New Raw Material Registration

As required by regulations, the natural or artificial raw materials used in cosmetics for the first time in China are new raw materials for cosmetics.On June 29, 2020, the State Council of the People's Republic of China issued the Regulations on the Supervision and Administration of Cosmetics (effective as of January 1, 2021), which carries out classified management of cosmetics raw materials according to the degree of risk, carries out registration management of new cosmetics raw materials with a higher degree of risk, and filing management of other new cosmetics raw materials.

 

New cosmetics raw materials with functions of antisepsis, sun protection, coloring, hair coloring and freckle-removal,whitening may not be used until they have been registered by the pharmaceutical regulatory department under the State Council.Other new cosmetic raw materials shall be filed with the drug regulatory department under the State Council before adoption.

 

The applicant shall be responsible for the authenticity and scientificity of the materials submitted.

The state implements a safety monitoring system for new raw materials that have been registered.The period of safety monitoring shall be 3 years from the date on which cosmetics with new raw materials are registered or filed for the first time.

Within three years, the registrant of new raw materials shall annually report to the drug regulatory department under the State Council on the use and safety of the new raw materials.The drug regulatory department under the State Council shall revoke the registration or filing of any new cosmetic raw materials with safety problems.

New cosmetics raw materials that have not experienced safety problems within three years shall be included in the list of used cosmetics raw materials formulated by the drug regulatory department under the State Council.New cosmetics raw materials that have been registered and filing shall still be managed in accordance with new cosmetics raw materials before being included in the list of used cosmetics raw materials.

 

Legal Accordance

Regulations on the Supervision and Administration on Cosmetics,Measures for the Administration of Registration and Filing of Cosmetics,Provisions on the Management of Registration and Filing Information of New Cosmetic Raw Materials,Technical Guidelines for Safety Assessment of Cosmetics (2021 Edition). 

 

New Raw Material Registration and Filing Process

Registration Process

 

Filing Process

 

Qualification of the Applicant

A registrant of new raw materials shall meet the following basic requirements:

It has a safety risk monitoring and evaluation system suitable for new raw materials.

If the registrant of the new raw material is an overseas enterprise, the enterprise legal person within the territory of China shall be designated as the responsible person in China. The responsible person in China shall fulfill the following obligations :

(1) In the name of the registrant, handle the registration and filing of new cosmetic raw materials;

(2) Assist the registrant to carry out the safety monitoring and reporting of new cosmetic raw materials;

(3) Assist the registrant in implementing the recall of new cosmetic raw materials;

(4) In accordance with the agreement with the registrant, assume the corresponding quality and safety responsibilities for the new cosmetic raw materials put on the domestic market;

(5) Cooperate with the supervision and inspection work of the drug regulatory department. 

 

Materials Required for Registration or filing of new cosmetics raw materials:

1. Name, address and contact information of the registration applicant and the responsible person in China;

2. Development report of new raw materials;

3. Research data on the preparation process, stability and quality control standards of the new raw materials;

4. Safety assessment data of new raw materials. 

 

Professional Services from ZOOP

1. Assist in the preparation of the development report of new raw materials according to the basic information of new raw materials, R&D background, R&D purpose and the latest research progress provided by the applicant;

2. Guide the applicant to compile the preparation technology of new raw materials;

3. Guide the applicant to compile quality control standards, including stability test data, quality specification indexes and their inspection methods, possible safety risk substances and their control materials;

4. Guide the applicant to conduct toxicological test on the new raw materials and prepare toxicological safety evaluation data and safety evaluation data.

5. Collect relevant data on the functional basis of new raw materials, including scientific literature, regulatory data, in vitro or animal test data, human functional evaluation test data, etc.

6. Instruct applicants to formulate technical requirements for new raw materials.

7. Full agency services for raw material registration and filing .