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Date: 12-Jan-2024 Category: Not Applicable State: Union Government Country: Europe

Commission Implementing Regulation (EU) 2024/216 of 11 January 2024 amending the Annex to Implementing Regulation (EU) 2018/1882 concerning listed diseases of aquatic animals and the list of species and groups of species posing a considerable risk for the spread of those listed diseases

Issued by European Commission · Directorate-General for Health and Food Safety

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Executive Summary & Key Takeaways

What it means

  • Commission Implementing Regulation (EU) 2024/216 amends the Annex to Implementing Regulation (EU) 2018/1882, updating the lists of aquatic animal diseases, susceptible species, and vector species that pose a considerable risk for spreading these diseases within the European Union.
  • The changes are based on scientific advice from the European Food Safety Authority (EFSA) and the World Organisation for Animal Health (WOAH).

Key Changes

  • The list of vector species in the Annex to Implementing Regulation (EU) 2018/1882 has been updated to reflect EFSA's scientific opinions on species of fish, molluscs, and crustaceans that may act as vectors of listed diseases.
  • Vector species that have not been identified by EFSA as having demonstrated the ability to transmit the causative agent of a listed disease of aquatic animals to susceptible species have been removed from the list.
  • The list of species susceptible to infection with Marteilia refringens has been amended to align with the World Organisation for Animal Health (WOAH) Aquatic Animal Health Code, with exceptions for Mytilus edulis and Mytilus galloprovincialis.
  • Rows 51 to 63 in the Annex to Implementing Regulation (EU) 2018/1882, concerning listed diseases, categories of listed diseases, and listed species of aquatic animals, have been replaced with updated information.

Impact Analysis

Aquaculture Industry

  • Action Item: Review and update biosecurity protocols based on the updated lists of susceptible and vector species.

Member State Authorities

  • Action Item: Communicate the changes to relevant stakeholders, including aquaculture farmers, importers, and veterinarians.

Research and Scientific Community

  • Action Item: Conduct research to validate and refine the lists of susceptible and vector species.

