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瑞旭FAQs丨关于“产品长期食用的安全性论证报告”
2025-01-24

 

关于产品长期食用的安全性论证报告

 

答:《换证审查要点》附件3,产品上市后食用安全性报告是指参照现行延续注册要求,由注册人(证书持有人)法人代表或授权签字人签字确认的,产品上市销售后开展的质量安全性投诉处置以及情况收集、处理过程结果等情况汇总报告以及产品上市销售过程中是否涉及安全性问题的结论性承诺。《换证审查要点》附件2,产品上市后食用安全性报告,涉及需要对产品配方中原辅料进行再确认情形的,还应当相应提交产品长期食用的安全性论证报告(包括产品配方配伍和用量的理依据、文献依据等)、保健食品新原料安全性评价材料等。

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