOVERNMENTAL ORGANIZATIONS IN THE WORK OF THE CODEX ALIMENTARIUS COMMISSION

1. PURPOSE

The purpose of collaboration with International Non-Governmental Organizations is to secure for the Codex Alimentarius Commission, expert information, advice and assistance from international non-governmental organizations and to enable organizations which represent important sections of public opinion and are authorities in their fields of professional and technical competence to express the views of their members and to play an appropriate role in ensuring the harmonizing of intersectoral interests among the various sectoral bodies concerned in a country, regional or global setting.

Arrangements made with such organizations shall be designed to advance the purposes of the Codex Alimentarius Commission by securing maximum cooperation from International Non-Governmental Organizations in the execution of its programme.

2. TYPES OF RELATIONSHIP

Only one category of relationship shall be recognized, namely "Observer Status"; all other contacts, including working relations, shall be considered to be of an informal character.

3. ORGANIZATIONS ELIGIBLE FOR "OBSERVER STATUS"

The following shall be eligible for Observer Status:

• International Non-Governmental Organizations in consultative status, specialized consultative status or liaison status with FAO;

• International Non-Governmental Organizations having official relations with WHO; and

• International Non-Governmental Organizations that:

  (a) are international in structure and scope of activity, and representative of the specialized field of interest in which they operate;

  (b) are concerned with matters covering a part or all of the Commission's field of activity;

  (c) have aims and purposes in conformity with the Statutes of the Codex Alimentarius Commission; and

  (d) have a permanent directing body, authorized representatives and systematic procedures and machinery for communicating with its membership in various countries. Its members shall exercise voting rights in relation to its policies or action or shall have other appropriate mechanisms to express their views.

4. PROCEDURE FOR OBTAINING "OBSERVER STATUS"

4.1 INTERNATIONAL NON-GOVERNMENTAL ORGANIZATIONS HAVING STATUS OR OFFICIAL RELATIONS WITH FAO AND WHO

"Observer status" shall be accorded to those International Non-Governmental Organizations in consultative status, specialized consultative status or liaison status with FAO or International Non-Governmental Organizations having official relations with WHO that inform the Secretary of the Codex Alimentarius Commission of their desire to participate in the work of the Commission and/or any or all of the Commission's subsidiary bodies^[11] on a regular basis. They may also request invitations to participate at specific sessions of the Commission or its subsidiary bodies on an ad hoc basis.

4.2 NON-GOVERNMENTAL ORGANIZATIONS NOT HAVING STATUS OR OFFICIAL RELATIONS WITH FAO AND WHO

Before any form of formal relationship is established with a Non-Governmental Organization, such Organization shall supply the Secretary of the Commission with the information outlined in the Annex to these Procedures. The Secretary shall transmit this information to the Directors-General of FAO and WHO.

Upon confirmation that the Directors-General are satisfied that the applicant Organization is in a position to make a significant contribution in advancing the purposes of the Codex Alimentarius Commission, Observer Status shall be granted to the applicant Organization.

Observer Status at specific meetings will not normally be granted to individual organizations that are members of a larger organization authorized and that intends to represent them at these meetings.

5. PRIVILEGES AND OBLIGATIONS

International Non-governmental Organizations in Observer status shall have the following privileges and obligations:

5.1 PRIVILEGES OF INTERNATIONAL NON-GOVERNMENTAL ORGANIZATIONS IN "OBSERVER STATUS"

An Organization in Observer Status:

(a) shall be entitled to send an observer (without the right to vote) to sessions of the Commission, who may be accompanied by advisers; to receive from the Secretary of the Commission, in advance of the session, all working documents and discussion papers; to circulate to the Commission its views in writing, without abridgement; and to participate in discussions when invited by the Chairperson^[12];

(b) shall be entitled to send an observer (without the right to vote) to sessions of specified Subsidiary Bodies, who may be accompanied by advisers; to receive from the Secretaries of the Subsidiary Bodies, in advance of the session, all working documents and discussion papers; to circulate to these Bodies its views in writing, without abridgement; and to participate in discussions when invited by the Chairperson^[13];

(c) may be invited by the Directors-General to participate in meetings or seminars on subjects organized under the Joint FAO/WHO Food Standards Programme which fall within its fields of interest, and if it does not so participate it may submit its views in writing to any such meeting or seminar;

(d) will receive documentation and information about meetings planned on subjects agreed upon with the Secretariat;

(e) may submit, under the authority of its governing body, written statements on matters before the Commission, in one of the languages of Commission, to the Secretary, who may communicate them to the Commission or the Executive Committee as appropriate.

5.2 OBLIGATIONS OF INTERNATIONAL NON-GOVERNMENTAL ORGANIZATIONS IN "OBSERVER STATUS"

An Organization in Observer Status shall undertake:

(a) to cooperate fully with the Codex Alimentarius Commission for the furtherance of the objectives of the Joint FAO/WHO Food Standards Programme;

(b) in cooperation with the Secretariat, to determine the ways and means of co-ordinating activities within the scope of the Joint FAO/WHO Food Standards Programme, with a view to avoiding duplication and overlapping;

(c) to contribute, as far as possible, and at the request of the Directors-General, to the promotion of a better knowledge and understanding of the Codex Alimentarius Commission and the Joint FAO/WHO Food Standards Programme through appropriate discussions or other forms of publicity;

(d) to send to the Secretary of the Commission on an exchange basis, its reports and publications concerned with matters covering all or part of the Commission's field of activity;

(e) to keep the Secretary of the Commission informed of changes in its structure and membership, as well as of important changes in its secretariat.

6. REVIEW OF "OBSERVER STATUS"

The Directors-General may terminate arrangements for Observer Status which are no longer considered necessary or appropriate in the light of changing programmes or other circumstances, and will report such action to the Commission. However, the international non-governmental organization concerned may appeal the termination of Observer Status.

An international non-governmental organization in Observer Status which has not shown any interest and has not attended any meetings during a period of four years may be deemed not to have sufficient interest to warrant the continuance of such relationship.

The Secretary shall report to the Codex Alimentarius Commission on the relations between the Codex Alimentarius Commission and international non-governmental organizations established in accordance with the present Procedures and shall provide a list of organizations granted Observer Status, with an indication of the membership that they represent.

The Commission shall periodically review these principles and procedures and shall consider, as necessary, any amendments which may seem desirable.

