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To meet the needs of the K-REACH regulation, chemicals companies may need to carry out tests on animals. However, animal tests can be avoided if there is a weight of evidence (WoE) which points to the likely properties of a substance. As more and more companies are calling for change in the way that chemical safety is assessed for regulatory purposes, the authority is piloting projects to develop alternatives to animal testing.
According to Mr. Dong-Jin KIM, the Director of the National Institute of Environmental Research (NIER), the authority will invest KRW 4.2 billion in five years (2022-2026) in production and verification of alternative data for all existing toxicity endpoints, and publish corresponding WoE guidelines and checklist by 2027, starting from the reproductive toxicity.
The first guidelines1, published on April 29, introduces how to integrate evidence and perform WoE analysis for reproductive toxicity. Reproductive toxicity test data is required for K-REACH registration for substances manufactured or imported in annual volumes of 10 tonnes or above. The checklist2 is provided alongside to ensure the relevance and reliability of enough information or evidence.
Meanwhile, the NIER started running a new expert discussion forum aiming to extend the use of alternative data and improve the related research projects, which was formerly operated as the Non-animal Testing Hazard Assessment Research Group since 2020. About 10 external and internal experts from the fields of toxicity, alternative testing, toxicity prediction, and non-testing assessment will join the forum this year to have 6 meetings about assessment procedures for non-testing methods for reproductive toxicity assessment.
