欧盟化妆品指令

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Annex III – Restricted Substances 附录III－限用的物质
Over 60 chemicals and groups 超过60种化学剂和类别，还包括： Strong alkalines: potassium hydroxide, lithium hydroxide, etc. 强碱，氢氧化钾，氢氧化锂 Phenol, formaldehyde, methanol 苯酚，甲醛，甲醇 Boric acid, oxalic acid, hydrogen peroxide 硼酸，草酸，过氧化氢 Ammonia, dichloromethane, trialkanolamines (e.g. triethanolamine 氨水，二氯甲烷，三烷基胺 （如：三乙醇胺） Lead, strontium and selenium compounds 铅、锶和硒化合物 Only allowed in certain specified up to a certain %. 只允许特定的产品按一定的比例使用． Specific warning phrases may be required. 要求警句
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Definition of Mucous Membranes 粘膜的定义
in the vicinity of the eyes, on the lips, in the oral cavity or the external genital organs, and does not included any cosmetic product which is intended to come into only brief contact with the skin. 指眼睛、嘴唇、口腔或外生殖器官的附近部位，但 不包括短暂接触皮肤的化妆品
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Annex V – Preservatives Allowed 附录V－允许使用的防腐剂
~50 preservatives 约50种的防腐剂允许使用 All with concentration limits 所有防腐剂的使用都有浓度和百分比要求 Some with application limitation 一些有应用的限制 May require specific warning to go on the label 可能需要在标签上加上警句 Common examples 常用的防腐剂 Benzoic acid(苯甲酸), parabens, 2-phenoxyethanol, Kathon CG, glutaraldehyde戊二醛
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Annex II – Prohibited Substances 附录II – 禁用物质
Over 450 chemicals and groups 超过420种化学物和类别 Include toxic elements and their compounds: antimony, arsenic, cadmium & chromium, etc. 有毒金属及其化合物：锑、砷、铍、镉和铬等 Lead, barium, mercury & selenium with limited use 铅、钡、汞和硒等限制使用 Organic solvents, e.g. benzene, chloroform, carbon tetrachloride, etc. 有机溶剂：苯、三氯甲烷、四氯化碳等 Some colorants: CI12410, CI26105, CI42555, CI42640, CI42535, CI13065, CI61554, CI15585, etc. 某些着色剂
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Definition of a Cosmetic Product 化妆品的定义
Any substance or preparation intended to be placed in contact with any part of the external surface of the human body (that is to say, the 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 to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours except where such cleaning, perfuming, protecting, changing, keeping or correcting is wholly for the purpose of treating or preventing disease. 化妆品是以涂抹、喷洒或其它类似方法，施于人体表面任何部位 (皮肤、毛发、指甲、嘴唇、粘膜等)，以达到清洁、清除不良气 味、护肤、美容和修饰的产品，完全出于治疗或疾病防护的产品 除外。
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Annex VI – UV Filters Allowed 附录VI – 允许使用的紫外过滤剂
~20 UV filters allowed 约20种紫外过滤剂允许使用 All with concentration limits 所有都有浓度和百分比要求 Some with application limitation 可以有其他的应用限制 May require specific warning to go on the label 可能需要在标签上加上警句 Common examples: 4-aminobenzoic acid, octylsalicylate 常见的紫外过滤剂: 对氨基苯甲酸，辛基水杨酸
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Cosmetic Regulations in Europe 欧洲化妆品法规
EU 欧盟 Directive 76/768/EEC 欧洲指令76/768/EEC th 7 Amendment on 27 Feb 2003 第7次修订 th 6 Amendment before Feb 2003 第6次修订 UK 英国 Statutory Instrument 2003 No. 835 2003年第835号法 The Cosmetic Products (Safety) Regulations 化妆品(安全)法规 Previously Statutory Instrument 1996 No. 2925 1996年第2925号法规
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Examples of Cosmetic Products 化妆品举例
Creams, lotions, gels and oils for skin 皮肤用的乳液、洗液、者哩和油 Make-up powders, blushes, lipsticks 化妆用的粉、胭脂、口红 Toilet soaps, deodorant soaps 香皂 Bath and shower preparations 沐浴产品 Shaving products (creams, foams, lotions) 剃须用品（乳液、泡沫和洗液） Face masks 面膜 Anti-wrinkle products 抗皱产品 Sunbathing products 防晒产品
wk.baidu.com76/768/EEC European Cosmetic Directive 欧盟化妆品指令
Sept. 23, 2003 Intertek Shenzhen
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CONTENTS 内容
Introduction of Cosmetic Regulations in Europe 欧洲关于化妆品的条例 Definition of Cosmetic Products 化妆品的定义 Permitted and Restricted Substances 允许和限制物质 Lab Test Requirements 实验室测试要求 Good Manufacturing Practice (GMP) 良好的操作规范 Product Information Pack (PIP) 产品的资料套装 New Amendments to 76/768/EEC 新的修订
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Lab Test and Certification 实验测试和认证
Microbial contamination (BP/EP) 微生物污测试 Preservative effectiveness (BP/EP) 防腐剂有效性测试 Colouring agent identification 颜料鉴定 Analysis of preservatives 防腐剂的分析 Toxicological risk assessment 毒理性的安全评估 Labelling review 标签检查 Good Manufacturing Practice (GMP) certification 良好的操作规范认证 Product Information Pack (PIP) compilation 产品的资料套装
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Annex IV – Colourants Allowed 附录IV – 允许使用的着色剂
~158 colouring agents allowed 约158种着色剂允许使用 Many required to fulfil certain purity requirements 很多要求符合一定的纯度的要求 Mostly labelled by Colour Index (CI) numbers 大多数由着色剂编码（CI）号码来标记
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Directive lists:指令的列表
Annex II – Prohibited substances 附录II – 禁用物质 Annex III – Restricted substances 附录III – 限用物质 Annex IV – Colouring Agents allowed 附录IV - 允许使用的着色剂 Annex V – Preservatives allowed 附录V- 允许使用的防腐剂 Annex VI – UV filters allowed 附录VI- 允许使用的紫外过滤剂
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Annex IV – Colourants Allowed 附录IV – 允许使用的着色剂
4 groups四组 allowed in all cosmetic products 允许用于所有的化妆品 allowed in all cosmetic products except those use near the eye 允许用于除了眼部使用之外的所有化妆品 for cosmetic products intended to come into contact with the mucous membranes 用于与粘膜接触的化妆品 for cosmetic products intended to come into contact only briefly with the skin 用于只和皮肤短暂接触的化妆品