[UPDATED] CSAR Subsidiary Regulations: Animal Testing Alternatives Data to be Accepted for New Cosmetic Ingredient Registration/Notification

Dossiers categories required for new cosmetic ingredient (NCI) registration and notification are the same. Animal testing alternative methods data can be accepted under certain conditions. Detailed test data, laboratory qualification analysis, etc. shall be attached if the safety assessment report is issued by an international authoritative safety assessment agency.

On August 28, 2020, China National Institutes for Food and Drug Control (NIFDC) released the draft Instructions for New Cosmetic Ingredient Registration and Notification Dossiers for public consultation ^[1], which is one of the subsidiary regulations of CSAR. Any suggestions can be mailed to ChemLinked (cosmetic@chemlinked.com) prior to September 14, 2020, and we'll submit to the NIFDC.

Background

Before a new cosmetic ingredient is used to produce cosmetics in China, it must be registered with NMPA. Since there is no classified management and the review criteria have not been refined with the ingredient characteristics, only 10 new ingredients have been approved from 2008 to 2020.

The CSAR issued on June 29 stipulates that new cosmetic ingredients shall be managed based on risks ^[2]. New high-risk ingredients are required to be registered with NMPA and obtain approval, while low-risk ingredients will be subject to notification management. Registrants and notifiers need to report the new ingredients' use and safety data to the NMPA annually for three years.

This Instruction is formulated to guide and regulate the NCI registration and notification in China.

Key Points of the Instruction

1. Dossiers categories required for registration and notification are consistent

Although new low-risk ingredients are subject to notification management, the safety standards are not relaxed. The dossiers categories required for registration and notification are the same.

No.	Dossiers
1	Application Form
2	R&D Report
3	Preparation Technique
4	Stability
5	Quality Control Standards
6	Safety Assessment
7	Functional Basis
8	Technical Requirements
9	Samples

For anti-hair loss, anti-acne, anti-wrinkle, anti-dandruff, and antiperspirant ingredients subject to notification management, the requirements on safety dossiers are the same with high-risk ingredients (preservatives, sunscreens, colorants, hair dyes and freckle-removing/whitening agents), which means additional tests should be carried out ^[3].