Commission Decision

of 31 October 2008

implementing Council Directive 2006/88/EC as regards surveillance and eradication programmes and disease-free status of Member States, zones and compartments

(notified under document number C(2008) 6264)

(Text with EEA relevance)

(2009/177/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals [1], and in particular the first subparagraph of Article 44(1), the first subparagraph of Article 44(2), Article 44(3), Article 49(1), Article 50(2)(a), Articles 50(3), 51(2), 59(2) and 61(3) and Article 64 thereof,

Whereas:

(1) Directive 2006/88/EC lays down minimum preventive measures aimed at increasing the awareness and preparedness of the competent authorities, aquaculture production business operators and others related to this industry, for diseases in aquaculture animals, and minimum control measures to be applied in the event of a suspicion of, or an outbreak of certain diseases in aquatic animals. It repeals and replaces, from 1 August 2008, Council Directive 91/67/EEC of 28 January 1991 concerning the animal health conditions governing the placing on the market of aquaculture animals and products [2].

(2) Article 44(1) of Directive 2006/88/EC provides that, where a Member State not known to be infected but not declared free of one or more of the non-exotic diseases listed in Part II of Annex IV thereto draws up a surveillance programme for achieving disease-free status for one or more of those diseases, it is to submit that programme for approval in accordance with the regulatory procedure.

(3) Article 44(1) of Directive 2006/88/EC also provides that where that surveillance programme is to cover individual compartments or zones which comprise less than 75 % of the territory of the Member State and the zone or compartment consists of a water catchment area not shared with another Member State or third country, a different procedure, including the model forms to be submitted to the Standing Committee on the Food Chain and Animal Health (the Committee), is to be followed, as provided for in Article 50(2) of Directive 2006/88/EC.

(4) Article 44(2) of Directive 2006/88/EC provides that, where a Member State known to be infected by one or more of the non-exotic diseases listed in Part II of Annex IV thereto draws up an eradication programme for one or more of those disease, it is to submit that programme for approval in accordance with the regulatory procedure.

(5) Where a Member State wishes to achieve the disease-free status of one or more of the non-exotic diseases listed in Part II of Annex IV to that Directive for its whole territory pursuant to Article 49(1) of Directive 2006/88/EC, it is to submit the evidence in order to be declared disease-free in accordance with the regulatory procedure.

(6) Article 50(1) of Directive 2006/88/EC provides that a Member State may declare a zone or compartment within its territory free of one or more of the non-exotic diseases listed in Part II of Annex IV thereto under certain conditions. A Member State making such a declaration is to submit it to the Committee in accordance with the procedure laid down in paragraph 2 of that Article.

(7) In addition, Article 50(3) of Directive 2006/88/EC provides that where that zone or compartment comprises more than 75 % of the territory of the Member State or consists of a water catchment area shared with another Member State or third country, the procedure laid down in Article 50(2) of that Directive is to be replaced by the regulatory procedure.

(8) It is necessary to lay down detailed provisions to specify in which cases surveillance programmes and disease-free status declarations should be approved in accordance with the regulatory procedure.

(9) Lists of Member States, zones or compartments subject to surveillance or eradication programmes approved in accordance with the regulatory procedure, or for which disease-free status has been approved, should be drawn up.

(10) Model forms for the submission of surveillance programmes for approval and for declarations of such programmes should be laid down. A model form for Member States to report on the evolution of certain eradication programmes and certain surveillance programmes should also be drawn up. In addition, a model form for the submission of applications for disease-free status for approval and declarations of such status, should be laid down.

(11) Annex V to Commission Decision 2008/425/EC of 25 April 2008 laying down the standard requirements for the submission by Member States of national programmes for the eradication, control and monitoring of certain animal diseases and zoonoses for Community financing [3] includes the detailed analysis of the cost of the programmes for which Member States wish to receive a financial contribution. In the interests of consistency of Community legislation, the model form for the submission of eradication programmes for approval pursuant to Directive 2006/88/EC should comply with the model set out in that Annex.

(12) Annual information from Member States is needed to assess the evolution of approved surveillance programmes, as well as of approved eradication programmes not subject to Community funding. For that purpose, a report should be submitted each year to the Commission. Since eradication programmes subject to Community funding fall within the scope of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field [4], Member States are to report the technical and financial issues of those programmes in accordance with that Decision.

(13) Declarations of surveillance programmes and declarations of disease-free status submitted by the Member States to the Committee should be accessible to the Commission and to the other Member States by electronic means. An Internet-based information page is technically the most feasible solution, as it ensures easy access to such declarations.

(14) Pursuant to Directive 91/67/EEC, the following decisions approved disease-free zones, fish farms and programmes for the purpose of obtaining disease-free status: Commission Decision 2002/308/EC of 22 April 2002 establishing lists of approved zones and approved farms with regard to one or more of the fish diseases viral haemorrhagic septicaemia (VHS) and infectious haematopoietic necrosis (IHN) [5], Commission Decision 2002/300/EC of 18 April 2002 establishing the list of approved zones with regard to Bonamia ostreae and/or Marteilia refringens [6], Commission Decision 2003/634/EC of 28 August 2003 approving programmes for the purpose of obtaining the status of approved zones and of approved farms in non-approved zones with regard to viral haemorrhagic septicaemia (VHS) and infectious haematopoietic necrosis (IHN) in fish [7], and Commission Decision 94/722/EC of 25 October 1994 approving the programme concerning bonamiosis and marteiliosis submitted by France [8].

(15) The criteria for disease-free status in Directive 2006/88/EC are equivalent to those laid down in Directive 91/67/EEC, as regards the approval of the entire territory of Member States, continental zones and farms in non-approved zones.

(16) Therefore, continental zones and farms approved pursuant to Directive 91/67/EEC should not be required to be declared to the Committee in accordance with Directive 2006/88/EC. They should also be included in the list of zones and compartments accessible on the Internet-based pages established by this Decision.

(17) However, the concept of coastal zone is not provided for in Directive 2006/88/EC. Areas approved as disease-free coastal zones pursuant to Directive 91/67/EEC should therefore be reassessed by the Member States and a new application, or if appropriate a new declaration, should be submitted pursuant to Directive 2006/88/EC.

