Commission Implementing Regulation (EU) 2020/2002 of 7 December 2020 laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council with regard to Union notification and Union reporting of listed diseases, to formats and procedures for submission and reporting of Union surveillance programmes and of eradication programmes and for application for recognition of disease-free status, and to the computerised information system (Text with EEA relevance) (c. 2002)

ANNEX VI INFORMATION ON THE RESULTS OF THE IMPLEMENTATION OF COMPULSORY AND OPTIONAL ERADICATION PROGRAMMES TO BE PROVIDED IN ACCORDANCE WITH POINT B OF ARTICLE 7(2) AND INFORMATION TO BE INCLUDED IN APPLICATIONS FOR THE RECOGNITION OF DISEASE-FREE STATUS OF MEMBER STATES OR ZONES AS REGARDS DISEASES OF TERRESTRIAL AND AQUATIC ANIMALS AND IN APPLICATIONS FOR THE RECOGNITION OF DISEASE-FREE STATUS OF COMPARTMENTS AS REGARDS DISEASES OF AQUATIC ANIMALS IN ACCORDANCE WITH ARTICLE 11

SECTION 1 Compliance with general criteria

General information to be included in applications for the recognition of disease-free status:

1.

Date of application.

2.

Name of the country.

3.

Name of disease.

4.

Territorial scope as regards the recognition of disease-free status.

5.

Statement confirming that the relevant general criteria in accordance with point (a) of Article 66 of Delegated Regulation (EU) 2020/689 for Member States or zones, or with point (a) of Article 73(1) of that Delegated Regulation for aquatic compartments, are complied with.

SECTION 2 Disease-free status based on the absence of listed species

Information to be included in applications for the recognition of disease-free status based on the absence of listed species:

Documentation in accordance with Articles 67(2) or 74(2) of Delegated Regulation (EU) 2020/689.

SECTION 3 Disease-free status based on the disease agent’s incapacity to survive

Information to be included in applications for the recognition of disease-free status based on the disease agent’s incapacity to survive:

Documentation in accordance with Articles 68(2) or 75(2) of Delegated Regulation (EU) 2020/689.

SECTION 4 Disease-free status based on the incapacity to survive of listed vectors for listed diseases of terrestrial animals

Information to be included in applications for the recognition of disease-free status based on the incapacity to survive of listed vectors for listed diseases of terrestrial animals:

Documentation in accordance with Article 69(2) of Delegated Regulation (EU) 2020/689.

SECTION 5 Disease-free status based on historical and surveillance data

1. Information to be included by the competent authority in applications for the recognition of disease-free status based on historical and surveillance data, provided the disease has never been reported in the territory concerned or it has been eradicated and not reported for at least 25 years prior to the application for the recognition of disease-free status in that territory:

(a)

if recognition of the status free from infestation with Varroa spp. is requested:

documented evidence on the fulfilment of the requirements set out in points (a) to (f) of Section 1 of Part III of Annex V to Delegated Regulation (EU) 2020/689;

(b)

if recognition of the status free from infection with Bonamia exitiosa is requested:

(i)

the results of a survey conducted for at least one year in all establishments or groups of establishments keeping listed species within the Member State, zone or compartment, and where required, sampling points in wild populations. They must have been tested using a sample size that allows detection of infection with Bonamia exitiosa with a 95 % level of confidence, if the disease agent is present in the population at a prevalence rate of 2 %;

(ii)

measures applied to prevent the introduction of Bonamia exitiosa into the territory concerned;

(iii)

disease control measures applied in the event of an outbreak;

(c)

if recognition of the status free from infection with WSSV is requested:

(i)

the results of a survey conducted for at least one year in all establishments or groups of establishments keeping listed species within the Member State, zone or compartment, and where required, sampling points in wild populations. They must have been tested using a sample size that allows detection of infection with WSSV with a 95 % level of confidence, if the disease agent is present in the population at a prevalence rate of 2 %;

(ii)

measures applied to prevent the introduction of WSSV into the territory concerned;

(iii)

disease control measures applied in the event of an outbreak.

