# L_2016032EN.01015801.xml

| 9.2.2016 | EN | Official Journal of the European Union | L 32/158 |
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9.2.2016

EN

Official Journal of the European Union

L 32/158

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COMMISSION IMPLEMENTING DECISION (EU) 2016/169

of 5 February 2016

amending Decision 2010/221/EU as regards national measures for preventing the introduction of certain aquatic animal diseases into Ireland, Finland, Sweden and the United Kingdom

(notified under document C(2016) 605)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

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 Article 43(2) thereof,

Whereas:

| (1) | Commission Decision 2010/221/EU (2) allows certain Member States to apply placing on the market and import restrictions on consignments of aquatic animals in order to prevent the introduction of certain diseases into their territory, provided that they have either demonstrated that their territory, or certain demarcated areas of their territory, are free of such diseases or that they have established an eradication or surveillance programme to obtain such freedom. Member States which have an approved eradication programme for one or more of those diseases, may according to Article 3(2) of that Decision only apply placing on the market and import restrictions with regard to those diseases until 31 December 2015. |
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(1)

Commission Decision 2010/221/EU (2) allows certain Member States to apply placing on the market and import restrictions on consignments of aquatic animals in order to prevent the introduction of certain diseases into their territory, provided that they have either demonstrated that their territory, or certain demarcated areas of their territory, are free of such diseases or that they have established an eradication or surveillance programme to obtain such freedom. Member States which have an approved eradication programme for one or more of those diseases, may according to Article 3(2) of that Decision only apply placing on the market and import restrictions with regard to those diseases until 31 December 2015.

| (2) | Decision 2010/221/EU provides that the Member States and parts thereof listed in Annex I thereto are to be regarded as free from the diseases listed in that Annex. In addition, that Decision approved the eradication programmes adopted by certain Member States in respect of the areas and the diseases listed in Annex II thereto. That Decision also approves the surveillance programmes regarding ostreid herpes virus 1 μvar (OsHV-1μVar) adopted by certain Member States in respect of the areas set out in Annex III thereto. |
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(2)

Decision 2010/221/EU provides that the Member States and parts thereof listed in Annex I thereto are to be regarded as free from the diseases listed in that Annex. In addition, that Decision approved the eradication programmes adopted by certain Member States in respect of the areas and the diseases listed in Annex II thereto. That Decision also approves the surveillance programmes regarding ostreid herpes virus 1 μvar (OsHV-1μVar) adopted by certain Member States in respect of the areas set out in Annex III thereto.

| (3) | Finland has in accordance with Article 43 of Directive 2006/88/EC submitted an application to the Commission for approval of placing on the market and import restrictions on consignments of aquatic animals in order to prevent the introduction of salmonid alphavirus (SAV) into the continental parts of its territory. The main justification for Finland's application is that SAV may cause serious fish diseases like Pancreas disease (PD) and Sleeping disease (SD) in susceptible species. Those diseases are easily transmitted and are shown to cause substantial losses in particular to farms rearing Atlantic salmon (Salmo salar), but also populations of rainbow trout (Oncorhynchus mykiss) and brown trout (Salmo trutta) may be heavily affected. Finland has a substantial yearly production of those species reared both for food production and for restocking purposes. Those species need to be protected from introduction of SAV. |
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(3)

Finland has in accordance with Article 43 of Directive 2006/88/EC submitted an application to the Commission for approval of placing on the market and import restrictions on consignments of aquatic animals in order to prevent the introduction of salmonid alphavirus (SAV) into the continental parts of its territory. The main justification for Finland's application is that SAV may cause serious fish diseases like Pancreas disease (PD) and Sleeping disease (SD) in susceptible species. Those diseases are easily transmitted and are shown to cause substantial losses in particular to farms rearing Atlantic salmon (Salmo salar), but also populations of rainbow trout (Oncorhynchus mykiss) and brown trout (Salmo trutta) may be heavily affected. Finland has a substantial yearly production of those species reared both for food production and for restocking purposes. Those species need to be protected from introduction of SAV.

