China NMPA Introduces Eight Toothpaste Efficacy Categories: What Changes in 2027?

On October 15, 2026, China’s National Medical Products Administration (NMPA) published the Toothpaste Classification Catalog (Announcement No. 100 of 2026), establishing a unified framework for toothpaste efficacy classification, product codes, and claims. The Catalog addresses inconsistencies in how toothpaste efficacy has been classified and claimed, providing a standardized technical basis for product filing, efficacy assessment, and labeling in China.

The Catalog takes effect on May 1, 2027, when newly filed products must comply with its classification and claim requirements. Existing filed products must update their filing information by January 1, 2028, including any necessary revisions to classification codes, efficacy claims, labeling, and supporting documentation. Products manufactured or imported before these filing updates are completed may continue to be sold until the end of their shelf life, provided they have no product quality or safety issues.

The requirements apply to toothpaste filed, manufactured, or imported in China. Overseas manufacturers must file through their domestic responsible person before importation.

Eight Toothpaste Efficacy Categories Introduced

Under the Cosmetics Supervision and Administration Regulation, toothpaste is managed in accordance with the provisions applicable to general cosmetics. The Measures for the Supervision and Administration of Toothpaste, effective December 1, 2023, established the filing and efficacy-claim framework and required the NMPA to develop a classification catalog.

The new Catalog divides toothpaste efficacy claims into eight categories:

• Basic cleaning
• Cavity prevention
• Plaque inhibition
• Relief of dentin hypersensitivity
• Relief of gum problems
• Stain removal and whitening
• Anti-calculus
• Relief of bad breath

For each category, the Catalog specifies corresponding efficacy mechanisms and permitted claim terminology, providing a technical basis for classifying products and evaluating their efficacy claims.

The Catalog also restricts efficacy claims for children's toothpaste. Products intended for children aged 12 and under (inclusive) may only claim basic cleaning and cavity prevention.

When filing toothpaste products in China, companies must select the applicable efficacy classification codes according to both the product's efficacy and intended user groups. Multiple codes may be selected where a product has several efficacy functions or is suitable for different user groups.

New Requirements for Toothpaste Efficacy Claims and Labeling in China

The Catalog establishes different requirements for efficacy claim terminology across the eight categories. Manufacturers and importers must ensure that product claims comply with the applicable requirements when preparing filing documentation, packaging, and marketing materials.

The requirements are divided into three groups:

• Basic cleaning: Claims must be strictly limited to terminology listed in the Catalog.
• Cavity prevention, plaque inhibition, dentin hypersensitivity relief, and gum problem relief: Claims must be semantically and substantively equivalent or similar in efficacy to the listed terminology.
• Stain removal and whitening, anti-calculus, and bad breath relief: Claims may be adjusted or supplemented based on the Catalog’s examples and the product’s actual characteristics.

The three-tier approach reflects the different risk levels associated with each efficacy category. Claims relating to cavity prevention, plaque inhibition, dentin hypersensitivity, and gum problems receive tighter controls because of their closer relationship to oral health and the potential for misleading or exaggerated claims.

Descriptions of sensory characteristics, such as color, smell, and taste, are not considered efficacy claims and fall outside the Catalog's claim terminology restrictions.

Across all categories, toothpaste claims must not explicitly state or imply medical effects, including when combined with other wording. Companies should therefore assess claims in context, reviewing not only individual efficacy terms but also the overall wording of product labels and marketing materials.

Future Adjustments to Toothpaste Efficacy Categories

The NMPA has established a dynamic adjustment mechanism to accommodate scientific advances and developments in the toothpaste industry. Although the current Catalog covers established toothpaste efficacy categories, new efficacy types and mechanisms may emerge. The NMPA may revise or expand the Catalog following sufficient technical evaluation and industry consensus.

However, toothpaste is managed under the general cosmetics filing framework and does not have access to the separate new-efficacy registration pathway available for cosmetics. Any new toothpaste efficacy categories or mechanisms must therefore be considered through the Catalog's adjustment mechanism.

Key Compliance Actions for Toothpaste Manufacturers and Importers

The transition deadlines give companies time to assess their portfolios, but products with non-compliant claims or labeling may require coordinated changes to filing information and packaging. 

Companies marketing toothpaste in China should:

• Review existing and pipeline toothpaste products: Compare efficacy claims and labeling against the Catalog, identifying wording that exceeds the permitted scope or may imply medical effects.
• Confirm toothpaste efficacy classification codes: Select the appropriate codes based on efficacy and intended user groups, and update filing documentation.
• Coordinate toothpaste label and packaging revisions: Align overseas manufacturers and domestic responsible persons on claim wording, label designs, and supporting documentation.
• Plan filing changes: Establish a schedule for updating existing products and complete submissions before January 1, 2028.
• Prepare for regulatory inspections: Ensure that efficacy claims, classification codes, labeling, and supporting documentation are consistent with the Catalog. Following implementation, regulatory authorities will strengthen inspections and take enforcement action against non-compliant efficacy claims.
• Monitor NMPA regulatory developments: Track subsequent NMPA interpretations and revisions. The Catalog is subject to a dynamic adjustment mechanism, so companies should account for potential changes in their ongoing compliance procedures.

Preparing for China's New Toothpaste Regulations

While the Catalog brings long-awaited clarity to toothpaste classification and marketing in China, it also presents a critical hurdle: many existing product portfolios will require strategic updates to claims, classification codes, and packaging artwork. Identifying these regulatory gaps early gives your business the lead time needed to prioritize revisions and complete filing updates seamlessly ahead of strict enforcement deadlines.

To ensure your portfolio transitions smoothly, Cisema delivers comprehensive, end-to-end regulatory support, from thorough claim and label audits and precise classification code assignments to in-depth gap analyses and streamlined filing update management.

To assess your toothpaste portfolio and prepare for China's new toothpaste regulations taking effect in 2027, contact Cisema today.

Further Information

• Explore Cisema’s services for cosmetics registration in China.

References

• Announcement of the National Medical Products Administration on Issuing the "Classification Catalog for Toothpaste" (No. 100 of 2026) 国家药监局关于发布《牙膏分类目录》的公告（2026年第100号）
• Policy Interpretation of the "Classification Catalog for Toothpaste" 国家药监局《牙膏分类目录》政策解读