Turck Dominique, Castenmiller Jacqueline, De Henauw Stefaan, Hirsch-Ernst Karen Ildico, Kearney John, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pelaez Carmen, Pentieva Kristina, Siani Alfonso, Thies Frank, Tsabouri Sophia, Vinceti Marco, Cubadda Francesco, Engel Karl Heinz, Frenzel Thomas, Heinonen Marina, Marchelli Rosangela, Neuhäuser-Berthold Monika, Poulsen Morten, Schlatter Josef Rudolf, van Loveren Henk, Ackerl Reinhard, Knutsen Helle Katrine
EFSA J. 2020 May 13;18(5):e06099. doi: 10.2903/j.efsa.2020.6099. eCollection 2020 May.
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on a botanical extract derived from both and (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 and a hot water extract of the roots of . 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 Panel considers 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 Panel identified the overall no observed adverse effect level (NOAEL) of the NF at 100 mg/kg body weight (bw) per day. By applying an uncertainty factor of 200, the Panel concludes 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.
应欧盟委员会的要求，欧洲食品安全局营养、新型食品和食品过敏原专家小组（NDA）被要求根据欧盟法规（EU）2015/2283，就一种源自人参和黄芪的植物提取物（AstraGin™）作为新型食品（NF）发表科学意见。该新型食品是人参根乙醇提取物和黄芪根热水提取物的混合物。该新型食品含有1.5 - 5%的总皂苷、0.1 - 0.5%的人参皂苷Rb1和0.01 - 0.1%的黄芪甲苷。用于生产该新型食品的两种植物都有悠久的使用历史，尤其是在传统中药中。关于该新型食品生产工艺和成分的信息充分，不存在安全问题。申请人提议将该新型食品作为一般成年人群（不包括孕妇）的食品补充剂，最大日摄入量为350毫克。考虑到这些使用条件，专家小组认为食用该新型食品在营养方面并无不利之处。所提供的遗传毒性研究未引发对该新型食品遗传毒性的担忧。基于一项亚慢性毒性研究的结果，并得到一项亚急性毒性研究的支持，专家小组确定该新型食品的总体未观察到有害作用水平（NOAEL）为每天100毫克/千克体重（bw）。通过应用200的不确定性系数，专家小组得出结论，该新型食品在每天0.5毫克/千克bw的摄入量水平下是安全的，这相当于目标人群（即不包括孕妇的成年人）每天最大摄入量为35毫克该新型食品。
