2006D0415 — EN — 01.07.2008 — 003.001

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►B COMMISSION DECISION of 14 June 2006 concerning certain protection measures in relation to highly pathogenic avian influenza of the subtype H5N1 in poultry in the Community and repealing Decision 2006/135/EC (notified under document number C(2006) 2400) (Text with EEA relevance) (2006/415/EC) (OJ L 164, 16.6.2006, p.51)

Amended by:









▼B

COMMISSION DECISION

of 14 June 2006

concerning certain protection measures in relation to highly pathogenic avian influenza of the subtype H5N1 in poultry in the Community and repealing Decision 2006/135/EC

(notified under document number C(2006) 2400)

(Text with EEA relevance)

(2006/415/EC)







THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market ( 1 ), and in particular Article 9(4) thereof, Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market ( 2 ), and in particular Article 10(4) thereof, Having regard to Regulation (EC) No 998/2003 of the European Parliament and of the Council of 26 May 2003 on the animal health requirements applicable to the non-commercial movement of pet animals and amending Council Directive 92/65/EEC ( 3 ), and in particular Article 18 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 ( 4 ), and in particular Article 66(2) thereof, Whereas: (1) Avian influenza is an infectious viral disease in poultry and birds, causing mortality and disturbances which can quickly take epizootic proportions liable to present a serious threat to animal health and to reduce sharply the profitability of poultry farming. Under certain circumstances the disease may also pose a risk to human health. There is a risk that the disease agent might be spread to other holdings, to wild birds and from one Member State to other Member States and third countries through the international trade in live birds or their products. (2) Where a highly pathogenic avian influenza A virus of the subtype H5 is detected in a sample collected from poultry on the territory of a Member State and where, pending the determination of the neuraminidase (N) type, the clinical picture and the epidemiological circumstances justify the suspicion of highly pathogenic avian influenza caused by highly pathogenic influenza A virus of subtype H5N1 or the presence of highly pathogenic avian influenza of that subtype has been confirmed, the affected Member State should apply certain protection measures to minimise the risk of disease spread. (3) Such protection measures were adopted by Commission Decision 2006/135/EC of 22 February 2006 concerning certain protection measures in relation to highly pathogenic avian influenza in poultry in the Community ( 5 ) to be implemented in addition to those adopted in the framework of Council Directive 92/40/EEC of 19 May 1992 introducing Community measures for the control of avian influenza ( 6 ), in particular as regards the movement of certain birds and of products from poultry and other birds originating in the zone affected by the disease. (4) The measures laid down in Directive 92/40/EEC have been fundamentally reviewed in the light of recent scientific knowledge on the risks of avian influenza for animal and public health, the development of new laboratory tests and vaccines and the lessons learnt during recent outbreaks of this disease in the Community as well as in third countries. Taking account of that review, Directive 92/40/EEC was repealed and replaced by Directive 2005/94/EC, which is to be transposed by Member States into national law by 1 July 2007. (5) Pending the transposition of Directive 2005/94/EC and given the current disease situation in relation to avian influenza in the Community it was necessary to lay down transitional measures to be applied on holdings where outbreaks of avian influenza caused by highly pathogenic avian influenza viruses are suspected or confirmed in poultry or other captive birds. (6) Those transitional measures which are laid down in Commission Decision 2006/416/EC ( 7 ) should enable the Member States to adopt disease control measures in a proportionate and flexible manner, taking into account the various levels of risk posed by the different virus strains, the likely social and economic impact of the measures in question on the agriculture sector and other sectors involved, while at the same time ensuring that the measures taken for each specific scenario are the most appropriate. (7) With progress made in transposition of Directive 2005/94/EC by certain Member States, any reference to the transitional measures should be construed as a reference to the corresponding paragraph in Directive 2005/94/EC. (8) However, given the particular disease risk and the epidemiological situation with regard to highly pathogenic avian influenza and taking into account the severe economic impact the disease may have, in particular when occurring in densely populated poultry areas, certain supplementary measures as adopted under Decision 2006/135/EC should be maintained. Those measures should aim at reinforcing the local control measures, regionalising the affected Member State by separating the affected part of the territory from the disease free part thereof, and providing reassurance to the poultry sector and the trade partners about the safety of products dispatched from the disease free part of the country. (9) The measures provided for in Decision 2006/135/EC should be brought in line with those laid down in Decision 2006/416/EC and it is therefore appropriate for reasons of clarity and consistency to repeal Decision 2006/135/EC and replace it by the present Decision which only retains the additional control measures applicable to the specific disease situation with respect to highly pathogenic avian influenza of the H5N1 subtype. (10) Taking account of the differences in disease risk in case of an outbreak of highly pathogenic avian influenza, the affected Member State in close collaboration with the Commission should establish a high-risk area and a low-risk area which should be separated from the disease-free part of the territory. (11) If the epidemiological situation so requires, measures appropriate in relation to the areas concerned by the outbreak or suspected outbreak of highly pathogenic avian influenza should be taken, in particular by describing these areas, and keeping this description updated depending on the situation, in the Annex to the present Decision in accordance with the procedure provided for in Article 10(3) or (4) of Directive 90/425/EEC and Article 9(3) or (4) of Directive 89/662/EEC. (12) The measures laid down in 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 ( 8 ) should be implemented in the areas affected by the disease. (13) In the interests of consistency, it is appropriate for the purposes of this Decision to apply certain definitions provided for in Directive 2005/94/EC, Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs ( 9 ), Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin ( 10 ), Regulation (EC) No 998/2003. (14) 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 ( 11 ) provides for approved bodies, institutes and centres and a model certificate to accompany animals or their gametes between such approved premises in different Member States. A derogation from the transport restrictions should be envisaged for birds coming from and going to bodies, institutes and centres approved in accordance with that Directive. (15) Transport of hatching eggs from the protection zones should be permitted under certain conditions. The dispatch of hatching eggs to other countries should be permitted subject in particular to compliance with the conditions referred to in Directive 2005/94/EC. In such cases the animal health certificates provided for in accordance with Directive 90/539/EEC should include a reference to this Decision. (16) The dispatch from protection zones of meat, minced meat, mechanically separated meat, meat preparations and meat products from wild feathered game should be permitted subject to certain conditions, in particular as regards compliance with certain requirements of Regulation (EC) No 853/2004 and Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption ( 12 ). (17) Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption ( 13 ) establishes a list of treatments rendering meat from restricted areas safe, provides for the possibility to establish a specific identification mark and sets out the identification mark required for meat not authorised for placing on the market for animal health reasons. It is appropriate to permit the dispatch from the protection zones of meat bearing the health mark provided for in that Directive and meat products subjected to treatment referred to therein. (18) Regulation (EC) No 2076/2005 provides for transitional measures allowing the use of a national identification mark for products of animal origin intended for human consumption which may only be marketed in the territory of the Member State where they are produced. (19) Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption ( 14 ) authorises the placing on the market of a range of animal by-products originating in areas of the Community under animal health restrictions, because those products are considered safe due to the specific conditions of production, processing and utilisation that effectively inactivate possible pathogens or prevent contact with susceptible animals. (20) Taking account of the measures in place following an outbreak of highly pathogenic avian influenza of the subtype H5N1 in a backyard poultry flock in Denmark and the establishment of areas A and B in accordance with Article 2(4)(b) and (c) of Decision 2006/135/EC these areas should continue to be listed in the Annex of this Decision and further areas A and B should be included following a recent outbreak of avian influenza of the subtype H5 in a geese flock in Hungary. (21) Decision 2006/135/EC should therefore be repealed and replaced by this Decision. (22) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Whereas: HAS ADOPTED THIS DECISION:







