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

(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 (the ‘Animal Health Law’) (1), and in particular Article 47(1), Article 53(2), Article 54(3), Article 55(2), Article 58(2), the first paragraph of Article 63, Article 64(4), the first paragraph of Article 67, Article 68(3), Article 70(3), Article 72(2), Article 73(3), Article 74(4), Article 76(5), Article 77(2) and Article 272(2) thereof,

Whereas:

(1) Regulation (EU) 2016/429 lays down rules for the prevention and control of animal diseases which are transmissible to animals or to humans, including rules on disease awareness, preparedness and control. In particular, Regulation (EU) 2016/429 lays down disease-specific rules for the prevention and control of diseases referred to in its Article 5. Regulation (EU) 2016/429 also provides that those disease-specific rules apply to species and groups of animal species that pose a considerable risk for the spread of specific diseases and which are listed as such in Commission Implementing Regulation (EU) 2018/1882 (2).

(2) It is necessary to lay down rules supplementing the rules on disease control measures set out in Title II of Part III of Regulation (EU) 2016/429 for certain listed diseases. Those supplementing rules and the rules set out in Regulation (EU) 2016/429 are closely linked and should be applied in tandem. In the interest of simplicity, transparency and ease of application, the supplementing rules should be laid down in a single act rather than in a number of separate acts with many cross-references and risks of duplication.

(3) Article 53, Article 54(3), Article 55(2), Article 58(2), and Articles 63, 64, 67, 68 and 70 in Chapter 1 of Title II of Regulation (EU) 2016/429 relate to various technical aspects of the measures to be taken if there is suspicion and confirmation of diseases referred to in Article 9(1)(a) of that Regulation. Similarly, Article 72(2), Article 73(3), Article 74(4), Article 76(5) and Article 77 in Chapter 2 of Title II of Regulation (EU) 2016/429 relate to technical aspects of the measures to be taken if there is suspicion and confirmation of diseases referred to in Article 9(1)(b) and (c) of that Regulation.

(4) The rules to be laid down pursuant to Articles in Title II are interrelated as they apply to disease control measures for different categories of listed diseases in Regulation (EU) 2016/429. Therefore, for the effective application of those rules and in the interests of clarity, they should be laid down in a single delegated act providing a comprehensive set of technical measures for the control of listed diseases and contributing to the overall simplification of the legal framework on animal disease control.

(5) Previous disease control provisions were laid down in a number of directives, each of which contained rules for one or few animal diseases. Some of those rules have been replaced by Regulation (EU) 2016/429, while others need to be replaced by this Delegated Regulation in order to simplify and remove possible inconsistencies. This will provide clear, harmonised and detailed rules to control animal diseases throughout the Union. This will also enable the application of the relevant provisions by competent authorities and operators, and will increase the transparency of the rules and therefore will ensure a better response to animal disease risks.

(6) To eradicate an outbreak of a category A disease as soon as possible and to ensure a high level of animal health and animal welfare protection, it is necessary to provide for disease control measures at Union level.

(7) The scope of this Regulation should therefore include disease control measures for category A diseases in terrestrial and aquatic animals, as well as certain disease control measures for category B and C diseases. In the case of category B and C diseases, those disease control measures should be applied in conjunction with the rules on surveillance and eradication set out in Commission Delegated Regulation (EU) 2020/689 (3).

(8) The disease control measures set out in this Delegated Regulation should apply to animals and to products obtained from animals, including products of animal origin, germinal products, animal by-products and derived products. These animal by-products are subject to public and animal health rules set out in Regulation (EC) No 1069/2009 of the European Parliament and of the Council (4). The rules for safe collection, disposal and processing of animal by-products and derived products laid down in that Regulation apply in the event of the onset of a category A disease. However, that Regulation does not include disease control measures and restrictions intended to apply in such events. Therefore, those rules should be provided for in this Delegated Regulation.

(9) Directive 2008/68/EC of the European Parliament and of the Council (5) lays down rules for the safe transport of dangerous goods. When transporting infected animal by-products or other infected material which may be considered as dangerous goods, competent authorities should comply with the rules laid down in that Directive.

(10) It is appropriate to follow a single approach for the measures to apply in the event of a category A disease. However, the epidemiology of diseases should be taken into account to establish the appropriate moment for the competent authority to apply control measures and to carry out investigations if there is suspicion or confirmation of those diseases. Therefore ‘monitoring periods’ should be provided, as reference time frames for each category A disease affecting terrestrial animals based on incubation periods and other relevant elements that may affect the spread of the disease.

(11) Article 54 of Regulation (EU) 2016/429 requires the competent authority to carry out investigations on the occurrence of a category A disease at different stages: (i) when the disease is suspected; (ii) when the disease is confirmed; and (iii) when it is necessary to rule out its spreading to epidemiologically linked establishments and locations as well as neighbouring establishments and zones. Those investigations include clinical examination and sampling for laboratory testing. It is appropriate to lay down general rules on sampling in order to ensure the validity of sampling procedures, diagnostic methods and biosecurity measures.

(12) Article 43 of Regulation (EU) 2016/429 requires the competent authority to draw up and update contingency plans and, where necessary, provide detailed instruction manuals on implementing of measures to be taken in case of a category A disease as provided for in Part III of that Regulation. The measures set out in this Delegated Regulation supplement those laid down in Part III of Regulation (EU) 2016/429 and it is therefore necessary that they be implemented in accordance with the contingency plans provided for in Regulation (EU) 2016/429.

(13) Articles 53 and 55 of Regulation (EU) 2016/429 lay down obligations on operators and competent authorities in the case of a suspicion of a category A disease. The aim is to prevent the spread of the disease from affected animals and establishments under their responsibility to unaffected animals or to humans even before the disease has been confirmed. The disease control and biosecurity measures provided for in Regulation (EU) 2016/429 should be applied at this early stage in the affected establishment as regards movements of animals and products from and to that establishment and its surroundings. It is also necessary to detail those measures in order to ensure their effectiveness and proportionality.

(14) Article 54 of Regulation (EU) 2016/429 requires the competent authority to conduct an official investigation if there is a suspicion of a category A disease, to either confirm or rule out the presence of the disease. In order to establish a standard operating procedure for such official investigations in all Member States, it is necessary to detail the circumstances which justify the conduct of an investigation, the minimum investigation tasks to be performed by official veterinarians and the way those tasks should be carried out.

(15) Regulation (EU) 2016/429 requires that, if there is a suspicion or confirmation of a category A disease, disease control measures be applied not only in establishments keeping animals but also in food and feed businesses, in animal by-products establishments or in other locations that may pose a risk of spreading of diseases. It is necessary to specify which control measures apply in those cases, in particular in the case of border control posts and means of transport.

(16) Regulation (EU) 2016/429 requires that the confirmation of a category A disease is the starting point for the competent authority to implement stricter disease control measures than those applied in the suspicion phase and to carry out further investigations. It is therefore necessary to specify when a category A disease should be considered confirmed. This confirmation should be done in accordance with Union acts adopted pursuant to Regulation (EU) 2016/429 on surveillance of diseases, eradication programmes and disease-free status.

(17) Regulation (EU) 2016/429 lays down the basic rules on the disease control measures to apply in the affected establishments in the event of an outbreak of a category A disease. At the same time, it provides competent authorities with a certain flexibility in deciding which of those measures should apply. In order to allow competent authorities to take the most proportionate and efficient control measures and ensure a harmonised implementation of the measures taken by Member States, it is appropriate to establish detailed decision making criteria based on epidemiological circumstances, type and location of establishments, species and categories of animals and economic or social conditions of the area affected by the disease.

(18) The competent authority should have the possibility to grant, in justified cases and under supplementary guarantees if necessary, derogations from certain disease control measures, in particular from the requirement to kill the animals in the affected establishment, taking into account epidemiological factors and after carrying out an accurate risk assessment. Such derogations could be granted for confined establishments, for animals kept for scientific purposes or for purposes related to conservation of protected or endangered species and for officially registered rare breeds or for animals with a justified high genetic, cultural or educational value. In such cases, the application of general measures could have undesirable and disproportioned consequences.

(19) In order to adapt the disease control measures to each specific situation, the competent authority should have the possibility to apply disease control measures that are not specifically provided for in Regulation (EU) 2016/429 or in this Delegated Regulation, taking into consideration epidemiological factors and after carrying out a risk assessment.

(20) Cleaning and disinfection in the affected establishment is one of the basic disease control measures provided for in Regulation (EU) 2016/429 to minimise the risk of spreading a confirmed category A disease. Preliminary cleaning and disinfection are the most effective measures to reduce the disease agent load in the affected establishment once the affected animals have been taken off. The competent authority should therefore have the obligation to check the performance of the immediate preliminary cleaning and disinfection and, when necessary, the control of insects and rodents. It is appropriate to detail the cleaning and disinfection procedure, specifying when it must be initiated and the criteria for selecting the biocidal products to be used.

