Delegated regulation 2020/689 - Supplement to Regulation 2016/429 as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases - Main contents

EN

Official Journal of the European Union

L 174/211

The Animal Health Law lays down rules for the prevention and control of animal diseases transmissible to animals or to humans. The rules laid down in this Regulation are required to supplement those laid down in Chapters 2, 3 and 4 of Part II of the Animal Health Law on surveillance, eradication programmes and disease-free status, as well as those in Part IX on transitional arrangements concerning existing surveillance or eradication programmes and existing disease-free status.

These rules are substantially linked with many intended to be applied together. In the interest of simplicity and transparency, as well as to facilitate their application and avoid a multiplication of rules, they should therefore be laid down in a single act rather than in a number of separate acts with many cross-references and the risk of duplication.

Indeed, surveillance represents an intrinsic part of any eradication programme and disease-free status is in most cases an outcome of a successful surveillance and eradication process. Moreover, surveillance is needed, besides other measures, as a key tool for maintaining the disease-free status after its achievement. The rules on surveillance, eradication programmes and disease-free status, including transitional rules, often serve common purposes and refer to complementary activities of operators, veterinarians and competent authorities. Therefore it is appropriate to group together these rules in a single delegated regulation.

Surveillance is a key element of an efficient and effective disease prevention and control policy. It should be implemented jointly by operators and the competent authority. It should also be designed to meet the objectives of early detection of outbreaks of any listed and emerging disease and to demonstrate compliance with the criteria for the granting, maintaining, suspension or withdrawal of disease-free status.

The competent authority should put in place a basic general surveillance system for listed and emerging diseases of terrestrial animals based on notification and investigations of disease events in targeted animal population.

These general surveillance requirements for terrestrial animals should be complemented by more specific requirements depending on the expected output of surveillance. They should be designed to serve different specific purposes such as Union surveillance programmes, compulsory and optional eradication programmes, demonstration of disease-free status, disease control measures, in the context of the approval of certain establishments and the movements of animals and animal products.

The approach to designing general surveillance requirements for aquatic animals is similar to that for terrestrial animals, although not identical. All aquaculture establishments need to implement a basic surveillance system based on notification and investigation of disease events in a targeted animal population. In addition, surveillance for listed and emerging diseases of aquatic animal needs to incorporate certain disease control measures, when it is necessary to take such measures in aquaculture establishments.

In addition to the general surveillance requirements, which apply to all aquaculture establishments, specific surveillance requirements apply to certain approved aquaculture establishments. These specific measures include implementing a risk-based surveillance scheme based on assessment of the risk that an establishment has of contracting and spreading an aquatic disease, be it listed or non-listed.

The specific surveillance requirements also relate to the implementation of eradication programmes for certain listed diseases in order to obtain disease-free status from that disease and to maintain that status once achieved.

In addition, Member States should be given the possibility to implement surveillance, in the form of ‘surveillance programmes’ for Category C diseases of aquatic animals at establishment level, without opting for a disease eradication programme. Surveillance programmes differ from eradication programmes in that they are based on a system of targeted surveillance which is comprehensive but which does not encompass all the elements of an eradication programme. Unlike eradication programmes, surveillance programmes do not offer the possibility to achieve official disease-free status.

The specific eradication and surveillance programmes set out in this Regulation serve to substantiate health requirements for certain movements of animals and products of animal origin within the Union and in certain cases, of animals and products of animal origin entering the Union.

The Animal Health Law requires rules for listed diseases to apply to listed species. Surveillance may not be relevant for all categories of animals of listed species, in particular as regards wild animals or certain categories of kept animals. Therefore this Regulation should provide rules to specify the relevant targeted animal population for the purpose of surveillance. It should also be possible to expand the targeted animal population to non-listed kept species to ensure early detection of emerging diseases.

Derogations should also make possible to further limit targeted terrestrial animal populations to specific surveillance purposes, namely: (i) Union surveillance programmes; (ii) compulsory or optional eradication programmes; and (iii) surveillance-based animal health requirements for movements within the Union or for entry into the Union.

Diagnostic methods, together with the subsequent collection of samples to perform them, techniques, validation and interpretation are of a very technical nature and are subject to frequent modifications due to developments in scientific standards. Therefore to ensure that they are up to date, the rules on diagnostic methods should indicate in a flexible manner which methods should be used and how. In the area of animal diseases, there are different possible sources of scientific standards for diagnostic methods. It is therefore important to indicate the hierarchical order in which the methods should be considered, taking into account the general principles of sampling, analyses, tests and diagnoses laid down in Regulation (EU) 2017/625 of the European Parliament and of the Council (2).

To ensure optimal use of all resources and to avoid unnecessary administrative burdens and costs for operators and the competent authorities, the detection of listed and emerging diseases should draw on sources of information gathered during official controls and other official activities not primarily intended for the surveillance of those diseases.

The confirmation of a disease according to its case definition is the responsibility of the competent authority; it should be supported by appropriate investigations to confirm or rule out the presence of a suspected disease. Such investigations are relevant where the confirmation of the disease triggers disease control measures, as well as in certain other circumstances depending on the consequences of the confirmation of the disease. It is therefore important that this Regulation should lay down the additional circumstances where the confirmation of the disease is necessary.

The definitions of a suspected case and confirmed case of a listed disease and, where relevant, an emerging disease are of key importance. These enable operators, veterinarians and other stakeholders involved in surveillance to identify circumstances where it is necessary to notify the competent authority and for the competent authority to apply disease control measures. Therefore it is necessary to provide general criteria for the definitions of a suspected case and a confirmed case and to provide, where needed, disease-specific definitions, depending on the specific characteristics of certain diseases.

A Union surveillance programme is a surveillance programme relevant for the Union as a whole. This is necessary in order to achieve greater harmonisation of surveillance of a specific disease across the Union due to its specific public or animal health concerns. Therefore it is necessary to lay down the criteria that diseases eligible for Union surveillance programme should meet.

Commission Decision 2010/367/EU (3) lays down minimal requirements for surveillance programmes for avian influenza in poultry and in wild birds and sets out technical guidelines in its annexes. This Regulation should provide for similar technical guidelines in an annex. However, the level of detail in this Regulation is lower to ensure a good capacity to adapt to changes in the situation as regards surveillance of avian influenza. Therefore the technical requirements for the Union surveillance programme for avian influenza focus exclusively on the objectives, the scope and the methodological principles to follow.

The Animal Health Law sets out rules for the application of compulsory and optional eradication programmes for category B and category C diseases in Member States. These diseases, or groups of them, have their own characteristics. Their eradication should be based on a disease control strategy specific for the disease in question. This should include at least: (i) the surveillance that needs to be performed in order to achieve disease-free status as the ultimate goal; (ii) the timeframe; (iii) a definition of the animal population that is subject to the eradication programme; (iv) the territory in which this eradication programme will apply; and (v) specific disease prevention and control measures that will apply to the disease during the eradication phase.

If the territory in which an eradication programme will be implemented includes the external border of the Member State, the competent authority should make efforts to address the risk of introduction of the disease from outside its borders.

The purpose of an eradication programme is to achieve disease-free status on the territory covered by the programme. Ideally, for terrestrial animals it should cover the whole territory of the Member State where the disease is present. If this is not possible, the minimum area that is acceptable should be defined. The minimum surface of the area should take into account the experience gained through previous eradication programmes and allow for flexibility depending on the specific characteristics of the disease.

The programme’s qualitative or quantitative targets should be set by the competent authority. Final targets should be based on the criteria for granting disease-free status, while intermediate targets may also comprise other activities or steps important for achieving the disease-free status, reflecting the evolution of the programme.

The competent authority should determine the period of application of the eradication programmes. In the case of optional eradication programmes for category C diseases, a maximum period of application of the programme is laid down in order to prevent disproportionate and long lasting disruption of movements within the Union. Nevertheless, the competent authority may start the eradication programme before its approval by the Commission but should not implement restrictions to the movements within the Union at that stage. A possibility should also be provided for Member States to request that the Commission extend this period where justified circumstances exist.

The eradication strategy of certain diseases might be based on granting disease-free status at establishment level. The disease-specific measures for such diseases should be grouped and spell out obligations for the operators and for the competent authorities.

The targeted animal population to be included in the disease eradication programme should be set out on a disease-specific basis. The possibility for the competent authority to include in the programme certain additional animal populations should also be set out on a disease-specific basis.

The primary responsibility for obtaining and maintaining the establishment’s disease-free status lies with the operator as it is the primary recipient of the benefits linked to the disease-free status. Therefore the operator should comply with certain obligations in order to be granted and maintain disease-free status.

Once the general and disease specific criteria for achieving disease-free status have been met by the operator, it is for the competent authority to grant that status. When these specific criteria are no longer met, it is also for the competent authority to either suspend or withdraw the status.

Moreover, the obligations for operators and competent authorities in the context of eradication programmes should, where necessary, be detailed considering the specific disease profile. The disease-specific requirements are of a technical nature and are set out for each specific disease in annexes to this Regulation.

Commission Implementing Regulation (EU) 2018/1882 (4) lists infection with Brucella abortus, B. melitensis and B. suis and infection with Mycobacterium tuberculosis complex for compulsory eradication programmes and lists enzootic bovine leukosis, infection with Aujeszky’s disease virus, infectious bovine rhinotracheitis/infectious pustular vulvovaginitis and bovine viral diarrhoea for optional eradication programmes. For these diseases, eradication programmes should be based on the granting of establishment disease-free status.

Eradication programmes based on granting disease-free status at establishment level should include all establishments keeping animals from the targeted animal population. However, the competent authority should have the possibility to exclude certain specific types of establishments and slaughterhouses from the eradication programme provided appropriate risk mitigating measures are implemented.

In the case of eradication programmes based on granting disease-free status at establishment level, the competent authority should have the possibility to attribute different health status to different epidemiological units.

In the case of terrestrial animals, the requirements to demonstrate disease-free status at establishment level are based on the absence of infection supported by the testing and surveillance regime, by the conditions for introducing animals and germinal products into the establishments and, if necessary, by restrictions on the use of vaccination. When the conditions for maintaining the disease-free status are no longer satisfied, specific requirements apply to suspend, withdraw and restore this status. Due to their technical nature, the disease-specific detailed requirements and the list of diagnostic methods to be used for granting and maintenance of the status are laid down in annexes.

