APPENDIX III

AMENDMENTS TO THE PROCEDURAL MANUAL

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

Principles for the Establishment of Codex Methods of Analysis

Add the following new subsection at the end of General Criteria for the Selection of Methods of Analysis:

a) General Criteria for the Selection of Methods of Analysis using the Criteria Approach

In the case of Codex Type III methods, method criteria may be identified and values quantified for incorporation into the appropriate Codex commodity standard. Method criteria which are developed will include the criteria in section Methods of Analysis, paragraph (c) above together with other appropriate criteria, e.g., recovery factors.

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AMENDMENT TO THE RELATIONS BETWEEN COMMODITY COMMITTEES AND GENERAL COMMITTEES - METHODS OF ANALYSIS AND SAMPLING

Add the following new paragraphs at the end of the section "Normal Practice":

The Codex Committee on Methods of Analysis and Sampling will assess the actual analytical performance of the method which has been determined in its validation. This will take account of the appropriate precision characteristics obtained in collaborative trials which may have been carried out on the method together with results from other development work carried out during the course of the method development. The set of criteria that are developed will form part of the report of the endorsement by the Codex Committee on Methods of Analysis and Sampling and will be inserted in the appropriate Codex Commodity Standard.

In addition, the Codex Committee on Methods of Analysis and Sampling will identify numeric values for the criteria for which it would wish such methods to comply.

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AMENDMENT TO SECTION III OF THE PROCEDURAL MANUAL:
SUBSIDIARY BODIES UNDER RULE IX.1 (b)(i)

Amendment to the Terms of Reference of the Codex Committee on Food Hygiene:

Add the following new Terms of Reference:

(f) to suggest and prioritize areas where there is a need for microbiological risk assessment at the international level and to develop questions to be addressed by the risk assessors;

(g) to consider microbiological risk management matters in relation to food hygiene and in relation to the risk assessment of FAO and WHO.

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AMENDMENT TO THE STATEMENTS OF PRINCIPLE ON THE ROLE OF SCIENCE IN THE CODEX DECISION-MAKING PROCESS AND THE EXTENT TO WHICH OTHER FACTORS ARE TAKEN INTO ACCOUNT

Add the following text immediately following the Fourth Statement of Principle:

Criteria for the Consideration of the Other Factors Referred to in the Second Statement of Principle

• when health and safety matters are concerned, the Statements of Principle Concerning the Role of Science and the Statements of Principle Relating to the Role of Food Safety Risk Assessment should be followed;

• other legitimate factors relevant for health protection and fair trade practices may be identified in the risk management process, and risk managers should indicate how these factors affect the selection of risk management options and the development of standards, guidelines and related texts;

• consideration of other factors should not affect the scientific basis of risk analysis; in this process, the separation between risk assessment and risk management should be respected, in order to ensure the scientific integrity of the risk assessment;

• it should be recognized that some legitimate concerns of governments when establishing their national legislation are not generally applicable or relevant world-wide; [ Confusion should be avoided between justification of national measures under the SPS and TBT Agreements and their validity at the international level.]

• only those other factors which can be accepted on a world-wide basis, or on a regional basis in the case of regional standards and related texts, should be taken into account in the framework of Codex;

• the consideration of specific other factors in the development of risk management recommendations of the Codex Alimentarius Commission and its subsidiary bodies should be clearly documented, including the rationale for their integration, on a case-by-case basis;

• the feasibility of risk management options due to the nature and particular constraints of the production or processing methods, transport and storage, especially in developing countries, may be considered; concerns related to economic interests and trade issues in general should be substantiated by quantifiable data;

• the integration of other legitimate factors in risk management should not create unjustified barriers to trade [ According to the WTO principles, and taking into account the particular provisions of the SPS and TBT Agreements.] ; particular attention should be given to the impact on developing countries of the inclusion of such other factors.