Functional cosmetics is a special category in South Korea, with stricter requirements than general cosmetics. It requires additional official evaluations and labeling items.
Chapter 1. Regulatory Framework and Competent Authority
1.1 Regulations Related to Functional Cosmetics
Superordinate Laws | Effective Date | Status |
The act comprehensively regulates cosmetics from all aspects, providing the framework of cosmetic management in South Korea) | 2021-08-17 | In Force |
Enforcement Rule of Cosmetics Act (화장품법 시행규칙) The regulation details the general rules for enterprises to refer to. | 2023-06-22 | In Force |
Main Supporting Regulations Related to Functional Cosmetics (MFDS Notifications) | Effective Date | Status |
This regulation details the specifications of functional ingredients specified by the authority, the standards and test methods of the functional texture, and other general requirements for functional cosmetics. | 2020-12-30 | In Force |
Functional Cosmetics Evaluation Regulation (기능성화장품 심사에 관한 규정) This regulation specifies the scope and requirements for the evaluation of functional cosmetics and the evaluation criteria. | 2020-6-30 | In Force |
Regulation on Safety Standards, etc., for Cosmetics (Cosmetic Safety Standard) (화장품 안전기준 등에 관한 규정) This regulation outlines the cosmetic safety control standards, such as microbial limits, heavy metal limits, etc. Besides, the scopes of prohibited and restricted ingredients are also listed in the regulation. | 2023-08-22 | In Force |
Types, Standards, and Test Methods of Cosmetic Color Additives (화장품 색소 종류와 기준 및 시험방법) This regulation details the scope of colorants that can be used in cosmetic products, including the usage limits, specifications and test methods for colorants. | 2022-1-14 | In Force |
This regulation introduces mandatory labeling items, including precautions for different cosmetic types and the specified ingredients. The 25 kinds of fragrance allergens are also outlined in the regulation, which are also required to be indicated on the cosmetic product packaging. | 2019-12-16 | In Force |
1.2 Authority
In South Korea, The Ministry of Food and Drug Safety (MFDS) is the most vital authority for cosmetic management. As for functional cosmetics, MFDS is responsible for standard establishment, product licensing, test institute designation, etc.
The Korea Pharmaceutical Traders Association (KPTA), a quasi-governmental organization, also plays a key role in cosmetic management. It is responsible for pre-evaluating the products and issuing approval to the compliant products before the import procedures.
Note, that animal testing is banned for cosmetic products and ingredients in South Korea. The ban on animal testing also applies to imported cosmetics. Nevertheless, MFDS also published twenty-nine guidelines on alternative animal testing methods to guide cosmetic enterprises in smoothly conducting safety tests.
Chapter 2. Functional Cosmetic Products
2.1. Definition of Functional Cosmetic Products
In South Korea, "cosmetics" are products applied to human bodies for cleansing, beautifying, promoting attractiveness, or maintaining/improving skin and hair health. The cosmetics with efficacies such as whitening, antiaging, etc., are referred to as "functional cosmetics (기능성화장품)”.
