91/665/EEC: Council Decision of 11 December 1991 designating a Community Coordinating Institute for foot- and-mouth disease vaccines and laying down its functions
Date: 1991-12-11
Institutions: Council of the European Union
Subjects: EU aid, animal disease, foot-and-mouth disease, research body













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31991D0665

91/665/EEC: Council Decision of 11 December 1991 designating a Community Coordinating Institute for foot- and-mouth disease vaccines and laying down its functions  


Official Journal L 368 , 31/12/1991 P. 0019 - 0020 Finnish special edition: Chapter 3 Volume 39 P. 0260  Swedish special edition: Chapter 3 Volume 39 P. 0260  





COUNCIL  DECISIONof 11 December 1991designating a Community Coordinating Institute for foot-and-mouth  disease vaccines and laying down its functions(91/665/EEC)THE COUNCIL OF THE  EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 85/511/EEC of 18 November 1985 introducing Community measures  for the control of foot-and-mouth disease (1), as amended by Directive 90/423/EEC (2), and in  particular Article 14 thereof, Having regard to the proposal from the Commission, Whereas Article 14 (1) of Directive 85/511/EEC authorizes Member States to retain reserves of  antigens and to designate establishments for the packaging and storage of ready-to-use vaccines for  emergency vaccination; Whereas, pursuant to Article 14 (3) of that Directive, the Commission is required in particular to  make proposals for the setting-up of at least two Community reserves of foot-and-mouth disease  vaccines; Whereas Article 14 (2) of that same Directive provides for the designation of a specialized  institute responsible for carrying out checks on foot-and-mouth disease vaccines and cross-immunity  checks, as well as providing for the institute's powers to be determined, HAS ADOPTED THIS DECISION: Article 1Coordination of the control of foot-and-mouth disease vaccines used  within the Community shall be carried out by the 'Centraal Diergeneeskundig Instituut, Lelystad,  Nederland`, hereinafter referred to as the 'Community Coordinating Institute`. Article 2The functions of the Community Coordinating Institute shall be: 1.  to coordinate the methods of control carried out by the national laboratories on foot-and-mouth  disease antigens and vaccines intended for use in accordance with Articles 13 (3) and 14 (1) of  Directive 85/511/EEC; 2. to coordinate the control of foot-and-mouth disease vaccines by national laboratories in each  Member State specifically by: (a)  at regular intervals or at the request of the Institute or the Commission, receiving  representative samples of batches of foot-and-mouth disease vaccines intended for use in the  Community, including those produced in third countries for use either in the Community or in  Community-supported vaccination campaigns, and testing such vaccines for safety and potency; (b)carrying out comparative studies to ensure that safety and potency testing in each Member State  is carried out by comparable methodology; (c)testing, by means of cross-immunity assays in live cattle, the efficacy of existing vaccines  against important new field strains of foot-and-mouth disease virus and communicating the results  of such assays without delay to the Commission and the Member States; (d)gathering data and information on the control procedures and the vaccine tests and the periodic  transmission of such information to the Commission and the Member States; 3. (a)to implement the necessary arrangements for further training of experts in vaccine verification  and testing with a view to harmonizing such techniques; (b)to organize an annual meeting where representatives of the national laboratories may review  vaccine control and testing techniques and the progress of coordination; 4. (a)to check antigen submitted for the Community foot-and-mouth disease vaccine reserves, as set up  in accordance with Decision 91/666/EEC (3), for potency, safety and compliance with veterinary  technical supply conditions; (b)to carry out routine potency testing of antigen stored in the Community foot-and-mouth disease  vaccine reserves; (c)to check the sterility of vaccine produced from the Community antigen reserves when needed, in  accordance with the European Pharmacopoeia; 5. (a)in cooperation with appropriate Community experts, to assist and advise the Commission in  ensuring that institutes which produce foot-and-mouth disease vaccines meet the necessary minimum  safety requirements and in particular those laid down in accordance with Article 3 (2) of Council  Decision 89/531/EEC of 25 September 1989 designating a reference laboratory for the identification  of foot-and-mouth disease virus and determining the functions of that laboratory (1); (b)in cooperation with appropriate Community experts, to assist the Commission in reviewing the  list of establishments and laboratories authorized to manipulate the virus in connection with  vaccine production, in accordance with Article 13 (2) of Directive 85/511/EEC; 6.  in cooperation with the suppliers of antigen and the reference laboratory for the  identification of the foot-and-mouth disease virus, to review strains stored in the Community  reserves and to assist in selecting suitable new strains to be adapted to tissue culture for future  vaccine production; 7. to store important seed virus strains other than those held in Community foot-and-mouth disease  vaccine reserves; 8. at the request of the Commission, and taking account of scientific and technological developments,  to carry out research into the efficacy and innocuity of vaccines, which is necessary or useful for  their monitoring, in conformity with detailed conditions to be determined under the procedure  provided for in Article 16 of Directive 85/511/EEC; 9. to collaborate with the reference laboratory for the identification of the foot-and-mouth disease  virus in all relevant aspects of foot-and-mouth disease, including the publishing of an annual  bulletin on the respective activities of the Community Coordinating Institute and the said  laboratory and the training of veterinarians concerned in the clinical diagnosis and epidemiology  of foot-and-mouth disease. Article 31.  The Community Coordinating Institute shall operate according to recognized  conditions of strict disease security as indicated in 'Minimum standards for institutes working  with foot-and-mouth disease virus in vitro and in vivo` - European Commission for the control of  foot-and-mouth disease - 26th session, Rome, April 1985. 2.  The Community Coordinating Institute shall formulate and recommend the disease security  measures to be taken by national laboratories in accordance with the standards referred to in  paragraph 1, particularly as regards monitoring of foot-and-mouth disease vaccines, except for  those tasks which Article 3 (2) of Decision 89/531/EEC assigns to the reference laboratory for the  identification of foot-and-mouth disease virus. Article 4The rules to be followed with regard to funding shall be adopted in accordance with  Article 28 of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field  (2), as amended by Decision 91/133/EEC (3). Article 5The Community Coordinating Institute shall be appointed for a period of 5 years as from  1 January 1992. Before that period expires, the Council, acting by a qualified majority on a proposal from the  Commission, shall decide whether the said period should be continued or whether this Decision  should be amended. Article 6This Decision is addressed to the Member States. Done at Brussels, 11 December 1991. For the CouncilThe PresidentP. BUKMAN(1) OJ N° L 315, 26. 11. 1985, p. 11. (2) OJ N° L 224, 18. 8. 1990, p. 13. (3) See page 21 of this Official Journal. (1) OJ N° L 279, 28. 9. 1989, p. 32. (2) OJ N° L 224, 18. 8. 1990, p. 19. (3) OJ N° L 66, 13. 3. 1991, p. 18.