Everything You Need to Know About Korean Cosmetics Laws, Certifications, and Compliance Requirements

Introduction

K-beauty is one of the most dynamic and influential sectors in the global cosmetics market. From innovative skincare to cutting-edge makeup, Korean products are trusted by millions worldwide. Behind the glitz and glass-skin glow, there is a strict regulatory system. This system ensures quality, safety, and transparency adhering to Korean cosmetics laws.

If you’re a foreign company looking to manufacture, import, or sell cosmetics in Korea, this post will guide you. This is especially true if you work through Korean beauty OEM/ODM. You will learn what you need to know about Korean cosmetics Laws.

Why You Need to Understand Korean Cosmetic Laws?

South Korea is known for its strict and highly detailed cosmetic regulations. For both emerging beauty startups and established global brands, navigating these rules isn’t just optional. It’s a key step toward successful market entry.

Complying with Korean cosmetics law helps you to:

• Guarantee product safety and meet regulatory standards
• Prevent legal issues, fines, or product recalls
• Earn the trust of Korean consumers and international distributors

Understanding local compliance is more than just about avoiding risk. It’s about building a reputation for quality and transparency in one of the most competitive beauty markets in the world.

Who Regulates Cosmetics in Korea?

• The Ministry of Food and Drug Safety (MFDS) is Korea’s primary regulatory authority for cosmetics.
  Previously known as the KFDA, the MFDS oversees:
• Manufacturing facility approvals
• Product registration (for certain cosmetics)
• Advertising and labeling compliance
• Post-market surveillance

Main Content

1. What Is the Korean Cosmetics Law?

The Korean Cosmetics Law is governed and enforced by the Ministry of Food and Drug Safety (MFDS). It establishes detailed regulations for the manufacturing, import, sale, and export of cosmetic products.
The law’s primary objective is to safeguard public health. It also aims to promote the sustainable development and global competitiveness of Korea’s cosmetics industry.

2. What Is Defined as a Cosmetics Under Korean Law?

Under Korean law, a cosmetic is defined as a product intended to be applied on the human body. It can be rubbed or sprayed. This includes use on the skin or hair. It is used for cleansing, beautifying, enhancing attractiveness, or maintaining and improving health of the skin or hair.
These products are considered to have only mild effects on the human body. They are distinct from pharmaceutical products. These pharmaceutical products are regulated separately under the Pharmaceutical Affairs Act.

2-1. Functional Cosmetics Classification Under Korean Cosmetics Laws

In South Korea, certain cosmetic products are legally classified as “functional cosmetics” under the Cosmetics Act. They must demonstrate specific benefits. These products also need to pass efficacy and safety evaluations conducted by the Ministry of Food and Drug Safety (MFDS).

These products are subject to pre-market notification and must include supporting data to prove their claimed effects. Unlike general cosmetics, they are considered to have active functions that improve or support skin, scalp, or hair health.

2-2. What Is a “Natural Beauty” Under Korean Cosmetics Law?

In South Korea, natural cosmetics are defined as products that contain ingredients derived from natural sources. These sources include plants, animals, and minerals. The products must meet the standards set by the Ministry of Food and Drug Safety (MFDS).

To be officially recognized as a natural cosmetic, the product must:

• Contain 95% or more natural substances (including pure natural ingredients, natural-derived materials, and water)
• Follow formulation and safety standards regulated by the MFDS
• Avoid synthetic chemicals that do not originate from nature

Breakdown of Natural Content Requirements:

For a cosmetic product to qualify as “natural” in Korea:

• Water + Natural Ingredients + Naturally Derived Ingredients
  → Must collectively account for at least 95% of the total content

This high threshold ensures that the product maintains authentic natural integrity. This is crucial for both consumer trust and eco-conscious branding.

Why This Matters for Green Beauty Brands?

K-beauty’s global rise has fueled demand for eco-friendly and clean beauty solutions.

From my experience working with indie brands, meeting the “natural cosmetic” criteria in Korea offers significant opportunities. It appeals to eco-conscious buyers. However, “natural” is not just a marketing term in Korea — it’s a regulated category.
Brands aiming to launch natural cosmetics in the Korean market must guarantee full compliance with regulations. This is essential to gain consumer trust. It is also crucial to avoid legal issues.

2-3. What Are Organic Cosmetics in Korea?

In South Korea, the guidelines set by the Ministry of Food and Drug Safety (MFDS) strictly define organic cosmetics. These products must be formulated with ingredients that are organically grown. They should also be sourced from natural origins. Furthermore, they must meet specific composition standards to be marketed as “organic.”

Korean MFDS Criteria for Organic Cosmetics

To qualify as an “organic cosmetic” in the Korean market, a product must:

• Contain at least 10% organically certified ingredients in the total formulation
• Contain 95% or more of the product made up of a combination of:

• Organic ingredients
• Natural ingredients
• Naturally derived ingredients
• Water

This dual necessity ensures that organic cosmetics are both genuinely natural and contain a meaningful level of certified organic content.

Ingredient Source Requirements

Organic cosmetics may include:

• Botanicals cultivated without synthetic fertilizers or pesticides
• Animal-derived materials from certified organic systems
• Plant extracts or oils produced using eco-friendly and traceable methods

All ingredients must comply with MFDS-approved certification systems and safety assessments.

🚫 Mislabeling Risks

Marketing a product as “organic” without meeting the required composition or certification may result in:

• Fines or product recalls
• Import/export restrictions
• Consumer distrust and damage to brand reputation

Thus, accurate labeling and proper documentation are essential when promoting organic products in Korea.

Organic vs. Natural: What’s the Difference?

Natural cosmetics must include 95% natural or naturally derived ingredients. Organic cosmetics have an added condition. 10% of these ingredients must be certified organic.
All organic cosmetics are natural, but not all natural cosmetics meet the organic threshold.

Why Organic Certification Matters in K-Beauty?

K-beauty consumers are increasingly drawn to eco-conscious, sustainable, and clean beauty products. Certification helps brands establish credibility, transparency, and competitive advantage in a global market that values ethical sourcing.

3. Product Categories Regulated by Korean Cosmetics Laws

In South Korea, cosmetics are categorized based on their intended use, application area, and formulation characteristics. These categories are established and regulated by the Ministry of Food and Drug Safety (MFDS). The aim is to ensure safe and appropriate usage for consumers of all ages.

Here’s a detailed breakdown of each cosmetic type:

1. Bath Products

These are used during showers or baths and are rinsed off immediately after use.
Examples:

• Bath oils and capsules
• Bath salts
• Bubble baths
• Other bath-related items

2. Body Cleansing Products

Formulated to cleanse the body, including face and intimate areas.
Examples:

• Foam cleansers
• Body washes
• Liquid and bar soaps
• Feminine hygiene washes
• Wet wipes (excluding restaurant and mortuary wipes)

3. Skincare (Basic Cosmetics)

Designed to moisturize, tone, soften, or nourish the skin.
Examples:

• Cleansing water, oil, lotion, cream
• Toners and softening lotions
• Serums and essences
• Eye creams
• Body lotions and creams
• Hand and foot creams
• Massage creams and masks
• Powders and face mists

4. Nail Care Products

Used to groom or decorate fingernails and toenails.
Examples:

• Nail polish and removers
• Base coats and top coats
• Nail essences, creams, and lotions

5. Eye Makeup Products

Enhance the eyes and surrounding area.
Examples:

• Eyebrow pencils
• Eyeliners
• Eyeshadows
• Mascaras
• Eye makeup removers

6. Color Makeup Products

Used on the face and body to enhance appearance and color.
Examples:

• Makeup base and foundations (liquid, cream, cake)
• Face powders and blush
• Lipsticks, lip liners, lip balms, and gloss
• Setting sprays
• Body and face paints
• Stage and costume makeup

7. Baby and Infant Care Products

Intended for children under the age of 3, with milder formulations.
Examples:

• Baby shampoos and conditioners
• Baby bath and cleansing products
• Baby lotions, creams, and oils

8. Hair Care Products

Used to cleanse, condition, and style hair.
Examples:

• Shampoos and conditioners
• Hair masks and serums
• Hair waxes, mousses, and sprays
• Straightening or volumizing products

9. Hair Coloring Products

Change or lighten the hair’s natural color.
Examples:

• Hair dyes and tints
• Color sprays and rinses
• Bleaching and lightening products

10. Shaving Products

Used before, during, or after shaving to protect or soothe the skin.
Examples:

• Pre-shave lotions
• Shaving creams and foams
• Aftershave lotions
• Men’s talcum powder

11. Hair Removal Products

Designed to remove body hair, excluding manual or mechanical tools.
Examples:

• Hair removal creams
• Depilatory waxes

12. Deodorants

Used to control or neutralize body odor.
Examples:

• Deodorant sprays, sticks, or roll-ons

13. Fragrance Products

Used to impart sent to the body.
Examples:

• Perfumes and colognes
• Fragrance powders
• Scented sachets

4. Business Types Defined by Korean Cosmetics Laws

Under the Korean Cosmetics Act, the specific types and scopes of cosmetic-related businesses are defined by Presidential Decree. The main categories include Cosmetic Manufacturing Business, Cosmetic Responsible Distribution Business, and Customized Cosmetic Sales Business.

4-1. Manufacturing Business Requirements Under Korean Cosmetics Laws

This category includes businesses involved in the full or partial manufacturing of cosmetics. It excludes secondary packaging and promotional display processes. The scope includes:

• Businesses that manufacture cosmetic products directly.
• Businesses that manufacture cosmetics under contract (OEM/ODM).

Maintaining sanitary conditions during primary packaging is critical, especially when handling products produced by third parties.

4-2. Distribution Business Requirements Under Korean Cosmetics Laws

This business type oversees the quality, safety, and compliance of cosmetic products. It engages in their distribution, sale, or facilitation of import transactions. It includes:

• Distributing and selling cosmetics manufactured in-house.
• Distributing and selling products manufactured by contract manufacturers.
• Distributing and selling imported cosmetics.
• Acting as a broker or intermediary for import agency transactions involving cosmetics.

Companies in this category ensure that all products, regardless of the source, meet legal and safety standards before reaching consumers.

5. Business Registration and Notification under the Korean Cosmetics Law

The procedures, required documents, and rules for registering or notifying cosmetic-related businesses are defined by Prime Ministerial Decree in Korea. The process may vary based on the type of business. You may need to register with the local Regional Office. Alternatively, it might require notification with the Ministry of Food and Drug Safety (MFDS).

5-1. Registration for Cosmetic Manufacturing Business

Cosmetic manufacturers must register their business and submit the following documents to the MFDS office that has jurisdiction over their business location:

• Business Registration Application Form
• Health Certificate of the Business Representative (proving no mental illness or substance addiction)
• Certificate of Corporate Registration
• Facility Specifications and Layout

This process ensures that manufacturers meet hygiene, safety, and facility standards before producing cosmetic products.

5-2. Registration for Cosmetic Responsible Distribution Business

Businesses engaged in the responsible distribution of cosmetics must also complete registration by submitting these documents:

• Business Registration Application Form
• Certificate of Corporate Registration
• Documentation verifying the qualifications of the Responsible Distribution Manager
• Internal guidelines for Quality Control and Post-Marketing Safety Management

The MFDS uses these documents for confirmation. They verify that the business is capable of handling cosmetics. This ensures compliance with safety and quality regulations.

5-3. Notification for Customized Cosmetic Sales Business

Customized cosmetic sellers are required to notify the MFDS rather than register, but must still submit several documents:

• Notification Form for Customized Cosmetic Sales Business
• Copy of Certification for the Customized Cosmetic Compounding Manager
• Certificate of Corporate Registration
• Copy of the Contract with a registered Responsible Distributor who supplies the ingredients or base products
• Copy of the Insurance Policy for consumer damage compensation

This ensures traceability and safety in the personalization and repackaging of cosmetic products.

5-4. Change Notification and Business Closure Requirements

• Cosmetic manufacturers and responsible distributors must report any business changes (e.g., representative, address, facility changes) within 30 days.
• If changes are due to administrative district restructuring, reports must be made within 90 days.
• Customized cosmetic sellers must also report changes by submitting relevant updated documents.
• All business types must submit a notification in the event of business closure.

