Free Report | Compliance Guideline for Overseas Companies Looking to Export New Cosmetic Ingredients to China

China will adopt classified management on the pre-market approval of new cosmetic ingredients (NCI) from Jan 1, 2021. ChemLinked summarized a compliance guideline to assist overseas companies to export NCI to China under the new management scheme.

New cosmetic ingredients (NCI) are defined as the natural or artificial ingredients used in cosmetics for the first time in China. More specifically, a cosmetic ingredient is deemed as "new" if it is not included in the Inventory of Existing Cosmetic Ingredients in China (IECIC). Before exporting NCI to China, all companies are required to apply for a pre-market approval with the NMPA.

Currently, for the pre-market approval all NCI are subject to a uniformed registration scheme with strict application requirements, unclear review time and low pass rate, which has resulted in impassivity to export NCI to China. This situation will soon change however. According to the newly finalized Cosmetic Supervision and Administration Regulation (CSAR), China will adopt classified management on the pre-market approval of NCI from Jan 1, 2021: only high-risk NCI require registration with NMPA and a maximum review duration of 128 working days, while low-risk NCI require only a simple notification which is deemed to be completed just after submission of notification documents. In such a case, cosmetic ingredient companies looking to export NCI would enjoy greatly expedited market access to China.

Based on the current finalized CSAR and the Administrative Measures on Cosmetic Registration (Draft for Comments), ChemLinked summarized a compliance guideline to assist overseas companies to export NCI to China under the new management scheme. The guideline will be updated in real-time on ChemLinked in accordance with the latest regulatory progress in China.

Table of Contents:
I Preface
II Details of the Compliance Guideline
1 Determining the Classification of NCI
2 Notifying or Registering NCI
2.1 Determine the Domestic Responsible Person
2.2 Arrange the Testing of NCI
2.3 Prepare the Notification/Registration Documents
2.4 Submit the Applications
3 Establishing a Safety Monitoring System
4 Safety Re-assessment
III CSAR and the Future 7

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