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GeraldRenner欧盟化妆品协会技术法规总监2014.07.25欧盟化妆品法规体系介绍IntroductiontotheEUCosmeticsRegulation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Fastmovingconsumergoods•低生物/系统活性Lowbiological/systemicactivity•天然低风险Inherentlylowrisk•提升幸福感Well-beingbenefit•慢速流通品Slowmovinggoods•高生物/系统活性Highbiological/systemicactivity•天然高风险Inherentlyhighrisk•健康/医疗功能Health/medicalbenefit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•Responsibilityforsafetyandcomplianceiswiththeentitywhoplacesonthemarket•成员国行政部门进行产品的市场监管•Inmarketcontrolbyauthorities•无事前产品注册，但有简单的产品备案，以便政府的市场监管•Nopre-marketregistrationofproducts,butsimplenotificationtofacilitatein-marketcontrol•对化妆品重要原料（三个允许列别）的新原料，需要事前注册•Premarketregistrationforpriorityingredients(i.e.positivelists)•对国产产品和进口产品的监管没有区别•Nodifferentiationbetweendomesticandimportedproducts政府、企业、行业的分工与职责Rolesandresponsibilities欧盟委员会EuropeanCommission:•监督整个法规和监管体统的运行•Monitorstheoverallfunctioningofthesystem•获取来自成员国政府、行业、消费者的反馈•ReceivesfeedbackfromMemberStates,industryandconsumerrepresentatives•一旦发现成员国行政部门对法规的执行和落实出现偏离，要求其采取改正措施•Requirescorrectiveactionsifmemberstatesdeviatefromtheirobligations•在行业与成员国的协作下，制定法规实施指南，•Developsguidanceincollaborationwithindutryandmemberstates•发起法规的更新和修改•Initiatesregulatoryupdates/changes成员国行政部门NationalCompetentAuthorities:•当化妆品产品符合欧盟法规时，不得限制产品的自由流通•Mustnotrestrictthecirculationofcosmeticproductswhichcomplywiththelaw•对产品进行市场监管和安全风险监测•Checkcomplianceatlocallevelthroughin-marketcontrolandcosmetovigilance•当发现违规产品时，要求产品责任人采取纠正措施•Holdthereponsibleentityliableincaseofnon-complianceandensurecorrectiveaction•与欧盟委员会和其他成员国行政部门进行交流和合作•CollaboratewithothermemberstatesandEUCommissionintheircontrolactivities政府、企业、行业的分工与职责Rolesandresponsibilities行业：遵守法律法规！Industry:Complywiththelaw!行业协会：（CosmesticsEurope）Industryassociations:•协助化妆品企业将符合要求的产品推向市场•AssistcompaniesintheirendevourtoplacecompliantproductontheEUmarket•发布欧盟或成员国的法规实施指南•Issuehands-onEUand/ornationalguidelines•发布推荐性的最佳标准/操作/指南•Issuerecommendationsforbestpractice•与欧盟和成员国行政部门间交换信息，以识别产品问题和风险预警•ExchangeinformationwithEUandlocalauthoritiestoidentifyproblems/issuesarising•参与欧盟法规和指南的制修订工作•InputinEUguidelinesandregulatorychanges政府、企业、行业的分工与职责RolesandresponsibilitiesChapterTitleArticlesIScope,definitions1-2IISafety,responsibleperson,freemovement3-9IIISafetyAssessment,productinformationfile,notification10-13IVRestrictionsforcertainsubstances14-17VAnimaltesting18VIConsumerinformation19-21VIIMarketsurveillance22-24VIIINon-compliance,safeguardclause25-28IXAdministrativecooperation29-30XImplementingmeasures,finalprovisions31-40ANNEXESI-X欧盟法规内容排布LayoutoftheRegulationtext章节标题条款I范围，定义1-2II产品安全，责任人，自由流通3-9III安全性评价，产品信息文件，产品备案10-13IV对特定成分的限制14-17V动物实验18VI消费者信息19-21VII市场监督22-24VIII违规行为，保护条款25-28IX行政合作29-30X执行措施，最末的条款31-40附录I-X化妆品的定义和范围Scope化妆品：指用于接触人体表面（表皮、头发、指甲、唇及外生殖器）或牙齿及口腔粘膜的物质或混合物，其主要目的是—Cosmeticproduct:“anysubstanceormixtureintendedtobeplacedincontactwiththeexternalpartsofthehumanbody(epidermis,hairsystem,nails,lipsandexternalgenitalorgans)orwiththeteethandthemucousmembranesoftheoralcavitywithaviewexclusivelyormainlyto....”清洁Cleaningthem增加香味Perfumingthem改变容颜ChangingtheirAppearance保护Protectingthem保持其处于良好状态Keepingthemingoodcondition纠正体臭CorrectingBodyOdours对于该化妆品法规中提及到的责任方及运用该法规的相关方，需要达成对该法规清晰且相同的理解。NeededtoachieveclearandcommonunderstandingofallthosewhoaresubjectedtoorapplyingtheRegulation在法规通篇内容中保持一致的定义：–供应链中的主要参与者（生产商、进口商、最终使用者）–参与者的主要行为（首次投放市场、投放市场销售、撤回、召回……）–技术术语（防腐剂、防晒剂、着色剂、纳米材料……）Defineconsistentlythroughoutthetext:–themainactorsinthesupplychain(manufacturer,importer,enduser)–themainactionscarriedoutbythem(placingonthemarket,makingavai