Commission Regulation (EC) No 1266/2007 of 26 October 2007 on implementing rules for Council Directive 2000/75/EC as regards the control, monitoring, surveillance and restrictions on movements of certain animals of susceptible species in relation to bluetongue (Text with EEA relevance)
Date: 2007-10-26
Institutions: European Commission
Subjects: EU control, animal disease, animal welfare, epidemiology, health control, protection of animals, sheep, trade restriction, transport of animals

27.10.2007

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Official Journal of the European Union

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COMMISSION REGULATION (EC) No 1266/2007

of 26 October 2007

on implementing rules for Council Directive 2000/75/EC as regards the control, monitoring,
surveillance and restrictions on movements of certain animals of susceptible species in relation
to bluetongue

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

Having regard to the Treaty
Community,

establishing the European

Having regard to Directive 82/894/EEC of 21 December 1982
on the notification of animal diseases within the Community (1),
and in particular the second indent of Article 5(2),

(4)

Having regard to Council Directive 2000/75/EC of 20
the
November 2000 laying down specific provisions
control and eradication of bluetongue (2), and in particular
Article 6(1) and (3), Article 8(2)(d), Article 8(3), Article
9(1)(c), Articles 11 and 12 and the third paragraph of Article
19 thereof,

for

Whereas:

(1)

(2)

the

Directive 2000/75/EC lays down control
rules and
measures to combat bluetongue in the Community,
and
including
establishment
surveillance zones and a ban on animals of
the
susceptible species
leaving those zones. Exemptions
from that ban may de decided by the Commission in
accordance with the procedure provided for
in that
Directive.

protection

of

Commission Decision 2005/393/EC of 23 May 2005 on
protection and surveillance zones in relation to blue-
tongue and conditions applying to movements from or
through these zones (3) provides for the demarcation of
the global geographic
areas where protection and
surveillance zones (the restricted zones) are to be estab-
lished by the Member States.

(1) OJ L 378, 31.12.1982. Directive as last amended by Commission

Decision 2004/216/EC (OJ L 67, 5.3.2004, p. 27).

(2) OJ L 327, 22.12.2000, p. 74. Directive as last amended by Directive

2006/104/EC (OJ L 363, 20.12.2006, p. 352).

(3) OJ L 130, 24.5.2005, p. 22. Decision as last amended by Decision

2007/357/EC (OJ L 133, 25.5.2007, p. 44).

(5)

(6)

(7)

Following the adoption of Decision 2005/393/EEC, the
bluetongue situation in the Community has considerably
changed and new experience has been gained on disease
control, in particular following the recent incursions of
new serotypes of bluetongue virus, namely of serotype 8
in an area of the Community where outbreaks had never
been reported before and which was not considered at
risk of bluetongue, and of serotype 1 of that virus.

On the basis of the experience gained, it is appropriate to
improve harmonisation at Community level of the rules
on the control, monitoring, surveillance, and restrictions
on movements of susceptible animals, excluding wild
animals, in relation to bluetongue as they are of funda-
mental
importance for safe trade in susceptible farmed
animals moving within and from restricted zones, with
the aim of establishing a more sustainable strategy for
the control of bluetongue. For the sake of harmonisation
and clarity,
it is therefore necessary to repeal Decision
2005/393/EC and to replace it by this Regulation.

The new situation as regards bluetongue has also led the
Commission to request scientific advice and support
from the European Food Safety Authority (EFSA) which
has delivered two scientific reports and two scientific
opinions on bluetongue in 2007.

factors connected with bluetongue and of

Pursuant to Directive 2000/75/EC, the demarcation of
protection and surveillance zones must take account of
geographical, administrative, ecological and epizootio-
logical
the
control arrangements. In order to take account of those
factors, it is necessary to lay down rules as regards the
minimum harmonised requirements for monitoring and
surveillance of bluetongue in the Community.

a

and exchange of

information are key
Surveillance
elements of
risk-based approach to bluetongue
control measures. For that purpose, it is appropriate, in
addition to the definitions laid down in Article 2 of
Directive 2000/75/EC, to provide in particular for a defi-
nition of a case of bluetongue, to enable a common
understanding of the essential parameters related to an
outbreak of bluetongue.

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(8)

(9)

the concept of restricted zones, used in
In addition,
Decision 2005/393/EC, has proven adequate, especially
if the presence of the bluetongue virus is detected in the
affected area in two consecutive seasons. For practical
reasons and for the sake of clarity of Community legis-
lation,
it is appropriate to provide for a definition of
restricted zones, consisting of both the protection and
surveillance zones demarcated by the Member States
pursuant to Article 8(1) of Directive 2000/75/EC.

(14)

The determination of a bluetongue seasonally-free zone
for which surveillance demonstrates no evidence of blue-
is an
tongue transmission or of competent vectors
essential
of
outbreaks of bluetongue enabling safe movements. For
that purpose,
the
harmonised criteria that should be used for the definition
of the seasonally vector-free period.

is appropriate to provide for

sustainable management

tool

for

it

a

Community financial contribution for the eradication,
control and monitoring of bluetongue.

