Cosmetic Compliance
Intelligence & Solutions
Human Cell Line Activation Test (Draft for Comments)
Local Title:
体外皮肤变态反应:人细胞活化试验(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—Human Cell Line Activation Test. 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 specifies the basic principles, requirements, and methods of in vitro skin sensitization: human cell line activation test and applies to the evaluation of potential sensitization of chemical ingredients used in cosmetics. Under this method, animal test is not required.

Main contents of the draft are as follows:

  1. Scope

  2. Test objective

  3. Definition

  4. Basic principles of test

  5. Test reagents

  6. Test methods

  7. Evaluation of results

  8. Interpretation of results

Document
Original Language
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