China Relaxes the Requirements for Cosmetics Ingredient Safety Information Submission

In addition to ingredient suppliers, cosmetic registrants, notifiers and domestic responsible person are now allowed to fill in and submit ingredient safety information documents by themselves on the premise of obtaining authorization from ingredient suppliers.

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 the submission of cosmetic ingredients safety information, which requires that:

Starting from Jan. 1, 2022, for newly registered and notified cosmetics, the applicant shall provide safety information (ingredient safety information documents, namely Annex 14 of the Provisions, or the ingredient submission code) of preservative, sunscreen, colorant, hair dye, as well as freckle removing and whitening ingredients;
Starting from Jan. 1, 2023, for newly registered and notified cosmetics, the applicant shall provide safety information on all ingredients. For cosmetics previously registered or notified, registrants or notifiers shall supplement safety information of all the ingredients in the product formula before May 1, 2023.

On Dec. 31, 2021, the Cosmetic Ingredients Safety Information Submission Platform came into service. Cosmetic ingredient manufacturers or their authorized enterprises can log on to the platform to apply for ingredient submission codes. As of Sept. 30, 2022, the submission platform has recorded 150,660 pieces of ingredient submission code information. Nonetheless, since the platform allows different suppliers of the same ingredient to obtain their own unique ingredient submission codes, the actual number of ingredients that have applied for an ingredient submission code is nowhere near the number required for cosmetic registration and notification.

Relaxed Requirements

Given the above changes and situations, China’s National Institutes for Food and Drug Control (NIFDC) issued a notice on Sept. 28, 2022, providing two feasible solutions for enterprises whose ingredients have not yet obtained the ingredient submission code when applying for cosmetic notification or registration. The registrant, notifier or domestic responsible person can, according to their own situation:

Provide ingredient quality specification documents or ingredient safety information (Annex 14 of the Provisions) stamped with the official seal of the ingredient manufacturer. It is worth noting that the registrant or domestic responsible person should also stamp the official seal page by page on the documents;
In the case that the ingredient manufacturer authorizes the registrant, notifier or domestic responsible person to fill in Annex 14, provide Annex 14 stamped with the official seal of the registrant, notifier or domestic responsible person, and make the following remarks under "other issues that need explanation":

ChemLinked Comments

In the past, when filling in and submitting product registration or notification dossiers, cosmetic registrants and notifiers need to either fill in the ingredient submission code to directly link with the ingredient safety information or submit Annex 14 provided by the ingredient manufacturer.

The new rule practically provides a new option for cosmetic registrants and notifiers to fill in and submit Annex 14 on their own through authorization from ingredient suppliers. Such submission method can partly alleviate the difficulties faced by enterprises in submitting ingredient safety information at this stage, and facilitate the cosmetic registration and notification process.

*ChemLinked expects to assist companies in applying for ingredient submission codes and registering/notifying cosmetics in China. If you have any further cosmetic compliance consultation needs, please contact us at [email protected].