Conditions for granting, maintaining, suspending and withdrawing disease-free status at establishment level were set out in the following Union rules in place before the date of application of this Regulation: Council Directive 64/432/EEC (5) for bovine brucellosis and bovine tuberculosis and Council Directive 91/68/EEC (6) for brucellosis in sheep and goats. The Animal Health Law repealed those provisions. Also, Commission Delegated Regulation (EU) 2018/1629 (7) has aligned the scope of disease agents involved in brucellosis and bovine tuberculosis with the Terrestrial Animal Health Code of the World Organisation for Animal Health (8) (OIE) (‘the Terrestrial Code’). They are now infection with Brucella abortus, Brucella melitensis and Brucella suis and infection with Mycobacterium tuberculosis complex. It is therefore appropriate to revise the technical requirements related to the status of these diseases, so as to seek alignment with the Terrestrial Code while taking into account the experience gained in previous eradication programmes for these diseases.

In the case of disease eradication programmes for terrestrial animals based on granting disease-free status at establishment level, if a disease is suspected or confirmed, the competent authority should implement measures to prevent its spread. These measures are to be implemented primarily in the establishment where the suspected case is kept but the competent authority should have the possibility to expand the measures to other animals or establishments when there is a risk of spreading the disease.

When applying the disease control measures in response to a suspected or confirmed case, the competent authority should introduce certain prohibitions on movements of animals. However, the competent authority should also have the possibility to allow the movement of certain animals from the establishment where a suspected or confirmed case is kept, to take account of animal welfare conditions and to facilitate the sustainability of the disease control measures.

Following the confirmation of a case, at least all animals recognised as confirmed cases should be removed. When these animals are put to death, the competent authority should have the possibility to decide whether this is done by slaughtering, meaning that their meat is intended to enter the food chain, or by killing, meaning that the meat is not intended for that purpose.

For certain diseases that can be spread by infected products of animal origin or fomites, or which may have a potential public health impact, the competent authority should introduce measures in infected establishments to prevent the spread of those diseases through these products or fomites. The measures to mitigate such risks should therefore be set out in this Regulation.

In the case of terrestrial animals, once disease-free status has been achieved at establishment level, for the sake of programme efficiency, it should be possible to carry out a stepwise reduction in the level of surveillance activities after a certain period of continuous disease-free status in the establishment.

Enzootic bovine leukosis (EBL) was subject to compulsory eradication under the Union rules in place before the date of application of this Regulation. This disease is now categorised for optional eradication in accordance with Implementing Regulation (EU) 2018/1882.

Union rules in place before the date of application of this Regulation contained well-established and effective principles and criteria for the recognition, maintenance, suspension and restoring of officially EBL-free status. Many Member States successfully applied these rules during the implementation of past EBL eradication programmes. The rules have been reviewed against the Terrestrial Code and included in this Regulation.

Member States or zones which have been free from EBL for several years and have therefore reached a steady animal health situation free of EBL, should continue to demonstrate the absence of infection. Risk-based surveillance is an appropriate means of ensuring early detection if the disease is reintroduced and of substantiating freedom from EBL. Member States should therefore establish a suitable surveillance system from the date of application of this Regulation.

Additional guarantees for intra-Union trade of pigs in relation to infection with Aujeszky’s disease virus (ADV) were part of Union rules in place before the date of application of this Regulation. A number of Member States have successfully applied those rules and eradicated infection with ADV in the pig population kept in their territory. The strategy for the eradication of infection with ADV in this Regulation takes account of the Terrestrial Code and of criteria that have proven successful in eradicating the infection with ADV.

The rules in this Regulation on infectious bovine rhinotracheitis/Infectious pustular vulvovaginitis (IBR/IPV) are based on Commission Decision 2004/558/EC (9) with provisions on additional guarantees for intra-Community trade of bovine animals. These include requirements to obtain, maintain and restore freedom at establishment level from bovine herpesvirus 1 (BoHV-1). The rules have been developed taking into consideration the standards of the Terrestrial Code and the EFSA scientific opinion (10).

Union rules in place before the date of application of this Regulation do not contain provisions for bovine viral diarrhoea (BVD) with the exception of provisions related to the trade of germinal products. In Implementing Regulation (EU) 2018/1882, BVD is now listed as a ‘category C disease’ for optional eradication. Therefore provisions on eradication programmes and the granting and maintenance of disease-free status with regard to BVD are laid down in this Regulation.

The Terrestrial Code lacks a chapter on BVD and criteria for BVD freedom and related animal movements. However, a chapter on BVD is available in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the OIE. These diagnostic standards have been considered for the provisions related to BVD in this Regulation.

Implementing Regulation (EU) 2018/1882 lists infection with the rabies virus as a category B disease. Therefore this Regulation includes provisions on compulsory eradication programmes and the granting and maintenance of disease-free status with regard to infection with the rabies virus.

Wild foxes constitute the main reservoir of infection with the rabies virus in the EU. It is therefore appropriate that the measures in eradication programmes are primarily focused on the wild fox population. However, all other mammal species are susceptible and many other animal species are listed in Implementing Regulation (EU) 2018/1882 for this disease. The competent authorities should address other animal populations in the eradication programmes when there is a risk to human or animal health.

For infection with rabies eradication programmes, the disease control strategy is primarily based on vaccination of the relevant targeted animal population, supported by other important activities such as surveillance, implementation of disease control measures, the control of pet movements and monitoring of the effectiveness of the vaccination. As the vaccination provisions are of a very technical nature, they are laid down in an annex.

Implementing Regulation (EU) 2018/1882 lists infection with bluetongue virus (serotypes 1-24) (infection with BTV) as a category C disease for optional eradication programme. This implies a change in the policy against this disease as Council Directive 2000/75/EC (11), applicable prior to this Regulation, provided for its immediate eradication. New provisions are laid down in this Regulation to address the new status of the disease.

For infection with BTV, the disease control strategy is primarily based on vaccination of the relevant targeted animal population supported by other activities such as surveillance, implementation of disease control measures, control of the movements of animals and germinal products, and minimising exposure to vectors.

In its opinion (12) on the control, surveillance and movement of animals in the case of infection with BTV, EFSA indicates that for eradication to succeed, vaccination coverage should be at least 95 % of susceptible bovine and ovine animals for a minimum period of 5 years. It is therefore expected that the eradication programmes for infection with BTV include a vaccination campaign, although flexibility should be provided for in this Regulation to take into account the specific circumstances of each case.

A Member State or zone thereof free from infection with BTV or under an eradication programme for infection with BTV should be protected from the introduction of any BTV serotypes by the movement of kept animals or germinal products. Therefore requirements for the introduction of kept animals or germinal products into Member States or zones thereof free from infection with BTV or under an eradication programme for infection with BTV should be part of the provisions on eradication programmes. This should also be reflected in the criteria for the maintenance of the disease-free status. The same principles should apply to movements of animals through the Member States or zones thereof free from infection with BTV or under an eradication programme for infection with BTV.

In addition, because of the diversity of the local situations that may prevail, the competent authority should have the possibility to allow the introduction of animals or germinal products based on ad hoc requirements, provided that such introduction does not jeopardise the health status at the destination. It is therefore appropriate that this Regulation provides for the requirements and conditions under which such introduction may be authorised. Such requirements should be based on the status of animals or germinal products, independently of the Member State or zone of origin.

An eradication programme for a category B or category C disease of aquatic animals should take account of the type of surveillance requirements required to obtain and maintain disease-free status, of details of the territory and the animal population to be covered by the programme; and of the programme’s intermediate and final targets. The eradication programme should include the control measures to be implemented in infected establishments of aquatic animals.

The eradication programme for aquatic animal diseases should include intermediate and final targets which will be used to assess progress towards achieving disease-free status. Where relevant, these targets should take account of the risk wild animals pose to the success of the eradication programme. In particular, any possibility of deviation from the proposed period of application of 6 years should be taken in to account when devising the programme’s intermediate and final targets.

In the case of aquatic animals, the population which is to be included in the eradication programme consists of those species which are listed in Implementing Regulation (EU) 2018/1882. However, the competent authority should have the possibility to exclude from the programme the species listed as a vector in Implementing Regulation (EU) 2018/1882 if it has carried out a risk assessment which has resulted in the risk posed by those animals being deemed negligible.

The competent authority should have the possibility to include additional aquatic animal populations when such animals pose a significant risk to the health status. It also should be able to exclude certain low-risk establishments from the eradication programme if their exclusion does not jeopardise its successful completion.

When a Member State has decided to participate in an eradication programme for a category C disease, operators are obliged to comply with conditions for introductions of animals of listed species, to notify suspicion of listed diseases, to comply with disease control measures when a disease is suspected or confirmed and to take any other measures that may be required by the competent authority, including vaccination.

When the presence of a listed disease of aquatic animals is suspected or confirmed in a disease-free Member State, zone or compartment, or in one which is subject to a eradication programme, the competent authority should take appropriate measures to control the disease. These rules should therefore be laid down in this Regulation. These include establishing a restricted zone when the presence of a listed disease has been confirmed in an establishment participating in the eradication programme or in an establishment which has been declared disease-free. This also includes the minimum requirements applying to geographical demarcation of a restricted zone and the factors affecting it.

Following the confirmation of a listed aquatic disease in a disease-free Member State, zone or compartment, or in one which is subject to a eradication programme, the competent authority carries out strict controls in infected establishments and in other establishments located in the restricted zone. The nature of the controls and the level of flexibility the competent authority applies to movements are set out in this Regulation. Where flexibility is applied, it is limited to circumstances where the health status of aquatic animals at the establishment of destination or enroute to that destination is not jeopardised.

Once an aquatic disease outbreak has occurred in an establishment and that establishment remains or commences an eradication programme, it is important to remove aquatic animals that are dead, moribund or showing clinical signs within a period set by the competent authority and in accordance with Regulation (EC) No 1069/2009 of the European Parliament and of the Council (13). In this way, the disease can be successfully controlled.

The Animal Health Law requires the Commission to develop detailed rules for the granting of disease-free status to Member States, zones and compartments. These rules should include disease-specific criteria to demonstrate the absence of the disease in the targeted animal population and the general criteria that support effective control of the health status of that targeted animal population.