Key Entities Referenced

European Commission: The executive branch of the European Union, responsible for proposing and implementing legislation. European Food Safety Authority (EFSA): An agency of the European Union that provides independent scientific advice on food and feed safety. World Organisation for Animal Health (WOAH): An intergovernmental organization responsible for improving animal health worldwide. Regulation (EU) 2016/429: Also known as the Animal Health Law, it lays down rules for the prevention and control of animal diseases. Implementing Regulation (EU) 2018/1882: A regulation that applies certain disease prevention and control rules to categories of listed diseases and establishes a list of species and groups of species posing a considerable risk for the spread of those listed diseases. It is amended by this new regulation. Commission Implementing Regulation (EU) 2024/216: The regulation amending the Annex to Implementing Regulation (EU) 2018/1882 concerning listed diseases of aquatic animals and the list of species and groups of species posing a considerable risk for the spread of those listed diseases.
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Official Journal EN of the European Union L series 2024/216 12.1.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/216 of 11 January 2024 amending the Annex to Implementing Regulation (EU) 2018/1882 concerning listed diseases of aquatic animals and the list of species and groups of species posing a considerable risk for the spread of those listed diseases (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 8(2), Article 8(3), and Article 8(4), point (b) thereof, Whereas: (1) Regulation (EU) 2016/429 lays down rules for the prevention and control of diseases, which are transmissible to animals or humans, including rules for the prioritisation and categorisation of listed diseases that are of concern at Union level. Those rules for the prevention and control of listed diseases apply to species and groups of species, which can transmit the listed diseases, by virtue of either being susceptible to them or by acting as vectors. Those species and groups of species are listed in the table in the Annex to Commission Implementing Regulation (EU) 2018/1882(2), in accordance with the criteria laid down in Article 8 of Regulation (EU) 2016/429. (2) The European Food Safety Authority (EFSA) has provided scientific advice in its Scientific Opinions of 1 August 2023, concerning species of fish(3), molluscs(4), and crustaceans(5), which may act as vectors of diseases falling within the scope of Regulation (EU) 2016/429. (3) It is, therefore, timely and important, to review the list of vectors of the aquatic diseases listed in the table set out in the Annex to Implementing Regulation (EU) 2018/1882, taking into account the scientific advice provided by EFSA, as well as the criteria laid down in Article 8 of Regulation (EU) 2016/429 which specifically stipulates that the list is to comprise those animal species, or groups of animal species which pose a considerable risk for the spread of specific listed diseases. According to the working definition set out in the EFSA Scientific Opinions, vector species are those species which have been demonstrated to transmit the causative agent of a listed disease to susceptible species. Such vector species clearly present a considerable risk for the spread of listed diseases. (1) OJ L 84, 31.3.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/429/oj. (2) 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 groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21), ELI: https://eur-lex.europa.eu/eli/reg_impl/2018/1882/oj (3) Species which may act as vectors or reservoirs of diseases covered by the Animal Health Law: Listed pathogens of fish. EFSA Journal 2023; 21(8): 8174 (4) Species which may act as vectors or reservoirs of diseases covered by the Animal Health Law: Listed pathogens of molluscs EFSA Journal 2023; 21(8): 8173 (5) Species which may act as vectors or reservoirs of diseases covered by the Animal Health Law: Listed pathogens of crustaceans EFSA Journal 2023; 21(8): 8172 ELI: http://data.europa.eu/eli/reg_impl/2024/216/oj 1/4EN OJ L, 12.1.2024 (4) In so far as the risk posed by the vector species which have been identified in the EFSA Scientific Opinions can be managed by the competent authorities of Members States, those vector species should be listed in the fourth column of the table set out in the Annex to Implementing Regulation (EU) 2018/1882. In addition, the vector species which are currently listed in that column, and which have not been identified by EFSA as having demonstrated the ability to transmit the causative agent of a listed disease of aquatic animals to susceptible species, should be deleted from that column. The list of vector species for the aquatic diseases set out in the Annex to Implementing Regulation (EU) 2018/1882 should, therefore, be amended accordingly. (5) Moreover, the World Organisation for Animal Health (WOAH) has recently reviewed the aquatic species, which are susceptible to infection with Marteilia refringens. A revised list of species which are susceptible to that disease is set out in Article 11.4.2. of the Aquatic Animal Health Code(6). As this disease is also currently listed in the table set out in the Annex to Implementing Regulation (EU) 2018/1882, the Commission has reviewed the Report of the WOAH ad hoc group on susceptible species to infection with WOAH listed