进口保健食品在我国注册备案情况及发展趋势
目的 分析申请进口保健食品的“瓶颈”及原因, 并提出进口保健食品未来的发展管理趋势。方法 通过对我国上市的进口保健食品注册和备案产品总数、保健功能、原料及申请国家情况的统计分析, 梳理进口保健食品注册备案法规, 并对已获得注册和备案的进口保健食品建立数据库, 通过excel软件进行描述性分类统计分析。结果 根据进口注册的保健食品总量分析, 2003年以前批准的产品占65%, 2003年以后批准的产品占35%; 注册产品保健功能以增强免疫力最多, 其次为辅助降血脂, 申报的保健功能涉及18个; 申请备案的保健食品中保健功能以补充钙最多, 其次是维生素D, 申报的营养素涉及17个; 进口保健食品注册和备案申请最多的是美国, 涉及国家达到15个。结论 面对巨大的国内消费市场, 在我国获得注册批准证书和备案凭证的进口保健食品数量却不足一千个, 远低于国外上市健康产品种类。这与我国对进口保健食品法规要求较严, 国外保健食品类似产品管理不同等有关。作为进口到中国的保健食品, 必须确保产品长期食用的安全性。未来随着保健食品原料目录的调整及法规完善, 更多符合我国法律法规要求的进口保健食品将给国人带来更多的健康选择。
Objective To analyze the "bottleneck" and reasons of applying for importing health food and put forward the development and management trend of imported health food in the future. Methods Through the statistical analysis of the total number of listed imported health food registered and filed products, health care functions, raw materials and the situation of applying countries, the registration and filing regulations of imported health food were sorted out. Create a database of registered and registered dietary supplement and perform statistical analysis by category using excel software. Results According to the analysis of the total amount of imported and registered dietary supplement, 65% of the products approved before 2003 and 35% of the products approved after 2003 were registered. The health care functions of the registered products were mainly to enhance immunity, followed by auxiliary blood lipid reduction, and 18 health function were declared. The largest number of dietary supplement applications were for calcium supplements, followed by vitamin D, and 17 for nutrients. The largest number of dietary supplement applications were filed in the United States, there were 15 countries involved. Conclusion In the face of the huge domestic consumer market, the number of import dietary supplement that have obtained the registration approval certificate and the record-keeping certificate in our country is less than 1000, which is far lower than the health products listed abroad. It has something to do with the strict laws and regulations on import dietary supplement and the different management of similar products in foreign dietary supplement. But as importers of dietary supplement, they must ensure that their products are safe to eat over the long term. In the future, along with the health food raw material catalogue adjustment and the law consummation, more and more imported dietary supplement that meet the requirements of our laws and regulations will bring more and more healthy choices to the Chinese people.
标题：进口保健食品在我国注册备案情况及发展趋势
英文标题：Registration and development trend of imported health food in China
作者：
萨翼 国家市场监督管理总局食品审评中心
李淑娟 国家市场监督管理总局食品审评中心
中文关键词:进口保健食品,维生素,矿物质,注册,备案,
英文关键词:imported health food,vitamin,mineral,register,file,
发表日期：2020-05-14
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