Diverging Views Remain on Art. 13.1 Health Claims Assessment Process

EHPM recently submitted a complaint to the European ombudsman arguing that the assessment of article 13.1 claims is not in accordance with the requirements of the EU Nutrition and Health Claims Regulation.

Dec 14 2011 --- Consensus among academics, scientists, authorities and the food supplement sector on the assessment of article 13.1 health claims is still a long way off, but opportunities for more dialogue have opened up, European trade association EHPM has said.

Commenting at the conclusion of a two-day food supplement conference in Berlin last week (8-9 December 2011), EHPM said that the event highlighted the still hugely diverging opinions on the interpretation of the EU Nutrition and Health Claims Regulation’s claims assessment requirements, but welcomed the invitation from the European Food Safety Authority (EFSA) for more dialogue to take place involving the different interested bodies.

The event focused heavily on health claims, with issues raised by representatives of the European food supplement industry regarding the discrepancy in understanding of recital 26 of the regulation, which states that article 13.1 claims should undergo a different assessment to article 13.5 and 14 claims.

Professor David Richardson, scientific adviser to the UK Council for Responsible Nutrition and speaker at the event, also stressed the regulation’s reference to assessment based on the totality of the available data, highlighting that the legislation requires an assessment of the weight of the evidence and the ‘extent to which’ the cause and effect can be assessed, a procedure that many in the food sector have argued has not been followed for article 13.1 claims.

“The reference to the ‘extent to which’ a cause and effect can be assessed is to me an assessment of whether it is strong, moderate or weak,” said Professor Richardson. “This type of assessment is helpful for regulators too, as it is a thorough basis upon which they can base their decisions. However, EFSA requires conclusive evidence. This is a challenge for the scientific community as a whole, because to get conclusive evidence of anything is very difficult.”

European trade association EHPM agreed, reiterating its argument for EFSA to assess the strength, consistency and biological plausibility of the evidence in a similar way to the diet and health relationships assessed by the World Health Organization and the World Cancer Research Fund.

“The regulation does not require a focus on conclusive evidence of cause and effect and this requirement is not proportionate legally or scientifically,” said EHPM Chairman Peter van Doorn. “The legislation requires a scientific assessment of the highest possible standard but this standard cannot be automatically associated with the EFSA interpretation for conclusive proof of cause and effect and simple yes or no opinion. What we need is a transparent and proportionate scientific and regulatory framework for assessing the weight of the totality of the evidence in support of a beneficial nutritional and/or physiological effect. This is an argument that we have brought to the table since the regulation’s terms of reference was published years ago.”

EHPM recently submitted a complaint to the European ombudsman arguing that the assessment of article 13.1 claims is not in accordance with the requirements of the EU Nutrition and Health Claims Regulation.