ANNEX: INFORMATION REQUIRED OF NON-GOVERNMENTAL ORGANIZATIONS REQUESTING "OBSERVER STATUS"

(a) Official name of the organization in different languages (with initials)

(b) Full postal address, Telephone, Telex address, Facsimile and Email as appropriate

(c) Aims and subject fields (mandate) of organization, and methods of operation. (Enclose charter, constitution, by-laws, rules of procedures, etc.)

(d) Member organizations (name and address of each national affiliate, method of affiliation, giving number of members where possible, and names of principal officers. If the organization has individual members, please indicate approximate number in each country)

(e) Structure (assembly or conference; council or other form of governing body; type of general secretariat; commissions on special topics, if any; etc.)

(f) Indication of source of funding (e.g., membership contributions, direct funding, external contributions, or grants)

(g) Meetings (indicate frequency and average attendance; send report of previous meeting, including any resolutions passed) that are concerned with matters covering all or part of the Commission's field of activity

(h) Relations with other international organizations:

- UN and organs (indicate consultative status or other relationship, if any)
- Other international organizations

(i) Expected contribution to the Joint FAO/WHO Food Standards Programme

(j) Past activities on behalf of, or in relation to, the Codex Alimentarius Commission and the Joint FAO/WHO Food Standards Programme (indicate any relationship by national affiliates with the Regional Coordinating Committees and/or the National Codex Contact Points or Committees)

(k) Area of activity in which participation as an observer is requested (Commission and/or Subsidiary Bodies). If more than one organization with similar interests is requesting observer status in any field of activity, such organizations will be encouraged to form themselves into a federation or association for the purpose of participation. If the formation of such a single organization is not feasible, the application should explain why this is so.

(l) Language (English, French or Spanish)in which documentation should be sent to the international non-governmental organizations

(m) Name, Function and address of the person providing the information

(n) Signature and date

CRITERIA FOR THE ESTABLISHMENT OF WORK PRIORITIES

When a Codex Committee proposes to elaborate a standard, code of practice or related text within its terms of reference, it should first consider the priorities established by the Commission in the Medium-Term Plan of Work, any specific relevant strategic project currently being undertaken by the Commission and the prospect of completing the work within a reasonable period of time. It should also assess the proposal against the criteria set out below.

If the proposal falls in an area outside the Committee's terms of reference the proposal should be reported to the Commission in writing together with proposals for such amendments to the Committee's terms of reference as may be required.

CRITERIA

Criteria applicable to general subjects

(a) Consumer protection from the point of view of health and fraudulent practices.

(b) Diversification of national legislations and apparent resultant or potential impediments to international trade.

(c) Scope of work and establishment of priorities between the various sections of the work.

(d) Work already undertaken by other international organizations in this field.

Criteria applicable to commodities

(a) Consumer protection from the point of view of health and fraudulent practices.

(b) Volume of production and consumption in individual countries and volume and pattern of trade between countries.

(c) Diversification of national legislations and apparent resultant or potential impediments to international trade.

(d) International or regional market potential.

(e) Amenability of the commodity to standardization.

(f) Coverage of the main consumer protection and trade issues by existing or proposed general standards.

(g) Number of commodities which would need separate standards indicating whether raw, semi processed or processed.

(h) Work already undertaken by other international organizations in this field.

CRITERIA FOR THE ESTABLISHMENT OF SUBSIDIARY BODIES OF THE CODEX ALIMENTARIUS COMMISSION

When there is a proposal for the elaboration of a standard, code of practice or related text in an area not covered by the terms of reference of any existing subsidiary body^[14], or the revision of standards, codes of practice or other texts elaborated by subsidiary bodies adjourned sine die, such a proposal should be accompanied by a written statement to the Commission explaining its justification in light of the Commission's Medium-Term Objectives and containing, as far as practicable, the information contained in the Criteria for the Establishment of Work Priorities.

Should the Commission decide to establish a Subsidiary Body for the purpose of elaborating an appropriate draft standard or related text or for the purpose of revising an existing standard(s) or related text(s), first consideration should be given to the establishment of an ad hoc Intergovernmental Task Force under Rule IX.1(b)(i) of the Commission's Rules of Procedure under the following conditions:

1. TERMS OF REFERENCE:

• the terms of reference of the proposed ad hoc Intergovernmental Task Force shall be limited to the immediate task at hand and normally shall not be subsequently modified;

• the terms of reference shall clearly state the objective(s) to be achieved by the establishment of the ad hoc Intergovernmental Task Force;

• the terms of reference shall clearly state either (i) the number of sessions to be convened, or (ii) the date (year) by which the work is expected to be completed, which in any case shall not exceed five years.

2. REPORTING:

The ad hoc Intergovernmental Task Force shall report to the Codex Alimentarius Commission and to the Executive Committee on the progress of its work. The reports of the ad hoc Intergovernmental Task Force shall be transmitted to all Members of the Commission and interested international organization.

3. OPERATING EXPENSES:

No provision shall be made concerning the operating expenditures of the ad hoc Intergovernmental Task Force in the estimate of expenditures of the Joint FAO/WHO Food Standards Programme, except insofar as costs involved in preparatory work are recognized as operating expenses of the Commission in accordance with Article 10 of its Statutes.

4. HOST GOVERNMENT ARRANGEMENTS:

The Commission, at the time of the establishment of the ad hoc Intergovernmental Task Force shall ascertain that there will be appropriate host government arrangements adequate to ensure the functioning of the Task Force for the duration of its assignment.^[15]

5. WORKING PROCEDURES:

Ad hoc Intergovernmental Task Forces shall be open to all Members of the Commission and the Rules of Procedure of the Codex Alimentarius Commission and the Uniform Procedure for the Elaboration of Codex Standards and Related Texts shall apply mutatis mutandis to ad hoc Intergovernmental Task Forces.

6. DISSOLUTION:

The ad hoc Intergovernmental Task Force shall be dissolved after the specified work has been completed or when the number of sessions or the time limit allocated for the work has expired.

GUIDELINES FOR THE INCLUSION OF SPECIFIC PROVISIONS IN CODEX STANDARDS AND RELATED TEXTS

GUIDELINES ON THE ELABORATION AND/OR REVISION OF CODES OF HYGIENIC PRACTICE FOR SPECIFIC COMMODITIES

The establishment of additional food hygiene requirements for specific food items or food groups should be limited to the extent necessary to meet the defined objectives of individual codes.

Codex Codes of Hygienic Practice should serve the primary purpose of providing advice to governments on the application of food hygiene provisions within the framework of national and international requirements.

