On 8 September, the European Parliament voted to adopt a new law replacing the nearly 25-year-old Directive 86/609/EEC, which regulates the use of more than 12 million animals in European laboratories each year.

The new Directive 2010/63/EU introduces a number of substantial improvements, including:

  • Mandatory authorisation and project evaluation for all applications to use animals, including checks to ensure that the 3Rs are fully applied.
  • Establishment of Union Reference Laboratory at the JRC to promote the development and use of alternative methods, not only in toxicology, but now also in the areas of basic and applied research, and to promote dialogue on the 3Rs between legislators, regulators and all relevant stakeholders.
  • A requirement that Member States promote 3Rs approaches and information at a national level and assist the Commission in identifying and nominating suitable laboratories to participate in validation studies.
  • A ban on the use of great apes, with limited opportunities to lift it.
  • Periodic 3R-oriented thematic reviews by the Commission, paying specific attention to technological developments and new scientific and animal welfare knowledges.


The final text of the new directive was published on 20 October, and will enter into force 20 days after its publication, with a deadline for transposition into national legislation of 10 November 2012. Member States must apply the provisions as of 1 January 2013.