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国内外化妆品植物类新原料监管制度对比分析OA

Comparative Analysis of Regulatory Systems for New Plant-Based Raw Materials in Cosmetics at Home and Abroad

中文摘要英文摘要

目的 为我国构建化妆品植物类新原料监管模式提供理论参考.方法 运用政策分析和文献研究法,从法规框架、管理要求、安全评估要求等方面,对比分析中国、欧盟、美国化妆品植物类新原料监管制度的差异,分析我国相应监管制度面临的问题与挑战.结果 中国、欧盟、美国化妆品植物类原料监管模式存在系统性差异,我国的监管架构在中央统筹与风险前置控制方面具有优势,但在申报效率、企业成本及创新活力等方面,与欧盟和美国相比仍有一定差距.我国目前在植物原料分类标准、毒理学资料要求及安全证据规范使用等方面仍有提升空间.结论 建议我国借鉴国际经验,建立基于风险等级的植物类原料安全评估体系,明确历史安全使用证据在安全评估中的权重认定与采信规则,并加快完善植物类原料行业标准体系.同时,应积极推进监管信息化转型,以增强安全评估的科学性与监管效率.

Objective To provide theoretical reference for the construction of a regulatory model for new plant-based raw materials in cosmetics in China.Methods Policy analysis and literature research methods were adopted to conduct comparative analysis on the differences in regulatory frameworks,management requirements,and safety assessment requirements for new plant-based raw materials in cosmetics among China,the European Union,and the U.S.,and the problems and challenges faced by China's corresponding regulatory system were analyzed.Results There were systematic differences in the regulatory models of plant-based raw materials in cosmetics among China,the European Union,and the U.S..China's regulatory framework had advantages in central coordination and pre-risk control,but compared to the European Union and the U.S.,there was still a certain gap in terms of declaration efficiency,enterprise costs,and innovation vitality.There was still room for improvement in China's classification standards for plant-based raw materials,requirements for toxicological data,and standardized use of safety evidence.Conclusion It is suggested that China learn from international experience,establish a risk level-based safety assessment system for plant-based raw materials,clarify the weight recognition and acceptance rules of history of safety use evidence in safety assessment,and accelerate the improvement of the industry standard system for plant raw materials.At the same time,actively promote the transformation of regulatory informatization to enhance the scientificity of security assessment and regulatory efficiency.

邹艳琳;陈坚生;柳鹏程;梁毅

中国药科大学国际医药商学院,江苏 南京 211198广东省药品监督管理局审评认证中心,广东 广州 510080中国药科大学国际医药商学院,江苏 南京 211198中国药科大学国际医药商学院,江苏 南京 211198

医药卫生

化妆品植物类原料监管制度政策研究安全评估

cosmeticplant-based raw materialsupervisory systempolicy researchsafety assessment

《中国药业》 2026 (16)

5-10,6

国家自然科学基金[72474225].

10.3969/j.issn.1006-4931.2026.16.002

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