2001/181/EC: Commission Decision of 22 February 2001 amending Annex I to Council Decision 91/666/EEC establishing Community reserves of foot-and-mouth disease vaccines and updating Decision 2000/112/EC with regard to distribution between antigen banks of antigen reserves (Text with EEA relevance) (notified under document number C(2001) 425)
Date: 2001-02-22
Institutions: European Commission
Subjects: EU Member State, EU stock, foot-and-mouth disease, research body, vaccine, veterinary legislation

8.3.2001

EN

Official Journal of the European Communities

L 66/39

COMMISSION DECISION

of 22 February 2001

amending Annex I to Council Decision 91/666/EEC establishing Community reserves of foot-and-
mouth disease vaccines and updating Decision 2000/112/EC with regard to distribution between
antigen banks of antigen reserves

(notified under document number C(2001) 425)

(Text with EEA relevance)

(2001/181/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty establishing the European
Community,

Having regard to Council Decision 91/666/EEC of 11
December 1991 establishing Community reserves of foot-and-
mouth disease vaccines (1), as last amended by Decision 1999/
762/EC (2), and in particular Articles 7 and 9 thereof,

Having regard to Council Decision 90/424/EEC of 26 June
1990 on expenditure in the veterinary field (3), as last amended
by Regulation (EC) No 1258/1999 (4), and in particular Article
14 thereof,

Whereas:

(1)

(2)

(3)

(4)

In conformity with Decision 91/666/EEC, the purchase
of antigens is a part of the Community action to estab-
lish Community reserves of
foot-and-mouth disease
vaccines.

Annex I to Decision 91/666/EEC details the quantities
and subtypes of antigen of the foot-and-mouth disease
virus to be stored in Community antigen reserves.

Forced by the epidemiological situation and following
the advice of
the World Reference Laboratory for
Foot-and-Mouth Disease, Pirbright, United Kingdom, and
the advice of an expert group established to review
certain provisions of Directive 85/511/EEC (5), as last
amended by the Act of Accession of Austria, Finland
and Sweden, the Community has made purchases of
subtypes and quantities of foot-and-mouth disease virus
antigens.

By Commission Decision 93/590/EC of 5 November
1993 for the purchase by the Community of foot-and-
mouth disease antigens within the framework of the
Community action concerning reserves of
foot-and-
mouth disease vaccines (6), as last amended by Decision
2000/112/EC (7), arrangements were made for purchase
of A5, A22 and O1 foot-and-mouth disease virus
antigens.

(1) OJ L 368, 31.12.1991, p. 21.
(2) OJ L 301, 24.11.1999, p. 6.
(3) OJ L 224, 18.8.1990, p. 19.
(4) OJ L 160, 26.6.1999, p. 103.
(5) OJ L 315, 26.11.1985, p. 11.
(6) OJ L 280, 13.11.1993, p. 33.
(7) OJ L 33, 8.2.2000, p. 21.

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 (8), as last amended by Decision 2000/
112/EC, arrangements were made for the purchase of
A22-Iraq, C1 and ASIA1 foot-and-mouth disease virus
antigens.

By Commission Decision 2000/77/EC of 17 December
1999 for the purchase by the Community of foot-and-
mouth disease antigens and for the formulation, produc-
tion, bottling and distribution of vaccines against
foot-and-mouth disease (9), arrangements were made for
purchase of certain quantities 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 virus
antigen.

By Commission Decision 2000/569/EC of 8 September
2000 for the purchase by the Community of foot-and-
mouth disease antigens and for the formulation, produc-
tion, bottling and distribution of vaccines against
foot-and-mouth disease (10), arrangements were made for
purchase
of A22-Iraq,
O1-Manisa, ASIA 1-Shamir, A Malaysia 97, SAT 1,
SAT 2 (East African and Southern African strains) and
SAT 3 foot-and-mouth disease virus antigen.

additional

quantities

of

It appears necessary to align Annex I to Decision 91/
666/EEC to the purchases made by the Community in
the light of the epidemiological development.

2000/112/EC detailing

It appears also appropriate to update the Annex to
Decision
distribution
between antigen banks of antigen reserves established
within the
the Community action
concerning reserves of foot-and-mouth disease vaccines
and amending Decisions 93/590/EC and 97/348/EC.

framework of

the

(6)

(7)

(8)

(9)

(10)

The measures provided for in this Decision are in
accordance with the opinion of the Standing Veterinary
Committee,

(8) OJ L 148, 6.6.1997, p. 27.
(9) OJ L 30, 4.2.2000, p. 35.
(10) OJ L 238, 22.9.2000, p. 61.

L 66/40

EN

Official Journal of the European Communities

8.3.2001

HAS ADOPTED THIS DECISION:

Annex I to Decision 91/666/EEC is replaced by Annex I to this Decision.

Article 1

The Annex to Decision 2000/112/EC is replaced by Annex II to this Decision.

Article 2

This Decision is addressed to the Member States.

Article 3

Done at Brussels, 22 February 2001.

For the Commission

David BYRNE

Member of the Commission

ANNEX I

‘ANNEX I

Quantities and sub-types of antigen to be held in the antigen banks

Potent well-tested vaccine strains corresponding to:

1.

2.

3.

4.

5.

O

A

European strain

Middle East strain

O1-BFS

O1-Manisa

South American strain

A24-Cruzeiro

Middle East strain

Middle East strain

Middle East strain

Asian strain

European strain

SAT 1

SAT 2

SAT 3

C

ASIA1

SAT

A22-Iraq

A-Iran 96

A-Iran 99

A-Malaysia 97

C1-Noville

ASIA1-Shamir

— East African strain
— Southern African strain

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 the Community 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.’

8.3.2001

EN

Official Journal of the European Communities

L 66/41

ANNEX II

‘ANNEX

EUROPEAN
ANTIGEN BANK

Designated antigen banks

IZP
Brescia

LNPB
Lyon

Antigen type/subtype

Quantity (1)
(× 1 000 000)

Quantity (1)
(× 1 000 000)

Merial SAS
Pirbright/Lyon

Quantity (1)
(× 1 000 000)

EUROPEAN
ANTIGEN BANK

Totals
(× 1 000 000)

O1 — Manisa

O1 — BFS

A24 — Cruzeiro

A22 — Iraq

A Iran 96

A Iran 99

A Malaysia 97

C1 — Noville

ASIA1 — Shamir

SAT 1

SAT 2 (E Africa)

SAT 2 (S Africa)

SAT 3

Quantity (1)
(× 1 000 000)
total per site

2,5

2,5

2,5

2,2

2,5

2,5

2,5

2,5

1,0

2,5

1,0

1,0

0,5

2,5

1,0

0,5

0,5

0,5

0,5

5,0

3,5

5,0

4,7

1,0

1,0

0,5

5,0

3,5

0,5

0,5

0,5

0,5

10,0

9,7

11,5

31,2

(1) quantity in vaccine equivalent antigen doses.’