Home Europe European Commission Commission Implementing Decision (EU) 2019/81 of 17 January ...
Date: 2019-01-21 Category: Not Applicable State: Union Government Country: Europe

Commission Implementing Decision (EU) 2019/81 of 17 January 2019 amending Annex I to Implementing Decision (EU) 2016/2008 concerning animal health control measures relating to lumpy skin disease in certain Member States (notified under document C(2019) 102) (Text with EEA relevance.)

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

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Executive Summary & Key Takeaways

Executive Summary: This Commission Implementing Decision EU 2019/81 amends Annex I to Implementing Decision EU 2016/2008 concerning animal health control measures relating to lumpy skin disease (LSD) in certain Member States. It acknowledges Croatia's disease-free status following preventive vaccination and surveillance, leading to the removal of restrictions related to LSD vaccination in that Member State. The decision is effective as of January 17, 2019. Key Points / Main Content: * **Amendment of Annex I to Implementing Decision EU 2016/2008:** * Annex I is replaced with the text set out in the Annex to this Decision. * **Croatia's Status:** * Croatia has stopped LSD vaccination due to a favorable epidemiological situation. * Croatia implemented an approved LSD surveillance program. * Surveillance results indicate no evidence of LSD presence in Croatia. * Croatia fulfills OIE requirements for disease-free status. * **Removal of Restrictions for Croatia:** * The entry for Croatia is deleted from the list of Member States with free zones with vaccination in Annex I to Implementing Decision EU 2016/2008. * **Free zones with vaccination:** * Bulgaria: Specified provinces and municipalities are listed. * Greece: Specified regions are listed, excluding certain regional units. * **Infected zones:** * Greece: Specified regions and regional units are listed. * Bulgaria: The entire territory of Bulgaria excluding the areas listed in Part I. Impact Analysis: * **Croatia:** * *Impact:* Lifting of restrictions related to LSD vaccination. * *Action Required:* Continue implementing the approved LSD surveillance program. * **Greece and Bulgaria:** * *Impact:* Continued application of animal health control measures in listed free zones with vaccination and infected zones, as defined in the amended Annex I. * *Action Required:* Maintain relevant measures based on their zones’ classifications. * **Other Member States:** * *Impact:* Awareness of the updated list of free and infected zones for LSD within the EU. * *Action Required:* Take note of the changes to Annex I of Implementing Decision EU 2016/2008 and adjust animal health control measures accordingly, if necessary.

Key Entities Referenced

European Commission: The executive branch of the European Union, responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day affairs. Lumpy Skin Disease (LSD): An infectious disease affecting cattle, characterized by fever, skin nodules, and sometimes death. The document discusses control measures and vaccination programs related to LSD outbreaks. Bulgaria: A Member State of the European Union, which experienced cases of Lumpy Skin Disease (LSD). The document outlines specific provinces and municipalities within Bulgaria designated as free zones with vaccination. Greece: A Member State of the European Union, which experienced cases of Lumpy Skin Disease (LSD). The document outlines specific regions and regional units within Greece affected by or free from LSD. Croatia: A Member State of the European Union that implemented a mass vaccination program against LSD as a preventive measure. The document discusses the lifting of restrictions in relation to LSD vaccination in Croatia due to its disease-free status. Commission Implementing Decision EU 2016/2008: A European Union decision concerning animal health control measures relating to lumpy skin disease in certain Member States. The document amends Annex I of this decision. Council Directive 92/119/EEC: A Council Directive introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease. European Food Safety Authority (EFSA): An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
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21.1.2019 EN Official Journal of the European Union L 18/43 DECISIONS COMMISSION IMPLEMENTING DECISION (EU) 2019/81 of 17 January 2019 amending Annex I to Implementing Decision (EU) 2016/2008 concerning animal health control measures relating to lumpy skin disease in certain Member States (notified under document C(2019) 102) (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra- Community trade with a view to the completion of the internal market (1), and in particular Article 9(4) thereof, Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary checks applicable in intra-Union trade in certain live animals and products with a view to the completion of the internal market (2), and in particular Article 10(4) thereof, Having regard to Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease (3), and in particular Article 14(2), Article 19(1)(a) and(3)(a) and Article 19(4) and (6) thereof, Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (4), and in particular Article 4(3) thereof, Whereas: (1) Directive 92/119/EEC lays down general control measures to be applied in the event of an outbreak of certain animal diseases, including lumpy skin disease (LSD). These control measures include the establishment of protection and surveillance zones around the infected holding, and they also provide for emergency vaccination in the case of an outbreak of LSD in addition to other control measures. (2) Commission Implementing Decision (EU) 2016/2008 (5) lays down animal health control measures to be taken in relation to outbreaks of LSD in the Member States or parts thereof as listed in Annex I thereto, including the minimum requirements for vaccination programmes against LSD submitted by the Member States to the Commission for approval. Implementing Decision (EU) 2016/2008 defines ‘infected zones’ as the part of the territory of a Member State listed in Part II of Annex I thereto, which includes the area where LSD was confirmed and any protection and surveillance zones established in accordance with Directive 92/119/EEC, and where vaccination against LSD may be implemented following the approval of vaccination programmes. It also defines ‘free zones with vaccination’ as the part of the territory of a Member State listed in Part I of that Annex which includes the areas outside the infected zones, where vaccination against LSD is implemented following the approval of vaccination programmes. (3) In August 2015, LSD was confirmed in Greece for the first time. In 2016, there were cases of LSD in Bulgaria and additional cases in Greece, as well as in a number of neighbouring third countries. In 2017, LSD was present to a lesser extent in South-East Europe, with a large scale recurrence of the disease in Albania, and a few additional sporadic outbreaks in Greece and the former Yugoslav Republic of Macedonia. (1) OJ L 395, 30.12.1989, p. 13. (2) OJ L 224, 18.8.1990, p. 29. (3) OJ L 62, 15.3.1993, p. 69. (4) OJ L 18, 23.1.2003, p. 11. (5) Commission 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).L 18/44 EN Official Journal of the European Union 21.1.2019 (4) In 2018, there has been an improvement of the LSD epidemiological situation and no case of LSD has been reported in any Member State or in any neighbouring third country in South-East Europe, excluding Turkey. (5) In response to the outbreaks of LSD, the affected Member States, namely Greece and Bulgaria, as well as the affected neighbouring third countries, implemented mass vaccination programmes of their live bovine animals and captive wild ruminants. Croatia, where LSD has not occurred to date, also implemented a mass vaccination programme against LSD, in 2016 and 2017, as a preventive measure in view of the epidemiological situation in neighbouring Member States and third countries. The LSD vaccination programmes in Greece, Bulgaria and Croatia were approved by the Commission under Commission Implementing Decision (EU) 2016/2009 (6). (6) Since the first occurrence of LSD in continental Europe, the European Food Safety Authority (EFSA) has produced an ‘Urgent advice on LSD, adopted on 29 July 2016 (7) and three reports, namely ‘Lumpy skin disease: I. Data collection and analysis’ approved on 27 March 2017 (8), ‘Lumpy skin disease II. Data collection and analysis’ approved on 29 January 2018 (9) and ‘Lumpy skin disease: scientific and technical assistance on control and surveillance activities’ approved on 28 September 2018 (10). All these scientific assessments suggest that mass vaccination campaigns against LSD, when they are properly implemented, bring the disease under control by preventing the occurrence of new outbreaks. (7) Mass vaccination against LSD has continued in 2018 in all the Member States and neighbouring third countries in South-East Europe that have been affected by LSD. (8) Since the beginning of 2018, Croatia has stopped vaccination against LSD in view of the favourable epidemiol­ ogical situation in that Member State and in neighbouring third countries. Instead, Croatia started implementing a LSD surveillance programme approved by the Commission. That programme involves clinical, virological and serological surveillance with an emphasis on high risk areas, situated close to Member States and neighbouring third countries where outbreaks of LSD have been reported in recent years. (9) In accordance with Article 11.9.4 of the Terrestrial Animal Health Code of the World Health Organisation for Animal Health (OIE), in the case of preventive vaccination, conducted in a country or zone free from LSD, in response to a threat but without the occurrence of a case of LSD, disease-free status may be regained eight months after the last vaccination when clinical, virological and serological surveillance has been conducted in accordance with Article 11.9.15 of that Code. (10) According to a report, submitted by Croatia to the Commission on 13 October 2018, the results of clinical, virological and serological surveillance indicate that there is no evidence of the presence of LSD in its territory. Hence, Croatia fulfils all OIE requirements for disease-free status for LSD in the absence of the occurrence of LSD cases and since more than eight months have elapsed since the last LSD vaccination. It is therefore appropriate to lift the restrictions in relation to LSD vaccination in that Member State. (11) As a result, the entry for Croatia should be deleted from the list of Member States with ‘free zones with vaccination’ in Annex I to Implementing Decision (EU) 2016/2008. (12) Annex I to Implementing Decision (EU) 2016/2008 should therefore be amended accordingly. (13) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, HAS ADOPTED THIS DECISION: Article 1 Annex I to Implementing Decision (EU) 2016/2008 is replaced by the text set out in the Annex to this Decision. (6) Commission Implementing Decision (EU) 2016/2009 of 15 November 2016 approving the vaccination programmes against lumpy skin disease submitted by the Member States (OJ L 310, 17.11.2016, p. 66). (7) EFSA Journal 2016;14(8):4573. (8) EFSA Journal 2017;15(4):4773. . (9) EFSA Journal 2018;16(2):5176. (10) EFSA Journal 2018;16(10):5452.21.1.2019 EN Official Journal of the European Union L 18/45 Article 2 This Decision is addressed to the Member States. Done at Brussels, 17 January 2019. For the Commission Vytenis ANDRIUKAITIS Member of the CommissionL 18/46 EN Official Journal of the European Union 21.1.2019 ANNEX ‘ANNEX I PART I “Free zones with vaccination” 1. Bulgaria A. The following provinces in Bulgaria: — Province of Burgas — Province of Varna — Province of Dobrich — Province of Razgrad — Province of Silistra — Province of Ruse — Province of Pleven B. The following municipalities in Bulgaria: — The municipalities of Opaka, Popovo and Antonovo in the province of Targovishte. — The municipalities of Shumen, Kaspichan, Novi Pazar, Nikola Kozlevo, Kaolinovo, Venets and Hitrino in the province of Shumen. — The municipalities of Svishtov, Polski Trambesh and Strazhitsa, in the province of Veliko Tarnovo. 2. Greece The following regions in Greece: — Region of Ionian Islands, excluding the regional unit of Kerkyra — Region of North Aegean, excluding the regional unit of Limnos — Region of South Aegean — Region of Crete PART II “Infected zones” 1. Greece A. The following regions in Greece: — Region of Attica — Region of Central Greece — Region of Central Macedonia — Region of Eastern Macedonia and Thrace — Region of Epirus — Region of Peloponnese — Region of Thessaly — Region of Western Greece — Region of Western Macedonia21.1.2019 EN Official Journal of the European Union L 18/47 B. The following regional units in Greece: — Regional unit of Limnos — Regional unit of Kerkyra 2. Bulgaria The entire territory of Bulgaria excluding the areas listed in Part I.’

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