On December 1, 2025, China's National Medical Products Administration (NMPA) issued the Draft Catalogue for Toothpaste Classification for public consultation, with the comment period open until December 22, 2025.
According to the draft, toothpaste notifier will be required to assign a product classification code when submitting a notification, based on the product’s efficacy category and target user group. Efficacy categories are detailed in Annex 1, while user groups are outlined in Annex 2.
Annex 1 establishes eight efficacy categories, each with a specific code, mechanism of action, and recommended claim wording:
01 Basic Cleaning
02 Anti-Caries
03 Plaque Inhibition
04 Anti-Dentin Sensitivity
05 Gum Care
06 Stain Removal & Whitening
07 Anti-Calculus
08 Fresh Breath
Annex 2 defines two user groups:
Individuals aged 12 and above (non-children's toothpaste)
Children aged 12 and under (labelled as "children's toothpaste")
Toothpaste intended for children may only carry claims under categories 01 (Basic Cleaning) and 02 (Anti-Caries).
Under the draft, notifiers must select the appropriate efficacy category and user group in sequence to form the product classification code.
The efficacy categories must not exceed the scope specified in Annex 1.
Products must remain consistent with the mechanism of action described for the selected category.
For categories 01-05, claim wording must strictly follow Annex 1.
For categories 06-08, claim wording may be adjusted or expanded with reference to the provided examples.
https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjhzhp/20251201152806143.html