2.2. Classification of Functional Cosmetic Products
Functional cosmetics can be sorted into the following 11 types as per their efficacy:
1 | Cosmetics that help whiten the skin by preventing the deposition of melanin pigments, thereby inhibiting the formation of freckles, blemishes, and other skin discolorations. 피부에 멜라닌색소가 침착하는 것을 방지하여 기미ㆍ주근깨 등의 생성을 억제함으로써 피부의 미백에 도움을 주는 기능을 가진 화장품 |
2 | Cosmetics that help whiten the skin by lightening the melanin pigments deposited in the skin. 피부에 침착된 멜라닌색소의 색을 엷게 하여 피부의 미백에 도움을 주는 기능을 가진 화장품 |
3 | Cosmetics that provide elasticity to skin and alleviate or improve wrinkles. 피부에 탄력을 주어 피부의 주름을 완화 또는 개선하는 기능을 가진 화장품 |
4 | Cosmetics that protect the skin from intense sunlight and help evenly tan the skin. 강한 햇볕을 방지하여 피부를 곱게 태워주는 기능을 가진 화장품 |
5 | Cosmetics that block or scatter ultraviolet rays to protect the skin from sun damage. 자외선을 차단 또는 산란시켜 자외선으로부터 피부를 보호하는 기능을 가진 화장품 |
6 | Cosmetics that alter the color of hair (including hair dyeing and bleaching). However, products that temporarily change the color of hair are excluded. 모발의 색상을 변화(탈염ㆍ탈색 포함한다)시키는 기능을 가진 화장품. 다만, 일시적으로 모발의 색상을 변화시키는 제품은 제외한다 |
7 | Cosmetics that remove body hair. However, products that physically remove body hair are excluded. 체모를 제거하는 기능을 가진 화장품. 다만, 물리적으로 체모를 제거하는 제품은 제외한다 |
8 | Cosmetics that help alleviate hair loss. However, products that physically thicken hair, such as coating, are excluded. 탈모 증상의 완화에 도움을 주는 화장품. 다만, 코팅 등 물리적으로 모발을 굵게 보이게 하는 제품은 제외한다 |
9 | Cosmetics that help alleviate acne-prone skin (only applicable for cleansing products. 여드름성 피부를 완화하는 데 도움을 주는 화장품. 다만, 인체세정용 제품류로 한정한다 |
10 | Cosmetics that help restore the functions of the skin barrier (referring to the epidermis, the outermost layer of the skin), thereby relieving skin itches. 피부장벽(피부의 가장 바깥 쪽에 존재하는 각질층의 표피를 말한다)의 기능을 회복하여 가려움 등의 개선에 도움을 주는 화장품 |
11 | Cosmetics that help reduce the appearance of redness caused by striae distensae. 튼살로 인한 붉은 선을 엷게 하는 데 도움을 주는 화장품 |
2.3. Safety Requirements for Functional Cosmetics
2.3.1. Functional Cosmetic Evaluation
The KFCC specifies the quality control standards for functional cosmetics, including the general provisions and the scope of notified functional ingredients.
Suppose the product's primary functional ingredient’s type, contents, efficacy, usage method, and test methods are all the same as those notified in the KFCC; In that case, enterprises can simply submit a report about the relevant product to MFDS without evaluation by the authority.
However, for the product whose functional ingredient is not listed in the KFCC, the product should undergo the evaluation (심사) conducted by MFDS. Only when the result shows the product is of no harm, the functional cosmetics can be imported and sold in South Korea.
The dossiers for functional cosmetic evaluation should cover the functional ingredient’s origin and development, safety data, efficacy data, and so on:
Dossiers related to safety, efficacy, or functionality | A. Documentation on origin and development process. B. Data on safety: (1) Single-dose toxicity (2) Primary skin irritation (3) Ocular irritation or other mucosal irritation (4) Skin sensitization (5) Phototoxicity and photoallergenicity (6) Human skin absorption (7) Human cumulative exposure testing C. Data on efficacy or functionality (1) Data on efficacy testing. (2) Data on human application testing. (3) Data on hair dye efficacy. (If applicable) D. Basis for setting the Sun Protection Factor (SPF), Water Resistance Sun Protection Factor (SPF, water resistance or sustained water resistance), and UA Protection Grade (PA) ratings. (If applicable) |
Dossiers related to standards and testing methods (including samples): | 1. Evidence of safety, efficacy, or functionality A. Documentation on origin and development process: There should be clear and concise information about the origin and development process of the functional cosmetic product that can provide support for the product evaluation B. Data on safety: The data should be obtained from studies conducted following "General Principles of Nonclinical Safety Testing" (GLP) guidelines. Testing methods should be the toxicity testing methods specified in Annex 1 of Functional Cosmetics Evaluation Regulation. Scientifically and rationally justified testing methods, and the animal alternative methods recognized by the OECD or the regulatory authority are acceptable. Please note that the cosmetics tested on animals are prohibited from sales in South Korea. C. Data on efficacy or functionality: (1) Data on efficacy testing: Nonclinical trial data supporting the efficacy of the product, including the intended effects and the underlying mechanism of action, can be adopted. (2) Data on human application testing. a. It should be data demonstrating the efficacy, effects, or other functionalities when applied to humans, which is generated under the supervision and guidance of a specialist in the relevant field, by professionals, research institutes, hospitals, or other relevant organizations with at least 5 years of experience in conducting such tests, including:
b. Supporting documentation for product usage and dosage (3) Data on hair dye efficacy testing: (If applicable) It should be the data demonstrating the efficacy and effects of the product, specifically related to the color indicated for human hair. D. Data on the establishment of SPF, Water Resistance SPF, and UVA (PA) ratings: (If applicable) (1) UVB SPF rating: It should be data based on the measurement methods for sun protection effectiveness specified by regulatory authorities like MFDS, Japan Cosmetic Industry Association (JCIA), U.S. Food and Drug Administration (FDA), Cosmetic Europe, Australia/New Zealand (AS/NZS), or the International Organization for Standardization (ISO 24444). (2) Water Resistance SPF rating: The data should be collected by the measurement methods for sun protection effectiveness specified by regulatory authorities like MFDS, JCIA, FDA, Cosmetic Europe, AS/NZS, or ISO 24444. (3) UVA (PA) rating: The data should be collected by the measurement methods for UVA protection effectiveness specified by regulatory authorities like MFDS, JCIA, or ISO 24444. 2. Data on criteria and testing methods The data should be the documentation providing the basis for establishing appropriate criteria and testing methods for quality control, including validation of the testing methods for each test item and the rationale for setting reference values. In this situation, the testing methods should be verified by using approved methods such as standard operating procedures (SOPs), International Organization for Standardization (ISO) standards, or other recognized methods. For primary ingredients or raw materials, the criteria and testing methods should follow that specified in the KFCC or relevant specifications. For the formulation, information should be provided on its appearance, pH value, verification, and content measurement. |
MFDS will examine the dossiers and notify the applicant of the result. Only products with a compliance result can be deemed as qualified functional cosmetics and sold in South Korea.
If the dossiers are found incomplete, the authority will ask the applicant to submit additional documents.
(Procedure of Functional Ingredient Evaluation)
Note that the functional cosmetics whose information is not reported to MFDS and those without an evaluation result issued by MFDS, can not be put on the Korean market.
2.3.2. Ingredients Requirements for Functional Cosmetic
(1) Functional Ingredients
The notified functional ingredients under KFCC include:
Main functional raw materials in whitening cosmetics (36 items)
Main functional raw materials in anti-wrinkle cosmetics (15 items)
Main functional raw materials in sun-blocks (28 kinds)
Main functional raw materials in whitening and anti-wrinkle cosmetics (21 items)
Main functional raw materials in hair dyeing and hair bleach (75 items)
Main functional raw materials in hair removal products (2 items)
Main functional raw materials in acne/pimple products (rinse-off products only) (1 item)
Main functional raw materials in anti-hair loss products (5 items)
(Find all lists in English here: South Korea: Approved Ingredients for Functional Cosmetics)
(2) General Ingredients
South Korea employs a "negative list" approach to regulate cosmetic ingredients. This means that if a substance is not a prohibited ingredient or falls within the limits set for restricted ingredients, it can be used in cosmetics manufacturing.
Prohibited ingredients | A total of 1040 kinds of prohibited ingredients for cosmetics are listed in Annex 1 of Cosmetic Safety Standard. (English version here: South Korea: Prohibited Ingredients in Cosmetics) |
Restricted ingredients | Substances for particular use, such as preservatives, colorants and UV filters, are regulated with limits when being used in cosmetics. The scope of restricted ingredients and their limitation requirements are listed in Annex 2 of Cosmetic Safety Standard.
(English version here: South Korea: Restricted List of Preservatives in Cosmetics South Korea: Restricted List of Hair Dye Ingredients |
(3) Colorant
The term "colorants (색소)" refers to substances used in cosmetics or skincare products to provide color. The scope of colorants allowable for cosmetics, including tar colorants(타르색소), pure colorants (순색소) and color lakes (레이크), are specified under the Types, Standards, and Test Methods of Cosmetic Color Additives. (English version here: South Korea: Permitted Colorants Used in Cosmetics.
