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 Legislation • 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 with 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 responsibility 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 • 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 •Responsibility 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 registration 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 feedback 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 updates/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 reponsible 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：（Cosmestics 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 information 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 Assessment, 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 ANNEXES 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 29-3。