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)

• (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

Section 1

General approach and requirements

1. TERRITORIAL SCOPE

Surveillance must be implemented in all Member States.

2. PERIOD OF APPLICATION

Until revoked.

3. GENERAL APPROACH

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.

Section 2

Objectives for Surveillance

• 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.

Section 3

Early detection of HPAI in poultry

• 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.

Section 4

Early detection of HPAI in 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.

Section 5

Risk-based complementary surveillance for HPAI in poultry species which generally do not show significant clinical signs

• 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.

Section 6

risk-based surveillance in order to identify clusters of establishments infected with lpaiv and with continuous spread of LPAIV

• 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.

Section 7

Targeted poultry populations

• 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.

Section 8

Targeted Wild bird populations

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.

Section 9

Sampling and laboratory testing methods

• 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.

Section 10

Surveillance in species that are not listed for HPAI

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 [^E0008]	individual serum samples [^E0011]
non-vaccinated bovine animals	BoHV-1 I-ELISA [^E0008]	milk samples
non-vaccinated bovine animals	gB B-ELISA [^E0009]	individual serum samples [^E0011]
non-vaccinated bovine animals	gB B-ELISA [^E0009]	individual meat juice samples
DIVA vaccinated bovine animals with a gE-deleted vaccine	gE B-ELISA [^E0010]	individual serum samples
DIVA vaccinated bovine animals with a gE-deleted vaccine	gE B-ELISA [^E0010]	individual meat juice samples

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.

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.

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.

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 [^E0012]	individual or up to 5 pooled serum (or plasma) samples
non-vaccinated porcine animals	ADV ELISA [^E0012]	individual or up to 5 pooled filter paper samples
non-vaccinated porcine animals	ADV ELISA [^E0012]	individual meat juice samples
DIVA vaccinated porcine animals with a gE-deleted vaccine	gE ELISA [^E0013]	individual serum samples

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.

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

CHAPTER 1

Establishment free from infection with Brucella abortus, B. melitensis and B. suis without vaccination

Section 1

Granting of the status

• 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.

Section 2

Maintenance of the status

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.

Section 3

Suspension and restoring of the status

• 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.

Section 4

Withdrawal and regaining of the status

• 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.

CHAPTER 2

Establishment free from infection with Brucella abortus, B. melitensis and B. suis with vaccination

Section 1

Granting of the status

• 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.

Section 2

Maintenance of the status

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.

Section 3

Suspension and restoring of the status

• 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.

Section 4

Withdrawal and regaining of the status

• 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.

CHAPTER 3

Member State or zone free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals

Section 1

Granting of the status as regards kept bovine animals

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.

Section 2

Maintenance of the status as regards kept bovine animals

• 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.

CHAPTER 4

Member State or zone free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals

Section 1

Granting of the status as regards kept ovine and caprine animals

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.

Section 2

Maintenance of the status as regards kept ovine and caprine animals

• 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

CHAPTER 1

Establishment free from infection with Mycobacterium tuberculosis complex

Section 1

Granting of the status

• 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.

Section 2

Maintenance of the status

• 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).

Section 3

Suspension and restoring of the status

• 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.

Section 4

Withdrawal and regaining of the status

• 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.

CHAPTER 2

Member State or zone free from infection with MTBC

Section 1

Granting of the status as regards kept bovine animals

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.

Section 2

Maintenance of the status

• 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

CHAPTER 1

Establishment free from enzootic bovine leukosis

Section 1

Granting of the status

• 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;

• (c) since the beginning of the sampling referred to in point (b), all bovine animals introduced into the establishment:
• (i) originate from establishments free from EBL; or
• (ii) originate from establishments where there has been no evidence of EBL either clinical, post-mortem, or as a result of a diagnostic test for EBL within the 24 months prior to their dispatch; and
• — if over 24 months of age, they have been subjected to serological tests, with negative results, on two occasions at an interval of not less than 4 months while kept in isolation from other bovine animals of the establishment; or they have been subjected to a serological test, with a negative result, within 30 days prior to their introduction provided all bovine animals have been tested in accordance with point (b);
• — if less than 24 months of age, they were born to dams, that have been subjected to a serological test for EBL, with negative results, carried out on samples taken during the past 12 months on two occasions at an interval of not less than 4 months; and

• (d) since the beginning of the sampling referred to in point (b), all germinal products of bovine animals introduced into the establishment originate from:
• (i) establishments free from EBL; or
• (ii) approved germinal product establishments.

