# Official Journal L 290/2021

| | ISSN 1977-0677 |
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| Official Journal
  of the European Union | L 290 |
| | |
| English edition | Legislation | Volume 6412 August 2021 |

ISSN 1977-0677

Official Journal

of the European Union

L 290

English edition

Legislation

Volume 6412 August 2021

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS |
| | * | Decision No 1/2021 of the ACP-EU Committee of Ambassadors of 29 June 2021 to amend Decision No 3/2016 of the ACP-EU Committee of Ambassadors on the Centre for the Development of Enterprise [2021/1330] | 1 |

Contents

II   Non-legislative acts

page

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

*

Decision No 1/2021 of the ACP-EU Committee of Ambassadors of 29 June 2021 to amend Decision No 3/2016 of the ACP-EU Committee of Ambassadors on the Centre for the Development of Enterprise [2021/1330]

1

| | | III   Other acts |
| --- | --- | --- |
| | | EUROPEAN ECONOMIC AREA |
| | * | EFTA Surveillance Authority Delegated Decision of 13 April 2021 recognising the disease-free status of Norway regarding Brucella melitensis in small ruminants [2021/1331] | 3 |
| | * | EFTA Surveillance Authority Decision of 21 April 2021 regarding approval of disease-free and non-vaccination statuses and eradication programmes of Norway and Iceland or certain zones or compartments thereof as regards certain listed diseases in accordance with Regulation (EU) 2016/429 of the European Parliament and of the Council and Commission Delegated Regulation (EU) 2020/689 [2021/1332] | 5 |
| | * | EFTA Surveillance Authority Delegated Decision of 22 April 2021 approving the disease-free status of rabies virus (RABV) of Norway and amending Decision No 032/21/COL [2021/1333] | 11 |

III   Other acts

EUROPEAN ECONOMIC AREA

*

EFTA Surveillance Authority Delegated Decision of 13 April 2021 recognising the disease-free status of Norway regarding Brucella melitensis in small ruminants [2021/1331]

Brucella melitensis

3

*

EFTA Surveillance Authority Decision of 21 April 2021 regarding approval of disease-free and non-vaccination statuses and eradication programmes of Norway and Iceland or certain zones or compartments thereof as regards certain listed diseases in accordance with Regulation (EU) 2016/429 of the European Parliament and of the Council and Commission Delegated Regulation (EU) 2020/689 [2021/1332]

5

*

EFTA Surveillance Authority Delegated Decision of 22 April 2021 approving the disease-free status of rabies virus (RABV) of Norway and amending Decision No 032/21/COL [2021/1333]

11

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
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EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

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II Non-legislative acts

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

| 12.8.2021 | EN | Official Journal of the European Union | L 290/1 |
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12.8.2021

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Official Journal of the European Union

L 290/1

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DECISION No 1/2021 OF THE ACP-EU COMMITTEE OF AMBASSADORS

of 29 June 2021

to amend Decision No 3/2016 of the ACP-EU Committee of Ambassadors on the Centre for the Development of Enterprise [2021/1330]

THE ACP-EU COMMITTEE OF AMBASSADORS,

Having regard to the Partnership Agreement between the members of the African, Caribbean and Pacific Group of States of the one part, and the European Community and its Member States, of the other part, signed in Cotonou on 23 June 2000 (1),

Whereas:

| (1) | Article 15(4) of the Partnership Agreement between the members of the African, Caribbean and Pacific Group of States of the one part, and the European Community and its Member States, of the other part, signed in Cotonou on 23 June 2000 (2) (the ‘ACP-EU Partnership Agreement’) states that the ACP-EU Council of Ministers may delegate powers to the ACP-EU Committee of Ambassadors. |
| --- | --- |

(1)

Article 15(4) of the Partnership Agreement between the members of the African, Caribbean and Pacific Group of States of the one part, and the European Community and its Member States, of the other part, signed in Cotonou on 23 June 2000 (2) (the ‘ACP-EU Partnership Agreement’) states that the ACP-EU Council of Ministers may delegate powers to the ACP-EU Committee of Ambassadors.

| (2) | At its 39th session held on 19 and 20 June 2014 in Nairobi, the ACP-EU Council of Ministers agreed, in a Joint Declaration, to proceed with the orderly closing of the Centre for the Development of Enterprise (CDE). For that purpose, the ACP-EU Council of Ministers decided to grant a delegation of powers to the ACP-EU Committee of Ambassadors to take the matter forward with a view to adopting the necessary decisions. |
| --- | --- |

(2)

At its 39th session held on 19 and 20 June 2014 in Nairobi, the ACP-EU Council of Ministers agreed, in a Joint Declaration, to proceed with the orderly closing of the Centre for the Development of Enterprise (CDE). For that purpose, the ACP-EU Council of Ministers decided to grant a delegation of powers to the ACP-EU Committee of Ambassadors to take the matter forward with a view to adopting the necessary decisions.

| (3) | On 12 July 2016, the ACP-EU Committee of Ambassadors adopted Decision No 3/2016 (3) amending Annex III to the ACP-EU Partnership Agreement to introduce the necessary changes, establish the new legal framework of the CDE as from 1 January 2017, and maintain the legal personality of the CDE, solely for the purposes of its liquidation, as from that date. |
| --- | --- |

(3)

On 12 July 2016, the ACP-EU Committee of Ambassadors adopted Decision No 3/2016 (3) amending Annex III to the ACP-EU Partnership Agreement to introduce the necessary changes, establish the new legal framework of the CDE as from 1 January 2017, and maintain the legal personality of the CDE, solely for the purposes of its liquidation, as from that date.

| (4) | Pursuant to Article 2(1) of Decision No 3/2016, a Curator is to ensure the implementation of the passive phase, in which the CDE is to solely exist for the purposes of its liquidation, as from 1 January 2017 for a period of 4 years or until the CDE has settled all its liabilities and realised all its assets, whichever happens earlier. |
| --- | --- |

(4)

Pursuant to Article 2(1) of Decision No 3/2016, a Curator is to ensure the implementation of the passive phase, in which the CDE is to solely exist for the purposes of its liquidation, as from 1 January 2017 for a period of 4 years or until the CDE has settled all its liabilities and realised all its assets, whichever happens earlier.

| (5) | By 31 December 2020, the CDE had not settled all its liabilities and realised all its assets. It is therefore necessary to amend Decision No 3/2016 to ensure the proper implementation of the passive phase under the Curator’s management and to end that phase. In order to ensure continuity of the passive phase, the amendment of Decision No 3/2016 should apply as of 1 January 2021, |
| --- | --- |

(5)

By 31 December 2020, the CDE had not settled all its liabilities and realised all its assets. It is therefore necessary to amend Decision No 3/2016 to ensure the proper implementation of the passive phase under the Curator’s management and to end that phase. In order to ensure continuity of the passive phase, the amendment of Decision No 3/2016 should apply as of 1 January 2021,

HAS ADOPTED THIS DECISION:

Article 1

Article 2(1) of Decision No 3/2016 of the ACP-EU Committee of Ambassadors shall be replaced by the following:

‘1.   The European Commission shall contract a Curator to ensure the implementation of the passive phase as from 1 January 2017 until the CDE has settled all its liabilities and realised all its assets.’.

Article 2

Article 1 shall apply as of 1 January 2021.

Article 3

This Decision shall enter into force on the date of its adoption.

Done at Brussels, 29 June 2021.

For the ACP-EU Council of Ministers

by the ACP-EU Committee of Ambassadors

The President

Moses Kouni MOSE

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(1)  
  OJ L 317, 15.12.2000, p. 3.

1

(2)  Partnership Agreement between the members of the African, Caribbean and Pacific Group of States of the one part, and the European Community and its Member States, of the other part, signed in Cotonou on 23 June 2000 (OJ L 317, 15.12.2000, p. 3).

2

(3)  Decision No 3/2016 of the ACP-EU Committee of Ambassadors of 12 July 2016 regarding the revision of Annex III to the ACP-EU Partnership Agreement [2016/1163] (OJ L 192, 16.7.2016, p. 77).

3

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III Other acts

EUROPEAN ECONOMIC AREA

| 12.8.2021 | EN | Official Journal of the European Union | L 290/3 |
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12.8.2021

EN

Official Journal of the European Union

L 290/3

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EFTA SURVEILLANCE AUTHORITY DELEGATED DECISION

of 13 April 2021

recognising the disease-free status of Norway regarding Brucella melitensis in small ruminants [2021/1331]

THE EFTA SURVEILLANCE AUTHORITY,

Having regard to the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice, in particular Articles 1(2) and 3 of Protocol 1 thereof,

Having regard to the Act referred to at point 2. of Part 4.1 of Chapter I of Annex I to the Agreement on the European Economic Area (‘EEA Agreement’),

Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (‘Directive 91/68/EEC’),

as amended and as adapted to the EEA Agreement by the specific adaptations and the sectoral adaptations referred to in Annex I to that Agreement, by point 4(d) of Protocol 1 to the EEA Agreement, and in particular Article 15(1) and (2) and point 1. of Part II. of Chapter 1 of Annex A of Directive 91/68/EEC;

Whereas:

By letter dated 25 November 2020 (Document No 1166399), the Norwegian Food Safety Authority (‘NFSA’) requested that Norway be recognised by the EFTA Surveillance Authority (‘Authority’) as being officially free from Brucella melitensis in Norwegian small ruminants (‘the request’). The request was accompanied by a report of the Norwegian Veterinary Institute provided for the purpose of demonstrating freedom from Brucella melitensis in sheep and goats in accordance with the requirements of Directive 91/68/EEC (Document No 1166397).

By email dated 18 December 2020 (Document No 1171269), the Authority requested additional information from the NFSA regarding the legal basis for the request.

By letter dated 5 January 2021 (Document No 1171267), the Norwegian Ministry of Agriculture and Food (‘the Ministry’) responded to the Authority’s request for additional information attaching a letter from the NFSA dated 21 December 2020 (Document No 1171265) specifying that the legal basis for the request was point 1.(a), or alternatively points 1.(b) and (c), of Part II. of Chapter 1 of Annex A of Directive 91/68/EEC.

Point 1. of Part II. of Chapter I of Annex A of Directive 91/68/EEC determines that a Member State may be recognized as being officially brucellosis-free:

| | |
| --- | --- |

The Authority, in close co-operation with the European Commission, examined the information provided by Norway and was unable to conclude on that basis that the conditions laid down in point 1.(a) of Part II. of Chapter 1 of Annex A of Directive 91/68/EEC were fulfilled. The Authority therefore considered whether the conditions laid down in point 1.(b) of Part II. of Chapter 1 of Annex A of Directive 91/68/EEC were fulfilled.

By letter dated 28 January 2021 (Document No 1172699), the Authority requested the Ministry to confirm that vaccination against brucellosis had been prohibited in small ruminants for at least the last three years in Norway.

By letter dated 23 February 2021 (Document No 1182614), the Ministry responded to the Authority’s request for confirmation attaching a letter from the NFSA (Document No 1182612) confirming that vaccination against brucellosis had been prohibited in small ruminants for at least the last three years in Norway.

The Authority, in close co-operation with the European Commission, has examined all the relevant documentation submitted by Norway and, in light of that information, considers that the conditions laid down in point 1.(b) of Part II. of Chapter 1 of Annex A of Directive 91/68/EEC required to be met for Norway to be recognised as officially free from Brucella melitensis in Norwegian small ruminants are fulfilled.

The Authority, by its Delegated Decision No 20/21/COL (Document No 1174462), duly submitted the draft Decision to the EFTA Veterinary and Phytosanitary Committee (‘the Committee’) in accordance with Article 15 and point 1.(c) of Part II. of Chapter 1 of Annex A of Directive 91/68/EEC. The Committee approved the draft Decision. Accordingly, the draft Decision is in accordance with the opinion of the Committee,

HAS ADOPTED THIS DECISION:

Article 1

The disease-free status of Norway regarding Brucella melitensis in small ruminants is recognised.

Article 2

This Decision shall enter into force on the day of its signature.

Article 3

This Decision is addressed to Norway.

Article 4

This Decision shall be authentic in the English language.

Done at Brussels, 13 April 2021.

For the EFTA Surveillance Authority, acting under Delegated Decision No 130/20/COL,

Högni S. KRISTJÁNSSON

Responsible College Member

Carsten ZATSCHLER

Countersigning as Director,

Legal and Executive Affairs

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| 12.8.2021 | EN | Official Journal of the European Union | L 290/5 |
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12.8.2021

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Official Journal of the European Union

L 290/5

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EFTA SURVEILLANCE AUTHORITY DECISION

of 21 April 2021

regarding approval of disease-free and non-vaccination statuses and eradication programmes of Norway and Iceland or certain zones or compartments thereof as regards certain listed diseases in accordance with Regulation (EU) 2016/429 of the European Parliament and of the Council and Commission Delegated Regulation (EU) 2020/689 [2021/1332]

THE EFTA SURVEILLANCE AUTHORITY,

Having regard to the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice, in particular Articles 1(2) and 3 of Protocol 1 thereof,

Having regard to the Act referred to at Point 13. of Part 1.1 of Chapter I of Annex I to the Agreement on the European Economic Area (‘EEA Agreement’), Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (1) (‘Regulation (EU) 2016/429’), as amended and as adapted to the EEA Agreement by point 4(d) of Protocol 1 thereof and the specific and the sectoral adaptations referred to in Annex I to that Agreement, and in particular Articles 31(3), 36(4) and 280 thereof,

Having regard to the Act referred to at Point 13e. of Part 1.1 of Chapter I of Annex I to the EEA Agreement, Commission Delegated Regulation (EU) 2020/687 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council (2), as regards rules for the prevention and control of certain listed diseases (‘Delegated Regulation (EU) 2020/687’), as adapted to the EEA Agreement by the sectoral adaptations referred to in Annex I to that Agreement, and in particular Article 112 thereof,

Having regard to the Act referred to at Point 13h. of Part 1.1 of Chapter I of Annex I to the EEA Agreement, Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (3) (‘Delegated Regulation (EU) 2020/689’), as adapted by point 4(d) of Protocol 1 thereof and the sectoral adaptations referred to in Annex I to that Agreement, and in particular Article 84 thereof.

Whereas:

Regulation (EU) 2016/429 Delegated Regulation (EU) 2020/687 and Delegated Regulation (EU) 2020/689 were incorporated into the Annexes to the EEA Agreement with effect from 17 April 2021. In accordance with the application date stated in each of Regulation (EU) 2016/429, Delegated Regulation (EU) 2020/687 and Delegated Regulation (EU) 2020/689, those Regulations apply from 21 April 2021.

Regulation (EU) 2016/429 establishes a new legislative framework for the prevention and control of diseases transmissible to animals or humans. In particular, it provides for approval of the disease-free or non-vaccination status and eradication programmes of States of the European Economic Area (‘EEA States’) or zones or compartments thereof with regard to certain diseases listed in Article 5(1) of that Regulation for one or more relevant animal species.

Article 280(1) of Regulation (EU) 2016/429 lays down transitional measures for disease-free or non-vaccination statuses (‘statuses’) approved prior to application of that Regulation in accordance with, as relevant, Council Directives 64/432/EEC (4), 91/68/EEC (5) and 2006/88/EC (6) or Council Directive 2009/158/EC (7) (‘the relevant previous Directive’). These are referred to herein as ‘existing statuses’.

Article 84(1) of Delegated Regulation (EU) 2020/689 supplements Article 280(1) of Regulation (EU) No 2016/429 by providing that existing statuses shall be deemed approved in accordance with Delegated Regulation (EU) 2020/689 where the relevant existing status was approved before the date of application of that Regulation.

The EFTA Surveillance Authority (‘the Authority’) adopted a number of Decisions approving statuses of Norway and Iceland, or certain zones thereof, in accordance with the relevant previous Directive prior to the implementation of Delegated Regulation (EU) 2020/689 (‘the former status Decisions’).

The former status Decisions include decisions adopted by the Authority under EEA legislation preceding the relevant previous Directive, where the approval criteria under that legislation was equivalent to the approval criteria under the relevant previous Directive. These existing statuses concern the following listed diseases:

| — | infection with Brucella abortus, B. melitensis, B. suis in bovine, ovine and caprine animal populations; |
| --- | --- |

—

infection with Brucella abortus, B. melitensis, B. suis in bovine, ovine and caprine animal populations;

| — | infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae, M. Tuberculosis) (‘MTBC’); |
| --- | --- |

—

infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae, M. Tuberculosis) (‘MTBC’);

| — | enzootic bovine leucosis (‘EBL’); |
| --- | --- |

—

enzootic bovine leucosis (‘EBL’);

| — | infectious bovine rinotracheitis/infectious pustular vulvovaginitis (‘IBR/IPV’); |
| --- | --- |

—

infectious bovine rinotracheitis/infectious pustular vulvovaginitis (‘IBR/IPV’);

| — | infection with Aujeszky’s disease virus (‘ADV’); |
| --- | --- |

—

infection with Aujeszky’s disease virus (‘ADV’);

| — | infection with Newcastle disease virus without vaccination; |
| --- | --- |

—

infection with Newcastle disease virus without vaccination;

| — | viral haemorrhagic septicaemia (‘VHS’); |
| --- | --- |

—

viral haemorrhagic septicaemia (‘VHS’);

| — | infectious haematopoietic necrosis (‘IHN’); |
| --- | --- |

—

infectious haematopoietic necrosis (‘IHN’);

| — | infection with Marteilia refringens, and |
| --- | --- |

—

infection with Marteilia refringens, and

| — | infection with Bonamia ostreae. |
| --- | --- |

—

infection with Bonamia ostreae.

Pursuant to Article 280(1) of Regulation (EU) 2016/429 and Articles 84(1) of Delegated Regulation (EU) 2020/689, such existing statuses are deemed approved in accordance with those Regulations. For the purpose of clarity, this Decision repeals the former status Decisions and lists in its Annex those statuses deemed approved.

Norway and Iceland may apply to the Authority for approval of disease-free or non-vaccination status and eradication programmes for one or more of the listed diseases in accordance with Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/689 for one or more of the relevant animal species, for its entire territory or for one or more zones or compartments thereof, provided that the conditions set out in Regulation (EU) 2016/429 are fulfilled. The Authority may approve, subject to amendments where necessary, applications by EEA EFTA States for disease-free status or non-vaccination status or eradication programmes when the relevant conditions are fulfilled.

The Authority is required, in accordance with Articles 31(3), 36(4) and 266(2) of Regulation (EU) 2016/429, to submit any draft Decision regarding approval of disease-free and non-vaccination statuses, or approval of eradication programmes of Norway and Iceland or certain zones or compartments thereof, as regards certain listed diseases (‘draft Approval Decision’) to the EFTA Veterinary and Phytosanitary Committee (‘the Committee’). The Committee is the relevant Committee designated to assist the Authority in carrying out this function under the Decision of the Standing Committee of the EFTA States No 4/2012/SC of 26 October 2012.

The Committee is required to deliver its opinion on any draft Approval Decision submitted, in accordance with the examination procedure established pursuant to Article 3 of the Decision of the Standing Committee of the EFTA States No 3/2012/SC of 26 October 2012. If the draft Approval Decision is approved by the Committee, the respective Annex to this Decision shall be amended to include the approved new disease-free and non-vaccination statuses or eradication programmes.

The Authority previously adopted Decisions No 67/95/COL, No 300/08/COL and No 265/12/COL approving the contingency plans submitted by Norway for the control of, respectively, foot-and-mouth disease, avian influenza and listed exotic diseases in aquatic animals. The Acts requiring approval of the respective contingency plans and on which those Decisions were based, respectively Council Directives 90/423/EEC (8), 2005/94/EC (9) and 2006/88/EC (10), were repealed by Regulation (EU) 2016/429 and, in the case of Directive 2005/94/EC only, by Delegated Regulation (EU) 2020/687. Articles 43 and 44 of Regulation (EU) 2016/429 concerning contingency plans neither require EEA States to submit contingency plans for approval, nor to provide transitional measures permitting recognition of contingency plans approved prior to application of that Regulation. Therefore, for the sake of clarity, this Decision repeals Decisions No 67/95/COL, No 300/08/COL and No 265/12/COL,

HAS ADOPTED THIS DECISION:

Article 1

The disease-free and non-vaccination statuses and eradication programmes of Norway and Iceland and zones or compartments thereof approved in accordance with Regulations (EU) 2016/429 and Delegated Regulation (EU) 2020/689 are listed in the Annex to this Decision.

Article 2

The previous decisions of the Authority in this field, as indicated in the fourth and final column of the tables in the Annex to this Decision, are hereby repealed.

Article 3

Decisions No 67/95/COL, No 300/08/COL and No 265/12/COL are hereby repealed.

Article 4

This Decision shall enter into force on the day of its signature.

Article 5

This Decision is addressed to Norway and Iceland.

Article 6

This Decision shall be authentic in the English language.

Done at Brussels, 21 April 2021.

For the EFTA Surveillance Authority,

Bente ANGELL-HANSEN

President

Högni KRISTJÁNSSON

Responsible College Member

Frank J. BÜCHEL

College Member

Carsten ZATSCHLER

Countersigning as Director, Legal and Executive Affairs

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(1)  
  OJ L 84, 31.3.2016, p. 1. Incorporated into the EEA Agreement by Decision of the EEA Joint Committee No 179/2020 of 11 December 2020.

1

(2)  
  OJ L 174, 3.6.2020, p. 67. Incorporated into the EEA Agreement by Decision of the EEA Joint Committee No 3/2021 of 5 February 2021.

2

(3)  
  OJ L 174, 3.6.2020, p. 211. Incorporated into the EEA Agreement by Decision of the EEA Joint Committee No 4/2021 of 5 February 2021.

3

(4)  The Act previously referred to at Point 1. of Part 4.1. of Chapter I of Annex I to the EEA Agreement, Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (OJ 121, 29.7.1964, p. 1977), as amended and as adapted to the EEA Agreement by the specific and the sectoral adaptations referred to in Annex I to the EEA Agreement.

4

(5)  The Act previously referred to at Point 2. of Part 4.1. of Chapter I of Annex I to the EEA Agreement, Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (OJ L 46, 19.2.1991, p. 19), as amended and as adapted to the EEA Agreement by the specific and the sectoral adaptations referred to in Annex I to the EEA Agreement.

5

(6)  The Act previously referred to at Point 8a. of Part 3.1.and at Point 4a. of Part 8.1. of Chapter I of Annex I to the EEA Agreement, Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof (OJ L 328, 24.11.2006, p. 14), and on the prevention and control of certain diseases of aquatic animals, as amended and as adapted to the EEA Agreement by the sectoral adaptations referred to in Annex I to the EEA Agreement.

6

(7)  The Act previously referred to at Point 4a. of Part 4.1. of Chapter I of Annex I to the EEA Agreement, Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs, (OJ L 343, 22.12.2009, p. 74), as amended and as adapted to the EEA Agreement by the specific and the sectoral adaptations referred to in Annex I to the EEA Agreement.

