On October 15, 2026, to strengthen toothpaste supervision, standardize toothpaste efficacy classification and claims, and protect consumers’ oral health, China National Medical Products Administration (NMPA) released the Toothpaste Classification Catalog (hereinafter referred to as the “Catalog”). Based on oral science and industry development practice, the Catalog systematically classifies toothpaste efficacy into eight categories. CIRS Group has summarized the Catalog and the official policy interpretation below for your reference.
The relevant matters are hereby announced as follows:
1. When notifying toothpaste, the notifier shall select the corresponding codes in accordance with the Catalog based on the toothpaste’s efficacy category and target users, and combine them to form the product classification code. Where a toothpaste has the efficacy of multiple categories and suits different user groups at the same time, multiple corresponding codes may be selected simultaneously.
2. The efficacy claims that may be made for toothpaste shall fall within the scope determined by the Catalog:
(1) Basic cleansing toothpastes: the efficacy claim wording shall be strictly limited to the scope of claim wording listed for the corresponding category in the Catalog.
(2) Anti-caries, anti-dental plaque, anti-dentin sensitivity, and gum problem relief toothpastes: the efficacy claim wording shall be identical or similar in meaning and substantive efficacy to the claim wording listed for the corresponding category in the Catalog.
(3) Stain removal and whitening, anti-tartar, and bad breath relief toothpastes: the efficacy claim wording may refer to the examples of claim wording listed for the corresponding category in the Catalog, and be adjusted or supplemented according to actual conditions.
Content on toothpaste labels describing sensory experiences such as the product’s color, smell and taste does not constitute efficacy claim wording and is not subject to the scope of claim wording listed in the Catalog.
3. Where the efficacy claim wording on toothpaste labels is used in combination with other words, it shall comply with laws and regulations, mandatory national standards, technical specifications and other relevant requirements, and shall not expressly indicate or imply medical effects or the like.
4. The Catalog will take effect on May 1, 2027. For toothpastes notified before the Catalog takes effect, notifiers shall complete the change of notification information before January 1, 2028 so that their products comply with the Catalog; toothpastes that have been produced or imported before the notifier completes the change of notification information may be sold lawfully until the end of the product’s shelf life.
Drug regulatory departments at all levels shall guide and urge toothpaste notifiers and toothpaste manufacturers to implement the requirements of this announcement and standardize toothpaste efficacy classification and claims. After the Catalog takes effect, they shall strengthen supervision and inspection, and investigate and punish, in accordance with the law, acts that fail to comply with the Catalog or that claim toothpaste efficacy illegally.
NMPA will establish a dynamic adjustment mechanism for the Catalog and adjust it in due course in light of scientific research progress, industry development and the actual practice of toothpaste regulation.
Official Policy Interpretation
1. Background of the Catalog
The Cosmetic Supervision and Administration Regulations provides that toothpaste is regulated with reference to the provisions for general cosmetics. The Measures for the Supervision and Administration of Toothpaste further clarify the institutional framework for toothpaste notification management and efficacy claims, and stipulate that the National Medical Products Administration shall formulate, publish and adjust the toothpaste classification catalog based on factors such as toothpaste efficacy claims and user groups.
In recent years, China’s oral care market has developed rapidly and toothpaste efficacy claims have become increasingly diversified, with some products involving non-standardized claims, exaggerated efficacy or even implied medical effects. There has been a lack of unified implementation standards for how toothpaste efficacy should be classified and how claims should be standardized.
The Catalog is formulated precisely to fill this institutional gap. By scientifically classifying toothpaste efficacy categories and defining the scope of claim wording, it provides clear technical guidance for toothpaste regulation and safeguards consumers’ oral health and legitimate rights and interests.
2. Efficacy Categories and Management Requirements
Based on oral science and industry development practice, the Catalog systematically classifies toothpaste efficacy into eight categories: basic cleansing, anti-caries, anti-dental plaque, anti-dentin sensitivity, gum problem relief, stain removal and whitening, anti-tartar, and bad breath relief. Each category specifies the corresponding efficacy mechanism and claim wording, forming a complete technical system for toothpaste efficacy classification.
Based on the risk level of each efficacy, the Catalog divides the management of claim wording into the following three scenarios:
Scenario 1: basic cleansing. Basic cleansing is the most fundamental functional attribute of toothpaste and the basic efficacy shared by all toothpastes. The claim wording is strictly limited to that listed in the Catalog, and notifiers may not add, remove or change it on their own. This is intended to prevent companies from using the basic cleansing concept for excessive embellishment and exaggerated publicity, so as to avoid misleading consumers.
Scenario 2: anti-caries, anti-dental plaque, anti-dentin sensitivity, and gum problem relief. These four efficacies are closely related to consumers’ oral health, carry relatively high safety risks, and have occasionally been subject to illegal and non-compliant publicity in the past. The Catalog applies relatively strict management over the claim wording: the claim wording of products must be identical or similar in meaning and substantive efficacy to the claim wording listed for the corresponding category in the Catalog, which strictly defines the scope of product claims while allowing toothpaste notifiers a degree of flexibility for differentiated claims.
Scenario 3: stain removal and whitening, anti-tartar, and bad breath relief. These three efficacies focus on general oral cleansing and care, with relatively low safety risks. The Catalog treats the listed wording of the corresponding categories as reference examples, allowing toothpaste notifiers to design claim wording independently according to actual product conditions to meet diversified market demands.
3. Dynamic Adjustment Mechanism of the Catalog
Given that the Cosmetic Supervision and Administration Regulation clearly provides that toothpaste is subject to notification management with reference to general cosmetics, a registration channel for “new-efficacy toothpastes” cannot be established by reference to the cosmetics system. The Catalog currently covers basically all mature toothpaste efficacy categories on the market, but considering scientific and technological progress and industry development, new efficacy types may still emerge in the future. To this end, the Catalog establishes a dynamic adjustment mechanism, reserving institutional space for the inclusion of new efficacy categories. Meanwhile, new efficacy mechanisms and claim wording may also be incorporated through this mechanism in due course after full demonstration and the formation of industry consensus.
Going forward, NMPA will revise and adjust the Catalog in due course in light of scientific research progress, industry development and regulatory practice, so that toothpaste classification management keeps pace with the frontiers of science and technology, fits industrial realities and responds to social concerns.
4. Transition Arrangements for Implementation
The Catalog comprehensively regulates the management of toothpaste efficacy classification and claim wording, with a wide scope and far-reaching impact, and requires a sufficient and well-founded transition period to ensure smooth and orderly implementation of the policy. Based on industry realities, the NMPA Announcement on Issuing the Toothpaste Classification Catalog sets out scientifically designed, phased implementation arrangements on the basis that the Catalog formally takes effect on May 1, 2027:
First, newly notified products. From the date the Catalog takes effect, newly notified toothpastes shall comply with the toothpaste classification codes and efficacy claim requirements stipulated in the Catalog.
Second, notified products. For toothpastes notified before the Catalog takes effect, notifiers shall complete the change of notification information before January 1, 2028 to ensure that their products comply with the Catalog.
Third, produced or imported products. For toothpastes notified before the Catalog takes effect that have been produced or imported before the notifier completes the change of notification information, and where there are no product quality or safety issues, they may continue to be sold lawfully until the end of their shelf life.
These transition arrangements take both the standardization of newly launched products and the destocking of existing products into account, leaving companies ample room for product adjustment while effectively avoiding unnecessary waste of social resources, and fully reflect the regulatory philosophy of being scientific and rigorous, steady and orderly, pragmatic and efficient.
CIRS Reminder
The Toothpaste Classification Catalog will take effect on May 1, 2027. Cosmetics companies are advised to sort out their toothpaste products in advance, standardize classification codes and label claims according to efficacy categories and target users, and make use of the transition period to complete the notification information updates for existing products. Meanwhile, companies should pay attention to the differences in claim control corresponding to different efficacies, so as to avoid non-compliant publicity.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
Our Services
- China Cosmetics Registration and Filing
- China New Cosmetic Ingredients Registration and Filing
- China Toothpaste Filing
- China Cosmetics Safety and Efficacy Test
- Being Domestic Responsible Person
- Safety Evaluation Report
- Cosmetic Ingredient Quality
- Formula/Label/Ingredient Review
- Regulatory Consulting/Reporting/Training
- Custom Clearance
Further Information:
