02020R0687 — EN — 14.07.2021 — 001.001

This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B COMMISSION DELEGATED REGULATION (EU) 2020/687 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council, as regards rules for the prevention and control of certain listed diseases (Text with EEA relevance) (OJ L 174 3.6.2020, p. 64)

Amended by:









▼B

COMMISSION DELEGATED REGULATION (EU) 2020/687

of 17 December 2019

supplementing Regulation (EU) 2016/429 of the European Parliament and the Council, as regards rules for the prevention and control of certain listed diseases

(Text with EEA relevance)







PART I

GENERAL PROVISIONS

Article 1

Subject matter and scope

This Regulation supplements the rules on disease awareness, preparedness and control to be applied with regard to the listed diseases referred to in Article 9(1)(a), (b) and (c) of Regulation (EU) 2016/429.

Those rules cover the following:

(a) Part II covers kept and wild terrestrial animals, and in particular: (i) Chapter I lays down supplementing rules on disease control measures in the event of suspicion and official confirmation of a category A disease in kept animals as referred to in Articles 53, 54, 55, 58 and 63 of Regulation (EU) 2016/429; (ii) Chapter II lays down supplementing rules regarding the establishment of restricted zones in the event of official confirmation of a category A disease in kept animals as referred to in Article 64 and 67 of Regulation (EU) 2016/429; (iii) Chapter III lays down supplementing rules regarding the repopulation of the restricted zone with kept animals in the event of official confirmation of a category A disease as referred to in Articles 63 and 68 of Regulation (EU) 2016/429; (iv) Chapter IV lays down supplementing rules regarding disease control measures in the event of suspicion and official confirmation of a category A disease in wild animals as referred to in Article 70 of Regulation (EU) 2016/429; (v) Chapter V lays down supplementing rules on disease control measures in the event of suspicion and official confirmation of category B and C diseases in terrestrial animals as referred to in Article 74 and 77 of Regulation (EU) 2016/429;

(b) Part III covers kept and wild aquatic animals, and in particular: (i) Chapter I lays down supplementing rules on disease control measures in the event of suspicion and official confirmation of a category A disease in aquatic animals as referred to in Articles 53, 54, 55, 58 and 63 of Regulation (EU) 2016/429; (ii) Chapter II lays down supplementing rules regarding the establishment of restricted zones in the event of official confirmation of a category A disease in aquaculture animals as referred to in Article 64 and 67 of Regulation (EU) 2016/429; (iii) Chapter III lays down supplementing rules regarding disease control measures in the event of suspicion and official confirmation of a category A disease in wild aquatic animals as referred to in Article 70 of Regulation (EU) 2016/429; (iv) Chapter IV lays down supplementing rules on disease control measures in the event of suspicion and official confirmation of category B and C diseases in aquatic animals as referred to in Article 74 and 77 of Regulation (EU) 2016/429;

(c) Part IV covers final provisions.

Article 2

Definitions

For the purposes of this Regulation, definitions laid down in Regulation (EU) 2018/1882 and Annex I to Regulation (EC) No 853/2004 of the European Parliament and of the Council ( 1 ) shall apply, except where those definitions cover terms that are defined in the second paragraph of this Article.

In addition, the following definitions shall also apply:

(1) ‘means of transport’ means road or rail vehicle, vessels and aircrafts;

(2) ‘day-old chicks’ means poultry less than 72 hours old;

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

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

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

(6) ‘fresh meat’ means meat, minced meat and meat preparations, including vacuum-wrapped or wrapped in a controlled atmosphere, which has not undergone any process other than chilling, freezing or quick-freezing;

(7) ‘carcass of an ungulate’ means the whole body of a slaughtered or killed ungulate after: — bleeding, in the case of slaughtered animals, — evisceration, — removal of the limbs at the carpus and tarsus, — removal of the tail, the udder, the head and the skin, except in porcine animals;

(8) ‘offal’ means fresh meat other than that of the carcass as defined in (7), even if it remains naturally connected to the carcass;

(9) ‘meat products’ means processed products, including treated stomachs, bladders, intestines, rendered fats, meat extracts and blood products, resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat;

(10) ‘casings’ means the bladders and intestines that after cleaning have been processed by tissue scraping, defatting and washing and have been dried after salting;

(11) ‘colostrum’ means the fluid secreted by the mammary glands of kept animals up to five days post parturition that is rich in antibodies and minerals, and precedes the production of raw milk.

(12) ‘colostrum-based products’ means processed products resulting from the processing of colostrum or from the further processing of such processed products;

(13) ‘safe commodity’ means a commodity that can be moved without the need for risk mitigation measures specifically directed against a particular listed disease regardless of the status of the Member State or zone of origin for that disease;

(14) ‘supply chain’ means an integrated production chain of a common health status as regards listed diseases consisting of a collaborative network of specialised establishments approved by the competent authority for the purpose of Article 45, between which animals are moved to complete the production cycle;

(15) ‘infected zone’ means a zone in which restrictions on the movements of kept and wild animals or products and other disease control and biosecurity measures may be applied with the view to preventing the spread of a category A disease in the event of official confirmation of the disease in wild animals.

Article 3

Clinical examinations, sampling procedures and diagnostic methods

1. Where clinical examinations of animals are required pursuant to this Regulation in order to confirm or rule out the presence of a category A disease, the competent authority shall ensure that: (a) the sampling of animals for clinical examination is carried out in accordance with: (i) point A.1 of Annex I for terrestrial animals; and (ii) point 1 of Annex XII for aquatic animals; (b) the clinical examination comprises: (i) an initial general evaluation of the animal health status of the establishment which comprises all the animals of listed species kept in the establishment; and (ii) an individual examination of the animals included in the sample referred to in point (a).

2. Where laboratory examinations are required pursuant to this Regulation in order to confirm or rule out the presence of a category A disease, the competent authority shall ensure that: (a) the sampling of animals for laboratory examination is carried out in accordance with: (i) point A.2 of Annex I for terrestrial animals; and (ii) point 1(b), (c), (d) and (e) of Annex XII for aquatic animals; (b) the diagnostic methods for laboratory examinations fulfil the requirements set out in: (i) point B of Annex I for terrestrial animals; and (ii) point 2 of Annex XII for aquatic animals; (c) the samples are sent: (i) without delay to an official laboratory designated in accordance with Article 37 of Regulation (EU) 2017/625 of the European Parliament and of the Council ( 2 ); (ii) in accordance with point C of Annex I for terrestrial animals and point 1(f) of Annex XII for aquatic animals; and (iii) following any other instruction from the competent authority and from the laboratory regarding biosecurity and biosafety conditions to prevent the spread of category A disease agents; (d) in the case of kept animals: (i) an inventory of all kept animals on the establishment and their species and categories is compiled; for poultry and aquaculture animals the number of animals may be estimated; and (ii) an identification mark of each sampled animal of listed species, or in the case of poultry and aquaculture animals the batch number, is recorded.

Article 4

Contingency plans

The competent authority shall implement the measures laid down in this Regulation in accordance with the contingency plan referred to in Article 43 of Regulation (EU) 2016/429.







PART II

TERRESTRIAL ANIMALS







CHAPTER I

Disease control measures for category A diseases in kept terrestrial animals







Section 1

Preliminary disease control measures in the event of suspicion of a category A disease in kept animals

Article 5

Obligations on operators in the event of suspicion of a category A disease in kept animals in an establishment

In the event of suspicion of a category A disease in kept animals, operators shall take the following disease control measures in order to prevent the spread of the category A disease from the affected animals and establishments under their responsibility to other unaffected animals or to humans until the competent authority rules out the presence of the category A disease:

(a) isolate all animals suspected of being infected with the category A disease;

(b) keep the manure, including litter and used bedding, and any product, material or substance likely to be contaminated with and to transmit category A diseases isolated and protected from insects and rodents, kept animals of non-listed species and wild animals to the extent technically and practically feasible;

(c) implement the appropriate additional biosecurity measures to avoid any risk of spread of the category A disease;

(d) cease all movements of kept animals of listed species from or to the establishment;

(e) prevent non-essential movements of animals of non-listed species, products, materials, substances, persons and means of transport from or to the establishment;

(f) ensure that production, health and traceability records of the establishment are updated;

(g) provide the competent authority, on its request, with any relevant information regarding the category A disease; and

(h) follow any instructions given by the competent authority regarding the control of the category A disease, in accordance with Regulation (EU) 2016/429 and this Regulation.

Article 6

Investigation by the competent authority in the event of suspicion of a category A disease in kept animals in an establishment

1. In the event of suspicion of a category A disease in kept animals in an establishment, in accordance with Article 9(1), (3) and (4) of Delegated Regulation (EU) 2020/689, the competent authority shall immediately conduct an investigation to confirm or rule out the presence of the suspected listed disease.

2. In the course of the investigation referred to in paragraph 1 the competent authority shall ensure that official veterinarians perform at least: (a) clinical examinations of kept animals of listed species at the establishment; and (b) collection of samples for laboratory examinations.

