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South Korea Alternative Animal Testing Methods Guidelines: Recap and Latest Developments

An introduction to South Korea's cosmetic animal testing requirement and a collection of all South Korea's Animal Testing Guidelines.

Animal testing is banned in many countries. South Korea was one of the pioneers that protected animal rights since 2013. According to South Korea's Cosmetics Act, no cosmetics or cosmetic ingredients for which animal testing was conducted, should be distributed in South Korea. The ban on animal testing also applies to imported cosmetics.

To guide cosmetic enterprises in smoothly conducting safety tests, the Korean authority has published twenty-nine guidelines on alternative animal testing methods. This article summarises all Korean officially published alternative animal testing methods, along with the latest developments. 

Alternative Animal Testing Guidelines Published by MFDS

Testing Type

Guideline

Year of Adoption/Revision

Phototoxicity

Guideline of Alternative Animal Testing Methods for Cosmetics: In Vitro 3T3 NRU Phototoxicity Test)

In vitro 3T3 NRU 광독성시험법

2007(2021)

Guideline of Alternative Animal Testing Methods for Phototoxicity Test of Cosmetics: Ros (Reactive Oxygen Species) Assay for Photoreactivity

활성산소종(ROS) 분석을 이용한 광독성시험법

2020

Guideline of Alternative Animal Testing Methods for Cosmetics: Phototoxicity Test Using Reconstructed Human Epidermis

인체피부모델을 이용한 광독성시험법

2024

Skin Sensitizing

Guideline of Alternative Animal Testing Methods of Skin Sensitizing for Cosmetics (Local Lymph Node Assay, LLNA)

국소림프절시험법(LLNA)

2007(2021)

Guideline of Alternative Animal Testing Methods of Skin Sensitizing for Cosmetics (Local Lymph Node Assay: DA)

DA법을 이용한 국소림프절시험법

2013(2021)

Guideline of Alternative Animal Testing Methods of Skin Sensitizing for Cosmetics (Local Lymph Node Assay: BrdU-ELISA)

ELISA법을 이용한 국소림프절시험법

2013(2021)

Guideline of Alternative Animal Testing Methods of Skin Sensitizing for Cosmetics (In Chemico Direct Peptide Reactivity Assay, DPRA)

In Chemico 펩타이드 반응성시험법(DPRA)

2016(2022)

Guideline of Alternative Animal Testing Methods (In Vitro Skin Sensitisation: human Cell Line Activation Test, h-CLAT)

인체세포주 활성화 방법(h-CLAT)

2017

Guideline of Alternative Animal Testing Methods for Cosmetics (In Vitro Skin Sensitization: ARE-Nrf2 Luciferase KeratinoSensTM Test 

ARE-Nrf2 루시퍼라아제 시험법(KeratinoSensTM)

2024

Guideline of Alternative Animal Testing Methods for Cosmetics (In Vitro Skin Sensitization: ARE-Nrf2 Luciferase LuSens Test)

ARE-Nrf2 루시퍼라아제 LuSens 시험법

2019

Guideline of Alternative Animal Testing Methods of Skin Sensitizing for Cosmetics (Local Lymph Node Assay by using flow cytometry, LLNA: BrdU-FCM)

유세포분석을 이용한 국소림프절시험법(LLNA:BrdU-FCM)

2018

Guideline of Alternative Animal Testing Methods of Skin Sensitizing for Cosmetics (In Chemico Direct Peptide Reactivity Assay, DPRA)

In Chemico 아미노산유도체 결합성 시험법(ADRA)

2020(2023)

Guideline of Alternative Animal Testing Methods of Skin Sensitizing for Cosmetics (Interleukin-8 luciferase)

IL-8 루시퍼라아제 시험법

2021

Guideline of Alternative Animal Testing Methods of Skin Sensitizing for Cosmetics (In Chemico kinetic Direct Peptide Reactivity Assay, kDPRA)

In Chemico 피부감작성시험법, kDPRA

2022

Skin Corrosion

Guideline of Alternative Animal Testing Methods of Skin Corrosivity for Cosmetics (Transcutaneous Electrical Resistance)

경피성 전기저항 시험법(TER)

2018

Guideline of Alternative Animal Testing Method for Cosmetics (In vitro Skin Corrosion Reconstructed Human Epidermis, RhE Test Method)

인체피부모델을 이용한 피부부식 시험법

2019

Guideline of Alternative Animal Testing Method for Cosmetics (In Vitro Membrane Barrier Test Method for Skin Corrosion)

장벽막을 이용한 피부부식 시험법

2019

Skin Irritation

Guideline of Alternative Animal Testing Methods for Cosmetic Skin Irritation (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

인체피부모델을 이용한 피부자극시험법

2014(2021)

Skin Absorption

Guideline of Alternative Animal Testing Methods for Cosmetics (Skin Absorption: in vitro Method)

생체외 피부흡수시험법

2009(2023)

 

Eye Irritation 

 

Guideline of Alternative Animal Testing Methods for Cosmetics (Bovine Corneal Opacity and Permeability Test Method, BCOP)

소각막을 이용한 안점막자극시험법(BCOP)

2011(2020)

Guideline of Alternative Animal Testing Methods of Eye Test for Cosmetics (Isolated Chicken Eye Test Methods, ICE)

닭의 안구를 이용한 안점막자극시험법(ICE)

2015(2021)

Guideline of Alternative Animal Testing Methods for Cosmetics [Eye Irritation Test using Reconstructed human Cornea-like Epithelium (RhCE)]

인체각막유사 상피모델을 이용한 안자극시험

2016(2020)

Guideline of Alternative Animal Testing Methods for Cosmetics (Short Time Exposure (STE) in vitro Test Method)

단시간 노출법(STE)

2017(2020)

Guideline of Alternative Animal Testing Methods for Cosmetics (Vitrigel-Eye Irritancy Test Method)

인체 각막세포주(Vitrigel)를 이용한 안자극시험

2020(2022)

Guideline of Alternative Animal Testing Methods of Eye Test for Cosmetics (In vitro Macromolecular Test Method: Ocular Iritection)

In vitro 고분자 시험법: Ocular Irritection®

2021

Guideline of Alternative Animal Testing Methods for Cosmetics: Eye Irritation(Acute Eye Damage or Irritation) Test using Reconstructed human Cornea-like Epithelium (RhCE)

인체각막유사 상피모델을 이용한 안 유해성 시험법

2023

Acute Oral Toxicity

Guideline of Alternative Animal Testing Methods for Cosmetics (Acute Oral Toxicity-Fixed Dose Procedure)

고정용량법

2008(2018)

Guideline of Alternative Animal Testing Methods for Cosmetics (Acute Oral Toxicity-Acute Toxic Class Method)

독성등급법

2008(2018)

Guideline of Alternative Animal Testing Methods for Cosmetics (Acute Oral Toxicity-Up-and-Down-Procedure, UDP)

용량고저방법

2015(2018)

Exemptions from Animal Testing Ban

However, MFDS specifies six situations which animal testing can be adopted on cosmetics:

  1. Situation when animal testing is needed to determine the standards for using raw materials requiring a specific restriction on usage, such as preservatives, coloring or sun-blocks, or to assess hazards of cosmetics raw materials, etc., posing risks to public health;

  2. Situation when animal testing is needed because no alternative to animal testing exists;

  3. Situation when animal testing is needed to export cosmetics following the statutes and regulations of the exporting country;

  4. Situation when animal testing is needed for product development following the statutes and regulations of the importing country;

  5. Situation when raw materials developed through animal testing conducted under other statutes and regulations are used for the manufacture, etc. of cosmetics;

  6. Other cases prescribed by MFSD, where it is impractical to conduct alternatives to animal testing.

Latest Developments 

On October 18, 2023, Ministry of Food and Drug Safety (MFDS) issued a new alternative animal testing guideline, named Guideline of Alternative Animal Testing Methods for Cosmetics: Eye Irritation(Acute Eye Damage or Irritation) Test using Reconstructed human Cornea-like Epithelium (RhCE)(인체각막유사 상피모델을 이용한 안 유해성 시험법). This guideline is established based on the latest OECD-approved alternative testing methods. The “eye damage or irritation” refers to harmful effects such as damage or irritation that occur when the test substance comes into contact with the eyes. RhCE eye irritation test method is expected to help enterprises develop safer cosmetic products without animal testing. 

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