31.12.91 Official Journal of the European Communities No L 368/19 COUNCIL DECISION of 11 December 1991 designating 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 (!), 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 1 Coordination 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 2 The 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; (1) OJ No L 315, 26. 11. 1985, p. 11. (2) OJ No L 224, 18. 8. 1990, p. 13. 2. to coordinate the control of foot-and-mouth disease vaccines by national laboratories in each Member State specifically by: (a) (b) {c) (b) (a) (b) at regular intervals or at the request of the Institute or the Cornmission, 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; carrying out comparative studies to ensure that safety and potency testing in each Member State is carried out by comparable methodology; 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 ard the Member States; 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; to implement the necessary arrangements for further training of experts in vaccine verification and testing with a view to harmonizing such techniques; to organize an annual meeting where representatives of the national laboratories may review vaccine control and testing techniques and the progress of coordination; ' 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; to carry out routine potency testing of antigen stored in the Community foot-and-mouth disease vaccine reserves; () See page 21 of this Official Journal.