South Korea General Cosmetics and Functional Cosmetics Notification Guidance

1. Background Introduction

The Cosmetic Act of South Korea serves as the core regulation governing the manufacture, distribution, and sale of cosmetics within the country. Since its implementation in 2000, the Act has undergone multiple revisions with the aim of ensuring the safety and functional efficacy of cosmetic products. According to the Act, cosmetics are primarily classified into two categories: general cosmetics and functional cosmetics. Functional cosmetics are subject to additional procedures, including functional claims notification and evaluation. In addition, certain products exhibiting specific pharmacological effects are classified as quasi-drugs and are regulated under the Pharmaceutical Affairs Act. These products must undergo the appropriate approval or notification procedures in accordance with the relevant provisions of that Act.

To ensure consumer safety, enhance product transparency, and strengthen the regulation of functional and special-use products, the Ministry of Food and Drug Safety (MFDS) of South Korea has established a comprehensive system for notification and approval.

This guideline is based on the current laws and regulations of South Korea and systematically outlines the notification requirements and operational procedures for both general cosmetics and functional cosmetics. Its purpose is to assist enterprises in accurately understanding regulatory requirements, standardizing product registration and notification practices, and ensuring compliant market entry and successful commercialization of cosmetic products in the Korean market.

2. Definition of Cosmetics

According to the Cosmetic Act of South Korea (화장품법), cosmetics refer to products intended for application to the human body by means of spreading, rubbing, spraying, or similar methods, with the purpose of cleansing, beautifying, enhancing attractiveness, brightening appearance, or maintaining and improving the health of the skin or hair. These products exert mild effects on the human body. This excludes products classified as drugs under Article 2, Subparagraph 4 of the Pharmaceutical Affairs Act.

3. Classification of Cosmetics

According to the Cosmetic Act of South Korea, cosmetics are categorized into the following types: functional cosmetics, natural cosmetics, organic cosmetics, customized cosmetics, and general cosmetics.

(The subsequent sections of this guidance will focus on the two main categories: general cosmetics and functional cosmetics.)

3.1 Types of Cosmetics

The table below summarizes the types of cosmetics in South Korea along with relevant descriptions.

In South Korea, the following products are not classified as cosmetics:

• Deodorants: classified as quasi-drugs
• Toothpastes and oral fresheners: classified as quasi-drugs

3.2 Scope of Functional Cosmetics

According to the Enforcement Rule of the Cosmetics Act, the scope of functional cosmetics is summarized as follows:

4. Regulatory Authorities for Cosmetics in South Korea

In South Korea, the primary regulatory authority for cosmetics is the Ministry of Food and Drug Safety (MFDS), which operates under the Office for the Prime Minister. Its regulatory framework is composed of the headquarters, affiliated evaluation agencies, and regional branch offices.

The Ministry of Food and Drug Safety (MFDS)

MFDS is responsible for the full-chain regulation of cosmetics, including the management of ingredients, approval and notification of functional cosmetics, review of labeling and advertising, as well as market surveillance and adverse event monitoring, thereby ensuring the safety of cosmetics and protecting consumer rights.

The National Institute of Food and Drug Safety Evaluation (NIFDS)

NIFDS consists of six departments: the Food Safety Evaluation Department, Drug Evaluation Department, Herbal Medicine Evaluation Department, Medical Device Evaluation Department, Medical Products Research Department, and Toxicological Evaluation and Research Department.

Within the Herbal Medicine Evaluation Department, the Cosmetics Evaluation Division is responsible for the review of cosmetic standards and testing methods; examination of documentation supporting cosmetic labeling and advertising; and technical support related to human application testing of cosmetics.

Within the Medical Products Research Department, the Cosmetics Research Division is in charge of conducting risk assessment studies for cosmetics; research and investigations related to the manufacturing and quality control of cosmetics; studies on hazard management and standards for hazardous substances in cosmetics; technical support for cosmetic safety evaluations; designation of cosmetic testing institutions and on-site investigations.

5. Requirements for Placing Cosmetics on the South Korea Market

In South Korea, cosmetics should comply with the Cosmetics Act and its subordinate regulations, including the Enforcement Decree of the Cosmetics Act and the Enforcement Rule of the Cosmetics Act, before being placed on the market. The requirements for market entry and regulatory oversight differ between general cosmetics and functional cosmetics.

• General Cosmetics: Subject to notification-based registration; submitted through the online platform of the Korea Pharmaceutical Traders Association (KPTA).
• Functional Cosmetics: Subject to pre-market registration; either approved by the Ministry of Food and Drug Safety (MFDS) or reported to the MFDS, depending on the product type.
  

6. Responsibilities and Qualification Requirements for Marketing Authorization Holder

According to the Cosmetics Act, any applicant intending to import, distribute, and sell cosmetics in Korea must be registered with the Ministry of Food and Drug Safety (MFDS) as a Marketing Authorization Holder (MAH). The MAH is responsible for the registration, importation, and sale of cosmetics in the South Korean market. Furthermore, manufacturers, manufacturing sellers, universities, and research institutions (laboratories) are eligible to apply for MFDS registration of functional cosmetics.

