Cosmetic Compliance
Intelligence & Solutions
In Chemico Skin Sensitisation - Amino Acid Derivative Reactivity Assay (ADRA) (Draft for Comments)
Local Title:
化妆品用化学原料体外皮肤变态反应:氨基酸衍生化反应试验(征求意见稿)
Country/Region:
China
Status:
Draft
Type:
Regulation
Release Date:
2021-11-12
Implementation Date:
/
Competent Authority:
National Institutes for Food and Drug Control
Document:
Summary

On November 12, 2021, China National Institutes for Food and Drug Control (NIFDC) opened a public consultation on a draft testing standard for cosmetic ingredient—In Chemico Skin Sensitisation - Amino Acid Derivative Reactivity Assay (ADRA). Stakeholders with any comments can send them to the NIFDC via email at hzpbwh@nifdc.org.cn before November 28, 2021.

Notably, this method is a new in-vitro alternative methods for cosmetic ingredients’ skin sensitization test. It aims to determine whether the chemical ingredients used in cosmetics can cause skin sensitization and applies to the evaluation of potential sensitization of known single-component cosmetic ingredients. Under this method, animal test is not required.

Main contents of the draft are as follows:

  1. Scope

  2. Test objective

  3. Definition

  4. Test principles

  5. Test materials and reagents

  6. Test procedures

  7. Data processing

  8. Quality control standard of the method

  9. Results judgment criteria

  10. Notes

Document
Original Language
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