Notification Cancellation and Notification Withdrawal of New Cosmetic Ingredients and General Cosmetics in China

1. Cancellation and Withdrawal of New Cosmetic Ingredients (NCIs) Notification

By Nov 30, 2024, a total of 79 NCIs have been notified year to date ¹, surpassing 69 NCI notifications in 2023, with more and more market participants. However, some of the notified NCIs have had their notifications cancelled or withdrawn. This article compiles and explores the relevant information.

1.1 Distinction Between Notification Cancellation and Notification Withdrawal

1.1.1 Notification Cancellation

According to Article 59 of the Administrative Measures on Cosmetics Registration and Notification, the NMPA will cancel NCIs or general cosmetics notifications under the following circumstances:

• Submission of false documents during notification;

• Non-compliance with document requirements, failure to make necessary corrections within the specified time frame, or failure to suspend the sales and use of NCIs and general cosmetics as required;

• Notification of NCIs or general cosmetics that fall outside the notification scope.

"Notification Cancellation" is an administrative action taken by the regulatory department. If an NCI is ordered with use suspension or notification cancellation, the cosmetic product registrant and notifier must immediately cease production and operation of cosmetics containing this NCI.

1.1.2 Notification Withdrawal

Under the Cosmetic Supervision and Administration Regulation (CSAR), Administrative Measures on Cosmetics Registration and Notification, and other relevant regulations, "Notification Withdrawal" refers to the voluntary action taken by the notifier. If there are no violations of laws or regulations, cosmetic products containing NCIs with withdrawn notifications can continue to be sold until the end of their shelf life. If production or sales resume later, the registrant and notifier may re-apply for notification using the same name.

1.2 Information on NCIs with Cancelled or Withdrawn Notifications

According to the NCI notification system data from the National Medical Products Administration (NMPA), 7 NCIs have had their notifications cancelled and 6 have been withdrawn. For details, please refer to the table below:

1.3 Basis for Determining if an Ingredient is an NCI

The notification cancellation of 5 NCIs is due to that they should be managed as existing cosmetic ingredients in China. Before submitting notifications for NCIs, enterprises must carefully assess whether the ingredient is an NCI.

1.3.1 Determination Basis

The CSAR defines an NCI as a natural or artificial ingredient used in cosmetic products for the first time in China. In January and December 2023, China released the first and second draft of the Technical Guidelines for Determination and Research of New Cosmetic Ingredients, to provide further guidance on the research and classification of NCIs. The draft Guidelines clarifies the definition of NCIs from various perspectives to address the evolving development and supervision needs of the cosmetics industry under the new regulations.

1.3.2 Ingredients that are Considered NCIs

The criteria for identifying ingredients that are classified as NCIs specified in the second draft Guidelines are:

1) Based on management attributes

2) Based on management categories

 1.3.3 Ingredients that are not Considered NCIs

The second draft Guidelines also clarifies the criteria for identifying ingredients that are not classified as NCIs, including:

1) Ingredients whose intended usage method, application site, or purpose in cosmetics exceeds the boundaries of the cosmetic’s definition;

2) Ingredients explicitly prohibited by cosmetic technical regulations; ingredients sharing similar basic structures, physical and chemical properties, and/or actual functions with prohibited ingredients; and ingredients deemed to be harmful to human health under normal, reasonable, and foreseeable conditions of use;

3) Ingredients listed in the Inventory of Existing Cosmetic Ingredients in China (IECIC), specific ingredients falling under group categories in the IECIC, and ingredients whose material foundation aligns with any ingredients listed in the IECIC.

ChemLinked reminds companies that although low-risk NCIs can be used in cosmetic products after notification, these notified NCIs are still subject to technical review and on-site inspection by regulatory authorities later. The implementation of the NCI notification system does not lower regulatory standards. If the definition of NCI, notification dossier, R&D, or production processes fail to meet regulatory requirements, the notification may be canceled. This cancellation can result in significant losses for both the applicant company and the finished product company utilizing the NCI.

2. Cancellation of General Cosmetic Notification

2.1 Information on General Cosmetics with Cancelled Notifications

In 2024, provinces such as Shandong, Zhejiang, Hunan, and Fujian announced the cancellation of general cosmetic notifications for over 5,000 products, including both imported and Chinese domestic items. Affected categories include shampoo, shower gel, essence, face cream, facial masks, and nail polish. Products with cancelled notifications cannot be sold or imported from the cancellation date. Non-compliance will result in penalties imposed by regulatory authorities.

The primary reasons for cancellation include the applicant’s failure to submit annual reports, notifiers being out of touch, and inadequate notification dossiers. Most cancellations in 2024 stemmed from notifiers failing to submit annual reports on time. Under new regulations, notifiers must submit annual reports for cosmetics notified more than one year ago via the NMPA Registration and Notification Information Service Platform between January 1 and March 31 each year. Failure to do so will result in cancellation.

Li Jincong, founder of the cosmetics banned word website, noted that various factors contribute to notification cancellation. For example, some notifiers are unaware of their reporting obligations, the position of quality and safety personnel is just nominal and does not act a positive role in some companies, and some notifiers cooperate with deregistered factories. Another significant concern is that some notifiers and retailers are unaware that products they sell have had their notifications cancelled, which may risk penalties. ²

Zhang Taijun, R&D director at the Tsuen Chi Beauty Biotechnology Research Institute, stated, "In the annual report, notifiers must submit any issues identified during self-inspections or adjustments made. The high number of cancellations also indicates that the new regulations are effectively taking hold." ²

2.2 Key Considerations for Notifiers

To avoid cancellation, notifiers should: ³

1. Sort out notified products: For products intended for continued production and sale, timely submission of annual reports and relevant information is essential.

2. Withdraw notifications for products whose production and/or sale has been suspended: For products no longer in production or sale, notifiers should proactively apply for notification withdrawal to prevent cancellation by regulatory authorities (the differences between cancellation and withdrawal are explained in the above content.)

3. Cultivate legal awareness: Engage in cosmetics production and operations in strict compliance with laws, regulations, national standards, and technical specifications. Strengthen management, maintain honesty and self-discipline, as well as ensure the quality and safety of cosmetics.

With extensive experience in cosmetic and NCI registration and notification, ChemLinked’s parent company REACH24H Consulting Group offers compliance solutions to assist overseas cosmetic enterprises entering into China market. Welcome to contact us at [email protected] for more advice.

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