Commission Implementing Decision (EU) 2023/1521 of 19 July 2023 concerning certain special disease control measures for a limited period of time relating to infection with lumpy skin disease virus in certain Member States (notified under document C(2023) 4811) (Text with EEA relevance)

21.7.2023 EN Official Journal of the European Union L 184/77 COMMISSION IMPLEMENTING DECISION (EU) 2023/1521 of 19 July 2023 concerning certain special disease control measures for a limited period of time relating to infection with lumpy skin disease virus in certain Member States (notified under document C(2023) 4811) (Text with EEA relevance) 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’)(1), and in particular Article 71(3), point (a), thereof, Whereas: (1) Infection with lumpy skin disease (LSD) virus, caused by lumpy skin disease virus (LSDV), is a vector-borne disease of bovine animals that causes substantial economic losses, reduces milk yield, causes severe emaciation, permanent damage to hides, several secondary complications, months-long chronic debility, and incurs trade bans. The disease is endemic in Africa and is included in the World Organisation for Animal Health list of notifiable diseases. (2) LSD occurred in the Union for the first time in 2015 in Greece. In 2016, the disease quickly spread in many countries of South East Europe including Albania, Bulgaria, Greece, Kosovo*, North Macedonia, Montenegro and Serbia. In all affected countries the disease was placed effectively under control through mass vaccination of bovine animals, with live homologous vaccines, repeated on an annual basis, in accordance with vaccines’ specifications. In addition, Croatia and Bosnia and Herzegovina, that were not affected by LSD, implemented vaccination as a preventive measure, in view of disease occurrence in neighbouring countries. (3) Commission Implementing Regulation (EU) 2021/1070(2) was adopted within the framework of Regulation (EU) 2016/429, and it lays down special control measures against LSD for a limited period of time. That Implementing Regulation applied until 21 April 2023. (4) More particularly, Implementing Regulation (EU) 2021/1070, defines the zones of a Member State, where vaccination against LSD is carried out, and the special disease control rules within each zone. These zones are classified as restricted zone I, located outside an area where an outbreak of infection with LSDV has been confirmed, and restricted zone II, which includes an area where an outbreak of infection with LSDV has been confirmed. (5) Furthermore, Implementing Regulation (EU) 2021/1070, provided for restrictions regarding the movements of bovine animals and products thereof, germinal products, and animal by-products from restricted zone I and II, and derogations in relation to these restrictions. In addition, it provided rules for the operators’ obligations with regard to animal health certificates for movements of bovine animals, germinal products and unprocessed animal by-products thereof, from restricted zones I and II, outside these zones. (1) OJ L 84, 31.3.2016, p. 1. * This designation is without prejudice to positions on status, and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence. (2) Commission Implementing Regulation (EU) 2021/1070 of 28 June 2021 laying down special control measures for a limited period of time related to infection with lumpy skin disease virus (OJ L 230, 30.6.2021, p. 10).L 184/78 EN Official Journal of the European Union 21.7.2023 (6) Commission Delegated Regulation (EU) 2023/361(3), entered into force on 12 March 2023, and it lays down rules for the use of certain veterinary medicinal products for the purpose of prevention and control of certain listed diseases, including rules for vaccination against LSD. In addition, Article 9 of that Delegated Regulation and Annex IX thereto provide for the establishment of vaccination zones I and II that correspond to the restricted zones I and II of Implementing Regulation (EU) 2021/1070. (7) In addition, Delegated Regulation (EU) 2023/361 lays down rules and restrictions in relation to bovine animals vaccinated for LSD, their germinal products and unprocessed animal by-products thereof that correspond to the rules and restrictions laid down in Implementing Regulation (EU) 2021/1070, except for those related to the operators’ obligations with regard to animal health certificates. (8) Delegated Regulation (EU) 2023/361 also provides for recovery periods for LSD, following emergency protective vaccination, that range between 8 and 26 months, depending on the type of surveillance, the vaccination zone, and the time of the slaughter or killing of the last LSD case and/or the time of the last vaccination. (9) Since 2017, no LSD outbreaks have been reported in Europe although LSD was recorded until 2021 in parts of Anatolia, Türkiye and remains present in Russia while it continues to spread in Asia, affecting countries of the Indian subcontinent, East Asia and South East Asia. In view of the favourable epidemiological situation in Europe, all countries in South East Europe that implemented vaccination against LSD have now