FAQs Vol. 30 | China NIFDC Answers Questions on New Cosmetic Ingredients Notification/Registration

According to the Cosmetic Supervision and Administration Regulation (CSAR), China implements classified management of cosmetic ingredients based on their risk level. NCIs with functions such as preservative, sunscreen, colorant, hair dye, or whitening/freckle-removing are subject to registration management and can only be used after passing review and obtaining a registration certificate. Other NCIs are subject to notification management and must be notified before use. Notification means that the notifier submits documents to medical products administration department for inspection and reference. The public disclosure of information on a completed notification does not represent an endorsement of the quality and safety of the new ingredient, and the notion of “successfully obtaining approved notification” is incorrect.

According to the Administrative Measures on Cosmetics Registration and Notification, the NMPA’s technical review institution is responsible for the technical review of the notification dossiers of NCIs after they have been notified.

If the post-notification technical review finds that the notified documents for a NCI do not meet the requirements, a time-limited correction will be ordered. If the non-compliant documents are related to the safety of the NCI, a suspension of sale and use may also be ordered simultaneously. In cases specified in Article 59 of the Administrative Measures on Cosmetics Registration and Notification, the notification of the NCI shall be canceled. This includes submitting false documents at the time of notification, failing to make corrections within the specified time limit as required, or the ingredient not falling within the scope of NCI notification.

After a NCI is notified, the cosmetic technical review institution conducts a technical review of the notification dossier and tracks and evaluates the use and safety of the new ingredient. Therefore, notifiers should pay close attention to the administrative updates after notification.

New ingredient notifiers should regularly check and stay informed about the post-notification technical review feedback through the Cosmetic Smart Application and Review System. The path to view is: New Ingredient Notification → Application Management → View Documents.

According to Article 60 of the Administrative Measures on Cosmetics Registration and Notification, the time of notification and the associated deadline are determined by the time the notice is sent through the information service platform. When viewing the post-notification technical review notice, notifiers should pay attention to the date on the notice and the deadline for correction, and submit the correction documents within the specified time limit. The path to submit is: New Ingredient Notification → Application Management → Submit Correction Documents.

Upon receiving the post-notification technical review feedback, the notifier should study and respond to each point. When submitting the correction documents, a statement of explanation must be provided simultaneously, detailing the revisions and improvements made in response to each point of the technical review feedback.

When sending the feedback, the technical review institution will grant the necessary permissions to modify the notification documents based on the feedback. If the notifier needs to modify other parts of the dossier based on actual research, they can apply to expand the modification permissions by explaining the reasons through the Cosmetic Smart Application and Review System. The path to apply is: New Ingredient Notification → Application Management → Expand Modification Permissions.

After submitting the correction documents, the notifier should promptly check the acceptance status. During the document processing stage, correction documents that are found to be non-compliant upon review (e.g., not responding to all feedback points) will be returned. The notifier should promptly check the reason for return (path: New Ingredient Notification → Application Management → Reason for Return), supplement and improve the documents, and resubmit them within the deadline specified in the post-notification technical review notice.

After receiving the order for correction, the notifier should start the research work as soon as possible. If it is genuinely impossible to submit all research data within the specified time limit due to objective reasons like the testing cycle, the correction documents must still be submitted on time. In the submission, the notifier should provide a factual explanation for the inability to submit on time, along with necessary supporting documents. This should include a scientifically sound analysis of the specific technical review, the research plan, progress, and estimated completion time. The notifier must also fully analyze and evaluate the potential impact on the quality and safety assessment of the new ingredient and submit the relevant data promptly upon completion of the research.