Abstract
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.
Keywords: Yeast, beta‐glucans, fiber, novel food, ingredient
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) ; Scientific Opinion on the safety of “Yeast beta‐glucans” as a Novel Food ingredient. EFSA Journal 2011;9(5):2137. [22 pp.]. doi: 10.2903/j.efsa.2011.2137.
Panel members: Carlo Virginio Agostoni, Jean‐Louis Bresson, Susan Fairweather‐Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser‐Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen
Correspondence: nda@efsa.europa.eu
Acknowledgement: The Panel wishes to thank for the preparatory work on this scientific opinion: The members of the Working Group on Novel Foods: Karl‐Heinz Engel, Ines Golly, Marina Heinonen, Pagona Lagiou, Rosangela Marchelli, Bevan Moseley, Monika Neuhäuser‐Berthold, Annette Pöting, Seppo Salminen, Hendrik Van Loveren and Hans Verhagen, and EFSA's staff member Wolfgang Gelbmann for the support provided to this scientific opinion.
Adoption date: 8 April 2011
Published date: 10 May 2011
Question number: EFSA‐Q‐2010‐00952
On request from: European Commission
References
- Babíček K, 2003. Imucell™ WGP Oral Powder Repeated Dose 90‐day Oral Toxicity Study and Immunological Effects in Rats (Project57/2002), Final Report, February 2003.
- Babíček K, Čechová I, Simon RR, Harwood M, Cox DJ, 2007. Toxicological assessment of aparticulate yeast (1,3/1,6 β‐D‐glucan in rats. Food and Chemical Toxicology 45:1719–1730. [DOI] [PubMed] [Google Scholar]
- Babineau TJ, Marcello P, Swails W, Kenler A, Bistrian B, Forse RA, 1994a. Randomized phase I/II trial of a macrophage‐specific immunomodulator (PGG‐glucan) in high‐risk surgical patients. Annals of Surgery 220:601–609. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Babineau TJ, Hackford A, Kenler A, Bistrian B, Forse RA, Fairchild PG, Heard S, Keroack M, Caushaj P, Benotti P, 1994b. A phase II multicenter, double‐blind, randomized, placebocontrolled study of three dosages of an immunomodulator (PGG‐glucan) in high risk surgical patients. Archives of Surgery 129:1204–1210. [DOI] [PubMed] [Google Scholar]
- Beier R and Gebert A, 1998. Kinetics of particle uptake in the domes of Peyer's patches. The American Journal of Physiology 275:G130–G137. [DOI] [PubMed] [Google Scholar]
- Biothera , 2005a. Ninety Effect of Imucell™ WGP® 3–6 beta‐glucan given per os (PO) on the immune system of healthy human volunteers. Unpublished and confidential.
- Biothera , 2005b. Ninety Final Report on the Evaluation of the Efficacy of β‐1, 3/β1,6 glucan for prevention of experimental rhinovirus infection (common cold) in human volunteers. Unpublished and confidential.
- Biothera , 2009. Ninety‐day toxicity study of Wellmune WGP in rats by oral administration. Final Study Report.
- Blagović B, Rupčić J, Mesarić M, Georgiú K, Marić V, 2001. Lipid composition of brewer's yeast. Food Technology and Biotechnology 39:175–181. [Google Scholar]
- EFSA (European Food Safety Authority) , 2010. Scientific Opinion of the Panel on Dietetic Products Nutrition and Allergies on a request from the European Commission on Dietary Reference Values for carbohydrates and dietary fibre. The EFSA Journal 2010; 8(3):1462 [77 pp.]. doi:10.2903/j.efsa.2010.1462. Available online: www.efsa.europa.eu/efsajournal.htm [Google Scholar]
- EFSA (European Food Safety Authority) , 2010b. Scientific Opinion on the safety of “Chitin‐Glucan” as a Novel Food ingredient. EFSA Journal 2010; 8(7):1687. [22 pp.]. doi:10.2903/j.efsa.2010.1687. Available online: www.efsa.europa.eu/efsajournal.htm [DOI] [PMC free article] [PubMed] [Google Scholar]
- EFSA (European Food Safety Authority) , 2010c. “Lentinus edodes extract” as a Novel Food ingredient. EFSA Journal 2010; 8(7):1685 [22 pp.]. doi:10.2903/j.efsa.2010.1685. Available online: www.efsa.europa.eu/efsajournal.htm [DOI] [PMC free article] [PubMed] [Google Scholar]
- EFSA (European Food Safety Authority) , 2010d. Scientific Opinion on the substantiation of a health claim related to oat beta‐glucan and lowering blood cholesterol and reduced risk of (coronary) heart disease pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 2010; 8(12):1885. [22 pp.] doi:10.2903/j.efsa.2010.1885. Available online: www.efsa.europa.eu/efsajournal.htm [DOI] [PMC free article] [PubMed] [Google Scholar]
- FAO (Food and Agriculture Organization) , 2003. Food Balance Sheets. Food and Agriculture Organization of the United Nations, Rome, Italy. FAOSTAT Database. faostat.fao.org/site/368/DesktopDefault.aspx?PageID=368#ancor. [Google Scholar]
- Feletti F, De Bernardi di Valserra M, Contos S, Mattaboni P, Germogli R, 1992. Chronic toxicity study on a new glucan extracted from Candida albicans in rats. Arzneim.‐ Forsch./Drug Res. 42 (II), Nr 11 (1992). [PubMed] [Google Scholar]
- Hong F, Yan J, Baran JT, Allendorf DJ, Hansen RD, Ostroff GR, Xing PX, Cheung N‐KV, Ross GD, 2004. Mechanism by which orally administered β‐1, 3‐glucans enhance the tumoricidal activity of antitumor monoclonal antibodies in murine tumor models. The Journal of Immunology 173:797–806. [DOI] [PubMed] [Google Scholar]
- Jonker D, Hasselwander O, Tervilä‐Wilo A, Tenning PP, 2010. 28‐Day oral toxicity study in rats with high purity barley beta‐glucan (Glucagel). Food and Chemical Toxicology 48(1):422–8. [DOI] [PubMed] [Google Scholar]
- Ko Y‐T and Lin Y‐L, 2004. 13‐β‐glucan quantification by a fluorescence microassay and analysis of its distribution in foods. Journal of Agricultural and Food Chemistry 52:3313–3318. [DOI] [PubMed] [Google Scholar]
- Lehne G, Haneberg B, Gaustad P, Johansen PW, Preus H, Abrahamsen TG, 2005. Oral administration of a new soluble branched β‐1, 3‐D‐glucan is well tolerated and can lead to increased salivary concentrations of immunoglobulin A in healthy volunteers. Clinical and Experimental Immunology 143:65–69. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Müller A, Mayberry W, Acuff R, Thedford S, Browder W, Williams D, 1994. Lipid content of microparticulate (1–>3)‐β‐D‐glucan isolated from Saccharomyces cerevisiae. Microbios 79:253–261. [PubMed] [Google Scholar]
- Newberne PM, Conner MW, Estes P, 1988. The influence of food additives and related materials on lower bowel structure and function. Toxicologic Pathology 16:184–197. [DOI] [PubMed] [Google Scholar]
- Nicolosi R, Bell SJ, Bistrian BR, Greenberg I, Forse RA, Blackburn GL, 1999. Plasma lipid changes after supplementation with β‐glucan fiber from yeast. The American Journal of Clinical Nutrition, 70:208–212. [DOI] [PubMed] [Google Scholar]
- Nguyen TH, Fleet, GH , Rogers PL, 1998. Composition of the cell walls of several yeast species. Applied Microbiology and Biotechnology 50:206–212. [DOI] [PubMed] [Google Scholar]
- ONS (Office for National Statistics) , 2005. The National Diet and Nutrition Survey: Adults Aged 19 to 74 Years: 2000–2001 [Computer File]. Social and Vital Statistics Division & Foods Standards Agency (FSA); Colchester, Essex, UK, UK Data Archive. SN: 5140. [Google Scholar]
- Pajno GB, Passalacqua G, Salpietro C, Vita D, Caminiti L, Barberio G, 2005. Looking for immunotolerance: a case of allergy to baker's yeast (Saccharomyces cerevisiae). European Annals Of Allergy And Clinical Immunology 37:271–272. [PubMed] [Google Scholar]
- Rice PJ, Adams EL, Ozment‐Skelton T, Gonzalez AJ, Goldman MP, Lockhart BE, Barker LA, Breuel KF, DePonti WK, Kalbfleisch JH, Ensley HE, Brown GD, Gordon S, Williams DL, 2005. Oral delivery and gastrointestinal absorption of soluble glucans stimulate increased resistance to infectious challenge. Journal of Pharmacology and Experimental Therapeutics 314:1079–1086. [DOI] [PubMed] [Google Scholar]
- Šajbidor J, Kopecká M, Sandula J, Kacuráková M, 1991. Lipids in yeast cell wall glucans. Microbios 68:169–177. [PubMed] [Google Scholar]
- Sandvik A, Wang YY, Morton HC, Aasen AO, Wang JE, Johansen E, 2007. Oral and systemic administration of β‐glucan protects against lipopolysaccharide‐induced shock and organ injury in rats. Clinical and Experimental Immunology 148:168–177 & [Corrigendum, 149:399]. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Schulze U, 1995. Anaerobic Physiology of Saccharomyces cerevisiae. Technical University of Denmark, Department of Biotechnology, Kgs. Lyngby, Denmark, Ph.D. Thesis. [Google Scholar]
- UKDA (UK Data Archive) , 1995. National Diet, Nutrition and Dental Survey of Children Aged 1 ½ to 4 ½ Years, 1992–1993 [computer file]. Office of Population Censuses and Surveys, Social Survey Division, Medical Research Council Centre for Human Nutrition Research, Ministry of Agriculture, Fisheries and Food (MAFF), and U.K. Department of Health. Colchester, Essex, SN: 3481. [Google Scholar]
- UKDA (UK Data Archive) , 2001. National Diet Nutrition Survey: Young People Aged 4 to 18 Years, 1997. Office for National Statistics Social Survey Division, Medical Research Council Centre for Human Nutrition Research, Ministry of Agriculture, Fisheries and Food (MAFF), and Department of Health. Colchester, Essex. SN: 4243. [Google Scholar]
- Van der Rest ME, Kamminga AH, Nakano A, Anraku Y, Poolman B, Konings WN, 1995. The plasma membrane of Saccharomyces cerevisiae: Structure, function, and biogenesis. Microbiological Reviews 59:304–322. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Volkheimer G, 1974. Passage of particles through the wall of the gastrointestinal tract. Environmental Health Perspectives 9:215–225. [DOI] [PMC free article] [PubMed] [Google Scholar]
- WHO (World Health Organization) , 1987. Toxicological versus physiological responses. In: Principles for the Safety Assessment of Food Additives and Contaminants in Food. (WHO), International Programme on Chemical Safety (IPCS), Geneva, Switz. Environmental Health Criteria, No. 70, p. 82. Available from: www.inchem.org/documents/ehc/ehc/ehc70.htm#SubSectionNumber:5.5.3 [Google Scholar]
- Williams DL, Sherwood ER, Browder IW, McNamee RB, Jones EL, Di Luzio NR, 1988. Pre‐clinical safety evaluation of soluble glucan. International Journal of Immunopharmacology 10:405–414. [DOI] [PubMed] [Google Scholar]
- Yuji M, Tsubata M, Chin K, Onishi S, Inamoto T, Qi WM, Warita K, Yokoyama T, Hoshi N, Kitagawa H, 2006. Persorption of luminal antigenic molecule and its specific antibody via apoptotic epithelial cells of intestinal villi and Peyer's patches into peripheral blood in rats. Journal of Veterinary Medical Science 68:1297–1305. [DOI] [PubMed] [Google Scholar]
- Yuji M Fujimoto M Miyata H Inamoto T Qi WM Yamamoto K Warita K Yokoyama T Hoshi N Kitagawa H, 2007. Persorption mechanisms of luminal antigenic particulates via apoptotic epithelial cells of intestinal villi into systemic blood circulation in orally immunized rats. Journal of Veterinary Medical Science 69:339–346. [DOI] [PubMed] [Google Scholar]
