Korea Expands the Scope of Functional Cosmetics

Takehome:

According to the amendment of the "Cosmetic Act", four categories of quasi-drugs have been designated as functional cosmetics.

Note: if bath solvents are not intended to alleviate acne, they are subject to general cosmetics.

Starting from 30th May 2017, the above 4 categories will be deleted from list of quasi-drugs, and subsequently designated as functional cosmetics. To comply with functional cosmetic regulations these categories are subject to safety and efficacy evaluation before manufacturing/importing. If a product has already obtained a quasi-drug license, please submit the license together with other necessary documentation. MFDS will issue approval after 30th May 2017.

Only manufacturers/importers registered as "cosmetic manufacturers" or "marketing authorization holder" can manufacture or import functional cosmetics. Once the new categorization system is implemented, manufacturers/importers should register or assign other functional cosmetics manufacturer/importer to operate.

Exemption: Functional cosmetics which are exclusively for export purposes (not sold domestically) are exempted from evaluation pursuant to Article 30 of the Cosmetic Act.