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食品审评中心丨蒽醌原料经乙醇提取或包含柱层析等精制工艺时,应提交哪些申报资料?
保健食品原料
2024-12-24

八、蒽醌原料经乙醇提取或包含柱层析等精制工艺时,应提交哪些申报资料?

答: 应具备可以完整折算得到原料用量的完整证据,且要比较该工艺原料的成分与传统水提取制得的成分对比分析(包括游离蒽醌及总蒽醌含量变化),并提供蒽醌成分含量变化对原料安全性变化的证明资料。对于因采用乙醇提取或柱层析等精制工艺,导致总蒽醌每日食用量超过30mg时,应提供该提取物长期食用的安全性文献依据。

 

官方链接:国家市场监督管理总局食品审评中心

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