A Summary for China's Cosmetics Supervision

Created on:2020-10-19 15:41

With the rapid development of China's economy and the huge change of residents' consumption demand, the cosmetics industry has also developed rapidly,domestic brands emerge in endlessly, and foreign brands rush in China.In order to ensure the quality of the products and protect the rights and interests of consumers, the China Food and Drug Administration has spared no effort in the supervision of cosmetics.In view of this, in order to enable the production and trade enterprises to develop the Chinese cosmetic market smoothly, we hereby introduce the Chinese supervision regulations of cosmetics.

 

Firstly, the definition and classification of cosmetics.

 

According to the Regulations on the Supervision of Cosmetics Hygiene, a cosmetic refers to the daily chemical industrial product which spreads to any part of the body surface (skin, hair, nails, lips, etc.) by smearing, spraying or other similar methods to achieve the purpose of cleaning, eliminating bad smell, skin care, beauty and modification.

 

According to the Regulations on the Supervision of Cosmetics Hygiene and its detailed rules for implementation, China's cosmetics are divided into special purpose cosmetics and non-specialpurpose cosmetics, and special purpose cosmetics are divided into nine categories: hair raising, hair coloring, perming, hair removal, breasts beautifying, body building, deodorization, freckle removal and sunscreen.

 

Secondly, the China’s supervisory system.

 

China implements the systems of cosmetics licensing (record), production licensing and market supervision, and establishes a multi sectoral supervision system based on hygiene supervision.

 

Cosmetics licensing (record) includes the administrative licensing of the use of new cosmetic raw materials, domestic special purpose cosmetics and the first import of a cosmetic, and the record of domestic non-special purpose cosmetics. The administrative licensing of cosmetics implements a system which has three separate steps: acceptance, review and approval. The pre-market licensing system is implemented for new cosmetic raw materials and special purpose cosmetics. Record management is implemented for imported non-special purpose cosmetics. The cosmetics administrative licensing certificate (record certificate) is valid for 4 years. The post-market record system is implemented for domestic non-special purpose cosmetics.

 

The production licensing includes the production licensing and the hygiene licensing of the production enterprise. The production certificate is issued by the Quality Supervision Department and is valid for 5 years. The hygiene license of the production enterprise is issued by the provincial level Food and Drug Supervision Department and is valid for 4 years.

 

The market supervision is carried out by the Food and Drug Supervision Department, the Quality Supervision, Inspection and Quarantine Department and the Industry and Commerce Administrative Department in accordance with their functions.

 

Thirdly, the process of cosmetics licensing (record).

 

  1. The record process of domestic non-special purpose cosmetics:

 

Domestic non-special purpose cosmetics

Inspection

Acceptance

Formality examination

Record registration certificate

The testing agency designated by the provincial level Food and Drug Supervision Department

Provincial level Food and Drug Supervision Department

 

  1. The administrative licensing (record) process of imported special purpose cosmetics, imported non-special purpose cosmetics and domestic special purpose cosmetics:

 

Imported special purpose cosmetics

Inspection

Acceptance

Examination and evaluation of technology

Administrative examination and approval

The testing agency designated by the Food and Drug Supervision Department

Administrative acceptance service center of the Food and Drug Supervision Department

Imported non-special purpose cosmetics

Domestic special purpose cosmetics

Formality examination

Examination and evaluation committee

Substantive examination

Examination and evaluation center of the Food and Drug Supervision Department

China Food and Drug Administration

 

 

Finally, the application materials of the cosmetics licensing (record) and the analysis of their main points.

Application Materials

Imported non-Special

Imported Special

Domestic non-Special

Domestic Special

Application form for cosmetics administrative licensing

 

Product formula

The naming basis of the product name

Brief description and sketch of production process

Control requirements of product quality safety

Product original / design package (including product label, product specification)

The inspection report issued by the licensing inspection agency which wasdesignated by the China Food and Drug Administration and related information (for domestic non-special, shall be the inspection agency designated by the provincial level Food and Drug Supervision Department)

Safety assessment information related to that the security risk substances may exist in the product

Audit opinion on production hygiene conditions issued by the provincial level Food and Drug Supervision Department

 

 

 

For applying for the products of hair raising, body building and breasts beautifying, the scientific literatures relating to their functions, components and use basis shall be submitted.

