进口化妆品申报资料及要求 英文版(XXXX年新版)

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。

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
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。

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
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。

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。