74 CAC/LIM 21 (ALINORM 97/9-Rev. 1); and ALINORM 97/4, paras. 10-14.
ACTION PLAN FOR CODEX-WIDE DEVELOPMENT AND APPLICATION OF RISK ANALYSIS PRINCIPLES AND GUIDELINES
160. The Commission noted that since its 20th Session it had been considering matters regarding risk analysis in Codex. So far in the area of risk analysis, expert consultations had been held on the application of risk analysis to food standard issues, risk management and food safety, and food consumption and exposure assessment of chemicals. At present risk analysis was considered to be an integral part of the decision-making process of Codex. The Commission recalled that it agreed earlier in this Session to include risk analysis definitions in the Procedural Manual75.
75 See paras. 29-31.
161. The original paper, ALINORM 97/9, had been prepared with an objective to develop an action plan to be taken by Codex to apply risk analysis more consistently and uniformly with a particular emphasis on risk management. The paper included the recommendations made by the Joint Expert Consultation on Risk Management and Food Safety76 for consideration by the Commission. The Executive Committee held immediately before this Session, after considering ALINORM 97/9, amended the proposed action plan for Codex-wide development and application of risk analysis principles and guidelines. Based on this decision, CAC/LIM 21 was subsequently published.
76 Annex 1 of CAC/LIM 21.
162. The Commission focused its discussions on the proposed action plan as amended by the Executive Committee77. The Commission unanimously agreed on the importance of risk analysis in Codex work and to show positive responses to the recommendations in the paper. However, some delegations stated that due to the late availability of the original and amended papers, there needed to be sufficient time provided to consider thoroughly both the content of the paper and its implications.
77 ALINORM 97/4, para. 14; and CAC/LIM 21, para. 32.
163. In developing a strategy and action plan for development and application of risk analysis principles and guidelines in all Codex activities where appropriate, the Codex Alimentarius Commission:
· took note of recommendations 2 to 6 addressed to it by the Joint FAO/WHO Expert Consultation on Risk Management, and requested the relevant Codex Committees to consider the recommendations and to propose action as necessary;
· welcomed recommendations 778, 9 and 11 of the Expert Consultation addressed to FAO and WHO and, in particular, commended recommendation 9 to provide assistance to developing countries in the application of risk management, and noted recommendation 8;78 Concerning Recommendation 7, see paragraph 139.
· noted that it might not be possible or appropriate to apply risk management policies based on a single risk management strategy for the different classes of hazards which needed to be addressed: different policies might need to be applied under the same generic principles to the management of different classes of hazards79.79 It was explained that different risk management policies had been applied within the Codex system, e.g., ADI-based models representing notional "zero-risk" policies for chemicals; microbiological criteria representing notional "zero-risk" for specific pathogens in cooked foods; ALARA policies for non-threshold chemical contaminants such as genotoxic carcinogens and some environmental contaminants; and ALARA policies for risks associated with biological hazards in raw foods.
164. The Commission will:
(i) Circulate the proposed Definitions for Risk assessment policy and Risk profile to governments, Codex committees and interested international organizations for comment, and request the Codex Committee on General Principles to consider these comments with a view to making firm recommendations for adoption of these definitions to the 23rd Session of the Commission;
(ii) Request the Codex Committee on General Principles to elaborate integrated principles for risk management and risk assessment policy setting, risk communication and documentation for inclusion in the Procedural Manual. Proposed "working principles" are contained in Annex 2 to ALINORM 97/9 -Rev. 1;
(iii) Once principles have been established, prepare specific guidelines as required to aid in the uniform application of the principles. The Codex Committee on General Principles should be requested to co-ordinate this exercise and all relevant Codex Committees should be involved;8080 This would include requiring that Codex Committees involved in any aspect of risk analysis formally describe their implementation of the Codex principles and guidelines, using a standardised summary format, for publication in their respective reports and recommend that advisory bodies such as JECFA and JMPR do the same. It would also require that that Codex Committees develop standards using these principles and guidelines as a checklist, and in doing so adhere closely to their documented risk assessment/risk management policies.
(iv) As the principles and guidelines have been established, include them in the Procedural Manual, with the addition of an introductory narrative on risk analysis in the Codex system and identification of the responsibilities of Committees in implementation of the principles and guidelines;
(v) Recognise that the judgement of equivalence of food control systems in different countries is a critical issue, and that Codex principles and guidelines associated with determination of equivalence will facilitate this process;
(vi) Until such time as the principles are adopted by the Commission, request JECFA, JMPR and other advisory bodies and Codex Committees to continue evaluating and improving the application of the elements of risk assessment and risk management that they have prioritised for attention;
(vii) Encourage further development of qualitative risk assessment approaches so as to achieve early improvements in elaboration of food standards.
Discussion on Matters other than the Action Plan
165. The Commission agreed that the Codex Working Principles for Risk Analysis would be elaborated through the step-wise procedure, with the possibility of omission of steps should the Committee on General Principles so recommend.
166. As regards the recommendation on maximum accessibility of published documents, the Delegation of the United States stated that in addition to make all process of risk analysis transparent, it was extremely important that results of risk assessment be published to be available for others to obtain information and/or to confirm their own evaluations. The Observer from the Consumers International also expressed interest in reference to interactive communication with consumers in the Proposed Codex Working Principles. The Observer from Consumers International commended the reference to interactive communication with consumers in all aspects of the risk analysis process in the Proposed Working Principles for Risk Analysis but noted inconsistencies in the application of this principle by Codex and stressed the need for Codex to address risk management as a democratic policy-making process in which openness, transparency and effective participation are central.
167. It was requested that assistance of FAO and WHO to developing countries in the application of risk management be extended to the risk assessment area. The Delegation of India supported by some other delegations strongly expressed the view that the risk analysis needs of the developing countries should be specifically identified and addressed, and that adequate and flexibility should be provided where appropriate to meet any special needs of developing countries.