The general criteria comprise the territorial scope, surveillance, biosecurity, disease control measures and consistent implementation of other operational rules set out in the Animal Health Law as regards the registration and approval of establishments, traceability of animals and movement requirements.

This Regulation lays down disease-specific criteria based on the absence of listed species or based on the disease agent or vector’s incapacity to survive. These criteria should be drawn up in a flexible way to allow the competent authority to justify the case for obtaining disease-free status based on the specific situation. Therefore general requirements are laid down in this Regulation to indicate on what basis Member States may request the granting of disease-free status for their entire territory or a zone thereof or, in the case of aquaculture animals, for compartments.

This Regulation lays down disease-specific criteria based on the outcome of eradication programme and on historical and surveillance data. These criteria are based on results of the surveillance, the implementation of measures to prevent introduction of the disease and conditions for the use of vaccines.

Because of their technical nature these criteria are laid down in annexes and grouped by disease with the criteria for maintaining the disease-free statuses.

It is appropriate that this Regulation lay down modernised requirements for the granting and maintenance of disease-free status taking account of the Union rules in place before the date of application of this Regulation, the Terrestrial Code, the Aquatic Animal Health Code of the OIE and, in the absence of existing provisions, the best available scientific evidence.

Implementing Regulation (EU) 2018/1882 lists infestation with Varroa spp. as a category C disease for optional eradication. This Regulation lays down provisions for achieving and maintaining infestation with Varroa spp.-free status.

Implementing Regulation (EU) 2018/1882 lists infection with Newcastle disease virus as a category A disease for immediate eradication measures. Therefore this Regulation does not contain provisions for an eradication programme for infection with Newcastle disease virus. However, it should be possible for the competent authority to grant the status free from infection with Newcastle disease virus without vaccination on the basis of historical and surveillance data.

Two different types of compartments are possible in the case of aquatic animals. Independent compartments operate under strictly defined conditions which ensure they operate independently of the health status of the surrounding waters. Dependent compartments on the other hand, are influenced by the health status of the surrounding waters and operate therefore, under more flexible conditions. Dependent compartments are however, only established once the competent authority has assessed a number of epidemiological factors and put in place whatever risk mitigating measures are necessary to prevent the introduction of disease into the compartment.

In the case of aquatic animals, and given the lower level of risk associated with individual establishments which are independent of the surrounding waters, special provisions are laid down in this Regulation for independent compartments when they commence aquaculture activities for the first time or when they recommence aquaculture activities after a break in production. In such cases, disease-free status should be declared immediately provided certain conditions are met. Provisions are also laid down for independent compartments where a disease outbreak has occurred. To ensure that such outbreaks have been successfully dealt with by the cleaning, disinfection and fallowing which have been carried out after de-population, a sample of the animals used to repopulate the compartment should be tested before disease-free status can be declared.

When conditions to maintain disease-free status are no longer fulfilled because of suspicion or confirmation of the disease, the competent authority should apply disease control measures. These measures should apply during the different steps of disease control from when an outbreak of the disease is suspected to when the event is resolved and the disease-free status restored.

If the competent authority detects a breach of the conditions required to maintain disease-free status in the Member State, zone or compartment, measures should be implemented to remedy the situation. The competent authority should have the option to suspend the disease-free status when it is still possible to satisfactorily resolve the breach and therefore not to have the disease-free status withdrawn by the Commission.

When a Member State wishes to obtain disease-free status for a listed aquatic disease for its entire territory or for a zone thereof accounting for more than 75 % of its territory, or which is shared with another Member State or third country, it will apply to the Commission for approval. In all other cases, a system of self-declaration is followed.

Self-declaration of freedom from aquatic animal diseases for zones and compartments other than those which are Commission-approved follows a system which is designed to give transparency to the process and which will make it easier and potentially quicker for Member States to declare disease-free status. The entire process will be completed electronically unless another Member State or the Commission indicate concerns which cannot be resolved satisfactorily. If there are concerns that cannot be resolved satisfactorily, the declaration is brought to the Standing Committee on Plants, Animals, Food and Feed.

This Regulation contains provisions on the approval of disease-free status of Member States or zones thereof. These rules may differ from the rules in force before the date of application of this Regulation. Appropriate transitional rules are needed to ensure a smooth transition from the existing regime on the approval of disease-free status to the new requirements.

With a view to the uniform application of Union legislation on surveillance, eradication programmes and disease-free status and to ensure that it is clear and transparent, Commission Decision 2000/428/EC (14), Commission Decision 2002/106/EC (15); Commission Decision 2003/422/EC (16), Commission Decision 2006/437/EC (17), Commission Regulation (EC) No 1266/2007 (18), Commission Decision 2008/896/EC (19) and Commission Implementing Decision (EU) 2015/1554 (20) should be repealed by this Regulation.

The Animal Health Law applies from 21 April 2021. Accordingly, the rules laid down in this Regulation should also apply from that date,

the design of the surveillance including the targeted animal population and the diagnostic methods;

the disease confirmation and the case definition;

Union surveillance programmes.

the disease control strategy, the territory, the animal populations, the targets and the period of application;

the obligations of operators and competent authorities;

the disease control measures in the event of suspicion and of confirmation.

the disease control strategy, the territory, the animal populations, the targets and the period of application;

the obligations of operators and competent authorities;

the disease control measures in the event of suspicion and of confirmation.

the criteria for the approval of the disease-free status of Member States and zones;

the criteria for the approval of the disease-free status for compartments keeping aquaculture animals;

the criteria for the maintenance of the disease-free status;

the suspension, the withdrawal and the restoration of disease-free status.

the approval of the disease-free status of Member States, zones and compartments which are recognised disease-free under the legislation in force before the date of application of this Regulation;

the approval of eradication programmes of Member States, zones and compartments which have an approved eradication or surveillance programme under the legislation in force before the date of application of this Regulation.

‘category E disease’: means a listed disease for which there is a need for surveillance within the Union, as referred to in point (e) of Article 9(1) of Regulation (EU) 2016/429;

‘targeted animal population’ means the population of animals of listed species defined by species and, as appropriate, by categories, relevant for the surveillance activities, the eradication programmes or the disease-free status of a specific disease;

‘additional animal population’ means the population of kept or wild animals of listed species subjected to optional prevention, surveillance and disease control measures necessary to achieve or maintain the disease-free status of a targeted animal population;

‘category A disease’: means a listed disease that does not normally occur in the Union and for which immediate eradication measures must be taken as soon as it is detected, as referred to in point (a) of Article 9(1) of Regulation (EU) 2016/429;

‘category B disease’: means a listed disease which must be controlled in all Member States with the goal of eradicating it throughout the Union, as referred to in point (b) of Article 9(1) of Regulation (EU) 2016/429;

‘category C disease’: means a listed disease which is of relevance to some Member States and for which measures are needed to prevent it from spreading to parts of the Union that are officially disease-free or that have eradication programmes for the listed disease concerned, as referred to in point (c) of Article 9(1) of Regulation (EU) 2016/429;

‘bovine animal’ or ‘animal of the bovine species’ means an animal of the species of ungulates belonging to the genera Bison, Bos (including the subgenera Bos, Bibos, Novibos, Poephagus) and Bubalus (including the subgenus Anoa) and the offspring of crossings of those species;

‘ovine animal’ or ‘animal of the ovine species’ means an animal of the species of ungulates belonging to the genus Ovis and the offspring of crossings of those species;

‘caprine animal’ or ‘animal of the caprine species’ means an animal of the species of ungulates belonging to the genus Capra and the offspring of crossings of those species;

‘travelling circus’ means an exhibition or fair that includes animals or animal acts which is intended to move between Member States;

‘animal acts’ means any act featuring animals kept for the purpose of an exhibition or fair, and which may form part of a circus;

‘porcine animal’ or ‘animal of the porcine species’ means an animal of the species of ungulates of family Suidae listed in Annex III to Regulation (EU) 2016/429;

‘means of transport’ means road or rail vehicles, vessels and aircrafts;

‘dog’ means a kept animal of the Canis lupus species;

‘cat’ means a kept animal of the Felis silvestris species;

‘ferret’ means a kept animal of the Mustela putorius furo species;

‘seasonally BTV-free area’ means the whole territory of a Member State or a zone thereof where the competent authority has established a temporary status of freedom from infection with bluetongue virus (serotype 1-24) (‘infection with BTV’) in accordance with Article 40(3) on the basis of a vector-free period and the demonstration of absence of the disease in listed animal species;

‘vector protected establishment’ means part or all facilities of an establishment that are protected against attacks from Culicoides by appropriate physical and management means, with a status of vector protected establishment being granted by the competent authority in accordance with Article 44;

‘well-boat’ means a vessel used by the aquaculture industry which has a well or tank for the storage and transport of live fish in water;

‘fallowing’ means, for disease management purposes, an operation where an establishment is emptied of aquaculture animals from listed species, and where feasible, of water;

‘eligibility period’ means the period of time before the competent authority submits the application for disease-free status or, when relevant, before the provisional declaration referred to in point (a) of Article 83(1) is published electronically;

‘non-listed species’, means an animal species or group of animal species not listed in the Annex to Commission Implementing Regulation (EU) 2018/1882 for a particular disease;

‘flock’ means all poultry or captive birds of the same health status kept on the same premises or in the same enclosure and constituting a single epidemiological unit; in housed poultry includes all birds sharing the same airspace;

‘DIVA (differentiating infected from vaccinated animals) vaccination’ means a vaccination using vaccines that enable in conjunction with appropriate serological diagnostic methods, the detection of infected animals in a vaccinated population;

‘DIVA vaccinated animals’ means animals that have been vaccinated in the framework of a DIVA vaccination;

‘approved germinal product establishment’ means a semen collection centre, an embryo collection team, an embryo production team, a germinal product processing establishment or a germinal product storage centre, approved in accordance with Article 97(1) of Regulation (EU) 2016/429;

‘semen’ means the ejaculate of an animal or animals, either in the unaltered state or prepared or diluted;

‘oocytes’ means the haploid stages of the ootidogenesis including secondary oocytes and ova;

‘embryo’ means the initial stage of development of an animal while it is capable of being transferred to a recipient dam;

‘vector-free period’ means in a defined area the period of inactivity of Culicoides determined in accordance with Section 5 of Chapter 1 of Part II of Annex V;

‘honeybees’ means animals of the Apis mellifera species;

‘breeding poultry’ means poultry 72 hours old or more, intended for the production of hatching eggs;

‘random annual surveillance’ means a surveillance consisting of at least one survey of a targeted animal population organised during the year for which probability-based sampling methods are used to select units to examine.

general surveillance requirements based on:

specific surveillance requirements:

general surveillance requirements based on:

specific surveillance requirements:

kept animals of listed species;

wild animals of listed species if:

they are moved to establishments in another Member State, zone or compartment; and

due to the number of animals or the frequency of the movements, the competent authority considers the animals to constitute a risk that might impair the health status of other kept animals in another Member State, zone or compartment, should a disease emerge in that species.