(18) Decisions 2002/300/EC and 2002/308/EC should therefore be repealed from 1 August 2009, thereby allowing Member States sufficient time to submit new declarations or applications as regards those coastal zones.

(19) The distinction between surveillance and eradication programmes is not provided for in Directive 91/67/EEC. However, since the requirements applicable to such programmes are equivalent, the programmes approved pursuant to Decisions 2003/634/EC and 94/722/EC should be regarded as complying with Directive 2006/88/EC. For the purpose of identifying which of those programmes should be regarded as surveillance or eradication programmes and included in the relevant lists set out in this Decision, the Member States should provide information on those programmes to the Commission by 30 April 2009.

(20) 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:

SECTION 1

SUBMISSION OF SURVEILLANCE PROGRAMMES AND DISEASE-FREE STATUS DECLARATIONS FOR APPROVAL

Article 1

Conditions for submission of surveillance programmes for approval

1. Surveillance programmes shall only be submitted for approval, as provided in the first subparagraph of Article 44(1) of Directive 2006/88/EC, if they cover:

(a) the whole territory of a Member State;

(b) compartments or groups thereof, comprising more than 75 % of the coastal area of the Member State concerned as regards diseases which only affect salt water species;

(c) zones and compartments, or groups thereof, comprising more than 75 % of the continental area of the Member State concerned as regards diseases which only affect fresh water species;

(d) zones and compartments, or groups thereof, comprising more than 75 % of the continental area and coastal area of the Member State concerned as regards diseases which affect both fresh water and salt water species; or

(e) zones and compartments, which consist of water catchment areas shared with another Member State or third country.

2. For the purpose of this Decision, a compartment or group of compartments of a coastal area shall be considered to cover more than 75 % of the coastal area of a Member State when it covers more than 75 % of the coastline, measured along the baseline of the coast.

Article 2

Conditions for the submission of disease-free status declarations for approval

Disease-free status declarations shall only be submitted for approval, as provided for in Article 50(3) of Directive 2006/88/EC, if the declaration complies with one of the conditions set out in Article 1(1) of this Decision.

SECTION 2

LISTS OF MEMBER STATES, ZONES AND COMPARTMENTS SUBJECT TO APPROVED SURVEILLANCE AND ERADICATION PROGRAMMES AND DISEASE-FREE AREAS

Article 3

Member States, zones and compartments subject to approved surveillance programmes

Member States, zones and compartments subject to a surveillance programme approved in accordance with the first subparagraph of Article 44(1) of Directive 2006/88/EC are listed in the second and fourth column of the table in Part A of Annex I to this Decision as regards the diseases specified in that table.

Article 4

Member States, zones and compartments subject to approved eradication programmes

Member States, zones and compartments subject to an eradication programme approved in accordance with the first subparagraph of Article 44(2) of Directive 2006/88/EC are listed in the second and fourth column of the table in Part B of Annex I to this Decision as regards the diseases specified in that table.

Article 5

Disease-free Member States, zones and compartments

Member States declared disease-free in accordance with Article 49(1) of Directive 2006/88/EC, and zones and compartments declared disease-free in accordance of Article 50(3) of that Directive, are listed in the second and fourth column of the table in Part C of Annex I to this Decision as regards the diseases specified in that table.

SECTION 3

MODEL FORMS FOR SUBMISSIONS OF DECLARATIONS AND APPLICATIONS

Article 6

Model forms for surveillance programmes

1. Submissions for the approval of surveillance programmes, as provided for in the first subparagraph of Article 44(1) of Directive 2006/88/EC, shall be in conformity with the model forms set out in Annexes II and III to this Decision.

2. Submissions for declarations of surveillance programmes, provided for in the fourth subparagraph of Article 44(1) of Directive 2006/88/EC, shall be in conformity with the model form set out in Annex II to this Decision.

Article 7

Model form for eradication programmes

Submissions for the approval of eradication programmes, as provided for in the first subparagraph of Article 44(2) of Directive 2006/88/EC, shall be in conformity with the model form set out in Annex V to Decision 2008/425/EC.

Article 8

Model forms for the submission for disease-free status

1. Submissions of documentation for the approval of disease-free status, as provided for in Article 49(1) and Article 50(3) of Directive 2006/88/EC, shall be in conformity with the model forms set out in Annexes IV and V to this Decision.

2. Submissions of declarations of disease-free status of zones or compartments, as provided for in Article 50(2) of Directive 2006/88/EC, shall be in conformity with the model forms set out in Annexes IV and V to this Decision.

3. By way of derogation from paragraphs 1 and 2, when disease-free status is to be achieved in accordance with Articles 49(1)(a), (b) or point 1 of Part I of Annex V to Directive 2006/88/EC, Member States shall not be required to submit the model forms set out in Annex V to this Decision.

SECTION 4

OBLIGATIONS FOR REPORTS AND INTERNET-BASED INFORMATION

Article 9

Reporting

By 30 April each year at the latest, Member States shall submit a report to the Commission on:

(a) surveillance programmes approved in accordance with the first subparagraph of Article 44(1) of Directive 2006/88/EC;

(b) eradication programmes not subject to Community funding and approved in accordance with the first subparagraph of Article 44(2) of that Directive.

The report shall be in conformity with the model form set out in Annex VI to this Decision.

Article 10

Internet-based information pages

1. Member States shall establish and keep up-to-date Internet-based information pages in order to make:

(a) declarations of surveillance programmes submitted to the Standing Committee on the Food Chain and Animal Health (the Committee), in accordance with the fourth subparagraph of Article 44(1) and Article 50(2) of Directive 2006/88/EC, accessible to the Commission and the other Member States;

(b) declarations of disease-free status submitted to the Committee, in accordance with Article 50(2) of that Directive, accessible to the Commission and the other Member States;

(c) publicly available the list of zones or compartments declared subject to an approved surveillance programme or disease-free, in accordance with Article 50(2) of that Directive.

2. When Member States publish on the Internet-based information pages the declarations referred to in points (a) and (b) of paragraph 1, they shall immediately notify the Commission thereof.

3. Member States shall communicate to the Commission the Internet addresses of the Internet-based information pages provided for in paragraph 1.

