Activities of the Animal Welfare Body at the Istituto Zooprofilattico Sperimentale Umbria and Marche “Togo Rosati” from 2016 to 2025

Animal welfare and ethical responsibility are central considerations in animal research. In Italy, European Directive 2010/63/EU was implemented through Legislative Decree No. 26/2014, establishing Animal Welfare Bodies (AWBs) to ensure ethical project evaluation and promote the Replacement, Reduction, and Refinement (3Rs) principles. Despite their regulatory importance, long-term analyses of AWB activities remain limited, particularly within the Italian context. This study presents a ten-year retrospective analysis of the AWB of the Istituto Zooprofilattico Sperimentale dell’Umbria e delle Marche “Togo Rosati” (IZSUM) from 2016 to 2025. The study collected data on project evaluations, species involved, opinions issued, retrospective assessments, personnel competence management, and welfare monitoring procedures. Over the study period, the AWB evaluated 33 projects, issuing 26 positive opinions, 6 positive opinions with reservations, and 1 negative opinion, and conducted 11 retrospective assessments. The data showed marked fluctuations in authorised animal numbers, including a substantial reduction in mouse authorisations between successive five-year regulatory testing cycles. These trends occurred alongside the implementation of alternative methods and changes in regulatory testing strategies. The findings describe the activities and longitudinal outcomes of a single institutional AWB and are consistent with a potential contribution to 3Rs implementation, while the single-institution observational design does not allow causal attribution of these changes to AWB activities alone.