Yeast beta glucan
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) this week issued a positive scientific opinion for the yeast-derived immunity ingredient.
“We are pleased with the finding of EFSA’s review of our clinical and safety data supporting Wellmune WGP,” said Richard Mueller, chief executive officer of the ingredient’s manufacturer, Biothera.
“We have ongoing discussions with a number of companies about product concepts in anticipation of this opinion from EFSA.”
The novel foods application related to doses of up to 375 mg per day and in food supplements and 600mg in foods for particular nutritional uses. The NDA found that, “the ‘high intake’ scenario for ‘yeastbeta-glucans’ is grossly similar to the background intake ofbeta-glucans from other dietary sources.”
“Data provided on (sub)acute and sub-chronic toxicity, absorption, and limited human data do not give reason for concern. The Panel considers that the allergenic risk of the ‘yeastbeta-glucans’ is not higher than the risk from other products containing baker’s yeast.Beta-glucans from other sources have already been evaluated for safety by EFSA. On the basis of the nature of ‘yeast beta-glucans’, the significant history of use of its source, the provided intake estimate and the supplementary data from human and animal studies, Panel concludes that ‘yeastbeta-glucans’ is safe at the proposed conditions of use.”
The company sells Wellmune in about 30 countries and won approval recently from theMinistry of Health in China.
Wellmune WGP is derived from the cell walls of a proprietary strain of yeast (Saccharomyces cerevisiae) via a patented manufacturing process.
The fermented black bean extract called Touchi is manufactured by CBC Ltd and employs by hot water extraction of small soybeans (Glycine max) fermented with Aspergillus oryzae.
CBC proposed dosage of 0.3g Touchi extract to be consumed with every meal of the day, with an average intake of 0.9-1.2g per day and maximum intake of 4.5g per day.
The NDA said: “The documentation on the safety of Touchi extract is based mainly on the history of the source of the novel food, on the significant human consumption of traditional fermented black bean products in and outside of Europe, data on the production process and on the compositional similarity between fermented black beans and Touchi extract. Toxicological and clinical data provide limited evidence for the safety of Touchi extract and do not raise concerns.”