SECTION 5

TRANSITIONAL PROVISIONS

Article 11

Transitional provisions as regards disease-free areas

1. Continental zones recognised as approved with regard to viral haemorrhagic septicaemia (VHS) and infectious haematopoietic necrosis (IHN) by Decision 2002/308/EC and listed in Annex I thereto shall be regarded as zones complying with the requirements for disease-free zones set out in Annex V to Directive 2006/88/EC.

2. Fish farms recognised as approved with regard to VHS and IHN by Decision 2002/308/EC and listed in Annex II thereto shall be regarded as compartments complying with the requirements for disease-free compartments set out in Annex V to Directive 2006/88/EC.

3. Continental zones and fish farms referred to in paragraphs 1 and 2 of this Article shall be included in the list of zones and compartments established in accordance with Article 10(1)(c).

4. By way of derogation from Article 50(2) of Directive 2006/88/EC, Member States shall not be required to submit declarations to the Committee, as regards the continental zones and fish farms referred to in paragraphs 1 and 2 of this Article.

Article 12

Transitional provisions as regards approved programmes

1. By way of derogation from Article 44 of Directive 2006/88/EC, Member States shall not be required to submit surveillance and eradication programmes which were approved for the purpose of obtaining approved zone status with regard to:

(a) VHS and IHN by Decision 2003/634/EC;

(b) bonamiosis and marteiliosis by Decision 94/722/EC.

2. By 30 April 2009 at the latest, the Member States concerned shall submit to the Commission a report on the programmes referred to in paragraph 1, which shall contain at least:

(a) information on the geographical demarcation of the programmes;

(b) the information required under Annex VI for the previous four years of implementation of the programmes.

SECTION 6

FINAL PROVISIONS

Article 13

Repeal

Decisions 2002/300/EC and 2002/308/EC are repealed with effect from 1 August 2009.

Article 14

Application

This Decision shall apply from 1 November 2008.

Article 15

Addressees

This Decision is addressed to the Member States.

Done at Brussels, 31 October 2008.

For the Commission

Androulla Vassiliou

Member of the Commission

[1] OJ L 328, 24.11.2006, p. 14.

[2] OJ L 46, 19.2.1991, p. 1.

[3] OJ L 159, 18.6.2008, p. 1.

[4] OJ L 224, 18.8.1990, p. 19.

[5] OJ L 106, 23.4.2002, p. 28.

[6] OJ L 103, 19.4.2002, p. 24.

[7] OJ L 220, 3.9.2003, p. 8.

[8] OJ L 288, 9.11.1994, p. 47.

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ANNEX I

PART A

Member States, zones and compartments subject to approved surveillance programmes

Disease | Member State | Code | Geographical demarcation of the area under a surveillance programme (Member State, zones or compartments) |

Viral haemorrhagic septicaemia (VHS) | | | |

Infectious haematopoietic necrosis (IHN) | | | |

Koi herpes virus (KHV) disease | | | |

Infectious salmon anaemia (ISA) | | | |

Infection with Marteilia refringens | | | |

Infection with Bonamia ostreae | | | |

White spot disease | | | |

PART B

Member States, zones and compartments subject to approved eradication programmes

Disease | Member State | Code | Geographical demarcation of the area under an eradication programme (Member State, zones or compartments) |

Viral haemorrhagic septicaemia (VHS) | | | |

Infectious haematopoietic necrosis (IHN) | | | |

Koi herpes virus (KHV) disease | | | |

Infectious salmon anaemia (ISA) | | | |

Infection with Marteilia refringens | | | |

Infection with Bonamia ostreae | | | |

White spot disease | | | |

PART C

Member States, zones and compartments declared disease-free

Disease | Member State | Code | Geographical demarcation of the disease-free area (Member State, zones or compartments) |

Viral haemorrhagic septicaemia (VHS) | Denmark | DK | The water catchment areas and the coastal areas of: Hansted ?Hovm?lle ?Gren?Tre?Alling ?KastbjergVillestrup ?Korup ?S?by ?Elling ?Uggerby ?Lindenborg ??ster ?Hasseris ?Binderup ?Vidk?r ?Dybvad ?Bj?rnsholm ?Trend ?Lerkenfeld ?Vester ?L?nnerup med till?bFiskb?k ?Slette ?Bredk?r B?kVandl?b til KilenResenk?r ?Klosterm?lle ?Hvidbjerg ?Knidals ?Spang ?Simested ?Skals ?Jordbro ?F?rem?lle ?Flynder ?Damhus ?Karup ?Guden?enHalk?r ?Stor?en?rhus ?Bygholm ?Grejs ??rum ? |

Ireland | IE | All continental and coastal areas within its territory, except: 1.Cape Clear Island |

Cyprus | CY | All continental areas within its territory |

Finland | FI | All continental and coastal areas within its territory, except: 1.the Province of ?land;2.the municipalities of Uusikaupunki, Pyh?ranta and Rauma |

Sweden | SE | Whole territory |

The United Kingdom | UK | All continental and coastal areas within its territory, except: 1.the catchment areas of the River Ouse from its sources to its normal tidal limit at Naburn Lock and Weir; and2.a buffer zone consisting of the waters of the Humber Estuary from the normal tidal limits at Barmby Barrage, Naburn Lock and Weir, the Railway Bridge at Ulleskelf, Chapel Haddlesey Weir and Long Sandall Lock to a line drawn due north from the jetty at WhitgiftAll continental and coastal areas within Northern Ireland, Guernsey, the Isle of Man and Jersey |

Infectious haematopoietic necrosis (IHN) | Denmark | DK | Whole territory |

Ireland | IE | Whole territory |

Cyprus | CY | All continental areas within its territory |

Finland | FI | Whole territory |

Sweden | SE | Whole territory |

The United Kingdom | UK | All continental and coastal areas within Great Britain, Northern Ireland, Guernsey, the Isle of Man and Jersey |

