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31.5.2012 Official
Journal
of
the
European
Union L
141/7
COMMISSION IMPLEMENTING REGULATION (EU) No 456/2012
of 30 May 2012
amending Regulation (EC) No 1266/2007 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 EUROPEAN COMMISSION,
(4) However,
experience
shows
that
there
is
sufficient
information available in the framework of other
existing Union disease notification and reporting
Having regard to the Treaty on the Functioning of the European
obligations. The obligation to exchange information
Union,
through the BT-Net system is therefore no longer
necessary.
Having regard to Council Directive 2000/75/EC of 20 November
2000 laying down specific provisions for the control and eradi
(5) Regulation
(EC)
No
1266/2007,
as
amended
by
cation of bluetongue ( 1 ), and in particular Article 9(1)(c),
Commission Regulation (EC) No 123/2009 ( 4 ) introduced
Articles 11 and 12 and the third paragraph of Article 19
the possibility for Member States to demarcate, under
thereof,
certain conditions, ‘lower risk areas’ to facilitate
preventive vaccination in parts of their territory
without virus circulation. As a consequence of the
Whereas:
entry into force of Directive 2012/5/EU, whereby vacci
nation against bluetongue may be performed also outside
restricted zones the provisions for the demarcation of
‘lower risk areas’ are no longer necessary.
(1) Commission
Regulation
(EC)
No
1266/2007
(


2 ) lays
down rules for the control, monitoring, surveillance
and restrictions on movements of animals, in relation
to bluetongue, in and from the restricted zones. It also
(6) In
accordance
with
Article
6(2)
of
Regulation
(EC)
No
establishes the conditions for exemptions from the exit
1266/2007, a Member State may decide to remove an
ban applicable to movements of susceptible animals,
epidemiological geographical relevant area from a
their semen, ova and embryos provided for in Directive
restricted zone, and thereby claim freedom from disease
2000/75/EC, including rules on the use of vaccines
in that area after two years of absence of virus circulation
against bluetongue.
as proven by monitoring.
(2) Under
the
current
rules
laid
down
in
Directive (7) However,
those
parts
of
a
restricted
zone
where
for
at
2000/75/EC, the use of vaccines against bluetongue is
least one year, including a full vector activity season,
not permitted outside protection zones. Directive
monitoring and surveillance show that no virus circu
2012/5/EU of the European Parliament and of the
lation of a specific bluetongue serotype or serotypes
Council of 14 March 2012 amending Council Directive
has taken place, are at risk of reintroduction of the
2000/75/EC as regards vaccination against bluetongue ( 3 )
disease by introduction of infectious animals from
makes the rules on vaccination laid down in Directive
other parts of the same restricted zone where the blue
2000/75/EC more flexible in order to allow vaccination
tongue virus is still circulating. For these situations, in
with inactivated vaccines against bluetongue also outside
order to provide for a safe transition towards freedom
the areas subject to animal movement restrictions. As a
from disease under favourable epidemiological
consequence, Regulation (EC) No 1266/2007 should be
conditions, Member States should be allowed to
amended. Furthermore, amendments are necessary to
demarcate a ‘provisionally free area’ subject to the
simplify the process of monitoring and surveillance and
condition that monitoring and surveillance to ascertain
to adapt the procedures established by Regulation (EC)
the absence of virus circulation is carried out.
No 1266/2007 to recent scientific opinions.
(8)
According to the Scientific Opinion of the Panel on
(3) For
the
purpose
of
gathering
and
analysing
epidemi
Animal Health and Welfare of the EFSA on the ‘Risk
ological information on bluetongue, Regulation (EC) No
of Bluetongue Transmission in Animal Transit’, adopted
1266/2007 provides that Member States are to transmit
on 11 September 2008 ( 5 ), there is a theoretical possi
to the BlueTongue NETwork application (BT-Net system)
bility that infectious midges co-travel with the animals.
information on bluetongue gathered in the course of the
That risk might be controlled by cleaning the vehicle and
implementation of the bluetongue monitoring and
treating it with insecticides or repellents before loading
surveillance programmes.
the animals or when moving animals through areas
known to be at low risk or at a period of time when
( 1 ) OJ L 327, 22.12.2000, p. 74.
( 2 ) OJ L 283, 27.10.2007, p. 37.
( 4 ) OJ L 40, 11.2.2009, p. 3.
( 3 ) OJ L 81, 21.3.2012, p. 1.
( 5 ) EFSA Journal 2008; 795, 18-65.

