Korea Functional Cosmetics Regulations by Angelita Hu, Chemlinked

Korea defines functional cosmetics as products that aid in brightening skin, improving wrinkles in skin, tanning skin gently or protecting skin from sun’s ultraviolet radiation. Functional cosmetics are subject to more stringent evaluation than general cosmetics. Based on the definition three kinds of products are confirmed as functional cosmetics: anti-aging products, whitening products and sunscreens.

All these three kinds of products are subject to the supervision of Korea Ministry of Food and Drug Safety. The manufacture and import shall strictly comply with related regulations.

Obligations

To conduct cosmetic business in Korea, an enterprise intending to manufacture cosmetics shall be registered as a “manufacturer” while an enterprise that intends to import cosmetics shall be registered as a “Marketing authorization Holder”. Enterprise must first successfully attain these qualifications before they can register their products with the MFDS. After obtaining the approval from MFDS, the enterprise can proceed with manufacture or import.

Registration dossiers

With respect to registration application, companies shall prepare and submit the following documents for approval.

• Products specification
• PH test results with 3 batch no.
• Efficacy data (SPF for sunscreens)
• Assay and identification method of active ingredients contained by the product
• Product sample (5 pieces)
• Formula
• Bovine spongiform encephalopathy
• Free Sale Certification
• Fragrance specification if have

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