Article 7

Preliminary restriction and biosecurity measures in the event of suspicion of a category A disease in kept animals in an establishment

1. In the event of suspicion of a category A disease in an establishment, the competent authority shall place the establishment under official surveillance and immediately impose the following preliminary restriction and biosecurity measures, in order to prevent the spread of the category A disease from the affected animals and the establishment to other unaffected animals or to humans: (a) prohibition of movements of kept animals of listed species into and from the establishment; (b) prohibition of movements of kept animals of non-listed species into and from the establishment; (c) prohibition of movements of any product, material or substance likely to be contaminated with or likely to transmit category A diseases from the establishment; (d) isolation of kept animals of listed species and protection from wild animals, animals of non-listed species and, when necessary, from insects and rodents; (e) prohibition of killing of animals of listed species, unless authorised by the competent authority; and (f) prohibition of non-essential movements of products, materials, substances, persons and means of transport into the establishments.

2. By way of derogation from point 1(a), (b) and (c) the competent authority may authorise movements of animals and products from the establishment where a category A disease is suspected, after carrying out a risk assessment and provided that: (a) the movements of animals and products comply with all conditions and biosecurity measures necessary in order to avoid the spread of the disease; (b) in the establishment of destination there are not other kept animals of listed species; and (c) the establishment of destination is not a slaughterhouse.

3. Where derogations provided for in paragraph 2 are granted, the competent authority may impose the disease control measures provided for in paragraph 1 in the establishment of destination.

4. The competent authority may order preventive killing, in accordance with Article 12(1) and (2), of animals of listed species in the establishment where a category A disease is suspected when the epidemiological situation so requires.

5. All animal by-products from dead animals, which have died or have been killed in the establishment where a category A disease is suspected shall be processed or disposed of in accordance with Regulation (EC) No 1069/2009 to ensure that the suspected disease agent is inactivated and to prevent the spread of the disease to unaffected animals or to humans.

Article 8

Inventory and records analysis in the event of suspicion of a category A disease in kept animals in an establishment

1. In the event of suspicion of a category A disease, the competent authority shall order and verify that, without delay, operators of the establishments where a category A disease is suspected compile and maintain an up-to-date inventory of the following: (a) the species, categories and number of animals kept on the establishment; for poultry, the number of animals may be estimated; (b) the individual identification number of all the animals of species for which the individual identification is compulsory in accordance with Commission Delegated Regulation (EU) 2019/2035 ( 3 ); (c) the species, categories and number of kept animals of listed species which have been born, died, showed clinical signs or are likely to be infected or contaminated with the category A disease in the establishment; (d) any product, material or substance likely to be contaminated with or likely to transmit the relevant category A disease in the establishment; and (e) when relevant, all places likely to enable the survival of the vectors of the relevant category A disease in the establishment.

2. Where the establishment consists of several epidemiological units, the information in paragraph 1 shall be specified for each epidemiological unit.

3. In the framework of the epidemiological enquiry, as referred to in Article 57 of Regulation (EU) 2016/429, the competent authority shall analyse at least the following records of the establishment where a category A disease is suspected: (a) the inventory referred to in paragraph 1; (b) the records concerning the origin and date of arrival and departure at or from the establishment of kept animals of listed species; (c) the records concerning the origin and date of arrival and departure at or from the establishment of other relevant transport movements; (d) the production records; and (e) the records concerning to visits to the establishment, if available.

4. The records analysis referred to in paragraph 3 shall cover, at least, the monitoring period set out in Annex II for the relevant disease, calculated backwards from the date on which the suspicion was notified.

Article 9

Temporary restricted zones in the event of suspicion of a category A disease in kept terrestrial animals in an establishment

1. In the event of suspicion of a category A disease in kept animals in an establishment, the competent authority may establish a temporary restricted zone taking into account the following circumstances: (a) the location of the establishment in an area with a high density of kept animals of listed species for which a category A disease is suspected; (b) the movement of animals or persons in contact with kept animals of listed species for which a category A disease is suspected; (c) the delay in confirming the category A disease pursuant to Article 11; (d) the insufficient information on the possible origin and routes of introduction of the suspected category A disease; and (e) the disease profile, in particular the routes and speed of transmission of the disease and the persistence of the disease in the animal population.

2. In the establishments within the temporary restricted zone the competent authority shall apply at least the measures provided for in Article 7.

3. The competent authority may maintain the temporary restricted zone until the moment that the presence of the category A disease has been ruled out in the establishment where it was suspected or the presence of that disease has been confirmed and a restricted zone is established pursuant to Article 21.

4. The competent authority may order preventive killing, in accordance with Article 12(1) and (2), or slaughtering of animals of listed species, in the temporary restricted zones when the epidemiological situation so requires.

Article 10

Measures to apply in the event of suspicion of a category A disease in food and feed businesses, border control posts, animal by-products establishments or any other location of relevance, including means of transport

1. In the event of suspicion of a category A disease in accordance with Article 9(1), (3) and (4) of Delegated Regulation (EU) 2020/689 in food and feed businesses, border control posts, animal by-products establishments or any other location of relevance, including means of transport, the competent authority shall apply: (a) the relevant provisions laid down in Articles 5 to 9; and (b) if needed, additional measures adapted to the specific situation in order to prevent the spread of the category A disease to unaffected animals or to humans.

2. The competent authority shall also apply provisions laid down in Articles 5 to 9 in the establishments of origin of the animals or products present in the establishments and locations referred to in paragraph 1 which are suspected to be infected.







Section 2

Disease control measures in the event of the official confirmation of a category A disease in kept animals

Article 11

Official confirmation of a category A disease in kept terrestrial animals

The competent authority shall officially confirm an outbreak of a category A disease in kept terrestrial animals when a case is confirmed in accordance with Article 9(2), (3) and (4) of Delegated Regulation (EU) 2020/689.

Article 12

Disease control measures in the event of official confirmation of an outbreak of a category A disease in kept animals in an establishment

1. Following the official confirmation of an outbreak of a category A disease in an establishment in accordance with Article 11, the competent authority shall order that, in addition to measures provided for in Article 7, the following disease control measures are immediately applied under the supervision of official veterinarians: (a) all animals of listed species kept in the affected establishment shall be killed as soon as possible on the spot, within the establishment, in such a way as to avoid any risk of spreading the relevant category A disease agent during and after killing; (b) all appropriate and necessary biosecurity measures shall be taken to avoid any possible spread of the category A disease to unaffected kept or wild animals or to humans; (c) bodies or parts of kept animals of listed species which have died or which have been killed pursuant to point (a) of this paragraph shall be disposed of in accordance with Regulation (EC) No 1069/2009; (d) all potentially contaminated products, materials or substances present in the establishment shall be isolated until: (i) they are disposed of or processed in accordance with Regulation (EC) No 1069/2009, in the case of animal by-products (including those resulting from the killing and products of animal origin and germinal products); (ii) cleaning and disinfection measures are completed in accordance with the Article 15, in the case of other materials and substances fit for cleaning and disinfection; (iii) disposal is completed under the supervision of official veterinarians, in the case of feeding stuff and other materials unfit for cleaning and disinfection.

2. The competent authority shall order and supervise that: (a) the transport from the affected establishment of animal by-products referred to in paragraphs 1(c) and 1(d)(i) complies with the provisions of Regulation (EC) No 1069/2009; (b) the transport from the affected establishment of materials or substances referred to in paragraph 1(d)(iii) complies with its instructions regarding biosecurity and biosafety conditions to prevent the spread of category A disease agent.

3. The competent authority shall collect samples for laboratory examination from kept animals of listed species, before or when they are killed or dead, for the purposes of the epidemiological enquiry referred to in Article 57 of Regulation (EU) 2016/429.

4. By way of derogation of point (a) of paragraph 1, the competent authority may, after carrying out a risk assessment and taking into account the possibility of applying other risk-mitigating measures, decide: (a) to order the killing of kept animals of listed species at the nearest suitable place in such a way as to avoid any risk of spreading the category A disease during killing or transport; or (b) postpone the killing of kept animals of listed species, provided that those animals are subject to emergency vaccination as provided for in Article 69 of Regulation (EU) 2016/429.

Article 13

Specific derogations from Article 12(1)(a)

1. In the event of an outbreak of a category A disease in establishments keeping animals of listed species in two or more epidemiological units, the competent authority may grant derogation from Article 12(1)(a) to the epidemiological units in which the disease has not been confirmed, after carrying out a risk assessment, and, when necessary, after obtaining favourable results in laboratory examinations, and provided that: (a) the epidemiological enquiry referred to in Article 57 of Regulation (EU) 2016/429 has not revealed any epidemiological link between the epidemiological units in which the category A disease has been confirmed and those in which the disease has not been confirmed, to suspect the spread of the category A disease between them; and (b) the competent authority has confirmed that, at least during the monitoring period, set out in Annex II for the relevant disease, before the confirmation of the category A disease, the epidemiological units in which the disease has not been confirmed were kept completely separated and handled by different personnel.

2. The competent authority may grant derogation from Article 12(1)(a) to the following categories of animals provided that the conditions in paragraph 3 are fulfilled: (a) animals kept in a confined establishment; (b) animals kept for scientific purposes or purposes related to conservation of protected or endangered species; (c) animals officially registered in advance as rare breeds; and (d) animals with a duly justified high genetic, cultural or educational value.

