Appendix IV. Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius

SCOPE

1) These principles for risk analysis are intended for application in the framework of the Codex Alimentarius.

2) The objective of these Working Principles is to provide guidance to the Codex Alimentarius Commission and the joint FAO/WHO expert bodies and consultations, so that food safety and health aspects of Codex standards and related texts are based on risk analysis.

3) Within the framework of the Codex Alimentarius Commission and its procedures, the responsibility for providing advice on risk management lies with the Commission and its subsidiary bodies (risk managers), while the responsibility for risk assessment lies primarily with the joint FAO/WHO expert bodies and consultations (risk assessors).

RISK ANALYSIS - GENERAL ASPECTS

4) The risk analysis used in Codex should be:

- applied consistently;

- open, transparent and documented;

- conducted in accordance with both the Statements of Principle Concerning the Role of Science in the Codex Decision-Making Process and the Extent to Which Other Factors are Taken into Account and the Statements of Principle Relating to the Role of Food Safety Risk Assessment; and

- evaluated and reviewed as appropriate in the light of newly generated scientific data.

5) The risk analysis should follow a structured approach comprising the three distinct but closely linked components of risk analysis (risk assessment, risk management and risk communication) as defined by the Codex Alimentarius Commission^[118], each component being integral to the overall risk analysis.

6) The three components of risk analysis should be documented fully and systematically in a transparent manner. While respecting legitimate concerns to preserve confidentiality, documentation should be accessible to all interested parties^[119].

7) Effective communication and consultation with all interested parties should be ensured throughout the risk analysis.

8) The three components of risk analysis should be applied within an overarching framework for management of food related risks to human health.

9) There should be a functional separation of risk assessment and risk management, in order to ensure the scientific integrity of the risk assessment, to avoid confusion over the functions to be performed by risk assessors and risk managers and to reduce any conflict of interest. However, it is recognized that risk analysis is an iterative process, and interaction between risk managers and risk assessors is essential for practical application.

10) When there is evidence that a risk to human health exists but scientific data are insufficient or incomplete, the Codex Alimentarius Commission should not proceed to elaborate a standard but should consider elaborating a related text, such as a code of practice, provided that such a text would be supported by the available scientific evidence.^[120]

11) Precaution is an inherent element of risk analysis. Many sources of uncertainty exist in the process of risk assessment and risk management of food related hazards to human health. The degree of uncertainty and variability in the available scientific information should be explicitly considered in the risk analysis. Where there is sufficient scientific evidence to allow Codex to proceed to elaborate a standard or related text, the assumptions used for the risk assessment and the risk management options selected should reflect the degree of uncertainty and the characteristics of the hazard.

12) 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.

RISK ASSESSMENT POLICY

13) Determination of risk assessment policy should be included as a specific component of risk management.

14) Risk assessment policy should be established by risk managers in advance of risk assessment, in consultation with risk assessors and all other interested parties. This procedure aims at ensuring that the risk assessment is systematic, complete, unbiased and transparent.

15) The mandate given by risk managers to risk assessors should be as clear as possible.

16) Where necessary, risk managers should ask risk assessors to evaluate the potential changes in risk resulting from different risk management options.

RISK ASSESSMENT^[121]

17) The scope and purpose of the particular risk assessment being carried out should be clearly stated and in accordance with risk assessment policy. The output form and possible alternative outputs of the risk assessment should be defined

18) Experts responsible for risk assessment should be selected in a transparent manner on the basis of their expertise, experience, and their independence with regard to the interests involved. The procedures used to select these experts should be documented including a public declaration of any potential conflict of interest. This declaration should also identify and detail their individual expertise, experience and independence. Expert bodies and consultations should ensure effective participation of experts from different parts of the world, including experts from developing countries.

19) Risk assessment should be conducted in accordance with the Statements of Principle Relating to the Role of Food Safety Risk Assessment and should incorporate the four steps of the risk assessment, i.e. hazard identification, hazard characterization, exposure assessment and risk characterization.

20) Risk assessment should be based on all available scientific data. It should use available quantitative information to the greatest extent possible. Risk assessment may also take into account qualitative information.

21) Risk assessment 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.

22) Risk assessment should seek and incorporate relevant data from different parts of the world, including that from developing countries. These data should particularly include epidemiological surveillance data, analytical and exposure data. Where relevant data are not available from developing countries, the Commission should request that FAO/WHO initiate time-bound studies for this purpose. The conduct of the risk assessment should not be inappropriately delayed pending receipt of these data; however, the risk assessment should be reconsidered when such data are available.

23) Constraints, uncertainties and assumptions having an impact on the risk assessment should be explicitly considered at each step in the risk assessment and documented in a transparent manner. Expression of uncertainty or variability in risk estimates may be qualitative or quantitative, but should be quantified to the extent that is scientifically achievable.

24) 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, where relevant.

25) The report of the risk assessment should indicate any constraints, uncertainties, assumptions and their impact on the risk assessment. Minority opinions should also be recorded. The responsibility for resolving the impact of uncertainty on the risk management decision lies with the risk manager, not the risk assessors.

26) The conclusion of the risk assessment including a risk estimate, if available, should be presented in a readily understandable and useful form to risk managers and made available to other risk assessors and interested parties so that they can review the assessment.

RISK MANAGEMENT

27) While recognizing the dual purposes of the Codex Alimentarius are protecting the health of consumers and ensuring fair practices in the food trade, Codex decisions and recommendations on risk management should have as their primary objective the protection of the health of consumers. Unjustified differences in the level of consumer health protection to address similar risks in different situations should be avoided.

28) Risk management should follow a structured approach including preliminary risk management activities^[122], evaluation of risk management options, monitoring and review of the decision taken. The decisions should be based on risk assessment, and taking into account, where appropriate, other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in food trade, in accordance with the Criteria for the Consideration of the Other Factors Referred to in the Second Statement of Principles^[123].

29) The Codex Alimentarius Commission and its subsidiary bodies, acting as risk managers in the context of these Working Principles, should ensure that the conclusion of the risk assessment is presented before making final proposals or decisions on the available risk management options, in particular in the setting of standards or maximum levels, bearing in mind the guidance given in paragraph 10.

30) 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, feasibility of enforcement and compliance, and the prevalence of specific adverse health effects.

31) The risk management process should be transparent, consistent and fully documented. Codex decisions and recommendations on risk management 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 by all interested parties.

32) The outcome of the preliminary risk management activities and the risk assessment should be combined with the evaluation of available risk management options in order to reach a decision on management of the risk.

33) Risk management options should be assessed in terms of the scope and purpose of risk analysis and the level of consumer health protection they achieve. The option of not taking any action should also be considered.

34) In order to avoid unjustified trade barriers, risk management should ensure transparency and consistency in the decision-making process in all cases. Examination of the full range of risk management options should, as far as possible, take into account an assessment of their potential advantages and disadvantages. When making a choice among different risk management options, which are equally effective in protecting the health of the consumer, the Commission and its subsidiary bodies should seek and take into consideration the potential impact of such measures on trade among its Member countries and select measures that are no more trade-restrictive than necessary.

35) Risk management should take into account the economic consequences and the feasibility of risk management options. Risk management should also recognize the need for alternative options in the establishment of standards, guidelines and other recommendations, consistent with the protection of consumers’ health. In taking these elements into consideration, the Commission and its subsidiary bodies should give particular attention to the circumstances of developing countries.

36) 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 should be reviewed regularly and updated as necessary to reflect new scientific knowledge and other information relevant to risk analysis.

RISK COMMUNICATION

37) Risk communication should:

i) promote awareness and understanding of the specific issues under consideration during the risk analysis;

ii) promote consistency and transparency in formulating risk management options/recommendations;

iii) provide a sound basis for understanding the risk management decisions proposed;

iv) improve the overall effectiveness and efficiency of the risk analysis;

v) strengthen the working relationships among participants;

vi) foster public understanding of the process, so as to enhance trust and confidence in the safety of the food supply;

vii) promote the appropriate involvement of all interested parties; and

viii) exchange information in relation to the concerns of interested parties about the risks associated with food.

38) Risk analysis should include clear, interactive and documented communication, amongst risk assessors (Joint FAO/WHO expert bodies and consultations) and risk managers (Codex Alimentarius Commission and its subsidiary bodies), and reciprocal communication with member countries and all interested parties in all aspects of the process.

39) Risk communication should be more than the dissemination of information. Its major function should be to ensure that all information and opinion required for effective risk management is incorporated into the decision making process.

40) Risk communication involving interested parties should include a transparent explanation of the risk assessment policy and of the assessment of risk, including the uncertainty. The need for specific standards or related texts and the procedures followed to determine them, including how the uncertainty was dealt with, should also be clearly explained. It should indicate any constraints, uncertainties, assumptions and their impact on the risk analysis, and minority opinions that had been expressed in the course of the risk assessment (see para.25).

41) The guidance on risk communication in this document is addressed to all those involved in carrying out risk analysis within the framework of Codex Alimentarius. However, it is also of importance for this work to be made as transparent and accessible as possible to those not directly engaged in the process and other interested parties while respecting legitimate concerns to preserve confidentiality (See para. 6).

ANNEX 1

DEFINITIONS

Definitions included in the Procedural Manual

Hazard: A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.

Risk: A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.

Risk Analysis: A process consisting of three components: risk assessment, risk management and risk communication.

Risk Assessment: A scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization.

Hazard Identification: The identification of biological, chemical, and physical agents capable of causing adverse health effects and which may be present in a particular food or group of foods.

Hazard Characterization: The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents, which may be present in food. For chemical agents, a dose-response assessment should be performed. For biological or physical agents, a dose-response assessment should be performed if the data are obtainable.

Dose-Response Assessment: The determination of the relationship between the magnitude of exposure (dose) to a chemical, biological or physical agent and the severity and/or frequency of associated adverse health effects (response).

Exposure Assessment: The qualitative and/or quantitative evaluation of the likely intake of biological, chemical, and physical agents via food as well as exposures from other sources if relevant.

Risk Characterization: The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment.

Risk Management: The process, distinct from risk assessment of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.

Risk Communication: The interactive exchange of information and opinions throughout the risk analysis process concerning risk, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions.

Other Definitions

Risk Assessment Policy: Documented guidelines on the choice of options and associated judgements for their application at appropriate decision points in the risk assessment such that the scientific integrity of the process is maintained.

Risk profile: The description of the food safety problem and its context

Risk estimate: The quantitative estimation of risk resulting from risk characterization.