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South Korea to Reinforce the Evaluation of Functional Cosmetics Registration

If false documents are submitted during functional cosmetics registration or other improper means are used to pass the evaluation, the Ministry of Food and Drug Safety (MFDS) will ban the sale of the product and revoke the business registration of the enterprises, etc.

On August 9, 2019, South Korea released an announcement amending Cosmetics Act [1]. If false documents are submitted during functional cosmetics registration or other improper means are used to pass the evaluation, MFDS will [2]:

  • Prohibit the products from selling (including supplying or awarding for the purpose of import agency business) or manufacturing, importing, storing or displaying for the purpose of sale;

  • Revoke the business registration of the enterprises, etc.

Functional Cosmetics Scope [3]

Functional cosmetics in South Korea falling under any of the following:

(a) Products aiding in the whitening of the skin;
(b) Products aiding in improving wrinkles in the skin;
(c) Products aiding in tanning skin gently or protecting skin from ultraviolet rays;
(d) Products aiding in changing or removing the color of hair, or nourishing hair;
(e) Products aiding in preventing or improving dryness, splits, loss, cornification, etc. resulting from weakened functions of skin or hair.

Functional Cosmetics Compliance Requirements [4]

To manufacture or import functional cosmetic in South Korea, it is required that the product undergoes a complex evaluation and approval procedure. After being approved by MFDS, functional cosmetics can be sold in the market. For imported functional cosmetics, the import approval letter form Korea Pharmaceutical Traders Association is also required. Detailed procedures of functional cosmetics import can be referred to our cosmepedia.

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