国际化妆品监管模式对比分析与启示

doi:10.3969/j.issn.1001-1803.2022.02.012

Abstract

Abstract:

The aim is to study the similarities and differences of cosmetics supervision modes in the United States（US）, European Union（EU）, Japan, and China, and learn from the advanced experience of foreign cosmetics supervision modes, so as to provide reference for promoting the innovation of China’s cosmetics supervision, looking for more new methods, tools, standards and systems, and promoting the modernization of cosmetics management system and management ability. Literature research method and comparative analysis method were adopted to find documents related to cosmetics supervision mode through relevant literature and websites, and comparative analysis was conducted on cosmetics definitions, regulatory departments, laws and regulations, relevant social organizations and supervision methods in the US, EU, Japan and China. The regulatory systems of US and EU are relatively mature and complete, and the supervision modes have their own different characteristics. Japan and China are in line with US and EU. The EU adopts a market-oriented model, implements a cosmetics responsible person system and a filing system,relatively weakens the current pre-regulation of production access, strengthens the government’s supervision during and after the event, and the role of industry associations in formulating standards and regulating industry self-discipline is at the world’s leading level.

Key words: cosmetics regulation, supervision method, comparative analysis, experience revelation

CLC Number:

TQ658

Cao Xi,Chen Jiansheng,Liu Zuoren,Xie Zhijie,Chen Min. Comparative analysis and enlightenment of international cosmetics supervision modes[J].China Surfactant Detergent & Cosmetics, 2022, 52(2): 190-198.

Figures/Tables 5

Tab. 1

Tab. 2

Tab. 3

Tab. 4

Cosmetic-related social organizations in various countries"

	美国	欧盟	日本	中国
主要行业协会	PCPC和CIR	SCCS、COLIPA和 EAPCCT	JCIA、JFFMA和JSDA	中国香料香精化妆品工业协会、中华全国工商联合会美容化妆品业商会、中国药品监督管理研究会
主要行业协会职能	PCPC工作重点在现代化政府政策、倡导声音科学、确保全球访问以及维持消费者信心;CIR主要负责原料安全性的评估	SCCS就有关食品之外的消费产品和服务的健康及安全风险进行评估并提供科学建议。 COLIPA在沟通和协调政府管理部门和生产企业之间的关系以及本行业自我约束方面起着十分重要的作用	JCIA负责讨论和制定行业的自主管理标准,并参与国际组织的合作交流活动,还会发布一系列相关的指导文件,以供化妆品企业进行参考。JFFMA其中安全小组委员会与厚生劳动省合作,对政府指定的对健康有害的化妆品成分进行安全评估;此外,还会收集国内的安全、法规信息,并将这些信息向社会公开。JSDA就脂肪衍生化学品工业和洗涤剂工业健康发展所需的话题形成公正的行业意见,努力实现,并以此为提高人们生活的稳定性做出贡献	中国香料香精化妆品工业协会受政府委托起草行业发展规划和产业政策,参与政府部门有关本行业法规、政策、标准等的制定、修订工作,并组织宣讲培训和贯彻实施等。中华全国工商联合会美容化妆品业商会指导行业内企业、团体和会员执行政府的方针、政策和法规;向政府有关部门提出制定我国美容化妆品行业发展规划、技术政策、行业标准、经济立法等方面的建议等。中国药品监督管理研究会化妆品专委会职责是组织、协调社会相关资源,开展化妆品监管相关理论和实际问题研究,促进我国化妆品监管事业和行业高质量发展,提供理论、政策和技术等支持

Tab. 4

Tab. 5

References 35

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	美国	欧盟	日本	中国
属性	物品	物质和混合物	产品	日用化学工业产品
使用方法	涂抹、喷洒、喷雾或其他方法	没有规定	涂抹、喷洒或其他类似方法	涂擦、喷洒或者其他类似方法
使用部位	人体	人体外部器官或牙齿、口腔黏膜	身体	皮肤、毛发、指甲、口唇等人体表面
使用目的	清洁、美化、提升魅力或改变外观	清洁、具有香气、改变外观、起到保护作用、保持其处于良好	清洁、美化、增添魅力,改变容颜,保护皮肤头发健康	清洁、保护、美化、修饰为目的
作用机理	不影响人体结构和功能	没有规定	对人体作用缓和	没有规定
收载的法规	《联邦食品、药品和化妆品法案》	《化妆品法规1223/2009》	《医药品、医疗器械等品质、功效及安全性保证等有关法律》	《化妆品监督管理条例》（国务院令第727号）

	美国	欧盟	日本	中国
监管机构	FDA	欧盟层面-化妆品立法机构、DG SANTE;成员国层面-NCA	厚生劳动省	药品监督管理部门
具体监管部门	OCC	DG SANTE下设化妆品常务委员会;BMELV、FAMHP等	医药卫生局	各级药品监督管理部门及其技术支撑机构
化妆品监管职能	相关法律法规的颁布和修订;实验室的检测标准的研究和指定,化妆品市场和生产企业的监管;进出口化妆品的监管;化妆品的抽样检查;产品相关信息的收集和管理;化妆品质量、卫生标签等内容的检查和监督等	欧盟层面负责化妆品的立法、DG SANTE负责实施欧盟关于食品和其他产品安全、消费者权利和保护人民健康的法律;各成员国主管部门的监管职责主要包括：检查化妆品生产者是否符合良好生产规范要求;化妆品及其生产经营者的监督检查等	负责法规的制订和修订工作;对医药部外品的注册许可;生产和进口企业的许可;新原料审批;产品标签及上市后监管	负责包括制定并监督实施化妆品相关的规范性文件、标准法规等;化妆品注册备案、生产许可、监督检查、行政处罚等有关工作,以及组织开展化妆品审评、检查、检测、监测和评价等技术工作

	美国	欧盟	日本	中国
主要法律法规	FD&C Act	《化妆品法规1223/2009》	《医药品、医疗器械等品质、功效及安全性保证等有关法律》	《化妆品监督管理条例》
法规出台意义	化妆品正式纳入了FDA的监管范围	将欧盟化妆品的监管主要依据由指令上升至法规,并在原来76/768/EEC指令上进行了扩充与完善	该法规定了医药部外品、化妆品等用语的定义、标签广告、监督管理、进出口等相关事宜	更突出企业主体地位和充分发挥市场机制作用,体现风险管理、全程管理的理念

	美国	欧盟	日本	中国
按照政府监管强度	社会组织主导模式	市场主导模式	政府主导模式	政府主导模式
按照监管介入的时机	事后监管模式	事中监管模式	事前、事中监管模式	事前监管模式
按照监管的侧重点	规范原料和标签	产品责任和安全评估	生产许可、产品许可（制造销售业许可）	原料、产品、生产等

Comparative analysis and enlightenment of international cosmetics supervision modes

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