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| Announcement of the National Medical Products Administration on Issuing the Measures for the Administration of Cosmetic Safety Risk Monitoring and Evaluation | | 国家药监局关于发布《化妆品安全风险监测与评价管理办法》的公告 |
| (Announcement No. 37 [2025] of the National Medical Products Administration) | | （国家药监局公告2025年第37号） |
| For the purposes of strengthening the supervision and administration of cosmetics and regulating cosmetic safety risk monitoring and evaluation, in accordance with the Regulation on the Supervision and Administration of Cosmetics and other regulations, the National Medical Products Administration has developed the Measures for the Administration of Cosmetic Safety Risk Monitoring and Evaluation, which are hereby issued and shall come into force on August 1, 2025. | | 为加强化妆品监督管理，规范化妆品安全风险监测与评价工作，根据《化妆品监督管理条例》等法规，国家药监局组织制定了《化妆品安全风险监测与评价管理办法》，现予公布，自2025年8月1日起施行。 |
| | 特此公告。 |
| Annex: Measures for the Administration of Cosmetic Safety Risk Monitoring and Evaluation | | 附件：化妆品安全风险监测与评价管理办法 |
| National Medical Products Administration | | 国家药监局 |
| April 9, 2025 | | 2025年4月9日 |
| Annex | | 附件 |
| Measures for the Administration of Cosmetic Safety Risk Monitoring and Evaluation | | 化妆品安全风险监测与评价管理办法 |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 For the purposes of strengthening the supervision and administration of cosmetics and regulating cosmetic safety risk monitoring and evaluation (hereinafter referred to as “risk monitoring and evaluation”), these Measures are developed in accordance with the Regulation on the Supervision and Administration of Cosmetics and other regulations. | | 第一条 为了加强化妆品监督管理，规范化妆品安全风险监测与评价（以下简称风险监测与评价）工作，根据《化妆品监督管理条例》等法规，制定本办法。 |
| Article 2 The medicinal product regulatory departments that organize and conduct risk monitoring and evaluation within the territory of the People's Republic of China shall comply with these Measures. | | 第二条 在中华人民共和国境内，药品监督管理部门组织实施风险监测与评价工作，应当遵守本办法。 |
| Article 3 For the purpose of these Measures, “risk monitoring and evaluation” means medicinal product regulatory departments' monitoring of the risk factors that may affect the quality and safety of cosmetics and analysis, research and judgment and effective disposal of the risk factors discovered. | | 第三条 本办法所称风险监测与评价，是指药品监督管理部门对可能影响化妆品质量安全的风险因素进行监测，并对发现的风险因素进行分析研判和有效处置的活动。 |
| The purposes of risk monitoring and evaluation are to discover and prevent and control cosmetics quality and safety risks and provide a scientific basis for developing cosmetics quality and safety risk control measures and cosmetic standards, conducting sampling inspections of cosmetics, and exchanging information and providing early warnings on cosmetic safety risks. | | 风险监测与评价的目的是发现和防控化妆品质量安全风险，为制定化妆品质量安全风险控制措施和化妆品标准、开展化妆品抽样检验以及化妆品安全风险信息交流和预警提供科学依据。 |
| Article 4 The National Medical Products Administration shall be responsible for the administration of risk monitoring and evaluation nationwide and organizing and conducting the national risk monitoring and evaluation work. The National Institutes for Food and Drug Control shall undertake the technical support for national risk monitoring and evaluation, and organize and coordinate in the specific implementation of national risk monitoring and evaluation work. | | 第四条 国家药品监督管理局负责全国风险监测与评价管理工作，组织开展国家风险监测与评价工作。中国食品药品检定研究院承担国家风险监测与评价的技术支撑工作，组织协调国家风险监测与评价工作的具体实施。 |
| The medicinal product regulatory departments of all provinces, autonomous regions, and municipalities directly under the Central Government shall undertake specific risk monitoring and evaluation tasks according to the requirements of the National Medical Products Administration; and may, as needed for work, organize and conduct risk monitoring and evaluation work within their respective administrative regions. | | 省、自治区、直辖市药品监督管理部门按照国家药品监督管理局的要求，承担具体风险监测与评价任务；可以根据工作需要，组织开展本行政区域内的风险监测与评价工作。 |
| The medicinal product regulatory departments at the districted city or county level shall, according to the requirements of the medicinal product regulatory departments at higher levels, undertake sampling, inspection and testing, investigation and handling, and other work. | | 设区的市级、县级药品监督管理部门按照上级药品监督管理部门的要求，承担采样、检验检测、调查处理等工作。 |
| Article 5 The National Medical Products Administration shall be responsible for establishing a national risk monitoring and evaluation information system and strengthening the information technology construction of risk monitoring and evaluation. | | 第五条 国家药品监督管理局负责建立国家风险监测与评价信息系统，加强风险监测与评价信息化建设。 |
| Article 6 Medicinal product regulatory departments shall keep confidential the trade secrets, personal privacy and other information to which medicinal product regulatory departments and the entities and personnel participating in risk monitoring have access during risk monitoring and evaluation, and shall not disclose relevant information without authorization. | | 第六条 药品监督管理部门及参与风险监测与评价的单位和人员对在风险监测与评价工作中知悉的商业秘密、个人隐私等信息应当予以保密，不得擅自披露相关信息。 |
| Chapter II Plan Development | | 第二章 计划制定 |
| Article 7 The National Medical Products Administration shall develop and revise national risk monitoring and evaluation plans based on the needs for preventing and controlling potential cosmetics quality and safety risks and providing a scientific basis for the development and revision of cosmetics standards. | | 第七条 国家药品监督管理局根据防控化妆品潜在质量安全风险和为化妆品标准制修订提供科学依据的需要，制定国家风险监测与评价计划。 |
| The medicinal product regulatory departments of all provinces, autonomous regions, and municipalities directly under the Central Government shall develop the work schemes for risk monitoring and evaluation according to the national risk monitoring and evaluation plans and in consideration of the needs of the regulatory work in their administrative regions. | | 省、自治区、直辖市药品监督管理部门根据国家风险监测与评价计划，结合本行政区域监管工作需要，制定风险监测与评价工作方案。 |
| Article 8 The focuses of risk monitoring and evaluation shall be put on the following risk factors that may affect the quality and safety of cosmetics: | | 第八条 风险监测与评价应当重点对以下可能影响化妆品质量安全的风险因素开展监测和评价： |
| 1. Substances that are prone to be added to cosmetics and may cause harm to human health. | | （一）易在化妆品中添加、可能对人体健康造成危害的物质； |
| 2. Substances in cosmetics that are prone to cause health hazards to key groups such as children. | | （二）化妆品中易对儿童等重点人群造成健康危害的物质； |
| 3. Risk substances that may be introduced into cosmetic raw materials or packaging materials or may be generated or introduced during production, storage, or transportation of cosmetics. | | （三）化妆品原料或者包装材料可能带入，化妆品生产、贮存和运输过程中可能产生或者带入的风险物质； |
| 4. Items involved in the development and revision of cosmetic standards. | | （四）化妆品标准制修订工作需要涉及的项目； |
| 5. Other items under special monitoring. | | （五）其他重点监测项目。 |
| Article 9 Risk monitoring and evaluation plans shall include the following: | | 第九条 风险监测与评价计划应当包括下列内容： |
| 1. Overall work requirements such as varieties under monitoring, monitoring purposes, task assignment, and work arrangements. | | （一）监测品种、监测目的、任务分配、工作安排等总体工作要求； |
| 2. Work requirements for sampling such as areas, processes, locations, quantities, and time limits of sampling. | | （二）采样地域、环节、场所、数量、时限等采样工作要求； |
| 3. Work requirements for inspection and testing such as monitoring items, inspection and testing institutions, and inspection and testing methods. | | （三）监测项目、检验检测机构、检验检测方法等检验检测工作要求； |
| 4. Requirements for the investigation and handling of substandard products. | | （四）对问题产品的调查处理要求； |
| 5. Requirements for risk evaluation, risk management, and application of results, among other. | | （五）风险评价、风险管理、结果应用等要求； |
| 6. Other work requirements. | | （六）其他工作要求。 |
| Chapter III Sampling and Inspection and Testing | | 第三章 采样和检验检测 |
| ．．．．．． | | ．．．．．． |
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