Pursuant to Decision 90/424/EEC, Commission Decision
2007/367/EC of 25 May 2007 concerning a financial
contribution by the Community to Italy for the im-
plementation of a system for collection and analysis of
epidemiological information on bluetongue (4) established
the BlueTongue NETwork application (BT-Net system),
which is a web-based system to collect, store, and
analyse bluetongue surveillance data in the Member
fundamental
States. Full use of
importance to establish the most appropriate measures
for controlling the disease, verifying their efficacy and
susceptible
allowing safe movements of animals of
efficient
ensure more
species.
exchanges of information on the bluetongue monitoring
in place between the
and surveillance programmes
those exchanges
Member States and the Commission,
should therefore be carried out
through the BT-Net
system.

system is of

effective

that

and

To

(10) Outbreaks

of

be

should

notified

bluetongue

in
accordance with Article 3 of Council Directive
82/894/EEC, using the codified forms and the codes set
out in Commission Decision 2005/176/EC of 1 March
2005 laying down the codified form and the codes for
the notification of animal diseases pursuant to Council
Directive 82/894/EEC (1).
the current
epidemiological development of bluetongue, the scope
of this notification requirement should be temporarily
adapted by defining more precisely the obligation to
notify primary outbreaks.

In the light of

(11) According to the opinion of

the Scientific Panel on
Animal Health and Welfare of the EFSA on bluetongue
origin and occurrence (2), adopted on 27 April 2007, it is
essential that appropriate surveillance programmes are in
the
place to detect
earliest possible stage. Such surveillance programmes
should include a clinical, serological and entomological
component
that should operate seamlessly across all
Member States.

the occurrence of bluetongue at

(12) An integrated approach at Community level is required
in order to be able to analyse the epidemiological infor-
mation provided by the bluetongue monitoring and
surveillance programmes,
including both regional and
global distribution of the bluetongue infection, as well
as of the vectors.

(13)

Council Decision 90/424/EEC of 26 June 1990 on
expenditure in the veterinary field (3) provides for a

(1) OJ L 59, 5.3.2005, p. 40. Decision as amended by Decision

2006/924/EC (OJ L 354, 14.12.2006, p. 48).

(2) The EFSA Journal (2007) 480, 1-20.
(3) OJ L 224, 18.8.1990, p. 19. Decision as last amended by Regulation

(EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).

zones

protection
and
level pursuant

(15) Unless it appears necessary to proceed to the demar-
surveillance
at
cation
of
to Article 8(2)(d) of
Community
that demarcation should be
Directive 2000/75/EC,
for the
carried out by the Member States. However,
sake of transparency, Member States should notify to
the Commission their protective and surveillance zones
and any changes thereof without delay. In particular, if a
Member State intends not to maintain an epidemiological
relevant geographical area in a restricted zone, it should
provide to the Commission in advance with relevant
information to substantiate the absence of bluetongue
virus circulation in that area.

(16)

the

through

bluetongue

Exemptions from the exit ban applicable to movements
of susceptible animals, their semen, ova and embryos,
from the restricted zone should be authorised on the
the data
basis of a risk analysis taking into account
collected
surveillance
programme, the exchange of data with other Member
States and the Commission through the BT-Net system,
the destination of the animals, and their compliance with
certain health requirements guaranteeing the safety of the
animals. Movements of animals for immediate slaughter
should also be exempted from the exit ban under certain
conditions. Taking into account the low level of risk of
immediate slaughter and
movements of animals
for
certain risk mitigation factors,
is appropriate to
provide for specific conditions minimizing the risk of
transport of
virus
animals from a holding located in a restricted zone
towards slaughterhouses designated on the basis of a
risk assessment.

transmission by channelling the

it

(4) OJ L 139, 31.5.2007, p. 30.

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(17) Movements of animals within the same restricted zone
where the same bluetongue virus serotype or serotypes
are circulating, does not pose an additional risk to animal
health and should therefore be allowed by the competent
authority under certain conditions.

of the positive outcome of a case-by-case risk assessment
which takes into account geographical, epidemiological,
ecological, environmental, entomological data and a
cost/benefit assessment.

(18) According to the opinion of

the Scientific Panel on
Animal Health and Welfare of the EFSA on vectors and
vaccines (1), adopted on 27 April 2007, movements of
immunised animals due to vaccination or naturally
immunised animals can be considered safe irrespective
of the virus circulation at the place of origin or the
is
vectors
therefore necessary to provide for the conditions that
immunised animals must fulfil before moving from a
restricted zone.

the place of destination.

activity at

It

(19)

(20)

referred

Council Directive 64/432/EEC of 26 June 1964 on
animal health problems affecting intra-Community trade
in bovine animals and swine (2), Council Directive
91/68/EEC of 28 January 1991 on animal health
conditions governing intra-Community trade in ovine
and caprine animals (3), Council Directive 92/65/EEC of
13 July 1992 laying down animal health requirements
governing trade in and imports into the Community of
animals, semen, ova and embryos not subject to animal
health requirements laid down in specific Community
rules
to Directive
90/425/EEC (4) and Commission Decision 93/444/EEC
of 2 July 1993 on detailed rules governing intra-
Community trade in certain live animals and products
intended for exportation to third countries (5) provide
that
the
movements of animals. Where exemptions from the
exit ban applicable
animals of
susceptible species from the restricted zone are applied
to animals intended for intra-Community trade or for
export
should
to a third country,
include a reference to this Regulation.

