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"B COUNCIL DECISION
of 11 December 1991
establishing Community 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
"M1 Council Decision 1999/762/EC of 15 November 1999 L 301 6 24.11.1999
"M2 Commission Decision 2001/181/EC of 22 February 2001 L 66 39 8.3.20011991D0666 — EN — 08.03.2001 — 002.001 — 1
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-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 possibility of
emergency vaccination in a limited area, in circumstances where slaughter ofthe 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 ofbeing 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 forfoot-and-mouth disease vaccines designated by Decision 91/665/EEC (
3)i n
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 bythe 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,
HAS ADOPTED THIS DECISION:
Article 1
The establishment of Community reserves of foot-and-mouth disease vaccine
shall consist of:
— the supply of concentrated inact ivated 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.!B
(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. 18.1991D0666 — EN — 08.03.2001 — 002.001 — 2
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 concentrated inactivatedantigen for the production of foot-and-mouth disease vaccine;
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:
— the Laboratoire de pathologie bovine du centre national d’études
vétérinaires et alimentaires, Lyon (France),
— the Istituto Zooprofilatico Sperimentale di Brescia (Italy),
— any other establishment designated in accordance with the procedure laid
down in Article 10.
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 antigenfor vaccine production is guaranteed by the other antigen banks.
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 maintain their usefulness
for the production of a safe and potent vaccine for emergency use againstfoot-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 Article10, 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 requestof 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 thevaccine 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 to Article 13 ofDirective 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.!B
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!B1991D0666 — EN — 08.03.2001 — 002.001 — 3
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 storagemethods 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 replicatessuitable 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 forvaccine;
(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, onthe 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.
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 generally
accepted standards for good manufacturing practice in Europe, which shall 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 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.
Article 8
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 inaccordance 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.!B1991D0666 — EN — 08.03.2001 — 002.001 — 4
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 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 therequest 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 laiddown in Article 148 (2) of the Treaty in the case of decisions which theCouncil 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 delaysubmit 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.
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.!B
(1) OJ No L 255, 18. 10. 1968, p. 23.1991D0666 — EN — 08.03.2001 — 002.001 — 5
ANNEX I
Quantities and sub-types of antigen to be held in the antigen banks
Potent well-tested vaccine strains corresponding to:
1. O European strain O1-BFS
Middle East strain O1-Manisa
2. A South American strain A24-Cruzeiro
Middle East strain A22-Iraq
Middle East strain A-Iran 96Middle East strain A-Iran 99
Asian strain A-Malaysia 97
3. C European strain C1-Noville4. ASIA1 ASIA1-Shamir
5. SAT SAT 1
SAT 2 — East African strain
— Southern African strain
SAT 3
The above strains shall be kept in quantities sufficient to carry out an emergency
vaccination taking into account the estimated risks the different subtypes present to theCommunity livestock and in any case not less than two million doses of each subtype.
Each dose of vaccine reconstituted from the above antigen should have an observed
potency of 6 PD50 in cattle, when tested according to the European Pharmacopoeia.!
M21991D0666 — EN — 08.03.2001 — 002.001 — 6
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 emulsion
vaccines for pigs, in which case1⁄6of a dose volume must protect at least 5 out
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
confirmatory 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 inactivation must
be followed and documented by the producer. The range of inactivation
must be such that the batch as a whole is free from infective virus, and thesafety 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, ultrafiltrationor a combination 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, outsidethe 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
conventional vaccines. The producer must indicate the number of vaccine
doses per 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 vitro andin vivo tests; 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 vitro and in cattle using
the method prescribed for vaccine in the European Pharmacopoeia; and
(b) potency of the vaccines prepared from the concentrated antigen will be
tested by the CCI. Vaccines will be formulated according to theprescription of the producer. Vaccines for pigs will be formulated as oilemulsions. For cattle, aluminium-hydroxide-, saponin- or oil-adjuvanted
vaccines may be used. Any batches found to be unsatisfactory when tested
immediately upon reconstitution following deposit in the antigen bank willbe rejected and be replaced at the producer’ s expense. The cost of testingthe replacement batch will be met by the producer;
(c) components of the concentrated antigen must not interfere with the
preparation 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.
7. (a) The concentration and quality of the vaccine adjuvants will be agreed with
the CCI.!
B1991D0666 — EN — 08.03.2001 — 002.001 — 7
(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 maintain the
correct temperature during distribution, until administered.!
B1991D0666 — EN — 08.03.2001 — 002.001 — 8