Consisting of 11 parts, the Guidelines specifies cosmetic registrants’ and notifiers’ responsibility for ingredient quality and safety, refines the requirements for filling in and submitting ingredient safety information, as well as gives instructions on handling changes to ingredient safety information.

Background

• According to the Provisions for Management of Cosmetic Registration and Notification Dossiers (the Provisions), when applying for cosmetic registration and notification, it is required to submit ingredient safety information.
• On March 27, 2023, National Medical Products Administration (NMPA) announced to extend the transition period of the cosmetic ingredient safety information submission policies to January 1, 2024. Since then, the cosmetic registrant or notifier shall fill in and submit the ingredient safety information documents for all ingredients used in the product formula per relevant regulations and technical specifications.

In May 2023, China National Institutes for Food and Drug Control (NIFDC) initiated a public consultation on the Technical Guidelines for Filling in and Submitting Safety Information of Cosmetic Ingredients (the Guidelines).¹ On September 4, 2023, NIFDC released the finalized Guidelines with immediate effect.

The Guidelines consist of 11 parts and systematically outline vital points and technical principles for filling in and submitting ingredient safety information, covering aspects of ingredient basic information, brief descriptions of ingredient production technique, necessary quality control requirements, limit requirements for risk substances, etc. It should be noted that the Guidelines is applicable to situations where cosmetic registrants, notifiers and Chinese domestic responsible persons fill in and submit ingredient safety information in cosmetic registration or notification documents on their own, and not applicable to cases where ingredient manufacturers fill in and submit ingredient safety information through the Cosmetic Ingredients Safety Information Submission Platform.

Source: ChemLinked

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