• 2.By way of derogation from point 1, the status free from EBL may be granted to an establishment if all bovine animals originate from establishments free from EBL located either in a Member State or zone free from EBL or in a Member State or zone covered by an approved eradication programme.

Section 2

Maintenance of the status

The status free from EBL of an establishment keeping bovine animals may only be maintained if:

• (a) the requirements laid down in points (a), (c) and (d) of point 1 of Section 1 continue to be fulfilled; and

• (b) serological testing for EBL is carried out, with negative results, on samples taken
• (i) at intervals of not more than 36 months from all bovine animals over 24 months of age; or
• (ii) in accordance with point (b) or (c) of Section 2 of Chapter 2, as relevant, if the establishment is located in a Member State or zone free from EBL.

Section 3

Suspension and restoring of the status

• 1.The status free from EBL 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;

• (b) a case of EBL in a bovine animal that is kept on the establishment is suspected.

• 2.The status free from EBL may only be restored if:

• (a) the requirements laid down in points (c) and (d) of point 1 of Section 1 and point (b) of Section 2 are fulfilled;

• (b) the results of further investigations substantiate absence of EBL and the status of all suspected cases has been determined.

Section 4

Withdrawal and regaining of the status

• 1.The status free from EBL 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; or

• (b) a case of EBL has been confirmed in a bovine animal kept in the establishment.

• 2.If the status free from EBL has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in points (c) and (d) of point 1 of Section 1 and point (b) of Section 2 are fulfilled.

• 3.If the status free from EBL has been withdrawn in accordance with point 1(b), it may only be regained if:

• (a) any bovine animal presenting a positive test result for EBL and all of their offspring younger than 24 months of age have been removed;

• (b) all bovine animals over 12 months of age have been tested negative in a serological test, on two occasions at an interval of not less than 4 months, where the first test must be carried out on samples not taken earlier than 4 months after the removal of the last confirmed case.

• 4.By way of derogation from point (3)(a), the offspring of dams that have been tested positive in a serological test for EBL or which have shown lesions of EBL may be kept in the establishment if:

• (a) they have been separated from the dam immediately after calving and tested negative in a PCR test, on two occasions, where the first sample must be taken within the period of 3 to 5 weeks and the second within 8 to 10 weeks postpartum; and

• (b) they remain in the establishment until they are 24 months of age and are tested negative in a serological test, or they are sent before that test directly to the slaughterhouse in accordance with the requirements laid down in Article 27(4).

CHAPTER 2

Member State or zone free from EBL

Section 1

Granting of the status

The status free from EBL as regards kept bovine animals may only be granted to a Member State or a zone if:

• (a) at least 99,8 % of the bovine establishments are free from EBL; and

• (b) all bovine animals over 24 months of age slaughtered within this Member State or zone are subjected to an official post-mortem examination with samples from all animals with tumours that could be caused by EBL being subjected to laboratory examination to confirm or rule out the presence of EBL.

Section 2

Maintenance of the status

The status free from EBL as regards kept bovine animals of a Member State or a zone may only be maintained if:

• (a) the requirements set out in Section 1 continue to be fulfilled; and

• (b) during the first 5 years after the granting of the status free from EBL, surveillance is carried out based on:
• (i) annual random sampling to detect at least, with a 95 % level of confidence, establishments infected with EBL at a target prevalence rate of 0,2 %; or
• (ii) serological testing of all bovine animals over 24 months of age on at least one occasion;

• (c) following the first 5 years after the granting of the status free from EBL, surveillance is carried out to demonstrate the absence of infection, taking into account the systems of production and the risk factors identified.

