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保健食品所用原料不同,生产情况不同,其产品理化指标制定时需注意什么?
保健食品
保健食品原料
理化指标
2023-11-22

答:申请人应按《保健食品注册申请服务指南》5.2.2.42)要求制定产品理化指标,同时根据产品所用原料不同,还应制定相应指标,如:含水产品原料的,应制定镉、总砷、总汞;含油脂类原料的,应制定酸价、过氧化值;含芦荟、大黄、何首乌、决明子等蒽醌类原料的,应制定总蒽醌(指标值以范围标示);含红曲原料的,应制定桔青霉素、黄曲霉毒素;含苹果、山楂及其制品原料的,应制定展青霉素。根据生产情况不同,还应制定相应指标,如:使用植物性原料直接生产或经有机溶剂提取的,应制定农药残留指标,如六六六、滴滴涕等;使用苯乙烯骨架型大孔吸附树脂分离纯化工艺的,应制定二乙烯苯指标,其它类型的参照苯乙烯骨架型并结合具体品种制定相应的树脂残留物指标;生产过程中可能产生有毒有害物质的,应制定相应限量指标,如:酸水解法生产氨基酸形成的副产物氯丙醇等。

 

官方链接:国家市场监督管理总局食品审评中心

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