On June 10, 2026, the Ministry of Food and Drug Safety (MFDS) of South Korea published the "Guide for Preparation of Cosmetic Safety Assessment Documentation" , providing detailed guidance for cosmetic responsible distributors on preparing safety assessment documentation prior to product distribution and sale.
South Korea plans to implement a mandatory cosmetic safety assessment system in phases starting from 2028. The guide published this time will help companies and safety assessors prepare in advance. CIRS Group has compiled the key contents of the guide below for reference.
Background
Cosmetic safety assessment is the process of demonstrating, through scientific evidence, that a product is safe for human health under normal or reasonably foreseeable conditions of use. Major markets such as the European Union, the United States, and China have implemented cosmetic safety assessment systems for many years.
Since joining the International Cooperation on Cosmetics Regulation (ICCR), South Korea has continuously promoted international regulatory harmonization in the cosmetics sector, and formally established the legal basis for the cosmetic safety assessment system through the partial amendment to the Cosmetics Act (Law No. 21302) on December 30, 2025.
Under the amended Cosmetics Act, cosmetic responsible distributors are required to prepare safety assessment documentation on a product-by-product basis prior to distribution and sale, and have it reviewed by a "safety assessor" with safety-related academic qualifications or experience, and retain the documentation.
South Korea plans to introduce this system in phases starting from 2028. To assist companies and assessors in understanding the preparation requirements, the MFDS has developed this guide, which clarifies the structure and preparation methods for safety assessment documentation.
Guide Framework
The guide is divided into four parts:
I. Introduction (Purpose, Background, Relevant Regulations)
II. Preparation of Safety Assessment Documentation
III. Annex Materials
IV. References
Detailed Requirements for Safety Assessment Documentation
1. Product Information
Product information should include: product name or product code, product type and usage method, names and addresses of the cosmetic manufacturer and responsible distributor, etc. If the product specification sheet or import management record already contains the above information, it may be used as a substitute.
2. Cosmetic Safety Assessment Report
The safety assessment report is the core part of the documentation, containing the following:
2.1 Cosmetic Safety Information
- Qualitative and quantitative composition: Names of all ingredients, names of compositional substances, content (weight percentage), and purpose of formulation. Fragrances may be labeled with fragrance name and supplier information. If the manufacturer provides complete data, the formulation range may be used instead of the exact formulation amount.
- Physicochemical properties and stability of the product and ingredients: Including the product's physical state, dosage form, color, odor, viscosity, etc., as well as the molecular formula, molecular weight, solubility, partition coefficient, etc. of the ingredients. Product stability assessment must refer to the MFDS "Guide for Cosmetic Stability Testing" to establish the shelf life and period after opening.
- Microbiological quality: Based on the microbiological sensitivity of the product, it is divided into three categories:
① Products with low microbiological risk (e.g., products with alcohol content >70%, products with extremely high or low pH) may be exempt from microbiological limit testing and preservative efficacy testing;
② Low-risk products such as single-use products may only require microbiological limit testing;
③ Other products must undergo both microbiological limit testing and preservative efficacy testing. International standards such as ISO 11930 and ISO 29621 may be referenced.
- Impurities and packaging material information: Including unintended substances generated during the manufacturing process of ingredients and products, as well as safety and migration assessment of packaging containers in direct contact with the contents.
- Product usage method: Detailed usage methods including application area, frequency of use, etc.
- Exposure assessment: Comprehensively considering the purpose of use, application area, frequency of use, amount used, duration of use, etc., to establish exposure scenarios and quantify human exposure to cosmetic ingredients. The MFDS "Guide for Cosmetic Hazard Assessment" should be referenced.
- Exposure calculation and Margin of Safety (MOS): Based on ingredient content and exposure information, calculate systemic or local exposure, and combine with toxicity information to calculate the Margin of Safety.
- Toxicity information hazard assessment: Covering endpoints such as acute toxicity, skin and eye mucosa irritation and skin sensitization, repeated dose toxicity, reproductive and developmental toxicity, genotoxicity, carcinogenicity, phototoxicity, etc. If toxicity data is unavailable, alternative methods such as QSAR may be used for toxicity prediction.
- Adverse case information: Including adverse case information learned during cosmetic distribution and use, and corrective measures taken.
2.2 Safety Assessment Conclusion and Safe Use Plan
After comprehensively evaluating all safety information, clearly state whether the product is safe for human health under normal and reasonably foreseeable conditions of use, and provide labeling recommendations for usage methods, precautions, etc.
2.3 Safety Assessor Signature and Qualification Proof
The safety assessor must provide qualification proof in accordance with statutory qualification requirements.
Key Takeaways
Guide nature: This guide is a public guidance document without external legal force, representing only the general interpretation of the MFDS. Companies may use internationally authoritative data and scientific literature as alternative bases.
Reference to international standards: The guide extensively cites internationally recognized norms such as OECD Test Guidelines, ECHA registration dossiers, SCCS opinions, ISO standards, and China NIFDC technical specifications.
Substitution and simplification mechanism: For products with similar ingredients and identical packaging materials, existing stability test data and microbiological assessment data may be used as substitutes for repeated testing, reducing compliance costs for companies.
Animal testing ban: The guide emphasizes that South Korea prohibits the sale of cosmetics tested on animals, and safety assessments should prioritize alternative methods (e.g., QSAR, in vitro testing, etc.).
Fragrance-specific requirements: Fragrances require documentation related to allergenicity, such as IFRA certificates, and confirmation of compliance with allergen labeling regulations.
CIRS Reminder
South Korea's cosmetic safety assessment system will be implemented in phases starting from 2028. Relevant cosmetic companies should focus on the following:
- Understand assessment requirements in advance. Companies should carefully study this guide, understand the structure of safety assessment documentation, preparation requirements for each section, and acceptable alternative approaches, to build knowledge reserves for future compliance.
- Establish product safety files. Companies may refer to the guide requirements to proactively organize product formulation information, ingredient specification sheets, stability test data, microbiological test reports, and other basic materials to prepare for safety assessment.
- Monitor system progress. The MFDS is assisting companies in transitioning through initiatives such as the "Cosmetic Safety Assessment Introduction Support Project." Companies should closely monitor the system implementation timeline.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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