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South Korea stands at the forefront of the cosmetics industry, with a thriving market that places particular emphasis on functional cosmetics. Functional cosmetic is a distinct category of beauty and personal care items that has specific claims of therapeutic-like benefits beyond basic cleansing and moisturizing. In order to market cosmetics as "functional cosmetics" in South Korea, enterprises should submit a report or undergo a rigorous evaluation to substantiate their product’s efficacy. This article aims to provide a detailed overview of functional cosmetic regulations in South Korea, including the definition of functional cosmetics, the relevant laws and requirements, the procedures for submitting functional cosmetic reports, and the preparation of product evaluation dossiers. Understanding these regulatory requirements is essential for companies intending to place functional cosmetic products into the lucrative South Korean market.
1. Overview of Functional Cosmetics
In South Korea, functional cosmetics refers to cosmetics that have efficacies and benefits to human skin and hair. According to Article 2 of the Enforcement Rule of the Cosmetics Act1, “functional cosmetics” refers to any of the following cosmetics:
(1) Cosmetics that help whiten skin by preventing the deposition of melanin pigments, thereby inhibiting the formation of freckles and blemishes. Efficacy and Benefits: Helping with skin whitening.
(2) Cosmetics that help whiten the skin by lightening the color of deposited melanin pigments. Efficacy and Benefits: Helping with skin whitening.
(3) Cosmetics that provide elasticity to the skin and alleviate or improve wrinkles. Efficacy and Benefits: Helping with wrinkle improvement.
(4) Cosmetics that protect the skin from intense sunlight and prevent sunburn. Efficacy and Benefits: Protecting the skin from ultraviolet (UV) rays.
(5) Cosmetics that block or scatter UV rays and protect the skin from UV damage (sun protection factor (SPF), UA Protection Grade (PA) ). Efficacy and Benefits: Protecting the skin from UV rays.
(6) Cosmetics that change hair color, including hair dyeing and bleaching. However, products that temporarily change hair of hair are excluded. Efficacy and Benefits: Hair dyeing or hair bleaching.
(7) Cosmetics that remove body hair. However, cosmetics that physically remove body hair are excluded. Efficacy and Benefits: Hair removal.
(8) Cosmetics that help alleviate symptoms of hair loss. However, products that artificially make the hair appear thicker, such as coating products, are excluded. Efficacy and Benefits: Helping alleviate symptoms of hair loss.
(9) Cosmetics that help alleviate acne-prone skin (only applicable for cleansing products). Efficacy and Benefits: Helping alleviate acne-prone skin.
(10) Cosmetics that restore the function of the skin barrier (the outermost layer of the epidermis) and help improve itchiness and other conditions. Efficacy and Benefits: Restoring the skin barrier's function and helping improve itchiness.
(11) Cosmetics that help reduce redness caused by striae distensae. Efficacy and Benefits: Helping reduce redness caused by striae distensae. |
The laws and regulations related to functional cosmetic requirements are as follows:
Superordinate Laws |
The Act comprehensively regulates cosmetics from all aspects, providing the framework of cosmetic management in South Korea. |
Enforcement Rule of Cosmetics Act The Rule details the general rules for enterprises. |
Main Supporting Regulations Related to Functional Cosmetics |
Standards and Testing Methods of Functional Cosmetics (Korean Functional Cosmetics Codex, KFCC) KFCC details the specifications of functional ingredients specified by the authority, the standards and test methods of functional ingredient’s textures, the general requirements for functional cosmetics, and general test methods. |
Functional Cosmetics Evaluation Regulation This Regulation specifies the scope and requirements for evaluation dossiers , as well as the evaluation criteria. |
Regulation on Safety Standards, etc., for Cosmetics (Cosmetic Safety Standards) This Standards outlines cosmetic safety control requirements, such as microbial and heavy metal limits. Besides, the scopes of prohibited and restricted ingredients are also listed in the Standards. |
Types, Standards, and Test Methods of Cosmetic Color Additives This regulation details the scope of colorants that can be used in cosmetic products, including the usage limits, specifications, and test methods for colorants. |
Regulation of Labelling Cosmetics Precautions for Use and Fragrance Allergens This Regulation introduces mandatory labeling items, including precautions for different cosmetic types and the specified ingredients. |
To help enterprises better understand the requirements and smoothly conduct business, the Korean Ministry of Food and Drug Safety (MFDS) also published some guidelines related to functional cosmetics:
2. Scope of Cosmetics Subject to Evaluation and Report
As per Article 4 of the Cosmetic Act2, cosmetic manufacturer, responsible cosmetic distributor, and research institute that intends to obtain the recognition of functional cosmetics and engage in the sale of recognized functional cosmetics, shall undergo an examination conducted by the MFDS or submit a product information report.
Article 10 of the Enforcement Rule of the Cosmetics Act1, further explains the specific cases where functional cosmetics products are only subject to report submission instead of a separate evaluation:
(1) Cosmetics whose category and main ingredients, efficacy and effects, methods of use and optimal dosage, standards, and testing methods are all the same as those publicly notified by the MFDS in the KFCC;
(2) Cosmetics whose following items are the same as functional cosmetics having already undergone an examination [only limited to functional cosmetics whose cosmetic responsible distributor is the one and the same, or functional cosmetics whose “cosmetic manufacturers” (limited to where the “cosmetic manufacturers” have manufactured cosmetics in a manner of designing, developing and producing them) is one and the same, or functional cosmetics whose research institutes, etc. have undergone an examination of functional cosmetics is one and the same]. Provided, that for functional cosmetics with efficacies of whitening, anti-wrinkling, anti-hair loss, anti-acne, skin barrier restorage, and skin redness reduction, this shall apply only where the efficacy of the already examined items is proven through the experiments comparing with the control group:
The category, standards, and contents (densities in cases of liquids) of raw materials displaying the efficacy and effects;
The efficacy and effects (in cases of functional cosmetics with UV blocking efficacy, the difference of measured SPF values of cosmetics and the functional cosmetics having already undergone an examination should not exceed -20%;
Standards (excluding pH-related standards) and testing methods;
Methods of use and optimal dosage;
The dosage form (in cases of functional cosmetics with efficacies of whitening, anti-wrinkling, dying, anti-hair loss, anti-acne, skin barrier restoring, and redness reduction, liquid form, lotion form, and cream form can be deemed as the same form).
(3) Cosmetics whose following items are the same as a functional cosmetic having already undergone an examination or an MFDS-notified whitening/anti-winkling cosmetic [only limited to functional cosmetics whose cosmetic responsible distributor is one and the same, or functional cosmetics whose cosmetic manufacturers (limited to where the cosmetic manufacturers have manufactured them in a manner of designing, developing and producing them) is one and the same, or functional cosmetics whose research institutes, etc. have undergone an examination of functional cosmetics is one and the same]:
The kinds, standards, and contents of those raw materials displaying the efficacy and effects;
The efficacy and effects (in cases of functional cosmetics with UV blocking efficacy, the measured values of sun protection factor (SPF) should be within the band not exceeding minus 20 percent);
Standards (excluding pH-related standards) and testing methods;
Methods of use and optimal dosage;
The dosage form.
As per Article 9 of the Enforcement Rule of the Cosmetics Act1, the target products for functional cosmetics evaluation are products that meet the definition of cosmetics and are intended to be recognized as functional cosmetics, excluding the items that are o are only subject to report submission.
In other words, the functional cosmetic evaluation applies to all cosmetic products seeking functional cosmetic recognition, except for the situations where only report submission is required, as outlined above.
3. Procedures for Submitting the Required Documents for Functional Cosmetic Report
In accordance with Article 10 of the Enforcement Rule of the Cosmetics Act1, the National Institute of Food and Drug Safety Evaluation (NIFDS), designated by MFDS, is responsible for the review of functional cosmetic reports. Enterprises can submit the report online via NIFDS website (www.nedreg.mfds.go.kr).
Information to be reported includes the applicant’s basic information, the manufacturer’s information, product name, pH value, product category, relevant standards or the evaluated product information, test methods, main functional ingredient’s efficacies, usage methods, precautions, net weight, ingredient list, etc.
Please note that for different situations, the items to be filed may be different. Besides, once the report is submitted, no items can be shifted afterwards. Enterprises intending to modify the report can only withdraw the report and refile the application form from the beginning. Therefore, it’s suggested to click the "Draft (임시저장)” button instead of the “Report completed (보고완료)” before double-checking the filed items. By clicking the “Report completed (보고완료)”, the application status will turn into “Application finished (신청완료)”.
After confirming that the reported product information meets the relevant requirements, the NIFDS will record the report and product information in the ledger of functional cosmetics reports. Then the application situation will be “Accepted (처리완료)”. At the same time, the relevant product’s information can be checked on NIFDS website. If any reported item is found unqualified, NIFDS will ask the applicant to withdraw the application form to refile it.
Please note that the report will be effective upon submission. It can be printed at the stages of both the “Application Finished(신청완료)” and “Accepted(처리완료)”. However, only after being checked by NIFDS, the product information is officially published and can be checked online.
4. Procedures of Functional Cosmetic Evaluation
The functional cosmetic evaluation compliance is more complex and costly compared with the above functional cosmetic report submission. According to Article 9 of the Enforcement Rule of the Cosmetics Act1, enterprises should submit product dossiers for functional cosmetic evaluation to NIFDS either offline or online (www.nedrug.mfds.go.kr).
NIFDS will examine the dossiers and notify the applicant of the result within 60 working days. Only products with a compliance result can be deemed qualified functional cosmetics and sold in South Korea. If the dossiers are found incomplete, the authority will ask the applicant to submit additional documents.
The dossiers for functional cosmetic evaluation should cover the functional ingredient’s origin and development, safety data, efficacy data, etc. The scope and requirements are as follows:
Dossiers for Functional Cosmetic Evaluation | Requirements for the Dossiers |
1. Dossiers related to safety, efficacy, or functionality: | |
A. Documentation on functional ingredient’s origin and development process. | The information for the functional cosmetic evaluation should be clearly described. |
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 irritation test
| The data should be obtained based on the tests following the Good Laboratory Practice (GLP) Standards3.
For test methods:
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C. Data on efficacy or functionality (1) Data on efficacy testing. (2) Data on human application testing. (3) Data on hair dye efficacy. (Applicable for cosmetics with the function of changing (including bleaching or removing) the hair color, excluding the products that temporarily change the color of hair.) | Non-clinical trial data that supports the efficacy of the ingredients with the targeted efficacy, including data on the mechanism of action for the effects. Human application test data that can prove the efficacy or functionality is required when applied to humans. Data on hair dye efficacy as claimed for the efficacy and effects by using human hair samples as the test subject.
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D. Data supporting the setting of SPF, Water Resistance Sun Protection Factor (SPF, water resistance or sustained water resistance), and PA ratings. (Applicable for “cosmetics with efficacy in tanning skin gently by screening strong sun light”, and “cosmetics with efficacy in protecting skin from ultraviolet rays by intercepting or scattering them”.
| (1) SPF Test Methods can be any of the following：
(2) Water Resistance SPF Test Methods can be any of the following：
(3) PA Test Methods can be any of the following:
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2. Dossiers related to standards and test methods (including samples) | Applicants should submit supporting data related to the establishment of test items for proper quality control, the validation, and criteria of the test methods for each test item. |
Nevertheless, under specific situations, part of the data can be exempted. Details are as follows:
(1) Functional cosmetics added with ingredients specified in the KFCC, the International Cosmetic Ingredient Dictionary (ICID), or the Food Standards and Specifications are exempt from submitting safety data.
(2) When submitting human application test data, efficacy test data can be exempted.
(3) Submission of ingredient’s origin, development history, safety, efficacy or functionality data can be exempted, when the ingredients and amounts of the functional cosmetics are the same as those listed under [Annex 4] Categories of Functional Cosmetics Exempted from Dossier Submission of the Regulation on the Examination of Functional Cosmetics4.
(4) When the product is identical to a previously reviewed functional cosmetic in terms of the type of main ingredients, specifications, quantity, and usage methods, and falls under one of the following categories, the submission of origin, development history, safety, efficacy or functionality data can be exempted for the following situations (limited to the same applicant):
The efficacy has been proven through comparative testing (excluding the main ingredient).
The product only differs in colorants, fragrances, suspending agents, emulsifiers, solubilizers, stabilizers, isotonic agents, pH adjusters, viscosity adjusters, or solvents. (For “cosmetics that help restore skin barrier function” and “cosmetics that help with stretch marks”, products can be different in only fragrance and preservatives.)
(5) For products with SPF 10 or lower, the submission of data related to SPF and protection grade data can be exempted.
(6) For sunscreen products identical to a previously reviewed product in terms of main ingredients, specifications, quantity, usage method, and formulation (except for water-resistant products, where all ingredients must be identical except for fragrances and preservatives), the origin, development history, safety, efficacy or functionality data can be exempte
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