Cosmetics Regulations For Korea In A Nutshell

Cosmetic products in Korea are governed by the Cosmetics Act (Korean) (Act. No. 14264 of 2016 (Eng)) and broadly classified into 2 main categories 'general cosmetics' and 'functional cosmetics'.

Definition of Categories:

1) General cosmetics

Refers to any item intended to be used by means of spreading, rubbing, spraying on or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness or brightening the appearance, or maintaining or improving the health of skin and hair, which have light effects on the human body: Provided, that goods constituting medicines defined in subparagraph 4 of Article 2 of the Pharmaceutical Affairs Act shall be excluded here from.

2) Functional cosmetics

Refers to cosmetics prescribed by Ordinance of the Prime Minister, 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

As of May 30th, 2017, 4 categories of quasi drugs were deleted from the quasi-drug lists and re-classified as “functional cosmetics” due to the expansion of the scope of functional cosmetics:

Categories converted from Quasi-drugs to functional cosmetics:

1. Hair colorants (including bleaching and demineralizing agents) (Quasi-drug classification code (QCC): 4220)

2. Depilatory (external use only) (QCC:4230)

3. External products for anti-hair loss or increase of hair thickness (QCC: 4210)

4. Bath care products (external use only) Agents intended for acne relief in bath solvents (QCC: 4150)

※ Quasi-drugs that fall under the above classification numbers will be removed from the quasi drug list and converted to cosmetics as of May 30th, 2017.

Products not intended to alleviate acne in bath solvents are not covered by functional cosmetics but should be manufactured, sold and imported in accordance with regulations stipulated for regular cosmetics.

[Source data from MFDS: 의약외품에서 기능성화장품 전환 절차]

Newly added functional cosmetics:

1. Products reducing dryness of sensitive skin (such as atopic skin)

2. Products preventing acne skin from skin keratinization and dryness

3. Products protecting damaged skin by improving skin chapping and stretch marks

Regulations regarding functional cosmetics evaluations (No. 2017-42)

Registration and Approval Matters:

Before conducting any commercial operations related to cosmetic products, an enterprise should register for the type of cosmetic business. Pursuant to the “Cosmetic Act”, 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".

Cosmetic manufacturers or importers registered with the the Ministry of Food and Drug Safety (hereafter referred to as "MFDS") can manufacture or import general cosmetics without pre-market registration but are subject to post-market supervision.

Functional cosmetics are required to be evaluated for safety and efficacy and can only be marketed upon approval by the MFDS. However, pursuant to Article 30 of the "Cosmetic Act", functional cosmetics which are meant for exportation only that are not sold domestically may comply with the provisions of the supposed importing country, notwithstanding Articles 8 through 16.

Mandatory Labelling Items:

(Cosmetics Act (Korean) (Act. No. 14264 of 2016 (Eng)):

1. Name of cosmetic product 2. Trade name and address of a manufacturer or manufacturer-seller 3. All ingredients used in manufacturing the relevant cosmetic (excluding ingredients prescribed by Ordinance of the Prime Minister, such as trace ingredients that are not harmful to the human body) 4. Volume or weight of contents 5. Manufacturing number 6. Use-by date or best-before date after opening (the date of manufacture shall be also entered when the best-before date after opening is entered 7. Price of cosmetic product 8. The words "functional cosmetics" in cases of functional cosmetics; 9. Cautions for use 10. Other matters prescribed by Ordinance of the Prime Minister.

All false/misleading labels/adertisements that may deceive or mislead consumers are prohibited.

Other governing laws and regulations:

English:

1. Enforcement Rule of the Cosmetics Act (No. 1405 of July 31, 2017)

2. Enforcement Decree of the Cosmetics Act (No. 27827 of Jan. 31, 2017)

Korean:

1. Enforcement Rule of the Cosmetics Act (No. 1426 of Nov 17, 2017)

2. Enforcement Decree of the Cosmetics Act (No. 27827 of Jan. 31, 2017)