Article 1

Subject matter and scope

1. This Decision lays down certain protection measures to be applied in cases of highly pathogenic avian influenza in poultry in the territory of a Member State (the ‘affected Member State’), caused by a highly pathogenic influenza A virus of subtype H5 suspected (‘suspected outbreak’) or confirmed (‘outbreak’) to be of the neuraminidase type N1, in order to prevent the spread of avian influenza into the disease free parts of the Community through movement of poultry, other birds as well as products thereof.

▼M7

2. The measures laid down in this Decision shall be applied without prejudice to the measures to be applied in the event of an outbreak of highly pathogenic avian influenza in poultry taken in accordance with Directive 2005/94/EC.

▼B

Article 2

Definitions

For the purpose of this Decision, the definitions in Directive 2005/94/EC shall apply. In addition, the following definitions shall apply:

(a) ‘hatching eggs’ means eggs for incubation laid by poultry as defined in Article 2(4) of Directive 2005/94/EC;

(b) ‘wild feathered game’ means game as defined in point 1.5, second indent, and as far as avian species are concerned, in point 1.7 of Annex I to Regulation (EC) No 853/2004;

(c) ‘other captive birds’ means birds as defined in point 6 of Article 2 of Directive 2005/94/EC, including: (i) pet animals of the bird species as referred to in Article 3(a) of Regulation (EC) No 998/2003; and (ii) birds destined for approved bodies, institutes or centres as defined in Article 2(1)(c) of Directive 92/65/EEC.

▼M7

Article 3

Areas A and B

1. The area listed in Part A of the Annex (‘area A’) is classified as the high risk area consisting of the protection and surveillance zones established in accordance with Article 16 of Directive 2005/94/EC.

2. The area listed in Part B of the Annex (‘area B’) is classified as the low risk area which may include all or parts of the further restricted zone established in accordance with Article 16 of Directive 2005/94/EC, and which shall separate area A from the disease free part of the affected Member State, if such part is identified, or from neighbouring countries.

▼B

Article 4

Establishment of areas A and B

▼M7

1. Immediately following a suspected or confirmed outbreak of highly pathogenic avian influenza caused by highly pathogenic influenza A virus of subtype H5 suspected or confirmed to be of the neuraminidase type N1, the affected Member State shall establish:

(a) area A, having regard to the legal requirements as set out in Article 16 of Directive 2005/94/EC;

(b) area B having regard to geographical, administrative, ecological and epizootiological factors relating to avian influenza.

The affected Member State shall notify areas A and B to the Commission, to the other Member States and, as appropriate, to the public.

▼B

2. The Commission, in collaboration with the affected Member State, shall examine the areas established by the affected Member State and take the appropriate measures in relation to those areas pursuant to Article 9(3) and (4) of Directive 89/662/EEC and Article 10(3) or (4) of Directive 90/425/EEC.

3. If the neuraminidase type is confirmed as being different from N1, the affected Member State shall abolish the measures taken by it in relation to the areas concerned and notify the Commission and the other Member States.

The Commission, in collaboration with the affected Member State, shall take the appropriate measures pursuant to Article 9(3) or (4) of Directive 89/662/EEC and Article 10(3) or (4) of Directive 90/425/EEC.

4. If the presence of a highly pathogenic influenza A virus of the subtype H5N1 is confirmed in poultry, the affected Member States shall:

(a) notify the Commission and the other Member States;

(b) apply the measures provided for in Article 5: ▼M7 (i) for at least 21 days in the case of the protection zone and 30 days in the case of the surveillance zone after the date of completion of the preliminary cleansing and disinfection on the holding where an outbreak is confirmed in accordance with Article 11(8) of Directive 2005/94/EC; and ▼B (ii) as long as is necessary having regard to the geographical, administrative, ecological and epizootiological factors relating to avian influenza; or (iii) until the date indicated for the affected Member State in the Annex;

(c) keep the Commission and the other Member States informed about any development with regard to areas A and B.

The Commission, in collaboration with the affected Member State, shall take the appropriate measures pursuant to Article 9(3) or (4) of Directive 89/662/EEC and Article 10(3) or (4) of Directive 90/425/EEC.

Article 5

General prohibition

▼M7

In addition to the restrictions on the movement of poultry, other captive birds, their hatching eggs and products derived from such birds laid down in Directive 2005/94/EC, for holdings in the protection, surveillance and further restricted zones, the affected Member State shall ensure that:

▼B

(a) no live poultry and other captive birds, except birds referred to in Article 2(c)(i) and (ii), and hatching eggs of poultry, other captive birds, except those from birds referred to in Article 2(c)(ii), and of wild feathered game birds are dispatched from area B to the remaining part of the territory of the affected Member State, if applicable, or to other Member States or to third countries;

(b) no products intended for human consumption derived from wild feathered game, are dispatched from areas A and B to the remaining part of the territory of the affected Member State, if applicable, or to other Member States and to third countries;

(c) no animal by-products derived entirely or partially from avian species from areas A and B and subject to the provisions of Regulation (EC) No 1774/2002 are transported between areas A and B or dispatched from those areas to the remaining part of the territory of the affected Member State, if applicable, or to other Member States or to third countries;

(d) no poultry or other captive birds are gathered at gatherings within area B such as fairs, markets or shows.

