EC publishes health claim comments

By Shane Starling

- Last updated on GMT

DG Sanco, the European Commission’s health and consumer protection arm, has published comments made to it by concerned parties about varying health claim opinions as they have come in from the European Food safety Authority (EFSA).

As is to be expected from those that have been handed negative opinions, there are many expressions of disappointment in EFSA’s verdicts.

Omega-3

In a letter sent to DG Sanco on January 19 this year, UK-based omega-3 supplements specialist, Efamol, reacted to five of its article 14 children’s health and disease reduction claims being rejected by EFSA by expressing its disappointment in a system that lacked clarity.

“Unfortunately the dossiers for the claims had to be submitted before the rules by which they would be evaluated were known,”​ Efamol technical director, Peter Clough wrote.

“As has been widely reported it has become clear that the criteria being used by EFSA are basically those applicable to pharmaceutical products, criteria which are not necessarily suitable for evaluation of foods, nutrients and health, as opposed to disease treatment, claims.”

Clough added: “This has lead to the bizarre situation whereby a statement such as ‘ a blend of DHA EPA AA and GLA may help support brain development’ has been rejected despite the fact that it would be almost universally accepted in scientific circles and it is questionable if the evaluation has even been undertaken in accordance with the terms of reference of the EU Commission itself which states that the totality of evidence must be taken into account.”

Probiotics

In support of a rejected article 13.5 probiotic digestive health claim submitted by Finnish company, Valio, the Dutch Association of Natural Products Manufacturers (NPN) took issue with EFSA’s approach.

NPN took EFSA to task in a detailed response that criticised the opinion of November 14 for being unclear in many of the points made.

On one matter, a probiotic strain was found not be sufficiently characterised by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), but NPN said it had not been made clear why.

The manner in which strains were kept for observation was deemed problematic by the NDA, again without clarity, NPN said.

“On both issues EFSA must be asked whether the information is obligatory and whether applicants are given the opportunity to remedy the perceived omissions.”

NPN said EFSA had failed to elaborate on the clinical data it evaluated to a sufficient degree, and hence there was a lack of scientific clarity in its rulings.

In regard to two probiotic “mixtures”​ referenced in studies, EFSA found one to be characterized and one not, a fact NPN took issue with as it determined that, “this conclusion, regretfully so, is not substantiated by EFSA itself.”

NPN added that EFSA’s definition of intestinal discomfort was not defined.

A document containing all published comments can be found here​.

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