1991D0666 — EN — 24.11.1999 — 001.001 — 1
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►B COUNCIL DECISION
of 11 December 1991
establishingCommunity reserves of foot-and-mouth disease vaccines
(91/666/EEC)
(OJ L 368, 31.12.1991, p. 21)
Amended by:
Official Journal
No page date
►M1Council Decision 1999/762/EC of 15 November 1999 L 301 6 24.11.1999
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COUNCIL DECISION
of 11 December 1991
establishingCommunity 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-mouthdisease(
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 poss-ibility of emergency vaccination in a limited area, in circumstanceswhere slaughter of the entire herd may not be sufficient to eliminate thevirus;
Whereas Community reserves of foot-and-mouth disease vaccine should
be established, based on stocks of concentrated inactivated antigencapable 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 beprovided;
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 Institutefor 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 thequantity and sub-types kept are appropriate to the risk, on the basis, inparticular, of information supplied by the reference laboratory for theidentification of foot-and-mouth disease virus designated by Decision89/531/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,
HAS ADOPTED THIS DECISION:
Article 1
The establishment of Community reserves of foot-and-mouth disease
vaccine shall consist of:
(1) OJ No L 315, 26. 11. 1985, p. 11.
(2) OJ No L 224, 18. 8. 1990, p. 13.
(3) See page 19 of this Official Journal.
(4) OJ No L 279, 28. 9. 1989, p. 32.
(5) OJ No L 224, 18. 8. 1990, p. 19.
(6) OJ No L 66, 13. 3. 1991, p. 18.
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— 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.
Article 2
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 concentratedinactivated antigen for the production of foot-and-mouth diseasevaccine;
2. Community Coordinating Institute for foot-and-mouth disease
vaccine (CCI): the institute designated by Decision 91/665/EEC.
Article 3
1. Antigen banks shall be established at:
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— the Laboratoire de pathologie bovine ducentre national d’étu des
vétérinaires et alimentaires, Lyon (France),
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— the Istituto Zooprofilatico Sperimentale di Brescia (Italy),
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— any other establishment designated in accordance with the procedure
laid down in Article 10.
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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 resultin deterioration of the antigen in one of the said banks, the availabilityof antigen for vaccine production is guaranteed by the other antigenbanks.
Article 4
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 maintaintheir usefulness for the production of a safe and potent vaccine foremergency use against foot-and-mouth disease, including thekeeping of adequate records of the conditions under which theantigen 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 laiddown in Article 10, following an opinion from the ScientificVeterinary 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 desig-
nated for the formulation, bottling and distribution of the vaccine, atthe request of the Commission or a Member State under the condi-
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tions provided for in the second and third subparagraphs of Article13 (3) of Directive 85/511/EEC, for use in the Member State orthird country in which the vaccine is to be used.
Article 5
1. The establishments which are to supply the quantities and sub-
types of antigens mentioned in Annex I and, without prejudice toArticle 13 of Directive 85/511/EEC, those which are to ensure theformulation, production, bottling and distribution of the foot-and-mouthdisease vaccine produced from the antigen shall be designated inaccordance 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 otherstorage methods recognized, under the procedure laid down inArticle 10 after obtaining the opinion of the Scientific VeterinaryCommittee, as giving at least equivalent stability, including theprovision 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 Pharma-copoeia, as well as the required potency (6 PD 50/dose) when testedas 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 Euro-
pean 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 orlanguages 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-mouthdisease virus in vitroand in vivo'— European Commission for the
control of foot-and-mouth disease — 26th session, Rome, April1985, on the basis, where necessary, of a report by experts actingunder the procedure laid down in Article 10;
(h) quoted costs for the supply of the antigen or the provision of the
service, as appropriate.
Article 6
The antigen banks, the establishments supplying the antigen and the
establishments carrying out formulation and bottling shall operate understrict conditions of hygiene and safety, in accordance with the generallyaccepted standards for good manufacturing practice in Europe, whichshall be monitored by the CCI.
Article 7
Detailed arrangements for the implementation of this Decision shall be
adopted under the procedure laid down in Article 10, in particular asregards:
— 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 anti-gens to be replaced in accordance with the second indent,
— any derogations, after obtaining the opinion of the Standing Veter-
inary Committee, from the figure of 6 PD 50/dose laid down inArticle 5 (2) (c) for new vaccines.
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Article 8
Commission veterinary experts may, in collaboration with the
competent authorities of the Member States, carry out on-the-spotinspections to verify whether or not the establishments and antigenbanks 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 accom-plishment of their task.
General rules for the application of this Article shall be adopted in
accordance with the procedure laid down in Article 10.
Article 9
Annexes I and II may be supplemented or amended in accordance with
the procedure laid down in Article 10.
Article 10
1. Where the procedure laid down in this Article is to be followed,
the chairman of the Standing Veterinary Committee set up by Decision68/361/EEC (
1), hereinafter referred to as ‘the Committee', shall refer
the matter without delay to the Committee either on his own initiativeor 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 shalldeliver its opinion on the draft within a time limit which the chairmanmay lay down according to the urgency of the matter. The opinion shallbe delivered by the majority laid down in Article 148 (2) of the Treatyin the case of decisions which the Council is required to adopt on aproposal from the Commission. The votes of the representatives of theMember States within the Committee shall be weighted in the mannerset 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 shallwithout delay submit to the Council a proposal relating to the measuresto 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 simplemajority.
Article 11
The Council, acting by a qualified majority on a proposal from the
Commission, shall review this Decision before 1 January 1995.
Article 12
This Decision is addressed to the Member States.
(1) OJ No L 255, 18. 10. 1968, p. 23.
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ANNEX I
Quantities and sub-types of antigen to be held in the antigen banks
Potent, well-tested vaccine strains corresponding to:
O1European strain
O2Middle East strain
A5European strain
A24South American strain
A Middle East strainC
1European strain
ASIA1
SAT2
SAT1
A recent type A strain like A/87 Argentina should be included in the collection
of strains.
The above strains shall be kept in quantities sufficient to provide at least five
million doses of each sub-type. Each dose should have an observed potency of 6PD50 in cattle, when tested according to the European Pharmacopoeia.
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ANNEX II
Technical requirements for supply of concentrated inactivated monovalent
foot-and-mouth disease virus antigen and its formulation into vaccine
1. Availability of concentrated inactivated antigen suitable for storage in liquid
nitrogen, or by a method giving at least equivalent stability.
2. Availability of antigen corresponding to each of the sub-types specified in
Annex I. The antigen must also be suitable for the preparation of oil emulsionvaccines for pigs, in which case 1/6 of a dose volume must protect at least 5out of 10 pigs if challenged by intrapodal injection of 1 000 ID50.
3. Full information should be provided on the tests conducted by the producer on
seed virus, cells and other materials used in the production.
Samples of each master seed virus must be submitted to the CCI for confirm-
atory tests of identity and purity.
Samples of the cells used to produce the virus should be submitted to the CCI.
4. The manufacture and quality of antigen must be consistent with the generally
accepted standards for good manufacturing practice in Europe.
The vaccines to be produced on the basis of the antigen must comply with the
requirements of the European Pharmacopoeia. In addition:
(a) the antigen shall have been inactivated before concentration using a first
order inactivant. For each batch of antigen the kinetics of inactivationmust be followed and documented by the producer. The range of inactiva-tion must be such that the batch as a whole is free from infective virus,and the safety margin should be in the range of about 3 log10 (based onextrapolation); and
(b) the mixture of virus preparation/inactivant must have been transferred to a
second sterile container when half of the inactivation time has elapsed insuch a manner as to prevent contamination; an equivalent method could,however, be acceptable; and
(c) subsequent processing of the antigen should be carried out in a non-
contaminated environment (FMD virus free). Polyethyleneglycol (PEG)precipitation, polyethyleneoxide (PEO) precipitation, ultrafiltration or acombination of these are permitted methods for the concentration ofinactivated antigen; and
(d) before and during the performance of innocuity tests, the inactivated
antigen should be stored in a sealed container, in a quarantine area,outside the restricted (high-security) area; and
(e) the concentrated product containing the inactivated antigen should be in a
volume at least 100 times less than that used for formulation of conven-tional vaccines. The producer must indicate the number of vaccine dosesper volume unit of concentrated material; and
(f) the main bulk of the inactivated antigen should be supplied in containers
suitable for storage over liquid nitrogen and divided into volumes to beagreed between the producer and the CCI.
In consultation with, and under the supervision of, the CCI, the producer
must also provide 20 representative samples containing at least 1 mg eachof concentrated 146S antigen for periodic in vitroand in vivotests; and
(g) the producer must provide relevant information about the antigen and its
formulation into vaccine for consideration by the CCI.
5. (a) On receipt, each batch of concentrated inactivated antigen will be
checked by the CCI for possible residual infective virus in vitroand in
cattle using the method prescribed for vaccine in the European Pharmaco-poeia; and
(b) potency of the vaccines prepared from the concentrated antigen will be
tested by the CCI. Vaccines will be formulated according to the prescrip-tion of the producer. Vaccines for pigs will be formulated as oil emul-sions. For cattle, aluminium-hydroxide-, saponin- or oil-adjuvantedvaccines may be used. Any batches found to be unsatisfactory whentested immediately upon reconstitution following deposit in the antigenbank will be rejected and be replaced at the producer’s expense. The costof testing the replacement batch will be met by the producer;
(c) components of the concentrated antigen must not interfere with the prepa-
ration and stability of the oil-emulsion vaccines.
6. The antigen as provided by the producer should have an expected stability of
at least five years.
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7. (a) The concentration and quality of the vaccine adjuvants will be agreed
with the CCI.
(b) The producer should also specify the expected shelf-life of the product
after formulation into vaccine. This shelf-life should be at least fourmonths.
8. Vaccines which have exceeded their expiry date must not be used; this date
can be checked and if necessary reviewed by the CCI.
9. Formulated vaccines must be kept under cool temperature conditions as
specified in the European Pharmacopoeia. Care should be taken to maintainthe correct temperature during distribution, until administered.