LegalizeCommission 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)
(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 (3) 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.
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;
(c) Section 1 of Chapter 2 of Part III of Annex IV for status free from EBL;
(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;
(c) impose whatever measures are found to be necessary to prevent the introduction of disease.
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.
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 the disease-free status considering that:
(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.
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;
(c) Section 2 of Chapter 2 of Part II of Annex VI for status free from infection with HPR-deleted ISAV;
(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
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.
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 %;
(c) results of the testing described in point (b) are negative.
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 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;
(c) Section 2 of Chapter 2 of Part III of Annex IV for status free from EBL;
(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;
(c) order any necessary risk mitigating measures.
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.
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.
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.
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;
(c) free from EBL, when EBL-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 (4);
(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 (5);
(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 (6).
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 (7);
(b) free from VHS, when VHS-free status was granted in accordance with Directive 2006/88/EC;
(c) free from IHN, when IHN-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.
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;
(c) VHS, when the VHS surveillance or eradication programme was approved in accordance with Directive 2006/88/EC;
(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.
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
(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 of infection with LPAIV must be any influenza A virus of H5 and H7 subtypes that are not HPAI viruses.
Section 3
Infection with Newcastle disease virus (NDV)
1.An animal or a group of animals must be considered, by the competent authority, as a suspected case of infection with NDV when it meets the criteria laid down in Article 9(1).
2.An animal or a group of animals must be considered, by the competent authority, as a confirmed case of infection with NDV when:
(a) the disease agent responsible for infection with NDV, 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 NDV, 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 infection with NDV must be any avian paramyxovirus type 1 (APMV-1) (avian Avulavirus type 1) that either:
(a) has an intracerebral pathogenicity index (ICPI) of 0,7 or greater; or
(b) presents multiple basic amino acids at the C-terminus of the F2 protein and phenylalanine at residue 117, which is the N-terminus of the F1 protein. The term ‘multiple basic amino acids’ refers to at least three arginine or lysine residues between residues 113 and 116. Failure to demonstrate the characteristic pattern of amino acid residues as described above would require characterisation of the isolated virus by an ICPI test. In this definition, amino acid residues are numbered from the N-terminus of the amino acid sequence deduced from the nucleotide sequence of the F0 gene (113–116 corresponds to residues –4 to –1 from the cleavage site).
ANNEX II
UNION SURVEILLANCE PROGRAMME
PART I
AVIAN INFLUENZA SURVEILLANCE IN ANIMALS
Surveillance must be implemented in all Member States.
Until revoked.
The surveillance system must address the objectives provided for in Section 2 and must be built on a comprehensive approach including different components of surveillance activities complementing each other in poultry and wild bird populations:
— Early detection systems as provided for in Sections 3 and 4;
— Risk-based surveillance as provided for in Sections 5 and 6.
1.Early detection of highly pathogenic avian influenza (HPAI) in poultry.
2.Early detection of HPAI in wild birds providing for:
(a) an early warning for possible HPAI introduction into poultry, in particular when viruses enter the Union through migratory movements of wild birds;
(b) information for the assessment of risks for virus spread following findings of HPAI in wild birds.
3.Detection of HPAI in poultry species which generally do not show significant clinical signs.
4.Detection of circulating low pathogenic avian influenza viruses (LPAIV) that may easily spread between poultry flocks in particular in areas with a high density of poultry establishments in view of their potential to mutate to HPAI in order to:
(a) identify clusters of infection with LPAIV; and
(b) monitor the risk of spread of LPAIV by movements of poultry and by fomites in certain production systems at risk.
5.Contribution to increased knowledge on HPAI and LPAIV posing a potential zoonotic risk.
1.The early detection systems for of HPAI in poultry must be part of the general surveillance requirements as provided for in point (a) of Article 3(1) and must be implemented throughout the poultry sector.
2.The surveillance referred to in point 1 must at least include the early detection and investigation in establishments located in an area identified as being at heightened risk for HPAI introduction and spread, of:
(a) any change in normal production and health parameters such as mortality rate, feed and water intake and egg production; and
(b) any clinical sign or post-mortem lesion suggesting HPAI.
3.Regular testing of samples collected from dead and sick poultry in establishments located in an area identified as being at heightened risk for HPAI introduction and spread may also be relevant when an increased risk has been identified at national, EU or regional level due to outbreaks of HPAI in poultry and/or wild birds.
1.The early detection of HPAI in wild birds must be based on sampling and testing of birds that have been:
(a) found dead;
(b) found injured or sick;
(c) hunted with clinical signs.
This surveillance may need to be increased, when HPAI has been detected in wild birds, by monitoring systems using organised patrols for detecting and collecting dead and sick birds.
2.The design of this surveillance must be risk-based, taking into account at least relevant information on ornithology, virology, epidemiology and environmental matters.
3.The surveillance must apply to birds from targeted wild bird species, as provided for in Section 8. However, all suspected episodes of mortality in wild birds must be investigated to exclude HPAI.
In addition to targeted wild bird species, additional wild bird species may also be included when their specific epidemiological relevance on the Member State’s territory has been assessed.
4.In addition, the surveillance may include, at priority locations and key sites in particular those where birds of targeted wild birds species are entering the Union during their migratory movements, at least from North-East and Eastern routes, the sampling and testing of:
(a) birds trapped;
(b) hunted healthy birds;
(c) sentinel birds.
