New Rules for China Cosmetics and New Raw Materials Registration are Updated
- Chaileedo Press
- Jun 5, 2023
- 2 min read
China National Institute for Food and Drug Control released the Guidelines for the Registration and Approval of Cosmetics and New Raw Materials. The application for an extension of registration for domestic and imported special cosmetics should be submitted within 90 to 30 working days before the expiration of the product registration certificate.
June 5th, the China National Institute for Food and Drug Control released the Guidelines for the Registration and Approval of Cosmetics and New Raw Materials (hereinafter referred to as the "Guidelines"). The Guidelines announced nine guidelines for the registration and approval of new cosmetic raw materials with a higher risk, changes in domestic special cosmetics, first-time registration, extension, and cancellation of registration, changes in imported special cosmetics, first-time registration, extension, and cancellation of registration.
According to the annex of the Guidelines, the application for an extension of registration for domestic and imported special cosmetics should be submitted within 90 to 30 working days before the expiration of the product registration certificate. Applications will no longer be accepted after the deadline. The acceptance agency will review the application within 5 working days of receiving it and issue a new registration certificate to the applicant within 10 working days from the date of acceptance.
For the registration and approval of new cosmetic raw materials with a higher risk, as well as changes, first-time registration, and cancellation of domestic and imported special cosmetics, the Guidelines also clearly state that the acceptance time limit is 5 working days, the legal approval period is 20 working days, the technical evaluation time is 90 working days, and the approval time is 20 working days.
It is worth noting that raw materials listed in the Inventory of Existing Cosmetic Ingredients in China 2021, specific raw materials included in the used category, raw materials specified as banned components in the Safety and Technical Standards for Cosmetics, and raw materials with actual functions beyond the definition of cosmetics are not considered new cosmetic raw materials and cannot be managed as such.
The Guidelines state that if the original product registration certificate does not reflect the PA value, according to Article 44 of the Provisions for Management of Cosmetic Registration and Notification Dossiers, the product should increase the SPF/PA value according to the changes in the label sample content, submit a change application, and provide the corresponding efficacy test report of the intended changed product.
In addition, if the registration extension application cannot be submitted within the prescribed time limit due to force majeure or other reasons not caused by the cosmetic registrant or domestic responsible person, the registrant or domestic responsible person shall submit a written explanation and provide corresponding supporting materials to the provincial drug regulatory department where they are located within 10 working days after the relevant impact has been eliminated.
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