2007/598/EC: Commission Decision of 28 August 2007 concerning measures to prevent the spread of highly pathogenic avian influenza to other captive birds kept in zoos and approved bodies, institutes or centres in the Member States (notified under document number C(2007) 3987) (Text with EEA relevance )
Date: 2007-08-28
Institutions: European Commission
Subjects: animal disease, bird, disease prevention, infectious disease, vaccination, veterinary inspection, zoo

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Official Journal of the European Union

1.9.2007

COMMISSION DECISION

of 28 August 2007

concerning measures to prevent the spread of highly pathogenic avian influenza to other captive
birds kept in zoos and approved bodies, institutes or centres in the Member States

(notified under document number C(2007) 3987)

(Text with EEA relevance)

(2007/598/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to 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 referred to in Annex A(I)
to
Directive 90/425/EEC (1), and in particular the first paragraph
of Article 22 thereof,

Having regard to Council Directive 2005/94/EC of 20
December 2005 on Community measures for the control of
avian influenza and repealing Directive 92/40/EEC (2), and in
particular Articles 56(3), 57(2) and 63(3) thereof,

Whereas:

(1)

(2)

certain preventive
Directive 2005/94/EC sets out
measures
relating to the surveillance and the early
detection of avian influenza and the minimum control
measures to be applied in the event of an outbreak of
that disease in poultry or other captive birds.

Directive 2005/94/EC also lays down rules for the intro-
duction of preventive vaccination against avian influenza
of poultry and other captive birds, such as other captive
institutes or
birds kept in zoos and approved bodies,
centres, and provides for detailed rules thereof
to be
established by the Commission. That Directive also
provides for the submission by the Member States to
the Commission for approval of their preventive vacci-
nation plans for poultry or other captive birds.

(3)

Commission Decision 2006/474/EC of 6 July 2006
the spread of highly
concerning measures to prevent
pathogenic avian influenza caused by influenza A virus

of subtype H5N1 to birds kept in zoos and approved
bodies, institutes and centres in the Member States and
repealing Decision 2005/744/EC (3) lays down rules to
prevent the spread of avian influenza caused by highly
pathogenic influenza A virus of subtype H5N1 from
birds living in the wild to birds kept
in zoos and
approved bodies, institutes or centres. It also lays down
in zoos and
rules for the vaccination of birds kept
approved bodies,
institutes or centres and provides for
detailed rules for the submission by the Member States to
the Commission of their vaccination plans.

authorised

the European Parliament and of

For the purposes of such preventive vaccination, only
in accordance with Directive
vaccines
2001/82/EC of
the
Council of 6 November 2001 on the Community code
relating to veterinary medicinal products (4) or Regulation
No 726/2004 of the European Parliament and of the
Council of 31 March 2004 laying down Community
procedures
the authorisation and supervision of
medicinal products for human and veterinary use and
establishing a European Medicines Agency (5) should be
used.

for

Council Directive 1999/22/EC of 29 March 1999
relating to the keeping of wild animals in zoos (6)
defines zoos which are covered by that Directive.
In
the interests of consistency of Community legislation,
that definition should be taken into account
for the
purposes of this Decision.

Pursuant to Decision 2006/474/EC, the Commission has
approved 17 preventive vaccination plans against avian
influenza for birds kept in zoos submitted by Member
States. Vaccination plans have been implemented by 14
Member States. In general no adverse reactions in almost
45 000 vaccinated birds have been observed and most
bird species have produced a
immune
response following two administrations of the vaccines.

significant

(4)

(5)

(6)

(3) OJ L 187, 8.7.2006, p. 37.
(4) OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive

2004/28/EC (OJ L 136, 30.4.2004, p. 58).

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

last amended by

(5) OJ L 136, 30.4.2004, p. 1. Regulation as amended by Regulation

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

(EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).

(2) OJ L 10, 14.1.2006, p. 16.

(6) OJ L 94, 9.4.1999, p. 24.

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Official Journal of the European Union

L 230/21

(7)

(8)

(9)

(10)

the preventive vaccination plans

In addition, experience gained during the latest vacci-
the Scientific
nation campaign and the opinions of
Panel on Animal Health and Animal Welfare of
the
European Food Safety Authority of 1 February 2007
on preventive vaccination of zoo birds against avian
influenza of H5 and H7 subtypes and of 11 May 2007
on vaccination in domestic poultry and captive birds,
demonstrate that it is appropriate to extend the scope
of
to any highly
pathogenic avian influenza of the H5 and H7 subtypes,
thereby taking into account
the risks posed by wild
migratory birds proceeding from areas where avian
influenza cases in wild birds or outbreaks in poultry
occur and in the event an outbreak in poultry occurs
in the same Member State, a neighbouring Member
State or a third country that is liable to endanger the
health status of birds kept in zoos and approved bodies,
institutes or centres.

Furthermore the administrative requirements for approval
and implementation of preventive vaccination plans
should be amended, provided they do not endanger
disease control. Accordingly, requirements which ease
the administrative burden should be taken into account
in the present Decision.

