Cosmetic Compliance
Intelligence & Solutions
Technical Guidelines for Dermal Irritation/Corrosion Test (Draft for Comments)
Local Title:
皮肤刺激性腐蚀性试验技术指导原则 (征集意见稿)
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 Dermal Irritation/Corrosion Test (Draft for Comments)
ZH
Official Drafting Instruction for Technical Guidelines for Dermal Irritation/Corrosion 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.

Dermal irritation/corrosion test assesses the irritation or corrosion effect and degree of a test substance on mammalian skin. The Safety and Technical Standards for Cosmetics (STSC) sets it a compulsory testing item for cosmetic products and new cosmetic ingredients (NCIs). The Working Rules for Cosmetic Registration and Notification Testing (the Working Rules) and Provisions for Management of Cosmetic Registration and Notification Dossiers further specify that hair care and aromatic cosmetics shall undergo acute dermal irritation test, and skin care and makeup cosmetics shall take multiple dermal irritation tests.

This guideline is developed to standardize the application of dermal irritation/corrosion tests in assessing the dermal irritation of cosmetic products and NCIs. Its main contents include the formulation background, legal basis, application scope, basic principles, operation requirements, result analysis and evaluation, etc.