Establishment of alternatives to animal testing

Following the addition of the reconstructed human corneal-like dermal modelling method (RhCE method) in 2019 as an alternative to the ophthalmic stimulation test that can be used in the application for quasi-drugs, guidance was issued in 2021 on single-dosage and dermal stimulation in 2022 on the evaluation system. In addition, discussions on next-generation risk assessment without using animals are still ongoing. In Japan, however, the safety evaluation of quasi-drugs with new ingredients necessarily requires results of animal experiments as a hazard evaluation of raw materials, and it cannot be said that other available scientific grounds have been sufficiently reviewed. In addition, in each country, discussions are actively underway for the development of evaluation methods that do not use animals at all, the establishment of safety evaluation methods, and the use of animal experiment results carried out for purposes other than cosmetics. Although Japan is also participating in the discussion, the policy for the safety assessment of the final product in Japan remains insufficient.


  • Japan should promptly establish risk assessment methods for final products utilising available scientific evidence to prevent the implementation of unnecessary animal experiments. In addition, Japan should alsopromote the rapid development of alternative methods that do not use animals at all and the active use of such methods in the application for quasi-drugs.