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European Centre for the Validation of Alternative Methods (ECVAM): its role and contribution

Abstract: 
The European Centre for the Validation of Alternative Methods (ECVAM) is a unit of the Institute for Health and Consumer Protection of the European Commission¿s Joint Research Centre (JRC) at Ispra, Italy. ECVAM was created by a Communication from the Commission to the Council and the Parliament in October 1991 (SEC(91)1794) in response to a requirement in Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes, namely that the Commission and the Member States should actively support the development, validation and acceptance of methods which could reduce, refine or replace the use of laboratory animals. The main tasks of ECVAM are the funding and management of validation studies and the support to other Commission Services on issues related to alternatives to animal testing. For this purpose, ECVAM has established a broad network of international experts in order to identify the most promising methods and to develop testing strategies, which could reduce, refine or replace animal testing for regulatory purposes, e.g. safety assessment of chemicals (REACH), cosmetics (7th Amendment to the Cosmetics Directive), agrochemicals, pharmaceuticals, biologicals and other products. The ECVAM Key Area ¿Biologicals¿ is supported by a group of six experts (Steering Group Biologicals) coming from industry and national control authorities. ECVAM¿s activities on biologicals started in 1994 with the workshop on Alternatives to Animal Testing in the Quality Control of Immunobiologicals: Current Status and Future Prospects (Hendriksen et al., 1994, ATLA 22, 420-434). Recommendations of this workshop were followed up by various bodies and resulted in several validation projects, revision of monographs, deletion of tests, acceptance of alternative methods, etc. ECVAM itself was involved as sponsor, partner or co-ordinator in a number of feasibility and (pre)validation studies, results of two recent studies are presented at this conference (presentation on Alternative to Kendrick test - whole cell pertussis vaccines). Up to now, 12 workshops were held and 11 published (download http://ecvam.jrc.it/index.htm). Two of the recent workshops deal with the consistency approach in vaccine testing, a concept which is already implemented for the newer human vaccines but not for the conventional ones and veterinary vaccines. With its Steering Group Biologicals, ECVAM is commenting on monographs and other guidelines for the testing of biologicals. The comments relate to all of the Three Rs, since sometimes the number of animals used might not be justified or the procedure inflicted on the animals might not correspond to the best practice. Future plans will tackle in more depth the consistency approach, follow-up the studies on the use of serological methods for the potency testing of whole-cell pertussis vaccines, possible replacement of the NIH test for the potency testing of rabies vaccines and harmonisation of requirements for safety testing; hopefully, in collaboration with all of the stakeholders.