Prováděcí nařízení Komise (EU) 2021/620 ze dne 15. dubna 2021, kterým se stanoví prováděcí pravidla k nařízení Evropského parlamentu a Rady (EU) 2016/429, pokud jde o schválení statusu území prostého nákazy a statusu území, kde se neprovádí vakcinace, některých členských států nebo jejich oblastí či jednotek pro některé nákazy uvedené na seznamu a schválení eradikačních programů pro zmíněné nákazy uvedené na seznamu (Text s významem pro EHP)

THE EUROPEAN COMMISSION,

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

Having regard to 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 (Animal Health Law)OJ L 84, 31.3.2016, p. 1 . , and in particular Articles 31(3) and 36(4) and Article 37(4)(a) thereof,

This Regulation lays down implementing rules for the listed diseases referred to in Article 9(1)(a), (b) and (c) of Regulation (EU) 2016/429 of animals, as regards the disease-free and non-vaccination status of certain Member StatesIn accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Regulation references to Member States include the United Kingdom in respect of Northern Ireland. or zones or compartments thereof, and the approval of eradication programmes for those listed diseases.

The Annexes to this Regulation list both the Member States or zones or compartments thereof whose disease-free status or eradication programmes shall be deemed to be approved as provided for in Article 280 of Regulation (EU) 2016/429, and those whose disease-free status and eradication programmes shall be duly approved by this Regulation and also duly listed in the Annexes thereto.

This Regulation lists in the Annexes thereto:

(a) the Member States or zones or compartments thereof with approved compulsory eradication programmes for Category B diseases and optional eradication programmes for Category C diseases.

(b) the Member States or zones thereof with approved disease-free status and non-vaccination status;

(c) the compartments of Member States with recognised disease-free status.

OJ L 84, 31.3.2016, p. 1 .

(1) Regulation (EU) 2016/429 establishes a new legislation framework for the prevention and control of diseases, which are transmissible to animals or humans. In particular, Regulation (EU) 2016/429 lays down disease-specific rules for the diseases listed in accordance with Article 5(1) thereof (listed diseases), and Article 9 thereof provides how those rules are to be applied to different categories of listed diseases. Regulation (EU) 2016/429 also provides for the Member States to establish compulsory eradication programmes for the listed diseases referred to in Article 9(1)(b) thereof, and for optional eradication programmes for listed diseases referred to in Article 9(1)(c) thereof, and for the approval of such programmes by the Commission. In addition, it provides for the approval by the Commission of the disease-free status or non-vaccination status of Member States or zones or compartments thereof with regard to certain listed diseases referred to in Article 9(1)(a), (b) and (c) of Regulation (EU) 2016/429.

(2) Commission Implementing Regulation (EU) 2018/1882Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and group of species posing a considerable risk for the spread of those diseases (OJ L 308, 4.12.2018, p. 21 ). defines listed diseases into Categories A to E diseases, and provides that the disease prevention and control rules for listed diseases referred to in Article 9(1) of Regulation (EU) 2016/429 are to apply to the categories of listed diseases for the listed species and groups of listed species referred to in the table set out in the Annex to that Regulation. This Regulation should lay down rules that concern Category A, Category B or Category C diseases.

(3) Regulation (EU) 2016/429 regards the following as listed diseases: infection with Brucella abortus, B. melitensis and B. suis , infection with Mycobacterium tuberculosis complex (MTBC), infection with rabies virus (RABV), enzootic bovine leucosis (EBL), infection with bluetongue virus (serotypes 1-24) (infection with BTV), bovine viral diarrhoea (BVD), infectious bovine rinotracheitis/infectious pustular vulvovaginitis (IBR/IPV), infection with Aujeszky’s disease virus (ADV), infestation with Varroa spp., infection with Newcastle disease virus, infection with highly pathogenic avian influenza (HPAI), viral haemorrhagic septicaemia (VHS), infectious haematopoietic necrosis (IHN), infection with highly polymorphic region deleted infectious salmon anaemia virus (HPR-deleted ISAV), infection with Marteilia refringens , infection with Bonamia exitiosa , infection with Bonamia ostreae , and infection with white spot syndrome virus (WSSV). All those listed diseases fall within the definitions of Category A, Category B or Category C diseases laid down in Implementing Regulation (EU) 2018/1882, and are duly listed in the table in the Annex to that Implementing Regulation.