3. The competent authority shall ensure that the following conditions are fulfilled when granting the derogation provided for in paragraph 2: (a) the competent authority has carried out an assessment of the effects of granting such derogation and, in particular, of the effects on the animal health status of the Member State concerned and of the adjacent countries and the outcome of this assessment indicated that the animal health status is not endangered; (b) appropriate biosecurity measures are applied to prevent the risk of transmission of the category A disease to unaffected kept animals or to wild animals or to humans taking into account: (i) the disease profile; and (ii) the affected species of animals; (c) the animals are subject to appropriate isolation and clinical surveillance, including laboratory examinations, until the competent authority can ensure that the animals do not pose a risk of transmission of the category A disease.

4. The competent authority may grant specific derogations from Article 12(1)(a) to equine animals kept in establishments where an outbreak of the category A diseases referred to in Annex III has been confirmed under the conditions set out in that Annex.

Article 14

Additional disease control measures in the event of an outbreak of a category A disease in kept terrestrial animals in an establishment

1. The competent authority may establish, in addition to the measures provided for in Article 12, sampling procedures for kept animals of non-listed species and wild animals of listed species, based on the information obtained from the epidemiological enquiry referred to in Article 57 of the Regulation (EU) 2016/429.

2. The competent authority may, after carrying out a risk assessment of the further spread of the relevant category A disease and taking into account the possibility of applying other risk-mitigating measures, order the killing of kept animals of non-listed species and wild animals in such a way as to avoid any risk of spreading the category A disease during killing, transport and until disposal of the entire bodies or parts of the dead animals.

Article 15

Preliminary cleaning and disinfection and control of insects and rodents in the affected establishment

1. Immediately after the completion of the measures provided for in Article 12, and when relevant in Article 14, the competent authority shall order and supervise a preliminary cleaning and disinfection and, when relevant, control of insects and rodents, in the affected establishment in order to avoid spreading of the category A disease.

2. The preliminary cleaning, disinfection and control referred to in paragraph 1 shall be: (a) performed in accordance with the procedures set out in points A and B of Annex IV using the appropriate biocidal products to ensure destruction of the relevant category A disease agent; and (b) adequately documented.

3. When the competent authority grants one of the derogations provided for in Article 13(2) and (4), it shall order the preliminary cleaning, disinfection and the control referred to in paragraph 1 adapting the procedures referred to in point 2(a) to the specific situation without detriment to the control of spreading of the category A disease from the affected animals and affected establishments and locations to other unaffected animals or to humans.

4. In addition to the measures referred to in paragraphs 1 and 2, the competent authority shall order and supervise that the means of transport used for the transport of animals to and from the affected establishment are properly cleaned and disinfected and, where relevant, subjected to measures ensuring the control of insects and rodents.

Article 16

Derogations and special rules for the preliminary cleaning and disinfection and control of vectors

The competent authority may grant derogation to the requirement regarding cleaning and disinfection and control of insects and rodents set out in Article 15 in the case of:

(a) pastures epidemiologically linked to the affected establishment, under specific procedures to ensure effective inactivation of the relevant category A disease agent taking into account the disease profile, the type of establishment and the climatic conditions; and

(b) manure, including litter and used bedding, from the affected establishment, under specific procedures to ensure effective inactivation of the relevant category A disease agent in accordance with scientific evidence.

Article 17

Identification of epidemiologically linked establishments and other locations of relevance, including means of transport

1. In the frame of the epidemiological enquiry, as referred to in Article 57 of the Regulation (EU) 2016/429, and in order to identify all the epidemiologically linked establishments and other locations of relevance, including means of transport, the competent authority shall trace all kept animals present in the establishment where an outbreak of a category A disease has been confirmed and any products, materials, substances, means of transport or people likely to spread the relevant category A disease including: (a) those dispatched into and from the establishment; and (b) those that have entered into contact with the establishment.

2. The tracing referred to in paragraph 1 shall cover at least the monitoring period, set out in Annex II for the relevant disease, calculated backwards from the date the suspicion was notified.

3. After carrying out a risk assessment, the competent authority may exclude from the tracing referred to in paragraph 1 those products considered as safe commodities, as provided for in Annex VII.

Article 18

Measures to be applied in the epidemiologically linked establishments and other locations of relevance, including means of transport

1. When the tracing provided for in Article 17(1) demonstrates that animals of listed species were dispatched from or to the affected establishment during the period referred to in paragraph 2 of that Article, the competent authority shall: (a) carry out investigations and impose restriction and biosecurity measures in accordance with Article 6, Article 7 and Article 8 in the establishments of destination or origin of the movement; or (b) immediately extend the measures in Article 12 to the establishment of origin or the establishment of destination of the movement in the case that there is epidemiological evidence of spreading of the disease to, from or through that establishment.

2. The competent authority shall apply the measures referred to in paragraph 1 in other establishments and locations of relevance, including means of transport, likely to be contaminated as a result of contact with animals, products, materials, substances, persons or means of transport from the affected establishment identified in the frame of the tracing referred to in Article 17 or based on any other relevant information from the epidemiological enquiry, as referred to in Article 57 of the Regulation (EU) 2016/429.

Article 19

Measures to be applied to the products identified by the tracing

1. The competent authority shall order and supervise that semen, oocytes and embryos identified as contaminated by the tracing referred to in Article 17 are disposed of in accordance with Regulation (EU) No 1069/2009.

2. The competent authority shall order and supervise the treatment, processing or disposing of the products identified by the tracing referred to in Article 17, at least up to: (a) the first food processing establishment in the case of products of animal origin; (b) the hatchery or the establishment where eggs were sent for hatching, in the case of hatching eggs which did not yet hatch; and (c) the first establishment of processing in the case of animal by products, except manure; or (d) the location where it is stored, in the case of manure, including litter and used bedding.

3. The competent authority shall establish official surveillance on poultry hatched during the tracing period referred to in Article 17(2) from hatching eggs originating from the affected establishment; this surveillance shall be established in all the establishments of destination of the hatching eggs and shall be maintained for a period of time of 21 days after hatching.

4. The competent authority shall order and supervise that the transport from the establishments of animal by-products is subject to the provisions laid down in Regulation (EC) No 1069/2009.

5. The competent authority shall order and supervise that materials or substances likely to be contaminated or likely to transmit the relevant category A disease comply with its instructions regarding biosecurity and biosafety conditions to prevent the spread of category A disease agent.

Article 20

Measures to be applied in the event of official confirmation of an outbreak of a category A disease in food and feed businesses, border control posts, animal by-products establishments and any other location of relevance, including means of transport

1. In the event of official confirmation of an outbreak in accordance with Article 11 in food and feed businesses, border control posts, animal by-products establishments or any other locations of relevance, including means of transport, the competent authority shall apply: (a) the relevant provisions laid down in Articles 12 to 19; and (b) if needed, additional measures adapted to the specific situation in order to prevent the spread of the category A disease from the affected animals and affected establishments and locations to other unaffected animals or to humans.

2. The competent authority shall apply provisions laid down in Articles 12 to 19 also in the establishments of origin of the affected animals or products present in the establishments and locations referred to in paragraph 1.







CHAPTER II

Disease control measures for category A diseases of kept terrestrial animals in the restricted zones







Section 1

General disease control measures in the restricted zone

Article 21

Establishment of a restricted zone

1. In the event of an outbreak of a category A disease in an establishment, food and feed business, animal by–products establishment or other locations, including means of transport, the competent authority shall immediately establish around the affected establishment or location a restricted zone, which comprises: (a) a protection zone based on the minimum radius from the outbreak set out for the relevant category A disease in Annex V; (b) a surveillance zone based on the minimum radius from the outbreak set out for the relevant category A disease in Annex V; and (c) if necessary, on the basis of the criteria set out in paragraph 1 of Article 64 of Regulation (EU) 2016/429, further restricted zones around or adjacent to the protection and surveillance zones, where the competent authority shall apply the same measures as those provided for in Section 3 of this Chapter for the surveillance zone.

2. The competent authority shall adapt the boundaries of the initial restricted zone, including the boundaries of the protection, surveillance and the further restricted zones, in the case of the overlapping of two or more restricted zones due to further outbreaks of the category A disease.

▼M1

3. By way of derogation from paragraph 1, the competent authority may decide, after carrying out a risk assessment taking into account the disease profile, not to establish a restricted zone when an outbreak of a category A disease occurs in the following locations: ▼B (a) establishments keeping animals referred to Article 13(2); (b) hatcheries; (c) food and feed businesses, border control posts, animal by-products establishments; (d) means of transport; (e) locations where assembly operations or temporal exhibition or veterinary assistance of animals take place; and (f) any other location which is not an establishment.

Article 22

Measures to be applied in the restricted zone

1. The competent authority shall without delay compile and keep up to date an inventory of all establishments keeping animals of listed species located in the restricted zone including the species, categories and number of animals in each establishment; for poultry, the number of animals may be estimated.

2. The competent authority may, in order to prevent the spreading of the disease and based on epidemiological information or other evidence, implement preventive killing, in accordance with Article 12(1) and (2), or slaughtering of kept animals of listed species in the establishments located in the restricted zone.

