02020R0689 — EN — 21.04.2021 — 001.001

This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B COMMISSION DELEGATED REGULATION (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (Text with EEA relevance) (OJ L 174 3.6.2020, p. 211)

Amended by:









▼B

COMMISSION DELEGATED REGULATION (EU) 2020/689

of 17 December 2019

supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases

(Text with EEA relevance)







PART I

GENERAL PROVISIONS

Article 1

Subject-matter and scope

1. This Regulation supplements the rules on surveillance, eradication programmes and disease-free status for certain listed and emerging diseases of terrestrial, aquatic and other animals as provided for in Regulation (EU) 2016/429.

2. Chapter 1 of Part II of this Regulation lays down the rules for surveillance of the diseases referred to in Article 9(1) of Regulation (EU) 2016/429 and the emerging diseases as defined in Article 6(2) of that Regulation in relation to: (a) the design of the surveillance including the targeted animal population and the diagnostic methods; (b) the disease confirmation and the case definition; (c) Union surveillance programmes.

3. Chapter 2 of Part II of this Regulation lays down the rules for eradication programmes for the diseases of terrestrial animals referred to in points (b) and (c) of Article 9(1) of Regulation (EU) 2016/429 in relation to: (a) the disease control strategy, the territory, the animal populations, the targets and the period of application; (b) the obligations of operators and competent authorities; (c) the disease control measures in the event of suspicion and of confirmation.

4. Chapter 3 of Part II of this Regulation lays down the rules for eradication programmes for the diseases of aquatic animals referred to in points (b) and (c) Article 9(1) of Regulation (EU) 2016/429 in relation to: (a) the disease control strategy, the territory, the animal populations, the targets and the period of application; (b) the obligations of operators and competent authorities; (c) the disease control measures in the event of suspicion and of confirmation.

5. Chapter 4 of Part II of this Regulation lays down the rules for disease-free status with regard to certain diseases of terrestrial and aquatic animals referred to in Article 9(1) of Regulation (EU) 2016/429 in relation to: (a) the criteria for the approval of the disease-free status of Member States and zones; (b) the criteria for the approval of the disease-free status for compartments keeping aquaculture animals; (c) the criteria for the maintenance of the disease-free status; (d) the suspension, the withdrawal and the restoration of disease-free status.

6. Part III of this Regulation lays down transitional and final provisions in relation to: (a) 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; (b) 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.

Article 2

Definitions

For the purpose of this Regulation, the following definitions shall apply:

(1) ‘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;

(2) ‘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;

(3) ‘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;

(4) ‘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;

(5) ‘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;

(6) ‘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;

(7) ‘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;

(8) ‘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;

(9) ‘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;

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

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

(12) ‘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;

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

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

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

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

(17) ‘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;

(18) ‘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;

(19) ‘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;

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

(21) ‘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;

(22) ‘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;

(23) ‘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;

(24) ‘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;

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

(26) ‘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;

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

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

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

(30) ‘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;

(31) ‘honeybees’ means animals of the Apis mellifera species;

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

(33) ‘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.







PART II

SURVEILLANCE, ERADICATION PROGRAMMES, DISEASE-FREE STATUS







CHAPTER 1

Surveillance







Section 1

Design of surveillance, Targeted animal population and diagnostic methods

Article 3

Design of surveillance

1. The competent authority shall design the surveillance for listed and emerging diseases of terrestrial animals and other animals taking into account: (a) general surveillance requirements based on: (i) notification as provided for in Article 18(1) of Regulation (EU) 2016/429; (ii) appropriate veterinary investigation of increased mortalities and other signs of serious diseases or significantly decreased production rates with an undetermined cause; (iii) investigation by the competent authority in the event of the suspicion of a category E disease or, if relevant, of an emerging disease; (iv) targeted animal population for surveillance as provided for in Article 4; (v) the contribution of official controls and other official activities as provided for in Article 7; (b) specific surveillance requirements: (i) in Union surveillance programme; (ii) as a part of compulsory or optional eradication programmes; (iii) for demonstrating and maintaining disease-free status; (iv) as a part of disease control measures; (v) in the context of approval of certain establishments; (vi) for the movements of terrestrial animals within the Union or their entry into the Union.

2. The competent authority shall design the surveillance for listed and emerging diseases of aquatic animals taking into account: (a) general surveillance requirements based on: (i) notification as provided for in Article 18(1) of Regulation (EU) 2016/429; (ii) appropriate veterinary investigation of increased mortalities and other signs of serious diseases or significantly decreased production rates with an undetermined cause; (iii) investigation by the competent authority in the event of the suspicion of a category E disease or, if relevant, of an emerging disease; (iv) targeted animal population for surveillance as provided for in Article 4; (v) the contribution of official controls and other official activities as provided for in Article 7; (vi) disease control measures; (b) specific surveillance requirements: (i) as a part of the risk-based surveillance scheme set out in Chapter 1 of Part I of Annex VI, involving a risk ranking and regular animal health visits as provided for in Chapters 2 and 3 of Part I of Annex VI; (ii) as a part of the eradication programmes provided for in Chapters 1 to 6 of Part II of Annex VI; (iii) for demonstrating and maintaining disease-free status; (iv) for demonstrating, in accordance with the surveillance programmes provided for in Chapters 1 to 6 of Part III of Annex VI, that establishments which are not participating in the eradication programme referred to in point (ii) or which have not obtained the disease-free status referred to in point (iii) are not infected; (v) for the movements of aquatic animals within the Union or their entry into the Union.

Article 4

Targeted animal population

1. The competent authority shall specify the targeted animal population relevant to the surveillance referred to in Article 3 for each listed disease and, when relevant, for each emerging disease and shall include: (a) kept animals of listed species; (b) wild animals of listed species if: (i) they are subject to a Union surveillance programme, or to a compulsory or an optional eradication programme or to the surveillance necessary for the granting or maintenance of a disease-free status; (ii) the competent authority considers that they constitute a risk that may impair the health status of other species in a Member State, zone or compartment; or (iii) surveillance is necessary to assess animal health requirements for entry into the Union or movements within the Union.

2. To ensure the early detection of an emerging disease in species other than those referred to in point (a) of paragraph 1, the competent authority shall include, in the targeted animal population, kept animals of species that are not listed for the purpose of the relevant listed disease if the following criteria apply: (a) they are moved to establishments in another Member State, zone or compartment; and (b) 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.

Article 5

Exclusion of certain kept terrestrial animals from the targeted animal population

1. By way of derogation from point (a) of Article 4(1), the competent authority may limit the targeted animal population for the surveillance of a disease other than a category A disease to the categories of kept animals of listed species that are subject, for that disease, to: (a) Union surveillance programmes; (b) compulsory or optional eradication programmes or surveillance necessary for the granting or maintenance of a disease-free status; or (c) surveillance-based animal health requirements for the movements within the Union or the entry into the Union.

2. The categories of kept animals referred to in paragraph 1 may be based on the animals’ age, their sex, the location and type of production.

Article 6

Diagnostic methods

1. The competent authority shall ensure that the collection of samples, the techniques, validation and interpretation of the diagnostic methods for the purposes of surveillance shall comply: (a) 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; (b) 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; (c) 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.

