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South Korea Releases Guidelines for Animal Testing Alternative Methods and Risk Assessment

  •   11 Oct 2019
  •    Hedy He
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    On Oct. 1st and 2nd, 2019, South Korea MFDS released 3 guidelines for animal testing alternative methods [1]and risk assessment [2].

    1. Two Guidelines for animal testing alternative methods: In Vitro Skin Corrosion: Reconstructed Human Epidermis (RhE) Test Method [3] and In Vitro Membrane Barrier Test Method for Skin Corrosion [4]

    These 2 Guidelines include principles of the test, considerations and limitations, method of the test, approval requirements, result and report of the test.

    Until now, South Korea has released 21 guidelines for alternative methods. The following shows the details: [5]

    No.Year of AdoptionTest Guidelines3R Principle
    12007Skin Sensitization: Local Lymph Node AssayReduction and Refinement
    22007 (revised in 2018)In Vitro 3T3 NRU Phototoxicity TestReplacement
    32008 (revised in 2018)Acute Oral Toxicity: Fixed Dose ProcedureReduction and Refinement
    42008 (revised in 2018)Acute Oral Toxicity: Acute Toxic Class MethodReduction and Refinement
    52009Skin Absorption: In Vitro MethodReplacement
    62013Skin Sensitization: Local Lymph Node Assay: DAReduction and Refinement
    72013Skin Sensitization: Local Lymph Node Assay: BrdU-ELISAReduction and Refinement
    82008 (revised in 2014)Bovine Corneal Opacity and Permeability (BCOP) Test MethodReplacement
    92014In Vitro Skin Irritation: Reconstructed Human Epidermis Test MethodReplacement
    102015Isolated Chicken Eye Test MethodReplacement
    112015 (revised in 2018)Acute Oral Toxicity: Up-and-Down-Procedure (UDP)Reduction and Refinement
    122016In Chemico Skin Sensitization: Direct Peptide Reactivity Assay (DPRA)Replacement
    132016Reconstructed human Cornea-like Epithelium (RhCE) Test MethodReplacement
    142017In Vitro Skin Sensitization: ARE-Nrf2 Luciferase Test MethodReplacement
    152017In Vitro Skin Sensitization Assays: h-CLATReplacement
    162017Short Time Exposure In Vitro Test MethodReplacement
    172018Transcutaneous Electrical Resistance Test Method (TER)Replacement
    182018Local Lymph Node Assay: BrdU-FCMReduction and Refinement
    192019In Vitro Skin Sensitization: ARE-Nrf2 Luciferase LuSens TestReplacement
    202019In vitro Skin Corrosion: Reconstructed Human Epidermis (RhE) Test MethodReplacement
    212019In Vitro Membrane Barrier Test Method for Skin CorrosionReplacement

    2. Guideline for Risk Assessment of Human Applied Products [6]

    This guideline includes the overview, risk assessment system, methods, related regulations, etc. and applies to cosmetics, food, medicines, medical devices, etc.

    Products Require Risk Assessment:

    Products1) Human applied products that are prohibited from being manufactured or sold by international institutions and foreign governments in consideration of possible harm to human health

    2) Human applied products that do not specify safety standards and specifications

    3) Other human applied products that have been proven to be harmful to human health

    Risk Elements
    • Chemical: Pesticide residues, heavy metals, food additives, residues of medicines for animals, environmental pollutants, substances produced in manufacturing/processing/cooking, radioactivity, etc.
    • Physical: The state and foreign matters of food
    • Microorganism: bacteria that induce food poisoning, antibiotic-resistant bacteria, etc.
    • Other ingredients used in human applied products, and chemical, physical and microorganism factors

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    ChemLinked Editor

    Tracking regulatory change news in Asia Pacific area and focusing on cosmetic ingredient requirements, registration/filing/notification procedures of China and South Korea.

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