Safety of a botanical extract derived from Panaxnotoginseng and Astragalus membranaceus (AstraGin™) 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 a scientific opinion on a botanical extract derived from both Panaxnotoginseng and Astragalus membranaceus (AstraGin™) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a combination of an ethanol extract of the roots of A.membranaceus and a hot water extract of the roots of P.notoginseng. The NF contains 1.5-5% total saponins, 0.1-0.5% ginsenoside Rb1 and 0.01-0.1% astragaloside I. Both plants that are used to produce the NF have a long history of use, especially in traditional Chinese medicine. Information on the production process and the composition of the NF is sufficient and does not raise safety concerns. The applicant proposed to use the NF as a food supplement for the general adult population, excluding pregnant women, at a maximum daily amount of 350 mg. Taking into account these conditions of use, the Panelconsiders that the consumption of the NF is not nutritionally disadvantageous. The provided genotoxicity studies do not raise concerns for genotoxicity of the NF. Based on the findings of a subchronic toxicity study, supported by a subacute toxicity study, the Panelidentified the overall no observed adverse effect level (NOAEL) of the NF at 100mg/kg body weight (bw) per day. By applying an uncertainty factor of 200, the Panelconcludes that the NF is safe at an intake level of 0.5 mg/kg bw per day, corresponding to a maximum daily intake of 35 mg of the NF for the target population, i.e. adults excluding pregnant women.