欧盟化妆品法规体系介绍.pdf

1、 Gerald Renner 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 Introduction to the EU Cosmetics Regulation 提纲 Agenda 欧盟介绍 The European Union 欧盟化妆品法规介绍 EU Cosmetic Regulation 欧盟化妆品市场监管体系介绍 EU Cosmetic In-market Control 欧盟化妆品的检测分析方法 EU Cosmetic Analytical Methods 欧盟介绍 The European Union 由28个独立主权国家（成员国）组成的政治经济联合

2、体 Economic and political union of 28 sovereign nations(member states)超过5亿人口 Over 500 million citizens 占全球GDP21%Represents 21%of Global GDP 具有法人资格，可决定欧盟的条约/协议 Legal personality,able to conclude treaties 居民、产品、服务、资本可以自由通行 Free movement of people,goods,services,and capital 欧盟的立法欧盟的立法 EU Level Legislati

3、on 欧盟法律是由EU law is 欧盟委员会提出proposed by the EU Commission 欧联理事会和欧盟议会决定decided by the EU Council of Member States and the European Parliament 各成员国组织实施Applied/enforced by local Member States Authorities 立法过程：成员国和欧盟各利益相关者的广泛参与 Legislative process:involvement of national and EU stakeholders 一旦制定欧盟一体化法规，各成

4、员国不可制定不同的国家法规 In case of EU legislation,no more room for differing national laws.目前，欧盟内并非完全一体化立法 Not all areas of law are harmonized by the EU 欧盟的共同市场欧盟的共同市场 The Single Market in the EU 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 Differences in safety standards in 28 Member States are incompatible wit

5、h free circulation of consumer goods 中国与欧盟面临相似的挑战中国与欧盟面临相似的挑战 China is not the EU,but faces similar challenges 13亿人口 1.3 billion citizens 30多个省级行政区域，包括省、自治区、直辖市 Around 30 provinces,autonomous regions,and municipalities 药监总局和各地方食药监局 Central CFDA/local FDAs 需要清晰的职责链条 Need a clear chain of responsibili

6、ty 欧盟对化妆品的界定欧盟对化妆品的界定 The EU approach on cosmetics Cosmetics are not drugs 化妆品 不是 药品 快速消费品Fast moving consumer goods 低生物/系统活性 Low biological/systemic activity 天然低风险Inherently low risk 提升幸福感 Well-being benefit 慢速流通品Slow moving goods 高生物/系统活性 High biological/systemic activity 天然高风险Inherently high risk

7、 健康/医疗功能Health/medical benefit 市场监管被认为是最有效的政府监管途径 In-market control is considered the most effective and efficient regulatory approach 化妆品法规的基本原则化妆品法规的基本原则 The basic principles 投放市场的产品必须经安全评估确认其安全性 Products placed on the market must be safe,based on a safety assessment 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 Res

8、ponsibility for safety and compliance is with the entity who places on the market 成员国行政部门进行产品的市场监管 In market control by authorities 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 No pre-market registration of products,but simple notification to facilitate in-market control 对化妆品重要原料（三个允许列别）的新原料，需要事前注册 Premarket registr

9、ation for priority ingredients(i.e.positive lists)对国产产品和进口产品的监管没有区别 No differentiation between domestic and imported products 政府政府、企业、行业的分工与职责、企业、行业的分工与职责 Roles and responsibilities 欧盟委员会European Commission:监督整个法规和监管体统的运行 Monitors the overall functioning of the system 获取来自成员国政府、行业、消费者的反馈 Receives fe

10、edback from Member States,industry and consumer representatives 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 Requires corrective actions if member states deviate from their obligations 在行业与成员国的协作下，制定法规实施指南，Develops guidance in collaboration with indutry and member states 发起法规的更新和修改 Initiates regulatory update

11、s/changes 成员国行政部门成员国行政部门 National Competent Authorities:当化妆品产品符合欧盟法规时，不得限制产品的自由流通 Must not restrict the circulation of cosmetic products which comply with the law 对产品进行市场监管和安全风险监测 Check compliance at local level through in-market control and cosmetovigilance 当发现违规产品时，要求产品责任人采取纠正措施 Hold the reponsibl

