China New Cosmetic Ingredients Registration/Notification
In China, a new cosmetic ingredient is a natural or artificial ingredient that is applied in cosmetic products for the first time in China.
The Inventory of Existing Cosmetic Ingredients in China (IECIC 2021) issued by the National Medical Products Administration on April 27, 2021, replaced the previous version (IECIC 2015) as the standard for judging cosmetic ingredients in China. Ingredients not listed on IECIC 2021 have to be registered or notified before their use in cosmetics.
Existing or listed cosmetic ingredients that adjust the purpose of use, safe usage, etc. shall be subject to NCI registration or notification as well.
National Medical Products Administration (NMPA)
Registration or Notification
According to the “Regulations concerning the Supervision and Administration of Cosmetics”, new cosmetic ingredients (NCI) are divided into 2 categories: high-risk NCI and medium/low-risk NCI.
|High-risk NCI||1. Preservatives
2. UV filters
4. Hair dyes
5. Freckle removing or whitening agents
|Medium-risk and Low-risk NCI||All NCIs except for high-risk NCIs|
China implements registration management for high-risk NCIs and notification management for medium-risk and low-risk NCIs.
After successful registration or notification of NCIs, registrants and notifiers shall establish a safety monitoring system for the notified/registered NCIs within 3 years of completing the notification or obtaining the registration certificate. During the 3 years, they shall report the NCI’s use and safety data to the NMPA annually and may be required to conduct a safety assessment. If there are no safety issues found within the 3 years, the NCI will be included in the Inventory of Existing Cosmetic Ingredients in China (IECIC).
Relevant Regulations on Cosmetics
- Regulations concerning the Supervision and Administration of Cosmetics
- Administrative Measures on Cosmetics Registration and Notification
- Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers
- Inventory of Existing Cosmetic Ingredients in China IECIC2021
NCI Registration/Notification Process
|Account Application||· Information of registrant and notifier of new cosmetic ingredient.
· Safety risk monitoring and evaluation system overview of registrant and notifier of new cosmetic ingredient.
· Original authorization letter of the domestic responsible person and the original notarial certificate (for overseas registrant/notifier).
|NCIs Registration/Notification||· The name, address, and contact information of the registrant, notifier, and domestic responsible person.
· New cosmetic ingredient R&D report.
· Research documents on the NCIs preparation techniques, stability, and quality control standards.
· Safety assessment documents for NCIs.
· Technical requirements (available for the public).
· Other supportive documents.
- Cosmetics Regulatory and Technical Advisory
- Cosmetics Registration/Notification
- China Responsible Person
- Cosmetic Product Safety Report (CPSR)
- Efficacy Claim Evaluation Report
- Labeling and Ingredient Reviews