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:
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).
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).