(4) Commission Delegated Regulation (EU) 2020/689Commission 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 (OJ L 174, 3.6.2020, p. 211 ). supplements the rules on eradication programmes and disease-free status for certain listed diseases of terrestrial, aquatic and other animals, as provided for in Regulation (EU) 2016/429. In particular, Delegated Regulation (EU) 2020/689 establishes criteria for the granting of disease-free status for Member States or zones or compartments thereof, and the requirements for the approval of eradication programmes for Member States or zones or compartments thereof.

(5) Article 85 of Regulation (EU) 2020/689 provides that the Member States or zones thereof with an approved eradication programme or an approved surveillance programme for category C diseases before the date of application of that Regulation are to be deemed to have an approved eradication programme in accordance with that Regulation for a period of six years from the date of application of that Regulation. Accordingly, this limitation should be indicated in the relevant Annexes to this Regulation.

(6) Article 280 of Regulation (EU) 2016/429 provides the rules for the maintenance of the existing disease-free status or approved eradication and surveillance programmes of Member States or zones or compartments thereof for certain listed diseases that were approved by Commission acts adopted in accordance with Council Directives 64/432/EECCouncil 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. 1977/64 ). , 91/68/EECCouncil 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 ). , 92/65/EECCouncil Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC (OJ L 268, 14.9.1992, p. 54 ). , 2005/94/ECCouncil 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 ). , 2006/88/ECCouncil 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 of aquatic animals (OJ L 328, 24.11.2006, p. 14 ). or 2009/158/ECCouncil 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 ). . In addition, Articles 84 and 85 of Delegated Regulation (EU) 2020/689 supplement the rules laid down in Regulation (EU) 2016/429 in that respect by laying down transitional measures concerning existing disease-free statuses, and existing approved eradication and surveillance programmes, with regard to those listed diseases.

(7) For the sake of simplification and transparency, this Regulation should replace the lists of existing disease-free Member States, zones and compartments and the existing approved eradication and surveillance programmes set out in the Commission acts adopted pursuant to the Directives referred to in Article 280 of Regulation (EU) 2016/429 and in certain Directives referred to in Articles 84 and 85 of Delegated Regulation (EU) 2020/689 with lists set out in the Annexes to this Regulation.

(8) For certain listed diseases, Delegated Regulation (EU) 2020/689 lays down rules for the first time for the approval of the disease-free status for Member States or zones or compartments thereof and therefore the provisions of Article 280 of Regulation (EU) 2016/429 do not apply to such situations. This is the case for infection with rabies virus (RABV), infection with bluetongue virus (serotypes 1-24) (infection with BTV), bovine viral diarrhoea (BVD) or infection with Bonamia exitiosa. Several Member States have submitted to the Commission applications to have disease-free status granted for those listed diseases. Following the assessment by the Commission, those applications have been shown to comply with the criteria of Sections 1 and 2 of Chapter 4 of Part II of Delegated Regulation (EU) 2020/689 that lay down rules for the granting of disease-free status for Member States or zones and compartments thereof. Therefore, the disease-free status of those Member States or the relevant zones or compartments thereof, should be granted and they should be duly listed in the Annexes to this Regulation.

(9) For certain listed diseases, Delegated Regulation (EU) 2020/689 lays down rules for the approval of eradication programmes for Member States or zones or compartments thereof that are not subject to the provisions of Article 280 of Regulation (EU) 2016/429. This is the case for infection with Brucella abortus, B. melitensis and B. suis , infection with Mycobacterium tuberculosis complex (MTBC), infection with rabies virus (RABV), enzootic bovine leucosis (EBL), infection with bluetongue virus (serotypes 1-24) (infection with BTV), bovine viral diarrhoea (BVD) or infection with Bonamia exitiosa . Several Member States have submitted to the Commission applications to have the eradication programmes approved for those listed diseases. Following the assessment by the Commission, those applications have been shown to comply with the criteria of Chapters 2 and 3 of Part II of Delegated Regulation (EU) 2020/689 that lay down criteria to be complied with for the approval of eradication programmes for Category B and Category C diseases of terrestrial and aquatic animals, respectively. Therefore, those eradication programmes should be approved and the Member States or zones and compartments thereof should be duly listed in the Annexes to this Regulation.