Koi herpes virus (KHV) disease | | | |

Infectious salmon anaemia (ISA) | Belgium | BE | Whole territory |

Bulgaria | BG | Whole territory |

Czech Republic | CZ | Whole territory |

Denmark | DK | Whole territory |

Germany | DE | Whole territory |

Estonia | EE | Whole territory |

Ireland | IE | Whole territory |

Greece | EL | Whole territory |

Spain | ES | Whole territory |

France | FR | Whole territory |

Italy | IT | Whole territory |

Cyprus | CY | Whole territory |

Latvia | LV | Whole territory |

Lithuania | LT | Whole territory |

Luxembourg | LU | Whole territory |

Hungary | HU | Whole territory |

Malta | MT | Whole territory |

Netherlands | NL | Whole territory |

Austria | AT | Whole territory |

Poland | PL | Whole territory |

Portugal | PT | Whole territory |

Romania | RO | Whole territory |

Slovenia | SI | Whole territory |

Slovakia | SK | Whole territory |

Finland | FI | Whole territory |

Sweden | SE | Whole territory |

United Kingdom | UK | Whole territory |

Infection with Marteilia refringens | Ireland | IE | The whole territory |

The United Kingdom | UK | The whole coastline of Great Britain, Northern Ireland, Guernsey, Herm and the Isle of Man The whole coastline of Northern Ireland The whole coastline of Guernsey and Herm The coastal area of the States of Jersey: the area consists of the intertidal and immediate coastal area between the mean high-water mark on the Island of Jersey and an imaginary line drawn three nautical miles from the mean low-water mark of the Island of Jersey. The area is situated in the Normano-Breton Gulf, on the south side of the English Channel The whole coastline of the Isle of Man |

Infection with Bonamia ostreae | Ireland | IE | The whole coastline of Ireland, except: 1.Cork Harbour2.Galway Bay3.Ballinakill Harbour4.Clew Bay5.Achill Sound6.Loughmore, Blacksod Bay7.Lough Foyle8.Lough Swilly |

The United Kingdom | UK | The whole coastline of Great Britain, except: 1.the south coast of Cornwall from the Lizard to Start Point;2.the coast of Dorset, Hampshire and Sussex from Portland Bill to Selsey Bill;3.the area along the coast of North Kent and Essex from North Foreland to Felixstowe;4.the area along the coast in south-west Wales from Wooltack Point to St Govan’s Head, including Milford Haven and the tidal waters of the East and West Cleddau River;5.the area containing the waters of Loch Sunart east of a line drawn south-south-east from the northernmost tip of Maclean’s Nose to Auliston Point;6.the area containing West Loch Tarbert north east of a line drawn east south east at Ardpatrick Point NR 734 578 to North Dunskeig Bay at NR 752 568The whole coastline of Northern Ireland, except: 1.Lough FoyleThe whole coastline of Guernsey, Herm and the Isle of Man The coastal area of the States of Jersey: the area consists of the intertidal and immediate coastal area between the mean high-water mark on the Island of Jersey and an imaginary line drawn three nautical miles from the mean low-water mark of the Island of Jersey. The zone is situated in the Normano-Breton Gulf, on the south side of the English Channel |

White spot disease | | | |

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ANNEX II

Model for submission of surveillance programmes for approval and for declarations of surveillance programmes

Requirements/information to be submitted

Information/further explanation and justification

1. Identification of the programme

1.1. Declaring Member State

1.2. Competent authority (address, fax, e-mail)

1.3. Reference of this document

1.4. Date sent to the Commission

2. Type of communication

2.1. Declaration for surveillance programme

2.2. Application for surveillance programme

3. National legislation (1)

4. Diseases

4.1. Fish

VHS

IHN

ISA

KHV

4.2. Molluscs

Marteilia refringens

Bonamia ostreae

4.3. Crustaceans

White spot disease

5. General information on the programmes

5.1. Competent authority (2)

5.2. Organisation, supervision of all stakeholders involved in the programme (3)

5.3. An overview of the structure of the aquaculture industry in the area in question, including types of production and species kept

5.4. The notification to the competent authority of the suspicion and confirmation of the disease(s) in question has been compulsory since when (date)?

5.5. Early detection system in place throughout the Member State, enabling the competent authority to undertake effective disease investigation and reporting since when (date)? (4)

+++++ TIFF +++++

Requirements/information to be submitted

Information/further explanation and justification

5.6. Source of aquaculture animals of species susceptible to the disease in question entering in the Member State, zone or compartments for farming

5.7. Guidelines on good hygiene practice (5)

5.8. Epidemiological situation of the disease in at least the previous four years before the commencement of the programme (6)

5.9. Description of the submitted programme (7)

5.10. Duration of the programme

6. Area covered (8)

6.1. Member State

6.2. Zone (entire water catchment area) (9)

6.3. Zone (part of water catchment area) (10)

Identify and describe the artificial or natural barrier that delimits the zone and justify its capability to prevent the upward migration of aquatic animals from the lower stretches of the water catchment area

6.4. Zone (more than one water catchment area) (11)

6.5. Compartment independent of the surrounding health status (12)

Identify and describe for each farm the water supply (13)

Well, borehole or spring

Water treatment plant inactivating the relevant pathogen (14)

Identify and describe for each farm natural or artificial barriers and justify its capability to prevent that aquatic animals enter each farm in a compartment from the surrounding watercourses

Identify and describe for each farm the protection against flooding and infiltration of water from the surrounding watercourses

6.6. Compartment dependent on the surrounding health status (15)

One epidemiological unit due to geographical localisation and distance from other farms/farming areas (16)

All farms comprising the compartment fall within a common biosecurity system (17)

Any additional requirements (18)

6.7. Farms or mollusc farming areas covered by the programme (registration numbers and geographical situation)

+++++ TIFF +++++

Requirements/information to be submitted

Information/further explanation and justification

7. Measures of the submitted programme

7.1. Summary of the measures under the programme

First year

Testing

Harvesting for human consumption or further processing

Immediate

Delayed

Removal and disposal

Immediate

Delayed

Other measures (specify)

Last year

Testing

Harvesting for human consumption or further processing

Immediate

Delayed

Removal and disposal

Immediate

Delayed

Other measures (specify)

7.2. Description of the measures of the programme (19)

Target population/species

Used tests and sampling schemes. Laboratories involved in the programme (20)

Rules on movements of animals

Measures in case of a positive result (21)

Control and supervision on the implementation of the programme and reporting

+++++ TIFF +++++

(1) National legislation in force applicable to the surveillance programme.