2.3.3. Cosmetic Safety Standards
To control the safety of cosmetics distributed in the Korean market, MFDS sets the limits of contaminants and microorganisms in addition to the ingredient requirements. These limits apply to all cosmetic products, including functional cosmetics.
According to the Cosmetic Safety Standard, the substances below are prohibited from being added to cosmetics. If they are unintentionally immigrated from packages or other inevitable situations, the permissible limits for these substances are as follows:
Lead | Less than 50 μg/g (for powdered products in which clay is used as a raw material); Less than 20 μg/g (for other products) |
Nickel | Less than 35 μg/g (for eye make-up products) Less than 30 μg/g (for color make-up products); Less than 10 μg/g (for other products). |
Arsenic | Less than 10 μg/g |
Mercury | Less than 1 μg/g |
Antimony | Less than 10 μg/g |
Cadmium | Less than 5 μg/g |
Dioctyl phthalate | Less than 100 μg/g |
Methanol | Less than 0.002% (v/v) (for wet wipes); Less than 0.2% (v/v) (for other products). |
Formaldehyde | Less than 20 μg/g (for wet wipes); Less than 2000 μg/g (for other products). |
Phthalates | Less than 100 μg/g (Total sum of the phthalates, including dibutyl phthalate, butylbenzyl phthalate, and diethylhexyl phthalate) |
The microbial limits are as follows:
Total aerobic bacterial count: | Less than 500 CFU/g (mL) (for eye make-ups and products intended for infants and young children) |
Bacterial and fungal counts | Less than 100 CFU/g (mL) each (for wet wipes) |
Microorganisms | Less than 1,000 CFU/g (mL) (for other cosmetics) |
Escherichia coli (E. coli), Pseudomonas aeruginosa, and Staphylococcus aureus | Negative |
2.3.4. Label Requirements for Functional Cosmetic
The general required items to be displayed on a cosmetic product include the product name, business entity name, ingredient list, content volume, manufacturing number, use-by date, price, precautions, and bar code. The fragrance components used in cosmetics can be collectively marked as “fragrances (향료)”, except for the fragrance allergens designated under the Regulation of Labelling Cosmetics Precautions for Use and Fragrance Allergens, whose name should be detailed. Besides, for imported cosmetics, enterprises should indicate the product's manufacturing country, as well as manufacturing company's name and location.
Apart from the above-mentioned items, the product's efficacy and use methods should be labeled on the functional cosmetic's packaging or container. For products with efficacies of "anti-hair loss", "anti-acne", "anti-itching", or "thinning red lines", a statement of "this product is not a medicine for curing or preventing disease (질병의 예방 및 치료를 위한 의약품이 아님)" should be placed. Notably, the phrase "functional cosmetic (기능성화장품)" or a functional cosmetic logo is essential for qualified functional cosmetics.
(Logo of Functional Cosmetic)
Chapter 3. Import Procedure
For overseas enterprises intending to sell cosmetics in South Korea, they shall first set up a branch company in South Korea or delegate an agency to act as the "responsible cosmetic distributor", who must be familiar with Korean laws and regulations and conduct relevant obligations. This person will be in charge of all business activities related to the functional cosmetics sold in South Korea, including business registration, product information report, product evaluation, customs clearance, product labeling, product distribution, as well as product safety and quality management.
Each time before importing cosmetic products to South Korea, the "responsible cosmetic distributor" needs to submit an entry notice of imported products to KPTA for a prereview. The documents to be submitted include an application letter, business registration certificates, report record or evaluation result of the functional cosmetic, manufacture certificate, sale certificate, and BSE-related documents if needed. Only after being issued with approval from KPTA, will the product's customs clearance formality begin to process.
After customs clearance and mandatory quality inspection, enterprises can place a Korean label on the container, or packaging of the products.
The import procedure of functional cosmetics is briefly concluded below:
Read More
South Korea Quasi-Drug Regulation
South Korea Functional Cosmetic Evaluation Situation
South Korea Officially Bans Five Genotoxic Substances in Cosmetic
ChemLinked Services about S. Korea Cosmetics
Regulation Monitoring and Interpretation
One-step service for exporting cosmetics to S. Korea
Consulting service about ingredient compliance
Consulting service about custom clearance
Contact us at contact@chemlinked.com
