New Cosmetic Ingredient notification procedure and dossier requirements

What is New Cosmetic Ingredient ?
  1. The natural or artificial ingredient first used in cosmetics within the territory of China
  2. The Ingredient Inventory in China--IECIC 2021can be used as one of the basis to preliminarily judge whether the cosmetic ingredient is NCI
  3. When adjusting the use purpose and safe use amount of the existing cosmetic ingredient, the notification and registration shall be applied for according to the requirements of NCI notification and registration.
NCI shall be notified or registered before used in cosmetics
NCI notifier and registrant

1.Chinese cosmetic ingredient manufacturers and R&D institutions

2.Overseas enterprises that intend to export NCI to the Chinese market

 Administrative department
New Cosmetic Ingredient notification procedure
NCI application case classification and dossiers requirements

NCI monitoring period

Safety monitoring system is implemented on the registered and notified New Cosmetic Ingredient. The monitoring period is 3 years, counting from the date when the notification or registration has been completed for the cosmetics which use the NCI for the first time.

(1) NCI safety monitoring annual report

Cosmetic NCI registrant and notifier shall establish NCI post-market safety monitoring&evaluation system to track and study the safety of NCI and continuously monitor and evaluate the use and safety of NCI. The use and safety of NCI shall be summarized and analyzed within 30 working days before each full year of safety monitoring and an annual report should be formed and submitted to NMPA. Requirements: ingredient basic info., ingredient production situation, the info. of cosmetics using NCI, supervision and spot-check, investigation and handling, recall of cosmetics using NCI, CARM, risk monitoring and evaluation management. Other content to be explained: Eg. Supplement long-term keeping test data with NCI remaining useful life, summary analysis and conclusion of monitoring report.

(2) NCI safe risk control report

If cosmetic registrant, notifier or Chinese RP in the process of NCI use find the circumstances stipulated in the Provisions for Registration and Notification of Cosmetic that they should be reported to the technical review institution, Eg. serious cosmetic adverse reaction or group cosmetic adverse reaction is found in other countries(regions) because of suspicious use of the same category ingredient, or, other circumstances that need to report, they should immediately collect and manage the ingredient basic info., ingredient production and use, safety problems or cause analysis of emergency, handling measures and the results, organize and write NCI safe risk control report and submit it to the technical review institution through info. service platform. Requirements: Basic info., production situation, the info. of cosmetics using NCI, emergencies, other content that need to be explained, summary analysis and conclusion.

For further information please contact us➡:


ZMUni Chinese Cosmetic Regulation Compliance Centre 中贸合规中心

Website | Blogger | LinkedIn | Facebook | Instagram | Twitter | Newsletter | Youtube |

Post a Comment