Common Technical Q&As on New Cosmetic Ingredients by China NIFDC

On March 17, 2025, the National Institutes for Food and Drug Control (NIFDC) released a FAQ document on technical review of cosmetics related to new cosmetic ingredients. We have collected the latest FAQs and translated them into English for your reference.

1. How is the Safety Monitoring Period for New Cosmetic Ingredients Calculated?

According to Article 19 of the Measures for the Administration of Cosmetic Registration and Filing, new cosmetic ingredients that have been registered or notified are subject to a safety monitoring system. The safety monitoring period is three years, starting from the date when the first cosmetic product using the new ingredient obtains registration or completes notification.

2. What Are the Obligations of the New Ingredient Registrant/Notifier and the Cosmetic Product Registrant/Notifier During the Safety Monitoring Period?

The new ingredient registrant/notifier should establish a post-market safety risk monitoring and evaluation system to track and assess the safety of the new ingredient. They should continuously monitor and evaluate its usage and safety profile. Additionally, they are required to collect and analyze data on the ingredient's use and safety, and submit an "Annual Report" within the specified timeframe as required. If any circumstances outlined in Article 22 of the Measures for the Administration of Cosmetic Registration and Filing arise, the registrant/notifier should immediately conduct research, implement necessary risk control measures, and promptly submit a "Risk Control Report."

The cosmetic product registrant/notifier using the new ingredient in cosmetic production should promptly provide feedback to the new ingredient registrant/notifier regarding its usage and safety. If any adverse reactions or safety issues potentially related to the new ingredient occur, they should immediately take risk control measures, notify the new ingredient registrant/notifier, and report the issue to the provincial, autonomous region, or municipal drug regulatory authority in accordance with regulations.

3. When Should the New Ingredient Registrant/Notifier Submit the Annual Report, and What Should It Include?

According to Article 21 of the Administration of Cosmetic Registration and Filing, the new ingredient registrant/notifier should summarize and analyze the usage and safety of the new cosmetic ingredient and submit an Annual Report to the National Medical Products Administration (NMPA) within 30 working days before the completion of each full year of the safety monitoring period.

According to the Provisions on the Management of Cosmetic Registration and Filing Data, the Annual Report should generally include the following:

• Information on the cosmetic product registrants/notifiers or entrusted manufacturers using the new ingredient;
• Details of cosmetic products produced using the new ingredient;
• Information on supervisory sampling, investigations, and recalls of cosmetic products containing the new ingredient;
• Data related to adverse reaction monitoring;
• Information on risk monitoring and evaluation.

For specific compilation requirements, refer to Annex 7 of the Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data. The Annual Report should be submitted through the Cosmetic Intelligent Registration and Evaluation System.

4. Under What Circumstances Should the New Ingredient Registrant/Notifier Submit a Risk Control Report, and What Should It Include?

According to Article 22 of the Administration of Cosmetic Registration and Filing, the new ingredient registrant/notifier should immediately conduct research and report to the technical review institution if any of the following situations occur:

• Serious adverse reactions or group adverse reaction incidents suspected to be caused by the same type of ingredient are reported in other countries or regions.
• Cosmetic regulations or standards in other countries or regions impose stricter usage standards, additional restrictions, or a ban on the same type of ingredient.
• Any other safety-related issues concerning the new cosmetic ingredient.

Additionally, if there is evidence suggesting that the new cosmetic ingredient poses a safety risk, the new ingredient registrant/notifier should immediately implement risk control measures and report to the technical review institution.

According to the Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data, the Risk Control Report should generally include:

• Basic information about the new ingredient;
• Production and usage details of the new ingredient;
• Analysis of the causes of the safety issue or emergency situation;
• Measures taken and the results of the actions implemented.

For specific compilation requirements, refer to Annex 8 of the above provisions. And the Risk Control Report should be submitted through the Cosmetic Intelligent Registration and Evaluation System.

5. Can Other Documents Be Submitted Along with the Annual Report or Risk Control Report?

Certain technical documents may be submitted together with the Annual Report. For example, for new ingredients being used for the first time domestically or internationally, at the time of registration or notification, the registrant/notifier may submit stability test data of at least:

• Three batches of the ingredient under accelerated conditions, or long-term storage test data for at least one year.
• The remaining long-term storage test data may be submitted either all at once or annually along with the Annual Report.

Except for cases explicitly permitted by the Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data, any other documents unrelated to the Annual Report or Risk Control Report will be considered invalid submissions.

About CIRS

The CIRS cosmetic team is dedicated to ensuring that cosmetic products meet stringent global regulatory standards. It can provide one-stop services covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in vitro), efficacy studies (in vivo & in vitro), ingredient registration, and product registration.

Cosmetic services in China:

• China Cosmetic Registration and Filing;
• China New Cosmetic Ingredient Registration and Filing;
• China Cosmetic Ingredient Quality and Safety Information Code Application (NMPA Code);
• China Cosmetics Safety and Efficacy Test;
• China Cosmetic Safety Assessment Report;
• China Toothpaste Filing;
• China Disinfectant Notification; and
• China Cosmetic Formula/Label/Claim Review

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

https://www.nifdc.org.cn//nifdc/bshff/hzhpjssp/hzhpspcjwtjd/hzhpwtjdjssp/202503170836001483678.html