Project evaluation in animal research – Possibilities for Harmonization in Nordic Countries

This paper is a report of discussion between responsible persons throughout the Nordic region on the activities, issues and problems encountered with evaluating project applications for experimental work involving the use of animals. Harmonization of the actions of responsible authorities in the evaluation of animal experimental projects is encouraged by policy makers at the European level, and the possibilities to encourage this are discussed. While the process of evaluation and the composition of the committees are broadly similar across the region there are differences. Applications are often made with insufficient attention, better guidance and simplification may improve this. Training was identified as a common problem, and training sources are available which could be used. The inclusion of persons with experimental design and statistical expertise is recommended.   It is concluded that it would be to the benefit of each committee if there were communication between the committees in the Nordic states, to share best practice and flag common errors and problems

Overview of the Test Requirements in the Area of Food and Feed Safety

The mission of the European Food Safety Authority - EFSA - is to provide scientific opinions and technical support in all fields which have a direct or indirect impact on food and feed safety. The Authority shall also "contribute to a high level of protection of human life and health, and in this respect take account of animal health and welfare". In the area of hazard and risk assessment, EFSA receives studies as part of the dossiers provided by applicants who applied for approval of the use of a substance. The content of such dossiers relies on legal requirements which generally include experiments on animals. EFSA decided to adopt a pro-active animal welfare approach summarized as follows: "While recognizing that animal testing cannot be eliminated at present, EFSA should make every effort to stimulate, and participate in, the development of new food and feed assessment approaches that would minimize the use of experimental animals and would reduce, to the extent possible, the level of suffering of animals". The paper gives an overview of the work in this area at EFSA and suggests future developments considering the 3Rs and the animal welfare.JRC.I.2-In-vitro Toxicolog

One science-driven approach for the regulatory implementation of alternative methods: A multi-sector perspective

EU regulations call for the use of alternative methods to animal testing. During the last decade, an increasing number of alternative approaches have been formally adopted. In parallel, new 3Rs-relevant technologies and mechanistic approaches have increasingly contributed to hazard identification and risk assessment evolution. In this changing landscape, an EPAA meeting reviewed the challenges that different industry sectors face in the implementation of alternative methods following a science-driven approach. Although clear progress was acknowledged in animal testing reduction and refinement thanks to an integration of scientifically robust approaches, the following challenges were identified: i) further characterization of toxicity pathways; ii) development of assays covering current scientific gaps, iii) better characterization of links between in vitro readouts and outcome in the target species; iv) better definition of alternative method applicability domains, and v) appropriate implementation of the available approaches. For areas having regulatory adopted alternative methods (e.g., vaccine batch testing), harmonised acceptance across geographical regions was considered critical for broader application. Overall, the main constraints to the application of non-animal alternatives are the still existing gaps in scientific knowledge and technological limitations. The science-driven identification of most appropriate methods is key for furthering a multi-sectorial decrease in animal testing.JRC.F.3-Chemicals Safety and Alternative Method