title: COMMISSION IMPLEMENTING REGULATION (EU) …/... 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:
               COMMISSION IMPLEMENTING REGULATION (EU) …/...

               of 7.12.2020

               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)

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’)
                  1
               , and in particular Article 23, Article 30(1)(b) and Articles 35 and 40 thereof,

               Whereas:

               (1)Regulation (EU) 2016/429 lays down rules for animal diseases that are transmissible to animals or humans, including provisions for disease notification and reporting, Union surveillance programmes, eradication programmes and disease-free status.

               (2)Commission Delegated Regulation (EU) 2020/689
                  2
                supplements Regulation (EU) 2016/429 and lays down rules on surveillance, eradication programmes and disease-free status for certain listed and emerging animal diseases. The information, formats and procedural requirements for the surveillance, eradication programmes and for disease-free status should be set out in this Regulation.

               (3)Listed diseases, as defined in Article 4(18) of Regulation (EU) 2016/429, are listed in accordance with Article 5(1) of that Regulation. Due to their different disease profile, outbreaks of certain of the listed diseases should be subject to immediate Union notification, whereas outbreaks of the others should be subject to Union reporting.

               (4)Taking into account the disease profile and the health status of a given Member State, zone or compartment, an immediate Union notification to the Commission and the other Member States about an outbreak of certain of the listed diseases should be required in order to allow a timely implementation of necessary risk management measures. A dedicated list of those listed diseases, for which an immediate Union notification is necessary, as well as the timeframe for such immediate notification, should be set out in this Regulation.

               (5)Animal health guarantees apply to disease-free Member States, zones and compartments for listed diseases referred to in points (b) and (c) of Article 9(1) of Regulation (EU) 2016/429. As reporting on surveillance carried out to maintain disease-free status is not mandatory, the obligation to notify primary outbreaks of those diseases within 24 hours of confirmation is justified.

               (6)In case of secondary outbreaks of listed diseases subject to notification, the well-established use of grouped weekly notifications is appropriate, considering the disease profile and depending on the health status of a Member State, zone or compartment.

               (7)Commission Implementing Regulation (EU) 2018/1882
                  3
                determines the application of disease prevention and control rules to the categories of listed diseases for the listed species or groups of listed species. Member States’ obligation for Union reporting on detection of category E diseases according to that Regulation for the relevant listed species or groups of listed species, the procedural requirements and information for such reporting, should be laid down in this Regulation.

               (8)To ensure uniform conditions for the implementation of Union notification and reporting, the rules to establish the information to be provided, the rules to establish the necessary procedures, formats, data and the rules for the listing of notification and reporting regions should be laid down.

               (9)For the purpose of the information to be transmitted when carrying out a Union notification as laid down in Article 19 of Regulation (EU) 2016/429, some of the information requirements should be further detailed to ensure uniform application of that provision and facilitate data entry into the computerised information system referred to in Article 22 of that Regulation (Animal Disease Information System (ADIS)).

               (10)For the purpose of Union reporting of listed diseases in accordance with Article 20 of Regulation (EU) 2016/429, the level of information to be provided on the detection of listed diseases and on eradication programmes should be specified in this Regulation.

               (11)Article 21 of Regulation (EU) 2016/429 requires Member States to establish notification and reporting regions. In order to ensure clarity in Union notification and reporting, this Regulation should list the types of notification and reporting regions.

               (12)Furthermore, it is appropriate to establish harmonised procedures and formats to ensure uniform reporting of the results of Union surveillance programmes and eradication programmes in the ADIS.

               (13)The information provided on the results of the implementation of eradication programmes should be available in the ADIS to enable the Commission to monitor the progress of Member States’ ongoing eradication programmes. Such information should be supplemented by additional information for the purpose of recognition of disease-free status once eradication has been achieved.

               (14)For listed diseases referred to in points (b) and (c) of Article 9(1) of Regulation (EU) 2016/429, the health status within a Member State’s territory might be different between a part of the territory recognised as disease-free and other parts of the territory with or without an approved eradication programme for the same disease. The ADIS should enable data compilation and, where relevant, integration with additional data regarding the total number of outbreaks and the affected listed species or groups of listed species.

               (15)Article 28 of Regulation (EU) 2016/429 requires Member States to submit Union surveillance programmes to the Commission. Article 31 of Regulation (EU) 2016/429 requires Member States to submit compulsory and optional eradication programmes for listed diseases referred to in points (b) and (c) of Article 9(1) of that Regulation. In order to ensure the uniform application of these provisions, a common format and procedure for those submissions should be laid down in this Regulation.

               (16)Member States should submit an application to the Commission for approval of disease-free status for category B diseases and category C diseases. In order to ensure the uniform submission of these applications by Member States, it is appropriate to specify the required information, format and means of data transfer for these applications.

               (17)As Regulation (EU) 2016/429 applies from 21 April 2021, this Regulation should also apply from that date.

