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 (Text with EEA relevance) (Text with EEA relevance)

PART I

GENERAL PROVISIONS

Article 1

Subject-matter and scope

Chapter 1 of Part II of this Regulation lays down the rules for surveillance of the diseases referred to in Article 9(1) of Regulation (EU) 2016/429 and the emerging diseases as defined in Article 6(2) of that Regulation in relation to:

(a) the design of the surveillance including the targeted animal population and the diagnostic methods;

(b) the disease confirmation and the case definition;

(c) Union surveillance programmes.

Chapter 2 of Part II of this Regulation lays down the rules for eradication programmes for the diseases of terrestrial animals referred to in points (b) and (c) of Article 9(1) of Regulation (EU) 2016/429 in relation to:

(a) the disease control strategy, the territory, the animal populations, the targets and the period of application;

(b) the obligations of operators and competent authorities;

(c) the disease control measures in the event of suspicion and of confirmation.

Chapter 3 of Part II of this Regulation lays down the rules for eradication programmes for the diseases of aquatic animals referred to in points (b) and (c) Article 9(1) of Regulation (EU) 2016/429 in relation to:

(a) the disease control strategy, the territory, the animal populations, the targets and the period of application;

(b) the obligations of operators and competent authorities;

(c) the disease control measures in the event of suspicion and of confirmation.

Chapter 4 of Part II of this Regulation lays down the rules for disease-free status with regard to certain diseases of terrestrial and aquatic animals referred to in Article 9(1) of Regulation (EU) 2016/429 in relation to:

(a) the criteria for the approval of the disease-free status of Member States and zones;

(b) the criteria for the approval of the disease-free status for compartments keeping aquaculture animals;

(c) the criteria for the maintenance of the disease-free status;

(d) the suspension, the withdrawal and the restoration of disease-free status.

Part III of this Regulation lays down transitional and final provisions in relation to:

(a) the approval of the disease-free status of Member States, zones and compartments which are recognised disease-free under the legislation in force before the date of application of this Regulation;

(b) the approval of eradication programmes of Member States, zones and compartments which have an approved eradication or surveillance programme under the legislation in force before the date of application of this Regulation.

Article 2

Definitions

For the purpose of this Regulation, the following definitions shall apply:

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

(2) ‘targeted animal population’ means the population of animals of listed species defined by species and, as appropriate, by categories, relevant for the surveillance activities, the eradication programmes or the disease-free status of a specific disease;

(3) ‘additional animal population’ means the population of kept or wild animals of listed species subjected to optional prevention, surveillance and disease control measures necessary to achieve or maintain the disease-free status of a targeted animal population;

(4) ‘category A disease’: means a listed disease that does not normally occur in the Union and for which immediate eradication measures must be taken as soon as it is detected, as referred to in point (a) of Article 9(1) of Regulation (EU) 2016/429;

(5) ‘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 point (b) of Article 9(1) of Regulation (EU) 2016/429;

(6) ‘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 point (c) of Article 9(1) of Regulation (EU) 2016/429;

(7) ‘bovine animal’ or ‘animal of the bovine species’ means an animal of the species of ungulates belonging to the genera Bison, Bos (including the subgenera Bos, Bibos, Novibos, Poephagus) and Bubalus (including the subgenus Anoa) and the offspring of crossings of those species;

(8) ‘ovine animal’ or ‘animal of the ovine species’ means an animal of the species of ungulates belonging to the genus Ovis and the offspring of crossings of those species;

(9) ‘caprine animal’ or ‘animal of the caprine species’ means an animal of the species of ungulates belonging to the genus Capra and the offspring of crossings of those species;

(10) ‘travelling circus’ means an exhibition or fair that includes animals or animal acts which is intended to move between Member States;

(11) ‘animal acts’ means any act featuring animals kept for the purpose of an exhibition or fair, and which may form part of a circus;

(12) ‘porcine animal’ or ‘animal of the porcine species’ means an animal of the species of ungulates of family Suidae listed in Annex III to Regulation (EU) 2016/429;

(13) ‘means of transport’ means road or rail vehicles, vessels and aircrafts;

(14) ‘dog’ means a kept animal of the Canis lupus species;

(15) ‘cat’ means a kept animal of the Felis silvestris species;

(16) ‘ferret’ means a kept animal of the Mustela putorius furo species;

(17) ‘seasonally BTV-free area’ means the whole territory of a Member State or a zone thereof where the competent authority has established a temporary status of freedom from infection with bluetongue virus (serotype 1-24) (‘infection with BTV’) in accordance with Article 40(3) on the basis of a vector-free period and the demonstration of absence of the disease in listed animal species;

(18) ‘vector protected establishment’ means part or all facilities of an establishment that are protected against attacks from Culicoides by appropriate physical and management means, with a status of vector protected establishment being granted by the competent authority in accordance with Article 44;

(19) ‘well-boat’ means a vessel used by the aquaculture industry which has a well or tank for the storage and transport of live fish in water;

(20) ‘fallowing’ means, for disease management purposes, an operation where an establishment is emptied of aquaculture animals from listed species, and where feasible, of water;

