Safety of cellobiose as a novel food pursuant to regulation (EU) 2015/2283.

Abstract

Following a request from the European Commission, the EFSA Panelon Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on cellobiose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of two glucose monomers linked by a β-(1-4) glucosidic bond. The applicant intends to add the NF to a variety of foods, and to food supplements aimed at the general population 3 years and older. The information provided on the manufacturing process, composition and specifications of the NF is sufficient and does not raise safety concerns. The applicant provided a subchronic toxicological study which did not raise safety concerns. The applicant provided a human dose-escalation study from which the Panelconcludes that the consumption of 20g per day of cellobiose (equivalent to 290mg/kg body weight (bw) per day in a 70-kg adult) does not raise concern regarding gastrointestinal tolerability. The maximum anticipated daily intake of cellobiose from the proposed uses is below 290mg/kg bw per day in the target population. Considering the nature, source, compositional characterisation, and production process of the NF, as well as the toxicological data provided, the Panelconsiders that the NF does not raise safety concerns under the proposed conditions of use.