FAQs Vol. 24 | China Answers Questions on the Annual and Risk Control Report for New Cosmetic Ingredients

According to Article 19 of the Administrative Measures on Cosmetics Registration and Notification, NCIs that have been registered or notified are subject to a safety monitoring system. The monitoring period lasts for three years, starting from the date when the cosmetic product that first use the NCI obtains a registration certificate or completes notification.

1) Obligations of NCI registrants/notifiers

NCI registrants and notifiers must establish a safety risk monitoring and evaluation system after the ingredient is introduced to the market. They are required to:

• Conduct ongoing safety research and continuously monitor and assess the use and safety of NCIs;

• Summarize and analyze the use and safety condition and submit an annual report within the prescribed timeframe;

• If an NCI meets the conditions specified in Article 22 of the Administrative Measures on Cosmetics Registration and Notification, registrants and notifiers must immediately conduct research, implement necessary risk control measures, and submit a risk control report promptly.

2) Obligations of cosmetic product registrants/notifiers using NCIs

• Provide timely feedback on the use and safety of NCIs to the respective NCI registrants and notifiers;

• If adverse reactions or safety concerns arise that may be linked to an NCI, take immediate risk control measures, notify the NCI registrants and notifiers, and report the issue to the provincial, autonomous regional, or municipal medical products administration.

According to Article 21 of the Administrative Measures on Cosmetics Registration and Notification, NCI registrants and notifiers must summarize and analyze the use and safety of NCIs within 30 working days before the completion of the first full year of safety monitoring and submit an annual report to the National Medical Products Administration (NMPA).

As per the Provisions for the Management of New Cosmetic Ingredient Registration and Notification Dossiers, the annual report should generally include:

• Information on the registrants, notifiers, or entrusted manufacturers of cosmetics using NCIs;

• Details of cosmetic products produced using NCIs;

• Regulatory supervision, sampling inspections, investigations, penalties and recalls of cosmetics containing NCIs;

• Relevant information on adverse reaction monitoring;

• Data on risk monitoring and evaluation.

For specific requirements, refer to Appendix 7 of the Provisions for the Management of New Cosmetic Ingredient Registration and Notification Dossiers. The annual report must be submitted through the E-system for Cosmetic Submission and Intelligent Evaluation.

According to Article 22 of the Administrative Measures on Cosmetics Registration and Notification, NCI registrants and notifiers must promptly conduct research and report to the Technical Review Institute if any of the following situations arise:

1) Serious cosmetic adverse reactions or group incidents abroad

If serious adverse reactions or group incidents suspected to be caused by similar ingredients are reported in other countries or regions.

2) Regulatory changes in other countries

If other countries or regions revise their cosmetic laws, regulations, or standards by tightening usage restrictions, increasing limitations, or banning similar ingredients.

3) Other safety-related concerns

If there is any other evidence indicating potential safety risks associated with the NCI. If safety issues are confirmed, the registrant or notifier must take immediate risk control measures and report them to the Technical Review Institute.

As per the Provisions for the Management of New Cosmetic Ingredient Registration and Notification Dossiers, a risk control report should generally include:

• Basic information on the NCI

• Details on its production and use

• Analysis of the causes of safety concerns or emergencies

• Measures taken to address the issue and the results of those actions

For specific requirements, refer to Appendix 8 of the Provisions for the Management of New Cosmetic Ingredient Registration and Notification Dossiers. Risk control reports must be submitted through the E-system for Cosmetic Submission and Intelligent Evaluation.

According to the Provisions for the Management of New Cosmetic Ingredient Registration and Notification Dossiers, certain technical information may be submitted alongside the annual report. For instance:

• For NCIs used for the first time domestically or internationally, registrants and notifiers may submit accelerated test data from at least three batches of ingredients or long-term storage test data of more than one year when conducting registration and notification. For long-term storage test data covering the remaining shelf life, supplementary data may be provided once or annually with the annual report.

However, unless explicitly permitted by the Provisions for the Management of New Cosmetic Ingredient Registration and Notification Dossiers, any unrelated information submitted alongside the annual or risk control report will be considered invalid.