(21) ‘eligibility period’ means the period of time before the competent authority submits the application for disease-free status or, when relevant, before the provisional declaration referred to in point (a) of Article 83(1) is published electronically;

(22) ‘non-listed species’, means an animal species or group of animal species not listed in the Annex to Commission Implementing Regulation (EU) 2018/1882 for a particular disease;

(23) ‘flock’ means all poultry or captive birds of the same health status kept on the same premises or in the same enclosure and constituting a single epidemiological unit; in housed poultry includes all birds sharing the same airspace;

(24) ‘DIVA (differentiating infected from vaccinated animals) vaccination’ means a vaccination using vaccines that enable in conjunction with appropriate serological diagnostic methods, the detection of infected animals in a vaccinated population;

(25) ‘DIVA vaccinated animals’ means animals that have been vaccinated in the framework of a DIVA vaccination;

(26) ‘approved germinal product establishment’ means a semen collection centre, an embryo collection team, an embryo production team, a germinal product processing establishment or a germinal product storage centre, approved in accordance with Article 97(1) of Regulation (EU) 2016/429;

(27) ‘semen’ means the ejaculate of an animal or animals, either in the unaltered state or prepared or diluted;

(28) ‘oocytes’ means the haploid stages of the ootidogenesis including secondary oocytes and ova;

(29) ‘embryo’ means the initial stage of development of an animal while it is capable of being transferred to a recipient dam;

(30) ‘vector-free period’ means in a defined area the period of inactivity of Culicoides determined in accordance with Section 5 of Chapter 1 of Part II of Annex V;

(31) ‘honeybees’ means animals of the Apis mellifera species;

(32) ‘breeding poultry’ means poultry 72 hours old or more, intended for the production of hatching eggs;

(33) ‘random annual surveillance’ means a surveillance consisting of at least one survey of a targeted animal population organised during the year for which probability-based sampling methods are used to select units to examine.

PART II

SURVEILLANCE, ERADICATION PROGRAMMES, DISEASE-FREE STATUS

CHAPTER 1

Surveillance

Section 1

Design of surveillance, Targeted animal population and diagnostic methods

Article 3

Design of surveillance

The competent authority shall design the surveillance for listed and emerging diseases of terrestrial animals and other animals taking into account:

(a) general surveillance requirements based on: (i) notification as provided for in Article 18(1) of Regulation (EU) 2016/429; (ii) appropriate veterinary investigation of increased mortalities and other signs of serious diseases or significantly decreased production rates with an undetermined cause; (iii) investigation by the competent authority in the event of the suspicion of a category E disease or, if relevant, of an emerging disease; (iv) targeted animal population for surveillance as provided for in Article 4; (v) the contribution of official controls and other official activities as provided for in Article 7;

(b) specific surveillance requirements: (i) in Union surveillance programme; (ii) as a part of compulsory or optional eradication programmes; (iii) for demonstrating and maintaining disease-free status; (iv) as a part of disease control measures; (v) in the context of approval of certain establishments; (vi) for the movements of terrestrial animals within the Union or their entry into the Union.

The competent authority shall design the surveillance for listed and emerging diseases of aquatic animals taking into account:

(a) general surveillance requirements based on: (i) notification as provided for in Article 18(1) of Regulation (EU) 2016/429; (ii) appropriate veterinary investigation of increased mortalities and other signs of serious diseases or significantly decreased production rates with an undetermined cause; (iii) investigation by the competent authority in the event of the suspicion of a category E disease or, if relevant, of an emerging disease; (iv) targeted animal population for surveillance as provided for in Article 4; (v) the contribution of official controls and other official activities as provided for in Article 7; (vi) disease control measures;

(b) specific surveillance requirements: (i) as a part of the risk-based surveillance scheme set out in Chapter 1 of Part I of Annex VI, involving a risk ranking and regular animal health visits as provided for in Chapters 2 and 3 of Part I of Annex VI; (ii) as a part of the eradication programmes provided for in Chapters 1 to 6 of Part II of Annex VI; (iii) for demonstrating and maintaining disease-free status; (iv) for demonstrating, in accordance with the surveillance programmes provided for in Chapters 1 to 6 of Part III of Annex VI, that establishments which are not participating in the eradication programme referred to in point (ii) or which have not obtained the disease-free status referred to in point (iii) are not infected; (v) for the movements of aquatic animals within the Union or their entry into the Union.

Article 4

Targeted animal population

The competent authority shall specify the targeted animal population relevant to the surveillance referred to in Article 3 for each listed disease and, when relevant, for each emerging disease and shall include:

(a) kept animals of listed species;

(b) wild animals of listed species if: (i) they are subject to a Union surveillance programme, or to a compulsory or an optional eradication programme or to the surveillance necessary for the granting or maintenance of a disease-free status; (ii) the competent authority considers that they constitute a risk that may impair the health status of other species in a Member State, zone or compartment; or (iii) surveillance is necessary to assess animal health requirements for entry into the Union or movements within the Union.

