Request a DemoSouth Korea's cosmetic ingredient regulation is governed by the Cosmetics Act and its subordinate regulations, under the supervision of the Ministry of Food and Drug Safety (MFDS). The regulatory framework adopts a structured approach based on both positive and negative lists, classifying ingredients as permitted, restricted, or prohibited to ensure product safety and quality.
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The Ultimate Guide to Cosmetic Regulatory Compliance in Southeast Asia, Japan And South KoreaThis online course is to interpret compliance requirements in Indonesia, Malaysia, Philippines, Singapore, Thailand, Vietnam, Japan and South Korea, to help stakeholders seek new opportunities. You will clearly understand how to export cosmetics to these eight regions through this course and avoid problems due to non-compliance.1. Prohibited and Restricted Ingredients
The Regulation on Safety Standards, etc. for Cosmetics establishes a list of ingredients prohibited for use in cosmetics distributed in South Korea, as well as four lists of restricted ingredients covering preservatives, hair dye ingredients, UV filters, and other controlled ingredients. The prohibited list includes over 1,000 ingredients, such as galanthamine, gold salts, and other chemicals deemed unsafe for cosmetic use. The four restricted lists specify permitted functions, maximum concentration limits, and other conditions of use.
No. | List of ingredients and usage limits |
|---|---|
1 | |
2 | |
3 | |
4 | |
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If a company intends to use a new preservative, hair dye ingredient, or UV filter that is not included in the above lists, or to use a restricted ingredient outside its prescribed limitations, it must obtain approval from the MFDS. Separately, companies may also apply for re-evaluation of a prohibited ingredient to lift or modify its ban for use purposes. In both cases, a comprehensive dossier must be submitted to the MFDS.
No. | Document Type | Key Data Points |
|---|---|---|
1 | Summary of Submitted Materials | |
2 | Data on the origin and development of raw materials, domestic and international usage standards, and usage status | |
3 | Data on the characteristics of the raw materials | |
4 | Information on safety and efficacy | A. Safety evaluation data (can be exempt from submission for reasonable reasons)
B. Evaluation data on validity (can be exempt from submission for reasonable reasons), including:
C. Data for establishing usage criteria |
5 | Test reports on the standards and testing methods of raw materials |
For the detailed requirements for the submission documents, enterprises can refer to Regulations on the Lifting or Modification of Bans on Cosmetic Ingredients and the Designation or Change of Cosmetic Ingredient Standards.
2. Color Additives
South Korea maintains a positive list of color additives permitted for use in cosmetics. The approved color additives, along with their scope of application (e.g., permitted in all cosmetics, prohibited for use in the eye area, or limited to rinse-off products), are specified in the Types, Standards and Test Methods of Cosmetic Color Additives. Only the color additives included in this list may be used, and they must comply with the prescribed purity criteria and usage restrictions.
3. Functional Cosmetic Ingredients
Functional cosmetics are products that provide a specific, government-recognized efficacy, such as skin whitening, anti-wrinkle care, or UV protection. The regulation of these products centers heavily on the active ingredients used. There are two primary pathways for using a functional ingredient:
1) Using Notified Ingredients: The MFDS publishes a list of "notified" functional ingredients in the Standards and Testing Methods of Functional Cosmetics (KFCC). If companies use an ingredient from this list within the specified concentration and for the designated purpose, a full pre-market evaluation of the finished functional cosmetic product is not required. Instead, they can simply submit a report to the MFDS.
2) Using New Functional Ingredients: If a company wishes to use an ingredient not included on the notified list, it must undergo a full pre-market evaluation of the finished functional cosmetic product by the MFDS. This requires submitting comprehensive data on the ingredient's identity, safety, and efficacy to demonstrate its intended function. Furthermore,
4. Animal Testing for Cosmetic Ingredients
South Korea has prohibited animal testing for cosmetic ingredients and finished products since February 4, 2017. This ban applies to cosmetics that have undergone animal testing, as well as those manufactured or imported using ingredients tested on animals, covering both domestically produced and imported products.
While there are six exceptions (for example, when animal testing is required under the laws of an importing country, or for certain ingredients such as preservatives where no validated alternative methods are available to address public health concerns), the overarching principle remains a strict prohibition on animal testing. The MFDS actively promotes the use of alternative testing methods and has issued a range of guidelines to support industry adoption of such methods.
5. Special Requirements for Specific Ingredients
Beyond the main lists, certain ingredients are subject to unique regulatory scrutiny due to consumer interest, safety concerns, or their classification.
Fragrance Allergens: South Korea mandates the labeling of specific fragrance allergens. There are 25 designated allergens that must be individually listed in the ingredient declaration if their concentration exceeds 0.01% in rinse-off products or 0.001% in leave-on products.
Microplastics (microbeads): The use of microplastics (microbeads) in cosmetic products has been prohibited in South Korea, with a full ban on their use in cosmetics taking effect from July 2017, followed by a further restriction from July 2018 prohibiting the sale of cosmetics containing microplastics.
Exosomes: Human cells, tissues, and their culture media are prohibited in cosmetics, except for those that meet the safety standards for human cell and tissue culture media outlined in Appendix 3 of the Regulation on Safety Standards, etc. for Cosmetics. For non-human exosomes, there are no specific management requirements. It is recommended to evaluate them based on the actual circumstances of the ingredient.
