[Replacing EC directive 86/609].

EC Directive 86/609, governing the protection of animals used for scientific purposes, is currently under review. The new text remains to be finalized but will likely include the following measures:--prior authorization will be required for all scientific projects,--authorization will include on an ethical evaluation,--the 3Rs doctrine will be formally integrated,--ethical committees will be officially recognized. Clear guidelines are also provided on the scope, methodology and compliance monitoring of the protocols. Better public communication and, in some cases, retrospective assessment will be required. Implementation in national legislation will lead to a better integration of ethical considerations in scientific projects. The new Directive will also help to harmonize practices between the public and private sectors, with integrated internal controls during the implementation of ethical protocols. The impact of these new rules on the competitiveness of European research is discussed.