The Appendix contains the various proposals put forward in relation to paragraphs 5 and 34-35 of the Proposed Draft Working Principles for Risk Analysis (see para. 70 of the Report)
PARAGRAPH 5
[5. Precaution is an essential element of risk analysis. This is particularly important where the scientific evidence is insufficient and negative effects on health difficult to evaluate. Precaution should be exercised through the use of appropriate assumptions in the risk assessment and the choice of risk management options that reflect the confidence in the available scientific information.]
Additional Australian Proposal
[5 bis. Many sources of uncertainty exist in the process of risk assessment of food borne hazards to human health. The degree of uncertainty and variability in the available scientific information should be explicitly considered in the risk analysis process. As the degree of scientific uncertainty increases, the assumptions used for the risk assessment and the risk management options selected should become more cautious and conservative.]
PARAGRAPH 34
ORIGINAL TEXT (CX/GP 01/3)
"When relevant scientific evidence is insufficient to objectively and fully assess risk from a hazard in food [1], 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 their extent, it may be appropriate for [risk managers/members governments] to apply precaution [2] through interim measures to protect the health of consumers, without awaiting additional scientific data and a full risk assessment.
However, additional information for a more objective risk assessment should be sought and the measures taken reviewed accordingly [within a reasonable time frame/until a more complete risk assessment is performed]."
[1] It is recognized that hazard identification is a crucial step in this process.
[2] Some Members refer to this concept as the "precautionary principle".
WORKING GROUP COMPROMISE TEXT
[34. When relevant scientific evidence is insufficient to objectively and fully assess risk from a hazard in food, and where there is reasonable evidence from a preliminary risk assessment to suggest that adverse effects on human health may occur, but it is difficult to evaluate their nature and their extent, it may be appropriate for risk managers to apply precaution [1] through actions adapted to circumstances, in order to protect the health of consumers without awaiting additional scientific data and full risk assessment.
34bis. In the case of Codex, such precautionary actions could comprise the development of guidelines, recommendations or, where possible, standards. [In circumstances in which there is insufficient confidence in available information, Codex should not take any action.]
34ter. In addition, in the case of member governments, precaution may be applied through interim measures.
34qua. In both cases, additional information should be sought, a more complete risk assessment should be performed, and the measures taken reviewed, all in a reasonable time frame.]
[[1] Some Members refer to this concept as the "precautionary principle".]
AUSTRALIAN TEXT
[33bis. In deciding whether to elaborate a standard, guideline or recommendation relating to a particular hazard in food, Codex should consider the adequacy of current scientific knowledge, the level and extent of the risk to human health. Where there is evidence of a risk to human health but scientific knowledge is insufficient to provide a sound basis for a standard (such as maximum limit for a contaminant) Codex may consider other risk management options (such as Codes of Practice to minimise contamination of food) while awaiting further developments in scientific knowledge.
34. When relevant scientific evidence is insufficient to objectively and fully assess risk from a hazard in food, and where there is reasonable evidence from a preliminary risk assessment 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 governments to apply precaution [1] through interim measures, in order to protect the health of consumers without awaiting additional scientific data and a full risk assessment.
However, additional information should be sought, a more complete risk assessment should be performed, and the measures taken reviewed, all in a reasonable time frame.]
[[1] Some Members refer to this concept as the "precautionary principle".]
PARAGRAPH 35
ORIGINAL TEXT (CX/GP 01/3)
[35. In such situations the following considerations should be taken into account:
a) Examination of the full range of management options should be undertaken with all the stakeholders. This should include an assessment of the potential advantages and disadvantages of the alternative measures, including, where appropriate, flexibility and cost, effectiveness considerations.b) There should be a transparent explanation of the need for the measures and the procedures followed to establish them.
c) The decisions/measures taken are proportional to the potential extent of the health risk and based on the available scientific data.
d) The decisions/measures taken are consistent with those taken in similar circumstances, based on all the available pertinent information, including available scientific information.
e) The measures taken are the least trade restrictive to achieve protection of the health of consumers.
f) The decisions/measures are subject to an on-going, transparent review process involving interested stakeholders.
g) Information should continue to be gathered to strengthen the scientific evidence. The original decisions should be reviewed and decisions taken to retain, modify, strengthen or rescind any measures as appropriate in the light of such information.]
