CSAR Subsidiary Regulations: China Modifies Requirements for New Cosmetic Ingredients Registration and Notification Dossiers

The second draft modifies new cosmetic ingredients (NCI) registration and notification dossiers requirements and refines the requirements for testing institutions qualification and testing method. Internationally accepted methods and newly developed testing methods are accepted for NCI physical and chemical test, microbiological test and efficacy evaluation. If the animal testing alternative methods are used for toxicological test, the evidence proving the consistency of results obtained from the animal testing alternatives and the traditional toxicological test methods should be submitted.

On Aug. 28, 2020, China National Institutes for Food and Drug Control (NIFDC) released the first draft Instructions for New Cosmetic Ingredient Registration and Notification Dossiers for public consultation ^[1]. The registration and notification dossiers of a natural or artificial ingredient that is applied in cosmetic products for the first time in China shall meet the requirements stipulated in the Instructions.

Based on the collected public opinions, National Medical Products Administration (NMPA) drafted and released the second edition of the Instructions on Nov. 5 ^[2]. Any suggestions can be mailed to ChemLinked (cosmetic@chemlinked.com) before Nov. 29, 2020, and we'll submit to the NMPA.

The following summarizes the key points of the second draft. The differences from the first draft have been marked in red.

*For the analysis of the first draft you can refer to CL News.

1. Registration and Notification Dossiers

1) Dossiers Necessary for Applying an Account in the NCI Registration and Notification Information System

Information form of registrant and notifier;
Overview of the adverse reaction monitoring and evaluation system;
For oversea registrant and notifier, the information form and the original power of attorney of the domestic responsible person (RP), and the original notarial certificate.

A power of attorney should include at least: