Selling into South Korea

Korea’s Cosmetics Act defines functional cosmetics as a closed list of five effects, and a product sold for any of them must first undergo an examination by the Minister of Food and Drug Safety, or have a report submitted to the Minister on its safety and effectiveness, before it may be sold.

The five effects are close to the default vocabulary of Western skincare packaging, so a brand can move a product into a pre-market approval regime by writing one line of front-of-pack copy, without changing the formula or intending to make a regulated claim.

Article 13 of the Cosmetics Act prohibits labelling or advertising likely to mislead consumers into thinking a cosmetic is a medicine, likely to mislead them into thinking a non-functional cosmetic is a functional one, or different from the examination results of the product’s safety and efficacy.

The third limb is the one that catches careful brands: copy can be accurate about the product and still unlawful because it goes beyond what was examined, so the marketing ceiling is set by the regulatory file rather than by what the formula does.

Korea’s Cosmetics Act defines a class of functional cosmetics that includes products aiding in protecting the skin from ultraviolet rays, and a responsible seller who manufactures or imports one must undergo an evaluation by the Minister of Food and Drug Safety or file a report on its safety and effectiveness, against a published review period of sixty days and a stated fee of 189,000 KRW.

A sun-protection product is an over-the-counter drug in the United States and a functional cosmetic in Korea, so the same bottle meets a labelling rule on one side of the corridor and an application queue on the other.