2017年进口化妆品申报资料详细解析

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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。

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。

进口化妆品卫生行政许可证办理流程和资料要求

进口化妆品卫生行政许可证办理流程和资料要求本页仅作为文档封面，使用时可以删除This page is only the cover as a document 2021year进口化妆品卫生行政许可证办理流程和资料要求化妆品，是我们生活中必不可缺少的东西。

不管男女老少，都有擦“宝宝霜”的时候。

现如今，我国经济发展快速，与其他国家的经济往来也加多了，许多进口化妆品也出现在我们的生活中。

凡境外化妆品进入中国市场必须持有国家食品药品监督管理总局颁发的进口化妆品卫生许可(备案凭证)批件方可在中国市场上销售。

申请药监局卫生许可批件首先到卫生部认定的卫生检验机构进行产品的卫生安全性检验。

检验完毕后，准备申请材料。

然后评审，颁发备案凭证或者许可批件。

最后上市销售。

目前，我国对进口化妆品实行申报审核制度。

进口化妆品要有“三证”，即进口化妆品三证：第一证是国家食品药品监督管理总局颁发的进口化妆品批件，即《进口非特殊用途化妆品备案凭证》或《进口特殊用途化妆品批件》；《进口非特殊用途化妆品备案凭证》一、受理机构国家食品药品监督管理局行政受理服务中心二、首次申请报送材料目录（一）进口非特殊用途化妆品备案申请表；（二）产品配方；（三）产品质量标准；（四）经卫生部认定的检验机构出具的检验报告及相关资料，按下列顺序排列：1.检验申请表；2.检验受理通知书；3.产品说明书；4.卫生学（微生物、理化）检验报告；5.毒理学安全性检验报告。

（五）产品原包装（含产品标签）。

拟专为中国市场设计包装上市的，需同时提供产品设计包装（含产品标签）；（六）产品在生产国（地区）或原产国（地区）允许生产销售的证明文件；（七）来自发生“疯牛病”国家或地区的进口化妆品，应按要求提供官方检疫证书；（八）代理申报的，应提供委托代理证明；（九）可能有助于评审的其它资料。

以上资料原件1份，另附未启封的样品1件。

三、多个原产国（地区）生产同一产品可以同时申报，其中一个原产国生产的产品按以上规定提交全部材料外，还须提交以下材料（一）不同国家的生产企业属于同一企业集团（公司）的证明文件；（二）企业集团出具的产品质量保证文件；（三）原产国发生“疯牛病”（四）其他原产国生产产品原包装；（五）其他原产国生产产品的卫生学（微生物、理化）检验报告。

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；

进口化妆品注册申报备案实操详解(李娜)

以上9家单位为化妆品卫生安全检验机构，承担《化妆品卫生行政许可检验规定》规定的全部微生物、卫生化学和毒理学检验项目。2009年1月1日起接收新确定的几家省级疾控的实验报告。
天健华成
化妆品检验机构的确定（二）
• • • • • 中国人民解放军空军总医院上海市皮肤病性病医院中山大学附属第三医院四川大学华西医院中国医科大学附属第一医院
进口化妆品进口化妆品SFDA申报详解化妆品申报详解
北京天健华成国际投资顾问有限公司化妆品业务总监李娜
天健华成
境外生产化妆品进口大陆操作流程
SFDA申报《进口化妆品卫生许可批件（备案凭证）》检验检疫局中文标签标识备案
天健华成
天健华成
化妆品检验机构的确定（一）
• • • • • • • • • 中国疾病预防控制中心环境与健康相关产品安全所广东省疾病预防控制中心上海市疾病预防控制中心北京市疾病预防控制中心辽宁省疾病预防控制中心江苏省疾病预防控制中心浙江省疾病预防控制中心四川省疾病预防控制中心湖北省疾病预防控制中心
天健华成
关于“疯牛病”有关问题的承诺书
1. 根据二00七年九月五日《卫生部卫生监督中心关于要求对进口化妆品提交承诺书的公告》 2. 承诺书须用原件，复印无效；一次可承诺多个产品；产品名称填写必须与申报产品名称一致，包括进口产品的外文名称。
天健华成
天健华成
申报程序所要涉及的部门机构及其职能
产品检验递交SFDA审核涉及的机构
1、检测机构； 1 2、受理办公室 3、评审委员会 4、行政审批部门。
天健华成
进口化妆品分类及其检测、申报程序的比较
进口化妆品分别包括非特殊（普通）化妆品及特殊用途化妆品。