5.Additional sources of information obtained from investigations of wild birds in the context of HPAI outbreaks in kept birds must be included in the results of the surveillance of HPAI in wild birds.
1.The risk-based surveillance for infection with HPAI in poultry establishments keeping ducks, geese, poultry belonging to the species of Anseriformes for supplies of game or quails to be released into the wild must take into account at least the following risk factors:
(a) the historical and current epidemiological situation of the disease and its evolution over time in poultry and wild birds;
(b) the proximity of establishments to water bodies and other places where migratory birds, in particular water birds, may gather in higher numbers or have their stop-over places during their movements into and through the Union;
(c) the period of increased movements of migratory wild birds of targeted species into and through the Union;
(d) the structure of poultry farming including the broader sector involved in the different production systems;
(e) the geographical location of the establishments in an area with a high density of poultry;
(f) the biosecurity practices on the establishments;
(g) the type and frequency of movements of poultry, products and vehicles transporting poultry and trade patterns; and
(h) the risk assessments and scientific advice in relation to the relevance of the spread of HPAI by wild birds.
2.Based on scientific justifications, additional risk factors than those listed in points (a) to (h) of point 1 may be included and factors that are not relevant for the specific situation of the Member State may be omitted.
1.The risk-based surveillance for the detection of circulating low pathogenic avian influenza viruses (LPAIV) that may easily spread between poultry flocks in particular in areas with a high density of poultry establishments, as referred to in point 4 of Section 2, must apply to poultry establishments for which the competent authority has assessed that clusters of infection with LPAIV have repeatedly occurred in the past or are deemed more likely to occur.
2.Such clusters are characterised by infection with LPAIV of groups of establishments related in time and geographical proximity.
3.The assessment for the selection of establishments for targeted surveillance must take into account the risk for lateral transmission of the virus due to the structure and complexity of the production system and functional connections between establishments, in particular when operating in areas with a high density of establishments.
4.In addition to the selection criteria for targeted surveillance of establishments referred to in point 3, the following risk factors must be taken into account at the establishment level:
(a) the kept species;
(b) the cycle and duration of production;
(c) presence of several poultry species;
(d) presence of multi-age poultry flocks;
(e) presence of long-lived poultry;
(f) practice of all-in all-out principle;
(g) length of waiting period between batches; and
(h) biosecurity practices and housing conditions.
1.Early detection systems for infection with HPAI referred to in Section 3 must apply to all poultry populations.
2.Complementary surveillance for infection with HPAI referred to in Section 5 in poultry species that do generally not display significant signs when infected with HPAI must apply to:
(a) breeding ducks
(b) breeding geese;
(c) fattening ducks;
(d) fattening geese;
(e) quails;
(f) poultry of species belonging to Anseriformes for supplies of game to be released into the wild.
3.In addition to the species and categories listed under point 2 the targeting of sampling and testing for infection with LPAIV referred to in Section 6 may apply to the following poultry species and production categories:
(a) laying hens including those kept in free-range;
(b) breeding turkeys;
(c) fattening turkeys;
(d) the poultry of species belonging to Galliformes for supplies of game to be released into the wild.
Targeted wild birds species, in particular migratory water birds have shown to be at higher risk of becoming infected with, and transmitting HPAI.
The list of ‘wild bird targeted species’ compiled and updated in the light of the most recent knowledge is available on the website of the EURL.
1.The number of poultry establishments to be sampled and the number of poultry to be tested per establishment and, as appropriate, by epidemiological unit (e.g. poultry flock, shed, etc.) on the concerned establishment must be based on a statistically valid sampling method. This method may be that used for representative sampling; i.e. an estimated prevalence to be detected according to a pre-defined level of confidence determined by the competent authority.
2.Frequency and period for testing:
(a) the frequency for sampling and testing of poultry establishments must be determined based on the outcome of a risk assessment by the competent authority;
(b) the time period for sampling must coincide with seasonal production for each production category, but must not compromise the risk-based surveillance approach;
(c) when relevant, the time period for sampling must take into account the period of heightened risk as referred to in point 3 of Section 3. Samples must be subjected to laboratory testing by virological methods, when taken for: (i) early detection of HPAI in poultry referred to in Section 3; (ii) early detection of HPAI in wild birds referred to in Section 4; (iii) complementary surveillance for HPAI in poultry species which generally do not show significant clinical signs of HPAI referred to in Section 5; (iv) follow-up of sero-positive findings referred to in point 4(b).
For virological testing the prevalence and time window for detection of active infection must be taken into account.
3.Samples must be subjected to laboratory testing by serological methods, when taken for:
(a) complementary surveillance for HPAI in poultry species which generally do not show significant clinical signs of HPAI referred to in Section 5 supplementing virological testing, as appropriate;
(b) detection of clusters of LPAIV infected establishments referred to in Section 6. When for technical reasons or other duly justified reasons sampling for serology is not appropriate, virological testing must be performed.
HPAI surveillance must include surveillance activities in kept and wild animals of species not listed when the epidemiological situation indicates that those species may constitute a risk for animal and human health.