7

(8)  The Act previously referred to at Point 2. of Part 3.1. of Chapter I of Annex I to the EEA Agreement, Council Directive 90/423/EEC of 26 June 1990 amending Directive 85/511/EEC introducing Community measures for the control of foot-and-mouth disease, Directive 64/432/EEC on animal health problems affecting intra-Community trade in bovine animals and swine and Directive 72/462/EEC on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat or meat products from third countries (OJ L 224, 18.8.1990, p. 13), as adapted to the EEA Agreement by the sectoral adaptations referred to in Annex I to the EEA Agreement.

8

(9)  The Act previously referred to at Point 5a. of Part 3.1. of Chapter I of Annex I to the EEA Agreement, Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza and repealing Directive 92/40/EEC (OJ L 10, 14.1.2006, p. 16), as amended and as adapted to the EEA Agreement by the sectoral adaptations referred to in Annex I to the EEA Agreement.

9

(10)  More specifically, Article 5(4) of Directive 90/423/EEC, Article 62(4) of Directive 2005/94/EC and Article 47(4) of Directive 2006/88/EC.

10

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ANNEX

Disease-free and non-vaccination statuses and eradication programmes of Norway and Iceland or zones or compartments thereof approved in accordance with Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/689

In Norway:

| Disease-free or non- vaccination status | Area: Whole territory or zone | Legal Basis | No of previous or new EFTA Surveillance Authority Decision |
| --- | --- | --- | --- |
| infection with Brucella abortus, B. melitensis and B. suis in bovine animal populations | Whole territory | Article 84(1)(a)(i) of Delegated Regulation (EU) 2020/689 | 28/07/COL of 19 February 2007 (previous Decision repealed) |
| infection with Brucella melitensis in ovine and caprine animal populations | Whole territory | Article 84(1)(a)(ii) of Delegated Regulation (EU) 2020/689 | 029/21/COL of 13 April 2021 (previous Decision repealed) |
| infection with Mycobacterium tuberculosis complex (M. bovis, M.caprae and M. tuberculosis) (‘MTBC’) | Whole territory | Article 84(1)(b) of Delegated Regulation (EU) 2020/689 | 28/07/COL of 19 February 2007
  (previous Decision repealed) |
| Enzootic bovine leucosis (‘EBL’) | Whole territory | Article 84(1)(c) of Delegated Regulation (EU) 2020/689 | 28/07/COL of 19 February 2007
  (previous Decision repealed) |
| Infectious bovine rhinotracheitis (‘IBR’)/infectious pustular vulvovaginitis (‘IPV’) | Whole territory | Article 84(1)(d) of Delegated Regulation (EU) 2020/689 | 159/10/COL of 21 April 2010 (previous Decision repealed) |
| infection with Aujeszky’s disease virus (‘ADV’) | Whole territory | Article 84(1)(e) of Delegated Regulation (EU) 2020/689 | 160/10/COL of 21 April 2010 (previous Decision repealed) |
| infection with Newcastle disease virus without vaccination | Whole territory | Article 84(1)(g) of Delegated Regulation (EU) 2020/689 | 221/96/COL of 4 December 1996 (previous Decision repealed) |
| infection with Marteilia refringens | Zone: the entire coastline of Norway, with the exception of the containment area in the municipality of Bømlo in the County of Hordaland in southern Norway, specifically described in § 2 of the Norwegian Regulations on the control area to fight the disease Marteiliose in molluscs, Bømlo municipality, Hordaland (FOR-2017- 09-08-1377) | Article 84(1)(l) of Delegated Regulation (EU) 2020/689 | 18/18/COL of 9 February 2018 (previous Decision repealed) |
| infection with Bonamia ostreae | Zone: The entire coastline of Norway, with the exception of the county of Aust-Agder in southern Norway | Article 84(1)(k) of Delegated Regulation (EU) 2020/689 | 18/18/COL of 9 February 2018 (previous Decision repealed) |
| Infectious haematopoietic necrosis (‘IHN’) | Whole territory, with the exception of the Norwegian part of the catchment areas of Grense Jacobselv and Pasvik river and the rivers in between and the associated coastal region (Zone) | Article 84(1)(i) of Delegated Regulation (EU) 2020/689 | 264/12/COL of 5 July 2012 (previous Decision repealed) |
| Viral haemorrhagic septicaemia (‘VHS’) | Whole territory, with the exception of the Norwegian part of the catchment areas of Grense Jacobselv and Pasvik river and the rivers in between and the associated coastal region (Zone) | Article 84(1)(h) of Delegated Regulation (EU) 2020/689 | 264/12/COL of 5 July 2012 (previous Decision repealed) |

Disease-free or non- vaccination status

Area: Whole territory or zone

Legal Basis

No of previous or new EFTA Surveillance Authority Decision

infection with Brucella abortus, B. melitensis and B. suis in bovine animal populations

Whole territory

Article 84(1)(a)(i) of Delegated Regulation (EU) 2020/689

28/07/COL of 19 February 2007 (previous Decision repealed)

infection with Brucella melitensis in ovine and caprine animal populations

Whole territory

Article 84(1)(a)(ii) of Delegated Regulation (EU) 2020/689

029/21/COL of 13 April 2021 (previous Decision repealed)

infection with Mycobacterium tuberculosis complex (M. bovis, M.caprae and M. tuberculosis) (‘MTBC’)

Whole territory

Article 84(1)(b) of Delegated Regulation (EU) 2020/689

28/07/COL of 19 February 2007

(previous Decision repealed)

Enzootic bovine leucosis (‘EBL’)

Whole territory

Article 84(1)(c) of Delegated Regulation (EU) 2020/689

28/07/COL of 19 February 2007

(previous Decision repealed)

Infectious bovine rhinotracheitis (‘IBR’)/infectious pustular vulvovaginitis (‘IPV’)

Whole territory

Article 84(1)(d) of Delegated Regulation (EU) 2020/689

159/10/COL of 21 April 2010 (previous Decision repealed)

infection with Aujeszky’s disease virus (‘ADV’)