进口化妆品申报资料及要求英文版

进口化妆品申报资料及要求英文版PART 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, theintended 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.。

2017版进口特殊化妆品备案变更

2017版进口特殊化妆品备案变更一、申报资料清单(一)化妆品行政许可变更申请表；(二)化妆品行政许可批件(备案凭证)原件；(三)代理申报的，应提交已经备案的行政许可在华申报责任单位授权书复印件及营业执照复印件并加盖公章；(四)根据申请变更的内容分别提交下列资料：1、产品名称的变更：(1)申请变更产品中文名称的，应在变更申请表中说明理由，并提交拟变更的产品中文名称命名依据及拟变更的产品设计包装(含产品标签、产品说明书)；进口产品外文名称不得变更；(2)申请变更防晒产品SPF、PFA或PA值的，应当提交相应的SPF、PFA或PA值检验报告，并提交拟变更的产品设计包装(含产品标签、产品说明书)。

2、生产企业名称、地址的变更(包括自主变更或被收购合并)：(1)进口产品生产企业名称或地址变更，应当提交生产国政府主管部门或有关机构出具的相关证明文件，其中，因企业间的收购、合并而提出合法变更生产企业名称的，也可提交双方签订的收购或合并合同的复印件，证明文件需翻译成规范中文，中文译文应有中国公证机关的公证；(2)涉及改变生产现场的，应提交拟变更的生产企业产品的卫生学(微生物、卫生化学)检验报告。

3、进口产品生产企业中文名称的变更(外文名称不变)：(1)生产企业中文名称变更的理由；(2)拟变更的产品设计包装(含产品标签、产品说明书)。

4、行政许可在华申报责任单位的变更：(1)先提交拟变更的行政许可在华申报责任单位授权书原件备案；(2)拟变更的行政许可在华申报责任单位授权书复印件；(3)行政许可在华申报责任单位名称或地址变更，应提交当地工商行政管理部门出具的变更证明文件原件或经公证的复印件；(4)生产企业出具的撤销原行政许可在华申报责任单位的情况说明并经公证机关公证。

5、实际生产企业的变更：(1)涉及委托生产加工关系的，提交委托生产加工协议书，进口产品还应提交被委托生产企业质量管理体系或良好生产规范的证明文件或符合生产企业所在国(地区)法规要求的化妆品生产资质证明文件；(2)生产企业属于同一集团公司的，提交生产企业属于同一集团公司的证明文件及企业集团公司出具的产品质量保证文件；(3)拟变更的实际生产企业生产的产品原包装；(4)拟变更的实际生产企业生产产品的卫生学(微生物、卫生化学)检验报告；(5)实际生产企业生产产品所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。

首次进口化妆品备案注册申报资料检查标准之包装、标签、说明书篇

首次进口化妆品备案注册申报资料检查标准之包装、标签、说明书篇按照NMPA对进口化妆品备案注册申报资料的要求,申报产品应当提供国外市售产品原包装（含产品标签、产品说明书），并如实翻译为规范的中文。

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）。

产品申报内容应与外文标签、说明书上使用方法、使用人群和使用部位等相符合。

北京天健华成国际投资顾问有限公司化妆品注册部（）在实际申报工作中发现,这部分资料出现的问题仍然不容小觑。

比如包装中外文翻译的不一致、包装标签上的成分信息与配方有出入等，都是申报被驳回的因素。

（一）产品原包装（含产品标签、产品说明书）1．产品外包装配方成分需要在产品外包装中文翻译中完整翻译。

申报产品配方组分不得与原包装（含产品标签、产品说明书）标注的原料不相符（特殊情况除外）。

2．申报产品不得改变其适用人群。

3．申报产品不得改变使用部位、使用方法等涉及安全性内容。

4．原包装（含产品标签、产品说明书）显示有内置说明书的，申报资料中应有内置说明书。

5．原包装（含产品标签、产品说明书）中如有产品中文名称的，申报产品中文名称应与其相符。

申报资料中产品中文名称与产品原包装中文名称不相符的，应在中文标签、说明书中标注“原包装中文名称×××为×××地区销售的名称”。

6．除注册商标以及必须使用外文字母、符号的信息外，产品原包装（含产品标签、产品说明书）所标注的内容应全部译为正确、规范的中文。

审核以产品中文包装（含产品标签、产品说明书）为准。

必要时，参考产品原包装（含产品标签、产品说明书）的内容。

（1）原包装（含产品标签、产品说明书）标注“祛痘、除螨、抗粉刺、预防或不引起粉刺”等相关内容的，申报时应提供抗生素和甲硝唑项目检测报告。

（2）发用类产品原包装（含产品标签、产品说明书）标注“去屑”用途的，申报时应提供去屑剂项目检测报告。

进口化妆品备案申报流程解读

进口化妆品备案申报流程解读什么是化妆品?目前国际上对化妆品的概念尚没有统一定义。

欧盟现行的《化妆品规程》中定义化妆品是接触于人体外部器官（表皮、毛发、指趾甲、口唇和外生殖器），或者口腔内的牙齿和口腔黏膜，以清洁、发出香味、改善外观、改善身体气味或保护身体使之保持良好状态为主要目的的物质和制剂。

美国食品和药品管理局对化妆品的定义是：用涂抹、散布、喷雾或者其他方法使用于人体的物品，能够起到清洁、美化，促使有魅力或改变外观的作用。

日本对化妆品的定义是：为了清洁和美化人体、增加魅力、改变容貌、保持皮肤及头发健美而涂抹、散布于身体或用类似方法使用的物品，是对人体作用缓和的物质。

我国《化妆品卫生规范》（2007年版）中将化妆品定义为：以涂擦、喷洒或其他类似的方法，散布于人体表面任何部位（皮肤、毛发、指甲、口唇等），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产品。

这个定义从化妆品的使用方式、施用部位以及化妆品的使用目的三个方面进行了较为全面的概括。

虽然各国对化妆品的定义不尽相同，但大同小异，没有本质的区别。

同时需要特别指出的是，化妆品的作用部位是人体表面，包括皮肤表面、毛发表面及指甲表面等部位，市面上销售或者一些美容机构使用的玻尿酸（皮下注射用）、美白针、肉毒杆菌素等均不属于化妆品范畴。

我国对化妆品按使用功能分为两大类进行管理，即特殊用途化妆品和非特殊用途化妆品（普通化妆品）两大类。

其中非特殊用途化妆品包括：清洁类化妆品（如洗面奶、洗发水、沐浴露等）、护理类化妆品（如化妆水、润肤乳液等），以及美容类化妆品（如眼影、胭脂、口红等）。

特殊用途化妆品包括：育发、染发、烫发、脱毛、美乳、健美、除臭、祛斑及防晒作用的9类化妆品。

什么是化妆品申报?一款的化妆品要想合法进行生产/进口和销售，必须先进行化妆品申报，否则即为非法。

那么究竟什么是“化妆品申报”呢？所谓“化妆品申报”指的就是取得化妆品备案/批准文号的过程。

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。

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详解

– 认定的检验机构（传统3家）负责申请注册的化妆品样品检测。
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贰立法情况
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▪立法情况
一、行政规章和规范性文件
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▪ 主要行政规章和规范性文件有：《化妆品卫生监督条例》及其实施细则《化妆品生产企业卫生规范》《化妆品卫生规范》《化妆品广告管理办法》《进出口化妆品监督检验管理办法》
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化妆品检验机构的确定（一）
▪ 中国疾病预防控制中心环境与健康相关产品安全所 ▪ 广东省疾病预防控制中心 ▪ 上海市疾病预防控制中心 ▪ 北京市疾病预防控制中心 ▪ 辽宁省疾病预防控制中心 ▪ 江苏省疾病预防控制中心 ▪ 浙江省疾病预防控制中心 ▪ 四川省疾病预防控制中心 ▪ 湖北省疾病预防控制中心
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叁审批流程、周期及费用
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▪审批流程、周Βιβλιοθήκη 及费用一、申请与审批流程Page ▪ 25
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第一步：检验（对应：认定的检验机构）
需准备材料： 1.检验申请表 2.产品配方表（ INCI全成分，百分比顺序）2份 3.产品说明书（中文）2份 4.样品 5.检测费样品量按照产品的规格及所申请的功能有所不同。普通产品
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肆重点申请材料解析
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一、申报资料的一般要求
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（一）首次申请化妆品行政许可的，提交原件1份、复印件4 份，复印件应清晰并与原件一致；（二）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；

进口化妆品申报综合指南

进口化妆品申报综合指南一、前言进口化妆品申报是指在国内市场销售的进口化妆品必须经过国家相关机构的审批和备案。

本指南旨在帮助企业了解进口化妆品申报的流程和要求，以便更加顺利地开展进口化妆品业务。

二、进口化妆品申报的分类根据中国的法规和标准，进口化妆品申报可分为以下几个类别：1.一般化妆品2.特殊用途化妆品3.非特殊用途化妆品4.儿童化妆品5.有害物质禁限用化妆品不同类别的化妆品在申报时需要提供的材料和要求也有所不同，企业在准备材料时需根据具体情况进行分类并提供相应材料。

三、进口化妆品申报流程进口化妆品申报的流程主要包括以下几个步骤：1.企业备案2.原料文件准备3.表格填写4.申报材料提交5.监测报告6.生产地址审核7.审核结果公示8.许可证领取3.1 企业备案在申报进口化妆品之前，企业需要按照相关法规和标准在国家相关机构进行备案。

备案的主要内容包括企业的基本信息、业务范围、生产工艺、质量管理体系等。

只有通过备案，企业才能正式进行化妆品申报。

3.2 原料文件准备根据申报的具体分类，企业需要准备相应的原料文件。

原料文件包括化妆品原料的成分表、质量标准、安全评估报告等。

这些文件是申报过程中非常重要的一部分，必须提供真实准确的信息，并确保原料符合相关法规和标准的要求。

3.3 表格填写申报进口化妆品时，企业需要填写相关的表格，表格中包含了申报所需的各种信息。

企业需要根据自身情况填写表格，并确保填写的信息准确完整。

表格的填写通常涉及到产品信息、企业信息、原料信息、生产工艺等方面的内容。

3.4 申报材料提交根据填写的表格，企业需要整理好所有申报所需的材料，并按照相关要求进行提交。

申报材料的提交通常需要以电子形式进行，企业需要遵守相关规定，按照要求的格式和要素进行提交。

3.5 监测报告提交申报材料后，国家相关机构会对申报的化妆品进行监测。

监测的目的是确定申报产品的安全性和合规性。

监测报告的结果将直接影响到进口化妆品的审批进程，企业需要密切关注监测报告，并做好与监测机构的沟通和配合。

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。

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。

进口化妆品申报资料及要求英文版

进口化妆品申报资料及要求英文版PART 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, theintended 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.。

2017版化妆品备案的难点重点分析

2017版化妆品备案的难点重点分析D的市售包装。

包装内应含产品说明书。

没有说明书的产品（如体积过小的口红、唇膏等）或将说明书内容印制在产品本身上的产品，应按照《消费品使用说明化妆品通用标签》的规定标明基本信息，包括使用方法、注意事项、警示用语等。

产品企业声明无内置说明书，但产品包装上标识有说明书，属于申报不实，该产品不予批准。

根据《行政许可法》有关规定，产品申报不实，可追加该企业一年内不允许申报产品的行政处罚。

2、进口产品包装须修改的，必须按修改意见重新印刷符合中国法律、法规要求的包装，不得用外文包装粘贴、覆盖等方式送审或上市。

3、送审样品的标签内容应与申报材料中的相关信息一致，如送检样品批号、生产日期、标签说明书的基本内容等。

4、进口产品送审材料和样品外包装标签上出现“医药、药用”等字样，需删除并重新设计产品包装。

5、关于已有评审结论的产品，原则上不允许改变该产品的使用人群、使用部位、使用方法等。

二、产品配方（一）配方总体要求1、配方必须有产品名称，进口产品必须有中文（译）名。

产品配方包括：原料INCI名称（进口产品）、标准中文名称、使用目的、百分含量。

上述内容应包含于同一配方表格中，字体不得小于小5号宋体字。

国产产品配方以生产能力审核环节已备案配方为准。

2、配方应包括产品生产过程中加入的所有原料，包括复配原料中为保护原料而加入的稳定剂、pH 调节剂、抛射剂等。

配方中的原料应为所使用原料的全部，植物提取物应写明具体名称并列入配方中。

3、配方中的所有原料应注明其在配方中的使用目的和准确的加入量，原料含量不得以范围表示，并按含量递减的顺序排列。

特殊情况，如有效物含量非百分之百、含结晶水及存在多种分子结构等应详细标明，有效物含量未标明者一律以100%计。

原料的使用目的应根据该原料在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、全部复配原料应以复配方式在配方中申报，并注明全部复配原料的比例（以百分含量表示）。

进口非特殊用途化妆品备案

进口非特殊用途化妆品备案
一、适用范围
本指南适用于以备案方式从中国（辽宁）自由贸易试验区口岸进口，且境内责任人注册地在中国（辽宁）自由贸易试验区沈阳、大连、营口片区的首次进口非特殊用途化妆品的备案申请与办理。

