China NMPA Overhauls Cosmetic Compliance with Strict New Limits & Testing Pathways

On October 8, 2026, China’s National Medical Products Administration (NMPA) released Announcement No. 99 of 2026 (signed September 30, 2026), establishing nationwide transition rules for the revised Technical Safety Specifications for Cosmetics.

These measures apply across mainland China to all registered or notified cosmetics, explicitly including toothpaste. They govern updates to formulas, labels, safety assessments, test reports, and technical execution standards.

Announcement No. 99 sets clear transition pathways for on-market products, pending reviews, and upcoming filings, resolving implementation friction from 2026 updates (Announcements No. 5, No. 6, No. 48, and No. 51) to the foundational 2015 safety framework.

For overseas registrants, the primary compliance task is conducting portfolio self-assessment audits to determine which files remain valid and which require updated assessments, re-testing, or formula adjustments before enforcement deadlines take effect.

Tightened Safety Thresholds and Technical Scope

The 2026 revisions tighten microbiological and chemical impurity limits, update ingredient catalogs, and modernize analytical methods.

These lowered limits require manufacturers to re-evaluate raw material quality, production processes, and quality controls ahead of specific technical enforcement dates.

Crucially, specific technical effective dates govern when each rule takes force. This establishes the exact deadline by which formula modifications or re-testing must be finalized.

Exemption Pathways for Formula Modifications

To reduce administrative burden, Announcement No. 99 creates a simplified modification pathway for qualifying formula changes. This pathway applies when adjustments are made solely to align with revised ingredient restrictions or concentration limits.

When replacing restricted ingredients with base matrix components (e.g., solvents or fillers) or reducing raw material concentrations, overseas registrants can submit an explanatory statement and an updated safety assessment without full re-testing.

However, if formula changes impact declared product efficacy, companies must re-evaluate claims and update labels accordingly. For non-matrix ingredient changes beyond basic base adjustments, full re-testing and safety assessments remain mandatory.

Heightened Compliance for Fragrance and Flavors

Formula adjustments involving fragrances or flavors require a comprehensive safety assessment for any new composition.

Overseas brand owners must also supply official documentation proving fragrance ingredients comply with Chinese National Standards or relevant International Fragrance Association (IFRA) standards. Given supply chain lead times, early engagement with raw material suppliers is critical.

Retainable Test Reports vs. Mandatory Re-Testing

Announcement No. 99 outlines distinct rules depending on whether a product is already registered, under technical review, or in pre-submission planning.

Existing Registered and Notified Products

Companies must audit historical test data against the revised specifications:

• Compliant Data: Where historical testing and assessments satisfy the updated limits and methods, registrants may independently update product execution standards within the NMPA database and maintain internal files for inspection without re-testing.
• Non-Compliant Data: If existing data fails new limits or method updates alter test outcomes, companies must adjust manufacturing controls, re-test, and file formal modifications before enforcement deadlines.

Applications Under Review and Pending Submissions

For products where registration or filing testing was conducted prior to the implementation of the revised specifications, those historical testing reports remain valid for submission.

Special cosmetics currently under technical review may adjust prohibited, restricted, or permitted raw materials during the supplementary material review stage. If changes involve non-matrix ingredients, new testing and safety assessments are required.

Additionally, products registered for testing prior to efficacy method updates (specifically for sunscreen, whitening/anti-freckle, or anti-hair loss claims) are explicitly exempt from re-testing under newly revised efficacy methodologies.

Compliance Action Plan for Foreign Brands

To maintain market access and avoid sales disruptions in mainland China, overseas brand owners should execute four core operational steps:

• Audit registered formulas, labels, raw material specifications, and past test reports against revised catalogs and analytical methods to identify non-compliant SKUs
• Request official compliance certificates from raw material and fragrance suppliers early to confirm adherence to Chinese National Standards or IFRA frameworks
• File explanatory statements and updated safety assessments in the NMPA portal for qualifying base matrix swaps, and update technical execution standards where re-testing is exempt
• Map internal project timelines to NMPA enforcement dates, prioritizing products requiring formula adjustments, full laboratory re-testing, or long-lead documentation

Final Thoughts

Announcement No. 99 establishes a clear yet complex framework, balancing streamlined administrative pathways for minor matrix adjustments against strict re-testing mandates for non-matrix formula updates and method-driven compliance changes. The primary challenge for overseas brands lies in correctly categorizing existing product files to leverage these simplified filing exemptions before individual technical enforcement dates take effect. 

To navigate Announcement No. 99's transition rules without risking China market access, brands can leverage Cisema’s end-to-end regulatory support, including:

• Impact Audits: Assessing portfolio formulas, labels, and execution standards against revised specifications.
• Modification Dossier Filing: Preparing and submitting registration modifications, ingredient statements, safety assessments, and standard revisions.
• Fragrance & Testing Guidance: Managing fragrance compliance (National Standards/IFRA), testing gap analyses, and efficacy evaluation strategies.

To evaluate your product portfolio against China's revised cosmetic safety rules, contact Cisema today.

Further Information

• Explore Cisema’s services for cosmetic product registration in China.

References

Announcement of the National Medical Products Administration on Matters Related to the Implementation of the Revised Content of the Safety and Technical Standards for Cosmetics (2026 No. 99) 国家药监局关于《化妆品安全技术规范》修订内容实施有关事宜的公告(2026年第99号)