ceased, except for Bulgaria, Greece and Türkiye. (10) Bulgaria and Greece have already submitted their 2023 LSD vaccination programmes to the Commission, and these have already been evaluated and approved, in the framework of Regulation (EU) 2021/690 of the European Parliament and of the Council(4). The nature and content of the technical evaluation and approval of those vaccination programmes also fulfil the requirements of the official vaccination plan for the prevention and control of category A diseases in terrestrial animals laid down in Article 6 of Delegated Regulation (EU) 2023/361. (11) In view of the expiry of Implementing Regulation (EU) 2021/1070, it is essential to list the areas defined as vaccination zones I and II in relation to LSD, in Bulgaria and Greece, that correspond to the restricted zones I and II of Implementing Regulation (EU) 2021/1070, and to lay down additional rules regarding the operators’ obligations with regard to animal health certificates for movements of bovine animals, as well as those for germinal products and unprocessed animal by-products thereof, from vaccination zones I and II, outside these zones, to ensure that these animal health certificates provide adequate and accurate health information and there is a continuity with the measures previously in place. (12) Taking into account the LSD vaccination plans of Bulgaria and Greece for 2023, the epidemiological situation as regards that disease in the Union, and the recovery period for LSD, as laid down in Delegated Regulation (EU) 2023/361, this Decision should apply until 31 August 2024, (13) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, (3) Commission Delegated Regulation (EU) 2023/361 of 28 November 2022 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council as regards rules for the use of certain veterinary medicinal products for the purpose of prevention and control of certain listed diseases (OJ L 52, 20.2.2023, p. 1). (4) Regulation (EU) 2021/690 of the European Parliament and the Council of 28 April 2021 establishing a programme for the internal market, competitiveness of enterprises, including small and medium-sized enterprises, the area of plants, animals, food and feed, and European statistics (Single Market Programme) and repealing Regulations (EU) No 99/2013, (EU) No 1287/2013, (EU) No 254/2014 and (EU) No 652/2014 (OJ L 153, 3.5.2021, p. 1).21.7.2023 EN Official Journal of the European Union L 184/79 HAS ADOPTED THIS DECISION: Article 1 Subject matter and scope This Decision establishes at Union level: (a) vaccination zones I and II, in relation to emergency protective vaccination against lumpy skin disease in kept terrestrial animals, that are required to be established in accordance with Article 9(1), point (b)(i), of Delegated Regulation (EU) 2023/361, and Annex IX, Part 1, thereto; (b) operators’ obligations with regard to animal health certificates for movements of the following consignments from vaccination zones I and II outside those zones, in accordance with the derogations for such movements provided for in Article 13(2), (3) and (4) of Delegated Regulation (EU) 2023/361, and the specific conditions laid down in Annex IX, Part 3, thereto: (i) bovine animals; (ii) germinal products of bovine animals; (iii) unprocessed animal by-products. Article 2 Establishment of vaccination zones I and II Member States implementing emergency protective vaccination against lumpy skin disease shall ensure that: (a) vaccination zones I and II are established immediately by their competent authorities, in accordance with: (i) the rules for the implementation of emergency protective vaccination laid down in Article 9 of Delegated Regulation (EU) 2023/361; (ii) the specific conditions for the implementation of emergency protective vaccination for the prevention and control of lumpy skin disease laid down in Annex IX, to Delegated Regulation (EU) 2023/361; (b) the vaccination zones I and II comprise at least the areas listed in the Annex to this Decision. Article 3 Operators’ obligations with regard to animal health certificates for movements of consignments of bovine animals from vaccination zones I and II outside those zones Operators shall only move consignments of bovine animals from vaccination zones I and II outside those zones within the same Member State or to another Member State if the animals to be moved, in accordance with the derogation for such movements laid down in Article 13(2) of Delegated Regulation (EU) 2023/361, and the specific conditions laid down in Annex IX, Part 3, thereto, are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Article 149(1) of Regulation (EU) 2016/429, that contains at least one of the following attestations: (a) ‘Bovine animals from vaccination zone I in relation to emergency protective vaccination against lumpy skin disease, in compliance with Article 13(2) of, and Annex IX, Part 3, point (3.1), to Commission Delegated Regulation (EU) 2023/361.’;L 184/80 EN Official Journal of the European Union 21.7.2023 (b) ‘Bovine animals from vaccination zone II in relation to emergency protective vaccination against lumpy skin disease, in compliance with Article 13(2) of, and Annex IX, Part 3, point (3.2), to Commission Delegated Regulation (EU) 2023/361.’; (c) ‘Bovine animals from vaccination zone...(I or II, indicate as appropriate) in relation to emergency protective vaccination against lumpy skin disease, in compliance with Article 13(2) of, and Annex IX, Part 3, point (3.3), to Commission Delegated Regulation (EU) 2023/361.’. However, in the case of movements within the same Member State, the competent authority may decide that an animal health certificate does not have to be issued as referred to in the second subparagraph of Article 143(2) of Regulation (EU) 2016/429. Article 4 Operators’ obligations with regard to animal health certificates for movements of consignments of germinal products obtained from bovine animals from establishments located in vaccination zones I and II outside those zones Operators shall only move consignments of germinal products obtained from bovine animals from vaccination zones I and II outside those zones within the same Member State or to another Member State, in accordance with the derogation for such movements laid down in Article 13(3) of Delegated Regulation (EU) 2023/361, and the specific conditions laid down Annex IX, Part 3, thereto, if those consignments are accompanied by an animal health certificate issued by the competent authority of the Member State of origin, in accordance with Article 161(4) of Regulation (EU) 2016/429, that contains at least one of the following attestations: (a) ‘Germinal products… (semen, ova and/or embryos, indicate as appropriate) obtained from bovine animals kept in vaccination zone I in relation to emergency protective vaccination against lumpy skin disease, in compliance with Article 13(3) of, and Annex IX, Part 3, point (3.4.1), to Commission Delegated Regulation (EU) 2023/361.’; (b) ‘Germinal products ... (semen, ova and/or embryos, indicate as appropriate) obtained from bovine animals kept in vaccination zone II in relation to emergency protective vaccination against lumpy skin disease, in compliance with Article 13(3) of, and Annex IX, Part 3, point (3.4.2), to Commission Delegated Regulation (EU) 2023/361.’. However, in the case of movements within the same Member State, the competent authority may decide that an animal health certificate does not have to be issued as referred to in the second subparagraph of Article 161(2) of Regulation (EU) 2016/429. Article 5 Operators’ obligations with regard to animal health certificates for movements of consignments of unprocessed animal by-products from bovine animals from vaccination zones I and II outside those zones Operators shall only move consignments of unprocessed animal by-products from bovine animals from vaccination zones I and II outside those zones within the same Member State or to another Member State, in accordance with the derogation for such movements laid down in Article 13(3) of Delegated Regulation (EU) 2023/361, and the specific conditions laid down in Annex IX, Part 3, thereto, if those consignments are accompanied by an animal health certificate referred to in Article 22(5) and (6) of Commission Delegated Regulation (EU) 2020/687(5) using the health model certificate for the movement of animal by-products from restricted zones set out in Annex VIII, Chapter ΙΙΙ, point 7, to Commission Regulation (EU) No 142/2011(6), containing at least one of the following attestations: (5) 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). (6) Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1).21.7.2023 EN Official Journal of the European Union L 184/81 (a) ‘Unprocessed animal by-products… (unprocessed animal by-products other than hides and skins, hides and skins, colostrum, milk and dairy products, indicate as appropriate) obtained from bovine animals kept in vaccination zone I in relation to emergency protective vaccination against lumpy skin disease, in compliance with Article 13(3) of, and Annex IX, Part 3, points (3.5) and (3.7), to Commission Delegated Regulation (EU) 2023/361.’; (b) ‘Unprocessed animal by-products… (unprocessed animal by-products other than hides and skins, hides and skins, colostrum, milk and dairy products, indicate as appropriate) obtained from bovine animals kept in vaccination zone II in relation to emergency protective vaccination against lumpy skin disease, in compliance with Article 13(3) of, and Annex IX, Part 3, points (3.6) and (3.7), to Commission Delegated Regulation (EU) 2023/361.’. However, in the case of movements within the same Member State, the competent authority may decide that an animal health certificate shall not be issued as referred to in Article 22(6) of Delegated Regulation (EU) 2020/687. Article 6 Application This Decision shall apply until 31 August 2024. Article 7 Addressee This Decision is addressed to the Member States. Done at Brussels, 19 July 2023. For the Commission Stella KYRIAKIDES Member of the CommissionL 184/82 EN Official Journal of the European Union 21.7.2023 ANNEX VACCINATION ZONES I and II Vaccination zone I 1. Bulgaria: The entire territory of Bulgaria 2. Greece: The entire territory of Greece Vaccination zone II None