6. Facility and Compliance Requirements in Korean Cosmetics Laws

In order to operate legally under the Korean Cosmetics Act, cosmetic manufacturers and sellers must meet specific facility standards. They must also comply with clearly defined operational obligations. These requirements help ensure product safety, hygiene, and quality for both domestic and export markets.

6-1. Facility Standards for Cosmetic Manufacturers

In order to register as a Cosmetic Manufacturing Business, the following facilities must be in place:

• Pest and dust control systems to prevent contamination
• Manufacturing tools and clean workbenches suitable for production
• Separate rooms with ventilation or powder-dust removal equipment for handling powders
• Storage areas for raw materials, packaging components, and finished products
• A laboratory or testing room for product quality inspection

Third-party quality testing can be outsourced to authorized institutions such as:

• Regional Institutes of Health and Environment
• Licensed manufacturers with in-house laboratories
• Korea Pharmaceutical Traders Association (KPTA)

6-2. Legal Obligations for Each Business Type

A. Cosmetic Manufacturers

Manufacturers are responsible for the entire production process, including:

• Keeping detailed records of raw materials, equipment, and manufacturing processes
• Performing tests and inspections on ingredients, semi-finished, and finished products
• Ensuring quality and safety from production to shipment

B. Cosmetic Responsible Distributors

Responsible distributors must:

• Follow strict Quality Control (QC) and Post-Marketing Safety (PMS) protocols
• Report cosmetic ingredients, production/import records, and quality testing procedures to the MFDS before distribution
• Prepare safety plans and reports on product efficacy and stability
• Ensure that the Responsible Distribution Manager completes annual safety and quality training (minimum 4 hours, maximum 8 hours)

C. Customized Cosmetic Sellers

Sellers of customized cosmetics must:

• Maintain hygienic facilities and tools used for mixing or repackaging
• Adhere to safety management standards for personalized products
• Provide clear explanations of ingredients and formulations used in mixed or repackaged cosmetics

This category is subject to stricter on-site compliance, especially because products are tailored per customer.

7-1. Safety: No Toxicity, No Harmful Effects

Cosmetic products must be free from toxic substances. They must be safe for use without causing skin irritation. Allergic reactions or any adverse effects should not occur from their use.

What Is Considered a Serious Adverse Event (SAE)?

An SAE (Serious Adverse Event) may include:

• Death or life-threatening conditions
• Hospitalization or extended hospital stays
• Permanent disability or functional impairment
• Congenital anomalies
• Other medically significant cases

Common Safety Tests and Evaluation Methods

• Phototoxicity Test: Assesses UV-induced irritation using light exposure
• Photosensitization Test: Evaluates allergic contact reactions under UV light
• Human Patch Test: Measures irritation or sensitization on the inner forearm or back
• Genotoxicity Tests: Includes bacterial reverse mutation tests and chromosomal aberration tests in rodents to assess genetic damage potential

Institutions with at least 5 years of experience must conduct these tests. Medical experts or certified researchers must supervise them.

7-2. Stability: Shelf Life & Resistance to Degradation

A cosmetic product should maintain its quality throughout its shelf life. There should be no deterioration in texture, smell, or color. It must also remain free from microbial contamination.

Types of Stability Testing

• Long-Term Stability Test: Simulates real storage conditions to establish shelf life
• Accelerated Test: Uses elevated temperatures and humidity to predict degradation
• Stress Test (Challenging Conditions): Evaluates the product under extreme temperatures, physical shocks, or UV exposure
• Post-Opening Stability Test: Determines product safety over time after opening

Products containing 0.5% or more of ingredients like retinol (Vitamin A), ascorbic acid (Vitamin C), tocopherol (Vitamin E), enzymes, or peroxides. These products must retain their stability data for at least one year after the expiration date.

7-3. Efficacy: Meeting the Purpose of Use

Cosmetics must serve their intended function—whether it’s moisturizing, cleansing, brightening, anti-aging, or UV protection.

General Cosmetic Effectiveness Tests

• Moisturizing Test: Measures Transdermal Water Loss (TEWL)
• Astringent Test: Assesses protein coagulation from blood samples

Functional Cosmetics

For products claiming anti-wrinkle, whitening, or sun protection benefits:

• Clinical data and efficacy test reports are mandatory
• Products must provide SPF (Sun Protection Factor) and PA (Protection Grade of UVA) ratings based on standardized testing

7-4. Usability: Sensory Appeal and User Preference

Beyond performance, cosmetics should offer an enjoyable user experience in terms of:

• Fragrance
• Color
• Spreadability
• Absorption
• Ease of Use

These subjective qualities directly influence brand loyalty and product repurchase rates.

8. Korean Cosmetics Laws on Quality Control

In the Korean cosmetics industry, Quality Control (QC) is mandatory. It aims to ensure product integrity at the time of market release. These guidelines are vital for Responsible Cosmetic Distributors (RCMs) who seek to maintain regulatory compliance. They are also crucial for Manufacturers pursuing consumer trust.

What Is Cosmetic Quality Control?

Cosmetic quality control involves overseeing manufacturing, testing, and inspection processes. This ensures that products meet the necessary quality standards before distribution. It involves both manufacturers and responsible sellers.

To effectively manage this, companies are required to create and maintain a Quality Control Procedure Manual that includes the following:

Additional necessary procedures for ongoing quality assurance

Procedures for proper manufacturing and quality assurance

Protocols for quality-related complaints and defective products

Product recall procedures

Training and education programs for relevant personnel

Documentation and record keeping systems

Market release procedures

Responsibilities of the Responsible Cosmetic Distributor (RCM)

The RCM must:

Confirm Product Quality:

Verify that products were properly manufactured before distribution.

Monitor Adverse Events:

Investigate any safety-related information affecting human health and take appropriate corrective actions.

Duties of the Quality Control Manager

Under the Quality Control Procedure Manual, the Quality Control Manager must:

• Oversee all QC operations
• Submit written reports to the RCM when needed
• Communicate with manufacturers or custom cosmetic sellers in writing for instructions or clarifications
• Maintain QC records for at least three years from the manufacturing date
• Document and report cosmetic recalls, separating and discarding them after a certain period

If quality testing is outsourced to third-party manufacturers or labs, the RCM must thoroughly manage and supervise them. This management ensures that proper quality assurance processes are followed.

Annual Reporting Obligations

By the end of February every year, the Responsible Cosmetic Distributor must submit the following to the Ministry of Food and Drug Safety (MFDS) via relevant cosmetic industry associations like the Korea Cosmetic Association:

• Previous year’s production volumes
• List of raw materials used in cosmetic manufacturing
• Updates to any previously submitted material lists before market distribution

These reporting duties ensure regulatory transparency and product safety throughout the supply chain.

9. Penalties and Legal Risks Under Korean Cosmetics Laws

Korea enforces cosmetic law violations strictly. Risks include:

• Fines or sales bans
• Product recalls
• Import rejection at customs
• Suspension of business license

Common mistakes include:

• Using prohibited ingredients
• Omitting proper labels
• False or unproven marketing claims

10. Imported Product Compliance with Korean Cosmetics Laws

Even if your products are made abroad, Korean law still applies.
Foreign cosmetic brands must:

• Appoint a Korean Responsible Person
• Ensure the product complies with ingredient safety lists
• Submit import notification and customs documentation
• Handle product registration (if functional)

Without a Korean local representative, it is nearly impossible to sell legally in Korea.

Conclusion

A colleague once said, “It’s like learning a new language”. But once I understood the purpose behind each rule, it made sense. They ensure consumer safety, transparency, and product quality. It felt more like a roadmap than a restriction. For anyone planning to enter the Korean beauty market, embracing the regulatory process isn’t just a legal step. It’s a signal to your customers that you care about quality and integrity.

If you’re just starting out, don’t be discouraged by the complexity. With the right guidance and commitment, the Korean beauty market offers immense opportunities for genuine, value-driven brands. Here is Are Korean Skincare Products Really Safe? for a complete guide for you.

Disclaimer: This content is provided for informational purposes only and should not be considered as legal or regulatory advice. Please consult a qualified expert or the MFDS for formal guidance.

CTA (call to action)

Understanding these laws is crucial for market entry. If you’re planning to launch in Korea, consider seeking professional insights to navigate the process with confidence.