2. The diagnostic methods for granting and maintaining disease-free status are laid down in: (a) Section 1 of Annex III for infection with Brucella abortus, B. melitensis and B.suis; (b) Section 2 of Annex III for infection with Mycobacterium tuberculosis complex (Mycobacterium bovis, M.caprae and M. tuberculosis) (MTBC); (c) Section 3 of Annex III for enzootic bovine leukosis (EBL); (d) Section 4 of Annex III for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV); (e) Section 5 of Annex III for infection with Aujeszky’s disease virus (ADV); (f) Section 6 of Annex III for bovine viral diarrhoea (BVD); (g) point 2 of Section 5 of Chapter 1 of Part II of Annex VI for viral haemorrhagic septicaemia (VHS); (h) point 2 of Section 5 of Chapter 1 of Part II of Annex VI for infectious haematopoietic necrosis (IHN); (i) 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); (j) point 2 of Section 5 of Chapter 3 of Part II of Annex VI for infection with Marteilia refringens; (k) point 2 of Section 5 of Chapter 4 of Part II of Annex VI for infection with Bonamia exitiosa; (l) point 2 of Section 5 of Chapter 5 of Part II of Annex VI for infection with Bonamia ostreae; (m) point 2 of Section 5 of Chapter 6 of Part II of Annex VI for infection with white spot syndrome virus (WSSV).

Article 7

Contribution of official controls and other official activities to animal health surveillance

1. The competent authority shall, if relevant, include in the design of the surveillance referred to in Article 3 of this Regulation the outcome of the official controls and other official activities defined in Article 2 of Regulation (EU) 2017/625. These official controls and other official activities include: (a) ante-mortem and post-mortem inspections; (b) inspections at border control posts; (c) official controls and other official activities at markets and assembly operations; (d) official controls and other official activities during transport of live animals; (e) public health related inspections and sampling in establishments; (f) any other official controls during which establishments, animals or samples are inspected or examined.

2. When the competent authority suspects a listed disease or an emerging disease in the context of official controls or other official activities referred to in paragraph 1, it shall ensure that all relevant authorities are informed. This shall be done: (a) immediately in case of a category A disease or of an emerging disease; (b) without delay for other diseases.







Section 2

Disease confirmation and case definitions

Article 8

Criteria for official confirmation of listed diseases, other than category A diseases, and certain emerging diseases and subsequent confirmation of outbreaks

1. The competent authority shall, on suspicion of listed diseases, other than category A disease, or of an emerging disease, conduct an investigation to confirm or to rule out the presence of that disease when: (a) there is a need to determine the health status of the Member State, zone or compartment thereof; or (b) there is a need to collect necessary information on the occurrence of the disease for any of the following purposes: (i) to implement measures to protect animal or human health; (ii) to implement animal health requirements for movements of animals or products; or (iii) to comply with the requirements laid down in a Union surveillance programme.

2. The competent authority shall confirm an outbreak of any of the diseases referred to in paragraph 1 when it has classified an animal or a group of animals as a confirmed case of these diseases in accordance with Article 9(2).

Article 9

Case definitions

1. The competent authority shall classify an animal or a group of animals as a suspected case of a listed disease or of an emerging disease when: (a) clinical, post-mortem or laboratory examinations conclude that clinical sign(s), post-mortem lesion(s) or histological findings are indicative of that disease; (b) 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 (c) an epidemiological link with a confirmed case has been established.

2. The competent authority shall classify an animal or a group of animals, as a confirmed case of a listed disease or of an emerging disease when: (a) the disease agent, excluding vaccine strains, has been isolated in a sample from an animal or from a group of animals; (b) 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 (c) 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.

3. Disease specific definitions of a suspected case and a confirmed case of listed diseases are laid down for terrestrial animals in Annex I and for aquatic animals in point 3 of Section 5 of Chapters 1 to 6 of Part II of Annex VI.

4. In the absence of disease specific definitions as provided for in paragraph 3, the criteria laid down in paragraphs 1 and 2 shall apply to definitions of a suspected case and a confirmed case of listed diseases and, if relevant, emerging diseases.







Section 3

Union surveillance programme

Article 10

Criteria for and contents of Union surveillance programmes

1. A category E disease shall be subject to a Union surveillance programme in accordance with Article 28 of Regulation (EU) 2016/429 if it meets all of the following criteria: (a) 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; (b) it is susceptible to an evolution of the disease profile, in particular with regard to the risk for human health and animal health; (c) infected wild animals pose a particular threat for the introduction of the disease into a part or the whole of the Union territory; (d) 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.

2. The competent authority shall implement Union surveillance programmes for the relevant disease in accordance with the contents set out in Annex II.

Article 11

Information to be included in the submission of and reporting on Union surveillance programmes

1. The competent authority shall, when submitting a Union surveillance programme, include in that submission at least the following information: (a) 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; (b) targeted animal population, epidemiological units and zones of the programme; (c) 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; (d) description and demarcation of the geographical and administrative areas in which the programme is to be implemented; (e) indicators to measure the progress of the programme; (f) diagnostic methods used, number of samples tested, frequency of testing and sampling patterns; (g) risk factors to be considered for the design of a risk-based targeted surveillance.

2. The competent authority shall, when reporting on a Union surveillance programme, include in that report at least the following information: (a) 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 (b) the results of the follow-up of the epidemiological evolution of the disease in case of a suspected or confirmed case.







CHAPTER 2

Eradication programmes for category B and C diseases of terrestrial animals







Section 1

General provisions

Article 12

Disease control strategy for the eradication of category B and C diseases of terrestrial animals

1. The competent authority shall, when establishing a compulsory eradication programme for a category B disease or an optional eradication programme for a category C disease of terrestrial animals, base those programmes on a disease control strategy that includes for each disease: (a) the territory and animal population covered by the eradication programme as provided for in Article 13(1); (b) 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 (c) the disease specific requirements laid down: (i) in Articles 16 to 31 for infection with Brucella abortus, B. melitensis and B. suis, infection with MTBC, EBL, IBR/IPV, infection with ADV and BVD; (ii) in Articles 32 to 36 for infection with rabies virus (RABV); (iii) in Articles 37 to 45 for infection with BTV.

2. The competent authority may include in the eradication programme coordinated measures at its common land or coastal border with other Member States or third countries to ensure that the objectives of the programme are achieved and that the results will last.

Where such coordination has not been established, the competent authority shall include in the eradication programme, if feasible, effective risk mitigating measures, including intensified surveillance.

Article 13

Territorial scope and animal populations

1. The competent authority shall determine the scope of the eradication programme, including: (a) the territory covered; and (b) the targeted animal population and, as necessary, additional animal populations.

2. The territory covered by the eradication programme referred to in point (a) of paragraph 1 shall be: (a) the entire territory of the Member State; or (b) 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.

3. By way of derogation from paragraph 2, the competent authority may define zones smaller than 2 000 km2 taking into account: (a) a minimum surface not significantly lower than 2 000 km2; or (b) the existence of natural barriers relevant to the disease profile.

Article 14

Final and intermediate targets

1. The competent authority shall include in the eradication programme qualitative and quantitative final targets that are covering all the disease specific requirements laid down in Article 72 for granting disease-free status.

2. The competent authority shall include in the eradication programme qualitative and quantitative intermediate annual or multiannual targets to reflect progress made towards the final targets. These intermediate targets shall include: (a) all of the disease specific requirements referred to in paragraph 1; and (b) if necessary, additional requirements that are not included in the criteria for granting disease-free status to assess progress towards eradication.

Article 15

Period of application

1. The competent authority shall include in the eradication programme the period of application taking into account the initial situation and the intermediate targets indicated in Article 14(2).

