食品与发酵工业 >

2020 , Vol. 46 >Issue 7: 283 - 288

DOI: https://doi.org/10.13995/j.cnki.11-1802/ts.022789

综述与专题评论

褪黑素类保健食品注册审评审批状况分析与建议

  • 李菲菲 ,
  • 张李伟 ,
  • 付宗强 ,
  • 姜雨
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  • 1(国家市场监督管理总局食品审评中心,北京,100070);
    2(北京工商大学 材料与机械工程学院,北京,100048)
李菲菲硕士研究生和张李伟副高级研究员为共同第一作者(张李伟为通讯作者,E-mail:zhangliwei123@sina.com)

收稿日期: 2019-11-12

  网络出版日期: 2020-02-02

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Analysis and suggestions of evaluation and approval for health foods containing melatonin

  • LI Feifei ,
  • ZHANG Liwei ,
  • FU Zongqiang ,
  • JIANG Yu
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  • 1(Center for Food Evaluation, State Administration for Market Regulation, Beijing 100070, China);
    2(School of Materials and Mechanical Engineering, Beijing Technology and Business University, Beijing 100048, China)

Received date: 2019-11-12

  Online published: 2020-02-02

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摘要

旨在通过对以褪黑素为主要原料的保健食品产品注册审评审批状况分析,为该类保健食品申报及监督管理提供依据及政策建议。1996—2015年,国家共批准含褪黑素保健食品164个,其中91.3%产品配方原料为褪黑素或褪黑素复配维生素B6,84.8%产品剂型为片剂和硬胶囊,94%产品每日食用量为褪黑素1~3 mg/d。综合分析国内外褪黑素的研究表明,中短期食用1~3 mg/d褪黑素的安全性较高,改善睡眠功效确定,加之原料生产工艺可控,适合制定专属褪黑素的保健食品原料标准,建议将褪黑素类保健食品纳入备案制管理。

关键词： 褪黑素; 保健食品; 注册管理; 安全性; 有效性; 质量可控性

本文引用格式

李菲菲 , 张李伟 , 付宗强 , 姜雨 . 褪黑素类保健食品注册审评审批状况分析与建议[J]. 食品与发酵工业, 2020 , 46(7) : 283 -288 . DOI: 10.13995/j.cnki.11-1802/ts.022789

Abstract

The paper aims to provide suggestions for regulation as well as research and development of health food products containing melatonin. Among 740 products claiming the function of improving sleep, which were approved by administrative departments of Chinese government from 1996 to 2015, 164 kinds of products contained melatonin. Of which, 91.3% of them used melatonin as a main component supplemented with or without vitamin B6. 84.8% of them were tablets and capsules, and 94% of them recommended a daily dosage of 1-3 mg melatonin. A comprehensive analysis based on published researches of melatonin indicated that 1-3 mg/d dosage of melatonin in short- and medium-term was very safe, and its efficacy of improving sleep quality was acceptable. In view of this and in addition to the controllability in melatonin's quality, a transition from an examination and approval system to an easing registration and recording system should be made on regulation of these products in recent future.

Key words： melatonin; health food; registration regulation; safety; efficacy; quality control

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