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CRITERIA FOR EVALUATING ACCEPTABLE METHODS OF ANALYSIS FOR CODEX PURPOSES[5] (Agenda Item 5)

12. The Committee recalled that this item had been discussed at the two previous sessions without reaching an agreement. The Delegation of the United Kingdom presented the paper. It was stated that in order to overcome disadvantages of the current system and to give analysts freedom of choice, an alternative approach was proposed - to define criteria and to choose methods which met criteria instead of specifying individual methods. The Committee noted that in the new approach Types I and IV would remain as at present whereas Types II and III would be converted into criteria.

13. The majority of delegations were in favour of this new approach. Nonetheless, several delegations foresaw the enormity of the task to convert these methods into criteria, including selection of criteria. Some delegations preferred to include other criteria such as “accuracy” (“trueness” or “bias”). It was pointed out that some criteria for selecting methods had already been adopted by the Commission[6].

14. It was stressed that the methods which met criteria should be collaboratively studied and validated according to the protocol on inter-laboratory studies. Some delegations noted that an external standard, such as Horwitz curve, should be applied. The Delegation of Hungary stated that sample preparation be taken into consideration in addition to measurement of analytes.

15. The Delegation of the USA pointed out some discrepancies in Appendices I and II. The Delegation of the UK responded that these problems represent limitations of the current system of selecting methods.

16. The Delegation of the USA stated while it could accept this new approach for Type III methods, it was strongly opposed to the application of this approach to Type II methods. In the case of disputes, only one method should be chosen (current Type II methods) and used by all parties involved, especially when a dispute becomes a legal or administrative issue. It was stressed that the Committee should retain the prerogative to determine Type II methods.

17. The Committee agreed to recommendation 1[7], to accept the approach in principle. The Committee also agreed to proceed along the line set out in the other recommendations with the understanding that there should be a clear indication that the problems related to TypeII/TypeIII classification were deliberately not dealt with. The Committee agreed to separate recommendation 3 into two i.e. new 3 and 4. The recommendations are cited below:

1. Accept the criteria approach in principle;

2. Draw up detailed working guidelines for the operation of the criteria approach by CCMAS. This would include the definitions and selection of the criteria to be used;

3. Clarify the procedures to be used in the ‘dispute situation’; and

4. Emphasise that procedures are to be used to ensure that laboratories are ‘in control’ and operating proficiently in all cases.

18. The Committee requested the Delegations of the United Kingdom and Canada in collaboration with the Codex Secretariat to prepare a paper on working procedures for the new approach in horizontal manner, using Codex General Methods for Contaminants as examples, for consideration by the Committee at its next session and by its ad hoc Working Group on Endorsement. The Committee invited other delegations to make contribution.
[5] CX/MAS 95/3
Comment papers (USA, IDF & IUPAC)
[6] “Recommendations for a Checklist of Information Required to Evaluate Methods of Analysis Submitted to the Codex Committee on Methods of Analysis and Sampling for Endorsement”, Codex Alimentarius, Second Edition, Volume 13, pp. 129, and “Methods of Analysis Submitted for Endorsement by the Codex Committee on Methods of Analysis and Sampling: Precision Criteria”, ALINORM 93/23, Appendix III.
[7] Page 5, CX/MAS 95/3

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