China NMPA Allows Self-Updating the Notified Ingredient Safety Information by Cosmetic Notifiers

Background

The Provisions for Management of Cosmetic Registration and Notification Dossiers (the Provisions), one of the significant subsidiary regulations of the Cosmetic Supervision and Administration Regulation (CSAR), puts forward provisions on changing the ingredient safety information, which requires that:

For a registered or notified product, if the ingredient manufacturer or ingredient quality specifications have been added or changed, and the ingredients’ content in the formula as well as the types and proportions of specific components in the ingredients have not been changed, the information of ingredient manufacturer and ingredient safety shall be updated and maintained through the registration and notification information platform. In case of any change in product safety assessment documents, the product safety assessment documents shall also be changed.
For a registered or notified product, if the ingredient manufacturer or ingredient quality specifications have been added or changed, and the ingredients’ content in the formula as well as the content of main functional components and solvents in ingredients have not been changed, while trace stabilizers, antioxidants, preservatives and/or other components added to ensure ingredient quality have been changed in types and/or contents, the following documents shall be submitted: (I) Special Cosmetics Change Application Form or General Cosmetics Change Information Form; (II) Product formula; (III) Description of the change, including the reason of the change and the application purpose of the changed components in the ingredients, etc.; (IV) Product safety assessment document of the product to be changed; (V) Where the product executive standards change, the executive standards to be changed shall be submitted; (VI) If the items to be changed involve changes in the labeling of all ingredients, safety warnings, etc. in the product label sample manuscript, the product label sample manuscript to be changed shall be submitted.

Although the Provisions has allowed self-updating the ingredient manufacturers information by notifiers via NMPA’s general cosmetics notification information system, but since the corresponding functions have not been activated on the system, the changes of this information can only be updated through the notification change application, rather than by themselves.

Activated "Ingredient Safety Information Self-Update" Function

On December 8, 2022, China Cosmetics Notification System announced that a new function of "Ingredient Safety Information Self-Update" had been added to the general cosmetics notification information system. The function provides different solutions for the following two types of ingredient information changes: ¹

The newly added

In case of any changes to the ingredient manufacturers and the ingredient quality specifications but the content of the ingredients used in the formula as well as the types and proportions of the specific components in the ingredients have not been changed, the enterprises are allowed to use this new function for self-updating and maintenance.
In case of any changes in the types or contents of trace stabilizers, antioxidants, preservatives, and other components added to ensure the ingredients’ quality, but the content of the ingredients in the formula and the content of main functional components and solvents in the ingredients have not been changed, the enterprise shall apply for notification change with the submission of the required documents listed above, including general cosmetics change information form, product formula, description of the change, etc.

Industry Comments

In actual production, it is very common to change or increase manufacturers for the same ingredient. The previous practice requires notification change application with NMPA for every change, which is not only time-consuming, but also may lead to the rejection of the notification because of various reasons other than the reasons related to change itself.
The newly added "Ingredient Safety Information Self-Update" function allows cosmetics companies to update or add ingredient submission codes and ingredient manufacturers without applying for notification changes, provided that the composition and proportions of ingredients remain unchanged. This is a good news for cosmetics companies, as it will make the notification of cosmetics more flexible and significantly facilitate the operation of companies.
However, it shall be noted that if the type or content of trace stabilizers, antioxidants, preservatives and/or other components in the ingredients change, the updated information cannot be updated directly through this function, and is still subject to the notification change application as before.
This new function can also help solve another problem that has plagued the industry for a long time—correcting errors in ingredient safety information. Previously, many cosmetics companies reported that some ingredient manufacturers did not fill in and submit the ingredient safety information carefully, resulting in errors in the generated ingredient safety information. The cosmetic ingredient safety information submission platform did not allow changes and error correction for various reasons. As a result, the wrong ingredient safety information submitted by the ingredient manufacturer will affect the authenticity and standardization of the cosmetic notification dossiers.
With the new function activated, this situation can be avoided. If the original ingredient safety information is wrong, the cosmetics company can ask the ingredient manufacturers to re-submit the ingredient safety information to obtain a new ingredient submission code, so that they can directly update the correct ingredient submission code in the notification system. ²
In addition, the launch of this new function by NMPA will greatly facilitate the supplementation work of ingredient safety information of cosmetics companies. According to the Provisions, from January 1, 2023, the newly registered and notified cosmetics shall provide safety information of all ingredients. For cosmetics that have been registered or notified before January 1, 2023, the registrant and notifier shall supplement safety information of all ingredients before May 1, 2023.