Industry groups urge EC to rethink health claim criteria (again)

By Shane Starling

- Last updated on GMT

EU industry groups have written to the EC arguing for wholesale health claims assessment changes
EU industry groups have written to the EC arguing for wholesale health claims assessment changes

Related tags European union European food safety authority

The ongoing high rejection rate of health claim submissions under European Union regulations has prompted EU trade groups to reiterate their stance that the claims assessment process needs a severe and serious rethink.

The three Brussels-based groups – the European Federation of Associations of Health Product Manufacturers (EHPM), the European Botanical Forum (EBF) and the European Responsible Nutrition Alliance (ERNA) – announced their criticisms in the wake of the publication on Friday of the fourth batch of article general function health opinions, although their 33-page letter was mailed to the Commission on the March 16, 2011.

The letter urges Basil Mathioudakis, the Commission’s head of Food Law, Nutrition and Labelling, to conduct a complete reappraisal of the 2006 nutrition and health claims regulation (NHCR) to allow thousands of claims to be re-evaluated, based on an alternative and more appropriate approach”.

Such an approach would, “consider the totality and a weighing of the evidence to provide a balanced view on the strength, consistency and plausibility of health benefits of food components.”


Three “major reasons” ​are given for many of the health claim rejections:

  • Problems with the format in which dossiers have been compiled.​ “Discrepancy between the way in which the information has been compiled and presented and the way in which EFSA is carrying out its assessments”.
  • Reliance on randomised controlled trials.“These weaknesses include the focus on isolated food components (which often do not exist in isolation) rather than on foods…”
  • Interpretation of the NHCR. We have reasons to believe that these interpretations are unduly restrictive and lead to the impossibility to acknowledge and assess a number of health effects under the terms of the claims legislation.”

Call for change

It is not the first time the three groups have written to the EC. Previous missives expressed similar misgivings and contributed to the EC pulling botanicals from the system and deciding to authorise all European Food Safety Authority (EFSA) opinions simultaneously – probably at the end of this year.

The current letter brings focus to the EFSA and EC acknowledged “learning process”​ of the NHCR as a principal reason for a process rethink.

“It has now been widely recognised that the implementation of the claims legislation is a learning process and that consequences only become fully clear as the process progresses,”​ said ERNA secretary general, Patrick Coppens.

“Many claims, for example, are receiving negative EFSA opinions because the format used to submit them is not consistent with the format adopted by EFSA to assess them. This is the result of no guidance being available for industry on the submission of claims, and as a consequence EFSA has rejected many claims without assessing the evidence.”

The groups called on the EC not to prohibit any claims based on negative EFSA opinions until they could be resubmitted under different criteria.

They called on EFSA to:

  • Consider the totality of evidence
  • Involve academics in discussions on specific topics, to achieve a consensus based acceptance of the health effects under consideration.”
  • Reconsider claims rejected due to characterisation of substance or non-specific claim issues.
  • Reconsider treatment of ‘contains antioxidant’ or ‘contains probiotic’ claims.

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