欧盟评估AstraGin作为新型食品的安全性

　　食品伙伴网讯  2020年5月13日，应欧盟委员会的要求，欧盟食品安全局（EFSA）营养、新型食品和食品过敏原小组（NDA）就AstraGin作为新型食品的安全性发布意见。

 

　　据了解，AstraGi是一种从三七（Panax notoginseng）和黄芪（Astragalus membranaceus）中提取的植物提取物。申请人建议这种新型食品作为普通成年人（不包括孕妇）的食品补充剂，每日最高剂量为350毫克。部分原文报道如下：

 

　　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 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.

 

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