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URL: http://ecvam.jrc.it/

Proper Citation: European Centre for the Validation of Alternative Methods (RRID:SCR_008504)

Description: ECVAM was created by a Communication from the Commission to the Council and the Parliament in October 1991*, pointing to a requirement in Directive 86/609/EEC** on the protection of animals used for experimental and other scientific purposes, which requires 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: Article 7.2: An experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practicably available. Article 23: The Commission and Member States should encourage research into the development and validation of alternative techniques which could provide the same level of information as that obtained in experiments using animals, but which involve fewer animals or which entail less painful procedures, and shall take such other steps as they consider appropriate to encourage research in this field. ECVAM has been established in 1992 as a unit of the Environment Institute, part of the Joint Research Centre, and has been transferred to, at that time, newly formed Institute for Health and Consumer Protection in Ispra, Italy in 1998 of which ECVAM is still part of. Duties of ECVAM As defined in the Communication of the European Commission to Council and the European Parliament in October 1991*: 1. To coordinate the validation of alternative test methods at the European Union level. 2. To act as a focal point for the exchange of information on the development of alternative test methods. 3. To set up, maintain and manage a data base on alternative procedures. 4. To promote dialogue between legislators, industries, biomedical scientists, consumer organisations and animal welfare groups, with a view to the development, validation and international recognition of alternative test methods. Moreover, ECVAM should help to expand the JRC''s role in prenormative research. ECVAM thus seeks to promote the scientific and regulatory acceptance of alternative methods which are of importance to the biosciences, through research, new test development and validation, and the establishment of specialised databases, with the aim of contributing to the replacement, reduction and refinement of laboratory animal precedures (in accordance with the 3Rs concept of Russell & Burch***) Due to the political sensitivity of its duties, ECVAM, uniquely at the JRC, has its own Scientific Advisory Committee (ESAC) with participation from all Member States, relevant industrial associations, academic toxicology, the animal welfare movement, as well as other Commission services with interest in the alternatives topic area. The Validation Process Validation is the process by which the reliability and relevance of a procedure are established for a specific purpose. In 1995, based upon experience gained during several recent large-scale validation studies, and in consultation with various international experts (including members of ERGATT), ECVAM published recommendations concerning the practical and logistical aspects of validating alternative test methods (ECVAM workshop report 5). Five main stages in the evolution of new test methods were identified: test development; prevalidation; validation (involving a formal interlaboratory study with the testing of coded chemicals); independent assessment; and progression toward regulatory acceptance. ECVAM has implemented a prevalidation scheme, which includes three main phases: protocol refinement, protocol transfer, and protocol performance. The objective of the prevalidation process is to ensure that any method included in a formal validation study adequately fulfills the criteria defined for inclusion in such a study, so that financial and human resources are used more efficiently, and so that there is a greater likelihood that the expectations of those in the scientific, regulatory and animal welfare communities, who seek the replacement of current animal tests by relevant and reliable alternative methods, will be met. In 2004, ECVAM has published the Modular Approach to the ECVAM Principles on Test Validity (select from the top-menu bar the sector Publications followed by ECVAM Selected Articles) that makes the validation process more flexible, by breaking down the various steps in validation into indipendent modules, and defining for each module the information needed for assessing test validity. Collaborations ECVAMs activities are undertaken in collaboration with numerous laboratories and organisations in the EU Member States, and all over the world. ECVAM also works in close collaboration with other Commission services, such as DG Environment, DG Enterprise, DG Research and DG Health and Consumer Protection. Sponsor. This is a Five years project funded by DG RTD that aims to develop a testing strategy to improve the prediction of oral acute toxicity using non-animals based systems.

Synonyms: EcVam

Resource Type: data or information resource, portal, organization portal