diseases(7), which led to the revised list of species, which is set out in the Aquatic Animal Health Code. (6) Following that review by the Commission, it is appropriate to amend the list of species and groups of species, which is set out in the third column of the table in the Annex to Implementing Regulation (EU) 2018/1882, concerning infection with Marteilia refringens. This amendment takes the latest scientific knowledge into account and seeks to achieve an appropriate level of convergence with WOAH standards, while still taking previous risk management decisions concerning two species of mussels, namely Mytilus edulis and Mytilus galloprovincialis, into account. (7) That list should therefore reflect the list of susceptible species set out in Article 11.4.2. of the WOAH Aquatic Animal Health Code, with the exception of the species Mytilus edulis and Mytilus galloprovincialis. (8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, HAS ADOPTED THIS REGULATION: Article 1 The Annex to Implementing Regulation (EU) 2018/1882 is amended in accordance with the Annex to this Regulation. Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 11 January 2024. For the Commission The President Ursula VON DER LEYEN (6) 2023 OIE – Aquatic Animal Health Code, 25th edition (7) https://www.woah.org/app/uploads/2022/10/a-ahg-susceptibility-mollusc-marteilia-refringens-nov-dec-2021-may-june-2022.pdf 2/4 ELI: http://data.europa.eu/eli/reg_impl/2024/216/ojEN OJ L, 12.1.2024 ANNEX In the Annex to Implementing Regulation (EU) 2018/1882, in the table, rows 51 to 63 concerning listed diseases, categories of listed diseases and listed species of aquatic animals are replaced by the following: Listed species Category of Name of listed disease listed disease Species and group of species Vector species ‘Epizootic A+D+E Ameiurus melas, Bidyanus bidyanus, Esox lucius, haematopoietic necrosis Galaxias olidus, Gambusia affinis, Gambusia holbrooki, Macquaria australasica, Melanotaenia fluviatilis, Oncorhynchus mykiss, Perca fluviatilis, Sander lucioperca Viral haemorrhagic C+D+E Alosa immaculata, Ameiurus nebulosus, septicaemia Ambloplites rupestris, Ammodytes hexapterus, Aplodinotus grunniens, Centrolabrus exoletus, Clupea harengus, Clupea pallasii pallasii, Coregonus artedii, Coregonus clupeaformis, Coregonus lavaretus, Ctenolabrus rupestris, Cyclopterus lumpus, Cymatogaster aggregata, Dorosoma cepedianum, Danio rerio, Engraulis encrasicolus, Esox lucius, Esox masquinongy, Fundulus heteroclitus, Gadus macrocephalus, Gadus morhua, Gaidropsarus vulgaris,Gasterosteus aculeatus, Labrus bergylta, Labrus mixtus, Lampetra fluviatilis, Lepomis gibbosus, Lepomis macrochirus, Limanda limanda, Merlangius merlangus, Micropterus dolomieu, Micropterus salmoides, Micromesistius poutassou, Morone americana, Morone chrysops, Morone saxatilis, Mullus barbatus, Neogobius melanostomus, Notropis atherinoides, Notropis hudsonius, Oncorhynchus kisutch, Oncorhynchus mykiss, Oncorhynchus mykiss x Oncorhynchus kisutch hybrids, Oncorhynchus tshawytscha, Paralichthys olivaceus, Perca flavescens, Pimephales notatus, Pimephales promelas, Platichthys flesus, Pleuronectes platessa, Pomatoschistus minutus, Pomoxis nigromaculatus, Raja clavata, Salmo marmoratus, Salmo salar, Salmo trutta, Salvelinus namaycush, Sander vitreus, Sardina pilchardus, Sardinops sagax, Scomber japonicus, Scophthalmus maximus, Solea senegalensis, Sprattus sprattus, Symphodus melops, Thaleichthys pacificus, Trachurus mediterraneus, Trisopterus esmarkii, Thymallus thymallus, Uranoscopus scaber Infectious C+D+E Esox lucius, Onchorynchus clarkii, Oncorhynchus haematopoietic necrosis keta, Oncorhynchus kisutch, Oncorhynchus masou, Oncorhynchus mykiss, Oncorhynchus nerka, Oncorhynchus tshawytscha, Salmo marmoratus, Salvelinus namaycush, Salmo salar, Salmo trutta, Salvelinus alpinus, Salvelinus fontinalis ELI: http://data.europa.eu/eli/reg_impl/2024/216/oj 3/4EN OJ L, 12.1.2024 Infection with HPR- C+D+E Oncorynchus mykiss, Salmo salar, Salmo trutta deleted infectious salmon anaemia virus Koi herpes virus disease E All varieties and subspecies of Cyprinus carpio, Carassius auratus, Carassius and Cyprinus carpio hybrids e.g., Cyprinus carpio × gibelio, Ctenopharyngodon Carassius auratus, Cyprinus carpio × Carassius idella, Gymnocephalus cernua, carassius Hypophthalmichthys molitrix, Rutilus rutilus, Tinca tinca Infection with Mikrocytos A+D+E Crassostrea gigas, Crassostrea sikamea, Ostrea edulis Crassostrea virginica mackini Infection with Perkinsus A+D+E Crassostrea gigas, Crassostrea virginica marinus Infection with Bonamia C+D+E Crassostrea ariakensis, Crassostrea virginica, Ostrea exitiosa puelchana, Ostrea angasi, Ostrea chilensis, Ostrea equestris, Ostrea edulis, Ostrea lurida Infection with Bonamia C+D+E Crassostrea ariakensis, Ostrea chilensis, Ostrea edulis ostreae Infection with Marteilia C+D+E Chamelea gallina, Ostrea edulis, Ostrea stentina, refringens Solen marginatus, Xenostrobus securis Infection with Taura A+D+E Metapenaeus ensis, Penaeus aztecus, Penaeus Episesarma mederi, syndrome virus monodon, Penaeus setiferus, Penaeus stylirostris, Macrobrachium lanchesteri’ Penaeus vannamei Infection with yellow A+D+E Metapenaeus affinis, Penaeus monodon, head virus Palaemonetes pugio, Penaeus stylirostris, Penaeus vannamei Infection with white spot C+D+E All decapod crustaceans (order Decapoda) syndrome virus 4/4 ELI: http://data.europa.eu/eli/reg_impl/2024/216/oj

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