Key points of new raw material management in Administrative Measures for Cosmetics Registration and Recordation

On January 12, 2021, the State Administration for Market Regulation issued the "Administrative Measures for Cosmetics Registration and Recordation " (hereinafter referred to as the "Measures"), which will come into force on May 1, 2021. The "Methods" is one of the important supporting documents of the "Regulations on the Supervision and Administration of Cosmetics" (hereinafter referred to as the "Regulations"), which elaborates on the registration and recordation management system of cosmetics and their raw materials.

 

The dual-track system of registration and recordation of new cosmetic raw materials will be implemented, and it is predicted that there will be a blowout in the recordation of new cosmetic raw materials.

Article 4 of the "Measures" stipulates that: the state implements registration management for special cosmetics and new cosmetic raw materials with a higher degree of risk, and recordation management for ordinary cosmetics and other new cosmetic raw materials.

Article 18 stipulates that the applicant of new cosmetic raw materials shall complete the recordation after submitting the materials in accordance with the requirements of the National Medical Products Administration.

 

 

Article 26 provides that: 3 years after the expiration of the safety monitoring period for new cosmetic raw materials, the technical review agency shall submit an opinion on whether the new cosmetic raw materials meet the safety requirements to the National Medical Products Administration. For new cosmetic raw materials with safety issues, the National Medical Products Administration shall withdraw the registration or cancel the recordation; if no safety problems occur, the National Medical Products Administration shall include them in the list of used cosmetic raw materials.

The company submits the relevant materials of the new cosmetic raw materials and completes the recordation without having at least 90 working days of review, and if there is no safety problem during the three-year monitoring period after recordation, the recorded new cosmetic raw materials can be included in the list of used cosmetic raw materials after the technical review agency provides comments. In this context, it is expected that a large number of new cosmetic raw materials (not high-risk) will be added to the market after the implementation of the new regulations on May 1.

 

In-process and post-event supervision of new cosmetic raw materials, annual reports and adverse reaction monitoring during the three-year monitoring period, and record data verification.

Articles 19 to 27 of the “Measures” clearly stipulate the supervision of new cosmetic raw materials during and after the 3-year safety monitoring period. The safety monitoring period shall be within 3 years after the completion of the registration/recordation. During the monitoring period, the registrant/filer shall track the safety of the raw materials, and provide annual reports on schedule (summarizing the use and safety of raw materials).

At the same time, Article 58 of the "Measures" stipulates that "If the medical products administration undertaking the recordation management work finds that the recordation materials of the registered cosmetics and new cosmetic raw materials do not meet the requirements, it shall order corrections within a time limit. Among them, if the recordation materials related to the safety of cosmetics and new cosmetic raw materials do not meet the requirements, they can be ordered to suspend sales and use at the same time. For cosmetics and new cosmetics raw materials that have been recorded but the recordation information has not been released to the public, the medical products administration responsible for recordation management finds that the recordation materials do not meet the requirements, can order the filing person to make corrections and publish the filing information to the public after meeting the requirements”, this avoids the risk of completing the record without reviewing the record data in the new cosmetic raw material record system.

 

Please check the link below for the full text of the “Measures”:

http://gkml.samr.gov.cn/nsjg/fgs/202101/t20210112_325127.html