Background Cosmetic Supervision and Administration Regulation (CSAR), effective from January 1, 2021, mandates that toothpaste must be regulated with reference to general cosmetics regulations. Three years later, on December 1, 2023, China implemented Administrative Measures on Toothpaste (Measures) and Provisions for Management of Toothpaste Notification Dossiers (Provisions), which marked the official commencement of toothpaste notification procedures and a new era for toothpaste regulation.   The Measures introduces a registration and notification system for new toothpaste ingredients. Natural and artificial ingredients used in toothpaste for the first time within the territory of the People's Republic of China are new toothpaste ingredients. Toothpaste ingredients with preservative or coloring functions require registration with National Medical Products Administration (NMPA), while others are subject to notification administration.

To better enforce toothpaste administration regulations and assist companies in determining the regulatory status of their ingredients, NMPA authorized China Oral Care Products Industry Association (COCIA) to compile the initial Inventory of Existing Toothpaste Ingredients in China. COCIA began collecting existing toothpaste ingredients from companies on July 29, 2020.

On January 12, 2024, COCIA released the initial version of the Inventory, comprising 1,026 ingredients. ¹ The Inventory includes information such as the Chinese name, INCI/English name, highest historical use concentration, and note. For ingredients with specific usage requirements stated in GB 22115 General Requirements on Raw Materials of Toothpastes, the note in the Inventory indicates that these ingredients should be used in accordance with the requirements of GB 22115.

The full Inventory can be found in Coslist.

Excerpts of Inventory of Existing Toothpaste Ingredients in China

All the ingredients listed in the Inventory have a usage history of three years or more. When conducting safety assessments for toothpaste, companies can reference to the highest use concentration of ingredients in the Inventory as an evidence of ingredient safety.

For ingredients not included in the Inventory:

• If the marketed product contains such ingredients and has undergone simplified notification, the company is responsible for monitoring the product's adverse reactions;

• If such ingredients have not been used in toothpaste product, the company must register or notify the ingredients in accordance with the Provisions for Management of Toothpaste Notification Dossiers.

ChemLinked expects to assist enterprises in notifying toothpaste in China. If you have any further toothpaste compliance consultation needs, please contact us at [email protected].

Further Reading

• China SAMR Implements Administrative Measures on Toothpaste: Notification Mandatory for All Toothpastes

• China Simplifies Notification Document Requirements for Marketed Toothpastes

• China Finalizes Detailed Dossier Requirements for Toothpaste Notification

• Webinar | Ensure Compliance with China's New Toothpaste Notification Regulations