2. Information covering at least the previous 10 years to be included in applications for the recognition of the status free from BVD based on historical and surveillance data, when it has been reported in the past 25 years and it has been eradicated from the territory concerned:

(a)

number of establishments keeping bovine animals by health status(1) and number of bovine animals kept in these establishments at 31 December of each year;

(b)

testing strategy/regimes and diagnostic methods used to determine the BVD-status of the establishments keeping bovine animals (infected, non-infected);

(c)

testing strategy/regimes and diagnostic methods used to prove the maintenance of the non-infected status of establishments keeping bovine animals;

(d)

measures to prevent the introduction of BVD virus into the territory concerned;

(e)

disease control measures applied in the event of an outbreak;

(f)

number of outbreaks per year;

(g)

number of confirmed cases during the previous 18 months;

(h)

vaccination history and date of prohibition of vaccination against BVD for kept bovine animals.

3. Information to be included in applications for the recognition of disease-free status based on historical and surveillance data if recognition of the status free from infection with Newcastle disease virus infection without vaccination is requested:

documented evidence on the fulfilment of the requirements set out in points (a) to (e) of Section 1 of Part IV of Annex V to Delegated Regulation (EU) 2020/689.

SECTION 6 Disease-free status based on eradication programmes

Information to be included in applications for the recognition of disease-free status based on eradication programmes, by calendar year:

1.

in case of eradication programmes for infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals by zone or region, if more than one region is included in the territorial scope of the programme:

(a)

number of establishments keeping bovine animals, excluding establishments falling under the derogation in accordance with Article 19 of Delegated Regulation (EU) 2020/689 and number of bovine animals kept in these establishments at 31 December;

(b)

number of establishments keeping bovine animals with the status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination or without vaccination including establishments with suspended disease-free status and number of bovine animals kept in these establishments at 31 December;

(c)

number of establishments keeping bovine animals tested annually with a serological test for the granting or for the maintenance of the status and number of bovine animals tested;

(d)

number of establishments with suspicion following the testing referred to in point (c);

(e)

number of bovine animals introduced into an establishment referred to in point (a);

(f)

number of bovine animals tested with a serological test in the context of their introduction into an establishment;

(g)

number of establishments with suspicion following the testing referred to in point (f);

(h)

number of establishments confirmed infected among those referred in points (d) and (g);

(i)

number of establishments with investigations for abortions cases that may have been caused by infection with Brucella abortus, B. melitensis and B. suis;

(j)

number of establishments confirmed infected among those referred in point (i);

(k)

total number of establishments confirmed infected if different from the sum of those reported in points (h) and (j);

(l)

date of last vaccination against infection with Brucella abortus, B. melitensis and B. suis of kept bovine animals;

(m)

number of establishments falling under the derogation in accordance with Article 19 of Delegated Regulation (EU) 2020/689 and number of bovine animals kept in these establishments at 31 December;

2.

in case of eradication programmes for infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals, by zone or region, if more than one region is included in the territorial scope of the programme:

(a)

number of establishments keeping ovine or caprine animals, excluding establishments falling under the derogation in accordance with Article 19 of Delegated Regulation (EU) 2020/689 and number of ovine or caprine animals kept in these establishments at 31 December;

(b)

number of establishments keeping ovine or caprine animals with the status free from infection with Brucella abortus, B. melitensis and B. suis with or without vaccination including establishments with suspended disease-free status and number of ovine or caprine animals kept in these establishments at 31 December;

(c)

number of establishments keeping ovine or caprine animals tested annually with a serological test for the granting or for the maintenance of the status and number of ovine or caprine animals tested;

(d)

number of establishments with suspicion following the testing referred to in point (c);

(e)

number of ovine or caprine animals introduced in an establishment referred to in point (a);

(f)

number of ovine or caprine animals tested with a serological test in the context of their introduction into an establishment;

(g)

number of establishments with suspicion following the testing referred to in point (f);

(h)

number of establishments confirmed infected among those referred in points (d) and (g);

(i)

number of establishments with investigations for abortions cases that may have been caused by infection with Brucella abortus, B. melitensis and B. suis;

(j)

number of establishments confirmed infected among those referred in point (i);

(k)

total number of establishments confirmed infected if different from the sum of those reported in points (h) and (j);

(l)

date of last vaccination against infection with Brucella abortus, B. melitensis and B. suis of kept ovine and caprine animals;

(m)

number of establishments falling under the derogation in accordance with Article 19 of Delegated Regulation (EU) 2020/689 and number of ovine or caprine animals kept in these establishments at 31 December;

3.

in case of eradication programmes for infection with MTBC, by zone or region, if more than one region is included in the territorial scope of the programme:

(a)

number of establishments keeping bovine animals, excluding establishments falling under the derogation in accordance with Article 19 of Delegated Regulation (EU) 2020/689 and number of bovine animals kept in these establishments at 31 December;

(b)

number of establishments keeping bovine animals with the status free from infection with MTBC including establishments with suspended disease-free status and number of bovine animals kept in these establishments at 31 December;

(c)

number of establishments keeping bovine animals tested during the year for the granting or for the maintenance of the status and number of bovine animals tested for each of the following testing regime as provided for in Section 2 of Chapter 1 of Part II of Annex IV to Delegated Regulation (EU) 2020/689:

(i)

testing required every 12 months;

(ii)

testing required every 24 months;

(iii)

testing required every 36 months;

(iv)

testing required every 48 months;

(d)

number of establishments with suspicion following the testing referred to in point (c);

(e)

number of bovine animals introduced in an establishment referred to in point (a);

(f)

number of bovine animals tested in the context of their introduction in an establishment;

(g)

number of establishments with suspicion following the testing referred to in point (f);

(h)

number of establishments confirmed infected among those referred in points (d) and (g);

(i)

number of bovine animals sent to slaughterhouse from an establishment with the status free from infection with MTBC;

(j)

number of bovine animals slaughtered, among those referred in point (i), presenting suspected lesions of infection with MTBC that have been investigated;

(k)

number of bovine animals, among those referred in point (j), confirmed infected;

(l)

total number of establishments confirmed infected following detection of a suspected lesion at the slaughterhouse;

(m)

total number of establishments confirmed infected if different from the sum of those reported in points (h) and (l);

(n)

number of establishments falling under the derogation in accordance with Article 19 of Delegated Regulation (EU) 2020/689 and number of bovine animals kept in these establishments at 31 December;

4.

in case of eradication programmes for EBL, by zone or region, if more than one region is included in the territorial scope of the programme:

(a)

number of establishments keeping bovine animals, excluding establishments falling under the derogation in accordance with Article 19 of Delegated Regulation (EU) 2020/689 and number of bovine animals kept in these establishments at 31 December;

(b)

number of establishments with the status free from EBL including establishments with suspended disease-free status and number of bovine animals kept in these establishments at 31 December;

(c)

number of establishments that have been the granted the status free from EBL and number of bovine animals tested in these establishments;

(d)

number of establishments tested for the maintenance of the status free from EBL and number of bovine animals tested in these establishments;

(e)

number of establishments referred to in point (c) and number of establishments referred to in point (d) with one or more suspected case(s);

(f)

number of establishments and number of bovine animals referred to in point (c) with confirmed cases following the investigation of the suspected case(s) referred to in point (e);

(g)

number of establishments and number of bovine animals referred to in point (d) with confirmed cases following the investigation of the suspected case(s) referred to in point (e) including number of confirmed cases;

(h)

number of bovine animals over 24 months of age that have been slaughtered;

(i)

number of suspected cases that have been identified in the context of the official post-mortem examination of the animals referred to in point (h) and that have been investigated to confirm or rule out the presence of EBL;

(j)

number of confirmed cases following the examination referred to in point (i) of bovine animals that have been kept in an establishment;

