HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 173/12
EN
Official Journal of the European Union
3.7.2012
DECISIONS
COMMISSION IMPLEMENTING DECISION
of 27 June 2012
concerning a financial contribution by the Union to Belgium, Germany, Spain, France, Italy, the
Netherlands and the United Kingdom for studies on Schmallenberg virus
(notified under document C(2012) 4203)
(Only the Dutch, English, French, German, Italian and Spanish texts are authentic)
(2012/349/EU)
THE EUROPEAN COMMISSION,
United Kingdom, France, Luxembourg, Italy and Spain
have reported stillbirth and congenital malformations.
Schmallenberg virus presence was confirmed through
the Polymerase Chain Reaction (PCR) tests.
Having regard to the Treaty on the Functioning of the European
Union,
(4)
As this is the first time that this virus is isolated in the
Union, there are no harmonised rules as regards control
Having regard to Council Decision 2009/470/EC of 25 May
or notification of Schmallenberg virus.
2009 on expenditure in the veterinary field ( 1 ), and in particular
Article 23 thereof,
(5) No
efficient
diagnostic
tools
are
available
to
assess
the
actual spread of Schmallenberg virus and its impact on
animal health.
Whereas:
(6) Several
trading
partners
have
taken
temporary
protective
(1) In
accordance
with
Article
75
of
the
Financial
Regulation
measures including trade restrictions and requested for
and Article 90(1) of the Implementing Rules, the
additional guarantees for certain commodities awaiting
commitment of expenditure from the budget of the
for further scientific knowledge before resuming trade.
European Union shall be preceded by a financing
decision setting out the essential elements of the action
involving expenditure and adopted by the institution or
(7)
On 23 January 2012, the Agriculture Council requested
the authorities to which powers have been delegated by
the Commission to take actions with respect to this
the institution.
emerging disease.
(2) Schmallenberg
virus
is
an
emerging
contagious
pathogen (8) In
a
meeting
organised
on
14
February
2012,
the
of ruminants putatively included in the Simbu serogroup
Commission in close collaboration with the Member
of the Bunyaviridae family, genus Orthobunyavirus. Very
States identified the priorities and areas for which
little information is known on this emerging pathogen,
additional information should be gathered prior to
most assumptions are extrapolated from scientific
considering the development of veterinary legislation
information available on other viruses of the Simbu
addressing this new infection. These are in particular,
serogroup.
the mechanism by which the disease is caused (patho
genesis), the epidemiology, notably focusing on trans
mission pathways, the host range, the role of vectors
and reservoirs; and the confirmation of the non-
(3) Only
some Orthobunyavirus had been isolated in the
zoonotic potential of this virus and the methods to
Union (Tahyna virus from the California serogroup) but
diagnose the disease in animal samples and their
never from the Simbu serogroup. Schmallenberg virus
validation.
was first detected in November 2011 in Germany in
samples collected in the summer and autumn 2011
from diseased animals. In December 2011, congenital
(9) Belgium,
Germany,
Spain,
France,
Italy,
the
Netherlands
malformations were reported in newborn lambs in the
and the United Kingdom have drawn up scientific studies
Netherlands, linked to the presence of the virus.
intended to gain knowledge on Schmallenberg virus in
Subsequently up to March 2012, Belgium, Germany,
the areas identified above and submitted them to the
Commission on 5 March 2012, requesting EU financial
( 1 ) OJ L 155, 18.6.2009, p. 30.
support.