2. For category C diseases, the period of application of the eradication programme shall not exceed 6 years from the date of its initial approval by the Commission in accordance with Article 31(3) of Regulation (EU) 2016/429. In duly justified cases, the Commission may, upon request of Member States, extend the period of application of the eradication programme for an additional 6-year period.







Section 2

Requirements for eradication programmes based on granting disease-free status at the level of establishments

Article 16

Disease control strategy based on the disease-free status at establishment level

1. The competent authority shall design the disease control strategy of an eradication programme with respect to the targeted animal population kept in establishments for the following diseases of terrestrial animals: (a) infection with Brucella abortus, B. melitensis and B. suis; (b) infection with MTBC; (c) EBL; (d) IBR/IPV; (e) infection with ADV; (f) BVD.

2. Disease control strategies of eradication programmes referred to in paragraph 1 shall be based on: (a) the implementation of disease specific measures laid down in Articles 18 to 31 until all relevant establishments reach disease-free status; (b) the granting, suspension and withdrawal by the competent authority of the disease-free status of all relevant establishments; (c) the implementation of biosecurity and other risk mitigating measures; (d) the optional implementation of vaccination programmes.

Article 17

Targeted and additional animal populations for eradication programmes for certain diseases

1. The competent authority shall apply a compulsory eradication programme to the following targeted animal populations: (a) for infection with Brucella abortus, B. melitensis and B. suis, kept bovine animals, kept ovine animals and kept caprine animals; (b) for infection with MTBC, kept bovine animals.

2. The competent authority shall apply the optional eradication programme to the following targeted animal populations: (a) for EBL, kept bovine animals; (b) for IBR/IPV, kept bovine animals; (c) for infection with ADV, kept porcine animals; (d) for BVD, kept bovine animals.

3. The competent authority shall include additional animal populations where it considers that such animals pose a significant risk to the health status of animals referred to in paragraphs 1 or 2.

Article 18

Obligations of operators with respect to eradication programmes for certain diseases

1. The operators of establishments where animals from the targeted animal populations referred to in Article 17 are kept, other than slaughterhouses, shall comply with the following general and disease specific requirements to obtain and maintain the disease-free status of the establishments: (a) general requirements: (i) surveillance of the targeted and additional animal populations for the relevant disease as ordered by the competent authority pursuant to Article 3(1); (ii) in the case of movement of animals from the targeted animal populations, ensuring that the health status of the establishments is not jeopardised due to transport or introduction into the establishments of animals of the targeted or additional animal populations or products thereof; (iii) vaccination of the kept animals of targeted animal populations against the relevant disease; (iv) disease control measures in the event the disease is suspected or confirmed; (v) any additional measures considered necessary by the competent authority that may include, if relevant, separation of animals according to their health status by physical protection measures and management measures; (b) disease specific requirements laid down in: (i) Chapters 1 and 2 of Part I of Annex IV for infection with Brucella abortus, B. melitensis and B. suis; (ii) Chapter 1 of Part II of Annex IV for infection with MTBC; (iii) Chapter 1 of Part III of Annex IV for EBL; (iv) Chapter 1 of Part IV of Annex IV for IBR/IPV; (v) Chapter 1 of Part V of Annex IV for infection with ADV; (vi) Chapter 1 of Part VI of Annex IV for BVD.

2. The operators of slaughterhouses, where animals from the targeted animal populations referred to in Article 17 are kept and slaughtered shall comply with the general requirements laid down in points (a)(i), (iv) and (v) of paragraph 1.

Article 19

Derogation with regard to granting disease-free status to establishments

By way of derogation from Article 18 and provided that the relevant targeted animal populations comply with the general requirements laid down in point (a) of Article 18(1), the competent authority may decide that the obligations of operators to obtain and maintain disease-free status laid down in Article 18(1) do not apply to operators of the following establishments:

(a) confined establishments;

(b) establishments where animals are only kept for assembly operations;

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

(d) travelling circuses.

Article 20

Obligation of the competent authority to grant, suspend and withdraw disease-free status

1. The competent authority shall grant disease-free status at establishment level according to the compliance of the establishments’ operators with the requirements laid down in Article 18.

2. The competent authority shall suspend or withdraw disease-free status at establishment level when the conditions for suspension or withdrawal have been met. Those conditions are laid down in: (a) 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; (b) Sections 3 and 4 of Chapter 1 of Part II of Annex IV for infection with MTBC; (c) Sections 3 and 4 of Chapter 1 of Part III of Annex IV for EBL; (d) Sections 3 and 4 of Chapter 1 of Part IV of Annex IV for IBR/IPV; (e) Sections 3 and 4 of Chapter 1 of Part V of Annex IV for infection with ADV; (f) Sections 3 and 4 of Chapter 1 of Part VI of Annex IV for BVD.

3. The competent authority shall specify: (a) 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 (b) 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.

4. The competent authority may attribute distinct health status to different epidemiological units of the same establishment provided that its operator: (a) 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; (b) 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 (c) 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.

Article 21

Disease control measures in the event of suspicion of certain diseases

1. The competent authority shall, when it suspects a case of the relevant disease, conduct investigations, initiate an epidemiological enquiry and suspend the disease-free status of the establishment where the suspected case occurred until the investigations and the epidemiological enquiry are concluded.

2. Pending the outcome of the investigations and the epidemiological enquiry referred to in paragraph 1, the competent authority: (a) 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; (b) shall, when it considers it necessary for the control of the risk of spreading the disease: (i) where technically possible, order the isolation of the suspected cases in the establishment; (ii) restrict the introduction of animals from the relevant targeted animal population into the establishment; (iii) restrict the movement of products from the relevant targeted animal population from or to the establishment.

3. The competent authority shall maintain the measures referred to in paragraphs 1 and 2 until the presence of the disease has been ruled out or confirmed.

Article 22

Extension of disease control measures in the event of suspicion of certain diseases

1. The competent authority shall, when it considers it necessary, extend the measures laid down in Article 21 to: (a) relevant additional animal populations kept in the establishment; (b) any establishment which has an epidemiological link with the establishment where the suspected case occurred.

2. If the presence of the disease is suspected in wild animals, the competent authority shall, when it considers it necessary, extend to the establishments that are at risk of infection the measures laid down in Article 21.

Article 23

Derogations from disease control measures in the event of suspicion of certain diseases

1. By way of derogation from Article 21(1), based on duly justified grounds, the competent authority may decide not to suspend the disease-free status of the whole establishment when there are different epidemiological units as referred to in Article 20(4).

2. By way of derogation from point (a) of Article 21(2), the competent authority may authorise movement of animals from the relevant targeted animal population to an establishment under its official supervision provided that the following requirements are complied with: (a) the animals shall only be moved by direct transport; (b) 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.

3. By way of derogation from point (a) of Article 21(2), in the case of a category C disease, the competent authority may authorise movement of animals from the relevant targeted animal population provided that 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.

4. When making use of the derogation laid down in paragraph 2, the competent authority shall: (a) 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); (b) 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; (c) 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.

5. The competent authority may use the derogations provided for in paragraphs 1 to 3 only if operators of establishments of origin and of destination and transporters of the animals that are subject to the derogations: (a) apply appropriate biosecurity and other risk mitigating measures necessary to prevent the spread of the disease; and (b) provide the competent authority with guarantees that all the necessary biosecurity and other risk mitigating measures have been taken.

Article 24

Official confirmation of certain diseases and disease control measures

1. If a case is confirmed, the competent authority shall: (a) withdraw the disease-free status of the infected establishment(s); (b) adopt the measures laid down in Articles 25 to 31 in the infected establishment(s).

