欧美日韩化妆品法规标准.doc

欧美日韩化妆品法规标准以下法规标准仅供参考,请注意查询使用最新规定。1、美国联邦法典化妆品规定法规/标准编号中文名称英文名称21CFR1总则General Regulations21CFR70着色剂总则Colors General70.3定义Definitions.70.5着色剂使用的一般限定General restrictions on use of color additives.70.1标准化食品和新药中的着色添加剂Color additives in standardized foods and new drugs.70.11相关物质Related substances.70.19清单Fees for listing.70.2直接着色剂包装要求（染发剂除外）Packaging requirements for straight colors (other than hair dyes).70.25着色剂标签要求（染发剂除外）Labeling requirements for color additives (other than hair dyes).70.4需要考虑的安全Safety factors to be considered.70.42着色剂安全评价标准Criteria for evaluating the safety of color additives.70.45着色剂配置Allocation of color additives.21CFR73允许使用的化妆品着色剂Colors Exempt From Certification COSMETICS73.1食品中允许使用的调色添加剂Diluents in color additive mixtures for food use exempt from certification.73.3胭脂树橙提取物Annatto extract.73.35叶黄素Astaxanthin.73.4脱水甜菜（甜菜粉末）Dehydrated beets (beet powder).73.5群青蓝Ultramarine blue.73.75角黄素Canthaxanthin.73.85焦糖Caramel.73.9-阿朴-8-胡萝卜醛-Apo-8-carotenal.73.95-胡萝卜素-Carotene.73.1胭脂虫提取物；胭脂洋红Cochineal extract; carmine.73.125叶绿素铜钠Sodium copper chlorophyllin.73.14烘烤椰子粉Toasted partially defatted cooked cottonseed flour.73.16葡萄糖酸铁Ferrous gluconate.73.165乳酸铁Ferrous lactate.73.169葡萄色素提取物Grape color extract.73.17葡萄皮提出取物（依诺他滨）Grape skin extract (enocianina).73.185血色球菌海藻粉Haematococcus algae meal.73.2合成铁氧化剂Synthetic iron oxide.73.25果汁Fruit juice.73.26蔬菜汁Vegetable juice.73.275干海藻粉Dried algae meal.73.295万寿菊粉和提取物Tagetes (Aztec marigold) meal and extract.73.3胡萝卜油Carrot oil.73.315玉米胚油Corn endosperm oil.73.34红辣椒Paprika.73.345辣椒红色素Paprika oleoresin.73.35云母钛珠光颜料Mica-based pearlescent pigments.73.355法夫酵母Phaffia yeast.73.45核黄素Riboflavin73.5藏红花Saffron.73.575二氧化钛Titanium dioxide.73.585番茄红素提取物，番茄红素浓缩物Tomato lycopene extract; tomato lycopene concentrate.73.6姜黄Turmeric.73.615姜黄油性树脂Turmeric oleoresin.73.1001未批准药用着色剂混合物稀释液Diluents in color additive mixtures for drug use exempt from certification.73.101氧化铝（干氢氧化铝）Alumina (dried aluminum hydroxide).73.1015铬-钴-氧化铝Chromium-cobalt-aluminum oxide.73.1025柠檬酸铁铵Ferric ammonium citrate73.103胭脂树橙提取物Annatto extract.73.107碳酸钙Calcium carbonate.73.1075斑蝥黄Canthaxanthin.73.1085焦糖Caramel.73.1095-胡萝卜素-Carotene.73.11胭脂虫提取物；胭脂洋红Cochineal extract; carmine.73.1125叶绿素钾钠铜（叶绿素盐混合物）Potassium sodium copper chloropyhllin (chlorophyllin-copper complex).73.115二羟基丙酮Dihydroxyacetone73.1162氯氧化铋Bismuth oxychloride.73.12合成氧化铁Synthetic iron oxide.73.1298亚铁氰化铁铵Ferric ammonium ferrocyanide.73.1299亚铁氰化铁Ferric ferrocyanide.73.1326氢氧化铬绿Chromium hydroxide green.73.1327氧化铬绿Chromium oxide greens.73.1329鸟嘌呤Guanine.73.135云母钛珠光颜料Mica-based