to movements of

in Annex A(I)

those certificates

accompany

certificates

health

are

to

to

loading of

the vehicles

In accordance with the opinion of the EFSA on vectors
and vaccines, it is appropriate to lay down the conditions
for the treatment with authorised insecticides at the place
of
transporting susceptible
animals from a restricted zone to or through areas
outside a restricted zone. When during the transit
through a restricted zone, a rest period is foreseen in a
control post the animals should be protected from any
attacks by
treatment with
authorised insecticides of animals, premises and their
should only be
surroundings
carried out following a defined protocol on the basis

in infected holdings

vectors. However,

the

(21)

(22)

(23)

The health certificates provided for
in Directives
64/432/EEC, 91/68/EEC and 92/65/EEC and Decision
intra-
for
intended
animals
93/444/EEC covering
Community trade or
to a third country
for export
should include a reference to any insecticide treatment
carried out pursuant to this Regulation.

In view of the need to avoid unnecessary disruptions in
trade it is urgent to establish a sustainable strategy for
the control of the bluetongue virus enabling safe trade in
animals of susceptible species moving within and from
restricted zones.

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:

CHAPTER 1

SUBJECT MATTER AND DEFINITIONS

Article 1

Subject matter

This Regulation lays down rules for the control, monitoring,
surveillance and restrictions on movements of animals with
the meaning of Article 2(c) of Directive 2000/75/EC,
in
relation to bluetongue, in and from the restricted zones.

Article 2

Definitions

For the purposes of this Regulation, the definitions in Article 2
of Directive 2000/75/EC shall apply.

(1) The EFSA Journal (2007) 479, 1-29.
(2) OJ 121, 29.7.1964, p. 1977/1964. Directive as last amended by

Directive 2006/104/EC.

(3) OJ L 46, 19.2.1991, p. 19. Directive as last amended by Directive

2006/104/EC.

(4) OJ L 268, 14.9.1992, p. 54. Directive as

last amended by
Commission Decision 2007/265/EC (OJ L 114, 1.5.2007, p. 17).

(5) OJ L 208, 19.8.1993, p. 34.

In addition, the following definitions shall apply:

(a)

‘case of bluetongue’ means an animal that meets one of the
following requirements:

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(i) it presents clinical signs consistent with the presence of

(i) from or through a restricted zone;

bluetongue;

(ii) it is a sentinel animal that had showed negative sero-
logical results in a previous test and has seroconverted
from negative to positive for antibodies to at least one
bluetongue serotype since that test;

(iii) it is an animal from which the bluetongue virus has

been isolated and identified as such;

(iv) it is an animal which has tested positive to bluetongue
serological tests or from which viral antigen or viral
ribonucleic acid (RNA) specific to one or more of the
bluetongue serotypes has been identified.

In addition, a set of epidemiological data must indicate that
the clinical signs or results of laboratory tests suggesting
bluetongue infection are the consequence of virus circu-
lation in the holding in which the animal is kept and not
the result of the introduction of vaccinated or seropositive
animals from restricted zones.

(b) ‘outbreak of bluetongue’ means an outbreak of that disease

as defined in Article 2(c) of Directive 82/894/EEC;

(c)

‘primary outbreak of bluetongue’ means an outbreak as
defined in Article 2(d) of Directive 82/894/EEC,
taking
into account that, for the purposes of the application of
the first indent of Article 3(1) of that Directive, a case of
bluetongue is a primary outbreak in the following cases:

(ii) from a restricted zone through a non-restricted zone

back to the same restricted zone; or

(iii) from a restricted zone through a non-restricted zone to

another restricted zone.

CHAPTER 2

MONITORING AND SURVEILLANCE AND EXCHANGE OF
INFORMATION

Article 3

Notification of bluetongue

Member States shall notify primary outbreaks and outbreaks of
bluetongue through the Animal Disease Notification System,
using the codified forms and the codes set out in Decision
2005/176/EC.

Article 4

Bluetongue monitoring and surveillance programmes

implement the following programmes in
Member States shall
accordance with the minimum requirements set out in Annex I:

(a) bluetongue monitoring programmes in restricted zones (the

bluetongue monitoring programmes);

(i) if

it

is not epidemiologically linked with a previous

(b) bluetongue

surveillance programmes outside

restricted

outbreak; or

zones (bluetongue surveillance programmes).

(ii) it implies the demarcation of a restricted zone or a
change in an existing restricted zone as referred to in
Article 6.

