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 (Text with EEA relevance)
Commission Implementing Regulation (EU) 2021/1070of 28 June 2021laying down special control measures for a limited period of time related to infection with lumpy skin disease virus(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")OJ L 84, 31.3.2016, p. 1., and in particular Article 71(3) thereof,Whereas:(1)Infection with lumpy skin disease virus, caused by the lumpy skin disease virus (LSDV), is a vector-borne disease of cattle and Asian water buffalo that can cause substantial economic losses, reduce milk yield, cause severe emaciation, permanent damage to hides, several secondary complications, chronic debility, and incur movement or trade bans. It is on the list of notifiable diseases of the World Organisation for Animal Health (OIE)OIE – Listed diseases, infections and infestations in force in 2021. OIE - Terrestrial Animal Health Code, Twenty-eighth edition, 2019, ISBN 978-92-95108-85-1 (https://www.oie.int/en/animal-health-in-the-world/oie-listed-diseases-2021/)..(2)Regulation (EU) 2016/429 establishes a new legislative framework for the prevention and control of diseases. Infection with lumpy skin disease virus is listed in Annex II to Regulation (EU) 2016/429, and accordingly it is a listed disease for the purposes of that Regulation, and it is subject to the disease prevention and control rules laid down therein. In addition, infection with LSDV is listed in the Annex to 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 groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21). as a category A, D and E disease.(3)Commission Delegated Regulation (EU) 2020/687Commission 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). supplements the rules for the control of category A, B and C diseases laid down in Regulation (EU) 2016/429, including disease control measures against infection with LSDV. Regulation (EU) 2016/429, Implementing Regulation (EU) 2018/1882 and Delegated Regulation (EU) 2020/687 all apply from 21 April 2021.(4)Previously, Commission Implementing Decision (EU) 2016/2008Commission Implementing Decision (EU) 2016/2008 of 15 November 2016 concerning animal health control measures relating to lumpy skin disease in certain Member States (OJ L 310, 17.11.2016, p.51). laid down rules on animal health control measures in relation to infection with LSDV in the Member States or parts thereof listed in Annex I thereto, including the minimum requirements for vaccination programmes against infection with LSDV submitted by the Member States to the Commission for approval. Bulgaria and Greece are concerned by such listing. Implementing Decision (EU) 2016/2008 ceased to apply on 20 April 2021, and the rules laid down in this Regulation should replace those laid down in that Implementing Decision.(5)Since 2017, no outbreaks of infection with LSDV have been reported in Europe, but that disease is still present in Anatolia, Turkey, and in Russia, as well as in eastern Asia affecting Bangladesh, China and India. Therefore, the spread of that disease represents a potential risk for the agricultural sector in the Union.(6)Apart from Bulgaria and Greece, Croatia and a considerable number of neighbouring third countries, such as Bosnia and Herzegovina, KosovoThis 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., Montenegro, North Macedonia, Serbia and Turkey have notified to the Commission that vaccination against infection with LSDV has been included in their disease control policy. Most of those third countries have now stopped vaccination and are maintaining surveillance measures.(7)The epidemiological situation in Eastern Europe and in neighbouring regions suggests that a certain risk of disease re-introduction or re-emergence, in high-risk areas where vaccination against infection with LSDV has ceased, may still exist.(8)Based on the available epidemiological information to date, the results of surveillance for infection with LSDV and vaccination against that disease, it is appropriate that vaccination against infection with LSDV should at least continue in the high-risk areas of Bulgaria and Greece. In addition, in all Member States or parts thereof where vaccination against that disease has been reduced or completely ceased, systematic surveillance, both active and passive, should continue.(9)According to the scientific report of the European Food Safety Authority (EFSA) on infection with LSDV, approved on 30 January 2020EFSA Journal 2020; 18(2):6010. (the EFSA Report), a homologous vaccine should be used to reduce the risk of the further spread of infection with LSDV to south-eastern Europe. After vaccination has stopped, in the case of the re-emergence of that disease, a contingency plan and vaccine stockpiling, even on a regional basis, would be needed in order to react quickly with emergency vaccination.(10)The general disease control measures laid down in Regulation (EU) 2016/429, and the supplementing rules laid down in Delegated Regulation (EU) 2020/687, do not cover all necessary aspects of vaccination against infection with LSDV. It is therefore appropriate to lay down uniform implementing rules at Union level in this Regulation to cover special disease control measures for a limited period of time, under conditions appropriate to the epidemiological situation of that disease in the Union and in neighbouring third countries. The control measures laid down in this Regulation should take account of the experience gained in the application of Implementing Decision (EU) 2016/2008, as well as international standards set out in Chapter 11.9 "Infection with lumpy skin disease virus" of the Terrestrial Animal Health Code of the OIE (OIE Code)OIE – Terrestrial animal health code (2019). OIE - Terrestrial Animal Health Code, Twenty-eighth edition, 2019, ISBN 978-92-95108-85-1 (www.oie.int/en/standard-setting/terrestrial-code/access-online/)..