Spielmann Horst
National Centre for Documentation and Evaluation of Alternative Methods to Animal Experiments (ZEBET) at the Federal Institute for Health Protection of Consumers and Veterinary Medicine (BgVV), D-Berlin, Germany.
ALTEX. 2002;19(2):69-73.
An overview is given on the legal framework in Europe for the use of experimental animals set by EU (European Union) Directive 86/609/EEC and on the activities of EU member states to implement this directive in the field of regulatory testing in animals. The significant decrease in the number of experimental animals in Germany during the past decade is described with particular reference to the recent increase that is due to transgenic animal models. From the regulatory and the animal welfare perspective the international harmonisation of test guidelines and the mutual acceptance of data are the way forward for chemical safety testing. The recent White Paper of the EU Commission for the future chemicals policy calls for an immediate increase in the number of validated in vitro toxicity tests to be accepted for regulatory purposes in the EU. In addition, deficits of properly educating young scientists in Germany in conducting animal experiments and implementing the 3-Rs concept of Russel and Burch are described. It is therefore, quite urgent to establish new chairs on animals and alternatives at universities in Europe. They should focus on both education young students of the biomedical sciences in the humane use of laboratory animals according to the 3-Rs concept and on developing new toxicity tests to be validated for regulatory purposes under the new EU chemicals policy by the established validation centres in Europe.
本文概述了欧盟(EU)第86/609/EEC号指令所设定的欧洲实验动物使用法律框架,以及欧盟成员国在动物监管测试领域实施该指令的活动。描述了德国过去十年实验动物数量的显著减少,特别提到了由于转基因动物模型导致的近期增长。从监管和动物福利的角度来看,测试指南的国际协调和数据的相互认可,是化学品安全测试的前进方向。欧盟委员会最近关于未来化学品政策的白皮书呼吁立即增加经验证的体外毒性测试数量,以便在欧盟用于监管目的。此外,还描述了德国在对年轻科学家进行动物实验教育以及实施拉塞尔和伯奇的3R概念方面存在的不足。因此,在欧洲各大学设立动物与替代方法新职位非常紧迫。这些职位应专注于两方面,一是根据3R概念教育生物医学科学专业的年轻学生如何人道地使用实验动物,二是开发新的毒性测试方法,以便由欧洲现有的验证中心根据新的欧盟化学品政策进行监管目的的验证。