Animal use in the safety evaluation of chemicals: harmonization and emerging needs

An overview is provided of the legal framework in Europe for the use of experimental animals set by European Union (EU) Directive 86/609/EEC and of the activities of EU member states to implement this directive for regulatory testing in animals. The use of animal data in the safety assessment of chemicals by services of the EU Commission and by EU member states is described. Specific examples are given for the current use of animal tests in Europe for the safety evaluation of industrial chemicals, pesticides and biocides, cosmetics, endocrine disrupters, and existing chemicals. Recent progress in implementing the 3Rs concept of Russell and Burch into regulatory guidelines of the EU are described, with particular reference to acute systemic and local toxicity testing. Progress in implementing the 3Rs concept in the EU is compared with the situation outside Europe, particularly with the incentive initiated by the Organisation for Economic Co-operation and Development, to reduce regulatory testing in animals. The harmonization of toxicity test guidelines initiated by the Organisation for Economic Co-operation and Development in 1982 has been the most successful measure to reduce pain and distress of laboratory animals in regulatory testing. From the animal welfare perspective, the international harmonization of test guidelines and the mutual acceptance of data are, therefore, the way forward for all areas of chemicals testing.