South Korea Cosmetic Regulation

The South Korean cosmetics market is centrally regulated by the Ministry of Food and Drug Safety (MFDS) under the Cosmetics Act. This regulatory framework is further reinforced by the Enforcement Decree and Enforcement Rules, along with a range of subsidiary regulations and official notices that collectively ensure consistent interpretation and enforcement of the law.

The MFDS classifies cosmetics into two main categories: General Cosmetics and Functional Cosmetics. General cosmetics are subject to baseline safety and labeling requirements but do not require pre-market registration or product-specific evaluation before being placed on the market. In contrast, Functional Cosmetics—such as products claiming whitening, wrinkle improvement, UV protection, hair coloring, and anti-hair loss effects—are subject to stricter regulatory control. Depending on the product type, they must either undergo MFDS's evaluation or submit a report to obtain functional recognition prior to marketing.

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Part 1 Regulatory Framework and Competent Authority

1.1 Existing Main Cosmetic Regulations in South Korea

South Korea's legal hierarchy comprises superordinate laws and supporting rules. The primary overarching law, typically designated as an "Act", outlines the fundamental requirements of a subject. This main act, coupled with a Presidential Decree (Enforcement Decree) and an Ordinance of the Prime Minister (Enforcement Rule), forms the superordinate legal framework. Furthermore, several supporting regulations and notices enrich the detailed management scheme.

The primary regulations governing the cosmetic industry in South Korea include:

1.2 Competent Authority

In South Korea, the Ministry of Food and Drug Safety (MFDS) is the primary authority in charge of cosmetic safety management. The MFDS is responsible for formulating cosmetic regulations, reviewing business registrations, and conducting functional cosmetics evaluations.

Additionally, the Korea Pharmaceutical Traders Association (KPTA), an authorized non-governmental organization, plays a critical role for imported cosmetics. The KPTA evaluates the safety and efficacy documents of imported cosmetics and issues the standard customs clearance notice for such products.

Part 2 Cosmetic Products

2.1 Definition and Classification

In South Korea, cosmetics are products intended to be applied to the human body by rubbing, spraying, or other similar methods, to cleanse and beautify the body, enhance attractiveness, brighten the appearance, or maintain or promote the health of the skin and hair, with mild effects on the human body.

Cosmetics are generally classified into two main categories: General Cosmetics and Functional Cosmetics.

2.2 Registration of Responsible Cosmetic Distribution Business

To distribute cosmetics (including imported cosmetics) in South Korea, a business entity must register as a "Responsible Cosmetic Seller" with the MFDS.

2.2.1 Qualification Requirements

The entity must establish and comply with strict standards for quality control and post-market safety management as prescribed by the Enforcement Rule of Cosmetics Act. Additionally, the company must employ a qualified "Responsible Distribution Manager" to oversee these standards.

2.2.2 Application Procedure

The applicant must submit the following dossiers to the MFDS:

• Application form

• Evidential documents proving compliance with quality control and post-market safety management standards

• Qualification certificates and medical certificates of the designated Responsible Distribution Manager

• Certificate of Corporate Registry

2.3 Product Application Requirements

Different regulatory pathways apply depending on the product classification.

2.3.1 General Cosmetics

General cosmetics do not require pre-market registration or evaluation by the MFDS. However, before market placement, the Responsible Cosmetic Seller must ensure cosmetics comply with the regulations. For imported general cosmetics, a standard customs clearance notice must be obtained from the KPTA before customs clearance.

2.3.2 Functional Cosmetics

Functional cosmetics are subject to strict pre-market scrutiny by the MFDS. The product must undergo an evaluation or submit a report to obtain functional recognition:

1. Report Submission: If the functional ingredients, their efficacy, dosage, and usage match the monographs listed in the Korean Functional Cosmetics Codex (KFCC), the enterprise can simply submit a report to the MFDS online. Upon system verification, a certificate is automatically issued.

2. Evaluation Submission: If the functional ingredient or formulation is new and not listed in the KFCC, the product must undergo a rigorous examination by the MFDS. Enterprises must submit comprehensive dossiers, including:

• Data regarding the origin and development history.

• Safety data (e.g., single-dose toxicity, primary skin irritation).

• Efficacy/Effectiveness clinical trial data.

• Evidential data for UV-protection factors (for sunblocks).

• Data regarding product specifications and testing methods.

The functional cosmetics report or evaluation results are essential for obtaining the Standard Customs Clearance Notice for imported products in South Korea.

2.4 Standard Customs Clearance Notice

Before each importation, the importer must apply for obtaining a standard customs clearance notice from the KPTA. The following dossiers are generally required for the first import:

Note: Original copies of the Certificate of Manufacture and the Certificate of Free Sale must be submitted in the following cases:

• For the first imported item by a Cosmetics Responsible Seller importing for the first time.

• For documents that are bundled, embossed, or notarized on the reverse side.

• When additional verification is required.

2.5 Label Requirement

Cosmetic labels must be provided in Korean and accurately reflect the product's characteristics to prevent consumer deception.

2.5.1 General Mandatory Label Items

• Product name

• Trade name and address of the manufacturer and the responsible cosmetic seller

• Full list of ingredients

• Net volume or weight

• Batch number

• Use-by date or expiration date after opening

• Price

• For functional cosmetics, the words "Functional Cosmetics" or a symbol that represents functional cosmetics

• Precautions for use

• Others information required

2.5.2 Label Information for Special Situations

• Barcodes: As determined by the MFDS.

• Ingredient Name and Content: Where an ingredient name is included in the product name (excluding fragrance products).

• Human Cell/Tissue Culture Fluid Content: Where such ingredients are contained.

• Natural/Organic Ingredient Content: Where the product is labeled or advertised as "natural" or "organic."

• Manufacturing Information (Imported Cosmetics): Manufacturing country (may be omitted if compliant with the Foreign Trade Act), manufacturer name, and location.

• Non-Medicinal Statement (functional cosmetics with the efficacy of anti-hair loss, anti-acne, anti-itching or thinning red lines): "Not a medicine for the prevention or treatment of diseases."

• Efficacy/Usage (Functional Cosmetics): Efficacy/effects and usage/dosage as reviewed or reported.

• Preservative Content (Infant/Children Products): Content of preservatives subject to standards.

• Fragrance Allergens: Labeling of MFDS-designated allergens when thresholds are exceeded (0.01% for rinse-off products, 0.001% for leave-on products).

2.6 Ingredient Requirements

South Korea adopts a structured approach based on both positive and negative lists, classifying ingredients as permitted, restricted, or prohibited to ensure product safety and quality.

• Prohibited Ingredients: The MFDS maintains a list of prohibited ingredients that are strictly forbidden in cosmetic formulations.

• Restricted Ingredients: Manufacturers can only use restricted preservatives, restricted UV-filters, restricted hair dyes, and other restricted ingredients within the maximum allowed concentration limits specified by the MFDS.

• Color Additives: Only color additives (including their aluminum lakes/salts) explicitly listed in the Types, Standards, and Test Methods of Cosmetic Color Additives may be used.

2.6.1 New Ingredient Application

If an enterprise intends to use a restricted ingredient such as a new preservative or UV filter not currently specified in the relevant standards, or to exceed the established use conditions, or to use a prohibited ingredient, it may apply to the MFDS for prior approval. The application dossiers must include:

• Application form

• Summary of submitted documents

• Data on the origin and development of raw materials, domestic and international usage standards, and usage status

• Data on the characteristics of the raw materials

• Information on safety and efficacy

• Test reports on the standards and testing methods of raw materials

Part 3 Animal Testing Ban

South Korea strictly prohibits the distribution of cosmetics and cosmetic ingredients tested on animals. This cruelty-free requirement, introduced through an amendment to the Cosmetics Act in 2017, applies to both domestically manufactured and imported products. To support the ban, the MFDS actively develops and updates alternative test methods (ATMs).

While the ban is comprehensive, the MFDS allows the following six exceptions:

• Where it is necessary to establish usage standards for restricted raw materials (e.g., preservatives, colorants, or UV filters) or to assess the safety of cosmetic ingredients that may pose risks to public health;

• Where no alternative testing methods are available;

• Where required to comply with the laws and regulations of an exporting country;

• Where required for product development under the laws and regulations of an importing country;

• Where raw materials developed through animal testing conducted under other applicable laws and regulations are used in cosmetic manufacturing;

• Other cases specified by the MFDS where alternative methods are impracticable.