Commission Regulation (EC) No 123/2009 of 10 February 2009 amending Regulation (EC) No 1266/2007 as regards conditions for movements of animals within the same restricted zone and the conditions for exempting animals from the exit ban provided for in Council Directive 2000/75/EC (Text with EEA relevance)
Date: 2009-02-10
Institutions: European Commission
Subjects: animal breeding, animal disease, disease prevention, sheep, trade restriction, transport of animals

11.2.2009

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Official Journal of the European Union

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COMMISSION REGULATION (EC) No 123/2009

of 10 February 2009

amending Regulation (EC) No 1266/2007 as regards conditions for movements of animals within
the same restricted zone and the conditions for exempting animals from the exit ban provided for
in Council Directive 2000/75/EC

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

to

regard

Council Directive

Having
of
20 November 2000 laying down specific provisions for the
control and eradication of bluetongue (1), and in particular
Articles 9(1)(c), 11 and 12 and the third paragraph of
Article 19 thereof,

2000/75/EC

Whereas:

(1)

(2)

(3)

(4)

Directive 2000/75/EC lays down control
rules and
measures to combat and eradicate bluetongue, including
rules on the establishment of protection and surveillance
zones, the implementation of vaccination programmes,
and an exit ban on animals leaving those zones.

Commission Regulation (EC) No 1266/2007 (2)
lays
the control, monitoring, surveillance
down rules for
and restrictions on movements of animals,
in relation
to bluetongue, in and from a protection and surveillance
zone (restricted zone).

exemptions

Annex III to that Regulation establishes the conditions
for
to
movements of susceptible animals,
their semen, ova
and embryos provided for in Directive 2000/75/EC.

exit ban applicable

from the

According to the opinion of
the Scientific Panel on
animal health and welfare of the EFSA on vectors and
vaccines (3), adopted on 27 April 2007, vaccination is a

(1) OJ L 327, 22.12.2000, p. 74.
(2) OJ L 283, 27.10.2007, p. 37.
(3) The EFSA Journal (2007) 479, 1-29.

for

suitable tool
avoiding clinical outbreaks and therefore to limit
losses of farmers.

the control of bluetongue and for
the

(5)

(6)

(7)

(8)

The vaccination of animals against bluetongue represents
a major change of the immune status of the susceptible
population. The proof of
the absence of general or
specific bluetongue virus serotype or serotypes circu­
lation in a part of the restricted zone should be made
by the Member States by means of the results of the
bluetongue monitoring programmes in place pursuant
to Regulation (EC) No 1266/2007. Such monitoring
programmes should include passive clinical surveillance
and active laboratory-based surveillance by means of at
least monitoring with sentinel animals.

Laboratory-based surveillance by means sentinel animals
should not be restricted only to serological test but it
may also be carried out by other diagnostic methods,
namely agent identification tests.

Vaccination in the absence of virus circulation should not
be discouraged and preventive vaccination in restricted
zones without virus circulation should not be impeded.
However, pursuant to Directive 2000/75/EC, vaccination
against bluetongue
is only permitted within the
protection zone. Article 7(1) of Regulation (EC) No
1266/2007 provides that movements of animals within
the same restricted zone where the same bluetongue
virus serotype or serotypes are circulating are to be
allowed by the competent authority provided that the
animals to be moved do not show any clinical signs of
bluetongue on the day of transport, assuming that these
animals do not pose an additional risk to animal health.

Areas where vaccination has been applied and where
there is no circulation of
specific bluetongue virus
serotype or serotypes present a lower risk than the
other areas which are part of the restricted zone where
there is virus circulation. Therefore, Member States
should be permitted to demarcate, within the protection
zone areas where vaccination has been applied and where
specific bluetongue virus
there is no circulation of
serotype or serotypes. The intention to demarcate these
areas should be notified to the Commission, together
with all
information demonstrating that it is justified.
The other Member States should be also informed of
such demarcation.

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Official Journal of the European Union

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(9)

conditions

Article 7(2) of that Regulation permits movements of
animals from a protection zone to a surveillance zone,
to certain conditions. Movements of animals
subject
within the same restricted zone,
from a part of that
zone with virus circulation to a part with vaccination
circulation should be permitted
and without virus
under
for
similar
movements of animals from a protection zone to a
surveillance zone within the same restricted zone to
the
the risk of virus spread into the part of
limit
restricted zone with vaccination and without virus circu­
lation. Therefore, the current rules for movements of
animals within the same restricted zone where the
same bluetongue virus serotype or serotypes are circu­
lating should be amended.

required

those

to

(10) Movements of animals from a part of a restricted zone
with vaccination and without virus circulation to an area
outside the restricted zone are currently permitted subject
to the same conditions as those applied when animals
are moved from a restricted zone with virus circulation
to an area outside the restricted zone. However, taking
into account the relative low level of risk of movements
of animals from a part of a restricted zone with vacci­
nation and without virus circulation, it is appropriate to
permit such movements under less strict conditions as
regards the virus identification test that is required for
certain categories of vaccinated animals. Annex III to
Regulation (EC) No 1266/2007 should therefore be
amended accordingly.

(11)

Regulation (EC) No 1266/2007 should therefore be
amended accordingly.