Union surveillance programmes;

compulsory or optional eradication programmes or surveillance necessary for the granting or maintenance of a disease-free status; or

surveillance-based animal health requirements for the movements within the Union or the entry into the Union.

with the specific legislation adopted in accordance with Regulation (EU) 2016/429 and the relevant details and guidance made available on the websites of the European Union Reference Laboratories (EURL) and of the Commission;

when not covered by the legislation, details and guidance referred to in point (a), with the collection of samples, the techniques, validation and interpretation of the diagnostic methods laid down in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE) (‘the Terrestrial Manual’ (21) as amended or the Manual of Diagnostic Tests for Aquatic Animals of the OIE (‘the Aquatic Manual’ (22) as amended;

when not covered by points (a) and (b) of this paragraph, with the methods laid down in point (b) of Article 34(2) and Article 34(3) of Regulation (EU) 2017/625.

Section 1 of Annex III for infection with Brucella abortus, B. melitensis and B.suis;

Section 2 of Annex III for infection with Mycobacterium tuberculosis complex (Mycobacterium bovis, M.caprae and M. tuberculosis) (MTBC);

Section 3 of Annex III for enzootic bovine leukosis (EBL);

Section 4 of Annex III for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV);

Section 5 of Annex III for infection with Aujeszky’s disease virus (ADV);

Section 6 of Annex III for bovine viral diarrhoea (BVD);

point 2 of Section 5 of Chapter 1 of Part II of Annex VI for viral haemorrhagic septicaemia (VHS);

point 2 of Section 5 of Chapter 1 of Part II of Annex VI for infectious haematopoietic necrosis (IHN);

point 2 of Section 5 of Chapter 2 of Part II of Annex VI for infection with highly polymorphic region deleted infectious salmon anaemia virus (HPR-deleted ISAV);

point 2 of Section 5 of Chapter 3 of Part II of Annex VI for infection with Marteilia refringens;

point 2 of Section 5 of Chapter 4 of Part II of Annex VI for infection with Bonamia exitiosa;

point 2 of Section 5 of Chapter 5 of Part II of Annex VI for infection with Bonamia ostreae;

point 2 of Section 5 of Chapter 6 of Part II of Annex VI for infection with white spot syndrome virus (WSSV).

ante-mortem and post-mortem inspections;

inspections at border control posts;

official controls and other official activities at markets and assembly operations;

official controls and other official activities during transport of live animals;

public health related inspections and sampling in establishments;

any other official controls during which establishments, animals or samples are inspected or examined.

immediately in case of a category A disease or of an emerging disease;

without delay for other diseases.

there is a need to determine the health status of the Member State, zone or compartment thereof; or

there is a need to collect necessary information on the occurrence of the disease for any of the following purposes:

clinical, post-mortem or laboratory examinations conclude that clinical sign(s), post-mortem lesion(s) or histological findings are indicative of that disease;

result(s) from a diagnostic method are indicating the likely presence of the disease in a sample from an animal or from a group of animals; or

an epidemiological link with a confirmed case has been established.

the disease agent, excluding vaccine strains, has been isolated in a sample from an animal or from a group of animals;

an antigen or nucleic acid specific to the disease agent that is not a consequence of vaccination has been identified in a sample from an animal or from a group of animals showing clinical signs consistent with the disease or an epidemiological link with a suspected or confirmed case; or

a positive result from an indirect diagnostic method that is not a consequence of vaccination has been obtained in a sample from an animal or from a group of animals showing clinical signs consistent with the disease or an epidemiological link with a suspected or confirmed case.

it poses a particular threat to animal and possibly human health on the whole Union territory with possible serious economic consequences for the farming community and the wider economy;

it is susceptible to an evolution of the disease profile, in particular with regard to the risk for human health and animal health;

infected wild animals pose a particular threat for the introduction of the disease into a part or the whole of the Union territory;

it is fundamental to obtain, through surveillance, regularly updated information on the evolution of its circulation and on the characterisation of the disease agent, to assess those risks and adapt risk mitigating measures accordingly.

description of the epidemiological situation of the disease before the date of the beginning of the implementation of the programme and data on the epidemiological evolution of the disease;

targeted animal population, epidemiological units and zones of the programme;

organisation of the competent authority, supervision of the implementation of the programme, official controls to be applied during the implementation of the programme and the role of all relevant operators, animal health professionals, veterinarians, animal health laboratories and other natural or legal persons concerned;

description and demarcation of the geographical and administrative areas in which the programme is to be implemented;

indicators to measure the progress of the programme;

diagnostic methods used, number of samples tested, frequency of testing and sampling patterns;

risk factors to be considered for the design of a risk-based targeted surveillance.

the description of the measures implemented and the results obtained based on the information referred to in point (b) and points (d) to (f) of paragraph 1; and

the results of the follow-up of the epidemiological evolution of the disease in case of a suspected or confirmed case.

the territory and animal population covered by the eradication programme as provided for in Article 13(1);

the duration of the eradication programme as provided for in Article 15, including its final and intermediate targets as provided for in Article 14; and

the disease specific requirements laid down:

the territory covered; and

the targeted animal population and, as necessary, additional animal populations.

the entire territory of the Member State; or

one or several zones, provided that each zone corresponds to administrative unit(s) of at least 2 000 km2 and includes at least one of the regions established in accordance with Article 21 of Regulation (EU) 2016/429.

a minimum surface not significantly lower than 2 000 km2; or

the existence of natural barriers relevant to the disease profile.

all of the disease specific requirements referred to in paragraph 1; and

if necessary, additional requirements that are not included in the criteria for granting disease-free status to assess progress towards eradication.

infection with Brucella abortus, B. melitensis and B. suis;

infection with MTBC;

EBL;

IBR/IPV;

infection with ADV;

BVD.

the implementation of disease specific measures laid down in Articles 18 to 31 until all relevant establishments reach disease-free status;

the granting, suspension and withdrawal by the competent authority of the disease-free status of all relevant establishments;

the implementation of biosecurity and other risk mitigating measures;

the optional implementation of vaccination programmes.

for infection with Brucella abortus, B. melitensis and B. suis, kept bovine animals, kept ovine animals and kept caprine animals;

for infection with MTBC, kept bovine animals.

for EBL, kept bovine animals;

for IBR/IPV, kept bovine animals;

for infection with ADV, kept porcine animals;

for BVD, kept bovine animals.

general requirements:

disease specific requirements laid down in:

confined establishments;

establishments where animals are only kept for assembly operations;

establishments where animals are only kept for the purpose of animal acts;

travelling circuses.

Sections 3 and 4 of Chapters 1 and 2 of Part I of Annex IV for infection with Brucella abortus, B. melitensis and B. suis;

Sections 3 and 4 of Chapter 1 of Part II of Annex IV for infection with MTBC;

Sections 3 and 4 of Chapter 1 of Part III of Annex IV for EBL;

Sections 3 and 4 of Chapter 1 of Part IV of Annex IV for IBR/IPV;

Sections 3 and 4 of Chapter 1 of Part V of Annex IV for infection with ADV;

Sections 3 and 4 of Chapter 1 of Part VI of Annex IV for BVD.

the details of the testing regime, including as necessary, the disease specific requirements referred to in point (b) of Article 18(1) when the disease-free status is suspended or withdrawn; and

the maximum period of time during which disease-free status may be suspended where there is a breach of the conditions referred to in paragraph 2.

has submitted for the consideration of the competent authority the information about the different epidemiological units established within the establishment to be granted distinct health status prior to any suspicion or confirmation of the disease in accordance with Articles 21 and 24;

has set up a system, to which the competent authority has access upon request, to trace the movements of animals and germinal products to, from and between the epidemiological units; and

has separated the epidemiological units by physical and management means and complies with any risk mitigating measures requested by the competent authority for that purpose.

shall prohibit movement of animals from the relevant targeted animal population out of the establishment unless it has authorised their immediate slaughter in a designated slaughterhouse;

shall, when it considers it necessary for the control of the risk of spreading the disease:

relevant additional animal populations kept in the establishment;

any establishment which has an epidemiological link with the establishment where the suspected case occurred.

the animals shall only be moved by direct transport;

in the establishment of destination, the animals shall be kept in closed facilities, with no contact with kept animals of a higher health status or with wild animals of listed species for the relevant disease.

suspend the disease-free status of the establishment of destination of the animals that are subject to the derogations, until the end of the investigations referred to in Article 21(1);

prohibit, until the end of the investigations referred to in Article 21(1), the movement of animals from that establishment, unless it has authorised their direct transport to a designated slaughterhouse for immediate slaughter;

in case of suspicion of infection with Brucella abortus, B. melitensis and B. suis or with MTBC, maintain the prohibition laid down in point (b) after the end of the investigation until all the animals that moved in the establishment following the derogation laid down in paragraph 2 have been slaughtered.

apply appropriate biosecurity and other risk mitigating measures necessary to prevent the spread of the disease; and

provide the competent authority with guarantees that all the necessary biosecurity and other risk mitigating measures have been taken.

withdraw the disease-free status of the infected establishment(s);

adopt the measures laid down in Articles 25 to 31 in the infected establishment(s).

order relevant disease control measures as provided for in Articles 21 to 25 and in Article 30 in establishments keeping the targeted animal population and the additional animal populations;

conduct or order other proportionate and necessary prevention, surveillance and disease control measures with respect to the relevant wild animal population or in its habitat.

conduct an epidemiological enquiry;

conduct investigations and apply the measures laid down in Article 21 in all epidemiologically linked establishments; and

adapt the surveillance to the identified risk factors, taking into account the conclusions of the epidemiological enquiry.

operators and relevant authorities from the Member States concerned by the epidemiological links with the confirmed case; and

the competent authorities from other Member States or third countries that may be concerned by the epidemiological links with the infected establishment(s).

order the isolation of the suspected and confirmed cases in the establishment where technically possible;

restrict the movements of animals from targeted animal population within the establishment;

restrict the introduction of animals from targeted animal population in the establishment;

restrict the movement of products of animals from targeted animal population from and to the infected establishment.

testing of those animals whose testing is considered necessary to complete the epidemiological enquiry;

testing to restore the disease-free status as laid down in:

any additional testing it considers necessary to ensure the swift detection of infected animals that may contribute to the spreading of the disease.

point 2 of Section 1 of Chapters 1 and 2 of Part I of Annex IV for infection with Brucella abortus, B. melitensis and B. suis;

point 2 of Section 1 of Chapter 1 of Part II of Annex IV for infection with MTBC;

point 2 of Section 1 of Chapter 1 of Part III of Annex IV for EBL;

point 2 of Section 1 of Chapter 1 of Part IV of Annex IV for IBR/IPV;

point 2 of Section 1 of Chapter 1 of Part V of Annex IV for infection with ADV;

point 2 of Section 1 of Chapter 1 of Part VI of Annex IV for BVD.

milk from confirmed cases shall either be fed only to animals in the same establishment after it has been processed to ensure the inactivation of the disease agent, or it shall be disposed of;

manure, straw, feed or any other matter and substance which has come into contact with a confirmed case or with contaminated material shall be either collected and disposed of as soon as possible or, following an appropriate risk assessment, stored and processed to reduce to an acceptable level the risk of spreading of the disease.

the movement does not jeopardise the health status of animals at the establishment of destination or enroute to that destination;

the animals shall only be moved by direct transport; and

in the establishment of destination, the animals shall be kept, in closed facilities, with no contact with kept animals of a higher health status or with wild animals of listed species for the relevant disease.

they are moved, if necessary by direct transport, to an establishment located in an area that is neither disease-free nor covered by an optional eradication programme; and

the movement does not jeopardise the health status of targeted or additional animal populations at the establishment of destination or enroute to that destination.

order the movement of the animals by direct transport, within a maximum period of time it determines, from the establishment of destination to a designated slaughterhouse for immediate slaughter; or

in case of a category C disease order the disease control measures laid down in Articles 26 to 30 until the disease-free status of the establishment is regained.

apply appropriate biosecurity and other risk mitigating measures necessary to prevent the spread of the disease; and

provide the competent authority with the guarantees that all the necessary biosecurity and other risk mitigating measures have been taken.

all parts of the establishments that may have been contaminated after the removal of the confirmed and suspected cases and before repopulation;

any feed, materials, substances, husbandry related equipment, medicinal equipment and production related equipment that may have been contaminated;

any protective clothing or safety equipment used by operators and visitors;

all means of transport, containers and equipment after the transport of animals or products from infected establishments;

loading areas for animals after each use.

persistence of the disease agent in the environment or in wild animals; and

biosecurity measures that are adapted to the specificities of the establishment.

vaccination of the animals from the targeted animal population that it considers relevant;

implementation of measures to reduce the risk of contact with infected animals;

control of the risk of spread and introduction of the disease in the territory of its Member State.

based on a risk assessment, updated, as necessary, according to the evolution of the epidemiological situation;

supported by public information campaigns involving all relevant stakeholders;

coordinated, if necessary, with relevant authorities in charge of public health, wild animal populations or hunting;

scaled according to a territorial risk-based approach.

conduct surveillance of infection with RABV for the purposes of:

carry out disease control measures in the event of suspicion or confirmation of infection with RABV as laid down in Articles 35 and 36;

apply, if necessary, risk mitigating measures to prevent the spread of RABV by movements of dogs, cats and ferrets.

vaccination, and the monitoring of the effectiveness of vaccination, in accordance with Section 2 of Chapter 1 of Part I of Annex V of wild foxes and, if relevant, of other animals referred to in Article 33(3);

the identification and registration of dogs, cats and ferrets;

movement restrictions of relevant kept animals of species referred to in Article 33(3) that are not vaccinated against infection with RABV in accordance with Section 1 of Chapter 1 of Part I of Annex V;

the measures provided for in Article 35 when an animal of a listed species wounded a person or an animal without an understandable reason and in contradiction with its normal behaviour or presented an unexplained change in behaviour followed by death within 10 days.

conduct further investigations to confirm or rule out the presence of the disease;

order relevant movement restrictions or killing of suspected cases to protect humans and animals against the risk of being infected pending the results of the investigations;

order any risk mitigating measures justified to reduce the risk of further transmission of RABV to humans or to animals.

it shall conduct an epidemiological enquiry, which shall include the identification of the RABV strain involved, to identify the likely source of the infection and epidemiological links;

it shall, unless it considers further investigations are necessary, rule out an infection with RABV in animals with an epidemiological link when:

it shall, when it considers it necessary, take one or more of the measures laid down in Articles 34 and 35;

it shall ensure that carcasses of confirmed cases of infected wild animals are disposed of or processed in accordance with the rules laid down in Article 12 of Regulation (EC) No 1069/2009.

surveillance of infection with BTV in accordance with the requirements set out in Chapter 1 of Part II of Annex V;

vaccination of the relevant targeted animal population for eradicating the disease by means of regular vaccination campaigns to be implemented, as relevant, in accordance with a long-term strategy;

movement restrictions of the targeted animal population in accordance with the requirements laid down in Articles 43 and 45;

risk mitigating measures to minimise transmission of infection with BTV through vectors.

it shall detect and eradicate all the serotypes 1-24 present in the territory covered by the eradication programme;

the territory covered by the eradication programme shall be:

the geographical situation of the infected establishment(s) and the boundaries of the corresponding administrative units;

the ecological and meteorological conditions;

the abundance, activity and distribution of the vectors present in the zone(s);

the BTV serotype involved;

the results of the epidemiological enquiry provided for in Article 42;

the results of the surveillance activities.

comply with the requirements ordered by the competent authority as regards the surveillance of animals from the targeted animal population;

comply with the requirements ordered by the competent authority as regards the entomological surveillance;

have animals from the targeted animal population vaccinated following the orders of the competent authority;

implement disease control measures in the event the disease is suspected or confirmed following the orders of the competent authority;

comply with movement requirements following the orders of the competent authority;

implement any additional measures considered necessary by the competent authority which may include, if relevant, protection of kept animals from attacks by vectors in accordance with the animals’ health status.

comply with the requirements ordered by the competent authority as regards the surveillance of animals from the targeted animal population;

implement disease control measures in the event the disease is suspected or confirmed following the orders of the competent authority;

implement any additional measures considered necessary by the competent authority which may include, if relevant, protection of kept animals from attacks by vectors in accordance with the animals’ health status.

map the territory covered in a set of geographical units in accordance with point 1 of Section 4 of Chapter 1 of Part II of Annex V;

conduct surveillance of infection with BTV in each geographical unit, as relevant with regard to the epidemiological situation, according to the requirements laid down in Chapter 1 of Part II of Annex V;

apply the disease control measures laid down in Articles 41 and 42 in the event of suspicion or confirmation of the disease;

order operators of establishments of bovine, ovine or caprine animals and, if necessary, other targeted animal populations to have their animals vaccinated; and

apply the requirements laid down in Articles 43 and 45 to the movements of animals from the targeted animal population.

information demonstrating the fulfilment of the specific criteria for determining the seasonally BTV-free period;

the start and end dates of the period;

information demonstrating the cessation of the transmission of BTV in the area; and

the delimitation of the area which complies with the minimum requirements laid down in Article 13.

restrict movement of animals and germinal products from the targeted animal population from the establishment where they are kept unless authorised for the purpose of immediate slaughter;

order relevant risk mitigating measures, when necessary and technically feasible, to prevent or reduce exposure of animals from the targeted animal population to attacks by vectors.

confirm the outbreak and, if necessary, establish or extend the zone under eradication programme;

conduct an epidemiological enquiry, if necessary;

restrict movement of animals of the targeted animal population from the establishment where they are kept unless authorised for the purpose of immediate slaughter;

restrict movement of germinal products of animals from the targeted animal population from the establishment where they are kept;

order relevant risk mitigating measures, when it considers it necessary and technically feasible, to prevent or reduce exposure of animals from the targeted animal population to attacks by vectors;

apply the disease control measures provided for in Article 41 to all establishments having an epidemiological link with the confirmed case, including those keeping animals from the targeted animal population having a similar exposure to infectious vectors to that of the confirmed case.

order operators of establishments of bovine, ovine or caprine animals and, if necessary, other targeted animal populations to have their animals vaccinated against the infection with the relevant BTV serotype(s) as provided for in point (d) of Article 40(1);

investigate and monitor the health status of the targeted animal population in the proximity of the establishment where the confirmed case is kept.

it has assessed the risk that the introduction poses to the health status of the place of destination as regards infection with BTV, taking into account possible risk mitigating measures it may adopt at the place of destination;

it prohibits the movement of these animals to another Member State:

it adapts, if necessary, the surveillance in accordance with point 6 of Section 4 of Chapter 1 of Part II of Annex V; and

the animals comply with any one of the requirements set out in points 5 to 8 of Section 1 of Chapter 2 of Part II of Annex V.

it has assessed the risk that the introduction poses to the health status of the place of destination as regards infection with BTV, taking into account possible risk mitigating measures it may adopt at the place of destination;

it prohibits the movement of these germinal products to another Member State; and

the germinal products comply with the requirements set out in point 4 of Section 2 of Chapter 2 of Part II of Annex V.

inform the Commission thereof as soon as possible;

accept animals or germinal products from the targeted animal population that comply with the requirements for the relevant derogation regardless of the Member State or zone of origin of the animal or germinal products.

the animals from the targeted animal population comply with at least one of the requirements set out in points 1 to 3 of Section 1 of Chapter 2 of Part II of Annex V; or

the means of transport onto which the animals are loaded have been protected from attacks by vectors and the journey does not include the unloading of the animals for a period longer than 1 day, or the animals are unloaded for a period longer than 1 day in a vector protected establishment or during the vector-free period.

the type of surveillance requirements necessary to achieve the conditions for granting and maintaining disease-free status taking into account point (b)(ii) of Article 3(2);

the territory and animal population covered by the eradication programme as provided for in Articles 47 and 51;

the duration of the eradication programme provided for in Article 49 including its final and intermediate targets as provided for in Article 48;

the disease specific preventive and control measures laid down in Articles 55 to 65.

the territory covered; and

the targeted animal population and, if necessary, additional animal populations.

the entire territory of the Member State;

one or several zones; or

the geographical location of the establishments of which the compartment or compartments are comprised.

all of the disease specific requirements referred to in paragraph 1 and the targets provided for in paragraph 2; and

if necessary, additional requirements that are not included in the requirements for granting disease-free status to assess progress towards eradication.

