China's toothpaste catalogue links efficacy codes and claims, requiring coordinated filing, labeling, and inventory planning
Product classification combines efficacy and user-group codes
The National Medical Products Administration (NMPA) has published the Toothpaste Classification Catalogue through Announcement No. 100 of 2026. It establishes eight efficacy categories and requires filing entities to select codes based on both efficacy and the intended user group. The catalogue takes effect on May 1, 2027; toothpaste filed before that date must have its filing information amended before January 1, 2028.
The catalogue places efficacy mechanisms, claim wording, and user groups within a single classification system. In practice, companies need to review filing codes, product labels, and proposed claims together. Changing a code alone will not resolve an out-of-scope label claim or a mismatch between the user group and the claimed benefit. Products with multiple benefits or suitable for different user groups may select multiple corresponding codes, subject to the requirements for each category and user group.
Three levels of control govern claim wording
The eight efficacy categories are subject to different controls on wording. Label reviews should therefore first identify the relevant category and then assess whether wording may be adapted, instead of applying one rewriting rule to every claimed benefit.
| Efficacy codes and categories | Wording limits | Review focus |
|---|---|---|
| 01 Basic cleaning | Restricted to the listed terms; the official interpretation states that filing entities may not independently add, remove, or alter them | Check that the wording actually used appears in the list |
| 02 Anticaries, 03 Plaque inhibition, 04 Dentin hypersensitivity relief, 05 Gum-problem relief | The meaning and underlying efficacy must be the same as or similar to the listed terms | Rewording must not expand the nature of the benefit or turn it into a medical-effect claim |
| 06 Stain removal and whitening, 07 Anticalculus, 08 Bad-breath relief | Examples may be adapted or supplemented according to the actual product | Wording must match actual efficacy and remain compliant with other applicable requirements |
Descriptions of sensory experiences such as color, smell, and taste fall outside the efficacy-claim wording covered by the announcement. This distinction does not remove the label's overall compliance obligations. Efficacy wording combined with other terms must likewise not expressly or implicitly claim medical effects.
In the attachment, freshening breath belongs to basic cleaning, while relieving bad breath belongs to a separate efficacy category. Reducing plaque through cleaning is listed under basic cleaning, whereas plaque inhibition has its own specified mechanisms. Similar keywords therefore do not necessarily indicate the same category. Companies should consider the complete phrase, mechanism, and actual product characteristics rather than selecting codes by keyword alone.
For children's products, check the permitted efficacy scope first
User-group code 01 covers children aged 12 and under and permits only basic-cleaning and anticaries claims. Code 02 covers people over 12 and allows claims within all efficacy categories in the catalogue.
Reviews of children's products should first establish the permitted efficacy scope for the user group and then address label wording. A term's suitability for an adult product, or its inclusion in a category with adaptable claim examples, does not make it automatically suitable for children's toothpaste. Combining user-group codes likewise does not expand the efficacy scope available for children.
The effective date, filing amendment deadline, and inventory provisions serve different purposes
Toothpaste newly filed from May 1, 2027 must meet the catalogue's classification-code and efficacy-claim requirements. For toothpaste filed before the catalogue takes effect, filing information must be amended before January 1, 2028.
For toothpaste filed before implementation, products manufactured or imported before the filing entity completes the amendment may continue to be sold lawfully until the end of their shelf life, provided there are no product quality or safety issues. Assessing inventory eligibility therefore requires the actual filing-amendment date and the manufacturing or import date. The catalogue's effective date should not be treated as a universal sales cutoff.
Companies should plan separately for new filings, existing filed products, and the relevant inventory. For existing products, the filing amendment schedule can be checked against label changes, manufacturing batches, and import plans. Focusing only on the final amendment deadline could leave companies without the records needed to assess whether inventory qualifies for the transitional treatment.
A dynamic adjustment mechanism accommodates future developments
The official interpretation explains that toothpaste is managed through filing by reference to general cosmetics and that a registration route for toothpaste with new efficacy claims cannot be established by analogy with the cosmetics system. The catalogue instead provides for dynamic adjustment of efficacy categories in light of research and regulatory practice. New mechanisms and claim wording may also be added or revised through that process after sufficient substantiation and industry consensus.
A new phrase or mechanism under development therefore cannot be treated as already admitted to the current catalogue merely because a future adjustment is possible. Companies should check the catalogue in force when initiating a product project and finalizing its label, and separately assess the regulatory route for innovative claims outside its scope.
Apply the classification review to filing and labeling materials
Filing entities should consider a product-level matrix linking efficacy mechanisms, proposed claims, user-group codes, efficacy codes, and label versions, with the required changes and completion dates recorded. This is an internal compliance recommendation; the announcement does not prescribe a standardized form.
Products with multiple benefits or intended for children can be prioritized for review. For existing products, companies should also organize manufacturing, import, and inventory records relating to the period before filing amendments. This approach connects classification decisions, dossier changes, and market-facing label transitions within one implementation plan.
Regulix® can provide China market-access regulatory assessments related to toothpaste filing, help companies review classification and claim requirements, prepare and review filing-amendment materials, and support consistency checks between filing information and labeling.
