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14 April 2010—In its first official action, CRN International (CRN-I) has submitted comments to the European Food Safety Authority (EFSA) on its document, “Guidance on human health risk benefit assessment of foods.” EFSA asked its Scientific Committee to prepare a guidance document for performing risk benefit assessments of food related to human health risks and human health benefits, and gave stakeholders the opportunity to comment. CRN-I pointed out a number of ambiguities requiring clarification as well as instances of double standards. For example, the draft declared that benefits must be “likely” but risks need to be only “potential.” CRN-I observed, “This double standard can produce pernicious neglect of providing benefits, while overreacting to possible risks.”

The comments also called for acknowledgement on EFSA’s part that use of risk benefit analysis to control entry of new products into the marketplace would require new legislation or regulation because most jurisdictions now regulate citation of benefit and safety under separate reviews and decisions. Further, the comments noted that a major limitation of randomized control trials (RCT) is not mentioned in the draft, but should be. “Although RCTs are necessary to show causality in humans, a failure to identify a specific beneficial effect in a specific RCT should not be overly generalized.  The failure to find benefit may reflect a choice of an inappropriate endpoint, or it may reflect the status of the test cohort but not a majority of the population or a significant subpopulation,” CRN-I’s comments explained.

Click here to download the comments and corresponding draft (PDF).