(10) For certain listed diseases, applications from Member States to have disease-free status granted or to have eradication programmes approved have not yet been received by the Commission or their assessment has not yet been finalised. Once received or once the assessment is finalised the relevant Member States, zones or compartments may be listed in the Annexes to this Regulation.

(11) In addition, for infection with Brucella abortus, B. melitensis and B. suis a Member States has recently submitted to the Commission an application to have disease-free status from infection with Brucella abortus, B. melitensis and B. suis granted for a zone. Following the assessment by the Commission, the application has been shown to comply with the criteria of Article 71 of Delegated Regulation (EU) 2020/689 that lay down rules for the recognition of disease-free status based on eradication programmes. Therefore, the disease-free status of the zone should be granted and it should be duly listed in the Annexes to this Regulation.

(12) With respect to avian influenza, Commission Regulation (EC) No 616/2009Commission Regulation (EC) No 616/2009 of 13 July 2009 implementing Council Directive 2005/94/EC as regards the approval of poultry compartments and other captive birds compartments with respect to avian influenza and additional preventive biosecurity measures in such compartments (OJ L 181, 14.7.2009, p. 16 ). , which was adopted pursuant to Directive 2005/94/EC, provides for the approval by the Member States of poultry compartments and other captive birds’ compartments. The list of approved compartments is publicly available and the Commission’s website includes links to the internet-based information pages of the Member States. Poultry compartments and other captive birds’ compartments approved with respect to avian influenza under Regulation (EC) No 616/2009 should have their disease-free status maintained in accordance with Regulation (EU) 2016/429 and should be duly listed in the Annexes to this Regulation.

(13) Commission Decision 2003/467/ECCommission Decision 2003/467/EC of 23 June 2003 establishing the official tuberculosis, brucellosis, and enzootic-bovine-leukosis-free status of certain Member States and regions of Member States as regards bovine herds (OJ L 156, 25.6.2003, p. 74 ). lists the Member States and regions thereof with tuberculosis-free status, brucellosis-free status and EBL-free status in accordance with Directive 64/432/EEC. Those Member States and regions thereof should be duly listed in the Annexes to this Regulation.

(14) Commission Decision 93/52/EECCommission Decision 93/52/EEC of 21 December 1992 recording the compliance by certain Member States or regions with the requirements relating to brucellosis (B. melitensis ) and according them the status of a Member State or region officially free of the disease (OJ L 13, 21.1.1993, p. 14 ). sets out the list of Member States and regions thereof with official brucellosis-free (B. melitensis ) status in accordance Directive 91/68/EEC. Those Member States and regions thereof should be duly listed in the Annexes to this Regulation.

(15) Commission Implementing Decision 2013/503/EUCommission Implementing Decision 2013/503/EU of 11 October 2013 recognising parts of the Union as free from varroosis in bees and establishing additional guarantees required in intra-Union trade and imports for the protection of their varroosis-free status (OJ L 273, 15.10.2013, p. 38 ). sets out the list of Member States or territories thereof which are recognised as free from varroosis in accordance with Directive 92/65/EEC. Those Members States or territories thereof should be duly listed in the Annexes to this Regulation.

(16) Commission Decisions 94/963/ECCommission Decision 94/963/EC of 28 December 1994 establishing the status of Finland as non vaccinating as regards Newcastle disease (OJ L 371, 31.12.1994, p. 29 ). and 95/98/ECCommission Decision 95/98/EC of 13 March 1995 establishing the status of Sweden as non-vaccinating as regards Newcastle disease (OJ L 75, 4.4.1995, p. 28 ). establish the status of Finland and Sweden as non-vaccinating as regards Newcastle disease in accordance with Directive 2009/158/EC. Those Member States should be duly listed in the Annexes to this Regulation.

(17) Commission Decision 2004/558/ECCommission Decision 2004/558/EC of 15 July 2004 implementing Council Directive 64/432/EEC as regards additional guarantees for intra-Community trade in bovine animals relating to infectious bovine rhinotracheitis and the approval of the eradication programmes presented by certain Member States (OJ L 249, 23.7.2004, p. 20 ). sets out the lists of regions of Member States that have the IBR-free status and the regions of Member States that have an approved IBR eradication programme in accordance with Directive 64/432/EEC. The regions with IBR-free status should be duly listed in the Annexes to this Regulation, whereas the regions with approved IBR eradication programmes should maintain their programme for a limited period of time in accordance with Regulation (EU) 2020/689, and should be listed in the Annexes to this Regulation.

