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On September 28, 2020, China NMPA issued the first draft of Measures for the Management of Cosmetic Adverse Reaction Monitoring. On September 29, 2021, China NMPA promulgated the second draft of Measures for the Management of Cosmetic Adverse Reaction Monitoring (the new Measures) for public comments until October 19. This round of consultation is expected to be the last version before its issuance.
The new Measures includes a total of 7 chapters and 54 articles. Compared to the first draft released in 2020, the second draft is further modified and refined to add clarity and increase the logicality.
The main revisions are as follows:
1. Specify the reporting contents of cosmetic adverse reactions and the reporting methods for cosmetic registrants and notifiers.
The cosmetic adverse reaction reports shall include the information of the reporter and the the person experiencing the adverse reaction, the information of the adverse reaction, the information of the cosmetic used, etc.
Cosmetic registrants and notifiers shall publish effective contact information such as telephone numbers and e-mail addresses to the public through product labels or their official websites, designate a contact person or contact department, and actively collect reports from entrusted production enterprises, cosmetics operators, medical institutions, consumers, etc. on adverse reactions of their cosmetics on the market.
2. Adjust the time limit of cosmetic stakeholders for reporting cosmetic adverse reactions.
Report Items | The time limit set by the first draft | The time limit set by the second draft |
Cosmetic adverse reactions | Report within 20 working days from the date of finding or learning the cosmetic adverse reactions | Report within 30 days from the date of finding or learning the cosmetic adverse reactions |
Serious cosmetic adverse reactions | Report immediately | Report within 7 days after finding or learning the cosmetic adverse reactions |
Cosmetic adverse reactions that may cause significant social impacts | Report immediately | Report immediately |
Cosmetic adverse reaction information received by cosmetics e-commerce platform operators | - | Record and transfer it to the cosmetics operator on the platform for processing within 3 days |
3. Change the requirements for monitoring records of cosmetic adverse reactions. The record retention period has been adjusted from "not less than one year after the expiration of the product shelf life (if the product shelf life is less than one year, the record shall be kept for not less than two years)” to “not less than three years from the date of reporting."
4. Add several new provisions on the disposal and punishment of cosmetic adverse reactions, including the safety reassessment requirements and the legal responsibilities of registrants, notifiers, domestic responsible persons, entrusted production enterprises, cosmetics operators, and medical institutions.
Note:
For detailed requirements of cosmetic adverse reaction monitoring in China, please refer to the English translation of the second draft (coming soon).
For more analysis of the first draft, please refer to "Draft Regulations on Cosmetic Adverse Reaction Monitoring Unveiled."
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