ANNEX III
DIAGNOSTIC METHODS FOR THE GRANTING AND MAINTENANCE OF DISEASE-FREE STATUS FOR CERTAIN DISEASES OF TERRESTRIAL ANIMALS
Section 1
Infection with Brucella abortus, B. melitensis and B. suis
1.Serological tests
(a) tests for blood samples (i) buffered Brucella antigen tests; (ii) complement fixation test (CFT) (iii) indirect enzyme-linked immunosorbent assay (I-ELISA) (iv) fluorescence polarisation assay (FPA) (v) competitive enzyme-linked immunosorbent assay (C-ELISA)
(b) tests for milk samples (i) ring test (MRT) (ii) I-ELISA
2.Brucellin skin test (BST)
For the testing as referred to in section 1 and 2 of Chapter 1 of Part I of Annex IV, Brucellin skin test (BST) shall only be used in ovine and caprine animals.
Section 2
Infection with mycobacterium tuberculosis complex
1.Tuberculin skin tests
(a) the single intradermal tuberculin test (SITT)
(b) the comparative intradermal tuberculin test (CITT)
2.Gamma-interferon assay
Section 3
Enzootic bovine leukosis
1.Serological tests
(a) tests for blood samples (i) agar gel immuno-diffusion test (AGID) (ii) blocking enzyme-linked immunosorbent assay (B-ELISA) (iii) I-ELISA
(b) tests for milk samples (i) I-ELISA
Section 4
Infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV)
| Methods: | Matrix: | |
|---|---|---|
| non-vaccinated bovine animals | BoHV-1 I-ELISA () | individual serum samples () |
| milk samples | ||
| gB B-ELISA () | individual serum samples () | |
| individual meat juice samples | ||
| DIVA vaccinated bovine animals with a gE-deleted vaccine | gE B-ELISA () | individual serum samples |
| individual meat juice samples | ||
| (1) I-ELISA for the detection of antibodies against BoHV-1 whole virus. Pools of up to 50 milk samples (individual or bulk milk) may be used in tests for granting and up to 100 milk samples (individual or bulk milk) may be used in tests for the maintenance of the status free from IBR/IPV. (2) B-ELISA for the detection of antibodies against BoHV-1-gB protein. When referred to tests for the detection of antibodies against whole BoHV-1 in Part IV of Annex IV this method may also be used. (3) B-ELISA for the detection of antibodies against BoHV-1-gE protein. Individual milk samples may be used when testing to proof the maintenance of the status free from IBR/IPV. The samples may be pooled whereat the number of samples per pool may be chosen based on documented evidence that the test is under all circumstances of day to day laboratory work sensitive enough to detect one single positive sample in the pool. (4) When testing is carried out to proof the maintenance of the status free from IBR/IPV individually collected samples may be pooled. The number of samples per pool may be modulated based on documented evidence that the test system is under all circumstances of day to day laboratory work sensitive enough to detect one weak positive sample in the pool of the modulated size. |
Section 5
Infection with Aujeszky’s disease virus (ADV)
| Methods: | Matrix: | |
|---|---|---|
| non-vaccinated porcine animals | ADV ELISA () | individual or up to 5 pooled serum (or plasma) samples |
| individual or up to 5 pooled filter paper samples | ||
| individual meat juice samples | ||
| DIVA vaccinated porcine animals with a gE-deleted vaccine | gE ELISA () | individual serum samples |
| (1) ELISA for the detection of antibodies against whole ADV, ADV-gB protein or ADV-gD protein. For batch control of ADV-gB kits and ADV-gD kits or whole ADV kits, Community reference serum ADV 1, or sub-standards, must be scored positive at the dilution of 1:2. When referred to tests for the detection of whole ADV in Part V of Annex IV either of these tests may be used. (2) ELISA for the detection of antibodies against ADV-gE protein. For batch control, Community reference serum ADV 1, or sub-standards, must be scored positive at the dilution 1:8. |
Section 6
Bovine viral diarrhoea (BVD)
1.Direct methods:
(a) Real-time reverse transcription PCR
(b) BVDV antigen detection ELISA
2.Serological tests:
(a) I-ELISA
(b) B-ELISA
Section 7
Infestation with Echinococcus multilocularis
1.Sedimentation and counting technique (SCT), or a technique of equivalent sensitivity and specificity, for the detection of the Echinococcus multilocularis parasite on intestinal contents.
2.Polymerase chain reaction (PCR) methods, or a technique of equivalent sensitivity and specificity, for the detection of species-specific deoxyribonucleic acid (DNA) from tissue or eggs of the Echinococcus multilocularis parasite on intestinal contents or faeces.