(k)

number of establishments with one or more confirmed cases at 31 December;

(l)

number of establishments falling under the derogation in accordance with Article 19 of Delegated Regulation (EU) 2020/689 and number of bovine animals kept in these establishments at 31 December;

5.

in case of eradication programmes for IBR/IPV, by zone or region, if more than one region is included in the territorial scope of the programme:

(a)

number of establishments keeping bovine animals, excluding establishments falling under the derogation in accordance with Article 19 of Delegated Regulation (EU) 2020/689 and number of bovine animals kept in these establishments at 31 December;

(b)

number of establishments with the status free from IBR/IPV including establishments with suspended disease-free status and number of bovine animals kept in these establishments at 31 December;

(c)

number of establishments that have been granted the status free from IBR/IPV and number of bovine animals tested in these establishments;

(d)

number of establishments tested for the maintenance of the status free from IBR/IPV and number of bovine animals tested in these establishments by testing regimes provided for in Section 2 of Chapter 1 of Part IV of Annex IV to Delegated Regulation (EU) 2020/689;

(e)

number of establishments with confirmed cases including the number of confirmed cases;

(f)

number of establishments referred to in points (a) and (b) keeping differentiating infected from vaccinated animals (DIVA) vaccinated bovine animals and number of DIVA vaccinated animals kept in these establishments at 31 December;

(g)

number of bovine animals that have been DIVA vaccinated during the reporting period;

(h)

where appropriate, date of last vaccination against IBR/IPV of kept bovine animals;

(i)

number of establishments falling under the derogation in accordance with Article 19 of Delegated Regulation (EU) 2020/689 and number of bovine animals kept in these establishments at 31 December;

6.

in case of eradication programmes for infection with ADV, by zone or region, if more than one region is included in the territorial scope of the programme:

(a)

number of establishments keeping porcine animals, excluding establishments falling under the derogation in accordance with Article 19 of Delegated Regulation (EU) 2020/689, and number of porcine animals kept in these establishments at 31 December;

(b)

number of establishments with the status free from infection with ADV including establishments with suspended disease-free status and number of porcine animals kept in these establishments at 31 December;

(c)

number of establishments that have been granted the status free from infection with ADV and number of porcine animals tested in these establishments;

(d)

number of establishments tested for the maintenance of the status free from infection with ADV and number of porcine animals tested in these establishments;

(e)

number of establishments with clinical, virological or serological evidence of infection with ADV;

(f)

number of establishments with confirmed cases at 31 December;

(g)

number of establishments referred to in point (a) carrying out DIVA vaccination and number of porcine animals that have been DIVA vaccinated;

(h)

where appropriate, date of last vaccination against ADV of kept porcine animals;

(i)

number of establishments falling under the derogation in accordance with Article 19 of Delegated Regulation (EU) 2020/689 and number of porcine animals kept in these establishments at 31 December;

7.

in case of eradication programmes for BVD, by zone or region, if more than one region is included in the territorial scope of the programme:

(a)

number of establishments keeping bovine animals, excluding establishments falling under the derogation in accordance with Article 19 of Delegated Regulation (EU) 2020/689 and number of bovine animals kept in these establishments at 31 December;

(b)

number of establishments with the status free from BVD including establishments with suspended disease-free status and number of bovine animals kept in these establishments at 31 December;

(c)

number of establishments with the status free from BVD in accordance with point 2(b) of Section 1 of Chapter 1 of Part VI of Annex IV to Delegated Regulation (EU) 2020/689 which have the status free from BVD maintained in accordance with point 2 of Section 2 of Chapter 1 of Part VI of Annex IV to that Delegated Regulation and number of bovine animals kept in these establishments at 31 December;

(d)

number of establishments that have been granted the status free from BVD and number of bovine animals tested in these establishments;

(e)

number of establishments tested for the maintenance of the status free from BVD and number of bovine animals tested in these establishments;

(f)

number of establishments with confirmed cases at 31 December including the number of confirmed cases;

