Factors stimulating or obstructing the implementation of the 3Rs in the regulatory process.

Approximately 30% of animal use within the European Union (EU) is done to meet regulatory requirements. The tests are often repetitive in nature and may cause severe suffering, due to the procedures used and to rigidly predefined end points. In addition, product evaluation procedures often take long and are very expensive. Over the last decades the heavy reliance on animal experimentation in this area has met serious objections, both ethical and economical in nature. This study describes obstacles and opportunities to implement the 3Rs in regulatory animal testing. The findings are based primarily on interviews with legislators, regulators, industry, science and animal welfare organisations and reflect shared perceptions of these respondents. In order to increase the application of the 3Rs in regulatory testing a number of technical, political and social obstacles must be overcome. This study offers insight into the persistent character of regulatory animal testing and can function as a starting point for further discussion on how to tackle these problems. To this end, several recommendations are made ranging from strategic test approaches and data sharing to strengthening the policy network and improving communication between 3Rs experts and regulators. The study is an initiative of the national project group "Regulatory Animal Testing", which consists of a group of Dutch experts on animal testing working for a variety of organisations in the field.1 They felt the need for cooperation to initiate a discussion at relevant levels and to identify possible solutions in order to implement the objectives of the three R's in testing for regulatory purposes without loss of scrutiny in safety and/or efficacy evaluation needed for product release.