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South Korean Updates Cosmetics Testing Guidelines

  •   6 Aug 2019
  •    Hedy He
  •  186
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    Takehome:

    • MFDS released a Guideline on the In Vitro Skin Sensitization: ARE-Nrf2 Luciferase LuSens Test.
    • Guideline for Cosmetic Ingredient Analysis is to be amended. Analytical methods for 6 preservatives and a UV filter are newly added.

    1. On July 10, 2019, South Korean MFDS released a Guideline for the animal testing alternative method: In Vitro Skin Sensitization: ARE-Nrf2 Luciferase LuSens Test [1].

    The Guideline [2] includes 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 19 Guidelines for alternative methods. The following shows the details [3].
     

    No.Year of AdoptionTest Guidelines
    12007Skin Sensitization: Local Lymph Node Assay
    22007 (revised in 2018)In Vitro 3T3 NRU Phototoxicity Test
    32008 (revised in 2018)Acute Oral Toxicity: Fixed Dose Procedure
    42008 (revised in 2018)Acute Oral Toxicity: Acute Toxic Class Method
    52009Skin Absorption: In Vitro Method
    62013Skin Sensitization: Local Lymph Node Assay: DA
    72013Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA
    82008 (revised in 2014)Bovine Corneal Opacity and Permeability (BCOP) Test Method
    92014In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method
    102015Isolated Chicken Eye Test Method
    112015 (revised in 2018)Acute Oral Toxicity: Up-and-Down-Procedure (UDP)
    122016In Chemico Skin Sensitization: Direct Peptide Reactivity Assay (DPRA)
    132016Reconstructed human Cornea-like Epithelium (RhCE) Test Method
    142017In Vitro Skin Sensitization: ARE-Nrf2 Luciferase Test Method
    152017In Vitro Skin Sensitization Assays: h-CLAT
    162017Short Time Exposure In Vitro Test Method
    172018Transcutaneous Electrical Resistance Test Method (TER)
    182018Local Lymph Node Assay: BrdU-FCM
    192019In Vitro Skin Sensitization: ARE-Nrf2 Luciferase LuSens Test

    2. On July 25, 2019, South Korea released an announcement amending Guideline for Cosmetic Ingredient Analysis [4]. The main amendments are as follows.

    • Analytical methods for 6 preservatives are newly added.
    Chlorhexidine
    Benzethonium chloride
    2,4-Dichlorobenzyl alcohol
    Chlorophene
    p-Chloro-m-cresol
    2-Bromo-2-nitropropane-1,3-Diol
    • Analytical method for UV filter, Diethylamino Hydroxybenzoyl Hexyl Benzoate, is newly added.
    • Analytical method for 2,4-Diamino- pyrimidine-3-Oxide is newly added.

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    ABOUT THE AUTHOR

    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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