3. The competent authority shall order and supervise that all movements of entire bodies or parts of dead wild and kept animals of listed species from the restricted zone are destined for processing or disposal in accordance with Regulation (EC) No 1069/2009 in a plant approved for those purposes: (a) within the territory of the Member State; or (b) in another Member State in accordance with Article 48(1) and (3) of Regulation (EC) No 1069/2009, where it is not feasible to process or dispose the entire bodies or parts of dead animals in an approved plant in the territory of the Member State where the outbreak occurred.

4. The competent authority shall impose specific conditions for the transport of animals and products through the restricted zone in order to ensure that they are performed: (a) without stopping or unloading in the restricted zone; (b) prioritising major highways or mainline railways; and (c) avoiding the vicinity of establishments keeping animals of listed species.

▼M1

5. Animal by-products from animals of listed species, originating from and moved outside the restricted zone shall be accompanied by an animal health certificate issued by an official veterinarian stating that they are allowed to be moved from the restricted zone under the conditions established by the competent authority in accordance with this Chapter.

▼B

6. The competent authority may decide that the certificate referred to in paragraph 5 shall not be issued for movements of animal by-products within the Member State concerned when that authority considers that an alternative system is in place ensuring that consignments of such products are traceable and that products fulfil the animal health requirements for such movements.

7. Any collection of samples in the establishments in the restricted zone keeping animals of listed species for purposes other than to confirm or rule out the presence of the relevant category A diseases must be authorised by the competent authority.

Article 23

Derogations from measures to be applied in the restricted zone

The competent authority may grant derogations from the provisions set out in this Chapter concerning the measures to be applied in restricted zones, to the extent necessary and after carrying out a risk assessment:

(a) in the further restricted zones referred to in Article 21(1)(c);

(b) in the case that the competent authority decides to establish a restricted zone when an outbreak of a category A disease occurs in establishments and locations referred to in Article 21(3);

(c) in the case that the outbreak occurs in an establishment keeping up to 50 captive birds; or

(d) in establishments and locations referred to in Article 21(3) located in a restricted zone.

Article 24

Requirements for the means of transport of kept animals of listed species and products thereof

1. The competent authority shall ensure that the means of transport used for movements of kept animals of listed species and products thereof within, from, to and through the restricted zone have been: (a) constructed and maintained in such a way to avoid any leakage or escape of animals, products or any item representing an animal health risk; (b) cleaned and disinfected immediately after every transport of animals, products or any item representing an animal health risk and, if necessary, subsequently disinfected again, and in any case dried or allowed to dry, before any new loading of animals or products; and (c) where relevant, subjected to measures for the control of insects and rodents before the transport.

2. The cleaning and disinfection of the means of transport referred to in paragraph 1 shall be performed: (a) in accordance with the instructions or procedures provided for by the competent authority using the appropriate biocidal products to ensure the destruction of the relevant category A disease agent; and (b) adequately documented.







Section 2

Disease control measures in the protection zone

Article 25

Measures to be applied in establishments keeping animals of listed species in the protection zone

1. The competent authority shall order without delay the application of the following measures in establishments in the protection zone keeping animals of listed species, other than the establishment in which the category A disease has been confirmed: (a) to keep animals of listed species separate from wild animals and animals of non-listed species; (b) to implement additional surveillance in order to identify any further spread of the category A disease to the establishments, including any increased morbidity or mortality or significant drop in production data; any such increase or drop shall be immediately notified to the competent authority; (c) when appropriate, to implement adequate means of controlling insects and rodents and other disease vectors in and around the establishment; (d) to use appropriate means of disinfection at the entrances and exits of the establishment; (e) to apply appropriate biosecurity measures to all persons in contact with kept animals of listed species or entering or leaving the establishment as well as to means of transport in order to avoid any risk of spread of the relevant category A disease; (f) to keep records of all persons visiting the establishment, maintain them up to date in order to facilitate disease surveillance and control and made them available to the competent authority upon request; (g) to dispose entire bodies or parts of dead or killed kept animals of listed species according to Article 22(3).

2. By way of derogation of point (f) of paragraph 1 the records on visitors are not required in establishments where animals referred to in Article 13(2) are kept, if visitors have no access to the areas where the animals are kept.

Article 26

Visits by official veterinarians in establishments in the protection zone

1. The competent authority shall ensure that official veterinarians carry out at least one visit to all the establishments referred to in Article 25, as soon as possible and without unjustified delay, after the official confirmation of an outbreak of a category A disease.

2. When carrying out the visits referred to in paragraph 1, official veterinarians shall perform at least the following activities: (a) documentary checks, including production, health and traceability records analysis; (b) verification of the implementation of the measures applied to prevent the introduction or spread of the relevant category A disease in accordance with Article 25; (c) clinical examination of kept animals of listed species; and (d) if necessary, collection of samples of animals for laboratory examination in order to confirm or rule out the presence of the relevant category A disease.

3. The competent authority may require further veterinary visits to the establishments in the protection zone to follow up on the situation.

4. The competent authority shall keep a record of activities and visits referred to in paragraph 1, 2 and 3 and the findings thereof.

5. By way of derogation from paragraph 1, where the radius of the protection zone set in Annex V is larger than 3 km, the competent authority may decide to require not the visit to all the establishments referred to in Article 25 but the visit of a representative number of those establishments in accordance with point A.3 of Annex I.

Article 27

Prohibitions in relation to activities, including movements, concerning animals, products and other material within, from or to the protection zone

1. The competent authority shall prohibit the activities, including movements, concerning animals of listed species and their products and other materials within, from and to the protection zone in accordance with the table in Annex VI.

2. The competent authority may extend the prohibitions provided for in paragraph 1 to: (a) animals of non-listed species and products from such animals; and (b) activities, including movements, other than those set out in Annex VI.

3. The following products are exempted from prohibitions provided for in paragraphs 1 and 2: (a) products of animal origin considered as safe commodities, in accordance with Annex VII, as regards the relevant disease; (b) products of animal origin which have undergone the relevant treatment in accordance with Annex VII; (c) products or other materials likely to spread the disease obtained or produced before the monitoring period set out in Annex II for the relevant disease calculated backwards from the date on which the suspicion was notified; (d) products produced in the protection zone which have been obtained from kept animals of listed species: (i) kept outside the protection zone; (ii) kept and slaughtered outside the protection zone; or (iii) kept outside the protection zone and slaughtered in the protection zone; (e) derived products.

4. Prohibitions provided for in paragraph 1 and 2 shall apply to products referred to in paragraph 3 if: (a) the products were not clearly separated, during the production process, storage and transport, from products not eligible for dispatch outside the restricted zone pursuant to this Regulation; or (b) the competent authority has epidemiological evidences of spreading of the disease to, from or through those products.

Article 28

General conditions to grant derogations from prohibitions in the protection zone

1. By way of derogation from prohibitions provided for in Article 27, the competent authority may authorise movements of animals and products in the cases covered by Articles 29 to 38 and under the specific conditions provided for in those Articles and the general conditions laid down in paragraphs 2 to 7 of this Article.

Prior to granting the authorisation, the competent authority shall assess the risks deriving from that authorisation and the assessment must indicate that the risk of spreading the category A disease is negligible.

2. All authorised movements must be performed: (a) exclusively via designated routes, (b) prioritising major highways or mainline railways, (c) avoiding the vicinity of establishments keeping animals of listed species; and (d) without unloading or stopping, until the unloading in the establishment of destination.

3. The competent authority of the establishment of origin shall designate the establishment of destination for movements from or to the protection zone. If the competent authority of the establishment of origin is different from the competent authority of the establishment of destination, it shall inform the competent authority of the establishment of destination about such designation.

4. The competent authority of the establishment of origin shall verify that the establishment of destination agrees to be designated and to receive each consignment of animals or products.

5. When authorising movements of animals from the protection zone, the competent authority shall ensure that such movements do not pose a risk of spreading of the category A disease based on: (a) a clinical examination, with favourable results, of animals kept in the establishment, including those animals to be moved; (b) if necessary, a laboratory examination, with favourable results, of animals kept in the establishment, including those animals to be moved; and (c) the outcome of the visits referred to in Article 26.

6. When authorising the transport of products from the protection zone, the competent authority shall order and supervise that: (a) during the whole production process and their storage, products were clearly separated from products not eligible for dispatch outside the restricted zone in accordance with this Regulation; and (b) products will not be transported with products not eligible for dispatch outside the restricted zone pursuant to this Regulation.

7. When granting an authorisation pursuant to paragraph 1, the competent authority shall ensure that supplementary biosecurity measures are applied from the moment of loading, during all transport operations and until the unloading in the designated establishment of destination in accordance with its instructions.

Article 29

Specific conditions for authorising movements for slaughter of kept animals of listed species in the protection zone

1. The competent authority may authorise movements of kept animals of listed species from establishments located in the protection zone to a slaughterhouse located: (a) as near as possible to the establishment of origin, within the protection zone; (b) in the surveillance zone, when it is not possible to slaughter the animals in the protection zone; or (c) as near as possible to the surveillance zone when it is not possible to slaughter the animals in the restricted zone.

