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阿什瓦甘达:这是安全的吗? 第1部分:监管审查

T Brendler^1,2, R Al-Mondhiry³, L Lang⁴

¹Department of Botany and Plant Biotechnology, University of Johannesburg, Johannesburg, South Africa.

Phytotherapy research : PTR

|December 20, 2025

概括

由于安全问题,阿什瓦甘达 (Withania somnifera) 面临潜在的欧盟禁令,这会影响其在食品补充剂中的使用. 这篇评论审查了全球阿什瓦甘达法规.

科学领域:

药理学和毒理学药理学和毒理学
监管科学监管科学
草药研究草药研究

背景情况:

阿什瓦甘达 (Withania somnifera (L.) Dunal,AS) 面临着欧盟监管机构关于其食品补充剂使用安全性的日益严格审查.
这一审查导致了根据 (EC) 号法规推实施第8条程序的建议. 1925/2006,可能会在欧盟禁止其使用.
对于AS的监管环境是复杂的,在全球主要市场上有很大的差异.

研究的目的:

提供关于阿什瓦甘达 (AS) 在主要国际市场当前监管状况的全面概述.
分析导致AS监管审查增加的因素,特别是在欧盟内.
通知利益相关者关于潜在的监管行动及其对全球食品补充剂行业的影响.

主要方法:

系统审查与阿什瓦甘达安全和监管有关的监管文件和科学文献.
对全球主要市场中管理草药成分的监管框架的比较分析.
审查欧盟的监管程序,包括第 (EC) 号法规. 1925/2006年和第八条程序.

主要成果:

欧盟正在考虑在食品补充剂中禁止使用阿什瓦甘达,因为存在安全问题,并建议采用第8条程序.
对阿什瓦甘达的监管方法在各大市场上有很大差异,监管和限制水平各不相同.
审查强调需要协调的国际标准来评估草本成分的安全性和有效性.

结论:

欧盟对阿什瓦甘达的潜在禁令强调了在食品补充剂中使用植物性药物的强有力的安全评估至关重要.
对于参与阿什瓦甘达国际贸易的企业来说,了解全球多样化的监管环境至关重要.
需要进一步的研究和透明的沟通,以解决监管问题,并确保在全球范围内安全使用阿什瓦甘达.

关键词:

维塔尼亚·维塔尼亚 (Withania Withania) 是一个适应物适应物适应物阿什瓦甘达 (Ashwagandha) 是一个规则条例条例规章规章规章在安全方面,安全是安全的.

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