Article 6

Derogations for live poultry and day-old chicks

1. By way of derogation from Article 5(a), the affected Member State may authorise the direct transport of poultry from holdings in area B, to slaughterhouses in the affected Member State designated by the competent authority, or following agreement between the competent authorities, to a designated slaughterhouse in another Member State or third country.

2. By way of derogation from Article 5(a), the affected Member State may authorise the direct transport of poultry from holdings in area B to holdings under official control in the same Member State where the poultry shall remain for at least 21 days.

3. By way of derogation from Article 5(a), the affected Member State may authorise the direct transport of poultry from holdings in area B to a designated holding in another Member State or a third country, provided that:

(a) the competent authorities have agreed;

(b) no other poultry is kept on the designated holding;

(c) the designated holding is placed under official surveillance;

(d) the poultry remain on the designated holding for at least 21 days.

4. By way of derogation from Article 5(a), the affected Member State may authorise the transport of day-old chicks from a hatchery situated in area B:

(a) to holdings under official control in the affected Member State, preferably situated outside area A;

(b) to any holding, preferably situated outside area A, provided that the day-old chicks are hatched from eggs complying with the requirements in Article 7(1)(b);

(c) to any holding, preferably situated outside area A, provided that the day-old chicks are hatched from eggs collected from holdings which were on the date of collection situated outside areas A and B and were transported in disinfected packaging.

5. The animal health certificates accompanying consignments of poultry or day-old chicks referred to in paragraph 1, 2, 3 and 4(b) and (c) to other Member States shall include the words:

‘The consignment complies with the animal health conditions laid down in Commission Decision 2006/415/EC’.

6. Movements pursuant to paragraphs 1, 2, 3 and 4 shall be executed under official control. They shall be authorised only after the official veterinarian has ascertained that the holding of origin is not subject to any suspicion relating to highly pathogenic avian influenza. The means of transport used must be cleaned and disinfected before and after use.

Article 7

Derogations for hatching eggs and SPF-eggs

1. By way of derogation from Article 5(a), the affected Member State may authorise the dispatch of hatching eggs

(a) collected from holdings situated on the day of collection in area B, to a designated hatchery in the affected Member State, or following agreement between the competent authorities, to a designated hatchery in another Member State or third country;

(b) collected from holdings situated on the day of collection in area B, on which the poultry have tested negative in a serological survey for avian influenza capable of detecting 5 % prevalence of disease with at least a 95 % level of confidence and traceability is ensured, to any hatchery.

2. By way of derogation from Article 5(a), the affected Member State shall authorise the dispatch of hatching eggs or SPF-eggs for scientific, diagnostic or pharmaceutical uses collected from holdings situated on the day of collection in area A or B to designated laboratories, institutes, pharmaceutical or vaccine producers in the affected Member State, or following agreement between the competent authorities, in another Member State or a third country.

3. The animal health certificates accompanying consignments of hatching eggs referred to in paragraphs 1(a) and (b) and 2 to other Member States shall include the words:

‘The consignment complies with the animal health conditions laid down in Commission Decision 2006/415/EC’.

4. Movements which are permitted pursuant to paragraph 1 or 2 shall be executed under official control. They shall be authorised only after the official veterinarian has ascertained that the holding of origin is not subject to any suspicion relating to highly pathogenic avian influenza. The means of transport used must be cleaned and disinfected before and after use.

Article 8

Derogations for meat, minced meat and mechanically separated meat of wild feathered game and meat preparations and meat products prepared from such meat

▼M4

1. By way of derogation from Article 5(b), the affected Member State may authorise the dispatch onto the national market of fresh meat, minced meat, mechanically separated meat and meat preparations or meat products from wild feathered game originating in areas A or B, if such meat is marked:

(a) either in accordance with the special identification mark provided for in Annex II to Directive 2002/99/EC, or

(b) in accordance with Article 2 of Decision 2007/118/EC.

