Rejected EU health claim challenged over mystery rewording
The company, which preferred not to be named until its appeal was heard, said the claim’s wording was altered at some stage between it delivering its dossier and proposed article 13 claim to its local member state authority (believed to be in Germany) and it reaching EFSA.
The new wording gave the claim an unintentional medicinal slant.
Lost in translation
It is a problem that has previously been highlighted by trade groups such as the European Federation of Associations of Health Product Manufacturers(EHPM), which publicly wondered why some of the 4000 or so article 13 claims appeared to have had their meaning altered in the translation process from language of origin to the English EFSA requires.
About 80 other claims that formed part of a 700+-claim list submitted by EHPM and other major trade groups such as the Confederation of Food and Drink Industries of the EU (CIAA) have been ommitted, according to EHPM.
Speaking at a satiety and weight management workshop in Amsterdam yesterday, Dr Katrin Stade, senior project manager at German-based consultancy, analyze & realize, which is acting on the unnamed company’s behalf, said it was shocked when EFSA’s health claims assessment panel published its negative opinion because the wording was so drastically altered.
“It had become a medical claim and it was not submitted as a medical claim – we don’t undertsand how this happened and are confident this appeal will succeed because it is a very strong dossier,” Stade told NutraIngredients.com.
“Whether this is some kind of lost-in-translation problem or something else we don’t really know. We hope to find out soon.”
Ongoing concerns
Running in conjunction with a well-attended weight management and satiety seminar today, the day-long workshop was characterised by feisty feedback from an assembled group of health claim-stressed food and ingredient company representatives.
The likes of Coca-Cola, Nestle, Nizo Food Research, Danisco, National Food Starch Innovation, Kerry Group and KitoZyme were present and the common battleground of health claims and how to go about having them approved under the EU-wide 2006 nutrition and health claims regulation was the distinct and unifying theme.
Confusion about EFSA’s scientific requirements to back claims, and concern about the potential commercial fall-out of negative opinions has turned many companies coy about their involvement in the process.
Companies including Valio and Nestle have withdrawn article 14 claims (children’s and disease reduction claims) rather than face a potential negative opinion, and some companies at the conference refused to confirm the status of claims they may or may not have in the process.
A Nestle spokesperson said the company had a weight management dossier close to being “ready to go” but was canvassing last-minute opinion from European claims experts before making the submission.
Other topics of discussion at the workshop included an in-depth analysis of what makes a good gold standard clinical trial and the mooted reform of the Novel Foods regulation.
