[Updated] China SAMR Implements Administrative Measures on Toothpaste: Notification Mandatory for All Toothpastes

On March 23, 2023, China SAMR issued the finalized Administrative Measures on Toothpaste, which 1) clarifies the responsibilities of all stakeholders; 2) clarifies toothpaste’s definition; 3) clarifies management requirements for toothpaste products and new ingredients; 4) clarifies requirements for toothpaste safety assessment, efficacy claims and labeling; 5) clarifies the ongoing use of the existing toothpaste production licensing system.

Editor's Note: This article was originally published on March 24, 2023, and was updated on December 5, 2023, as per the latest developments.

Updates

Administrative Measures on Toothpaste (Measures) came into effect on December 1, 2023. Toothpaste must adhere to the requirements outlined in the Measures. For Chinese domestic toothpaste, notification should be submitted to the provincial medical products administration department in the notifier's location prior to market entry. Imported toothpaste must be notified to the National Medical Products Administration (NMPA) before importation.

According to Cosmetic Supervision and Administration Regulation (CSAR), toothpaste shall be managed with reference to the provisions on general cosmetics. In order to implement this provision and standardize the supervision of toothpaste, on March 23, 2023, China State Administration for Market Regulation (SAMR) issued the finalized Administrative Measures on Toothpaste (Measures) and will implement it on December 1, 2023. ¹

Encompassing 25 articles, the Measures mainly

Clarifies the responsibilities of all stakeholders;
Clarifies toothpaste’s definition;
Clarifies the management requirements for toothpaste products and new ingredients;
Clarifies the ongoing use of the existing toothpaste production licensing system;
Clarifies the requirements for toothpaste safety assessment, efficacy claims and labeling.

In addition, the Measures emphasizes that matters not specified shall be managed with reference to Administrative Measures on Cosmetics Registration and Notification and Supervision and Administration Measures on Cosmetics Produce and Operation.

[Updated] China SAMR Implements Administrative Measures on Toothpaste: Notification Mandatory for All Toothpastes

Specifics of the Measures

1. Clarifying the responsibilities of all stakeholders