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.

© European Food Safety Authority, 2011

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 (100 – 200 kDa) polysaccharides derived from the cell wall of baker’s yeast Saccharomyces cerevisiae. ‘Yeast beta-glucans’ differs from their cereal counterparts in that they contain ß-1,3- and 1,6-glucosydic bonds, compared to the cereal derivatives which contain ß-1,3- and 1,4-glucosydic bonds. This novel food application concerns both insoluble [BetaRight WGP (BWGP) and Wellmune WGP Dispersible (WGPD)] as well as soluble [Wellmune WGP soluble (WGPS)] ‘yeast beta-glucans’. The insoluble products contain at least 70 % (BWGP) or 75 % (WGPD) carbohydrate in the form of beta-glucans; the soluble product (WGPS) contains at least 75 % beta-glucans. The characterisation, specification and production process do not give reasons for concern.

The source, baker’s yeast, traditionally used for the production of bread, beer and wine, does not give reason for concern since it has a long history of use in and outside Europe.

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, as specified by Directive 2009/39/EC) at dose levels of up to 600 mg per day, with the exception of infant formulae and follow-on formulae (as defined by Commission Directive 2006/141/EC). In addition, the applicant intends to market ‘yeast beta-glucans’ in a variety of foods including beverages for the general population.
Based on these proposed uses, the applicant has provided an intake estimate for ‘yeast beta-glucans’ for different population groups, using data from the United Kingdom National Diet and Nutrition Surveys. Of the individual population groups, male teenagers had the greatest mean and 97.5^th percentile all-user intakes of ‘yeast beta-glucans’ resulting of 0.80 and 1.94 g/person per day, respectively. On a body weight basis, children were identified as having the highest mean and 97.5^th percentile all-user intakes of any population group, of 49 and 105 mg/kg body weight per day, respectively. In response to a Member State request, the applicant provided an intake estimate of beta-glucans naturally present in foods based on the contents in foods and based on UK consumption data. For normal beta-glucans intake, male adults were determined to have the greatest mean and 97.5^th percentile all-user intakes of beta-glucans at 726 and 4,673 mg/person per day (9 and 52 mg/kg bw per day), respectively. An analysis of the impact of individual food categories on the intake of beta-glucans by male adults revealed that the consumption of beer produced the largest individual food intakes of beta-glucans in this population group. Children of 1.5 – 4.5 years old had the lowest mean estimates for daily beta-glucans intake with values of 281 mg/person. On a body weight basis, infants/young children (1.5 - 4.5 years old) were identified as the population group having the highest mean and 97.5^th percentile all-user intakes of normal beta-glucans at 20 and 115 mg/kg body weight per day, respectively.

The Panel notes that the “high intake” scenario for beta-glucans from BWGP, WGPD, or WGPS 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 conservative intake estimates of ‘yeast beta-glucans’, which at its maximum is grossly similar to the background intake of beta-glucans from other sources, and the supplementary data from human and animal studies, the Panel considers that the intake of the NFI at the proposed conditions of use, does not raise concerns. The Panel concludes that ‘yeast beta-glucans’ is safe at the proposed conditions of use.

Yeast, beta-glucans, fiber, novel food, ingredient