ANNEX IV
DISEASE-SPECIFIC REQUIREMENTS FOR THE GRANTING, MAINTENANCE, SUSPENSION AND WITHDRAWAL OF THE DISEASE-FREE STATUS AT THE LEVEL OF ESTABLISHMENTS AND DISEASE-SPECIFIC REQUIREMENTS FOR THE GRANTING AND MAINTENANCE OF THE DISEASE-FREE STATUS AT THE LEVEL OF MEMBER STATES OR ZONES
PART I
INFECTION WITH BRUCELLA ABORTUS, B. MELITENSIS AND B. SUIS
1.The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination may only be granted to an establishment keeping bovine, ovine or caprine animals if:
(a) during the past 12 months there has been no confirmed case of infection with Brucella abortus, B. melitensis and B. suis in bovine, ovine or caprine animals kept in the establishment;
(b) during the past 3 years none of the bovine, ovine or caprine animals in the establishment has been vaccinated against infection with Brucella abortus, B. melitensis and B. suis;
(c) the entire bovine animals over 12 months of age and the entire ovine or caprine animals over 6 months of age present in the establishment at the time of sampling have tested negative to serological test, on two occasions as follows: (i) the first test must be carried out on samples taken not earlier than 3 months after the removal of the last confirmed case and of the last animal that tested positive in an immunological test; (ii) the second test must be carried out on samples taken not earlier than 6 months and not later than 12 months following the date of sampling referred to in point (i);
(d) animals showing clinical signs consistent with infection with Brucella abortus, B. melitensis and B. suis, such as abortions, have been subjected to investigations with negative results;
(e) since the beginning of the sampling referred to in point (c)(i) all bovine, ovine or caprine animals introduced into the establishment originate from establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination, or free with vaccination and have not been vaccinated against infection with Brucella abortus, B. melitensis and B. suis during the past 3 years, and (i) originate from a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis for the relevant animal population; (ii) are entire bovine animals over 12 months of age or entire ovine or caprine animals over 6 months of age and must have tested negative in a serological test carried out on a sample taken: — during the 30 days prior to their introduction into the establishment; or — during the 30 days following their introduction provided they have been kept isolated during this period; or (iii) are post-parturient females kept in isolation since their introduction into the establishment until they have tested negative in a serological test carried out on a sample taken not earlier than 30 days after parturition; and
(f) since the beginning of the sampling referred to in point (c)(i), all germinal products of bovine, ovine or caprine origin introduced into or used in the establishment originate from: (i) establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination; or (ii) approved germinal product establishments.
2.By way of derogation from point 1, the status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination may be granted to an establishment if all bovine, ovine or caprine animals originate from establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination, or free with vaccination and have not been vaccinated during the past 3 years, and:
(a) originate from a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis for the relevant animal population;
(b) are entire bovine animals over 12 months of age or entire ovine or caprine animals over 6 months of age and have tested negative in a serological test carried out on a sample taken: — during the 30 days prior to their introduction into the establishment; or — during the 30 days following their introduction into the establishment provided they have been kept isolated during this period; or
(c) are post-parturient females kept in isolation since their introduction into the establishment until they tested negative in a serological test carried out on a sample taken not earlier than 30 days after parturition.
3.By way of derogation from point 1, the status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination may be granted to an establishment with the status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination if:
(a) the requirements set out in points (a), (b), (d), (e) and (f) of point 1 are fulfilled; and
(b) the requirement set out in point (b)(i) of Section 2 is fulfilled.
The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination of an establishment keeping bovine, ovine or caprine animals may only be maintained if:
(a) the requirements set out in points (a), (b), (d), (e) and (f) of point 1 of Section 1 continue to be fulfilled; and
(b) serological testing is carried out with negative results on samples taken from: (i) all entire bovine animals over 12 months of age and all entire ovine or caprine animals over 6 months of age at appropriate intervals of not more than 12 months determined by the competent authority, taking into account the type of production, the situation of the disease and the identified risk factors; or (ii) entire bovine animals over 12 months of age and entire ovine or caprine animals over 6 months of age kept in establishments located in a Member State or in a zone free from infection with Brucella abortus, B. melitensis and B. suis, in accordance with a testing regime set up by the competent authority, taking into account the type of production and the identified risk factors.
1.The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination of an establishment keeping bovine, ovine or caprine animals must be suspended if:
(a) one or more of the requirements set out in Section 2 are not fulfilled; or
(b) a case of infection with Brucella abortus, B. melitensis and B. suis is suspected in a bovine, ovine or caprine animal kept in the establishment.
2.The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination may only be restored if:
(a) the requirements set out in points (b), (d), (e) and (f) of point 1 of Section 1 and in point (b) of Section 2 are fulfilled;
(b) the results of further investigations substantiate absence of infection with Brucella abortus, B. melitensis and B. suis and the status of all suspected cases has been determined.
1.The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination of an establishment keeping bovine, ovine or caprine animals must be withdrawn if:
(a) one or more of the requirements set out in Section 2 are not fulfilled after the maximum period of time referred to in point (b) of Article 20(3) has lapsed since the status was suspended;
(b) the infection with Brucella abortus, B. melitensis and B. suis cannot be ruled out in accordance with point 2(b) of Section 3;
(c) a case of infection with Brucella abortus, B. melitensis and B. suis has been confirmed in a bovine, ovine or caprine animal kept in the establishment; or
(d) it is justified by other needs to control infection with Brucella abortus, B. melitensis, B. suis.
2.If the status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in Section 2 are fulfilled.
3.If the status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination has been withdrawn in accordance with point 1(b), 1(c) or 1(d), it may only be regained if all confirmed cases and all animals that have tested non-negative have been removed and the remaining bovine, ovine or caprine animals fulfil the requirements set out in point 1(c) of Section 1.