According to Article 11 of the Cosmetics Act, the main responsibilities of the Marketing Authorization Holder (MAH) include:

• Compliance with quality control standards;
• Compliance with Good Safety Practice (GSP) standards;
• Retention of the Product Master File and quality control standards submitted by the manufacturer;
• Preparation and retention of import control records for imported cosmetics by the Marketing Authorization Holder;
• Sales after conducting batch-wise quality control testing;
• Obtaining import approval through Electronic Data Interchange (EDI) via the Korea Pharmaceutical Traders Association (KPTA) for customs clearance, reporting new data and information related to the safety and efficacy of products that may affect public health (including case reports of adverse effects from the use of cosmetics), and taking necessary safety measures.

7. Procedure and Documentation Requirements for Cosmetics Notification

7.1 Overview of Procedure and Documentation Requirements

All cosmetics must be registered through the Korea Pharmaceutical Traders Association (KPTA) online platform. Among them, functional cosmetics must be registered with the Ministry of Food and Drug Safety (MFDS), and all products are also required to submit their ingredient lists to the Korea Customs Service (KCA) for notification.

The required documents for product registration via the KPTA online platform include:

• Standard Pre-Import Notification Application Form (electronic format submitted online)
• Importer’s Business Registration Certificate and a copy of the Cosmetic Sales Business Registration Certificate
• Certificate of Free Sale (CFS) -original copy
• Certificate of Manufacture (including product name, ingredients and concentrations, responsible person’s signature, etc.) -original copy
• BSE/TSE-related documents (Certificate of Origin or Certificate of No Ruminant Animal Ingredients) -original copy
• For functional cosmetics, product review or report documents-copy
• Other information (e.g., manufacturing batch number, expiration date, etc.)

7.2 General Cosmetics Notification Procedure

*Products from different import batches must be re-notified to KPTA.

7.3 Functional Cosmetics Notification Procedure

*Products from different import batches must be re-notified to KPTA.

For functional cosmetics, unlike general cosmetics, it is necessary to first determine the type of registration before preparing the corresponding documentation. The registration types are categorized into Report Type and Review Type, each of which is subject to different regulatory submission requirements.

Notification Type: After completing and submitting the notification form, the National Institute of Food and Drug Safety Evaluation (NIFDS) confirms the notification, thereby completing the reporting process.

Type 1:

Functional cosmetics that meet the relevant requirements regarding efficacy, types of ingredients, ingredient concentrations, usage methods, usage amounts, and test methods, as announced by the MFDS Minister.

Type 2:

Products that conform to the same requirements as previously approved products.

Requirements: Type, specification, and concentration of the main active ingredients; efficacy; quality control standards; test methods; usage methods; usage amounts; and dosage forms.

Note: The following functional cosmetics are only applicable if their efficacy has been demonstrated through comparative testing with an approved product: whitening, wrinkle improvement, relief of hair loss symptoms, restoration of skin barrier function, reduction of stretch marks.

Type 3:

Products that conform to the same requirements as previously approved sunscreen products, and functional cosmetics for whitening and wrinkle improvement as announced by the MFDS Minister.

Requirements: Type, specification, and concentration of the main active ingredients; efficacy; quality control standards; test methods; usage methods; usage amounts; and dosage forms.

Approval Type: Submit the application form along with the required review documents. The NIFDS (National Institute of Food and Drug Safety Evaluation) will conduct the review, which will be completed within 60 working days, and the review result will be notified.

The review documents required for functional cosmetics include:

• Documentation on the origin and development background
• Safety-related data (single-dose toxicity test data, skin irritation test data, eye mucosal or other mucosal irritation test data, skin sensitization test data, phototoxicity and photosensitization test data, human skin patch test data)
• Efficacy or functional performance data (efficacy test data, human application test data)
• Data related to sun protection factor (applicable only to sunscreen products)
• Standards and test method data (including samples)

8. Technical and Testing Requirements for Cosmetics Notification

Cosmetic notification in South Korea must comply with technical regulations regarding ingredient compliance, manufacturing standards, and product safety, ensuring regulatory compliance and safety throughout all stages of the product life-cycle.

8.1 Ingredient Naming Requirements

According to Article 21 of the Enforcement Rule of the Cosmetics Act, the labeling principle for all ingredients is to use standardized Korean generic names. Since 2008, the Korea Cosmetics Association (KCA) has been operating the Korean Cosmetic Ingredient Dictionary (KCID), and standardized names are assigned through the Cosmetic Ingredient Standardization Committee. The purpose is to provide standardized names for use in cosmetic ingredient labeling, but this does not imply that all ingredients listed in the dictionary are approved or certified for use.

The diagram below illustrates the decision-making process for confirming the compliance of cosmetic ingredient names. It is intended to help companies determine whether an ingredient can be used directly, ensuring compliance with relevant Korean cosmetic regulations.