(18) Commission Decision 2008/185/ECCommission Decision 2008/185/EC of 21 February 2008 on additional guarantees in intra-Community trade of pigs relating to Aujeszky’s disease and criteria to provide information on this disease (OJ L 59, 4.3.2008, p. 19 ). sets out the lists of Member States or regions thereof that have the Aujeszky’s disease-free status and the regions that have an approved Aujeszky’s disease eradication programme in accordance with Directive 64/432/EEC. Those Member States or regions thereof with Aujeszky’s disease-free status should be duly listed in the Annexes to this Regulation, whereas the regions with approved Aujeszky’s disease eradication programmes should maintain them for a limited period of time in accordance with Regulation (EU) 2020/689, and should be duly listed in the Annexes to this Regulation.

(19) Commission Decision 2009/177/ECCommission Decision 2009/177/EC of 31 October 2008 implementing Council Directive 2006/88/EC as regards surveillance and eradication programmes and disease-free status of Member States, zones and compartments (OJ L 63, 7.3.2009, p. 15 ). establishes lists of Member States and certain zones and compartments with disease-free status, or subject to approved surveillance programmes or eradication programmes with regard to listed diseases of aquatic animals in accordance with Directive 2006/88/EC. The disease-free status of those Member States, zones and compartments should be duly listed in the Annexes to this Regulation, whereas the approved programmes should be maintained for a limited period of time in accordance with Article 85 of Regulation (EU) 2020/689, and should be duly listed in the Annexes to this Regulation.

(20) With regard to listed diseases of aquatic animals, there are certain disease-free zones and compartments, and approved surveillance programmes, not listed in Decision 2009/177/EC but lists of which are publicly available on the internet-based information pages of the Member States in accordance with Directive 2006/88/EC. Those zones and compartments should have their disease-free status maintained, whereas the programmes should be maintained for a limited period in accordance with Article 85 of Regulation (EU) 2020/689. Up-to-date information concerning the establishments that are located in those disease-free zones and compartments, or which are subject to those programmes, are set out in the publicly available internet page that has been established and maintained in accordance with Article 185(3) of Regulation (EU) 2016/429 and with Article 21(2) of Commission Delegated Regulation (EU) 2020/691Commission Delegated Regulation (EU) 2020/691 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of Council as regards rules for aquaculture establishments and transporters of aquatic animals (OJ L 174, 3.6.2020, p. 345 ). .

(21) As the lists set out in Decisions 93/52/EEC, 94/963/EC, 95/98/EC, 2003/467/EC, 2004/558/EC, 2008/185/EC and 2009/177/EC, Regulation (EC) No 616/2009 and Implementing Decision 2013/503/EU are being replaced by the lists set out in the Annexes to this Regulation, those acts should be repealed and replaced by this Regulation.

(22) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (Withdrawal Agreement), and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, Regulation (EU) 2016/429, as well as the Commission acts based on it, apply to and in the United Kingdom in respect of Northern Ireland after the end of the transition period provided for in the Withdrawal Agreement. For that reason, the United Kingdom (Northern Ireland) should be listed in the Annexes to this Regulation where relevant for Northern Ireland.

(23) As Regulation (EU) 2016/429 applies from 21 April 2021 , this Regulation should also apply from that date.

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

The Member States or zones thereof with disease-free status from infection with Brucella abortus, B. melitensis and B. suis in bovine animal populations shall be listed in Chapter 1 of Part I of Annex I.

The Member States or zones thereof with disease-free status from infection with Brucella abortus, B. melitensis and B. suis in ovine and caprine animal populations shall be listed in Chapter 2 of Part I of Annex I.

The Member States or zones thereof with an approved compulsory eradication programme for infection with Brucella abortus, B. melitensis and B. suis shall be listed in Part II of Annex I.

Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and group of species posing a considerable risk for the spread of those diseases (OJ L 308, 4.12.2018, p. 21 ).

