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日用化学工业（中英文）

日用化学工业（中英文） ›› 2026, Vol. 56 ›› Issue (9): 1251-1259.doi: 10.3969/j.issn.2097-2806.2026.09.014

• 专论与综述 • 上一篇    下一篇

基于欧盟Safety Gate通报数据的化妆品安全风险监管启示研究

张伟清1,刘慧锦1,何欢1,陈镭2,贺丽英3,王思敏4,刘丹5,庞丰平1,冯克然1,*()   

  1. 1 中国药品检定研究院， 北京 100050
    2 江苏省药品监督检验研究院， 江苏 南京 210019
    3 重庆市食品药品检验检测研究院， 重庆 401121
    4 湖北省药品监督检验研究院（湖北生物制品检定所）， 湖北 武汉 430073
    5 贵州省食品药品检验所， 贵州 贵阳 550004
  • 收稿日期:2025-12-12 修回日期:2026-09-03 出版日期:2026-09-22 发布日期:2026-09-30
  • 基金资助:
    中国药品监督管理研究会课题(2025-Y-H-002)

Regulatory implications for cosmetic safety risks based on EU Safety Gate notification data

Weiqing Zhang1,Huijin Liu1,Huan He1,Lei Chen2,Liying He3,Simin Wang4,Dan Liu5,Fengping Pang1,Keran Feng1,*()   

  1. 1 National Institutes for Drug Control, Beijing 100050, China
    2 Jiangsu Institute for Drug Control, Nanjing, Jiangsu 210019, China
    3 Chongqing Institute for Food and Drug Control, Chongqing 401121, China
    4 Hubei Institute for Food and Drug Control, Wuhan, Hubei 430073, China
    5 Guizhou Institute for food and Drug Control, Guiyang, Guizhou 550004, China
  • Received:2025-12-12 Revised:2026-09-03 Online:2026-09-22 Published:2026-09-30
  • Contact: *E-mail: fengkeran@nidc.org.cn.

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摘要：

2025年我国《化妆品安全风险监测与评价管理办法》正式实施，标志着作为化妆品上市后监管重要环节之一的国家化妆品安全风险监测与评价工作，迈入法治化、系统化的全新发展阶段。以2019年1月至2025年9月欧盟“Safety Gate”预警系统的化妆品相关通报数据为核心研究对象，系统剖析欧盟市场化妆品风险通报的总体特征、重点产品类型分布、核心安全风险构成及针对性处置措施逻辑，同时聚焦我国化妆品在该系统中的被通报情况，明确我国出口化妆品的风险短板与适应国际标准的改进方向并从构建一体化风险预警架构、建立快速响应运行机制、聚焦核心风险实现精准监管三个关键维度，为我国化妆品安全风险监测与评价体系的优化升级提供可落地的实践路径，旨在为我国构建与国际接轨、兼具中国特色的化妆品安全监管体系提供有力支撑，推动行业实现从“规模发展”向“质量优先”的转型，切实保障消费者安全与合法权益。

关键词: “Safety Gate”预警系统, 化妆品安全风险监测与评价, 化妆品监管

Abstract:

The formal implementation of China’s Measures for the Administration of Cosmetics Safety Risk Monitoring and Evaluation in 2025 marks a new stage of legalization and systematization in the national cosmetics safety risk monitoring and evaluation framework—a critical component of post-market regulation for cosmetics. This paper focuses on cosmetics-related notification data from the European Union’s “Safety Gate” alert system between January 2019 and September 2025. It systematically analyzes the overall characteristics of cosmetics risk notifications in the EU market, the distribution of key product categories, the composition of core safety risks, and the regulatory logic behind targeted response measures. Additionally, the study investigates notifications involving Chinese cosmetic products within this system to identify vulnerabilities in the risk profile of China’s cosmetic exports and clarifies directions for improvement in alignment with international standards. From three key dimensions—building an integrated risk warning framework, establishing a rapid response operational mechanism, and focusing on core risks to achieve targeted supervision—this paper provides practical pathways for optimizing and upgrading China’s cosmetics safety risk monitoring and evaluation system. The aim is to support the development of a cosmetic safety regulatory framework in China that balances global harmonization with domestic contextualization, to promote the industry’s transition from “scale-driven growth” to “quality-first” development, and effectively safeguard consumer health and rights.

Key words: “Safety Gate” alert system, cosmetics safety risk monitoring and evaluation, cosmetics regulation

中图分类号: 

  • TQ658