pearlescent pigments.73.1375焦倍酚；邻苯三酚Pyrogallol.73.14叶蜡石Pyrophyllite.73.141苏木膏Logwood extract.73.1496云母Mica.73.155滑石Talc.73.1575二氧化钛Titanium dioxide.73.1645铝粉Aluminum powder.73.1646青铜粉Bronze powder.73.1647铜粉Copper powder.73.1991氧化锌Zinc oxide.73.203胭脂树橙Annatto.73.2085焦糖Caramel.73.2087胭脂洋红Carmine.73.2095-胡萝卜素-Carotene.73.211枸橼酸铋；柠檬酸铋Bismuth citrate.73.212乙二胺四乙酸铜二钠Disodium EDTA-copper.73.2125叶绿素钾钠铜（叶绿素铜混合物）Potassium sodium copper chlorophyllin (chlorophyllin-copper complex).73.215二羟丙酮Dihydroxyacetone.73.2162氯氧化铋Bismuth oxychloride.73.218愈创蓝油烃Guaiazulene.73.219棕红Henna.73.225氧化铁Iron oxides.73.2298亚铁氰化铁铵Ferric ammonium ferrocyanide.73.2299亚铁氰化铁Ferric ferrocyanide.73.2326氢氧化铬绿Chromium hydroxide green.73.2327氧化铬绿Chromium oxide greens.73.2329鸟嘌呤Guanine.73.2396醋酸铅Lead acetate.73.24叶蜡石Pyrophyllite.73.2496云母Mica.73.25银白色Silver.73.2575二氧化钛Titanium dioxide.73.2645铝粉Aluminum powder.73.2646青铜粉Bronze powder.73.2647铜粉Copper powder.73.2725群青Ultramarines.73.2775锰紫Manganese violet.73.2991氧化锌Zinc oxide.73.2995发光硫化锌Luminescent zinc sulfide.73.311,4-二(2-羟乙基)氨基-9,10-蒽二酮二(2-丙烯)酯共聚物1,4-Bis(2-hydroxyethyl)amino-9,10-anthracenedione bis(2-propenoic)ester copolymers.73.31051,4-二(2-甲基苯基)氨基-9,10-蒽二酮1,4-Bis(2-methylphenyl)amino-9,10-anthracenedione.73.31061,4-二4-(2-甲基丙烯酸氧乙基)苯氨基蒽醌共聚物1,4-Bis4-(2-methacryloxyethyl) phenylaminoanthraquinone copolymers.73.3107咔唑紫Carbazole violet.73.311叶绿素铜复合物,油溶性Chlorophyllin-copper complex, oil soluble.73.3110a铬-钴-铝氧化物Chromium-cobalt-aluminum oxide.73.3111氧化铬绿Chromium oxide greens.73.3112还原橙1C.I. Vat Orange 1.73.31152-2,5-二乙氧基-4-(4-甲基)硫醇偶氮-1,3,5-间苯三酚2-2,5-Diethoxy-4-(4-methylphenyl)thiolphenylazo-1,3,5-benzenetriol.73.311716,23-Dihydrodinaphtho2,3-a:2,3-i naphth 2,3:6,7 indolo 2,3-c carbazole-5,10,15,17,22,24-hexone.73.3118N,N-(9,10-二氢-9,10-二氧代蒽-1,5-蒽二基)二苯甲酰胺N,N-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide.73.31197,16-二氯-6,15-二氢-5,9,14,18-二蒽1,2-1,2哒嗪四酮7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.73.31216,17-Dimethoxydinaphtho 1,2,3-cd:3,2,1-lm perylene-5,10-dione.73.3121聚(甲基丙烯酸 羟基乙酯)-染料共聚物Poly(hydroxyethyl methacrylate)-dye copolymers.73.31224-(2,4-二甲基苯)偶氮-2,4-二氢-5-甲基-2-庚烯-3H-吡唑酰基-3-酮4-(2,4-dimethylphenyl)azo-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one.73.31236-乙氧基-2-(6-乙氧基-3-氧苯并B噻嗯-2(3H)-亚基)苯并B噻吩-3(2H)-酮6-Ethoxy-2-(6-ethoxy-3-oxobenzobthien-2(3H)-ylidene) benzobthiophen-3 (2H)-one.73.3124酞菁绿Phthalocyanine green.73.3125氧化铁Iron oxides.73.3126二氧化锑Titanium dioxide.73.3127乙烯醇/甲基丙烯酸甲酯染色反应产物Vinyl alcohol/methyl methacrylate-dye reaction products.73.3128云母钛珠光颜料Mica-based pearlescent