2. By way of derogation from point (a) of paragraph 1, the competent authority may limit the withdrawal of the disease-free status to the epidemiological units where a case was confirmed.

3. If the disease is confirmed in wild animals, the competent authority shall conduct, if necessary, an epidemiological enquiry and investigations as provided for in Article 25. If it considers it necessary in order to prevent the spread of the disease, it shall: (a) 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; (b) 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.

Article 25

Epidemiological enquiry and investigations in case of confirmation of certain diseases

1. When the disease is confirmed, the competent authority shall: (a) conduct an epidemiological enquiry; (b) conduct investigations and apply the measures laid down in Article 21 in all epidemiologically linked establishments; and (c) adapt the surveillance to the identified risk factors, taking into account the conclusions of the epidemiological enquiry.

2. The competent authority shall consider the need to conduct an investigation on wild animals from additional animal populations where the epidemiological enquiry reveals epidemiological links between kept and wild animals.

3. The competent authority shall as soon as possible inform about the situation: (a) operators and relevant authorities from the Member States concerned by the epidemiological links with the confirmed case; and (b) the competent authorities from other Member States or third countries that may be concerned by the epidemiological links with the infected establishment(s).

Article 26

Movement of animals to or from infected establishments

1. The competent authority shall prohibit movements of animals from targeted animal population out of the infected establishment unless it has authorised their immediate slaughter in a designated slaughterhouse.

2. When the competent authority considers it necessary in order to prevent the spread of the disease, it shall: (a) order the isolation of the suspected and confirmed cases in the establishment where technically possible; (b) restrict the movements of animals from targeted animal population within the establishment; (c) restrict the introduction of animals from targeted animal population in the establishment; (d) restrict the movement of products of animals from targeted animal population from and to the infected establishment.

3. The competent authority shall, when it considers it necessary, extend the measures in paragraphs 1 and 2 to animals and products from additional animal populations to prevent the spread of the disease.

Article 27

Testing and removal of animals from infected establishments

1. Following confirmation of the disease, the competent authority shall order that in infected establishments the following testing is conducted within a maximum period of time to be determined by it: (a) testing of those animals whose testing is considered necessary to complete the epidemiological enquiry; (b) testing to restore the disease-free status as laid down in: (i) Section 4 of Chapters 1 and 2 of Part I of Annex IV for infection with Brucella abortus, B. melitensis and B. suis; (ii) Section 4 of Chapter 1 of Part II of Annex IV for infection with MTBC; (iii) Section 4 of Chapter 1 of Part III of Annex IV for EBL; (iv) Section 4 of Chapter 1 of Part IV of Annex IV for IBR/IPV; (v) Section 4 of Chapter 1 of Part V of Annex IV for infection with ADV; (vi) Section 4 of Chapter 1 of Part VI of Annex IV for BVD; and (c) any additional testing it considers necessary to ensure the swift detection of infected animals that may contribute to the spreading of the disease.

2. By way of derogation from point (b) of paragraph 1, testing shall not be ordered when disease-free status is restored in accordance with: (i) 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; (ii) point 2 of Section 1 of Chapter 1 of Part II of Annex IV for infection with MTBC; (iii) point 2 of Section 1 of Chapter 1 of Part III of Annex IV for EBL; (iv) point 2 of Section 1 of Chapter 1 of Part IV of Annex IV for IBR/IPV; (v) point 2 of Section 1 of Chapter 1 of Part V of Annex IV for infection with ADV; (vi) point 2 of Section 1 of Chapter 1 of Part VI of Annex IV for BVD.

3. The competent authority shall order that in infected establishments all animals recognised as confirmed cases and, if necessary, as suspected cases are slaughtered within a maximum period of time it determines.

4. The slaughtering of the animals referred to in paragraph 3 shall be carried out under official supervision in a designated slaughterhouse.

5. The competent authority may order the killing and destruction of some or all of the animals referred to in paragraph 3 instead of their slaughtering.

6. The competent authority shall extend the measures laid down in this Article to animals from additional animal populations when this is necessary to eradicate the disease in the infected establishments.

Article 28

Management of products from infected establishments

1. The competent authority shall in all establishments infected with Brucella abortus, B. melitensis and B. suis or with MTBC, order that: (a) 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; (b) 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.

2. In the event of infection with Brucella abortus, B. melitensis and B. suis, the competent authority shall order that in all infected establishments foetuses, still-born animals, animals which have died from the disease after birth and placentae shall be collected and disposed of.

3. In the event of infection with a category C disease, the competent authority shall when it considers it necessary, order any appropriate measures provided for paragraphs 1 and 2.

4. The competent authority shall, when it considers it necessary, order the trace-back, the processing or the disposal of any products from infected establishments that may constitute a risk of spreading the disease or affect human health.

Article 29

Derogations from the restriction of movement of animals from infected establishments

1. By way of derogation from Article 26(1), the competent authority may authorise movement of clinically healthy animals, other than confirmed cases, to an establishment under its official supervision provided that the following requirements are complied with: (a) the movement does not jeopardise the health status of animals at the establishment of destination or enroute to that destination; (b) the animals shall only be moved by direct transport; and (c) 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.

2. By way of derogation from Article 26(1) in the case of a category C disease, the competent authority may authorise movement of clinically healthy animals from the relevant targeted animal population, other than confirmed cases, provided that: (a) 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 (b) the movement does not jeopardise the health status of targeted or additional animal populations at the establishment of destination or enroute to that destination.

3. When making use of the derogation laid down in paragraph 1, the competent authority shall withdraw the disease-free status of the establishment of destination of the animals that are subject to the derogation and shall: (a) 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 (b) 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.

4. The competent authority may use the derogations provided for in paragraphs 1 and 2 only if operators of establishments of origin and of destination and transporters of the animals that are subject to the derogations: (a) apply appropriate biosecurity and other risk mitigating measures necessary to prevent the spread of the disease; and (b) provide the competent authority with the guarantees that all the necessary biosecurity and other risk mitigating measures have been taken.

Article 30

Cleaning and disinfection and other measures to prevent the spread of infection

1. The competent authority shall order the operators of all infected establishments and those receiving animals from infected establishments the cleaning and disinfection or, where relevant, the safe disposal of: (a) all parts of the establishments that may have been contaminated after the removal of the confirmed and suspected cases and before repopulation; (b) any feed, materials, substances, husbandry related equipment, medicinal equipment and production related equipment that may have been contaminated; (c) any protective clothing or safety equipment used by operators and visitors; (d) all means of transport, containers and equipment after the transport of animals or products from infected establishments; (e) loading areas for animals after each use.

2. The competent authority shall approve the protocol for the cleaning and disinfection.

3. The competent authority shall supervise the cleaning and disinfection, or where relevant, the safe disposal and shall not restore or grant again disease-free status to the establishment until it considers that the cleaning and disinfection, or where relevant, the safe disposal, has been completed.

4. The competent authority may, based on a risk assessment, regard a pasture as contaminated and prohibit its use for kept animals of higher health status than that of the targeted animal population or, if epidemiologically relevant, additional animal populations, for a period of time sufficient to consider the risk of persistence of the disease agent to be negligible.

Article 31

Risk mitigating measures to prevent reinfection

Before or upon lifting of the disease control measures, the competent authority shall order proportionate risk mitigating measures to prevent the reinfection of the establishment taking into account relevant risk factors as indicated by the results of the epidemiological enquiry. These measures shall at least take account of:

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

(b) biosecurity measures that are adapted to the specificities of the establishment.







Section 3

Provisions for eradication programmes for infection with RABV

Article 32

Disease control strategy of eradication programmes for infection with RABV

1. The competent authority shall, when establishing an eradication programme for infection with RABV, base it on a disease control strategy that includes: (a) vaccination of the animals from the targeted animal population that it considers relevant; (b) implementation of measures to reduce the risk of contact with infected animals; (c) control of the risk of spread and introduction of the disease in the territory of its Member State.

2. The competent authority shall implement the eradication programme taking into account that it shall be: (a) based on a risk assessment, updated, as necessary, according to the evolution of the epidemiological situation; (b) supported by public information campaigns involving all relevant stakeholders; (c) coordinated, if necessary, with relevant authorities in charge of public health, wild animal populations or hunting; (d) scaled according to a territorial risk-based approach.

3. The competent authority may be involved in the implementation of eradication programmes for infection with RABV in a third country or territory, to prevent the risk of spread and introduction of RABV in the territory of its Member State.

Article 33

Targeted animal population for eradication programmes for infection with RABV

1. The competent authority shall apply the eradication programme for infection with RABV to the following targeted animal population: kept and wild animals of species of the following families: Carnivora, Bovidae, Suidae, Equidae, Cervidae and Camelidae.

2. The competent authority shall address the measures in the eradication programme primarily to wild foxes, being the main reservoir of RABV.

3. The competent authority shall subject other targeted animal populations than wild foxes to the measures of the eradication programme when it considers that such animals pose a significant risk.

4. The competent authority may include wild animals of species of the order Chiroptera in the targeted animal population relevant to surveillance referred to in Article 4.

Article 34

Obligations of the competent authority in the context of eradication programmes for infection with RABV

1. The competent authority shall: (a) conduct surveillance of infection with RABV for the purposes of: (i) early detection of the infection; and (ii) follow up of the trend in the number of infected animals, which shall include, according to a risk-based approach, the collection and testing of wild foxes and other wild carnivores found dead; (b) carry out disease control measures in the event of suspicion or confirmation of infection with RABV as laid down in Articles 35 and 36; (c) apply, if necessary, risk mitigating measures to prevent the spread of RABV by movements of dogs, cats and ferrets.

2. The competent authority shall, when it considers it necessary, order: (a) 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); (b) the identification and registration of dogs, cats and ferrets; (c) 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; (d) 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.

Article 35

Disease control measures in the event of suspicion of infection with RABV

When infection with RABV is suspected, the competent authority shall:

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

(b) 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;

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

Article 36

Disease control measures in the event of confirmation of infection with RABV

When infection with RABV is confirmed, the competent authority shall take measures to prevent further transmission of the disease to animals and to humans, for which:

(a) 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;

(b) it shall, unless it considers further investigations are necessary, rule out an infection with RABV in animals with an epidemiological link when: (i) a minimum period of 3 months has lapsed since the epidemiological link with the confirmed case occurred; and (ii) no clinical signs have been detected in those animals;

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

(d) 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.







Section 4

Provisions for eradication programmes for infection with BTV

Article 37

Disease control strategy of eradication programmes for infection with BTV

1. The competent authority shall, when establishing an optional eradication programme for infection with BTV, base the programme on a disease control strategy that includes: (a) surveillance of infection with BTV in accordance with the requirements set out in Chapter 1 of Part II of Annex V; (b) 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; (c) movement restrictions of the targeted animal population in accordance with the requirements laid down in Articles 43 and 45; (d) risk mitigating measures to minimise transmission of infection with BTV through vectors.

2. The competent authority shall implement the eradication programme taking into account that: (a) it shall detect and eradicate all the serotypes 1-24 present in the territory covered by the eradication programme; (b) the territory covered by the eradication programme shall be: (i) the whole territory of the Member State; or (ii) a zone or zones that include a territory within at least a 150-km radius of each infected establishment.

3. By way of derogation from point (b)(ii) of paragraph 2, the competent authority may adapt the zone(s) covered by the eradication programme in accordance with: (a) the geographical situation of the infected establishment(s) and the boundaries of the corresponding administrative units; (b) the ecological and meteorological conditions; (c) the abundance, activity and distribution of the vectors present in the zone(s); (d) the BTV serotype involved; (e) the results of the epidemiological enquiry provided for in Article 42; (f) the results of the surveillance activities.

Article 38

Targeted and additional animal populations for eradication programmes for infection with BTV

1. The competent authority shall apply the eradication programme for infection with BTV to the following targeted animal population: kept animals from species of families of Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Moschidae and Traguilidae.

2. The competent authority shall, when it considers it is necessary, apply the eradication programme to the following additional animal populations: wild animals from species of families of Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Moschidae and Traguilidae.

Article 39

Obligations of operators in the context of eradication programmes for infection with BTV

1. The operators of establishments, other than slaughterhouses, where animals from the targeted animal population referred to in Article 38(1) are kept shall: (a) comply with the requirements ordered by the competent authority as regards the surveillance of animals from the targeted animal population; (b) comply with the requirements ordered by the competent authority as regards the entomological surveillance; (c) have animals from the targeted animal population vaccinated following the orders of the competent authority; (d) implement disease control measures in the event the disease is suspected or confirmed following the orders of the competent authority; (e) comply with movement requirements following the orders of the competent authority; (f) 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.

2. The operators of slaughterhouses, where animals from the targeted animal population referred to in Article 38(1) are kept and slaughtered, shall: (a) comply with the requirements ordered by the competent authority as regards the surveillance of animals from the targeted animal population; (b) implement disease control measures in the event the disease is suspected or confirmed following the orders of the competent authority; (c) 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.

Article 40

Obligations of the competent authority in the context of eradication programmes for infection with BTV

1. The competent authority shall in the territory covered by an eradication programme for infection with BTV referred to in point (b) of Article 37(2): (a) 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; (b) 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; (c) apply the disease control measures laid down in Articles 41 and 42 in the event of suspicion or confirmation of the disease; (d) order operators of establishments of bovine, ovine or caprine animals and, if necessary, other targeted animal populations to have their animals vaccinated; and (e) apply the requirements laid down in Articles 43 and 45 to the movements of animals from the targeted animal population.

2. By way of derogation from point (d) of paragraph 1, the competent authority may decide not to order operators to have their animals vaccinated if following a risk assessment, it duly justifies that the implementation of other measures is sufficient to eradicate the disease.

3. The competent authority shall, when it considers it necessary and if possible, establish a seasonally BTV-free area as provided for in Chapter 5 of Part II of Annex V. In that event, the competent authority shall make available to the Commission and to the other Member States: (a) information demonstrating the fulfilment of the specific criteria for determining the seasonally BTV-free period; (b) the start and end dates of the period; (c) information demonstrating the cessation of the transmission of BTV in the area; and (d) the delimitation of the area which complies with the minimum requirements laid down in Article 13.

Article 41

Disease control measures in the event of suspicion of infection with BTV

1. In the event of suspicion of infection with BTV, the competent authority shall conduct an investigation to confirm or rule out the disease.

2. Pending the outcome of the investigation referred to in paragraph 1, the competent authority shall: (a) 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; (b) 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.

3. The competent authority shall, when it considers it necessary, extend the measures provided for in paragraphs 1 and 2 to establishments where animals from the targeted animal population had a similar exposure to infectious vectors to that of the suspected cases.

4. The measures provided for in this Article may be withdrawn when the competent authority considers that they are no longer necessary to limit the risk of spreading the disease.

Article 42

Disease control measures in the event of confirmation of infection with BTV

1. In the event of confirmation of infection with BTV, the competent authority shall: (a) confirm the outbreak and, if necessary, establish or extend the zone under eradication programme; (b) conduct an epidemiological enquiry, if necessary; (c) restrict movement of animals of the targeted animal population from the establishment where they are kept unless authorised for the purpose of immediate slaughter; (d) restrict movement of germinal products of animals from the targeted animal population from the establishment where they are kept; (e) 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; (f) 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.

2. In addition to measures laid down in paragraph 1 and in order to prevent the disease from spreading, the competent authority shall, when it considers it necessary: (a) 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); (b) investigate and monitor the health status of the targeted animal population in the proximity of the establishment where the confirmed case is kept.

3. The measures provided for in this Article may be withdrawn when the competent authority considers that they are no longer necessary to limit the risk of spreading the disease.

Article 43

Movement of kept animals and germinal products from the targeted animal population to Member States or zones covered by eradication programmes for infection with BTV

1. The competent authority shall only authorise the introduction of animals from the targeted animal population in the territory covered by an eradication programme for infection with BTV referred to in point (b) of in Article 37(2) if they comply with at least one of the requirements set out in points 1 to 4 of Section 1 of Chapter 2 of Part II of Annex V.

2. By way of derogation from paragraph 1, the competent authority may also authorise the introduction of animals from the targeted animal population in the territory covered by the eradication programme for infection with BTV if: (a) 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; (b) it prohibits the movement of these animals to another Member State: (i) for a period of 60 days after the introduction; or (ii) until a negative polymerase chain reaction (PCR) test for BTV serotypes 1-24 was carried out on samples collected not earlier than 14 days after the introduction; (c) it adapts, if necessary, the surveillance in accordance with point 6 of Section 4 of Chapter 1 of Part II of Annex V; and (d) 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.

3. The competent authority shall only authorise the introduction of germinal products from the targeted animal population in the territory covered by an eradication programme for infection with BTV referred to in point (b) of Article 37(2) if they comply with at least one of the requirements set out in points 1 to 3 of Section 2 of Chapter 2 of Part II of Annex V.

4. By way of derogation from paragraph 3, the competent authority may also authorise the introduction of germinal products from the targeted animal population in the territory covered by an eradication programme for infection with BTV if: (a) 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; (b) it prohibits the movement of these germinal products to another Member State; and (c) the germinal products comply with the requirements set out in point 4 of Section 2 of Chapter 2 of Part II of Annex V.

5. When the competent authority receiving the animals or the germinal products uses the derogations provided for in paragraphs 2 or 4, it shall: (a) inform the Commission thereof as soon as possible; (b) 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.

6. When the competent authority receiving the animals or the germinal products no longer uses the derogations provided for in paragraphs 2 or 4, it shall inform the Commission as soon as possible.

Article 44

Vector protected establishment

1. The competent authority may, upon request by the operator, grant the status ‘vector protected establishment’ to establishments or facilities complying with the criteria laid down in Chapter 3 of Part II of Annex V.

2. The competent authority shall verify at the appropriate frequency, but at least at the beginning, during and at the end of the required protection period, the effectiveness of the measures carried out by means of a vector trap inside the establishment.

3. The competent authority shall immediately withdraw the status vector protected establishment when the conditions referred to in paragraph 1 are no longer complied with.

Article 45

Movement of animals through Member States or zones covered by eradication programmes for infection with BTV

1. The competent authority shall only authorise movement of animals from the targeted animal population through the territory covered by an eradication programme for infection with BTV referred to in point (b) of Article 37(2) if: (a) 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 (b) 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.

2. By way of derogation from paragraph 1, the competent authority may also authorise the movement of animals from targeted animal population through the territory covered by an eradication programme for infection with BTV if the requirements laid down in points (a), (c) and (d) of Article 43(2) are complied with.







CHAPTER 3

Eradication programmes for category B and C diseases of aquatic animals







Section 1

General provisions

Article 46

Disease control strategy for the eradication of category B and C diseases of aquatic animals

1. The competent authority shall, when establishing a compulsory eradication programme for a category B disease or an optional eradication programme for a category C disease of aquatic animals, base those programmes on a disease control strategy that includes for each disease: (a) 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); (b) the territory and animal population covered by the eradication programme as provided for in Articles 47 and 51; (c) the duration of the eradication programme provided for in Article 49 including its final and intermediate targets as provided for in Article 48; (d) the disease specific preventive and control measures laid down in Articles 55 to 65.

2. The competent authority may include in the eradication programme coordinated measures at its common land or coastal border with other Member States or third countries to ensure that the objective of the programmes are achieved and will last.

Where such coordination has not been established, the competent authority shall include in the eradication programme, if feasible, effective risk mitigating measures including intensified surveillance.

Article 47

Territorial scope and animal population

1. The competent authority shall determine the scope of the eradication programme including: (a) the territory covered; and (b) the targeted animal population and, if necessary, additional animal populations.

2. The territory covered by the eradication programme referred to in point (a) of paragraph 1 may be: (a) the entire territory of the Member State; (b) one or several zones; or (c) the geographical location of the establishments of which the compartment or compartments are comprised.

3. All establishments located within the Member State, zone or compartment covered by the eradication programme shall be included in the eradication programme.

4. By way of derogation from paragraph 3 the competent authority may exclude from the eradication programme, aquaculture establishments which do not pose a significant risk to the success of that programme and which are exempted from the obligation to apply for approval.

Article 48

Final and intermediate targets

1. The competent authority shall include in the eradication programme qualitative and quantitative final targets that cover all the disease specific requirements laid down in Article 72 for granting disease-free status.

2. Where this is technically possible, the competent authority implementing an eradication programme shall also include in that programme qualitative and quantitative final targets based on the health status of wild animal populations that constitute a threat to the achievement of disease-free status.

3. The competent authority shall include in the eradication programme qualitative and quantitative intermediate annual or multiannual targets to reflect progress made towards the final targets. These intermediate targets shall include: (a) all of the disease specific requirements referred to in paragraph 1 and the targets provided for in paragraph 2; and (b) if necessary, additional requirements that are not included in the requirements for granting disease-free status to assess progress towards eradication.

Article 49

Period of application

1. The period of application of eradication programmes for listed aquatic animal diseases are laid down in Part II of Annex VI, specifically Sections 2 and 3 of: (a) Chapter 1 for VHS and IHN; (b) Chapter 2 for infection with HPR-deleted ISAV; (c) Chapter 3 for infection with Marteilia refringens; (d) Chapter 4 for infection with Bonamia exitiosa; (e) Chapter 5 for infection with Bonamia ostreae; (f) Chapter 6 for infection with WSSV.

2. For category C diseases, the period of application of an eradication programme shall not exceed 6 years from the date of its initial approval by the Commission in accordance with Article 31(3) of Regulation (EU) 2016/429. In duly justified cases, the Commission may, upon request of Member States, extend the period of application of the eradication programme for an additional 6-year period.







Section 2

Requirements for Eradication programmes

Article 50

Minimum requirements for an eradication programme

The competent authority shall base the eradication programme for a specific category B or C disease in a Member State, zone, or compartment on:

(a) 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;

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

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

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

Article 51

Animal population to be included in eradication programmes for category B and C diseases

1. The competent authority shall apply the eradication programme to listed species kept in establishments within the territory of the Member State, the zone or compartment.