The Revised Recommended International Code of Practice - General Principles of Food Hygiene (including the Guidelines for the Application of the Hazard Analysis Critical Control Point (HACCP) System) and the Revised Principles for the Establishment and Application of Microbiological Criteria for Foods are the base documents in the field of food hygiene.

All Codex Codes of Hygienic Practice applicable to specific food items or food groups shall refer to the General Principles of Food Hygiene and shall only contain material additional to the General Principles which is necessary to take into account the particular requirements of the specific food item or food group.

Provisions in Codex Codes of Hygienic Practice should be drafted in a sufficiently clear and transparent manner such that extended explanatory material is not required for their interpretation.

The above considerations should also apply to Codex Codes of Practice which contain provisions relating to food hygiene.

PRINCIPLES FOR THE ESTABLISHMENT OF CODEX METHODS OF ANALYSIS

PURPOSE OF CODEX METHODS OF ANALYSIS

The methods are primarily intended as international methods for the verification of provisions in Codex standards. They should be used for reference, in calibration of methods in use or introduced for routine examination and control purposes.

METHODS OF ANALYSIS

Definition of types of methods of analysis

(a) Defining Methods (Type I)

Definition: A method which determines a value that can only be arrived at in terms of the method per se and serves by definition as the only method for establishing the accepted value of the item measured.

Examples: Howard Mould Count, Reichert-Meissl value, loss on drying, salt in brine by density.

(b) Reference Methods (Type II)

Definition: A Type II method is the one designated Reference Method where Type I methods do not apply. It should be selected from Type III methods (as defined below). It should be recommended for use in cases of dispute and for calibration purposes.

Example: Potentiometric method for halides.

(c) Alternative Approved Methods (Type III)

Definition: A Type III Method is one which meets the criteria required by the Codex Committee on Methods of Analysis and Sampling for methods that may be used for control, inspection or regulatory purposes.

Example: Volhard Method or Mohr Method for chlorides

(d) Tentative Method (Type IV)

Definition: A Type IV Method is a method which has been used traditionally or else has been recently introduced but for which the criteria required for acceptance by the Codex Committee on Methods of Analysis and Sampling have not yet been determined.

Examples: chlorine by X-ray fluorescence, estimation of synthetic colours in foods.

General Criteria for the Selection of Methods of Analysis

(a) Official methods of analysis elaborated by international organizations occupying themselves with a food or group of foods should be preferred.

(b) Preference should be given to methods of analysis the reliability of which have been established in respect of the following criteria, selected as appropriate:

(i) specificity

(ii) accuracy

(iii) precision; repeatability intra-laboratory (within laboratory), reproducibility inter-laboratory (within laboratory and between laboratories)

(iv) limit of detection

(v) sensitivity

(vi) practicability and applicability under normal laboratory conditions

(vii) other criteria which may be selected as required.

(c) The method selected should be chosen on the basis of practicability and preference should be given to methods which have applicability for routine use.

(d) All proposed methods of analysis must have direct pertinence to the Codex Standard to which they are directed.

(e) Methods of analysis which are applicable uniformly to various groups of commodities should be given preference over methods which apply only to individual commodities.

General Criteria for the Selection of Methods of Analysis using the Criteria Approach

In the case of Codex Type II and Type III methods, method criteria may be identified and values quantified for incorporation into the appropriate Codex commodity standard. Method criteria which are developed will include the criteria in section Methods of Analysis, paragraph (c) above together with other appropriate criteria, e.g., recovery factors."

General Criteria for the Selection of Single-Laboratory Validated Methods of Analysis

Inter-laboratory validated methods are not always available or applicable, especially in the case of multi-analyte/multi substrate methods and new analytes. The criteria to be used to select a method are included in the General Criteria for the Selection of Methods of Analysis. In addition the single-laboratory validated methods must fulfill the following criteria:

i. the method is validated according to an internationally recognized protocol (e.g. those referenced in the harmonized IUPAC Guidelines for Single-Laboratory Validation of Methods of Analysis)

ii. the use of the method is embedded in a quality system in compliance with the ISO/IEC 17025: 1999 Standard or Principles of Good Laboratory Practice;

The method should be complemented with information on accuracy demonstrated for instance with:

- regular participation in proficiency schemes, where available;
- calibration using certified reference materials, where applicable;
- recovery studies performed at the expected concentration of the analytes;
- verification of result with other validated method where available

WORKING INSTRUCTIONS FOR THE IMPLEMENTATION OF THE CRITERIA APPROACH IN CODEX

Any Codex Commodity Committee may continue to propose an appropriate method of analysis for determining the chemical entity, or develop a set of criteria to which a method used for the determination must comply. In some cases a Codex Commodity Committee may find it easier to recommend a specific method and request the Codex Committee on Methods of Analysis and Sampling (CCMAS) to "convert" that method into appropriate criteria. The Criteria will then be considered by the CCMAS for endorsement and will, after the endorsement, form part of the commodity standard replacing the recommended method of analysis. If a Codex Commodity Committee wishes to develop the criteria by itself rather than allowing the CCMAS to do so, it should follow instructions given for the development of specific criteria as outlined below. These criteria must be approved for the determination in question.

However, the primary responsibility for supplying methods of analysis and criteria resides with the Commodity Committee. If the Commodity Committee fails to provide a method of analysis or criteria despite numerous requests, then the CCMAS may supply an appropriate method and "convert" that method into appropriate criteria.

The minimum "approved" Codex analytical characteristics will include the following numeric criteria as well as the general criteria for methods laid down in the Analytical Terminology for Codex Use (see page ##):

• precision (within and between laboratories, but generated from collaborative trial data rather than measurement uncertainty considerations)

• recovery

• selectivity (interference effects etc.)

• applicability (matrix, concentration range and preference given to 'general' methods)

• detection/determination limits if appropriate for the determination being considered

• linearity

CCMAS will generate the data corresponding to the above criteria.

CONVERSION OF SPECIFIC METHODS OF ANALYSIS TO METHOD CRITERIA BY THE CCMAS

When a Codex Commodity Committee submits a Type II or Type III method to CCMAS for endorsement, it should also submit information on the criteria listed below to enable the CCMAS to convert it into suitable generalized analytical characteristics:

• accuracy

• applicability (matrix, concentration range and preference given to 'general' methods)

• detection limit

• determination limit

• precision; repeatability intra-laboratory (within laboratory), reproducibility inter-laboratory (within laboratory and between laboratories), but generated from collaborative trial data rather than measurement uncertainty considerations

• recovery

• selectivity

• sensitivity

• linearity

These terms are defined in the Analytical Terminology for Codex Use (see page 83), as are other terms of importance.

The CCMAS will assess the actual analytical performance of the method which has been determined in its validation. This will take account of the appropriate precision characteristics obtained in collaborative trials which may have been carried out on the method together with results from other development work carried out during the course of the method development. The set of criteria that are developed will form part of the report of the CCMAS and will be inserted in the appropriate Codex Commodity Standard.

In addition, the CCMAS will identify numeric values for the criteria for which it would wish such methods to comply.

ASSESSMENT OF THE ACCEPTABILITY OF THE PRECISION CHARACTERISTICS OF A METHOD OF ANALYSIS

The calculated repeatability and reproducibility values can be compared with existing methods and a comparison made. If these are satisfactory then the method can be used as a validated method. If there is no method with which to compare the precision parameters then theoretical repeatability and reproducibility values can be calculated from the Horwitz equation. (M. Thompson, Analyst, 2000, 125, 385-386).

ANALYTICAL TERMINOLOGY FOR CODEX USE

Result: The final value reported for a measured or computed quantity, after performing a measuring procedure including all sub-procedures and evaluations.

Notes:

When a result is given, it should be made clear whether it refers to:

• the indication [signal];

• the uncorrected result;

• the corrected result; and

• whether several values were averaged.

A complete statement of the result of a measurement includes information about the uncertainty of measurement.

Selectivity: Selectivity is the extent to which a method can determine particular analyte(s) in mixtures or matrices without interferences from other components of similar behaviour.

Selectivity is the recommended term in analytical chemistry to express the extent to which a particular method can determine analyte(s) in the presence of interferences from other components. Selectivity can be graded. The use of the term specificity for the same concept is to be discouraged as this often leads to confusion.

Accuracy: The closeness of agreement between a test result and the accepted reference value.

Note:

The term accuracy, when applied to a set of test results, involves a combination of random components and a common systematic error or bias component.

Trueness: The closeness of agreement between the average value obtained from a series of test results and an accepted reference value.

Notes:

1 The measure of trueness is usually expressed in terms of bias.
2 Trueness has been referred to as "accuracy of the mean". This usage is not recommended.

Bias: The difference between the expectation of the test results and an accepted reference value.

Notes:

Bias is the total systematic error as contrasted to random error. There may be one or more systematic error components contributing to bias. A larger systematic difference from the accepted reference value is reflected by a larger bias value.

When the systematic error component(s) must be arrived at by a process that includes random error, the random error component is increased by propagation of error considerations and reduced by replication.

Precision: The closeness of agreement between independent test results obtained under stipulated conditions.

Notes:

Precision depends only on the distribution of random errors and does not relate to the true value or to the specified value.

The measure of precision is usually expressed in terms of imprecision and computed as a standard deviation of the test results. Less precision is reflected by a larger standard deviation.

"Independent test results" means results obtained in a manner not influenced by any previous result on the same or similar test object. Quantitative measures of precision depend critically on the stipulated conditions. Repeatability and reproducibility conditions are particular sets of extreme conditions.

Repeatability [Reproducibility]: Precision under repeatability [reproducibility] conditions.

Repeatability conditions: Conditions where independent test results are obtained with the same method on identical test items in the same laboratory by the same operator using the same equipment within short intervals of time.

Reproducibility conditions: Conditions where test results are obtained with the same method on identical test items in different laboratories with different operators using different equipment.

Notes:

When different methods give test results that do not differ significantly, or when different methods are permitted by the design of the experiment, as in a proficiency study or a material-certification study for the establishment of a consensus value of a reference material, the term "reproducibility" may be applied to the resulting parameters. The conditions must be explicitly stated.

Repeatability [Reproducibility] standard deviation: The standard deviation of test results obtained under repeatability [reproducibility] conditions.

Notes:

Repeatability [Reproducibility] standard deviation is a measure of the dispersion of the distribution of test results under repeatability [reproducibility] conditions.

Similarly "repeatability [reproducibility] variance" and "repeatability [reproducibility] coefficient of variation" could be defined and used as measures of the dispersion of test results under repeatability [reproducibility] conditions.

Repeatability [Reproducibility] limit: The value less than or equal to which the absolute difference between two test results obtained under repeatability [reproducibility] conditions may be expected to be with a probability of 95%.

Notes:

The symbol used is r [R].

When examining two single test results obtained under repeatability [reproducibility] conditions, the comparison should be made with the repeatability [reproducibility] limit r [R] = 2.8 sr[sR].

When groups of measurements are used as the basis for the calculation of the repeatability [reproducibility] limits (now called the critical difference), more complicated formulae are required that are given in ISO 5725-6:1994, 4.2.1 and 4.2.2.

Interlaboratory Study: A study in which several laboratories measure a quantity in one or more "identical" portions of homogeneous, stable materials under documented conditions, the results of which are compiled into a single document.

Notes:

The larger the number of participating laboratories, the greater the confidence that can be placed in the resulting estimates of the statistical parameters. The IUPAC-1987 protocol (Pure & Appl. Chem., 66, 1903-1911(1994)) requires a minimum of eight laboratories for method-performance studies.

Method-Performance Study: An interlaboratory study in which all laboratories follow the same written protocol and use the same test method to measure a quantity in sets of identical test samples. The reported results are used to estimate the performance characteristics of the method. Usually these characteristics are within-laboratory and among-laboratories precision, and when necessary and possible, other pertinent characteristics such as systematic error, recovery, internal quality control parameters, sensitivity, limit of determination, and applicability.

Notes:

The materials used in such a study of analytical quantities are usually representative of materials to be analyzed in actual practice with respect to matrices, amount of test component (concentration), and interfering components and effects. Usually the analyst is not aware of the actual composition of the test samples but is aware of the matrix.

The number of laboratories, number of test samples, number of determinations, and other details of the study are specified in the study protocol. Part of the study protocol is the procedure which provides the written directions for performing the analysis.

The main distinguishing feature of this type of study is the necessity to follow the same written protocol and test method exactly.

Several methods may be compared using the same test materials. If all laboratories use the same set of directions for each method and if the statistical analysis is conducted separately for each method, the study is a set of method-performance studies. Such a study may also be designated as a method-comparison study.

Laboratory-Performance (Proficiency) Study: An interlaboratory study that consists of one or more measurements by a group of laboratories on one or more homogeneous, stable, test samples by the method selected or used by each laboratory. The reported results are compared with those from other laboratories or with the known or assigned reference value, usually with the objective of improving laboratory performance.

Notes:

Laboratory-performance studies can be used to support accreditation of laboratories or to audit performance. If a study is conducted by an organization with some type of management control over the participating laboratories - organizational, accreditation, regulatory, or contractual - the method may be specified or the selection may be limited to a list of approved or equivalent methods. In such situations, a single test sample is insufficient to judge performance.

A laboratory-performance study may be used to select a method of analysis that will be used in a method-performance study. If all laboratories, or a sufficiently large subgroup, of laboratories, use the same method, the study may also be interpreted as a method-performance study, provided that the test samples cover the range of concentration of the analyte.

Laboratories of a single organization with independent facilities, instruments, and calibration materials, are treated as different laboratories.

Material-Certification Study: An interlaboratory study that assigns a reference value ("true value") to a quantity (concentration or property) in the test material, usually with a stated uncertainty.

Note:

A material-certification study often utilizes selected reference laboratories to analyze a candidate reference material by a method(s) judged most likely to provide the least-biased estimates of concentration (or of a characteristic property) and the smallest associated uncertainty.

Applicability: The analytes, matrices, and concentrations for which a method of analysis may be used satisfactorily to determine compliance with a Codex standard.

Note:

In addition to a statement of the range of capability of satisfactory performance for each factor, the statement of applicability (scope) may also include warnings as to known interference by other analytes, or inapplicability to certain matrices and situations.

Sensitivity: Change in the response divided by the corresponding change in the concentration of a standard (calibration) curve; i.e., the slope, s_i, of the analytical calibration curve.

Note:

This term has been used for several other analytical applications, often referring to capability of detection, to the concentration giving 1% absorption in atomic absorption spectroscopy, and to ratio of found positives to known, true positives in immunological and microbiological tests. Such applications to analytical chemistry should be discouraged.

A method is said to be sensitive if a small change in concentration, c, or quantity, q, causes a large change in the measure, x; that is, when the derivative dx/dc or dx/dq is large.

Although the signal may vary with the magnitude of c_i or q_i, the slope, s_i, is usually constant over a reasonable range of concentrations. s_i may also be a function of the c or q of other analytes present in the sample.

Ruggedness: The ability of a chemical measurement process to resist changes in results when subjected to minor changes in environmental and procedural variables, laboratories, personnel, etc.

TERMS TO BE USED IN THE CRITERIA APPROACH

Detection Limit: The detection limit is conventionally defined as field blank + 3ó, where is the standard deviation of the field blank value signal (IUPAC definition).

However, an alternative definition which overcomes most of the objections to the above approach (i.e. the high variability at the limit of measurement can never be overcome) is to base it on the rounded value of the reproducibility relative standard deviation when it goes out of control (where 3 s_R = 100%; s_R = 33%, rounded to 50% because of the high variability). Such a value is directly related to the analyte and to the measurement system and is not based on the local measurement system.

Determination limit: As for detection limit except that 6 or 10 is required rather than 3.

However, an alternative definition that corresponds to that proposed for the detection limit is to use s_R = 25%. This value does not differ much from that assigned to the detection limit because the upper limit of the detection limit merges indistinguishably into the lower limit of the determination limit.

Recovery: Proportion of the amount of analyte present or added to the test material which is extracted and presented for measurement.

Selectivity: Selectivity is the extent to which a method can determine particular analyte(s) in mixtures or matrices without interferences from other components of similar behaviour.

Selectivity is the recommended term in analytical chemistry to express the extent to which a particular method can determine analyte(s) in the presence of interferences from other components. Selectivity can be graded. The use of the term specificity for the same concept is to be discouraged as this often leads to confusion.

Linearity: The ability of a method of analysis, within a certain range, to provide an instrumental response or results proportional to the quality of analyte to be determined in the laboratory sample. This proportionality is expressed by an a priori defined mathematical expression. The linearity limits are the experimental limits of concentrations between which a linear calibration model can be applied with a known confidence level (generally taken to be equal to 1%).

PRINCIPLES FOR THE ESTABLISHMENT OR SELECTION OF CODEX SAMPLING PROCEDURES

PURPOSE OF CODEX METHODS OF SAMPLING

Codex Methods of Sampling are designed to ensure that fair and valid sampling procedures are used when food is being tested for compliance with a particular Codex commodity standard. The sampling methods are intended for use as international methods designed to avoid or remove difficulties which may be created by diverging legal, administrative and technical approaches to sampling and by diverging interpretation of results of analysis in relation to lots or consignments of foods, in the light of the relevant provision(s) of the applicable Codex standard.

METHODS OF SAMPLING

Types of Sampling Plans and Procedures

(a) Sampling Plans for Commodity Defects:

These are normally applied to visual defects (e.g. loss of colour, mis-graded for size, etc.) and extraneous matter. They will normally be attributes plans, and plans such as those included in the FAO/WHO Codex Alimentarius Sampling Plans for Prepackaged Foods (AQL 6.5)^[16] may be applied.

(b) Sampling Plans for Net Contents:

These are sampling plans which apply to pre-packaged foods generally and are intended to serve to check compliance of lots or consignments with provisions for net contents.

(c) Sampling Plans for Compositional Criteria:

Such plans are normally applied to analytically determined compositional criteria (e.g., loss on drying in white sugar, etc.). They are predominantly based on variable procedures with unknown standard deviation.

(d) Specific Sampling Plans for Health-related Properties:

Such plans are generally applied to heterogeneous conditions, e.g., in the assessment of microbiological spoilage, microbial by-products or sporadically occurring chemical contaminants.

General Instructions for the Selection of Methods of Sampling

(a) Official methods of sampling as elaborated by international organizations occupying themselves with a food or a group of foods are preferred. Such methods, when attracted to Codex standards, may be revised using Codex recommended sampling terms (to be elaborated).

(b) The appropriate Codex Commodity Committee should indicate, before it elaborates any sampling plan, or before any plan is endorsed by the Codex Committee on Methods of Analysis and Sampling, the following:

(i) the basis on which the criteria in the Codex Commodity standards have been drawn up (e.g. whether on the basis that every item in a lot, or a specified high proportion, shall comply with the provision in the standard or whether the average of a set of samples extracted from a lot must comply and, if so, whether a minimum or maximum tolerance, as appropriate, is to be given);

(ii) whether there is to be any differentiation in the relative importance of the criteria in the standards and, if so, what is the appropriate statistical parameter each criterion should attract, and hence, the basis for judgement when a lot is in conformity with a standard.

(c) Instructions on the procedure for the taking of samples should indicate the following:

(i) the measures necessary in order to ensure that the sample taken is representative of the consignment or of the lot;

(ii) the size and the number of individual items forming the sample taken from the lot or consignment;

(iii) the administrative measures for taking and handling the sample.

(d) The sampling protocol may include the following information:

(i) the statistical criteria to be used for acceptance or rejection of the lot on the basis of the sample;

(ii) the procedures to be adopted in cases of dispute.

GENERAL CONSIDERATIONS

(a) The Codex Committee on Methods of Analysis and Sampling should maintain closest possible relations with all interested organizations working on methods of analysis and sampling.

(b) The Codex Committee on Methods of Analysis and Sampling should organize its work in such a manner as to keep under constant review all methods of analysis and sampling published in the Codex Alimentarius.

(c) In the Codex methods of analysis, provision should be made for variations in reagent concentrations and specifications from country to country.

(d) Codex methods of analysis which have been derived from scientific journals, theses, or publications, either not readily available or available in languages other than the official languages of FAO and WHO, or which for other reasons should be printed in the Codex Alimentarius in extenso, should follow the standard layout for methods of analysis as adopted by the Codex Committee on Methods of Analysis and Sampling.

(e) Methods of analysis which have already been printed as official methods of analysis in other available publications and which are adopted as Codex methods need only be quoted by reference in the Codex Alimentarius.

UNIFORM SYSTEM OF REFERENCES FOR CODEX DOCUMENTS

In referencing Codex documents, the Document Reference given in the table below appear first, followed by the year in which the session will be held, the session number, and finally the consecutive number of the document.

For example, documents prepared for the 20^th session of the Codex Committee on General Principles meeting in 2004, are identified by the series CX/GP 04/20/1, 2, 3 etc.

Prior to 2003, most documents are identified by the Document Reference, year, and series number only (except for the Executive Committee).

FORMAT FOR CODEX COMMODITY STANDARDS

INTRODUCTION

The Format is also intended for use as a guide by the subsidiary bodies of the Codex Alimentarius Commission in presenting their standards, with the object of achieving, as far as possible, a uniform presentation of commodity standards. The Format also indicates the statements which should be included in standards as appropriate under the relevant headings of the standard. The sections of the Format require to be completed in a standard only insofar as such provisions are appropriate to an international standard for the food in question.

NAME OF THE STANDARD
SCOPE
DESCRIPTION
ESSENTIAL COMPOSITION AND QUALITY FACTORS
FOOD ADDITIVES
CONTAMINANTS
HYGIENE
WEIGHTS AND MEASURES
LABELLING
METHODS OF ANALYSIS AND SAMPLING

NOTES ON THE HEADINGS

NAME OF THE STANDARD

The name of the standard should be clear and as concise as possible. It should usually be the common name by which the food covered by the standard is known or, if more than one food is dealt with in the standard, by a generic name covering them all. If a fully informative title should be inordinately long, a subtitle could be added.

SCOPE

This section should contain a clear, concise statement as to the food or foods to which the standard is applicable unless this is self-explanatory in the name of the standard. In the case of a general standard covering more than one specific product, it should be made clear as to which specific products the standard applies.

DESCRIPTION

This section should contain a definition of the product or products with an indication, where appropriate, of the raw materials from which it is derived and any necessary references to processes of manufacture. It may also include references to types and styles of product and to type of pack. There may also be additional definitions when these are required to clarify the meaning of the standard.

ESSENTIAL COMPOSITION AND QUALITY FACTORS

This section should contain all quantitative and other requirements as to composition including, where necessary, identity characteristics, provisions on packing media and requirements as to compulsory and optional ingredients. It should also include quality factors which are essential for the designation, definition or composition of the product concerned. Such factors could include the quality of the raw material, with the object of protecting the health of the consumer, provisions on taste, odour, colour and texture which may be apprehended by the senses, and basic quality criteria for the finished products, with the object of preventing fraud. This section may refer to tolerances for defects, such as blemishes or imperfect material, but this information should be contained in an appendix to the standard or in another advisory text.

FOOD ADDITIVES

This section should contain the names of the additives permitted and, where appropriate, the maximum amount permitted in the food. It should be prepared in accordance with guidance given on page 65 and may take the following form:

"The following provisions in respect of food additives and their specifications as contained in section........ of the Codex Alimentarius are subject to endorsement [have been endorsed] by the Codex Committee on Food Additives and Contaminants."

Then should follow a tabulation, viz.:

"Name of additive, maximum level (in percentage or mg/kg)."

CONTAMINANTS

Pesticide Residues:

This section should include, by reference, any levels for pesticide residues that have been established by the Codex Alimentarius Commission for the product concerned. ^[17]

Other Contaminants:

In addition, this section should contain the names of other contaminants and where appropriate the maximum level permitted in the food, and the text to appear in the standard may take the following form:

"The following provisions in respect of contaminants, other than pesticide residues, are subject to endorsement [have been endorsed] by the Codex Committee on Food Additives and Contaminants."

Then should follow a tabulation, viz.:

"Name of contaminant, maximum level (in percentage or mg/kg)."

HYGIENE

Any specific mandatory hygiene provisions considered necessary should be included in this section. They should be prepared in accordance with the guidance given on page 66. Reference should also be made to applicable codes of hygienic practice. Any parts of such codes, including in particular any end-product specifications, should be set out in the standard, if it is considered necessary that they should be made mandatory. The following statement should also appear:

"The following provisions in respect of the food hygiene of this product are subject to endorsement [have been endorsed] by the Codex Committee on Food Hygiene."

WEIGHTS AND MEASURES

This section should include all provisions, other than labelling provisions, relating to weights and measures, e.g. where appropriate, fill of container, weight, measure or count of units determined by an appropriate method of sampling and analysis. Weights and measures should be expressed in S.I. units. In the case of standards which include provisions for the sale of products in standardized amounts, e.g. multiples of 100 grams, S.I. units should be used, but this would not preclude additional statements in the standards of these standardized amounts in approximately similar amounts in other systems of weights and measures.

LABELLING

This section should include all the labelling provisions contained in the standard and should be prepared in accordance with the guidance given on page 64. Provisions should be included by reference to the General Standard for the Labelling of Prepackaged Foods. The section may also contain provisions which are exemptions from, additions to, or which are necessary for the interpretation of the General Standard in respect of the product concerned provided that these can be justified fully. The following statement should also appear:

"The following provisions in respect of the labelling of this product are subject to endorsement [have been endorsed] by the Codex Committee on Food Labelling."

METHODS OF ANALYSIS AND SAMPLING

This section should include, either specifically or by reference, all methods of analysis and sampling considered necessary and should be prepared in accordance with the guidance given on page 66. If two or more methods have been proved to be equivalent by the Codex Committee on Methods of Analysis and Sampling, these could be regarded as alternative and included in this section either specifically or by reference. The following statement should also appear:

"The methods of analysis and sampling described hereunder are to be endorsed [have been endorsed] by the Codex Committee on Methods of Analysis and Sampling." ^[18]

RELATIONS BETWEEN COMMODITY COMMITTEES AND GENERAL COMMITTEES

Codex Committees may ask the advice and guidance of committees having responsibility for matters applicable to all foods on any points coming within their province.

The Codex Committees on Food Labelling; Food Additives and Contaminants; Methods of Analysis and Sampling; Food Hygiene; Nutrition and Foods for Special Dietary Uses; and Food Import and Export Inspection and Certification Systems may establish general provisions on matters within their terms of reference. These provisions should only be incorporated into Codex Commodity Standards by reference unless there is a need for doing otherwise.

Codex Commodity standards shall contain sections on hygiene, labelling and methods of analysis and sampling and these sections should contain all of the relevant provisions of the standard. Provisions of Codex General Standards, Codes or Guidelines shall only be incorporated into Codex Commodity Standards by reference unless there is a need for doing otherwise. Where Codex Committees are of the opinion that the general provisions are not applicable to one or more commodity standards, they may request the responsible Committees to endorse deviations from the general provisions of the Codex Alimentarius. Such requests should be fully justified and supported by available scientific evidence and other relevant information. Sections on hygiene, labelling, and methods of analysis and sampling which contain specific provisions or provisions supplementing the Codex General Standards, Codes or Guidelines shall be referred to the responsible Codex Committees at the most suitable time during Steps 3, 4 and 5 of the Procedure for the Elaboration of Codex Standards and Related Texts, though such reference should not be allowed to delay the progress of the standard to the subsequent steps of the Procedure.

Subject and commodity Committees should refer to the principles and guidelines developed by the Codex Committee on Food Import and Export Inspection and Certification Systems when developing provisions and/or recommendations on inspection and certification and make any appropriate amendments to the standards, guidelines and codes within the responsibility of the individual committees at the earliest convenient time.

FOOD LABELLING

The provisions on food labelling should be included by reference to the Codex General Standard for the Labelling of Prepackaged Foods (CODEX STAN 1-1985). Exemptions from, or additions to, the General Standard which are necessary for its interpretation in respect of the product concerned should be justified fully, and should be restricted as much as possible.

Information specified in each draft standard should normally be limited to the following: a statement that the product shall be labelled in accordance with the Codex General Standard for the Labelling of Prepackaged Foods (CODEX STAN 1-1985) the specified name of the food date marking and storage instructions (only if the exemption foreseen in Section 4.7.1 of the General Standard is applied)

Where the scope of the Codex Standard is not limited to prepackaged foods, a provision for labelling of non retail containers may be included.

In such cases the provision may specify that:

"Information on...^[19] shall be given either on the container or in accompanying documents, except that the name of the product, lot identification, and the name and address of the manufacturer or packer shall appear on the container.^[20]

However, lot identification, and the name and address of the manufacturer or packer may be replaced by an identification mark provided that such a mark is clearly identifiable with the accompanying documents."

In respect of date marking (Section 4.7 of the General Standard), a Codex Committee may, in exceptional circumstances, determine another date or dates as defined in the General Standard, either to replace or to accompany the date of minimum durability, or alternatively decide that no date marking is necessary. In such cases, a full justification for the proposed action should be submitted to the Codex Committee on Food Labelling.

FOOD ADDITIVES AND CONTAMINANTS

Codex commodity committees should prepare a section on food additives in each draft commodity standard and this section should contain all the provisions in the standard relating to food additives. The section should include the names of those additives which are considered to be technologically necessary or which are widely permitted for use in the food within maximum levels where appropriate.

All provisions in respect of food additives (including processing aids) and contaminants contained in Codex commodity standards should be referred to the Codex Committee on Food Additives and Contaminants preferably after the Standards have been advanced to Step 5 of the Procedure for the Elaboration of Codex Standards or before they are considered by the Commodity Committee concerned at Step 7, though such reference should not be allowed to delay the progress of the Standard to the subsequent Steps of the Procedure.

All provisions in respect of food additives will require to be endorsed by the Codex Committee on Food Additives and Contaminants, on the basis of technological justification submitted by the commodity committees and of the recommendations of the Joint FAO/WHO Expert Committee on Food Additives concerning the safety-in-use (acceptable daily intake (ADI) and other restrictions) and an estimate of the potential and, where possible, the actual intake of the food additives, ensuring conformity with the General Principles for the Use of Food Additives.

In preparing working papers for the Codex Committee on Food Additives, the Secretariat should make a report to the Committee concerning the endorsement of provisions for food additives (including processing aids), on the basis of the General Principles for the Use of Food Additives. Provisions for food additives should indicate the International Numbering System (INS) number, the ADI, technological justification, proposed level, and whether the additive was previously endorsed (or temporarily endorsed).

When commodity standards are sent to governments for comment at Step 3, they should contain a statement that the provisions "in respect of food additives and contaminants are subject to endorsement by the Codex Committee on Food Additives and Contaminants and to incorporation into the General Standard for Food Additives or the General Standard for Contaminants and Toxins in Foods."

When establishing provisions for food additives, Codex committees should follow the General Principles for the Use of Food Additives and the Preamble of the General Standard for Food Additives. Full explanation should be provided for any departure from the above recommendations.

When an active commodity committee exists, proposals for the use of additives in any commodity standard under consideration should be prepared by the committee concerned, and forwarded to the Codex Committee on Food Additives and Contaminants for endorsement. When the Codex Committee on Food Additives and Contaminants decides not to endorse specific additives provisions (use of the additive, or level in the end-product), the reason should be clearly stated. The section under consideration should be referred back to the Committee concerned if further information is needed, or for information if the Codex Committee on Food Additives and Contaminants decides to amend the provision.

When no active commodity committee exists, proposals for new additive provisions or amendment of existing provisions, should be forwarded directly by member countries to the Codex Committee on Food Additives and Contaminants.

