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21.3.2012 Official
Journal
of
the
European
Union
L
81/1
I
(Legislative acts)
DIRECTIVES
DIRECTIVE 2012/5/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 14 March 2012
amending Council Directive 2000/75/EC as regards vaccination against bluetongue
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
the Union of bluetongue virus serotypes 1 and 8 in the
EUROPEAN UNION,
years 2006 and 2007, the bluetongue virus has become
more widespread in the Union, with the potential to
become endemic in certain areas. It has therefore
Having regard to the Treaty on the Functioning of the European
become difficult to control the spread of that virus.
Union, and in particular Article 43(2) thereof,
(3)
The rules on vaccination against bluetongue laid down in
Directive 2000/75/EC are based on experience of the use
Having regard to the proposal from the European Commission,
of so-called ‘modified live vaccines’, or ‘live attenuated
vaccines’, which were the only vaccines available when
that Directive was adopted. The use of those vaccines
After transmission of the draft legislative act to the national
may lead to an undesired local circulation of the
parliaments,
vaccine virus in unvaccinated animals.
Having regard to the opinion of the European Economic and
(4) In
recent
years,
as
a
result
of
new
technology,
‘inactivated
Social Committee (
vaccines’ against bluetongue have become available

1 ),
which do not pose the risk of undesired local circulation
of the vaccine virus to unvaccinated animals. The
extensive use of such vaccines during the vaccination
Acting in accordance with the ordinary legislative procedure ( 2 ),
campaign in the years 2008 and 2009 has led to a
significant improvement in the disease situation. It is
now widely accepted that vaccination with inactivated
Whereas:
vaccines is the preferred tool for the control of blue
tongue and for the prevention of clinical disease in the
Union.
(1) Council
Directive
2000/75/EC
of
20
November
2000
laying down specific provisions for the control and eradi
(5)
In order to ensure better control of the spread of the
cation of bluetongue ( 3 ) lays down control rules and
bluetongue virus and to reduce the burden on the agri
measures to combat and eradicate bluetongue, including
cultural sector posed by that disease, it is appropriate to
rules on the establishment of protection and surveillance
amend the current rules on vaccination laid down in
zones and the use of vaccines against bluetongue.
Directive 2000/75/EC in order to take account of the
recent technological developments in vaccine production.
(2) In
the
past,
only
sporadic
incursions
of
certain
serotypes
of the bluetongue virus were recorded in the Union.
(6)
In order to enable the vaccination season 2012 to benefit
Those incursions mainly occurred in the southern parts
from the new rules, this Directive should enter into force
of the Union. However, since the adoption of Directive
on the day following its publication in the Official Journal
2000/75/EC, and particularly since the introduction into
of the European Union.
( 1 ) OJ C 132, 3.5.2011, p. 92.
( 2 ) Position of the European Parliament of 7 April 2011 (not yet
(7) The
amendments
provided
for
in
this
Directive
should
published in the Official Journal) and position of the Council at
make the rules on vaccination more flexible and also take
first reading of 15 December 2011 (OJ C 46 E, 17.2.2012,
into account the fact that inactivated vaccines that can
p. 15). Position of the European Parliament of 14 February 2012
(not yet published in the Official Journal).
also be successfully used outside areas subject to animal
( 3 ) OJ L 327, 22.12.2000, p. 74.
movement restrictions are now available.

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L 81/2
EN
Official Journal of the European Union
21.3.2012
(8)
In addition, and provided that appropriate precautionary
(4) in Article 8(2), point (b) is replaced by the following:
measures are taken, the use of live attenuated vaccines
should not be excluded, as their use might still be
necessary under certain circumstances, such as
‘(b) The surveillance zone shall consist of a part of the
following the introduction of a new bluetongue virus
Union territory with a depth of at least 50 kilometres
serotype against which inactivated vaccines may not be
extending beyond the limits of the protection zone and
available.
in which no vaccination against bluetongue with live
attenuated vaccines has been carried out during the
previous 12 months.’;
(9) Directive
2000/75/EC
should
therefore
be
amended
accordingly,
(5) in Article 10, point 2 is replaced by the following:
HAVE ADOPTED THIS DIRECTIVE:
‘2. any vaccination against bluetongue using live attenuated
Article 1
vaccines is prohibited in the surveillance zone.’.
Directive 2000/75/EC is hereby amended as follows:
Article 2
(1) in Article 2, the following point is added:
1. Member
States
shall
adopt
and
publish,
by
23
September
2012 at the latest, the laws, regulations and administrative
‘(j) “live attenuated vaccines”: vaccines which are produced
provisions necessary to comply with this Directive. They shall
by adapting bluetongue virus field isolates through
communicate immediately to the Commission the text of those
serial passages in tissue culture or in embryonated
provisions.
hens’ eggs.’;
(2) Article 5 is replaced by the following:
They shall apply those provisions from 24 September 2012 at
the latest.
‘Article 5
When Member States adopt those provisions, they shall contain
1. The
competent
authority
of
a
Member
State
may a reference to this Directive or shall be accompanied by such a
decide to allow the use of vaccines against bluetongue
reference on the occasion of their official publication. Member
provided that:
States shall determine how such reference is to be made.
(a) such decision is based on the result of a specific risk
assessment carried out by the competent authority;
2. Member
States
shall
communicate
to
the
Commission
the
text of the main provisions of national law which they adopt in
the field covered by this Directive.
(b) the Commission is informed before such vaccination is
carried out.
Article 3
2. Whenever
live
attenuated
vaccines
are
used,
Member This Directive shall enter into force on the day following its
States shall ensure that the competent authority demarcates:
publication in the Official Journal of the European Union.
(a) a protection zone, consisting of at least the vaccination
area;
Article 4
This Directive is addressed to the Member States.
(b) a surveillance zone, consisting of a part of the Union
territory with a depth of at least 50 kilometres
extending beyond the limits of the protection zone.’;
Done at Strasbourg, 14 March 2012.
(3) in Article 6(1), point (d) is replaced by the following:
‘(d) implement the measures adopted in accordance with
For the European Parliament
For the Council
the procedure laid down in Article 20(2), in particular
with regard to the introduction of any vaccination
The President
The President
programme or other alternative measures;’;
M. SCHULZ
N. WAMMEN

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