Whole territory

Article 84(1)(e) of Delegated Regulation (EU) 2020/689

160/10/COL of 21 April 2010 (previous Decision repealed)

infection with Newcastle disease virus without vaccination

Whole territory

Article 84(1)(g) of Delegated Regulation (EU) 2020/689

221/96/COL of 4 December 1996 (previous Decision repealed)

infection with Marteilia refringens

Zone: the entire coastline of Norway, with the exception of the containment area in the municipality of Bømlo in the County of Hordaland in southern Norway, specifically described in § 2 of the Norwegian Regulations on the control area to fight the disease Marteiliose in molluscs, Bømlo municipality, Hordaland (FOR-2017- 09-08-1377)

Article 84(1)(l) of Delegated Regulation (EU) 2020/689

18/18/COL of 9 February 2018 (previous Decision repealed)

infection with Bonamia ostreae

Zone: The entire coastline of Norway, with the exception of the county of Aust-Agder in southern Norway

Article 84(1)(k) of Delegated Regulation (EU) 2020/689

18/18/COL of 9 February 2018 (previous Decision repealed)

Infectious haematopoietic necrosis (‘IHN’)

Whole territory, with the exception of the Norwegian part of the catchment areas of Grense Jacobselv and Pasvik river and the rivers in between and the associated coastal region (Zone)

Article 84(1)(i) of Delegated Regulation (EU) 2020/689

264/12/COL of 5 July 2012 (previous Decision repealed)

Viral haemorrhagic septicaemia (‘VHS’)

Whole territory, with the exception of the Norwegian part of the catchment areas of Grense Jacobselv and Pasvik river and the rivers in between and the associated coastal region (Zone)

Article 84(1)(h) of Delegated Regulation (EU) 2020/689

264/12/COL of 5 July 2012 (previous Decision repealed)

| Eradication programme | Area: Whole territory, zone or compartment | Legal Basis | No of EFTA Surveillance Authority Decision |
| --- | --- | --- | --- |
| Currently no entries | | | |

Eradication programme

Area: Whole territory, zone or compartment

Legal Basis

No of EFTA Surveillance Authority Decision

Currently no entries

In Iceland:

| Disease-free or non- vaccination status | Area: Whole territory or zone | Legal Basis | No of previous or new EFTA Surveillance Authority Decision |
| --- | --- | --- | --- |
| Infectious haematopoietic necrosis (‘IHN’) | Whole territory | Article 84(1)(i) of Delegated Regulation (EU) 2020/689 | 227/04/COL of 9 September 2004 and No 36/16/COL of 9 February 2016 (previous Decision repealed) |

Disease-free or non- vaccination status

Area: Whole territory or zone

Legal Basis

No of previous or new EFTA Surveillance Authority Decision

Infectious haematopoietic necrosis (‘IHN’)

Whole territory

Article 84(1)(i) of Delegated Regulation (EU) 2020/689

227/04/COL of 9 September 2004 and No 36/16/COL of 9 February 2016 (previous Decision repealed)

| Eradication programme | Area: Whole territory, zone or compartment | Legal Basis | No of EFTA Surveillance Authority Decision |
| --- | --- | --- | --- |
| Currently no entries | | | |

Eradication programme

Area: Whole territory, zone or compartment

Legal Basis

No of EFTA Surveillance Authority Decision

Currently no entries

---

| 12.8.2021 | EN | Official Journal of the European Union | L 290/11 |
| --- | --- | --- | --- |

12.8.2021

EN

Official Journal of the European Union

L 290/11

---

EFTA SURVEILLANCE AUTHORITY DELEGATED DECISION

of 22 April 2021

approving the disease-free status of rabies virus (RABV) of Norway and amending Decision No 032/21/COL [2021/1333]

THE EFTA SURVEILLANCE AUTHORITY,

Having regard to the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice, in particular Articles 1(2) and 3 of Protocol 1 thereof,

Having regard to the Act referred to at Point 13. of Part 1.1 of Chapter I of Annex I to the Agreement on the European Economic Area (‘EEA Agreement’), Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (1) (‘Regulation (EU) 2016/429’), as amended and as adapted to the EEA Agreement by the specific and the sectoral adaptations referred to in Annex I to that Agreement, and in particular Articles 36(3) and 266 (2) thereof,

Having regard to the Act referred to at Point 13h. of Part 1.1 of Chapter I of Annex I to the EEA Agreement, Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (2) (‘Delegated Regulation (EU) 2020/689’), as adapted by the specific and the sectoral adaptations referred to in Annex I to that Agreement, and in particular Article 70(3) thereof,

as adapted to the EEA Agreement by point 4(d) of the Protocol 1 to the EEA Agreement,

Whereas:

Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/689 were incorporated into the Annexes to the EEA Agreement with effect from 17 April 2021. In accordance with the application date stated in each of Regulation (EU) 2016/429, Commission Delegated Regulation (EU) 2020/687 (3) and Delegated Regulation (EU) 2020/689, those Regulations apply from 21 April 2021.

Regulation (EU) 2016/429 establishes a new legislative framework for the prevention and control of diseases transmissible to animals or humans. In particular, it provides for approval of the disease-free status of States of the European Economic Area (‘EEA States’) or zones thereof with regard to certain diseases listed in Article 5(1) of that Regulation for one or more relevant animal species (‘statuses’).

Decision No 032/21/COL lists the disease-free and non-vaccination statuses and eradication programmes of Norway and Iceland and zones or compartments thereof approved in accordance with Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/689.

For certain listed diseases, including infection with rabies virus (RABV), Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/689 establish for the first time rules for the approval of the disease-free status for Member States or zones or compartments thereof.

Article 36(3) of Regulation (EU) 2016/429 provides that applications for disease-free status of EEA States or zones thereof for certain listed diseases shall be approved where freedom from the disease in question has been demonstrated by historical and surveillance data.

Pursuant to Article 39(a)(iii) of Regulation (EU) 2016/429, Article 70 of Delegated Regulation (EU) 2020/689 establishes the criteria for recognition of the disease-free status of an EEA State or zone thereof based on historical or surveillance data, including in relation to infection with rabies virus (RABV).

Article 70(3) of Delegated Regulation (EU) 2020/689 provides that the Authority
  “may, for a period of two years following the entry of application of this Regulation, grant disease-free status to [Norway] or zones as regards:

| (a) | infection with RABV, if it was notifiable in accordance with Article 8 of Directive 64/432/EEC and, when necessary monitoring was implemented in accordance with Article 4 of Directive 2003/99/EC of the European Parliament and of the Council (4)
  , and no case was reported in listed animals species for the past two years;”
  . |
| --- | --- |

(a)

infection with RABV, if it was notifiable in accordance with Article 8 of Directive 64/432/EEC and, when necessary monitoring was implemented in accordance with Article 4 of Directive 2003/99/EC of the European Parliament and of the Council (4)
  , and no case was reported in listed animals species for the past two years;”
  .

By letter dated 25 November 2020 (Doc No 1166401), the Norwegian Food Safety Authority submitted to the Authority an application for approval of disease-free status for the whole territory of Norway concerning infection with rabies virus (RABV). This application was accompanied by a report of the Norwegian Veterinary Institute provided for the purpose of demonstrating the historical freedom of Norway from infection from rabies virus (RABV) (Doc No 1166395).

The Authority, in close cooperation with the European Commission, has examined the report and, in light of that information, considers that the conditions laid down in Article 36(3) of Regulation (EU) 2016/429 and Article 70(3)(a) of Delegated Regulation (EU) 2020/689 are fulfilled by Norway (Doc No 1190351). The status of Norway as free from infection with rabies virus (RABV) is therefore approved by the Authority by this Decision and the Annex to Decision No 032/21/COL is amended accordingly.

The Authority, by its Delegated Decision No 030/21/COL (Document No 1194415), duly submitted the draft Decision to the Committee in accordance with Articles 36(4) and 266(2) of Regulation (EU) 2016/429. The Committee approved the draft Decision. Accordingly, the draft Decision is in accordance with the opinion of the Committee.

Consequently Decision No 032/21/COL is to be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The status of free from infection with rabies virus (RABV) for the whole territory of Norway is hereby approved.

The Annex of Decision No 032/21/COL is hereby replaced by the Annex to this Decision.

Article 2

This Decision shall enter into force on the day of its signature.

Article 3

This Decision is addressed to Norway.

Article 4

This Decision shall be authentic in the English language.

Done at Brussels, 22 April 2021.

For the EFTA Surveillance Authority, acting under Delegation Decision No 130/20/COL,

Högni S. KRISTJÁNSSON

Responsible College Member

Carsten ZATSCHLER

Countersigning as Director, Legal and Executive Affairs

---

(1)  
  OJ L 84, 31.3.2016, p. 1.

1

(2)  
  OJ L 174, 3.6.2020, p. 211.

2

(3)  Commission Delegated Regulation (EU) 2020/687 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council, as regards rules for the prevention and control of certain listed diseases (OJ L 174, 3.6.2020, p. 64).

3

(4)  The Act referred to at Point 8a. of Part 7.1. of Chapter I of Annex I to the EEA Agreement, Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC, as amended and as adapted to the EEA Agreement by the sectoral adaptations referred to in Annex I to the EEA Agreement.

4

---

ANNEX

Disease-free and non-vaccination statuses and eradication programmes of Norway and Iceland or zones or compartments thereof approved in accordance with Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/689

In Norway:

| Disease-free or non- vaccination status | Area: Whole territory or zone | Legal Basis | No of previous or new EFTA Surveillance Authority Decision |
| --- | --- | --- | --- |
| infection with Brucella abortus,


  B. melitensis and B. suis in bovine animal populations | Whole territory | Article 84(1)(a)(i) of Delegated Regulation (EU) 2020/689 | 28/07/COL of 19 February 2007 (previous Decision repealed) |
| infection with Brucella melitensis in ovine and caprine animal populations | Whole territory | Article 84(1)(a)(ii) of Delegated Regulation (EU) 2020/689 | 029/21/COL of 13 April 2021 (previous Decision repealed) |
| infection with Mycobacterium tuberculosis complex (M. bovis, M.caprae and M. tuberculosis) (‘MTBC’) | Whole territory | Article 84(1)(b) of Delegated Regulation (EU) 2020/689 | 28/07/COL of 19 February 2007 (previous Decision repealed) |
| Enzootic bovine leucosis (‘EBL’) | Whole territory | Article 84(1)(c) of Delegated Regulation (EU) 2020/689 | 28/07/COL of 19 February 2007 (previous Decision repealed) |
| Infectious bovine rhinotracheitis (‘IBR’)/infectious pustular vulvovaginitis (‘IPV’) | Whole territory | Article 84(1)(d) of Delegated Regulation (EU) 2020/689 | 159/10/COL of 21 April 2010 (previous Decision repealed) |
| infection with Aujeszky’s disease virus (‘ADV’) | Whole territory | Article 84(1)(e) of Delegated Regulation (EU) 2020/689 | 160/10/COL of 21 April 2010 (previous Decision repealed) |
| infection with Newcastle disease virus without vaccination | Whole territory | Article 84(1)(g) of Delegated Regulation (EU) 2020/689 | 221/96/COL of 4 December 1996 (previous Decision repealed) |
| Rabies virus (‘RABV’) | Whole territory | Article 36(4) of Regulation (EU) 2016/429 and Article 70(3)(a) of Delegated Regulation (EU) 2020/689 | 033/21/COL of 22 April 2021 |
| infection with Marteilia refringens | Zone: the entire coastline of Norway, with the exception of the containment area in the municipality of Bømlo in the County of Hordaland in southern Norway, specifically described in § 2 of the Norwegian Regulations on the control area to fight the disease Marteiliose in molluscs, Bømlo municipality, Hordaland (FOR-2017-09-08- 1377) | Article 84(1)(l) of Delegated Regulation (EU) 2020/689 | 18/18/COL of 9 February 2018 (previous Decision repealed) |
| infection with Bonamia ostreae | Zone: The entire coastline of Norway, with the exception of the county of Aust-Agder in southern Norway | Article 84(1)(k) of Delegated Regulation (EU) 2020/689 | 18/18/COL of 9 February 2018 (previous Decision repealed) |
| Infectious haematopoietic necrosis (‘IHN’) | Whole territory, with the exception of the Norwegian part of the catchment areas of Grense Jacobselv and Pasvik river and the rivers in between and the associated coastal region (Zone) | Article 84(1)(i) of Delegated Regulation (EU) 2020/689 | 264/12/COL of 5 July 2012 (previous Decision repealed) |
| Viral haemorrhagic septicaemia (‘VHS’) | Whole territory, with the exception of the Norwegian part of the catchment areas of Grense Jacobselv and Pasvik river and the rivers in between and the associated coastal region (Zone) | Article 84(1)(h) of Delegated Regulation (EU) 2020/689 | 264/12/COL of 5 July 2012 (previous Decision repealed) |

Disease-free or non- vaccination status

Area: Whole territory or zone

Legal Basis

No of previous or new EFTA Surveillance Authority Decision

infection with Brucella abortus,

B. melitensis and B. suis in bovine animal populations

Whole territory

Article 84(1)(a)(i) of Delegated Regulation (EU) 2020/689

28/07/COL of 19 February 2007 (previous Decision repealed)

infection with Brucella melitensis in ovine and caprine animal populations

Whole territory

Article 84(1)(a)(ii) of Delegated Regulation (EU) 2020/689

029/21/COL of 13 April 2021 (previous Decision repealed)

infection with Mycobacterium tuberculosis complex (M. bovis, M.caprae and M. tuberculosis) (‘MTBC’)

Whole territory

Article 84(1)(b) of Delegated Regulation (EU) 2020/689

28/07/COL of 19 February 2007 (previous Decision repealed)

Enzootic bovine leucosis (‘EBL’)

Whole territory

Article 84(1)(c) of Delegated Regulation (EU) 2020/689

28/07/COL of 19 February 2007 (previous Decision repealed)

Infectious bovine rhinotracheitis (‘IBR’)/infectious pustular vulvovaginitis (‘IPV’)

Whole territory

Article 84(1)(d) of Delegated Regulation (EU) 2020/689

159/10/COL of 21 April 2010 (previous Decision repealed)

infection with Aujeszky’s disease virus (‘ADV’)

Whole territory

Article 84(1)(e) of Delegated Regulation (EU) 2020/689

160/10/COL of 21 April 2010 (previous Decision repealed)

infection with Newcastle disease virus without vaccination

Whole territory

Article 84(1)(g) of Delegated Regulation (EU) 2020/689

221/96/COL of 4 December 1996 (previous Decision repealed)

Rabies virus (‘RABV’)

Whole territory

Article 36(4) of Regulation (EU) 2016/429 and Article 70(3)(a) of Delegated Regulation (EU) 2020/689

033/21/COL of 22 April 2021

infection with Marteilia refringens

Zone: the entire coastline of Norway, with the exception of the containment area in the municipality of Bømlo in the County of Hordaland in southern Norway, specifically described in § 2 of the Norwegian Regulations on the control area to fight the disease Marteiliose in molluscs, Bømlo municipality, Hordaland (FOR-2017-09-08- 1377)

Article 84(1)(l) of Delegated Regulation (EU) 2020/689

18/18/COL of 9 February 2018 (previous Decision repealed)

infection with Bonamia ostreae

Zone: The entire coastline of Norway, with the exception of the county of Aust-Agder in southern Norway

Article 84(1)(k) of Delegated Regulation (EU) 2020/689

18/18/COL of 9 February 2018 (previous Decision repealed)

Infectious haematopoietic necrosis (‘IHN’)

Whole territory, with the exception of the Norwegian part of the catchment areas of Grense Jacobselv and Pasvik river and the rivers in between and the associated coastal region (Zone)

Article 84(1)(i) of Delegated Regulation (EU) 2020/689

264/12/COL of 5 July 2012 (previous Decision repealed)

Viral haemorrhagic septicaemia (‘VHS’)

Whole territory, with the exception of the Norwegian part of the catchment areas of Grense Jacobselv and Pasvik river and the rivers in between and the associated coastal region (Zone)

Article 84(1)(h) of Delegated Regulation (EU) 2020/689

264/12/COL of 5 July 2012 (previous Decision repealed)

| Eradication programme | Area: Whole territory, zone or compartment | Legal Basis | No of EFTA Surveillance Authority Decision |
| --- | --- | --- | --- |
| Currently no entries | | | |

Eradication programme

Area: Whole territory, zone or compartment

Legal Basis

No of EFTA Surveillance Authority Decision

Currently no entries

In Iceland:

| Disease-free or non- vaccination status | Area: Whole territory or zone | Legal Basis | No of previous or new EFTA Surveillance Authority Decision |
| --- | --- | --- | --- |
| Infectious haematopoietic necrosis (‘IHN’) | Whole territory | Article 84(1)(i) of Delegated Regulation (EU) 2020/689 | 227/04/COL of 9 September 2004 and No 36/16/COL of 9 February 2016 (previous Decision repealed) |

Disease-free or non- vaccination status

Area: Whole territory or zone

Legal Basis

No of previous or new EFTA Surveillance Authority Decision

Infectious haematopoietic necrosis (‘IHN’)

Whole territory

Article 84(1)(i) of Delegated Regulation (EU) 2020/689

227/04/COL of 9 September 2004 and No 36/16/COL of 9 February 2016 (previous Decision repealed)

| Eradication programme | Area: Whole territory, zone or compartment | Legal Basis | No of EFTA Surveillance Authority Decision |
| --- | --- | --- | --- |
| Currently no entries | | | |

Eradication programme

Area: Whole territory, zone or compartment

Legal Basis

No of EFTA Surveillance Authority Decision

Currently no entries

---