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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) (Text with EEA relevance)

Type Delegated Regulation

Publication 2020-06-03

Last updated 2026-04-22

State In force

Department European Commission, SANTE

Source EUR-Lex

articles 87

Reform history JSON API

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.

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

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.

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

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.

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

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.

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

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

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

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.

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.

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

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;

(d) Chapter 4 for infection with Bonamia exitiosa;

(e) Chapter 5 for infection with Bonamia ostreae;

(f) Chapter 6 for infection with WSSV.

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

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.

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.

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

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.

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.

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;

Article 55

Disease control measures in the event of suspicion of certain diseases

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

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.

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

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.

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

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.

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.

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

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);

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

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;

(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.

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.

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;

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;

Article 59

Epidemiological enquiry and investigations in case of confirmation of certain diseases

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.

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.

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

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.

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

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.

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.

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

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.

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

Article 62

Removal of infected animals

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;

(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.

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.

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.

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.

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.

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

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;

(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.

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

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

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.

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;

(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.

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;

(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 animals and products thereof;

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

Article 67

Disease-free status based on the absence of listed species

The criteria to recognise the disease-free status of a Member State or of a zone because of the absence of the listed species for that disease are as follows:

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

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

The Member State shall provide documentary evidence to substantiate the fulfilment of the criteria in paragraph 1. The documentary evidence shall demonstrate the sustainability of disease-free status considering that:

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

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

Article 68

Disease-free status based on the disease agent’s incapacity to survive

The criteria to recognise the disease-free status of a Member State or of a zone because of the disease agent’s incapacity to survive are as follows:

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

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

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

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

The Member State shall provide the following evidence to substantiate the fulfilment of the criteria in paragraph 1:

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

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

Article 69

Disease-free status of terrestrial animals based on the incapacity to survive of listed vectors for listed diseases of terrestrial animals

The criteria to recognise the disease-free status of a Member State or of a zone because of the incapacity to survive of listed vectors for that listed disease are as follows:

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

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

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

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

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

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

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

The Member State shall provide the following evidence to substantiate the fulfilment of the criteria in paragraph 1:

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

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

If the disease has occurred, the Member State shall provide documentary evidence that surveillance has demonstrated with a 95 % level of confidence that the prevalence rate of the disease was lower than 1 %.

Article 70

Disease-free status based on historical and surveillance data

The criteria to recognise the disease-free status of a Member State or a zone thereof based on historical and surveillance data are as follows:

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

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

A Member State wishing to obtain the approval of disease-free status for its entire territory or for a zone thereof on the basis of the provisions set out in point (a) of paragraph 1 shall have implemented the following measures for an eligibility period of at least 10 years:

(a) disease surveillance of kept animals of listed species;

(b) prevention to control the introduction of the disease agent;

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

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

By way of derogation from point (b) of paragraph 1 the Commission may, for a period of two years following the entry of application of this Regulation, grant disease-free status to Member States or zones as regards:

(a) infection with RABV, if it was notifiable in accordance with Article 8 of Directive 64/432/EEC and, when necessary monitoring was implemented in accordance with Article 4 of Directive 2003/99/EC ([^E0003]) of the European Parliament and of the Council, and no case was reported in listed animals species for the past two years;

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

Article 71

Disease-free status based on eradication programmes

The criteria to recognise the disease-free status of a Member State or a zone based on eradication programmes are as follows:

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

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

By way of derogation from paragraph 1, in the case of aquatic animals where a zone covers less than 75 % of the territory of a Member State and is not shared with another Member State or third country, disease-free status may be achieved in accordance with Article 83.

Article 72

Disease specific requirements for disease-free status

Disease specific requirements for the granting of disease-free status to a Member State or to a zone are provided in:

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

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

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

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

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

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

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

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

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

(ja) Section 2 of Part V of Annex V for status free from infestation with Echinococcus multilocularis;

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

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

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

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

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

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

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

Section 2 Approval of disease-free status for compartments keeping aquaculture animals

Article 73

Criteria for the granting of disease-free status to compartments keeping aquaculture animals

Disease-free status may only be granted to a compartment keeping aquaculture animals when the following general and specific criteria are complied with:

(a) general criteria:
(i) the territorial scope complies with point (c) of Article 47(2);
(ii) the surveillance for the disease complies with the requirements laid down in Articles 3(2), 4 and 6 to 9;
(iii) operators comply with obligations as regards biosecurity measures as laid down in Article 10 of Regulation (EU) 2016/429;
(iv) compliance with the disease control measures relevant to the disease in the event of a suspicion or confirmation;
(v) the establishments of which the compartment is comprised are approved;
(vi) traceability of the animals from the targeted animal population was ensured;
(vii) when moved, the animals from the targeted animal population or products thereof complied with the animal health requirements for movement within the Union or for entry into the Union of those animals and products thereof;

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

The disease-free status referred to in paragraph 1 may be granted to:

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

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

In the case of the dependent compartments referred to in point (b) of paragraph 2, the competent authority shall:

(a) assess at least the following epidemiological factors:
(i) geographical location of each establishment in the compartment and the nature of the water supply;
(ii) health status of other aquaculture establishments in the water system;
(iii) the location of the establishments referred to in point (ii) and their distance from the dependent compartment;
(iv) production volume of the establishments referred to in point (ii) as well as their method of production and the source of their animals;
(v) presence and abundance of wild aquatic animals from relevant listed species in the water system and their health status;
(vi) details of whether the species referred to in point (v) are sedentary or migratory;
(vii) possibility of the wild aquatic animals referred to in point (v) entering the compartment;
(viii) general biosecurity measures in the compartment;
(ix) general hydrological conditions in the water system;

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

When a disease-free declaration for a dependent compartment is made to the Commission in accordance with Article 83, the competent authority shall provide the assessment referred to in point (a) of paragraph 3 and details of any measure which were put in place to prevent the introduction of the disease into the compartment.

The competent authority shall communicate to the Commission without delay any subsequent changes to the epidemiological factors set out in point (a) of paragraph 3 and measures taken to mitigate their impact.

Article 74

Disease-free status based on the absence of listed species

The criteria to recognise the disease-free status of a compartment keeping aquaculture animals because of the absence of the listed species for that disease are as follows:

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

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

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

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

Article 75

Disease-free status based on the disease agent’s incapacity to survive

The criteria to recognise the disease-free status of a compartment keeping aquaculture animals because of the disease agent’s incapacity to survive are as follows:

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

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

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

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

The Member State shall provide the following evidence to substantiate the fulfilment of the criteria in paragraph 1:

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

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

Article 76

Disease-free status based on historical and surveillance data

The criteria to recognise the disease-free status of a compartment keeping aquaculture animals based on historical and surveillance data are as follows:

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

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

A Member State wishing to obtain the approval of disease-free status for the compartment on the basis of the provisions set out in point (a) of paragraph 1 shall have implemented the following measures for an eligibility period of at least 10 years:

(a) disease surveillance of kept animals of listed species;

(b) prevention to control the introduction of the disease agent;

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

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

Article 77

Disease-free status based on eradication programmes

The criteria to recognise the disease-free status of a compartment keeping aquaculture animals based on eradication programmes are:

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

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

By way of derogation from paragraph 1, where a compartment covers less than 75 % of the territory of a Member State and the water catchment supplying the compartment is not shared with another Member State or third country, disease-free status may be achieved in accordance with Article 83.

Article 78

Disease specific requirements for disease-free status

Disease-specific requirements for the granting of disease-free status to a compartment keeping aquaculture animals are provided in:

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

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

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

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

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

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

Article 79

Specific requirements for compartments which are independent of the health status of the surrounding natural waters

In addition to the general criteria for granting disease-free status to compartments keeping aquaculture animals as set out in Article 73(1), a compartment which comprises one or more individual establishments where the health status regarding a specific disease is independent of the health status of the surrounding natural waters, may obtain disease-free status if it complies with paragraphs 2 to 6.

An independent compartment may comprise:

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

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

An independent compartment shall be supplied with water:

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

(b) directly from a well, a borehole or a spring.

Where such water supply originates from a source outside the establishment, the water shall be supplied directly to the establishment, and be channelled to the establishment by means which afford appropriate protection from infection.

There shall be natural or artificial barriers that prevent aquatic animals from entering each establishment in the compartment from the surrounding natural waters.

The compartment shall, where appropriate, be protected against flooding and infiltration of water from the surrounding natural waters.

The compartment shall comply with the disease-specific requirements referred to in Article 78.

