Korea to Expand Functional Cosmetic Regulatory Scope

Take home:

• 8 kinds of beauty products currently classified as quasi drugs or drugs will be regulated as functional cosmetics.

Korea MFDS recently proposed the addition of 8 kinds of products into the functional cosmetic category, including:

• Hair dye products
• Decolorizing products
• Depilatories
• Hair growth products
• Hair loss protection products
• Products reducing dryness of sensitive skin
• Product preventing acne skin from skin keratinizing and dryness
• Products improving the stretch marks and skin chapping and protecting damaged skin

In future functional cosmetics will include 11 kinds of products in addition to whitening products, sunscreens and anti-wrinkle cosmetics. Among the newly added products, hair growth products were previously regulated as drugs while the rest were previously regulated as quasi drugs. Different categories are subject to different degrees of regulatory strictness in respect of registration requirements and inspection stringency whereby:

Functional cosmetics < Quasi drugs < Drugs

For the importers of the above 8 product categories the pending changes are beneficial. In the future they don’t need to go through the complicated and strict registration and testing requirements associated with drugs and quasi-drugs. The procedure is illustrated in the diagram below.

However some issues relating to ingredients standards and review rules still require clarification. MFDS adopts a positive ingredient list for functional cosmetics. There is still no information regarding the release dates, contents and ingredient scope of the positive lists for new functional cosmetics. The review rules for registration of such products are also need to be further specified.