As the COVID-19 resurges repeatedly, cosmetics registrant and notifier are confronted with practical difficulties when fulfilling the requirements for registration and notification. To help cosmetic enterprises withstand the impact of the COVID-19, China National Institutes for Food and Drug Control (NIFDC) introduced temporary measures for cosmetics registration and notification on June 2, 2022. 1
1. Incompleteness-tolerant Policy Is Adopted for Cosmetics Registration and Notification
Affected by the lockdown and restrictions due to COVID-19's repeat resurgence, some cosmetics registrants and notifiers are unable to provide complete dossiers as required when applying for registration and notification. For these applicants, the acceptance departments can implement temporary incompleteness-tolerant policy. Under this policy, registrant and notifier are allowed to submit the electronic copies or photocopies first, and supplement the original copy of relevant dossiers after the lockdown ends.
| Application for Incompleteness Tolerance | |
Applicable applicant | Registrant and notifier unable to: - provide dossiers with official seals - provide original certification documents - mail the paper dossiers |
Application documents | a. A written statement b. List of missing items, and promise that the supplemented documents will be consistent with the items stated in the list. c. Certification materials proving COVID-19's impact on registration and notification does exist, such as the epidemic-control notice released by the government where the applicant is located, the quarantine certificate issued by the community where the dossiers handler lives, or a proof showing lockdown's impact on logistics status. |
Requirements | The documents provided after the lockdown ends shall be: - consistent with the missing items stated when applying for incompleteness tolerance; - true and accurate. |
Notes: For registration and notification, whose electronic application dossiers have been submitted and passed the technical review, while their to be submitted paper dossiers cannot be sent out due to the COVID-19, a written statement and relevant certification materials shall be sent to [email protected].
After receiving the application documents for incompleteness tolerance, the cosmetic technical review department will set a deadline for the registrant and notifier to provide the missing dossiers. If the registrant, notifier or the Chinese domestic responsible person miss this deadline or submit false dossiers, corresponding registration and notification application will thus be canceled.
2. Extra Eight Months Are Granted to Complete Documents Supplementation and Formula Change
1) Documents Supplementation of Cosmetics Registered or Notified on the Previous Platform
For cosmetics that had been registered or notified on the previous cosmetics registration and notification platform, the registrant and notifier shall submit supplementary information, such as product’s executive standards, through the new platform before May 1, 2022.
If the registrant and notifier failed to complete the documents supplementation before May 1, 2022, they are allowed to submit a written statement to the acceptance department and attach certification materials. In principle, the documents supplementation shall be completed before December 31, 2022. Otherwise, the corresponding cosmetics shall not be further produced or imported.
For the registrant intending to apply for renewing the special cosmetic registration certificate, the application shall be made after supplementing the required documents of these cosmetics. Under the impact of COVID-19, if the registrant is not able to submit required documents for renewing the registration within the time limit, he/she shall submit a statement of the situation and corresponding evidence to the local provincial MPA within 10 working days after the impact is eliminated, so as to obtain a written opinion issued by provincial MPA. Then within 5 working days, the registrant shall submit the required documents and the written opinion to NMPA to renew the registration.
2) Formula Change to Registered and Notified Cosmetics Containing Newly Prohibited Ingredients
On May 28, 2021, China implemented the updated prohibited ingredient lists. For cosmetics containing the newly prohibited ingredients registered or notified before May 28, 2021, the registrant and notifier could retain the original registration and notification number with an application for formula change. The application as well as the relevant testing report, safety assessment report, etc., was required to be submitted before May 1, 2022.
If the registrant and notifier failed to satisfy the requirements for a formula change before May 1, 2022, they need to submit a written statement and certification materials to the acceptance department. In this case, they are allowed to submit the application and required documents for a formula change after the lockdown ends. The latest deadline to complete the formula change is December 31, 2022, otherwise the corresponding cosmetics shall not be further produced, imported or sold before the completion of formula change.
3. Digital Certificate Authority Can be Used to Seal the Electronic Registration and Notification Dossiers
According to Technical Guidance for Submission of Cosmetics Registration and Notification Dossiers (Trial) (Technical Guidance), the required dossiers for cosmetics registration and notification can be exempted from the paper version when the following conditions are met:
For third-party certification, its issuing institution has adopted the digital Certificate Authority (CA) and the CA can be accessed and verified on the Cosmetics Registration and Notification Platform;
For other dossiers, the registrant, notifier or Chinese domestic responsible person has been sealing documents with CA, and the seal is complete.
At present, the Cosmetics Registration and Notification Platform accepts digital CA, which can be applied in accordance with relevant requirements in Technical Guidance. For registrant, notifier and Chinese domestic responsible person who have already received this digital certificate, they can seal the electronic registration and notification dossiers with it.
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