The NIFDC Consults on the Draft Guidelines of Updating Notification Information of NCIs

1. Notifier/domestic responsible person (RP) information change (no entity change)

• The relevant information shall be updated through the Enterprise Information Management System. For overseas notifiers with changes to their name or address, supporting documents issued by competent government authorities or relevant agencies of their home country/region shall be provided to certify that the entity itself remains unchanged.

• After completing the user information update, an update of the corresponding content in the NCI notification information shall be made through the Cosmetics Intelligent Application and Review system.

2. Manufacturer address change: The textual address information of the NCI manufacturer has changed, but the actual production site remains unchanged.

Update corresponding information through the Cosmetics Intelligent Application and Review system, and provide necessary supporting documents (e.g., government certificate), confirming that the production site remains unchanged.

3. Notifier replacement (e.g., merger/division)

• A statement and supporting documents regarding company merger, deregistration, division, etc.

• Declaration and notarized documents from stakeholders (such as the original notifier, new notifier, domestic responsible person, etc.) and their legal representatives to confirm that there is no dispute over the ownership of the NCI notification certificate;

• A statement issued by the new notifier confirms that they have understood all details of the NCIs and are willing to assume responsibility for their quality and safety.

4. Domestic RP replacement

• List of NCIs for which the domestic RP is proposed to be replaced;

• A signed and stamped written consent from the original domestic RP agreeing to change the RP, or an effective legal document proving the domestic RP has been replaced;

• A commitment letter issued by the new domestic RP undertaking all responsibilities related to the NCIs (including those already notified).

1. Manufacture site change/addition

• Information on the new manufacture site, including name, address, and relevant qualification statements;

• A statement confirming through research that no substantial changes have occurred to the production process or quality/safety of the new ingredient, with supporting research materials retained for future reference.

2. Manufacture process optimization

• Justification for the necessity of optimizing the production process, including relevant research and evidence, explaining in detail how the optimization will improve ingredient quality, reduce safety risks, or enhance environmental friendliness;

• A description and relevant materials for the optimized production process;

• Comparative analysis of ingredient quality and safety before and after the process optimization;

• Reanalysis the impurities and risk substances, and update or confirm related materials, such as quality specifications and their testing methods, risk substances, and their control standards;

• An updated safety risk assessment report, with additional research data and related testing reports if necessary;

• Update the NCI technical requirements document if needed

• Additional necessary research materials based on actual changes in the NCI and related safety risks.

3. Quality standard improvement

• The reason for and research on updating the ingredient’s quality standards;

• Revised quality standards with supporting studies;

• A detailed analysis of changes compared to the original quality standards, and an explanation of the improvement in quality standards;

• Testing reports for at least three batches of NCIs conducted according to the new quality standards;

• Update the NCI technical requirements document if needed

4. Usage period extension

• A long-term stability research plan, including test and packaging conditions, test items, analytical methods, and timepoints;

• Long-term stability test results with supporting analysis;

• Revised shelf-life period;

• Update the NCI technical requirements document if needed

5. Usage purpose increase

• Comprehensive description of the ingredient’s research process and relevant background information;

• Supporting materials for the proposed additional usage purposes and functional claims;

• Reconfirmation of the NCI notification scenario based on human interaction mechanisms, and safety risks, with additional toxicological test data and/or other research materials if necessary;

• Updated safety assessment report;

• Update the NCI technical requirements document if needed

6. Cautionary note and warning label updates

• Updated cautionary notes and warning labels for the NCI;

• Necessary toxicological test data and/or other research materials;

• Updated safety assessment report;

• Update the NCI technical requirements document if needed