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:
[F21.]
In this Decision—
(a)“the appropriate authority” means—
(i)in relation to England, the Secretary of State;
(ii)in relation to Wales, the Welsh Ministers;
(iii)in relation to Scotland, the Scottish Ministers;
but the appropriate authority is the Secretary of State if consent is given—
(i)in respect of functions exercisable in relation to Scotland, by the Scottish Ministers;
(ii)in respect of functions exercisable in relation to Wales, by the Welsh Ministers;
(b)“the Aquatic Animal Health Regulations” means—
(i)in relation to England and Wales, the Aquatic Animal Health (England and Wales) Regulations 2009;
(ii)in relation to Scotland, the Aquatic Animal Health (Scotland) Regulations 2009;
(c)“constituent GB territory”, means England, Wales or Scotland as the case may be;
(d)“Decision 2015/1554” means Commission Implementing Decision (EU) 2015/1554 laying down rules for the application of Directive 2006/88/EC as regards requirements for surveillance and diagnostic methods;
(e)“Regulation 1251/2008” means Commission Regulation (EC) No 1251/2008 implementing Council Directive 2006/88/EC as regards conditions and certification requirements for the placing on the market and the import into the Community of aquaculture animals and products thereof and laying down a list of vector species.]
[F32.In this Decision an animal is of a species susceptible to a disease if it is of a species listed as susceptible to that disease in a document published by the appropriate authority under Article 3a(1) of Regulation (EC) No 1251/2008.]
Textual Amendments
F1Art. A1 inserted (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 9(2)
F2Words in Art. A1 renumbered as Art. A1(1) (15.8.2022) by The Aquatic Animal Health (Amendment) Regulations 2022 (S.I. 2022/835), regs. 1(2), 5(2)(a)
F3Art. A1(2) inserted (15.8.2022) by The Aquatic Animal Health (Amendment) Regulations 2022 (S.I. 2022/835), regs. 1(2), 5(2)(b)
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Textual Amendments
1.The appropriate authority for a constituent GB territory may declare that territory free of one or more of the non-exotic diseases listed in Annex 1A to Regulation 1251/2008 if—
(a)the conditions in paragraph 2 and, where applicable, paragraph 3 are met; and
(b)the requirements for surveillance, buffer zones, sampling and diagnostic methods set out in Decision (EU) 2015/1554 have been met.
2.The first condition is that—
(a)none of the species susceptible to the disease in question are present in the constituent GB territory;
(b)the pathogen is known not to be able to survive in the constituent GB territory and its water source; or
(c)the conditions in Part 1 of Annex 5 to Directive 2006/88/EC are met.
3.Where adjoining constituent GB territories or water catchment areas shared with a neighbouring constituent GB territory are not declared disease-free, the second condition is that appropriate buffer zones have been established to protect the disease-free territory from passive introduction of the disease.
Textual Amendments
1.The appropriate authority may declare a zone or compartment free of one or more of the non-exotic diseases listed in Annex 1A to Regulation 1251/2008 if—
(a)the condition in paragraph 2 is met; and
(b)the requirements for surveillance, buffer zones, sampling and diagnostic methods set out in Decision (EU) 2015/1554 have been met.
2.The first condition is that—
(a)none of the species susceptible to the disease in question are present in the zone or compartment;
(b)the pathogen is known not to be able to survive in the zone or compartment and, where relevant, its water source; or
(c)the conditions in Part 2 of Annex 5 to Directive 2006/88/EC are met.
Textual Amendments
Where a constituent GB territory is declared free from one or more non-exotic diseases listed in Annex 1A to Regulation 1251/2008 in accordance with Article 2a, the appropriate authority may discontinue targeted surveillance and maintain its disease-free status provided that the conditions conducive to clinical expression of the disease in question exist.
However, for disease-free zones or compartments in a constituent GB territory not declared disease-free, and in all cases where conditions are not conducive to clinical expression of the disease in question, targeted surveillance shall be continued in accordance with the methods provided for in Decision 2015/1554, but at a level commensurate with the degree of risk.
Textual Amendments
1.Where the appropriate authority has reason to believe that any of the conditions for maintaining disease-free status are no longer met in respect of their constituent GB territory, zone or compartment, the appropriate authority must apply the provisions of Part 4 of the Aquatic Animal Health Regulations.
2.Where the epizootic investigation required by Part 4 of the Aquatic Animal Health Regulations confirms that the conditions for maintaining disease-free status are still met, the disease-free status of the constituent GB territory, zone or compartment may be restored.
