Korea MFDS, Announcement of guidelines on alternative animal testing methods for skin sensitization and ocular toxicity of cosmetics

 

In June 2025, the Ministry of Food and Drug Safety (MFDS) of Korea announced the publication of the following two guidelines concerning alternative animal testing methods for cosmetic product safety

- Guideline on In vitro skin sensitization assay (EpiSens A) for cosmetics and related products

- Guideline on Ocular irritation test method using reconstructed human cornea-like epithelium (RhCE) for identifying non-eye irritants in cosmetics and related products.

 

Laboratories that routinely perform these methods are required to demonstrate technical proficiency by using the 10 proficiency substances (for EpiSens A) and 15 proficiency substances (for the ocular test) specified in the respective guidelines.

 

All test results must fully meet the acceptance criteria outlined in the guidelines in order to be considered valid.

 

The guidelines provide comprehensive information including the principles, limitation and considerations, test procedures, acceptance criteria and validity requirements, the interpretation and reporting of results.

 

Please refer to the link below. 

https://www.mfds.go.kr/brd/m_1060/view.do?seq=15669&srchFr=&srchTo=&srchWord=&srchTp=0&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&Data_stts_gubun=C1006&page=1

 

식품의약품안전처>법령/자료>법령정보>공무원지침서/민원인안내서>민원인안내서 | 식품의약품

https://www.mfds.go.kr/brd/m_1060/view.do?seq=15674&srchFr=&srchTo=&srchWord=&srchTp=0&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&Data_stts_gubun=C1006&page=1

식품의약품안전처>법령/자료>법령정보>공무원지침서/민원인안내서>민원인안내서 | 식품의약품

 

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