12、e entity liable in case of non-compliance and ensure corrective action 与欧盟委员会和其他成员国行政部门进行交流和合作 Collaborate with other member states and EU Commission in their control activities 政府政府、企业、行业的分工与职责、企业、行业的分工与职责 Roles and responsibilities 行业：遵守法律法规！行业：遵守法律法规！Industry:Comply with the law!行业协会：（行业协会：（Cosme

13、stics Europe）Industry associations:协助化妆品企业将符合要求的产品推向市场 Assist companies in their endevour to place compliant product on the EU market 发布欧盟或成员国的法规实施指南 Issue hands-on EU and/or national guidelines 发布推荐性的最佳标准/操作/指南 Issue recommendations for best practice 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 Exchange informati

14、on with EU and local authorities to identify problems/issues arising 参与欧盟法规和指南的制修订工作 Input in EU guidelines and regulatory changes 政府政府、企业、行业的分工与职责、企业、行业的分工与职责 Roles and responsibilities Chapter Title Articles I Scope,definitions 1-2 II Safety,responsible person,free movement 3-9 III Safety Assessme

15、nt,product information file,notification 10-13 IV Restrictions for certain substances 14-17 V Animal testing 18 VI Consumer information 19-21 VII Market surveillance 22-24 VIII Non-compliance,safeguard clause 25-28 IX Administrative cooperation 29-30 X Implementing measures,final provisions 31-40 AN

16、NEXES I-X 欧盟法规内容排布欧盟法规内容排布 Layout of the Regulation text 章节 标题 条款 I 范围，定义 1-2 II 产品安全，责任人，自由流通 3-9 III 安全性评价，产品信息文件，产品备案 10-13 IV 对特定成分的限制 14-17 V 动物实验 18 VI 消费者信息 19-21 VII 市场监督 22-24 VIII 违规行为，保护条款 25-28 IX 行政合作 29-30 X 执行措施，最末的条款 31-40 附录 I-X 化妆品的定义和范围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

17、器）或牙齿及口腔粘膜的物质或混合物，其主要目的是 Cosmetic product:“any substance or mixture intended to be placed in contact with the external parts of the human body(epidermis,hair system,nails,lips and external genital organs)or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly

18、to.”清洁清洁 Cleaning them 增加香味增加香味 Perfuming them 改变容颜改变容颜 Changing their Appearance 保护保护 Protecting them 保持其处于良好状态保持其处于良好状态 Keeping them in good condition 纠正体臭纠正体臭 Correcting Body Odours 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。Needed to achieve clear and common understanding of all those who are s

19、ubjected to or applying the Regulation 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）Define consistently throughout the text:the main actors in the supply chain(manufacturer,importer,end user)the main actions carried out by them(placing on the market,mak

20、ing available,withdrawal,recall,)Technical terms(preservative,UV filter,colorant,nanomaterial,关键关键:避免不同参与者共担同一职责，否则只会互相推诿，避免不同参与者共担同一职责，否则只会互相推诿，无人负责！无人负责！Avoid allocating the same repsonsibility to different actors.If several actors are responsible,none will take up the responsability!更多相关解释和定义更多相关

21、解释和定义 Many more definitions 只有当化妆品产品有指定的“责任人”时，方可投放到欧盟市场 Only cosmetic products for which a responsible person is designated can be placed on the EU market.产品责任人负责产品的安全和合法性 He is responsible for safety and legal compliance 该产品责任人必须是欧盟范围内的实体，包括法人和自然人 Must be an entity(natural or legal person)establis

22、hed in the EU 通常情况下，产品责任人是产品生产商或进口商 Most times,it is the manufacturer or importer 产品责任人的名称和地址必须标注在产品上 His name and address must be labelled on the product 一旦政府市场监管发现产品没有标注责任人信息，将停止其进口或将其从市场撤回（停止销售）If in-market control detects a product without a RP address,it will be stopped at customs or withdrawn

23、from the market 产品责任人的核心作用产品责任人的核心作用 Central role of the Responsible Person(RP)保证产品安全 Safety of the product 遵守良好生产规范cGMP Good manufacturing practice 向政府提供包括由安全评价员出具的安全性评价在内的产品信息文件 Authorities access to Technical Product Information File including safety assessment by a qualified safety assessor 在备案门

24、户网站上进行产品备案（CPNP）Notification of product at central database(CPNP)保证产品配方符合原料限制要求 Formulation compliance with specific ingredient restrictions 遵守动物实验禁令 Respecting of animal testing bans 提供完整正确的标签 Completeness and correctness of labelling 符合对产品宣称的共同标准 Compliance with the common criteria for claims 记录和处

25、理不良反应并且当严重不良反应发生时，向政府部门及时上报 Manage undesirable effect reports and notify serious undesirable effects to authorities 配合市场监管的政府行政部门的相关工作 Collaboration with in-market control authorities 产品责任人的主要法律责任产品责任人的主要法律责任 Main legal Obligations of the Responsible Person(RP)生产卫生要求还是安全要求？生产卫生要求还是安全要求？Manufacturing

26、 Hygiene Rules or Safety Rules?GMP良好生产规范=一套关于生产和质量控制的措施，用以确保：生产和检测流程有清晰的规定，验证，回顾和记录；有配套且合适的生产人员，设施和材料;有效的文件管理系统 GMP=set of measures for production and quality control to ensure that production and testing processes are clearly defined,validated,reviewed,and documented,personnel,premises and material

27、s are suitable;an appropriate documentation is performed 欧盟法规主要关注产品配方的安全性欧盟法规主要关注产品配方的安全性 Main focus of EU Regulation is on safety of the formulation GMP本身并不能保证产品的安全性，但是它可以通过确保生产的可再现性，文件管理，产品可追溯性来帮助达到产品安全。GMP does not in itself ensure safe products,but contributes to it by ensuring reproducibility,d

28、ocumentation and traceability 原料管理原则原料管理原则 Principle of ingredient regulation 根据产品责任人原则和政府市场监管 原则提出 Arises from principle of“Responsible Person”and authorities in-market control 选择安全原料用于化妆品生产是产品责任人（及安全评估员）的责任 The choice of safe ingredients is generally in the responsibility of the responsible person

29、(and his safety assessor).对于重要的化妆品原料，立法者已经将其纳入统一的限制要求和事前注册的欧盟法规 化妆品法规中的附录（允许和限制列表）For priority substances,the legislator introduced EU-harmonised restrictions and/or pre-market registration Annexes(positive and negative ingredient lists)of Cosmetic Regulation 重点原料重点原料 Ingredients with specific atten

30、tion 着色剂，防腐剂，防晒剂 允许列表（附录 IV-VI）Colorants,Preservatives,UV-filters positive list(Annex IV-VI)明确的风险物质：禁限用物质 限制列表(Annex II-III)Specific substances of concern:banned/restricted negative lists(Annex II-III)CMR（致癌性，致突变性和生殖毒性）物质：禁止但有例外 CMR Substances:ban with exceptional derogations 染发剂：根据其机理，将来可能放入允许列表中 H

31、air Colorants:mechanism for future positive lists 纳米材料：特殊的上市前备案管理（产品）Nanomaterials:special pre-notification regime 动物实验动物实验 Animal Testing 从2013年3月开始，欧盟全面禁止：Since March 2013 the EU Regulation fully prohibits 在欧盟范围内对化妆品及其成分进行动物实验，以期满足化妆品法规要求 the performance of animal tests in the EU to meet the requi

32、rements of the Cosmetics Regulation for finished products and ingredients/combinations 如果化妆品或其成分曾为满足化妆品法规要求而进行动物实验，将被禁止在欧盟销售，无论该试验是在欧盟范围内还是世界其他地区发生 the sale cosmetics products,when the final formulation or ingredients have been tested on animals-in the EU or outside the EU-to meet the requirements o

33、f the Regulation 动物实验禁令的范围？动物实验禁令的范围？Scope of Animal Testing Bans?为符合本法规的要求而做的动物实验 animal tests carried out in order to meet the requirements of the Regulation 为符合其他国家和地区法规要求，或其他地区进行的动物实验？What about tests made in other fields of legislation or to meet requirements of the third countries legislation?欧盟委员会已经就该禁令发布了释义，但最终将由欧洲法院裁定 European Commission published its interpretation,but definitive answer