Scientific Opinion on the safety of ‘yeast beta-glucans’ as a Novel Food ingredient
Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety of ‘yeast beta-glucans’ as a novel food ingredient in the context of Regulation (EC) No. 258/97 taking account of the comments/objections of a scientific nature raised by the Member States. ‘Yeast beta-glucans’ consists of complex, high molecular mass polysaccharides derived from the cell wall of baker’s yeast Saccharomyces cerevisiae. This novel food application concerns both insoluble as well as soluble ‘yeast beta-glucans’. The source, characterisation, specification and production process do not give reasons for concern. The applicant intends to market ‘yeast beta-glucans’ in food supplements at dose levels of up to 375 mg per day and in foods for particular nutritional uses (PARNUTS) at dose levels of up to 600 mg per day. It is not intended for infant formulae and follow-on formulae. In addition, the applicant intends to market ‘yeast beta-glucans’ in a variety of foods including beverages for the general population. The Panel notes that the “high intake” scenario for ‘yeast beta-glucans’ is grossly similar to the background intake of beta-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 ‘yeast beta-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 ‘yeast beta-glucans’ is safe at the proposed conditions of use.