# L_2008092EN.01003701.xml

| 3.4.2008 | EN | Official Journal of the European Union | L 92/37 |
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3.4.2008

EN

Official Journal of the European Union

L 92/37

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COMMISSION DECISION

of 19 March 2008

concerning emergency 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) 1077)

(Only the Portuguese text is authentic)

(2008/285/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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 (1), and in particular Article 54(2) thereof,

Whereas:

| (1) | Directive 2005/94/EC sets out the minimum control measures to be applied in the event of an outbreak of avian influenza in poultry or other captive birds. |
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(1)

Directive 2005/94/EC sets out the minimum control measures to be applied in the event of an outbreak of avian influenza in poultry or other captive birds.

| (2) | Since September 2007, outbreaks of low pathogenic avian influenza have occurred in certain poultry holdings in the central-western part of Portugal, in particular in holdings that keep poultry intended for re-stocking supplies of game. Portugal has taken measures in accordance with Directive 2005/94/EC to control the spread of that disease. |
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(2)

Since September 2007, outbreaks of low pathogenic avian influenza have occurred in certain poultry holdings in the central-western part of Portugal, in particular in holdings that keep poultry intended for re-stocking supplies of game. Portugal has taken measures in accordance with Directive 2005/94/EC to control the spread of that disease.

| (3) | Portugal has carried out a risk assessment and identified that holdings keeping mallard ducks (Anas platyrhynchos) intended for re-stocking supplies of game (mallard ducks), are at an increased risk of infection from avian influenza viruses, in particular by contact with wild birds and that a significant and immediate threat of spread of avian influenza exists. |
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(3)

Portugal has carried out a risk assessment and identified that holdings keeping mallard ducks (Anas platyrhynchos) intended for re-stocking supplies of game (mallard ducks), are at an increased risk of infection from avian influenza viruses, in particular by contact with wild birds and that a significant and immediate threat of spread of avian influenza exists.

| (4) | Early detection systems and biosecurity measures to reduce the risk of transmission of avian influenza to poultry flocks are in place in Portugal in the areas that have been defined by that Member State as high risk areas pursuant to Commission Decision 2005/734/EC of 19 October 2005 laying down biosecurity measures to reduce the risk of transmission of highly pathogenic avian influenza caused by Influenza virus A subtype H5N1 from birds living in the wild to poultry and other captive birds and providing for an early detection system in areas at particular risk (2). |
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(4)

Early detection systems and biosecurity measures to reduce the risk of transmission of avian influenza to poultry flocks are in place in Portugal in the areas that have been defined by that Member State as high risk areas pursuant to Commission Decision 2005/734/EC of 19 October 2005 laying down biosecurity measures to reduce the risk of transmission of highly pathogenic avian influenza caused by Influenza virus A subtype H5N1 from birds living in the wild to poultry and other captive birds and providing for an early detection system in areas at particular risk (2).

| (5) | In relation to trade in poultry intended for re-stocking supplies of game, additional measures have been taken by Portugal pursuant to Commission Decision 2006/605/EC of 6 September 2006 on certain protection measures in relation to intra-Community trade in poultry intended for re-stocking of wild game supplies (3). |
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(5)

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

| (6) | Portugal has by letter dated 25 January 2008, submitted an emergency vaccination plan to the Commission for approval and a revised version of that plan was submitted on 31 January 2008. |
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(6)

Portugal has by letter dated 25 January 2008, submitted an emergency vaccination plan to the Commission for approval and a revised version of that plan was submitted on 31 January 2008.

| (7) | According to that emergency vaccination plan, Portugal intends to introduce emergency vaccination on one holding in the region of Lisboa e Vale do Tejo, Ribatejo Norte, Vila Nova da Barquinha keeping valuable breeding mallard ducks and using a bivalent vaccine directed against avian influenza virus of subtypes H7 and H5 which is to be applied until 31 July 2008. |
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(7)

According to that emergency vaccination plan, Portugal intends to introduce emergency vaccination on one holding in the region of Lisboa e Vale do Tejo, Ribatejo Norte, Vila Nova da Barquinha keeping valuable breeding mallard ducks and using a bivalent vaccine directed against avian influenza virus of subtypes H7 and H5 which is to be applied until 31 July 2008.

| (8) | In its scientific opinions on the use of vaccination to control avian influenza issued by the European Food Safety Authority in 2005 (4) and 2007 (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. |
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(8)

In its scientific opinions on the use of vaccination to control avian influenza issued by the European Food Safety Authority in 2005 (4) and 2007 (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.

| (9) | In addition, the Commission has examined the emergency vaccination plan submitted by Portugal, together with the Portuguese authorities, and after its amendment is satisfied that it conforms with relevant Community legislation. In view of the epidemiological situation as regards low pathogenic avian influenza in Portugal, the type of holding to be vaccinated and the limited scope of the vaccination plan, it is appropriate to approve the emergency vaccination plan submitted by Portugal to supplement the control measures already taken by that Member State. |
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(9)

In addition, the Commission has examined the emergency vaccination plan submitted by Portugal, together with the Portuguese authorities, and after its amendment is satisfied that it conforms with relevant Community legislation. In view of the epidemiological situation as regards low pathogenic avian influenza in Portugal, the type of holding to be vaccinated and the limited scope of the vaccination plan, it is appropriate to approve the emergency vaccination plan submitted by Portugal to supplement the control measures already taken by that Member State.

| (10) | For the purposes of the emergency vaccination 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 (6) or Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (7) should be used. |
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(10)

For the purposes of the emergency vaccination 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 (6) or Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (7) should be used.

| (11) | In addition, surveillance and monitoring in the holding keeping the vaccinated mallard ducks and in unvaccinated poultry holdings, as set out in the emergency vaccination plan, should be carried out. |
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(11)

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

| (12) | 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. Due to the small number of mallard ducks present on the holding where emergency vaccination is to be carried out, as well as for reasons of traceability and logistics, vaccinated birds should not be moved from that holding. |
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(12)

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. Due to the small number of mallard ducks present on the holding where emergency vaccination is to be carried out, as well as for reasons of traceability and logistics, vaccinated birds should not be moved from that holding.

| (13) | In order to reduce the economic impact on the holding concerned certain derogations from movement restrictions for mallard ducks derived from vaccinated mallard ducks should be provided for, since such movements do not pose a specific risk for spread of disease and provided that surveillance and monitoring measures are carried out and that the specific animal health requirements for intra-Community trade are complied with. |
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(13)

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

| (14) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(14)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

Subject matter and scope

1.   This Decision lays down certain measures to be applied in Portugal where emergency vaccination of mallard ducks (Anas platyrhynchos) intended for re-stocking supplies of game (mallard ducks) is carried out in a holding, which is at particular risk for introduction 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.

2.   This Decision shall apply without prejudice to the protection measures to be taken by Portugal in accordance with Directive 2005/94/EC and Decision 2006/605/EC.

Article 2

Approval of the emergency vaccination plan

1.   The plan for emergency vaccination against low pathogenic avian influenza in Portugal, as submitted by Portugal to the Commission on 25 January 2008, in its revised version submitted on 31 January 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 2008 (the emergency vaccination plan) is approved.

2.   The Commission shall publish the emergency vaccination plan.

Article 3

Conditions for implementing the emergency vaccination plan

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

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

3.   Portugal shall ensure that the emergency vaccination plan 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; |
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(a)

marked individually;

| (b) | not moved to other poultry holdings within Portugal or dispatched to other Member States. |
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(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 originating 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 the monitoring area established in Portugal around the holding referred to in Article 2(1), as set out in the emergency vaccination plan.

2.   By way of derogation from paragraph 1 and provided that 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 |
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(a)

released into the wild in Portugal; or

| (b) | dispatched to other Member States provided that:






  (i) | the results of the surveillance and monitoring measures set out in the emergency vaccination plan, including laboratory tests, are favourable; and |
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(b)

dispatched to other Member States provided that:

(i)

the results of the surveillance and monitoring measures set out in the emergency vaccination plan, including laboratory tests, are favourable; and

| (ii) | the conditions for dispatch of poultry for re-stocking supplies of wild game laid down in Decision 2006/605/EC are met. |
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(ii)

the conditions for dispatch of poultry for re-stocking supplies of wild game laid down in Decision 2006/605/EC are met.

Article 7

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

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

‘The animal health conditions of this consignment are in accordance with Decision 2008/285/EC’.

Article 8

Reports

Portugal shall submit to the Commission a report on the implementation of the emergency 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

Addresses

This Decision is addressed to the Portuguese Republic.

Done at Brussels, 19 March 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission

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(1)  
  OJ L 10, 14.1.2006, p. 16.

1

(2)  
  OJ L 274, 20.10.2005, p. 105. Decision as last amended by Decision 2007/803/EC (OJ L 323, 8.12.2007, p. 42).

2

(3)  
  OJ L 246, 8.9.2006, p. 12.

3

(4)  The EFSA Journal (2005) 266, 1-21; Scientific Opinion on Animal health and welfare aspects of Avian Influenza.

4

(5)  The EFSA Journal (2007) 489, Scientific Opinion on Vaccination against avian influenza of H5 and H7 subtypes in domestic poultry and captive birds.

5

(6)  
  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).

6

(7)  
  OJ L 136, 30.4.2004, p. 1. Regulation as last amended by Regulation (EC) No 1394/2007 (OJ L 324, 10.12.2007, p. 121).

7

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