进口化妆品申报资料及要求 英文版(XXXX年新版)
进口化妆品申报注册备案须知
国外化妆品进入中国大陆市场都必须接受国家卫生部门的审批。
国家食品药品监督管理局对进口化妆品实行备案审批制，进口化妆品只有取得进口化妆品卫生许可证才能在中国市场上销售。
化妆品如何取得该批件，化妆品审批的周期，费用如何，请仔细阅读下面的文章，如果有什么不明白的，欢迎和笔者联系：1.进口化妆品销售前必须经中国国家食品药品监督管理局（SFDA)批准。
具体主管部门为国家食品药品监督管理局食品许可司。
2.进口化妆品申报分类：特殊类和非特殊类。
特殊类是指宣称育发，防晒，祛斑，染发，烫发，健美，美乳等这些有特殊功效的化妆品。
经常有人问，抗皱和美白的是不是特殊类？回答是：抗皱和美白的产品属于普通类产品。
3.化妆品的定义：指以涂擦、喷洒或者其他类似的方法，散布于人体表面任何部位（皮肤、毛发、指甲、口唇）以达到清洁、消除不良气味、护肤、美容和修饰目的的日用化学工业品。
所以如果您的产品是食用的，就不要考虑申请化妆品了，可以考虑保健食品4.国外的药妆按照普通类申报还是特殊类申报？中国没有药妆的概念，中国只有特殊和非特殊。
因此需要根据产品功能具体定。
如果是祛痘的，那就是普通类，如果是祛斑的，那就是特殊类。
5.化妆品申报不是直接向SFDA提交，而是要先做检测，检测合格才能向SFDA提交申请6.进口化妆品备案费用是按单品计算的。
比分说某公司的最新产品系一美白系列，里面有5款产品，比如洗面奶，润肤水，润肤乳，面霜，眼霜，申请时需按照5种产品分别检测，分别申请5个许可证。
7、进口化妆品申报需要以谁的名义进行申请？答：是以国外生产企业的名义来进行申请的8.进口化妆品申报工作可以以个人名义进行吗？答：不可以9.申请企业即国外产品的生产企业在大陆需要指定一家在华申报责任单位，在华申报责任单位承担提交申报材料真实性的责任。
10.何种企业可以做在华申报责任单位？答：只要在大陆注册的具有独立法人资格的法人即可，对营业范围和注册资金均没有要求。
进口特殊用途化妆品申报资料的具体要求
进口特殊用途化妆品申报资料的具体要求1、逐项提交各项资料。
2、应按照申请表填表说明的要求填写申请表各项。
行政许可申请表保证书应由进口化妆品生产企业或进口化妆品新原料生产企业法定代表人或其授权的该生产企业的签字人或其授权的行政许可在华申报责任单位的签字人签字；无公章的，应在保证书生产企业签章处予以注明。
行政许可申请表承诺书应由行政许可在华申报责任单位法定代表人或法定代表人授权该单位的签字人签字并加盖行政许可在华申报责任单位公章。
授权委托签字时，应提供授权委托书公证件及其中文译文，并做中文译文与原文内容一致的公证。
根据《化妆品行政许可申报资料要求》(以下称《资料要求》)第二十四条的要求，在每次提交行政许可申请时应同时提交授权委托书原件或经公证后的复印件，并书面说明委托签字授权书原件所在的申报产品名称。
授权委托签字的内容不应包含于行政许可在华申报责任单位授权书中。
3、产品配方应包括许可检验机构对进口产品配方的确认证明，其确认日期应与检验样品的受理日期一致。
4、产品质量安全控制要求应包括在原产国执行的产品质量安全控制要求(外文版及中文译文)及产品符合《化妆品卫生规范》要求的承诺。
5、因体积过小(如口红、唇膏等)而无产品说明书或将说明内容印制在产品容器上的，应在申报资料中产品包装部分提交相关说明。
6、经国家食品药品监督管理总局认定的许可检验机构出具的检验报告及相关资料或境外实验室出具的防晒指数(SPF、PFA或PA值)检验报告应符合以下要求：(1)许可检验机构出具的检验报告，应当包括以下资料：1) 检验申请表。
2) 检验受理通知书。
3) 产品使用说明。
4) 卫生安全性检验报告(微生物、卫生化学、毒理学)。
5) 如有以下资料应当提交：①人体安全性检验报告(皮肤斑贴、人体试用试验)；②防晒指数SPF、PFA或PA值检验报告；③其他新增项目检测报告(如化妆品中石棉检测报告等)。
(2)使用境外实验室出具的防晒指数(SPF、PFA或PA值)检验报告的，应当提交如下资料：1) 出具报告的实验室已经过实验室资格认证的，应提交资格认证证书；2) 出具报告的实验室未经过实验室资格认证的，应提交实验室严格遵循《良好临床操作规范》(Good Clinical Practice, GCP)或《良好实验室操作规范》(Good Laboratory Practice, GLP)的证明；3) 其他有助于说明实验室资质的资料。
【市场营销(国际贸易)】进口化妆品申报资料及要求 英文版(xxxx年新版)
Application dossiers for administrative licensing of imported cosmetic required bySFDAPART ONE: Imported cosmetics classificationThe imported cosmetics are divided into two major categories by SFDA: imported cosmetic for particular purpose, and imported cosmetic for non- particular purpose. The detailed description about the classification is set forth in Appendix 3.PART TWO: Administrative licensing of imported cosmetic for particular purposeAdministrative licensing of imported cosmetic for particular purpose for the first time, the application dossiers should be provided as follows,(1) Application form of administrative licensing of imported cosmetic for particular purpose,(2) The reason for name of the imported products in Chinese,(3) Product formula,(4) Briefly description and schematics about the manufacturing processes,(5) Requirements in quality control to ensure the safety of the product,(6) Original packaging of the product (including the direction and the lable). In case of the product with a proprietary packaging for marketing in China, the intended packaging design (including the direction and the lable) should be provided simultaneously.(7) The certificate of analysis and relevant dossiers issued by the inspection agency which must be recognized and accepted by SFDA, or the certificate of analysis on SPF, PFA or PA value issued by abroad laboratory,(8) Safety evaluation date on materials that maybe exist in the finished products which have the safety risk.(9) Application for products used in nurturing hair, bodybuilding and breast, the effective constituent and the reference literatures containing the scientific proofs should be provide,(10) The letter of authority for the applicant in China (copy), which has been recorded by SFDA, and the business licence of the applicant in China (copy with official seal),(11) The letter of commitment that the raw material and the source of the raw material in production should meet the requirements of the restrictions or prohibitions in using high risk materials from bovine spongiform encephalopathy (BSE) disease areas,(12) The certificate of manufacturing and marketing from the country (region) which the products are manufactured or the country (region) of origin,(13) Additional dossiers which are conducive for the administrative licensing.1 unopened sample product from the market which is sealed by the inspection agency with license should be provided simultaneously. The detailed description about the application dossiers are set forth in Appendix 1. PART THREE: Administrative licensing of imported cosmetic for non-particular purposeAdministrative licensing of imported cosmetic for non-particular purpose for the first time, the application dossiers should be provided as follows,(1) Application form of administrative licensing of imported cosmetic for non-particular purpose,(2) The reason for name of the imported products in Chinese,(3) Product formula,(4) Requirements in quality control to ensure the safety of the product,(5) Original packaging of the product (including the direction and the lable). In case of the product with a proprietary packaging for marketing in China, the intended packaging design (including the direction and the lable) should be provided simultaneously.(6) The certificate of analysis and relevant dossiers issued by the inspection agency which must be recognized and accepted by SFDA,(7) Safety evaluation date on materials that maybe exist in the finished products which have the safety risk,(8) The letter of authority for the applicant in China (copy), which has been recorded by SFDA, and the business licence of the applicant in China (copy with official seal),(9) The letter of commitment that the raw material and the source of the raw material in production should meet the requirements of the restrictions or prohibitions in using high risk materials from bovine spongiform encephalopathy (BSE) disease areas,(10) The certificate of manufacturing and marketing from the country (region) which the products are manufactured or the country (region) of origin,(13) Additional dossiers which are conducive for the administrative licensing.1 unopened sample product from the market which is sealed by the inspection agency with license should be provided simultaneously. The detailed description about the application dossiers are set forth in Appendix 2. PART FOUR: The process flow diagram of administrative licensing of imported cosmeticPART FIVE: ChargeThere is no charge in administrative licensing of imported cosmetic by SFDAAppendix 1The detailed description about the application dossiers for administrative licensing of imported cosmetic for particularpurpose1. The dossiers should be provided following the list,2. Fill out the application form under the instruction of the form notices, Application form for administrative licensing should be filled out by the manufacturing enterprises of imported cosmetic, or the authorizer of the manufacturing enterprises, or the authorized agency for the administrative licensing in China. Indications should be written in the seal place of the letter of assurance from manufacturing enterprises in case of no official seals.Letter of commitment in application form should be signed by the legal person of the authorized agency for the administrative licensing in China, or the authorizer of the legal person, with official seal on the letter.When signing in the power of attorney, a notarized copy and Chinese copy should be provided, the consistent of the Chinese copy with the original one should be notarized simultaneously. According to the requirements in Article 24 of “The Requirements Of The Application Dossiers For Administrative Licensing Of Cosmetic”(short for The Requirements Of The Dossiers), the original of the power of attorney and the notarized copy should be provided while the application, and a written explanation of the product’s name in the original of the power of attorney. The content of the signature in the power of attorney should not be contained by the content of the certificate of authorization from the applicant in China.3. The product formula should contain the confirmation of the formula issued by the inspection agency with license, and the date of the confirmation should be consistent with the application date.4. Requirements in quality control should contain the requirements conducted by the original manufacturer (foreign language and the Chinese copy), and a letter of commitment declaring the products meet the requirements in "Hygienic Standard for Cosmetics".5. In case of no product directions or directions printed on the containers (such as lipstick and lip rouges at compact size), the relevant explanation should be made in the Packaging Part.6. The certificate of analysis and relevant dossiers issued by the inspection agency which must be recognized and accepted by SFDA, or the certificate of analysis on SPF, PFA or PA value issued by abroad laboratory should meet the requirements as follows,1) Application form for inspection;2) Notification of acceptance for inspection;3) Direction of the product;4) Health & Safety testing report (microorganism, sanitary chemistry and toxicology);5) The dossiers as follows should be provided in case of existing:①Human safety testing report (skin patch test , human trials);②SPF、PFA or PA value reports;③Additional reports (such as Asbestos inspection report).(2) The application dossiers containing SPF, PFA or PA value reports issued by abroad laboratory, the additional dossiers as follows should be provided simultaneously: 1) In case of that the laboratory has been recognized and accepted by SFDA, the authentication certificate should be provided; 2) In case of no authentication certificate, GCP certificate or GLP certificate should be provided; 3) Additional dossiers which are conducive for qualifying.In case of that the reports issued by abroad laboratory are provided for the first time, the original report, or the copy which is notarized by the local embassy or relevant associations from the country (region) of manufacturer.The copy of the report would be allowed in the re-application after having been recognized and accepted by SFDA.The original report issued by abroad laboratory should be provided. The original report of at least one product should be provided in case of series products, the copy ones of other products are allowed, and the product name in the original report should be pointed.The certificate of the relationship between the inspecting sample and the report issued by the relevant laboratory should be provided, while the report of abroad laboratory is provided in the application dossiers.In case of that the relationship between the inspecting sample and the report has been clearly stated in the report (such as the product name has been noted in the report, and the name of the sample is consistent with the product name), the certificate of above is needless.7. The certificate of manufacturing and marketing from the country (region) which the products are manufactured or the country (region) of origin should meet the requirements as follows,(1) The certificate should be issued by the regulatory authorities or relevant associations. The copy of the certificate is allowed in case of without the original l one. The copy of the certificate should be notarized by local embassy or the regulatory authorities.(2) The certificate should contain the name of product, name of manufacturer, name of the regulatory authority which issues the certificate, and the official seal or the signature of legal person (or authorizer) should be on the certificate.(3) The name of product and manufacturer should be consistent with the application dossiers. In case of contract manufacturing or other ways and that the name of manufacturer in certificate isn’t consistent with application dossiers, a written explanation from the applicant should be provided. The certificate of manufacturing and marketing for the imported part of the product which containing various forms should be provided.(4) The certificate of manufacturing and marketing should be translated into Chinese in case of being foreign languages. And the Chinese copy should be notarized by notary public in China.8. The product belongs to the following situations, additional dossiers as follows should be provided simultaneously:(1) In case of contract manufacturing, additional dossiers are as follows,1) The protocol about contract manufacturing between the consignor and the consignee,2) For imported products, the certificate of QMS or GMP from the consignee, or the approved certificate of cosmetic manufacturing from the country (region) of manufacturer,3) The approved certificate of cosmetic manufacturing from the country (region) of manufacturer should meet the requirements as follows,①The certificate should be issued by regulatory authority or third parties, The copy of the certificate is allowed in case of without the original l one. The copy of the certificate should be notarized by local embassy or notary public.②The name and address of the manufacture should be consistent with the application dossiers.(2) In case of the manufacture (applicant) and the actual manufacture belong to a same company group, the certificate of the relationship and the quality assurance documents issued by the company group should be provided.9. In case of the product is manufactured by more than one enterprises, one of the manufacturers should provide the above application dossiers and additional dossiers as follows,(1)In case of contract manufacturing, the protocol about contract manufacturing should be provided. For imported products, the certificate of QMS or GMP from the consignee or the approved certificate of cosmetic manufacturing from the country (region) of manufacturer should be provided.(2) In case of the manufacturers belong to a same company group, the certificate of the relationship and the quality assurance documents issued by the company group should be provided.(3) The original packaging from other actual manufactures(4) Health & Safety inspection report (microorganism, sanitary chemistry) from other actual manufactures(5) The letter of commitment that the raw material and the source of the raw material in production should meet the requirements of the restrictions or prohibitions in using high risk materials from bovine spongiform encephalopathy (BSE) disease areas from other actual manufactures.10. In case of the product containing the forms of packaging as follows, the applications should be made as the following regulations,(1) One sample packaging contains more than two (including two) individually packaging, or separated samples (such as eye shadow, pressed powder, blush, etc.), and the application is made with one product name, the certificates of analysis and formulas of each separated products should be provided. Sample without individually packaging and separated samples, formulas of each parts and one certificate of analysis should be provided.(2) The Sample with a collective packaging which could not be split, the application is made with one product name, and the sample has varied raw materials & states of matter, the certificates of analysis and formulas for each product should be provided respectively.(3) In case of the product which contain more than two (including two) formulations, and must be used as a mixture, the application should be made for one product. According to whether the product with multiple formulations is used as a mixture or separated ones, the certificates of analysis for the mixture or each formulation should be provided.(4)In case of that the application of imported products are made by the same manufacturing enterprises, which contain more than two (including two) original packaging with the same foreign language name but differentappearances, the description of the appearances should be added to the foreign language name column of the certificate of manufacturing & marketing and application form, while attached with relevant explanation.11.In case of that the sunscreen cosmetics with multiple series have a same basic formula, and make sampling inspection for testing SPF, PFA, PA value, the application is allowed to be made as one group of product. The application dossiers for each series should be attached with the name of each product in this series, basic formula, colorants list and sampling inspection list.12.In case of that the imported products which are manufactured by the enterprise abroad with a contract manufacturing from resident enterprise, the products are provide as homemade ones.Appendix 2The detailed description about the application dossiers for administrative licensing of imported cosmetic for non-particularpurpose1. The dossiers should be provided following the list,2. Fill out the application form under the instruction of the form notices, Application form for administrative licensing should be filled out by the manufacturing enterprises of imported cosmetic, or the authorizer of the manufacturing enterprises, or the authorized agency for the administrative licensing in China. Indications should be written in the seal place of the letter of assurance from manufacturing enterprises in case of no official seals.Letter of commitment in application form should be signed by the legal person of the authorized agency for the administrative licensing in China, or the authorizer of the legal person, with official seal on the letter.When signing in the power of attorney, a notarized copy and Chinese copy should be provided, the consistent of the Chinese copy with the original one should be notarized simultaneously. According to the requirements in Article 24 of “The Requirements Of The Application Dossiers For Administrative Licensing Of Cosmetic”(short for The Requirements Of The Dossiers), the original of the power of attorney and the notarized copy should be provided while the application, and a written explanation of the product’s name in the original of the power of attorney. The content of the signature in the power of attorney should not be contained by the content of the certificate of authorization from the applicant in China.3. The product formula should contain the confirmation of the formula issued by the inspection agency with license, and the date of the confirmation should be consistent with the application date.4. Requirements in quality control should contain the requirements conducted by the original manufacturer (foreign language and the Chinese copy), and a letter of commitment declaring the products meet the requirements in "Hygienic Standard for Cosmetics".5. In case of no product directions or directions printed on the containers (such as lipstick and lip rouges at compact size), the relevant explanation should be made in the packaging part.6. The certificate of analysis and relevant dossiers issued by the inspection agency which must be recognized and accepted by SFDA should meet the requirements as follows,1) Application form for inspection;2) Notification of acceptance for inspection;3) Direction of the product;4) Health & Safety testing report (microorganism, sanitary chemistry and toxicology);5) The dossiers as follows should be provided in case of existing:①Human safety testing report (skin patch test , human trials);②Additional reports (such as Asbestos inspection report).7. The certificate of manufacturing and marketing from the country (region) which the products are manufactured or the country (region) of origin should meet the requirements as follows,(1) The certificate should be issued by the regulatory authorities or relevant associations. The copy of the certificate is allowed in case of without the original l one. The copy of the certificate should be notarized by local embassy or the regulatory authorities.(2) The certificate should contain the name of product, name of manufacturer, name of the regulatory authority which issues the certificate, and the official seal or the signature of legal person (or authorizer) should be on the certificate.(3) The name of product and manufacturer should be consistent with the application dossiers. In case of contract manufacturing or other ways and that the name of manufacturer in certificate isn’t consistent with application dossiers, a written explanation from the applicant should be provided. The certificate of manufacturing and marketing for the imported part of the product which containing various forms should be provided.(4) The certificate of manufacturing and marketing should be translated into Chinese in case of being foreign languages. And the Chinese copy should be notarized by notary public in China.8. The product belongs to the following situations, additional dossiers as follows should be provided simultaneously:(1) In case of contract manufacturing, additional dossiers are as follows,1) The protocol about contract manufacturing between the consignor and the consignee,2) For imported products, the certificate of QMS or GMP from the consignee, or the approved certificate of cosmetic manufacturing from the country (region) of manufacturer,3) In case of that the imported products are manufactured by the enterprise abroad with a contract manufacturing from resident enterprise, the power of attorney, certificates of manufacturing and marketing, and the original packaging would not be necessary, the packaging design should be provided.4) The certificate of QMS or GMP from the consignee, or the approved certificate of cosmetic manufacturing from the country (region) of manufacturer, should meet the requirements as follows,①The certificate should be issued by regulatory authority or third parties, The copy of the certificate is allowed in case of without the original l one. The copy of the certificate should be notarized by local embassy or notary public.②The name and address of the manufacture should be consistent with the application dossiers.(2) In case of the manufacture (applicant) and the actual manufacture belong to a same company group, the certificate of the relationship and the quality assurance documents issued by the company group should be provided.9. In case of the product is manufactured by more than one enterprises, one of the manufacturers should provide the above application dossiers and additional dossiers as follows,(1)In case of contract manufacturing, the protocol about contract manufacturing should be provided. For imported products, the certificate of QMS or GMP from the consignee or the approved certificate of cosmetic manufacturing from the country (region) of manufacturer should be provided.(2) In case of the manufacturers belong to a same company group, the certificate of the relationship and the quality assurance documents issued by the company group should be provided.(3) The original packaging from other actual manufactures(4) Health & Safety inspection report (microorganism, sanitary chemistry) from other actual manufactures(5) The letter of commitment that the raw material and the source of the raw material in production should meet the requirements of the restrictions or prohibitions in using high risk materials from bovine spongiform encephalopathy (BSE) disease areas from other actual manufactures.10. In case of the product containing the forms of packaging as follows, the applications should be made as the following regulations,(1) One sample packaging contains more than two (including two) individually packaging, or separated samples (such as eye shadow, pressed powder, blush, etc.), and the application is made with one product name, the certificates of analysis and formulas of each separated products should be provided. Sample without individually packaging and separated samples, formulas of each parts and one certificate of analysis should be provided.(2) The Sample with a collective packaging which could not be split, the application is made with one product name, and the sample has varied raw materials & states of matter, the certificates of analysis and formulas for each product should be provided respectively.(3) In case of the product which contain more than two (including two) formulations, and must be used as a mixture, the application should be made for one product. According to whether the product with multiple formulations is used as a mixture or separated ones, the certificates of analysis for the mixture or each formulation should be provided.(4)In case of the imported products made application by the same manufacturing enterprises, which contain more than two(including two) original packaging with the same foreign language name but different appearances, the description of the appearance should be added to the foreign language name column of the certificate of manufacturing & marketing and application form, while attached with relevant explanation.11.In case of that the sunscreen cosmetics with multiple series have a same basic formula, and make sampling inspection for testing SPF, PFA, PA value, the application is allowed to be made as one group of product. The application dossiers for each series should be attached with the name of each product in this series, basic formula, colorants list and sampling inspection list.12.In case of that imported products are manufactured by the enterprise abroad with a contract manufacturing from resident enterprise, the products are provide as homemade ones.Appendix 3Cosmetics for particular purpose classification1. Cosmetics for nurturing hair;2. Cosmetics for hair color（permanent or temporary）;3. Cosmetics for depilation4. Cosmetics for breast,5. Cosmetics for bodybuilding (including for losing weight)6. Cosmetics for deodorization7. Cosmetics for dispeling freckle,8. Cosmetics for sunscreen,9. Cosmetics for perm or straight hair.。
化妆品进口报关前期准备资料和注意事项
化妆品进口报关前期准备资料和注意事项
中国是化妆品消费的大国，据粗略统计，2009年以后，销售额就高达1400多亿元。
现在化妆品的安全问题已经渐渐的引起了大多消费者的重视，国家出台一系列相关检测检验机制严把化妆品进口质量关。
化妆品进口报关详解
一、化妆品进口前需具备一下条件
1. 发货方在中国进行“进口化妆品发货人备案”。
2. 收货方在中国进行“进口化妆品收货人备案”；另外，营业执照须包含与化妆品有关的经营许可范围。
3. 然后办理食药局的批文每一个产品，需要提前到药监局审批(通常3个月左右）。
4. 产品标签备案，外文标签的原件或原标签彩色扫描件；前后标中文相对应翻译件+单独中文标签(中文标签要做预审)。
二、化妆品进口报关注意事项
1、货物发货前，请提供品名/成分/用途，以便于确认海关商品编码，从而明确是否涉相关证明
2、如商品较复杂，海关编码书上无具体列明，建议企业做商品归类，可以保护企业避免因日后税差问题进缉私局
3、产品明确海关商品编码后，如涉及相关进口证明材料，请事先办理好，再发货资料齐全后，货物包装上贴好中文标签，就可以发货。
三、进口到上市简要流程
1.取得化妆品进口许可批文，
2.在进口口岸出入境检验检疫局取得中文标签备案。
3.准备化妆品进口报关报检材料，取得通关单，然后报关。
4.报关通过缴税之后在商检局领取CIQ方可上架销售。
进口非特殊用途化妆品备案
√ 6、经国家食品药品监督管理总局认定的许可检验机构出具的查验报告及相关资料 √ 7、产品中可能存在安全性风险物质的有关安全性评估资料 √ 8、已经备案的行政许可在华申报单位授权书复印件及行政许可在华申报责任单位营业执
照复印件并加盖公章
√ 9、化妆品使用原料及原料来源符合疯牛病疫区高风险物质禁限用要求的承诺书 √10、产品在生产国（地区）或原产国（地区）生产和销售的证明文件 √ 11、许可检验机构封样并未启封的市售样品1件和有助于行政许可的其他资料 √ 12、产品技术要求
进口非特殊用途化妆品备案 申请表
产品中文名称
国家食品药品监督管理总局制
填表说明
1、 本申请表可从国家食品药品监督管理总局网站上下载使用。 网址： HTTP：//
2、 本表申报内容及所有申报资料均须打印。 3、 本表申报内容应完整、清楚、不得涂改。 4、 填写此表前，请认真阅读有关法规及申报受理规定。 5、 申报时应同时提交与纸质申请表数据一致的电子表格。
生产企业（签章）
法定代表人（签字） 年月日
承诺书
本在华申报责任单位在此郑重声明，我单位理解《化妆品行政许可申报受理规 定》中关于应当按照国家有关法律、法规、标准和规范的要求申报化妆品行政许 可，对申报资料负责并承担相应的法律责任的要求。我单位对所申报的内容和所附 资料进行审核并承诺提交的申报资料均真实、合法，复印件和原件一致，所附资料 中的数据均为研究和检测该产品得到的数据，符合《化妆品卫生规范》要求。如有 不实之处，我单位愿负相应法律责任，并承担由此造成的一切后果。
产品名称 产品检验受理
编号
生产企业
中文 外文
中文 外文 地址
在华申报责任 单位
进口特殊化妆品申报流程资料详解
进口特殊化妆品申报流程资料详解申报资料的一般要求如下：（一）首次申请特殊用途化妆品行政许可的，提交原件1份、复印件4份，复印件应清晰并与原件一致；（二）申请备案、延续、变更、补发批件的，提交原件１份；（三）除检验报告、公证文书、官方证明文件及第三方证明文件外，申报资料原件应由申请人逐页加盖公章或骑缝章；（四）使用A4规格纸张打印，使用明显区分标志，按规定顺序排列，并装订成册；（五）使用中国法定计量单位；（六）申报内容应完整、清楚，同一项目的填写应当一致；（七）所有外文（境外地址、网址、注册商标、专利名称、SPF、PFA或PA、UVA、UVB 等必须使用外文的除外）均应译为规范的中文，并将译文附在相应的外文资料前；（八）产品配方应提交文字版和电子版；（九）文字版与电子版的填写内容应当一致。
鑫金证：1、委托方与被委托方签订的委托加工协议书；2、进口产品应提供被委托生产企业的质量管理体系（ISO9002）或良好生产规范（GMP）的证明文件（提供原件或者经过复印件与原件一致公证的复印件；鑫金证：主要为以下三种：1、产品在生产国（地区）或原产国（地区）开具的自由销售的证明文件（原产国政府机关或者行业协会出具）；2、外商即（申请企业）生产企业给国内在华申报责任单位开具的“授权书”；1、授权书应由化妆品生产企业和行政许可在华申报责任单位双方共同签署并经公证机关公证；授权书为外文的，还应译成中文，并对中文译文公证；2、授权书应包括以下内容：授权单位名称、行政许可在华申报责任单位名称、授权有效期、所授权的产品范围、授权权限等；授权权限应包括委托行政许可在华申报责任单位代理申报，还可以包括代表化妆品生产企业加盖印章确认申报资料；3、申请在华申报责任单位授权书备案时，除按有关规定提交相关文件外，还应同时提交在华申报责任单位营业执照复印件。
生产企业地址应与进口化妆品或进口化妆品新原料行政许可申请表中相应内容一致，在华申报责任单位地址应与营业执照中相应内容一致，生产企业应对地址信息的真实性和相关申报资料中地址信息的一致性负责。
进口非特殊用途化妆品申报备案提交的资料及要求
资料要求
（一）首次申请特殊用途化妆品行政许可的，提交原 件1份、复印件4份，复印件应清晰并与原件一致；
（二）申请备案、延续、变更、补发批件的，提交原 件１份；
（三）除检验报告、公证文书、官方证明文件及第三 方证明文件外，申报资料原件应由申请人逐页加盖公 章或骑缝章；
（四）使用A4规格纸张打印，使用明显区分标志， 按规定顺序排列，并装订成册；
（五）使用中国法定计量单位；
资料要求
（六）申报内容应完整、清楚，同一项目的填 写应当一致；
（七）所有外文（境外地址、网址、注册商标、 专利名称、SPF、PFA或PA、UVA、UVB等 必须使用外文的除外）均应译为规范的中文， 并将译文附在相应的外文资料前；
（八）产品配方应提交文字版和电子版； （九）文字版与电子版的填写内容应当一致。
进口非特殊用途化妆品申 报备案提交的资料及要求
作者：北京天健华成
பைடு நூலகம்
资料准备
（一）进口非特殊用途化妆品行政许可申请表； （二）产品中文名称命名依据； （三）产品配方； （四）产品质量安全控制要求； （五）产品原包装（含产品标签、产品说明书）；拟
专为中国市场设计包装的，需同时提交产品设计包装 （含产品标签、产品说明书）； （六）经国家食品药品监督管理局认定的许可检验机 构出具的检验报告及相关资料；