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EN
3.7.2012 Official
Journal
of
the
European
Union L
173/13
(10) Some
of
the
scientific
studies
have
been
presented
by
for the studies listed in Annex I and in accordance with the
several Member States in the form of a consortium, in
budgets listed in Annex II, for the period 1 April 2012 to
these cases and for the purpose of clarity, one of the
31 December 2013;
partners has been identified as coordinator of the
consortium and responsible for communication with
(b) shall not exceed the following:
the Commission and transmission of technical reports.
(i) EUR 438 615 for Belgium;
(11) Pursuant to Article 22 of Decision 2009/470/EC, the
Union may undertake, or assist the Member States or
(ii) EUR 595 883 for Germany;
international organisations in undertaking, the technical
and scientific measures necessary for the development of
(iii) EUR 146 590 for Spain;
EU veterinary legislation and for the development of
veterinary education or training.
(iv) EUR 589 380 for France;
(v) EUR 124 120 for Italy;
(12) A
financial
contribution
should
be
granted
to
the
studies
on Schmallenberg virus implemented by Belgium,
(vi) EUR 639 342 for the Netherlands;
Germany, Spain, France, Italy, the Netherlands and the
United Kingdom as the outcomes may lead to new
(vii) EUR 371 811 for the United Kingdom;
insights on the subject mentioned above.
(c) Belgium, Germany, Spain, France, Italy, the Netherlands and
the United Kingdom, or in cases when the scientific studies
(13) The
Commission
has
evaluated
all
the
proposals
and
are carried out by more than one Member State in a
selected those that matched with the agreed priorities.
consortium, the coordinator Member State as listed in
Considering the resources needed to develop the studies
Annex I, shall submit to the Commission:
and the need to start as soon as possible the activities in
order to get the results, it is appropriate to start financing
them as from 1 April 2012.
— no later than 31 March 2013 an intermediate technical

report per project,
(14) Under Council Regulation (EC) No 1290/2005 of
— no later than 31 March 2014 a final technical report per
21 June 2005 on the financing of the common agri
project;
cultural policy
( 1 ), veterinary measures are to be
financed under the European Agricultural Guarantee
(d) Belgium, Germany, Spain, France, Italy, the Netherlands and
Fund. For financial control purposes, Articles 9, 36 and
the United Kingdom shall submit to the Commission:
37 of that Regulation are to apply.
— no later than 31 March 2014 a paper version and an
electronic version of their financial report drawn up in
(15) The payment of the financial
contribution shall be
accordance with Annex IV. The supporting documents,
subject to the condition that the studies planned have
evidencing all the expenditure referred to in the appli
actually been carried out and that the authorities
cation for reimbursement, shall be sent to the
supply all the necessary information to the Commission.
Commission on request;
(16) The
measures provided for in this Decision are in
(e) the outcome of the studies must be made available to the
accordance with the opinion of the Standing
Commission, all Member States and EFSA and presented at
Committee on the Food Chain and Animal Health,
the Standing Committee on the Food Chain and Animal
Health.
HAS ADOPTED THIS DECISION:
Article 2
1. The
maximum
overall
contribution
authorised
by
this
Article 1
Decision for the costs incurred for the work referred to in
Article 1(1) is set at EUR 2 905 741 to be financed from the
1. The
Union
shall
grant
Belgium,
Germany,
Spain,
France, following budgetary line of the general budget of the European
Italy, the Netherlands and the United Kingdom financial
Union for 2012:
assistance for their scientific studies on Schmallenberg virus,
as summarised in Annex I. The present decision constitutes a
— budgetary line No 17 04 02 01.
financing decision in the meaning of Article 75 of the Financial
Regulation.
2. Expenditure relating to staff dedicated to the projects,
consumables, animal studies, travel costs linked to meetings
2. The
financial
contribution
by
the
Union
and overheads shall be eligible within the limits set out in
Article 1 and in accordance with the eligibility rules set out
in Annex III.
(a) shall be at the rate of 50 % of the eligible costs to be
incurred by each Member State referred to in paragraph 1
3. The
Union’s
financial
assistance
shall
be
paid
following
presentation and approval of the reports and supporting
( 1 ) OJ L 209, 11.8.2005, p. 1.
documents referred to Article 1(2)(c) and (d).

