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Here - Stiftung Forschung 3R

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1INTRODUCTION<br />

It is the aim of the AXLR8 project to lay the groundwork for a<br />

transition in toxicology toward a more pathway-based in vitro<br />

and computational approach through enhanced networking<br />

and collaboration among scientists, regulators and other key<br />

stakeholders at European and international levels.<br />

To date almost € 140 million in funding has been provided under the 6 th and 7 th EU<br />

Framework Programmes to advance the development and validation of <strong>3R</strong>s methods<br />

and testing strategies for regulatory purposes (Table 1). These funding activities have<br />

been ‘policy-driven’ by Directive 86/609/EEC for the protection of animals used for<br />

experimental and other scientific purposes, as well as the 7th Amendment of the EU<br />

Cosmetics Directive, and the Registration, Evaluation, Authorisation and Restriction of<br />

Chemicals (REACH) regulation—all of which provide explicit legislative mandates to<br />

replace regulatory toxicity testing in animals with non-animal approaches. To achieve<br />

this goal, a variety of large-scale ‘integrated projects’ have been funded by DG R&I, in<br />

which scientists from academia, industry and government collaborate toward animal<br />

replacement on the level of classical toxicological endpoints such as acute and repeated<br />

dose toxicity. In 2011, in a joint venture between DG R&I and the European Cosmetics<br />

Association (COLIPA), € 50 million was raised for the ‘replacement of in vivo repeated<br />

dose systemic toxicity testing’ with the long-term target of ‘safety evaluation ultimately<br />

replacing animal testing’ (SEURAT).<br />

Similar funding programmes have been launched by <strong>3R</strong>s centres in several EU Member<br />

States and also in Japan, the United States, and elsewhere. Monitoring the scope<br />

INTRODUCTION<br />

Progress Report 2011 & AXLR8-2 Workshop Report<br />

13

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