英文 进口化妆品注册申报流程
Imported Cosmetics Registration Process---Both Special Cosmeticsand Normal Cosmetics1. Imported Special Cosmetics Registration ProcessFirst step: Sign agency contract (Tianjianhuacheng)Second step: Confirm related products’ information (Tianjianhuacheng)Third step: Agency contract filing, meanwhile apply for filing user name and password (CFDA acceptance center)Forth step: Sample testing (testing institutions which qualified by CFDA)Fifth step: Submit for form evaluation (CFDA acceptance center)Sixth: Technique evaluation/documents modificationSeventh: Issue the approval certificate2. Imported Normal Cosmetics Registration ProcessFirst step: Sign agency contract (Tianjianhuacheng)Second step: Confirm related products’ information (Tianjianhuacheng)Third step: Agency contract filing, meanwhile apply for filing user name and password (CFDA acceptance center)Forth step: Sample testing (testing institutions which qualified by CFDA)Fifth step: Submit for form evaluation (CFDA acceptance center)Sixth: Technique evaluation/documents modificationSeventh: Issue the approval certificateGenerally speaking, during the registration process, CFDA needs to proceed these following steps, and some are necessary depend on the documents submitted or the type of the cosmetics,1. Applicant & Manufacture Company provide registration documents and samples2. CFDA related products evaluation committee3. Evaluation opinions4. Submit the supplement documents if necessary5. CFDA administrative approve6. Issue the approval certificate(To find more cosmetics registration information, please contact with Tianjianhuacheng.)ATTACHMENT:IMPORTED SPECIAL AND NORMAL COSMETICS CFDA REGISTRATION FLOWCHARTAPPROVE。
进口(国产)化妆品申报
进口（国产）化妆品申报
中国对化妆品管理采用审批制，化妆品或其新原料在生产或进口之前需向国家食品药品监督管理局（SFDA）申请化妆品卫生行政许可或备案，获得化妆品卫生行政许可或备案凭证后方可进行销售；国家食品药品监督管理局从2010年4月1日开始发布并实施了新《化妆品行政许可申报受理规定》，规定要求进口化妆品申报人需重新指定和备案在华申报责任单位。
申报范围
《化妆品卫生监督条例》要求对化妆品生产和经营进行监督；生产或进口化妆品新原料和化妆品需经国务院卫生行政部门（SFDA直接受理）批准，并获得相关批件。
申报主体
●拟在中国生产化妆品并在中国市场销售的生产商
●拟在中国生产化妆品仅供出口的生产商
●拟在中国市场销售的进口化妆品境内机构
●拟在中国市场销售的进口化妆品的境外机构
●拟在中国市场销售的国产化妆品的境外机构
●拟在中国市场销售的国产化妆品的境内机构
注：境内机构作为申报人时，可直接或委托他人进行化妆品申报；但境外机构作为申报人时，应委托一个在华申报责任单位进行申报，可以为其进口商、经销商、咨询机构、外商独资子公司等。
申报类型
●化妆品新原料行政许可申报
●国产特殊用途化妆品行政许可申报
●国产非特殊用途化妆品备案凭证申请（省级药监部门受理）
●进口非特殊用途化妆品备案凭证申请
●进口特殊用途化妆品行政许可申报
注：只要化妆品成分或者产品名称不同的化妆品，且没有进行任何备案或行政许可的化妆品都需要进行申报。
整理-化妆品申报资料具体要求
化妆品申报资料具体要求一、产品配方总体要求：1．产品配方应有产品名称，进口产品应有中文（译）名。
产品配方应以表格形式在同一张表中提供包含原料序号、国际化妆品原料名称（INCI名称）（国产产品除外）、原料标准中文名称、百分含量、使用目的等内容，字号不小于宋体小五号。
2．产品配方应提供全部原料的名称，实际含量以百分比计，并注明有效物含量（未注明者均以有效物含量100%计）；复配原料（香精除外）应当以复配形式申报，并应标明各组分在其中的含量（以百分比计）；特殊情况，如含结晶水、原料存在不同的分子式或结构式等应加以说明，全部原料按含量递减顺序排列。
3．产品配方中使用了香精原料，可以申报香精在配方中的用量，不须申报香精中具体香料组分的种类和含量，原料名称以“香精”命名。
如同时申报香精及香精中香料组分的种类和含量时，则须提交香精原料生产企业出具的关于该香精所含全部香料组分种类及含量的证明文件。
证明文件是外文的，应译成中文，并对中文译文进行公证。
原料的使用目的应根据申报产品原料在其产品中的实际作用标注，例如：润肤剂、乳化剂、溶剂、防腐剂等，但不得使用医疗术语。
4．配方组分（含复配原料中的各组分）的中文名称应按国际化妆品原料标准中文名称目录使用标准中文名称。
无INCI名称或未列入国际化妆品原料标准中文名称目录的，应使用中国药典中的名称或化学名称或植物拉丁学名，不得使用商品名或俗名，但复配原料除外。
5．着色剂应提供化妆品卫生规范上载明的着色剂索引号（简称CI号），无CI号的除外。
每个产品申报资料中均应附上系列产品名单、基础配方和着色剂一览表以及抽样产品名单；未被检测的产品申报资料中应指明抽样产品检测报告所在的产品中文名称，并提供一份抽样产品检测报告复印件。
6．凡宣称为孕妇、哺乳期妇女、儿童或婴儿使用的产品，应当提供基于安全性考虑的产品配方设计原则（含产品配方整体分析报告）、原料的选择原则和要求、生产工艺、质量安全控制等内容的资料。
进口化妆品申报讲义及要求英文版某某某年新版
{国际贸易}进口化妆品申报讲义及要求英文版某某某年新版Applicationdossiersforadministrativelicensingo fimportedcosmeticrequiredbySFDAPARTONE:Importedcosmeticsclassification TheimportedcosmeticsaredividedintotwomajorcategoriesbySFDA:importedco smeticforparticularpurpose,andimportedcosmeticfornon-particularpurpos e.ThedetaileddescriptionabouttheclassificationissetforthinAppendix3. PARTTWO:Administrativelicensingofimportedcosmeticforparticularpurpose Administrativelicensingofimportedcosmeticforparticularpurposeforthefi rsttime,theapplicationdossiersshouldbeprovidedasfollows,(1)Applicationformofadministrativelicensingofimportedcosmeticforparti cularpurpose,(2)ThereasonfornameoftheimportedproductsinChinese,(3)Productformula,(4)Brieflydescriptionandschematicsaboutthemanufacturingprocesses,(5)Requirementsinqualitycontroltoensurethesafetyoftheproduct,(6)Originalpackagingoftheproduct(includingthedirectionandthelable).In caseoftheproductwithaproprietarypackagingformarketinginChina,theinten dedpackagingdesign(includingthedirectionandthelable)shouldbeprovideds imultaneously.(7)Thecertificateofanalysisandrelevantdossiersissuedbytheinspectionag encywhichmustberecognizedandacceptedbySFDA,orthecertificateofanalysis onSPF,PFAorPAvalueissuedbyabroadlaboratory,(8)Safetyevaluationdateonmaterialsthatmaybeexistinthefinishedproducts whichhavethesafetyrisk.(9)Applicationforproductsusedinnurturinghair,bodybuildingandbreast,th eeffectiveconstituentandthereferenceliteraturescontainingthescientifi cproofsshouldbeprovide,(10)TheletterofauthorityfortheapplicantinChina(copy),whichhasbeenreco rdedbySFDA,andthebusinesslicenceoftheapplicantinChina(copywithofficia lseal),(11)Theletterofmitmentthattherawmaterialandthesourceoftherawmateriali nproductionshouldmeettherequirementsoftherestrictionsorprohibitionsin usinghighriskmaterialsfrombovinespongiformencephalopathy(BSE)diseasea reas,(12)Thecertificateofmanufacturingandmarketingfromthecountry(region)wh ichtheproductsaremanufacturedorthecountry(region)oforigin,(13)Additionaldossierswhichareconducivefortheadministrativelicensing.1unopenedsampleproductfromthemarketwhichissealedbytheinspectionag encywithlicenseshouldbeprovidedsimultaneously.Thedetaileddescriptiona bouttheapplicationdossiersaresetforthinAppendix1.PARTTHREE:Administrativelicensingofimportedcosmeticfornon-particularp urposeAdministrativelicensingofimportedcosmeticfornon-particularpurposefort hefirsttime,theapplicationdossiersshouldbeprovidedasfollows,(1)Applicationformofadministrativelicensingofimportedcosmeticfornon-p articularpurpose,(2)ThereasonfornameoftheimportedproductsinChinese,(3)Productformula,(4)Requirementsinqualitycontroltoensurethesafetyoftheproduct,(5)Originalpackagingoftheproduct(includingthedirectionandthelable).In caseoftheproductwithaproprietarypackagingformarketinginChina,theinten dedpackagingdesign(includingthedirectionandthelable)shouldbeprovideds imultaneously.(6)Thecertificateofanalysisandrelevantdossiersissuedbytheinspectionag encywhichmustberecognizedandacceptedbySFDA,(7)Safetyevaluationdateonmaterialsthatmaybeexistinthefinishedproducts whichhavethesafetyrisk,(8)TheletterofauthorityfortheapplicantinChina(copy),whichhasbeenrecor dedbySFDA,andthebusinesslicenceoftheapplicantinChina(copywithofficial seal),(9)Theletterofmitmentthattherawmaterialandthesourceoftherawmaterialin productionshouldmeettherequirementsoftherestrictionsorprohibitionsinu singhighriskmaterialsfrombovinespongiformencephalopathy(BSE)diseasear eas,(10)Thecertificateofmanufacturingandmarketingfromthecountry(region)w hichtheproductsaremanufacturedorthecountry(region)oforigin,(13)Additionaldossierswhichareconducivefortheadministrativelicensi ng.1unopenedsampleproductfromthemarketwhichissealedbytheinspectionag encywithlicenseshouldbeprovidedsimultaneously.Thedetaileddescriptiona bouttheapplicationdossiersaresetforthinAppendix2.PARTFOUR:Theprocessflowdiagramofadministrativelicensingofimportedcosm eticAppendix1 Thedetaileddescriptionabouttheapplicationdossiersforadministrativelic ensingofimportedcosmeticforparticularpurpose1.Thedossiersshouldbeprovidedfollowingthelist,2.Fillouttheapplicationformundertheinstructionoftheformnotices, Applicationformforadministrativelicensingshouldbefilledoutbythemanu facturingenterprisesofimportedcosmetic,ortheauthorizerofthemanufactur ingenterprises,ortheauthorizedagencyfortheadministrativelicensinginCh ina.Indicationsshouldbewritteninthesealplaceoftheletterofassurancefro mmanufacturingenterprisesincaseofnoofficialseals. Letterofmitmentinapplicationformshouldbesignedbythelegalpersonoftheau thorizedagencyfortheadministrativelicensinginChina,ortheauthorizeroft helegalperson,withofficialsealontheletter.Whensigninginthepowerofattorney,anotarizedcopyandChinesecopyshould beprovided,theconsistentoftheChinesecopywiththeoriginaloneshouldbenot arizedsimultaneously.AccordingtotherequirementsinArticle24of“TheRequ irementsOfTheApplicationDossiersForAdministrativeLicensingOfCosmetic ”(shortforTheRequirementsOfTheDossiers),theoriginalofthepowerofattor neyandthenotarizedcopyshouldbeprovidedwhiletheapplication,andawritten explanationoftheproduct’snameintheoriginalofthepowerofattorney.Theco ntentofthesignatureinthepowerofattorneyshouldnotbecontainedbythecontentofthecertificateofauthorizationfromtheapplicantinChina.3.Theproductformulashouldcontaintheconfirmationoftheformulaissuedbyth einspectionagencywithlicense,andthedateoftheconfirmationshouldbeconsi stentwiththeapplicationdate.4.Requirementsinqualitycontrolshouldcontaintherequirementsconductedby theoriginalmanufacturer(foreignlanguageandtheChinesecopy),andalettero fmitmentdeclaringtheproductsmeettherequirementsin"HygienicStandardfor Cosmetics".5.Incaseofnoproductdirectionsordirectionsprintedonthecontainers(sucha slipstickandliprougesatpactsize),therelevantexplanationshouldbemadein thePackagingPart.6.Thecertificateofanalysisandrelevantdossiersissuedbytheinspectionage ncywhichmustberecognizedandacceptedbySFDA,orthecertificateofanalysiso nSPF,PFAorPAvalueissuedbyabroadlaboratoryshouldmeettherequirementsasf ollows,1)Applicationformforinspection;2)Notificationofacceptanceforinspection;3)Directionoftheproduct;4)Health&Safetytestingreport(microorganism,sanitarychemistryandto xicology);5)Thedossiersasfollowsshouldbeprovidedincaseofexisting:①Humansafetytestingreport(skinpatchtest,humantrials);②SPF、PFAorPAvaluereports;③Additionalreports(suchasAsbestosinspectionreport).(2)TheapplicationdossierscontainingSPF,PFAorPAvaluereportsissuedb yabroadlaboratory,theadditionaldossiersasfollowsshouldbeprovidedsimul taneously:1)IncaseofthatthelaboratoryhasbeenrecognizedandacceptedbySF DA,theauthenticationcertificateshouldbeprovided;2)Incaseofnoauthentic ationcertificate,GCPcertificateorGLPcertificateshouldbeprovided;3)Add itionaldossierswhichareconduciveforqualifying.Incaseofthatthereportsissuedbyabroadlaboratoryareprovidedforthefi rsttime,theoriginalreport,orthecopywhichisnotarizedbythelocalembassyo rrelevantassociationsfromthecountry(region)ofmanufacturer.Thecopyofth ereportwouldbeallowedinthere-applicationafterhavingbeenrecognizedanda cceptedbySFDA.Theoriginalreportissuedbyabroadlaboratoryshouldbeprovided.Theorig inalreportofatleastoneproductshouldbeprovidedincaseofseriesproducts,t hecopyonesofotherproductsareallowed,andtheproductnameintheoriginalrep ortshouldbepointed.Thecertificateoftherelationshipbetweentheinspectingsampleandtherep ortissuedbytherelevantlaboratoryshouldbeprovided,whilethereportofabro adlaboratoryisprovidedintheapplicationdossiers.Incaseofthattherelationshipbetweentheinspectingsampleandthereporth asbeenclearlystatedinthereport(suchastheproductnamehasbeennotedinthereport,andthenameofthesampleisconsistentwiththeproductname),thecertifi cateofaboveisneedless.7.Thecertificateofmanufacturingandmarketingfromthecountry(region)whic htheproductsaremanufacturedorthecountry(region)oforiginshouldmeetther equirementsasfollows,(1)Thecertificateshouldbeissuedbytheregulatoryauthoritiesorrelevan tassociations.Thecopyofthecertificateisallowedincaseofwithouttheorigi nallone.Thecopyofthecertificateshouldbenotarizedbylocalembassyorthere gulatoryauthorities.(2)Thecertificateshouldcontainthenameofproduct,nameofmanufacturer, nameoftheregulatoryauthoritywhichissuesthecertificate,andtheofficials ealorthesignatureoflegalperson(orauthorizer)shouldbeonthecertificate.(3)Thenameofproductandmanufacturershouldbeconsistentwiththeapplica tiondossiers.Incaseofcontractmanufacturingorotherwaysandthatthenameof manufacturerincertificateisn’tconsistentwithapplicationdossiers,awri ttenexplanationfromtheapplicantshouldbeprovided.Thecertificateofmanuf acturingandmarketingfortheimportedpartoftheproductwhichcontainingvari ousformsshouldbeprovided.(4)Thecertificateofmanufacturingandmarketingshouldbetranslatedinto Chineseincaseofbeingforeignlanguages.AndtheChinesecopyshouldbenotariz edbynotarypublicinChina.8.Theproductbelongstothefollowingsituations,additionaldossiersasfollowsshouldbeprovidedsimultaneously:(1)Incaseofcontractmanufacturing,additionaldossiersareasfollows,1)Theprotocolaboutcontractmanufacturingbetweentheconsignorandtheco nsignee,2)Forimportedproducts,thecertificateofQMSorGMPfromtheconsignee,ort heapprovedcertificateofcosmeticmanufacturingfromthecountry(region)ofm anufacturer,3)Theapprovedcertificateofcosmeticmanufacturingfromthecountry(regi on)ofmanufacturershouldmeettherequirementsasfollows,①Thecertificateshouldbeissuedbyregulatoryauthorityorthirdparties,Theco pyofthecertificateisallowedincaseofwithouttheoriginallone.Thecopyofth ecertificateshouldbenotarizedbylocalembassyornotarypublic.②Thenameandaddressofthemanufactureshouldbeconsistentwiththeapplication dossiers.(2)Incaseofthemanufacture(applicant)andtheactualmanufacturebelong toasamepanygroup,thecertificateoftherelationshipandthequalityassuranc edocumentsissuedbythepanygroupshouldbeprovided.9.Incaseoftheproductismanufacturedbymorethanoneenterprises,oneofthema nufacturersshouldprovidetheaboveapplicationdossiersandadditionaldossi ersasfollows,(1)Incaseofcontractmanufacturing,theprotocolaboutcontractmanufacturin gshouldbeprovided.Forimportedproducts,thecertificateofQMSorGMPfromthe consigneeortheapprovedcertificateofcosmeticmanufacturingfromthecountr y(region)ofmanufacturershouldbeprovided.(2)Incaseofthemanufacturersbelongtoasamepanygroup,thecertificateo ftherelationshipandthequalityassurancedocumentsissuedbythepanygroupsh ouldbeprovided.(3)Theoriginalpackagingfromotheractualmanufactures(4)Health&Safetyinspectionreport(microorganism,sanitarychemistry) fromotheractualmanufactures(5)Theletterofmitmentthattherawmaterialandthesourceoftherawmateri alinproductionshouldmeettherequirementsoftherestrictionsorprohibition sinusinghighriskmaterialsfrombovinespongiformencephalopathy(BSE)disea seareasfromotheractualmanufactures.10.Incaseoftheproductcontainingtheformsofpackagingasfollows,theapplic ationsshouldbemadeasthefollowingregulations,(1)Onesamplepackagingcontainsmorethantwo(includingtwo)individuallypac kaging,orseparatedsamples(suchaseyeshadow,pressedpowder,blush,etc.),a ndtheapplicationismadewithoneproductname,thecertificatesofanalysisand formulasofeachseparatedproductsshouldbeprovided.Samplewithoutindividu allypackagingandseparatedsamples,formulasofeachpartsandonecertificate ofanalysisshouldbeprovided.(2)TheSamplewithacollectivepackagingwhichcouldnotbesplit,theapplicati onismadewithoneproductname,andthesamplehasvariedrawmaterials&statesof matter,thecertificatesofanalysisandformulasforeachproductshouldbeprov idedrespectively.(3)Incaseoftheproductwhichcontainmorethantwo(includingtwo)formulation s,andmustbeusedasamixture,theapplicationshouldbemadeforoneproduct.Acc ordingtowhethertheproductwithmultipleformulationsisusedasamixtureorse paratedones,thecertificatesofanalysisforthemixtureoreachformulationsh ouldbeprovided.(4)Incaseofthattheapplicationofimportedproductsaremadebythesamemanufa cturingenterprises,whichcontainmorethantwo(includingtwo)originalpacka gingwiththesameforeignlanguagenamebutdifferentappearances,thedescript ionoftheappearancesshouldbeaddedtotheforeignlanguagenamecolumnofthece rtificateofmanufacturing&marketingandapplicationform,whileattachedwit hrelevantexplanation.11.Incaseofthatthesunscreencosmeticswithmultipleserieshaveasamebasicf ormula,andmakesamplinginspectionfortestingSPF,PFA,PAvalue,theapplicat ionisallowedtobemadeasonegroupofproduct.Theapplicationdossiersforeach seriesshouldbeattachedwiththenameofeachproductinthisseries,basicformu la,colorantslistandsamplinginspectionlist.12.Incaseofthattheimportedproductswhicharemanufacturedbytheenterprise abroadwithacontractmanufacturingfromresidententerprise,theproductsareprovideashomemadeones.Appendix2 Thedetaileddescriptionabouttheapplicationdossiersforadministrativelic ensingofimportedcosmeticfornon-particularpurpose1.Thedossiersshouldbeprovidedfollowingthelist,2.Fillouttheapplicationformundertheinstructionoftheformnotices, Applicationformforadministrativelicensingshouldbefilledoutbythemanu facturingenterprisesofimportedcosmetic,ortheauthorizerofthemanufactur ingenterprises,ortheauthorizedagencyfortheadministrativelicensinginCh ina.Indicationsshouldbewritteninthesealplaceoftheletterofassurancefro mmanufacturingenterprisesincaseofnoofficialseals. Letterofmitmentinapplicationformshouldbesignedbythelegalpersonoftheau thorizedagencyfortheadministrativelicensinginChina,ortheauthorizeroft helegalperson,withofficialsealontheletter.Whensigninginthepowerofattorney,anotarizedcopyandChinesecopyshould beprovided,theconsistentoftheChinesecopywiththeoriginaloneshouldbenot arizedsimultaneously.AccordingtotherequirementsinArticle24of“TheRequ irementsOfTheApplicationDossiersForAdministrativeLicensingOfCosmetic ”(shortforTheRequirementsOfTheDossiers),theoriginalofthepowerofattor neyandthenotarizedcopyshouldbeprovidedwhiletheapplication,andawritten explanationoftheproduct’snameintheoriginalofthepowerofattorney.Theco ntentofthesignatureinthepowerofattorneyshouldnotbecontainedbythecontentofthecertificateofauthorizationfromtheapplicantinChina.3.Theproductformulashouldcontaintheconfirmationoftheformulaissuedbyth einspectionagencywithlicense,andthedateoftheconfirmationshouldbeconsi stentwiththeapplicationdate.4.Requirementsinqualitycontrolshouldcontaintherequirementsconductedby theoriginalmanufacturer(foreignlanguageandtheChinesecopy),andalettero fmitmentdeclaringtheproductsmeettherequirementsin"HygienicStandardfor Cosmetics".5.Incaseofnoproductdirectionsordirectionsprintedonthecontainers(sucha slipstickandliprougesatpactsize),therelevantexplanationshouldbemadein thepackagingpart.6.Thecertificateofanalysisandrelevantdossiersissuedbytheinspectionage ncywhichmustberecognizedandacceptedbySFDAshouldmeettherequirementsasf ollows,1)Applicationformforinspection;2)Notificationofacceptanceforinspection;3)Directionoftheproduct;4)Health&Safetytestingreport(microorganism,sanitarychemistryandto xicology);5)Thedossiersasfollowsshouldbeprovidedincaseofexisting:①Humansafetytestingreport(skinpatchtest,humantrials);②Additionalreports(suchasAsbestosinspectionreport).7.Thecertificateofmanufacturingandmarketingfromthecountry(region)whic htheproductsaremanufacturedorthecountry(region)oforiginshouldmeetther equirementsasfollows,(1)Thecertificateshouldbeissuedbytheregulatoryauthoritiesorrelevan tassociations.Thecopyofthecertificateisallowedincaseofwithouttheorigi nallone.Thecopyofthecertificateshouldbenotarizedbylocalembassyorthere gulatoryauthorities.(2)Thecertificateshouldcontainthenameofproduct,nameofmanufacturer, nameoftheregulatoryauthoritywhichissuesthecertificate,andtheofficials ealorthesignatureoflegalperson(orauthorizer)shouldbeonthecertificate.(3)Thenameofproductandmanufacturershouldbeconsistentwiththeapplica tiondossiers.Incaseofcontractmanufacturingorotherwaysandthatthenameof manufacturerincertificateisn’tconsistentwithapplicationdossiers,awri ttenexplanationfromtheapplicantshouldbeprovided.Thecertificateofmanuf acturingandmarketingfortheimportedpartoftheproductwhichcontainingvari ousformsshouldbeprovided.(4)Thecertificateofmanufacturingandmarketingshouldbetranslatedinto Chineseincaseofbeingforeignlanguages.AndtheChinesecopyshouldbenotariz edbynotarypublicinChina.8.Theproductbelongstothefollowingsituations,additionaldossiersasfollo wsshouldbeprovidedsimultaneously:(1)Incaseofcontractmanufacturing,additionaldossiersareasfollows,1)Theprotocolaboutcontractmanufacturingbetweentheconsignorandtheco nsignee,2)Forimportedproducts,thecertificateofQMSorGMPfromtheconsignee,ort heapprovedcertificateofcosmeticmanufacturingfromthecountry(region)ofm anufacturer,3)Incaseofthattheimportedproductsaremanufacturedbytheenterpriseabr oadwithacontractmanufacturingfromresidententerprise,thepowerofattorne y,certificatesofmanufacturingandmarketing,andtheoriginalpackagingwoul dnotbenecessary,thepackagingdesignshouldbeprovided.4)ThecertificateofQMSorGMPfromtheconsignee,ortheapprovedcertificat eofcosmeticmanufacturingfromthecountry(region)ofmanufacturer,shouldme ettherequirementsasfollows,①Thecertificateshouldbeissuedbyregulatoryauthorityorthirdparties,Theco pyofthecertificateisallowedincaseofwithouttheoriginallone.Thecopyofth ecertificateshouldbenotarizedbylocalembassyornotarypublic.②Thenameandaddressofthemanufactureshouldbeconsistentwiththeapplication dossiers.(2)Incaseofthemanufacture(applicant)andtheactualmanufacturebelong toasamepanygroup,thecertificateoftherelationshipandthequalityassuranc edocumentsissuedbythepanygroupshouldbeprovided.9.Incaseoftheproductismanufacturedbymorethanoneenterprises,oneofthema nufacturersshouldprovidetheaboveapplicationdossiersandadditionaldossi ersasfollows,(1)Incaseofcontractmanufacturing,theprotocolaboutcontractmanufacturin gshouldbeprovided.Forimportedproducts,thecertificateofQMSorGMPfromthe consigneeortheapprovedcertificateofcosmeticmanufacturingfromthecountr y(region)ofmanufacturershouldbeprovided.(2)Incaseofthemanufacturersbelongtoasamepanygroup,thecertificateo ftherelationshipandthequalityassurancedocumentsissuedbythepanygroupsh ouldbeprovided.(3)Theoriginalpackagingfromotheractualmanufactures(4)Health&Safetyinspectionreport(microorganism,sanitarychemistry) fromotheractualmanufactures(5)Theletterofmitmentthattherawmaterialandthesourceoftherawmateri alinproductionshouldmeettherequirementsoftherestrictionsorprohibition sinusinghighriskmaterialsfrombovinespongiformencephalopathy(BSE)disea seareasfromotheractualmanufactures.10.Incaseoftheproductcontainingtheformsofpackagingasfollows,theapplic ationsshouldbemadeasthefollowingregulations,(1)Onesamplepackagingcontainsmorethantwo(includingtwo)individuallypac kaging,orseparatedsamples(suchaseyeshadow,pressedpowder,blush,etc.),a ndtheapplicationismadewithoneproductname,thecertificatesofanalysisandformulasofeachseparatedproductsshouldbeprovided.Samplewithoutindividu allypackagingandseparatedsamples,formulasofeachpartsandonecertificate ofanalysisshouldbeprovided.(2)TheSamplewithacollectivepackagingwhichcouldnotbesplit,theapplicati onismadewithoneproductname,andthesamplehasvariedrawmaterials&statesof matter,thecertificatesofanalysisandformulasforeachproductshouldbeprov idedrespectively.(3)Incaseoftheproductwhichcontainmorethantwo(includingtwo)formulation s,andmustbeusedasamixture,theapplicationshouldbemadeforoneproduct.Acc ordingtowhethertheproductwithmultipleformulationsisusedasamixtureorse paratedones,thecertificatesofanalysisforthemixtureoreachformulationsh ouldbeprovided.(4)Incaseoftheimportedproductsmadeapplicationbythesamemanufacturingen terprises,whichcontainmorethantwo(includingtwo)originalpackagingwitht hesameforeignlanguagenamebutdifferentappearances,thedescriptionofthea ppearanceshouldbeaddedtotheforeignlanguagenamecolumnofthecertificateo fmanufacturing&marketingandapplicationform,whileattachedwithrelevante xplanation.11.Incaseofthatthesunscreencosmeticswithmultipleserieshaveasamebasicf ormula,andmakesamplinginspectionfortestingSPF,PFA,PAvalue,theapplicat ionisallowedtobemadeasonegroupofproduct.Theapplicationdossiersforeach seriesshouldbeattachedwiththenameofeachproductinthisseries,basicformula,colorantslistandsamplinginspectionlist.12.Incaseofthatimportedproductsaremanufacturedbytheenterpriseabroadwi thacontractmanufacturingfromresidententerprise,theproductsareprovidea shomemadeones.Appendix3 Cosmeticsforparticularpurposeclassification1.Cosmeticsfornurturinghair;2.Cosmeticsforhaircolor（permanentortemporary）;3.Cosmeticsfordepilation4.Cosmeticsforbreast,5.Cosmeticsforbodybuilding(includingforlosingweight)6.Cosmeticsfordeodorization7.Cosmeticsfordispelingfreckle,8.Cosmeticsforsunscreen,9.Cosmeticsforpermorstraighthair.感谢阅读多年企业管理咨询经验，专注为企业和个人提供精品管理方案，企业诊断方案，制度参考模板等欢迎您下载，均可自由编辑价值管理月日对深市所有个股分析参考价值高代码名称千股千评最新价涨跌额涨跌幅买入/卖出昨收今开最高最低成交量成交额sz000001 深发展Ａ调整未结束,近期出局 22.90 -0.40 -1.717% 22.90/22.91 23.30 23.25 23.25 22.72 4,121 94,445sz000002 万科Ａ走势弱于大盘,近期观望 10.36 0.00 0.000% 10.35/10.36 10.36 10.35 10.51 10.20 13,586 140,576sz000004 *ST国农停牌 0.00 0.00 0.000% 0.00/0.00 10.00 0.00 0.00 0.00 0 0sz000005 世纪星源主力洗筹完毕,入货为主 6.08 -0.12 -1.935% 6.08/6.09 6.20 6.13 6.28 6.06 4,940 30,513sz000006 深振业Ａ沿5日均线下挫,出局为主 10.83 +0.03 +0.278% 10.83/10.84 10.80 10.79 11.04 10.72 1,384 15,004 sz000007 ST 达声股价反弹较好,可入为主 7.19 0.00 0.000% 7.18/7.19 7.19 7.17 7.30 7.12 436 3,153sz000008 ST宝利来停牌 0.00 0.00 0.000% 0.00/0.00 12.28 0.00 0.00 0.00 0 0sz000009 中国宝安沿5日均线下挫,出局为主 10.55 -0.01 -0.095% 10.55/10.56 10.56 10.56 10.75 10.37 2,341 24,669 sz000010 S ST华新下跌能量不足,观望为主 11.72 +0.12 +1.034% 11.72/11.73 11.60 11.61 11.73 11.55 152 1,763sz000011 深物业A 目前又再展跌势,出局为主 10.34 +0.03 +0.291% 10.33/10.34 10.31 10.27 10.52 10.11 614 6,336 sz000012 南玻Ａ下行空间不大,低吸为主 19.67 +0.59 +3.092% 19.67/19.68 19.08 19.04 19.68 18.91 1,381 26,804sz000014 沙河股份走势明显较弱,建议观望 14.83 +0.15 +1.022% 14.82/14.83 14.68 14.66 15.06 14.44 610 8,986sz000016 深康佳Ａ均线多头发散,建议买入 7.13 -0.45 -5.937% 7.12/7.13 7.58 7.53 7.54 7.13 3,507 25,531sz000017 S ST中华停牌 0.00 0.00 0.000% 0.00/0.00 3.49 0.00 0.00 0.00 0 0sz000018 *ST中冠A 有震荡上行趋势,建议持有 8.95 +0.04 +0.449% 8.93/8.95 8.91 8.91 8.97 8.76 90 801sz000019 深深宝Ａ均线助涨有力,建议介入 10.70 +0.10 +0.943% 10.70/10.71 10.60 10.61 11.05 10.56 477 5,166sz000020 深华发Ａ短期攻势较急,建议介入 11.00 -0.36 -3.169% 11.00/11.01 11.36 11.20 11.34 10.96 519 5,794sz000021 长城开发震荡上行走势,建议持有 13.31 -0.09 -0.672% 13.31/13.32 13.40 13.40 13.86 13.31 1,704 23,222sz000022 深赤湾Ａ均线助涨有力,建议介入 15.61 +0.32 +2.093% 15.61/15.62 15.29 15.50 15.97 15.50 657 10,356sz000023 深天地Ａ震荡上行走势,建议持有 10.15 +0.28 +2.837% 10.13/10.15 9.87 9.88 10.21 9.77 511 5,117sz000024 招商地产走势明显较弱,建议观望 24.75 +0.16 +0.651% 24.75/24.76 24.59 24.59 25.25 24.40 2,936 72,941 sz000025 特力Ａ震荡上行走势,建议持有 11.32 +0.11 +0.981% 11.32/11.33 11.21 11.20 11.50 11.10 172 1,952sz000026 飞亚达Ａ均线多头发散,建议买入 13.30 +0.62 +4.890% 13.29/13.30 12.68 12.56 13.30 12.50 509 6,601sz000027 深圳能源仍有向上空间,建议持仓 13.38 -0.02 -0.149% 13.37/13.38 13.40 13.42 13.62 13.37 973 13,147sz000028 一致药业均线多头发散,建议买入 28.75 +0.44 +1.554% 28.75/28.76 28.31 28.15 29.05 28.10 238 6,845 sz000029 深深房Ａ均线空头发散,建议出局 7.09 +0.04 +0.567% 7.09/7.10 7.05 7.06 7.25 6.99 1,049 7,484sz000030 *ST盛润A 仍有向上空间,建议持仓 7.75 -0.09 -1.148% 7.73/7.75 7.84 7.78 7.86 7.73 88 681sz000031 中粮地产均线强力阻挡,建议离场 10.76 +0.02 +0.186% 10.76/10.77 10.74 10.69 10.99 10.56 1,984 21,462 sz000032 深桑达Ａ均线助涨有力,建议介入 8.79 -0.20 -2.225% 8.78/8.79 8.99 8.95 8.99 8.77 597 5,297sz000033 新都酒店均线强力阻挡,建议离场 7.53 +0.32 +4.438% 7.53/7.54 7.21 7.21 7.56 7.20 1,385 10,190sz000034 *ST深泰停牌 0.00 0.00 0.000% 0.00/0.00 8.80 0.00 0.00 0.00 0 0sz000035 ST 科健均线强力支撑,建议介入 6.66 -0.04 -0.597% 6.65/6.66 6.70 6.71 6.75 6.64 131 877sz000036 *ST华控走势属多头势,建议介入 6.53 -0.08 -1.210% 6.53/6.54 6.61 6.59 6.66 6.51 1,136 7,462sz000037 深南电Ａ两阳夹一阴震仓,建议吸纳 7.33 +0.04 +0.549% 7.32/7.33 7.29 7.28 7.42 7.26 590 4,342sz000039 中集集团走势属多头势,建议介入 13.51 +0.24 +1.809% 13.51/13.52 13.27 13.32 13.85 13.32 2,867 39,187 sz000040 深鸿基均线强力阻挡,建议离场 7.34 +0.46 +6.686% 7.33/7.34 6.88 6.86 7.41 6.85 882 6,291sz000042 深长城均线空头发散,建议出局 21.02 +0.32 +1.546% 21.02/21.03 20.70 20.68 21.44 20.60 356 7,478 sz000043 中航地产均线强力阻挡,建议离场 14.67 +0.07 +0.479% 14.66/14.67 14.60 14.60 14.92 14.39 318 4,677 sz000045 深纺织Ａ走势属多头势,建议介入 14.40 +0.11 +0.770% 14.40/14.41 14.29 14.21 14.67 14.20 330 4,770 sz000046 泛海建设均线强力阻挡,建议离场 13.37 +0.01 +0.075% 13.37/13.38 13.36 13.50 13.74 13.25 940 12,647 sz000048 ST康达尔有震荡上行趋势,建议持有 4.98 -0.01 -0.200% 4.98/4.99 4.99 5.00 5.06 4.97 275 1,379sz000049 德赛电池走势强于大盘,建议持仓 11.12 +0.47 +4.413% 11.12/11.13 10.65 10.61 11.20 10.57 697 7,713 sz000050 深天马Ａ均线强力支撑,建议介入 6.76 -0.18 -2.594% 6.76/6.77 6.94 6.93 6.93 6.76 1,210 8,260sz000055 方大Ａ短期攻势较急,建议介入 10.31 +0.20 +1.978% 10.31/10.32 10.11 10.12 10.50 10.05 1,770 18,178 sz000056 深国商走势属多头势,建议介入 9.95 -0.19 -1.874% 9.95/9.96 10.14 10.08 10.18 9.89 419 4,207sz000058 深赛格均线强力支撑,建议介入 6.94 +0.32 +4.834% 6.93/6.94 6.62 6.62 7.05 6.56 3,117 21,472sz000059 辽通化工短线有上攻可能,介入 12.18 +0.05 +0.412% 12.17/12.18 12.13 11.98 12.39 11.98 1,647 20,111 sz000060 中金岭南慢牛上扬格局,买入 30.18 +0.63 +2.132% 30.17/30.18 29.55 29.40 31.08 29.22 3,391 103,628sz000061 农产品锁量大幅拉高,可追 13.77 -0.36 -2.548% 13.76/13.77 14.13 14.10 14.10 13.75 1,749 24,294sz000062 深圳华强股价小幅走高,观望 10.35 +0.09 +0.877% 10.34/10.35 10.26 10.26 10.43 10.11 323 3,342sz000063 中兴通讯股价可看高一线,介入 45.30 -0.95 -2.054% 45.30/45.31 46.25 46.30 46.58 45.20 1,043 47,784sz000065 北方国际短期支撑5日线,持有 28.50 -0.37 -1.282% 28.47/28.50 28.87 28.71 29.40 28.50 91 2,645sz000066 长城电脑多头市道,建议买入 17.00 -0.12 -0.701% 16.99/17.00 17.12 17.12 17.39 16.99 712 12,239sz000068 赛格三星中期强势确立,建议吸纳 8.23 +0.27 +3.392% 8.23/8.24 7.96 7.95 8.27 7.89 2,336 18,892sz000069 华侨城Ａ有启动迹象,建议介入 16.02 +0.16 +1.009% 16.02/16.03 15.86 