Since the legalized management of health food in China from 1996,the development of health food industry has been spiraling. The management policies of health food have undergone great changes for past more than 30 years,and the regulatory departments of health food have changed from the Ministry of Health to the China Food and Drug Administration. In addition to the nutritional supplements, there are 27 kinds of functional claims for the functional health foods. In accordance with the newly revised Law of Food Safety,the regulation of health food has changed from a single registration system to the dual systems of registration and record filing in China. The China Food and Drug Administration is responsible for the registration of health food products which use raw materials other than the Catalogue of Raw Mate-rials for Health Food and imported for the first time. The China Food and Drug Administration is also re-sponsible for the record filing of health food which is imported for the first time,as well as belongs to sup-plement nutrients such as vitamins and minerals. The Food and Drug Administration of the provinces and municipalities directly under the central government is responsible for the record of health food produced with the catalogue of health food raw materials. The Catalogue of Raw Materials for Health Food (Ⅰ) and the Catalogue of Health Functions that Health Food Claim (Ⅰ) contains only nutrient supplements and the function of nutrients supplementation. In recent years,the China Food and Drug Administration has promulgated a series of policies and regulations on health food products, including the Measures for the Registration and Record Filing of Health Food,the Detailed Rules for the Examination and Approval of Health Food Registration (2016 edition), the Registration and Application of Health Food Service Guide (2016 edition),and the Working Guide of Health Food Record Filing(trial) etc. The systematic summary and analysis of the development process and management policy of health food in China will play an important guiding role in the rapid development of the industry.%我国保健食品自1996年法制化管理以来,保健食品行业的发展呈现螺旋式上升的趋势.30余年来保健食品的相关管理政策发生了较大变化,监管部门也从原来的卫生部改为国家食品药品监督管理总局.除营养素补充剂,功能型保健食品的功能声称现有27种,按照新修订的《食品安全法》,我国保健食品的监管实现了从单一注册制到注册与备案双轨制的改变.国家食品药品监督管理总局负责对使用保健食品原料目录以外原料的保健食品和首次进口的保健食品的注册以及首次进口的属于补充维生素、矿物质等营养物质的保健食品的备案,而各省及直辖市食品药品监督管理局负责用保健食品原料目录生产的保健食品的备案.已经颁布的《保健食品原料目录(一)》和《允许保健食品声称的保健功能目录(一)》仅包含营养素补充剂和补充营养素功能.近年来国家食品药品监督管理总局出台了一系列保健食品的政策和法规,包括《保健食品注册与备案管理办法》、《保健食品注册审评审批工作细则(2016年版)》、《保健食品注册申请服务指南(2016年版)》、《保健食品备案工作指南(试行)》等.对我国保健食品的发展历程及管理政策进行系统总结和分析对行业更快发展将起到重要的指导作用.
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