Algues et Mer’s dossier containing three studies specific to the polyphenols extract, InSea2, was registered with the European Food Safety Authority (EFSA) last week, sales and marketing manager, Jean-Noël Villemin, told NutraIngredients this morning.
He said the company, in conjunction with French claims consultancy, Nutraveris, has paid ultra-close attention to EFSA opinions and guidance – especially article 13.5 opinions – in constructing its dossier containing one clinical and two in vivo studies.
“We have learnt from what has gone before so we are very confident about this dossier,” he said, even though EFSA has to date issued only one weight management-related, positive health claim opinion for liquid meal replacements.
“We have been very careful to ensure the studies were conducted on healthy subjects and that that same dosages were used in the studies as appear in the InSea2 products [500mg per meal].”
Villemin said attention had also been paid to ensure the submitted claims were specific to the science rather than any ideal, end-product marketing messaging.
The dossier contains two suggested claims:
“Helps maintain normal activity of post-prandial glycaemic regulation mechanism.”
- “Helps improve insulin sensitivity”
Given EFSA’s mass rejection of weight management and other health claims so far, he said utilising other phraseology such as insulin control stood a better chance of success as it tended to be closer to the language used in the scientific literature.
“You have to be clever to find claims in this market,” he said.
Article 28.5 leeway
Even though the claim has not been assessed by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) it is usable from the time of submission under article 28.5 of the NHCR. Hence, now.
Villemin said even if the claim was rejected by the NDA his company would be able to engage in weight management marketing for InSea2 for two or more years, as it would likely take that long before any EFSA opinion became law in the European Union.
Algues et Mer has worked on the polyphenols extract for about three years in conjunction with its Quebec-based North American partner, Innovactiv.
The extract has been available on the North American market since last year and has been launched in three food supplement products there as well as one in Taiwan.
It is being officially launched in Europe this week at Vitafoods.