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

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

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.

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.

Article 4

Union reporting on the detection of listed diseases

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

Article 7

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

The reports referred to in paragraph 1 shall contain for every year, covering the previous calendar year, the information specified in:

(a) 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;

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

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

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

Article 8

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

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.

Article 9

Submission and substantial modifications of Union surveillance programmes

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.

Article 10

Submission of eradication programmes

Member States shall submit to the Commission 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.

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

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, with the exception of the information previously provided in reports referred to in Article 7 of this Regulation, 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.

Applications 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.

Article 12

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

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.

ANNEX I

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

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. For all category A diseases as defined in Article 1, point (1), of Implementing Regulation (EU) 2018/1882, indicate if the outbreak occurred in a location already subject to restrictions following the establishment of restricted zones for the same category A disease in accordance with Articles 64, 70, 71, 257, 258 or 259 of Regulation (EU) 2016/429.

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 completion of the preliminary cleaning and disinfection following an outbreak in kept animals of any category A disease as defined in Article 1, point (1), of Implementing Regulation (EU) 2018/1882.

ANNEX III

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