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L 141/8
EN
Official Journal of the European Union
31.5.2012
the risk is known to be low. In order to limit undesired
with the OIE, the term ‘vector proof establishment’,
effects to the environment of those substances and to
currently used in Regulation (EC) No 1266/2007,
avoid possible problems as regards waiting periods and
should be replaced by ‘vector protected establishment’.
possible residues in the animals, the treatment of animals
with authorised insecticides or repellents should no
longer be required as this treatment provides for
(14) In
response
to
new
scientific
information
which
indicates
limited additional safety.
the possibility of transplacental transmission of the blue

tongue virus, in particular for bluetongue virus serotype
8, precautionary measures to prevent the possible spread
(9) Regulation
(EC)
No
1266/2007,
as
amended
by
Imple
of bluetongue by pregnant animals or certain newborn
menting Regulation (EU) No 648/2011 ( 1 ), allows, for a
animals were introduced in Regulation (EC) No
transitional period, Member States of destination, in
1266/2007, as amended by Regulation (EC) No
which the introduction of non-immune animals under
384/2008 ( 3 ).
certain circumstances could pose a risk for animal
health, to require that the movement of such animals
(15) According to the Scientific Opinion of the Panel on
is subject to certain additional conditions. As rules on
Animal Health and Welfare of the EFSA on bluetongue
criteria for vector protected establishments are laid down
serotype 8 ( 4 ), there is scientific evidence for transpla
in this Regulation, that transitional provision is no longer
cental transmission of bluetongue virus serotype 8
necessary.
which was introduced in the Union in 2006. However,
transplacental transmission of other serotypes of the
(10) Due
to
the
different
levels
of
virus
circulation,
environ
bluetongue virus in affected areas where no modified
mental conditions and different vaccination strategies in
live vaccines have been used has not been shown. In
the Member States, the epidemiological situations as
the light of the conclusions of that opinion, the
regards bluetongue may differ considerably in different
precautionary measure as regards the movement of
areas of the Union. Experience has shown that different
pregnant animals should only apply for zones which
surveillance strategies may be successfully implemented
are restricted for bluetongue virus serotype 8.
to achieve the desired objectives. Therefore, the
minimum harmonised requirements for monitoring and
(16) Regulation
(EC) No 1266/2007 should therefore be
surveillance as laid down in Annex I to Regulation (EC)
amended accordingly.
No 1266/2007 should be simplified to allow for more
flexibility for the Member States to design their national
monitoring and surveillance programmes, taking into
(17) The
measures
provided
for
in
this
Regulation
are
in
account the Scientific Opinion of the EFSA Panel on
accordance with the opinion of the Standing
Animal Health and Welfare on bluetongue monitoring
Committee on the Food Chain and Animal Health,
and surveillance ( 2 ).
HAS ADOPTED THIS REGULATION:
(11) Based
on
the
abovementioned
Scientific
Opinion,
the
minimum sample size to detect a prevalence of 5 %
Article 1
with 95 % confidence in the susceptible species popu
lation should be sufficient for surveillance for the
Regulation (EC) No 1266/2007 is amended as follows:
purpose of demonstrating the absence of virus circulation
in an epidemiological relevant geographical area during a
(1) Article 4 is replaced by the following:
period of two years.
‘Article 4
(12) Keeping
bluetongue
susceptible
animals
in
a
vector
proof
establishment for a specified period of time is an
Bluetongue monitoring and surveillance programmes
important requirement for certain conditions for
Member States shall implement bluetongue monitoring and
exemptions from the exit ban as set out in Annex III
surveillance programmes in accordance with the minimum
to Regulation (EC) No 1266/2007. Experience shows that
requirements set out in Annex I.’;
it is difficult for Member States to establish proper
criteria for the implementation of a vector proof estab
lishment for regular movements for trade in animals of
(2) Article 5 is deleted;
susceptible species such as cattle, sheep and goats.
(3) in Article 6, paragraph 2 is replaced by the following:
(13) In
order
to
improve
the
effectiveness
of
vector
proof
establishments and to assist the Member States in their
‘2. Before
taking
any
decision
to
remove
an
epidemi
implementation of that control measure, a number of
ologically relevant geographical area from a restricted
criteria should be established. Those criteria should be
zone, Member States shall provide the Commission with
based on experiences of the Member States and the
substantiated information demonstrating the absence of
Terrestrial Animal Health Code of the World Organi
bluetongue virus circulation in that area during a period
sation for Animal Health (OIE). To align the terminology
of two years, including two full vector activity seasons,
( 1 ) OJ L 176, 5.7.2011, p. 18.
( 3 ) OJ L 116, 30.4.2008, p. 3.
( 2 ) EFSA Journal 2011; 9(6): 2192.
( 4 ) EFSA Journal 2011; 9(5): 2189.