(11)The rules laid down in this Regulation should provide for a regionalisation approach, and apply in tandem with the disease control measures laid down in Delegated Regulation (EU) 2020/687. In addition, this Regulation should list the restricted zones of Member States carrying out preventive vaccination plans with live attenuated vaccines where there are no outbreaks of infection with LSDV(restricted zone I); and areas with outbreaks of infection with LSDV (restricted zone II). The areas included in restricted zone I or in restricted zone II should be listed in Annex I to this Regulation taking account of the information provided by the competent authorities of the Member States affected by that disease.(12)Vaccinated bovine animals and products from those bovine animals may represent a risk for the spread of infection with LSDV. Therefore, this Regulation should provide for certain prohibitions and specific conditions on movements of consignments of bovine animals or different types of products from the restricted zones listed in Annex I to this Regulation. In order to avoid unnecessary disturbances for trade, certain derogations from those prohibitions and specific conditions should be laid down. Those derogations and specific conditions should take account of the principles of the OIE Code as regards risk mitigation measures against infection with LSDV, as well as the rules for the prevention and control of animal diseases laid down in Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/687.(13)In terms of the risk of the spread of infection with LSDV, different commodities pose different levels of risk. As indicated in the EFSA Report, the movement of live bovine animals, bovine semen and raw hides and skins from infected bovine animals pose a higher level of risk in terms of exposure and consequences than other products such as milk and dairy products, treated hides and skins or fresh meat, meat preparations and meat products originating from bovine animals. However, scientific or experimental evidence on their role in transmitting lumpy skin virus is not yet sufficient. The transmission of lumpy skin disease virus through semen, ova and embryos of animals of the bovine species cannot be excluded. Milk and dairy products, as well as colostrum, may represent a risk for the spread of lumpy skin disease virus only when destined for feeding to animals of the susceptible species.(14)Therefore, certain protective measures should be provided for those commodities based on the EFSA Report and the relevant most updated standards and recommendations from the OIE.(15)Movements of consignments of animals for immediate slaughter pose a lower level of risk for the spread of animal diseases than other types of movements of animals provided that risk mitigation measures are in place. It is therefore appropriate that the Member States should be permitted exceptionally to grant derogations from certain prohibitions laid down in this Regulation for movements of consignments of bovine animals, from restricted zones I and II, for immediate slaughter to a slaughterhouse located outside of restricted zones I and II in the same Member State.(16)The derogations for movements of consignments of certain bovine animals from a restricted zones I or II to another restricted zones I or II of another Member State with a similar disease status are justified where specific risk mitigating measures are applied. This requires the establishment of a safe channelling procedure under the strict control of the competent authorities of the Member State of origin, passage and destination.(17)Article 143 of Regulation (EU) 2016/429 provides that animal health certificates are to accompany the movements of animals, including bovine animals. Where derogations from the prohibition on movements of consignments of bovine animals from restricted zones I and II are applied to consignments of bovine animals intended for intra-Union movements, those animal health certificates should include a reference to this Regulation, to ensure that adequate and accurate health information is provided in those animal health certificates.(18)Where this Regulation provides for derogations from prohibitions on movements of consignments of germinal products from restricted zones I and II, the accompanying animal health certificates should include a reference to this Regulation, so as to ensure adequate and accurate health information in accordance with this Regulation and Commission Delegated Regulation (EU) 2020/686Commission Delegated Regulation (EU) 2020/686 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of germinal product establishments and the traceability and animal health requirements for movements within the Union of germinal products of certain kept terrestrial animals (OJ L 174, 3.6.2020, p. 1)..(19)The transport of bovine animals and animal by-products from those animals from restricted zones I and II should be carried out under animal welfare and biosecurity measures to avoid the spread of infection with LSDV.(20)Delegated Regulation (EU) 2020/687 applies from 21 April 2021. Accordingly, in the interest of legal certainty, this Regulation should enter into force as a matter of urgency.(21)This Regulation should apply for a period until 21 April 2023, taking into account the Union’s experience in the control of infection with LSDV, the current epidemiological situation of that disease in Member States and neighbouring third countries and any future rules on vaccination laid down pursuant to Article 47 of Regulation (EU) 2016/429.(22)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:
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