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Required documents and process timeliness for the registration certificate of imported non-special use cosmetics

Article editor: PengHai International Reading:127 Time:2020-10-27

Catalogue and requirements of filing application materials

Serial number

name

Require

1

Imported non-special use cosmetics filing application form

After filling in the application form online, print the paper application form, sign and seal as required. The content should be complete and clear, and must not be altered

2

Product Chinese name naming basis

The Chinese name of the product should meet the requirements of the "Regulations on Naming Cosmetics" and "Guidelines for Naming Cosmetics".

1) In the naming basis, an explanation of the specific meaning of the brand name, common name (including purpose of use or part of use), and attribute name of the declared product should be provided. The common name and attribute name can be omitted for the customary and customary cosmetic names.

2) If the Chinese name of the product indicates the physical properties or appearance of the product, as well as the color, color number, smell, applicable hair quality, skin quality or specific people, it should be explained.

3) If specific raw material names or vocabulary indicating raw material categories are used in the Chinese name of the product, it should be explained.

4) Modifications, adjectives, or foreign letters, symbols, etc. in the Chinese name of the product should be explained.

5) The Chinese pinyin name of the product must be marked.

3

product ingredients

The product formulation requirements shall be implemented in accordance with Article 14 and Article 26 of the "Notice on Printing and Distributing the Provisions on the Acceptance of Cosmetic Administrative License Application" (Guo Food and Drug Administration [2009] No. 856) appendix "Document Requirements for Cosmetic Administrative License Application".

4

Product quality and safety control requirements

It should include 1. The product quality and safety control requirements (foreign language version and Chinese translation) implemented in the country of origin and 2. Commitment that the product meets the requirements of the "Cosmetics Safety Technical Specification" (2015 version).

5

Product packaging picture

Pictures of the original product packaging (including product labels and product manuals); if you plan to design packaging specifically for the Chinese market, you must submit the product design packaging (including product labels and product manuals) at the same time.

6

Brief description of product production process

The production process brief provided should include a schematic diagram of the process flow, which should be able to concisely reflect the actual production process of the product, including the operating steps and the raw materials involved in each step. All raw materials in the product formula should be listed in the production process, and the name of the raw materials should be consistent with the product formula. The process description should be consistent with the process diagram.

7

Product technical requirements

Compile with reference to the "Notice on Printing and Distributing Technical Requirements and Specifications for Cosmetic Products" (Guo Shi Yao Jian Xu [2010] No. 454).

8

The inspection report and related materials issued by the cosmetics administrative license inspection agency

1) Product inspection requirements shall be implemented in accordance with the "Notice on Printing and Distributing the Administrative Measures for the Administration of Cosmetics Administrative License Inspection" (National Food and Drug Administration [2010] No. 82).


2) The inspection report requirements shall be implemented in accordance with Article 18 of the "Notice on Printing and Distributing the Provisions on Acceptance of Cosmetic Administrative License Application" (Guo Shi Yao Jian Xu [2009] No. 856) Annex "Document Requirements for Cosmetic Administrative License Application".


9

Relevant safety assessment materials for substances that may have safety risks in the product

Refer to the "Guidelines for Risk Assessment of Safety Risk Substances that May Exist in Cosmetics" (Guo Shi Yao Jian Xu [2010] No. 339).

10

Letter of Commitment that the raw materials applicable to cosmetics and the source of raw materials meet the requirements for the prohibition and restriction of high-risk substances in mad cow disease epidemic areas

Refer to the "Announcement of the Hygiene Supervision Center of the Ministry of Health on Requirements to Submit Letters of Commitment for Imported Cosmetics".

11

Proof of production and sales of the product in the country (region) or country (region) of origin

For the requirements of production and sales certification documents, please refer to Articles 21 and 24 of the "Notice on Issuing the Provisions on the Acceptance of Cosmetic Administrative License Application" (Guo Shi Yao Jian Xu [2009] No. 856) Annex "Document Requirements for Cosmetic Administrative License Application" Article execution.

12

Relevant certification materials for production quality management of overseas production enterprises

Relevant certification materials include certification documents of quality management system or good manufacturing practices or certification documents of cosmetic production qualifications that meet the requirements of the regulations of the country (region) where the manufacturer is located. The certification documents should be issued or approved by a certification body or a third party. If it is not possible to submit the original, a photocopy can be submitted. The photocopy should be notarized by the Chinese notary office or confirmed by the Chinese embassy (consulate); the name and address of the manufacturer stated should be exactly the same as the content declared。

13

Other information helpful for filing

Refer to the "Regulations on the Acceptance of the Application of Cosmetic Administrative License" (Guo Food and Drug Administration [2009] No. 856, for other information that may be helpful for filing.

The difficulty of filing is mainly in the process of data preparation. If the data is complete and there is no problem, then the non-special purpose cosmetics filing certificate can be obtained in 2-3 months. The required data template can be provided by the Penghai Commissioner


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