RESOLUTIONof the Council and the representatives of the Governments of the Member States, meetingwithin the Council,of 29 May 1986on a programme of action of the European Communities on toxicology for health protection(86/C 184/01)

THE COUNCIL OF THE EUROPEAN COMMUNITIES AND THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES, MEETING WITHIN THE COUNCIL, Having regard to the Treaties establishing the European Communities Having regard to the draft resolution submitted by the Commission (1) , Having regard to the opinion of the European Parliament (2) , Having regard to the opinion of the Economic and Social Committee (3) , Whereas one of the main objectives of the present programme is to contribute towards improving expertise, which is indispensable for the sectoral activities relating to toxicology carried out at Community level (relating, for example, to pharmaceuticals and cosmetics, human foodstuffs and animal feedingstuffs, including additives as well as chemicals present in the environment, pesticides and agents harmful to the domestic and working environment) ; Whereas the various scientific research programmes of the Community, whether planned or under way, cover from the research point of view several areas of the present programme and will therefore provide a valuable input of new knowledge; Whereas this programme, by fostering the development of experimental toxicology, clinical toxicology and the integration of experimental clinical and analytical data, should help to ensure the quality and comparability of data and of testing methods, and to promote the elimination of certain non-tariff barriers to trade; whereas to this end a better understanding must be achieved of the normal variability of biochemical and physiological parameters, and staff training in toxicology must be improved; whereas for the same reasons the exchange of experience and information in this field should be encouraged; Whereas in addition this programme, by helping to ensure the quality and comparability of data and by listing existing testing facilities and ongoing testing programmes, should help to eliminate any unnecessary duplication of effort by promoting a more rational and more economic use of the toxicological experiments carried out within the Communiy and facilitate their acceptance at international level; Whereas the pursuit of the above objectives should result in limiting the number of animals to be used and the number of toxicological tests on animals; Whereas toxicological awareness should be encouraged and, in the longer term, toxicological testing methods should be harmonized; Whereas cooperation with the various international agencies active in this area, in particular the World Health Organization (WHO) , the United Nations Environment Programme (UNEP) and the International Labour Organization (ILO) , through their Joint International Programme on Chemical Safety, as well as the International Agency for Research on Cancer (IARC) and the Organization for Economic Cooperation and Development (OECD) , and where appropriate the implementation of joint measures with those agencies, are necessary to avoid duplication of effort; Whereas toxicology and national priorities in this field are developing rapidly and it is therefore necessary to update the annual working schedule each year in liaison with the Member States, after consulting the international agencies concerned, I Express the political will to take, in keeping with the urgency of the matter and bearing in mind what is feasible at national and Community level, the measures required so that between now and the end of 1990 the following priority actions in particular can be undertaken: 1. Experimental toxicology with the exception of ecotoxicology (i) Compile and maintain a list of: - existing structures in the Member States for toxicological testing; -toxicological tests carried out in them in order to assess the toxicity of chemical products and preparations; (ii) assess current toxicological methods and practice and those being developed, in order to improve the quality and comparability of toxicological data, to facilitate their acceptability in the Community and internationally bearing in mind the activities of international agencies in this field, and to pay particular attention to tests involving a reduction in the number and suffering of animals thus used and to new approaches (in vitro, etc. ) ; (iii) assess the reliability of extrapolating toxicological data from animal and in vitro tests to human beings and encourage the development of new approaches to the subject; (iv) examine the normal variability of the biochemical and physiological parameters in the animals to be used in toxicological tests in order to have common criteria for the assessment of toxicity. 2. Clinical toxicology (i) Systematically review the role and functioning of clinical toxicological services, poison centres and other appropriate structures in order to implement pilot projects relating to exchanges of experience and information and to develop the use of clinical toxicology data (acute and chronic) within the framework of the overall assessment of the impact of chemical products and preparations on human health; (ii) systematically review current practice in the assessment of normal variability of biochemical and physiological parameters and seek common criteria. 3. Training and information (i) Promote the exchange of experience between Member States on needs for toxicology experts in all sectors and at all levels and establish guidelines for the training of toxicology experts; (ii) promote the exchange of expertise and information between Member States on toxicological data. II Request the Commission to prepare and submit, in collaboration with the Member States and on a coordinated basis with them, after the first year following the adoption of this resolution and thereafter annually, a work programme detailing the work it intends to carry out in order to implement this resolution. The annual work programme, together with a report on results achieved, will be forwarded to the Council, the European Parliament and the Economic and Social Committee. (1) OJ No C 156, 16. 6. 1984, p. 6.

(2) OJ No C 141, 10. 6. 1985, p. 504.

(3) OJ No C 104, 25. 4. 1985, p. 2.