2. The competent authority shall only grant authorisations provided for in paragraph 1 under the following conditions: (a) the means of transport must be sealed at the moment of loading by the competent authority of dispatch or under its supervision; (b) the competent authority of the slaughterhouse shall: (i) be informed in advance by the slaughterhouse operator of the intention to receive kept animals of listed species; (ii) confirm the absence of any signs indicative of the category A disease during the ante and post mortem inspections; (iii) supervise the slaughterhouse operator having effective procedures in place to ensure that kept animals of listed species originating in the protection zone are kept separately and slaughtered separately from such animals or at different times, preferably at the end of the working day of arrival; (iv) confirm the slaughter of the animals to the competent authority of the establishment of origin of the animals; (v) supervise the slaughterhouse operator cleaning and disinfecting the premises where the animals have been kept and slaughtered and the completion of the cleaning and disinfection is completed before other kept animals of listed species are kept or slaughtered in those premises; and (vi) supervise the obtaining of meat from such animals complying with the conditions laid down in Article 33.

3. The competent authority may authorise movements of kept animals of listed species from establishments located outside the protection zone to a slaughterhouse located in the protection zone if: (a) the animals are kept separately from other animals originating from the protection zone and are slaughtered separately from those animals or at a different time; (b) the fresh meat obtained is cut, transported and stored separately from fresh meat obtained from animals originating in the protection zone; and (c) the cleaning and disinfection of the means of transport referred to in Article 24 takes place under official supervision after unloading the animals.

4. By way of derogation of Article 9 of Regulation (EC) No 1069/2009 the competent authority may authorise the processing and use of animal by-products, obtained from animals slaughtered in accordance with paragraphs 1, 2 and 3 as category 3 material in accordance with Regulation (EC) No 1069/2009 in a plant approved for processing or disposal of animal by-products, located on its territory, or in another Member State, where it is not feasible to process or dispose them in an approved plant in the territory of the Member State where the outbreak occurred.

In case the animal by-products referred to in the first subparagraph are moved to a plant located in another Member State, the Member State of destination and the Member States of passage shall authorise such dispatch and the competent authority of destination shall authorise the processing and use of those animal by-products as category 3 material in accordance with Regulation (EC) No 1069/2009.

Article 30

Specific conditions for authorising certain movements of poultry from establishments located in the protection zone

1. The competent authority may authorise movements of day-old-chicks from an establishment located in the protection zone to an establishment located in the same Member State but, if possible, outside the restricted zone, provided that: (a) in the case of day-old-chicks hatched from eggs originating in the restricted zone: (i) the means of transport is sealed at the moment of loading by the competent authority or under its supervision; (ii) the establishment of destination is placed under official surveillance by the official veterinarians following the arrival of the animals; and (iii) if moved outside the restricted zone, the poultry remain in the establishment of destination at least for a period of 21 days. (b) in the case of day-old-chicks hatched from eggs originating outside the restricted zone, the hatchery of dispatch can ensure that no contact has occurred between those eggs and any other hatching eggs or day-old chicks originating in the restricted zone.

2. The competent authority may authorise movements of ready-to-lay poultry from establishments located in the protection zone to establishments located in the same Member State and, if possible, within the restricted zone, provided that: (a) in the establishment of destination there is no other kept animal of listed species; (b) the means of transport is sealed at the moment of loading by the competent authority or under its supervision; (c) the establishment of destination is placed under official surveillance by the official veterinarians following the arrival of the animals; and (d) if moved outside the restricted zone, the animals remain on the establishment of destination at least for a period of 21 days.

Article 31

Specific conditions for authorising certain movements of hatching eggs in the protection zone

1. The competent authority may authorise movements of hatching eggs either: (a) from an establishment located in the protection zone to a hatchery located in the same Member State; or (b) from an establishment located in the same member State to a hatchery located in the protection zone.

2. The authorisation provided for in paragraph 1(a) shall be subject to the following conditions: (a) the parent flocks from which the hatching eggs are derived have undergone a clinical examination and have been sampled for laboratory examination with favourable results; (b) the hatching eggs and their packaging are disinfected before dispatch and the tracing back of the hatching eggs can be ensured; and (c) the hatching eggs must be transported in means of transport sealed by the competent authority.

3. The competent authority may authorise movements of hatching eggs from an establishment located in the protection zone to an establishment for in-house hatching located in the same Member State, if: (a) the parent flocks from which the hatching eggs are derived have undergone a clinical examination and have been sampled for laboratory examination with favourable results; (b) the establishment of destination is placed under official supervision until 21 days following hatching of the eggs; (c) the poultry must remain on the establishment of destination during the period referred to in (b); and (d) the requirements referred to in paragraph 2(b) and (c) are complied with.

Article 32

Specific conditions for authorising movements of semen from approved germinal product establishments in the protection zone

The competent authority may authorise movements of semen collected from animals of listed species kept in approved germinal product establishments, excluding hatcheries, located in the protection zone after the estimated date of earliest infection of the affected establishment subject to the following conditions:

(a) all the disease control measures relating to the category A disease have been lifted in the protection zone in accordance with Article 39;

(b) all kept animals of listed species in the semen collection centre have undergone a clinical examination and have been sampled for laboratory examination in order to rule out the presence of the category A disease in the semen collection centre; and

(c) the donor animal has been subjected with favourable result to a laboratory examination on a sample taken not earlier than seven days after the monitoring period set out in Annex II for the relevant disease, calculated forwards from the date on which the semen was collected.

Article 33

Specific conditions for authorising movements of fresh meat and raw milk obtained from kept animals of listed species from establishments in the protection zone

1. The competent authority may authorise movements of fresh meat and raw milk obtained from animals of listed species kept in establishments located in the protection zone if: (a) they are moved to a processing establishment to undergo one of the relevant risk-mitigating treatments set out in Annex VII; or (b) in the case of fresh meat of poultry: (i) it has been marked in accordance with paragraph 1 of Annex IX from the moment it was obtained in the slaughterhouse; and (ii) it is not intended to another Member State.

2. The competent authority shall ensure that movements to a processing establishment referred to in paragraph 1(a) comply with the following conditions: (a) fresh meat must be marked in accordance with point 2 of Annex IX in the slaughterhouse after the post-mortem inspection and must bear such mark until it is treated; (b) the movement of fresh meat and raw milk from the establishment of origin to the processing establishment must be carried out in sealed containers; and (c) the processing establishment must be located in the same restricted zone or as near as possible to the restricted zone and must operate under the supervision of official veterinarians.

Article 34

Specific conditions for authorising movements of eggs for human consumption from establishments located in the protection zone

The competent authority may authorise the movement of eggs for human consumption from establishments located in the protection zone to the following destinations within the same Member State:

(a) to a packing centre, provided that they are packed in: (i) a disposable packaging; or (ii) a packaging which can be cleaned and disinfected in such way as to destroy the relevant category A disease agent;

(b) to an establishment for the manufacture of egg products as set out in Chapter II of Section X of Annex III to Regulation (EC) No 853/2004, in order to be handled and treated in accordance with Chapter XI of Annex II to Regulation (EC) No 852/2004 of the European Parliament and of the Council ( 4 ).

Article 35

Specific conditions for authorising movements of manure, including litter and used bedding from establishments located in the protection zone to a landfill

The competent authority may authorise movements of manure, including litter and used bedding, from establishments located in the protection zone for the purpose of their disposal in a designated landfill located within the same Member State only after processing in accordance with Article 13(c) of Regulation (EU) No 1069/2009.

Article 36

Specific conditions for authorising the movement of feed materials of plant origin and straw from the protection zone

The competent authority may authorise movements of feed materials of plant origin and straw produced in the protection zone provided that:

(a) they were produced in locations not keeping animals of listed species;

(b) they were produced in feed processing establishments not keeping animals of listed species and the raw plant material originates: (i) from locations referred to in point (a); or (ii) from outside the protection zone;

(c) they are intended for use within the protection zone; or

(d) they have undergone at least one of the risk-mitigating treatments in accordance with Annex VIII.

Article 37

Specific conditions for authorising movements of kept animals of listed species and products to an animal by-products approved plant

1. The competent authority may authorise movements of kept animals of listed species from establishments located in the protection zone to a plant approved for processing or disposal of animal by-products in which: (a) the kept animals are immediately killed; and (b) the resulting animal by-products are disposed of in accordance with Regulation (EC) No 1069/2009.

2. The competent authority may authorise movements of products from establishments and locations in the protection zone to a plant approved for processing or disposal of animal by-products, in which the products are disposed of or processed in accordance with Regulation (EC) No 1069/2009.

Article 38

Measures to be applied in food and feed businesses, border control posts, animal by-products establishments or any other location of relevance in the protection zone, including means of transport

1. The competent authority shall apply the relevant measures referred to in Article 25, and Articles 27 to 38 in food and feed businesses, border control posts, animal by-products establishments or any other location of relevance in the protection zone, including means of transport.

2. In the establishments and locations referred to in paragraph 1, the competent authority may apply additional measures adapted to the specific situation in order to prevent the spread of the category A disease within and from the protection zone.

Article 39

Duration of the disease control measures in the protection zone

1. The competent authority may lift the measures provided for in Section 1 and 2 of this Chapter only if the minimum period set out in Annex X has elapsed and the following conditions are fulfilled: (a) the preliminary cleaning and disinfection and, where relevant, control of insects and rodents, has been performed in accordance with Article 15 in the affected establishment; and (b) in all establishments keeping animals of listed species in the protection zone, animals of listed species have undergone, with favourable results, clinical and when necessary laboratory examinations in accordance with Article 26.