Chapter 1 for VHS and IHN;

Chapter 2 for infection with HPR-deleted ISAV;

Chapter 3 for infection with Marteilia refringens;

Chapter 4 for infection with Bonamia exitiosa;

Chapter 5 for infection with Bonamia ostreae;

Chapter 6 for infection with WSSV.

the determination of the health status of the Member State, zone or compartment by ascertaining the health status of all establishments where animals from the listed species are kept;

the implementation of disease control measures in all establishments where suspected and confirmed cases are detected;

the implementation of biosecurity and other risk mitigating measures to reduce the risk of the listed species in an establishment becoming infected;

in certain cases, vaccination, as part of the eradication programme.

pose a significant risk to the health status of animals referred to in paragraph 1;

are included due to the small number of aquaculture establishments in the eradication programme and when their inclusion is necessary to obtain a satisfactory epidemiological coverage of the Member State, zone or compartment.

the health status of each establishment as known at the time the eradication programme commences;

the compliance with conditions for the introduction of animals from listed species into the establishment;

the compliance by the operator with the obligation to notify the competent authority of any suspicion or detection of the disease;

the fulfilment of disease control measures to be applied if the disease is suspected or confirmed;

the vaccination regimes that may apply to animals from listed species kept in the establishment;

any additional measures considered necessary by the competent authority.

commence, maintain, or withdraw the eradication programme according to the compliance or non-compliance of establishments with the requirements laid down in paragraph 1;

inform the operators of the relevant establishments about the evolution of the health status and the necessary measures for granting disease-free status.

vaccination of listed species;

vaccination of an additional animal population of kept animals;

vaccination of an additional animal population of wild animals.

prohibit the introduction of animals or products of animal origin into the establishment;

where technically possible, order the isolation of units in the establishment where suspected animals are kept;

prohibit the movement of animals and products of animal origin out of the establishment unless authorised by the competent authority for the purpose of immediate slaughter or processing in a disease control aquatic food establishment, or for direct human consumption in the case of molluscs or crustacea which are sold live for that purpose;

prohibit the movement of equipment, feed and animal by-products from the establishment unless authorised by the competent authority.

any establishment which due to hydrodynamic conditions, has an increased risk of contracting the disease from the suspected establishment;

any establishment which has a direct epidemiological link with the suspected establishment.

only animals showing no symptoms of disease are moved;

the health status of aquaculture animals at the establishment of destination or aquatic animals enroute to that establishment is not jeopardised by the movement;

in the establishment of destination they have no contact with aquaculture animals of a higher health status with respect to the relevant disease; and

the animals are kept in the establishment of destination for a maximum period of time to be determined by the competent authority.

re-classify the health status of the establishment of destination, if relevant, in accordance with the criteria laid down in Article 52(1), until the end of the investigation referred to in Article 55(1);

prohibit the movement of animals from the establishment of destination until the end of the investigation, unless it has authorised their transport to a disease control aquatic food establishment for immediate slaughter or processing or for direct human consumption, in the case of molluscs or crustacea which are sold live for that purpose.

apply appropriate biosecurity and other risk mitigating measures necessary to prevent the spread of the disease;

provide the competent authority with guarantees that all the necessary biosecurity and other risk mitigating measures have been taken; and

provide the competent authority with guarantees that animal by-products as defined in point (1) of Article 3 of Regulation (EC) No 1069/2009 from the aquatic animals referred to in paragraph 1(c) of this Article are processed or disposed of as Category 1 or Category 2 material in accordance with Articles 12 or 13 of that Regulation.

declare the establishment(s) infected;

reclassify the health status of the infected establishment(s);

establish a restricted zone which is of an appropriate size;

adopt the measures laid down in Articles 59 to 65 in the infected establishment(s).

point 1(a) of Section 3 of Chapter 1 for VHS and IHN;

point 1(a) of Section 3 of Chapter 2 for infection with HPR-deleted ISAV;

point 1(a) of Section 3 of Chapter 3 for infection with Marteilia refringens;

point 1(a) of Section 3 of Chapter 4 for infection with Bonamia exitiosa;

point 1(a) of Section 3 of Chapter 5 for infection with Bonamia ostreae;

point 1(a) of Section 3 of Chapter 6 for infection with WSSV.

when an infected establishment does not discharge untreated effluent into surrounding waters; and

where the biosecurity measures which exist at the establishment are of a standard which ensures that infection is fully contained within it.

the movement of well-boats through the restricted zone;

fishing activities;

other activities that may pose a risk of disease spread.

develop and implement the prevention, surveillance and disease control measures that are necessary to prevent the spread of the disease to kept animals of listed species or to additional animal populations;

apply intensified surveillance of wild aquatic animal populations and in establishments having a direct epidemiological link with the confirmed case;

take measures to eradicate the disease from the relevant wild aquatic animal population, where feasible.

conduct an epidemiological enquiry;

conduct investigations and apply the measures laid down in Article 55(2) in all epidemiologically linked establishments;

adapt the surveillance to the identified risk factors, taking into account the conclusions of the epidemiological enquiry.

operators and relevant authorities from the Member State concerned by the epidemiological links with the confirmed case; and

the competent authorities from other Member States or third countries that may be concerned by the epidemiological links with the infected establishment(s).

where technically possible, order the isolation of suspected and confirmed cases;

prohibit the movement of animals or products of animal origin from the listed species for the relevant disease out of the establishment(s) unless authorised by the competent authority for immediate slaughter or processing in a disease control aquatic food establishment or for direct human consumption in the case of molluscs or crustacea which are sold live for that purpose;

prohibit the introduction of animals from the listed species for the relevant disease to the establishment(s) unless authorised by the competent authority on duly justified grounds;

prohibit the movement of equipment, feed and animal by-products from the establishment(s) unless authorised by the competent authority.

only animals showing no symptoms of disease are moved;

the health status of aquaculture animals at the establishment of destination or aquatic animals enroute to that establishment is not jeopardised by the movement;

in the establishment of destination they have no contact with aquaculture animals of a higher health status with respect to the relevant disease;

the animals are kept in the establishment of destination for a maximum period of time to be determined by the competent authority.

re-classify the health status of the establishment of destination, if relevant, in accordance with the criteria laid down in Article 52(1);

prohibit the movement of animals from the establishment of destination, unless it has authorised their transport to a disease control aquatic food establishment for immediate slaughter or processing or for direct human consumption, in the case of molluscs or crustacea which are sold live for that purpose. In all cases, animal by- products as defined in point (1) of Article 3 of Regulation (EC) No 1069/2009 shall be processed or disposed of as Category 1 or Category 2 material in accordance with Articles 12 or 13 of that Regulation.

keep the establishment of destination under its official supervision until the completion of cleaning, disinfection and appropriate fallowing of the establishment.

only animals showing no symptoms of disease are moved;

the health status of aquaculture animals at the establishment of destination or aquatic animals enroute to that establishment is not jeopardised by the movement; and

the movement complies with the certification requirements set out in Article 208(2) of Regulation (EU) 2016/429.

only animals showing no symptoms of disease are moved;

the slaughtering and processing facility is not located in a Member State, zone or compartment which is implementing an eradication programme for that specific disease or which has been declared disease-free;

the health status of aquatic animals enroute for the slaughtering and processing facility or in its vicinity is not jeopardised by the movement;

the movement complies with the certification requirements set out in Article 208(2) of Regulation (EU) 2016/429.

a risk assessment has been completed;

risk mitigating measures are implemented, where necessary, to ensure that the health status of the aquatic animals at the establishment of destination or enroute to that destination is not jeopardised; and

the movement complies with the certification requirements set out in Article 208(2) of Regulation (EU) 2016/429.

removal of all dead animals;

removal and killing of all moribund animals;

removal and killing of all animals showing symptoms of disease;

slaughtering for human consumption, or in the case of molluscs or crustacea which are sold live, removal from the water of the animals that remain at the establishment(s) after the measures in points (a) to (c) have been completed.

all animals from listed species for the relevant disease in the infected establishment(s), without testing these animals;

suspected animals which have an epidemiological link with a confirmed case.

the establishments, in so far as this is technically possible, after the removal of the animals referred to in Article 62(1) and of all feed that may have been contaminated;

any husbandry related equipment including but not limited to feeding, grading, treatment and vaccination equipment, and workboats;

any production related equipment including but not limited to cages, netting, trestles, bags and longlines;

any protective clothing or safety equipment used by operators and visitors;

all means of transport including tanks and other equipment used to move infected animals or personnel who have been in contact with infected animals.

point 1(c) of Section 3 of Chapter 1 for VHS and IHN;

point 1(c) of Section 3 of Chapter 2 for infection with HPR-deleted ISAV;

point 1(c) of Section 3 of Chapter 3 for infection with Marteilia refringens;

point 1(c) of Section 3 of Chapter 4 for infection with Bonamia exitiosa;

point 1(c) of Section 3 of Chapter 5 for infection with Bonamia ostreae;

point 1(c) of Section 3 of Chapter 6 for infection with WSSV.

point 1 of Section 3 of Chapter 1 for VHS and IHN;

point 1 of Section 3 of Chapter 2 for infection with HPR-deleted ISAV;

point 1 of Section 3 of Chapter 3 for infection with Marteilia refringens;

point 1 of Section 3 of Chapter 4 for infection with Bonamia exitiosa;

point 1 of Section 3 of Chapter 5 for infection with Bonamia ostreae;

point 1 of Section 3 of Chapter 6 for infection with WSSV.

