II. Amendments to the Procedural Manual

AMENDMENTS TO THE 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^[109], the General Standard on contaminants and toxins in foods^[110], the Food categorization 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^[111]. 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^[112]. 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.

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.. 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.

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^[113], 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.

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)^[114] 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^[115] 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)^[116] 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)^[117] 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 Chaipersons 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^[118]

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.

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^[119]

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;^[120]

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

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

PRINCIPLES FOR THE ESTABLISHMENT OF CODEX METHODS OF ANALYSIS

General Criteria for the Selection of Single-Laboratory Validated Methods of Analysis (to be included after the General Criteria)

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 fulfil 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.

Amendments to Analytical Terminology for Codex Use

Specificity: deleted

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 (as a concept) and Accuracy (as a statistic) to be replaced with the following definition:

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.

Terms to Be Used in the Criteria Approach

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.

DEFINITIONS FOR THE PURPOSE OF THE CODEX ALIMENTARIUS

DEFINITIONS OF RISK ANALYSIS TERMS RELATED TO FOOD SAFETY

Definitions to be added

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 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.

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.

DEFINITIONS FOR THE PURPOSE OF THE CODEX ALIMENTARIUS

Definition to be added

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

III. List of Standards and Related Texts adopted by the Twenty-seventh session of the Codex Alimentarius Commission

Part 1. Standards and Related Texts Adopted at Step 8 as Final Texts

Part 2. Standards and Related Texts Adopted at Step 5 and Step 8 as Final Texts with Recommendations to Omit Step 6 and 7

IV. List of Draft Standards and Related Texts adopted at Step 5 by the Twenty-seventh Session of the Codex Alimentarius Commission

V. List of Standards and Related Texts Revoked by the Twenty-seventh Session of the Codex Alimentarius Commission

^† Replaced by the Code of Hygienic Practice for Milk and Milk Products
* Replaced by the Guidelines for Packing Media/Canned Fruits (CAC/GL 51-2003)
^‡ Replaced by the General Guidelines on Sampling

The Commission took note of the omission in the Appendix VII of ALINORM 03/41 of two Maximum Levels below revoked by the 26^th Session of the Codex Alimentarius Commission:

VI. List of Approved New Work by the Twenty-seventh Session of the Codex Alimentarius Commission

VII. List of Approved Discontinuation of Work by the Twenty-seventh Session of the Codex Alimentarius Commission

VIII. Terms of Reference of the Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology

Objectives

To develop standards, guidelines or recommendations, as appropriate, for foods derived from modern biotechnology or traits introduced into foods by modern biotechnology, on the basis of scientific evidence, risk analysis and having regard, where appropriate, to other legitimate factors relevant to the health of consumers and the promotion of fair practices in the food trade.

Time frame

The Task Force shall complete its work within four years. The Task Force should submit a full report in 2009.

Terms of Reference

(a) To elaborate standards, guidelines, or other principles, as appropriate, for foods derived from modern biotechnology, taking account, in particular, of the Principles for the Risk Analysis of Foods derived from Modern Biotechnology;

(b) To coordinate and closely collaborate, as necessary, with appropriate Codex Committees within their mandate as relates to foods derived from modern biotechnology; and

(c) To take account of existing work carried out by national authorities, FAO, WHO, other international organizations and other relevant international fora.

IX. Countries Responsible for Appointing Chairpersons of coDex Subsidiary Bodies

X. Opinion of the Legal Offices of FAO and WHO on the Legal Aspects Involved in the Questions Raised by the Committee on Milk and Milk Products^[124]

INTRODUCTION

1. At it Sixth Session, held in Auckland, New Zealand, 26-30 April 2004, the Codex Committee on Milk and Milk Products (CCMMP) discussed the possibility of elaborating an individual cheese for parmesan but was not able to reach agreement on whether or not to proceed with this work. The Committee agreed to the following text in respect of specific questions to be asked to the Codex Alimentarius Commission:

“The majority of the CCMMP present at the 6^th Session are of the opinion that the name ‘Parmesan’ is and has been generic for quite some time. On the other hand, the denomination ‘Parmigiano-Reggiano’ is officially registered as a Protected Designation of Origin (PDO) by the European Community. The EC currently considers that there is a ‘indissoluble relationship’ between the words ‘Parmigiano-Reggiano’ and ‘Parmesan’.