3.Where the epizootic investigation confirms a significant likelihood that infection has occurred, the disease-free status of the constituent GB territory, zone or compartment must be withdrawn. The requirements laid down in Annex 5 to Directive 2006/88/EC must be complied with before disease-free status is restored.]
Textual Amendments
Textual Amendments
F5Section 2 heading substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 9(4)
1.The appropriate authority for a constituent GB territory may declare that territory, or a zone or compartment thereof, free of one or more of the exotic diseases listed in Annex 1A to Regulation 1251/2008 if the condition in paragraph 2 is met.
2.The condition is that—
(a)none of the species susceptible to the disease in question are present in the constituent GB territory, zone or compartment;
(b)the pathogen is known not to be able to survive in the constituent GB territory, zone or compartment and its water source;
(c)susceptible species are present, but there has not been any observed occurrence of the disease in the constituent GB territory, zone or compartment for at least ten years; or
(d)the last known occurrence was within the last ten years, but targeted surveillance has not detected the disease on a farm, or in a mollusc farming area, that rears any of the susceptible species.
Textual Amendments
1.Where the appropriate authority has reason to believe that the condition for maintaining exotic disease-free status is no longer met in respect of their constituent GB territory, zone or compartment, the appropriate authority must undertake an investigation.
2.Where the investigation required by paragraph 1 confirms that the condition for maintaining exotic disease-free status is still met, the disease-free status of the constituent GB territory, zone or compartment may be restored.
3.Where the investigation confirms a significant likelihood that infection has occurred, the exotic disease-free status of the constituent GB territory, zone or compartment must be withdrawn until the condition in Article 2e(2) is once again met.]
Textual Amendments
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Textual Amendments
F9Art. 3 omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 9(6)
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Textual Amendments
F10Art. 4 omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 9(6)
1.Subject to paragraph 2, declarations of disease-free status made before IP completion day which are listed in Part C of Annex 1 are to be treated as if—
(a)references to Great Britain were to the relevant constituent GB territory; and
(b)they had been made in accordance with Article 2a or 2b (as the case may be).
2.Paragraph 1 does not apply where, following IP completion day, disease-free status has been withdrawn in relation to any of the areas listed in Part C of Annex 1 in accordance with Article 2d.
3.The Internet-based information pages required by Article 10 are to be considered to be the definitive list of constituent GB territories, zones and compartments which are declared to be disease-free..]
Textual Amendments
Textual Amendments
F7Section 2A heading inserted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 9(5)
Textual Amendments
F12Section 3 omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 9(8)
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Textual Amendments
F14Art. 9 omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 9(10)
The appropriate authority must establish and keep up-to-date Internet-based information pages in order to make publicly available the list of constituent GB territories, zones or compartments declared to be disease-free.]
Textual Amendments
Textual Amendments
F13Words in Section 4 heading omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 9(9)
Textual Amendments
F16Section 5 omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 9(12)
Textual Amendments
F17Section 6 omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 9(12)
F18 ...
Textual Amendments
F18Annex 1 Pt. A omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 9(13)(a)
F19...
Textual Amendments
[F20Declarations of disease-free status prior to IP completion day
| Disease | Geographical demarcation of the disease-free area |
|---|---|
| Viral haemorrhagic septicaemia (VHS) | All continental and coastal areas within Great Britain. |
| Infectious haematopoietic necrosis (IHN) | All continental and coastal areas within Great Britain. |
| Infectious salmon anaemia (ISA); infection with genotype HPR-deleted of the genus Isavirus (ISAV) | All continental and coastal areas within Great Britain. |
| Infection with Marteilia refringens | The whole coastline of Great Britain. |
| Infection with Bonamia ostreae | 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 from Ardpatrick Point NR 734 578 to North Dunskeig Bay at NR 752 568; 7. The Dornoch Firth, the area of tidal waters west of a line drawn from NH808873 to NH835857 (Ordnance Survey Landranger 1:50,000 series) to the mean high water mark; 8. Lynn of Lorn, Loch Creran and Loch Etive, the area of marine waters south-east of the island of Lismore, contained within a circle of radius 7258 metres from point NM873391 (ordnance Survey Landranger 1:50,000 series) and including the tidal waters of Loch Etive and Loch Creran to the mean high water mark.] |
Textual Amendments
F20Annex 1 Pt. C table and heading substituted (E.W.S) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 9(13)(b)
Textual Amendments
F21Annexes 2-6 omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 9(14)