EFSA recognizes cellobiose as safe for human consumption
Cellobiose is a disaccharide consisting of two glucose monomers linked by a β-(1-4) glucosidic bond. The company SAVANNA Ingredients GmbH has submitted in May 2020 a novel food application to request the use of cellobiose in a range of food categories.
In its opinion, EFSA notes that the manufacturing process, compliant with GMP and HACCP principles, does not raise any safety concern. The novel food is obtained by enzymatic reaction by using two enzymes obtained from genetically modified micro-organisms (sucrose phosphorylase and cellobiose phosphorylase). As usual, 5 batches of the product have been analyzed, and show a purity of at least 99.3%, with residual fructose and glucose.
Safety data showed that cellobiose is not absorbed as such in significant quantities in intestine. A full safety evaluation has been provided by the applicant (AMES test, in vitro micronucleus test, 28-day study, and 90-day study), associated with a dose-escalation study in healthy subjects. All data did not raise any safety concern. EFSA concludes that cellobiose is safe for human consumption in the proposed condition of use, including several food categories, at doses up to 60g/100g in table-top sweeteners.
EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ,Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M,Prieto Maradona M, Marchelli R, Neuhauser-Berthold M, Poulsen M, Schlatter JR, van Loveren H, Albert Oand Knutsen HK, 2022. Safety of cellobiose as a novel food pursuant to regulation (EU) 2015/2283.. EFSA Journal 2022;20(11):7596.