Functional Cosmetics

Scope of Functional Cosmetics

Products that help whiten or brighten the skin

Products that help improve skin wrinkles

Products that help tan the skin evenly or protect the skin from ultraviolet (UV) radiation

Products that help change, remove, or maintain hair color, or provide nourishment to the hair

Products that help prevent or improve dryness, cracking, hair loss, or keratinization caused by diminished function of the skin or hair

Requirements for Nonclinical Safety Data for Functional Cosmetics Evaluation

Data generated in compliance with Good Laboratory Practice (GLP)

Toxicity test methods specified in [Appendix 1] of the Regulations for Functional Cosmetics Evaluation

Alternative test methods recognized by the Organisation for Economic Co-operation and Development or Ministry of Food and Drug Safety

Nonclinical Safety Study Data for Functional Cosmetics Evaluation (Article 4 of the Regulations for Functional Cosmetics Evaluation)

Single-Dose Toxicity Study Data

Primary Skin Irritation Study Data

Ocular Mucosal Irritation or Other Mucosal Irritation Study Data

Skin Sensitization Study Data

Phototoxicity and Photosensitization Study Data