Article 80

Special provisions for compartments which comprise individual establishments which commence or recommence aquaculture activities and where the health status regarding a specific disease is independent of the health status of the surrounding natural waters

A new establishment which is to commence aquaculture activities is considered to be disease-free when:

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

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

An establishment which recommences aquaculture activities after a break and complies with paragraph 1 is considered to be disease-free without the surveillance referred to in point (a)(ii) of Article 73(1) provided:

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

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

An establishment which recommences its activities after the confirmation of a category B or category C disease is considered to be disease-free from the confirmed disease, provided:

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

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

Section 3 Maintenance, suspension and withdrawal of disease-free status

Article 81

Specific criteria on surveillance and biosecurity measures for the maintenance of disease-free status

The Member States, zones or compartments thereof may maintain disease-free status only if, in addition to the criteria laid down in points (a) and (c) of Article 41(1) of Regulation (EU) 2016/429, they comply with:

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

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

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

In the case of aquatic animals, when a Member State is declared free from one or more of the listed diseases, it may discontinue targeted surveillance as referred to in points (k) to (q) of paragraph 3 and maintain its disease-free status provided that the risk of introduction of the relevant disease has been assessed and conditions conducive to clinical expression of the disease in question exist.

In disease-free zones or compartments in Member States which are not declared disease-free, or in all cases where conditions conducive to clinical expression of the disease in question do not exist, targeted surveillance shall be continued as referred to in points (k) to (q) of paragraph 3.

The disease specific requirements as regards surveillance and biosecurity measures are provided in:

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

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

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

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

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

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

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

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

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

(ja) Section 3 of Part V of Annex V for status free from infestation with Echinococcus multilocularis;

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

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

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

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

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

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

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

Article 82

Suspension, withdrawal and restoration of disease-free status

If the disease has been confirmed and therefore the conditions for maintaining the disease-free status of a Member State, a zone or compartment thereof are not fulfilled, the competent authority shall:

(a) apply without delay the relevant disease control measures;

(b) conduct specific surveillance to assess the extent of the outbreak;

If the disease has not been confirmed, but there has been a breach of one of the conditions for maintaining the disease-free status of a Member State, a zone or compartment thereof, the competent authority shall take the appropriate corrective measures and assess the risk that the health situation has changed.

The competent authority may where necessary, as a transitional measure, suspend the disease-free status of the Member State, a zone or compartment thereof rather than the Commission withdrawing the disease-free status. During that suspension, the competent authority shall:

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

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

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

Subject to compliance with the provisions of paragraph 3 the competent authority may restore the disease-free status of the Member State, zone or compartment thereof by lifting the suspension.

Section 4 Derogations from approval by the Commission

Article 83

Derogations from approval by the Commission for certain disease-free statuses and certain eradication programmes for aquatic animal diseases

By way of derogation from the requirement to submit eradication programmes to the Commission for approval as provided for in Article 31(1)(b) and Article 31(2) of Regulation (EU) 2016/429 or from the requirements to obtain approval by the Commission for disease-free status laid down in Article 36(4) and 37(4) of that Regulation, for aquatic animal diseases, such approval for zones or compartments which cover less than 75 % of the territory of a Member State, and where the water catchment supplying the zone or compartment is not shared with another Member State or third country, shall be gained in accordance with the following procedure:

(a) a Member State makes a provisional declaration of freedom or of the establishment of an eradication programme for the zone or compartment, which fulfils the requirements as set out in this Regulation;

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

(c) 60 days after publication, the provisional declaration shall take effect and the zone or compartment referred to in this paragraph shall achieve disease-free status or have the eradication programme approved.

Within the 60-day period referred to in point (c) of paragraph 1, the Commission or Member States may seek clarification or additional information in relation to the supporting evidence provided by the Member State making the provisional declaration.

Where written comments are made by at least one Member State, or the Commission, within the period referred to in point (c) of paragraph 1 indicating concerns relating to the evidence which supports the declaration, the Commission, the Member State which made the declaration and where relevant, the Member State which has sought clarification or additional information, shall together examine the submitted evidence in order to resolve the concerns.

In such cases, the period referred to in point (c) of paragraph 1 shall be prolonged automatically for 60 days from the date on which the first concerns were raised. There shall be no further prolongation of this period.

