2005/780/EC: Commission Decision of 8 November 2005 on the purchase and storage of foot-and-mouth disease virus antigens
Date: 2005-11-08
Institutions: European Commission
Subjects: EU stock, foot-and-mouth disease, storage, vaccine, veterinary legislation

10.11.2005

EN

Official Journal of the European Union

L 294/7

II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 8 November 2005

on the purchase and storage of foot-and-mouth disease virus antigens

(2005/780/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

Having regard to the Treaty
Community,

establishing the European

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,

For that purpose the number of doses and the diversity
of strains and subtypes 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.

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

91/665/EEC and

89/531/EEC and

Whereas:

(1)

(2)

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 express formulation of
vaccines against
foot-and-mouth disease and are kept
for security reasons at distinct designated sites of the
premises of the manufacturer.

the Commission is

Under Directive 2003/85/EC,
to
ensure that Community reserves of concentrated inac-
tivated antigens for the production of foot-and-mouth
disease vaccines are maintained on the premises of the
Community antigen and vaccine bank.

(1) OJ L 224, 18.8.1990, p. 19. Decision as last amended by Directive
2003/99/EC of the European Parliament and of the Council (OJ L
325, 12.12.2003, p. 31).

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

Decision 2005/615/EC (OJ L 213, 18.8.2005, p. 14).

(4)

(5)

Pending the designation of a Community Reference
Laboratory for foot-and-mouth disease, account is taken
of the report of the FAO World Reference Laboratory for
Foot-and-Mouth Disease on a list of priority antigens
recommended for antigen banks, which was endorsed
by
European
Commission for the Control of Foot-and-Mouth Disease
(EUFMD) at the Food and Agriculture Organisation (FAO)
at the 36th General Session of EUFMD.

Technical Committee

the

the

of

The deterioration of the foot-and-mouth disease situation
in certain parts of the world requires certain stocks of
antigens to be supplemented urgently in accordance with
the risks associated with this development for the epide-
miological situation in the Community and neighbouring
countries.

(6) When deciding about

the procurement of additional
quantities and subtypes of foot-and-mouth disease virus
antigens account should be taken of existing quantities of
such antigens, of the compatibility required for combi-
nation in polyvalent vaccines and of
the marketing
authorisation held by the manufacturer of the antigens
in at least one of the Member States in accordance with
Directive 2001/82/EC of the European Parliament and of
the Council of 6 November 2001 on the Community
code relating to veterinary medicinal products (4).

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

(4) OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive

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

2004/28/EC (OJ L 136, 30.4.2004, p. 58).

L 294/8

EN

Official Journal of the European Union

10.11.2005

(7)

(8)

(9)

Because the information on quantities and subtypes of
antigens or authorised vaccines stored in the Community
antigen and vaccine bank is to be treated as classified
information in accordance with Directive 2003/85/EC,
the Annex to this Decision should not be published.

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.

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

in this Decision are in
Standing
the

opinion

the

of

HAS DECIDED AS FOLLOWS:

Article 1

1.
The Commission shall purchase foot-and-mouth disease
virus antigens in the quantities and subtypes specified in the
Annex.

The Commission shall ensure that

2.
the antigens are
distributed for storage between the two designated sites of the
premises of the manufacturer in accordance with the Annex.

The measures mentioned in paragraphs 1 and 2 shall be
3.
carried out by the Commission in cooperation with the supplier
of the relevant antigens already stored in the European antigen
bank.

The measures provided for in Article 1 shall be completed

4.
by 31 December 2005 at the latest.

Article 2

1.
The Commission shall bear the full cost of the measures
referred to in Article 1(1) and (2) which shall not exceed a
maximum set up to EUR 2 500 000.

The Commission shall

2.
conclude a contract on the
purchases provided for in paragraph 1 in accordance with
Article 80(4) of Directive 2003/85/EC.

3.
The Commission shall ensure that the antigens referred to
in Article 1(1) are included in the scope of existing contracts
concerning the storage of antigens as well as the formulation,
labelling and delivery of vaccines recon-
production, bottling,
stituted from such antigens.

4.
The Director-General of the Directorate-General for Health
and Consumer Protection is hereby authorised to sign the
contract provided for
the
Commission.

in paragraph 2 on behalf of

Article 3

In accordance with Article 80(3) of Directive 2003/85/EC the
Annex to this Decision shall not be published.

Done at Brussels, 8 November 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission