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South Korean Updates Cosmetics Testing Guidelines

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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