| (4) | Infection with SAV is defined in the Aquatic Animal Health Code (Aquatic Code) of the World Organisation for Animal Health (OIE) as an infection with any subtype of SAV of the genus Alphavirus of the family Togaviridae. Such infections are notifiable to the OIE since 2014 and diagnostic methods to detect and identify the pathogen are set out in the OIE Manual of Diagnostic Test for Aquatic Animals (OIE Aquatic Manual). Furthermore, the Aquatic Code contains specific recommendations for achieving and maintaining disease free status with regard to SAV, and for importation and transit of aquatic animals and products thereof from a country not declared free from infections with SAV. |
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(4)

Infection with SAV is defined in the Aquatic Animal Health Code (Aquatic Code) of the World Organisation for Animal Health (OIE) as an infection with any subtype of SAV of the genus Alphavirus of the family Togaviridae. Such infections are notifiable to the OIE since 2014 and diagnostic methods to detect and identify the pathogen are set out in the OIE Manual of Diagnostic Test for Aquatic Animals (OIE Aquatic Manual). Furthermore, the Aquatic Code contains specific recommendations for achieving and maintaining disease free status with regard to SAV, and for importation and transit of aquatic animals and products thereof from a country not declared free from infections with SAV.

| (5) | Finland has provided information describing its system of control and compulsory notification of aquatic animal diseases, and furthermore describing the surveillance schemes which has been in place to document which continental parts of Finland are SAV-free. That information, confirming that passive surveillance for SAV has been in place since the disease was made notifiable in accordance with Finnish legislation in 2010 and targeted surveillance over a period of two years from 2013 to 2014, both using diagnostic methods in accordance with the OIE Aquatic Manual, supports the assessment of the continental parts of Finland being free of SAV. |
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(5)

Finland has provided information describing its system of control and compulsory notification of aquatic animal diseases, and furthermore describing the surveillance schemes which has been in place to document which continental parts of Finland are SAV-free. That information, confirming that passive surveillance for SAV has been in place since the disease was made notifiable in accordance with Finnish legislation in 2010 and targeted surveillance over a period of two years from 2013 to 2014, both using diagnostic methods in accordance with the OIE Aquatic Manual, supports the assessment of the continental parts of Finland being free of SAV.

| (6) | Finland has furthermore provided information describing the epidemiological situation with regard to SAV in water catchment areas shared with Norway, Sweden and Russia and the biosecurity measures in place to prevent possible transfer of SAV from the coastal areas into the continental areas of Finland. That information shows that the measures in place are in line with the OIE recommendations, and thus also supports the position that the continental parts of Finland may be regarded as free of SAV. |
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(6)

Finland has furthermore provided information describing the epidemiological situation with regard to SAV in water catchment areas shared with Norway, Sweden and Russia and the biosecurity measures in place to prevent possible transfer of SAV from the coastal areas into the continental areas of Finland. That information shows that the measures in place are in line with the OIE recommendations, and thus also supports the position that the continental parts of Finland may be regarded as free of SAV.

| (7) | Based on the OIE's recognition of SAV as a serious infectious disease affecting certain salmonid species and the information provided from Finland with regard to the current health status as regards SAV and the possible economic and ecological impact of the introduction of SAV into the continental parts of Finland, it is justified that the application of certain placing on the market and import restrictions in accordance with Article 43 of Directive 2006/88/EC to prevent such introduction should be approved. Consequently, salmonid alphavirus (SAV) should be listed in Annex I to Decision 2010/221/EU for the continental parts of the territory of Finland. |
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(7)

Based on the OIE's recognition of SAV as a serious infectious disease affecting certain salmonid species and the information provided from Finland with regard to the current health status as regards SAV and the possible economic and ecological impact of the introduction of SAV into the continental parts of Finland, it is justified that the application of certain placing on the market and import restrictions in accordance with Article 43 of Directive 2006/88/EC to prevent such introduction should be approved. Consequently, salmonid alphavirus (SAV) should be listed in Annex I to Decision 2010/221/EU for the continental parts of the territory of Finland.

| (8) | The United Kingdom is listed in Annex I to Decision 2010/221/EU with the territory of Great Britain, except Whitstable Bay in Kent, Blackwater Estuary and River Crouch in Essex and Poole Harbour in Dorset as recognised as free of OsHV-1μVar. |
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(8)

The United Kingdom is listed in Annex I to Decision 2010/221/EU with the territory of Great Britain, except Whitstable Bay in Kent, Blackwater Estuary and River Crouch in Essex and Poole Harbour in Dorset as recognised as free of OsHV-1μVar.

| (9) | The United Kingdom has notified to the Commission that OsHV-1μVar recently is detected in The River Roach in Essex and in an area outside Whitstable Bay at the north coast of Kent. Furthermore as a result of an epidemiological evaluation following the detection in The River Roach, the non-disease-free compartment in Essex is enlarged to incorporate the existing non-disease free compartment in the Blackwater and River Colne. Finally, The United Kingdom has notified the detection of OsHV-1μVar in the River Teign in Devon. Those areas should therefore no longer be recognised as being free of that disease. The geographical demarcations for the territory of the United Kingdom recognised as free of OsHV-1μVar should be amended accordingly. |
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(9)

The United Kingdom has notified to the Commission that OsHV-1μVar recently is detected in The River Roach in Essex and in an area outside Whitstable Bay at the north coast of Kent. Furthermore as a result of an epidemiological evaluation following the detection in The River Roach, the non-disease-free compartment in Essex is enlarged to incorporate the existing non-disease free compartment in the Blackwater and River Colne. Finally, The United Kingdom has notified the detection of OsHV-1μVar in the River Teign in Devon. Those areas should therefore no longer be recognised as being free of that disease. The geographical demarcations for the territory of the United Kingdom recognised as free of OsHV-1μVar should be amended accordingly.

| (10) | The continental part of the territory of Sweden is listed in Annex II to Decision 2010/221/EU as a territory with an approved eradication programme for bacterial kidney disease (BKD). Likewise, the coastal parts of the territory of Sweden are listed in that Annex with an approved eradication programme with regard to infectious pancreas necrosis (IPN). |
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(10)

The continental part of the territory of Sweden is listed in Annex II to Decision 2010/221/EU as a territory with an approved eradication programme for bacterial kidney disease (BKD). Likewise, the coastal parts of the territory of Sweden are listed in that Annex with an approved eradication programme with regard to infectious pancreas necrosis (IPN).

| (11) | Sweden has reported to the Commission that over the last three years of surveillance in areas subject to the approved eradication programme five farms have tested positive with regard to BKD. Those farms are currently being subject to control and eradication measures in order to establish disease free status. In order to follow up on these farms and to be able to make an overall evaluation of the entire BKD-programme, Sweden has requested an extension of the period for which it may apply placing on the market and import restrictions with regard to that disease as set out in Decision 2010/221/EU. In view of the results of the programme such prolongation is appropriate. |
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(11)

Sweden has reported to the Commission that over the last three years of surveillance in areas subject to the approved eradication programme five farms have tested positive with regard to BKD. Those farms are currently being subject to control and eradication measures in order to establish disease free status. In order to follow up on these farms and to be able to make an overall evaluation of the entire BKD-programme, Sweden has requested an extension of the period for which it may apply placing on the market and import restrictions with regard to that disease as set out in Decision 2010/221/EU. In view of the results of the programme such prolongation is appropriate.

