Codex Committee on General Principles, at its 1211 session held during 25 - 29 November 1996 in Paris, France has reached a number of resolutions to work in accordance with the WTO agreements on SPS/TBT measures to which Codex standards have been referred.

Review of the Status of Codex, Guidelines and Related Texts

The Committee recalled that all types of Codex texts when applied to foods in international trade would be covered either by the definitions of "international standards, guidelines and recommendations" under SPS or the definitions "technical regulations" or "standards" under TBT. Therefore, the Committee agreed to recommend that the use of the terms "advisory" and "mandatory" should be discouraged.

Following the discussions, the Committee has reached the following recommendations:

• In view of the confusion created by the use of the term "advisory" and as the term cannot be defined satisfactorily and the SPS and TBT Agreements do not appear to distinguish between mandatory and advisory texts, its use within the Codex framework should be discouraged, as well as the use of the term "mandatory".

• All Codex tests specific to the control of food moving in international trade should be elaborated with the same degree of rigour and scientific justification where appropriate as Codex standards.

• Codex Standards or any other texts which establish quality criteria for products additional to essential quality factors should clearly indicate that such criteria are intended for voluntary application by commercial partners, as follows: "This text is not intended as a standard, guideline, recommendation, or technical regulation within the meaning of the SPS and TBT Agreements".

• The degree of explanatory material contained in Codex texts should be adequate for the interpretation of the text.

Role of science in the decision making process

The committee recommended that 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 should be incorporated in the Procedural Manual.

Moreover, the Committee agreed to include the four statements of principle relating to the role of food safety risk assessment as well as its definitions of follows:

1. Statements of Principle relating to the Role of Food Safety Risk Assessment
   1. Health and safety aspects of Codex decisions and recommendations should be based on a risk assessment, as appropriate to the circumstances.

   2. Food safety risk assessment should be soundly based on science, should incorporate the four steps of the risk assessment process, and should be documented in a transparent manner.

   3. There should be a functional separation of risk assessment and risk management, while recognizing that some interactions are essential for a pragmatic approach.

   4. Risk assessments should use available quantitative information to the greatest extent possible and risk characterizations should be presented in a readily understandable and useful form.

2. Definitions of Risk Analysis Terms related to Food Safety*

   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 of weighing policy alternatives in the light of the results of risk assessment and, if required, selecting and implementing appropriate control options, including regulatory measures.

   RISK COMMUNICATION: The interactive exchange of information and opinions concerning risk among risk assessors, risk managers, consumers and other interested parties.

Review of the acceptance procedure for Codex Standards in the perspective of the WTO SPS/TBT agreements

The Committee supported the view that the current acceptance procedures, although they offered transparency in the use of Codex Standards, had not completely achieved this goal and in any case were no longer appropriat6 in the light of the SPS and TBT Agreements. The committee recommended the revised procedure to provide for:

• clearly defined objectives; and

• simple acceptance procedures, the least bureaucratic possible; and/or

• simple notification procedures, the least bureaucratic possible.

Revision of the Procedural Manual

Supporting the concept "transparency" of WTO, the Committee endorsed the proposal concerning participation in an observer capacity of international organizations other than those in formal relation with either FAO or WHO. It noted that such organizations were considered as "recognized" if they were listed as "international organizations" in the Yearbook of International Organizations published annually by the Union of International Organizations and also confirmed the attendance of Regional Coordinators as observers at sessions of the Executive Committee.

* These Definitions are proposed on an interim basis: they are subject to modification in the light of developments in the science of risk analysis and as result of efforts to harmonize similar definitions across various disciplines.