Article 1 Article 1 Subject matter and scope 1.This Regulation lays down implementing rules for the listed diseases referred to in Article 9(1)(a), (b) and (c) of Regulation (EU) 2016/429 of animals, as regards the disease-free and non-vaccination status of certain Member StatesIn accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Regulation references to Member States include the United Kingdom in respect of Northern Ireland. or zones or compartments thereof, and the approval of eradication programmes for those listed diseases. 2.The Annexes to this Regulation list both the Member States or zones or compartments thereof whose disease-free status or eradication programmes shall be deemed to be approved as provided for in Article 280 of Regulation (EU) 2016/429, and those whose disease-free status and eradication programmes shall be duly approved by this Regulation and also duly listed in the Annexes thereto. 3.This Regulation lists in the Annexes thereto: (a) the Member States or zones or compartments thereof with approved compulsory eradication programmes for Category B diseases and optional eradication programmes for Category C diseases.(b) the Member States or zones thereof with approved disease-free status and non-vaccination status;(c) the compartments of Member States with recognised disease-free status.

Article 2 Article 2 Infection with Brucella abortus , B. melitensis and B. suis 1.The Member States or zones thereof with disease-free status from infection with Brucella abortus, B. melitensis and B. suis in bovine animal populations shall be listed in Chapter 1 of Part I of Annex I. 2.The Member States or zones thereof with disease-free status from infection with Brucella abortus, B. melitensis and B. suis in ovine and caprine animal populations shall be listed in Chapter 2 of Part I of Annex I. 3.The Member States or zones thereof with an approved compulsory eradication programme for infection with Brucella abortus, B. melitensis and B. suis shall be listed in Part II of Annex I.

Article 3 Article 3 Infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis ) (MTBC) 1.The Member States or zones thereof with disease-free status from infection with Mycobacterium tuberculosis complex (Mycobacterium bovis, M.caprae and M. tuberculosis ) (MTBC) shall be listed in Part I of Annex II. 2.The Member States or zones thereof with an approved compulsory eradication programme for infection with MTBC shall be listed in Part II of Annex II.

Article 4 Article 4 Infection with rabies virus (RABV) 1.The Member States or zones thereof with disease-free status from infection with rabies virus (RABV) shall be listed in Part I of Annex III. 2.The Member States or zones thereof with an approved compulsory eradication programme for infection with RABV shall be listed in Part II of Annex III.

Article 5 Article 5 Enzootic bovine leukosis (EBL) 1.The Member States or zones thereof with disease-free status from enzootic bovine leukosis (EBL) shall be listed in Part I of Annex IV. 2.The Member States or zones thereof with an approved optional eradication programme for EBL shall be listed in Part II of Annex IV.

Article 6 Article 6 Infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV) 1.The Member States or zones thereof with disease-free status from infectious bovine rinotracheitis/infectious pustular vulvovaginitis (IBR/IPV) shall be listed in Part I of Annex V. 2.The Member States or zones thereof with an approved optional eradication programme for IBR/IPV shall be listed in Part II of Annex V.

Article 7 Article 7 Infection with Aujeszky’s disease virus(ADV) 1.The Member States or zones thereof with disease-free status from infection with Aujeszky’s disease virus (ADV) shall be listed in Part I of Annex VI. 2.The Member States or zones thereof with an approved optional eradication programme for infection with ADV shall be listed in Part II of Annex VI.

Article 8 Article 8 Bovine viral diarrhoea (BVD) 1.The Member States or zones thereof with disease-free status from Bovine viral diarroea (BVD) shall be listed in Part I of Annex VII. 2.The Member States or zones thereof with an approved optional eradication programme for infection with BVD shall be listed in Part II of Annex VII.

Article 9 Article 9 Infection with bluetongue virus (serotypes 1-24) (infection with BTV) 1.The Member States or zones thereof with disease-free status from infection with bluetongue virus (serotypes 1-24) (infection with BTV) shall be listed in Part I of Annex VIII. 2.The Member States or zones thereof with an approved optional eradication programme for infection with BTV shall be listed in Part II of Annex VIII.

Article 10 Article 10 Infestation with Varroa spp.

Article 11 Article 11 Infection with Newcastle disease virus

Article 12 Article 12 Infection with highly pathogenic avian influenza (HPAI)

Article 13 Article 13 Viral haemorrhagic septicaemia (VHS) 1.The following shall be listed in Part I of Annex XII: (a) Member States where their whole territory has disease-free status from viral haemorrhagic septicaemia (VHS);(b) zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from VHS; and(c) zones or compartments of Member States with disease-free status from VHS, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. 2.The following shall be listed in Part II of Annex XII: (a) Member States where their whole territory has an approved eradication programme for VHS;(b) zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for VHS; and(c) zones and compartments of Member States with an approved eradication programme for VHS, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

Article 14 Article 14 Infectious haematopoietic necrosis (IHN) 1.The following shall be listed in Part I of Annex XIII: (a) Member States where their whole territory has disease-free status from infectious haematopoietic necrosis (IHN);(b) zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from IHN; and(c) zones or compartments of Member States with disease-free status from IHN, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. 2.The following shall be listed in Part II of Annex XIII: (a) Member States where their whole territory has an approved eradication programme for IHN;(b) zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for IHN; and(c) zones and compartments of Member States with an approved eradication programme for IHN, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

Article 15 Article 15 Infection with highly polymorphic region deleted infectious salmon anaemia virus (HPR-deleted ISAV) 1.The following shall be listed in Part I of Annex XIV: (a) Member States where their whole territory has disease-free status from infection with highly polymorphic region deleted infectious salmon anaemia virus (HPR-deleted ISAV);(b) zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with HPR-deleted ISAV; and(c) zones or compartments of Member States with disease-free status from infection with HPR-deleted ISAV, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. 2.The following shall be listed in Part II of Annex XIV: (a) Member States where their whole territory has an approved eradication programme for infection with HPR-deleted ISAV;(b) zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with HPR-deleted ISAV; and(c) zones and compartments of Member States with an approved eradication programme for infection with HPR-deleted ISAV, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

Article 16 Article 16 Infection with Marteilia refringens 1.The following shall be listed in Part I of Annex XV: (a) Member States where their whole territory has disease-free status from infection with Marteilia refringens ;(b) zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with Marteilia refringens ; and(c) zones or compartments of Member States with disease-free status from infection with Marteilia refringens, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. 2.The following shall be listed in Part II of Annex XV: (a) Member States where their whole territory has an approved eradication programme for infection with Marteilia refringens ;(b) zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with Marteilia refringens ; and(c) zones and compartments of Member States with an approved eradication programme for infection with Marteilia refringens , where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

Article 17 Article 17 Infection with Bonamia exitiosa 1.The following shall be listed in Part I of Annex XVI: (a) Member States where their whole territory has disease-free status from infection with Bonamia exitiosa ;(b) zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with Bonamia exitiosa ; and(c) zones or compartments of Member States with disease-free status from infection with Bonamia exitiosa, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. 2.The following shall be listed in Part II of Annex XVI: (a) Member States where their whole territory has an approved eradication programme for infection with Bonamia exitiosa ;(b) zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with Bonamia exitiosa ; and(c) zones and compartments of Member States with an approved eradication programme for infection with Bonamia exitiosa , where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

Article 18 Article 18 Infection with Bonamia ostreae 1.The following shall be listed in Part I of Annex XVII: (a) Member States where their whole territory has disease-free status from infection with Bonamia ostreae ;(b) zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with Bonamia ostreae ; and(c) zones or compartments of Member States with disease-free status from infection with Bonamia ostreae, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. 2.The following shall be listed in Part II of Annex XVII: (a) Member States where their whole territory has an approved eradication programme for infection with Bonamia ostreae ;(b) zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with Bonamia ostreae ; and(c) zones and compartments of Member States with an approved eradication programme for infection with Bonamia ostreae , where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

Article 19 Article 19 Infection with white spot syndrome virus (WSSV) 1.The following shall be listed in Part I of Annex XVIII: (a) Member States where their whole territory has disease-free status from infection with white spot syndrome virus (WSSV);(b) zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with WSSV; and(c) zones or compartments of Member States with disease-free status from infection with WSSV, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country. 2.The following shall be listed in Part II of Annex XVIII: (a) Member States where their whole territory has an approved eradication programme for infection with WSSV;(b) zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with WSSV; and(c) zones and compartments of Member States with an approved eradication programme for infection with WSSV, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

Article 20 Article 20 Repeal

Article 21 Article 21 Entry into force and application

The Member States or zones thereof with disease-free status from infection with Mycobacterium tuberculosis complex (Mycobacterium bovis, M.caprae and M. tuberculosis ) (MTBC) shall be listed in Part I of Annex II.

The Member States or zones thereof with an approved compulsory eradication programme for infection with MTBC shall be listed in Part II of Annex II.

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

The Member States or zones thereof with disease-free status from infection with rabies virus (RABV) shall be listed in Part I of Annex III.

The Member States or zones thereof with an approved compulsory eradication programme for infection with RABV shall be listed in Part II of Annex III.

