(Returned to Step 3 of the Procedure)
SCOPE
1) The principles for risk analysis are intended for application in the framework of Codex Alimentarius and are also intended to provide advice to governments where applicable.
2) The primary purpose of risk analysis by the Codex Alimentarius Commission is protecting the health of consumers while at the same time ensuring fair practices in the food trade.
3) The objective of the Working Principles is to ensure that Codex standards and related texts intended to protect the health of consumers are based on risk analysis.
4) Within the framework of Codex Alimentarius Commission and its procedures, the responsibility for risk management lies with the Commission and its subsidiary bodies, while the responsibility for risk assessment normally lies with the Joint FAO/WHO Expert Committees and Consultations.
RISK ANALYSIS - GENERAL ASPECTS
1. The risk analysis process used in Codex should be [soundly based on science,] consistent, open and transparent and follow a structured approach comprising the three components of risk analysis (risk assessment, risk management and risk communication), each component being integral to the overall risk analysis process.
2. The three components of risk analysis should be documented fully and systematically in a transparent manner, with the documentation accessible to all interested parties.
3. Effective communication and consultation with all interested parties should be ensured throughout the risk analysis process.
4. There should be a functional separation of risk assessment and risk management, in order to ensure the scientific integrity of the risk assessment and reduce any conflict of interest between risk assessment and risk management. However it is recognized that risk analysis is an iterative process, and interaction between risk managers and risk assessors are essential for practical application
5. Precaution is an essential element of risk analysis. This is particularly important where scientific evidence is insufficient and negative effects on health are difficult to evaluate.
6. The needs and situations of developing countries should be specifically identified and taken into account by the responsible bodies in the different stages of the risk analysis process.
RISK ASSESSMENT
7. Health and safety aspects of Codex decisions and recommendations should be based on a risk assessment, as appropriate to the circumstances.
8. The scope and purpose of the particular risk assessment being carried out should be clearly stated. The output form and possible alternative outputs of the risk assessment should be defined
9. 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 and the procedures used to select these experts should be documented including a public declaration of any potential conflict of interest.
10. Risk assessment should be based soundly on science and should incorporate the four steps of the risk assessment process, i.e. hazard identification, hazard characterization, exposure assessment and risk characterization.
11. Risk assessment should take into account uncertainties at each step in the risk assessment process and variability in risk estimates.
12. Any constraints, uncertainties and assumptions and their impact on the risk assessment should be documented in a transparent manner, including constraints that are likely to influence the quality of the risk estimate. Expression of uncertainty or variability in risk estimates may be qualitative or quantitative.
13. Risk assessments should use available quantitative data to the greatest extent possible and may include non-measurable, qualitative data. Risk characterisations should be presented in a readily understandable and useful form.
14. Risk assessments should be based on realistic exposure scenarios, with consideration of different situations being defined by risk assessment policy. They should include consideration of susceptible and high risk population groups. Acute, chronic (including long-term), cumulative and/or combined adverse health effects should be taken into account in carrying out risk assessment.
15. Recognizing that primary production in developing countries is largely through small and medium enterprises, risk assessment should be based on data from different parts of the world, including that from developing countries. This data should particularly include epidemiological surveillance data and exposure studies.
16. Risk assessment should take into account all available scientific data and relevant production and handling practices used throughout the food chain including traditional practices, methods of analysis, sampling and inspection and the prevalence of specific adverse health effects.
17. The conclusions of the risk assessment should be conveyed to risk managers in a readily understandable form. The responsibility for resolving the impact of uncertainty on the risk management decision lies with the risk manager, not the risk assessor.
18. To ensure a transparent risk assessment, a formal record, including a summary, should be prepared and made available to other risk assessors and interested parties so that they can review the assessment. It should indicate any constraints, uncertainties, assumptions and their impact on the risk assessment, and minority opinions.
RISK ASSESSMENT POLICY
19. Determination of risk assessment policy should be included as a specific component of risk management. 20. Risk assessment policy consists of documented guidelines for scientific judgement and policy choices to be applied at appropriate decision points during risk assessment.
21. To ensure that the risk assessment process is systematic, complete and transparent, risk assessment policy should be established by risk managers in advance of risk assessment, in consultation with risk assessors and all other interested parties.
22. [The mandate given by risk managers to risk assessors should be achievable, taking into account available scientific evidence and any constraints affecting the risk assessment process.] 23. Where necessary, risk managers may ask risk assessors to evaluate the potential risk reduction resulting from different risk management options.
RISK MANAGEMENT
24. Risk management decisions should have as their primary objective the protecting the health of consumers. Decisions on acceptable levels of risk should be determined primarily by human health considerations, and unjustified differences in the level of acceptable risk should be avoided.[17]
25. Risk management should follow a structured approach [be grounded on science-based risk assessment and take into account other legitimate factors as appropriate]. The risk management framework includes [risk evaluation][18], assessment of risk management options, implementation of management decisions, and monitoring and review[19].
26. In achieving agreed outcomes, risk management should take into account relevant production, storage and handling practices used throughout the food chain including traditional practices, methods of analysis, sampling and inspection and the prevalence of specific adverse health effects.
27. The risk management process should be transparent, consistent and fully documented. Risk management decisions should be documented, and where appropriate clearly identified in individual Codex standards and related texts so as to facilitate a wider understanding of the risk management process.
28. Risk management options should be evaluated in terms of the overall risk reduction.
29. The outcome of the risk evaluation process should be combined with the assessment of available risk management options in order to reach a decision on management of the risk. In arriving at a decision on risk management, protection of consumers' health should be the primary consideration, with other legitimate factors being considered as appropriate.[20]
30. Guidelines should be defined for the integration in the risk management process of legitimate factors other than science relevant for the health protection of consumers and for the promotion of fair practices in food trade.
31. In order to avoid unjustified trade barriers, risk management should ensure transparency and consistency in the decision-making process in all cases including where legitimate factors other than science are applied.
32. Risk management should take into account the economic consequences and the feasibility of risk management options in developing countries. Risk management should also recognize the need for flexibility in the establishment of standards, guidelines and other recommendations, consistent with the protection of consumers' health.
33. Risk management should be a continuing process that takes into account all newly generated data in the evaluation and review of risk management decisions. Food standards and related texts must be consistent with new scientific knowledge and other information relevant to risk analysis.
The two following paragraphs are alternative proposals:
34. [Where relevant scientific evidence is insufficient, precaution can be exercised as an interim measure to protect the health of consumers. However, additional information for a more objective risk assessment should be sought and the measures taken reviewed accordingly within a reasonable timeframe.] 34. [When relevant scientific evidence is insufficient to objectively and fully assess risk from a hazard in food[21], and where there is reasonable evidence to suggest that adverse effects on human health may occur, but it is difficult to evaluate their nature and extent, it may be appropriate for risk managers to apply precaution through interim measures to protect the health of consumers without awaiting additional scientific data and a full risk assessment, in accordance with the following criteria[22]:] 35. [In such situations the following criteria should be taken into account to ensure the consistency and transparency of the decision process:
RISK COMMUNICATION
36. Risk analysis should include clear, interactive and documented communication, between risk assessors and risk managers, and communication with consumers and other interested parties in all aspects of the process. 37. A major function of risk communication is establishing a process whereby information and opinion essential to effective risk assessment and risk management is exchanged between all interested parties.
38. In their communication with the public, risk managers should include a transparent explanation of the risk assessment policy and risk assessors should identify the uncertainty in risk estimates. The need for specific measures and the procedures followed to determine them should also be clearly explained.
39. A risk communication strategy should be proactive and include a plan specifying how information and opinion is to be communicated.
40. An assessment of uncertainty in risk estimates should be
included in the communication process with the public and other interested
parties.
