Details of the Announcements

对于保健食品功能论证报告中功能声称科学依据的要求?
保健食品
功能声称
2023-11-09

答:科学依据及其相关综述内容应当完整规范,不仅包括科学依据的来源、目录和全文,还应当与产品的配方、工艺等技术要求进行研究比对,对产品配方及其功能声称科学依据充足性进行论证和综述。文献依据包括在国内核心专业期刊或国际专业期刊正式发表的科研论文;我国传统本草典籍的有关记述;文献分析和评价报告;国际公认的食品卫生权威机构、组织,或我国有关部门、权威机构正式发布的国际标准、国家标准、风险评估报告、统计信息等,汇总信息应完整准确,能够对产品配方及其功能声称形成有效支撑。报纸、网评、非科研杂志、专利文书、产品宣传页等不属于国内核心专业期刊等资料,视为无效资料,不纳入审评范围。

鼓励申请人对产品配方主要原料的功能依据及其他原料的配伍必要性相关文献依据,进行全面系统的检索和筛选,通过Meta分析等方法进行文献系统分析,提出对产品保健功能科学依据充足性和配方合理性的文献分析和评价报告。

 

官方链接:国家市场监督管理总局食品审评中心

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