Procedures for the Elaboration of Codex Standards and Related Texts

Note: Throughout this text the word “Standard” is meant to include any of the recommendations of the Commission intended to be submitted to Governments for acceptance. Except for provisions relating to acceptance, the Procedures apply mutatis mutandis to codes of practice and other texts of an advisory nature.

INTRODUCTION

1. The full procedure for the elaboration of Codex standards is as follows. The Commission decides, taking into account the “Criteria for the Establishment of Work Priorities”, 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 criteria subject to subsequent approval by the Commission or its Executive Committee 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 1 of this document.

2. The Commission or the Executive Committee, or any subsidiary body, subject to the confirmation of the Commission or the Executive Committee 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 2 of this document.

3. 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.

4. The Commission may authorize, on the basis of two-thirds majority of votes cast, the omission of Steps 6 and 7, where such an omission is recommended by the Codex Committee entrusted with the elaboration of the draft. Recommendations to omit steps shall be notified to Members and interested international organizations as soon as possible after the session of the Codex Committee concerned. When formulating recommendations to omit Steps 6 and 7, Codex Committees shall take all appropriate matters into consideration, including the need for urgency, and the likelihood of new scientific information becoming available in the immediate future.

5. 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.

6. 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.

7. 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 3 of this document. Details of notifications are published periodically by the Commission’s Secretariat.

PART 1: UNIFORM PROCEDURE FOR THE ELABORATION OF CODEX STANDARDS AND RELATED TEXTS

Steps 1, 2 and 3

(1) 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. 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 criteria, subject to subsequent approval by the Commission or its Executive Committee 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). 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 Commission or to the Executive Committee with a view to its adoption as a draft standard[1]. In taking any decision at this step, the Commission or the Executive Committee 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. 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 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 2: UNIFORM ACCELERATED PROCEDURE FOR THE ELABORATION OF CODEX STANDARDS AND RELATED TEXTS

Steps 1, 2 and 3

(1) The Commission or the Executive Committee between Commission sessions, on the basis of a two-thirds majority of votes cast, taking into account the “Criteria for the Establishment of Work Priorities”, shall identify those standards which shall be the subject of an accelerated elaboration process[2]. 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 or its Executive Committee by a two-thirds majority of votes cast.

(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). 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 Commission together with any written proposals received from Members and interested international organizations for amendments with a view to its adoption as a Codex standard. In taking any decision at this step, the Commission will give due consideration to any comments that may be submitted by any of its Members regarding the implications which the proposed draft standard or any provisions thereof may have for their economic interests.

PART 3: SUBSEQUENT PROCEDURE CONCERNING PUBLICATION AND ACCEPTANCE OF CODEX STANDARDS

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

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

The above mentioned publications will constitute the Codex Alimentarius.

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

Subsequent Procedure Concerning Publication, Acceptance and Possible Extension of Territorial Application of the Standard

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

It is open to the Commission to consider at any time the possible extension of the territorial application of a Codex Regional Standard or its conversion into a World-wide Codex Standard in the light of all notifications received.

Guide to the Consideration of Standards at Step 8 of the Procedure for the Elaboration of Codex Standards including Consideration of any Statements relating to Economic Impact

1. In order:

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

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

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

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

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

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

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

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

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

Guide to the Procedure for the Revision and Amendment of Codex Standards

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

2. Taking into account such information regarding the proposed amendment as may be supplied in accordance with paragraph 1 above, 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 3 and 4 of the Introduction to the Procedure for the Elaboration of Codex Standards (see page 18 above).

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

Arrangements for the Amendment of Codex Standards Elaborated by Codex Committees which have Adjourned sine die

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

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

(b) finalization of methods of analysis;

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

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

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

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

(g) modifications of standards being proposed following an examination of government notifications of acceptances and specified deviations by the Secretariat as required in accordance with the Procedure for the Elaboration of Codex standards i.e. “Subsequent Procedure concerning Publication and Acceptance of Codex Standards”, page 23.

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

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

(b) amendments of the type in para (f) and those of (e) of a substantive nature, the Secretariat in cooperation with the national secretariat of the adjourned Committee and, if possible, the Chairperson of that Committee, should agree on the need for such an amendment and prepare a working paper containing the wording of a proposed amendment and the reasons for proposing such amendment, and request comments from Member Governments: (a) on the need to proceed with such an amendment and (b) on the proposed amendment itself. If the majority of the replies received from Member Governments is affirmative on both the need to amend the standard and the suitability of the proposed wording for the amendment or an alternative proposed wording, the proposal should be submitted to the Commission with a request to approve the amendment of the standard concerned. In cases where replies do not appear to offer an uncontroversial solution then the Commission should be informed accordingly and it would be for the Commission to determine how best to proceed.