Article 5

Epidemiological information

(d) ‘restricted zone’ means a zone consisting of both protection
and surveillance zones established pursuant to Article 8(1)
of Directive 2000/75/EC;

(e)

‘bluetongue seasonally-free zone’ means an epidemiological
relevant geographical area of a Member State for which, for
a part of the year, surveillance demonstrates no evidence of
bluetongue virus transmission or of adult Culicoides likely to
be competent bluetongue vectors;

(BT-Net

1. Member States shall transmit to the BlueTongue NETwork
by Decision
application
2007/367/EC,
information on bluetongue gathered in the
course of the implementation of the bluetongue monitoring
and/or surveillance programmes, and in particular:

established

system),

(a) a monthly report, transmitted not later than one month
after the end of the reporting month, which shall contain
at least:

(f)

‘transit’ means the movement of animals:

(i) the data on the sentinel animals from the bluetongue
monitoring programmes in place in the restricted zones;

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(ii) the entomological data from the bluetongue monitoring

programmes in place in the restricted zones;

(b) an intermediate report covering the first six months of the
year, and transmitted each year by 31 July at the latest,
which shall contain at least:

(i) the data from the bluetongue surveillance programmes

in place outside the restricted zones;

(ii) the vaccination data from the restricted zones;

list shall

include information on the bluetongue virus
That
serotypes circulating in each restricted zone, which permits,
for the purposes of Articles 7 and 8, the identification of the
restricted zones demarcated in different Member States where
the same bluetongue virus serotypes are circulating.

Article 7

Conditions for movements within the same restricted zone

1. Movements of animals within the same restricted zone
where the same bluetongue virus serotype or serotypes are
authority
circulating shall be allowed by the
provided that
the animals to be moved do not show any
clinical signs of bluetongue on the day of transport.

competent

(c) an annual report, transmitted by 30 April of the following
the latest, which shall contain the information

year at
referred to in points (b)(i) and (ii) for the previous year.

However, movements of animals from a protection zone

2.
to a surveillance zone may only be allowed if:

The information to be transmitted to the BT-Net system is

2.
set out in Annex II.

(a)

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

CHAPTER 3

RESTRICTIONS ON MOVEMENTS OF ANIMALS AND OF THEIR
SEMEN, OVA AND EMBRYOS

Article 6

Restricted zones

(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 attacks by vectors, required by
the competent authority of the place of origin and approved
by the competent authority of the place of destination, prior
to the movement of such animals;

1. Member States shall notify to the Commission their
restricted zones, and any change in the situation of
those
zones within 24 hours.

(c)

the animals are destined for immediate slaughter.

2.
Before taking any decision to remove an epidemiologically
relevant geographical area from a restricted zone, Member
States shall provide the Commission with substantiated infor-
mation demonstrating the absence of bluetongue virus circu-
lation in that area during a period of two years following the
implementation of the bluetongue monitoring programme.

3.
The Member State of origin shall immediately inform the
Commission and the other Member States of the animal health
guarantees referred to in paragraph 2(b).

3.
The Commission shall inform the Member States in the
framework of the Standing Committee on the Food Chain and
Animal Health of the list of restricted zones.

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

4. Member States shall draw up and keep updated a list of
the restricted zones in their territory and make it available to
the other Member States and to the public.

‘Animals in compliance with .............
or
7(2)(a) or 7(2)(b) or 7(2)(c), indicate as appropriate) of Regu-
lation (EC) No 1266/2007 (*).

(Article

7(1)

The Commission shall publish, for information purposes

5.
only, on its website the updated list of restricted zones.

___________
(*) OJ L 283, 27.10.2007, p. 37.’

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Article 8

Conditions for exemption from the exit ban provided for
in Directive 2000/75/EC

1. Movements of animals, their semen, ova and embryos,
from a holding or semen collection or storage centre located
in a restricted zone to another holding or semen collection or
storage centre shall be exempted from the exit ban established
pursuant to Article 9(1)(c) and point 1 of Article 10 of Directive
2000/75/EC provided that the animals, their semen, ova and
embryos comply with:

(a)

the conditions set out in Annex III to this Regulation; or

(b) 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 attacks by vectors,
required by the
competent authority of the place of origin and approved
the place of destination,
by the competent authority of
prior to the movement of such animals.

The Member State of origin shall immediately inform the
2.
Commission and the other Member States of the animal health
guarantees referred to in paragraph 1(b).

the animals,

3.
A channelling procedure shall be set up, under the control
of the competent authority of the place of destination, to ensure
their semen, ova and embryos moved in
that
in paragraph
accordance with the conditions provided for
1(b), are not subsequently moved to another Member State
unless the animals comply with the conditions provided for
in paragraph 1(a).

4. Movements of animals from a holding located in a
restricted zone for
immediate slaughter shall be exempted
from the exit ban established pursuant to Article 9(1)(c) and
point 1 of Article 10 of Directive 2000/75/EC provided that:

(a) no case of bluetongue has been recorded in the holding of
origin for a period of at least 30 days prior to the date of
dispatch;

(b) the animals are transported under official

supervision
directly to the slaughterhouse for slaughter within 24
hours of arrival at the slaughterhouse of destination;

(c)

the competent authority at the place of dispatch notifies the
to the competent
intended movement of
authority of
least 48 hours
prior to the loading of the animals.

the place of destination at

the animals

Notwithstanding paragraph 4(b), the competent authority
5.
of the place of destination may require, on the basis of a risk
assessment, the competent authority of the place of origin to set
up a channelling procedure for the transport of the animals
referred to therein towards designated slaughterhouses.

Any such designated slaughterhouses shall be identified on the
the
basis of a risk assessment
criteria set out in Annex IV.

take into account

that shall

Information on the designated slaughterhouses shall be made
available to the other Member States and to the public. That
information shall also be made available through the BT-Net
system.

6.
For the animals, their semen, ova and embryos referred to
in paragraphs 1 and 4 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, semen, ova and embryos, indicate as appro-
priate) in compliance with ............. (Article 8(1)(a) or 8(1)(b)
or 8(4),
indicate as appropriate) of Regulation (EC) No
1266/2007 (*).

___________
(*) OJ L 283, 27.10.2007, p. 37.’

Article 9

Further conditions for the transit of animals

The transit of animals shall be allowed by the competent

1.
authority provided that:

(a) animals from a restricted zone being moved through areas
outside a restricted zone and the means in which they are
transported are treated with authorised insecticides and/or
repellents after adequate cleansing and disinfection at the
place of
loading and in any case prior to leaving the
restricted zone;

(b) animals being moved from an area outside a restricted zone
through a restricted zone and the means in which they are
transported are treated with authorised insecticides and/or
repellents after adequate cleansing and disinfection at the
place of loading and in any case prior to entry into the
restricted zone;

(c) when a rest period is foreseen at a control post during the
the animals are

movement
through a restricted zone,
protected against any attacks by vectors.

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

However, that exemption shall no longer apply after the end of
the seasonally vector-free period, on the basis of the bluetongue
monitoring programme.

‘Insecticide/repellent treatment with .............
the product) on ............. (insert date) at .........
conformity with Regulation (EC) No 1266/2007 (*).

(insert name of
(insert time) in

CHAPTER 4

FINAL PROVISIONS

Article 10

Repeal

___________
(*) OJ L 283, 27.10.2007, p. 37.’

Decision 2005/393/EC is repealed.

3.
Paragraph 1 of this Article shall no longer apply in an
epidemiologically relevant geographical area of a bluetongue
seasonally vector-free zone when more than 60 days have
elapsed from the date of commencement of
the seasonally
vector-free period, defined in accordance with Annex V.

Article 11

Entry into force

This Regulation shall enter into force on the fifth day following
the European
that of
Union.

its publication in the Official

Journal of

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

Done at Brussels, 26 October 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX I

Minimum requirements for bluetongue monitoring and surveillance programmes (referred to in Article 4)

1. Minimum requirements for bluetongue monitoring programmes to be implemented by Member States in

restricted zones

Bluetongue monitoring programmes in restricted zones shall be aimed at providing information on the dynamics of
bluetongue in a zone already subjected to restrictions.

The geographical unit of reference shall be defined by a grid of around 45 × 45 km (approximately 2 000 km2)
unless specific environmental conditions justify a different size. In certain Member States, the ‘region’ as defined in
Article 2 of Directive 64/432/EEC may be used as the geographical unit of reference for monitoring purposes.

Bluetongue monitoring programmes must consist at least of the following elements:

1.1. Serological monitoring with sentinel animals:

— Serological monitoring with sentinel animals shall consist of an active annual programme of testing sentinel
animals aimed at assessing the circulation of bluetongue virus within the restricted zones. Where possible,
sentinel animals must be bovine animals. They must be free from antibodies as demonstrated by means of a
preliminary seronegative test and must be located in areas of the restricted zone where, following a risk analysis
considering entomological and ecological evaluations, the presence of the vector has been confirmed or habitats
suitable for the vector’s breeding are present,

— Sentinel animals shall be tested at least every month during the period of activity of the vector involved, if
known. In the absence of such information the sentinel animals shall be tested at least monthly throughout the
year. However, the testing frequency may be adjusted to the seasonal variations of the epidemiological situation
during the year to establish the beginning and the end of the circulation of bluetongue virus within the restricted
zones,

— The minimum number of sentinel animals per geographical unit must be representative and sufficient in order to
detect a monthly incidence of seroconversion (1) of 2 % with a 95 % confidence in each geographical unit.

1.2. Entomological monitoring

— Entomological monitoring shall consist of an active programme of vector catching by means of permanently
sited traps intended to determine the population dynamics and overwintering features of the Culicoides species in
the sampled site in order to determine the seasonally vector-free period in the bluetongue seasonally-free zone in
accordance with Annex V,

— Only aspiration traps equipped with ultraviolet light shall be used in accordance with pre-established protocols.
The traps must be operated throughout the night and operate at a rate of at least one night per week at least
during the period of the year necessary to determine the beginning and the end of the seasonally vector free
period. At least one trap must be placed in each geographical unit all over the restricted zone. The frequency of
operation of the traps must be adjusted to the seasonal variations of the epidemiological situation during the year
to optimise the determination of the population dynamics and overwintering features of the Culicoides and may
be amended on the basis of the evidence obtained in the three first years of operation of the traps. An adequate
proportion of the midges collected in the insect traps must be sent to a specialised laboratory capable of
counting and identifying Culicoides species on a routine basis.

