Definitions (Agenda Item 3.1)
Working Principles for Risk Analysis (Agenda Item 3.2)
10. The Committee noted that definitions relating to risk analysis needed to be read in conjunction with the relevant texts in which the terms were used or applied. In this regard, it was agreed that definitions should be limited to an explanation of the terms used, and that substantive statements of application or principle should be made in the appropriate text and not in the definitions themselves.
11. The Committee noted that it had, at its last session, agreed that the current definitions for Risk Management and Risk Communication required further consideration in the light of reports of recently held Joint FAO/WHO Expert Consultations.[7] A draft definition for Risk Assessment Policy had been developed at the same time. These definitions had been circulated for comment. The Committee had also agreed that there was no need for a definition of Risk Profile.
12. The Committee agreed to use the definition of Risk Communication recommended by the Joint FAO/WHO Expert Consultation on Risk Communication in relation to Food Standards and Safety Matters as a basis for its discussions. It agreed to modify the definition on the basis of comments received, stressing in particular the relevance of including a reference to “risk-related factors” and to “perceptions of risk” and extending the specific examples of “interested parties”.
13. In relation to the definition of Risk Management, the Committee agreed to incorporate a reference to both prevention and control options, and to highlight the fact that risk management was distinct from risk assessment. It also noted that for Codex purposes, the result of risk management decisions would not be regulatory measures, but the elaboration of standards, codes of practice, or other advice to governments. The reference to implementation of regulatory measures was therefore deleted.
14. In regard to the definition of Risk Assessment Policy, the Committee noted the views of delegations that there had been recent conceptual changes in the relationships between risk assessment policy, risk management and risk assessment. In particular it was noted that risk management was a broad activity encompassing risk assessment policy and was not merely the following stage after risk assessment. The Committee also noted that these relationships were complex and implied an understanding of value judgements at steps in both the risk assessment and risk management processes. It agreed that working principles on the application of risk assessment policies needed to be developed at least to a common level of understanding before it would be possible to develop an appropriate definition.
Status of the Definitions
15. The Committee agreed to submit the revised definitions of Risk Communication and Risk Management as contained in Appendix III to this report, to the Commission for adoption.
16. The Committee recalled that the last session had considered Proposed Draft Working Principles, developed as part of an Action Plan adopted by Commission at its 22nd Session, and had agreed that the Principles should be redrafted for further consideration. The Committee examined the Working Principles section by section and had a general discussion on the application of the Principles, and especially whether they were directed to Codex Committees or to governments. Some delegations pointed out that several recommendations were of a general nature and could be used in both cases, while certain provisions could be interpreted differently at the national and international levels. The Committee recalled that the mandate of the Commission was to consider Working Principles for general application in Codex, following which guidelines should be developed to aid the uniform application of the principles.
Risk Analysis
17. The Committee agreed with the proposal of the Observer from Consumers International to insert a sentence indicating that the primary purpose of risk analysis was the protection of public health.
18. The Committee agreed that the section should be reorganized so that matters relating to risk assessment should be transferred to the appropriate section. It was further agreed that the three components of risk analysis should be separately and systematically documented, with the documentation accessible to interested parties. The Committee agreed to add a sentence on the need for communication and interaction where appropriate between the parties involved, as this should apply to all stages of the risk analysis process. Further references to documentation were therefore deleted.
19. The Committee discussed the need for harmonization of Codex procedures with those of other organizations. Several delegations pointed out that Codex should take the lead in this area and that harmonization should be a mutual process; some delegations proposed to refer only to intergovernmental organizations. The Committee agreed to retain the sentence with a reference to non-governmental organizations in square brackets and to refer to harmonization “where appropriate”.
20. The Committee had an exchange of views on the opportunity of including in the section a reference to the specific needs of developing countries. Several delegations, while recognizing that those needs should be addressed, pointed out that the document considered risk analysis principles in the Codex process and that the needs of countries at the national level were not under consideration. The Delegation of the Philippines pointed out that the situation of developing countries should be taken into account in the framework of Codex, for example to include the consideration of data from those countries in the risk analysis process. The Committee agreed to clarify that the needs of developing countries should be identified and addressed in this context.
21. The Committee agreed with the proposal of the Representative of WHO to specify that the risk analysis process should be consistent, in addition to the current reference to openness and transparency.
Risk Assessment
22. The four Statements of Principle Relating to the Role of Food Safety Risk Assessment were included in the section. The Committee agreed with the proposal of the Delegation of France to include a statement to the effect that experts should be selected on the basis of their competence and independence.
23. The section referring to acute and chronic health effects was combined with the section concerning exposure, and the Committee agreed to refer to “ different situations” instead of “ worst case” situations as this was a more general wording and covered all possible cases.
Risk Assessment Policy
24. Some delegations stressed the need for clarification on the identification of the risk assessors and risk managers, as the current text might be understood as applying to governments rather than to the Codex process. The Secretariat recalled that the mandate of the Commission to the CCGP was to define principles for risk analysis applicable within Codex, for inclusion in the Procedural Manual, and not recommendations to governments. The Committee noted that the identification of risk assessors (Joint FAO/WHO Expert Committees and Expert Consultations) and risk managers (Codex committees) might be included as a footnote after the definition had been finalized.
25. The Committee agreed with the proposal of the Observer from the EC to indicate that the mandate given by risk managers to risk assessors must be clearly specified and delineated. The Committee discussed the proposal of the Delegation of France concerning the achievability of the mandate given to risk assessors by risk managers and agreed to leave it in square brackets for further comments. The Committee agreed to add a sentence indicating that risk managers should invite interested parties to submit proposals and comments to ensure that the risk assessment process was systematic and complete.
26. The Committee recognized that it was not possible to come to a conclusion at this stage as further discussion was necessary on risk management and on the principles as a whole, in order to clarify the matters related to risk assessment policy. It was agreed that the amended text would be circulated for further comments and consideration at the next session.
Risk Management
27. The Committee noted that the important issue was how to address uncertainty in scientific evaluation while conducting the risk management process; several delegations and the Observer from the EC pointed out that there was always a measure of uncertainty in the scientific evidence available, and that should not prevent necessary measures to protect public health.
28. The Delegation of Sweden proposed to clarify that the precautionary principle could be applied in specific circumstances in the framework of risk management to address uncertainty, as follows: “Lack of full scientific certainty shall not be used as a reason to delay measures intended to prevent adverse effects on human health from hazards present in food. When a preliminary risk assessment indicates a threat of adverse effects on human health from a hazard present in food, it is justifiable to take measures to prevent such effects without awaiting additional scientific data and a full risk assessment. Such measures should be proportionate to the potential health risk and should be kept under review.”
29. The Delegation of Germany, speaking on behalf of the members of the European Union, supported the inclusion of the precautionary principle in view of its relevance in risk management decisions and the elaboration of guidelines on the use of this principle; this was also essential to build the confidence of consumers in the risk analysis process and reflect that the protection of public health was the primary objective of Codex. This position was supported by other delegations and the Observers of the EC, Consumers International, IBFAN, and IACFO.
30. The Delegation of the United States expressed its objection to the inclusion of the precautionary principle as there was no internationally recognized definition and a precautionary approach was already built in risk assessment; this concept should not be used by risk managers to overrule risk assessment. The Delegation recalled that under Article 5.7 of the SPS Agreement, national governments may adopt provisional measures in cases of insufficient scientific evidence but they should seek to obtain additional information for a more objective assessment of risk; at the international level and in the framework of Codex, standards should be based on scientific evidence. This position was supported by other delegations and the observers from CRN, COMISA and GCPF.
31. The Delegation of France proposed that if the precautionary principle were not integrated in the Working Principles, the following sentence should be included in the section on Risk Management: “ The Codex Alimentarius Commission should not adopt standards or related texts when scientific evidence is insufficient or adverse effects are difficult to assess.”
32. The Observer from CIAA pointed out that clear guidelines were needed to define the precautionary principle and its application in order to avoid constraints to technological innovation and to ensure that the industry could develop its activities in a transparent and predictable framework. The Observer from EFLA, referring to its written comments, drew the attention of the Committee to the legal implications of the debate and, if the principle were to be introduced as such, stressed the necessity of defining it and clarifying the conditions for its application, with special attention to the question of the burden of proof.
33. The Delegation of Canada referred to the definition of the precautionary principle in the area of environment and indicated that for the purposes of Codex, it would be preferable to refer to a precautionary approach, which corresponded to current practice when considering health protection issues and did not represent a new concept. The Delegation of New Zealand stressed the importance of clarifying the principles for risk assessment policy, as this was the essential element in the application of a precautionary approach in the framework of Codex, whereas the precautionary principle was more relevant at the national level.
34. Several delegations expressed the view that although there was general agreement on the application of a precautionary approach in order to protect public health, the main difficulty was to define and explain this approach in the framework of Codex risk management. The Committee recognized that for the purposes of health protection in the framework of Codex, a precautionary approach had been consistently taken in health protection matters, but it would be useful to consider further how to integrate this approach in the framework of risk management, possibly through the definition of guidelines. It was agreed that for the moment the text would remain in square brackets and that comments would be sought on a definition of the precautionary principle or a statement of precautionary approach and the conditions under which it would be applied. The Secretariat would then prepare an analysis of all relevant aspects and proposals for further consideration. The Delegation of the United Kingdom requested that the analysis include guidelines for the application of the precautionary principle or approach.
Risk Communication
35. The Delegation of Australia pointed out that since the principles were intended for use within Codex, the reference in the draft text to communication with the public was not appropriate. The Committee agreed that this matter should be clarified. The Secretariat informed the Committee that the Commission would be considering specifically the recommendations of the Joint FAO/WHO Expert Consultation on Risk Communication and this would provide guidance to the CCGP for further consideration of this matter. The Committee agreed to defer consideration of this section until the next session.
Documentation
36. The Committee noted that there were some repetition in this section and that it should be redrafted accordingly and further considered at the next session.
Status of the Proposed Draft Working Principles for Risk Analysis
37. The Committee agreed to return to Step 3 the Proposed Draft Working Principles, as amended during the current session, for further comments and consideration at the next session.