To ensure the early detection of an emerging disease in species other than those referred to in point (a) of paragraph 1, the competent authority shall include, in the targeted animal population, kept animals of species that are not listed for the purpose of the relevant listed disease if the following criteria apply:

(a) they are moved to establishments in another Member State, zone or compartment; and

(b) due to the number of animals or the frequency of the movements, the competent authority considers the animals to constitute a risk that might impair the health status of other kept animals in another Member State, zone or compartment, should a disease emerge in that species.

Article 5

Exclusion of certain kept terrestrial animals from the targeted animal population

By way of derogation from point (a) of Article 4(1), the competent authority may limit the targeted animal population for the surveillance of a disease other than a category A disease to the categories of kept animals of listed species that are subject, for that disease, to:

(a) Union surveillance programmes;

(b) compulsory or optional eradication programmes or surveillance necessary for the granting or maintenance of a disease-free status; or

(c) surveillance-based animal health requirements for the movements within the Union or the entry into the Union.

Article 6

Diagnostic methods

The competent authority shall ensure that the collection of samples, the techniques, validation and interpretation of the diagnostic methods for the purposes of surveillance shall comply:

(a) with the specific legislation adopted in accordance with Regulation (EU) 2016/429 and the relevant details and guidance made available on the websites of the European Union Reference Laboratories (EURL) and of the Commission;

(b) when not covered by the legislation, details and guidance referred to in point (a), with the collection of samples, the techniques, validation and interpretation of the diagnostic methods laid down in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE) (‘the Terrestrial Manual’ (¹) as amended or the Manual of Diagnostic Tests for Aquatic Animals of the OIE (‘the Aquatic Manual’ (²) as amended;

(c) when not covered by points (a) and (b) of this paragraph, with the methods laid down in point (b) of Article 34(2) and Article 34(3) of Regulation (EU) 2017/625.

The diagnostic methods for granting and maintaining disease-free status are laid down in:

(a) Section 1 of Annex III for infection with Brucella abortus, B. melitensis and B.suis;

(b) Section 2 of Annex III for infection with Mycobacterium tuberculosis complex (Mycobacterium bovis, M.caprae and M. tuberculosis) (MTBC);

(c) Section 3 of Annex III for enzootic bovine leukosis (EBL);

(d) Section 4 of Annex III for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV);

(e) Section 5 of Annex III for infection with Aujeszky’s disease virus (ADV);

(f) Section 6 of Annex III for bovine viral diarrhoea (BVD);

(g) point 2 of Section 5 of Chapter 1 of Part II of Annex VI for viral haemorrhagic septicaemia (VHS);

(h) point 2 of Section 5 of Chapter 1 of Part II of Annex VI for infectious haematopoietic necrosis (IHN);

(i) point 2 of Section 5 of Chapter 2 of Part II of Annex VI for infection with highly polymorphic region deleted infectious salmon anaemia virus (HPR-deleted ISAV);

(j) point 2 of Section 5 of Chapter 3 of Part II of Annex VI for infection with Marteilia refringens;

(k) point 2 of Section 5 of Chapter 4 of Part II of Annex VI for infection with Bonamia exitiosa;

(l) point 2 of Section 5 of Chapter 5 of Part II of Annex VI for infection with Bonamia ostreae;

(m) point 2 of Section 5 of Chapter 6 of Part II of Annex VI for infection with white spot syndrome virus (WSSV).

Article 7

Contribution of official controls and other official activities to animal health surveillance

The competent authority shall, if relevant, include in the design of the surveillance referred to in Article 3 of this Regulation the outcome of the official controls and other official activities defined in Article 2 of Regulation (EU) 2017/625. These official controls and other official activities include:

(a) ante-mortem and post-mortem inspections;

(b) inspections at border control posts;

(c) official controls and other official activities at markets and assembly operations;

(d) official controls and other official activities during transport of live animals;

(e) public health related inspections and sampling in establishments;

(f) any other official controls during which establishments, animals or samples are inspected or examined.

When the competent authority suspects a listed disease or an emerging disease in the context of official controls or other official activities referred to in paragraph 1, it shall ensure that all relevant authorities are informed. This shall be done:

(a) immediately in case of a category A disease or of an emerging disease;

(b) without delay for other diseases.

Section 2

Disease confirmation and case definitions

Article 8

Criteria for official confirmation of listed diseases, other than category A diseases, and certain emerging diseases and subsequent confirmation of outbreaks

The competent authority shall, on suspicion of listed diseases, other than category A disease, or of an emerging disease, conduct an investigation to confirm or to rule out the presence of that disease when:

(a) there is a need to determine the health status of the Member State, zone or compartment thereof; or

(b) there is a need to collect necessary information on the occurrence of the disease for any of the following purposes: (i) to implement measures to protect animal or human health; (ii) to implement animal health requirements for movements of animals or products; or (iii) to comply with the requirements laid down in a Union surveillance programme.

Article 9

Case definitions

The competent authority shall classify an animal or a group of animals as a suspected case of a listed disease or of an emerging disease when: