2008/838/EC: Commission Decision of 3 November 2008 concerning preventive vaccination against low pathogenic avian influenza in mallard ducks in Portugal and certain measures restricting the movements of such poultry and their products (notified under document number C(2008) 6348)
Date: 2008-11-03
Institutions: European Commission
Subjects: Portugal, animal disease, poultry, trade restriction, vaccination

L 299/40

EN

Official Journal of the European Union

8.11.2008

COMMISSION DECISION

of 3 November 2008

concerning preventive vaccination against low pathogenic avian influenza in mallard ducks in
Portugal and certain measures restricting the movements of such poultry and their products

(notified under document number C(2008) 6348)

(Only the Portuguese text is authentic)

(2008/838/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

to

regard

Council Directive

of
Having
20 December 2005 on Community measures for the control
of avian influenza and repealing Directive 92/40/EEC (1), and in
particular Article 57(2) thereof,

2005/94/EC

Whereas:

(1)

(2)

(3)

(4)

(5)

certain preventive
Directive 2005/94/EC sets out
measures
relating to the surveillance and the early
detection of avian influenza and increasing the level of
the competent authorities’ and the farming community's
awareness of, and preparation for,
that
disease.

the risks of

Since September 2007, outbreaks of
low pathogenic
avian influenza have occurred in certain poultry
in
holdings
particular in holdings that keep poultry intended for re-
stocking supplies of game.

in the central-western part of Portugal,

Portugal has taken measures in accordance with Directive
2005/94/EC to control the spread of that disease.

A risk assessment carried out by Portugal identified that
(Anas platyrhynchos)
holdings keeping mallard ducks
intended for
re-stocking supplies of game (mallard
ducks) could pose a significant and immediate threat of
spreading avian influenza within Portugal or into other
Member States. Portugal decided therefore to introduce
emergency vaccination in order to contain the outbreak.

Commission Decision 2008/285/EC (2) approved the
emergency vaccination plan submitted by Portugal. That
Decision also provided for certain measures to be applied
in a holding where vaccinated mallard ducks are kept and
in unvaccinated poultry holdings,
including movement
restrictions on vaccinated mallard ducks, their hatching
eggs and mallard ducks hatched from such eggs in
accordance with the approved vaccination plan.

(1) OJ L 10, 14.1.2006, p. 16.
(2) OJ L 92, 3.4.2008, p. 37.

(6)

(7)

(8)

(9)

(10)

The implementation of the emergency vaccination plan
applied by Portugal has been completed by 31 July 2008.

In accordance with Article 8 of Decision 2008/285/EC,
Portugal has submitted a report on the implementation
of the emergency vaccination plan and has reported to
the Standing Committee on the Food Chain and Animal
Health.

On the basis of the information provided by Portugal, it
appears
the outbreak has been successfully
contained.

that

Based on a further risk assessment, Portugal deems that
on the holding the high value mallard breeding ducks are
still exposed to the potential risk of avian influenza
infection, in particular by possible indirect contact with
wild birds. Portugal has therefore decided to continue
vaccination against avian influenza as a long-term
measure by implementing a preventive vaccination plan
on the holding at risk in the region of Lisboa e Vale do
Tejo, Ribatejo Norte, Vila Nova da Barquinha that keeps
such mallard ducks.

Portugal has by letter dated 10 September 2008
the
preventive
a
submitted
Commission for approval.

vaccination

plan

to

(11) According to that preventive vaccination plan, Portugal
intends to introduce preventive vaccination which is to
be applied until 31 July 2009.

(12)

In its scientific opinions on the use of vaccination to
control avian influenza issued by the European Food
Safety Authority in 2005 (3), 2007 (4) and 2008 (5), the
Animal Health and Welfare Panel stated that emergency
and preventive vaccination against avian influenza is a
valuable tool to complement the control measures for
that disease.

(3) The EFSA Journal (2005) 266, 1-21, Scientific Opinion on Animal

health and welfare aspects of avian influenza.

(4) The EFSA Journal

against avian influenza of H5 and H7 subtypes
poultry and captive birds.

(2007) 489, Scientific Opinion on Vaccination
in domestic

(5) The EFSA Journal (2008) 715, 1-161, Scientific Opinion on Animal
health and welfare aspects of avian influenza and the risks of its
introduction into the EU poultry holdings.

8.11.2008

EN

Official Journal of the European Union

L 299/41

(13)

(14)

(15)

(16)

(17)

(18)

In addition, the Commission has examined the preventive
vaccination plan submitted by Portugal, and is satisfied
that it conforms with relevant Community legislation. In
the epidemiological situation as regards low
view of
the type of
pathogenic avian influenza in Portugal,
holding to be vaccinated and the limited scope of the
vaccination plan,
is appropriate to approve that
preventive vaccination plan. The implementation of that
preventive vaccination plan will also provide with further
practical experience and knowledge on the efficacy of
vaccine in mallard ducks.

it

For the purposes of the preventive vaccination plan to be
carried out by Portugal, only vaccines authorised in
accordance with Directive 2001/82/EC of the European
Parliament and of the Council of 6 November 2001 on
the Community code relating to veterinary medicinal
products (1) or Regulation (EC) No 726/2004 of
the
European Parliament and of the Council of 31 March
2004 laying down Community procedures for the au­
thorisation and supervision of medicinal products for
human and veterinary use and establishing a European
Medicines Agency (2) should be used.

In addition, surveillance and laboratory testing in the
holding keeping the vaccinated mallard ducks and in
unvaccinated poultry holdings should be carried out as
set out in the preventive vaccination plan.

It is also appropriate to introduce certain restrictions on
the movement of vaccinated mallard ducks,
their
hatching eggs and mallard ducks derived from vaccinated
poultry in accordance with the preventive vaccination
plan. Due to the small number of mallard ducks
present on the holding where preventive vaccination is
to be carried out, as well as for reasons of traceability
and logistics, vaccinated birds should not be moved from
that holding.

Portugal

pursuant

In relation to trade in poultry intended for restocking
supplies of game, additional measures have been taken
Commission Decision
to
by
2006/605/EC of 6 September 2006 on certain
protection measures
in relation to intra-Community
trade in poultry intended for restocking of wild game
supplies (3).

certain

In order to reduce the economic impact on the holding
from movement
derogations
concerned,
restrictions for mallard ducks derived from vaccinated
mallard ducks
since such
movements do not pose a specific risk for spread of
disease and provided that official surveillance is carried
out and that the specific animal health requirements for
intra-Community trade are complied with.

should be provided for,

(1) OJ L 311, 28.11.2001, p. 1.
(2) OJ L 136, 30.4.2004, p. 1.
(3) OJ L 246, 8.9.2006, p. 12.

(19)

The preventive vaccination plan should be approved so
that it can be implemented until 31 July 2009.

(20) Decision 2008/285/EC should be repealed as it has

become obsolete after 31 July 2008.

(21)

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DECISION:

Article 1

Subject matter and scope

1.
This Decision lays down certain measures to be applied in
Portugal where preventive vaccination of mallard ducks (Anas
platyrhynchos) intended for re-stocking supplies of game (mallard
ducks) is carried out in a holding, which is exposed to the risk
of avian influenza. Those measures include certain restrictions
on the movement within and dispatch from Portugal of the
vaccinated mallard ducks,
their hatching eggs and mallard
ducks derived thereof.

This Decision shall apply without prejudice

2.
protection measures to be taken by Portugal
with Directive 2005/94/EC and Decision 2006/605/EC.

to the
in accordance

Article 2

Approval of the preventive vaccination plan

for

The

plan

preventive

low
against
1.
vaccination
pathogenic avian influenza in Portugal, as
submitted by
Portugal to the Commission on 10 September 2008, to be
implemented on a holding in the region of Lisboa e Vale do
Tejo, Ribatejo Norte, Vila Nova da Barquinha until 31 July 2009
(the preventive vaccination plan) is approved.

The Commission shall publish the preventive vaccination

2.
plan.

Article 3

Conditions for implementing the preventive vaccination
plan

1.
Portugal shall ensure that the mallard ducks are vaccinated
in accordance with the preventive vaccination plan with a
containing both
bivalent
avian influenza subtypes H5 and H7 authorised by that
Member State in accordance with Directive 2001/82/EC or
Regulation (EC) No 726/2004.

inactivated heterologous vaccine

2.
Portugal shall ensure that surveillance and laboratory
testing of the holding keeping the vaccinated mallard ducks
and in unvaccinated poultry holdings, as
in the
preventive vaccination plan, is carried out.

set out

L 299/42

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Official Journal of the European Union

8.11.2008

Portugal shall ensure that the preventive vaccination plan

3.
is implemented efficiently.

Article 4

Marking and restrictions on the movement and dispatch
and disposal of vaccinated mallard ducks

The competent authority shall ensure that vaccinated mallard
ducks on the holding referred to in Article 2(1) are:

(a) marked individually;

(b) not moved to other poultry holdings within Portugal or

dispatched to other Member States.

After their reproductive period, such ducks shall be killed
humanely on the holding referred to in Article 2(1) and their
carcases safely disposed of.

Article 5

Restrictions on the movement and dispatch of hatching
eggs originating from the holding referred to in Article 2(1)

The competent authority shall ensure that hatching eggs orig­
inating from mallard ducks on the holding referred to in
Article 2(1) may only be moved to a hatchery within
Portugal and not dispatched to other Member States.

Article 6

Restrictions on the movement and dispatch of mallard
ducks derived from vaccinated mallard ducks

1.
The competent authority shall ensure that mallard ducks
derived from vaccinated mallard ducks may only be moved after
hatching to a holding located in a surrounding area established
in Portugal in relation to the holding referred to in Article 2(1)
as set out in the preventive vaccination plan.

By way of derogation from paragraph 1 and provided that
2.
the mallard ducks derived from vaccinated mallard ducks are
more than four month old, they may be:

(a) released into the wild in Portugal; or

(b) dispatched to other Member States provided that:

(i) the results of the surveillance and laboratory tests as set
out in the preventive vaccination plan, are favourable;
and

(ii) the conditions for dispatch of poultry for re-stocking
down in Decision

game

laid

supplies of wild
2006/605/EC are met.

Article 7

Health certification for intra-Community trade in mallard
ducks derived from vaccinated mallard ducks

shall

ensure

intra-
Portugal
Community trade in poultry intended for re-stocking supplies
of game referred to in Article 6(2)(b)
include the following
sentence:

that health certificates

for

‘The animal health conditions of this consignment are in
accordance with Decision 2008/838/EC (*).
___________
(*) OJ L 299, 8.11.2008, p. 40.’.

Article 8

Reports

Portugal shall submit to the Commission a report on the im­
plementation of
the preventive vaccination plan within one
month from the date of application of this Decision and give
quarterly reports at the Standing Committee on the Food Chain
and Animal Health thereafter.

Article 9

Repeal

Decision 2008/285/EC shall be repealed.

Article 10

Applicability

This Decision shall apply until 31 July 2009.

Article 11

Addressees

This Decision is addressed to the Portuguese Republic.

Done at Brussels, 3 November 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission