欧盟化妆品法规体系介绍IntroductiontotheEUCosmeticsRegulationGeraldRenner欧盟化妆品协会技术法规总监2014.07.25提纲Agenda•欧盟介绍•TheEuropeanUnion•欧盟化妆品法规介绍•EUCosmeticRegulation•欧盟化妆品市场监管体系介绍•EUCosmeticIn-marketControl•欧盟化妆品的检测分析方法•EUCosmeticAnalyticalMethods欧盟介绍TheEuropeanUnion•由28个独立主权国家（成员国）组成的政治经济联合体•Economicandpoliticalunionof28sovereignnations(memberstates)•超过5亿人口•Over500millioncitizens•占全球GDP21%•Represents21%ofGlobalGDP•具有法人资格，可决定欧盟的条约/协议•Legalpersonality,abletoconcludetreaties•居民、产品、服务、资本可以自由通行•Freemovementofpeople,goods,services,andcapital欧盟的立法EULevelLegislation•欧盟法律是由EUlawis–欧盟委员会提出proposedbytheEUCommission–欧联理事会和欧盟议会决定decidedbytheEUCouncilofMemberStatesandtheEuropeanParliament–各成员国组织实施Applied/enforcedbylocalMemberStatesAuthorities•立法过程：成员国和欧盟各利益相关者的广泛参与•Legislativeprocess:involvementofnationalandEUstakeholders•一旦制定欧盟一体化法规，各成员国不可制定不同的国家法规•IncaseofEUlegislation,nomoreroomfordifferingnationallaws.•目前，欧盟内并非完全一体化立法•NotallareasoflawareharmonizedbytheEU欧盟的共同市场TheSingleMarketintheEU欧盟共同市场中，在消费品自由流通的前提下，不允许28个成员国制定不同的产品安全标准Differencesinsafetystandardsin28MemberStatesareincompatiblewithfreecirculationofconsumergoods中国与欧盟面临相似的挑战ChinaisnottheEU,butfacessimilarchallenges•13亿人口•1.3billioncitizens•30多个省级行政区域，包括省、自治区、直辖市•Around30provinces,autonomousregions,andmunicipalities•药监总局和各地方食药监局•CentralCFDA/localFDAs•需要清晰的职责链条•Needaclearchainofresponsibility欧盟对化妆品的界定TheEUapproachoncosmeticsCosmeticsarenotdrugs化妆品不是药品•快速消费品Fastmoving•慢速流通品Slowmovinggoodsconsumergoods•高生物/系统活性Highbiological/•低生物/系统活性Lowbiologicalsystemicactivity/systemicactivity•天然高风险Inherentlyhighrisk•天然低风险Inherentlylowrisk•健康/医疗功能Health/medical•提升幸福感Well-beingbenefitbenefit市场监管被认为是最有效的政府监管途径In-marketcontrolisconsideredthemosteffectiveandefficientregulatoryapproach化妆品法规的基本原则Thebasicprinciples•投放市场的产品必须经安全评估确认其安全性•Productsplacedonthemarketmustbesafe,basedonasafetyassessment•产品合法、安全等法律责任由其投放市场的产品责任人承担•Responsibilityforsafetyandcomplianceisw