(g)

number of establishments with confirmed cases epidemiologically linked to the introduction of animals;

(h)

number of establishments where kept bovine animals are vaccinated against BVD and number of vaccinated animals;

(i)

where appropriate, date of last vaccination against BVD of kept bovine animals;

(j)

number of establishments falling under the derogation in accordance with Article 19 of Delegated Regulation (EU) 2020/689 and number of bovine animals kept in these establishments at 31 December;

8.

in case of eradication programmes for infection with RABV, by zone or region, if more than one region is included in the territorial scope of the programme, information on:

(a)

surveillance, including at least maps with data of:

(i)

indicator animals tested per species;

(ii)

confirmed cases by species;

(b)

vaccination of wild animals:

(i)

number and dates of vaccination campaigns;

(ii)

vaccine bait density achieved per zone or region and, if the total size of the vaccination area per vaccination campaign is greater than 20 000 km², vaccine bait density maps;

(iii)

upon request of the Commission, electronic files with:

• flight routes recorded during the vaccine bait distribution,

• vaccine bait distribution: time and position of each bait released recorded during aerial distribution if the total size of the vaccination area per vaccination campaign is greater than 20 000 km²;

(iv)

monitoring of the effectiveness of the vaccination, with maps with data of:

• number of animals positive to the biomarker test/number of biomarker tests performed,

• number of animals positive to serological tests/number of serological tests;

(v)

number and results of the titration of the vaccine baits tests performed;

(c)

number of confirmed cases for which infection with RABV did not occur in the territory concerned (imported cases);

(d)

if epidemiological links in cases referred to in point (c) have been identified, the results of increased surveillance carried out over a period of 6 months following the death of the animal concerned, where relevant;

9.

in case of eradication programmes for infection with BTV:

(a)

territorial scope with a map and a description and demarcation of the geographical and administrative areas covered by the eradication programme and the names of the zones and regions, if more than one region is included in the territorial scope of the programme; where relevant, the reasons for applying the derogation provided for in Article 37(3) of Delegated Regulation (EU) 2020/689 and evolution of the zone during the programme;

(b)

the number of establishments keeping animals of the targeted animal population on 31 December;

(c)

the number of animals of the targeted animal population kept in the establishments referred to in point (b) on 31 December;

(d)

sampling schemes implemented annually: mapping unit and selection criteria implemented, frequency of testing, number of tests, type of diagnostic methods and results;

(e)

number of confirmed cases by zone, species, year/months and BTV serotype(s);

(f)

number of animals vaccinated by year, species and BTV serotype(s);

(g)

derogations for movements granted, number of animals concerned and, where relevant, adaptation of the surveillance implemented;

(h)

coordinated measures with other Member States or third countries, where relevant, and adaptation of the surveillance to external sources of infection with BTV;

10.

in case of eradication programmes for category B and C diseases of aquatic animals, by zone, compartment, or region, if more than one region is included in the territorial scope:

(a)

number of approved aquaculture establishments and where relevant, the number of registered aquaculture establishments keeping animals of the targeted animal population and sampling points in wild populations, which are included in the eradication programme, as well as maps showing the location of establishments and sampling points in wild populations, at 31 December;

(b)

number of aquaculture establishments and, where relevant, sampling points in wild populations, out of the number of establishments or sampling points referred to in point (a), which are not infected at 31 December;

(c)

number of animal health visits per approved and where relevant, registered aquaculture establishments;

(d)

number of samplings per approved and where relevant, registered aquaculture establishments or sampling points in wild populations, as well as details of species, results of sampling (positive/negative) and water temperature at the time of sampling;

(e)

number of infected aquaculture establishments and, where relevant, sampling points in wild populations with confirmed case(s) out of the number of establishments referred to in point (a) at 31 December;

(f)

number of new infected aquaculture establishments and, where relevant, sampling points in wild populations with confirmed case(s) out of the number of establishments referred to in point (a) at 31 December.

(1)

Infected, non-infected, unknown.