EFSA rejects two thirds of first batch of article 13.1 health claims

Two thirds of the article 13.1 health claims submitted for assessment under the health claims Regulation do not stand up to scrutiny, according to the European Food Safety Authority​ (EFSA).

Article 13.1 claims are based on 'generally accepted science​' and cover the role of nutrients in the body (eg ‘calcium is necessary for the normal structure of bone’) and have been collated by the Commission for assessment by EFSA based on lists of references to supporting science. Those that make it on to an approved ‘community list’ will become available for any firm to use.

While most claims relating to the beneficial effects of vitamins and minerals were given positive opinions, scores of other claims covering everything from gamma amino butyric acid (GABA) and cognitive function; selected probiotic strains and bowel function; and beta-glucans and bodyweight management were rejected.

However, there was good news for some dietary fibres, fatty acids and many other substances.

A substantial number of claims were impossible to assess because the substance in question had not been properly characterised, said EFSA. "Without clear identification of the substance in question, the panel could not verify that the scientific evidence provided to EFSA related to the same substance for which the health benefits are claimed."

This first batch of opinions relates to only around 523 of the 4,185 claims on EFSA’s article 13.1 assessment list.

Its opinions will be passed on to the European Commission for final validation.

What remains unclear is whether unsuccessful applicants can simply reapply under article 13.5 of the Regulation, said Adam Ismail at omega-3 trade body GOED​. 13.5 covers claims based on new/emerging science or proprietary data and requires applicants to submit a dossier of supporting evidence. "13.5 may be one route to ensure the full weight of scientific evidence is considered appropriately," he said. "However, since our studies were already submitted to support 13.1 claims, it would be difficult to demonstrate they are 'new' for the purposes of article 13.5 claims."

Frustratingly, firms were not allowed to submit dossiers analysing the clinical studies supporting article 13.1 claims, but only lists of academic references, said Ismail. "EFSA would have had to put extraordinary effort into analysing the lists.

"It's very unlikely they would have the resources to do the work they expect applicants to do for the thousands of claims they received. We tried to get dossiers to them in multiple ways, but it is unclear whether or not they ever reached EFSA."