Scientific Opinion of the Scientific Committee "Existing approaches incorporating replacement, reduction and refinement of animal testing: applicability in food and feed risk assessment" 1

SUMMARY The founding Regulation of EFSA 3 requires the Authority to contribute to a high level of protection of human life and health, and in this respect to take account of animal health and welfare. EFSA is committed to a proactive animal welfare approach, based on sound scientific principles and the need to ensure that adequate data are available for a reliable risk assessment. In this context, EFSA and its Scientific Committee recognise the importance to stimulate the use of food and feed assessment approaches that would not only minimise the number of experimental animals and any suffering, but also work towards their replacement. The present Opinion gives an overview of the legislation and guiding principles on the use of animals for experimental purposes and explains the principles of scientific validation of toxicity tests for regulatory purposes. It summarises possibilities for replacement, reduction and refinement (Three Rs) of toxicological animal testing within the different areas of EFSA’s activities. Finally, integrated testing and risk assessment strategies are considered and recommendations are given to implement better animal welfare within EFSA’s activities. Most of the assessments conducted by EFSA’s Scientific Committee and Scientific Panels require experimental data. The complete replacement of animal experiments while maintaining the same level of food and feed safety is not possible at present. However in the meantime, considerable improvements can be made to promote better animal welfare. In this 1 For citation purposes: Opinion of the Scientific Committee on a request from EFSA on existing approaches incorporating