It is further appropriate to consider certain preventive
vaccination plans that have been approved pursuant to
Decision 2006/474/EC as approved for the purposes of
the present Decision. Accordingly, such plans should be
listed in Annex III to the present Decision.

for approval

Since the date of adoption of Decision 2006/474/EC,
certain Member States have submitted preventive vacci-
nation plans
in accordance with the
that Decision. Those Member States
requirements of
have been informed of the requirements set out in the
present Decision. As those plans also comply with the
requirements of the present Decision,
they should be
approved and listed in Annex III hereto.

(11)

For the sake of clarity it is appropriate to repeal Decision
2006/474/EC and replace it by this Decision.

(12)

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

This Decision lays down detailed rules:

(a)

to be applied in order to prevent
the spread of highly
pathogenic avian influenza virus from birds living in the
wild or from outbreaks in poultry or other captive birds,
to other captive birds kept in zoos and approved bodies,
institutes or centres;

(b) for the preventive vaccination of other captive birds kept in

zoos and approved bodies, institutes or centres.

Article 2

Definitions

For the purposes of this Decision, the following definitions shall
apply:

(a)

the definitions in Article 2 of Directive 2005/94/EC;

(b) the definition of zoos in Article 2 of Directive 1999/22/EC;

(c)

the definition of approved bodies,
Article 2(1)(c) of Directive 92/65/EEC.

institutes or centres in

Article 3

Measures to reduce the risk of transmission of highly
pathogenic avian influenza

to reduce

take appropriate and practicable
1. Member States shall
measures
transmission of highly
risk of
the
pathogenic avian influenza from birds living in the wild to
other captive birds kept in zoos and approved bodies, institutes
or centres, taking into account the criteria and risk factors set
out in Annex I.

2.
Paragraph 1 shall also apply in the event of an outbreak in
poultry in the same Member State, a neighbouring Member
State or a third country that is liable to endanger the health
status of other captive birds kept in zoos and approved bodies,
institutes or centres.

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Depending on the specific epidemiological situation, the
3.
measures referred to in paragraph 1 shall,
in particular, be
directed at preventing direct and indirect contact between
living in the wild, especially waterfowl, and other
birds
institutes or
captive birds kept in zoos and approved bodies,
centres.

3. Member States
following:

shall

inform the Commission of

the

(a) planned amendments to their approved preventive vacci-

nation plans;

Article 4

Preventive vaccination plans

(b) the date of cessation of preventive vaccination of other
captive birds kept in zoos and approved bodies, institutes
or centres.

in zoos and approved bodies,

Preventive vaccination plans in respect of other captive birds
kept
institutes or centres,
submitted in accordance with Article 56(2) of Directive
in
2005/94/EC shall comply with the requirements set out
Annex II to this Decision.

Article 5

Approval of preventive vaccination plans

1.
The preventive vaccination plans submitted in accordance
with Article 56(2) of Directive 2005/94/EC and listed in Part I
of Annex III to this Decision are hereby approved.

The Commission shall publish the approved preventive

2.
vaccination plans referred to in paragraph 1.

Article 6

Availability

and

information
vaccination plans

concerning

preventive

shall, before preventive vaccination is
1. Member States
the
introduced, compile the exact address and location of
zoos and approved bodies,
institutes or centres, where vacci-
nation it is to be carried out by allocating approval or regis-
tration numbers, as appropriate, and shall keep that information
updated.

2. Member States shall submit to the Commission and the
other Member States each year, by 30 March at the latest, or
upon specific request by the Commission, a report on the
implementation of the approved preventive vaccination plans
for the preceding year using the reporting model as set out in
Annex IV.

That report shall be submitted in the framework of the Standing
Committee on the Food Chain and Animal Health.

Article 7

Repeal

Decision 2006/474/EC is repealed.

Article 8

Transitional provision

The preventive vaccination plans approved pursuant to Decision
2006/474/EC and listed in Part II of Annex III to this Decision
shall be considered as being approved for the purposes of the
present Decision.

Article 9

Compliance by Member States

Member States shall take the necessary measures to comply
with this Decision. They
inform the
shall
Commission thereof.

immediately

Article 10

Addressees

This Decision is addressed to the Member States.

Done at Brussels, 28 August 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX I

Criteria and risk factors to be considered when applying the measures set out in Article 3 in zoos and approved
bodies, institutes or centres

1. Location of zoos and approved bodies,

institutes or centres along migratory flyways of birds,

proceeding from countries where outbreaks of highly pathogenic avian influenza have occurred,
account the serotype detected and the likelihood of wild birds having been affected.

in particular if
taking into

2. Distance of zoos and approved bodies, institutes or centres from wetlands and water areas such as ponds, swamps,

lakes or rivers where migratory waterfowl may gather.

3. Location of zoos and approved bodies, institutes or centres in areas of a high density of migratory birds, particularly

waterfowl.

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Official Journal of the European Union

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ANNEX II

Requirements for the use of preventive vaccination as referred to in Αrticle 4

1.

2.

Extent of the vacci-
nation to be carried out

The vaccination against avian influenza shall only be carried out in birds kept in zoos
and approved bodies, institutes or centres. The competent authority shall keep lists of
zoos, approved bodies, institutes or centres for a period of at least five years from the
date of such vaccination.

Bird species to be
vaccinated

The competent authority shall be notified of a list of birds to be vaccinated together
with the individual identification and keep it for at least five years from the date of the
vaccination.

3.

Duration of vaccination

(a) All birds to be vaccinated in zoos and approved bodies institutes or centres shall be

vaccinated as quickly as possible.

(b) Offspring, newly introduced birds and birds for which an insufficient

immune

response has been demonstrated must also be vaccinated.

(c) Annual re-vaccination is recommended to maintain bird immunity.

4.

Specific requirements
for movements of birds

(a) Vaccinated birds kept

in approved bodies,

institutes or centres including zoos
approved in accordance with Directive 92/65/EEC where vaccination is carried
out may be moved to approved bodies,
institutes or centres in other Member
States provided that they meet the requirements set out in this Decision and are
accompanied by a health certificate as laid down in Part 3 of Annex E to Directive
92/65/EEC, where under point II.5. the following must be certified:

‘Birds conform to Decision 2007/598/EC were vaccinated against avian influenza on
… (date) with vaccine … (name)’.

(b) Vaccinated birds kept in zoos that are not approved in accordance with Directive
92/65/EEC where vaccination is carried out may be moved to other Member States
after authorisation by the Member State of destination provided that they meet the
requirements set out in this Decision and are accompanied by a health certificate as
laid down in Part 1 of Annex E to Directive 92/65/EEC to which the following
words shall be added at the end of point II.3.2.:

‘Birds conform to Decision 2007/598/EC and vaccinated against avian influenza on
… (date) with vaccine … (name)’.

(c) When vaccination of birds kept in zoos, approved bodies, institutes or centres is not
longer applied, the conditions for movements laid down in points (a) and (b) shall be
maintained for a period of 12 months from the date of the vaccination of the last
bird.

5.

6.

Special identification
and special registration
of the vaccinated birds

Vaccinated birds must be individually identifiable and the identity records of these birds
must be clearly annotated accordingly. An indelible identification of the other captive
birds indicating that they have been vaccinated shall be applied at the time of vacci-
nation wherever possible.

Execution of the vacci-
nation campaign

(a) Vaccination shall be carried out under the supervision of a veterinarian and necessary

measures must be in place to avoid possible spread of virus.

(b) A written record on the number of vaccinated birds and the number of vaccine
doses used shall be communicated to the competent authority after vaccination is
carried out and thereafter on a monthly basis, if further birds as referred to in point
3(b) are vaccinated.

(c) Wherever possible blood samples from 10 % of the birds shall be taken prior to and
at least 30 days from the date of each vaccination for serological testing for avian
influenza. A record of the test results must be kept for at least five years from the
date of vaccination.

7.

Vaccine to be used

The inactivated vaccine to be used shall be suitably formulated and be effective against
highly pathogenic avian influenza virus of subtype H5 or H7 or both. It shall be used in
accordance with the instructions of the manufacturer and/or the veterinary authorities.

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ANNEX III

Lists of approved preventive vaccination plans for birds kept in zoos and approved bodies, institutes or centres

Part I:
Preventive vaccination plans approved by this Decision and referred to in Article 5(1)

Code

BE

ES

FR

SE

UK

Member State

Date of submission of plan

Belgium

Spain

France

Sweden

United Kingdom

22 March 2007

27 June 2007

4 January 2007

7 March 2007

27 June 2007

Part II:
Preventive vaccination plans approved under Decision 2006/474/EC and referred to in Article 8 of the present Decision

Code

Member State

Date of submission

CZ

DK

DE

EE

IE

IT

LV

LT

HU

NL

AT

PT

Czech Republic

Denmark

Germany

Estonia

Ireland

Italy

Latvia

Lithuania

Hungary

21 March 2006

20 February 2006

31 March 2006

6 March 2006

6 March 2006

6 March 2006

28 February 2006

6 March 2006

1 March 2006

The Netherlands

16 November 2005

Austria

Portugal

21 April 2006

29 November 2005

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ANNEX IV

Reporting model for the implementation of the approved preventive vaccination plans referred to in article 6(2)

General information

Country

Zoo

Vaccine

Route
(specify if different in
different species)

Weight — Dose regime used
(Actual/estimated/average weight
of species)

Vaccine
interval

Interval from last
vaccination to
post-vaccination blood
collection

English name/
local name

Latin name

Taxonomic
Order

Individual
identification

Vaccine
Dose (ml)

Pre-vacc

Post-1st vacc

Post-2nd vacc

HI serum antibody titre

Adverse Individual effects

Mortality

Local

general

Direct
(catching/handling)

Delayed
(specify cause of death)

Virus strain of vaccine

Antigens (virus strains)
used in HI test

Cut-off or end-titre point used as
a measure of vaccine efficacy

Reference serum used

(reference to)
Methodology

Information required from the Laboratory