2. Minimum requirements for bluetongue surveillance programmes to be implemented by the Member States

outside restricted zones

Bluetongue surveillance programmes outside restricted zones shall be aimed at the detection of virus circulation in a
bluetongue-free Member State or epidemiologically relevant geographical area and must consist at least of the
following elements:

(1) 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 period of around six months (end of spring/mid autumn). Therefore 2 % is a conservative estimation
of the expected monthly rate of seroconversion.

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2.1. Passive clinical surveillance:

— shall consist of a formal and ongoing system aimed at detecting and investigating suspicions of bluetongue
including an early warning system for reporting suspicious cases. Owners or holders of animals as well as
veterinarians must report promptly any suspicion of bluetongue to the competent authority. All suspected cases
of bluetongue must be investigated immediately,

— must be specially reinforced during the season of vector activity, and in particular at its beginning,

— must ensure that awareness campaigns are put in place and aimed, in particular, at enabling veterinarians and

farmers in identifying clinical signs of bluetongue.

2.2. Serological surveillance:

— shall consist of an active annual programme of serological testing of susceptible species populations, aimed at
detecting evidence of the bluetongue virus transmission through random or targeted serological and/or viro-
logical testing proportional to the risk of infection of the Member State or epidemiologically relevant geo-
graphical area and performed in the period of the year when seroconversion is more likely to be detected,

— must be designed in such a way that the samples are representative of the bovine population in the Member
State or in an epidemiologically relevant geographical area and the sample size has been calculated to detect a
prevalence of 0,5 % with 95 % confidence in the bovine population of that Member State or geographical area,

— must ensure that samples sizes are adjusted to the structure of the bovine population to be sampled and for the
use of targeted surveillance, focusing the sampling for the surveillance on high-risk populations in which specific
commonly known risk factors exist. The design of the targeted surveillance must ensure that seropositive animals
from vaccinated or immunised populations referred to in points 5, 6 and 7 of Part A of Annex III do not
interfere with the bluetongue surveillance programme.

2.3. Entomological surveillance:

— shall consist of an active annual programme of vector catching aimed at gathering information on the proven
and potential vector species in the Member State or in an epidemiologically relevant geographical area, their
distribution and seasonal profiles,

— shall be implemented in all Member States where information on the proven and potential vector species, their

distribution and seasonal profiles in the Member State is lacking.

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ANNEX II

Information to be transmitted by the Member States to the BT-Net system (referred to in Article 5(2))

The information to be transmitted by the Member States to the BT-Net system shall

include at least the following:

1. Bluetongue serological/virological data

(a) Administrative division/unit

(b) Animal species tested

(c) Type of surveillance system scheme (sentinel system or periodical survey)

(d) Type of diagnostic tests performed (ELISA, Serum-neutralisation, PCR, virus isolation)

(e) Month and year

(f) Number of tested animals (1)

(g) Number of positive animals

(h) Serotype serologically or virologically determined (data to be provided in case of positive results to serum-

neutralization or virus isolation tests)

2. Bluetongue entomological data

(a) Administrative division

(b) Site unique identity (a unique code for each trapping site)

(c) Collection date

(d) Latitude and longitude

(e) Total number of Culicoides spp. collected

(f) Number of C. imicola collected, if available

(g) Number of C. obsoletus Complex collected, if available

(h) Number of C. obsoletus sensu strictu collected, if available

(i) Number of C. scoticus collected, if available

(j) Number of C. Pulicaris Complex collected, if available

(k) Number of C. Nubeculosus complex collected, if available

(l) Number of C. dewulfii collected, if available

(m) Other relevant data

3. Bluetongue vaccination data

(a) Administrative division

(b) Year/semester

(c) Type of vaccine

(d) Serotype combination

(e) Animal species vaccinated

(f)

Total number of herds in the Member State

(g) Total number of animals in the Member State

(1) If pools of sera are used, an estimation of the number of animals corresponding to the pools tested must be reported.

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(h) Total number of herds under the vaccination programme

(i)

(j)

Total number of animals under the vaccination programme

Total number of herds vaccinated

(k) Number of animals vaccinated (where the vaccination type is vaccination of young animals)

(l) Number of young animals vaccinated (where the vaccination type is mass vaccination)

(m) Number of adults vaccinated (where the vaccination type is mass vaccination)

(n) Doses of vaccine administered.

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ANNEX III

Conditions for exemption from the exit ban (referred to in Articles 7(2)(a) and 8(1)(a))

A. Animals

The animals must have been protected against attacks by vector Culicoides during transportation to the place of
destination.

In addition, at least one of the conditions set out in points 1 to 7 must be complied with:

1. The animals were kept until dispatch during the seasonally vector-free period defined in accordance with Annex V,
in a bluetongue seasonally-free zone since birth or for at least 60 days prior to the date of movement and were
subjected to an agent identification test according to the Manual of Diagnostic Tests and Vaccines for Terrestrial
Animals of the World Organisation for Animal Health (OIE) (1) (OIE Terrestrial Manual), with negative results,
carried out not earlier than seven days before the date of movement.

However, that agent identification test shall not be necessary for Member States or regions of a Member State
where sufficient epidemiological data, obtained following the implementation of a monitoring programme for a
period of not less than three years, substantiate the determination of the seasonally vector-free period defined in
accordance with Annex V.

The Member States making use of that possibility shall inform the Commission and the other Member States in the
framework of the Standing Committee on the Food Chain and Animal Health;

2. The animals have been kept until dispatch protected against attacks by vectors for a period of at least 60 days prior

to the date of dispatch;

3. The animals have been kept until dispatch in a bluetongue seasonally-free zone during the seasonally vector-free
period, defined in accordance with Annex V, or have been protected against attacks by vectors for a period of at
least 28 days and were subjected during that period to a serological test according to the OIE Terrestrial Manual to
detect antibodies to the bluetongue virus group, with negative results, carried out at least 28 days following the
date of the commencement of the period of protection against attacks by vectors or the seasonally vector-free
period;

4. The animals have been kept until dispatch in a bluetongue seasonally-free zone during the seasonally vector-free
period, defined in accordance with Annex V, or have been protected against attacks by vectors for a period of at
least 14 days and were subjected during that period to an agent identification test according to the OIE Terrestrial
Manual, with negative results, carried out at least 14 days following the date of the commencement of the period of
protection against attacks by vectors or the seasonally vector-free period;

5. The animals originate from a herd vaccinated according to a vaccination programme adopted by the competent
authority and the animals have been vaccinated against the serotype(s) present or likely to be present in an
epidemiologically relevant geographical area of origin, the animals are still within the immunity period of time
guaranteed in the specifications of the vaccine approved in the vaccination programme and the animals meet at
least one of the following requirements:

(a) they have been vaccinated more than 60 days before the date of movement;

the immunity protection set

(b) they have been vaccinated with an inactivated vaccine before at least the number of days necessary for the
the vaccine approved in the vaccination
in the specifications of
onset of
programme and were subjected to an agent identification test 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;

(c)

they were previously vaccinated and they have been re-vaccinated with an inactivated vaccine within the
immunity period of
the vaccine approved in the vaccination
programme;

time guaranteed in the specifications of

(d) they were kept during the seasonally vector-free period, defined in accordance with Annex V, in a bluetongue
seasonally-free zone, since birth or for a period of at least 60 days before the date of vaccination and have been
vaccinated with an inactivated vaccine before at least the number of days necessary for the onset of the
immunity protection set in the specifications of the vaccine approved in the vaccination programme.

(1) http://www.oie.int/eng/normes/en_mcode.htm?e1d10

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Where animals referred to in this point are intended for intra-Community trade or export to a third country, 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:

serotype(s))
‘Animal(s) vaccinated against bluetongue serotype(s)
with ...........................................................................
inactivated/modified live
vaccine (indicate, as appropriate) on .................... (insert date) in conformity with Regulation (EC) No 1266/2007 (*).

...........................................................................

vaccine) with a

(insert name

(insert

the

of

___________
(*) OJ L 283, 27.10.2007, p. 37.’

6. The animals were always kept in an epidemiologically relevant geographical area of origin where not more than

one serotype was or is present or likely to be present and:

(a) they were subjected to a serological test according to the OIE Terrestrial Manual to detect antibodies against the
bluetongue virus serotype, with positive results; the test must be carried out between 60 and 360 days before
the date of movement; or

(b) they were subjected to a serological test according to the OIE Terrestrial Manual to detect antibodies against the
bluetongue virus serotype, with positive results; the test must be carried out at least 30 days before the date of
the movement and the animals were subjected to an agent identification test according to the OIE Terrestrial
Manual, with negative results, carried out not earlier than seven days before date of the movement.

Where animals referred to in this point are intended for intra-Community trade or export to a third country, 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:

‘Animal(s) in compliance with Annex IV(6) to Regulation (EC) No 1266/2007 (*).

___________
(*) OJ L 283, 27.10.2007, p. 37.’

7. The animals were subjected to an adequate specific serological test according to the OIE Terrestrial Manual able to
detect the specific antibodies against all the bluetongue virus serotypes present or likely to be present, with positive
results to all serotypes present or likely to be present in the epidemiologically relevant geographical area of origin,
and:

(a) the specific serotype serological test is carried out between 60 and 360 days before the date of movement; or

(b) the specific serotype serological test is carried out at least 30 days before the date of the movement and the
animals were subjected to an agent identification test according to the OIE Terrestrial Manual, with negative
results, carried out not earlier than seven days before the date of movement.

Where animals referred to in this point are intended for intra-Community trade or export to a third country, 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:

‘Animal(s) in compliance with Annex IV(7) to Regulation (EC) No 1266/2007 (*).

___________
(*) OJ L 283, 27.10.2007, p. 37.’

B. Semen of animals

Semen must have been obtained from donor animals which comply with at least one of the following conditions:

(a) they have been kept outside a restricted zone for a period of at least 60 days before commencement of, and

during, collection of the semen;

(b) they have been protected against attacks by vectors for a period of at least 60 days before commencement of, and

during, collection of the semen;

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(c) they were kept during the seasonally vector-free period in a bluetongue seasonally-free zone, defined in accordance
with Annex V, for a period of at least 60 days before commencement of, and during, collection of the semen and
were subjected to an agent identification test according to the OIE Terrestrial Manual, with negative results, carried
out not earlier than seven days before the date of commencement of collection of the semen.

However, that agent identification test shall not be necessary in Member States or regions of a Member State
where sufficient epidemiological data, obtained following the implementation of a monitoring programme during
a period of not less than three years, substantiate the determination of the seasonally vector-free period, as defined
in Annex V.

The Member States making use of that possibility shall inform the Commission and the Member States in the
framework of the Standing Committee on the Food Chain and Animal Health.

(d) they have been subjected to a serological test according to the OIE Terrestrial Manual to detect antibodies to the
bluetongue virus group, with negative results, at least every 60 days during the collection period and between 21
and 60 days following the final collection;

(e) they have been subjected, with negative results, to an agent identification test according to the OIE Terrestrial

Manual carried out on blood samples collected:

(i) at commencement and final collection; and

(ii) during the period of semen collection:

— at least every seven days, in the case of a virus isolation test,

— at least every 28 days, in the case of a polymerase chain reaction test.

C. Ova and embryos of animals

1.

2.

In vivo derived embryos and ova of bovine animals must be collected in accordance with Council Directive
89/556/EEC (1).

In vivo derived embryos and ova of animals other than bovine animals and in vitro produced bovine embryos
must have been obtained from donor animals, which comply with at least one of the following conditions:

(a) they have been kept outside a restricted zone for at least 60 days before commencement of, and during,

collection of the embryos/ova;

(b) they have been protected against attacks by vectors for at least 60 days before commencement of, and during,

collection of the embryos/ova;

(c) they have been subjected to a serological test according to the OIE Terrestrial Manual to detect antibodies to
the bluetongue virus group, between 21 and 60 days following collection of the embryos/ova, with negative
results;

(d) they have been subjected to an agent identification test according to the OIE Terrestrial Manual on a blood

sample taken on the day of collection of the embryos/ova, with negative results.

(1) OJ L 302, 19.10.1989, p. 1. Directive as last amended by Commission Decision 2006/60/EC (OJ L 31, 3.2.2006, p. 24).

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ANNEX IV

Criteria for the designation of slaughterhouses for exemption from the exit ban (referred to in the second
paragraph of Article 8(4))

For the purpose of the risk assessment for the designation of slaughterhouses for the channelling of movements of
animals from a holding located in a restricted zone for immediate slaughter, the competent authority of destination shall
use at least the following criteria:

1. the data available through the monitoring and surveillance programmes, especially as regards the vector’s activity;

2. the distance from the point of entry in the non-restricted zone to the slaughterhouse;

3. the entomological data on the route;

4. the period of the day during which the transport takes place in relation to the hours of activity of the vectors;

5. the possible use of insecticides and repellents in compliance with Council Directive 96/23/EC (1);

6. the location of the slaughterhouse as regards livestock holdings;

7. the biosecurity measures in place at the slaughterhouse.

(1) OJ L 125, 23.5.1996, p. 10. Directive as last amended by Directive 2006/104/EC.

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ANNEX V

Criteria for the definition of the seasonally vector-free period (referred to in Article 9(3))

For the purpose of determining a bluetongue seasonally-free zone, the seasonally vector-free period for a determinate
epidemiologically relevant geographical area of a Member State (epidemiologically relevant geographical area) shall be
defined by the competent authority using at least the following criteria:

1. General criteria

(a) A bluetongue monitoring and/or surveillance programme must be in place.

(b) The specific criteria and thresholds used for the determination of the seasonally vector-free period shall be defined
considering the Culicoides species proven or suspected to be the main vectors in the epidemiologically relevant
geographical area.

(c) The criteria used for the determination of the seasonal vector-free period shall be applied considering data from
current and previous years (historical data). In addition, the aspects linked to surveillance data standardization shall
be taken into consideration.

2. Specific criteria

(a) No bluetongue virus circulation within the epidemiologically relevant geographical area, as demonstrated by

bluetongue surveillance programmes or other evidence suggesting a halt in bluetongue virus.

(b) Cessation of vector and likely vector activity, as demonstrated through entomological surveillance as part of the

bluetongue monitoring and/or surveillance programmes.

(c) Captures of Culicoides species proven or suspected to be the vectors of the serotype present in the epidemiologically
relevant geographical area below a maximum threshold of vectors collected that shall be defined for the epi-
demiologically relevant geographical area. In the absence of sound evidence supporting the determination of the
maximum threshold, total absence of Culicoides imicola specimens and less than five parous Culicoides per trap must
be used.

3. Additional criteria

(a) Temperature conditions that impact on the behaviour of the vectors activity for the epidemiologically relevant
geographical area. The temperature thresholds shall be defined in consideration of the ecological behaviour of
Culicoides species proven or suspected to be the vectors of the serotype present in the epidemiologically relevant
geographical area.