15.86 16.35 15.70 3,894 62,372sz000070 特发信息多头市道,建议买入 10.15 -0.15 -1.456% 10.14/10.15 10.30 10.28 10.32 10.15 476 4,866sz000078 海王生物均线空头排列,建议出局 16.47 -0.17 -1.022% 16.47/16.48 16.64 16.59 16.85 16.38 1,806 29,998sz000088 盐田港走势强于大盘,建议持仓 8.30 +0.05 +0.606% 8.29/8.30 8.25 8.24 8.39 8.20 709 5,898sz000089 深圳机场回档力度有限,建议持有 7.42 -0.11 -1.461% 7.42/7.43 7.53 7.52 7.55 7.42 1,255 9,399sz000090 深天健走势弱于大盘,建议观望 11.56 +0.12 +1.049% 11.55/11.56 11.44 11.39 11.83 11.30 1,004 11,695 sz000096 广聚能源均线多头排列,建议买入 7.84 0.00 0.000% 7.84/7.85 7.84 7.91 7.97 7.81 738 5,830sz000099 中信海直价跌量增,不入为宜 7.86 -0.04 -0.506% 7.86/7.87 7.90 7.93 8.02 7.85 780 6,194sz000100 TCL 集团运行于中期通道,持有为宜 5.23 -0.12 -2.243% 5.23/5.24 5.35 5.35 5.55 5.23 13,546 72,979sz000150 宜华地产有资金出局迹象,撤退为宜 7.72 -0.01 -0.129% 7.72/7.73 7.73 7.70 7.90 7.60 690 5,358sz000151 中成股份运行于中期通道,持有为宜 10.60 -0.40 -3.636% 10.60/10.61 11.00 10.88 11.05 10.60 855 9,254sz000153 丰原药业仍有向下空间,观望为宜 7.48 +0.01 +0.134% 7.48/7.49 7.47 7.45 7.55 7.39 394 2,957sz000155 川化股份中期有走好迹象,持有为宜 8.93 -0.05 -0.557% 8.92/8.93 8.98 8.98 9.04 8.90 477 4,283sz000157 中联重科有资金出局迹象,撤退为宜 26.13 +1.00 +3.979% 26.12/26.13 25.13 25.27 26.60 25.16 2,620 68,532 sz000158 常山股份中期有走好迹象,持有为宜 9.05 -0.43 -4.536% 9.04/9.05 9.48 9.48 9.56 9.00 3,094 28,471sz000159 国际实业停牌 0.00 0.00 0.000% 0.00/0.00 18.77 0.00 0.00 0.00 0 0sz000301 东方市场中长线上升趋势,低吸为宜 6.88 -0.08 -1.149% 6.88/6.89 6.96 6.96 6.99 6.88 1,285 8,907sz000338 潍柴动力有资金出逃迹象,减磅为宜 67.95 +5.60 +8.982% 67.95/67.96 62.35 62.05 68.59 62.05 1,262 85,249 sz000400 许继电气均线助跌明显,减磅为宜 23.23 +0.09 +0.389% 23.23/23.24 23.14 23.18 23.63 22.85 1,194 27,692 sz000401 冀东水泥价跌量减走势,观望为宜 18.36 -0.44 -2.340% 18.36/18.37 18.80 18.75 18.75 18.27 1,675 30,816sz000402 金融街短线弱势不改,减磅为宜 11.49 +0.04 +0.349% 11.48/11.49 11.45 11.40 11.67 11.32 4,595 52,778 sz000404 华意压缩价跌量减走势,观望为宜 8.36 -0.07 -0.830% 8.36/8.37 8.43 8.40 8.58 8.35 721 6,116sz000407 胜利股份有资金出逃迹象,减磅为宜 8.60 -0.06 -0.693% 8.59/8.60 8.66 8.61 8.72 8.51 883 7,618sz000408 ST 玉源仍有向下空间,观望为宜 8.70 -0.15 -1.695% 8.70/8.71 8.85 8.85 8.90 8.68 379 3,310sz000409 ST泰格仍有下跌空间,观望为宜 8.28 +0.02 +0.242% 8.27/8.28 8.26 8.22 8.35 8.05 88 725sz000410 沈阳机床走势比较弱,斩出为宜 11.40 +0.14 +1.243% 11.40/11.41 11.26 11.19 11.69 11.05 1,422 16,221 sz000411 英特集团主力拉抬明显,跟进为宜 7.37 +0.07 +0.959% 7.37/7.38 7.30 7.27 7.45 7.26 409 3,011sz000413 宝石Ａ两阴夹一阳形态,减磅为宜 9.22 -0.05 -0.539% 9.22/9.23 9.27 9.27 9.35 9.20 330 3,053sz000415 汇通集团中长线上升趋势,低吸为宜 8.99 -0.14 -1.533% 8.99/9.00 9.13 9.13 9.31 8.93 1,407 12,845sz000416 民生投资暂时多头格局,持有为宜 8.68 -0.12 -1.364% 8.68/8.69 8.80 8.85 8.85 8.60 511 4,443sz000417 合肥百货重回跌势,出局为宜 13.67 -0.38 -2.705% 13.67/13.68 14.05 13.99 13.99 13.50 1,044 14,248sz000418 小天鹅Ａ股价有调整要求,近期减磅 14.68 -0.50 -3.294% 14.67/14.68 15.18 15.00 15.00 14.50 724 10,664 sz000419 通程控股震荡上行走势,近期持有 7.75 +0.25 +3.333% 7.74/7.75 7.50 7.50 7.95 7.43 1,038 8,060sz000420 吉林化纤走势比较弱,近期斩出 5.57 +0.02 +0.360% 5.56/5.57 5.55 5.55 5.66 5.51 811 4,551sz000421 南京中北主力实力强大,近期买入 6.65 -0.01 -0.150% 6.65/6.66 6.66 6.65 6.78 6.62 587 3,940sz000422 湖北宜化多方占据主动,近期持有 21.76 +0.04 +0.184% 21.76/21.77 21.72 21.72 22.13 21.16 504 10,922 sz000423 东阿阿胶股价震荡上扬,近期持有 25.70 -0.16 -0.619% 25.70/25.71 25.86 25.70 25.86 25.40 413 10,602 sz000425 徐工机械仍有向上空间,近期持仓 36.07 +0.15 +0.418% 36.06/36.07 35.92 35.93 36.83 35.82 400 14,585 sz000426 富龙热电停牌 0.00 0.00 0.000% 0.00/0.00 15.35 0.00 0.00 0.00 0 0sz000428 华天酒店多方占据主动,近期持有 8.75 -0.02 -0.228% 8.75/8.76 8.77 8.78 8.87 8.62 792 6,923sz000429 粤高速Ａ股价震荡上扬,近期持有 0.00 0.00 0.000% 0.00/0.00 5.40 0.00 0.00 0.00 0 0sz000430 ST张家界走势比较弱,近期斩出 7.00 +0.02 +0.287% 7.00/7.01 6.98 6.98 7.10 6.92 199 1,392sz000488 晨鸣纸业股价震荡上扬,近期持有 8.59 -0.15 -1.716% 8.58/8.59 8.74 8.71 8.85 8.57 2,556 22,344sz000501 鄂武商Ａ仍有向上空间,近期持仓 14.33 -0.37 -2.517% 14.33/14.34 14.70 14.56 14.66 14.32 193 2,794sz000502 绿景地产股价震荡上扬,近期持有 10.05 -0.10 -0.985% 10.05/10.06 10.15 10.15 10.35 9.92 354 3,587。
进口化妆品申报要注意及流程
进口化妆品申报要注意的流程哪些化妆品需要注册？关于化妆品的定义。
《化妆品卫生监督条例》中规定化妆品的定义为：“是指以涂擦、喷洒或者其他类似的方法，散布于人体表面任何部位（皮肤、毛发、指甲、口唇）以达到清洁、消除不良气味、护肤、美容和修饰目的的日用化学工业品。
”（注：牙膏、沐浴露等产品也已纳入化妆品管理）。
符合上述定义的都属于“化妆品”。
关于化妆品的分类。
中国将化妆品分为两大类：特殊类和非特殊类，非特殊类也就是我们日常所说的普通类。
非特殊用途化妆品共五大类：发用类、护肤类、彩妆类、指（趾）甲类和芳香类；特殊用途化妆品共九类：育发、染发、烫发、脱毛、美乳、健美、除臭、祛斑、防晒。
目前，所有进口化妆品（无论特殊或非特殊）、国产特殊类上市前都需要到国家食品药品监督管理局（简称SFDA)进行申报备案。
关于化妆品的审批机构。
SFDA保化司主管全国化妆品注册管理工作，并负责对进口化妆品的审批。
所有进口化妆品在递交审批之前。
还要先到指定机构进行化妆品申报前置检测，检验合格后方可向SFDA提出进口化妆品的申报审批。
关于化妆品批件。
SFDA对国产特殊用途用途及进口化妆品（包括特殊类和非特殊类）实行申报审核制度：进口特殊类化妆品需领取《国家食品药品监督管理局进口特殊用途化妆品卫生许可批件》、进口非特殊类化妆品需领取《国家食品药品监督管理局进口非特殊用途化妆品备案凭证》（以下均简称《批件》），否则不得在中国大陆市场上销售。
批件的有效期为四年，期满之后需进行再注册（续证）。
关于申请人资格。
进口化妆品的申请人应为中国境外化妆品生产企业（非个人）。
申请应具备的先决条件：在生产所在国被允许生产和销售，并且可获得自由销售证明文件；在中国大陆地区有行政许可的在华申报责任单位（法人，分支机构或境内代理，可变更）；申请产品如为化妆品OEM形式也可。
关于进口化妆品关税。
目前我国对进口化妆品征收关税、增值税和消费税。
根据《中华人民共和国进出口货物征税管理办法》计算公式如下：(1)关税（实征关税税额）=完税价格*关税税率（一般护肤品6.5%，彩妆及香水10%）(2)增值税=（完税价格+实征关税税额+实征消费税税额）*增值税率（17%）(3)消费税={（完税价格+实征关税税额）/(1-消费税税额)}*消费税税率(4)总税款=关税款+增值税+消费税申请人需具备什么资格？国外化妆品进口行政许可的备案（审批）要求有在华责任申报单位，因此，如果是境外企业作为申报工作的主体，首先要做的就是找到一家合适的境内合作单位或成立中国境内办事机构。
进口化妆品申报
进口化妆品申报:1.什么样的化妆品进入中国需要办理手续？所有外国企业生产和销售的化妆品（含中国台湾和中国香港、澳门），在进入中国大陆销售时，必须到中国国家相关部门办理注册（备案）手续。
2.国外化妆品进入中国需要办理什么手续？到何机构办理？国外化妆品进入中国时，需要到中国国家卫生部等机构办理注册（备案）手续方可销售，具体程序为：①卫生部注册/备案（接收单位：卫生部卫生监督中心）；②制作中文标签（2006年4月之前需要到国家质量监督检验总局备案，现已取消备案）；③通关（含标签审核，海关）；④上市销售。
3在申报时如何进行产品分类？按照2007版《化妆品卫生规范》所规定的化妆品的定义，“是指以涂擦、喷洒或者其他类似的方法，散布于人体表面任何部位（皮肤、毛发、指甲、口唇）以达到清洁、消除不良气味、护肤、美容和修饰目的的日用化学工业品。
”进口化妆品分别包括普通化妆品及特殊用途化妆品。
普通化妆品分类：1.发用品2.护肤品3.彩妆品4.指(趾)甲用品5.芳香品特殊用途化妆品分类：1.育发类*2.健美类*3.美乳类*4.染发类5.烫发类*6.防晒类※7.除臭类※8.祛斑类※9.脱毛类※以上标有*的项目需做人体试用试验，标有※的项目需做人体斑贴试验。
4.卫生部注册（备案）的程序是怎样的？自二○○四年七月一日年开始，国家卫生部简化进口化妆品程序，特殊类产品仍沿袭原有的注册制，而普通类产品则实行备案制。
二者在程序上基本相同，不同的是前者在受理后需由评审委员会进行技术审评。
①进口普通化妆品的申报程序：需经过样品检验、整理申报材料、申请备案、材料审核、核发备案凭证等程序。
②进口特殊化妆品的申报程序：需经过样品检验、整理申报材料、申请注册、材料审评、核发注册批件等程序。
注册（备案）完成后由卫生部颁发行政许可：普通类颁发备案凭证，备案文号格式为：卫妆备进字(发证年份)第XXXX号。
特殊类产品颁发批件，格式为：卫妆特进字（发证年份）第XXXX号。
进口化妆品备案申报配方的基本要求及审核流程
进口化妆品备案申报配方的基本要求及审核流程我国规定，从2010年6月17日起，所有在中华人民共和国境内销售（包括国内生产的和进口报检的）的化妆品都需要在产品包装上真实地标注产品配方中加入的全部成分的名称。
实施全成分标识规定，既符合各国法规规定，保护消费者知情权，同时能提供更全面的产品信息，以方便消费者选择需要和喜爱的产品并避开过敏的原料。
但由于国内外国情与监管制度的不同，国外化妆品配方或成分不能在中国大陆使用就比较常见。
进口化妆品备案申报要想顺利通过，配方的合法性、科学性是最基本的条件之一。
故我们特撰此文，以飨读者。
进口化妆品备案申报关于配方的基本要求（一）应以表格形式在同一张表中提供包含原料序号、原料INCI名称（国际化妆品原料名称）（国产产品除外）、标准中文名称、百分含量、使用目的等内容的配方表，字号不小于小五号宋体；（二）应提供全部原料的名称，实际含量以百分比计，并注明有效物含量（未注明者均以有效物含量100%计）；复配原料必须以复配形式申报，并应标明各组分在其中的含量（以百分比计）；特殊情况，如含结晶水、原料存在不同的分子式或结构式等应加以说明，全部原料按含量递减顺序排列；（三）配方原料（含复配原料中的各组分）的中文名称应按《国际化妆品原料标准中文名称目录》使用标准中文名称，无INCI名称或未列入《国际化妆品原料标准中文名称目录》的应使用《中国药典》中的名称或化学名称或植物拉丁学名，不得使用商品名或俗名，但复配原料除外；（四）着色剂应提供《化妆品卫生规范》上载明的着色剂索引号（简称CI号），无CI号的除外；（五）含有动物脏器组织及血液制品提取物的，应提交原料的来源、质量规格和原料生产国允许使用的证明；（六）凡在产品配方中使用来源于石油、煤焦油的碳氢化合物（单一组分的除外）的，应在产品配方中标明相关原料的化学文摘索引号（简称CAS号）；（七）《化妆品卫生规范》对限用物质原料有规格要求的，还应提交由原料生产商出具的该原料的质量规格证明；（八）分装组配的多剂型产品（如染发、烫发类），或存在于同一不可拆分包装内的不同配方内容物组合而成的产品，应将各部分配方分别列出；（九）许可检验机构对进口产品配方的确认证明，其确认日期应与检验样品的受理日期一致；（十）凡宣称为孕妇、哺乳期妇女、儿童或婴儿使用的产品，应当提供基于安全性考虑的配方设计原则（含配方整体分析报告）、原料的选择原则和要求、生产工艺、质量控制等内容的资料。
进口化妆品备案申报方案(非特殊用途化妆品─普通护肤产品)
进口化妆品备案申报方案(非特殊类─普通护肤产品)友情提示1.所有进口化妆品，必须由国家药品监督管理局（NMPA）申报备案通过审批后方可报关进口销售。
2.申报备案前提：a.产品已在生产国上市销售；b.外商品牌产品在原产国政府机关或者行业协会开具已上市销售证明且在中国大陆有独立法人资格的单位作为在华申报责任单位或境内责任人。
备案凭证及有效期备案凭证编号:国妆网备进字（所在省份简写）+四位年份数字+六位顺序编号。
无有效期。
但须每年定期通过网上备案系统平台向化妆品监督管理部门报送已备案产品上一年度的生产或进口、上市销售、不良反应监测以及接受行政处罚等有关情况。
申报周期及流程大约在3-6个月左右，包括样品检测、授权书备案、资料编写及备案过程。
申报流程①授权书备案②产品检验③产品备案受理④形式审查并备案⑤制证（电子备案凭证）。
备案后期程序：文件审查—补充资料。
费用组成进口化妆品申报备案的费用组成，一般包括检测费、公证费、翻译费、代理费，当然，自主备案的话自然就无需代理费这项。
具体见下表：资料清单1.在华申报责任单位（境内责任人）授权书及签字委托书（需委托双方就各自的法人签字和盖章分别在所在国各做真实性公证）2.在华申报责任单位（境内责任人）营业执照复印件3.产品配方表（中英文或英文）4.使用说明书（或外包装的中文翻译件）5.样品（未启封的最终销售包装的样品。
数量视规格及使用方法不同）6.凡宣称为儿童或婴儿及哺乳期妇女使用的产品，还应提供基于安全性考虑每个原料的安全用量依据（例如美国CIR)的配方设计原则（含配方整体分析报告）、原料的选择原则和要求、生产工艺、质量控制等内容的资料。
7.产品原产国的质量安全控制要求(MSDS或COA)8.产品中可能存在安全性风险物质的有关安全性评估资料9.生产工艺简述及流程图10.产品在生产国（地区）已生产销售的证明文件原件11.OEM产品还应按规定提供相应证明文件申报准备1、《产品申报/备案信息确认函》请填写并确认，以便评估申报备案预期问题.2、计划委托产品的初期预审资料：①未启封的最终完整销售包装的样品及其全部文字对应面的中文译文（英文部分除外）；②包含所有原料及其含量的完整配方表；3、在华申报责任单位/境内责任人最新版营业执照扫描件.（本文由北京天健华成国际投资顾问有限公司化妆品注册部友情提供，转载请注明出处）IV 增值服务合作者在获得专业批文申报服务之外，还可以得到以下增值服务：免费提供申报技术指导。
化妆品进口报检流程和要求
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文档下载后可定制随意修改，请根据实际需要进行相应的调整和使用，谢谢!并且，本店铺为大家提供各种各样类型的实用资料，如教育随笔、日记赏析、句子摘抄、古诗大全、经典美文、话题作文、工作总结、词语解析、文案摘录、其他资料等等，如想了解不同资料格式和写法，敬请关注!Download tips: This document is carefully compiled by theeditor. I hope that after you download them,they can help yousolve practical problems. The document can be customized andmodified after downloading,please adjust and use it according toactual needs, thank you!In addition, our shop provides you with various types ofpractical materials,such as educational essays, diaryappreciation,sentence excerpts,ancient poems,classic articles,topic composition,work summary,word parsing,copy excerpts,other materials and so on,want to know different data formats andwriting methods,please pay attention!化妆品进口报检流程和要求如下：1. 准备工作在化妆品进口报检前，首先要确保所进口的化妆品符合我国的相关法规和标准。
进口化妆品申报资料及要求 英文版(XXXX年新版)
进口化妆品申报资料及要求英文版(XXXX年新版)Application dossiers for administrative licensing of imported cosmetic required bySFDAPART ONE: Imported cosmetics classificationThe imported cosmetics are divided into two major categories by SFDA: imported cosmetic for particular purpose, and imported cosmetic for non- particular purpose. The detailed description about the classification is set forth in Appendix 3.PART TWO: Administrative licensing of imported cosmetic for particular purposeAdministrative licensing of imported cosmetic for particular purpose for the first time, the application dossiers should be provided as follows,(1) Application form of administrative licensing of imported cosmetic for particular purpose,(2) The reason for name of the imported products in Chinese,(3) Product formula,(4) Briefly description and schematics about the manufacturing processes,(5) Requirements in quality control to ensure the safety of the product,(6) Original packaging of the product (including the direction and the lable). In case of the product with a proprietary packaging for marketing in China, the intended packaging design (including the direction and the lable) should be provided simultaneously.(7) The certificate of analysis and relevant dossiers issued by the inspection agency which must be recognized and accepted by SFDA, or the certificate of analysis on SPF, PFA or PA value issued by abroad laboratory,(8) Safety evaluation date on materials that maybe exist in the finished products which have the safety risk.(9) Application for products used in nurturing hair, bodybuilding and breast, the effective constituent and the reference literatures containing the scientific proofs should be provide,(10) The letter of authority for the applicant in China (copy), which has been recorded by SFDA, and the business licence of the applicant in China (copy with official seal),(11) The letter of commitment that the raw material and the source of the raw material in production should meet the requirements of the restrictions or prohibitions in using high risk materials from bovine spongiform encephalopathy (BSE) disease areas,(12) The certificate of manufacturing and marketing from the country (region) which the products are manufactured or the country (region) of origin,(13) Additional dossiers which are conducive for the administrative licensing.1 unopened sample product from the market which is sealed by the inspection agency with license should be provided simultaneously. The detailed description about the application dossiers are set forth in Appendix 1.PART THREE: Administrative licensing of imported cosmetic for non-particular purposeAdministrative licensing of imported cosmetic for non-particular purpose for the first time, the application dossiers should be provided as follows,(1) Application form of administrative licensing of imported cosmetic for non-particular purpose,(2) The reason for name of the imported products in Chinese,(3) Product formula,(4) Requirements in quality control to ensure the safety of the product,(5) Original packaging of the product (including the direction and the lable). In case of the product with a proprietary packaging for marketing in China, the intended packaging design (including the direction and the lable) should be provided simultaneously.(6) The certificate of analysis and relevant dossiers issued by the inspection agency which must be recognized and accepted by SFDA,(7) Safety evaluation date on materials that maybe exist in the finished products which have the safety risk,(8) The letter of authority for the applicant in China (copy), which has been recorded by SFDA, and the business licence of the applicant in China (copy with official seal),(9) The letter of commitment that the raw material and the source of the raw material in production should meet the requirements of the restrictions or prohibitions in using high risk materials from bovine spongiform encephalopathy (BSE) disease areas,(10) The certificate of manufacturing and marketing from the country (region) which the products are manufactured or the country (region) of origin,(13) Additional dossiers which are conducive for the administrative licensing.1 unopened sample product from the market which is sealed by the inspection agency with license should be provided simultaneously. The detailed description about the application dossiers are set forth in Appendix 2.PART FOUR: The process flow diagram of administrative licensing of imported cosmeticThe copy of the letter ofauthority and business licenceare recorded by SFDAApplication CenterFill out a form from SFDAadministrative licensingsystem on linePART FIVE: Charge There is no charge in administrative licensing of imported cosmetic by SFDAFormal examination by SFDA Application Center, 5wd Reviewed by CHFE, 60wd Approved by SFDA, 20wd （In case of disapprove, the applicationdossiers are able tobe recovered bypaper applicationwithin 6 months ）Appendix 1The detailed description about the application dossiers for administrative licensing of imported cosmetic for particularpurpose1. The dossiers should be provided following the list,2. Fill out the application form under the instruction of the form notices, Application form for administrative licensing should be filled out by the manufacturing enterprises of imported cosmetic, or the authorizer of the manufacturing enterprises, or the authorized agency for the administrative licensing in China. Indications should be written in the seal place of the letter of assurance from manufacturing enterprises