pigments.21CFR74认证化妆品的颜色Colors Subject to Certification COSMETICS74.101FD&C 蓝色1号FD&C Blue No. 1.74.102FD&C 蓝色2号FD&C Blue No. 2.74.203FD&C 绿色3号FD&C Green No. 3.74.25橙色BOrange B.74.302橘红2号Citrus Red No. 2.74.303FD&C 红色3号FD&C Red No. 3.74.34FD&C 红色40号FD&C Red No. 40.74.705FD&C 黄色5号FD&C Yellow No. 5.74.706FD&C 黄色6号FD&C Yellow No. 6.74.1101FD&C 蓝色1号FD&C Blue No. 174.1102FD&C 蓝色2号FD&C Blue No. 2.74.1104D&C 蓝色4号D&C Blue No. 4.74.1109D&C 蓝色9号D&C Blue No. 9.74.1203FD&C 绿色3号FD&C Green No. 3.74.1205D&C 绿色5号D&C Green No. 5.74.1206D&C 绿色6号D&C Green No. 6.74.1208D&C 绿色8号D&C Green No. 8.74.1254D&C 橙色4号D&C Orange No. 4.74.1255D&C 橙色5号D&C Orange No. 5.74.126D&C 橙色10号D&C Orange No. 10.74.1261D&C 橙色11号D&C Orange No. 11.74.1303FD&C 红色3号FD&C Red No. 3.74.1304FD&C 红色4号FD&C Red No. 4.74.1306D&C 红色6号D&C Red No. 6.74.1307D&C 红色7号D&C Red No. 7.74.1317D&C 红色17号D&C Red No. 17.74.1321D&C 红色21号D&C Red No. 21.74.1322D&C 红色22号D&C Red No. 22.74.1327D&C 红色27号D&C Red No. 27.74.1328D&C 红色28号D&C Red No. 28.74.133D&C 红色30号D&C Red No. 30.74.1331D&C 红色31号D&C Red No. 31.74.1333D&C 红色33号D&C Red No. 33.74.1334D&C 红色34号D&C Red No. 34.74.1336D&C 红色36号D&C Red No. 36.74.1339D&C 红色39号D&C Red No. 39.74.134FD&C 红色40号FD&C Red No. 40.74.1602D&C 紫色2号D&C Violet No. 2.74.1705FD&C 黄色50号FD&C Yellow No. 5.74.1706FD&C 黄色6号FD&C Yellow No. 6.74.1707D&C 黄色7号D&C Yellow No. 7.74.1707a外用D&C 黄色7号Ext. D&C Yellow No. 7.74.1708D&C 黄色8号D&C Yellow No. 8.74.171D&C 黄色10号D&C Yellow No. 10.74.1711D&C 黄色11号D&C Yellow No. 11.74.2052D&C 黑色2号D&C Black No. 2.74.2101FD&C 蓝色1号FD&C Blue No. 1.74.2104D&C 蓝色4号D&C Blue No. 4.74.2151D&C 棕色1号D&C Brown No. 1.74.2203FD&C 绿色3号FD&C Green No. 3.74.2205D&C 绿色5号D&C Green No. 5.74.2206D&C 绿色6号D&C Green No. 6.74.2208D&C 绿色8号D&C Green No. 8.74.2254D&C 橙色4号D&C Orange No. 4.74.2255D&C 橙色5号D&C Orange No. 5.74.226D&C 橙色10号D&C Orange No. 10.74.2261D&C 橙色11号D&C Orange No. 11.74.2304FD&C 红色4号FD&C Red No. 4.74.2306D&C 红色6号D&C Red No. 6.74.2307D&C 红色7号D&C Red No. 774.2317D&C 红色17号D&C Red No. 17.74.2321D&C 红色21号D&C Red No. 21.74.2322D&C 红色22号D&C Red No. 22.74.2327D&C 红色27号D&C Red No. 27.74.2328D&C 红色28号D&C Red No. 28.74.233D&C 红色30号D&C Red No. 30.74.2331D&C 红色31号D&C Red No. 31.74.2333D&C 红色33号D&C Red No. 33.74.2334D&C 红色34号D&C Red No. 34.74.2336D&C 红色36号D&C Red No. 36.74.234FD&C 红色40号FD&C Red No. 40.74.2602D&C 紫色2号D&C Violet No. 2.74.2602a外用 D&C 紫色2号Ext. D&C Violet No. 2.74.2705FD&C 黄色5号FD&C Yellow No. 5.74.2706FD&C 黄色6号FD&C Yellow No. 6.74.2707D&C 黄色7号D&C Yellow No. 7.74.2707a外用D&C 黄色7号Ext. D&C Yellow No. 7.74.2708D&C 黄色8号D&C Yellow No. 8.74.271D&C 黄色10号D&C Yellow No. 10.74.2711D&C 黄色11号D&C Yellow No. 11.74.3045酞菁根合(2-)铜Phthalocyaninato(2-) copper.74.3102FD&C 蓝色2号FD&C Blue No. 2.74.3106D&C 蓝色6号D&C Blue No. 6.74.3206D&C 绿色6号D&C Green No. 6.74.323D&C 红色17号D&C Red No. 17.74.3602D&C 紫色2号D&C Violet No. 2.74.371D&C 黄色10号D&C Yellow No. 10.21CFR82临时颜色物料Provisional Colors82.3定义Definitions.82.5纯色通用规范General specifications for straight colors.82.6已认证混合物Certifiable mixtures.82.5概述General.82.51色淀(FD&C)Lakes (FD&C).82.101FD&C 蓝色1号FD&C Blue No. 1.82.102FD&C 蓝色2号FD&C Blue No. 2.82.203FD&C 绿色3号FD&C Green No. 3.82.304FD&C 红色4号FD&C Red No. 4.82.705FD&C 黄色5号FD&C Yellow No. 5.82.706FD&C 黄色6号FD&C Yellow No. 6.82.105概述General.82.1051色淀(D&C)Lakes (D&C).82.1104D&C 蓝色4号D&C Blue No. 4.82.1205D&C 绿色5号D&C Green No. 5.82.1206D&C 绿色6号D&C Green No. 6.82.1254D&C 橙色4号D&C Orange No. 4.82.1255D&C 橙色5号D&C Orange No. 5.82.126D&C 橙色10号D&C Orange No. 10.82.1261D&C 橙色11号D&C Orange No. 11.82.1306D&C 红色6号D&C Red No. 6.82.1307D&C 红色7号D&C Red No. 7.82.1317D&C 红色17号D&C Red No. 17.82.1321D&C 红色21号D&C Red No. 21.82.1322D&C 红色22号D&C Red No. 22.82.1327D&C 红色27号D&C Red No. 27.82.1328D&C 红色28号D&C Red No. 28.82.133D&C 红色30号D&C Red No. 30.82.1331D&C 红色31号D&C Red No. 31.82.1333D&C 红色33号D&C Red No. 33.82.1334D&C 红色34号D&C Red No. 34.82.1336D&C 红色36号D&C Red No. 36.82.1602D&C 紫色2号D&C Violet No. 2.82.1707D&C 黄色7号D&C Yellow No. 7.82.1708D&C 黄色8号D&C Yellow No. 8.82.171D&C 黄色10号D&C Yellow No. 10.82.205概述General.82.2051色淀(外用 D&C)Lakes (Ext. D&C).82.2707a外用 D&C 黄色7号Ext. D&C Yellow No. 7.21CFR700US 21CFR700 化妆品概述Cosmetics General700.3定义Definitions.700.11含硫双二氯酚的化妆品Cosmetics containing bithionol.700.13汞化合物用于化妆品,包括在化妆品中用于抑制黑色素形成的药物同被视为药品Use of mercury compounds in cosmetics including use as skinbleaching agents in cosmetic preparations also regarded as drugs.700.14氯乙烯,包括化妆品雾剂产品的推进器Use of vinyl chloride as an ingredient, including propellant of cosmetic aerosol products.700.15化妆品中卤代水杨酰苯胺衍生物Use of certain halogenated salicylanilides as ingredients in cosmetic products.700.16含锆雾剂化妆品Use of aerosol cosmetic products containing zirconium.700.18化妆品中的氯仿Use of chloroform as an ingredient in cosmetic products.700.19化妆品中的二氯甲烷Use of methylene chloride as an ingredient of cosmetic products.700.23氟里昂碳喷射剂Chlorofluorocarbon propellants.700.25化妆品防拆包装要求Tamper-resistant packaging requirements for cosmetic products.700.27化妆品中使用禁用的牛源物料Use of prohibited cattle materials in cosmetic products.700.35含防晒成分的化妆品Cosmetics containing sunscreen ingredients.21CFR701US 21CFR701 化妆品标签Cosmetic Labeling701.1错误标识Misbranding.701.2标签格式Form of stating labeling requirements.701.3配料的设计Designation of ingredients.701.9标示内容的免除Exemptions from labeling requirements.701.1主要显示版面Principal display panel.701.11标签认可Identity labeling.701.12制造商,包装商和分销商的名称和地址Name and place of business of manufacturer, packer, or distributor.701.13成分的实际数量声明Declaration of net quantity of contents.701.2洗涤物,非肥皂,用于清洁身体Detergent substances, other than soap, intended for use in cleansing the body.701.3化妆品标签中的组分名称Ingredient names established for cosmetic ingredient labeling.21CFR710US 21CFR710 化妆品的自愿注册Voluntary Registration for Cosmetics710.1谁可以注册Who should register.710.2注册时间Time for registration.710.3注册方式和地点How and where to register.710.4要求索取的资料Information requested.710.5注册的变更Amendments to registration.710.6注册人的通知单;化妆品注册号Notification of registrant; cosmetic product establishment registration number.710.7注册的检查Inspection of registrations.710.8标签上提及注册或注册号码导视为错误标识Misbranding by reference to registration or to registration number.710.9免责事项Exemptions.21CFR720US 21CFR720 自愿把成分声明归档Voluntary Filing Ingredient Statements720.1谁可以归档Who should file.720.2归档时间Times for filing.720.3归档方式和时间How and where to file.720.4化妆品要求索取的资料Information requested about cosmetic products.720.6修改声明Amendments to statement.720.7个人提交化妆品成分声明的通知单Notification of person submitting cosmetic product ingredient statement.720.8声明的保密性Confidentiality of statements.720.9标签提及归档及声明号码均视为错误标识Misbranding by reference to filing or to statement number.21CFR740US 21CFR740 警告Warnings740.1警告声明的建立Establishment of warning statements.740.2警告声明的显著性Conspicuousness of warning statements.740.1标识化妆品产品中未知是否安全的物质Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.740.11自动加压容器中的化妆品Cosmetics in self-pressurized containers.740.12女士用除臭喷雾剂Feminine deodorant sprays.740.17泡沫沐浴品Foaming detergent bath products.740.18煤焦油燃料染发存在引发癌症的风险Coal tar hair dyes posing a risk of cancer.740.19促进晒黑的化妆品Suntanning preparations.2、欧盟化妆品法规标准法规/标准编号中文名称英文名称76/768/EEC关于统一各成员国有关化妆品法律的理事会指令Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic productsCouncil Directive 93/35/EEC理事会指令93/35/EEC:关于统一各成员国有关化妆品法律的76/768/EEC号的理事会指令Council Directive 93/35/EEC of 14 June 1993 amending for the sixth time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic productsCommission Directive 98/16/EC第22次委员会指令98/16/EC:为适应技术进步修改关于统一各成员国有关化妆品法律的76/768/EEC号的理事会指令附近件II, III, VI 和VIITwenty-Second Commission Directive 98/16/EC，of 5 March 1998adapting to technical progress Annexes II, III, VI and VII to Council Directive76/768/EEC on the approximation of the laws of the Member States relating tocosmetic productsCommission Directive 98/62/EC第23次委员会指令98/62/EC:为适应技术进步修改关于统一各成员国有关化妆品法律的76/768/EEC号的理事会指令附近件II, III, VI 和VII23rd Commission Directive 98/62/ECof 3 September 1998adapting to technical progress Annexes II, III, VI and VII to Council Directive76/768/EEC on the approximation of the laws of the Member States relating tocosmetic productsCommission Directive 2000/6/EC第24次委员会指令2000/6/EC:为适应技术进步修改关于统一各成员国有关化妆品法律的76/768/EEC号的理事会指令Twenty-fourth Commission Directive 2000/6/EC of 29 February 2000 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic productsCommission Directive 2000/11/EC第25次委员会指令2000/11/EC：为适应技术进步修改关于统一各成员国有关化妆品法律的76/768/EEC号的理事会指令附件Twenty-Fifth Commission Directive 2000/11/EC of 10 March 2000 adapting to technical progress Annex II to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic productsCommission Directive 2000/41/EC委员会指令2000/41/EC：关于化妆品原料和原料混凝土合物动物试验禁令和第二次延迟Commission Directive 2000/41/EC of 19 June 2000 postponing for a second time the date after which animal tests are prohibited for ingredients or combinations of ingredients of cosmetic productsCommission Directive 2002/34/EC第26次委员会指令2002/34/EC:修改关于统一各成员国有关化妆品法律的76/768/EEC号的理事会指令附件附件、和ITwenty-sixth Commission Directive 2002/34/EC of 15 April 2002 adapting to technical progress Annexes II, III and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic productsCommission Directive 2003/1/EC委员会指令2003/1/EC:修改关于统一各成员国有关化妆品法律的76/768/EEC号的理事会指令附件Commission Directive 2003/1/EC of 6 January 2003 adapting to technical progress Annex II to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic productsDirective 2003/15/EC委员会指令2003/15/EC:修订关于统一各成员国有关化妆品法律的76/768/EEC号的理事会指令Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic productsCommission Directive 2003/16/EC委员会指令2003/16/EC:为适应技术进步修改关于统一各成员国有关化妆品法律的76/768/EEC号的理事会指令附件Commission Directive 2003/16/EC of 19 February 2003 adapting to technical progress Annex III to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic productsCommission Directive 2003/80/EC委员会指令2003/80/EC:修改76/768/EEC号的理事会指令附件a建立化妆品保质期标识Commission Directive 2003/80/EC of 5 September 2003 establishing a symbol indicating the durability of cosmetic products in Annex VIIIa to Council Directive 76/768/EECCommission Directive 2003/83/EC委员会指令2003/84/EC:为适应技术进步修改关于统一各成员国有关化妆品法律的76/768/EEC号的理事会指令附件、和Commission Directive 2003/83/EC of 24 September 2003 adapting to technical progress Annexes II, III and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic productsCommission Directive 2004/87/EC委员会指令2004/87/EC：为适应技术进步修改有关化妆品的第76/768/EEC号理事会指令附件Commission Directive 2004/87/EC of 7 September 2004 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto t