PROPOSED DRAFT GUIDELINES ON THE APPLICATION OF THE CRITERIA APPROACH (Agenda Item 4a)
CRITERIA FOR THE EVALUATING ACCEPTABLE METHODS OF ANALYSIS FOR CODEX PURPOSES (Agenda Item 4b)
26) The Delegation of the United Kingdom introduced the document which had been prepared in cooperation with other countries, following the decision of the last session to develop guidelines for the implementation of the criteria approach. The Delegation stressed the need to provide guidance to Codex Committees and CCMAS to allow more flexibility in the selection of methods on a rational and scientific basis.
27) The Codex Secretariat recalled that the matter was approved as new work in 1996 in general terms and that the Committee might need to clarify the status of the document as Codex Guidelines providing guidance to governments and included in Volume 13, or as instructions for Codex Committees included in the Codex Procedural Manual.
28) The Delegation of Japan while supporting the principles of the criteria approach and its application to all validated methods, excluding defining methods, expressed concern on its implementation at the national level. The Delegation was of the opinion that the Guidelines should be redrafted in the format of Codex guidelines and should provide guidance not only to Codex committees but also to laboratories of Member countries especially on how to use the criteria approach in selecting methods of analysis.
29) Many delegations supported the criteria approach as being more scientific and flexible and as a consequence more easily applicable for Codex purposes. Some delegations were of the opinion that the criteria approach should be limited to Type III methods while other delegations indicated that it could be also applied to Type II methods in order to allow the use of more modern methods. It was pointed out that there was no need for Type II methods from the scientific point of view.
30) The Delegation of the United States, while fully supporting the criteria approach for Type III methods, supported retaining Type II methods especially for dispute situations and for that purpose Type II methods should be selected by the technical experts of the Commodity Committees or CCMAS. If reference methods were no longer available in legal proceedings, differences in results would eventually be interpreted by the legal profession and not on scientific grounds. Type II methods were therefore necessary to provide guidance to laboratories on specific methods and to eliminate method selection bias in dispute situations. The Delegation also pointed out that the simpler form of the Horwitz equation should be used in Appendix I of the document.
31) Some delegations indicated that dispute situations might occur not only because of methods but also due to inadequate sampling and indicated that in order to minimize situations with different results and disputes, it was necessary to rely more on the use of laboratory accreditation systems and proficiency testing, as already recommended by the CCFICS.
32) As a compromise, the Committee agreed that the criteria approach would be applied to Type III methods and that Type II methods would be prescribed by the CCMAS to be used in dispute situations.
Status of the Proposed Draft Guidelines on the Application of the Criteria Approach
33) The Committee noted that the current text provided recommendations to the CCMAS and Codex Committees and agreed that it should therefore be included in the Procedural Manual at the end of the current section on “Principles for the Establishment of the Codex Methods of Analysis”. The Committee agreed to forward the Proposed “Guidelines and Working Instructions to Aid the Implementation of the Criteria
Approach” (Appendix I, CX/MAS 01/4) to the Committee on General Principles for endorsement and to the Commission for adoption and inclusion in the Procedural Manual (see Appendix II, Part 2).
34) The Committee also agreed that the Delegation of the United Kingdom with the assistance of the Delegation of Sweden would redraft the current Guidelines to make them generally applicable to governments, for circulation at Step 3 and consideration at the next session of the Committee.
Dispute situations
35) The Observer from OIV drew the attention of the Committee to the fact that disputes were more likely to originate from differences in legal practices than from analytical problems and stressed the necessity of suitable analytical methods when the criteria approach was not applicable.
36) The Committee was informed about the existence of ISO standards 5725:1994 and 4259:1992 which provide advice in some dispute situations.
37) The Committee supported the general recommendations made by the Committee on Food Import and Export Inspection and Certification Systems[7] as regards dispute situations and noted that it did not prevent the development of more specific guidance in this area. Several delegations expressed the view that the Committee should address dispute situations from the practical point of view.
38) The Committee agreed that the Delegation of France with the assistance of Australia, Belgium, Brazil, Canada, Denmark, Egypt, Greece, the Netherlands, Norway, South Africa, the United Kingdom and the United States would prepare a discussion paper addressing dispute situations for consideration by the next session. Governments would be requested by Circular Letter to provide information on the current practices in this regard in member countries, in order to facilitate the preparation of the above discussion paper.
39) The Delegation of Sweden, speaking on behalf of the member states of the EU present at the session, and presenting a common EC position, proposed the following amendments: in the new section on General Criteria, to refer to Codex Type II and Type III (deleting the square brackets); to replace “Normal Process” with “Normal Practice” in the Relations between Commodity Committees and General Committees; and to clarify the presentation of the sections.
40) In view of the above discussion and the decision to apply criteria only to Type III methods at this stage, the Committee agreed to delete the reference to Type II methods in the new section. The Committee agreed to the editorial amendments proposed for clarification purposes.
41) The Committee agreed to forward the amendments to the Principles for the Establishment of Methods of Analysis and Relations between Commodity Committees and General Committees - Methods of Analysis and Sampling to the Committee on General Principles for endorsement and to the 24th Session of the Commission for adoption and inclusion in the Procedural Manual (see Appendix II, Part 1).