persistence of the disease agent in the environment or in wild animals;

biosecurity measures that are adapted to the specificities of the establishment.

general criteria:

specific criteria for granting disease-free status based on Articles 67 to 71.

the general criteria laid down in point (a)(i) and (a)(ii) of Article 66 have been fulfilled for an eligibility period of at least 5 years and the disease was not detected; and

the listed species relevant to the disease in question are absent from kept and wild animal populations.

the likelihood of the presence of animals from listed species in the Member State’s territory or a zone thereof was assessed and was found to be negligible; and

the likelihood of introduction of animals from listed species into the Member State’s territory or a zone thereof was found to be negligible.

the general criteria laid down in points (a)(i) and (a)(ii) of Article 66 have been fulfilled for an eligibility period of at least 5 years and the disease was not detected;

the disease has never been reported or, if reported, it has been demonstrated that the disease agent did not survive;

the value of at least one critical environmental parameter that is not compatible with the survival of the disease agent is reached;

the disease agent is exposed to that critical environmental parameter for a period of time that is sufficient to destroy it.

with respect to the fulfilment of the criteria set out in points (a) and (b) of paragraph 1, documentary evidence;

with respect to the fulfilment of the criteria set out in points (c) and (d) of paragraph 1, scientific evidence.

the general criteria laid down in points (a)(i) and (a)(ii) of Article 66 have been fulfilled for an eligibility period of at least 5 years and the disease was not detected;

the disease has never been reported, or, if reported, it has been demonstrated that the disease agent has not been transmitted;

the transmission of the disease agent is entirely dependent on the presence of listed vectors and no other mode of natural transmission is known to occur;

the listed vectors are not naturally present in the Member State or zones thereof;

the accidental or intentional introduction of listed vectors is unlikely to have occurred in the past or to occur in the future;

the value of at least one critical environmental parameter that is not compatible with the survival of the listed vectors is reached;

the listed vectors are exposed to that critical environmental parameter for a period of time that is sufficient to destroy it.

with respect to the fulfilment of the criteria set out in points (a) and (b) of paragraph 1, documentary evidence;

with respect to the fulfilment of the criteria set out in points (c) to (g) of paragraph 1, scientific evidence.

the disease has never been reported in the Member State or in the zone thereof or it has been eradicated in the Member State or the zone thereof and not reported for at least 25 years;

the disease has been reported in the past 25 years, it has been eradicated from the Member State or zone thereof and the disease specific requirements referred to in Article 72 are complied with.

disease surveillance of kept animals of listed species;

prevention to control the introduction of the disease agent;

ban on vaccination against the disease unless it is compliant with the disease specific requirements referred to in Article 72;

disease surveillance substantiating the fact that the disease is not known to be established in wild animals from listed species within the Member State or zone.

infection with RABV, if it was notifiable in accordance with Article 8 of Directive 64/432/EEC and, when necessary monitoring was implemented in accordance with Article 4 of Directive 2003/99/EC (23) of the European Parliament and of the Council, and no case was reported in listed animals species for the past two years;

infection with BTV, if all restricted zones have been lifted in accordance with Article 6 of Regulation (EC) No 1266/2007 before the date of application of this Regulation.

in a new Member State, during a maximum period of two years following its accession to the Union; or

for a maximum period of two years following the date of application of the implementing acts adopted in accordance with Article 9(2) of Regulation (EU) 2016/429 that categorise for the first time the relevant disease as a category B or C disease.

status free from infestation with Varroa spp.;

status free from infection with Newcastle disease virus without vaccination.

infection with Brucella abortus, B. melitensis and B. suis;

infection with MTBC;

EBL;

IBR/IPV;

infection with ADV;

VHS;

IHN;

infection with HPR-deleted ISAV;

infection with Bonamia ostreae;

infection with Marteilia refringens.

the competent authority has been running an approved eradication programme as referred to in Articles 12 or 46; and

the competent authority has completed the eradication programme and submitted to the Commission an application for recognition of disease-free status that demonstrates that the disease specific requirements laid down in Article 72 are complied with.

Section 1 of Chapter 3 of Part I of Annex IV for status free from infection with Brucella abortus, B. melitensis and B. suis in kept bovine animals and Section 1 of Chapter 4 of Part I of Annex IV for status free from infection with Brucella abortus, B. melitensis and B. suis in kept ovine and caprine animals;

Section 1 of Chapter 2 of Part II of Annex IV for status free from infection with MTBC;

Section 1 of Chapter 2 of Part III of Annex IV for status free from EBL;

Section 1 of Chapter 2 of Part IV of Annex IV for status free from IBR/IPV;

Section 1 of Chapter 2 of Part V of Annex IV for status free from infection with ADV;

Section 1 of Chapter 2 of Part VI of Annex IV for status free from BVD;

Section 1 of Chapter 2 of Part I of Annex V for status free from infection with RABV;

Section 1 of Chapter 4 of Part II of Annex V for status free from infection with BTV;

Section 1 of Part III of Annex V for status free from infestation with Varroa spp.;

Section 1 of part IV of Annex V for status free from infection with Newcastle disease virus without vaccination;

Section 2 of Chapter 1 of Part II of Annex VI for status free from VHS;

Section 2 of Chapter 1 of Part II of Annex VI for status free from IHN;

Section 2 of Chapter 2 of Part II of Annex VI for status free from infection with HPR-deleted ISAV;

Section 2 of Chapter 3 of Part II of Annex VI for status free from infection with Marteilia refringens;

Section 2 of Chapter 4 of Part II of Annex VI for status free from infection with Bonamia exitiosa;

Section 2 of Chapter 5 of Part II of Annex VI for status free from infection with Bonamia ostreae;

Section 2 of Chapter 6 of Part II of Annex VI for status free from infection with WSSV.

general criteria:

specific criteria for granting disease-free status based on the provisions of Articles 74 to 77.

compartments which are independent of the health status of the surrounding natural waters; and

compartments which are dependent on the health status of the surrounding natural waters but where conditions exist which create an effective disease specific separation between the compartment and other aquatic animal populations which may be infected.

assess at least the following epidemiological factors:

classify all establishments in the compartment as high risk, in compliance with Chapter 1 of Part I of Annex VI;

impose whatever measures are found to be necessary to prevent the introduction of disease.

the general criteria laid down in points (a)(i) and (a)(ii) of Article 73(1) have been fulfilled for an eligibility period of at least 5 years and the disease was not detected; and

the listed species relevant to the disease in question are absent from kept and wild animal populations.

the likelihood of the presence of animals from listed species in the compartment was assessed and found to be negligible; and

the likelihood of introduction of animals from listed species into the compartment was found to be negligible.

the general criteria laid down in points (a)(i) and (a)(ii) of Article 73(1) have been fulfilled for an eligibility period of at least 5 years and the disease was not detected;

the disease has never been reported or if reported, it has been demonstrated that the disease agent did not survive;

the value of at least one critical environmental parameter that is not compatible with the survival of the disease agent is reached;

the disease agent is exposed to that critical parameter during a sufficient period of time to destroy it.

with respect to the fulfilment of the criteria set out in points (a) and (b) of paragraph 1, documentary evidence;

with respect to the fulfilment of the criteria set out in points (c) and (d) of paragraph 1, scientific evidence.

the disease has never been reported in the compartment or it has been eradicated in the compartment and not reported for at least 25 years;

the disease has been reported in the past 25 years, it has been eradicated from the compartment and the disease specific requirements referred to in Article 78 are complied with.

disease surveillance of kept animals of listed species;

prevention to control the introduction of the disease agent;

ban on vaccination against the disease unless it is compliant with the disease specific requirements referred to in Article 78;

disease surveillance substantiating the fact that the disease is not known to be established in wild animals from listed species within the compartment.

in a new Member State, during a maximum period of two years following its accession to the Union; or

for a maximum period of two years following the date of application of the implementing acts adopted in accordance with Article 9(2) of Regulation (EU) 2016/429 that categorise for the first time the relevant disease as a category B or C disease.

VHS;

IHN;

infection with HPR-deleted ISAV;

infection with Bonamia ostreae;

infection with Marteilia refringens.

the competent authority has been running an approved eradication programme as referred to in Article 46; and

the competent authority has completed the eradication programme and submitted to the Commission the final report that demonstrates that the disease specific requirements laid down in Article 78 are complied with.

Section 2 of Chapter 1 of Part II of Annex VI for status free from VHS;

Section 2 of Chapter 1 of Part II of Annex VI for status free from IHN;

Section 2 of Chapter 2 of Part II of Annex VI for status free from infection with HPR-deleted ISAV;

Section 2 of Chapter 3 of Part II of Annex VI for status free from infection with Marteilia refringens;

Section 2 of Chapter 4 of Part II of Annex VI for status free from infection with Bonamia exitiosa;

Section 2 of Chapter 5 of Part II of Annex VI for status free from infection with Bonamia ostreae;

Section 2 of Chapter 6 of Part II of Annex VI for status free from infection with WSSV.

an individual establishment which is considered a single epidemiological unit, as it is not influenced by the animal health status of the surrounding natural waters; or

more than one establishment where each establishment in the compartment complies with the criteria laid down in point (a) of this paragraph and paragraphs 3 to 6 but due to extensive movements of animals between establishments, they are considered as a single epidemiological unit, provided that all establishments operate a common biosecurity system.

through a water treatment plant which inactivates the relevant disease agent; or

directly from a well, a borehole or a spring.

it complies with point (a) of paragraph 2 and paragraphs 3 to 5 of Article 79; and

it commences aquaculture activities with aquaculture animals from a disease-free Member State, zone or compartment.

the health history of the establishment is known to the competent authority and there has been no confirmation in the establishment of a category B or category C disease;

the establishment is cleaned, disinfected and fallowed, if necessary, prior to repopulation.

a representative sample of the animals which have been repopulated into the establishment from a disease-free Member State, zone or compartment following cleaning, disinfection and fallowing is tested for the relevant disease no sooner than 3 months and no later than 12 months after they have been exposed to conditions including water temperature, which are conducive to clinical expression of the disease;

the sampling and diagnostic tests set out in the relevant Chapter of Part II of Annex VI are used and samples are taken from the number of animals that will ensure the detection of the relevant disease with a 95 % confidence if the targeted prevalence is 2 %;

results of the testing described in point (b) are negative.

the undertaking of sufficient surveillance activities to enable the early detection of the disease and the demonstration of disease-free status;

the biosecurity measures ordered by the competent authority based on the risks identified to prevent the introduction of the disease;

the operational rules as referred to in points (a)(v), a(vi) and a(vii) of Article 66 or points (a)(v), a(vi) and a(vii) of Article 73(1).

