Glavonoid, typically sold with slimming claims, has been on-sale in the US and Japanese food supplement market for several years, and has reached, “an important milestone” with the EFSA positive opinion that will now pass to European Committee for consideration with member state input.
“We have been very careful with this dossier and answered all of EFSA’s queries so we don’t expect there to be any issues at committee,” Kaneka Europe business development manager, Peter Lambrechts, told NutraIngredients. “It could be approved for use by the end of the year.”
Lambrechts said even before the formal approval came, the company had begun project development work in the food supplements, fruit juices, yoghurts and yoghurt drink categories which featured in the opinion.
“This takes time so we must begin now in preparation for the approval. We actually thought we would achieve the positive opinion from EFSA sooner because we had submitted virtually the same dossier to the US Food and Drug Administration (FDA) and the Japanese agency where we have won approvals, but the process is more complex here and we found we had to respond to queries about certain things from EFSA.”
The Novel Foods opinion stated,“the novel food ingredient Glavonoid is safe for the general adult population up to 120 mg/day” in the categories above, but Lambrechts said the company would pursue others like margarines.
Despite Glavonoid-based “body shaping” claims being used on popular bodybuilding products in Japan, Lambrechts said the company was treading very cautiously about any health claims in Europe, with its press release on the Novel Foods approval referencing studies about the slimming potential of Glavonoid, but claiming nothing more specific.
That release states the extract is, “a unique two-way mechanism that genes involved in fatty acid synthesis are down regulated and those involved in fatty acid oxidation are up-regulated.”
The company has learnt much from seeing EU nutrition and health claims regulation (NHCR) article 13 general function rejection for a host of claims for the enzyme CoQ10 that included blood pressure, energy, cognitive and antioxidant benefits.
“We followed the industry lead on that when the claims were submitted a few years ago so we are still working out what to do with that and looking where the whole industry is going with these regulations,” he said. “But it has been a wake-up call, especially for the scientists who are trying to understand how these rules affect them.”
He said things would become critical when the article 13 general function list, of which most nutrients bar vitamins and minerals have been rejected, becomes European Union law, expected in the first half of 2012.
“There will be the positive and negative list and that will affect everybody. We are considering whether coQ10 could be considered a ‘vitamin-like substance’. But then again if the nutrient is being suggested by the medical profession you don’t need health claims.”
The CoQ10 opinion can be found here.
The Glavonoid Novel Foods opinion is here.