Cosmetic Compliance
Intelligence & Solutions
Technical Guidelines for Human Skin Patch Test (Draft for Comments)
Local Title:
人体皮肤斑贴试验技术指导原则 (征求意见稿)
Country/Region:
Chinese Mainland
Competent Authority:
National Institutes for Food and Drug Control
Type:
Regulation
Status:
Draft
Release Date:
2023-04-27
Implementation Date:
/
Document
Language Source Title Access
ZH
Official Technical Guidelines for Human Skin Patch Test (Draft for Comments)
ZH
Official Drafting Instruction for Technical Guidelines for Human Skin Patch Test (Draft for Comments)
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Summary

On April 27, 2023, China National Institutes for Food and Drug Control (NIFDC) opened a public consultation on seven technical guidelines for the testing of cosmetic products and new cosmetic ingredients. This guideline is one of the seven technical guidelines.

The human skin patch test aims at detecting the potential possibility of adverse reactions caused by the test substance on the skin. As an essential part of cosmetic safety assessment, it is a mandatory testing item for the registration application of sunscreens as well as freckle-removing and whitening cosmetics.

NIFDC produced this guideline to provide technical guidance for the practical operation of the human skin patch test. It explains the key contents of the test design, gives instructions for the major links in the test, and establishes safety assessment principles for products. 

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