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Amendments regarding reduction of vertebrate animal testing during generation of registration data have been passed and incorporated into the revised version of K-REACH as Law No. 15584 on 17 Apr 2018. The new requirements will come into force on 1 Jan 2019 as well as the other amendments (CL news) promulgated by the president on 20 Mar as Law No. 15512.
Development of alternatives to animal testing is an important issue in global regulatory affairs. Following the EU ban on animal testing, a definition of “alternative vertebrate animal testing” has been added to K-REACH. The authority will develop and adopt alternative tests to minimize the use of vertebrate animals (newly added Article 4 Paragraph 5 of K-REACH). In addition, industry also needs to prioritize alternative animal testing during data generation (newly added Article 5 Paragraph 5).
The vertebrate animal testing minimizing principle is adopted as a new Article 16-2 during chemical registration, hazard evaluation and risk assessment. Duplication of vertebrate animal testing data should be avoided except when a chemical is discovered to have new hazards which could negatively impact humans, animals and the environment.
As stipulated in Revised Article 17, any person who intends to apply for registration shall confirm in advance if there is existing vertebrate animal test data. Companies are encouraged to purchase existing test results rather than conducting their own tests on animals. However, if any registration data is more than 15 years old it can be used by others without an approval from the data owner.
