Safety of a botanical extract derived from panax notoginseng and astragalus membranaceus (astragin (tm)) as a novel food pursuant to regulation (eu) 2015/2283
Résumé
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods andFood Allergens (NDA) was asked to deliver a scientific opinion on a botanical extract derived from bothPanax notoginsengandAstragalus membranaceus(AstraGinTM) as a novel food (NF) pursuant toRegulation (EU) 2015/2283. The NF is a combination of an ethanol extract of the roots ofA. membranaceusand a hot water extract of the roots ofP. 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 toproduce the NF have a long history of use, especially in traditional Chinese medicine. Information onthe 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, excludingpregnant women, at a maximum daily amount of 350 mg. Taking into account these conditions of use,the Panel considers that the consumption of the NF is not nutritionally disadvantageous. The providedgenotoxicity studies do not raise concerns for genotoxicity of the NF. Based on thefindings of asubchronic toxicity study, supported by a subacute toxicity study, the Panel identified the overall noobserved adverse effect level (NOAEL) of the NF at 100 mg/kg body weight (bw) per day. By applyingan uncertainty factor of 200, the Panel concludes that the NF is safe at an intake level of 0.5 mg/kgbw per day, corresponding to a maximum daily intake of 35 mg of the NF for the target population,i.e. adults excluding pregnant women.
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EFSA Journal - 2020 - - Safety of a botanical extract derived from Panax notoginseng and Astragalus membranaceus AstraGin.pdf (1006.16 Ko)
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