Reference to EC legislation is preventing a decision on the establishment of a world wide standard for Parmesan Cheese by the CCMMP. Further, the inability to reach a decision on this issue is hindering the work of the CCMMP on this matter and might have important horizontal implications for work in other Codex Committees.

Two questions are addressed to the Commission.

1. To what extent, if any, should a PDO recognized in EC legislation for a product otherwise considered to be generic by the majority of the members present be grounds for rejecting elaboration of a Codex standard when in the opinion of the majority of members present existing criteria for acceptance of new work have been met?

2. Should aspects of intellectual property protection e.g. trademarks, certification marks, geographical indications (GI’s) or PDO’s be considered as legitimate criteria by Codex when deciding on acceptance of new work or adopting standards?

If the answers to both questions are that these matters are not legitimate considerations for CCMMP, will the CAC request that the CCMMP begin new work on the promulgation of a standard for Parmesan Cheese?”

2. The Legal Offices of FAO and WHO were asked to offer their views on the legal aspects involved in the questions raised.

3. Prior to examining the questions raised, in order to place them in a correct perspective, it would be useful to recall the relevant provisions of the Codex Alimentarus Commission’s mandate and procedures governing the decision to elaborate a standard, as well as past consideration of the issues at hand within the Codex Alimentarius Commission.

RELEVANT PROVISIONS OF THE CODEX ALIMENTARIUS COMMISSION‘S MANDATE AND PROCEDURES GOVERNING THE DECISION TO ELABORATE A STANDARD

4. Under the terms of its Statutes, the Codex Alimentarius is responsible for making proposals 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 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; and

(e) amending published standards, after appropriate survey, in the light of developments.

5. The Codex Alimentarius Commission has developed procedures for the elaboration of Codex Standards and related texts as set out in the Procedural Manual. Under these procedures, the Commission decides, taking into account the Criteria for the Establishment of Work Priorities, to elaborate a world-wide Codex Standard and also decides which subsidiary body or other body should undertake the work. Under such criteria, when a Codex Committee proposes to elaborate a standard 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 following criteria applicable to commodities:

(a) consumer protection from the point of view of health and consumer practices;^[125]

(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; and

(h) work already undertaken by other international organizations in their field.

PAST CONSIDERATION OF THE MATTER BY THE CODEX ALIMENTARIUS COMMISSION

6. The issue of whether the Commission could adopt standards with respect to commodities protected under geographical denominations was the subject of much debate in the Sixties and early Seventies. At its Ninth Session, held in 1971, the Commission, after having noted the complexity of the questions connected with “appellations d’origine”, agreed that some consideration should be given to this subject by the Executive Committee at its next session, insofar as the work of the Commission was concerned, in the light of background material to be made available by the Legal Office of FAO.

7. The Legal Office of FAO prepared an information note entitled “Appellations d’origine and international food standards”. The document reviewed past discussions on the matter within Codex Alimentarius Commission and its subsidiary bodies, international instruments relevant to the protection of “appellations d’origine” and the relevant provisions of the Codex Alimentarius. The document indicated that the general provisions on the elaboration of standards did not contain any rules on the matter. On the one hand, the “mere elaboration and adoption of a standard without special regard to the protection recognized in certain countries for a given name can in no way alter the law or detract from existing international obligations of those countries. If a government should find that acceptance of a standard would be incompatible with such laws or international obligations, it may wish to decline to accept the standard (...) On the other hand, the rules governing the work of the Codex Alimentarius Commission do not contain any provision which would enable these countries to prevent the elaboration and adoption of standards for the varieties concerned and under the names which are at present protected in their territory on the basis of national legislation or by virtue of bilateral or multilateral agreements, such as the Lisbon Agreement or the Stresa Convention”. The document further indicated that “the introduction of a special clause whereby countries accepting a standard may be allowed to maintain the status quo with regard to the protection for certain names, is neither prescribed nor excluded by any of the rules covering the work of the Codex Alimentarius Commission”.