4.By way of derogation from point 3, where the infection with B. suis biovar 2 was confirmed in a single bovine, ovine or caprine animal kept in the establishment, the status may be regained after negative testing was obtained on samples taken in accordance with the requirements set out in point 1(c)(i) of Section 1.
1.The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination may only be granted to an establishment keeping bovine, ovine or caprine animals if:
(a) the requirements set out in points (a), (c) and (d) of point 1 of Section 1 of Chapter 1 are fulfilled;
(b) since the beginning of the sampling referred to in point (c)(i) of point 1 of Section 1 of Chapter 1, all bovine, ovine, or caprine animals introduced into the establishment originate from establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination or free from infection with Brucella abortus, B. melitensis and B. suis with vaccination and: (i) originate from a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis for the relevant animal population; (ii) are entire bovine animals over 12 months of age or entire ovine or caprine animals over 6 months of age and have tested negative in a serological test on a sample taken — during the 30 days prior to their introduction into the establishment; or — during the 30 days following their introduction into the establishment provided they have been kept isolated during this period; or (iii) are post-parturient females kept in isolation since their introduction into the establishment until they have tested negative in a serological test carried out on a sample taken not earlier than 30 days after parturition; and
(c) since the beginning of the sampling referred to in point (c)(i) of point 1 of Section 1 of Chapter 1, all germinal products of bovine, ovine or caprine origin introduced into or used in the establishment originate from: (i) establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination or free from infection with Brucella abortus, B. melitensis and B. suis with vaccination; or (ii) approved germinal product establishments.
2.By way of derogation from point 1, the status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination may be granted to an establishment if all bovine, ovine or caprine animals originate from establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination, or free with vaccination, and:
(a) originate from a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis for the relevant animal population;
(b) are entire bovine animals over 12 months of age or entire ovine or caprine animals over 6 months of age and have tested negative in a serological test carried out on a sample taken: (i) during the 30 days prior to their introduction into the establishment; or (ii) during the 30 days following their introduction into the establishment provided they have been kept isolated during this period; or
(c) are post-parturient females kept in isolation since their introduction into the establishment until they have tested negative in a serological test carried out on a sample taken not earlier than 30 days after parturition.
The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination of an establishment keeping bovine, ovine or caprine animals may only be maintained if:
(a) the requirements set out in points (b) and (c) of point 1 of Section 1 of this Chapter and in points (a) and (d) of point 1 of Section 1 of Chapter 1 continue to be fulfilled; and
(b) serological testing is carried out with negative results on samples taken from all entire bovine animals over 12 months of age and all entire ovine or caprine animals over 6 months of age at appropriate intervals of not more than 12 months determined by the competent authority taking into account the type of production, the situation of the disease and the identified risk factors.
1.The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination of an establishment keeping bovine, ovine or caprine animals must be suspended if:
(a) one or more of the requirements set out in Section 2 are not fulfilled; or
(b) a case of infection with Brucella abortus, B. melitensis and B. suis is suspected in a bovine, ovine or caprine animal kept in the establishment.
2.The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination may only be restored if:
(a) the requirements set out in point 1(d) of Section 1 of Chapter 1 and points (b) and (c) of point 1 of Section 1 and point (b) of Section 2 are fulfilled;
(b) the results of further investigations substantiate absence of infection with Brucella abortus, B. melitensis and B. suis and the status of all suspected cases has been determined.
1.The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination of an establishment keeping bovine, ovine or caprine animals must be withdrawn if:
(a) one or more of the requirements set out in Section 2 are not fulfilled after the maximum period of time referred to in point (b) of Article 20(3) has lapsed since the status was suspended;
(b) the infection with Brucella abortus, B. melitensis and B. suis cannot be ruled out in accordance with point 2(b) of Section 3;
(c) a case of infection with Brucella abortus, B. melitensis and B. suis has been confirmed in a bovine, ovine or caprine animal kept in the establishment; or
(d) it is justified by other needs to control infection with Brucella abortus, B. melitensis, B. suis.
2.If the status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in Section 2 are fulfilled.
3.If the status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination has been withdrawn in accordance with point 1(b), 1(c) or 1(d), it may only be regained if all confirmed cases and all animals that have tested non-negative have been removed and the remaining bovine, ovine or caprine animals fulfil the requirements set out in point 1(c) of Section 1 of Chapter 1.
4.By way of derogation from point 3, where the infection with Brucella suis biovar 2 was confirmed in a single bovine, ovine or caprine animal kept in the establishment, the status may be regained after negative testing was obtained on samples taken in accordance with the requirements set out in point 1(c)(i) of Section 1 of Chapter 1.
The status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals may only be granted to a Member State or a zone if:
(a) for at least the past 3 years there has been no confirmed case of infection with Brucella abortus, B. melitensis and B. suis in kept bovine animals;
(b) general surveillance requirements have been carried out for the past 3 years in accordance with point (a) of Article 3(1) for the early detection of infection with Brucella abortus, B. melitensis and B. suis in kept bovine animals, which included at least: (i) the regular submission of samples from abortion cases for laboratory testing; (ii) the timely investigation of abortion cases that may have been caused by infection with Brucella abortus, B. melitensis and B. suis;
(c) during the past 3 years, at least 99,8 % of the establishments keeping bovine animals, representing at least 99,9 % of the bovine population, have maintained their status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination;
(d) vaccination of bovine animals against Brucella abortus, B. melitensis and B. suis has not taken place at least for the past 3 years and no bovine animal introduced into the Member State or zone has been vaccinated during the past 3 years prior to its introduction.