Where the process referred to in paragraph 3 fails, the provisions laid down in Articles 31(3), 36(4) and 37(4) of Regulation (EU) 2016/429 shall apply.

PART III

TRANSITIONAL AND FINAL PROVISIONS

Article 84

Transitional provisions concerning existing disease-free status

The Member States and zones thereof with an approved disease-free status before the date of application of this Regulation shall be deemed to have an approved disease-free status in accordance with this Regulation for the following statuses:

(a) free from infection with Brucella abortus, B. melitensis, B.suis:
(i) in bovine animal populations when the brucellosis-free status was granted in accordance with Directive 64/432/EEC;
(ii) in ovine and caprine animal populations, when the brucellosis-free (B. melitensis-free) status was granted in accordance with Directive 91/68/EEC;

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

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

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

(f) free from infestation with Varroa spp., when varroasis-free status was granted in accordance with Council Directive 92/65/EEC ([^E0004]);

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

(h) free from VHS, when VHS-free status was granted in accordance with Council Directive 2006/88/EC ([^E0005]);

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

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

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

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

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

(n) free from infestation with Echinococcus multilocularis, when Echinococcus multilocularis-free status was granted in accordance with Regulation (EU) No 576/2013 of the European Parliament and of the Council ([^E0006]).

The compartments in Member States with an approved disease-free status before the date of application of this Regulation shall be deemed to have an approved disease-free status in accordance with this Regulation for the following statuses:

(a) free from highly pathogenic avian influenza, when the compartment has been approved with respect to avian influenza in accordance with Commission Regulation (EC) No 616/2009 ([^E0007]);

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

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

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

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

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

The Member States deemed to have an approved disease-free status in accordance with paragraph 1 or 2 shall ensure that the conditions of maintenance of the status conform with those laid down in this Regulation.

Article 85

Transitional provisions concerning existing eradication or surveillance programmes

The Member States and zones thereof with an approved eradication programme or an approved surveillance programme before the date of application of this Regulation shall be deemed to have an approved eradication programme in accordance with this Regulation for the following diseases for a period of six years from the date of application of this Regulation:

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

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

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

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

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

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

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

The compartments in Member States with an approved eradication programme or an approved surveillance programme before the date of application of this Regulation shall be deemed to have an approved eradication programme in accordance with this Regulation for the following diseases for a period of six years from the date of application of this Regulation:

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

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

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

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

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

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

The Member States deemed to have an approved eradication programme in accordance with paragraphs 1 or 2 shall ensure that the measures in the programme conform with those laid down for eradication programmes in this Regulation.

Article 86

Repeal

The following acts are repealed as from 21 April 2021:

— Decision 2000/428/EC;

— Decision 2002/106/EC;

— Decision 2003/422/EC;

— Decision 2006/437/EC;

— Regulation (EC) No 1266/2007;

— Decision 2008/896/EC;

— Decision 2010/367/EU;

— Implementing Decision (EU) 2015/1554.

References to those repealed acts shall be construed as references to this Regulation.

Article 87

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 21 April 2021.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

SPECIFIC CASE DEFINITION OF DISEASE OF TERRESTRIAL ANIMALS

Section 1 Highly pathogenic avian influenza (HPAI)

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

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

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

(b) nucleic acid specific to the disease agent for HPAI, that is not a consequence of vaccination, has been identified in a sample from an animal or from a group of animals; or

(c) positive result to an indirect diagnostic method, that is not a consequence of vaccination, has been obtained in a sample from a kept animal or from a group of kept animals showing clinical signs consistent with the disease or epidemiologically linked to a suspected or confirmed case.

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

(a) an influenza A virus of H5 and H7 subtypes or any influenza A virus with an intravenous pathogenicity index (IVPI) greater than 1,2 ; or

(b) an influenza A virus of H5 and H7 subtypes with a sequence of multiple basic amino acids present at the cleavage site of the haemagglutinin molecule (HA0) that is similar to that observed for other HPAI isolates.

Section 2 Infection with low pathogenic avian influenza viruses (LPAIV)

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

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

(a) the disease agent responsible for infection with LPAIV, excluding vaccine strains, has been isolated in a sample from an animal or from a group of animals;

(b) nucleic acid specific to the disease agent for infection with LPAIV, that is not a consequence of vaccination, has been identified in a sample from an animal or from a group of animals; or

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