in case of no official seals.Letter of commitment in application form should be signed by the legal person of the authorized agency for the administrative licensing in China, or the authorizer of the legal person, with official seal on the letter.When signing in the power of attorney, a notarized copy and Chinese copy should be provided, the consistent of the Chinese copy with the original one should be notarized simultaneously. According to the requirements in Article 24 of “The Requirements Of The Application Dossiers For Administrative Licensing Of Cosmetic”(short for The Requirements Of The Dossiers), the original of the power of attorney and the notarized copy should be provided while the application, and a written explanation of the product’s name in the original of the power of attorney. The content of the signature in the power of attorney should not be contained by the content of the certificate of authorization from the applicant in China.3. The product formula should contain the confirmation of the formula issued by the inspection agency with license, and the date of the confirmation should be consistent with the application date.4. Requirements in quality control should contain the requirements conducted by the original manufacturer (foreign language and the Chinese copy), and a letter of commitment declaring the products meet the requirements in "Hygienic Standard for Cosmetics".5. In case of no product directions or directions printed on the containers (such as lipstick and lip rouges at compact size), the relevant explanation should be made in the Packaging Part.6. The certificate of analysis and relevant dossiers issued by the inspection agency which must be recognized and accepted by SFDA, or the certificate of analysis on SPF, PFA or PA value issued by abroad laboratory should meet the requirements as follows,1) Application form for inspection;2) Notification of acceptance for inspection;3) Direction of the product;4) Health & Safety testing report (microorganism, sanitary chemistry and toxicology);5) The dossiers as follows should be provided in case of existing:①Human safety testing report (skin patch test , human trials);②SPF、PFA or PA value reports;③Additional reports (such as Asbestos inspection report).(2) The application dossiers containing SPF, PFA or PA value reports issued by abroad laboratory, the additional dossiers as follows should be provided simultaneously: 1) In case of that the laboratory has been recognized and accepted by SFDA, the authentication certificate should be provided; 2) In case of no authentication certificate, GCP certificate or GLP certificate should be provided; 3) Additional dossiers which are conducive for qualifying.In case of that the reports issued by abroad laboratory are provided for the first time, the original report, or the copy which is notarized by the local embassy or relevant associations from the country (region) of manufacturer. The copy of the report would be allowed in there-application after having been recognized and accepted by SFDA.The original report issued by abroad laboratory should be provided. The original report of at least one product should be provided in case of series products, the copy ones of other products are allowed, and the product name in the original report should be pointed.The certificate of the relationship between the inspecting sample and the report issued by the relevant laboratory should be provided, while the report of abroad laboratory is provided in the application dossiers.In case of that the relationship between the inspecting sample and the report has been clearly stated in the report (such as the product name has been noted in the report, and the name of the sample is consistent with the product name), the certificate of above is needless.7. The certificate of manufacturing and marketing from the country (region) which the products are manufactured or the country (region) of origin should meet the requirements as follows,(1) The certificate should be issued by the regulatory authorities or relevant associations. The copy of the certificate is allowed in case of without the original l one. The copy of the certificate should be notarized by local embassy or the regulatory authorities.(2) The certificate should contain the name of product, name of manufacturer, name of the regulatory authority which issues the certificate, and the official seal or the signature of legal person (or authorizer) should be on the certificate.(3) The name of product and manufacturer should be consistent with the application dossiers. In case of contract manufacturing or other ways and that the name of manufacturer in certificate isn’t consistent withapplication dossiers, a written explanation from the applicant should be provided. The certificate of manufacturing and marketing for the imported part of the product which containing various forms should be provided.(4) The certificate of manufacturing and marketing should be translated into Chinese in case of being foreign languages. And the Chinese copy should be notarized by notary public in China.8. The product belongs to the following situations, additional dossiers as follows should be provided simultaneously:(1) In case of contract manufacturing, additional dossiers are as follows,1) The protocol about contract manufacturing between the consignor and the consignee,2) For imported products, the certificate of QMS or GMP from the consignee, or the approved certificate of cosmetic manufacturing from the country (region) of manufacturer,3) The approved certificate of cosmetic manufacturing from the country (region) of manufacturer should meet the requirements as follows,①The certificate should be issued by regulatory authority or third parties, The copy of the certificate is allowed in case of without the original l one. The copy of the certificate should be notarized by local embassy or notary public.②The name and address of the manufacture should be consistent with the application dossiers.(2) In case of the manufacture (applicant) and the actual manufacture belong to a same company group, the certificate of the relationship and the quality assurance documents issued by the company group should be provided.9. In case of the product is manufactured by more than one enterprises, one of the manufacturers should provide the above application dossiers and additional dossiers as follows,(1)In case of contract manufacturing, the protocol about contract manufacturing should be provided. For imported products, the certificate of QMS or GMP from the consignee or the approved certificate of cosmetic manufacturing from the country (region) of manufacturer should be provided.(2) In case of the manufacturers belong to a same company group, the certificate of the relationship and the quality assurance documents issued by the company group should be provided.(3) The original packaging from other actual manufactures(4) Health & Safety inspection report (microorganism, sanitary chemistry) from other actual manufactures(5) The letter of commitment that the raw material and the source of the raw material in production should meet the requirements of the restrictions or prohibitions in using high risk materials from bovine spongiform encephalopathy (BSE) disease areas from other actual manufactures.10. In case of the product containing the forms of packaging as follows, the applications should be made as the following regulations,(1) One sample packaging contains more than two (including two) individually packaging, or separated samples (such as eye shadow, pressed powder, blush, etc.), and the application is made with one product name, the certificates of analysis and formulas of each separated products should be provided. Sample without individually packaging and separated samples, formulas of each parts and one certificate of analysis should be provided.(2) The Sample with a collective packaging which could not be split, the application is made with one product name, and the sample hasvaried raw materials & states of matter, the certificates of analysis and formulas for each product should be provided respectively.(3) In case of the product which contain more than two (including two) formulations, and must be used as a mixture, the application should be made for one product. According to whether the product with multiple formulations is used as a mixture or separated ones, the certificates of analysis for the mixture or each formulation should be provided.(4)In case of that the application of imported products are made by the same manufacturing enterprises, which contain more than two (including two) original packaging with the same foreign language name but different appearances, the description of the appearances should be added to the foreign language name column of the certificate of manufacturing & marketing and application form, while attached with relevant explanation.11.In case of that the sunscreen cosmetics with multiple series have a same basic formula, and make sampling inspection for testing SPF, PFA, PA value, the application is allowed to be made as one group of product. The application dossiers for each series should be attached with the name of each product in this series, basic formula, colorants list and sampling inspection list.12.In case of that the imported products which are manufactured by the enterprise abroad with a contract manufacturing from resident enterprise, the products are provide as homemade ones.Appendix 2The detailed description about the application dossiers for administrative licensing of imported cosmetic for non-particularpurpose1. The dossiers should be provided following the list,2. Fill out the application form under the instruction of the form notices, Application form for administrative licensing should be filled out by the manufacturing enterprises of imported cosmetic, or the authorizer of the manufacturing enterprises, or the authorized agency for the administrative licensing in China. Indications should be written in the seal place of the letter of assurance from manufacturing enterprises in case of no official seals.Letter of commitment in application form should be signed by the legal person of the authorized agency for the administrative licensing in China, or the authorizer of the legal person, with official seal on the letter.When signing in the power of attorney, a notarized copy and Chinese copy should be provided, the consistent of the Chinese copy with the original one should be notarized simultaneously. According to the requirements in Article 24 of “The Requirements Of The Application Dossiers For Administrative Licensing Of Cosmetic”(short for The Requirements Of The Dossiers), the original of the power of attorney and the notarized copy should be provided while the application, and a written explanation of the product’s name in the original of the power of attorney. The content of the signature in the power of attorney should not be contained by the content of the certificate of authorization from the applicant in China.3. The product formula should contain the confirmation of the formula issued by the inspection agency with license, and the date of the confirmation should be consistent with the application date.4. Requirements in quality control should contain the requirements conducted by the original manufacturer (foreign language and the Chinese copy), and a letter of commitment declaring the products meet the requirements in "Hygienic Standard for Cosmetics".5. In case of no product directions or directions printed on the containers (such as lipstick and lip rouges at compact size), the relevant explanation should be made in the packaging part.6. The certificate of analysis and relevant dossiers issued by the inspection agency which must be recognized and accepted by SFDA should meet the requirements as follows,1) Application form for inspection;2) Notification of acceptance for inspection;3) Direction of the product;4) Health & Safety testing report (microorganism, sanitary chemistry and toxicology);5) The dossiers as follows should be provided in case of existing:①Human safety testing report (skin patch test , human trials);②Additional reports (such as Asbestos inspection report).7. The certificate of manufacturing and marketing from the country (region) which the products are manufactured or the country (region) of origin should meet the requirements as follows,(1) The certificate should be issued by the regulatory authorities or relevant associations. The copy of the certificate is allowed in case of without the original l one. The copy of the certificate should be notarized by local embassy or the regulatory authorities.(2) The certificate should contain the name of product, name of manufacturer, name of the regulatory authority which issues thecertificate, and the official seal or the signature of legal person (or authorizer) should be on the certificate.(3) The name of product and manufacturer should be consistent with the application dossiers. In case of contract manufacturing or other ways and that the name of manufacturer in certificate isn’t consistent with application dossiers, a written explanation from the applicant should be provided. The certificate of manufacturing and marketing for the imported part of the product which containing various forms should be provided.(4) The certificate of manufacturing and marketing should be translated into Chinese in case of being foreign languages. And the Chinese copy should be notarized by notary public in China.8. The product belongs to the following situations, additional dossiers as follows should be provided simultaneously:(1) In case of contract manufacturing, additional dossiers are as follows,1) The protocol about contract manufacturing between the consignor and the consignee,2) For imported products, the certificate of QMS or GMP from the consignee, or the approved certificate of cosmetic manufacturing from the country (region) of manufacturer,3) In case of that the imported products are manufactured by the enterprise abroad with a contract manufacturing from resident enterprise, the power of attorney, certificates of manufacturing and marketing, and the original packaging would not be necessary, the packaging design should be provided.4) The certificate of QMS or GMP from the consignee, or the approved certificate of cosmetic manufacturing from the country (region) of manufacturer, should meet the requirements as follows,①The certificate should be issued by regulatory authority or third parties, The copy of the certificate is allowed in case of without the original l one. The copy of the certificate should be notarized by local embassy or notary public.