Cosmetic Compliance in East Asia

Selling cosmetics in East Asia

East Asia contains three of the most demanding cosmetic regimes outside the EU and the United States, and they are genuinely distinct from one another. Each requires an in-country representative of some kind, each operates in its own language, and each draws its own line between an ordinary cosmetic and a higher-tier product needing pre-market approval. An EU or UK safety dossier is a sound starting point, but none of these markets accepts it as it stands.

China

China regulates under the Cosmetic Supervision and Administration Regulation (CSAR), in force since 1 January 2021 and administered by the National Medical Products Administration (NMPA). The CSAR divides products into special cosmetics and general cosmetics. Special cosmetics (hair dyes, perming products, freckle-removing and whitening products, sunscreens, anti-hair-loss products, and any product claiming a new efficacy) require registration with the NMPA, and the registration certificate is valid for five years. General cosmetics require only a filing, which does not expire.

Ingredients are the harder constraint. Only substances on the Inventory of Existing Cosmetic Ingredients in China (IECIC) may be used freely; anything else is a new cosmetic ingredient requiring NMPA registration or notification, followed by three years of post-market monitoring with annual safety reports. A domestic responsible person, an entity established in China, is mandatory, efficacy claims must be substantiated and the basis published, and the entire submission runs in Chinese.

Japan

Japan regulates cosmetics under the Pharmaceutical and Medical Devices Act, overseen by the Ministry of Health, Labour and Welfare with the PMDA. Importing requires an in-country Marketing Authorisation Holder licensed in Japan, who carries responsibility for the product. Ordinary cosmetics are notified rather than approved, but must comply with the Standards for Cosmetics, which set the positive and negative ingredient lists. The line that matters is the quasi-drug category: medicated products such as many whitening, anti-acne and certain sunscreen products are quasi-drugs and require pre-market approval, a substantially heavier route.

South Korea

South Korea regulates under the Cosmetics Act through the Ministry of Food and Drug Safety (MFDS). A registered responsible distributor established in Korea is required to place a product on the market. The distinctive feature is the functional cosmetics category, covering whitening, anti-wrinkle, ultraviolet protection, hair colouring and similar claims, which must be reviewed or reported to the MFDS before sale and supported by efficacy data. General cosmetics require a quality and safety report to be held.

How Oxford Biosciences helps

These markets reward preparation and punish improvisation. We map the existing safety evidence onto each regime, identify where a product falls on the special, quasi-drug or functional line that changes the route entirely, and prepare the dossier in the format each authority expects. Because each market also requires a local responsible person, distributor or authorisation holder, we set out what in-country partner each entry needs. East Asian engagements are quoted on application.