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L 173/14
EN
Official Journal of the European Union
3.7.2012
Article 3
This Decision is addressed to the Kingdom of Belgium, the Federal Republic of Germany, the Kingdom of
Spain, the French Republic, the Italian Republic, the Kingdom of the Netherlands and the United Kingdom
of Great Britain and Northern Ireland.
Done at Brussels, 27 June 2012.
For the Commission
John DALLI
Member of the Commission

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EN
3.7.2012 Official
Journal
of
the
European
Union L
173/15
ANNEX I
Description of the technical and scientific studies on Schmallenberg virus (SBV), referred to in Article 1(1)
Area 1 — Pathogenesis
Project 1.1
To determine the pathogenicity and dynamics of the virus in foetuses at different gestation stages by experimental
infection in pregnant ewes, goats and cattle.
— Member States involved: Belgium, Germany, France, the Netherlands and the United Kingdom.
Coordinator: Germany
Project 1.2
To identify the primary (and possibly secondary) replication sites and virus virulence in non-pregnant animals by
experimental infection studies in young animals of cattle, sheep and goats.
— Member States involved: Belgium, Germany, France, the Netherlands and the United Kingdom.
Coordinators: Sheep — the Netherlands, Goats — France
Project 1.3
To study the development of immunity to SBV by experimental infection studies in sero-positive as well as sero-negative
animals of the different species.
— Member States involved: Belgium, Germany, France, the Netherlands and the United Kingdom.
Coordinator: United Kingdom
Outcome for projects 1.1, 1.2 and 1.3:
Data on pathogenesis, viremia duration, incubation time, virus distribution, virus shedding and possible persistence of
Schmallenberg virus to be used for tests on live animals, generation of vaccines as well as collection of reference materials
for tests’ validation.
Project 1.4
To test available serological samples (cattle and sheep) for SBV. A case-control study will be undertaken to investigate the
clinical impact of the disease and the risk factors for introduction, transmission and clinical symptoms at the herd level.
Outcome:
Description of the current spread of SBV disease in the bovine and ovine population, the clinical consequences of SBV
infection and the risk factors for introduction, transmission and morbidity in holdings and animals.
— Member States involved: Belgium
Project 1.5
Collection of SBV case data, baseline data on abortion, stillbirth and malformations and results of epidemiological studies
(case/control study in cattle, sheep and goats; source identification study, seroprevalence study, sentinel study) to be
provided to for meta-analyses of study results.
Outcome:
Joint epidemiological analysis with EFSA of data on SBV in Germany and other affected EU Member States including
assessment of the impact of SBV on population dynamics, breeding management, and economy. Determination of the
within-herd prevalence and between-herd prevalence as well as the spatial distribution of SBV infections in different
susceptible species. Analysis of the route of entry, transmission pathways, the source of the epidemic and its temporal
development in Germany. Analysis of potential coincidence with animal density, herd/flock density, climate, and weather
conditions, geography and ecological parameters.
— Member State involved: Germany
Project 1.6
To identify clinical symptoms following SBV infection as well as potential risk factors for introduction and spread of SBV
in dairy cattle herds and sheep.

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L 173/16
EN
Official Journal of the European Union
3.7.2012
Outcome:
1. Analysis of the impact of the SBV infection on health and productivity of dairy cattle and their offspring, the
possibility of vertical transmission. Determination of how long infected calves stay viraemic. Guidance for potential
control measures (e.g. grazing management).
2. Description and quantification of clinical signs in adult infected sheep after a primary infection with SBV. Deter
mination of mortality rates in newborn lambs, relation between seroprevalence and clinical manifestations in herds.
Identification of potential risk factors for introduction and spread of SBV in sheep flocks. The study will obtain
baseline information on impact of SBV on sheep health and production, and risk factors associated with introduction,
spread and impact of SBV.
— Member State involved: the Netherlands
Area 2 — Epidemiology
Project 2.1
To clarify or exclude horizontal transmission by trying to provoke infection with most virulent virus (preferably not cell
cultured).
Outcome:
Determine if there are transmission routes without vector.
— Member States involved: Belgium, Germany, the Netherlands and the United Kingdom.
Coordinator: United Kingdom
Project 2.2a
To investigate which species are potential vectors for SBV by prospective and retrospective investigations.
Outcome:
To confirm status of a series of suspected SBV vectors from affected countries and their ability to effectively transmit the
virus.
— Member States involved: Belgium, Germany, the Netherlands.
Coordinator: the Netherlands
Project 2.2b
To perform an experimental assessment of the rates of infection, dissemination and probable transmission in each vector
group.
Outcome:
Epidemiological role played by the most common midge and mosquito species in transmitting SBV and assessment of the
rates of infection, dissemination and probable transmission in each vector group.
— Member States involved: Spain, France, Italy and the United Kingdom.
Coordinator: Spain
Project 2.3
To investigate if bulls may excrete SBV in semen and to investigate risk of transmission via embryos by using frozen
semen and in vitro fertilisation procedures with non-infected ovaries.
Outcome:
Reliable information on the risk of transmission of SBV via semen and embryos.
— Member States involved: Belgium, Germany, France, the Netherlands and the United Kingdom.
Coordinator: the Netherlands

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EN
3.7.2012 Official
Journal
of
the
European
Union L
173/17
Project 2.4
Determination of the role of other species (pigs, rabbits, mice or birds (chicken)) in the epidemiology of SBV.
Outcome:
Identification of other species susceptible to SBV.
— Member States involved: Belgium, Germany, the Netherlands and the United Kingdom.
Coordinator: Belgium
Project 2.5
Determination of the role of wildlife (deer, wild boar, etc.) in the epidemiology of SBV.
Outcome:
Clarify if the virus infects wildlife and if wildlife could play a role in the epidemiology of the virus.
— Member States involved: Germany, the Netherlands and the United Kingdom.
Coordinator: United Kingdom
Area 3 — Diagnostics
Project 3.1
To develop SBV specific monoclonal antibodies for the development and evaluation of a competitive or blocking enzyme-
linked immunosorbent assay (ELISA) to detect SBV specific antibodies in sera.
Outcome:
Development of diagnostic assays to detect SBV specific antibodies.
— Member States involved: France and the United Kingdom.
Coordinator: United Kingdom
Project 3.2
To harmonise the validation of the different RT-PCR methods for the detection of SBV
Outcome:
Common protocol and minimum criteria for the validation of molecular and serological diagnostic tools with the
involvement of the private sector.
— Member States involved: Belgium, Germany, France, the Netherlands and the United Kingdom.
Coordinator: Germany

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L 173/18
EN
Official Journal of the European Union
3.7.2012
ANNEX II
Budget per project (in EUR)
Area 1 — Pathogenesis
Projects 1.1, 1.2 and 1.3
Item Heading Belgium Germany France Netherlands
United
Kingdom
Total
1 Staff 70
000 235
200 119
012 111
010 105
356 640
578
2 Consumables 40
000 78
800 104
300 19
000 50
007 292
107
3 Animal
studies 140
000 98
000 112
000 127
147 86
708 563
855
4 Travel
costs
linked
to
meetings
0 3
000 8
200
0 7
076 18
276
5 Overheads
(7
%) 17
500 29
050 24
046 18
001 17
440 106
037
Total 267
500 444
050 367
558 275
158 266
587 1
620
853
Project 1.4
Item Heading Belgium
1 Staff
125 347
2 Consumables
90 000
3 Animal
studies
0
4 Travel
cost
linked
to
meetings
0
5 Overheads
(7
%) 15
074
Total 230
421
Project 1.5
Item Heading Germany
1 Staff
121 950
2 Consumables 100
850
3 Animal
studies
4 Travel
costs
linked
to
meetings 6
000
5 Overheads
(7
%) 16
016
Total 244
816

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EN
3.7.2012 Official
Journal
of
the
European
Union L
173/19
Project 1.6
Item Heading Netherlands
1 Staff
279 005
2 Consumables
77 500
3 Animal
studies 180
212
4 Travel
costs
linked
to
meetings 28
500
5 Overheads
(7
%) 39
565
Total 604
782
Area 2 — Epidemiology
Project 2.1, 2.2a, 2.3, 2.4 and 2.5
France
United
Item Heading
Belgium
(excl. 2.5)
Germany
(excl. 2.2a, Netherlands
Kingdom
Total
2.4 and 2.5)
(excl. 2.2a)
1 Staff 139
937 255
150 30
000 250
865 127
807 803
759
2 Consumables 173
200 160
850 120
000 33
108 41
653 528
811
3 Animal
studies 14
576 18
000
0 49
520 6
746 88
843
4 Travel
costs
linked
to
meetings
0 6
000
0 8
900 9
435 24
335
5 Overheads
(7
%) 22
940 30
800 10
500 23
968 12
955 101
202
Total 350
653 470
800 160
500 366
361 198
636 1
546
950
Project 2.2b
Item Heading Spain France Italy
United
Kingdom
Total
1 Staff 175
000 373
220 170
000 72
305 790
525
2 Consumables 93
000 115
000 56
000 36
000 300
000
3 Animal
studies
0
0
0
0
0
4 Travel
costs
linked
to
meetings 6
000 16
500 6
000 4
800 33
300
5 Overheads
(7
%) 19
180 35
330 16
240 7
917 78
667
Total 293
180 540
050 248
240 121
022 1
202
492