Follows are the key regulations and reference materials related to cosmetic ingredients and ingredient name compliance in South Korea:

• MFDS Notification No. 2020-12: Regulations on the Safety Standards for Cosmetics
• MFDS Notification No. 2022-4: Types, Standards, and Test Methods for Cosmetic Colorants
• Regulations on the Evaluation and Management of Functional Cosmetics
• Korean Cosmetic Ingredient Dictionary (KCID): https://kcia.or.kr/cid/search/ingd_list.php

8.2 Manufacturing Requirements

Cosmetic manufacturers or manufacturing sellers are required to register with the Ministry of Food and Drug Safety (MFDS) of Korea. Registered manufacturers must comply with the prescribed facility standards, be equipped with appropriate manufacturing facilities, and meet relevant regulatory requirements. Also, Korea encourages cosmetic manufacturers to follow the Good Manufacturing Practice (GMP) guidelines for cosmetics.

8.3 Testing Requirements

Enterprises are responsible for the safety of their products, and the quality of finished cosmetic products must comply with the relevant provisions of the Korean Safety Standards for Cosmetics.

The main testing requirements for cosmetics in Korea include: microbiological testing, physicochemical testing, toxicological testing, safety and efficacy testing (applicable only to children's cosmetics and functional cosmetics) and other efficacy-related tests.

• Microbiological Testing: Stricter requirements apply to products intended for use on children under the age of 3 and products intended for use around the eyes.

• Physicochemical Testing: This refers to the testing of substances such as lead, nickel, arsenic, mercury, antimony, cadmium, 1,4-dioxane, methanol, formaldehyde, etc. Common specification limits are set as follows:

• Toxicological Testing: According to the partial amendment of the Cosmetics Act promulgated in March 2016, the manufacture and import of cosmetics and cosmetic ingredients tested on animals shall be prohibited from distribution and sale, except under specific circumstances:

• Ingredients that require special regulatory control, such as preservatives, colorants, and UV filters, or cosmetic ingredients known to contain hazardous substances that pose public health risks domestically or internationally;
• Lack of available alternative testing methods;
• Compliance with legal or regulatory requirements of other countries.

9. Labeling Requirements for Cosmetics Notification

According to the Cosmetics Act and its Enforcement Rules, cosmetic products must be labeled in Korean on their packaging or labels. The required labeling items include:

• Product name
• Name and address of the manufacturer and the responsible distributor
• Full list of ingredients (using standardized Korean nomenclature)
• Net content (in mg, g, ml, or l)
• Batch number
• Expiration date or period-after-opening (PAO)
• Price: For products intended for consumer trial only, labels must indicate “Free Sample” or “Not for Sale”
• If the product is a functional cosmetic, it must be labeled as “Functional Cosmetic”
• Precautions for use
• Other items stipulated in the Enforcement Rules of the Cosmetics Act (Prime Ministerial Decree)

Note: For cosmetic products with a volume≤10 ml or weight≤10 g, the following minimum labeling items are required: product name, name of the manufacturer and responsible distributor, batch number, expiration date or period-after-opening (PAO) and price.

10. Notification Timeline

The time required for key stages may vary depending on factors such as the product category, the formulation complexity and the necessary testing. Below is a reference table outlining the South Korea cosmetic notification process and estimated timelines. For further professional assistance, please contact CIRS Group (cosmetic@cirs-group.com).

11. Post-Market Supervision Requirements

To ensure that cosmetics continuously comply with safety and quality standards after entering the market, the Ministry of Food and Drug Safety (MFDS) implements a series of post-market regulatory measures, mainly including the following two aspects: post-market inspections (regular and ad-hoc) and Korea Cosmetic Safety Reporting System (adverse event reports, periodic reports).

11.1 Post-market inspections

Korean regulatory authorities conduct regular or ad-hoc sampling and inspections of cosmetics distributed in the market. The scope includes, but is not limited to:

• Compliance of product labeling and advertising;
• Consistency between actual product ingredients and those reported;
• Presence of prohibited substances or restricted substances used beyond permitted limits;
• Operation and effectiveness of the company’s quality management system.

11.2 Cosmetic Safety Reporting System

To continuously monitor the safety of products on the market, Korea has established a system for adverse event reporting and periodic safety reporting:

• Adverse Event Reporting: When a company becomes aware that a product has caused a serious adverse reaction during use (such as dermatitis, allergic reactions, etc.), it must promptly report the relevant information to the MFDS. This includes product batch number, description of symptoms, corrective actions taken, and other related details.
• Periodic Safety Report: For certain product categories such as functional cosmetics, companies are required to submit safety assessment reports on a regular basis (twice a year, in January and July). These reports must include a summary of adverse events, records of complaint handling, results of market surveillance, and other relevant data.
  
  

Our Services

• Korean Cosmetics Product Notification & Registration (General Cosmetics, Functional Cosmetics)
• Standardization of Cosmetic Ingredient Names in Korea
• Korean Cosmetics Label Review
• Quality Inspection

If you need any assistance or have any questions, please get in touch with us via cosmetic@cirs-group.com

.