2008/581/EC: Commission Decision of 4 July 2008 on the financing of the storage of foot-and-mouth disease virus antigens and the formulation of vaccines reconstituted from such antigens
Date: 2008-07-04
Institutions: European Commission
Subjects: EU financing, EU stock, foot-and-mouth disease, storage, vaccine, veterinary legislation

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Official Journal of the European Union

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COMMISSION

COMMISSION DECISION

of 4 July 2008

on the financing of the storage of foot-and-mouth disease virus antigens and the formulation of
vaccines reconstituted from such antigens

(2008/581/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

disease vaccines are maintained on the premises of the
Community antigen and vaccine bank.

Having regard to the Treaty
Community,

establishing the European

(3)

Having regard to Council Decision 90/424/EEC of 26 June
1990 on expenditure in the veterinary field (1), and in particular
Article 14 thereof,

to

regard

Council Directive

of
Having
29 September 2003 on Community measures for the control
of foot-and-mouth disease repealing Directive 85/511/EEC and
Decisions 89/531/EEC and 91/665/EEC and amending Directive
92/46/EEC (2), and in particular Article 80(2) thereof,

2003/85/EC

Whereas:

(1)

In accordance with Council Decision 91/666/EEC of
11 December 1991 establishing Community reserves of
foot-and-mouth disease vaccines (3), stocks of antigens
have been established for
the rapid formulation of
vaccines against foot-and-mouth disease and are kept,
for security reasons, at distinct designated sites on the
premises of the manufacturer.

(2)

Under Directive 2003/85/EC,
to
ensure that Community reserves of concentrated inac­
tivated antigens for the production of foot-and-mouth

the Commission is

(4)

(5)

(6)

For that purpose the number of doses and the diversity
of serotypes and strains of antigens of foot-and-mouth
disease viruses stored in the Community antigen and
vaccine bank is to be decided taking into account the
needs as estimated in the context of the contingency
plans and the epidemiological situation, where appro­
priate after consultation with the Community Reference
Laboratory.

By Commission Decision 93/590/EC of 5 November
1993 for the purchase by the Community of foot-and-
the
mouth disease antigens within the framework of
Community action concerning reserves of
foot-and-
mouth disease vaccines (4), arrangements were made for
the purchase of A5 European, A22 Middle East and O1
European foot-and-mouth disease antigens.

By Commission Decision 97/348/EC of 23 May 1997 for
the purchase by the Community of
foot-and-mouth
disease antigens and for the formulation, production,
bottling and distribution of vaccines against foot-and-
mouth disease (5), arrangements were made for
the
purchase of A22 Iraq, C1 and ASIA1 foot-and-mouth
disease antigens.

antigens

and for

By Commission Decision 2000/77/EC of 17 December
1999 for the purchase by the Community of foot-and-
mouth disease
formulation,
production, bottling and distribution of vaccines against
foot-and-mouth disease (6), arrangements were made for
the purchase of certain doses of A Iran 96, A Iran 99, A
Malaysia 97, SAT 1, SAT 2 (East African and Southern
African strains) and SAT 3 foot-and-mouth disease
antigens.

the

(1) OJ L 224, 18.8.1990, p. 19. Decision as last amended by Regulation

(EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).

(4) OJ L 280, 13.11.1993, p. 33. Decision as last amended by Decision

(2) OJ L 306, 22.11.2003, p. 1. Directive as last amended by Directive

2000/112/EC (OJ L 33, 8.2.2000, p. 21).

2006/104/EC (OJ L 363, 20.12.2006, p. 352).

(5) OJ L 148, 6.6.1997, p. 27. Decision as amended by Decision

(3) OJ L 368, 31.12.1991, p. 21. Decision as last amended by Regu­

2000/112/EC.

lation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

(6) OJ L 30, 4.2.2000, p. 35.

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L 186/37

(7)

(8)

(9)

antigens

and for

By Commission Decision 2000/569/EC of 8 September
2000 for the purchase by the Community of foot-and-
mouth disease
formulation,
production, bottling and distribution of vaccines against
foot-and-mouth disease (1), arrangements were made for
the purchase of certain doses of A 22 Iraq, A Malaysia
97, O1 Manisa, ASIA 1, SAT 1, SAT 2 (East African and
Southern African strains) and SAT 3 foot-and-mouth
disease antigens.

the

In 2003 and in accordance with Commission Decision
C(2002) 4326 (2) on the purchase and storage of foot-
and-mouth disease antigens additional quantities of
epidemiologically relevant antigens were obtained.

In accordance with Article 14 of Decision 90/424/EEC,
the level of Community participation to set up such
antigen reserves and the conditions to which such parti­
cipation may be subject should also be set out.

HAS DECIDED AS FOLLOWS:

Article 1

The Commission must
take the necessary steps to ensure
storage of all FMD antigens listed in the Annex, starting from
1 January 2008 and for a minimum duration of five years.

The Commission shall also ensure potency testing, formulation,
distribution, bottling, labelling and transport of these antigens.

Article 2

The total cost to cover the services listed under Article 1 shall
not exceed EUR 4 000 000.

Article 3

(10) All antigens older than five years must be tested on their

potency.

The Director General of the Directorate-General for Health and
Consumer Protection is hereby authorised to sign the contracts
provided for in Article 1 on behalf of the Commission.

(11)

Since 2005, no binding long term legal commitment
between the contractor and the Commission is in place
for
formulation, distribution, bottling,
labelling and transport of FMD antigens purchased
between 1993 and 2005.

storage,

the

(12)

Storage costs for FMD antigens for the years 2005, 2006
and 2007 are covered by a financial commitment in
compliance with the Financial Regulation.

Article 4

A tendering procedure will be launched during the first semester
of 2008. A service contract in compliance with Council Regu­
lation (EC, Euratom) No 1605/2002 of 25 June 2002 applicable
to the general budget of the European Communities (3) and its
implementing rules defined in Commission Regulation (EC,
Euratom) No 2342/2002 (4)
in place before
30 September 2008.

should be

(13)

Between 2005 and 2007 no costs related to these FMD
antigens other than storage costs have occurred.

Done at Brussels, 4 July 2008.

(14)

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

For the Commission

Androulla VASSILIOU
Member of the Commission

(1) OJ L 238, 22.9.2000, p. 61.
(2) Decision not published.

(3) OJ L 248, 16.9.2002, p. 1.
(4) OJ L 357, 31.12.2002, p. 1.

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ANNEX

(Not for publication)