Impending Deadline | Guangzhou Government Reminds Cosmetic Notifiers to Complete the Annual Report, Product Confirmation and Document Supplement

1. Annual Report of Notified General Cosmetics

Under China’s new cosmetic regulatory scheme, general cosmetic notification no longer has an expiration date, but the annual report is newly required to be submitted before a due date. Starting from Jan. 1, 2022, the annual report system has been implemented uniformly for general cosmetics notified through the previous and new cosmetic registration and notification information management platform.

Notifiers shall submit the annual report of general cosmetics notified over one year through the new platform. The annual report’s submission period lasts from Jan. 1 to Mar. 31 of each year. ¹ Specifically,

• For products notified before Dec. 31, 2020, the annual report shall be submitted between Jan. 1 and Mar. 31, starting from the year of 2022;

• For products notified between Jan. 1, 2021 and Dec. 31, 2021, the annual report shall be submitted between Jan. 1 and Mar. 31, starting from the year of 2023.

• For products notified in the following years, notifiers shall proceed the annual report in the same manner.

If the notifier fails to submit the annual report as required, the local Medical Products Administration (MPA) will ask the notifier to make corrections. If the notifier doesn’t complete the corrections within the time limit, the notification of the product will be forcibly cancelled.

1) Annual Report Procedures

The preconditions for submitting the annual report are to open the user permission of notifier or domestic responsible person on the new platform, and complete the product confirmation.

Notifiers can log in to the new platform, enter the "General Cosmetics Notification Management" module, and click the button of “annual report” to enter the relevant interface.

All general cosmetics notified over one year will be listed on the interface. Notifiers can fill in item by item according to the actual situation.

2) Annual Report Content

According to Article 53 of Provisions for Management of Cosmetic Registration and Notification Dossiers, the annual report of general cosmetics shall include the following contents:

• The general situation of production and import of products, as well as the suspension of production during the period;

• Self-inspection on the conformity of products with laws and regulations, mandatory national standards, and technical specifications.

In practice, the notifier shall answer the following four questions on the new platform:

2. Confirmation of General Cosmetics Notified on the Previous Platform

The previous general cosmetics notification information management platform was closed on Sep. 15, 2021. For products notified on the previous platform, the notifier should claim and confirm on the new platform.

If the products notified on the previous platform have not been corrected after Sep. 15, 2021, or still do not meet the requirements after the rectification, the notifier shall voluntarily cancel the notification through the new platform, or apply to the local MPA for notification cancellation. If the notifier voluntarily cancels the notification after the products having been put on the market, the products can be sold until the end of the shelf life.

On Mar. 31, 2022, the notification of unclaimed general cosmetics on the previous platform will be cancelled.

3. Document Supplement of General Cosmetics Notified on the Previous Platform

Before May 1, 2022, notifier of general cosmetics that have been notified on the previous platform shall

• supplement product classification code, executive standard and label samples (for both imported and Chinese domestic general cosmetics);

• fill in the product formula (for Chinese domestic general cosmetics).

If the products whose documents are not supplemented as required, the local MPA will take measures in accordance with relevant regulations.

Industry Status

At present, there are still many products notified on the previous platform that have not been confirmed by the notifier. The main reason is that under the new regulation, the notifier is required to have a quality management system, an adverse reaction monitoring and evaluation system, as well as a person in charge of quality and safety. Notifiers who are not yet capable of equipping these systems cannot open the user permission on the new platform, and therefore cannot confirm their products.

In addition, NMPA has stricter control over product efficacy claims, but the claims of some previously notified products are not supported by a sufficient scientific basis. To avoid the non-compliance risk, the notifier leaves these products on the previous platform, and their notification will be cancelled on Mar. 31. ²

Industry insiders suggest that notifiers consider carefully, and confirm those products that can complete the document supplement and can meet the requirements of the new regulations.

Further Reading

• Noteworthy Regulatory Matters and Key Time Points for Cosmetic Registration and Notification in China in 2022 and Beyond

• 4 Authoritative Replies from NMPA: Explicit Guidelines on Cosmetic Supervision and Administration

• China NIFDC Consults on Limitation of Benzene in Cosmetics

• Unqualified Labeling: Primary Reason for the Rejection of 113 Batches of Cosmetics in 2021

• Webinar: Practical Guidance on Ingredient Submission Code Application

• Webinar: A Look Back at 2021 with ChemLinked: Cosmetics Regulation Updates