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CSAR Subsidiary Regulations: China Details Cosmetic Safety Assessment Requirements

Starting from Jan. 1, 2022, cosmetic registrants and notifiers shall conduct cosmetic safety assessments in accordance with the Technical Guidelines and submit product safety assessment documents when applying for special cosmetics registration or general cosmetics notification. The finalized Technical Guidelines for Cosmetic Safety Assessment clarify the detailed requirements for conducting safety assessment, requirements for safety assessors, content necessary in the assessment report, attach corresponding samples, and set transitional measures.

On Jul. 29, 2020, China opened a public consultation on Technical Guidelines for Cosmetic Safety Assessment, one of CSAR's subsidiary regulations. On Apr. 9, 2021, the finalized Technical Guidelines for Cosmetic Safety Assessment (hereinafter referred to as “the Technical Guidelines”) was officially published and will take effect on May 1, 2021. 1

Cosmetic registrants and notifiers can conduct cosmetic safety assessments on their own or entrust professional institutions. Cosmetic product safety assessment should be based on the assessment of all the ingredients and possible risk substances. If there are chemical or biological interactions between certain ingredients, the risk substances or potential safety risks arising from the interactions should also be assessed.

Transitional Measures

To ensure a smooth transition, China NMPA also introduced the following transitional measures: 

  • Starting from Jan. 1, 2022, cosmetic registrants and notifiers shall conduct cosmetic safety assessments in accordance with the Technical Guidelines and submit product safety assessment documents when applying for special cosmetics registration or general cosmetics notification.

  • Considering that there is a gap between the safety assessment capacity of China's cosmetic industry and that of the developed countries, cosmetic registrants and notifiers can submit a simplified version of the product safety assessment report before May 1, 2024.

Contents of the Cosmetic Product and Ingredient Safety Assessment Report

The Technical Guidelines clarify the content of the safety assessment report of cosmetic ingredient and product.

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