Making Validated Alternatives Available -the Strategies and Work of the European Centre for the Validation of Alternative Methods (ECVAM)

Abstract

ECVAM was created in 1991 further to Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes which prescribes to use alternative methods whenever possible. As a service of the EU Joint Research Centre, ECVAM has pioneered the validation process and became a proactive facilitator for effective animal protection, especially in the field of regulatory toxicology. The field of alternatives is currently driven by the expectations from both cosmetics and chemicals policies: The 7th amendment to the Cosmetics Directive published in 2003 foresees to phase out animal experiments completely within 10 years. A timetable for the phasing out of the individual animal tests published by the European Commission in September 2004 had been supported by a task-force of stakeholders chaired by ECVAM. The legislation is reinforced by an immediate testing ban for finished products and for all the human health effects, for which alternative methods have been validated by ECVAM. Furthermore, a testing ban and a marketing ban, which cannot be postponed, apply in 6 years for topical and acute systemic toxicity, while the animal tests for all the other human health effects should be phased out in 10 years with a possible postponement by codecision procedure.
The legislation for chemicals (REACH) is only emerging. It foresees data requirements for more than 30.000 substances produced at levels above 1 ton per year. Extensive in vivo data requirements are expected for a core of about 6.000 substances with highest production and concern. Alternative meth-ods shall first be considered throughout the testing and be predominantly used for the largest group of chemicals, namely those produced between 1-10 tons per year. A Commission proposal as to the legislation has been handed to the European Parliament and Council, and is currently under consultation.
ECVAM has restructured its services directly targeting the animal tests to be replaced by in vitro and in silico approaches. Given the short time-lines to make available and implement validated methods, ECVAM is offering to steer the process of making validated alternatives available by bundling the inputs of stakeholders and by involving regulators in the process at an early stage. Steering groups com-posed of ECVAM's senior staff and complemented by external experts carry out the project management, which coordinates the various inputs. The collaboration with various stakeholders has also been reinforced. A series of activities including the initiation of three Integrated Projects have put the tailored development and validation of alternative methods on a new scale.