Let the claims battle begin
Food manufacturers will lock horns with the experts processing EU health claims applications next month to thrash out concerns over how they are assessed.
Participants at the June 15 meeting in Brussels include the European Food Safety Authority's (EFSA's) NDA panel (tasked with processing applications under the EU health claims Regulation), European Commission officials, trade associations, consultants and food manufacturers.
The meeting has been called amid growing controversy over the assessment criteria for applications under articles 14 and 13.5 of the Regulation - most of which have been rejected to date.
Such is the concern that several high profile applications have been withdrawn in recent weeks, including three from Danone about Actimel and Activia under article 13.5 of the Regulation.
They will not be resubmitted until bosses are clearer about how to put a successful application together, said the firm. "We have the clinical data to support our claims; we've got 24 studies on Actimel and 16 on Activia, but there are still questions over wording and presentation."
Article 14 and 13.5 applications cover disease risk reduction claims, children's claims and claims based on proprietary data.
However, manufacturers also want to discuss how EFSA will approach the article 13.1 list of 4,000+ 'generic' health claim applications sitting in its in-tray. If this list is assessed in the same way as article 13.5/14 applications, it could be decimated, raising "serious legal questions" over the interpretation of the Regulation, according to Patrick Coppens, secretary general at the European Responsible Nutrition Alliance. "The Regulation foresees a different type of assessment between article 13.1 and other submissions, but so far EFSA has indicated it will not address them in a different way."
Legal experts had advised that article 13.1 and article 13.5/14 claims should be assessed differently, he said.
However, NDA panel chair professor Albert Flynn said there had been "a big misunderstanding" among applicants on this topic: "Some people thought the standard of evidence required to support claims for article 13.1 and 14 was different. That is not the case."
