中欧日韩化妆品监管概况及最新发展的差异分析
1.河北省药品职业化检查员总队（南片区），河北 石家庄 050000；
2.国家药品监督管理局特殊药品检查中心，河北 石家庄 050000收稿日期: 2025-05-05
修回日期: 2025-07-24
录用日期: 2026-05-26
网络出版日期: 2026-05-26
Comparative Analysis of Recent Regulatory Frameworks and Developments in Cosmetics： China， the EU， Japan， and South Korea
Received date: 2025-05-05
Revised date: 2025-07-24
Accepted date: 2026-05-26
Online published: 2026-05-26
通过对比分析中欧日韩化妆品法规体系、原料管理、安全评估、功效宣称与验证以及动物试验政策与替代方法等方面的差异，为我国化妆品监管提供借鉴。研究发现，中欧日韩在化妆品监管方面各有特色。欧盟以企业自律与事后监管为核心，实施严格的原料准入制度。中国采用注册备案双轨制，逐步完善安全评估体系，在功效宣称分类管理上与欧盟接近。日本以《药事法》为基础，建立“肯定列表”原料管理制度，功效宣称需经厚生劳动省分类审批，动物试验政策保持技术中立态度。韩国则融合欧盟与日本模式，近年通过《化妆品法》修订加强安全评估要求，全面禁止动物试验。对比分析显示：欧盟侧重事前预防与全生命周期监管，日本强调科学证据与分类管理，中国呈现渐进式改革特征，韩国正经历从宽松到严格的监管转型。在动物试验替代方法推广方面，欧盟处于全球领先地位，中国正加速替代技术转化应用，日本保持技术储备策略，韩国已实现全面替代。中欧日韩化妆品监管的差异为我国化妆品监管提供了启示。我国应借鉴各国的先进经验，不断完善法规体系，强化原料管理，提升安全评估水平，严格功效宣称监管，并积极推动动物试验替代方法的研究与应用，以更好地保障消费者权益和市场公平。
李晓平
,
李晓倩
,
郭亚秋
,
隋思强
,
李永辉
.
中欧日韩化妆品监管概况及最新发展的差异分析
Through comparative analysis of the regulatory frameworks， ingredient management， safety assessment， efficacy claims and verification， animal testing policies， and alternative methods in China， the European Union （EU）， Japan， and South Korea， this study provides references for China's cosmetic regulation. The research reveals distinct characteristics in cosmetic regulation across these regions. The EU adopts a corporate self-discipline and ex-post regulation model with stringent ingredient access control. China implements a dual-track registration and filing system， progressively enhancing its safety assessment framework while aligning efficacy claim classification with EU practices. Japan bases its system on the Pharmaceutical Affairs Law， featuring a "positive list" ingredient management system and requiring classification approval by the Ministry of Health， Labour and Welfare for efficacy claims， maintaining a technology-neutral stance on animal testing. South Korea integrates EU and Japanese models， having strengthened safety assessment requirements through recent Cosmetics Act amendments and achieved a complete ban on animal testing. Comparative findings indicate： the EU emphasizes precautionary principles and full-lifecycle regulation； Japan prioritizes scientific evidence and categorical management； China demonstrates incremental reform characteristics； and South Korea is undergoing regulatory transition from lenient to strict standards. Regarding alternative methods to animal testing， the EU leads globally， China accelerates technology conversion， Japan maintains technical reserve strategies， and South Korea has achieved full substitution. The regulatory differences among China， the EU， Japan， and South Korea offer significant insights for China's cosmetic regulation. China should leverage advanced international experiences to continuously improve regulatory frameworks， strengthen ingredient management， elevate safety assessment standards， rigorously regulate efficacy claims， and actively promote research and application of alternative methods to animal testing， thereby better protecting consumer rights and ensuring market fairness.
Key words： ; ; Cosmetics； ; Regulation； ; Supervision
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