               (18)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

               HAS ADOPTED THIS REGULATION:

               Article 1

               Subject matter and scope

               This Regulation lays down rules concerning:

               (1)category E diseases relevant to the Union notification of outbreaks and the information to be provided by Member States for Union notification and Union reporting as regards the detection of category E diseases;

               (2)the deadlines and frequencies of Union notification and Union reporting of diseases;

               (3)the format and procedure for reporting to the Commission the results of Union surveillance programmes and the information, format and procedure for reporting to the Commission and other Member States on the results of eradication programmes;

               (4)the format and structure of the data referred to in points 1 and 3 to be entered into the computerised information system for Union notification and Union reporting of diseases;

               (5)the listing of notification and reporting regions;

               (6)the format and procedure for the submission for information of Union surveillance programmes to the Commission and other Member States;

               (7)the information, format and procedural requirements as regards the submission of draft compulsory and draft optional eradication programmes to the Commission for approval and as regards performance indicators necessary to evaluate the effectiveness of the application of those programmes, as well as the formats and procedures for applications for recognition of disease-free status of the entire territory of Member States, or zones and compartments thereof and for exchanges of information between the Member States and the Commission on disease-free Member States, or zones and compartments thereof;

               (8)procedures for the establishment and use of the Animal Disease Information System (ADIS).

               Article 2

               Definitions

               For the purposes of this Regulation, the following definitions apply:

               (1)‘category B disease’ means a listed disease which must be controlled in all Member States with the goal of eradicating it throughout the Union, as referred to in Article 9(1)(b) of Regulation (EU) 2016/429;

               (2)‘category C disease’ means a listed disease which is of relevance to some Member States and for which measures are needed to prevent it from spreading to parts of the Union that are officially disease-free or that have eradication programmes for the listed disease concerned, as referred to in Article 9(1)(c) of Regulation (EU) 2016/429;

               (3)‘category E disease’ means a listed disease for which there is a need for surveillance within the Union, as referred to in Article 9(1)(e) of Regulation (EU) 2016/429;

               (4)‘primary outbreak’ means an outbreak not epidemiologically linked with a previous outbreak in the same notification and reporting region of a Member State or the first outbreak in a different notification and reporting region of the same Member State;

               (5)‘secondary outbreak’ means an outbreak other than a primary outbreak;

               (6)‘Animal Disease Information System (ADIS)’ means the computerised information system for Union notification and Union reporting of diseases referred to in Article 22 of Regulation (EU) 2016/429 that is to be set up and managed by the Commission;

               (7)‘territorial scope’ means the territory covered by the eradication programme in accordance with Article 13 of Delegated Regulation (EU) 2020/689 as regards terrestrial animals and in accordance with Article 47 of that Delegated Regulation as regards aquatic animals;

               (8)‘duration of the eradication programme’ means the period of application of the eradication programme in accordance with Article 15 of Delegated Regulation (EU) 2020/689 as regards terrestrial animals and in accordance with Article 49 of that Delegated Regulation as regards aquatic animals.

               Article 3

               Union notification

               1.Member States shall notify the Commission and the other Member States within 24 hours of confirmation of any primary outbreak in their territory of a listed disease referred to in:

               (a)points 1 and 2 of Annex I;

               (b)point 3 of Annex I, if the primary outbreak has been detected in the relevant targeted animal population in a disease-free Member State or zone;

               (c)points 4 and 5 of Annex I, if the primary outbreak has been detected in a disease-free Member State, zone or, where relevant, compartment.

               2.Member States shall notify to the Commission at the latest on the first working day of each week covering the previous week, from 0.00 on Monday until 24.00 on Sunday, secondary outbreaks in their territory of a listed disease referred to in:

               (a)points 1 and 2 of Annex I;

               (b)point 3 of Annex I, if such secondary outbreaks have been detected in the relevant targeted animal population in a disease-free Member State or zone;

               (c)points 4 and 5 of Annex I, if such secondary outbreaks have been detected in a disease-free Member State, zone or, where relevant, compartment.

               If no information is received by the Commission, this is considered to mean that no secondary outbreaks have been confirmed during the period referred to in the first subparagraph.

               3.The notifications referred to in paragraphs 1 and 2 shall contain the information specified in Annex II and be submitted electronically via the ADIS.

               Article 4

               Union reporting on the detection of listed diseases

               1.Member States shall report to the Commission and to the other Member States by 30 April of every year, covering the previous calendar year, on the detection of category E diseases that have been confirmed in their territory in listed species and groups of listed species referred to in the table set out in the Annex to Implementing Regulation (EU) 2018/1882.

               2.The first report referred to in point 1 is due by 30 April 2022.

               3.The reporting referred to in paragraph 1 shall contain the information specified in Annex III and be submitted electronically via the ADIS.

               Article 5

               Notification and reporting regions

               The notification and reporting regions established by the Member States in accordance with Article 21 of Regulation (EU) 2016/429 are listed in Annex IV to this Regulation.

               Article 6

               Union reporting on the results of Union surveillance programmes

               1.Member States shall report to the Commission by 15 March of every year, covering the previous calendar year, data on the results of the Union surveillance programmes.

               2.The data referred to in paragraph 1 shall be submitted electronically via the ADIS.

               Article 7

               Union reporting on the annual results of the implementation of approved eradication programmes

               1.Member States shall submit to the Commission by 30 April of every year reports on the results of the implementation of their ongoing approved eradication programmes.

