The publication is intended to help the cosmetics industry prepare well in advance of the phased implementation of South Korea’s mandatory cosmetic safety assessment system, which is scheduled to begin in 2028.
A step toward internationally aligned cosmetic regulation
Over the past several years, South Korea has continued to align its cosmetics legislation with internationally recognized regulatory practices. Following amendments to the country’s Cosmetics Act at the end of 2025, responsible distributors will be required to maintain a safety assessment for every cosmetic product before it is marketed.
The assessment must be reviewed by a qualified safety assessor with appropriate scientific expertise, after which the documentation must be retained as part of the company’s compliance records.
This approach closely resembles the product safety documentation already required in several major cosmetic markets, reflecting South Korea’s broader efforts to harmonize its regulatory system with international practices.
What is the purpose of a cosmetic safety assessment?
A cosmetic safety assessment is a scientific evaluation that determines whether a cosmetic product can be used safely under its intended conditions of use. Rather than relying on a single laboratory test, the assessment combines information about the formulation, exposure, toxicological data, microbiological quality, packaging, stability, and intended use of the product.
The final assessment should demonstrate that the product does not present an unacceptable risk to human health when used as intended or under reasonably foreseeable conditions.
Information expected in the safety documentation
The new MFDS guidance describes the types of information that companies should include when preparing their safety documentation. While existing technical documents may already contain some of the required information, manufacturers will generally need to assemble all relevant data into a structured safety file.
Product identification
The documentation begins with basic product information, including the product name or identification code, cosmetic category, intended method of use, and details of both the manufacturer and the responsible distributor. Existing product specification documents or import records may be used where they already contain the necessary information.
Complete formulation details
The assessment should include the qualitative and quantitative composition of the product, identifying every ingredient together with its function in the formulation.
For fragrance mixtures, supplier information and fragrance identification may be provided instead of disclosing the complete fragrance composition. Where full formulation data is supplied by the manufacturer, acceptable concentration ranges may be used under certain circumstances.
Physical characteristics and stability
Companies are expected to document both the physical characteristics of the finished product and relevant information for its ingredients. This includes characteristics such as appearance, odor, viscosity, dosage form and other physicochemical properties.
Evidence supporting the product’s shelf life and period after opening should also be included. Stability studies are expected to follow the recommendations published separately by the MFDS for cosmetic stability testing.
Microbiological quality
The guidance adopts a risk-based approach to microbiological testing.
Products that present minimal microbiological risk, such as formulations containing very high alcohol concentrations or products with extreme pH values, may qualify for reduced testing requirements. Other low-risk products may require only microbiological limit testing, while products with a higher potential for microbial contamination are expected to undergo both microbiological testing and preservative efficacy testing.
International standards, including ISO methods, may be used when performing these evaluations.
Packaging and potential impurities
The documentation should also consider substances that may be unintentionally present in the finished product, including impurities originating from raw materials or the manufacturing process.
In addition, companies are expected to evaluate packaging materials that come into direct contact with the cosmetic product, taking into account potential interactions or migration of substances into the formulation.
Consumer exposure assessment
A significant part of the safety assessment focuses on estimating consumer exposure.
The guidance recommends considering how and where the product is used, how frequently it is applied, the quantity typically used, and the duration of exposure. This information is then combined with ingredient concentrations to estimate both local and systemic exposure.
These calculations provide the basis for determining the Margin of Safety (MoS), an important indicator used to evaluate whether ingredient exposure remains within acceptable toxicological limits.
Toxicological evaluation
The safety assessment should review available toxicological information for cosmetic ingredients across a broad range of health endpoints.
These include acute toxicity, skin and eye irritation, skin sensitization, repeated exposure, reproductive and developmental toxicity, genotoxicity, carcinogenicity and phototoxicity, among others.
Where experimental toxicological data are unavailable, scientifically accepted alternative approaches, including computational prediction methods such as QSAR models, may be used where appropriate.
Post-market safety information
The guidance also recommends incorporating information obtained after products reach consumers.
Any reported undesirable effects, together with investigations and corrective actions, should become part of the product’s ongoing safety documentation.
The final safety conclusion
After evaluating all available evidence, the safety assessor is expected to provide an overall scientific conclusion regarding whether the cosmetic product is safe under its intended conditions of use.
Where appropriate, the assessment should also recommend instructions for use, warnings or other precautionary statements that should appear on the product label.
The documentation must be signed by a qualified safety assessor, with evidence demonstrating that the assessor meets the required professional qualifications.
Additional flexibility for manufacturers
One notable aspect of the guidance is its recognition that existing scientific information may often be reused.
For example, products sharing highly similar formulations and identical packaging materials may be able to rely on previously generated stability or microbiological data instead of repeating every study. This approach could reduce unnecessary testing while maintaining product safety.
The guidance also makes extensive reference to internationally recognised scientific resources, including OECD test guidelines, ISO standards, scientific opinions, toxicological databases and other established technical references.
Continued emphasis on alternative testing methods
The guidance reinforces South Korea’s existing policy against animal-tested cosmetics by encouraging the use of validated alternative approaches wherever possible.
In addition to laboratory-based non-animal methods, computational toxicology tools such as Quantitative Structure–Activity Relationship (QSAR) models are identified as valuable sources of supporting safety information when appropriate.
For fragrance ingredients, companies are also encouraged to maintain supporting documentation demonstrating compliance with allergen requirements and relevant industry standards, including IFRA documentation where applicable.
What cosmetic companies should do before 2028
Although the mandatory safety assessment system will not be fully introduced until 2028, companies marketing cosmetics in South Korea should begin preparing now.
Building complete product safety files, organizing formulation data, collecting ingredient specifications, maintaining stability and microbiological testing reports, and ensuring access to toxicological information will make the transition considerably easier once the new requirements become mandatory.
Businesses should also continue monitoring future MFDS publications, as additional guidance and implementation measures are expected before the phased rollout of the new system begins.
