导航菜单
On October 15, 2026, China's National Medical Products Administration (NMPA) issued Announcement No. 100 of 2026, introducing the Toothpaste Classification Catalogue. The new catalogue establishes a unified framework for classifying toothpaste products based on their efficacy claims and intended users, while setting clearer requirements for product filing and labelling.
The catalogue will take effect on May 1, 2027, with transitional arrangements for products already on the market.
The catalogue divides toothpaste products into eight efficacy categories, each with defined mechanisms of action and corresponding claim wording.
| Code | Efficacy Category |
|---|---|
| 01 |
Basic Cleaning |
| 02 |
Anti-Caries |
| 03 |
Anti-Plaque |
| 04 |
Anti-Dentin Sensitivity |
| 05 |
Gum Care |
| 06 |
Stain Removal and Whitening |
| 07 |
Anti-Tartar |
| 08 |
Bad Breath Reduction |
Based on the level of risk associated with each category, the NMPA has established three levels of claim management:
Basic cleaning: Claims are strictly limited to the wording listed in the catalogue, without additions or modifications.
Anti-caries, anti-plaque, anti-dentin sensitivity and gum care: Claims must be identical or similar in meaning and intended effect to those listed in the catalogue, allowing some flexibility in wording.
Stain removal and whitening, anti-tartar and bad breath reduction: The listed claims serve as examples, and companies may develop their own wording based on the product's actual effects.
The catalogue also distinguishes between two user groups:
Children aged 12 and under: Only basic cleaning and anti-caries claims are permitted.
Individuals over 12: All eight efficacy categories are permitted.
When filing a toothpaste product, companies must select the appropriate classification codes based on its efficacy and intended users. Multiple codes may be selected if a product offers several benefits or is intended for different user groups.
The NMPA has established a mechanism to update the catalogue in response to scientific advances, industry developments and regulatory needs.
As toothpaste is regulated under the filing framework for general cosmetics in China, there is no separate registration pathway for toothpaste products with new efficacy claims. Instead, future updates to the catalogue may introduce new efficacy categories, mechanisms of action and claim wording.
The catalogue will take effect on May 1, 2027, with the following arrangements:
New product filings: Products filed on or after May 1, 2027, must comply with the new classification codes and efficacy claim requirements.
Existing product filings: Products filed before the implementation date must have their filing information updated before January 1, 2028, to comply with the catalogue.
Existing inventory: Products filed before the implementation date and manufactured or imported before the relevant filing information is updated may continue to be sold until their expiry dates, provided there are no quality or safety issues.
These arrangements give companies time to update their product filings and manage existing inventory during the transition.
