Commission Decision

of 29 March 2010

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 C(2010) 1914)

(Only the Portuguese text is authentic)

(2010/189/EU)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

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 57(2) thereof,

Whereas:

(1) Directive 2005/94/EC sets out certain preventive 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, the risks of that disease.

(2) Following outbreaks of low pathogenic avian influenza in 2007 and 2008 in certain poultry holdings in central and western Portugal, in particular in holdings that keep poultry intended for restocking supplies of game, an emergency vaccination plan was carried out pursuant to Commission Decision 2008/285/EC [2] and that disease was successfully eradicated. However, based on a risk assessment it was decided that high value mallard breeding ducks kept on one holding located in the region of Lisboa e Vale do Tejo, Ribatejo Norte, Vila Nova da Barquinha were still exposed to the potential risk of avian influenza infection, in particular by possible indirect contact with wild birds (the holding).

(3) Portugal therefore decided to continue vaccination against avian influenza as a long term measure by implementing a preventive vaccination plan on the holding which was approved by Commission Decision 2008/838/EC 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 [3]. That Decision expired on 31 July 2009.

(4) Portugal has reported on the implementation of that preventive vaccination plan to the Standing Committee on the Food Chain and Animal Health and expressed its intention to continue to implement preventive vaccination, if an appropriate vaccine should become available.

(5) On 8 January 2010, Portugal submitted a preventive vaccination plan to the Commission for approval which is to be applied until 31 July 2011 (the preventive vaccination plan).

(6) In its scientific opinions on the use of vaccination to control avian influenza issued by the European Food Safety Authority in 2005 [4], 2007 [5] and 2008 [6], 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.

(7) In addition, the Commission has examined the preventive vaccination plan submitted by Portugal, and is satisfied that it conforms to the relevant Union 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 preventive vaccination plan, it should be approved.

(8) 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 [7] 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 [8] should be used.

(9) 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.

(10) It is also appropriate to introduce certain restrictions on the movement of vaccinated mallard ducks, their hatching eggs and mallard ducks derived from such ducks 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 mallard ducks should not be moved from that holding, but killed after the end of their reproductive cycle in accordance with the requirements of Article 10(1) of Council Directive 93/119/EEC of 22 December 1993 on the protection of animals at the time of slaughter or killing [9].

(11) In relation to trade in poultry intended for restocking 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 restocking of wild game supplies [10].

(12) 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 the spread of disease and provided that official surveillance is carried out and that the specific animal health requirements for trade within the Union are complied with.

(13) The preventive vaccination plan should be approved so that it can be implemented until 31 July 2011. Accordingly, this Decision should apply until that date.

(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 preventive vaccination of mallard ducks (Anas platyrhynchos) intended for restocking 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.

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 preventive vaccination plan

1. The plan for preventive vaccination against low pathogenic avian influenza in Portugal, as submitted by Portugal to the Commission on 8 January 2010, to be implemented on a holding in the region of Lisboa e Vale do Tejo, Ribatejo Norte, Vila Nova da Barquinha until 31 July 2011 (the preventive vaccination plan) is approved.

2. The Commission shall publish the preventive vaccination 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 monovalent inactivated heterologous vaccine containing the avian influenza subtype H5 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 laboratory testing of the holding keeping the vaccinated mallard ducks and of unvaccinated poultry holdings, as set out in the preventive vaccination plan, is carried out.

3. Portugal shall ensure that the preventive 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;

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

(c) dispatched from Portugal.

After their reproductive period, such ducks shall be killed on the holding referred to in Article 2(1) of this Decision, in accordance with the requirements in Article 10(1) of Directive 93/119/EEC, and their carcases safely disposed of.

Article 5

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

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

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 the vaccinated mallard ducks may only be moved after hatching to a holding located in a surrounding area established by Portugal in relation to the holding referred to in Article 2(1) as set out in the preventive vaccination plan.

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

(a) released into the wild in Portugal; or

(b) dispatched from Portugal 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 restocking supplies of wild game laid down in Decision 2006/605/EC are met.

Article 7

Health certification for trade within the Union in mallard ducks derived from vaccinated mallard ducks

Portugal shall ensure that health certificates for trade within the Union in poultry intended for restocking 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 Commission Decision 2010/189/EU".

Article 8

Reports

Portugal shall submit to the Commission a report on the implementation of the preventive vaccination plan within one month from the date of application of this Decision and report every six months thereafter to the Standing Committee on the Food Chain and Animal Health thereafter.

Article 9

Applicability

This Decision shall apply until 31 July 2011.

Article 10

Addressee

This Decision is addressed to the Portuguese Republic.

Done at Brussels, 29 March 2010.

For the Commission

John Dalli

Member of the Commission

[1] OJ L 10, 14.1.2006, p. 16.

[2] OJ L 92, 3.4.2008, p. 37.

[3] OJ L 299, 8.11.2008, p. 40.

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

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

[6] 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.

[7] OJ L 311, 28.11.2001, p. 1.

[8] OJ L 136, 30.4.2004, p. 1.

[9] OJ L 340, 31.12.1993, p. 21.

[10] OJ L 246, 8.9.2006, p. 12.

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