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 of the ingredient manufacturers’ information by notifiers via NMPA’s general cosmetics notification information system, 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, 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.

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