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.

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’ ( 1 ) as amended or the Manual of Diagnostic Tests for Aquatic Animals of the OIE (‘the Aquatic Manual’ ( 2 ) 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:

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.

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.

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.

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.

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.

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 ( 3 ) 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.

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.

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 or of the establishment of an eradication programme for the zone or compartment, which fulfils the requirements 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 disease-free status or have the eradication programme approved.

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 ( 4 );

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 ( 5 );

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 ( 6 );

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.