2001/75/EC: Commission Decision of 18 January 2001 for safety and potency testing of foot-and-mouth disease vaccines and bluetongue vaccines (notified under document number C(2001) 118)
Date: 2001-01-18
Institutions: European Commission
Subjects: EU stock, animal disease, foot-and-mouth disease, sheep, testing, vaccine

L 26/38

EN

Official Journal of the European Communities

27.1.2001

COMMISSION

COMMISSION DECISION

of 18 January 2001

for safety and potency testing of foot-and-mouth disease vaccines and bluetongue vaccines

(notified under document number C(2001) 118)

(2001/75/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Decision 90/424/EEC of 26 June
1990 on expenditure in the veterinary field (1), as last amended
by Regulation (EC) No 1258/1999 (2), and in particular Articles
6 and 14 thereof,

Having regard to Council Decision 91/666/EEC of 11
December 1991 establishing Community reserves of foot-and-
mouth disease vaccines (3), as last amended by Decision 1999/
762/EC (4), and in particular Article 5 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.

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
foot-and-
Community action concerning reserves of
mouth disease vaccines (5), as last amended by Decision
95/471/EC (6), arrangements were made for purchase of
A5, A22 and O1 foot-and-mouth disease antigen.

Foot-and-mouth disease virus antigens kept in the emer-
gency stock since 1993 must be tested with regard to
safety and potency to ensure that the antigen reserves
kept for emergency use are of high quality.

By Commission Decision 98/64/EC of 9 December
1997 on a Community financial contribution for
control
foot-and-mouth
improving

disease

the

(1) OJ L 224, 18.8.1990, p. 19.
(2) OJ L 160, 26.6.1999, p. 103.
(3) OJ L 368, 31.12.1991, p. 21.
(4) OJ L 301, 24.11.1999, p. 6.
(5) OJ L 280, 13.11.1993, p. 33.
(6) OJ L 269, 11.11.1995, p. 29.

programme in Turkey (7), it was agreed as a part of a
work plan that the European Commission would make
arrangements
foot-and-mouth disease
testing of
vaccine produced in Turkey.

for

By Commission Decision 2000/292/EC of 6 April 2000
for purchase by the Community of bluetongue vaccine
for emergency stock (8), arrangements were made for
purchase of bluetongue vaccine for emergency.

No bluetongue vaccine is produced by the pharmaceut-
ical industry based in the Member States of the Euro-
pean Union (EU).

Bluetongue vaccine purchased abroad for emergency use
should be tested with the objective of obtaining informa-
tion of importance for the use of the vaccine under
different epidemiological conditions.

Safety and potency testing of foot-and-mouth disease
vaccine and bluetongue vaccine can only be carried out
at laboratories being operated under approved biose-
curity levels.

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

(5)

(6)

(7)

(8)

(9)

HAS ADOPTED THIS DECISION:

Article 1

The Community shall make arrangements for appropriate

1.
safety and potency testing of:

— foot-and-mouth disease virus antigens purchased in 1993
and since then kept as a part of the EU emergency stock,

(7) OJ L 16, 21.1.1998, p. 45.
(8) OJ L 95, 15.4.2000, p. 39.

27.1.2001

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Official Journal of the European Communities

L 26/39

— foot-and-mouth disease vaccine produced in Turkey and
used in a prophylactic vaccination programme which
includes vaccination of susceptible animals kept in the area
of Turkish Thrace,

Article 3

To meet the objectives of Articles 1 and 2 the Commis-

1.
sion shall conclude contracts without delay.

— bluetongue

vaccines produced outside
Community and purchased for an emergency stock.

the European

The Director-General of

2.
for
Health and Consumer Protection shall be authorised to sign the
contracts on behalf of the European Commission.

the Directorate-General

The maximum cost of the measures referred to in para-

2.
graph 1 shall be up to EUR 430 000.

This Decision is addressed to the Member States.

Article 4

Article 2

Done at Brussels, 18 January 2001.

The measures mentioned in Article 1 shall be carried out by
the Commission in cooperation with the supplier designated by
call for tender.

For the Commission

David BYRNE

Member of the Commission