 

 

The copy of authorization of the administrative licensing application unit in China, and the copy of business license of the administrative licensing application unit in China, which shall be sealed.

 

 

A letter of commitment for that the raw materials using and source of the cosmetics are meet the prohibition and limit requirements of the high-risk substances from the BSE epidemic area.

 

 

The documentary evidence for the production and sale of the products in the producing country (region) or in the country of origin (region)

 

 

Copy of the entrustment production agreement (if there is an entrustment production)

Other information that may contribute to administrative licensing

Product technical requirements

One attached sample sold in the market which was sealed by the licensing inspection agency and is not unsealed.

 

 

The analysis of main points of the application materials is as follows:

 

(1) Authorization for the imported cosmetics by the foreign enterprise. This authorization shall be completed jointly by the application unit in China (a standards body in China that is registered according to law and has an independent legal person qualification) and the foreign enterprise, and shall be signed or sealed by both parties.

 

(2) Chinese cosmetic name. According to Naming provisions of Cosmetic, the name should be simple, understandable and conform to Chinese expressive habits, and should not cheat or misguide consumers. It is not allowed to use prohibitive information. The name of trademark should comply with Chinese regulation.

 

(3) Product formula. They shall comply with Chinese laws and regulations, Safety and Technical Standards for Cosmetics, List of the Standard Chinese Names of the Foreign Cosmetics Raw Materials, List of the Used Cosmetics Raw Materials Names and so on.

 

(4) Brief description and sketch of production process for the cosmetics. They shall be concise and to the point, and the process shall be complete; the brief description shall be consistent with the brief sketch, and the ingredients in the formula should be reflected and indispensable.

 

(5) Control requirements of product quality safety. It shall reflect the various product specifications (color, property, smell and microbiological index), and the applicant shall promise that the products meet the requirements of Safety and Technical Standards for Cosmetics.

 

(6) Product original/design package. The content of the product application shall consistent with the information such as original foreign labels and the use-method, users and human body parts on which the products are used, and the attentions, the content shall not be reduced for the purpose of reducing inspection items.

 

(7) The inspection report and related information. The products shall be tested by the testing agency designated by the CFDA or the provincial level Food and Drug Supervision Department, and the qualified reports shall be obtained.

 

(8) Safety assessment information related to that the security risk substances may exist in the product. Carry out the hazard identification against the contained substances one by one to analyze whether there are some security risk substances (dioxane, acrylamide, methanol and so on). For some substances, they are not contained in the raw materials but are generated in the process of production, so this part also needs to be analyzed and evaluated.

 

(9) A letter of commitment for that the raw materials using and source of the cosmetics are meet the prohibition and limit requirements of the high-risk substances from the BSE epidemic area. If the raw materials obtained from cattle, sheep and other animals are used, it is necessary to submit a letter of commitment related to the mad cow disease.

 

(10) The documentary evidence for the production and sale of the products in the producing country (region) or in the country of origin (region). The documentary evidence shall include the product name, the name of the production enterprise and the name of the institution to issue the document, and shall include the seal of the institution or the signature of its legal representative (or its authorized personnel) and the issuance date of the document.

 

(11) Entrustment production agreement. The production factory shall provide the certificate of quality management system or good production practice, or the documentary evidence of the cosmetics production qualification which is used to prove that the products meet the rules and regulations of the country (region) and shall be issued by a third-party certification body.

 

(12) Audit opinion on production hygiene conditions issued by the provincial level Food and Drug Supervision Department. Manufacturer should submit the application form and list of production workshop equipment, hygienic license and other data which are needed for their provincial level Food and Drug Supervision Department.

 

 

 

 

 

 

 

 

 

 

 

 

Beijing Oriental Chemical Information Co., Ltd (OCI), established in June 2006, is one of the leading Chemical Management Company in China, providing services in New Chemical Substance Notification, Registration of toxic chemical, cosmetic new material, cosmetic product, food additive, REACH Compliance, chemical market survey and industrial analysis. As one of the leading consulting company, specialized chemical consultation, substance information providing, testing dataanalysis, etc, by owning tremendous successful achievement, we are looking forwards to establish partner relationship with companies in fields of Chemical Industry, Environmental Protection, Labs and Testing, Daily Chemical Products, Food, etc, to provide excellent services in registration, notification, assessment, and legal support.