对我国单一原料保健食品审批概况的调查及注册管理的建议

目的了解我国单一原料保健食品注册现状。方法分析了2003-2007年期间国家食品药品监督管理局批准注册的419个单一原料保健食品的注册概况、功能分布、原料类别与特点及功效成分特点等情况。结果单一原料保健食品占此期间注册的功能类保健食品数量的13.1%,增强免疫力功能声称占50.3%,标志性成分特异性不强,以粗多糖、总皂苷、总黄酮等一类成分最为常见。原料类别以动植物原料、普通食品类及菌藻类为主。结论提取物原料的普遍使用给保健食品的质量和安全性带来一定隐患。急需对提取物原料实施标准化管理。以单一原料保健食品为试点,简化审评模式,探索保健食品分类管理制度。

Overview on the Single Raw Material Health Foods Approved in China and the Revelations for Their Registration and Administration

Objectives To investigate the current status of single raw material health foods registration in China. Methods The registration of 419 single raw material health foods from the State Food and Drug Administration (SFDA) in the period of 2003-2007 were studied and analyzed, including the registration number, function claims, material categories and active ingredients, etc. Results The number of single raw material health foods accounted for 13.1% of total registered functional foods in this period. Half of the function claims were enhancing immune function. The active ingredients were nonspecific. The most common ingredients were polysaccharide, total saponins and total flavonoid. The chief categories of component were traditional Chinese material, foodstuff, edible fungi and algae. Conclusions The use of extracted materials might bring potential quality and safety issues because of no unified standards and processing technique. It is necessary to standardize management for extracted materials urgently. Take the single raw material products as a trial to seek a simplified mode for the registration and management of health foods.