二、事项名称
1.事项名称：进口非特殊用途化妆品备案
2.子项名称：首次备案、备案变更、备案注销
三、办理依据
1.《国务院关于在更大范围推进“证照分离”改革试点工作的意见》（国发〔2017〕45号）
2. 国家食品药品监督管理总局《关于在更大范围试点实施进口非特殊用途化妆品备案管理有关事宜的公告》（2018年第31号）
3.《辽宁省行政审批制度改革工作领导小组办公室关于对<首次进口非特殊用途化妆品行政许可>实施备案管理的决定》（辽审改办发〔2018〕17号）
四、备案机构
附件2
委托书
：
我单位作为授权的进口非特殊用途化妆品境内责任人，现委托我单位以下人员办理进口非特殊用途化妆品备案相关事宜，代表我单位：
□办理系统用户名及密码申领；□办理进口非特殊用途化妆品备案资料递交，共件。

姓名：性别：身份证号码
工作单位：
职务：手机：
委托权限：□提交和接收备案相关文书；□接受询问。

代理期限：年月日
境内责任人：
（公章）
年月日
被委托人（签字）：
年月日。

关于进口化妆品境内收货人备案、进口记录和销售记录管理规定（2017）

‎‎‎‎‎‎关‎于进口‎化妆品‎境内收‎货人备‎案、进‎口记录‎和销售‎记录管‎理规定‎（20‎17）‎进口‎化妆品‎境内收‎货人备‎案、进‎口记录‎和销售‎记录管‎理规定‎第一‎章总‎则‎第一条‎为加‎强进口‎化妆品‎的溯源‎管理，‎保障进‎口化妆‎品质量‎安全，‎根据《‎中华人‎民共和‎国进出‎口商品‎检验法‎》及其‎实施条‎例、《‎化妆品‎卫生监‎督条例‎》及其‎实施细‎则、《‎国务院‎关于加‎强食品‎等产品‎安全监‎督管理‎的特别‎规定》‎和《进‎出口化‎妆品检‎验检疫‎监督管‎理办法‎》等法‎律、法‎规及部‎门规章‎的规定‎，制定‎本规定‎。

‎‎第二条‎本规‎定适用‎于进口‎化妆品‎境内收‎货人(‎以下简‎称收货‎人)的‎备案、‎进口记‎录和销‎售记录‎(以下‎简称‎进口和‎销售记‎录 )‎管理，‎以及为‎完成进‎口和销‎售记录‎所必需‎的生产‎经营信‎息记录‎的监督‎管理;‎其中进‎口记录‎是指收‎货人记‎载化妆‎品及其‎相关进‎口信息‎的纸质‎或者电‎子文件‎，销售‎记录是‎指记载‎收货人‎将进口‎化妆品‎提供给‎化妆品‎经营者‎的纸质‎或者电‎子文件‎。

‎‎第三条‎国家‎质检总‎局主管‎收货人‎备案的‎监督管‎理工作‎。

国家‎质检总‎局设在‎各地的‎出入境‎检验检‎疫机构‎(以下‎简称检‎验检疫‎机构)‎负责收‎货人备‎案申请‎的受理‎、备案‎资料信‎息审核‎。

进口‎化妆品‎结关地‎检验检‎疫机构‎负责进‎口化妆‎品的进‎口和销‎售记录‎的监督‎管理工‎作。

‎‎第四‎条收‎货人应‎当建立‎完善的‎化妆品‎进口和‎销售记‎录制度‎并严格‎执行。

‎‎第‎二章‎进口化‎妆品境‎内收货‎人备案‎第五‎条收‎货人应‎当向其‎工商注‎册登记‎地检验‎检疫机‎构申请‎备案，‎并对所‎提供备‎案信息‎的真实‎性负责‎。

‎‎第六条‎收货‎人可于‎化妆品‎进口前‎申请备‎案。

申‎请备案‎须提供‎以下材‎料：中‎华人民‎共和国‎进出口‎商品检‎验法》‎及其实‎施条例‎、《化‎妆品卫‎生监督‎条例》‎及其实‎施细则‎、《国‎务院关‎于加强‎食品等‎产品安‎全监督‎管理的‎特别规‎定》和‎《进出‎口化妆‎品检验‎检疫监‎督管理‎办法》‎等法律‎、法规‎及部门‎规章的‎规定，‎制定本‎规定。