Industry leaders say they are "puzzled" by a raft of negative opinions issued by the European Food Safety Authority in relation to the EU Nutrition & Health Claims Regulation.
On 2 October, EFSA released the first batch of opinions on article 13.1 health claims submitted by member states for inclusion on the so-called 'Community List' of approved claims, which will be available for use by any food and beverage company.
A total of 94 opinions were published, covering more than 500 separate applications and 200 foods or ingredients. Just a third of them were positive — mostly in relation to essential nutrients such as vitamins and minerals. The remainder were negative, with high profile victims including probiotics, taurine, chondrotin, glucosamine and several botanicals.
Many claims were rejected simply on the grounds that ingredients had not been "characterised" properly. That means the application had not described in sufficient detail what the ingredient was.
Some time ago, before reviewing the claims in detail, EFSA had sent many applications back to EU member states for clarification — but it appears it did not highlight at that stage where characterisation was insufficient. And this has surprised functional foods and supplements trade body the European Federation of Associations of Health Product Manufacturers (EHPM).
"We are pleased to see that EFSA has approved nearly all vitamin and mineral claimed effects," said Lorène Courrège, EHPM director of regulatory affairs. "However, we have noted that many other claims have been rejected for lack of characterisation, for example some probiotics or botanicals.
"We are somewhat puzzled that EFSA has not asked further clarification on those claims to member states, as it has done for so many other claims. We believe further clarification on this would be of interest to all, industry as well as consumers, and would avoid discrimination between the claims already evaluated and the ones that will be evaluated at a later stage.
"EHPM has repeatedly requested that the methodology be discussed with the stakeholders who have invested considerable effort into the elaboration of a joint EU industry list of claims. We are currently undertaking a detailed analysis of the reasons underlying EFSA's rejection of claimed effects, which we hope we will have the opportunity to discuss with the European Commission, member states and EFSA experts."
Brussels-based consultancy EAS also expressed unease. "While some aspects of EFSA's opinions are understandable, we have a number of concerns about its process for rejecting some of the claims," said EAS adviser Miguel da Silva. "Companies will need to thoroughly evaluate this first batch of opinions and start a dialogue with the decision-makers, as the final decision on these claims rests with the European Commission and the member states."