1.The status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals of a Member State or a zone may only be maintained if:
(a) the requirements set out in points (a), (b) and (d) of Section 1 continue to be fulfilled; and
(b) for the first 2 consecutive years following granting of the status, annual surveillance based on a representative sample of all establishments keeping bovine animals has been carried out that must allow at least for the detection, with a 95 % level of confidence, of infection with Brucella abortus, B. melitensis and B. suis, at a target prevalence rate of 0,2 % of the establishments keeping bovine animals or a target prevalence rate of 0,1 % of the bovine population;
(c) if no case of infection with Brucella abortus, B. melitensis and B. suis has been confirmed in kept bovine animals for 2 consecutive years following granting of the status, surveillance must be based on: (i) random annual surveillance that must allow at least for the detection, with a 95 % level of confidence, of infection with Brucella abortus, B. melitensis and B. suis, at a target prevalence rate of 0,2 % of the establishments keeping bovine animals or a target prevalence rate of 0,1 % of the bovine population; or (ii) risk-based annual surveillance to detect infection with Brucella abortus, B. melitensis and B. suis taking into account the systems of production and the risk factors identified, including spread of infection from other animals than kept bovine animals.
2.The status of a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals is not affected by the confirmation of infection of Brucella abortus, B. melitensis and B. suis in an animal population other than kept bovine animals provided that effective measures have been implemented, and are periodically assessed, to prevent transmission of infection with Brucella abortus, B. melitensis and B. suis to kept bovine animals.
3.By way of derogation from point 1(a), the status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals of a Member State or a zone may be maintained in the event of the confirmation of a case of infection with Brucella abortus, B. melitensis and B. suis if:
(a) the establishment in which the infection with Brucella abortus, B. melitensis and B. suis was detected in kept bovine animals has been immediately subjected to the relevant disease control measures laid down in Article 24;
(b) within 60 days after the first confirmation of the infection, the competent authority has conducted an epidemiological enquiry and investigations, as laid down in Article 25, to identify the likely source and the distribution of the infection and established conclusions on the likely source of infection and only a limited number of establishments were infected and those establishments are epidemiologically linked to the first detected outbreak;
(c) the relevant disease control measures laid down in Article 21 or Article 24 have been immediately implemented in each establishment identified with suspected or confirmed cases following implementation of the measures provided for in point (b) until their disease-free status is restored or regained;
(d) the surveillance referred to in point 1 has been adapted and has demonstrated that the incident has been resolved.
The status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals may only be granted to a Member State or a zone if:
(a) for at least the past 3 years there has been no confirmed case of infection with Brucella abortus, B. melitensis and B. suis in kept ovine and caprine animals;
(b) general surveillance requirements have been carried out for the past 3 years in accordance with point (a) of Article 3(1) for the early detection of infection with Brucella abortus, B. melitensis and B. suis in kept ovine and caprine animals, which included at least: (i) the regular submission of samples from abortion cases for laboratory testing; (ii) the timely investigation of abortion cases that may have been caused by infection with Brucella abortus, B. melitensis and B. suis;
(c) during the past 3 years, surveillance has been carried out on the ovine and caprine population and at least 99,8 % of the establishments keeping ovine or caprine animals, representing at least 99,9 % of the ovine and caprine population, have maintained their status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination; and
(d) vaccination of ovine and caprine animals against Brucella abortus, B. melitensis and B. suis has not taken place for at least the past 3 years and no ovine or caprine animal introduced into the Member State or zone has been vaccinated during the past 3 years prior to introduction.
1.The status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals of a Member State or a zone may only be maintained if:
(a) the requirements defined in points (a), (b) and (d) of Section 1 continue to be fulfilled; and
(b) for the first 2 consecutive years following granting of the status, annual surveillance based on a representative sample of all establishments where ovine or caprine animals are kept shall be carried out that must allow at least for the detection, with a 95 % level of confidence, of infection with Brucella abortus, B. melitensis and B. suis at a target prevalence rate of 0,2 % of the establishments keeping ovine or caprine animals or a target prevalence rate of 0,1 % of the ovine and caprine population;
(c) if no case of infection with Brucella abortus, B. melitensis and B. suis has been confirmed in kept ovine and caprine animals for 2 consecutive years following granting of the status, surveillance must be based on: (i) random annual surveillance that must allow at least for the detection, with a 95 % level of confidence, of infection with Brucella abortus, B. melitensis and B. suis at a target prevalence rate of 0,2 % of the establishments keeping ovine or caprine animals or a target prevalence rate of 0,1 % of the ovine and caprine population; or (ii) risk-based annual surveillance to detect infection with Brucella abortus, B. melitensis and B. suis, which takes into account the systems of production and the risk factors identified, including spread of infection from other animals than kept ovine and caprine animals.
2.The status of a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals is not affected by the confirmation of infection of Brucella abortus, B. melitensis and B. suis in an animal population other than kept ovine and caprine animals provided that effective measures have been implemented, and are periodically assessed, to prevent transmission of infection with Brucella abortus, B. melitensis and B. suis to kept ovine and caprine animals.
