食品科学 ›› 2022, Vol. 43 ›› Issue (15): 320-326.doi: 10.7506/spkx1002-6630-20220207-014

• 专题论述 • 上一篇    

辅酶Q10等5 种原料的保健食品纳入备案制目录管理的情况分析及启示

田明,王玉伟,李瑞锋,董雨桐,成晴,宋尧楠,刘雅馨,王薇   

  1. (1.国家市场监督管理总局发展研究中心,北京 100089;2.北京中医药大学管理学院,北京 100029)
  • 发布日期:2022-08-30
  • 基金资助:
    国家市场监督管理总局发展研究中心课题(2040071420120;90020671420001)

Putting Five Health Food of Raw Materials including Coenzyme Q10 under Directory Management: Analysis and Its Complications

TIAN Ming, WANG Yuwei, LI Ruifeng, DONG Yutong, CHENG Qing, SONG Yaonan, LIU Yaxin, WANG Wei   

  1. (1. Development Research Center of the State Administration for Market Regulation, Beijing 100089, China; 2. School of Management, Beijing University of Chinese Medicine, Beijing 100029, China)
  • Published:2022-08-30

摘要: 目前我国保健食品行业正处于迅速发展阶段,然而相关制度的不完善以及产品定位等问题导致我国保健食品行业后续发展受阻。2015年保健食品“双轨制”管理的概念首次提出,次年正式落地,新政策的出台顺应了保健食品行业快速发展的趋势,促进了行业扩大生产,同时新增的审批备案程序也对保健食品的功效要求更加严格,强化了企业主体责任。2020年12月1日,辅酶Q10、破壁灵芝孢子粉、鱼油、褪黑素、螺旋藻5 种原料正式纳入保健食品原料目录,并于2021年3月1日起执行,以上5 种功能性原料纳入保健食品原料目录对后续其他保健食品原料纳入备案管理有着深远的意义,解决了“重前置审批,轻后市监管”的问题,促进了保健食品行业不断规范发展。本文聚焦5 种原料纳入目录前的审批情况并进行分析,旨在根据分析启发如何进一步推进保健食品原料纳入目录的制修订工作,为完善保健食品的监管提供建议。

关键词: 保健食品;原料目录;监管;政策建议

Abstract: At present, the health food industry in China is under rapid development, but the relevant system is still imperfect and there are some problems in product positioning, impeding the development of the health food industry in China. The concept of “dual-track” management of health foods was first proposed in 2015 and officially implemented in the following year. The introduction of the new policies not only complies with the trend of rapid development of the health food industry, but also can promote the expansion of production in the industry. Meanwhile, the newly added approval and filing procedures place stricter requirements for making claims about the efficacy of health foods in order to strengthen the major responsibility of enterprises. On December 1, 2020, five health food raw materials such as coenzyme Q10, broken Ganoderma lucidum spore powder, fish oil, melatonin, and spirulina were included into the health food raw material directory, which started on March 1, 2021. This is of profound significance for putting other health food raw materials under directory management, which can solve the problem of “emphasizing pre-approval and neglecting post-market supervision” and promote the continuous standardized development of the industry. This paper focuses on the approval and analysis of the five health food raw materials before they were included into the directory, aiming to provide suggestions for promoting the compilation and revision of the directory of health food raw materials.

Key words: health food; raw material directory; regulation; policy suggestions

中图分类号: