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Comments and Correspondence
ICGMA LETTER TO FAO/WHO ON RISK ANALYSIS PRINCIPLES

January, 2001

Secretary
Joint FAO/WHO Food Standards
Programme – FAO
Viale delle Terme di Caracalla
00100 Rome, Italy
Fax: +39 (06) 5705 4593

RE: Request for Comments on CL 2001/24-GP

Dear Secretary:

The International Council of Grocery Manufacturers Associations (ICGMA) is an international non-governmental organization (INGO) with official recognition before the Codex Alimentarius Commission and other international fora. ICGMA represents the interests of national and regional associations who collaborate with all sectors of the consumer packaged goods industry. ICGMA promotes the harmonization of scientific standards and policies concerned with health, safety, packaging, and labeling, of foods, beverages and other consumer packaged goods. ICGMA also works to facilitate international trade in the sector by eliminating or preventing artificial barriers to trade. It is in this context that ICGMA submits the following comments to the CL 2001/24-GP as requested by your office.

The ICGMA commends the Secretariat in their diligent efforts in developing the Draft Working Principles for Risk Analysis (Draft) and believe that it fairly reflects the decisions and amendments made during the 24th Session of the Codex Alimentarius Commission.

ICGMA offers the following specific comments and recommendations to the Draft.

Comments are provided to specific paragraphs as numbered:

Scope:

1. This statement accurately reflects the decision of the Commission that principles of risk analysis be applied to the framework of Codex.

2. Insert the word, “scientific” after second “objective.”

7. Replace “consumers and their representative organizations, and other interested parties” with “all interested parties” for consistency with paragraph 8.

Risk Analysis- General Aspects:

10. Delete bracketed text. Precaution should be used when negative effects on health are identified – not when those effects “are difficult to evaluate.”

11. Delete the bracketed text.

12. We agree with the premise, but questions how all needs and situations for developing countries can be identified. We suggest paragraph 38 verbiage.

16. Delete this paragraph and combine the concept with paragraph as indicated in our suggested new paragraph 17.

17. We suggest, “The mandate given by risk managers to risk assessors should be as clear as possible, taking into account available scientific evidence and any constraints affecting the risk assessment process. Risk managers should evaluate human health and safety risk reductions resulting from different risk management options."

Risk Assessment:

18. Suggest combining this paragraph with paragraph 19 as follows, “Science based risk assessments should form the basis of Codex standards, guidelines and recommendations. The scope and purpose of each risk assessment should be clearly stated and the outputs of the risk assessment should be defined.”

20. For clarity, suggest, “Experts responsible for risk assessment should be selected in a transparent manner on the basis of their expertise and their independence with regard to the interests involved. The procedures used to select these experts should be documented, including details of their expertise and experience and a declaration of any potential conflict of interest."

26. Suggest second sentence, “Any expression of uncertainty or variability in risk estimates should be quantified to the extent it is scientifically achievable.”

Risk Management: As these principles are “intended for application in the framework of the Codex Alimentarius,” we request clarification as to the role of Codex Alimentarius in risk management.

30. In accordance with the scope of the document and for consistency we suggest using language in paragraph. 2, “The basis of risk management decisions should be to protect the health of consumers while not unjustly hinder fair practices in food trade.”

31. Suggest, “…as identified in Criteria for the Consideration of Other Factors Referred to in the Second Statement of Principles.” after OLF.

34. Suggest, “Risk management options should be evaluated/assessed in terms of the objective outcomes of risk assessment and risk characterization, as well as the overall scope and purpose of risk analysis considering the risk of taking no action.

35. Suggest, “The outcome of the risk evaluation process should derive from the appropriate exercise of objective and scientific standards, weighing risks against benefits, with protection of consumer health and safety the primary consideration, and the standard of proof based on that articulated in Article 5.7 of the Sanitary and Phytosanitary (SPS) Agreements.

36. Agree with deletion.

37. Suggest, “Risk management should ensure transparency in the decision making process. Decisions should ensure consistency in similar circumstances to avoid unjustified trade barriers.

Risk Communication: As these principles are “intended for application in the framework of the Codex Alimentarius,” we request clarification as to the role of Codex Alimentarius in risk communication.

ICGMA appreciates this opportunity to present our comments and views on the Draft. We welcome the opportunity to participate in further deliberations on this issue to ensure the adoption of a document that satisfies the mandate of the Codex Alimentarius Commission: to protect health of consumers, and to facilitate fair practices in food trade.

Sincerely,

Mari Stull
Executive Secretariat
International Council of Grocery Manufacturers Associations
1010 Wisconsin Avenue, Suite 900
Washington, DC 20007
USA

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