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.