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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)

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)

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:

  1. points 1 and 2 of Annex I;

  2. 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;

  3. 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:

  1. points 1 and 2 of Annex I;

  2. 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;

  3. 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

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

Article 8 Union reporting on the final results of the implementation of approved eradication programmes

Article 9 Submission and substantial modifications of Union surveillance programmes

Article 10 Submission of eradication programmes

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

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

Article 14 Entry into force and date of application

ANNEX ILISTED DISEASES SUBJECT TO UNION NOTIFICATION

ANNEX IIINFORMATION TO BE PROVIDED FOR UNION NOTIFICATION ON OUTBREAKS OF LISTED DISEASES IN ACCORDANCE WITH ARTICLE 3(3)

ANNEX IIIINFORMATION TO BE PROVIDED FOR UNION REPORTING ON THE DETECTION OF LISTED DISEASES IN ACCORDANCE WITH ARTICLE 4(3)

ANNEX IVREGIONS IN THE MEMBER STATES FOR THE PURPOSE OF NOTIFICATION AND REPORTING IN ACCORDANCE WITH ARTICLE 5

ANNEX VINFORMATION ON THE RESULTS OF THE IMPLEMENTATION OF COMPULSORY AND OPTIONAL ERADICATION PROGRAMMES TO BE PROVIDED IN ACCORDANCE WITH POINT A OF ARTICLE 7(2)

ANNEX VIINFORMATION 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

ANNEX VIIINFORMATION REQUIRED FOR THE SUBMISSION OF ERADICATION PROGRAMMES IN ACCORDANCE WITH ARTICLE 10