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EN
31.5.2012 Official
Journal
of
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European
Union L
141/9
following the implementation of the bluetongue monitoring
(6) Article 9 is replaced by the following:
and surveillance programme in accordance with point 3 of
Annex I.’;
‘Article 9
(4) in Article 7, paragraph 2a is replaced by the following:
Further conditions for the transit of animals
‘2a. Member
States
may
demarcate
an
epidemiological
1. The
transit
of
animals
shall
be
allowed
by
the
relevant geographical area in a restricted zone as a “pro
competent authority provided that:
visionally free area” provided that for a period of one year,
(a) after adequate cleansing and disinfection at the place of
including one full vector season, monitoring and
loading, the means in which the animals are transported
surveillance in accordance with point 3 of Annex I has
are treated with authorised insecticides and/or repellents.
demonstrated the absence of bluetongue virus circulation
This treatment must in any case take place prior to
in that part of the restricted zone for that specific blue
leaving or entering the restricted zone;
tongue serotype or combination of serotypes.
A Member State which intends to demarcate a restricted
(b) when a rest period of more than one day is foreseen at
zone or part of a restricted zone as a “provisionally free
a control post during the movement through a
area” shall notify its intention to the Commission. That
restricted zone, the animals are protected against
notification shall be accompanied by the information
attacks by vectors in a vector protected establishment
referred to in point 3 of Annex I.
in accordance with the criteria set out in Annex II.
The Commission shall inform the Member States in the
2. Paragraph
1
shall
not
apply
if
the
transit
takes
place:
framework of the Standing Committee on the Food Chain
and Animal Health of the list of “provisionally free areas”.
(a) exclusively from or through epidemiologically relevant
geographical areas of the restricted zone during the
Movements of animals within the same restricted zone from
bluetongue seasonally vector-free period defined in
an area where the same bluetongue virus serotype or
accordance with Annex V; or
serotypes are circulating to a part of the same restricted
zone demarcated as a “provisionally free area” may only
(b) from or through parts of the restricted zone demarcated
be permitted if:
as a “provisionally free area” in accordance with
Article 7(2a).
(a) the animals comply with the conditions set out in
Annex III; or
3. For
the
animals
referred
to
in
paragraph
1
of
this
Article, the following additional wording shall be added to
(b) the animals comply with any other appropriate animal
the corresponding health certificates laid down in Directives
health guarantees based on a positive outcome of a risk
64/432/EEC, 91/68/EEC and 92/65/EEC, or referred to in
assessment of measures against the spread of the blue
Decision 93/444/EEC: “Insecticide/repellent treatment with
tongue virus and protection against attacks by vectors,
… (insert name of the product) on … (insert date) in
required by the competent authority of the place of
conformity with Article 9 of Regulation (EC) No
origin and approved by the competent authority of
1266/2007.” ’;
the place of destination, prior to the movement of
such animals; or
(7) Article 9a is deleted;
(c) the animals are destined for immediate slaughter.’;
(8) Annexes I, II, III and V are amended in accordance with the
Annex to this Regulation.
(5) in Article 8(5), the third subparagraph is replaced by the
following:
Article 2
‘Information on the designated slaughterhouses shall be
This Regulation shall enter into force on the fifth day following
made available to the other Member States and to the
that of its publication in the Official Journal of the European
public.’;
Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 30 May 2012.
For the Commission
The President
José Manuel BARROSO

