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 .
The Guideline  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 .
|No.||Year of Adoption||Test Guidelines|
|1||2007||Skin Sensitization: Local Lymph Node Assay|
|2||2007 (revised in 2018)||In Vitro 3T3 NRU Phototoxicity Test|
|3||2008 (revised in 2018)||Acute Oral Toxicity: Fixed Dose Procedure|
|4||2008 (revised in 2018)||Acute Oral Toxicity: Acute Toxic Class Method|
|5||2009||Skin Absorption: In Vitro Method|
|6||2013||Skin Sensitization: Local Lymph Node Assay: DA|
|7||2013||Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA|
|8||2008 (revised in 2014)||Bovine Corneal Opacity and Permeability (BCOP) Test Method|
|9||2014||In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method|
|10||2015||Isolated Chicken Eye Test Method|
|11||2015 (revised in 2018)||Acute Oral Toxicity: Up-and-Down-Procedure (UDP)|
|12||2016||In Chemico Skin Sensitization: Direct Peptide Reactivity Assay (DPRA)|
|13||2016||Reconstructed human Cornea-like Epithelium (RhCE) Test Method|
|14||2017||In Vitro Skin Sensitization: ARE-Nrf2 Luciferase Test Method|
|15||2017||In Vitro Skin Sensitization Assays: h-CLAT|
|16||2017||Short Time Exposure In Vitro Test Method|
|17||2018||Transcutaneous Electrical Resistance Test Method (TER)|
|18||2018||Local Lymph Node Assay: BrdU-FCM|
|19||2019||In Vitro Skin Sensitization: ARE-Nrf2 Luciferase LuSens Test|
2. On July 25, 2019, South Korea released an announcement amending Guideline for Cosmetic Ingredient Analysis . The main amendments are as follows.
Analytical methods for 6 preservatives are newly added.
Analytical method for UV filter, Diethylamino Hydroxybenzoyl Hexyl Benzoate, is newly added.
Analytical method for 2,4-Diamino- pyrimidine-3-Oxide is newly added.