COUNCIL DECISION
of 11 December 1991
establishing Community  reserves of foot-and-mouth disease vaccines
(91/666/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 Decision 90/423/EEC (2), and in  particular Article 14 thereof,
Having regard to the proposal from the Commission,
Whereas by 1 January 1992 all Member States must have discontinued routine vaccination against  foot-and-mouth disease in their territory;
Whereas, however, in view of the high density of susceptible species in some parts of the  Community, it is necessary to provide for the possibility of emergency vaccination in a limited  area, in circumstances where slaughter of the entire herd may not be sufficient to eliminate the  virus;
Whereas Community reserves of foot-and-mouth disease vaccine should be established, based on stocks  of concentrated inactivated antigen capable of being quickly converted into vaccine for emergency  use;
Whereas the antigen should be stored at four separate locations; whereas facilities for  formulation, bottling and distribution must also be provided;
Whereas the criteria for the supply and storage of antigen and its conversion into vaccine should  be established;
Whereas the national institutes responsible for maintaining the reserve of antigen should cooperate  with the Community Coordinating Institute for foot-and-mouth disease vaccines designated by  Decision 91/665/EEC (3) in order to ensure the potency, safety and stability of the antigen, and  vaccines produced therefrom, and to ensure that the quantity and sub-types kept are appropriate to  the risk, on the basis, in particular, of information supplied by the reference laboratory for the  identification of foot-and-mouth disease virus designated by Decision 89/531/EEC (4);
Whereas Article 14 of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary  field (5), as amended by Decision 91/133/EEC (6), provides that the establishment of a Community  reserve of foot-and-mouth disease vaccines may be eligible for Community aid,
The establishment of Community reserves of foot-andmouth disease  vaccine shall consist of:
- the supply of concentrated inactivated antigen by establishments designated by Member States,
- the storage, in reserves, of the antigen referred to in the first indent,
- the guarantee of rapid formulation, bottling and distribution by establishments designated by  Member States.
For the purposes of this Decision the following definitions shall apply:
1.  antigen banks: appropriate premises, such as those designated in Article 3 (1), for the storage  of Community reserves of concentrated inactivated antigen for the production of foot-and-mouth  disease vaccine;
2.
Community Coordinating Institute for foot-andmouth disease vaccine (CCI): the institute designated  by Decision 91/665/EEC.
1.  Antigen banks shall be established at:
- the Institute for Animal Health, Pirbright (United Kingdom),
- the Laboratoire de pathologie bovine du centre national d'études vétérinaires et alimentaires,  Lyon (France),
- Bayer AG, Cologne (Germany),
- the Istituto Zooprofilatico Sperimentale di Brescia (Italy).
2.  The amounts and sub-types of antigen to be held in the antigen banks shall be as laid down in  Annex I.
3.  The antigen shall be distributed between the antigen banks in such a way as to ensure that, in  the event of technical problems which result in deterioration of the antigen in one of the said  banks, the availability of antigen for vaccine production is guaranteed by the other antigen  banks.
The functions and duties of the antigen banks shall be:
(a)  to store the Community reserves of concentrated inactivated foot-and-mouth disease virus  antigens in such a way as to maintain their usefulness for the production of a safe and potent  vaccine for emergency use against foot-and-mouth disease, including the keeping of adequate records  of the conditions under which the antigen is stored;
(b)  to liaise with the CCI for the purposes of:
(i)  checking incoming batches of antigen for stability, potency and safety;
(ii)
testing batches of stored antigen for stability, potency and safety at intervals to be  determined under the procedure laid down in Article 10, following an opinion from the Scientific  Veterinary Committee;
(iii)
advising on the need for replacement of an antigen if tests indicate that its potency is  inadequate;
(c)
to deliver concentrated inactivated antigen to establishments designated for the formulation,  bottling and distribution of the vaccine, at the request of the Commission or a Member State under  the conditions provided for in the second and third subparagraphs of Article 13 (3) of Directive  85/511/EEC, for use in the Member State or third country in which the vaccine is to be used.