3.By way of derogation from point 1(a), the status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals of a Member State or a zone may be maintained in the event of the confirmation of a case of infection with Brucella abortus, B. melitensis and B. suis if:
(a) the establishment in which the infection with Brucella abortus, B. melitensis and B. suis was detected in kept ovine and caprine animals has been immediately subjected to the relevant disease control measures laid down in Article 24;
(b) within 60 days after the first confirmation of the infection, the competent authority has conducted an epidemiological enquiry and investigations, as laid down in Article 25, to identify the likely source and the distribution of the infection and established conclusions on the likely source of infection and only a limited number of establishments were infected and those establishments are epidemiologically linked to the first detected outbreak;
(c) the relevant disease control measures laid down in Article 21 or Article 24 have been immediately implemented in each establishment identified with suspected or confirmed cases following implementation of the measures provided for in point (b) until their disease-free status is restored or regained; and
(d) the surveillance referred to in point 1 has been adapted and has demonstrated that the incident has been resolved.
PART II
INFECTION WITH MYCOBACTERIUM TUBERCULOSIS COMPLEX
1.The status free from infection with Mycobacterium tuberculosis complex (Mycobacterium bovis, Mycobacterium tuberculosis, Mycobacterium caprae) (MTBC) may only be granted to an establishment keeping bovine animals if:
(a) during the past 12 months there has been no confirmed case of infection with MTBC in bovine animals kept in the establishment;
(b) the bovine animals over 6 weeks of age present in the establishment at the time of testing or sampling have tested negative to immunological test on two occasions as follows: (i) the first test must be carried out on bovine animals or samples taken from bovine animals not earlier than 6 months after the removal of the last confirmed case and of the last animal that tested positive in an immunological test; (ii) the second test must be carried out on bovine animals or on samples taken from bovine animals not earlier than 6 months and not later than 12 months following the date of testing of the bovine animal or taking of the samples referred to in point (i);
(c) since the beginning of the testing or sampling referred to in point (b)(i), all bovine animals introduced into the establishment originate from establishments free from infection with MTBC and: (i) originate from a Member State or a zone free from infection with MTBC; or (ii) are bovine animals over 6 weeks of age and have tested negative in an immunological test: during the 30 days prior to their introduction into the establishment; or during the 30 days after their introduction provided they have been kept isolated during this period; and
(d) since the beginning of the testing or sampling referred to in point (b)(i), all germinal products of bovine origin introduced into or used in the establishment originate from: (i) establishments free from infection with MTBC; or (ii) approved germinal product establishments.
2.By way of derogation from point 1, the status free from infection with MTBC may be granted to an establishment if all bovine animals originate from establishments free from infection with MTBC and:
(a) originate from a Member State or a zone free from infection with MTBC; or
(b) if they are bovine animals over 6 weeks of age, they have tested negative to an immunological test: (i) during the 30 days prior to their introduction into the establishment; or (ii) during the 30 days after their introduction provided they have been kept in isolation during this period.
3.By way of derogation from points 1(c) and 2(b), the competent authority may not require the test if:
(a) the bovine animals introduced into the establishment: (i) have tested negative in an immunological test carried out during the past 6 months; and (ii) originate from establishments where the bovine animals have tested negative to a testing regime as provided for in points 1(c) or 2 of Section 2 carried out during the past 6 months; or
(b) the bovine animals introduced into the establishment: (i) have tested negative in an immunological test carried out during the past 12 months; and (ii) originate from establishments where the bovine animals have tested negative to a testing regime as provided for in point 2(b) or 2 (c) of Section 2 carried out during the past 12 months.
1.The status free from infection with MTBC of an establishment keeping bovine animals may only be maintained if:
(a) the requirements set out in points (a), (c) and (d) of point 1 of Section 1 continue to be fulfilled;
(b) any suspected case of infection with MTBC in a bovine animal kept on that establishment or introduced from that establishment into a slaughterhouse is notified to the competent authority and investigated; and
(c) an immunological test has been carried out, with negative results, on all bovine animals over 6 weeks of age, at intervals of not more than 12 months.
2.By way of derogation from point 1(c), the competent authority may modify the testing regime as follows:
(a) in a Member State or in a zone where the annual percentage, calculated on 31 December of each year, of establishments infected with MTBC is not more than 1 % during the last 24 months, the interval between tests may be extended to 24 months;
(b) in a Member State or in a zone where the annual percentage, calculated on 31 December of each year, of establishments infected with MTBC is not more than 0,2 % for the last 48 months, the interval between tests may be extended to 36 months;
(c) in a Member State or in a zone where the annual percentage, calculated on 31 December of each year, of establishments infected with MTBC is not more than 0,1 % for the last 72 months, the interval between tests may be extended to 48 months;
(d) in a Member State or a zone free from infection with MTBC, if the risk of transmission of MTBC from wild animals to bovine animals has been assessed by appropriate surveillance, the interval between tests may be based on the type of production and the risk factors identified, taking into account at least the following risks: (i) a location associated with suspected or confirmed infection with MTBC in wild animals; (ii) a history of infection with MTBC within the last 5 years; (iii) an epidemiological link with establishments in any of points (i) or (ii).