8. At its Tenth Session, held in 1974, the Commission examined the issue of “appellation d’origine” in relation to the work of the Commission in some detail. The Commission noted that the matter had been discussed by the Executive Committee at its May 1972 Session and that it was a question which had arisen in the Committee of Government Experts on the Code of Principles concerning Milk and Milk Products. The Commission noted the recommendation of the Executive Committee on the matter^[126]. In particular, the Commission agreed with the view of the Executive Committee that it was not essential to arrive at a definite recommendation at this stage since the controversial issues had been resolved within the Joint FAO/WHO Committee of Government Experts on the Code of Principles concerning Milk and Milk Products on a pragmatic basis and might not arise again in the immediate future. Eventually, in 1978, the Committee of Government Experts on the Code of Principles concerning Milk and Milk Products, completed work on the Standard for Extra Hard Grating Cheese which was adopted as Codex STAN C-35-1978.

9. At its Second Session, in 1996, the Codex Committee on Milk and Milk Products, considered a proposal of Germany to elaborate a new individual cheese standard for “Parmesan” and requested Germany to identify products in question and prepare a paper on trade statistics and justification for the elaboration of the Standard for consideration by the Committee at its next session. France and the International Dairy Federation offered to collaborate with Germany (ALINORM 97/11, paragraph 87). At its Third Session in 1998, the Committee noted the request of Italy to delete consideration of a Codex standard for “Parmesan” from the Provisional Agenda on the basis that Parmesan (Parmigiano Reggiano) was recognized all over the world. In view of the decision taken at the Second Session, the Committee decided to consider its elaboration as scheduled under Agenda Item 11 (ALINORM 99/11, paragraph 4). The proposal on the matter (CX/MMP 98/11) mentioned, inter alia, that Parmesan was a generic name and there is no clear definition of the product at international level. There was considerable trade on cheese under this denomination. The document referred to difficulties to provide statistical data from official sources on the production and marketing of Parmesan as in the majority of countries it was not recorded as a separate item but it was covered by headings such as “hard cheese” or “grated cheese” or cheese in general. Data provided by the International Dairy Federation indicated that Parmesan cheese was produced in 11 countries; consumed in 19 and that 6 countries had a legal standard. Production was at least 64,620 tons and exports amounted to 11,577 tons.

10. Due to time constraints the matter was deferred to the Fourth session of the Committee in 2000. At the Fourth session, the Delegation of Portugal, speaking on behalf of the member States of the European Community, and in view of continuing EC discussions on the question relating to the denomination “Parmesan”, indicated that it was premature for the Committee to make a decision at this time. Several delegations and the observer from IDF stated that, utilizing the Criteria for the Elaboration or Revocation of Individual Standards for Cheeses and the data contained in CX/MMP 00/18, the elaboration of a standard for “Parmesan” would be justified. Notwithstanding the opinion of several delegations, the Committee agreed that discussions concerning the possibility of a new individual cheese standard for “Parmesan” would be deferred until its next session where it would consider whether or not to proceed with work on the basis of CX/MMP 00/18 and preliminary texts of a standard as contained in CX/MMP 00/18-Add.1 (ALINORM 01/11, paragraphs 132-133).

11. At its Fifth Session in 2002, the delegation of Spain, speaking on behalf of the Member States of the European Community present at the Session, requested the postponement of the consideration of the elaboration of a standard, in view of ongoing negotiations within the Community related to the use of the term “Parmesan”. It was also suggested that the Codex Standard for Extra Hard Grating Cheese (Codex STAN C-35) could be revised, thereby avoiding the naming issue. Other delegations strongly supported the elaboration of a Codex Standard for Parmesan Cheese, and noted that information submitted and compiled in support of the elaboration of a standard was more than adequate to address the Codex Criteria for the Establishment of Work Priorities applicable to commodities, including a large volume of production and trade between countries, diverse national legislation with potential impediments to international trade and substantial market potential. It was also noted that regardless of the negotiations within the Community, a Codex standard would apply to all 165 member states of the Codex Alimentarius Commission, The Committee could not reach a consensus position and therefore, postponed the consideration of the elaboration of a proposed draft Codex Standard for Parmesan until its next meeting. The delegation of the United States objected to this decision (ALINORM 03/11, paragraphs 124-126). At its Sixth Session in 2004, the Committee raised the two questions.

