China Issues Technical Guidelines on Updating New Cosmetic Raw Material Filings

On December 15, 2025, the China National Institutes for Food and Drug Control issued the “Technical Guidelines for Updating the Filing Information of New Cosmetics Raw Materials,” consolidating regulatory expectations for how filed raw materials must be managed during the monitoring period.

The guidance draws a clear regulatory boundary around post-filing changes for new cosmetic raw materials that have completed filing but have not yet been incorporated into the Inventory of Existing Cosmetic Ingredients in China. Its central message is consistent throughout: once filing is complete, technical stability is the default. Changes are permitted only within clearly defined, evidence-based limits.

The Core Rule: Filing Establishes Technical Stability

After filing, information updates are treated as exceptions rather than routine actions. Filers remain fully responsible for the authenticity and scientific validity of all submitted materials, and post-filing changes are permitted only where explicitly allowed.

Three control points define this framework:

1. Updates beyond routine maintenance must be justified and follow prescribed procedures
2. Except for administrative or enterprise information, updates are generally prohibited within one month before the end of the monitoring period of new raw materials
3. Where substantive safety risks are identified, filers must report them and implement risk control measures rather than revise filing content on their own

The guidance allows a narrow category of updates that do not affect the technical substance of the raw material. Filers may directly maintain certain administrative information, including contact details for the filer, the domestic responsible person, and production-related contacts.

These updates may be submitted through the information system without technical review. However, supporting documentation must be retained and made available for inspection.

How Company-Level Changes Are Treated

The guidance then addresses situations involving changes to responsibility or identifying information, drawing careful distinctions to prevent unintended shifts in regulatory accountability.

Changes Without Altering the Legal Entity

Where a filer’s name, address, or contact details change but the legal entity itself remains unchanged, updates may be submitted through the designated systems. For overseas filers, official documentation confirming that the legal entity has not changed is required.

Similarly, where a production enterprise’s name or address changes but the production site itself remains unchanged, updates are permitted with appropriate supporting evidence.

Changes In Filing Responsibility

By contrast, changes in filing responsibility are subject to closer scrutiny. Where responsibility transfers due to merger, division, or similar legal events, the new filer must demonstrate:

• The legal basis for the transfer
• Undisputed ownership of the filing credential
• Acceptance of full quality and safety responsibility for the raw material

Replacement of the domestic responsible person follows the same logic and requires formal undertakings covering all affected raw materials.

Where Technical Changes Are Permitted

Technical changes are permitted only where equivalence can be demonstrated and safety is not compromised. Each permitted scenario is tied to specific research and documentation expectations.

Subject to supporting data, filers may apply to update:

• Supplementary basic information, such as CAS numbers or INCI names
• Production sites, where the production process is unchanged and equivalence is verified through comparative testing
• Production processes for single-structure substances, supported by comparative quality, impurity, and safety analysis
• Quality control standards, with validation data and multi-batch testing
• Use periods, based on stability study results
• Intended use, provided safe use levels are not increased
• Warnings or precautionary statements, based on updated safety assessments

In many cases, authorities require testing of at least three batches to demonstrate consistency and equivalence.

Changes That Are Not Treated as Updates

Certain changes are explicitly excluded from the update framework and require re-filing or registration

• Increasing safe use levels or expanding use scope requires re-filing
• Adding or adjusting production processes for non-single chemical substances (such as plant extracts, microbial fermentation products, polymers, etc.) generally requires re-filing
• Adjusting intended use to include registered functions such as sunscreen, whitening, or preservation should be re-registered

These changes are treated as alterations to the regulatory identity of the raw material rather than permissible refinements.

Mandatory Submission Pathways

To reinforce procedural discipline, the guidance specifies mandatory submission routes. All updates must be submitted using the standardized “Cosmetic New Raw Material Filing Information Update Form” through the relevant modules of the Cosmetic Information Service Platform or the Cosmetic Smart Submission and Review System.

Authorities explicitly prohibit submitting update materials through annual reports, risk control reports, or corrective action submissions, except where revisions are required following post-filing technical inspections.

Final Thoughts

The guidance signals a clear regulatory tightening. Once a new cosmetic raw material is filed, its technical profile is expected to remain fixed. Post-filing changes are no longer routine adjustments but regulated exceptions that must be justified, documented, and submitted through defined regulatory procedures, with technical review applied where required.

For overseas companies, this shifts compliance risk decisively to the filing stage. Early technical decisions now determine the scope of permissible change throughout the monitoring period, reducing flexibility and increasing downstream exposure. Sustained coordination with the domestic responsible person is therefore essential to maintaining regulatory control.

Meeting these expectations requires more than rule awareness. It demands a practical understanding of China’s regulatory logic and the experience to convert technical change into regulator-acceptable submissions. With more than 20 years of hands-on China regulatory experience, Cisema supports international companies in structuring filing strategies, managing post-filing updates, and maintaining compliance across the full lifecycle of new cosmetic raw materials.

Get in touch with Cisema today to manage your cosmetics compliance in China with confidence.

Further Information

For companies seeking support with cosmetics compliance in Asia, the following regulatory services are available:

• Explore Cisema’s cosmetics registration services in China
• See Cisema’s cosmetics registration services across Southeast Asia

References

• Read the original announcement in Simplified Chinese: “Notice of the Central Inspection Institute on the issuance of the ‘Technical Guidelines for Updating the Filing Information of New Cosmetic Raw Materials’”