2. Where the relevant category A disease is transmitted by a listed vector, as referred to in Regulation (EU) 2018/1882, the competent authority may: (a) establish the duration of the measures in the protection zone on a case by case basis, taking into account any factor influencing the risk of the disease spreading; and (b) provide for the introduction of sentinel animals.

3. After the lifting of the measures referred to in paragraph 1, the measures provided for in Section 3 of this Chapter shall apply in the protection zone for at least the additional period set out in Annex X.







Section 3

Disease control measures in the surveillance zone

Article 40

Measures to be applied in establishments in the surveillance zone

The competent authority shall order the application, without delay, of the measures provided for in Article 25 in all the establishments in the surveillance zone keeping animals of listed species.

Article 41

Visits by the official veterinarians in establishments in the surveillance zone

The competent authority shall ensure that official veterinarians carry out visits to a sample of establishments keeping animals of listed species in the surveillance zone in accordance with Article 26 and point A.3 of Annex I.

Article 42

Prohibitions in relation to activities, including movements, concerning animals, products and other material within, from or to the surveillance zone

The competent authority shall apply prohibitions, exemptions and derogations to activities, including movements concerning animals of listed species, the products thereof and other material, from and to the surveillance zone in accordance with Article 27.

Article 43

General conditions for granting derogations from prohibitions provided for in Article 42

1. By way of derogation from Article 42, the competent authority may authorise movements of animals and products only in the cases covered by Articles 44 to 52, under the specific conditions provided for in those Articles and the general conditions laid down in paragraphs 2 to 7 of this Article.

Prior to granting the authorisation, the competent authority shall assess the risks deriving from that authorisation. The assessment must indicate that the risk of spreading the category A disease is negligible.

2. All authorised movements shall be performed: (a) prioritising major highways or mainline railways; (b) avoiding the vicinity of establishments keeping animals of listed species; and (c) without unloading or stopping, until the unloading in the establishment of destination.

3. The competent authority of the establishment of origin shall designate the establishment of destination for movements from or to the surveillance zone. If the competent authority is not the same as in the establishment of destination, it shall inform the competent authority of the establishment of destination about such designation.

4. The competent authority of the establishment of origin shall verify that the establishment of destination agrees to be designated and to receive each consignment of animals or products.

5. When authorising movements of animals from the surveillance zone, the competent authority shall ensure that such movements do not pose a risk of spreading the category A disease based on: (a) a clinical examination with favourable results of animals kept in the establishment, including those animals to be moved; (b) if necessary, a laboratory examination with favourable results of animals kept in the establishment, including those animals to be moved; and (c) the outcome of the visits referred to in Article 41, if available.

6. When authorising the transport of products from the surveillance zone, the competent authority must ensure that: (a) during the whole production process and storage, products were clearly separated from products not eligible for dispatch outside the restricted zone pursuant this Regulation; (b) products will not be transported with products not eligible for dispatch outside the restricted zone pursuant this Regulation.

7. When granting derogations provided for in paragraph 1, the competent authority shall ensure that supplementary biosecurity measures are applied from the moment of loading, during all transport operations and until the unloading in the designated establishment of destination in accordance with its instructions.

Article 44

Specific conditions for authorising movements for slaughter of kept animals of listed species within, from and to the surveillance zone

1. The competent authority may authorise movements of kept animals of listed species originating in the surveillance zone to a slaughterhouse located: (a) as near as possible to the establishment of origin, within the restricted zone; or (b) outside the restricted zone, as near as possible to the surveillance zone, when it is not possible to slaughter the animals in the restricted zone, and after carrying out a risk assessment.

2. The meat obtained from animals referred to in paragraph 1 shall be subject to the measures provided for in Article 49.

3. The competent authority may authorise movements of kept animals of listed species originating outside the surveillance zone to a slaughterhouse situated in the surveillance zone.

4. The competent authority may authorise the processing and use of animal by-products, obtained from animals slaughtered in accordance with paragraphs 1, 2 and 3 as category 3 material in accordance with Regulation (EC) No 1069/2009 in a plant approved for processing or disposal of animal by-products, located on their territory, or in another Member State, where it is not feasible to process or dispose them in an approved plant in the territory of the Member State where the outbreak occurred.

In case the animal by-products referred to in the first subparagraph are moved to a plant located in another Member State, the Member State of destination and the Member States of passage shall authorise such dispatch and the competent authority of destination shall authorise the processing and use of those animal by-products as category 3 material in accordance with Regulation (EC) No 1069/2009.

Article 45

Specific conditions for authorising certain movements of kept ungulates of listed species from establishments in the surveillance zone

1. The competent authority may authorise the movement of kept ungulates of listed species to pastures situated within the surveillance zone, provided that: (a) a period of 15 days has elapsed after the preliminary cleaning and disinfection referred to in Article 15 has been completed and approved; and (b) the animals do not come into contact with animals of listed species from other establishments.

2. The competent authority may, after carrying out a risk assessment, authorise the movement of kept animals of listed species of ungulates to an establishment belonging to the same supply chain, located in or outside the surveillance zone, to complete the production cycle before slaughter. If the establishment of destination is located outside the surveillance zone, the competent authority shall apply in that establishment the measures provided for in Articles 40, Article 41 and Article 42 as long as the disease control measures in the surveillance zone of origin are maintained as provided for in Article 55.

Article 46

Specific conditions for authorising certain movements of poultry from establishments located in the surveillance zone

1. The competent authority may authorise movements of day-old chicks originating in the surveillance zone: (a) to establishments in the same Member State where they were hatched from eggs originating from establishments within the surveillance zone, if: (i) the establishment of destination is placed under official surveillance following the arrival of the animals; and (ii) if moved outside the restricted zone, the animals remain in the establishments of destination for at least 21 days; (b) to establishments in the same Member State where they were hatched from eggs originating outside the restricted zone, if the hatchery of dispatch can ensure that no contact has occurred between those eggs and any other hatching eggs or day-old chicks obtained from animals kept within the restricted zone.

2. The competent authority may authorise movements of ready-to-lay poultry from establishments in the surveillance zone to establishments in the same Member State, if: (a) in the establishment of destination there is no other kept animal of listed species; (b) the establishment of destination is placed under official surveillance following the arrival of the ready-to-lay poultry; and (c) the poultry remain on the establishment of destination for at least 21 days.

Article 47

Specific conditions for authorising certain movements of hatching eggs to and from establishments in the surveillance zone

1. The competent authority may authorise movements of hatching eggs from an establishment located in the same Member State to: (a) a hatchery located in the surveillance zone; or (b) an establishment for in-house hatching located in the surveillance zone.

2. The competent authority may authorise movements of hatching eggs from an establishment located in the surveillance zone to a hatchery in the same Member State or to an establishment for in-house hatching located in the same Member State, only if the hatching eggs and their packaging are disinfected before dispatch and the tracing back of these eggs can be ensured.

Article 48

Specific conditions for authorising movements of semen from approved germinal product establishments in the surveillance zone

The competent authority may authorise movements of semen collected from animals of listed species kept in approved germinal product establishments, excluding hatcheries, located in the surveillance zone after the estimated date of earliest infection of the affected establishment provided that:

(a) all the disease control measures relating to the relevant category A disease have been lifted in the surveillance zone in accordance with Article 55;

(b) all the kept animals of listed species in the semen collection centre have undergone a clinical examination and have been sampled for laboratory examinations in order to rule out the presence of the category A disease in the semen collection centre;

(c) the donor animal has been subjected with favourable results to a laboratory examination on a sample taken not earlier than seven days after the monitoring period set out in Annex II for the relevant disease, calculated forwards from the date on which the semen was collected.

Article 49

Specific conditions for authorising movements of fresh meat and raw milk obtained from kept animals of listed species from establishments located in the surveillance zone

1. The competent authority may authorise movements of fresh meat and raw milk obtained from animals of listed species kept in establishments located in the surveillance zone if, either: (a) the fresh meat or the raw milk is moved to a processing establishment to undergo one of the risk-mitigating treatments set out in Annex VII; or (b) the fresh meat is obtained from poultry.

2. The competent authority shall ensure that fresh meat and the raw milk moved pursuant paragraph 1(a), comply with the following: (a) fresh meat is marked in accordance with Annex IX when it is obtained in the slaughterhouse and keeps such mark until it is treated; and (b) the treatment is applied in an establishment situated in the same restricted zone or as near as possible of the restricted zone, which operates under the supervision of official veterinarians.

Article 50

Specific conditions for authorising movements of eggs for human consumption from establishments in the surveillance zone

1. The competent authority may authorise movements of eggs for human consumption from establishments in the surveillance zone to a packing centre located in the same Member State provided that they are packed in: (a) a disposable packaging; or (b) a packaging which can be cleaned and disinfected in such way as to destroy the category A disease agent.

