Recommendations of the ECVAM Workshop on "Alternatives to Animal Testing in the Quality Control of Immunobiologicals; State of the Art and Future Prospects"

With regard to the principles of replacement, reduction and refinement, art. 231 of the Council Directive 86/609/EEC on the Protection of Animals used for Experimental and other Scientific Purposes, is of utmost importance. This article states that "The Commission and Member States. would take steps. to encourage research into the development and validation of alternative techniques.". In order to carry into effect this article, the Commission of the European Communities (EC) has established the European Centre for the Validation of Alternative Methods (ECVAM) on October 29, 1991. The centre is located at the Joint Research Centre (DG XI) at Ispra (Italy), its first director is Michael Balls from the UK. The main goal of ECVAM is to promote the regulatory acceptance of alternative methods which are of importance to the biosciences and which reduce, refine or replace the use of laboratory animals. The activities of the centre are focused on facilitating, co-ordinating, supporting and/or organising international validation studies, preferably in collaboration with other bodies. A working program has been made for 1993 and 1994 by ECVAM"s scientific advisory committee. Animal testing in the quality control of vaccines was selected as one of the area"s of interest. As a first step it was decided to organise a workshop, with the aim to evaluate potential alternatives, to identify obstacles in development, validation and implementation and to discuss possible solutions. The workshop was held in Utrecht, April 16-17 and the 20 invited participants came from national control laboratories, regulatory bodies, vaccine manufacturers and academic world. (article in English) (The main conclusions and recommendations in the field of the quality control of veterinary vaccines have been published in ATLA 22, 420-434, 1994)