(21) Article 62 of Regulation (EU) 2016/429 requires the competent authority to extend the disease control measures applied in the affected establishments to other establishments, epidemiological units therein, food and feed businesses, or animal by-products establishments or any other location of relevance, including means of transport, where epidemiological evidences give reason to suspect the spread of the category A disease to, from or through them. It is necessary to specify the traceability investigation which the competent authority must perform, under the epidemiological enquiry provided for in Regulation (EU) 2016/429, in order to properly identify those epidemiological links.

(22) It is also appropriate to detail the control measures to apply in identified linked establishments and locations. In order to be effective, those measures should be flexible and proportionate, without imposing unnecessary burdens on operators or competent authorities. The competent authorities should consequently be allowed to derogate from general provisions in exceptional circumstances, after carrying out a risk assessment.

(23) Article 64 of Regulation (EU) 2016/429 requires competent authorities to establish a restricted zone around the affected establishment when an outbreak of a category A disease is confirmed, in order to prevent any further spread of the disease. The restricted zone may include a protection zone and a surveillance zone. It is appropriate to set supplementary rules on how to establish and modify, if necessary, the restricted zone, including details on the protection zone, on the surveillance zone and on the possibility to establish further restricted zones depending on the epidemiology of the disease. It is also appropriate to provide for specific derogations for those cases where the establishment of restricted zones would not contribute to control the spreading of the disease or would impose an unjustified burden on operators and competent authorities.

(24) Article 65 of Regulation (EU) 2016/429 lists the measures that the competent authority may take in the restricted zone to prevent the spreading of the disease. In order to allow competent authorities to take the most proportionate and efficient control measures and ensure a harmonised implementation of the measures in all Member States, it is appropriate to establish detailed decision making criteria based on epidemiological circumstances, type and location of production establishments, species and categories of animals and economic or social conditions of the area affected by the disease.

(25) It is necessary to specify the prohibitions of movements of animals and products within, from or through the protection and surveillance zone and the prohibitions of other activities that can pose a risk of spreading a category A disease. Those prohibitions should be proportional to the risk of spreading the disease linked to each activity and commodity. Consequently, they need to be established taking into account the epidemiological disease profile. This is especially important in respect of prohibitions concerning products since there are certain products that should be exempted, in particular those considered safe commodities in relation to the risk of spreading certain diseases.

(26) The prohibitions of activities in the restricted zone should be limited as far as possible. For that reason, there should be the possibility for the competent authority to grant derogations from the prohibitions when certain risk-mitigating measures are taken and certain procedural conditions are met. Such derogations may be granted, in particular, when the competent authority can check the reinforcement of biosecurity measures and when general and specific conditions, related to the relevant animals, products obtained from those animals, or other substances and materials that may be contaminated, are fulfilled.

(27) Movements of ungulates should be limited to transports to a slaughterhouse. Poultry movements should be limited to the transport to slaughterhouses and to younger animals such as day-old-chicks and ready-to-lay poultry. Movements of products of animal origin should be allowed if the products have been produced before the high-risk period determined for the disease. Movements of products of animal origin and by-products produced within or after the high risk period should be allowed if the products have been subjected to specific treatments that inactivate the disease agent. Those treatments should be in line with existing Union legislation, international standards and new scientific evidence.

(28) The competent authority should be able to visit establishments and to examine animals. To prevent the further spread of the disease, requirements should be set and be met before the measures applying to the protection zone can be lifted. Once those measures are lifted, the measures applying to the surveillance zone should be implemented, for an additional period, in the area previously covered by the protection zone, to ensure that the disease is controlled.

(29) The provisions on control measures applicable within the surveillance zone should include general and specific rules for animals, products obtained from those animals, or other substances and materials that may be contaminated. They should also include derogations to allow a proportional application of the control measures. The intensity of the control measures and the derogations for their proportional application should reflect the lower risk that the surveillance zone poses for the spread of the disease but should ensure that the control measures are sufficient to avoid any risk of a further spread of the disease.

(30) The competent authority should: (i) authorise the repopulation of the affected establishments with animals; (ii) ensure that a final cleaning and disinfection of the establishment is carried out; and, if relevant, (iii) carry out a check for vectors to ensure that diseases do not reappear. The competent authority should have the flexibility needed to decide on the most appropriate repopulation measures taking into account epidemiological circumstances and specific risk mitigation conditions.

(31) Wild animals of listed species could also be affected by category A diseases. Control measures for those wild animals are essential in preventing the spread of the diseases and in ensuring their eradication. As for diseases occurring in kept animals, the competent authority should consider control measures for diseases in wild animals as part of the contingency plans provided for by the Regulation (EU) 2016/429. The control measures should apply to suspected and confirmed cases of a disease affecting wild animals within an infected zone. Measures restricting the movement of kept animals that are listed species from the infected zone should be applied with flexibility in mind, based on the epidemiological situation. This is to ensure robust control measures while avoiding unnecessary burdens for operators and competent authorities.

(32) The collection and safe disposal of dead bodies of wild animals contributes to preventing the spread of category A diseases. It is appropriate to supplement Regulation (EU) 2016/429 with rules ensuring the safe collection and disposal of animal by-products from wild terrestrial and aquatic animals affected by category A diseases or subject to restriction measures imposed in response to those diseases in line with Regulation (EC) No 1069/2009.

(33) Article 43 of Regulation (EU) 2016/429 requires the competent authority to establish an operational expert group as part of the contingency plans. These plans are designed to ensure a high level of disease awareness and preparedness and to provide a rapid response in case of an outbreak of a category A disease. The main task of the operational expert group in the case of an outbreak of diseases in terrestrial animals is to support the competent authority assessing the relevant measures for the control or eradication of the disease. The operational expert group for diseases in wild terrestrial animals should be multidisciplinary and have representatives of relevant government departments such as environmental and forests authorities, as well as stakeholders concerned, local authorities, police or other organisations that can provide advice to the competent authority on possible actions and their implementation to control or eradicate the category A disease.

(34) Council Directive 2006/88/EC (6) includes provisions on animal health requirements for aquaculture animals and products and on the prevention and control of certain diseases in aquatic animals. The provisions in this Delegated Regulation should be based on the provisions from previous Union legislation that have worked well and have been revised and aligned, as far as possible, with the knowledge and experience gained in the past, and updated in accordance with new evidence and international standards.

(35) Article 61 of Regulation (EU) 2016/429 provides for the application of disease control measures in establishments and other locations upon confirmation of category A diseases. One of those measures is the killing of animals that may be contaminated or may contribute to the spread of the disease. The possibility to apply such preventive killing should be detailed in this Delegated Regulation as a disease control measure aimed at reducing the infective pressure of a category A disease and to facilitate its control.

(36) Article 62 of Regulation (EU) 2016/429 includes criteria for extending the disease control measures applied in an affected establishment to epidemiologically linked establishments and locations. The analysis of the hydrodynamic and topographic conditions, including data from water catchments, barriers in watercourses or water flow conditions, allows predicting the possible passive spread of a category A disease to other establishments or locations and this prediction may contribute to minimise the impact of a category A disease. The result of such an analysis permits the implementation of better-informed disease control measures, which should avoid or minimise the spread of a category A disease from a high-risk to a disease free area.

(37) The competent authority should be able to derogate from restrictions applicable upon confirmation of a category A disease in order to allow the use of aquaculture animals for human consumption, provided they do not show clinical signs of the disease and are processed in a way that reduces the risk of spreading the disease by infective material. The derogation should be aimed at reducing economic losses while minimising the risk of the disease spreading.

(38) Article 37 of Regulation (EU) 2016/429 provides for the recognition of a disease-free status of compartments for listed diseases. Compartments include different establishments with common and efficient biosecurity systems permitting those establishments to have a distinct animal health status. Therefore, if a category A disease is suspected or confirmed in an aquaculture establishment within a compartment, the disease control measures should be extended to other establishments within that compartment resulting in a more efficient control of the disease.

(39) Fallowing for aquatic animals is a disease control measure already included in previous Union legislation on prevention and control of diseases in aquaculture animals and should continue to be applied. The main objective of fallowing is to prevent or minimise the risk of re-infection of establishments with the category A disease, after cleaning and disinfection has been completed, and before introducing a new population of aquatic animals. Synchronous fallowing in areas with multiple infected establishments strengthens the disease control measures and contributes to a higher success rate. Different fallowing periods should be established for different category A diseases to reduce the fallowing time to a minimum while ensuring the effectiveness of this disease control measure.

(40) When an aquaculture establishment has been affected by a category A disease which does not pose a risk to human health, the placing on the marked of products from that establishment should be allowed after risk-mitigating measures have been taken. For fish, those measures should include slaughtering and evisceration. Crustaceans should be processed to non-viable products before they are dispatched. The products should be used for direct human consumption or undergo further processing in an establishment approved under Article 179 of Regulation (EU) 2016/429. Those measures are effective in controlling and avoiding the further spread of the disease while allowing those products to be used for human consumption rather than unnecessarily wasted.

(41) Article 64 of Regulation (EU) 2016/429 provides that, when a category A disease breaks out in aquatic animals, restricted zones be established as an effective measure to control the disease. Restricted zones may include a protection zone around establishments that have an increased risk of being affected by a category A disease. To ensure an effective disease control and to prevent the further spread of the disease, the introduction of aquaculture animals for farming in establishments located in the protection zone should be prohibited. To avoid re-infection, the protection zone should to be maintained until the infected aquaculture establishments are emptied of animals, cleaned and disinfected and the fallowing period has been completed.

(42) Control measures applied in a protection zone established for disease in aquatic animals should be lifted only if a series of conditions are met. Those conditions should include depopulation, cleaning, disinfection and fallowing of the affected establishments. Furthermore, the results of regular visits carried out in all establishments located in the protection zone must be satisfactory. When all those conditions are met, the protection zone should become a surveillance zone. That surveillance zone should be maintained until the surveillance period for the relevant category A disease has elapsed and there are no elements to suspect the presence of the disease.

(43) Article 43 of Regulation (EU) 2016/429 requires the competent authority to establish an operational expert group as part of the contingency plans designed to ensure a high level of disease awareness and preparedness and to provide a rapid response in case of an outbreak of a category A disease. The main task of the operational expert group in the case of an outbreak of diseases in aquatic animals is to support the competent authority in assessing the relevant measures for the control or eradication of the disease. The operational expert group for diseases in wild aquatic animals should be multidisciplinary and include representatives of government departments such as environmental and fisheries authorities, as well as stakeholders concerned, local authorities, police or other organisations that can provide advice to the competent authority on possible actions to control or eradicate the category A disease.

(44) Article 6 of Regulation (EC) No 1069/2009 provides for the implementation of general health restrictions in the case of a serious transmissible disease. When a category A disease is present in aquaculture animals, the competent authority may impose stricter rules for animal by-products originating from certain establishments. Those rules are intended to deal with situations where public health restrictions may not address the animal health risk. It is necessary, in particular, that animal by-products from such establishments must be processed or disposed of as category 2 material in compliance with Article 13 of Regulation (EC) No 1069/2009.

(45) Article 270 of Regulation (EU) 2016/429 repealed Council Directives 92/66/EEC (7), 2001/89/EC (8), 2002/60/EC (9), 2003/85/EC (10) and 2005/94/EC (11), which contained rules for the control of animal diseases. Article 272 of Regulation (EU) 2016/429 provides that the repealed Directives continue to apply for three years after the date of application of that Regulation or an earlier date to be determined by the Commission in a delegated act. In order to ensure a harmonised and simplified approach across species and diseases, this Regulation should apply from the date of application of Regulation (EU) 2016/429 and the repealed Directives should cease to apply from the same date,

HAS ADOPTED THIS REGULATION:

PART I

GENERAL PROVISIONS

Article 1 Subject matter and scope This Regulation supplements the rules on disease awareness, preparedness and control to be applied with regard to the listed diseases referred to in Article 9(1)(a), (b) and (c) of Regulation (EU) 2016/429. Those rules cover the following: (a) Part II covers kept and wild terrestrial animals, and in particular: (i) Chapter I lays down supplementing rules on disease control measures in the event of suspicion and official confirmation of a category A disease in kept animals as referred to in Articles 53, 54, 55, 58 and 63 of Regulation (EU) 2016/429; (ii) Chapter II lays down supplementing rules regarding the establishment of restricted zones in the event of official confirmation of a category A disease in kept animals as referred to in Article 64 and 67 of Regulation (EU) 2016/429; (iii) Chapter III lays down supplementing rules regarding the repopulation of the restricted zone with kept animals in the event of official confirmation of a category A disease as referred to in Articles 63 and 68 of Regulation (EU) 2016/429; (iv) Chapter IV lays down supplementing rules regarding disease control measures in the event of suspicion and official confirmation of a category A disease in wild animals as referred to in Article 70 of Regulation (EU) 2016/429; (v) Chapter V lays down supplementing rules on disease control measures in the event of suspicion and official confirmation of category B and C diseases in terrestrial animals as referred to in Article 74 and 77 of Regulation (EU) 2016/429; (b) Part III covers kept and wild aquatic animals, and in particular: (i) Chapter I lays down supplementing rules on disease control measures in the event of suspicion and official confirmation of a category A disease in aquatic animals as referred to in Articles 53, 54, 55, 58 and 63 of Regulation (EU) 2016/429; (ii) Chapter II lays down supplementing rules regarding the establishment of restricted zones in the event of official confirmation of a category A disease in aquaculture animals as referred to in Article 64 and 67 of Regulation (EU) 2016/429; (iii) Chapter III lays down supplementing rules regarding disease control measures in the event of suspicion and official confirmation of a category A disease in wild aquatic animals as referred to in Article 70 of Regulation (EU) 2016/429; (iv) Chapter IV lays down supplementing rules on disease control measures in the event of suspicion and official confirmation of category B and C diseases in aquatic animals as referred to in Article 74 and 77 of Regulation (EU) 2016/429; (c) Part IV covers final provisions.

Article 2 Definitions For the purposes of this Regulation, definitions laid down in Regulation (EU) 2018/1882 and Annex I to Regulation (EC) No 853/2004 of the European Parliament and of the Council (12) shall apply, except where those definitions cover terms that are defined in the second paragraph of this Article. In addition, the following definitions shall also apply: (1) ‘means of transport’ means road or rail vehicle, vessels and aircrafts; (2) ‘day-old chicks’ means poultry less than 72 hours old; (3) ‘semen’ means the ejaculate of an animal or animals, either in the unaltered state or prepared or diluted; (4) ‘oocytes’ means the haploid stages of the ootidogenesis including secondary oocytes and ova; (5) ‘embryo’ means the initial stage of development of an animal while it is capable of being transferred to a recipient dam; (6) ‘fresh meat’ means meat, minced meat and meat preparations, including vacuum-wrapped or wrapped in a controlled atmosphere, which has not undergone any process other than chilling, freezing or quick-freezing; (7) ‘carcass of an ungulate’ means the whole body of a slaughtered or killed ungulate after: — bleeding, in the case of slaughtered animals, — evisceration, — removal of the limbs at the carpus and tarsus, — removal of the tail, the udder, the head and the skin, except in porcine animals; (8) ‘offal’ means fresh meat other than that of the carcass as defined in (7), even if it remains naturally connected to the carcass; (9) ‘meat products’ means processed products, including treated stomachs, bladders, intestines, rendered fats, meat extracts and blood products, resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat; (10) ‘casings’ means the bladders and intestines that after cleaning have been processed by tissue scraping, defatting and washing and have been dried after salting; (11) ‘colostrum’ means the fluid secreted by the mammary glands of kept animals up to five days post parturition that is rich in antibodies and minerals, and precedes the production of raw milk. (12) ‘colostrum-based products’ means processed products resulting from the processing of colostrum or from the further processing of such processed products; (13) ‘safe commodity’ means a commodity that can be moved without the need for risk mitigation measures specifically directed against a particular listed disease regardless of the status of the Member State or zone of origin for that disease; (14) ‘supply chain’ means an integrated production chain of a common health status as regards listed diseases consisting of a collaborative network of specialised establishments approved by the competent authority for the purpose of Article 45, between which animals are moved to complete the production cycle; (15) ‘infected zone’ means a zone in which restrictions on the movements of kept and wild animals or products and other disease control and biosecurity measures may be applied with the view to preventing the spread of a category A disease in the event of official confirmation of the disease in wild animals.

Article 3 Clinical examinations, sampling procedures and diagnostic methods 1. Where clinical examinations of animals are required pursuant to this Regulation in order to confirm or rule out the presence of a category A disease, the competent authority shall ensure that: (a) the sampling of animals for clinical examination is carried out in accordance with: (i) point A.1 of Annex I for terrestrial animals; and (ii) point 1 of Annex XII for aquatic animals; (b) the clinical examination comprises: (i) an initial general evaluation of the animal health status of the establishment which comprises all the animals of listed species kept in the establishment; and (ii) an individual examination of the animals included in the sample referred to in point (a). 2. Where laboratory examinations are required pursuant to this Regulation in order to confirm or rule out the presence of a category A disease, the competent authority shall ensure that: (a) the sampling of animals for laboratory examination is carried out in accordance with: (i) point A.2 of Annex I for terrestrial animals; and (ii) point 1(b), (c), (d) and (e) of Annex XII for aquatic animals; (b) the diagnostic methods for laboratory examinations fulfil the requirements set out in: (i) point B of Annex I for terrestrial animals; and (ii) point 2 of Annex XII for aquatic animals; (c) the samples are sent: (i) without delay to an official laboratory designated in accordance with Article 37 of Regulation (EU) 2017/625 of the European Parliament and of the Council (13); (ii) in accordance with point C of Annex I for terrestrial animals and point 1(f) of Annex XII for aquatic animals; and (iii) following any other instruction from the competent authority and from the laboratory regarding biosecurity and biosafety conditions to prevent the spread of category A disease agents; (d) in the case of kept animals: (i) an inventory of all kept animals on the establishment and their species and categories is compiled; for poultry and aquaculture animals the number of animals may be estimated; and (ii) an identification mark of each sampled animal of listed species, or in the case of poultry and aquaculture animals the batch number, is recorded.

Article 4 Contingency plans The competent authority shall implement the measures laid down in this Regulation in accordance with the contingency plan referred to in Article 43 of Regulation (EU) 2016/429.

PART II

TERRESTRIAL ANIMALS

CHAPTER I

Disease control measures for category A diseases in kept terrestrial animals

Section 1

Preliminary disease control measures in the event of suspicion of a category A disease in kept animals

Article 5 Obligations on operators in the event of suspicion of a category A disease in kept animals in an establishment In the event of suspicion of a category A disease in kept animals, operators shall take the following disease control measures in order to prevent the spread of the category A disease from the affected animals and establishments under their responsibility to other unaffected animals or to humans until the competent authority rules out the presence of the category A disease: (a) isolate all animals suspected of being infected with the category A disease; (b) keep the manure, including litter and used bedding, and any product, material or substance likely to be contaminated with and to transmit category A diseases isolated and protected from insects and rodents, kept animals of non-listed species and wild animals to the extent technically and practically feasible; (c) implement the appropriate additional biosecurity measures to avoid any risk of spread of the category A disease; (d) cease all movements of kept animals of listed species from or to the establishment; (e) prevent non-essential movements of animals of non-listed species, products, materials, substances, persons and means of transport from or to the establishment; (f) ensure that production, health and traceability records of the establishment are updated; (g) provide the competent authority, on its request, with any relevant information regarding the category A disease; and (h) follow any instructions given by the competent authority regarding the control of the category A disease, in accordance with Regulation (EU) 2016/429 and this Regulation.

Article 6 Investigation by the competent authority in the event of suspicion of a category A disease in kept animals in an establishment 1. In the event of suspicion of a category A disease in kept animals in an establishment, in accordance with Article 9(1), (3) and (4) of Delegated Regulation (EU) 2020/689, the competent authority shall immediately conduct an investigation to confirm or rule out the presence of the suspected listed disease. 2. In the course of the investigation referred to in paragraph 1 the competent authority shall ensure that official veterinarians perform at least: (a) clinical examinations of kept animals of listed species at the establishment; and (b) collection of samples for laboratory examinations.

Article 7 Preliminary restriction and biosecurity measures in the event of suspicion of a category A disease in kept animals in an establishment 1. In the event of suspicion of a category A disease in an establishment, the competent authority shall place the establishment under official surveillance and immediately impose the following preliminary restriction and biosecurity measures, in order to prevent the spread of the category A disease from the affected animals and the establishment to other unaffected animals or to humans: (a) prohibition of movements of kept animals of listed species into and from the establishment; (b) prohibition of movements of kept animals of non-listed species into and from the establishment; (c) prohibition of movements of any product, material or substance likely to be contaminated with or likely to transmit category A diseases from the establishment; (d) isolation of kept animals of listed species and protection from wild animals, animals of non-listed species and, when necessary, from insects and rodents; (e) prohibition of killing of animals of listed species, unless authorised by the competent authority; and (f) prohibition of non-essential movements of products, materials, substances, persons and means of transport into the establishments. 2. By way of derogation from point 1(a), (b) and (c) the competent authority may authorise movements of animals and products from the establishment where a category A disease is suspected, after carrying out a risk assessment and provided that: (a) the movements of animals and products comply with all conditions and biosecurity measures necessary in order to avoid the spread of the disease; (b) in the establishment of destination there are not other kept animals of listed species; and (c) the establishment of destination is not a slaughterhouse. 3. Where derogations provided for in paragraph 2 are granted, the competent authority may impose the disease control measures provided for in paragraph 1 in the establishment of destination. 4. The competent authority may order preventive killing, in accordance with Article 12(1) and (2), of animals of listed species in the establishment where a category A disease is suspected when the epidemiological situation so requires. 5. All animal by-products from dead animals, which have died or have been killed in the establishment where a category A disease is suspected shall be processed or disposed of in accordance with Regulation (EC) No 1069/2009 to ensure that the suspected disease agent is inactivated and to prevent the spread of the disease to unaffected animals or to humans.

Article 8 Inventory and records analysis in the event of suspicion of a category A disease in kept animals in an establishment 1. In the event of suspicion of a category A disease, the competent authority shall order and verify that, without delay, operators of the establishments where a category A disease is suspected compile and maintain an up-to-date inventory of the following: (a) the species, categories and number of animals kept on the establishment; for poultry, the number of animals may be estimated; (b) the individual identification number of all the animals of species for which the individual identification is compulsory in accordance with Commission Delegated Regulation (EU) 2019/2035 (14); (c) the species, categories and number of kept animals of listed species which have been born, died, showed clinical signs or are likely to be infected or contaminated with the category A disease in the establishment; (d) any product, material or substance likely to be contaminated with or likely to transmit the relevant category A disease in the establishment; and (e) when relevant, all places likely to enable the survival of the vectors of the relevant category A disease in the establishment. 2. Where the establishment consists of several epidemiological units, the information in paragraph 1 shall be specified for each epidemiological unit. 3. In the framework of the epidemiological enquiry, as referred to in Article 57 of Regulation (EU) 2016/429, the competent authority shall analyse at least the following records of the establishment where a category A disease is suspected: (a) the inventory referred to in paragraph 1; (b) the records concerning the origin and date of arrival and departure at or from the establishment of kept animals of listed species; (c) the records concerning the origin and date of arrival and departure at or from the establishment of other relevant transport movements; (d) the production records; and (e) the records concerning to visits to the establishment, if available. 4. The records analysis referred to in paragraph 3 shall cover, at least, the monitoring period set out in Annex II for the relevant disease, calculated backwards from the date on which the suspicion was notified.

Article 9 Temporary restricted zones in the event of suspicion of a category A disease in kept terrestrial animals in an establishment 1. In the event of suspicion of a category A disease in kept animals in an establishment, the competent authority may establish a temporary restricted zone taking into account the following circumstances: (a) the location of the establishment in an area with a high density of kept animals of listed species for which a category A disease is suspected; (b) the movement of animals or persons in contact with kept animals of listed species for which a category A disease is suspected; (c) the delay in confirming the category A disease pursuant to Article 11; (d) the insufficient information on the possible origin and routes of introduction of the suspected category A disease; and (e) the disease profile, in particular the routes and speed of transmission of the disease and the persistence of the disease in the animal population. 2. In the establishments within the temporary restricted zone the competent authority shall apply at least the measures provided for in Article 7. 3. The competent authority may maintain the temporary restricted zone until the moment that the presence of the category A disease has been ruled out in the establishment where it was suspected or the presence of that disease has been confirmed and a restricted zone is established pursuant to Article 21. 4. The competent authority may order preventive killing, in accordance with Article 12(1) and (2), or slaughtering of animals of listed species, in the temporary restricted zones when the epidemiological situation so requires.

Article 10 Measures to apply in the event of suspicion of a category A disease in food and feed businesses, border control posts, animal by-products establishments or any other location of relevance, including means of transport 1. In the event of suspicion of a category A disease in accordance with Article 9(1), (3) and (4) of Delegated Regulation (EU) 2020/689 in food and feed businesses, border control posts, animal by-products establishments or any other location of relevance, including means of transport, the competent authority shall apply: (a) the relevant provisions laid down in Articles 5 to 9; and (b) if needed, additional measures adapted to the specific situation in order to prevent the spread of the category A disease to unaffected animals or to humans. 2. The competent authority shall also apply provisions laid down in Articles 5 to 9 in the establishments of origin of the animals or products present in the establishments and locations referred to in paragraph 1 which are suspected to be infected.

Section 2

Disease control measures in the event of the official confirmation of a category A disease in kept animals

Article 11 Official confirmation of a category A disease in kept terrestrial animals The competent authority shall officially confirm an outbreak of a category A disease in kept terrestrial animals when a case is confirmed in accordance with Article 9(2), (3) and (4) of Delegated Regulation (EU) 2020/689.

Article 12 Disease control measures in the event of official confirmation of an outbreak of a category A disease in kept animals in an establishment 1. Following the official confirmation of an outbreak of a category A disease in an establishment in accordance with Article 11, the competent authority shall order that, in addition to measures provided for in Article 7, the following disease control measures are immediately applied under the supervision of official veterinarians: (a) all animals of listed species kept in the affected establishment shall be killed as soon as possible on the spot, within the establishment, in such a way as to avoid any risk of spreading the relevant category A disease agent during and after killing; (b) all appropriate and necessary biosecurity measures shall be taken to avoid any possible spread of the category A disease to unaffected kept or wild animals or to humans; (c) bodies or parts of kept animals of listed species which have died or which have been killed pursuant to point (a) of this paragraph shall be disposed of in accordance with Regulation (EC) No 1069/2009; (d) all potentially contaminated products, materials or substances present in the establishment shall be isolated until: (i) they are disposed of or processed in accordance with Regulation (EC) No 1069/2009, in the case of animal by-products (including those resulting from the killing and products of animal origin and germinal products); (ii) cleaning and disinfection measures are completed in accordance with the Article 15, in the case of other materials and substances fit for cleaning and disinfection; (iii) disposal is completed under the supervision of official veterinarians, in the case of feeding stuff and other materials unfit for cleaning and disinfection. 2. The competent authority shall order and supervise that: (a) the transport from the affected establishment of animal by-products referred to in paragraphs 1(c) and 1(d)(i) complies with the provisions of Regulation (EC) No 1069/2009; (b) the transport from the affected establishment of materials or substances referred to in paragraph 1(d)(iii) complies with its instructions regarding biosecurity and biosafety conditions to prevent the spread of category A disease agent. 3. The competent authority shall collect samples for laboratory examination from kept animals of listed species, before or when they are killed or dead, for the purposes of the epidemiological enquiry referred to in Article 57 of Regulation (EU) 2016/429. 4. By way of derogation of point (a) of paragraph 1, the competent authority may, after carrying out a risk assessment and taking into account the possibility of applying other risk-mitigating measures, decide: (a) to order the killing of kept animals of listed species at the nearest suitable place in such a way as to avoid any risk of spreading the category A disease during killing or transport; or (b) postpone the killing of kept animals of listed species, provided that those animals are subject to emergency vaccination as provided for in Article 69 of Regulation (EU) 2016/429.

Article 13 Specific derogations from Article 12(1)(a) 1. In the event of an outbreak of a category A disease in establishments keeping animals of listed species in two or more epidemiological units, the competent authority may grant derogation from Article 12(1)(a) to the epidemiological units in which the disease has not been confirmed, after carrying out a risk assessment, and, when necessary, after obtaining favourable results in laboratory examinations, and provided that: (a) the epidemiological enquiry referred to in Article 57 of Regulation (EU) 2016/429 has not revealed any epidemiological link between the epidemiological units in which the category A disease has been confirmed and those in which the disease has not been confirmed, to suspect the spread of the category A disease between them; and (b) the competent authority has confirmed that, at least during the monitoring period, set out in Annex II for the relevant disease, before the confirmation of the category A disease, the epidemiological units in which the disease has not been confirmed were kept completely separated and handled by different personnel. 2. The competent authority may grant derogation from Article 12(1)(a) to the following categories of animals provided that the conditions in paragraph 3 are fulfilled: (a) animals kept in a confined establishment; (b) animals kept for scientific purposes or purposes related to conservation of protected or endangered species; (c) animals officially registered in advance as rare breeds; and (d) animals with a duly justified high genetic, cultural or educational value. 3. The competent authority shall ensure that the following conditions are fulfilled when granting the derogation provided for in paragraph 2: (a) the competent authority has carried out an assessment of the effects of granting such derogation and, in particular, of the effects on the animal health status of the Member State concerned and of the adjacent countries and the outcome of this assessment indicated that the animal health status is not endangered; (b) appropriate biosecurity measures are applied to prevent the risk of transmission of the category A disease to unaffected kept animals or to wild animals or to humans taking into account: (i) the disease profile; and (ii) the affected species of animals; (c) the animals are subject to appropriate isolation and clinical surveillance, including laboratory examinations, until the competent authority can ensure that the animals do not pose a risk of transmission of the category A disease. 4. The competent authority may grant specific derogations from Article 12(1)(a) to equine animals kept in establishments where an outbreak of the category A diseases referred to in Annex III has been confirmed under the conditions set out in that Annex.

Article 14 Additional disease control measures in the event of an outbreak of a category A disease in kept terrestrial animals in an establishment 1. The competent authority may establish, in addition to the measures provided for in Article 12, sampling procedures for kept animals of non-listed species and wild animals of listed species, based on the information obtained from the epidemiological enquiry referred to in Article 57 of the Regulation (EU) 2016/429. 2. The competent authority may, after carrying out a risk assessment of the further spread of the relevant category A disease and taking into account the possibility of applying other risk-mitigating measures, order the killing of kept animals of non-listed species and wild animals in such a way as to avoid any risk of spreading the category A disease during killing, transport and until disposal of the entire bodies or parts of the dead animals.

Article 15 Preliminary cleaning and disinfection and control of insects and rodents in the affected establishment 1. Immediately after the completion of the measures provided for in Article 12, and when relevant in Article 14, the competent authority shall order and supervise a preliminary cleaning and disinfection and, when relevant, control of insects and rodents, in the affected establishment in order to avoid spreading of the category A disease. 2. The preliminary cleaning, disinfection and control referred to in paragraph 1 shall be: (a) performed in accordance with the procedures set out in points A and B of Annex IV using the appropriate biocidal products to ensure destruction of the relevant category A disease agent; and (b) adequately documented. 3. When the competent authority grants one of the derogations provided for in Article 13(2) and (4), it shall order the preliminary cleaning, disinfection and the control referred to in paragraph 1 adapting the procedures referred to in point 2(a) to the specific situation without detriment to the control of spreading of the category A disease from the affected animals and affected establishments and locations to other unaffected animals or to humans. 4. In addition to the measures referred to in paragraphs 1 and 2, the competent authority shall order and supervise that the means of transport used for the transport of animals to and from the affected establishment are properly cleaned and disinfected and, where relevant, subjected to measures ensuring the control of insects and rodents.

Article 16 Derogations and special rules for the preliminary cleaning and disinfection and control of vectors The competent authority may grant derogation to the requirement regarding cleaning and disinfection and control of insects and rodents set out in Article 15 in the case of: (a) pastures epidemiologically linked to the affected establishment, under specific procedures to ensure effective inactivation of the relevant category A disease agent taking into account the disease profile, the type of establishment and the climatic conditions; and (b) manure, including litter and used bedding, from the affected establishment, under specific procedures to ensure effective inactivation of the relevant category A disease agent in accordance with scientific evidence.

Article 17 Identification of epidemiologically linked establishments and other locations of relevance, including means of transport 1. In the frame of the epidemiological enquiry, as referred to in Article 57 of the Regulation (EU) 2016/429, and in order to identify all the epidemiologically linked establishments and other locations of relevance, including means of transport, the competent authority shall trace all kept animals present in the establishment where an outbreak of a category A disease has been confirmed and any products, materials, substances, means of transport or people likely to spread the relevant category A disease including: (a) those dispatched into and from the establishment; and (b) those that have entered into contact with the establishment. 2. The tracing referred to in paragraph 1 shall cover at least the monitoring period, set out in Annex II for the relevant disease, calculated backwards from the date the suspicion was notified. 3. After carrying out a risk assessment, the competent authority may exclude from the tracing referred to in paragraph 1 those products considered as safe commodities, as provided for in Annex VII.

Article 18 Measures to be applied in the epidemiologically linked establishments and other locations of relevance, including means of transport 1. When the tracing provided for in Article 17(1) demonstrates that animals of listed species were dispatched from or to the affected establishment during the period referred to in paragraph 2 of that Article, the competent authority shall: (a) carry out investigations and impose restriction and biosecurity measures in accordance with Article 6, Article 7 and Article 8 in the establishments of destination or origin of the movement; or (b) immediately extend the measures in Article 12 to the establishment of origin or the establishment of destination of the movement in the case that there is epidemiological evidence of spreading of the disease to, from or through that establishment. 2. The competent authority shall apply the measures referred to in paragraph 1 in other establishments and locations of relevance, including means of transport, likely to be contaminated as a result of contact with animals, products, materials, substances, persons or means of transport from the affected establishment identified in the frame of the tracing referred to in Article 17 or based on any other relevant information from the epidemiological enquiry, as referred to in Article 57 of the Regulation (EU) 2016/429.

Article 19 Measures to be applied to the products identified by the tracing 1. The competent authority shall order and supervise that semen, oocytes and embryos identified as contaminated by the tracing referred to in Article 17 are disposed of in accordance with Regulation (EU) No 1069/2009. 2. The competent authority shall order and supervise the treatment, processing or disposing of the products identified by the tracing referred to in Article 17, at least up to: (a) the first food processing establishment in the case of products of animal origin; (b) the hatchery or the establishment where eggs were sent for hatching, in the case of hatching eggs which did not yet hatch; and (c) the first establishment of processing in the case of animal by products, except manure; or (d) the location where it is stored, in the case of manure, including litter and used bedding. 3. The competent authority shall establish official surveillance on poultry hatched during the tracing period referred to in Article 17(2) from hatching eggs originating from the affected establishment; this surveillance shall be established in all the establishments of destination of the hatching eggs and shall be maintained for a period of time of 21 days after hatching. 4. The competent authority shall order and supervise that the transport from the establishments of animal by-products is subject to the provisions laid down in Regulation (EC) No 1069/2009. 5. The competent authority shall order and supervise that materials or substances likely to be contaminated or likely to transmit the relevant category A disease comply with its instructions regarding biosecurity and biosafety conditions to prevent the spread of category A disease agent.

Article 20 Measures to be applied in the event of official confirmation of an outbreak of a category A disease in food and feed businesses, border control posts, animal by-products establishments and any other location of relevance, including means of transport 1. In the event of official confirmation of an outbreak in accordance with Article 11 in food and feed businesses, border control posts, animal by-products establishments or any other locations of relevance, including means of transport, the competent authority shall apply: (a) the relevant provisions laid down in Articles 12 to 19; and (b) if needed, additional measures adapted to the specific situation in order to prevent the spread of the category A disease from the affected animals and affected establishments and locations to other unaffected animals or to humans. 2. The competent authority shall apply provisions laid down in Articles 12 to 19 also in the establishments of origin of the affected animals or products present in the establishments and locations referred to in paragraph 1.

CHAPTER II

Disease control measures for category A diseases of kept terrestrial animals in the restricted zones

Section 1

General disease control measures in the restricted zone

Article 21 Establishment of a restricted zone 1. In the event of an outbreak of a category A disease in an establishment, food and feed business, animal by–products establishment or other locations, including means of transport, the competent authority shall immediately establish around the affected establishment or location a restricted zone, which comprises: (a) a protection zone based on the minimum radius from the outbreak set out for the relevant category A disease in Annex V; (b) a surveillance zone based on the minimum radius from the outbreak set out for the relevant category A disease in Annex V; and (c) if necessary, on the basis of the criteria set out in paragraph 1 of Article 64 of Regulation (EU) 2016/429, further restricted zones around or adjacent to the protection and surveillance zones, where the competent authority shall apply the same measures as those provided for in Section 3 of this Chapter for the surveillance zone. 2. The competent authority shall adapt the boundaries of the initial restricted zone, including the boundaries of the protection, surveillance and the further restricted zones, in the case of the overlapping of two or more restricted zones due to further outbreaks of the category A disease. 3. By way of derogation of paragraph 1, and after carrying out a risk assessment taking into account the disease profile, the competent authority may not establish a restricted zone when an outbreak of a category A disease occurs in the following locations: (a) establishments keeping animals referred to Article 13(2); (b) hatcheries; (c) food and feed businesses, border control posts, animal by-products establishments; (d) means of transport; (e) locations where assembly operations or temporal exhibition or veterinary assistance of animals take place; and (f) any other location which is not an establishment.

Article 22 Measures to be applied in the restricted zone 1. The competent authority shall without delay compile and keep up to date an inventory of all establishments keeping animals of listed species located in the restricted zone including the species, categories and number of animals in each establishment; for poultry, the number of animals may be estimated. 2. The competent authority may, in order to prevent the spreading of the disease and based on epidemiological information or other evidence, implement preventive killing, in accordance with Article 12(1) and (2), or slaughtering of kept animals of listed species in the establishments located in the restricted zone. 3. The competent authority shall order and supervise that all movements of entire bodies or parts of dead wild and kept animals of listed species from the restricted zone are destined for processing or disposal in accordance with Regulation (EC) No 1069/2009 in a plant approved for those purposes: (a) within the territory of the Member State; or (b) in another Member State in accordance with Article 48(1) and (3) of Regulation (EC) No 1069/2009, where it is not feasible to process or dispose the entire bodies or parts of dead animals in an approved plant in the territory of the Member State where the outbreak occurred. 4. The competent authority shall impose specific conditions for the transport of animals and products through the restricted zone in order to ensure that they are performed: (a) without stopping or unloading in the restricted zone; (b) prioritising major highways or mainline railways; and (c) avoiding the vicinity of establishments keeping animals of listed species. 5. Animal by-products originating from and moved outside the restricted zone shall be accompanied by an animal health certificate issued by an official veterinarian stating that they are allowed to be moved from the restricted zone under the conditions established by the competent authority in accordance with this Chapter. 6. The competent authority may decide that the certificate referred to in paragraph 5 shall not be issued for movements of animal by-products within the Member State concerned when that authority considers that an alternative system is in place ensuring that consignments of such products are traceable and that products fulfil the animal health requirements for such movements. 7. Any collection of samples in the establishments in the restricted zone keeping animals of listed species for purposes other than to confirm or rule out the presence of the relevant category A diseases must be authorised by the competent authority.

Article 23 Derogations from measures to be applied in the restricted zone The competent authority may grant derogations from the provisions set out in this Chapter concerning the measures to be applied in restricted zones, to the extent necessary and after carrying out a risk assessment: (a) in the further restricted zones referred to in Article 21(1)(c); (b) in the case that the competent authority decides to establish a restricted zone when an outbreak of a category A disease occurs in establishments and locations referred to in Article 21(3); (c) in the case that the outbreak occurs in an establishment keeping up to 50 captive birds; or (d) in establishments and locations referred to in Article 21(3) located in a restricted zone.

Article 24 Requirements for the means of transport of kept animals of listed species and products thereof 1. The competent authority shall ensure that the means of transport used for movements of kept animals of listed species and products thereof within, from, to and through the restricted zone have been: (a) constructed and maintained in such a way to avoid any leakage or escape of animals, products or any item representing an animal health risk; (b) cleaned and disinfected immediately after every transport of animals, products or any item representing an animal health risk and, if necessary, subsequently disinfected again, and in any case dried or allowed to dry, before any new loading of animals or products; and (c) where relevant, subjected to measures for the control of insects and rodents before the transport. 2. The cleaning and disinfection of the means of transport referred to in paragraph 1 shall be performed: (a) in accordance with the instructions or procedures provided for by the competent authority using the appropriate biocidal products to ensure the destruction of the relevant category A disease agent; and (b) adequately documented.

Section 2

Disease control measures in the protection zone

Article 25 Measures to be applied in establishments keeping animals of listed species in the protection zone 1. The competent authority shall order without delay the application of the following measures in establishments in the protection zone keeping animals of listed species, other than the establishment in which the category A disease has been confirmed: (a) to keep animals of listed species separate from wild animals and animals of non-listed species; (b) to implement additional surveillance in order to identify any further spread of the category A disease to the establishments, including any increased morbidity or mortality or significant drop in production data; any such increase or drop shall be immediately notified to the competent authority; (c) when appropriate, to implement adequate means of controlling insects and rodents and other disease vectors in and around the establishment; (d) to use appropriate means of disinfection at the entrances and exits of the establishment; (e) to apply appropriate biosecurity measures to all persons in contact with kept animals of listed species or entering or leaving the establishment as well as to means of transport in order to avoid any risk of spread of the relevant category A disease; (f) to keep records of all persons visiting the establishment, maintain them up to date in order to facilitate disease surveillance and control and made them available to the competent authority upon request; (g) to dispose entire bodies or parts of dead or killed kept animals of listed species according to Article 22(3). 2. By way of derogation of point (f) of paragraph 1 the records on visitors are not required in establishments where animals referred to in Article 13(2) are kept, if visitors have no access to the areas where the animals are kept.

Article 26 Visits by official veterinarians in establishments in the protection zone 1. The competent authority shall ensure that official veterinarians carry out at least one visit to all the establishments referred to in Article 25, as soon as possible and without unjustified delay, after the official confirmation of an outbreak of a category A disease. 2. When carrying out the visits referred to in paragraph 1, official veterinarians shall perform at least the following activities: (a) documentary checks, including production, health and traceability records analysis; (b) verification of the implementation of the measures applied to prevent the introduction or spread of the relevant category A disease in accordance with Article 25; (c) clinical examination of kept animals of listed species; and (d) if necessary, collection of samples of animals for laboratory examination in order to confirm or rule out the presence of the relevant category A disease. 3. The competent authority may require further veterinary visits to the establishments in the protection zone to follow up on the situation. 4. The competent authority shall keep a record of activities and visits referred to in paragraph 1, 2 and 3 and the findings thereof. 5. By way of derogation from paragraph 1, where the radius of the protection zone set in Annex V is larger than 3 km, the competent authority may decide to require not the visit to all the establishments referred to in Article 25 but the visit of a representative number of those establishments in accordance with point A.3 of Annex I.

Article 27 Prohibitions in relation to activities, including movements, concerning animals, products and other material within, from or to the protection zone 1. The competent authority shall prohibit the activities, including movements, concerning animals of listed species and their products and other materials within, from and to the protection zone in accordance with the table in Annex VI. 2. The competent authority may extend the prohibitions provided for in paragraph 1 to: (a) animals of non-listed species and products from such animals; and (b) activities, including movements, other than those set out in Annex VI. 3. The following products are exempted from prohibitions provided for in paragraphs 1 and 2: (a) products of animal origin considered as safe commodities, in accordance with Annex VII, as regards the relevant disease; (b) products of animal origin which have undergone the relevant treatment in accordance with Annex VII; (c) products or other materials likely to spread the disease obtained or produced before the monitoring period set out in Annex II for the relevant disease calculated backwards from the date on which the suspicion was notified; (d) products produced in the protection zone which have been obtained from kept animals of listed species: (i) kept outside the protection zone; (ii) kept and slaughtered outside the protection zone; or (iii) kept outside the protection zone and slaughtered in the protection zone; (e) derived products. 4. Prohibitions provided for in paragraph 1 and 2 shall apply to products referred to in paragraph 3 if: (a) the products were not clearly separated, during the production process, storage and transport, from products not eligible for dispatch outside the restricted zone pursuant to this Regulation; or (b) the competent authority has epidemiological evidences of spreading of the disease to, from or through those products.

Article 28 General conditions to grant derogations from prohibitions in the protection zone 1. By way of derogation from prohibitions provided for in Article 27, the competent authority may authorise movements of animals and products in the cases covered by Articles 29 to 38 and under the specific conditions provided for in those Articles and the general conditions laid down in paragraphs 2 to 7 of this Article. Prior to granting the authorisation, the competent authority shall assess the risks deriving from that authorisation and the assessment must indicate that the risk of spreading the category A disease is negligible. 2. All authorised movements must be performed: (a) exclusively via designated routes, (b) prioritising major highways or mainline railways, (c) avoiding the vicinity of establishments keeping animals of listed species; and (d) without unloading or stopping, until the unloading in the establishment of destination. 3. The competent authority of the establishment of origin shall designate the establishment of destination for movements from or to the protection zone. If the competent authority of the establishment of origin is different from the competent authority of the establishment of destination, it shall inform the competent authority of the establishment of destination about such designation. 4. The competent authority of the establishment of origin shall verify that the establishment of destination agrees to be designated and to receive each consignment of animals or products. 5. When authorising movements of animals from the protection zone, the competent authority shall ensure that such movements do not pose a risk of spreading of the category A disease based on: (a) a clinical examination, with favourable results, of animals kept in the establishment, including those animals to be moved; (b) if necessary, a laboratory examination, with favourable results, of animals kept in the establishment, including those animals to be moved; and (c) the outcome of the visits referred to in Article 26. 6. When authorising the transport of products from the protection zone, the competent authority shall order and supervise that: (a) during the whole production process and their storage, products were clearly separated from products not eligible for dispatch outside the restricted zone in accordance with this Regulation; and (b) products will not be transported with products not eligible for dispatch outside the restricted zone pursuant to this Regulation. 7. When granting an authorisation pursuant to paragraph 1, the competent authority shall ensure that supplementary biosecurity measures are applied from the moment of loading, during all transport operations and until the unloading in the designated establishment of destination in accordance with its instructions.

Article 29 Specific conditions for authorising movements for slaughter of kept animals of listed species in the protection zone 1. The competent authority may authorise movements of kept animals of listed species from establishments located in the protection zone to a slaughterhouse located: (a) as near as possible to the establishment of origin, within the protection zone; (b) in the surveillance zone, when it is not possible to slaughter the animals in the protection zone; or (c) as near as possible to the surveillance zone when it is not possible to slaughter the animals in the restricted zone. 2. The competent authority shall only grant authorisations provided for in paragraph 1 under the following conditions: (a) the means of transport must be sealed at the moment of loading by the competent authority of dispatch or under its supervision; (b) the competent authority of the slaughterhouse shall: (i) be informed in advance by the slaughterhouse operator of the intention to receive kept animals of listed species; (ii) confirm the absence of any signs indicative of the category A disease during the ante and post mortem inspections; (iii) supervise the slaughterhouse operator having effective procedures in place to ensure that kept animals of listed species originating in the protection zone are kept separately and slaughtered separately from such animals or at different times, preferably at the end of the working day of arrival; (iv) confirm the slaughter of the animals to the competent authority of the establishment of origin of the animals; (v) supervise the slaughterhouse operator cleaning and disinfecting the premises where the animals have been kept and slaughtered and the completion of the cleaning and disinfection is completed before other kept animals of listed species are kept or slaughtered in those premises; and (vi) supervise the obtaining of meat from such animals complying with the conditions laid down in Article 33. 3. The competent authority may authorise movements of kept animals of listed species from establishments located outside the protection zone to a slaughterhouse located in the protection zone if: (a) the animals are kept separately from other animals originating from the protection zone and are slaughtered separately from those animals or at a different time; (b) the fresh meat obtained is cut, transported and stored separately from fresh meat obtained from animals originating in the protection zone; and (c) the cleaning and disinfection of the means of transport referred to in Article 24 takes place under official supervision after unloading the animals. 4. By way of derogation of Article 9 of Regulation (EC) No 1069/2009 the competent authority may authorise the processing and use of animal by-products, obtained from animals slaughtered in accordance with paragraphs 1, 2 and 3 as category 3 material in accordance with Regulation (EC) No 1069/2009 in a plant approved for processing or disposal of animal by-products, located on its territory, or in another Member State, where it is not feasible to process or dispose them in an approved plant in the territory of the Member State where the outbreak occurred. In case the animal by-products referred to in the first subparagraph are moved to a plant located in another Member State, the Member State of destination and the Member States of passage shall authorise such dispatch and the competent authority of destination shall authorise the processing and use of those animal by-products as category 3 material in accordance with Regulation (EC) No 1069/2009.

Article 30 Specific conditions for authorising certain movements of poultry from establishments located in the protection zone 1. The competent authority may authorise movements of day-old-chicks from an establishment located in the protection zone to an establishment located in the same Member State but, if possible, outside the restricted zone, provided that: (a) in the case of day-old-chicks hatched from eggs originating in the restricted zone: (i) the means of transport is sealed at the moment of loading by the competent authority or under its supervision; (ii) the establishment of destination is placed under official surveillance by the official veterinarians following the arrival of the animals; and (iii) if moved outside the restricted zone, the poultry remain in the establishment of destination at least for a period of 21 days. (b) in the case of day-old-chicks hatched from eggs originating outside the restricted zone, the hatchery of dispatch can ensure that no contact has occurred between those eggs and any other hatching eggs or day-old chicks originating in the restricted zone. 2. The competent authority may authorise movements of ready-to-lay poultry from establishments located in the protection zone to establishments located in the same Member State and, if possible, within the restricted zone, provided that: (a) in the establishment of destination there is no other kept animal of listed species; (b) the means of transport is sealed at the moment of loading by the competent authority or under its supervision; (c) the establishment of destination is placed under official surveillance by the official veterinarians following the arrival of the animals; and (d) if moved outside the restricted zone, the animals remain on the establishment of destination at least for a period of 21 days.

Article 31 Specific conditions for authorising certain movements of hatching eggs in the protection zone 1. The competent authority may authorise movements of hatching eggs either: (a) from an establishment located in the protection zone to a hatchery located in the same Member State; or (b) from an establishment located in the same member State to a hatchery located in the protection zone. 2. The authorisation provided for in paragraph 1(a) shall be subject to the following conditions: (a) the parent flocks from which the hatching eggs are derived have undergone a clinical examination and have been sampled for laboratory examination with favourable results; (b) the hatching eggs and their packaging are disinfected before dispatch and the tracing back of the hatching eggs can be ensured; and (c) the hatching eggs must be transported in means of transport sealed by the competent authority. 3. The competent authority may authorise movements of hatching eggs from an establishment located in the protection zone to an establishment for in-house hatching located in the same Member State, if: (a) the parent flocks from which the hatching eggs are derived have undergone a clinical examination and have been sampled for laboratory examination with favourable results; (b) the establishment of destination is placed under official supervision until 21 days following hatching of the eggs; (c) the poultry must remain on the establishment of destination during the period referred to in (b); and (d) the requirements referred to in paragraph 2(b) and (c) are complied with.

Article 32 Specific conditions for authorising movements of semen from approved germinal product establishments in the protection zone The competent authority may authorise movements of semen collected from animals of listed species kept in approved germinal product establishments, excluding hatcheries, located in the protection zone after the estimated date of earliest infection of the affected establishment subject to the following conditions: (a) all the disease control measures relating to the category A disease have been lifted in the protection zone in accordance with Article 39; (b) all kept animals of listed species in the semen collection centre have undergone a clinical examination and have been sampled for laboratory examination in order to rule out the presence of the category A disease in the semen collection centre; and (c) the donor animal has been subjected with favourable result to a laboratory examination on a sample taken not earlier than seven days after the monitoring period set out in Annex II for the relevant disease, calculated forwards from the date on which the semen was collected.

Article 33 Specific conditions for authorising movements of fresh meat and raw milk obtained from kept animals of listed species from establishments in the protection zone 1. The competent authority may authorise movements of fresh meat and raw milk obtained from animals of listed species kept in establishments located in the protection zone if: (a) they are moved to a processing establishment to undergo one of the relevant risk-mitigating treatments set out in Annex VII; or (b) in the case of fresh meat of poultry: (i) it has been marked in accordance with paragraph 1 of Annex IX from the moment it was obtained in the slaughterhouse; and (ii) it is not intended to another Member State. 2. The competent authority shall ensure that movements to a processing establishment referred to in paragraph 1(a) comply with the following conditions: (a) fresh meat must be marked in accordance with point 2 of Annex IX in the slaughterhouse after the post-mortem inspection and must bear such mark until it is treated; (b) the movement of fresh meat and raw milk from the establishment of origin to the processing establishment must be carried out in sealed containers; and (c) the processing establishment must be located in the same restricted zone or as near as possible to the restricted zone and must operate under the supervision of official veterinarians.

Article 34 Specific conditions for authorising movements of eggs for human consumption from establishments located in the protection zone The competent authority may authorise the movement of eggs for human consumption from establishments located in the protection zone to the following destinations within the same Member State: (a) to a packing centre, provided that they are packed in: (i) a disposable packaging; or (ii) a packaging which can be cleaned and disinfected in such way as to destroy the relevant category A disease agent; (b) to an establishment for the manufacture of egg products as set out in Chapter II of Section X of Annex III to Regulation (EC) No 853/2004, in order to be handled and treated in accordance with Chapter XI of Annex II to Regulation (EC) No 852/2004 of the European Parliament and of the Council (15).

Article 35 Specific conditions for authorising movements of manure, including litter and used bedding from establishments located in the protection zone to a landfill The competent authority may authorise movements of manure, including litter and used bedding, from establishments located in the protection zone for the purpose of their disposal in a designated landfill located within the same Member State only after processing in accordance with Article 13(c) of Regulation (EU) No 1069/2009.

Article 36 Specific conditions for authorising the movement of feed materials of plant origin and straw from the protection zone The competent authority may authorise movements of feed materials of plant origin and straw produced in the protection zone provided that: (a) they were produced in locations not keeping animals of listed species; (b) they were produced in feed processing establishments not keeping animals of listed species and the raw plant material originates: (i) from locations referred to in point (a); or (ii) from outside the protection zone; (c) they are intended for use within the protection zone; or (d) they have undergone at least one of the risk-mitigating treatments in accordance with Annex VIII.

Article 37 Specific conditions for authorising movements of kept animals of listed species and products to an animal by-products approved plant 1. The competent authority may authorise movements of kept animals of listed species from establishments located in the protection zone to a plant approved for processing or disposal of animal by-products in which: (a) the kept animals are immediately killed; and (b) the resulting animal by-products are disposed of in accordance with Regulation (EC) No 1069/2009. 2. The competent authority may authorise movements of products from establishments and locations in the protection zone to a plant approved for processing or disposal of animal by-products, in which the products are disposed of or processed in accordance with Regulation (EC) No 1069/2009.

Article 38 Measures to be applied in food and feed businesses, border control posts, animal by-products establishments or any other location of relevance in the protection zone, including means of transport 1. The competent authority shall apply the relevant measures referred to in Article 25, and Articles 27 to 38 in food and feed businesses, border control posts, animal by-products establishments or any other location of relevance in the protection zone, including means of transport. 2. In the establishments and locations referred to in paragraph 1, the competent authority may apply additional measures adapted to the specific situation in order to prevent the spread of the category A disease within and from the protection zone.

Article 39 Duration of the disease control measures in the protection zone 1. The competent authority may lift the measures provided for in Section 1 and 2 of this Chapter only if the minimum period set out in Annex X has elapsed and the following conditions are fulfilled: (a) the preliminary cleaning and disinfection and, where relevant, control of insects and rodents, has been performed in accordance with Article 15 in the affected establishment; and (b) in all establishments keeping animals of listed species in the protection zone, animals of listed species have undergone, with favourable results, clinical and when necessary laboratory examinations in accordance with Article 26. 2. Where the relevant category A disease is transmitted by a listed vector, as referred to in Regulation (EU) 2018/1882, the competent authority may: (a) establish the duration of the measures in the protection zone on a case by case basis, taking into account any factor influencing the risk of the disease spreading; and (b) provide for the introduction of sentinel animals. 3. After the lifting of the measures referred to in paragraph 1, the measures provided for in Section 3 of this Chapter shall apply in the protection zone for at least the additional period set out in Annex X.

Section 3

Disease control measures in the surveillance zone

Article 40 Measures to be applied in establishments in the surveillance zone The competent authority shall order the application, without delay, of the measures provided for in Article 25 in all the establishments in the surveillance zone keeping animals of listed species.

Article 41 Visits by the official veterinarians in establishments in the surveillance zone The competent authority shall ensure that official veterinarians carry out visits to a sample of establishments keeping animals of listed species in the surveillance zone in accordance with Article 26 and point A.3 of Annex I.

Article 42 Prohibitions in relation to activities, including movements, concerning animals, products and other material within, from or to the surveillance zone The competent authority shall apply prohibitions, exemptions and derogations to activities, including movements concerning animals of listed species, the products thereof and other material, from and to the surveillance zone in accordance with Article 27.

Article 43 General conditions for granting derogations from prohibitions provided for in Article 42 1. By way of derogation from Article 42, the competent authority may authorise movements of animals and products only in the cases covered by Articles 44 to 52, under the specific conditions provided for in those Articles and the general conditions laid down in paragraphs 2 to 7 of this Article. Prior to granting the authorisation, the competent authority shall assess the risks deriving from that authorisation. The assessment must indicate that the risk of spreading the category A disease is negligible. 2. All authorised movements shall be performed: (a) prioritising major highways or mainline railways; (b) avoiding the vicinity of establishments keeping animals of listed species; and (c) without unloading or stopping, until the unloading in the establishment of destination. 3. The competent authority of the establishment of origin shall designate the establishment of destination for movements from or to the surveillance zone. If the competent authority is not the same as in the establishment of destination, it shall inform the competent authority of the establishment of destination about such designation. 4. The competent authority of the establishment of origin shall verify that the establishment of destination agrees to be designated and to receive each consignment of animals or products. 5. When authorising movements of animals from the surveillance zone, the competent authority shall ensure that such movements do not pose a risk of spreading the category A disease based on: (a) a clinical examination with favourable results of animals kept in the establishment, including those animals to be moved; (b) if necessary, a laboratory examination with favourable results of animals kept in the establishment, including those animals to be moved; and (c) the outcome of the visits referred to in Article 41, if available. 6. When authorising the transport of products from the surveillance zone, the competent authority must ensure that: (a) during the whole production process and storage, products were clearly separated from products not eligible for dispatch outside the restricted zone pursuant this Regulation; (b) products will not be transported with products not eligible for dispatch outside the restricted zone pursuant this Regulation. 7. When granting derogations provided for in paragraph 1, the competent authority shall ensure that supplementary biosecurity measures are applied from the moment of loading, during all transport operations and until the unloading in the designated establishment of destination in accordance with its instructions.

Article 44 Specific conditions for authorising movements for slaughter of kept animals of listed species within, from and to the surveillance zone 1. The competent authority may authorise movements of kept animals of listed species originating in the surveillance zone to a slaughterhouse located: (a) as near as possible to the establishment of origin, within the restricted zone; or (b) outside the restricted zone, as near as possible to the surveillance zone, when it is not possible to slaughter the animals in the restricted zone, and after carrying out a risk assessment. 2. The meat obtained from animals referred to in paragraph 1 shall be subject to the measures provided for in Article 49. 3. The competent authority may authorise movements of kept animals of listed species originating outside the surveillance zone to a slaughterhouse situated in the surveillance zone. 4. The competent authority may authorise the processing and use of animal by-products, obtained from animals slaughtered in accordance with paragraphs 1, 2 and 3 as category 3 material in accordance with Regulation (EC) No 1069/2009 in a plant approved for processing or disposal of animal by-products, located on their territory, or in another Member State, where it is not feasible to process or dispose them in an approved plant in the territory of the Member State where the outbreak occurred. In case the animal by-products referred to in the first subparagraph are moved to a plant located in another Member State, the Member State of destination and the Member States of passage shall authorise such dispatch and the competent authority of destination shall authorise the processing and use of those animal by-products as category 3 material in accordance with Regulation (EC) No 1069/2009.

Article 45 Specific conditions for authorising certain movements of kept ungulates of listed species from establishments in the surveillance zone 1. The competent authority may authorise the movement of kept ungulates of listed species to pastures situated within the surveillance zone, provided that: (a) a period of 15 days has elapsed after the preliminary cleaning and disinfection referred to in Article 15 has been completed and approved; and (b) the animals do not come into contact with animals of listed species from other establishments. 2. The competent authority may, after carrying out a risk assessment, authorise the movement of kept animals of listed species of ungulates to an establishment belonging to the same supply chain, located in or outside the surveillance zone, to complete the production cycle before slaughter. If the establishment of destination is located outside the surveillance zone, the competent authority shall apply in that establishment the measures provided for in Articles 40, Article 41 and Article 42 as long as the disease control measures in the surveillance zone of origin are maintained as provided for in Article 55.

Article 46 Specific conditions for authorising certain movements of poultry from establishments located in the surveillance zone 1. The competent authority may authorise movements of day-old chicks originating in the surveillance zone: (a) to establishments in the same Member State where they were hatched from eggs originating from establishments within the surveillance zone, if: (i) the establishment of destination is placed under official surveillance following the arrival of the animals; and (ii) if moved outside the restricted zone, the animals remain in the establishments of destination for at least 21 days; (b) to establishments in the same Member State where they were hatched from eggs originating outside the restricted zone, if the hatchery of dispatch can ensure that no contact has occurred between those eggs and any other hatching eggs or day-old chicks obtained from animals kept within the restricted zone. 2. The competent authority may authorise movements of ready-to-lay poultry from establishments in the surveillance zone to establishments in the same Member State, if: (a) in the establishment of destination there is no other kept animal of listed species; (b) the establishment of destination is placed under official surveillance following the arrival of the ready-to-lay poultry; and (c) the poultry remain on the establishment of destination for at least 21 days.

Article 47 Specific conditions for authorising certain movements of hatching eggs to and from establishments in the surveillance zone 1. The competent authority may authorise movements of hatching eggs from an establishment located in the same Member State to: (a) a hatchery located in the surveillance zone; or (b) an establishment for in-house hatching locat