Cosmetic Compliance
Intelligence & Solutions
Technical Guidelines for Dermal Phototoxicity Test (Draft for Comments)
Local Title:
皮肤光毒性试验技术指导原则 (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 Dermal Phototoxicity Test (Draft for Comments)
ZH
Official Drafting Instruction for Technical Guidelines for Dermal Phototoxicity 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 Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers stipulates that, NCIs with UV absorption properties shall be tested for dermal phototoxicity. Besides, according to the Working Rules, the following cosmetics shall undergo a dermal phototoxicity test:

  • General cosmetics with chemical sunscreen concentration ≥0.5% (w/w), except for perfumes, rinse-off and nail polish products;

  • All anti-hair loss, freckle-removing and whitening, and sunscreen products, as well as other special cosmetics with chemical sunscreen concentration ≥0.5% (w/w), except for perfumes and nail polish products.

This guideline is formulated to instruct the phototoxicity research and safety assessment 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.