China NIDC Issued a Notice to Further Optimize Matters Related to Changes of Special Cosmetics
China Cosmetics
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On November 9, 2026, the China National Institutes for Drug Control (NIDC) issued a notice to further optimize matters related to changes of special cosmetics, covering three aspects: change classification, review time limits, and supporting requirements. Notably, applications for changes of special cosmetics accepted on or after November 20, 2026 will be processed in accordance with this notice. On the same day, the China NIDC released related Q&As.

Matters concerning the further optimization of changes of special cosmetics are hereby notified as follows:

Change Classification

Based on the risk management principle, classified management is applied to change matters of special cosmetics according to their risk levels. Change matters are classified into major changes, moderate changes, and minor changes, with the specific classification set out in the annex. The classification of change matters will be adjusted dynamically in light of actual circumstances.

For major changes and moderate changes, registrants shall submit application dossiers in accordance with the requirements of the Provisions for the Administration of Cosmetic Registration and Filing Dossiers; for minor changes, registrants shall perform self-maintenance in the Cosmetic Intelligent Declaration and Review System, which may be performed once every 30 days, provided that no self-maintenance is allowed when other application matters are under review.

Review Time Limits

The review time limits for applications of major changes and moderate changes have been shortened from 90 working days to 60 and 45 working days, respectively.

Major changes and moderate changes may be applied for separately or together. A new change matter may be applied for only after the previously applied change matter has completed approval. If a major change and a moderate change are applied for simultaneously, the review time limit will be calculated as that for major change applications.

Relevant Requirements

When applying for changes of special cosmetics, cosmetic registrants shall ensure that the changed content is consistent with the selected classification of the change matter, and shall be responsible for the authenticity, accuracy, completeness, legality, and traceability of the submitted dossiers. The change application form shall be filled in a standardized, accurate, concise, and clear manner.

Registrants shall ensure that the minor changes being self-maintained do not involve product quality and safety, and that the relevant supporting materials are archived for inspection. Where authenticity issues exist, they shall bear the corresponding legal liability.

Applications for change matters of special cosmetics accepted on or after November 20, 2026 shall be implemented in accordance with this notice.

On the same day, the NIDC released Q&As on the relevant content:

Q1: Into Which Categories Are Changes of Special Cosmetics Classified?

A: Based on the risk management principle, the Notice of the NIFDC on Further Optimizing Matters Related to Changes of Special Cosmetics (hereinafter referred to as the “Notice”) classifies change matters of special cosmetics into three categories by risk level: major changes, moderate changes, and minor changes. Major changes and moderate changes are subject to technical review by the technical review institution, while minor changes are self-maintained by registrants.

For one-time change matters specified in the Provisions for the Administration of Cosmetic Registration and Filing Dossiers, such as changes in the name or address of the registrant, the domestic responsible person, or the manufacturer of a registered product (with the production site unchanged), applications shall be submitted under the batch change procedure.

The classification of change matters will be adjusted dynamically in light of actual circumstances.

Q2: What Adjustments Have Been Made to the Review Time Limits for Major and Moderate Changes?

A: To implement the Opinions of the NMPA on Deepening the Reform of Cosmetics Regulation to Promote the High-Quality Development of the Industry (Guo Yao Jian Zhuang [2025] No. 18) and improve the quality and efficiency of the technical review of changes of special cosmetics, the review time limits for applications of major changes and moderate changes have been shortened from the original 90 working days to 60 and 45 working days, respectively. If a major change and a moderate change are applied for simultaneously, the review time limit will be calculated as 60 working days, the review time limit for major change applications.

Q3: What Are the Requirements for the Self-Maintenance of Minor Changes?

A: For minor changes that do not involve product quality and safety, registrants shall perform self-maintenance in the Cosmetic Intelligent Declaration and Review System, with an interval of no less than 30 days between two self-maintenances. The relevant supporting materials for self-maintenance shall be archived for inspection; where authenticity issues exist, registrants shall bear the corresponding legal liability.

Minor changes shall not be self-maintained when other application matters are under review. Minor changes shall not be applied for simultaneously with major or moderate changes.

Q4: How to Understand the Change Matters Arising from the Revisions to the Safety and Technical Standards for Cosmetics?

A: The Announcement of the NMPA on Matters Concerning the Implementation of the Revisions to the Safety and Technical Standards for Cosmetics (No. 99 of 2026) has specified the circumstances for updating the registration information of registered products. Where the revisions to the Safety and Technical Standards for Cosmetics (hereinafter referred to as the “Standards”) involve adjustments to the catalogs of prohibited/restricted or permitted ingredients, registrants may apply to change the product formula through the “formula changes arising from the revisions to the Standards” under major changes; where the revisions involve adjustments to the limits for microorganisms and harmful substances or to testing methods, registrants may self-maintain and update the standards applied to the product through the “self-maintenance arising from the revisions to the Standards” under minor changes.

Q5: How to Apply for Changes of the Quality Specifications of Ingredients?

A: Both major changes and minor changes in the annex to the Notice involve changes of the quality specifications of ingredients. The “change of the quality specifications of ingredients” under major changes applies to circumstances where the types or contents of trace components added to ensure ingredient quality, such as stabilizers, antioxidants, and preservatives, change, or where the purity of the main functional ingredients increases due to reasons such as optimization of the production process, while the contents of the main functional ingredients and the solvents in the ingredient remain unchanged. The “addition or change of the ingredient manufacturer or quality specifications” under minor changes applies to circumstances where neither the types nor the proportions of the specific ingredients in the ingredient change.

Q6: How to Apply for Changes of the Brief Description of the Production Process?

A: Both major changes and minor changes in the annex to the Notice include the “change of the brief description of the production process”. Changes of the brief description of the production process involving adjustments to safety assessment or efficacy evaluation dossiers shall be applied for as major changes, while other circumstances may be self-maintained as minor changes.

Q7: How to Apply for Changes of Product Classification?

A: Both major changes and minor changes in the annex to the Notice include the “change of product classification”. Minor changes only apply to changing or adding efficacy claims other than hair dyeing, perming, whitening (spot-removing), sun protection, anti-hair loss, and new efficacy. All other product classification changes except minor changes are major changes, such as changes of the declared category, efficacy claims (except those via minor changes), site of application, product form, intended population, and method of use.

Please note that the English translation is for reference only; the Chinese original shall prevail in case of any differences.

CIRS Reminder

The new NIDC rules classify changes of special cosmetics into major, moderate, and minor categories by risk and shorten the review time limits, with change applications accepted on or after November 20, 2026 processed under the new rules. Relevant companies are advised to accurately determine the type of change, paying particular attention to the maintenance frequency of minor changes, restrictions on simultaneous applications, and the obligation to retain supporting materials.

For circumstances such as ingredient specifications, production processes, product classification, and changes arising from the revisions to the Standards, companies should distinguish the application pathways in accordance with the accompanying Q&As, and make adequate preparations in terms of dossiers and internal compliance controls.

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Further Information:

China NIDC

 

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