China’s NMPA Seeks Public Feedback on First Mandatory Toothpaste Safety Standard

On March 30, 2026, the National Medical Products Administration (NMPA) launched a public consultation on the mandatory national standard “General Technical Requirements for Toothpaste Safety (Draft for Public Comment).” The consultation, open through May 29, 2026, invites feedback from stakeholders across the toothpaste industry and forms part of China’s ongoing effort to strengthen oversight of cosmetic product safety.

If adopted, the standard would introduce the first mandatory national safety framework specifically for toothpaste in China, replacing a regulatory approach that has until now relied largely on recommended technical standards.

From Recommended Guidance to Mandatory Safety Requirements

The draft standard reflects a broader regulatory progression in China, where oversight of toothpaste has gradually been formalized in recent years. Several regulatory steps have already laid the foundation for the proposed mandatory standard:

• 2021 - Cosmetics Supervision and Administration Regulation: Toothpaste was formally brought under cosmetics management and regulated with reference to ordinary cosmetics.
• 2023 - Measures for the Supervision and Administration of Toothpaste and Regulations on the Management of Toothpaste Filing Data: These rules introduced dedicated filing requirements, safety assessment obligations, and clearer responsibilities for toothpaste filers.
• 2024 - Updates to the "Technical Specifications for Cosmetics Safety: Multiple toothpaste testing methods, including methods such as pH testing, were incorporated as official inspection methods for filing and supervision.

Despite these regulatory developments, a mandatory national safety standard specifically for toothpaste has not yet existed. The proposed "General Technical Requirements for Toothpaste Safety" is intended to close that gap by establishing baseline safety requirements for toothpaste produced or marketed in China.

The move is particularly notable given the scale of the domestic market. China is now the world's largest producer and consumer of toothpaste, increasing the importance of consistent product safety standards.

What the Draft Standard Covers

The draft standard goes beyond broad safety language and sets out a structured technical framework for toothpaste products. It covers areas including:

• Raw material safety
• Microbiological indicators
• Physicochemical indicators
• Hazardous substance limits
• Packaging material safety
• Labeling requirements
• Transportation and storage conditions

It also refines certain technical requirements already relevant in practice, including provisions related to fluoride content, microbial limits, hazardous substance controls, and oral mucosal irritation testing.

Together, these elements suggest that the proposed standard is intended not simply to restate existing principles, but to consolidate them into a single mandatory reference point for product safety assessment and regulatory review.

NMPA Opens Public Consultation on Toothpaste Safety Requirements

The consultation period allows cosmetics companies, including overseas manufacturers, brand owners, and importers, to review the draft provisions and submit comments on potential technical or implementation concerns.

Once the consultation closes, the NMPA will review submitted comments before advancing the standard through China’s national standard approval process. As is typical for mandatory standards, several months may pass between the consultation stage and the publication of the final regulation.

Although an effective date has not yet been announced, the drafting group has proposed a 12-month transition period between publication and implementation to allow manufacturers sufficient time to adjust product formulations, packaging, and production processes.

Because China is one of the world’s largest exporters of toothpaste products, the standard may also be notified to the World Trade Organization (WTO) due to its potential implications for international trade.

What the Draft Standard May Change for Overseas Manufacturers

For foreign toothpaste brands, importers, and contract manufacturers, the introduction of a mandatory safety framework may change both the depth and timing of regulatory scrutiny applied to toothpaste products entering the Chinese market.

Higher Short-Term Compliance Adjustment Costs

Companies may need to review product formulations, labeling, and technical documentation to confirm alignment with the proposed safety framework. Products currently marketed in China under the recommended standards system could require adjustments if the final standard introduces different or more explicit technical criteria.

Stricter Filing Reviews and Import Clearance

The presence of a mandatory technical standard may also influence how authorities evaluate toothpaste products during product filing reviews and customs clearance. Once formal safety benchmarks are in place, regulators may assess product documentation more directly against the technical provisions of the standard.

This could lead to more structured and potentially more detailed regulatory review during both product registration and import procedures.

Greater Regulatory Consistency Over Time

While the transition may introduce short-term compliance adjustments, the introduction of a dedicated safety standard may ultimately bring greater clarity to regulatory expectations for toothpaste products entering the Chinese market.

Over time, the presence of a dedicated national safety standard may reduce uncertainty around regulatory expectations by providing a more explicit reference point for both regulators and companies during product assessment.

Using the Consultation Period to Prepare

For international manufacturers producing or supplying toothpaste products to China, early review of the draft requirements can help identify potential compliance gaps and inform regulatory planning.

Preparation at this stage may include:

• Evaluating how the draft safety parameters align with existing product specifications and internal quality documentation
• Identifying technical provisions that may introduce ambiguity or implementation challenges in regulatory review
• Assessing whether proposed requirements could affect future product filing strategies or documentation expectations
• Preparing technically grounded feedback that regulators can consider during the standard revision process

Because mandatory national standards often become the reference point for regulatory interpretation and enforcement, engagement during the consultation phase can help companies anticipate how safety requirements may be applied once the framework enters into force.

Preparing for China’s Evolving Toothpaste Regulations

The proposed draft standard introduces technical provisions that may require careful interpretation before companies can assess their implications for product specifications, supporting documentation, and product filing strategies. For manufacturers operating outside China, evaluating these requirements — and responding effectively during the consultation process — can present practical regulatory challenges.

In this context, local regulatory expertise becomes particularly valuable. With an on-the-ground presence in China, Cisema supports global companies in interpreting evolving cosmetics regulations, conducting compliance gap analysis, and preparing technically grounded consultation submissions.

For companies seeking support in interpreting draft regulations, evaluating compliance implications, or preparing consultation submissions, contact Cisema today.

Further Information

Explore Cisema’s services for China cosmetics registration.

References

For the official announcement, see the NMPA public consultation notice on the “General Technical Requirements for Toothpaste Safety (Draft for Public Comment).”

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