On July 29, 2026, South Korea Cosmetic Association (KCIA) announced that the National Institute of Food and Drug Safety Evaluation (NIFDS) has officially completed the revision of the "Guideline for Animal Alternative Testing Methods for Cosmetics, Etc. (Applicant Guide)".
This revision formally incorporates into the Korean domestic guideline the "KeraSkin™ Human Skin Model Phototoxicity Test Method, which was developed and validated by the Korean Center for Validation of Alternative Methods (KoCVAM) and has been included in the OECD Test Guideline (TG 498). This marks a further alignment of Korea's animal alternative testing method system with international standards. CIRS Group has summarized the main content below for your reference.
I. Background
Since 2018, through progressive legislation such as the Cosmetics Act, South Korea has been gradually phasing out animal testing of cosmetic finished products and new ingredients (with certain exceptions), and has explicitly prohibited the sale of cosmetics or their ingredients that have been tested on animals. Against this backdrop, animal alternative testing methods have become an important pillar of cosmetic safety assessment in Korea.
The OECD Test Guidelines (TG) are internationally recognized standards for alternative methods, among which TG 498 is the "Reconstructed Human Epidermis Phototoxicity Test (RhE PT)". KoCVAM developed and validated a phototoxicity test method based on the domestically developed human skin model KeraSkin™, which has been included in OECD TG 498 as a "me-too" equivalent method (the KoCVAM-led validation study was published in the academic journal ALTEX in May 2025).
To promote the introduction and implementation of internationally harmonized alternative methods, MFDS/NIFDS solicited industry comments on the draft revision on July 10, 2026 (the comment period ended July 15). Following the completion of the comment period, the final version of the guideline has now been officially released.
II. Revision History and Overview of This Revision
The object of this revision is the "Guideline for Phototoxicity Animal Alternative Test Methods for Cosmetics, Etc. (Phototoxicity Test Method Using a Human Skin Model) (Applicant Guide)", an MFDS guidance document addressed to applicants, the nature of which is an explanatory and reference guideline. The revision history of this guideline is as follows:
- 1st revision (September 2022): Initial establishment of the "Guideline for Phototoxicity Animal Alternative Test Methods for Cosmetics, Etc. (Phototoxicity Test Method Using a Human Skin Model) (Applicant Guide)".
- 2nd revision (March 2024): Revised due to changes in proficiency substance information and vehicles.
- 3rd revision (July 2026): Revised due to the inclusion of the KeraSkin™ Phototoxicity Assay — i.e., this revision.
III. Core Revision Content
1. Incorporation of two validated test methods
The revised guideline now contains two validated phototoxicity test methods, using the commercialized reconstructed human epidermis (RhE) models-EpiDerm™and KeraSkin™, respectively.
2. Clarification of the VRM and me-too equivalent method framework
The OECD TG 498 framework of "Validated Reference Method (VRM, EpiDerm™ PT) + equivalent method (me-too, KeraSkin™ PA)", together with the validation logic of the Performance Standards (PS), has been incorporated into the Korean domestic guideline. Following an independent peer review, KeraSkin™ PA was confirmed to meet the me-too test method requirements specified in the PS, with a sensitivity of 100%, specificity of 98.6%, and accuracy of 99.3%.
3. Test principle and methodological lineage
The test substance is topically applied to the surface of a multilayered, highly differentiated and cultured RhE model; after standard incubation to allow the test substance to penetrate into the tissue, phototoxicity is determined by comparing the relative decrease in cell viability between the artificial sunlight-irradiated group and the non-irradiated group. Cell viability is measured by the MTT assay (MTT is converted via an enzymatic reaction into blue formazan, which is then quantified by microplate spectrophotometry). Methodologically, it combines OECD TG439 (test substance exposure and cell viability measurement) and OECD TG432 (standard irradiation procedure).
4. Scope of application and limitations
Since a photoreaction requires the absorption of sufficient energy, the UV/visible light absorption spectrum of the test substance should be confirmed according to OECD TG101 prior to testing; substances with a molar extinction coefficient (MEC) below 1000 L·mol⁻¹·cm⁻¹ have a low probability of causing a photoreaction and may not require a phototoxicity test.
In addition, mixtures and difficult-to-test substances (e.g., unstable substances) may be difficult to apply to this test method; this test method is also not designed to predict other photochemical-related adverse effects such as photogenotoxicity, photoallergy, and photocarcinogenicity.
5. Structure of the guideline document
The guideline released this time comprises a total of 94 pages and contains three main parts-the Korean summary, the Korean translation of OECD TG498, and the English original text-to facilitate applicants' accurate understanding and reference for implementation.
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