Risk Analysis (Agenda Item 4)

13. The Delegation of India made a general statement in regard to the application of risk analysis by the Codex Alimentarius Commission. The Delegation stressed the following:

The need for developing countries to gain sufficient knowledge and experience in the application of risk analysis;
The need for flexibility in the application of risk levels, since risk tolerances in various countries were different;
That data from developing countries, in particular epidemiological data and exposures studies, needed to be taken into account;
That special consideration needed to be given to the problems in the application of risk analysis at the primary production level and in small andartisanal businesses in developing countries.
That scientific advisory bodies should indicate the confidence limits of their evaluations on the basis of the data received from both developed and developing countries and clearly define the relevant assumptions;
That measures should be practical and achievable;
The need for FAO, WHO and WTO to provide education and training in risk analysis; and
That the economic consequences of the application of risk management decisions needed to be considered and where the concept was impractical for implementation by developing countries, that measures be introduced in a phased manner.

14. It was noted that a number of these points would be taken up under the present Agenda Item and under Item 6. Concerning the data from developing countries mentioned above, the Representative of WHO informed the Committee that WHO was implementing several activities to assist member countries in the surveillance of foodborne diseases.

Item 4.1 Definitions Related to Risk Management[3]

15. On the basis of the comments received and comments made by a number of Delegations, the Committee agreed that the Draft Definitions should be reworded to make them concise, clear and consistent with the Proposed Draft Working Principles for Risk Analysis. In the interest of achieving consensus on these issues, the Committee established an ad hoc working group, chaired by Sweden, to prepare draft revised definitions for Risk Assessment Policy and Risk Profile and consider the existing definitions forRisk Management and Risk Communication for the Committee's consideration.

16. On the basis of the recommendations of the ad hoc working group, the Committee proposed the following definition forRisk Assessment Policy and agreed that it should be circulated to governments for comment:

Risk Assessment Policy: Guidelines for scientific judgements and policy choices applied at appropriate decision points during the risk assessment process. These guidelines should be elaborated by risk managers in consultation with all interested parties and applied by risk assessors.

17. The Committee also agreed with the recommendation of thead hoc working group that there was no need for a definition ofRisk Profile. It also agreed that the current interim definitions ofRisk Management and Risk Communication required further consideration in the light of the reports of recently held FAO/WHO Expert Consultations and agreed to circulate these definitions for comment with a view to their revision.

Item 4.2 Working Principles for Risk Analysis (At Step 4 of the Procedure)[4]

18. The Committee noted that the Proposed Draft Working Principles had been developed as part of an Action Plan for Codex-Wide Development and Application of Risk Analysis Principles and Guidelines adopted by the Commission at its 22nd Session (ALINORM 97/37, para. 164). Several Delegations were of the opinion that the Working Principles needed to be redrafted to include an adequate Preamble indicating their relationship with other Codex texts and their scope of application, and to re-order the subsequent sections of the text to reflect better the hierarchy and inter-relationship of the components of Risk Analysis.

19. The Observer from the European Community recommended that the document should also indicate that the determination of level of protection that a country deemed to be appropriate was a sovereign right. Several countries stressed that the statement that risk analysis should be based on "sound science" needed to be maintained. It was agreed that the first priority of risk management was the protection of public health.

20. Several Delegations and the Observer from Consumers International requested the inclusion of a reference to the "precautionary principle", stating that the use of this principle was a common factor in many Codex decision-making procedures. Other Delegations, however, stated that the inclusion of such a reference would need to be based on an agreed definition of the "precautionary principle" and understanding of its scope of application.

21. Several delegations stressed the need for an explicit reference to the need for "realistic" estimates of intake or exposure, especially in different countries and cultures. Some delegations and the Observer from Consumers International stated that particular attention should be to be paid to high-risk consumers and exposures at high levels of intake.

22. Among other elements referred to by delegations and observers were: the need to take into account the economic and commercial effects of decisions; provisions to mention expressly divergent scientific opinions; openness and transparency and the participatory nature of decision-making.

Status of the Proposed Draft Working Principles for Risk Analysis

23. The Committee decided to return the Proposed Draft Principles to Step 2 for re-drafting by the Secretariat in light of the above discussion.

[3] ³ CX/GP 98/3; CX/GP 98/3.-Add.1 (Comments of Denmark, Spain, India, Consumers International); CRD 8 (Comments of IDF). Unnumbered CRD (European Commission).
[4] CX/GP 98/4; CX/GP 98/4-Add.1 (Comments of Canada, Slovak Republic, Spain, Consumers International); CRD 8 (Comments of IDF); Unnumbered CRD (European Community).