| (12) | As regards IPN, both Finland and Sweden have previously asked the Commission for an evaluation of the further approach and scope of the surveillance and eradication programmes for that disease. At current the definition of IPN includes all genogroups of IPN. Only strains of IPN-virus genogroup 5 are known to cause mortality and clinical disease in farmed salmonids in Europe. Therefore, other genogroups should not be included in those eradication programmes. A decision on this issue can, however, only be made on the basis of a comprehensive scientific evaluation. Such evaluation has not been carried out so far. Until such evaluation is completed it is appropriate to prolong Sweden's ongoing IPN eradication programme and consequently the possibility to apply placing on the market and import restrictions as set out in Decision 2010/221/EU. |
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(12)

As regards IPN, both Finland and Sweden have previously asked the Commission for an evaluation of the further approach and scope of the surveillance and eradication programmes for that disease. At current the definition of IPN includes all genogroups of IPN. Only strains of IPN-virus genogroup 5 are known to cause mortality and clinical disease in farmed salmonids in Europe. Therefore, other genogroups should not be included in those eradication programmes. A decision on this issue can, however, only be made on the basis of a comprehensive scientific evaluation. Such evaluation has not been carried out so far. Until such evaluation is completed it is appropriate to prolong Sweden's ongoing IPN eradication programme and consequently the possibility to apply placing on the market and import restrictions as set out in Decision 2010/221/EU.

| (13) | Evaluations concerning transmissible animal diseases which may be subject to national measures will be carried out by the Commission within the framework of the foreseen new Union legislation on animal health. In view of that it is appropriate to prolong the time limit set out in Article 3(2) of Decision 2010/221/EU for authorisation to apply certain national measures until those evaluations are concluded and the new Union animal legislation enters into force, which is foreseen to take place in 2021. |
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(13)

Evaluations concerning transmissible animal diseases which may be subject to national measures will be carried out by the Commission within the framework of the foreseen new Union legislation on animal health. In view of that it is appropriate to prolong the time limit set out in Article 3(2) of Decision 2010/221/EU for authorisation to apply certain national measures until those evaluations are concluded and the new Union animal legislation enters into force, which is foreseen to take place in 2021.

| (14) | Annex III to Decision 2010/221/EU lists seven compartments in the territory of Ireland with an approved surveillance programme as regards OsHV-1μVar. Ireland has recently informed the Commission that OsHV-1μVar was detected in Gweebara Bay (Compartment 2) and Kenmare Bay (Compartment 7). Consequently those compartments should be removed from the areas listed in Annex III. |
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(14)

Annex III to Decision 2010/221/EU lists seven compartments in the territory of Ireland with an approved surveillance programme as regards OsHV-1μVar. Ireland has recently informed the Commission that OsHV-1μVar was detected in Gweebara Bay (Compartment 2) and Kenmare Bay (Compartment 7). Consequently those compartments should be removed from the areas listed in Annex III.

| (15) | Ireland has further submitted a declaration of disease freedom with regard to OsHV-1μVar for the remaining five compartments listed in Annex III to Decision 2010/221/EU and for a new Compartment A: Tralee Bay Hatchery. That declaration complies with the requirements for a declaration of freedom of disease laid down in Directive 2006/88/EC. Accordingly the following compartments of the territory of Ireland: Compartment 1: Sheephaven Bay, Compartment 3: Killala, Broadhaven and Blacksod bays, Compartment 4: Streamstown Bay, Compartment 5: Bertraghboy and Galway bays, Compartment 6: Poulnashaary Bay and Compartment A: Tralee Bay Hatchery should be regarded as free of OsHV-1μVar and consequently listed in Annex I to Decision 2010/221/EU. |
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(15)

Ireland has further submitted a declaration of disease freedom with regard to OsHV-1μVar for the remaining five compartments listed in Annex III to Decision 2010/221/EU and for a new Compartment A: Tralee Bay Hatchery. That declaration complies with the requirements for a declaration of freedom of disease laid down in Directive 2006/88/EC. Accordingly the following compartments of the territory of Ireland: Compartment 1: Sheephaven Bay, Compartment 3: Killala, Broadhaven and Blacksod bays, Compartment 4: Streamstown Bay, Compartment 5: Bertraghboy and Galway bays, Compartment 6: Poulnashaary Bay and Compartment A: Tralee Bay Hatchery should be regarded as free of OsHV-1μVar and consequently listed in Annex I to Decision 2010/221/EU.

| (16) | As the declaration from Ireland demonstrates disease freedom of all five remaining compartments listed in Annex III to Decision 2010/221/EU, the surveillance programme for OsHV-1μVar for demonstration of freedom from disease as indicated in that Annex will no longer be applicable for the listed Irish compartments. The entry for Ireland in Annex III should therefore be deleted. |
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(16)

As the declaration from Ireland demonstrates disease freedom of all five remaining compartments listed in Annex III to Decision 2010/221/EU, the surveillance programme for OsHV-1μVar for demonstration of freedom from disease as indicated in that Annex will no longer be applicable for the listed Irish compartments. The entry for Ireland in Annex III should therefore be deleted.

| (17) | Article 3(2) of Decision 2010/221/EU limits the authorisation to apply certain national measures in accordance with Article 43 of Directive 2006/88/EC in time until 31 December 2015. In order to avoid disruption in the application of those measures, the proposed amendments should apply from 1 January 2016. |
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(17)

Article 3(2) of Decision 2010/221/EU limits the authorisation to apply certain national measures in accordance with Article 43 of Directive 2006/88/EC in time until 31 December 2015. In order to avoid disruption in the application of those measures, the proposed amendments should apply from 1 January 2016.

| (18) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(18)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS DECISION:

Article 1

In Article 3(2) of Decision 2010/221/EU, the date ‘31 December 2015’ shall be replaced by ‘1 July 2021’.

Article 2

Annexes I and III to Decision 2010/221/EU are replaced by the text in the Annex to this Decision.

Article 3

This Decision shall apply from 1 January 2016.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 5 February 2016.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

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(1)  
  OJ L 328, 24.11.2006, p. 14.

1

(2)  Commission Decision 2010/221/EU of 15 April 2010 approving national measures for limiting the impact of certain diseases in aquaculture animals and wild aquatic animals in accordance with Article 43 of Council Directive 2006/88/EC (OJ L 98, 20.4.2010, p. 7).

2

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ANNEX

Decision 2010/221/EU is amended as follows:

| (1) | Annex I to Decision 2010/221/EU is replaced by the following text:



  ‘ANNEX I

  Member States and areas regarded as being free of diseases listed in the table and approved to take national measures to prevent the introduction of those diseases in accordance with Article 43(2) of Directive 2006/88/EC









  Disease | Member State | Code | Geographical demarcation of the area with approved national measures |
| --- | --- | --- | --- | --- |
| Spring viraemia of carp (SVC) | Denmark | DK | Whole territory |
| Ireland | IE | Whole territory |
| Hungary | HU | Whole territory |
| Finland | FI | Whole territory |
| Sweden | SE | Whole territory |
| United Kingdom | UK | The whole territory of the United Kingdom
  The territories of Guernsey, Jersey and the Isle of Man |
| Bacterial kidney disease (BKD) | Ireland | IE | Whole territory |
| United Kingdom | UK | The territory of Northern Ireland
  The territories of Guernsey, Jersey and the Isle of Man |
| Infectious pancreatic necrosis (IPN) | Finland | FI | The continental parts of the territory |
| Sweden | SE | The continental parts of the territory |
| United Kingdom | UK | The territory of the Isle of Man |
| Infections with Gyrodactylus salaris (GS) | Ireland | IE | Whole territory |
| Finland | FI | The water catchment areas of the Tenojoki and Näätämöjoki; the water catchment areas of the Paatsjoki, Tuulomajoki, and Uutuanjoki are considered as buffer zones |
| United Kingdom | UK | The whole territory of the United Kingdom
  The territories of Guernsey, Jersey and the Isle of Man |
| Ostreid herpesvirus 1 μvar (OsHV-1 μVar) | Ireland | IE | Compartment 1: Sheephaven Bay
  Compartment 3: Killala, Broadhaven and Blacksod Bays
  Compartment 4: Streamstown Bay
  Compartment 5: Bertraghboy and Galway Bays
  Compartment 6: Poulnasharry Bay
  Compartment A: Tralee Bay Hatchery |
| United Kingdom | UK | The territory of Great Britain, except The River Roach, River Crouch, Blackwater Estuary and River Colne in Essex, the north Kent Coast, Poole Harbour in Dorset and The River Teign in Devon
  The territory of Northern Ireland except Dundrum Bay, Killough Bay, Lough Foyle, Carlingford Lough and Strangford Lough
  The territory of Guernsey |
| Infection with Salmonid alphavirus (SAV) | Finland | FI | The continental parts of the territory’ |

(1)

Annex I to Decision 2010/221/EU is replaced by the following text:

‘ANNEX I

Member States and areas regarded as being free of diseases listed in the table and approved to take national measures to prevent the introduction of those diseases in accordance with Article 43(2) of Directive 2006/88/EC

Disease

Member State

Code

Geographical demarcation of the area with approved national measures

Spring viraemia of carp (SVC)

Denmark

DK

Whole territory

Ireland

IE

Whole territory

Hungary

HU

Whole territory

Finland

FI

Whole territory

Sweden

SE

Whole territory

United Kingdom

UK

The whole territory of the United Kingdom

The territories of Guernsey, Jersey and the Isle of Man

Bacterial kidney disease (BKD)

Ireland

IE

Whole territory

United Kingdom

UK

The territory of Northern Ireland

The territories of Guernsey, Jersey and the Isle of Man

Infectious pancreatic necrosis (IPN)

Finland

FI

The continental parts of the territory

Sweden

SE

The continental parts of the territory

United Kingdom

UK

The territory of the Isle of Man

Infections with Gyrodactylus salaris (GS)

Ireland

IE

Whole territory

Finland

FI

The water catchment areas of the Tenojoki and Näätämöjoki; the water catchment areas of the Paatsjoki, Tuulomajoki, and Uutuanjoki are considered as buffer zones

United Kingdom

UK

The whole territory of the United Kingdom

The territories of Guernsey, Jersey and the Isle of Man

Ostreid herpesvirus 1 μvar (OsHV-1 μVar)

Ireland

IE

Compartment 1: Sheephaven Bay

Compartment 3: Killala, Broadhaven and Blacksod Bays

Compartment 4: Streamstown Bay

Compartment 5: Bertraghboy and Galway Bays

Compartment 6: Poulnasharry Bay

Compartment A: Tralee Bay Hatchery

United Kingdom

UK

The territory of Great Britain, except The River Roach, River Crouch, Blackwater Estuary and River Colne in Essex, the north Kent Coast, Poole Harbour in Dorset and The River Teign in Devon

The territory of Northern Ireland except Dundrum Bay, Killough Bay, Lough Foyle, Carlingford Lough and Strangford Lough

The territory of Guernsey

Infection with Salmonid alphavirus (SAV)

Finland

FI

The continental parts of the territory’

| (2) | Annex III to Decision 2010/221/EU is replaced by the following text:



  ‘ANNEX III

  Member States and areas with surveillance programmes regarding ostreid herpesvirus 1 μvar (OsHV-1μVar) and approved to take national measures to control that disease in accordance with Article 43(2) of Directive 2006/88/EC









  Disease | Member State | Code | Geographical demarcation of the area with approved national measures (Member States, zones and compartments)’ |
| --- | --- | --- | --- | --- |
| | | | |

(2)

Annex III to Decision 2010/221/EU is replaced by the following text:

‘ANNEX III

Member States and areas with surveillance programmes regarding ostreid herpesvirus 1 μvar (OsHV-1μVar) and approved to take national measures to control that disease in accordance with Article 43(2) of Directive 2006/88/EC

Disease

Member State

Code

Geographical demarcation of the area with approved national measures (Member States, zones and compartments)’

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