EHPM voices concern over claims not in the Article 13.1 permitted list

Article 13.1 health claims that have been given an unfavourable EFSA opinion should be carefully reassessed by applying a different type of assessment to that required for Article 13.5 and 14 claims, European trade association European Federation of Associations of Health Product Manufacturers has said.

Commenting on the vote today in favour of a list of permitted Article 13.1 claims for use in the European Union (EU), EHPM said that huge issues exist for claims that have not made it onto the permitted list.

The Standing Committee on the Food Chain and Animal Health today adopted the regulation establishing the permitted list of Article 13.1 claims.

Claims that will be considered rejected will be included as such in the Union Register and forbidden from use after a six-month transition period.

“Our problem is not with the permitted list of claims, but we remain concerned about claims that have not made it onto this list,” said EHPM Chairman Peter van Doorn. “In addition, some claims have received unfavourable opinions because they were not within the scope of the Nutrition and Health Claims Regulation. However, these should be authorised under the provision of article 10.3 of the regulation allowing reference to general and non specific benefits provided they are accompanied by a specific authorised health claim.”

“Claims that have received negative EFSA opinions should not automatically be considered as rejected,” he continued. “Many of the unfavourable opinions are the result of failures in the procedures, namely a lack of clarity in a number of important issues. We continue to call for further evaluation regarding EFSA’s assessment criteria, which we believe are not appropriate.”

EHPM has consistently called to grade evidence relating to Article 13.1 health claims rather than give yes/no opinions, arguing that both the Nutrition and Health Claims Regulation and the Terms of Reference that EFSA should be following require an assessment of the extent to which cause and effect can be shown.

“The ‘extent’ is determined by the strength, consistency and biological plausibility of the totality of the available data in support of a beneficial nutritional and/or physiological effect,” said Mr van Doorn. “The EFSA pharmaceutical approach does not recognise the complexities of nutrition research and instead opts for the easier route of requiring conclusive cause and effect evidence. EFSA’s only attempt at grading the evidence has been in under one percent of all evaluations, where it stated that there was insufficient evidence to assess the claim.” 

The European Federation of Associations of Health Product Manufacturers (EHPM) was created in 1975, working to provide consumers with safe, science-based, high quality products as well as accurate and helpful information about their nutritional value and use. Visit


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