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HARMONIZATION OF ANALYTICAL TERMINOLOGY IN ACCORDANCE WITH INTERNATIONAL STANDARDS[18] (Agenda Item 7)

25. The Committee recalled that at its last Session it had agreed on the tentative list of terms, specifically related to the work of the Committee, to be defined and requested the Delegations of Finland and the United States to undertake the preparation of a paper for circulation for comments[19]. Based on comments received on the paper[20], a revised paper, CX/MAS 97/5, was prepared.

26. In introducing the paper, the Delegation of the United States explained that the paper was prepared through the search of available literature. ISO and IUPAC definitions were essentially used with some minor modifications to make them more appropriate for food analysis laboratories. It was stated that the definitions of limits, e.g., limit of detection and limit of determination, were not included as the statement of applicability of a method would indicate if the method had the capability of providing results in the vicinity of the Codex specification. However, several delegations stated that in the case of the analysis of trace contaminants there were not so many collaboratively studied methods available, which necessitated establishing the limit of determination (quantification) by laboratories and therefore, the definitions of limits were necessary.

27. There was a general agreement that internationally agreed terms and definitions should be utilized as much as possible, and if they were applied to chemical analysis as opposed to microbiological analysis, they were acceptable to the Committee except matters related to "limits". The Committee then considered the paper term by term and made the following amendments:

- inserted "by the same operator" in the definition of repeatability conditions as in the original ISO definition;

- inserted "(Proficiency)" after the term "Laboratory-Performance" in the term heading; and

- inserted at the end of Note 2 of Laboratory-Performance (Proficiency) Study the following term: "provided that the test samples cover the range of concentration of the analyte".

There were other proposals made at the Session to amend the definitions of result, accuracy, bias, precision, reproducibility conditions, and applicability; and to add texts to some Notes; nonetheless the Committee decided to maintain the definitions of the above and Notes as contained in the paper in order not to change existing internationally agreed definitions.

28. The Committee decided to send the definitions of analytical terms as amended and contained in Appendix III of this report to the Commission for endorsement. It further decided to request the Inter-Agency Meeting to recommend whether it would be appropriate to include "limits" in the selected terminology and to elaborate their definitions. The Delegation of the USA would provide a background information paper as well as justification to the Inter-Agency Meeting. The Delegation of the United Kingdom stated that these terms and their definitions were to be taken into consideration when revising the paper on "criteria" approach (see para. 15.).


[18] CX/MAS 97/5 (Revised document and comments from Czech Republic, Denmark, Hungary, Mexico, Spain, AOAC INTERNATIONAL and IDF); CRD 6 (comments from France); written comments were submitted by Australia and Russia at the Session.
[19] ALINORM 97/23, paras. 34-35.
[20] CL 1996/22-MAS.

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