China NIFDC Takes Measures on Cosmetics Regulatory Compliance Due to COVID-19
As the COVID-19 resurges repeatedly, cosmetics registrants and notifiers 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.
Incompleteness-tolerant Policy Is Adopted for Cosmetics Registration and Notification
For some cosmetics registrants and notifiers who are unable to provide complete dossiers, the acceptance departments can implement a temporary incompleteness-tolerant policy. Under this policy, the 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.
Detailed requirements are on ChemLinked.
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 misses this deadline or submits false dossiers, the corresponding registration and notification application will thus be canceled.
Eight More Months Granted to Complete Documents Supplementation and Formula Change
1) Documents Supplementation of Cosmetics Registered or Notified on the Previous Platform
The registrant and notifier shall submit supplementary information, such as the product’s executive standards, through the new platform before May 1, 2022. If they failed to make it 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.
2) Formula Change to Registered and Notified Cosmetics Containing Newly Prohibited Ingredients
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 the formula change.
Digital CA Can be Used to Seal Electronic Registration & 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 accept digital CA, which can be applied in accordance with relevant requirements in Technical Guidance. For registrant, notifier, and Chinese domestic responsible person who has already received this digital certificate, they can seal the electronic registration and notification dossiers with it.
Reference Link: ChemLinked
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