对我国食品保健功能研发及评价问题的分析及建议  

Analysis and suggestions on food health function development and evaluation in China

作　　者：司原琦 付雨 刘洪宇 SI Yuanqi;FU Yu;LIU Hongyu(Center for Food Evaluation,State Administration for Market Regulation,Beijing 100045,China)

机构地区：[1]国家市场监督管理总局食品审评中心,北京100045

出　　处：《中国食品卫生杂志》2024年第10期1173-1178,共6页Chinese Journal of Food Hygiene

基　　金：国家市场监督管理总局科技计划项目(2023MK175)。

摘　　要：目的促进相关从业者对保健功能评价的了解、推动相关科学研究成果转化应用,探索如何提升保健功能评价的科学性严谨性,为保健食品研发和保健功能评价体系完善提供参考。方法介绍保健功能管理现状,梳理我国现行保健功能管理有关法规,阐释科学文献依据和功能评价试验在保健功能评价中的作用和要求,收集并分析保健功能申请材料中常见问题、认识误区和典型案例。结果从目前常见的文献类型形式、物质基础可比性、指标对应性、用量推算、人群外推以及配伍必要性等方面存在的问题出发,对保健功能评价和研发的步骤,科学研究证据搜集、筛选、分析评估的注意事项提出了建议,展望了保健功能评价的未来趋势。结论保健功能研发和评价需要准确理解法规要求,并注重科学研究证据质量,将其作为功能和产品研发设计的依据。Objective In order to promote the understanding of health function evaluation and the transformation and application of scientific research results,explore how to enhance the scientificity and preciseness of health function evaluation,and provide certain suggestions for health food development and evaluation system improvement.Methods Current status of health function management was introduced,relevant on health function regulations in China were sorted out,the role and requirements of scientific literature and functional experiments in health function evaluation were explained,common problems,misunderstandings,and typical cases in health function evaluation practice were collected and analyzed.Results In view of existing problems in literature types and forms,material comparability,indicator correspondence,dosage calculation,target population extrapolation,and compatibility necessity,strategies for function evaluation and research were brought forward,key points for scientific research evidence collection,screening,analysis and evaluation were proposed,future trends of health function evaluation were also proposed for discussion.Conclusion Development and evaluation of health functions require accurate understanding of regulatory requirements and focus on the quality of scientific evidence,which should be used as the basis for health function and product development and design.

关 键 词：保健食品 保健功能 技术审评 功能评价 问题 建议 

分 类 号：R155[医药卫生—营养与食品卫生学]