中国保健食品标准体系概述

目的：分析我国保健食品质量标准体系存在的问题，就加强我国保健食品质量标准化建设提出相应建议。方法：运用文献调查方式及比较分析的方法，系统梳理目前保健食品的标准体系，比较保健食品和药品标准体系的不同之处，以及存在的问题和解决的对策。结果：我国已经形成了国家食品安全标准、部门规章及规范性文件、产品技术要求和备案企业标准等4个层级的保健食品标准体系。结论：我国保健食品标准体系尚不完善，需要进一步明确部分标准执行或理解中存在的问题和产品技术要求与备案企业标准的关系，建立保健食品原料标准体系，以及提高标准的专属性、可行性和统一性等，为保健食品上市后监管提供依据和保障。

Overview of the Chinese Health Food Quality Standard System

Objective:To put forward suggestions for improving the Chinese health food quality standard system based on the analysis of the problems in Chinese health food quality standard system. Methods:The current standard system of health food was systematically reviewed with the methods of literature survey and comparative analysis. Moreover, the differences between health food standard system and drug standard system were compared. Results:Four levels of health food standard systems which include the national food safety standards, departmental rules and regulatory documents, product technical requirements and enterprise standards have been established in China. Conclusion:The Chinese health food standard system is not perfect and needs further improvement, such as clarifying problems encountered during implementation or understanding, defining the relationship between technical requirements and enterprise standards, establishing standard system for health food raw materials, as well as improving the specificity, feasibility and uniformity of the standards, so as to provide basis and protection for the regulation of health food on market.