Official Replies | China NMPA Answers FAQs about Cosmetics Registration and Notification
Apr 02, 2021
Hedy He
Starting from May 1, 2021, cosmetics registration and notification in China shall comply with the new regulations, which are Administrative Measures on Cosmetics Registration and Notification, and Provisions for Management of Cosmetic Registration and Notification Dossiers. On Apr. 2, 2021, China NMPA issued an announcement answering the frequently asked questions about cosmetics registration and notification. Below are the details of the Q&A.
1. How to apply for user permission on cosmetics registration and notification information service platform?
Domestic registrants, notifiers, domestic responsible persons (RP), and cosmetics manufacturers should start registration and notification after obtaining the user permissions through the information service platform. Overseas registrants and notifiers shall carry out cosmetics registration and notification through the users of their RP.
CSAR has the same requirements for cosmetics registrants and notifiers. The user permissions of registrants and notifiers will be activated together after submitting the required documents.
2. Which cosmetics registrants and notifiers need to designate a responsible person?
Situations | Whether to designate a responsible person |
Overseas cosmetic registrants and notifiers | Yes |
If an overseas registrant or notifier entrusts a domestic cosmetics manufacturer to produce cosmetics, the cosmetics belong to domestic cosmetics | Yes |
If a domestic registrant or notifier entrusts an overseas cosmetics manufacturer to produce cosmetics, the cosmetics belong to imported cosmetics | No |
3. What are the differences between the domestic responsible person (RP) and the previous responsible agent (RA) in China?
RA (previous) | RP |
Only responsible for special cosmetics registration. *If the RA cannot perform the corresponding obligations of RP, it cannot carry out cosmetic registration and notification as the RP. | Responsible for conducting special cosmetics registration and general cosmetics notification, assisting in adverse reactions monitoring, product recall, and ensuring product quality and safety. |
4. What contents need to be stated in the RP authorization letter?
The RP authorization letter should at least contain the following content and information:
Names of the registrant, notifier, and RP |
The relationship between authorizing and authorized parties |
The authorization scope |
The authorization period |
Notes: l If the authorization period is not specified, it will be deemed as a permanent authorization; l Regardless of whether the authorization letter states that the RP should assist in adverse reaction monitoring, implementing product recalls, and cooperating with supervision and inspection, the RP shall perform these obligations. |
5. Can the previous RP or RA authorization letter continue to be used for registration or notification?
| Situations | Requirements |
The previous RA authorization letter | Cannot be used |
The previous RP authorization letter | Can continue to be used for general cosmetics notification |
If the RP authorization letter has been submitted for notification and the original version cannot be provided | The RP should upload a scanned copy of the original authorization letter through the information service platform when applying for user permissions, and submit the photocopy of the authorization letter when submitting paper documents. |
If the overseas registrants or notifiers intend to expand the authorization scope of the RP | A new authorization letter should be issued; and The RP can first upload a scanned copy of the new authorization letter through the information service platform to apply for user permissions and supplement the original authorization letter and its notarial certificate before Sep. 30, 2021.
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6. How to register and notify cosmetic products containing new cosmetic ingredients (NCI) in the safety monitoring period?
After the NCI are registered or notified, the NMPA will announce the NCI registration/notification information to the public. If other registrants and notifiers use the NCI to produce cosmetic products, they should fill in the NCI registration/notification number when applying for cosmetic products registration/notification. After confirming by NCI registrants/notifiers, the cosmetic products registration/notification documents can be submitted.
The registrants and notifiers of cosmetic products containing NCI in the safety monitoring period shall perform the obligations to monitor the NCI use and safety conditions.
7. If the NCI are ordered to suspend the use, how to deal with related cosmetic products?
If the NCI in the safety monitoring period are ordered to be suspended, the information service platform will automatically identify the cosmetic products containing those problematic NCI and give a reminder. The relevant cosmetic registrants and notifiers should also suspend the production and operation of the cosmetic products using the problematic NCI.
8. How to apply for registration and notification of cosmetics that have been entrusted for production?
Situations | Requirements |
Domestic cosmetics that have been entrusted for production | After the cosmetic production enterprise confirms the entrustment production relationship through the information service platform, the registrants and notifiers can apply for registration and notification. |
Imported cosmetics that have been entrusted for production | Cosmetic registrants or notifiers shall submit relevant documents indicating the entrustment production relationship during registration or notification. |
9. How should cosmetic registrants and notifiers retain samples?
The cosmetics registrants and notifiers shall retain samples of each batch of cosmetics produced for future reference. The quantity of retained samples shall meet the requirements for conducting registration and notification testing. It may not include the samples required for human body efficacy evaluation test of sunscreen, freckle-removing and whitening, and anti-hair loss products.
10. How to register and notify the cosmetics used in conjunction with instruments or tools?
Cosmetics that must be used in conjunction with instruments or tools (except brushes, air cushions, hair perming tools, etc., which only assist in rubbing) shall be assessed for their safety under the conditions of use with instruments or tools.
In principle, the instruments or tools used in conjunction should not have cosmetic functions, should not participate in the reproduction process of cosmetics, and cannot change the mode and mechanism of action between cosmetics and skin.
11. Is the cosmetic formula allowed to be changed?
The formula of registered and notified cosmetic is not allowed to be changed, except for inevitable minor changes in the product formula due to changes of suppliers of ingredients used. Excluding the above situation, the product with the changed formula is a new product, and should be re-applied for registration and notification.
12. How to deal with the change of the administrative department for general cosmetics notification?
If the province of the general cosmetics notifier and the domestic responsible person's address is changed, which results in the administrative department changes, the product should be re-applied for notification. The original notification documents can be used when re-apply for notification, and the information service platform will also set up corresponding functions to facilitate the reapplication.
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