▼B

2. By way of derogation from Article 5(b), the affected Member State shall authorise the dispatch of:

(a) meat products produced from meat from wild feathered game originating in area A or B which were subjected to a treatment as required for avian influenza in row 1(a), (b) or (c) of Annex III to Directive 2002/99/EC;

(b) fresh meat from wild feathered game originating outside the areas A and B and produced in establishments within area A or B in accordance with Section IV of Annex III to Regulation (EC) No 853/2004 and controlled in accordance with Chapter VIII of Section IV of Annex I to Regulation (EC) No 854/2004;

(c) minced meat, meat preparations, mechanically separated meat and meat products containing meat referred to in point (b) and produced in establishments situated in area A or B in accordance with Sections V and VI of Annex III to Regulation (EC) No 853/2004.

Article 9

Derogation for animal by-products

1. By way of derogation from Article 5(c), the affected Member State shall authorise:

(a) the dispatch from area A or B of animal by-products of avian origin which: (i) comply with the conditions set out in the following Annexes, or parts thereof, to Regulation (EC) No 1774/2002: — Annex V, — Chapters II(A), III(B), IV(A), VI(A and B), VII(A), VIII(A), IX(A) and X(A) of Annex VII, and — Chapter II(B), Chapter III(II)(A) and Chapter VII(A)(1)(a) of Annex VIII; or (ii) are transported under biosecurity measures to avoid spread of the virus to designated, plants approved in accordance with Articles 12 to 15 or Articles 17 or 18 of Regulation (EC) No 1774/2002 for disposal, further transformation or use which ensure at least the inactivation of the avian influenza virus; or (iii) are transported under biosecurity measures to avoid spread of the virus to users or collection centres authorised and registered in accordance with Article 23(2) of Regulation (EC) No 1774/2002 for the feeding of animals after a treatment in accordance with points (5)(a)(ii) and (iii) of Annex IX to that Regulation to ensure at least the inactivation of the avian influenza virus;

(b) the dispatch from area B of untreated feathers or parts of feathers in accordance with point 1(a) of Section A of Chapter VIII of Annex VIII to Regulation (EC) No 1774/2002, produced from poultry or farmed feathered game;

(c) the dispatch from area A or B of feathers and parts of feathers that have been treated with a steam current, or by some other method that ensures that no pathogens remain, produced from poultry or wild feathered game.

2. The affected Member State shall ensure that the products referred to in paragraph 1(b) and (c) of this Article are accompanied by a commercial document in accordance with Chapter X of Annex II to Regulation (EC) No 1774/2002 stating, in the case of the products referred to in paragraph 1(c) of this Article, in point 6.1 of that document that those products have been treated with a steam current or by some other method ensuring that no pathogens remain.

However, that commercial document shall not be required for processed decorative feathers, processed feathers carried by travellers for their private use or consignments of processed feathers sent to private individuals for non-industrial purpose.

Article 10

Conditions for movements

1. Where movements of animals or products thereof covered by this Decision are authorised under Articles 6, 7, 8 and 9, the authorisation shall be based on the favourable outcome of a risk assessment carried out by the competent authority and all appropriate biosecurity measures shall be taken to avoid the spread of avian influenza.

2. Where the dispatch, movement or transport of products referred to in paragraph 1 are authorised under Articles 7, 8 and 9, subject to justified conditions or limitations, they must be obtained, handled, treated, stored and transported without compromising the animal health status of other products fulfilling all the animal health requirements for trade, placing on the market or export to third countries.

Article 11

Compliance and information

All Member States shall immediately adopt and publish the measures necessary to comply with this Decision. They shall immediately inform the Commission thereof.

The affected Member State shall apply those measures as soon as it reasonably suspects the presence of highly pathogenic avian influenza virus of the subtype H5N1 in poultry.

The affected Member State shall regularly provide to the Commission and the other Member States the necessary information on the epidemiology of the disease and, where appropriate the additional control and surveillance measures and the awareness campaigns implemented.

Article 12

Validity

This Decision shall apply until ►M23 30 June 2009 ◄ .

Article 13

Repeal

Decision 2006/135/EC is repealed.

Article 14

Addressee

This Decision is addressed to the Member States.

▼M22









ANNEX

PART A

Area A as established in accordance with Article 4(2):







ISO country code Member State Area A Date until applicable Article 4(4)(b)(iii) Code (if available) Name ▼M23 ————— ▼M22

PART B

Area B as established in accordance with Article 4(2):







ISO country code Member State Area B Date until applicable Article 4(4)(b)(iii) Code (if available) Name ▼M23 —————