               2.The reports referred to in paragraph 1 shall contain:

               (a)for every year, covering the previous calendar year, the information specified in:

               (i)Section 1 of Annex V for eradication programmes for category B and C diseases of terrestrial animals based on granting disease-free status at the level of establishments;

               (ii)Section 2 of Annex V for eradication programmes for infection with rabies virus (RABV);

               (iii)Section 3 of Annex V for eradication programmes for infection with bluetongue virus (serotypes 1-24) (infection with BTV);

               (iv)Section 4 of Annex V for eradication programmes for category B and C diseases of aquatic animals; and

               (b)for every 6 years after the initial approval of the eradication programmes, covering the previous 6 calendar years, with the exception of the information previously provided in reports referred to in point (a), the information specified in:

               (i)Point 1 of Section 6 of Annex VI for eradication programmes for infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals;

               (ii)Point 2 of Section 6 of Annex VI for eradication programmes for infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals;

               (iii)Point 3 of Section 6 of Annex VI for eradication programmes for infection with Mycobacterium tuberculosis complex (M. bovis, M. tuberculosis, M. caprae (MTBC));

               (iv)Point 8 of Section 6 of Annex VI for eradication programmes for infection with RABV.

               3.The reports referred to in paragraph 1 shall be submitted electronically via the ADIS.

               Article 8

               Union reporting on the final results of the implementation of approved eradication programmes

               1.Member States shall submit to the Commission the final report of their approved eradication programmes within 4 months of their completion.

               2.The final report referred to in paragraph 1 shall cover:

               (a)in case of compulsory eradication programmes, the period of application of these programmes from the last report submitted in accordance with point (b) of Article 7(2) until completion;

               (b)in case of optional eradication programmes, the entire period of application from approval until completion.

               3.The final report referred to in paragraph 1 shall contain the information specified in points (e) to (n) of Article 11(1) and in Article 11(2), as relevant, with the exception of the information previously provided in reports referred to in Article 7(1), when the Member States request:

               (a)the recognition of disease-free status; or

               (b)the extension of the period of application of eradication programmes in accordance with the second sentence of Article 15(2) of Delegated Regulation (EU) 2020/689 or the second sentence of Article 49(2) of that Delegated Regulation.

               4.When the Member State does not request the recognition for a category C disease of disease-free status or the extension of the period of application of eradication programes as referred to in points (a) and (b) of paragraph 3, the Member State shall not submit the final report referred to in paragraph 1. Instead, the Member State shall submit to the Commission a declaration confirming that the eradication programme did not achieve disease eradication and that the extension of its period of application is not requested.

               5.The final report referred to in paragraph 1 shall be submitted electronically via the ADIS.

               Article 9

               Submission and substantial modifications of Union surveillance programmes

               1.Member States shall submit to the Commission their Union surveillance programmes by 31 May of the year preceding the year of their start of application.

               2.The programmes referred to in paragraph 1 shall:

               (a)include at least the information listed in Article 11(1) of Delegated Regulation (EU) 2020/689;

               (b)be submitted electronically, using the standard electronic templates provided for that purpose.

               3.The programmes referred to in paragraph 1 that have been submitted to the Commission as the technical part of applications for Union funding are considered to be submitted in accordance with paragraph 1.

               4.In case of substantial modifications of ongoing Union surveillance programmes, Member States shall update and resubmit them.

               Article 10

               Submission of eradication programmes

               1.Member States shall submit to the Commission electronically, using the standard electronic templates provided for that purpose, for approval:

               (a)their compulsory eradication programmes by 31 May of the year preceding the year of their start of application;

               (b)their optional eradication programmes, at any time.

               2.The eradication programmes referred to in paragraph 1 shall contain the relevant information laid down in:

               (a)Section 1 of Annex VII for eradication programmes for category B and C diseases of terrestrial animals based on granting disease-free status at establishment level;

               (b)Section 2 of Annex VII for eradication programmes for infection with RABV;

               (c)Section 3 of Annex VII for eradication programmes for infection with BTV;

               (d)Section 4 of Annex VII for eradication programmes for category B and C diseases of aquatic animals.

               Article 11

               Application for recognition of disease-free status of Member States and zones as regards diseases of terrestrial and aquatic animals and disease-free status of compartments as regards diseases of aquatic animals

               1.Member States shall, when applying to the Commission for recognition of disease-free status in accordance with Sections 1 and 2 of Chapter 4 of Part II of Delegated Regulation (EU) 2020/689, include in their applications the relevant information specified in:

               (a)Sections 1 and 2 of Annex VI if the application for recognition of disease-free status is based on the absence of listed species;

               (b)Sections 1 and 3 of Annex VI if the application for recognition of disease-free status is based on the disease agent’s incapacity to survive;

               (c)Sections 1 and 4 of Annex VI if the application for recognition of disease-free status is based on the incapacity to survive of listed vectors for listed diseases of terrestrial animals;

               (d)Sections 1 and 5 of Annex VI if the application for recognition of disease-free status is based on historical and surveillance data;

               (e)Section 1 and point 1 of Section 6 of Annex VI if the application for recognition of disease-free status is based on eradication programmes for infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals;

               (f)Section 1 and point 2 of Section 6 of Annex VI if the application for recognition of disease-free status is based on eradication programmes for infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals;

               (g)Section 1 and point 3 of Section 6 of Annex VI if the application for recognition of disease-free status is based on eradication programmes for infection with MTBC;

               (h)Section 1 and point 4 of Section 6 of Annex VI if the application for recognition of disease-free status is based on eradication programmes for enzootic bovine leukosis (EBL);

               (i)Section 1 and point 5 of Section 6 of Annex VI if the application for recognition of disease-free status is based on eradication programmes for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV);

               (j)Section 1 and point 6 of Section 6 of Annex VI if the application for recognition of disease-free status is based on eradication programmes for infection with Aujeszky’s disease virus (ADV);

               (k)Section 1 and point 7 of Section 6 of Annex VI if the application for recognition of disease-free status is based on eradication programmes for bovine viral diarrhoea (BVD);

               (l)Section 1 and point 8 of Section 6 of Annex VI if the application for recognition of disease-free status is based on eradication programmes for infection with RABV;

               (m)Section 1 and point 9 of Section 6 of Annex VI if the application for recognition of disease-free status is based on eradication programmes for infection with BTV;

               (n)Section 1 and, where relevant, point 10 of Section 6 of Annex VI if the application for recognition of disease-free status is based on eradication programmes for diseases of aquatic animals.

               2Applications for recognition of disease-free status of compartments shall contain, in addition to the information referred to in point (n) of paragraph 1, the following information:

               (a)in case of compartments referred to in point (a) of Article 73(2) of Delegated Regulation (EU) 2020/689, documentation that substantiates compliance with the requirements provided for in Article 79(3), (4) and (5) of that Delegated Regulation;

               (b)in case of compartments referred to in point (b) of Article 73(2) of Delegated Regulation (EU) 2020/689, the assessment referred to in point (a) of Article 73(3) of that Delegated Regulation and details of any measures, which were put in place to prevent the introduction of the disease concerned into the compartment as referred to in point (c) of Article 73(3) of that Delegated Regulation.

               3.Member States shall inform the Commission immediately about any confirmed case of the relevant disease that is detected in the territory concerned after the date of submission of applications for recognition of disease-free status and before the date of recognition of that status.

               4.The applications referred to in paragraphs 1 and 2 shall be submitted electronically via the ADIS.

               Article 12

               Exchange of information on disease-free Member States, or zones and compartments thereof

               1.The list of territories, zones or compartments with disease-free status as refered to in Article 38 of Regulation (EU) 2016/429 shall be compiled using the standard electronic template provided on the Commission’s website.

               2.Member States shall amend the list referred to in paragraph 1 within two working days, if the disease-free status of the territory, zones or compartments changes due to non-compliance with the requirements for the maintenance of that status.

               3.Member States shall make the provisional declarations for zones or compartments for certain aquatic animal diseases as referred to in point (a) of Article 83(1) of Delegated Regulation (EU) 2020/689 using the standard electronic template provided on the Commission’s website.

               Article 13

               Procedures for the establishment and use of the ADIS

               Member States shall use the ADIS or any part thereof for data entry and transfer in accordance with this Regulation from the date communicated to them by the Commission.

               Article 14

               Entry into force and date of application

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

               It shall apply from 21 April 2021.

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

               Done at Brussels, 7.12.2020

                     For the Commission

                     The President
                     Ursula VON DER LEYEN

                     (1)

                        OJ L 84, 31.3.2016, p. 1.

                     (2)

                        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 (OJ L 174, 3.6.2020, p. 211).

                     (3)

                        Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21).

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               EN

               ANNEX I

               Listed diseases subject to Union notification

               1.Listed diseases of terrestrial animals subject to Union notification in accordance with point (a) of Article 3(1) and point (a) of Article 3(2)

               –Foot and mouth disease

               –Infection with rinderpest virus

               –Infection with Rift Valley fever virus

               –Infection with lumpy skin disease virus

               –Infection with Mycoplasma mycoides subsp. mycoides SC (Contagious bovine pleuropneumonia)

               –Sheep pox and goat pox

               –Infection with peste des petits ruminants virus

               –Contagious caprine pleuropneumonia

               –African horse sickness

               –Infection with Burkholderia mallei (Glanders)

               –Classical swine fever

               –African swine fever

               –Highly pathogenic avian influenza

               –Infection with Newcastle disease virus, excluding when diagnosed in:

               –Columbiformes unless kept as poultry; or

               –wild animals of listed species

               –Infection with rabies virus

               –Infection with epizootic haemorrhagic disease virus

               –Anthrax

               –Surra (Trypanosoma evansi)

               –Ebola virus disease

               –Equine infectious anaemia

               –Dourine

               –Venezuelan equine encephalomyelitis

               –Infestation with Aethina tumida (Small hive beetle)

               –Infestation with Tropilaelaps spp.

               –Infection with Batrachochytrium salamandrivorans

               –Japanese encephalitis

               –West Nile fever

               –Equine encephalomyelitis (Eastern and Western)

               2.Listed diseases of aquatic animals subject to Union notification in accordance with point (a) of Article 3(1) and point (a) of Article 3(2)

               –Epizootic haematopoietic necrosis

               –Infection with Mikrocytos mackini

               –Infection with Perkinsus marinus

               –Infection with Taura syndrome virus

               –Infection with yellow head disease virus

               3.Listed diseases of terrestrial animals subject to Union notification in accordance with point (b) of Article 3(1) and point (b) of Article 3(2)

               –Infection with Brucella abortus, B. melitensis, B. suis

               –Infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae, M. tuberculosis) (MTBC)

               –Infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV)

               –Bovine viral diarrhoea (BVD)

               –Enzootic bovine leukosis (EBL)

               –Infection with Aujeszky’s disease virus (ADV)

               4.Listed diseases of terrestrial animals subject to Union notification in accordance with point (c) of Article 3(1) and point (c) of Article 3(2)

               –Infection with bluetongue virus (serotypes 1-24) (‘infection with BTV’) by serotype

               –Infestation with Varroa spp.