PART IV

INFECTIOUS BOVINE RHINOTRACHEITIS/INFECTIOUS PUSTULAR VULVOVAGINITIS

CHAPTER 1

Establishment free from infectious bovine rhinotracheitis/infectious pustular vulvovaginitis

Section 1

Granting of the status

• 1.The status free from infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV) may only be granted to an establishment keeping bovine animals if:

• (a) during the past 12 months there has been no confirmed case of IBR/IPV in bovine animals kept in the establishment;

• (b) during the past 2 years none of the bovine animals kept in the establishment has been vaccinated against IBR/IPV;

• (c) the bovine animals kept in the establishment have been subjected to at least one of the following testing regimes taking into account previous DIVA vaccinations, where serological tests for the detection of antibodies against whole BoHV-1 or, if necessary, antibodies against BoHV-1-gE have been carried out on:
• (i) a blood, milk or meat juice sample taken from each bovine animal over a period of not more than 12 months; or
• (ii) blood, milk or meat juice samples taken on at least two occasions at an interval of not less than 2 months and not more than 12 months from
• — all female bovine animals over 12 months of age, and
• — all male bovine animals used or intended for breeding over 12 months of age, and
• — a random sample of male animals not intended for breeding over 12 months of age. The number of animals tested must allow at least for the detection, with a 95 % level of confidence, of seropositive animals at a target prevalence rate of 10 %; or
• (iii) in the case of an establishment in which at least 30 % of the bovine animals are lactating,
• — bulk milk samples taken on at least three occasions at intervals of not less than 3 months from lactating female bovine animals representing all epidemiological units of the establishment, and
• — blood samples taken from all non-lactating female bovine animals over 12 months of age, and from all male bovine animals used or intended for breeding over 12 months of age, and
• — a random blood or meat juice sample taken from male bovine animals not intended for breeding older than 12 months of age. The number of animals tested must allow at least for the detection, with a 95 % level of confidence, of seropositive animals at a target prevalence rate of 10 %; or
• (iv) in the case of an establishment in which less than 5 % of the kept bovine animals are male and at least 95 % of the female animals over 24 months are intended or used for milk production, bulk milk samples taken on at least six occasions at intervals of not less than 2 months from lactating female bovine animals representing all epidemiological units of the establishment;

• (d) since the beginning of the sampling referred to in point (c) all bovine animals introduced into the establishment:
• (i) originate from establishments free from IBR/IPV and, in case the establishments of origin are located in a Member State or zone that is neither free from IBR/IPV nor covered by an approved eradication programme, have tested negative in a serological test for the detection of antibodies against whole BoHV-1 or, if necessary, antibodies against BoHV-1-gE on a sample taken after their introduction and before the granting of the status free from IBR/IPV; or
• (ii) have been subjected to quarantine prior to their introduction and have tested negative in serological test for the detection of antibodies against whole BoHV-1 on a sample taken not earlier than 21 days after the beginning of the quarantine; and

• (e) since the beginning of the sampling referred to in point (c) all germinal products of bovine animals introduced into the establishment originate from:
• (i) establishments free from IBR/IPV; or
• (ii) approved germinal product establishments.

• 2.By way of derogation from point 1, the status free from IBR/IPV may be granted to an establishment if all bovine animals originate from establishments free from IBR/IPV located either in a Member State or zone free from IBR/IPV or in a Member State or zone under an approved eradication programme, provided they fulfil the requirements set out in points (c) and (d) of Section 2, as relevant.

Section 2

Maintenance of the status

The status free from IBR/IPV may only be maintained in an establishment keeping bovine animals if:

• (a) the requirements laid down in points (a), (b) and (e) of point 1 of Section 1 continue to be fulfilled;