2. The competent authority may authorise movements of eggs for human consumption from establishments located in the surveillance zone to an establishment for the manufacture of egg products located in the same Member State if: (a) the establishment for the manufacture of egg products complies with Chapter II of Section X of Annex III to Regulation (EC) No 853/2004; and (b) the eggs are moved to the establishment for the manufacture of egg products in order to be handled and treated in accordance with Chapter XI of Annex II to Regulation (EC) No 852/2004.

Article 51

Specific conditions for authorising movements of manure, including litter and used bedding, from establishments in the surveillance zone

The competent authority may authorise the movement of manure, including litter and used bedding, from establishments located in the surveillance zone:

(a) without processing, to a landfill, previously authorised for that purpose by the competent authority, located in the same surveillance zone; or

(b) following processing, to a landfill, previously authorised for that purpose by the competent authority, located in the territory in the Member State.

Article 52

Specific conditions for authorising the movement of feed materials of plant origin and straw from the surveillance zone

The competent authority may authorise movements of feed materials of plant origin or straw produced in the surveillance zone provided that the feed materials or the straw:

(a) were produced in locations not keeping animals of listed species, other than feed processing establishments;

(b) were produced in feed processing establishments not keeping animals of listed species and the raw plant material originates: (i) from locations referred to in paragraph (a); or (ii) from outside the surveillance zone;

(c) are intended for use within the surveillance zone;

(d) have undergone at least one of the risk-mitigating treatments set out in Annex VIII.

Article 53

Specific conditions for authorising movements of kept animals of listed species and products to an approved plant

1. The competent authority may authorise movements of kept animals of listed species from establishments located in the surveillance zone to a plant approved for processing or disposal of animal by-products where: (a) the kept animals are immediately killed; and (b) the resulting animal by-products are disposed of in accordance with Regulation (EC) No 1069/2009.

2. The competent authority may authorise movements of products from establishments and other locations in the surveillance zone to a plant approved for processing or disposal of animal by-products where they are disposed of or processed in accordance with Regulation (EC) No 1069/2009.

Article 54

Measures to be applied in food and feed businesses, border control posts, animal by-products establishments or any other location of relevance in the surveillance zone, including means of transport

1. The competent authority shall apply the relevant measures referred to in Article 40, and Articles 42 to 53 in food and feed businesses, border control posts, animal by-products establishments or any other location of relevance in the surveillance zone, including means of transport.

2. In the establishments and locations referred to in paragraph 1, the competent authority may apply additional measures adapted to the specific situation in order to prevent the spread of the category A disease within and from the surveillance zone.

Article 55

Duration of the disease control measures in the surveillance zone

1. The competent authority may lift the disease control measures applied in the surveillance zone pursuant to Sections 1 and 3 of this Chapter only if the period set out in Annex XI has elapsed and the following conditions are fulfilled: (a) the requirements provided for in Article 39 have been met in the protection zone; and (b) a representative number of establishments keeping animals of listed species have undergone, with favourable results, visits carried out by official veterinarians, in accordance with Article 41.

2. Where the relevant category A disease is transmitted by a listed vector, in accordance with Regulation (EU) 2018/1882, the competent authority may: (a) set the duration of the measures in the surveillance zone on a case by case basis taking into account factors influencing the risk of spreading the disease; and (b) provide for the introduction of sentinel animals.







Section 4

Derogations applicable in the restricted zone in the case of further disease outbreaks

Article 56

Derogations from prohibitions of movements of animals within the restricted zones when restriction measures are maintained

1. Where prohibitions of movement of animals provided for in Articles 27 and Article 42 are maintained beyond the period set out in Annex XI because of the official confirmation of further outbreaks of the category A disease, the competent authority may, under exceptional circumstances, authorise the movement of kept animals of listed species from an establishment within the restricted zone in cases not covered by derogations provided for in Articles 27 and Article 42, if: (a) the operator has submitted a reasoned application for that authorisation; (b) the risks derived from authorising such movements have been assessed prior to the authorisation and the assessment indicates that the risk of spreading of the category A disease is negligible; (c) official veterinarians have carried out clinical examinations and have collect samples for laboratory examinations from animals of listed species, including those to be moved, which have yielded favourable results.

2. Where movements of animals are authorised pursuant paragraph 1, the competent authority shall ensure that the transport complies with the requirements laid down in Article 24.







CHAPTER III

Repopulation with terrestrial animals of establishments in restricted zones

Article 57

Conditions to authorise the repopulation of the affected establishment

1. The competent authority shall only authorise the repopulation of the affected establishment if the following requirements are met: (a) a final cleaning and disinfection and, when relevant, control of insects and rodents has been: (i) carried out, in accordance with the procedures set out in points A and C of Annex IV, using the appropriate biocidal products to ensure destruction of the relevant category A disease agent; and (ii) adequately documented; (b) the monitoring period set out in Annex II for the relevant disease, calculated forwards from the date on which the final cleaning and disinfection provided for in point (a) was carried out, has elapsed.

2. The competent authority shall supervise that the final cleaning and disinfection and, when relevant, control of insects and rodents in the affected establishment is carried out in compliance with the requirements in paragraph 1(a).

3. The competent authority shall not allow access to a pasture of kept animals of listed species during the period of time during which it is considered contaminated; this period of time shall be established after carrying out a risk assessment.

4. Where for duly justified reasons the final cleaning and disinfection and, when relevant, the control of insects and rodents referred to in paragraph 1, have not been entirely accomplished in the affected establishment, the competent authority may authorise the repopulation by way of derogation from paragraph 1, provided that: (a) a period of at least 3 months has elapsed since the preliminary cleaning and disinfection, as referred to in Article 15, was performed; and (b) prior to granting the authorisation, the competent authority has assessed the risks deriving from that authorisation and the assessment indicates that the risk of spreading the category A disease is negligible.

Article 58

Derogation from the requirement provided for in Article 55(1)(b)

In the event of the official confirmation of an outbreak of a category A disease in food and feed businesses, assembly centres, border control posts, animal by-products establishments or any other location of relevance, including means of transport, the competent authority may authorise the reintroduction of kept animals of listed species for slaughter, assembly operations, inspection or transport, 24 hours after completion of:

(a) the measures referred to in Articles 12, Article 14, Article 15, Article 17, Article 18 and Article 57(1)(a); and

(b) any additional measure applied by the competent authority adapted to the specific situation.

Article 59

Requirements for the repopulation of the affected establishment with kept animals of listed species

1. The competent authority shall supervise the repopulation with kept animals of listed species of the affected establishment complying with the provisions of this Article.

2. Kept animals of listed species intended for repopulation shall: (a) not originate from an establishment subject to the restrictions provided for in Chapter III; and (b) be sampled for laboratory examination to rule out the presence of the disease with favourable results prior to their introduction into the establishment.

3. For the purposes of paragraph 2(b), samples shall be collected from: (a) a representative number of all the animals to be introduced in the establishment, if they are all introduced at the same time and from the same establishment of origin; or (b) a representative number of animals of each consignment, if animals are all to be introduced at different times or from different establishments of origin. In the case of day-old-chicks, the competent authority may decide not to perform the sampling for laboratory examination referred to in paragraph 2(b).

4. Kept animals of listed species intended for repopulation shall be introduced in the establishments as follows: (a) in all the epidemiological units and buildings of the affected establishment; (b) preferably at the same time or within the monitoring period set out in Annex II for the relevant disease, calculated forwards from the date on which the first animal was introduced; or (c) in case of open-air farming establishments or when the requirement set out in point (a) is impractical, by using sentinel animals which have been sampled for laboratory examinations with favourable results for the relevant category A disease before being introduced in the establishment.

5. Official veterinarians shall carry out at least a visit to the affected establishment on the last day of the monitoring period set out in Annex II for the relevant disease, calculated forwards from the date on which the animals were placed in the establishment, and in any case before 30 days have elapsed since that day, performing at least: (a) documentary checks, including production, health and traceability records analysis; (b) clinical examination of kept animals of listed species; and (c) collection of samples of animals for laboratory examination in order to confirm or rule out the presence of the relevant category A disease.

6. Any person entering or leaving the establishment shall comply with appropriate biosecurity measures aimed at preventing the spread of the relevant category A disease.

7. Kept animals of listed species shall only leave the establishment under the authorisation of the competent authority and only after obtaining favourable results from the laboratory examination referred to in paragraph 5(c).

8. From the date that the animals were placed in the establishment until the end of the repopulation, in accordance with Article 61, the operator shall: (a) keep up to date the records of health and production data for kept animals of listed species; and (b) immediately notify to the competent authority any significant change in production data and any other abnormalities.

9. If unusual mortalities or clinical signs of the relevant category A disease are notified to the competent authority during the period referred to in paragraph 8, the official veterinarians shall without delay collect samples for laboratory examination to rule out the presence of the relevant category A disease.

10. The competent authority may exempt confined establishments from one or more of the provisions laid down in paragraphs 1 to 9 after assessing the risks deriving from that exemption and the assessment indicates that the risk of spreading the category A disease is negligible.

Article 60

Additional requirements for the repopulation of the affected establishment

1. The competent authority shall authorise the repopulation of the affected establishment with animals other than kept listed species taking into account the risk of spreading the relevant category A disease and the risk of vector persistence.

2. The competent authority may extend some or all the provisions provided for in Articles 57 and 59 if preventive killing as provided for in paragraph 4 of Articles 7 and 9 is applied.

Article 61

End of the repopulation of the affected establishment and lifting of disease control measures in the affected establishment

1. The repopulation of the affected establishment shall be considered finalised when the measures provided in Articles 57 and 59, and when relevant in Article 60, have been successfully completed.

2. The competent authority shall lift all the disease control measures applied in the affected establishment in accordance with this Regulation when the repopulation is considered finalised as provided for in paragraph 1.







CHAPTER IV

Disease control measures in wild animals of listed species

Article 62

Measures in the event of suspicion of a category A disease in wild animals of listed species

1. In the event of suspicion of a category A disease in wild animals of listed species in accordance with Article 9(1), (3), and (4) of Delegated Regulation (EU) 2020/689, the competent authority shall immediately conduct an investigation to confirm or rule out the presence of the suspected listed disease.

2. In the course of the investigation referred to in paragraph 1 the competent authority shall at least organise post-mortem examinations and the collection of samples for laboratory examination of wild animals of listed species shot dead or found dead to confirm or rule out the presence of the category A disease.

3. As regards the bodies of dead wild animals in which the relevant category A disease is suspected, whether the wild animals were killed or found dead, the competent authority shall ensure that: (a) the entire bodies of the dead wild animals or parts thereof are disposed of or processed in accordance with Regulation (EC) No 1069/2009; and (b) where feasible, any material or substance likely to be contaminated by contact with the bodies of dead wild animals or animal by-products obtained therefrom undergoes cleaning and disinfection or is disposed of following the instructions and under the supervision of official veterinarians.

Article 63

Measures in the event of an outbreak of a category A disease in wild animals of listed species

1. In the event of an official confirmation of an outbreak of a category A disease in wild animals of listed species in accordance with Article 9(2), (3) and (4) of Delegated Regulation (EU) 2020/689, the competent authority may determine an infected zone in order to prevent the further spread of the disease based on: (a) the disease profile; (b) the estimated population of wild animals of listed species; (c) the risk factors contributing to the spread of the relevant category A disease, in particular, the risk of the introduction of a category A disease into establishments keeping animals of listed species; (d) sampling results; and (e) other relevant factors.

2. As regards the bodies of wild animals in which the relevant category A disease has been confirmed, whether the wild animals were killed or found dead, the competent authority shall ensure that: (a) their entire bodies of the dead wild animals or parts thereof are disposed of or processed in accordance with Regulation (EC) No 1069/2009; and (b) where feasible, any material or substance likely to be contaminated by contact with the bodies of dead wild animals or animal by-products therefrom undergoes cleaning and disinfection or is disposed of following the instructions and under the supervision of official veterinarians.

3. The competent authority may adapt the boundaries of the initial infected zone: (a) in order to control the further spread of the relevant category A disease; and (b) in the case of confirmation of further outbreaks of the category A disease in wild animals.

4. The competent authority shall immediately inform operators, clinical veterinarians, hunters, other relevant competent authorities and any other natural or legal person concerned about the outbreak of the disease and the control measures adopted.

Article 64

Measures to be applied in the infected zone

1. In the infected zone determined in accordance with Article 63, the competent authority shall organise post-mortem examinations of wild animals of listed species shot dead or found dead, including when necessary sampling for laboratory examination.

2. In the infected zone the competent authority shall at least: (a) implement risk mitigation and reinforced biosecurity measures in order to prevent the spread of the category A disease from the affected animals and infected zone to unaffected animals or to humans; (b) prohibit movements of wild animals of listed species and products of animal origin thereof as provided for to in Commission Delegated Regulation (EU) 2020/688 ( 5 ); and (c) ensure that all bodies of dead wild animals of listed species, whether the animals were killed or found dead, or parts thereof, are disposed of or processed in accordance with in Regulation (EC) No 1069/2009.

Article 65

Additional measures to apply in the infected zone

In order to avoid the spreading of the category A disease, in the infected zone the competent authority may:

(a) regulate movements of kept animals of listed species;

(b) regulate hunting activities and other outdoors activities;

(c) restrict the feeding of wild animals of listed species; and

(d) develop and implement an eradication plan for the category A disease in wild animals of listed species if the epidemiological situation so requires.

Article 66

Operational expert group

In the event of an officially confirmed outbreak of a category A disease in wild animals of listed species and in the case that the competent authority determines an infected zone in accordance with Article 63, the competent authority shall establish an operational expert group as referred to in Article 43 of Regulation (EU) 2016/429 to assist the competent authority in:

(a) assessing the epidemiological situation and its evolution;

(b) defining the infected zone;

(c) establishing the appropriate measures to be applied in the infected zone in accordance with this Chapter and their duration; and

(d) developing an eradication plan, when relevant.

Article 67

Duration of measures in the infected zone

The competent authority shall maintain the measures applied in the infected zone in accordance with this Chapter until the epidemiological information indicates that the relevant wild population no longer poses a risk of introduction of a category A disease into establishments keeping animals of listed species and the operational group recommends lifting of the measures.







CHAPTER V

Disease control measures for category B and C diseases of terrestrial animals

Article 68

Preliminary disease control measures to be applied when a category B or C disease is suspected by the competent authority in Member States or zones that have been granted with the disease free status

In the event of suspicion of a category B or C disease in accordance with Article 9(1), (3) or (4) of Delegated Regulation (EU) 2020/689, in Member States or zones that have been granted the disease free status pursuant to Article 36(4) of Regulation (EU) 2016/429 or Article 84(1) of Delegated Regulation (EU) 2020/689, the competent authority shall apply the measures laid down in:

(a) Articles 21, 22, 23 of Delegated Regulation (EU) 2020/689 for infection with Brucella abortus, B. melitensis, B. suis, infection with Mycobacterium tuberculosis complex, enzootic bovine leucosis, infectious bovine rhinotracheitis/infectious pustular vulvovaginitis, infection with Aujeszky’s disease virus and bovine viral diarrhoea;

(b) Article 35 of Delegated Regulation (EU) 2020/689 for infection with rabies virus; and

(c) Article 41 of Delegated Regulation (EU) 2020/689 for infection with bluetongue virus (serotype 1-24).

Article 69

Disease control measures to be applied when a category B or C disease is confirmed

In the event of confirmation of a category B or C disease in accordance with point (2) of Article 9 of of Delegated Regulation (EU) 2020/689 in Member States or zones that have been granted the disease free status in with paragraph 4 of Article 36 of Regulation (EU) 2016/429 or paragraph 1 Article 84 of Delegated Regulation (EU) 2020/689, the competent authority shall apply the measures laid down in:

(a) Articles 24 to 31 of Delegated Regulation (EU) 2020/689 for infection with Brucella abortus, B. melitensis, B. suis, infection with Mycobacterium tuberculosis complex, enzootic bovine leucosis, infectious bovine rhinotracheitis/infectious pustular vulvovaginitis, infection with Aujeszky’s disease virus and bovine viral diarrhoea;

(b) Article 36 of Delegated Regulation (EU) 2020/689 for infection with rabies virus; and

(c) Article 42 of Delegated Regulation (EU) 2020/689 for infection with bluetongue virus (serotype 1-24).







PART III

AQUATIC ANIMALS







CHAPTER I

Disease control measures for category A diseases in aquaculture animals







Section 1

Preliminary disease control measures in the event of suspicion of a category A disease in aquaculture animals

Article 70

Obligations on operators in the event of suspicion of category A disease in aquaculture animals in establishments

In the event of suspicion of a category A disease in aquaculture animals of listed species, operators shall take the following disease control measures in order to prevent the spread of the category A disease from the affected animals and aquaculture establishments under their responsibility to other unaffected aquatic animals until the competent authority rules out the presence of the category A disease:

(a) isolate, where technically possible, all aquaculture animals in the establishment suspected of being infected with the category A disease;

(b) prevent movements of aquaculture animals into and from the establishment;

(c) keep records of all visits and movements from and to the establishment;

(d) keep any product, piece of equipment, material or substance likely to be contaminated with and to transmit category A diseases isolated and as far as practicable protected from vectors and other aquatic animals;;

(e) implement the appropriate biosecurity measures to avoid spread of the category A disease;

(f) provide the competent authority, on its request, with any relevant information regarding the category A disease; and

(g) follow any instructions given by the competent authority regarding the control of category A disease, in accordance with Regulation (EU) 2016/429 and this Regulation.

Article 71

Investigation by the competent authority of the suspicion of a category A disease in aquaculture animals in an establishment

1. In the event of the suspicion of a category A disease in aquaculture animals in an establishment in accordance with Article 9(1), (3) and (4) of Delegated Regulation (EU) 2020/689, the competent authority shall immediately conduct an investigation to confirm or rule out the presence of the suspected listed disease.

2. In the course of the investigation referred to in paragraph 1 the competent authority shall ensure that the official veterinarians perform at least: (a) clinical examinations of aquaculture animals; and (b) the collection of samples for laboratory examination.

Article 72

Preliminary restriction and biosecurity measures to be applied in the event of the suspicion of a category A disease in aquaculture animals

1. In the event of suspicion of a category A disease in an establishment, the competent authority shall place the establishment under official surveillance and immediately impose the following preliminary restriction and