               –Infestation with Echinococcus multilocularis

               5.Listed diseases of aquatic animals subject to Union notification in accordance with point (c) of Article 3(1) and point (c) of Article 3(2)

               –Viral haemorrhagic septicaemia

               –Infectious haematopoietic necrosis

               –Infection with HPR deleted infectious salmon anaemia virus

               –Infection with Marteilia refringens

               –Infection with Bonamia exitiosa

               –Infection with Bonamia ostreae

               –Infection with white spot syndrome virus (‘infection with WSSV’)

               ANNEX II

               Information to be provided for Union notification on outbreaks of listed diseases in accordance with Article 3(3)

               1.Date of dispatch.

               2.Time of dispatch.

               3.Name of the country.

               4.Name of disease and type of pathogen, where appropriate.

               5.Serial number of outbreak.

               6.Type of outbreak (primary/secondary outbreak).

               7.Reference number of outbreak linked to this outbreak (where applicable).

               8.Region and geographical location of the outbreak.

               9.Date of suspicion.

               10.Date of confirmation.

               11.Diagnostic methods used.

               12.Origin of disease.

               13.Control measures taken.

               14.Animals involved in the outbreak:

               (a)Terrestrial animals (by species) except honeybees and bumble bees:

               (I)number of susceptible animals, including wild animals where applicable;

               (II)estimated number of clinically or subclinically infected or infested animals including wild animals, where applicable;

               (III)estimated number of animals that have died or, in the case of wild animals, that have been found dead;

               (IV)number of animals killed;

               (V)number of animals slaughtered;

               (b)Honeybees and bumble bees:

               (I)number of susceptible colonies;

               (II)number of clinically or subclinically infected or infested colonies;

               (III)number of dead colonies;

               (IV)number of destroyed colonies;

               (c)Aquatic animals (by species):

               (I)estimated number or biomass of susceptible animals, including wild animals where applicable;

               (II)estimated number or biomass of clinically or subclinically infected animals, including wild animals where applicable;

               (III)estimated number or biomass of animals that have died or in the case of wild animals, that have been found dead;

               (IV)estimated number or biomass of animals killed;

               (V)estimated number or biomass of animals slaughtered.

               15.Date of preliminary cleaning and disinfection (where applicable).

               ANNEX III

               Information to be provided for Union reporting on the detection of listed diseases in accordance with Article 4(3)

               1.Date of report.

               2.Reporting period.

               3.Name of the country.

               4.Name of disease and type of pathogen, where appropriate.

               5.Number of outbreaks by listed animal species or group of species during the reporting period.

               6.Date of confirmation of the last outbreak.

               ANNEX IV

               Regions in the Member States for the purpose of notification and reporting in accordance with Article 5

                        Member State:

                        Notification and reporting regions:

                        Belgium

                        province — provincie

                        Bulgaria

                        област

                        Czechia

                        okres

                        Denmark

                        veterinary units or municipalities

                        Germany

                        Kreis, Regierungsbezirk oder Bundesland

                        Estonia

                        maakond

                        Ireland

                        county

                        Greece

                        περιφερειακή ενότητα

                        Spain

                        provincia

                        France

                        département

                        Croatia

                        županija

                        Italy

                        provincia

                        Cyprus

                        επαρχία

                        Latvia

                        novads

                        Lithuania

                        apskritis

                        Luxembourg

                        entire country

                        Hungary

                        megye

                        Malta

                        entire country

                        Netherlands

                        gemeente

                        Austria

                        Bezirk

                        Poland

                        powiat

                        Portugal

                        mainland: distrito

                        other parts of the territory: região autónoma

                        Romania

                        județ

                        Slovenia

                        območni urad

                        Slovakia

                        kraj

                        Finland

                        maakunta/landskap

                        Sweden

                        kommun

               ANNEX V

               Information on the results of the implementation of compulsory and optional eradication programmes to be provided in accordance with point a of Article 7(2)

               Section 1

               Results of eradication programmes for category b and c diseases of terrestrial animals based on granting of disease-free status at the level of establishments

               Information to be provided on eradication programmes for category B and C diseases of terrestrial animals based on granting of the disease-free status at the level of establishments:

               1.Date of report.

               2.Reporting period.

               3.Name of the country.

               4.Name of disease.

               5.Territorial scope (in the event of a change in the territorial scope in accordance with point 4 of Section 1 of Annex VII).

               6.Information on the establishments and animals concerned located in the territory in accordance with point 5, by zone or by region if more than one region is included in the territorial scope of the programme:

               (a)Number of establishments keeping animals of the targeted animal population excluding establishments falling under the derogation in accordance with Article 19 of Commission Delegated Regulation (EU) 2020/689
                  1
                at 31 December;

               (b)Number of animals of the targeted animal population kept in the establishments referred to in point (a) at 31 December;

               (c)Number of establishments with disease-free status including establishments with suspended disease-free status, with vaccination or without vaccination, where relevant, out of the number of establishments referred to in point (a) at 31 December;

               (d)Number of animals kept in the establishments referred to in point (c);

               (e)Number of establishments with one or more confirmed cases out of the number of establishments referred to in point (a) at 31 December;

               (f)Number of outbreaks confirmed during the reporting period.

               Section 2

               Results of eradication programmes for infection with RABV

               Information to be provided on eradication programmes for infection with RABV:

               1.Date of report.

               2.Reporting period.

               3.Name of the country.

               4.Territorial scope (in the event of a change in the territorial scope in accordance with point 3 of Section 2 of Annex VII).

               5.Information on surveillance per zone or region if more than one region is included in the territorial scope of the programme, including at least maps with data of:

               (a)Number of indicator animals tested per species;

               (b)Number of confirmed cases by species.

               6.Information on vaccination of wild animals, per zone or region if more than one region is included in the territorial scope of the programme:

               (a)Number and dates of vaccination campaigns;

               (b)Vaccine bait density achieved and, if the total size of the vaccination area per vaccination campaign is greater than 20 000 km2, vaccine bait density maps;

               (c)Upon request of the Commission, electronic files containing:

               (I)Flight routes recorded during the vaccine bait distribution;

               (II)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;

               (d)Information on the monitoring of the effectiveness of the vaccination, with maps with data of :

               (I)number of animals positive to the biomarker test / number of biomarker tests performed;

               (II)number of animals positive to serological tests / number of serological tests performed.

               Section 3

               Results of eradication programmes for infection with BTV

               Information to be provided on eradication programmes for infection with BTV:

               1.Date of report.

               2.Reporting period.

               3.Name of the country.

               4.Territorial scope (in the event of a change in the territorial scope in accordance with point 3 of Section 3 of Annex VII).

               5.Information on surveillance in the territory in accordance with point 4, by zone or by region if more than one region is included in the territorial scope of the programme:

               (a)number of establishments keeping animals of the targeted animal population at 31 December;

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

               (c)number of establishments keeping animals of the targeted animal population where vaccination against infection with BTV has been carried out and number of animals vaccinated during the reporting period, by species and, if relevant, by serotypes of BTV;

               (d)number of outbreaks by BTV serotype confirmed during the reporting period;

               (e)number and location of vector protected establishments, where relevant;

               (f)description of seasonally BTV-free areas and dates of beginning and end of the vector-free period, where relevant.

               Section 4

               Results of eradication programmes for category B and C diseases of aquatic animals

               Information to be provided on eradication programmes for category B and C diseases of aquatic animals:

               1.Date of report.

               2.Reporting period.

               3.Name of the country.

               4.Name of disease.

               5.Territorial scope (in the event of a change in the territorial scope in accordance with point 4 of Section 4 of Annex VII).

               6.Information on the aquaculture establishments and animals concerned located in the territory referred to in point 5 by compartment, zone or region, if more than one region is included in the territorial scope of the programme:

               (a)number of approved aquaculture establishments and number of registered aquaculture establishments keeping animals of the targeted animal population and, where relevant, sampling points in wild populations, which are included in the eradication programme, 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 infected aquaculture establishments and, where relevant, sampling points in wild populations with confirmed case(s) out of the number of establishments and sampling points referred to in point (a) at 31 December;

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

               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
                  2
                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.

               ANNEX VII

               Information required for the submission of eradication programmes in accordance with Article 10

               Section 1

               Submission of eradication programmes for category B and C diseases of terrestrial animals based on granting disease-free status at the level of establishments

               Information to be included in eradication programmes for category B and C diseases of terrestrial animals based on granting of the disease-free status at the level of establishments:

               1.Date of submission.

               2.Name of the country.

               3.Name of disease.

               4.Territorial scope with 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.

               5.A description of the epidemiological situation for each zone or region, if more than one region is included in the territorial scope of the programme:

               (a)the number of establishments keeping animals of the targeted animal population by health status
                  3
                excluding establishments falling under the derogation referred to in point (6)(f) at 31 December;

               (b)the number of animals of the targeted animal population kept in the establishments referred to in point (a) by health status;

               (c)maps indicating the density of the targeted animal population referred to in point (b) by health status;

               (d)timeline with prevalence, incidence data and, where relevant, vaccination history covering at least the past 5 years; and

               (e)information as regards the epidemiological situation in additional animal populations, where relevant.

               6.A description of the disease control strategy of the eradication programme in accordance with Article 16 of Commission Delegated Regulation (EU) 2020/689 including at least:

               (a)the sampling schemes and diagnostic methods to be used in accordance with Annex IV to Delegated Regulation (EU) 2020/689:

               (i)for the granting of the disease-free status to establishments and the maintenance of that status;

               (ii)to confirm or rule out the disease in the event of a suspected case;

               (b)the disease control measures to be applied in the event of a confirmed case;

               (c)the biosecurity and risk mitigating measures to be implemented;

               (d)type of vaccine(s) to be used and the vaccination scheme, if relevant;

               (e)the measures to be implemented as regards additional animal populations, if relevant;

               (f)the derogations to be applied in accordance with Article 19 of Delegated Regulation (EU) 2020/689, if relevant;

               (g)coordinated measures with other Member States or third countries, if relevant.

               7.A description of the organisation, supervision and roles of the parties involved in the eradication programme including at least:

               (a)the authorities in charge of coordinating and supervising the implementation of the programme;

               (b)responsibilities of all stakeholders involved.

               8.The estimated duration of the eradication programme.

               9.The intermediate targets of the eradication programme including at least:

               (a)the expected annual decrease of the number of infected establishments;

               (b)the expected annual increase of the number of disease-free establishments;

               (c)the expected vaccination coverage, where relevant.

               Section 2

               Submission of eradication programmes for infection with RABV

               Information to be included in eradication programmes for infection with RABV:

               1.Date of submission.

               2.Name of the country.

               3.Territorial scope with a description and demarcation of the geographical and administrative areas covered by the eradication programme and names of zones and regions, if more than one region is included in the territorial scope of the programme.

               4.A description of the epidemiological situation during at least the past 5 years, including:

               (a)number of confirmed cases by listed animal species;

               (b)maps indicating the distribution of confirmed cases referred to in point (a) per year;

               (c)disease control strategy and results of control measures.

               5.A description of the disease control strategy of the eradication programme in accordance with Article 32 of Commission Delegated Regulation (EU) 2020/689:

               (a)
                     surveillance, including at least:

               (I)targeted animal population;

               (II)sampling schemes and details on the collection of dead animals;

               (III)diagnostic methods;

               (b)
                     if relevant, vaccination, including at least:

               (i)vaccination of kept animals in the framework of the eradication programme;

               –type of vaccine(s) to be used;

               –targeted population;

               (ii)vaccination of wild animals:

               –definition/demarcation of the vaccination area;

               –frequency and expected dates of the vaccination campaigns;

               –vaccine bait(s) to be used;

               –vaccine bait distribution method and designed vaccine bait density;

               –description of the methods to be used to assess the correct vaccine bait distribution;

               –description of the strategy to monitor the effectiveness of the vaccination as regards serology and vaccine bait uptake in the targeted animal population, the sampling schemes, with details on the collection of dead animals, and diagnostic methods;

               –description of the measures to ensure the maintenance of the quality of the vaccine bait before it is distributed particularly as regards titration of the vaccine baits and controls of the cold chain;

               –vaccination of stray dogs with the type of vaccine(s) to be used and the targeted population;

               (c)
                     the disease control measures to be applied in the event of a confirmed case;

               (d)
                     the public information campaigns to be implemented;

               (e)
                     the measures to be implemented to reduce the contact with infected animals;

               (f)
                     the coordinated measures with other Member States or third countries, where relevant.

               6.A description of the organisation, supervision and roles of the parties involved in the eradication programme including at least:

               (a)the authorities in charge of coordinating and supervising the implementation of the programme;

               (b)responsibilities of all stakeholders involved.

               7.The estimated duration of the eradication programme.

               8.The intermediate targets of the eradication programme including at least:

               (a)the expected annual decrease of the number of outbreaks;

               (b)the expected number of confirmed outbreaks in areas with outbreaks during the previous year;

               (c)the expected percentage of sero-conversion in targeted animal populations;

               (d)the expected percentage of vaccine uptake in animals of the targeted species.

               Section 3

               Submission of eradication programmes for infection with BTV

               Information to be included in eradication programmes for infection with BTV:

               1.Date of submission.

               2.Name of the country.

               3.Territorial scope with 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: and the reasons for applying the derogation provided for in Article 37(3) of Delegated Regulation (EU) 2020/689, where relevant.

               4.A description of the epidemiological situation for each zone or region, if more than one region is included in the territorial scope of the programme:

               (a)the number of establishments keeping animals of the targeted animal population at 31 December;

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

               (c)maps indicating:

               (I)the density of the targeted animal population referred to in point (b); and

               (II)the geographical distribution of cases of infection with BTV by serotypes covering at least the past 5 years;

               (d)timeline with prevalence, incidence data and, where relevant, vaccination history covering at least the past 5 years;

               (e)results of vector surveillance covering at least the past 5 years;

               (f)information as regards the epidemiological situation in additional animal populations, where relevant.

               5.A description of the disease control strategy of the eradication programme in accordance with Article 37 of Delegated Regulation (EU) 2020/689 including at least:

               (a)details of the active surveillance to be implemented in accordance with Section 4 of Chapter 1 of Part II of Annex V to Delegated Regulation (EU) 2020/689 with:

               (I)maps indicating the geographical units;

               (II)choice of sampling sites, sampling schemes and diagnostic methods used for the monitoring of sentinel animals;

               (III)choice of sampling sites, sampling schemes and diagnostic methods used for the structured prevalence surveys;

               (b)
                     type of vaccine(s) to be used and vaccination schemes for vaccination of the relevant targeted animal population, where relevant;

               (c)
                     procedure and diagnostic methods to confirm or rule out the disease in the event of a suspected case;

               (d)
                     the disease control measures to be applied in the event of a confirmed case;

               (e)
                     movement restrictions implemented for movements of kept animals and germinal products;

               (f)
                     the biosecurity and risk mitigating measures to be implemented;

               (g)
                     details on vector surveillance and, where relevant, the establishment of seasonally BTV-free areas;

               (h)
                     details on the granting to establishments of the status ‘vector protected establishment’, where relevant;

               (i)
                     coordinated measures with other Member States or third countries, where relevant.

               6.A description of the organisation, supervision and roles of the parties involved in the eradication programme including at least:

               (a)the authorities in charge of coordinating and supervising the implementation of the programme;

               (b)responsibilities of all stakeholders involved.

               7.The estimated duration of the eradication programme.

               8.The intermediate targets of the eradication programme including at least:

               (a)the expected annual decrease of the number of confirmed cases in the targeted animal population;

               (b)the expected annual increase of the number of disease-free geographical units;

               (c)the expected vaccination coverage, where relevant.

               Section 4

               Submission of eradication programmes for category B and C diseases of aquatic animals

               Information to be included in eradication programmes for category B and C diseases of aquatic animals:

               1.Date of submission.

               2.Name of the country.

               3.Name of disease.

               4.Territorial scope with a description and demarcation of the geographical and administrative areas covered by the eradication programme and the names of the zones or compartments.

               5.A description of the epidemiological situation for each zone, compartment or region if more than one region is included in the territorial scope of the programme:

               (a)the number of approved aquaculture establishments and the number of registered aquaculture establishments keeping animals of the targeted animal population, by type of production and by health status
                  4
                at 31 December;

               (b)listed species kept in the aquaculture establishments referred to in point (a) by health status;

               (c)maps indicating:

               (I)the geographical location of the aquaculture establishments referred to in point (a) and the relevant water catchment areas; and

               (II)the geographical distribution of cases of infection with the relevant category B or C disease covering at least the past 5 years;

               (d)information as regards the epidemiological situation in wild aquatic animals, where relevant.

               6.A description of the disease control strategy of the eradication programme in accordance with Article 46 of Delegated Regulation (EU) 2020/689 including at least:

               (a)the sampling schemes and diagnostic methods to be used in accordance with Annex VI to Delegated Regulation (EU) 2020/689 for:

               (I)health visits and sampling in aquaculture establishments;

               (II)targeted surveillance in wild populations, where relevant;

               (b)the disease control measures to be applied in the event of a confirmed case;

               (c)the biosecurity and risk mitigating measures to be implemented;

               (d)vaccination schemes, where relevant;

               (e)the measures to be implemented as regards wild aquatic animals and the number and geographical location of sampling points where relevant;

               (f)the derogations to be applied in accordance with Article 53 of Delegated Regulation (EU) 2020/689, where relevant;

               (g)coordinated measures with other Member States or third countries, where relevant.

               7.A description of the organisation, supervision and roles of the parties involved in the eradication programme including at least:

               (a)the authorities in charge of coordinating and supervising the implementation of the programme;

               (b)responsibilities of all stakeholders involved.

               8.The estimated duration of the eradication programme.

               9.The intermediate targets of, and the disease control strategies for implementing, the eradication programme including at least:

               (a)the expected annual decrease of the number of infected aquaculture establishments and where relevant, sampling points in wild populations;

               (b)the expected annual increase of the number of aquaculture establishments and, where relevant, sampling points in wild populations that tested negative;

               (c)the expected vaccination coverage, where relevant.

                     (1)

                        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 (OJ L 174, 3.6.2020, p. . 211).

                     (2)

                        Infected, non-infected, unknown.

                     (3)

                        Disease-free, infected or unknown.

                     (4)

                        Not-infected, infected, unknown.


title: Commission Implementing Regulation (EU) 2020/1363 of 30 September 2020 concerning the authorisation of the preparation of Bacillus amyloliquefaciens DSM 25840 as a feed additive for all porcine species (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance)

text:
                  1.10.2020

                  EN

                  Official Journal of the European Union

                  L 317/10

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1363
         of 30 September 2020
         concerning the authorisation of the preparation of Bacillus amyloliquefaciens DSM 25840 as a feed additive for all porcine species (holder of authorisation Chr. Hansen A/S)
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

                     Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003, applications were submitted for the authorisation of the preparation of Bacillus amyloliquefaciens DSM 25840. Those applications were accompanied by the particulars and documents required under Article 7(3) of that Regulation.

                     (3)

                     Those applications concern the authorisation of the preparation of Bacillus amyloliquefaciens DSM 25840 as a feed additive for all porcine species, to be classified in the additive category ‘zootechnical additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 21 February 2018 (2) and 4 October 2019 (3) that, under the proposed conditions of use, the preparation of Bacillus amyloliquefaciens DSM 25840 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive should be considered a potential respiratory sensitiser and no conclusion can be drawn on its potential irritancy on skin and eyes, and on skin sensitisation. Therefore, appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority concluded that the additive has a significant effect on improvement of zootechnical parameters in all porcine species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (5)

                     The assessment of the preparation of Bacillus amyloliquefaciens DSM 25840 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

                     (6)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Authorisation
            The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

            Article 2
            Entry into force
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 30 September 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 268, 18.10.2003, p. 29.

            (2)  EFSA Journal 2018;16(4):5200.

            (3)  EFSA Journal 2019;17(11):5881 and EFSA Journal 2019;17(11):5883.

            ANNEX

                        Identification number of the additive

                        Name of the holder of authorisation

                        Additive

                        Composition, chemical formula, description, analytical method

                        Species or category of animal

                        Maximum age

                        Minimum content

                        Maximum content

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

                        CFU/kg of complete feedingstuff with a moisture content of 12 %

                        CFU/l of water for drinking

                           Category of zootechnical additives. Functional group: gut flora stabilisers

                        4b1901

                        Chr. Hansen A/S

                           Bacillus amyloliquefaciens DSM 25840

                           Additive composition

                        Preparation of Bacillus amyloliquefaciens DSM 25840 containing a minimum of 1,25 ×1010 CFU/g of additive
                        Solid form

                        All porcine species

                        —

                        5 × 108

                        -

                        1,7 × 108

                        -

                                    1.

                                    In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

                                    2.

                                    The additive may be used in water for drinking. For use of the additive in water for drinking the homogenous dispersion of the additive shall be ensured.

                                    3.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eyes and breathing protection.

                        21 October 2030

                           Characterisation of the active substance

                        Viable spores of Bacillus amyloliquefaciens DSM 25840

                           Analytical method
                            (1)

                        For identification of Bacillus amyloliquefaciens DSM 25840: Identification: Pulsed Field Gel Electrophoresis (PFGE)
                        For enumeration of Bacillus amyloliquefaciens DSM 25840 in the feed additive, premixtures and feedingstuffs: Spread plate method using tryptone soya agar – EN 15784

               (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports