国内外益生菌安全性评估研究进展与监管
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作者单位:

1中国疾病预防控制中心营养与健康所,北京 100050;2国家食品安全风险评估中心,北京 100022

作者简介:

王红艳 女 在读研究生 研究方向为公共卫生 E-mail: 18439280443@163.com

通讯作者:

徐进 男 研究员 研究方向为食品安全风险评估 E-mail: xujin@cfsa.net.cn

中图分类号:

R155

基金项目:

国家食品安全风险评估中心青年科研基金项目(2025004)


Research progress and regulation on safety assessment of probiotics at home and abroad
Author:
Affiliation:

1National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing 100050, China;2China National Center for Food Safety Risk Assessment, Beijing 100022, China

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    摘要:

    随着益生菌在食品、保健品及医药领域的广泛应用,其安全性评估成为保障公众健康和产业发展的关键。尽管当前我国益生菌安全性评估体系较完善,但仍缺乏快速评估机制,使得益生菌开发面临收集安全性证据时间久、备案时间长等问题。文章概述了国内外益生菌安全性评估的研究进展,指出了易感人群的低免疫力、有害代谢产物、耐药性及产品生产加工过程中的污染等核心风险因素。在评估方法上,总结了基因组测序结合计算机模拟技术、体外试验、动物模型及临床试验等多维度手段。此外,文章还比较了FAO/WHO、欧盟、美国等国际监管法规和我国的差异,为加速益生菌行业的发展提供建议。

    Abstract:

    With the widespread application of probiotics in the fields of food, health foods, and medicine, safety assessment has become the key in ensuring public health and supporting industry development. Although current probiotic safety assessment system is complete in China, it lacks a rapid assessment mechanism, facing problems such as long time for evidence collection and filing. This article reviews recent advances on safety assessment of probiotics in China and abroad, highlighting core risk factors such as the low immunity in susceptible population, harmful metabolites, antimicrobial resistance, and pollution during the production and processing of products. In terms of assessment methods, it summarizes multiple approaches, including genomic sequencing combined with computational modeling, in vitro experiments, animal models, and clinical trials, achieving accurate safety evaluations of probiotics. In addition, this article also compares the differences between international regulations such as FAO/WHO, the European Union and the United States and regulations in China, providing suggestions for accelerating the development of the probiotics industry.

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王红艳,齐妍,李军,韩敏,徐进.国内外益生菌安全性评估研究进展与监管[J].中国食品卫生杂志,2025,37(9):870-879.

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  • 收稿日期:2025-06-30
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  • 在线发布日期: 2026-03-02
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