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L 141/10
EN
Official Journal of the European Union
31.5.2012
ANNEX
Annexes I, II, III and V to Regulation (EC) No 1266/2007 are amended as follows:
(1) Annex I is replaced by the following:
‘ANNEX I
Minimum requirements for bluetongue monitoring and surveillance programmes (referred to in Article 4)
1. General requirements
Bluetongue monitoring and surveillance programmes shall be aimed at;
(a) detecting any possible incursions of the bluetongue virus and;
(b) where appropriate, demonstrating the absence of certain serotypes of that virus in a Member State or
epidemiologically relevant geographical area; or
(c) determining the seasonally vector free period (entomological surveillance).
The geographical unit of reference for the purposes of bluetongue monitoring and surveillance shall be defined by
a grid of around 45 x 45 km (approximately 2 000 km 2 ) unless specific environmental conditions justify a
different size.
If appropriate, Member States may also use the “region” as defined in Article 2.2(p) of Directive 64/432/EEC or the
regions as defined in Annex X to 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 ) as the
geographical unit of reference for monitoring and surveillance purposes.
2. Bluetongue monitoring and surveillance programmes aimed at detecting any possible incursions of the bluetongue virus
Bluetongue monitoring and surveillance programmes aimed at detecting any possible incursions of the bluetongue
virus shall consist of at least passive clinical surveillance and active laboratory-based surveillance.
2.1. Passive clinical surveillance shall consist of a formal and properly documented ongoing system aimed at
detecting and investigating any suspicions, including an early warning system for reporting suspicions.
Owners or holders and veterinarians must promptly report any suspicion to the competent authority.
2.2. Active laboratory-based surveillance shall consist of an annual programme of at least one, or a combination
of, serological/virological monitoring with sentinel animals, serological/virological surveys, or targeted moni
toring and surveillance based on a risk assessment.
— Sampling may take place at pre-defined intervals throughout the year but shall at least be carried out once
a year performed in the period of the year when infection or seroconversion is most likely to be detected.
— The bluetongue monitoring and surveillance programmes must be designed in such a way that the
samples are taken from susceptible animals (that is animals which have not been vaccinated and which
have been exposed to the competent vector), which are representative for the structure of the susceptible
species population in the epidemiologically relevant geographical area.
— The sample size must be calculated to detect the appropriate design prevalence based on the known risk
of the target population with 95 % confidence in the susceptible species population of that epidemi
ologically relevant geographical area. In the absence of scientific information on the expected prevalence
for the target population the sample size must be calculated to detect a prevalence of 20 %.

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31.5.2012 Official
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— Whenever the samples do not originate from individual animals, the sample size must be adjusted
according to the sensitivity of the diagnostic procedures applied.
— Laboratory-based surveillance shall be designed in such a way that positive screening tests are followed by
the specific serotype serological/virological tests targeted to the bluetongue serotype or serotypes expected
to be present in the epidemiologically relevant geographical area necessary to ascertain the specific
serotype circulating.
3. Bluetongue monitoring and surveillance programmes aimed at demonstrating the absence of certain serotypes of the bluetongue
virus in a Member State or epidemiologically relevant geographical area
Bluetongue monitoring and surveillance programmes aimed at the demonstration of the absence of bluetongue
virus circulation must comply with the conditions set out in points 2.1 and 2.2. The sample size used for the
active laboratory-based surveillance must be calculated to detect a prevalence of 5 % ( 2 ) with 95 % confidence. In
addition:
(a) for the purpose of removing an epidemiologically relevant geographical area from a restricted zone as referred
to in Article 6(2), Member States must demonstrate the absence of bluetongue virus circulation during a period
of at least two years, including two seasons of vector activity;
Member States shall submit to the Commission relevant historical epidemiological information on the moni
toring and surveillance programme in place and its yearly results during the past three years, including at least:
(i) a description of the surveys currently being carried out and the type of diagnostic test performed (ELISA,
serum neutralisation, PCR, virus isolation);
(ii) the sampled species and the number of samples taken per susceptible animal species; if pools of sera are
used, an estimation of the numbers of animals corresponding to the pools tested must be reported;
(iii) the geographical coverage of the samples;
(iv) the frequency and timing of sampling;
(v) the number of positive results specified by animals species and geographical location.
(b) for the purpose of demarcating a “provisionally free area” as referred to in Article 7(2a), Member States must
demonstrate the absence of bluetongue virus circulation during a period of at least one year, including one
season of vector activity.
Member States shall submit to the Commission relevant historical epidemiological information on the moni
toring and surveillance programme in place and its results during the past two years, including at least the
information as laid down in points (a)(i) to (v).
4. Bluetongue monitoring and surveillance programmes aimed at determining the seasonally vector free period (entomological
surveillance)
Entomological surveillance to determine the seasonally vector-free period as referred to in Annex V, shall meet the
following requirements:
(a) it must consist of at least an active annual programme of vector catching by means of permanently sited
aspiration traps intended to determine the population dynamics of the vector;
(b) aspiration traps equipped with ultraviolet light must 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 during the month before the expected beginning and during the month before the
expected end of the seasonally vector-free period,
— one night per month during the seasonally vector-free period.
On the basis of the evidence obtained in the three first years of the operation of the aspiration traps, the
frequency of operation of those traps may be adjusted;

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L 141/12
EN
Official Journal of the European Union
31.5.2012
(c) at least one aspiration trap must be placed in each epidemiologically relevant area all over the bluetongue
seasonally free zone. A proportion of the midges collected in the aspiration traps must be sent to a specialised
laboratory capable of counting and identifying the suspected vector species.
___________
( 1 ) OJ L 59, 5.3.2005, p. 40.
( 2 ) For a transitional period until 31 August 2012, the sample size of the survey may be calculated to detect a
prevalence of 20 %.’;
(2) Annex II is replaced by the following:
‘ANNEX II
Criteria for the “vector protected establishment” (referred to in points 2, 3and 4 of Section A of Annex III,
point (b) of Section B and point 2(b) of Section C in that Annex)
1. A vector protected establishment shall at least comply with the following:
(a) it must have appropriate physical barriers at entry and exit points;
(b) openings of the vector protected establishment must be vector screened with mesh of appropriate gauge which
must be impregnated regularly with an approved insecticide according to the manufacturers’ instructions;
(c) vector surveillance and control must be carried out within and around the vector protected establishment;
(d) measures must be taken to limit or eliminate breeding sites for vectors in the vicinity of the vector protected
establishment;
(e) standard operating procedures must be in place, including descriptions of back-up and alarm systems, for
operation of the vector protected establishment and transport of animals to the place of loading.
2. The competent authority shall approve an establishment as vector protected, if the criteria in point 1 are met. It
shall verify at the appropriate frequency, but at least three times during the required protection period (at the
beginning, during and at the end of the period) the effectiveness of the measures carried out by means of a vector
trap inside the vector protected establishment.’;
(3) Annex III is amended as follows:
(a) Section A is amended as follows:
(i) in point 2, the first subparagraph is replaced by the following:
‘The animals have been kept, until dispatch, protected against attacks by vectors in a vector protected
establishment in accordance with the criteria set out in Annex II for a period of at least 60 days prior to
the date of dispatch.’;
(ii) in point 3, the first subparagraph is replaced by the following:
‘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 in a vector
protected establishment in accordance with the criteria set out in Annex II 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 on samples collected from that
animal 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.’;
(iii) in point 4, the first subparagraph is replaced by the following:
‘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 in a vector
protected establishment in accordance with the criteria set out in Annex II 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 on samples collected from that animal at least 14 days following the date of
commencement of the period of protection against attacks by vectors or the seasonally vector-free period.’;

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(iv) point 5 is replaced by the following:
‘5. The animals have been vaccinated against the serotype(s) present or likely to be present in an epidemi
ologically relevant geographical area of origin, the animals are still within the immunity period of time
guaranteed in the specifications of the vaccine 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;
(b) they 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 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;
(c) they were previously vaccinated and they have been revaccinated with an inactivated vaccine within
the immunity period of time guaranteed in the specifications of the vaccine;
(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.
Where animals referred to in this point are intended for intra-Union trade, 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:
“Animal(s) vaccinated against bluetongue serotype/s … (insert serotype/s) with … (insert name of the vaccine)
with a inactivated/modified live vaccine (indicate, as appropriate) in conformity with Annex III.A(5) to
Regulation (EC) No 1266/2007.” ’;
(v) in point 6, the introductory phrase is replaced by the following:
‘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:’;
(vi) point 7 is amended as follows:
— the introductory phrase is replaced by the following:
‘7. The animals were subjected with positive results to two adequate serological tests according to the
OIE Terrestrial Manual able to detect specific antibodies against all the bluetongue virus serotypes
present or likely to be present, in the epidemiologically relevant geographical area of origin, and:’;
— the third subparagraph is replaced by the following:
‘For pregnant animals being moved from a restricted zone for bluetongue virus serotype 8, at least one of
the conditions set out in points 5, 6 and 7 must have been 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.’;
(b) in Section B, point (b) is replaced by the following:
‘(b) they have been protected against attacks by vectors in a vector protected establishment in accordance with
the criteria set out in Annex II for a period of at least 60 days before commencement of, and during,
collection of the semen;’;
(c) in Section C, in point 2, (b) is replaced by the following:
‘(b) they have been protected against attacks by vectors in a vector protected establishment in accordance with
the criteria set out in Annex II for at least 60 days before commencement of, and during, collection of the
embryos/ova;’;
(4) in Annex V, the title is replaced by the following:
‘ANNEX V
Criteria for the definition of the seasonally vector-free period (referred to in Article 9(2))’

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