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: (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. 2. 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. 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 December 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).