②The name and address of the manufacture should be consistent with the application dossiers.(2) In case of the manufacture (applicant) and the actual manufacture belong to a same company group, the certificate of the relationship and the quality assurance documents issued by the company group should be provided.9. In case of the product is manufactured by more than one enterprises, one of the manufacturers should provide the above application dossiers and additional dossiers as follows,(1)In case of contract manufacturing, the protocol about contract manufacturing should be provided. For imported products, the certificate of QMS or GMP from the consignee or the approved certificate of cosmetic manufacturing from the country (region) of manufacturer should be provided.(2) In case of the manufacturers belong to a same company group, the certificate of the relationship and the quality assurance documents issued by the company group should be provided.(3) The original packaging from other actual manufactures(4) Health & Safety inspection report (microorganism, sanitary chemistry) from other actual manufactures(5) The letter of commitment that the raw material and the source of the raw material in production should meet the requirements of the restrictions or prohibitions in using high risk materials from bovine spongiform encephalopathy (BSE) disease areas from other actual manufactures.10. In case of the product containing the forms of packaging as follows, the applications should be made as the following regulations,(1) One sample packaging contains more than two (including two) individually packaging, or separated samples (such as eye shadow, pressed powder, blush, etc.), and the application is made with one product name, the certificates of analysis and formulas of each separated products should be provided. Sample without individually packaging and separated samples, formulas of each parts and one certificate of analysis should be provided.(2) The Sample with a collective packaging which could not be split, the application is made with one product name, and the sample has varied raw materials & states of matter, the certificates of analysis and formulas for each product should be provided respectively.(3) In case of the product which contain more than two (including two) formulations, and must be used as a mixture, the application should be made for one product. According to whether the product with multiple formulations is used as a mixture or separated ones, the certificates of analysis for the mixture or each formulation should be provided.(4)In case of the imported products made application by the same manufacturing enterprises, which contain more than two(including two) original packaging with the same foreign language name but different appearances, the description of the appearance should be added to the foreign language name column of the certificate of manufacturing & marketing and application form, while attached with relevant explanation.11.In case of that the sunscreen cosmetics with multiple series have a same basic formula, and make sampling inspection for testing SPF, PFA, PA value, the application is allowed to be made as one group of product. The application dossiers for each series should be attachedwith the name of each product in this series, basic formula, colorants list and sampling inspection list.12.In case of that imported products are manufactured by the enterprise abroad with a contract manufacturing from resident enterprise, the products are provide as homemade ones.Appendix 3Cosmetics for particular purpose classification1. Cosmetics for nurturing hair;2. Cosmetics for hair color（permanent or temporary）;3. Cosmetics for depilation4. Cosmetics for breast,5. Cosmetics for bodybuilding (including for losing weight)6. Cosmetics for deodorization7. Cosmetics for dispeling freckle,8. Cosmetics for sunscreen,9. Cosmetics for perm or straight hair.。
进口化妆品以国外品牌商的名义申报需要提交的资料
作者：北京天健华成
需要外商（申请企业）提供的证明性 材料有哪些？
❖ 第一种如为外文的需要进行翻译公证，后一 种需要就委托方和被委托方的法人签字和盖 章分别在各自的所在国进行真实性公证，经 过双方公证后的授权书如什么不明白的地方，可以随时联 系我，010-84828041，我这天健华成工作近 10年来，一直从事化妆品卫生许可批件（备 案凭证）的代理申报工作，这些年为国内、 国外化妆品企业成功获取了批文，这此发博 文，就是想与国外化妆品厂商和国内进口商 及经销商分享申报经验。
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Application dossiers for administrative licensing of imported cosmetic required bySFDAPART ONE: Imported cosmetics classificationThe imported cosmetics are divided into two major categories by SFDA: imported cosmetic for particular purpose, and imported cosmetic for non- particular purpose. The detailed description about the classification is set forth in Appendix 3.PART TWO: Administrative licensing of imported cosmetic for particular purposeAdministrative licensing of imported cosmetic for particular purpose for the first time, the application dossiers should be provided as follows,(1) Application form of administrative licensing of imported cosmetic for particular purpose,(2) The reason for name of the imported products in Chinese,(3) Product formula,(4) Briefly description and schematics about the manufacturing processes,(5) Requirements in quality control to ensure the safety of the product,(6) Original packaging of the product (including the direction and the lable). In case of the product with a proprietary packaging for marketing in China, the intended packaging design (including the direction and the lable) should be provided simultaneously.(7) The certificate of analysis and relevant dossiers issued by the inspection agency which must be recognized and accepted by SFDA, or thecertificate of analysis on SPF, PFA or PA value issued by abroad laboratory,(8) Safety evaluation date on materials that maybe exist in the finished products which have the safety risk.(9) Application for products used in nurturing hair, bodybuilding and breast, the effective constituent and the reference literatures containing the scientific proofs should be provide,(10) The letter of authority for the applicant in China (copy), which has been recorded by SFDA, and the business licence of the applicant in China (copy with official seal),(11) The letter of commitment that the raw material and the source of the raw material in production should meet the requirements of the restrictions or prohibitions in using high risk materials from bovine spongiform encephalopathy (BSE) disease areas,(12) The certificate of manufacturing and marketing from the country (region) which the products are manufactured or the country (region) of origin,(13) Additional dossiers which are conducive for the administrative licensing.1 unopened sample product from the market which is sealed by the inspection agency with license should be provided simultaneously. The detailed description about the application dossiers are set forth in Appendix 1.PART THREE: Administrative licensing of imported cosmetic fornon-particular purposeAdministrative licensing of imported cosmetic for non-particular purpose for the first time, the application dossiers should be provided as follows,(1) Application form of administrative licensing of imported cosmetic for non-particular purpose,(2) The reason for name of the imported products in Chinese,(3) Product formula,(4) Requirements in quality control to ensure the safety of the product,(5) Original packaging of the product (including the direction and the lable). In case of the product with a proprietary packaging for marketing in China, the intended packaging design (including the direction and the lable) should be provided simultaneously.(6) The certificate of analysis and relevant dossiers issued by the inspection agency which must be recognized and accepted by SFDA,(7) Safety evaluation date on materials that maybe exist in the finished products which have the safety risk,(8) The letter of authority for the applicant in China (copy), which has been recorded by SFDA, and the business licence of the applicant in China (copy with official seal),(9) The letter of commitment that the raw material and the source of the raw material in production should meet the requirements of the restrictions or prohibitions in using high risk materials from bovine spongiform encephalopathy (BSE) disease areas,(10) The certificate of manufacturing and marketing from the country (region) which the products are manufactured or the country (region) of origin,(13) Additional dossiers which are conducive for the administrative licensing.1 unopened sample product from the market which is sealed by the inspection agency with license should be provided simultaneously. Thedetailed description about the application dossiers are set forth in Appendix 2.PART FOUR: The process flow diagram of administrative licensing of imported cosmeticPART FIVE: ChargeThere is no charge in administrative licensing of imported cosmetic by SFDAAppendix 1The detailed description about the application dossiers for administrative licensing of imported cosmetic for particular purpose1. The dossiers should be provided following the list,2.Fill out the application form under the instruction of the form notices, Application form for administrative licensing should be filled out by the manufacturing enterprises of imported cosmetic, or the authorizer of the manufacturing enterprises, or the authorized agency for the administrative licensing in China. Indications should be written in the seal place of the letter of assurance from manufacturing enterprises in case of no official seals.Letter of commitment in application form should be signed by the legal person of the authorized agency for the administrative licensing in China, or the authorizer of the legal person, with official seal on the letter.When signing in the power of attorney, a notarized copy and Chinese copy should be provided, the consistent of the Chinese copy with the original one should be notarized simultaneously. According to the requirements in Article 24 of “The Requirements Of The Application Dossiers For Administrative Licensing Of Cosmetic”(short for The Requirements Of The Dossiers), the original of the power of attorney and the notarized copy should be provided while the application, and a written explanation of the product’s name in the original of the power of attorney. The content of the signature in the power of attorney should not be contained by the content of the certificate of authorization from the applicant in China.3. The product formula should contain the confirmation of the formula issued by the inspection agency with license, and the date of the confirmation should be consistent with the application date.4. Requirements in quality control should contain the requirements conducted by the original manufacturer (foreign language and the Chinese copy), and a letter of commitment declaring the products meet the requirements in "Hygienic Standard for Cosmetics".5. In case of no product directions or directions printed on the containers (such as lipstick and lip rouges at compact size), the relevant explanation should be made in the Packaging Part.6. The certificate of analysis and relevant dossiers issued by the inspection agency which must be recognized and accepted by SFDA, or the certificate of analysis on SPF, PFA or PA value issued by abroad laboratory should meet the requirements as follows,1) Application form for inspection;2) Notification of acceptance for inspection;3) Direction of the product;4) Health & Safety testing report (microorganism, sanitary chemistry and toxicology);5) The dossiers as follows should be provided in case of existing:① Human safety testing report (skin patch test , human trials);② SPF、PFA or PA value reports;③ Additional reports (such as Asbestos inspection report).(2) The application dossiers containing SPF, PFA or PA value reports issued by abroad laboratory, the additional dossiers as follows should be provided simultaneously: 1) In case of that the laboratory has been recognized and accepted by SFDA, the authentication certificate should be provided; 2) In case of no authentication certificate, GCP certificate or GLP certificate should be provided; 3) Additional dossiers which are conducive for qualifying.In case of that the reports issued by abroad laboratory are provided for the first time, the original report, or the copy which is notarizedby the local embassy or relevant associations from the country (region) of manufacturer. The copy of the report would be allowed in there-application after having been recognized and accepted by SFDA.The original report issued by abroad laboratory should be provided. The original report of at least one product should be provided in case of series products, the copy ones of other products are allowed, and the product name in the original report should be pointed.The certificate of the relationship between the inspecting sample and the report issued by the relevant laboratory should be provided, while the report of abroad laboratory is provided in the application dossiers.In case of that the relationship between the inspecting sample and the report has been clearly stated in the report (such as the product name has been noted in the report, and the name of the sample is consistent with the product name), the certificate of above is needless.7. The certificate of manufacturing and marketing from the country (region) which the products are manufactured or the country (region) of origin should meet the requirements as follows,(1) The certificate should be issued by the regulatory authorities or relevant associations. The copy of the certificate is allowed in case of without the original l one. The copy of the certificate should be notarized by local embassy or the regulatory authorities.(2) The certificate should contain the name of product, name of manufacturer, name of the regulatory authority which issues the certificate, and the official seal or the signature of legal person (or authorizer) should be on the certificate.(3) The name of product and manufacturer should be consistent with the application dossiers. In case of contract manufacturing or other ways and that the name of manufacturer in certificate isn’t consistent with application dossiers, a written explanation from the applicant should beprovided. The certificate of manufacturing and marketing for the imported part of the product which containing various forms should be provided.(4) The certificate of manufacturing and marketing should be translated into Chinese in case of being foreign languages. And the Chinese copy should be notarized by notary public in China.8. The product belongs to the following situations, additional dossiers as follows should be provided simultaneously:(1) In case of contract manufacturing, additional dossiers are as follows,1) The protocol about contract manufacturing between the consignor and the consignee,2) For imported products, the certificate of QMS or GMP from the consignee, or the approved certificate of cosmetic manufacturing from the country (region) of manufacturer,3) The approved certificate of cosmetic manufacturing from the country (region) of manufacturer should meet the requirements as follows,① The certificate should be issued by regulatory authority or third parties, The copy of the certificate is allowed in case of without the original l one. The copy of the certificate should be notarized by local embassy or notary public.② The name and address of the manufacture should be consistent with the application dossiers.(2) In case of the manufacture (applicant) and the actual manufacture belong to a same company group, the certificate of the relationship and the quality assurance documents issued by the company group should be provided.9. In case of the product is manufactured by more than one enterprises, one of the manufacturers should provide the above application dossiers and additional dossiers as follows,(1)In case of contract manufacturing, the protocol about contract manufacturing should be provided. For imported products, the certificate of QMS or GMP from the consignee or the approved certificate of cosmetic manufacturing from the country (region) of manufacturer should be provided.(2) In case of the manufacturers belong to a same company group, the certificate of the relationship and the quality assurance documents issued by the company group should be provided.(3) The original packaging from other actual manufactures(4) Health & Safety inspection report (microorganism, sanitary chemistry) from other actual manufactures(5) The letter of commitment that the raw material and the source of the raw material in production should meet the requirements of the restrictions or prohibitions in using high risk materials from bovine spongiform encephalopathy (BSE) disease areas from other actual manufactures.10.In case of the product containing the forms of packaging as follows, the applications should be made as the following regulations,(1) One sample packaging contains more than two (including two) individually packaging, or separated samples (such as eye shadow, pressed powder, blush, etc.), and the application is made with one product name, the certificates of analysis and formulas of each separated products should be provided. Sample without individually packaging and separated samples, formulas of each parts and one certificate of analysis should be provided.(2) The Sample with a collective packaging which could not be split, the application is made with one product name, and the sample has varied raw materials & states of matter, the certificates of analysis and formulas for each product should be provided respectively.(3) In case of the product which contain more than two (including two) formulations, and must be used as a mixture, the application should be made for one product. According to whether the product with multiple formulations is used as a mixture or separated ones, the certificates of analysis for the mixture or each formulation should be provided.(4)In case of that the application of imported products are made by the same manufacturing enterprises, which contain more than two (including two) original packaging with the same foreign language name but different appearances, the description of the appearances should be added to the foreign language name column of the certificate of manufacturing & marketing and application form, while attached with relevant explanation.11.In case of that the sunscreen cosmetics with multiple series have a same basic formula, and make sampling inspection for testing SPF, PFA, PA value, the application is allowed to be made as one group of product. The application dossiers for each series should be attached with the name of each product in this series, basic formula, colorants list and sampling inspection list.12. In case of that the imported products which are manufactured by the enterprise abroad with a contract manufacturing from resident enterprise, the products are provide as homemade ones.Appendix 2The detailed description about the application dossiers for administrative licensing of imported cosmetic for non-particular purpose1. The dossiers should be provided following the list,2.Fill out the application form under the instruction of the form notices, Application form for administrative licensing should be filled out by the manufacturing enterprises of imported cosmetic, or the authorizer of the manufacturing enterprises, or the authorized agency for the administrative licensing in China. Indications should be written in the seal place of the letter of assurance from manufacturing enterprises in case of no official seals.Letter of commitment in application form should be signed by the legal person of the authorized agency for the administrative licensing in China, or the authorizer of the legal person, with official seal on the letter.When signing in the power of attorney, a notarized copy and Chinese copy should be provided, the consistent of the Chinese copy with the original one should be notarized simultaneously. According to the requirements in Article 24 of “The Requirements Of The Application Dossiers For Administrative Licensing Of Cosmetic”(short for The Requirements Of The Dossiers), the original of the power of attorney and the notarized copy should be provided while the application, and a written explanation of the product’s name in the original of the power of attorney. The content of the signature in the power of attorney should not be contained by the content of the certificate of authorization from the applicant in China.3. The product formula should contain the confirmation of the formula issued by the inspection agency with license, and the date of the confirmation should be consistent with the application date.4. Requirements in quality control should contain the requirements conducted by the original manufacturer (foreign language and the Chinese copy), and a letter of commitment declaring the products meet the requirements in "Hygienic Standard for Cosmetics".5. In case of no product directions or directions printed on the containers (such as lipstick and lip rouges at compact size), the relevant explanation should be made in the packaging part.6. The certificate of analysis and relevant dossiers issued by the inspection agency which must be recognized and accepted by SFDA should meet the requirements as follows,1) Application form for inspection;2) Notification of acceptance for inspection;3) Direction of the product;4) Health & Safety testing report (microorganism, sanitary chemistry and toxicology);5) The dossiers as follows should be provided in case of existing:① Human safety testing report (skin patch test , human trials);② Additional reports (such as Asbestos inspection report).7. The certificate of manufacturing and marketing from the country (region) which the products are manufactured or the country (region) of origin should meet the requirements as follows,(1) The certificate should be issued by the regulatory authorities or relevant associations. The copy of the certificate is allowed in case of without the original l one. The copy of the certificate should be notarized by local embassy or the regulatory authorities.(2) The certificate should contain the name of product, name of manufacturer, name of the regulatory authority which issues the certificate, and the official seal or the signature of legal person (or authorizer) should be on the certificate.(3) The name of product and manufacturer should be consistent with the application dossiers. In case of contract manufacturing or other ways and that the name of manufacturer in certificate isn’t consistent with application dossiers, a written explanation from the applicant should be provided. The certificate of manufacturing and marketing for the imported part of the product which containing various forms should be provided.(4) The certificate of manufacturing and marketing should be translated into Chinese in case of being foreign languages. And the Chinese copy should be notarized by notary public in China.8. The product belongs to the following situations, additional dossiers as follows should be provided simultaneously:(1) In case of contract manufacturing, additional dossiers are as follows,1) The protocol about contract manufacturing between the consignor and the consignee,2) For imported products, the certificate of QMS or GMP from the consignee, or the approved certificate of cosmetic manufacturing from the country (region) of manufacturer,3) In case of that the imported products are manufactured by the enterprise abroad with a contract manufacturing from resident enterprise, the power of attorney, certificates of manufacturing and marketing, and the original packaging would not be necessary, the packaging design should be provided.4) The certificate of QMS or GMP from the consignee, or the approved certificate of cosmetic manufacturing from the country (region) of manufacturer, should meet the requirements as follows,① The certificate should be issued by regulatory authority or third parties, The copy of the certificate is allowed in case of without the original l one. The copy of the certificate should be notarized by local embassy or notary public.② The name and address of the manufacture should be consistent with the application dossiers.(2) In case of the manufacture (applicant) and the actual manufacture belong to a same company group, the certificate of the relationship and the quality assurance documents issued by the company group should be provided.9. In case of the product is manufactured by more than one enterprises, one of the manufacturers should provide the above application dossiers and additional dossiers as follows,(1)In case of contract manufacturing, the protocol about contract manufacturing should be provided. For imported products, the certificate of QMS or GMP from the consignee or the approved certificate of cosmetic manufacturing from the country (region) of manufacturer should be provided.(2) In case of the manufacturers belong to a same company group, the certificate of the relationship and the quality assurance documents issued by the company group should be provided.(3) The original packaging from other actual manufactures(4) Health & Safety inspection report (microorganism, sanitary chemistry) from other actual manufactures(5) The letter of commitment that the raw material and the source of the raw material in production should meet the requirements of therestrictions or prohibitions in using high risk materials from bovine spongiform encephalopathy (BSE) disease areas from other actual manufactures.10.In case of the product containing the forms of packaging as follows, the applications should be made as the following regulations,(1) One sample packaging contains more than two (including two) individually packaging, or separated samples (such as eye shadow, pressed powder, blush, etc.), and the application is made with one product name, the certificates of analysis and formulas of each separated products should be provided. Sample without individually packaging and separated samples, formulas of each parts and one certificate of analysis should be provided.(2) The Sample with a collective packaging which could not be split, the application is made with one product name, and the sample has varied raw materials & states of matter, the certificates of analysis and formulas for each product should be provided respectively.(3) In case of the product which contain more than two (including two) formulations, and must be used as a mixture, the application should be made for one product. According to whether the product with multiple formulations is used as a mixture or separated ones, the certificates of analysis for the mixture or each formulation should be provided.(4)In case of the imported products made application by the same manufacturing enterprises, which contain more than two(including two) original packaging with the same foreign language name but different appearances, the description of the appearance should be added to the foreign language name column of the certificate of manufacturing & marketing and application form, while attached with relevant explanation.11.In case of that the sunscreen cosmetics with multiple series have a same basic formula, and make sampling inspection for testing SPF, PFA,PA value, the application is allowed to be made as one group of product. The application dossiers for each series should be attached with the name of each product in this series, basic formula, colorants list and sampling inspection list.12.In case of that imported products are manufactured by the enterprise abroad with a contract manufacturing from resident enterprise, the products are provide as homemade ones.Appendix 3Cosmetics for particular purpose classification1. Cosmetics for nurturing hair;2. Cosmetics for hair color（permanent or temporary）;3. Cosmetics for depilation4. Cosmetics for breast,5. Cosmetics for bodybuilding (including for losing weight)6. Cosmetics for deodorization7. Cosmetics for dispeling freckle,8. Cosmetics for sunscreen,9. Cosmetics for perm or straight hair.。