Cosmetic Compliance
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Technical Guidelines for Cosmetic Safety Assessment 2021
Local Title:
化妆品安全评估技术导则(2021年版)
Country/Region:
China
Status:
In force
Type:
Regulation
Release Date:
2021-04-09
Implementation Date:
2021-05-01
Competent Authority:
National Medical Products Administration
Document:
Summary

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.

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.

Main Content of the Technical Guidelines

1. Scope of application

2. Basic principles and requirements

3. Safety assessors’ requirements

4. Risk assessment procedures

5. Toxicology research

6. Ingredient safety assessment

7. Product safety assessment

8. Safety assessment report

9. Instruction

10. Terms and definition

Appendix 1 Cosmetic ingredient safety assessment report

Appendix 2 Cosmetic product safety assessment report

Appendix 3 Sample Cosmetic Safety Assessment Report (Full Version)

Appendix 4 Sample Cosmetic Safety Assessment Report (Simplified Version)

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History
Technical Guidelines for Cosmetic Safety Assessment 2021
Date of Release: 2021-04-09
Date of Implementation : 2021-05-01
Status : In force
Technical Guidelines for Cosmetic Safety Assessment
Date of Release: 2020-07-29
Date of Implementation : /
Status : Draft
Guidance for Cosmetic Safety Risk Assessment (Draft for Comments)
Date of Release: 2015-11-10
Date of Implementation : /
Status : Draft
Technical Guidelines for Cosmetic Safety Assessment 2021
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