Speaking at the second CosmeticsDesign-Europe and NutraIngredients Beauty From Within conference, Innéov’s director for regulatory affairs and product safety Dr Michel Donat, told a packed room the nutrition and health claims regulation’s (NHCR) medicinal approach was producing inconsistent opinions that often ignored the totality of nutrition science in many areas.
“There is probably something wrong if companies like Unilever, Nestlé and L’Oreal are not able to get claims through,” Dr Donat said. “Maybe the standards are a little high...The European Commission is going to have to deal with this inconsistency. Member states will have their own approach as well. We think this regulation needs a complete reappraisal.”
Innéov in May 2010 had an article 13.5, dry skin claim rejected by the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) for its proprietary blend of blackcurrant seed oil, lycopene, vitamin C and vitamin E.
When asked if a fresh article 13.5 claim would be submitted, Dr Donat responded, “maybe”, but cautioned: “Applying for claims you can expose yourself to negative messages so you have to think about it.”
The NDA rejected Innéov’s 29-study strong dossier that proposed the claim, “helps to improve dry skin conditions”, and said much of the science was not applicable because it related to individual nutrients, not the Innéov blend itself.
Unilever submitted a similar claim with a similar blend, but withdrew it at the beginning of 2011 before it was assessed, citing “uncertainty as regards claims”.
Dr Donat suggested that beauty claims may yet be ruled as outside the scope of the NHCR.
Brussels-based EU food lawyer, Jean Savigny, from Keller and Heckman, said he expected EC guidance on beauty claims was unlikely to shed much light on the sector as it would reiterate a somewhat ambiguous methodology.
“I don’t expect much from it,” he said. “I expect three words. They will be, ‘case-by-case’.”
He expected that after the 2700+- article 13.1 list became EU law in the next months there would be an avalanche of resubmitted article 13.5 claims.
Head in the sand?
In a presentation about better trial design, Dr Lars Lindmark, from the Kasima Medical Development and Kafolinski Institute, said the regulation was tough but it shouldn’t halt the ongoing conduct of nutrition science – or be ignored.
“People are trying to bury their head in the sand because of EFSA. That’s not the way to go,” he said before highlighting a number of common faults in clinical trial design such as the selection of inconsistent sample populations.
“But the new bird on the block will be nutrigenomics in the skin.”
In another presentation, Dr Marie Bejot, the founder of Oenobiol, noted that bigger firms were hunting smaller firms that had trademarked brand names on the market before 2005, as under the NHCR these were permitted to remain on-market until at least 2020.
She used the example of “Flatbelly” as something, “you can claim until 2020”.