21-4 · 化粧品の製造・販売

機能性化粧品の審査および届出

To sell a product claiming a function listed in Article 2 of the Enforcement Rule of the Cosmetics Act, such as whitening, wrinkle improvement, UV protection, hair color change, relief of hair loss symptoms, or relief of acne-prone skin, Article 4 of the Cosmetics Act requires a review by the Director of the National Institute of Food and Drug Safety Evaluation, or the submission of a report, for each product. Applicants are cosmetics manufacturers, responsible cosmetics sellers, and research institutions. A product falls under the report track of Article 10 of the Enforcement Rule if its active ingredients and amounts, efficacy, directions and dosage, and specifications and test methods match a product notified by the Ministry of Food and Drug Safety, or if all key items match a product already reviewed for the same business operator. Other products must be reviewed under Article 9 with data on origin and development, safety, efficacy, and specifications and test methods, and the review request form states a processing period of 60 days. Under Article 15 of the Cosmetics Act, functional cosmetics that have not been reviewed or reported may not be sold or stored or displayed for sale.