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. 1977/64 ).

The Member States or zones thereof with disease-free status from enzootic bovine leukosis (EBL) shall be listed in Part I of Annex IV.

The Member States or zones thereof with an approved optional eradication programme for EBL shall be listed in Part II of Annex IV.

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 ).

The Member States or zones thereof with disease-free status from infectious bovine rinotracheitis/infectious pustular vulvovaginitis (IBR/IPV) shall be listed in Part I of Annex V.

The Member States or zones thereof with an approved optional eradication programme for IBR/IPV shall be listed in Part II of Annex V.

Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC (OJ L 268, 14.9.1992, p. 54 ).

The Member States or zones thereof with disease-free status from infection with Aujeszky’s disease virus (ADV) shall be listed in Part I of Annex VI.

The Member States or zones thereof with an approved optional eradication programme for infection with ADV shall be listed in Part II of Annex VI.

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 ).

The Member States or zones thereof with disease-free status from Bovine viral diarroea (BVD) shall be listed in Part I of Annex VII.

The Member States or zones thereof with an approved optional eradication programme for infection with BVD shall be listed in Part II of Annex VII.

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 of aquatic animals (OJ L 328, 24.11.2006, p. 14 ).

The Member States or zones thereof with disease-free status from infection with bluetongue virus (serotypes 1-24) (infection with BTV) shall be listed in Part I of Annex VIII.

The Member States or zones thereof with an approved optional eradication programme for infection with BTV shall be listed in Part II of Annex VIII.

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 ).

The Member States or zones thereof with disease-free status from infestation with Varroa spp. shall be listed in Annex IX.

Commission Regulation (EC) No 616/2009 of 13 July 2009 implementing Council Directive 2005/94/EC as regards the approval of poultry compartments and other captive birds compartments with respect to avian influenza and additional preventive biosecurity measures in such compartments (OJ L 181, 14.7.2009, p. 16 ).

The Member States or zones thereof with disease-free status from infection with Newcastle disease virus without vaccination shall be listed in Annex X.

Commission Decision 2003/467/EC of 23 June 2003 establishing the official tuberculosis, brucellosis, and enzootic-bovine-leukosis-free status of certain Member States and regions of Member States as regards bovine herds (OJ L 156, 25.6.2003, p. 74 ).

Compartments of the Member States free from HPAI shall be listed in Annex XI.

Commission Decision 93/52/EEC of 21 December 1992 recording the compliance by certain Member States or regions with the requirements relating to brucellosis (B. melitensis ) and according them the status of a Member State or region officially free of the disease (OJ L 13, 21.1.1993, p. 14 ).

The following shall be listed in Part I of Annex XII:

(a) Member States where their whole territory has disease-free status from viral haemorrhagic septicaemia (VHS);

(b) zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from VHS; and

(c) zones or compartments of Member States with disease-free status from VHS, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

The following shall be listed in Part II of Annex XII:

(a) Member States where their whole territory has an approved eradication programme for VHS;

(b) zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for VHS; and

(c) zones and compartments of Member States with an approved eradication programme for VHS, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

Commission Implementing Decision 2013/503/EU of 11 October 2013 recognising parts of the Union as free from varroosis in bees and establishing additional guarantees required in intra-Union trade and imports for the protection of their varroosis-free status (OJ L 273, 15.10.2013, p. 38 ).

The following shall be listed in Part I of Annex XIII:

(a) Member States where their whole territory has disease-free status from infectious haematopoietic necrosis (IHN);

(b) zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from IHN; and

(c) zones or compartments of Member States with disease-free status from IHN, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

The following shall be listed in Part II of Annex XIII:

(a) Member States where their whole territory has an approved eradication programme for IHN;

(b) zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for IHN; and

(c) zones and compartments of Member States with an approved eradication programme for IHN, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

Commission Decision 94/963/EC of 28 December 1994 establishing the status of Finland as non vaccinating as regards Newcastle disease (OJ L 371, 31.12.1994, p. 29 ).

The following shall be listed in Part I of Annex XIV:

(a) Member States where their whole territory has disease-free status from infection with highly polymorphic region deleted infectious salmon anaemia virus (HPR-deleted ISAV);

(b) zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with HPR-deleted ISAV; and

(c) zones or compartments of Member States with disease-free status from infection with HPR-deleted ISAV, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

The following shall be listed in Part II of Annex XIV:

(a) Member States where their whole territory has an approved eradication programme for infection with HPR-deleted ISAV;

(b) zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with HPR-deleted ISAV; and

(c) zones and compartments of Member States with an approved eradication programme for infection with HPR-deleted ISAV, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

Commission Decision 95/98/EC of 13 March 1995 establishing the status of Sweden as non-vaccinating as regards Newcastle disease (OJ L 75, 4.4.1995, p. 28 ).

The following shall be listed in Part I of Annex XV:

(a) Member States where their whole territory has disease-free status from infection with Marteilia refringens ;

(b) zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with Marteilia refringens ; and

(c) zones or compartments of Member States with disease-free status from infection with Marteilia refringens, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

The following shall be listed in Part II of Annex XV:

(a) Member States where their whole territory has an approved eradication programme for infection with Marteilia refringens ;

(b) zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with Marteilia refringens ; and

(c) zones and compartments of Member States with an approved eradication programme for infection with Marteilia refringens , where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

Commission Decision 2004/558/EC of 15 July 2004 implementing Council Directive 64/432/EEC as regards additional guarantees for intra-Community trade in bovine animals relating to infectious bovine rhinotracheitis and the approval of the eradication programmes presented by certain Member States (OJ L 249, 23.7.2004, p. 20 ).

The following shall be listed in Part I of Annex XVI:

(a) Member States where their whole territory has disease-free status from infection with Bonamia exitiosa ;

(b) zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with Bonamia exitiosa ; and

(c) zones or compartments of Member States with disease-free status from infection with Bonamia exitiosa, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

The following shall be listed in Part II of Annex XVI:

(a) Member States where their whole territory has an approved eradication programme for infection with Bonamia exitiosa ;

(b) zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with Bonamia exitiosa ; and

(c) zones and compartments of Member States with an approved eradication programme for infection with Bonamia exitiosa , where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

Commission Decision 2008/185/EC of 21 February 2008 on additional guarantees in intra-Community trade of pigs relating to Aujeszky’s disease and criteria to provide information on this disease (OJ L 59, 4.3.2008, p. 19 ).

The following shall be listed in Part I of Annex XVII:

(a) Member States where their whole territory has disease-free status from infection with Bonamia ostreae ;

(b) zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with Bonamia ostreae ; and

(c) zones or compartments of Member States with disease-free status from infection with Bonamia ostreae, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

The following shall be listed in Part II of Annex XVII:

(a) Member States where their whole territory has an approved eradication programme for infection with Bonamia ostreae ;

(b) zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with Bonamia ostreae ; and

(c) zones and compartments of Member States with an approved eradication programme for infection with Bonamia ostreae , where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

Commission Decision 2009/177/EC of 31 October 2008 implementing Council Directive 2006/88/EC as regards surveillance and eradication programmes and disease-free status of Member States, zones and compartments (OJ L 63, 7.3.2009, p. 15 ).

The following shall be listed in Part I of Annex XVIII:

(a) Member States where their whole territory has disease-free status from infection with white spot syndrome virus (WSSV);

(b) zones or compartments of Member States where more than 75 % of the territory of the Member State has disease-free status from infection with WSSV; and

(c) zones or compartments of Member States with disease-free status from infection with WSSV, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

The following shall be listed in Part II of Annex XVIII:

(a) Member States where their whole territory has an approved eradication programme for infection with WSSV;

(b) zones and compartments of Member States where more than 75 % of the territory of the Member State has an approved eradication programme for infection with WSSV; and

(c) zones and compartments of Member States with an approved eradication programme for infection with WSSV, where the water catchment area supplying those zones or compartments of the Member State is shared with another Member State or a third country.

Commission Delegated Regulation (EU) 2020/691 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of Council as regards rules for aquaculture establishments and transporters of aquatic animals (OJ L 174, 3.6.2020, p. 345 ).

The following acts are repealed:

In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Regulation references to Member States include the United Kingdom in respect of Northern Ireland.

Decision 93/52/EEC,

Decision 94/963/EC,

Decision 95/98/EC,

Decision 2003/467/EC,

Decision 2004/558/EC,

Decision 2008/185/EC,

Decision 2009/177/EC,

Regulation (EC) No 616/2009,

Implementing Decision 2013/503/EU.

This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union .

It shall apply from 21 April 2021 .

HAS ADOPTED THIS REGULATION: