Product Compliance
Test/Filing/Registration
Product Compliance
Test/Filing/Registration
This guide is applicable to the application and handling of the filing of imported non special purpose cosmetics in Shenzhen Qianhai Shekou area of Guangdong pilot free trade zone.
Filing of imported non special purpose cosmetics
Item name First filing Filing change Record cancellation
1. Circular of the State Council on promoting License separation Opinions on reform pilot work Guofa 2017 45number
2. Announcement of the General Administration on matters related to the pilot implementation of the filing administration of imported non special purpose cosmetics on a larger scale 2018Year31number
3. Food and Drug Administration On Issuing the procedures for the filing management of imported cosmetics for non special purposes in Pudong New Area of Shanghai provisional Announcement of 2017Year10number
Guangdong food and drug administration is responsible for filing management
Whether the filed products belong to the scope of filing Whether the filing materials are complete Whether the filing materials comply with the specified form, etc.
Meeting the filing requirements,Put on record.The domestic responsible person may hold the filing information certificate generated by the filing system of the former State Food and Drug Administration and the data receiving form issued by the food and drug regulatory department of Guangdong Province,Go to relevant departments to go through import related procedures in accordance with regulations.The product filing information is on the filing information system of imported non special purpose cosmetics of the former State Food and drug administration http://ft.zybh.gov.cn/province/webquery/list.jsp publish.
It is imported from the port of Shenzhen Qianhai Shekou area of Guangdong pilot free trade zone,The domestic responsible person of the overseas production enterprise is registered in the first import of non special purpose cosmetics in Shenzhen Qianhai Shekou area of Guangdong pilot free trade zone.
An enterprise legal person authorized by an overseas cosmetics manufacturer to register in Shenzhen Qianhai Shekou area of Guangdong pilot Free Trade Zone shall apply for product filing as a domestic responsible person,The user name shall be registered through the filing system first,And get the password.
one First filing
1 The product belongs to the scope of filing
2 Complete filing data
3 The filing data shall conform to the specified form
4 The electronic version of the record data is consistent with the paper version.
two Product change
For imported non special purpose cosmetics that have obtained the filing information certificate, change the relevant information.
three Record cancellation
The registered products are no longer imported from the port of Shenzhen Qianhai Shekou area of Guangdong pilot free trade zone.
No limit on the number of records.
one Catalogue and requirements of filing application materials
Serial number | Name of submission | requirement |
1 | Application form for filing imported non special purpose cosmetics | Print the paper application form after filling in the application form online,And sign as required Seal.The content shall be complete clear,No alteration is allowed |
2 | Product Chinese name naming basis | The Chinese name of the product shall comply with Cosmetic naming regulations Cosmetic nomenclature Guide Requirements. 1 The trademark name of the declared product shall be provided in the naming basis Common name Including purpose or part of use Explanation of specific meaning of attribute name.Conventional The commonly used name of cosmetics can be omitted Attribute name. 2 If any in the Chinese name of the product indicates the physical properties or appearance and color of the product Color number smell Applicable hair quality Skin type or specific population,It should be explained. 3 If the name of specific raw materials or words indicating the category of raw materials are used in the Chinese name of the product,It should be explained. 4 Modification in Chinese product name Adjectives or must use foreign letters Symbols, etc,It should be explained. 5 The Chinese Pinyin name of the Chinese name of the product shall be marked. |
3 | Product formula | Product formula requirements reference Notice on printing and distributing the provisions on accepting the application for administrative license of cosmetics State Food and Drug Administration 2009 856number enclosure Requirements for application materials of cosmetics administrative license Article 14 Article 26 execution. |
4 | Product quality and safety control requirements | It shall include product quality and safety control requirements implemented in the country of origin Foreign version and Chinese Translation And product compliance Safety technical specification for cosmetics 2015Annual Edition Required commitment. |
5 | Product packaging picture | Original product packaging Including product label Product specification picture To be specially designed for the Chinese market,Product design and packaging shall be submitted at the same time(Including product label Product specification). |
6 | Brief description of product production process | The brief description of production process provided shall include process flow diagram,The process description shall be able to reflect the actual production process of the product concisely and concisely,Including operation steps Raw materials involved in each step, etc.All raw materials in the product formula shall be listed in the production process,The name of raw materials shall be consistent with the product formula.The process description shall be consistent with the process diagram. |
7 | Product technical requirements | reference Notice on printing and distributing specifications for technical requirements of cosmetic products State Food and Drug Administration 2010 454number Required preparation. |
8 | Inspection report and relevant materials issued by cosmetics administrative licensing inspection agency | 1 Product inspection requirements refer to Notice on printing and distributing the administrative measures for the inspection of cosmetics administrative license State Food and Drug Administration 2010 82number implement. 2 Inspection report requirements refer to Notice on printing and distributing the provisions on accepting the application for administrative license of cosmetics State Food and Drug Administration 2009 856number enclosure Requirements for application materials of cosmetics administrative license Article 18 execution. |
9 | Relevant safety assessment data of substances that may have safety risks in the product | reference Guidelines for risk assessment of possible safety risks in cosmetics State Food and Drug Administration 2010 339number implement. |
10 | Letter of commitment that the applicable raw materials and raw material sources of cosmetics meet the requirements of prohibition and restriction of high-risk substances in mad cow disease epidemic area | reference Announcement of the health supervision center of the Ministry of health on requiring the submission of a letter of commitment for imported cosmetics implement. |
11 | Products in the producing country region Or country of origin region Supporting documents for production and sales | Production and sales documentation requirements refer to Notice on printing and distributing the provisions on accepting the application for administrative license of cosmetics State Food and Drug Administration 2009 856number enclosure Requirements for application materials of cosmetics administrative license Article 21 Article 24 implementation. |
12 | Relevant certification materials for production quality management of overseas production enterprises | Relevant certification materials include the certification documents of quality management system or good production practices or the country where the manufacturer is located region Certification documents of cosmetics production qualification required by laws and regulations.The supporting documents shall be issued or approved by the certification authority or a third party.The original cannot be submitted,Copies may be submitted,The copy shall be notarized by a Chinese notary organ or by a Chinese envoy collar Museum confirmation The name and address of the manufacturer specified shall be completely consistent with the contents declared. |
13 | Other materials helpful for filing | reference Provisions on acceptance of cosmetic administrative license application State Food and Drug Administration 2009 856number,Other materials that may be helpful for filing. |
two Formal standard
The electronic data shall be submitted through the filing information system of imported non special purpose cosmetics of the former State Food and drug administration,And must comply with the relevant requirements of the system description.
Paper filing materials shall be submitted to the acceptance window of Guangdong food and drug regulatory department,The following requirements shall be met:
Except inspection report Notarial document In addition to official documents and third-party documents,The original application materials shall be stamped with the official seal or cross seal page by page by the domestic responsible person.
2 useA4Size paper printing,Use clear distinguishing signs,Arrange in the specified order,And bound into a volume.
3 Use Chinese legal units of measurement.
4 The declaration contents shall be complete clear,The filling of the same item shall be consistent.
5 All foreign languages(Overseas address website Registered trademark Except that the patent name must be in a foreign language)Shall be translated into standard Chinese,The translation shall be attached to the corresponding foreign language materials.
6 Re declaration after termination of declaration,The reasons for termination and re declaration shall also be stated Failing to report again after filing,A copy of the decision not to file shall be submitted,And explain the reasons for re declaration,At the same time, a written explanation on whether the reasons for not filing involve product safety shall also be submitted.
7 Production and sales supporting documents Supporting documents of quality management system or good production practice Proof that production enterprises in different countries belong to the same group company Supporting documents such as entrusted processing agreement can list multiple products at the same time.If these products are declared at the same time,One product uses the original,Copies can be used for other products,And specify in writing the name of the declared product where the original is located If these products are not declared at the same time,One product uses the original,Notarized copies shall be used for other products,And specify in writing the name of the declared product where the original is located.
three Name of application document
Application form for filing imported non special purpose cosmetics ,Print after online filling.
If the filing materials meet the requirements, they shall be filed on the spot.
Registration information certificate of imported non special purpose cosmetics ,Online printing after filing.
There is no charge for this filing project
1 Online receiving
The electronic filing data shall be received by the filing information system of imported non special purpose cosmetics of the former State Food and drug administration.The domestic responsible person shall act in accordance with the appendix of these guidelines2Handle the user name registration of the filing system in accordance with the provisions of,After receiving the user name and initial password of the filing system,On the government website of the former State Food and Drug Administration website http://ft.zybh.gov.cn/enterprise/index.jsp Submit electronic filing materials.
2 Window reception
Paper filing materials shall be received by the filing acceptance window of imported non special purpose cosmetics of Guangdong food and drug administration.
Receiving address Guangdong pilot free trade zone Shenzhen Qianhai Shekou area QianhaieComprehensive acceptance window of station communication service center
Telephone 0755-88988988
two Receiving time
Monday to Friday morning9:00-12:00,afternoon14:00-18:00 Except holidays
1 Business description
1 Handling link apply receive to examine to review confirm
2 Review method Online review
2 Applicable situation
It is applicable to the filing of imported non special purpose cosmetics for the first time
1 Business description
1 Handling link apply receive to examine to review confirm
2 Review method Online review
2 Applicable situation
It is applicable to the change of information after the filing of imported non special purpose cosmetics Except for product formula .
1 Business description
1 Handling link apply receive to examine to review confirm
2 Review method Online review
2 Applicable situation
It is applicable to non special purpose cosmetics to be imported from the port of Shenzhen Qianhai Shekou area of Guangdong pilot free trade zone,Cancellation of product filing.
thirteen Public decision
Publish the filing information on the filing information system of imported non special purpose cosmetics of the former State Food and drug administration.
appendix1 Schematic diagram of work flow
appendix2
Registration of user name of filing system
The domestic responsible person shall report the import of cosmetics for non special purposes for the first time before filing,The following materials shall be submitted through the filing system for user registration
one Stamped with the official seal of the domestic responsible person Application for registration of user name of import non special purpose cosmetics filing management system signed by its person in charge
two Power of attorney and notarized copy of overseas production enterprise to domestic responsible person,The power of attorney is in a foreign language,It should also be translated into Chinese,And notarize the consistency between the translation and the original
three Business license of domestic responsible person.
After the system is approved,The domestic responsible person shall hold the paper-based materials consistent with the electronic version to the receiving address of the paper-based filing materials in this service guide to receive the user name and initial password of the filing system.
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