12. The above-mentioned provisions of the Statutes of the Codex Alimentarius Commission, the provisions on the elaboration of Codex Standards and related texts and the Criteria for the Establishment of Work Priorities (Cf. paragraphs 4 to 5 of this document) do not contain any clauses whereby, in deciding whether a standard should be prepared, under the above reference framework, the Commission and its subsidiary committees should be restricted by any national or related legislation regarding protection of geographical indications adopted by its Members. It may be of interest to recall that the same views on this matter were presented in 1972 by the Legal Office of FAO (Cf. paragraph 7 of this document).

13. Accordingly, the fact that Parmigiano-Reggiano is registered as a Protected Designation of Origin by the European Community would not preclude a majority of the Members of the Codex Alimentarius Commission from deciding to elaborate a Codex standard on Parmesan cheese, if applicable criteria for acceptance of new work have been met.

14. When deciding to elaborate a standard on a particular commodity, the Commission is required to act under the framework established by its mandate, the procedures for the elaboration of standards and the Criteria for the Establishment of Work Priorities and to take into account the criteria laid down in that framework.

15. From a legal point of view, insofar as this would not be precluded or incompatible with these provisions, the Commission could take into consideration additional criteria not listed among those criteria. As reflected earlier in this document, it would be entirely open to the Commission to take into account criteria of political convenience when deciding whether or not to proceed with the elaboration of a particular standard.

16. In the same vein, the Commission could decide to take into consideration criteria and aspects related to intellectual property protection such as trade marks, certification marks, geographical indications or protected designations of origin, when deciding to elaborate a particular standard. However, this would be done at the discretion of the Commission and not as a result of any specific legal requirement arising from its mandate, from the procedures for the elaboration of standards or from the Criteria for the Establishment of Work Priorities. Furthermore, the possibility for the Commission to do so would have to take into account the following two legal parameters.

17. First, at the Sixth Session of the Codex Committee on Milk and Milk Products, references were made to work in process under the Agreement on Trade-Related Aspects of Intellectual Property Rights (the so-called TRIPS Agreement). Under Article 22 of the TRIPS Agreement a minimum level of protection is established in respect of all goods for geographical indications which identify a good as originating in the territory of a Member where a given quality, reputation or other characteristic of the good is essentially attributable to its geographic origin. Under that Article geographical indications have to be protected in order to avoid misleading the public and to prevent unfair competition. A special, reinforced regime is established for geographical indications for wines and spirits in Article 23. As a result of the so-called Doha mandate, work is under way within the WTO on issues related to the extension of the higher level of protection beyond wines and spirits but no consensus on this matter has yet been reached. Once this work is completed, any results might be taken into account by Codex Members when reaching their decisions within the Codex Alimentarius Commission.

18. Second, following on the above observation, the rights and obligations of the Members of the Codex Alimentarius Commission derive from their membership of FAO or WHO and their decision to become Members of the Commission. Consequently, such rights and obligations are defined by the relevant statutory provisions of the Codex Alimentarius Commission which do not foresee, neither in their letter, nor in the practice developed thereunder, that aspects related to intellectual property protection be taken into consideration when deciding to undertake work on a particular standard. Consequently, within the Codex Alimentarius Commission, its Members are expected to act under the legal framework set forth above, as long as that framework is not amended with a view to introducing other criteria. A different approach to issues of the nature of that under consideration, would be likely to undermine the autonomy and integrity of the mandate of the Codex Alimentarius Commission.

19. In view of the foregoing considerations, from a strictly legal point of view, there are no requirements to the effect that aspects of intellectual property protection e.g. trademarks, certification marks, geographical indications (GI’s) or PDO’s be considered as criteria to be taken into consideration by Codex when deciding on acceptance of new work or adopting standards.

20. The above considerations are obviously without prejudice to the fulfilment of all relevant criteria and procedural requirements for the elaboration of standards, including the need for a document on the basis of which the Commission would take its decision.