《化妆品监督管理条例》背景下《化妆品安全评估技术导则》的解读刍议
Interpretation and appraisal of the Technical Guidelines for Cosmetic Safety Assessment under the Cosmetics Supervision and Administration Regulations
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摘要: 科学可行的化妆品安全评估体系是保障消费者用妆安全和推动中国特色化妆品产业健康、可持续发展的重要基础.为了配合2020年6月国务院颁布的《化妆品监督管理条例》的顺利实施，国家药品监督管理局陆续颁布了与化妆品质量安全相关的系列二级法规与技术规范.以2021年4月颁布的《化妆品安全评估技术导则》（简称《技术导则》）为切入点，主要从强化评估人员的责任、补充风险评估程序、优化评估方法、增加对儿童化妆品的安全评估等方面梳理了《技术导则》对我国化妆品安全评估带来的变革和影响，从化妆品原料、致癌物和皮肤致敏物三个类别介绍了我国化妆品安全评估的基本原则及与欧盟的异同，分析了新法规对政府、企业、消费者等不同受众的影响，并提出了培养风险评估人员及其风险管理能力、建立企业风险监测数据库、积极学习新方法、借鉴欧盟安全性评估先进经验等的应对建议，以期为我国化妆品行业科学、有序地开展安全评估工作提供有益的参考与指导.Abstract: A scientific and feasible cosmetic safety assessment system is the basis for ensuring the healthy and safety of consumers, standardizing the industrial order and promoting the sustainable development of Chinese cosmetic industry. In order to cooperate with the implementation of the Cosmetics Supervision and Administration Regulations issued on June of 2021, the state has successively promulgated a series of secondary regulations and technical specifications related to cosmetic safety. Taking the Technical Guidelines for Cosmetic Safety Assessment issued in April of 2021 as a starting point, this paper comprehensively reviewed the main changes related to cosmetic safety evaluation in China from the aspects of strengthening the responsibilities of evaluators, supplementing risk assessment procedures, optimizing assessment methods and increasing the safety evaluation of children's cosmetics, and analyzed the impact of the new laws and regulations on different audiences such as the government, enterprises and consumers, introduced the basic principles of cosmetic safety assessment in terms of normal ingredients, carcinogens and skin sensitizers as well as the differences with the European Commission, and put forward several suggestions for enterprises and relevant practitioners, including cultivating risk assessment personnel and risk management ability, constructing risk monitoring database, updating new risk assessment technologies and referring to the advanced experiences of European Commission, etc, which provided useful guidance and reference for the cosmetic industry to carry out risk assessment in a scientific and orderly manner.
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