1.  The establishments which are to supply the quantities and sub-types of antigens  mentioned in Annex I and, without prejudice to Article 13 of Directive 85/511/EEC, those which are  to ensure the formulation, production, bottling and distribution of the foot-and-mouth disease  vaccine produced from the antigen shall be designated in accordance with the procedure laid down in  Article 10 of this Decision.
2.  For the purposes of paragraph 1, the Commission shall issue a call for tenders, taking into  account the following criteria in particular:
(a)  the technical requirements concerning the supply of antigens, in accordance with Annex II;
(b)
the supply and delivery of the specified quantity to the antigen bank in a form suitable for  long-term storage in liquid nitrogen, or other storage methods recognized, under the procedure laid  down in Article 10 after obtaining the opinion of the Scientific Veterinary  Committee, as giving  at least equivalent stability, including the provision of separate replicates suitable for routine  testing;
(c)
a guarantee that any antigen supplied will meet the safety and stability requirements defined  for vaccine by the European Pharmacopoeia, as well as the required potency (6 PD 50/dose) when  tested as specified for vaccine;
(d)
the reagents and materials to be used in the formulation of the vaccine;
(e)
a guarantee that the vaccine supplied complies fully with the European Pharmacopoeia;
(f)
supply of the vaccine, within a given time and at a guaranteed rate of delivery, in bottles of  suitable size, labelled in the language or languages of the country in which the vaccine is to be  used;
(g)
compliance by the establishment which supplies an antigen with the 'minimum standards for  laboratories 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, on the basis, where  necessary, of a report by experts acting under the procedure laid down in Article 10;
(h)
quoted costs for the supply of the antigen or the provision of the service, as appropriate.
The antigen banks, the establishments supplying the antigen and the establishments  carrying out formulation and bottling shall operate under strict conditions of hygiene and safety,  in accordance with the generally accepted standards for good manufacturing practice in Europe,  which shall be monitored by the CCI.
Detailed arrangements for the implementation of this Decision shall be adopted under  the procedure laid down in Article 10, in particular as regards:
- the distribution of antigen reserves between antigen banks,
- general procedures for replacing antigen reserves,
- the rules to be followed, should Decision 90/424/EEC be invoked, in making available to third  countries vaccines produced from antigens to be replaced in accordance with the second indent,
- any derogations, after obtaining the opinion of the Standing Veterinary Committee, from the  figure of 6 PD 50/dose laid down in Article 5 (2) (c) for new vaccines.
Commission veterinary experts may, in collaboration with the competent authorities of  the Member States, carry out on-the-spot inspections to verify whether or not the establishments  and antigen banks are operating in accordance with this Decision.
The Commission shall inform the Member States of the outcome of such inspections.
The Member State in whose territory the inspections are carried out shall provide the experts with  all the assistance required for the accomplishment of their task.
General rules for the application of this Article shall be adopted in accordance with the procedure  laid down in Article 10.
Annexes I and II may be supplemented or amended in accordance with the procedure laid  down in Article 10.
0
1.  Where the procedure laid down in this Article is to be followed, the chairman of  the Standing Veterinary Committee set up by Decision 68/361/EEC (1), hereinafter referred to as  'the Committee`, shall refer the matter without delay to the Committee either on his own initiative  or at the request of the representative of a Member State.
2.  The representative of the Commission shall submit to the Committee a draft of the measures to  be taken. The Committee shall deliver its opinion on the draft within a time limit which the  chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the  majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is  required to adopt on a  proposal from the Commission. The votes of the representatives of the  Member States within the Committee shall be weighted in the manner set out in that Article. The  chairman shall not vote.
3.  The Commission shall adopt the measures envisaged if they are in accordance with the opinion of  the Committee.
4.  If the measures envisaged are not in accordance with the opinion of the Committee, or if no  opinion is delivered, the Commission shall without delay submit to the Council a proposal relating  to the measures to be taken. The Council shall act by a qualified majority.
If, within 15 days of the date of referral to the Council, the Council has not acted, the proposed  measures shall be adopted by the Commission, except where the Council has decided against the  measures by a simple majority.
1
The Council, acting by a qualified majority on a proposal from the Commission, shall  review this Decision before 1 January 1995.
2
This Decision is addressed to the Member States.