Good Manufacturing Practice means that:

• the quantity of the additive added to food does not exceed the amount reasonably required to accomplish its intended physical nutritional or other technical effect in food;

• the quantity of the additive that becomes a component of food as a result of its use in the manufacturing, processing or packaging of a food and which is not intended to accomplish any physical, or other technological effect in the food itself, is reduced to the extent reasonably possible;

• the additive is of appropriate food grade quality and is prepared and handled in the same way as a food ingredient. Food grade quality is achieved by compliance with the specifications as a whole and not merely with individual criteria in terms of safety.

FOOD HYGIENE

Commodity Committees should use in the commodity standards the following text:

• It is recommended that the products covered by the provisions of this standard be prepared and handled in accordance with the appropriate sections of the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969, Rev 4-2003), and other relevant Codex texts such as Codes of Hygienic Practice and Codes of Practice.

• The products should comply with any microbiological criteria established in accordance with the Principles for the Establishment and Application of Microbiological Criteria for Foods (CAC/GL 21-1997).

METHODS OF ANALYSIS AND SAMPLING

NORMAL PRACTICE

Except for methods of analysis and sampling associated with microbiological criteria, when Codex committees have included provisions on methods of analysis or sampling in a Codex commodity standard, these should be referred to the Codex Committee on Methods of Analysis and Sampling at Step 4, to ensure Government comments at the earliest possible stage in the development of the standard. A Codex Committee should, whenever possible, provide to the Codex Committee on Methods of Analysis and Sampling information, for each individual analytical method proposed, relating to specificity, accuracy, precision (repeatability, reproducibility) limit of detection, sensitivity, applicability and practicability, as appropriate. Similarly a Codex Committee should, whenever possible, provide to the Codex Committee on Methods of Analysis and Sampling information for each sampling plan relating to the scope or field of application, the type of sampling (e.g. bulk or unit), sample sizes, decision rules, details of plans (e.g. "Operating characteristic" curves), inferences to be made to lots or processes, levels of risk to be accepted and pertinent supportive data.

Other criteria may be selected as required. Methods of analysis should be proposed by the Commodity Committees in consultation if necessary with an expert body.

At Step 4 Codex Commodity Committees should discuss and report to the Codex Committee on Methods of Analysis and Sampling on matters connected with:

• Provisions in Codex standards which require analytical or statistical procedure;

• Provisions for which elaboration of specific methods of analysis or sampling are required;

• Provisions which are defined by the use of Defining Methods (Type I);

• All proposals to the extent possible should be supported by appropriate documentation; especially for Tentative Methods (Type IV);

• Any request for advice or assistance.

The Codex Committee on Methods of Analysis and Sampling should undertake a coordinating role in matters relating to the elaboration of Codex methods of analysis and sampling. The originating committee is, however, responsible for carrying out the Steps of the Procedure.

When it is necessary, the Codex Committee on Methods of Analysis and Sampling should try to ensure elaboration and collaborative testing of methods by other recognized bodies with expertise in the field of analysis.

The Codex Committee on Methods of Analysis and Sampling will assess the actual analytical performance of the method which has been determined in its validation. This will take account of the appropriate precision characteristics obtained in collaborative trials which may have been carried out on the method together with results from other development work carried out during the course of the method development. The set of criteria that are developed will form part of the report of the endorsement by the Codex Committee on Methods of Analysis and Sampling and will be inserted in the appropriate Codex Commodity Standard.

In addition, the Codex Committee on Methods of Analysis and Sampling will identify numeric values for the criteria for which it would wish such methods to comply.

METHODS OF ANALYSIS AND SAMPLING OF GENERAL APPLICATION TO FOODS

When the Codex Committee on Methods of Analysis and Sampling itself elaborates methods of analysis and sampling which are of general application to foods, it is responsible for carrying out the steps of the Procedure.

METHODS OF ANALYSIS OF FOOD ADDITIVES AS SUCH

Methods of analysis included in Codex Advisory Food Additives Specifications, for the purpose of verifying the criteria of purity and identity of the food additive, need not be referred to the Codex Committee on Methods of Analysis and Sampling for endorsement. The Codex Committee on Food Additives and Contaminants is responsible for carrying out the steps of the Procedure.

METHODS OF ANALYSIS OF PESTICIDE RESIDUES IN FOOD

The methods for determining the levels of pesticide residues in food need not be referred to the Codex Committee on Methods of Analysis and Sampling for endorsement. The Codex Committee on Pesticide Residues is responsible for carrying out the steps of the Procedure.

MICROBIOLOGICAL METHODS OF ANALYSIS AND SAMPLING

When Codex committees have included provisions on microbiological methods of analysis and sampling for the purpose of verifying hygiene provisions, they should be referred to the Codex Committee on Food Hygiene at the most suitable time during Steps 3, 4 and 5 of the Procedure for the Elaboration of Codex Standards, which will ensure that government comments on the methods of analysis and sampling are available to the Codex Committee on Food Hygiene. The procedure to be followed will be as in the normal practice described above, substituting the Codex Committee on Food Hygiene for the Codex Committee on Methods of Analysis and Sampling. Microbiological methods of analysis and sampling elaborated by the Codex Committee on Food Hygiene for inclusion in Codex commodity standards for the purpose of verifying hygiene provisions need not be referred to the Codex Committee on Methods of Analysis and Sampling for endorsement.

CORE FUNCTIONS OF CODEX CONTACT POINTS

CODEX CONTACT POINTS:

1. Act as the link between the Codex Secretariat and Member countries;

2. Coordinate all relevant Codex activities within their own countries;

3. Receive all Codex final texts (standards, codes of practice, guidelines and other advisory texts) and working documents of Codex sessions and ensure that they are circulated to those concerned within their own countries;

4. Send comments on Codex documents or proposals to the Codex Alimentarius Commission or its subsidiary bodies and/or the Codex Secretariat;

5. Work in close cooperation with the national Codex committee, where such a committee has been established. The Codex Contact Point acts as the liaison point with the food industry, consumers, traders and all other concerned to ensure that the government is provided with an appropriate balance of policy and technical advice upon which to base decisions relating to issues raised in the context of the Codex work;

6. Act as a channel for the exchange of information and coordination of activities with other Codex Members;

7. Receive the invitation to Codex sessions and inform the relevant chairpersons and the Codex Secretariat of the names of participants from their own countries;

8. Maintain a library of Codex final texts; and

9. Promote Codex activities throughout their own countries.