1.The status free from infection with MTBC of an establishment keeping bovine animals must be suspended if:
(a) one or more of the requirements laid down in Section 2 are not fulfilled; or
(b) a case of infection with MTBC is suspected in a bovine animal kept in the establishment.
2.The status free from infection with MTBC may only be restored, if:
(a) the requirements laid down in points 1(c) and 1(d) of point 1 of Section 1, 1(b), of Section 2 and, as relevant, in point 1(c) or in point 2 of Section 2 are fulfilled;
(b) the results of further investigations substantiate absence of infection with MTBC and the status of all suspected cases has been determined. In case, suspected bovine animals are slaughtered in that context, investigations must include examination of samples with direct diagnostic methods.
1.The status free from infection with MTBC of an establishment keeping bovine animals must be withdrawn if:
(a) one or more of the requirements laid down in Section 2 are not fulfilled after the maximum period of time referred to in point (b) of Article 20(3) has lapsed since the status was suspended;
(b) the infection with MTBC cannot be ruled out in accordance with point 2(b) of Section 3;
(c) a case of infection with MTBC has been confirmed in a bovine animal kept in the establishment; or
(d) it is justified by other needs to control infection with MTBC.
2.If the status free from infection with MTBC has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in Section 2 are fulfilled.
3.If the status free from infection with MTBC has been withdrawn in accordance with point 1(b), 1(c) or 1(d), it may only be regained if:
(a) all confirmed cases and all animals that have tested non negative in a immunological test have been removed; and
(b) the remaining bovine animals fulfil the requirements set out in point 1(b) of Section 1.
4.By way of derogation from point 3(b), the status may be regained if:
(a) all bovine animals over 6 weeks of age present in the establishment at the time of testing have tested negative in two immunological tests as follows: (i) the first test must be carried out on bovine animals or samples taken from bovine animals not earlier than 2 months after the removal of the last confirmed case and of the last animal that tested positive in an immunological test; (ii) the second test must be carried out on bovine animals or on samples taken from bovine animals not earlier than 2 months and not later than 12 months following the date of testing or sampling of the bovine animal as referred to in point (i); and
(b) at least one of the following conditions apply: (i) the conclusion of the epidemiological enquiry indicates that the infection is due to the introduction of one or more infected animals into the establishment during the past 12 months prior to the detection of the infection with MTBC; or (ii) only a single case was confirmed or only a single bovine animal tested positive in an immunological test for MTBC since the detection of the infection with MTBC, and the status of the establishment has not been withdrawn during the past 3 years; or (iii) bovine animals in the establishment have tested negative in an immunological test carried out less than 12 months prior to the detection of the infection with MTBC in accordance with point 1(c) or 2 of Section 2.
The status free from infection with MTBC as regards kept bovine animals may only be granted to a Member State or a zone if:
(a) during the past 3 years at least 99,8 % of the establishments keeping bovine animals, representing at least 99,9 % of the bovine population, have maintained their status free from infection with MTBC and the incidence rate of establishments confirmed infected during the year did not exceed 0,1 %; and
(b) general surveillance requirements have been carried out for the past 3 years in accordance with point (a) of Article 3(1) for the detection of infection with MTBC in kept bovine animals and included at least: (i) the systematic research of lesions of infection with MTBC in all bovine animals slaughtered through ante- and post-mortem surveillance; (ii) the investigations of lesions that could be due to infection with MTBC.
1.The status free from infection with MTBC as regards kept bovine animals of a Member State or a zone may only be maintained if:
(a) the requirements in point (b) of Section 1 continue to be fulfilled; and
(b) for the first 2 consecutive years following granting of the status random annual surveillance based on a representative sampling of all establishments where bovine animals are kept must be carried out to demonstrate with a 95 % level of confidence, that: (i) at least 99,8 % of the establishments, representing at least 99,9 % of the bovine population are free from infection with MTBC; (ii) the incidence rate of establishment confirmed infected during the year does not exceed 0,1 %;
(c) if the conditions in point (b) were fulfilled for 2 consecutive years, surveillance is based on: (i) random annual surveillance to demonstrate at least with a confidence level of 95 %, that the incidence rate of establishments confirmed infected during the year does not exceed 0,1 %; or (ii) risk-based annual surveillance carried out to detect infection with MTBC, taking into account the systems of production, the risk factors identified, including the spread of infection from other animals than kept bovine animals and increased surveillance in establishments associated with at least one of the specific risks referred to in point 2(d) of Section 2 of Chapter 1.
2.The status of a Member State or a zone free from infection with MTBC is not affected by the confirmation of infection with MTBC in the animal population other than kept bovine animals, provided that effective measures have been implemented, and are periodically assessed, to prevent transmission of infection with MTBC to kept bovine animals.
PART III
ENZOOTIC BOVINE LEUKOSIS
1.The status free from enzootic bovine leukosis (EBL) may only be granted to an establishment keeping bovine animals if:
(a) during the past 24 months there has been no confirmed case of EBL in bovine animals kept in the establishment;
(b) during the past 12 months, bovine animals older than 24 months of age kept in the establishment have tested negative to a serological test, on at least two occasions at an interval of not less than 4 months;
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