In Brazil, efforts towards the regulatory acceptance and implementation of innovative methods to replace experimental animal use in various fields began to gather force in 2008, with the approval of Law No. 11,794/2008 (the Arouca Law). This law represented a milestone, as it created the National Council for the Control of Animal Experimentation (CONCEA) to deal with the ethical and legal issues related to the use of laboratory animals. In 2014, CONCEA put together a framework for expanding the implementation of non-animal methodologies for use in research and education. It also promoted the regulatory acceptance in Brazil of 24 test guidelines, including 15 in vitro approaches. It should be emphasised that, in Brazilian legislation, replacement is generally based on the toxicological endpoint and not on the category of product, as tends to be the case in other countries (e.g. cosmetics in the European Union). The resolution-dependent deadlines for the obligatory replacement of in vivo methods with the CONCEA-approved tests are 2019 and 2021. Brazil has advanced considerably towards the replacement of animal experimentation, and in certain aspects, this has been in a highly progressive manner. However, there is still a lot of work to be done, especially considering the current political scenario with reduced investment in research, development and innovation. The chronology of significant events following the approval of the Arouca Law, which have contributed to the promotion of the Three Rs alternatives in Brazil, will be examined.
Keywords: Brazilian regulation; Three Rs methods; innovative methods; replacement of animal experimentation.