Regulation of Cosmetics in Korea

The main regulatory authorities for cosmetics in Korea are the Ministry of Food and Drug Safety (MFDS) and the Ministry of Health and Welfare (MHW).

The MFDS has a Cosmetics Policy Section, a Cosmetics Examination Section and a Cosmetics Research Group. The Cosmetics Policy Section is responsible for the formulation of cosmetic regulations and policies, etc., the Cosmetics Examination Section is responsible for the examination of functional cosmetics, etc., and the Cosmetics Research Group is responsible for the study of cosmetic inspection and testing methods, etc. MFDS has released a special Korean Cosmetic Regulatory Framework (brochure) for review by responsible persons.

Laws that Korea Enforces for Cosmetics:

• Cosmetics Act
• Regulations on the Standards of Organic Cosmetic Products
• Regulations on the Examination of Functional Cosmetics
• Regulations on the Demonstration of Labeling and Advertisement for Cosmetic Products

In particular, the Cosmetics Act, its implementing decree and implementing rules regulate matters related to the production, import, sale and export of cosmetics to promote national health and the cosmetics industry in Korea. The main contents of the Regulations on Examination of Functional Cosmetics include examination materials and examination criteria for functional cosmetics. The Regulations on Safety Standards for Cosmetics, etc. stipulate the standards for the use of ingredients that are not allowed to be used in cosmetics and those that are restricted in use, the ingredients that can be used in targeted cosmetics, and the safety management standards for circulating cosmetics. The Regulations on Cosmetics Labels and Advertising Provisions stipulate the content of cosmetics labels and advertising.

The recent revision of cosmetics regulations by the Korean government

• On 5 September 2022, the Korean Ministry of Food and Drug (MFDS) issued an administrative notice to amend the Regulation on the Safety Standards of Cosmetic Products to ban five hair dye ingredients and labels, the five ingredients being o-amino-phenol, m-phenylenediamine hydrochloride, m-phenylenediamine, catechol and o-benzotriol.
• On 17 August 2021, the Korea Food and Drug Safety Administration amended the Cosmetics Act with the following main changes. (1) Prohibition of the sale of "cosmetic products that imitate foodstuffs"; (2) Revised requirements for bespoke cosmetics; (3) Optimized requirements for solid soap; (4) Added administrative provisions.

Definition of "Cosmetic Product"

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 mild effect on the human body. *Oral care products (such as toothpaste, mouthwash, etc.) belong to quasi-drug.

Registration

The registration of cosmetics in Korea is divided into the registration of cosmetic manufacturers and the registration of cosmetic manufacturers and sellers. In particular, a cosmetic manufacturer is a manufacturer of all or part of a cosmetic product to be produced (excluding those who carry out 2-packaging or labels processes only). A cosmetic manufacturer and seller are person who distributes or sells manufactured or imported cosmetic products, or a person who imports cosmetic products on behalf of others.

Requirements

• Prohibited and restricted ingredients: Ingredient restrictions are listed as prohibited and restricted ingredients (preservatives, sunscreens, colors, others) according to the FDA bulletin.
• Labels Advertisements or claims: A cosmetic manufacturer, responsible person shall not make any false or misleading labeling or advertisements and shall be able to substantiate claims they displayed and/or advertised.
• List of ingredients: The ingredient list does not require labels of all ingredients. Certain ingredients specified by the Korean Ministry of Health and Social Welfare, such as coloring agents, restricted ingredients, gold leaf (including content) and phosphates (including content) contained in shampoos and conditioners, must be indicated on the product label.
• Packaging: There are no requirements for standard sizes. Korean regulations require that the use of laminated or coated PVC materials is prohibited. Simple, high-quality packaging materials that can be easily recycled are encouraged. The decree also requires the reuse of packaging bottles and cans for cosmetic products by allowing a 10% top gap (space ratio) for cosmetic products.

For R&D and Further Manufacturing ONLY.