EURL ECVAM strategy to avoid and reduce animal use in genotoxicity testing

Abstract

The assessment of genotoxicity represents an important component of the safety assessment of all types of substances. Although several in vitro tests are available at different stages of development and acceptance, they cannot at present be considered to fully replace animal tests needed to evaluate the safety of substances. Based on an analysis of regulatory requirements for this endpoint within different pieces of EU legislation, EURL ECVAM proposes a pragmatic approach to improve the traditional genotoxicity testing paradigm that offers solutions in both the shortand medium-term and that draws on the considerable experience of 40 years of regulatory toxicology testing in this area. EURL ECVAM considers that efforts should be directed towards the overall improvement of the current testing strategy for better hazard and risk assessment approaches, which either avoids or minimises the use of animals, whilst satisfying regulatory information requirements, irrespective of regulatory context. Several opportunities for the improvement of the testing strategy have been identified which aim to i) enhance the performance of the in vitro testing battery so that fewer in vivo follow-up tests are necessary and ii) guide more intelligent in vivo follow-up testing to reduce unnecessary use of animals. The implementation of this strategic plan will rely on the cooperation of EURL ECVAM with other existing initiatives and the coordinated contribution from various stakeholders. As the Commission’s in-house science service, the Joint Research Centre’s mission is to provide EU policies with independent, evidence-based scientific and technical support throughout the whole policy cycle. Working in close cooperation with policy Directorates-General, the JRC addresses key societal challenges while stimulating innovation through developing new standards, methods and tools, and sharing and transferring its know-how to the Member States and international community. Key policy areas include: environment and climate change; energy and transport; agriculture and food security; health and consumer protection; information society and digital agenda; safety and security including nuclear; all supported through a cross- cutting and multi-disciplinary approach. L B -N A -2 6 3 7 5 -E N -N