(2) A description shall be provided of the structure, competencies, duties and powers of the competent authority involved.

(3) A description shall be provided of the competent authorities in charge of the supervision and coordination of the programme and the different operators involved.

(4) The early detection systems shall in particular ensure the rapid recognition of any clinical signs consistent with the suspicion of a disease, emerging disease, or unexplained mortality in farms or mollusc farming areas, and in the wild, and the rapid communication of the event to the competent authority with the aim of activating diagnostic investigation with minimum delay. The early detection system shall include at least the following:

(a) broad awareness, among the personnel employed in aquaculture businesses or involved in the processing of aquaculture animals, of any signs consistent with the presence of a disease, and training of veterinarians or aquatic animals health specialists in detecting and reporting unusual disease occurrence;

(b) veterinarians or aquatic animal health specialists trained in recognising and reporting suspicious disease occurrence;

(c) access by the competent authority to laboratories with the facilities for diagnosing and differentiating listed and emerging diseases.

(5) A description shall be provided in accordance with Article 9 of Directive 2006/88/EC.

(6) Information shall be given using the table laid down in Part A of Annex III. Only applicable to surveillance programmes to be approved by the Commission.

(7) A concise description of the programme shall be given with the main objectives, the main measures, the target population, the areas of implementation and the definition of a positive case.

(8) The area covered shall be clearly identified and described in a map, which must be attached as an Annex to the application.

(9) An entire water catchment area from its sources to its estuary.

(10) Part of a water catchment area from the source(s) to a natural or artificial barrier that prevents the upward migration of aquatic animals from the lower stretches of the water catchment area.

(11) More than one water catchment area, including their estuaries, due to the epidemiological link between the catchment areas through the estuary.

(12) Compartments comprising one or more farms or mollusc farming areas where the health status regarding a specific disease is independent of the health status of surrounding natural waters regarding that disease.

(13) A compartment which is independent of the health status of surrounding waters, shall be supplied with water:

(a) through a water treatment plant inactivating the relevant pathogen in order to reduce the risk of the introduction of the disease to an acceptable level; or

(b) directly from a well, a borehole or a spring. Where such water supply is situated outside the premises of the farm, the water shall be supplied directly to the farm, and channelled through a pipe.

(14) Technical information shall be provided to demonstrate that the relevant pathogen is inactivated in order to reduce the risk of the introduction of the disease to an acceptable level.

(15) Compartments comprising one or more farms or mollusc farming areas where the health status regarding a specific disease is dependent on the health status of surrounding natural waters regarding that disease.

(16) A description shall be provided of the geographical localisation and the distance from other farms/farming areas that makes it possible to consider the compartment as one epidemiological unit.

(17) A description shall be provided of the common biosecurity system.

(18) Each farm or mollusc farming area in a compartment which is dependent on the health status of surrounding waters shall be subject to additional measures imposed by the competent authority, when considered necessary to prevent the introduction of diseases. Such measures may include the establishment of a buffer zone around the compartment in which a monitoring programme is carried out, and the establishment of additional protection against the intrusion of possible pathogen carriers or vectors.

(19) A comprehensive description needs to be provided unless reference can be made to Community legislation. The national legislation in which the measures are laid down shall be referred to.

(20) Describe diagnostic methods and sampling schemes. When OIE or EU standards are applied, refer to them. If not, describe them. Name the laboratories involved in the programme (national reference laboratory or designated laboratories).

(21) A description is provided of the measures as regards positive animals (immediate or delayed harvesting for human consumption, immediate or delayed removal and disposal, measures to avoid the spread of the pathogen when harvesting, further processing or removal and disposal, a procedure for the disinfection of the infected farms or mollusc farming areas, a procedure for restocking with healthy animals in farms or farming areas which have been depopulated and creation of surveillance zone around the infected farm or farming area, etc.).

+++++ TIFF +++++

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ANNEX III

PART A

Model for information to be submitted in relation to submissions of surveillance programmes for approval on the epidemiological situation/evolution of the disease in the last four years (one table for each year of implementation)

1. Data on testing animals

Member State, zone or compartment [1]

Disease:

Year:

Farm or mollusc farming area [2] | Number of samplings | Number of clinical inspections | Water temperature at sampling/inspection | Species at sampling | Species sampled | Number of animals sampled (total and by species) | Number of tests | Positive results of laboratorial examination | Positive results of clinical inspections |

| | | | | | | | | |

| | | | | | | | | |

| | | | | | | | | |

| | | | | | | | | |

| | | | | | | | | |

| | | | | | | | | |

Total | | Total |

2. Data on testing farms or farming areas

Disease:

Year:

Member State, zone or compartment [3] | Total number of farms or mollusc farming areas [4] | Total number of farms or mollusc farming areas under the programme | Number of farms or mollusc farming areas checked [5] | Number of positive farms or mollusc farming areas [6] | Number of new positive farms or mollusc farming areas [7] | Number of farms or mollusc farming areas depopulated | % positive farms or mollusc farming areas depopulated | Animals removed and disposed of [8] | Target indicators |

% farms or mollusc farming areas coverage | % positive farms or mollusc farming areas Period farms or mollusc farming areas prevalence | % new positive farms or mollusc farming areas Farms or mollusc farming areas incidence |

1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 = (7/5) × 100 | 9 | 10 = (4/3) × 100 | 11 = (5/4) × 100 | 12 = (6/4) × 100 |

| | | | | | | | | | | |

| | | | | | | | | | | |

| | | | | | | | | | | |

| | | | | | | | | | | |

| | | | | | | | | | | |

| | | | | | | | | | | |

Total | | | | | | | | | | | |

PART B

Model for information to be submitted in relation to submissions for approval of surveillance programmes on targets (one table for each year of implementation)

1. Targets related to testing animals

Member State, zone or compartment [9]

Disease:

Year:

Farm or mollusc farming area [10] | Number of samplings | Number of clinical inspections | Water temperature at sampling/inspection | Species at sampling | Species sampled | Number of animals sampled (total and by species) | Number of tests |

| | | | | | | |

| | | | | | | |

| | | | | | | |

| | | | | | | |

| | | | | | | |

| | | | | | | |

Total | |

2. Targets on testing farms or farming areas

Disease:

Year:

Member State, zone or compartment [11] | Total number of farms or mollusc farming areas [12] | Total number of farms or mollusc farming areas under the programme | Number of farms or mollusc farming areas expected to be checked [13] | Number of expected positive farms or mollusc farming areas [14] | Number of expected new positive farms or mollusc farming areas [15] | Number of farms or mollusc farming areas expected to be depopulated | % positive farms or mollusc farming areas expected to be depopulated | Target indicators |

Expected % farms or mollusc farming areas coverage | % positive farms or mollusc farming areas Expected period farms or mollusc farming areas prevalence | % new positive farms or mollusc farming areas Expected farms or mollusc farming areas incidence |

1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 = (7/5) × 100 | 9 = (4/3) × 100 | 10 = (5/4) × 100 | 11 = (6/4) × 100 |

| | | | | | | | | | |

| | | | | | | | | | |

| | | | | | | | | | |

| | | | | | | | | | |

| | | | | | | | | | |

| | | | | | | | | | |

Total | | | | | | | | | | |

[1] Member State, zone or compartment as defined in Point 6 of Annex II.

[2] When the number of farms/mollusc farming areas is limited or no farms/mollusc farming areas are present in whole or parts of the Member State, zone or compartment subject to the submission, and sampling therefore is carried out in wild populations, the geographical situation of the sampling must be given.

[3] Member State, zone or compartment as defined in Point 6 of Annex II.

[4] Total number of farms or mollusc farming areas existing in the Member State, zone or compartment as defined in Point 6 of Annex II.

[5] Check means to perform a farm/mollusc farming area level test under the programme for the respective disease with the purpose of upgrading the health status of the farm/mollusc farming area. In this column a farm/mollusc farming area must not be counted twice even if it has been checked more than once.

[6] Farms or mollusc farming areas with at least one positive animal during the period independent of the number of times the farms or mollusc farming areas have been checked.

[7] Farms or mollusc farming areas in which the health status for the past reporting period was, either category I, category II, category III or category IV in accordance with Part A of Annex III to Directive 2006/88/EC but which have had during this period of reference at least one positive animal for the disease in question.In the case of programmes submitted before 1 August 2008, farms or mollusc farming areas which were not positive to the disease in question in the previous period and have at least one positive animal in this period.

[8] Animals × 1000 or total weight of animals removed and disposed of.

[9] Member State, zone or compartment as defined in Point 6 of Annex II.

[10] When the number of farms/mollusc farming areas is limited or no farms/mollusc farming areas are present in whole or parts of the Member State, zone or compartment subject to the submission, and sampling therefore is carried out in wild populations, the geographical situation of the sampling must be given.

[11] Member State, zone or compartment as defined in Point 6 of Annex II.

[12] Total number of farms or mollusc farming areas existing in the Member State, zone or compartment as defined in Point 6 of Annex II.

[13] Check means to perform a farm/mollusc farming area level test under the programme for the respective disease with the purpose of upgrading the health status of the farm/mollusc farming area. In this column a farm/mollusc farming area must not be counted twice even if it has been checked more than once.

[14] Farms or mollusc farming areas with at least one positive animal during the period independent of the number of times the farms or mollusc farming areas have been checked.

[15] Farms or mollusc farming areas in which the health status for the past reporting period was, either category I, category II, category III or category IV in accordance with Part A of Annex III to Directive 2006/88/EC but which have had during this period of reference at least one positive animal for the disease in question.

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ANNEX IV

Model for submissions of applications for and declarations of disease-free status

Requirements/information needed

Information/further explanation and justification

1. Identification of the programme

1.1. Declaring Member State

1.2. Competent authority (address, fax, e-mail)

1.3. Reference of this document

1.4. Date sent to the Commission

2. Type of communication

2.1. Declaration of disease-free status

2.2. Submission of application for disease-free status

3. National legislation (1)

4. Diseases

4.1. Fish

VHS

IHN

ISA

KHV

4.2. Molluscs

infection with Marteilia refringens

infection with Bonamia ostreae

4.3. Crustaceans

White spot disease

5. Grounds for disease-free status

5.1. No susceptibles (2)

5.2. Pathogen not viable (3)

5.3. Historic free-status (4)

5.4. Targeted surveillance (5)

+++++ TIFF +++++

6. General information

6.1. Competent authority (6)

6.2. Organisation, supervision of all stakeholders involved in the programme to achieve disease-free status (7)

6.3. An overview of the structure of the aquaculture industry in the area in question (disease-free Member State, zone or compartment) including types of production and species kept

6.4. The notification to the competent authority of the suspicion and confirmation of the disease(s) in question has been compulsory since when (date)?

6.5. Early detection system in place throughout the Member State, enabling the competent authority to undertake effective disease investigation and reporting since when (date)? (8)

6.6. Source of aquaculture animals of species susceptible to the disease in question entering in the Member State, zone or compartments for farming

6.7. Guidelines on good hygiene practice (9)

7. Area covered

7.1. Member State

7.2. Zone (entire water catchment area) (10)

7.3. Zone (part of water catchment area) (11)

Identify and describe the artificial or natural barrier that delimits the zone and justify its capability to prevent the upward migration of aquatic animals from the lower stretches of the water catchment area

7.4. Zone (more than one water catchment area) (12)

7.5. Compartment independent of the surrounding health status (13)

Identify and describe for each farm the water supply (14)

Well, borehole or spring

Water treatment plant inactivating the relevant pathogen (15)

Identify and describe for each farm natural or artificial barriers and justify its capability to prevent that aquatic animals enter each farm in a compartment from the surrounding watercourses

Identify and describe for each farm the protection against flooding and infiltration of water from the surrounding watercourses

+++++ TIFF +++++

7.6. Compartment dependent on the surrounding health status (16)

One epidemiological unit due to geographical localisation and distance from other farms/farming areas (17)

All farms comprising the compartment fall within a common biosecurity system (18)

Any additional requirements (19)

8. Geographical demarcation (20)

8.1. Farms or mollusc farming areas covered (registration numbers and geographical situation)

8.2. Non-free buffer zone (21)

Geographical demarcation (19)

Farms or mollusc farming areas covered (registration numbers, geographical situation and health status (22)

Type of health surveillance

8.3. Non-free zones or compartments (23)

Geographical demarcation (19)

Farms or mollusc farming areas covered (registration numbers, geographical situation and health status (15)

8.4. Extension of disease-free zone to other Member States (24)

Geographical demarcation (19)

8.5. Existing disease-free zones/compartments in the vicinity

Geographical demarcation (19)

Farms or mollusc farming areas covered (registration numbers and geographical situation)

9. Farms or mollusc farming areas which commence or recommence their activities (25)

9.1. New farm

9.2. Recommencing farm

Health history of farm known to competent authority

Not subject to animal health measures in respect of listed diseases

Farm cleaned, disinfected and, as necessary, fallowed

+++++ TIFF +++++

(1) National legislation in force applicable to the declaration of and application for disease-free status

(2) Applicable if none of the species susceptible to the disease(s) in question is present in the Member State, zone or compartment, and where relevant in its water source.

(3) Applicable if the pathogen is known not to be able to survive in the Member State, zone or compartment, and where relevant in its water source. Provide the scientific information supporting the inability of the pathogen to survive in the Member State, zone or compartment.

(4) Applicable if susceptible species are present, but where there has not been any observed occurrence of the disease for at least a period of 10 years before the date of declaration of or application for the disease-free status, despite conditions that are conducive to its clinical expression, and if it complies mutatis mutandis with the requirements laid down in Part I.1 of Annex V to Directive 2006/88/EC. This ground for disease-free status must be declared or applied for by 1 November 2008. Provide detailed information on the compliance with Part I.1 of Annex V to Directive 2006/88/EC.

(5) Applicable if targeted surveillance complying with Community requirements has been in place for at least a period of two years without the detection of the disease agent on farm, or in mollusc farming areas that rear any of the susceptible species.

Where there are parts of the Member State, zone or compartment in which the number of farms or mollusc farming areas is limited, but in which there are wild populations of susceptible species, information on the targeted surveillance in those wild populations shall be given.

Describe diagnostic methods and sampling schemes. When OIE or EU standards are applied, reference must be made to them. If not, describe them. Name the laboratories involved in the programme (national reference laboratory or designated laboratories).

(6) A description shall be provided of the structure, competencies, duties and powers of the competent authority involved.

(7) A description shall be provided of the competent authority in charge of the supervision and coordination of the programme and the different operators involved.

(8) The early detection systems shall in particular ensure the rapid recognition of any clinical signs consistent with the suspicion of a disease, emerging disease, or unexplained mortality in farms or mollusc farming areas, and in the wild, and the rapid communication of the event to the competent authority with the aim of activating diagnostic investigation with minimum delay. The early detection system shall include at least the following:

(a) broad awareness, among the personnel employed in aquaculture businesses or involved in the processing of aquaculture animals, of any signs consistent with the presence of a disease, and training of veterinarians of aquatic animals health specialists in detecting and reporting unusual disease occurrence;

(b) veterinarians or aquatic animal health specialists trained in recognising and reporting suspicious disease occurrence;

(c) access by the competent authority to laboratories with the facilities for diagnosing and differentiating listed and emerging diseases.

(9) A description shall be provided in accordance with Article 9 of Directive 2006/88/EC.

(10) An entire water catchment area from its sources to its estuary.

(11) Part of a water catchment area from the source(s) to a natural or artificial barrier that prevents the upward migration of aquatic animals from the lower stretches of the water catchment area.

(12) More than one water catchment area, including their estuaries, due to the epidemiological link between the catchment areas through the estuary.

(13) Compartments comprising one or more farms or mollusc farming areas where the health status regarding a specific disease is independent of the health status regarding that disease of surrounding natural waters.

(14) A compartment which is independent of the health status of surrounding waters, shall be supplied with water:

(a) through a water treatment plant inactivating the relevant pathogen in order to reduce the risk of the introduction of the disease to an acceptable level; or

(b) directly from a well, a borehole or a spring. Where such water supply is situated outside the premises of the farm, the water shall be supplied directly to the farm, and be channelled through a pipe.

(15) Provide technical information to demonstrate that the relevant pathogen is inactivated in order to reduce the risk of the introduction of the disease to an acceptable level.

(16) Compartments comprising one or more farms or mollusc farming areas where the health status regarding a specific disease is dependent on the health status of surrounding natural waters regarding that disease.

(17) A description shall be provided of the geographical localisation and the distance from other farms/farming areas that makes it possible to consider the compartment as one epidemiological unit.

(18) A description shall be provided of the common biosecurity system.

(19) Each farm or mollusc farming area in a compartment which is dependent on the health status of surrounding waters shall be subject to additional measures imposed by the competent authority, when considered necessary to prevent the introduction of diseases. Such measures may include the establishment of a buffer zone around the compartment in which a monitoring programme is carried out, and the establishment of additional protection against the intrusion of possible pathogen carriers or vectors.

(20) The geographical demarcation shall be clearly described and identified on a map, which must be attached as an Annex to the declaration/application. Any substantial modification in the geographical demarcation of the zone or compartment to be declared free must be subjected to a new application.

(21) In connection with a zone or a compartment dependent on the health status of surrounding waters, a buffer zone in which a monitoring programme is carried out shall be established, as appropriate. The demarcation of the buffer zones shall be such that it protects the disease-free zone from passive introduction of the disease. (Part II.1.5 of Annex V to Directive 2006/88/EC).

(22) Health status in accordance with Part A of Annex III to Directive 2006/88/EC.

(23) Relevant in cases of declaration of disease-free Member States, where minor areas of the Member State are not considered disease-free.

(24) Where a zone extends to more than one Member State, it may not be declared a disease-free zone unless the conditions set out in points 1.3, 1.4 and 1.5 of Part II of Annex V to Directive 2006/88/EC apply to all areas of that zone. In that case both Member States concerned shall apply for approval for the part of the zone situated in their territory.

(25) In accordance with Part II.4 of Annex V to Directive 2006/88/EC.

+++++ TIFF +++++

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ANNEX V

Model for information to be submitted in relation to submissions of applications for and declarations of disease-free status (one table for each year of implementation)

1. Data on testing animals

Member State, zone or compartment [1]

Disease:

Year:

Farm or mollusc farming area [2] | Number of samplings | Number of clinical inspections | Water temperature at sampling/inspection | Species at sampling | Species sampled | Number of animals sampled (total and by species) | Number of tests | Positive results of laboratorial examination | Positive results of clinical inspections |

| | | | | | | | | |

| | | | | | | | | |

| | | | | | | | | |

| | | | | | | | | |

| | | | | | | | | |

| | | | | | | | | |

Total | | Total |

2. Data on testing farms or farming areas

Disease:

Year:

Member State, zone or compartment [3] | Total number of farms or mollusc farming areas [4] | Total number of farms or mollusc farming areas under the programme | Number of farms or mollusc farming areas checked [5] | Number of positive farms or mollusc farming areas [6] | Number of new positive farms or mollusc farming areas [7] | Number of farms or mollusc farming areas depopulated | % positive farms or mollusc farming areas depopulated | Animals removed and disposed of [8] | Target indicators |

% farms or mollusc farming areas coverage | % positive farms or mollusc farming areas Period farms or mollusc farming areas prevalence | % new positive farms or mollusc farming areas Farms or mollusc farming areas incidence |

1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 = (7/5) × 100 | 9 | 10 = (4/3) × 100 | 11 = (5/4) × 100 | 12 = (6/4) × 100 |

| | | | | | | | | | | |

| | | | | | | | | | | |

| | | | | | | | | | | |

| | | | | | | | | | | |

| | | | | | | | | | | |

| | | | | | | | | | | |

Total | | | | | | | | | | | |

[1] Member State, zone or compartment as defined in point 7 of Annex IV.

[2] When the number of farms/mollusc farming areas is limited or no farms/mollusc farming areas are present in whole or parts of the Member State, zone or compartment subject to the application or declaration, and sampling therefore is done in wild populations, the geographical situation of the sampling should be given.

[3] Member State, zone or compartment as defined in point 7 of Annex IV.

[4] Total number of farms or mollusc farming areas existing in the Member State, zone or compartment as defined in point 7 of Annex IV.

[5] Check means to perform a farm/mollusc farming area level test under the programme to achieve disease-free status for the respective disease with the purpose of upgrading the health status of the farm/mollusc farming area. In this column a farm/mollusc farming area must not be counted twice even if it has been checked more than once.

[6] Farms or mollusc farming areas with at least one positive animal during the period independent of the number of times the farms or mollusc farming areas have been checked.

[7] Farms or mollusc farming areas in which the health status for the past reporting period was, either category I, category II, category III or category IV in accordance with Part A of Annex III to Directive 2006/88/EC but which have had during this period of reference at least one positive animal for the disease in question.In the case of programmes submitted before 1 August 2008, farms or mollusc farming areas which were not positive to the disease in question in the previous period and have at least one positive animal in this period.

[8] Animals × 1000 or total weight of animals removed and disposed of.

--------------------------------------------------

ANNEX VI

MODEL REPORT

1. Report related to testing of animals

Member State, zone or compartment [1]

Disease:

Year:

Farm or mollusc farming area [2] | Number of samplings | Number of clinical inspections | Water temperature at sampling/inspection | Species at sampling | Species sampled | Number of animals sampled (total and by species) | Number of tests | Positive results of laboratorial examination | Positive results of clinical inspections |

| | | | | | | | | |

| | | | | | | | | |

| | | | | | | | | |

| | | | | | | | | |

| | | | | | | | | |

| | | | | | | | | |

Total | | Total |

2. Report on testing farms or farming areas

Disease:

Year:

Member State, zone or compartment [3] | Total number of farms or mollusc farming areas [4] | Total number of farms or mollusc farming areas under the programme | Number of farms or mollusc farming areas checked [5] | Number of positive farms or mollusc farming areas [6] | Number of new positive farms or mollusc farming areas [7] | Number of farms or mollusc farming areas depopulated | % positive farms or mollusc farming areas depopulated | Animals removed and disposed of [8] | Target indicators |

% farms or mollusc farming areas coverage | % positive farms or mollusc farming areas Period farms or mollusc farming areas prevalence | % new positive farms or mollusc farming areas Farms or mollusc farming areas incidence |

1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 = (7/5) × 100 | 9 | 10 = (4/3) × 100 | 11 = (5/4) × 100 | 12 = (6/4) × 100 |

| | | | | | | | | | | |

| | | | | | | | | | | |

| | | | | | | | | | | |

| | | | | | | | | | | |

| | | | | | | | | | | |

| | | | | | | | | | | |

Total | | | | | | | | | | | |

[1] Member State, zone or compartment as defined in point 6 of Annex II.

[2] When the number of farms/farming areas is limited or no farms/farming areas are present in whole or parts of the Member State, zone or compartment subject to the application, and sampling therefore is carried out in wild populations, the geographical situation of the sampling must be given.

[3] Member State, zone or compartment as defined in point 6 of Annex II.

[4] Total number of farms or mollusc farming areas existing in the Member State, zone or compartment as defined in point 6 of Annex II.

[5] Check means to perform a farm/mollusc farming area level test under the programme for the respective disease with the purpose of upgrading the health status of the farm/mollusc farming area. In this column a farm/mollusc farming area must not be counted twice even if it has been checked more than once.

[6] Farms or mollusc farming areas with at least one positive animal during the period independent of the number of times the farms or mollusc farming areas have been checked.

[7] Farms or mollusc farming areas in which the health status for the past reporting period was, either Category I, Category II, Category III or Category IV in accordance with Part A of Annex III to Directive 2006/88/EC but which have had during this period of reference at least one positive animal for the disease in question.In the case of programmes submitted before 1 August 2008, farms or mollusc farming areas which were not positive to the disease in question in the previous period and have at least one positive animal in this period.

[8] Animals × 1000 or total weight of animals removed and disposed of.

--------------------------------------------------