Cosmetic Compliance
Intelligence & Solutions
Technical Guidelines for Skin Sensitization Test (Draft for Comments)
Local Title:
皮肤变态反应试验技术指导原则 (征求意见稿)
Country/Region:
Chinese Mainland
Competent Authority:
National Institutes for Food and Drug Control
Type:
Regulation
Status:
Draft
Release Date:
2023-05-04
Implementation Date:
/
Document
Language Source Title Access
ZH
Official Technical Guidelines for Skin Sensitization Test (Draft for Comments)
ZH
Official Drafting Instruction for Technical Guidelines for Skin Sensitization Test (Draft for Comments)
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Summary

On May 4, 2023, China National Institutes for Food and Drug Control (NIFDC) released the draft Technical Guidelines for Skin Sensitization Test, and initiated a two-week consultation on it. 

Skin sensitization test is a key component in the toxicological test of cosmetic ingredients and products. Additionally, this test is used to assess the sensitization of NCIs, and is frequently employed as evidence in the safety assessment of cosmetic ingredients for assessing sensitization.

To guide the safety assessment of cosmetic products and NCIs, NIFDC drafted this guideline. Consisting of five parts, it introduces the basic test principles and contents, and gives instructions on result analysis and evaluation. 

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