Dossiers seeking approval for health claims are 'poor quality'

The quality of some dossiers submitted by applicants hoping to gain approval to make health claims under article 14 of the Nutrition and Health Claims Regulation has been "very bad", according to the panel tasked with assessing them.Professor Albert Flynn, who chairs the European Food Safety Authority's (EFSA's) NDA panel, said: "We've received some excellent applications and some very bad dossiers. The range of quality has been very wide."

A large number of dossiers were also incomplete, which meant EFSA has had to waste a lot of time requesting more information from applicants, said Flynn. As for quality, problems included a failure to properly characterise the ingredients in question and a failure to demonstrate a causal relationship between the ingredient and the claimed health benefit. There were also mismatches between the types of volunteers in the scientific studies submitted as evidence and the target groups for the proposed health claims, he said. "This has been a problem for some applications where the proposed claims are about children, but the clinical studies supplied by applicants are on babies or adults, for example."

There also appeared to be a "misunderstanding" over what was required from applicants, said Flynn. "Some people evidently thought the standard of scientific evidence required to support claims under article 13.1 [claims supported by generally accepted scientific evidence] was different to that required for disease risk reduction claims [article 14]. That is not the case. Evidence is evidence; you can't have two different standards just because the application process is different."

Article 13.1 applications were likely to be hard for EFSA to assess because of the sheer volume of claims submitted (c.2,800), said Flynn. "At least with article 14 we have individual applicants and dossiers to refer to if we need more information; with article 13.1, the application process was different.

"Here, we were presented by the European Commission with a long list of proposed claims, the name of each ingredient or food, the proposed benefit, the conditions of use, the nature of the evidence [eg. animal, human data], suggested wording for claims and references.

"But we are not in direct contact with all the applicants as such so going back for more information could be very time consuming."