Scientific Opinion on the safety of ‘Glavonoid®’, an extract derived from the roots or rootstock of Glycyrrhiza glabra L., 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 ‘Glavonoid’ as a food ingredient in the context of Regulation (EC) No 258/97 taking into account the comments and objections of a scientific nature raised by Member States. Glavonoid is an extract derived from the root or rootstock of Glycyrrhiza glabra L. by extraction with ethanol followed by further extraction with medium-chain triglycerides. The applicant provided sufficient information on the specification, production, composition and the stability of Glavonoid. The applicant intends to market Glavonoid as food supplements and as an ingredient for fruit juices, yoghurts and yoghurt drinks up to a dose of 300 mg per day to the general adult population. A 90-day rat study showed a lowest observed adverse effect level (LOAEL) at a dose of 400 mg/kg bw per day. Prothrombin-time and activated partial thromboplastin time (APTT) were analysed using a Benchmark Dose (BMD) modelling approach. The BMD lower confidence limit (BMDL05) for this study derived from APTT data is 167 mg/kg bw per day. There are no concerns related to genotoxicity. Studies on reproductive and developmental toxicity were not provided. Extrapolation of the BMDL05 from the rat study to a maximum intake for a 70 kg person results in 117 mg Glavonoid/day. The human studies provided do not raise safety concerns. The Panel considers that the human studies are consistent with the maximum level derived from the BMD approach. The Panel considers that there are no concerns related to genotoxicity. The safety of Glavonoid for pregnant and breast-feeding women has not been established. The Panel concludes that the novel food ingredient Glavonoid is safe for the general adult population up to 120 mg/day.