(12)

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 1266/2007 is amended as follows:

1. Article 7 is amended as follows:

‘2a. Member States may, on the basis of the outcome
of a risk assessment which must
take into account
sufficient epidemiological data obtained following the
implementation of monitoring with sentinel animals in
accordance with point 1.1.2.1 of Annex I, demarcate a
part of a protection zone as a “restricted zone with
vaccination and without circulation of bluetongue virus
of a specific serotype or serotypes” (lower-risk area),
subject to the following conditions:

(i) vaccination is applied in that part of the protection
zone for a specific bluetongue virus serotype or
serotypes;

(ii) there is no bluetongue virus circulating in that part
of the protection zone for that specific bluetongue
serotype or serotypes.

A Member State which intends to demarcate a part of a
protection zone as a “lower-risk area” shall notify its
intention to the Commission. That notification shall be
accompanied by all the necessary information and data
to justify the demarcation in view of the epidemiological
situation of the zone concerned, in particular with regard
to the bluetongue monitoring programme in place. It
shall also inform the other Member States without delay.

Movements of animals within the same restricted zone
from an area where the same bluetongue virus serotype
or serotypes are circulating to a part of
the same
restricted zone demarcated as a “lower-risk area” may
only be permitted if:

(a)

the animals comply with the conditions set out in
Annex III; or

(b) the animals comply with any other appropriate
animal health guarantees based on a positive
outcome of a risk assessment of measures against
the spread of the bluetongue virus and protection
against
the
vectors,
attacks
competent authority of
the place of origin and
approved by the competent authority of the place
of destination, prior
such
animals; or

to the movement of

required

by

by

(a)

the following paragraph 2a is inserted:

(c)

the animals are destined for immediate slaughter.’;

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(b) paragraphs 3 and 4 are replaced by the following:

The Member State of origin shall

‘3.
immediately
inform the Commission and the other Member States
of
to in
paragraph 2(b) or 2a(b).

animal health guarantees

referred

the

4.
For the animals referred to in paragraphs 1, 2 and
2a of this Article, the following additional wording shall
be added to the corresponding health certificates laid
down in Directives 64/432/EEC, 91/68/EEC and
92/65/EEC, or referred to in Decision 93/444/EEC:

“Animals in compliance with ...............
(Article 7(1), or
7(2)(a), or 7(2)(b), or 7(2)(c), or 7(2a)(a) or 7(2a)(b), or
7(2a)(c), indicate as appropriate) of Regulation (EC) No
1266/2007”.’;

2.

in Annex I, point 1.1.2.1. is replaced by the following:

‘1.1.2.1. Monitoring with sentinel animals:

— monitoring with sentinel animals shall consist
of an active annual programme of
testing
sentinel animals aimed at assessing the circu­
the bluetongue virus within the
lation of
restricted
sentinel
zone. Where
animals must be bovine animals. They must
be located in areas of
the restricted zone
following a risk analysis considering
where,
entomological and ecological evaluations,
the
presence of the vector has been confirmed or
habitats suitable for the vector’s breeding are
present,

possible,

— sentinel animals shall be tested at least once a
month during the period of activity of
the
vector involved,
In the absence of
if known.
such information the sentinel animals shall be
tested at least once a month throughout the
year,

detect a monthly incidence (*) of 2 % with 95 %
confidence
of
reference,

geographical

in each

unit

— laboratory testing shall be designed in such a
way that positive screening tests are followed by
the specific serotype serological/virological tests
targeted to the appropriate bluetongue serotype
or serotypes necessary to ascertain the specific
serotype circulation in each epidemiologically
relevant geographical area.;

___________
(*) It has been estimated that 20 % is the
normal annual rate of seroconversion in an
infected zone. However, in the Community,
virus circulation mainly takes place in a
(end of
period of
around six months
a
spring/mid-autumn). Therefore 2 % is
conservative
expected
the
estimation of
monthly rate of seroconversion.’

3.

in Annex III, Section A is amended as follows:

(a) point 5(b) is replaced by the following:

at

identification test

‘(b) they have been vaccinated with an inactivated
vaccine before
the number of days
least
necessary for the onset of the immunity protection
set in the specifications of the vaccine approved in
the vaccination programme and were subjected to an
agent
according to the OIE
Terrestrial Manual, with negative results, carried out
at least 14 days after the onset of the immunity
protection set in the specifications of the vaccine
approved in the vaccination programme; however,
that agent
is not necessary for
movements of animals from a part of a restricted
zone demarcated as a “lower-risk area” in accordance
with Article 7(2a) of this Regulation.’;

identification test

(b) the third paragraph is replaced by the following:

‘For pregnant animals, at least one of the conditions set
out in points 5, 6 and 7 must be complied with before
insemination or mating, or the condition set out in point
3 must be complied with. In case a serological test, as set
out in point 3, is carried out, that test shall be carried
out not earlier than seven days before the date of
movement.’.

— the minimum number of sentinel animals per
geographical unit of reference for the purposes
of bluetongue monitoring and surveillance must
to
be representative and sufficient

in order

Article 2

This Regulation shall enter into force on the third day following
its publication in the Official Journal of the European Union.

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Official Journal of the European Union

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This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 10 February 2009.

For the Commission

Androulla VASSILIOU
Member of the Commission