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L 173/20
EN
Official Journal of the European Union
3.7.2012
Area 3 — Diagnostics
Project 3.1 and 3.2
Item Heading
Belgium
Germany
United
(excl. 3.1)
(excl. 3.1)
France
Netherlands
(excl. 3.1)
Kingdom
Total
1 Staff 17
281 12
800 68
413 8
575 114
398 221
467
2 Consumables 9
000 16
200 30
000 6
150 28
224 89
574
3 Animal
studies 3
040 3
040
4 Travel
costs
linked
to
meetings 500 1
000 5
000 4
459 10
959
5 Overheads
(7
%) 1
875 2
100 7
239 1
244 10
296 22
754
Total 28
656 32
100 110
652 19
009 157
377 347
794
Coordination
Item Heading Netherlands
1 Staff
10 000
2 Travel
costs
linked
to
meetings 2
500
5 Overheads
(7
%)
875
Total 13
375

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EN
3.7.2012 Official
Journal
of
the
European
Union L
173/21
ANNEX III
Eligibility rules
1. Staff
Staff costs shall be limited to actual attributable labour costs (remuneration, wages, social charges and retirement costs)
accrued in implementation of the study. To this end monthly time sheets have to be maintained.
Daily rate will be calculated on a 220 working days/year.
2. Consumables
Reimbursement is to be based on actual costs incurred for laboratory tests:
— the purchase of test kits, reagents and all consumables identifiable and especially used to carry out the laboratory
test.
3. Animal studies
Reimbursement is to be based on actual costs incurred for the
— purchase of animals at market value,
— transport to facilities and housing and feeding,
— rendering of animals used in the experiments.
All other expenditure on administration and secretarial services is considered to be covered by ‘overheads’.
4. Meetings (travel costs)
Travel and hotel costs incurred by the staff for the participation to meetings related to the studies are eligible in
accordance with the rules laid down in Annex IV to Commission Implementing Regulation (EU) No 926/2011 ( 1 ).
5. Overheads
A flat rate contribution of 7 % of actual eligible costs, calculated on the basis of all direct costs listed in items 1 to 4,
may be claimed.
6. The expenditure submitted by the Member States for a financial contribution by the Union shall be expressed in euro
and shall exclude value added tax (VAT) and all other taxes.
7. Member States may adjust the estimated budgets listed in Annex II by transfer between headings of eligible costs,
provided that this adjustment of expenditure does not affect the implementation of the study, and without exceeding
the total eligible cost per project. The Member States shall submit a written request to the Commission for its prior
approval to increase the budget for one of the headings by more than 20 %.
( 1 ) OJ L 241, 17.9.2011, p. 2.

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L 173/22
EN
Official Journal of the European Union
3.7.2012
ANNEX IV
Financial report
Member State:
Project number and title:
Total expenditure for the project (real costs, VAT excl.)
Item Staff
category No
of
days Daily
rate Total
1 Staff
2 Consumables
3 Animal
studies
4 Travel
costs
linked
to
meetings
5 Overheads
(max.
7
%
of
total
costs)
TOTAL
Certification by the beneficiary
We certify that:
— the expenditure listed above was incurred in connection with the tasks defined,
— the expenditure was actually incurred, accurately accounted for and eligible under the provisions of Commission
Implementing Decision 2012/349/EU ( 1 ),
— all supporting documents relating to the expenditure are available for inspection,
— no other Union contribution was requested for the projects listed in this Decision.
Date:
Name and signature of the financial officer responsible:
( 1 ) OJ L 173, 3.7.2012, p. 12.

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