2. By way of derogation from paragraph 1, the competent authority may decide to exclude from the eradication programme, based on a risk assessment, establishments keeping only vector species referred to in the table set out in the Annex to Implementing Regulation (EU) 2018/1882.

3. Where technically feasible, the competent authority shall include in the eradication programme additional animal populations when such animals: (a) pose a significant risk to the health status of animals referred to in paragraph 1; (b) 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.

Article 52

Measures to be taken in Member States, zones or compartments covered by eradication programmes

1. In order to monitor the progress of eradication programmes, the competent authority shall classify the health status of all establishments where animals from the listed species are kept according to: (a) the health status of each establishment as known at the time the eradication programme commences; (b) the compliance with conditions for the introduction of animals from listed species into the establishment; (c) the compliance by the operator with the obligation to notify the competent authority of any suspicion or detection of the disease; (d) the fulfilment of disease control measures to be applied if the disease is suspected or confirmed; (e) the vaccination regimes that may apply to animals from listed species kept in the establishment; (f) any additional measures considered necessary by the competent authority.

2. The competent authority shall: (a) commence, maintain, or withdraw the eradication programme according to the compliance or non-compliance of establishments with the requirements laid down in paragraph 1; (b) inform the operators of the relevant establishments about the evolution of the health status and the necessary measures for granting disease-free status.

3. Operators shall comply with the requirements set out in points (b) to (f) of paragraph 1 so that the eradication programme can be implemented until such time as it has been successfully completed or is withdrawn.

Article 53

Derogation from classification of the health status of confined establishments

By way of derogation from Article 52(1), the competent authority may decide not to classify the health status of confined establishments, if the animal population kept in these confined establishments is subjected to appropriate risk mitigating measures and disease control measures to ensure that it does not constitute a risk of spreading the disease.

Article 54

Vaccination

The competent authority may, include in eradication programmes under its official supervision:

(a) vaccination of listed species;

(b) vaccination of an additional animal population of kept animals;

(c) vaccination of an additional animal population of wild animals.

Article 55

Disease control measures in the event of suspicion of certain diseases

1. The competent authority shall, when it suspects a case of the relevant disease in an establishment, conduct the necessary investigation.

2. Pending the outcome of the investigation referred to in paragraph 1, the competent authority shall: (a) prohibit the introduction of animals or products of animal origin into the establishment; (b) where technically possible, order the isolation of units in the establishment where suspected animals are kept; (c) 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; (d) prohibit the movement of equipment, feed and animal by-products from the establishment unless authorised by the competent authority.

3. The competent authority shall maintain the measures referred to in paragraphs 1 and 2 until the presence of the disease has been ruled out or confirmed.

Article 56

Extension of disease control measures in the event of suspicion of certain diseases

1. The competent authority shall, when it considers it necessary, extend the measures laid down in Article 55 to: (a) any establishment which due to hydrodynamic conditions, has an increased risk of contracting the disease from the suspected establishment; (b) any establishment which has a direct epidemiological link with the suspected establishment.

2. If the presence of the disease is suspected in wild aquatic animals, the competent authority shall, when it considers it necessary, extend the measures laid down in Article 55 to the concerned establishments.

Article 57

Derogation from disease control measures in the event of suspicion of disease

1. By way of derogation from point (c) of Article 55(2) the competent authority may authorise the movement of aquaculture animals to an establishment under its official supervision provided that the following requirements are complied with: (a) only animals showing no symptoms of disease are moved; (b) the health status of aquaculture animals at the establishment of destination or aquatic animals enroute to that establishment is not jeopardised by the movement; (c) in the establishment of destination they have no contact with aquaculture animals of a higher health status with respect to the relevant disease; and (d) the animals are kept in the establishment of destination for a maximum period of time to be determined by the competent authority.

2. When making use of the derogation laid down in paragraph 1, the competent authority shall: (a) 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); (b) 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.

3. The competent authority may use the derogation provided for in paragraph 1 only if operators of establishments of origin and of destination and transporters of the animals that are subject to the derogation: (a) apply appropriate biosecurity and other risk mitigating measures necessary to prevent the spread of the disease; (b) provide the competent authority with guarantees that all the necessary biosecurity and other risk mitigating measures have been taken; and (c) 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.

Article 58

Official confirmation of certain diseases and disease control measures

1. If a case is confirmed, the competent authority shall: (a) declare the establishment(s) infected; (b) reclassify the health status of the infected establishment(s); (c) establish a restricted zone which is of an appropriate size; (d) adopt the measures laid down in Articles 59 to 65 in the infected establishment(s).

2. The minimum requirements that shall apply with regard to the establishment(s) of the restricted zone are set out in Part II of Annex VI, specifically in: (a) point 1(a) of Section 3 of Chapter 1 for VHS and IHN; (b) point 1(a) of Section 3 of Chapter 2 for infection with HPR-deleted ISAV; (c) point 1(a) of Section 3 of Chapter 3 for infection with Marteilia refringens; (d) point 1(a) of Section 3 of Chapter 4 for infection with Bonamia exitiosa; (e) point 1(a) of Section 3 of Chapter 5 for infection with Bonamia ostreae; (f) point 1(a) of Section 3 of Chapter 6 for infection with WSSV.

3. By way of derogation from point (c) of paragraph 1, the competent authority may decide not to establish a restricted zone: (a) when an infected establishment does not discharge untreated effluent into surrounding waters; and (b) where the biosecurity measures which exist at the establishment are of a standard which ensures that infection is fully contained within it.

4. The competent authority may take risk mitigating measures relating to the following activities in the restricted zone: (a) the movement of well-boats through the restricted zone; (b) fishing activities; (c) other activities that may pose a risk of disease spread.

5. If the disease is confirmed in wild aquatic animals, the competent authority may: (a) 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; (b) apply intensified surveillance of wild aquatic animal populations and in establishments having a direct epidemiological link with the confirmed case; (c) take measures to eradicate the disease from the relevant wild aquatic animal population, where feasible.

Article 59

Epidemiological enquiry and investigations in case of confirmation of certain diseases

1. When the disease is confirmed, the competent authority shall: (a) conduct an epidemiological enquiry; (b) conduct investigations and apply the measures laid down in Article 55(2) in all epidemiologically linked establishments; (c) adapt the surveillance to the identified risk factors, taking into account the conclusions of the epidemiological enquiry.

2. The competent authority shall consider the need to conduct an investigation on wild animals where the epidemiological enquiry reveals epidemiological links between kept and wild animals.

3. The competent authority shall as soon as possible inform: (a) operators and relevant authorities from the Member State concerned by the epidemiological links with the confirmed case; and (b) the competent authorities from other Member States or third countries that may be concerned by the epidemiological links with the infected establishment(s).

Article 60

Movements to or from an infected establishment and any other establishment located in the restricted zone

1. The competent authority shall in all infected establishment(s) and any other establishment(s) located in the restricted zone: (a) where technically possible, order the isolation of suspected and confirmed cases; (b) 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; (c) 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; (d) prohibit the movement of equipment, feed and animal by-products from the establishment(s) unless authorised by the competent authority.

2. The competent authority shall extend the measures in points (a) to (c) of paragraph 1 to kept animals from additional animal populations if they present a risk of spreading the disease.

Article 61

Derogations from the restriction of movement of animals and products of animal origin from infected establishments

1. By way of derogation from point (b) Article 60(1), the competent authority may authorise the movement of aquaculture animals to an establishment under its official supervision located within the same restricted zone provided that: (a) only animals showing no symptoms of disease are moved; (b) the health status of aquaculture animals at the establishment of destination or aquatic animals enroute to that establishment is not jeopardised by the movement; (c) in the establishment of destination they have no contact with aquaculture animals of a higher health status with respect to the relevant disease; (d) the animals are kept in the establishment of destination for a maximum period of time to be determined by the competent authority.

2. When making use of the derogation laid down in paragraph 1, the competent authority shall: (a) re-classify the health status of the establishment of destination, if relevant, in accordance with the criteria laid down in Article 52(1); (b) 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. (c) keep the establishment of destination under its official supervision until the completion of cleaning, disinfection and appropriate fallowing of the establishment.

3. By way of derogation from point (b) Article 60(1), the competent authority may authorise the movement of aquaculture animals to other infected establishments which are not implementing an eradication programme for that specific disease provided that: (a) only animals showing no symptoms of disease are moved; (b) 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 (c) the movement complies with the certification requirements set out in Article 208(2) of Regulation (EU) 2016/429.

4. By way of derogation from point (b) of Article 60(1), the competent authority may authorise the movement of aquaculture animals and products of animal origin to slaughtering and processing facilities other than disease control aquatic food establishments provided that: (a) only animals showing no symptoms of disease are moved; (b) 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; (c) the health status of aquatic animals enroute for the slaughtering and processing facility or in its vicinity is not jeopardised by the movement; (d) the movement complies with the certification requirements set out in Article 208(2) of Regulation (EU) 2016/429.

5. By way of derogation from point (b) of Article 60(1), the competent authority may authorise the movement of animals and products of animal origin from additional animal populations from the infected establishment(s) to other establishments without further restrictions provided that: (a) a risk assessment has been completed; (b) 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 (c) the movement complies with the certification requirements set out in Article 208(2) of Regulation (EU) 2016/429.

Article 62

Removal of infected animals

1. Following confirmation of the disease, the competent authority shall in all infected establishments order, within a maximum period of time to be determined by the competent authority, the following measures in relation to aquatic animals from listed species for the relevant disease: (a) removal of all dead animals; (b) removal and killing of all moribund animals; (c) removal and killing of all animals showing symptoms of disease; (d) 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.

2. The competent authority may order, based on duly justified grounds, the slaughtering for human consumption, or in the case of molluscs or crustacea which are sold live, removal from the water of: (a) all animals from listed species for the relevant disease in the infected establishment(s), without testing these animals; (b) suspected animals which have an epidemiological link with a confirmed case.

3. Slaughtering for human consumption or removal from the water of the animals referred to in paragraph 1 shall be carried out under official supervision either in the infected establishment(s) with subsequent processing in a disease control aquatic food establishment, or in a disease control aquatic food establishment, as appropriate.

4. The competent authority shall extend the measures laid down in this Article to aquaculture animals of additional animal populations when it is necessary to control the disease.

5. The competent authority may order the killing and destruction of some or all the animals referred to in paragraph 1 and animals of non-listed species in the infected establishment(s) instead of their slaughter for human consumption.

6. All animal by-products from animals that are slaughtered or killed in compliance with this Article shall be processed or disposed of as Category 1 or Category 2 material in accordance with Articles 12 or 13 of Regulation (EC) No 1069/2009.

Article 63

Cleaning and disinfection

1. The competent authority shall for all infected establishments order the cleaning and disinfection of the following structures and items prior to repopulation: (a) 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; (b) any husbandry related equipment including but not limited to feeding, grading, treatment and vaccination equipment, and workboats; (c) any production related equipment including but not limited to cages, netting, trestles, bags and longlines; (d) any protective clothing or safety equipment used by operators and visitors; (e) all means of transport including tanks and other equipment used to move infected animals or personnel who have been in contact with infected animals.

2. The competent authority shall approve the protocol for the cleaning and disinfection.

3. The competent authority shall supervise the cleaning and disinfection and shall not restore or grant again disease-free status to the establishments until it considers that the cleaning and disinfection has been completed.

Article 64

Fallowing

1. The competent authority shall order the fallowing of all infected establishments. The fallowing shall be carried out following completion of the cleaning and disinfection process laid down in Article 63.

2. The duration of the fallowing shall be appropriate to the relevant pathogen and to the type of production system used in the infected establishments. Certain fallowing periods are laid down in Part II of Annex VI, specifically in: (a) point 1(c) of Section 3 of Chapter 1 for VHS and IHN; (b) point 1(c) of Section 3 of Chapter 2 for infection with HPR-deleted ISAV; (c) point 1(c) of Section 3 of Chapter 3 for infection with Marteilia refringens; (d) point 1(c) of Section 3 of Chapter 4 for infection with Bonamia exitiosa; (e) point 1(c) of Section 3 of Chapter 5 for infection with Bonamia ostreae; (f) point 1(c) of Section 3 of Chapter 6 for infection with WSSV.

3. The competent authority shall order synchronous fallowing of the infected establishments within the protection zone or where no protection zone has been established, within the restricted zone. Synchronous fallowing may also be extended to other establishments based on risk assessment. The duration of the synchronous fallowing and the extent of the area within which such fallowing shall take place are laid down in Part II of Annex VI, specifically in: (a) point 1 of Section 3 of Chapter 1 for VHS and IHN; (b) point 1 of Section 3 of Chapter 2 for infection with HPR-deleted ISAV; (c) point 1 of Section 3 of Chapter 3 for infection with Marteilia refringens; (d) point 1 of Section 3 of Chapter 4 for infection with Bonamia exitiosa; (e) point 1 of Section 3 of Chapter 5 for infection with Bonamia ostreae; (f) point 1 of Section 3 of Chapter 6 for infection with WSSV.

Article 65

Risk mitigating measures to prevent reinfection

Before or upon removal of the disease control measures, the competent authority shall order proportionate risk mitigating measures to prevent the reinfection of the establishment taking into account relevant risk factors as indicated by the results of the epidemiological enquiry. These measures shall at least take account of:

(a) persistence of the disease agent in the environment or in wild animals;

(b) biosecurity measures that are adapted to the specificities of the establishment.







CHAPTER 4

Disease-free status







Section 1

Approval of disease-free status of Member States and zones

Article 66

Criteria for the granting of disease-free status

Disease-free status may only be granted to Member States or zones thereof when the following general and specific criteria are complied with:

(a) general criteria: (i) the territorial scope complies with the requirements laid down in Articles 13 or 47 as relevant; (ii) the surveillance for the disease complies with the requirements laid down in paragraph 1 or 2 of Article 3 as relevant; (iii) operators comply with obligations as regards biosecurity measures as laid down in Article 10 of Regulation (EU) 2016/429; (iv) the disease control measures relevant to the disease in the event of a suspicion or confirmation of the disease comply with the requirements laid down for: — infection with Brucella abortus, B. melitensis and B. suis , infection with MTBC, EBL, IBR/IPV, infection with ADV and BVD in Articles 21 to 31; — infection with RABV in Articles 35 and 36; — infection with BTV in Articles 41 and 42; — VHS, IHN, infection with HPR-deleted ISAV, infection with Marteilia refringens , infection with Bonamia exitiosa , infection with Bonamia ostreae and infection with WSSV in Articles 55 to 65; (v) the establishments were registered or approved, as relevant to the type of establishment; (vi) identification of animals from the targeted animal population and traceability of germinal products were ensured, as relevant for the type of animal; (vii) when moved, the animals from the targeted animal population or products thereof complied with the animal health requirements for the movement within the Union and entry into the Union of those animal