Section 2 of Chapter 3 of Part I of Annex IV for status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals or Section 2 of Chapter 4 of Part I of Annex IV for status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals;

Section 2 of Chapter 2 of Part II of Annex IV for status free from infection with MTBC;

Section 2 of Chapter 2 of Part III of Annex IV for status free from EBL;

Section 2 of Chapter 2 of Part IV of Annex IV for status free from IBR/IPV;

Section 2 of Chapter 2 of Part V of Annex IV for status free from infection with ADV;

Section 2 of Chapter 2 of Part VI of Annex IV for status free from BVD;

Section 2 of Chapter 2 of Part I of Annex V for status free from infection with RABV;

Section 2 of Chapter 4 of Part II of Annex V for status free from infection with BTV;

Section 2 of Part III of Annex V for status free from infestation with Varroa spp;

Section 2 of Part IV of Annex V for status free from infection with Newcastle disease virus without vaccination;

Section 4 of Chapter 1 of Part II of Annex VI for status free from VHS;

Section 4 of Chapter 1 of Part II of Annex VI for status free from IHN;

Section 4 of Chapter 2 of Part II of Annex VI for status free from infection with HPR-deleted ISAV;

Section 4 of Chapter 3 of Part II of Annex VI for status free from infection with Marteilia refringens;

Section 4 of Chapter 4 of Part II of Annex VI for status free from infection with Bonamia exitiosa;

Section 4 of Chapter 5 of Part II of Annex VI for status free from infection with Bonamia ostreae;

Section 4 of Chapter 6 of Part II of Annex VI for status free from infection with WSSV.

apply without delay the relevant disease control measures;

conduct specific surveillance to assess the extent of the outbreak;

order any necessary risk mitigating measures.

adopt all necessary prevention, surveillance and control measures to manage the situation;

inform without delay the Commission and the other Member States about the measures adopted; and

inform regularly the Commission and the other Member States about the evolution of the situation, of its position as regards the restoration of the disease-free status, the prolongation of its suspension or its withdrawal by the Commission.

a Member State makes a provisional declaration of freedom for the zone or compartment which fulfils the requirements for disease-free status as set out in this Regulation;

this provisional declaration is published electronically by the Member State and the Commission and Member States are alerted to the publication;

60 days after publication, the provisional declaration shall take effect and the zone or compartment referred to in this paragraph shall achieve the disease-free status.

free from infection with Brucella abortus, B. melitensis, B.suis:

free from infection with MTBC, when the tuberculosis-free status was granted in accordance with Directive 64/432/EEC;

free from EBL, when EBL-free status was granted in accordance with Directive 64/432/EEC;

free from IBR/IPV, when IBR-free status was granted in accordance with Directive 64/432/EEC;

free from infection with ADV, when Aujeszky’s disease-free-status was granted in accordance with Directive 64/432/EEC;

free from infestation with Varroa spp., when varroasis-free status was granted in accordance with Council Directive 92/65/EEC (24);

free from infection with Newcastle disease virus without vaccination when Newcastle disease non-vaccination status was granted in accordance with Directive 2009/158/EC;

free from VHS, when VHS-free status was granted in accordance with Council Directive 2006/88/EC (25);

free from IHN, when IHN-free status was granted in accordance with Directive 2006/88/EC;

free from infection with HPR-deleted ISAV, when infection with HPR-deleted ISAV-free status was granted in accordance with Directive 2006/88/EC;

free from infection with Bonamia ostreae, when infection with Bonamia ostreae-free status was granted in accordance with Directive 2006/88/EC;

free from infection with Marteilia refringens, when infection with Marteilia refringens-free status was granted in accordance with Directive 2006/88/EC;

free from infection with WSSV, when white spot disease–free status was granted in accordance with Directive 2006/88/EC.

free from highly pathogenic avian influenza, when the compartment has been approved with respect to avian influenza in accordance with Commission Regulation (EC) No 616/2009 (26);

free from VHS, when VHS-free status was granted in accordance with Directive 2006/88/EC;

free from IHN, when IHN-free status was granted in accordance with Directive 2006/88/EC;

free from infection with HPR-deleted ISAV, when infection with HPR-deleted ISAV-free status was granted in accordance with Directive 2006/88/EC;

free from infection with Bonamia ostreae, when infection with Bonamia ostreae-free status was granted in accordance with Directive 2006/88/EC;

free from infection with Marteilia refringens, when infection with Marteilia refringens-free status was granted in accordance with Directive 2006/88/EC;

free from infection with WSSV, when white spot disease–free status was granted in accordance with Directive 2006/88/EC.

IBR/IPV, when the IBR/IPV eradication programme was approved in accordance with Directive 64/432/EEC;

infection with ADV, when the Aujeszky’s disease eradication programme was approved in accordance with Directive 64/432/EEC;

VHS, when the VHS surveillance or eradication programme was approved in accordance with Directive 2006/88/EC;

IHN, when the IHN surveillance or eradication programme was approved in accordance with Directive 2006/88/EC;

infection with HPR-deleted ISAV, when the infection with HPR-deleted ISAV surveillance or eradication programme was approved in accordance with Directive 2006/88/EC;

infection with Bonamia ostreae, when the infection with Bonamia ostreae surveillance or eradication programme was approved in accordance with Directive 2006/88/EC;

infection with Marteilia refringens, when the infection with Marteilia refringens surveillance or eradication programme was approved in accordance with Directive 2006/88/EC;

infection with WSSV, when the white spot disease eradication programme was approved in accordance with Directive 2006/88/EC.

VHS, when the VHS surveillance or eradication programme was approved in accordance with Directive 2006/88/EC;

IHN, when the IHN surveillance or eradication programme was approved in accordance with Directive 2006/88/EC;

infection with HPR-deleted ISAV, when the infection with HPR-deleted ISAV surveillance or eradication programme was approved in accordance with Directive 2006/88/EC;

infection with Bonamia ostreae, when the infection with Bonamia ostreae surveillance or eradication programme was approved in accordance with Directive 2006/88/EC;

infection with Marteilia refringens, when the infection with Marteilia refringens surveillance or eradication programme was approved in accordance with Directive 2006/88/EC;

infection with WSSV, when the white spot disease surveillance or eradication programme was approved in accordance with Directive 2006/88/EC.

Decision 2000/428/EC;

Decision 2002/106/EC;

Decision 2003/422/EC;

Decision 2006/437/EC;

Regulation (EC) No 1266/2007;

Decision 2008/896/EC;

Implementing Decision (EU) 2015/1554.

1.

An animal or a group of animals must be considered, by the competent authority, as a suspected case of HPAI when it meets the criteria laid down in Article 9(1).

2.

An animal or a group of animals must be considered, by the competent authority, as a confirmed case of HPAI when:

3.

For the purposes of this case definition, the disease agent responsible for HPAI must be either

1.

An animal or a group of animals must be considered, by the competent authority, as a suspected case of infection with LPAIV when it meets the criteria laid down in Article 9(1).

2.

An animal or a group of animals must be considered, by the competent authority, as a confirmed case of infection with LPAIV when:

3.

For the purposes of this case definition, the disease agent of infection with LPAIV must be any influenza A virus of H5 and H7 subtypes that are not HPAI viruses.

1.

An animal or a group of animals must be considered, by the competent authority, as a suspected case of infection with NDV when it meets the criteria laid down in Article 9(1).

2.

An animal or a group of animals must be considered, by the competent authority, as a confirmed case of infection with NDV when:

3.

For the purposes of this case definition, the disease agent responsible for infection with NDV must be any avian paramyxovirus type 1 (APMV-1) (avian Avulavirus type 1) that either:

Early detection systems as provided for in Sections 3 and 4;

Risk-based surveillance as provided for in Sections 5 and 6.

1.

Early detection of highly pathogenic avian influenza (HPAI) in poultry.

2.

Early detection of HPAI in wild birds providing for:

3.

Detection of HPAI in poultry species which generally do not show significant clinical signs.

4.

Detection of circulating low pathogenic avian influenza viruses (LPAIV) that may easily spread between poultry flocks in particular in areas with a high density of poultry establishments in view of their potential to mutate to HPAI in order to:

5.

Contribution to increased knowledge on HPAI and LPAIV posing a potential zoonotic risk.

1.

The early detection systems for of HPAI in poultry must be part of the general surveillance requirements as provided for in point (a) of Article 3(1) and must be implemented throughout the poultry sector.

2.

The surveillance referred to in point 1 must at least include the early detection and investigation in establishments located in an area identified as being at heightened risk for HPAI introduction and spread, of:

3.

Regular testing of samples collected from dead and sick poultry in establishments located in an area identified as being at heightened risk for HPAI introduction and spread may also be relevant when an increased risk has been identified at national, EU or regional level due to outbreaks of HPAI in poultry and/or wild birds.

1.

The early detection of HPAI in wild birds must be based on sampling and testing of birds that have been:

This surveillance may need to be increased, when HPAI has been detected in wild birds, by monitoring systems using organised patrols for detecting and collecting dead and sick birds.

2.

The design of this surveillance must be risk-based, taking into account at least relevant information on ornithology, virology, epidemiology and environmental matters.

3.

The surveillance must apply to birds from targeted wild bird species, as provided for in Section 8. However, all suspected episodes of mortality in wild birds must be investigated to exclude HPAI.

In addition to targeted wild bird species, additional wild bird species may also be included when their specific epidemiological relevance on the Member State’s territory has been assessed.

4.

In addition, the surveillance may include, at priority locations and key sites in particular those where birds of targeted wild birds species are entering the Union during their migratory movements, at least from North-East and Eastern routes, the sampling and testing of: