The EU, through ECVAM and similar bodies in some Member States, is established as the world leader in the development and acceptance of alternatives to animal testing. Twenty-six alternative methods have been endorsed by ECVAM’s Scientific Advisory Committee (ESAC), most of which have achieved formal acceptance under EU regulations. To date only five of the 26 ECVAM-sanctioned alternatives have been formally endorsed by the US validation authority, ICCVAM (Interagency Coordinating Committee on the Validation of Alternative Methods) and accepted by relevant US federal agencies. Without a clear endorsement by ICCVAM, US regulatory agencies have been disinclined to accept alternative methods pioneered in the EU. Consequently, European companies may be forced to double-test in order to market their products in the US (e.g. alternative methods and testing strategies accepted under REACH may not be recognised by US chemical regulators). Conversely, cosmetics manufactured and tested in the US may fail to satisfy the requirements of the EU cosmetics directive (Directive 76/768/EEC⁽¹⁾). Steps have been taken by ECVAM to improve transatlantic regulatory acceptance of validated alternative methods, including providing ICCVAM with an ex officio seat on ESAC. Also, nearly a decade of discussion at the OECD has led to the creation of an internationally harmonised set of criteria for test method validation and acceptance. Despite these commendable efforts, the US continues to accept only 20 % of alternative methods pioneered in the EU and endorsed by ECVAM.

Will the Commission enter into a formal reciprocity agreement with the US, whereby once an alternative has been approved by one validation authority, there is a rebuttable presumption that the other authority will also approve it? What additional measures will the Commission take with a view to improving transatlantic regulatory cooperation in this area and resolving this damaging lack of cooperation at the earliest opportunity?

(1) OJ L 262, 27.9.1976, p. 169.