The 22nd Session of the Codex Commission (1999) decided that risk analysis should be an integral part of the Codex decision-making process and adopted an Action Plan for Codex - wide development and application of risk analysis principles and guidelines.

The elaboration of Working Principles for Risk Analysis for inclusion in the Procedural Manual has been undertaken by the Codex Committee for General Principles (CCGP) following this decision.

The 13th Session of the Codex Committee on General Principles (1998) considered the first version of the Proposed Draft Working Principles. It was redrafted for consideration by the 14th Session (1999).

The 14th Session of CCGP discussed the inclusion of a reference to the precautionary principles/approach in the framework of risk management but could not come to a conclusion on the issue.

CCGP had recognized that precaution had consistently been a element of decision process in Codex for health protection. In practice, Governments may have to apply measures to protect the health of their consumers from serious hazards, even when there is not enough scientific evidence, for example, emergency measures in crisis situations.

Reference was also made to Article 5.7 of the SPS Agreement which recognizes the right of countries to take provisional measures in situations when scientific evidence is in sufficient, but there is a concomitant obligation to seek additional information necessary for a more objective risk assessment and to review any measures taken within a reasonable time frame.

Therefore guidelines on the application of Precaution could facilitate common understanding of risk analysis, but should not contradict the rights and obligations of member countries under SPS.

However, there was no consensus on the proposal to include a reference on precautionary principles in the section on risk management.

The discussion was carried forward to the 15th session (2000) and based on the views of the delegates two proposals referred to as 'alternative texts' were agreed to be included in the Working Principles. The drafting Group coordinated by the French Secretariat was requested to obtain comments and revise the text. The draft was retained at Step3.

At a meeting of the drafting group immediately preceding the 16th Session of CCGP, the comments and proposed wordings for the text were deliberated at length, however no consensus was achieved. A compromise text was put forth for discussions. The Committee decided to revise the draft and seek clarification from the Commission regarding:

a) Scope of Working Principles: i.e. whether it is intended as a text exclusively for application within the Codex framework or by member Governments;

b) How Codex should react when scientific data were insufficient or incomplete and evidence of risk to human health existed, in particular whether it should proceed to elaborate a Codex standard or related text or whether it should refrain from such action

The Commission discussed the subject at its 24th Session (2001) and made the following recommendations:

a) the current proposed draft of the Working Principles extends the Scope from guidance to Codex Committees to general guidance for both Codex Committees and governments.

b) referring to the recommendations to the FAO Conference on International Trade Beyond 2000; Science Based Decisions, Harmonization, Equivalence and Mutual Recognition, Melbourne, consideration of Precaution was supported by several delegations, whereas some others were of the view that the Commission should not elaborate standards and related texts when dated was insufficient as Codex recommendations represented a reference at the international level and should be based on adequate scientific evidence.

The Commission took the following position based on majority opinion although there was no consensus:

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

At the 17th Session of CCGP (2002) the proposed draft Working Principles on Risk Analysis was discussed in light of clarifications from CAC, comments and discussions and advanced to Step 5 for consideration by the 50th Session of the Executive Committee. When finalized it will be included in the Procedural Manual for general guidance to the Commission and its Subsidiary Bodies.