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Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (Text with EEA relevance)

Type Regulation

Publication 2016-03-31

Last updated 2021-04-21

State In force

Department Council of the European Union, European Parliament

Source EUR-Lex

articles 282

Reform history JSON API

REGULATION (EU) 2016/429 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 9 March 2016

on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’)

(Text with EEA relevance)

PART I

GENERAL RULES

CHAPTER 1 Subject matter, aim, scope and definitions

Article 1

Subject matter and aim

This Regulation lays down rules for the prevention and control of animal diseases which are transmissible to animals or to humans.

Those rules provide for:

(a) the prioritisation and categorisation of diseases of Union concern and for the establishment of responsibilities for animal health (Part I: Articles 1 to 17);

(b) the early detection, notification and reporting of diseases, surveillance, eradication programmes and disease–free status (Part II: Articles 18 to 42);

(d) the registration and approval of establishments and transporters, movements and traceability of animals, germinal products and products of animal origin within the Union (Part IV: Articles 84 to 228; and Part VI: Articles 244 to 248 and 252 to 256);

(e) the entry of animals, germinal products, and products of animal origin into the Union and the export of such consignments from the Union (Part V: Articles 229 to 243; and Part VI: Articles 244 to 246 and 252 to 256);

(f) non–commercial movements of pet animals into a Member State from another Member State or from a third country or territory, (Part VI: Articles 244 to 256);

(g) the emergency measures to be taken in the event of a disease emergency situation (Part VII: Articles 257 to 262).

The rules referred to in paragraph 1:

(a) aim to ensure:
(i) improved animal health to support sustainable agricultural and aquaculture production in the Union;
(ii) the effective functioning of the internal market;
(iii) a reduction in the adverse effects on animal health, public health and the environment of:
— certain diseases;
— the measures taken to prevent and control diseases;

(b) take into account:
(i) the relationship between animal health and:
— public health;
— the environment, including biodiversity and valuable genetic resources, as well as the impact of climate change;
— food and feed safety;
— animal welfare, including the sparing of any avoidable pain, distress or suffering;
— antimicrobial resistance;
— food security;
(ii) the economic, social, cultural and environmental consequences arising from the application of disease control and prevention measures;
(iii) relevant international standards.

Article 2

Scope

This Regulation shall apply to:

(a) kept and wild animals;

(b) germinal products;

(d) animal by–products and derived products, without prejudice to the rules laid down in Regulation (EC) No 1069/2009;

(e) facilities, means of transport, equipment and all other paths of infection and material involved or potentially involved in the spread of transmissible animal diseases.

This Regulation shall apply to transmissible diseases, including zoonoses, without prejudice to the rules laid down in:

(a) Decision No 1082/2013/EU;

(b) Regulation (EC) No 999/2001;

(d) Regulation (EC) No 2160/2003.

Article 3

Scope of Parts IV, V and VI

Title I of Part IV (Articles 84 to 171) shall apply to:

(a) terrestrial animals, and animals which are not terrestrial animals but which may transmit diseases affecting terrestrial animals;

(b) germinal products from terrestrial animals;

Title II of Part IV (Articles 172 to 226) shall apply to:

(a) aquatic animals, and animals which are not aquatic animals but which may transmit diseases affecting aquatic animals;

(b) products of animal origin from aquatic animals.

Title III of Part IV (Articles 227 and 228) shall apply to:

(a) other animals;

(b) germinal products and products of animal origin from the other animals referred to in point (a).

Parts IV and V shall not apply to non–commercial movements of pet animals as referred to in paragraph 6 of this Article or to non–commercial movements of pet animals within a Member State.

Movements of pet animals, other than non–commercial movements, shall comply with the animal health requirements laid down in Parts IV and V.

The Commission shall adopt delegated acts in accordance with Article 264 concerning the adaptations which are necessary in order to ensure that Parts IV and V are correctly applied to pet animals, in particular to take account of the fact that pet animals are kept in households by pet keepers.

Part VI shall only apply to non–commercial movements of pet animals that comply with the requirements laid down in Articles 245 and 246 as regards the maximum number of animals that may accompany their owner and the maximum number of days elapsing between the movement of the owner and the movement of the animal.

Article 4

Definitions

For the purposes of this Regulation, the following definitions apply:

(1) ‘animals’ means vertebrate and invertebrate animals;

(2) ‘terrestrial animals’ means birds, terrestrial mammals, bees and bumble bees;

(3) ‘aquatic animals’ means animals of the following species, at all life stages, including eggs, sperm and gametes:
(a) fish belonging to the superclass Agnatha and to the classes Chondrichthyes, Sarcopterygii and Actinopterygii;
(b) aquatic molluscs belonging to the phylum Mollusca;
(c) aquatic crustaceans belonging to the subphylum Crustacea;

(4) ‘other animals’ means animals of species other than those falling within the definition of terrestrial or aquatic animals;

(5) ‘kept animals’ means animals which are kept by humans, including, in the case of aquatic animals, aquaculture animals;

(6) ‘aquaculture’ means the keeping of aquatic animals where the animals remain the property of one or more natural or legal persons throughout the rearing or culture stages, up to and including harvesting, excluding the harvesting or catching for the purposes of human consumption of wild aquatic animals which are subsequently temporarily kept while awaiting slaughter without being fed;

(7) ‘aquaculture animals’ means any aquatic animals subject to aquaculture,

(8) ‘wild animals’ means animals which are not kept animals;

(9) ‘poultry’ means birds that are reared or kept in captivity for:
(a) the production of:
(i) meat;
(ii) eggs for consumption;
(iii) other products;
(b) restocking supplies of game birds;
(c) the purpose of breeding of birds used for the types of production referred to in points (a) and (b);

(10) ‘captive birds’ means any birds other than poultry that are kept in captivity for any reason other than those referred to in point (9), including those that are kept for shows, races, exhibitions, competitions, breeding or selling;

(11) ‘pet animal’ means a kept animal of the species listed in Annex I which is kept for private non–commercial purposes;

(12) ‘pet keeper’ means a natural person, and may include a pet owner, keeping a pet animal;

(13) ‘pet owner’ means a natural person indicated as the owner in the identification document referred to in point (c) of Article 247, point (c) of Article 248(2), point (c) of Article 249(1) and point (c) of Article 250(2);

(14) ‘non–commercial movement’ means any movement of a pet animal accompanying its owner and which
(a) does not have as its aim either the sale of or another form of transfer of ownership of the pet animal concerned; and
(b) is part of the movement of the pet owner:
(i) either under his direct responsibility; or
(ii) under the responsibility of an authorised person, in cases where the pet animal is physically separated from the pet owner;

(15) ‘authorised person’ means any natural person who has authorisation in writing from the pet owner to carry out the non–commercial movement of the pet animal on behalf of the pet owner;

(16) ‘disease’ means the occurrence of infections and infestations in animals, with or without clinical or pathological manifestations, caused by one or more disease agents;

(17) ‘disease agent’ means a pathogen transmissible to animals or to humans which is capable of causing a disease in animals;

(18) ‘listed diseases’ means diseases listed in accordance with Article 5(1);

(19) ‘disease profile’ means the criteria of a disease referred to in point (a) of Article 7;

(20) ‘listed species’ means an animal species or group of animal species listed in accordance with Article 8(2), or, in the case of emerging diseases, an animal species or group of animal species which meets the criteria for listed species laid down in Article 8(2);

(21) ‘hazard’ means a disease agent in, or a condition of, an animal or product with the potential to have an adverse effect on the health of humans or animals;

(22) ‘risk’ means the likelihood of the occurrence and the likely magnitude of the biological and economic consequences of an adverse effect on animal or public health;

(23) ‘biosecurity’ means the sum of management and physical measures designed to reduce the risk of the introduction, development and spread of diseases to, from and within:
(a) an animal population, or
(b) an establishment, zone, compartment, means of transport or any other facilities, premises or location;

(24) ‘operator’ means any natural or legal person having animals or products under his responsibility, including for a limited duration of time, but excluding pet keepers and veterinarians;

(25) ‘transporter’ means an operator transporting animals on his own account or on account of a third party;

(26) ‘animal professional’ means a natural or legal person having an occupational relationship with animals or products, other than operators or veterinarians;

(27) ‘establishment’ means any premises, structure, or, in the case of open-air farming, any environment or place, where animals or germinal products are kept, on a temporary or permanent basis, except for:
(a) households where pet animals are kept;
(b) veterinary practices or clinics;

(28) ‘germinal products’ means:
(a) semen, oocytes and embryos intended for artificial reproduction;
(b) hatching eggs;

(29) ‘products of animal origin’ means:
(a) food of animal origin, including honey and blood;
(b) live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods, intended for human consumption; and
(c) animals other than those referred to in point (b) intended to be prepared with a view to being supplied live to the final consumer;

(30) ‘animal by–products’ means entire bodies or parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption, excluding germinal products;

(31) ‘derived products’ means products obtained from one or more treatments, transformations or steps in the processing of animal by–products;

(32) ‘products’ means:
(a) germinal products;
(b) products of animal origin;
(c) animal by–products and derived products;

(33) ‘official control’ means any form of control performed in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council ([^E0001]);

(34) ‘health status’ means the disease status as regards the listed diseases relevant for a particular listed species with respect to:
(a) an animal;
(b) animals within:
(i) an epidemiological unit;
(ii) an establishment;
(iii) a zone;
(iv) a compartment;
(v) a Member State;
(vi) a third country or territory;

(35) ‘zone’ means:
(a) for terrestrial animals, an area of a Member State, third country or territory with a precise geographical delimitation, containing an animal subpopulation with a distinct health status with respect to a specific disease or specific diseases subject to appropriate surveillance, disease control and biosecurity measures;
(b) for aquatic animals, a contiguous hydrological system with a distinct health status with respect to a specific disease or specific diseases that forms an area that is referred to in one of the following:
(i) an entire water catchment from the source of a waterway to the estuary or lake;
(ii) more than one water catchment;
(iii) part of a water catchment from the source of a waterway to a barrier that prevents the introduction of a specific disease or diseases;
(iv) part of a coastal area with a precise geographical delimitation;
(v) an estuary with a precise geographical delimitation;

(36) ‘water catchment’ means an area or basin of land bounded by natural features such as hills or mountains, into which all run–off water flows;

(37) ‘compartment’ means an animal subpopulation contained in one or more establishments and, in the case of aquatic animals, in one or more aquaculture establishments, under a common biosecurity management system with a distinct health status with respect to a specific disease or specific diseases subject to appropriate surveillance, disease control and biosecurity measures;

(38) ‘quarantine’ means the keeping of animals in isolation with no direct or indirect contact with animals outside the epidemiological unit, for the purpose of ensuring that there is no spread of one or more specified diseases while the animals in isolation are undergoing observation for a specified length of time and, if appropriate, testing and treatment;

(39) ‘epidemiological unit’ means a group of animals with the same likelihood of exposure to a disease agent;

(40) ‘outbreak’ means the officially confirmed occurrence of a listed disease or an emerging disease in one or more animals in an establishment or other place where animals are kept or located;

(41) ‘restricted zone’ means a zone in which restrictions on the movements of certain animals or products and other disease control measures are applied, with a view to preventing the spread of a particular disease into areas where no restrictions are applied; a restricted zone may, when relevant, include protection and surveillance zones;

(42) ‘protection zone’ means a zone around and including the location of an outbreak, where disease control measures are applied in order to prevent the spread of the disease from that zone;

(43) ‘surveillance zone’ means a zone which is established around the protection zone, and where disease control measures are applied in order to prevent the spread of the disease from the protection zone;

(44) ‘hatching eggs’ means eggs, laid by poultry or captive birds, intended for incubation;

(45) ‘ungulates’ means the animals listed in Annex III;

(46) ‘germinal product establishment’ means:
(a) in relation to semen, an establishment where semen is collected, produced, processed or stored;
(b) in relation to oocytes and embryos, a group of professionals or structure supervised by a team veterinarian competent to perform the collection, production, processing and storage of oocytes and embryos;
(c) in relation to hatching eggs, a hatchery;

(47) ‘hatchery’ means an establishment which collects, stores, incubates and hatches eggs for the supply of:
(a) hatching eggs;
(b) day–old chicks or hatchlings of other species;

(48) ‘confined establishment’ means any permanent, geographically limited establishment, created on a voluntary basis and approved for the purpose of movements, where the animals are:
(a) kept or bred for the purposes of exhibitions, education, the conservation of species or research;
(b) confined and separated from the surrounding environment; and
(c) subject to animal health surveillance and biosecurity measures;

(49) ‘assembly operation’ means the assembling of kept terrestrial animals from more than one establishment for a period shorter than the required residency period for the species of animals concerned;

(50) ‘residency period’ means the minimum period necessary in order to ensure that an animal which has been introduced into an establishment is not of a lower health status than that of the animals in that establishment;

(51) ‘traces’ means a system component integrated into the IMSOC as referred to in Articles 131 to 136 of Regulation (EU) 2017/625;

(52) ‘disease control aquatic food establishment’ means a food business approved in accordance with Article 179;

(53) ‘official veterinarian’ means an official veterinarian as defined in Article 3(32) of Regulation (EU) 2017/625;

(54) ‘official veterinarian in a third country or territory’ means a veterinarian in a third country or territory corresponding to an official veterinarian as referred to in point (53);

(55) ‘competent authority’ means the central veterinary authority of a Member State responsible for the organisation of official controls and any other official activities in accordance with this Regulation and Regulation (EU) 2017/625, or any other authority to which that responsibility has been delegated;

(56) ‘competent authority of a third country or territory’ means the authority in a third country or territory corresponding to the competent authorities referred to in point (55).

CHAPTER 2 Listed diseases and emerging diseases and listed species

Article 5

Listing of diseases

The disease-specific rules for the prevention and control of diseases provided for in this Regulation shall apply to:

(a) the following listed diseases:
(i) foot and mouth disease;
(ii) classical swine fever;
(iii) African swine fever;
(iv) highly pathogenic avian influenza;
(v) African horse sickness; and

(b) the listed diseases set out in the list in Annex II.

The Commission shall adopt delegated acts in accordance with Article 264 concerning amendments to the list referred to in point (b) of paragraph 1 of this Article.

A disease shall be included on the list referred to in point (b) of paragraph 1 of this Article if it has been assessed in accordance with Article 7 and it meets:

(a) all of the following criteria:
(i) scientific evidence indicates that the disease is transmissible;
(ii) animal species are either susceptible to the disease or vectors and reservoirs thereof exist in the Union;
(iii) the disease causes negative effects on animal health or poses a risk to public health due to its zoonotic character;
(iv) diagnostic tools are available for the disease; and
(v) risk-mitigating measures and, where relevant, surveillance of the disease are effective and proportionate to the risks posed by the disease in the Union; and

(b) at least one of the following criteria:
(i) the disease causes or could cause significant negative effects in the Union on animal health, or poses or could pose a significant risk to public health due to its zoonotic character;
(ii) the disease agent has developed resistance to treatments which poses a significant danger to public and/or animal health in the Union;
(iii) the disease causes or could cause a significant negative economic impact affecting agriculture or aquaculture production in the Union;
(iv) the disease has the potential to generate a crisis or the disease agent could be used for the purpose of bioterrorism; or
(v) the disease has or could have a significant negative impact on the environment, including biodiversity, of the Union.

The Commission shall adopt delegated acts in accordance with Article 264 concerning the removal of a disease from the list referred to in point (b) of paragraph 1 of this Article when that disease no longer fulfils the criteria provided for in paragraph 3 of this Article.

The Commission shall review the listing of each disease in the light of newly available significant scientific data.

Article 6

Emerging diseases

The rules for the prevention and control of diseases shall apply to emerging diseases as provided for in this Regulation.

A disease other than a listed disease shall be considered to be an emerging disease (‘emerging disease’) provided it has the potential to meet the criteria for listing diseases provided for in Article 5(3) and:

(a) results from the evolution or change of an existing disease agent;

(b) is a known disease spreading to a new geographic area, species or population;

(d) is caused by an unrecognised or a previously unrecognised disease agent.

The Commission shall, by means of implementing acts, take the necessary measures regarding an emerging disease which fulfils the criteria set out in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

On duly justified imperative grounds of urgency relating to a disease representing an emerging risk having a highly significant impact, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 266(3).

Any obligation on operators in respect of an emerging disease, as set out in this Regulation, shall only apply if the Commission has adopted an implementing act for that disease in accordance with paragraph 3 of this Article or if the disease is covered by a contingency plan in accordance with Article 43.

Article 7

Assessment parameters for the listing of diseases

The Commission shall use the following assessment parameters in order to determine whether a disease meets the conditions requiring it to be listed in accordance with Article 5(2):

(a) the disease profile, which shall comprise the following:
(i) the animal species concerned by the disease;
(ii) the morbidity and mortality rates of the disease in animal populations;
(iii) the zoonotic character of the disease;
(iv) the resistance to treatments, including antimicrobial resistance;
(v) the persistence of the disease in an animal population or in the environment;
(vi) the routes and speed of transmission of the disease between animals and, when relevant, between animals and humans;
(vii) the absence or presence and distribution of the disease in the Union, and, where the disease is not present in the Union, the risk of its introduction into the Union;
(viii) the existence of diagnostic and disease control tools;

(b) the impact of the disease on:
(i) agricultural and aquaculture production and other parts of the economy, as regards:
— the level of presence of the disease in the Union;
— the loss of production due to the disease;
— other losses;
(ii) human health, as regards:
— transmissibility between animals and humans;
— transmissibility between humans;
— the severity of human forms of the disease;
— the availability of effective prevention or medical treatment in humans;
(iii) animal welfare;
(iv) biodiversity and the environment;

(d) the feasibility, availability and effectiveness of the following disease prevention and control measures:
(i) diagnostic tools and capacities;
(ii) vaccination;
(iii) medical treatments;
(iv) biosecurity measures;
(v) restrictions on the movement of animals and products;
(vi) killing of animals;
(vii) disposal of carcasses and other relevant animal by–products;

(e) the impact of disease prevention and control measures, as regards:
(i) the direct and indirect costs for the affected sectors and the economy as a whole;
(ii) their societal acceptance;
(iii) the welfare of affected subpopulations of kept and wild animals;
(iv) the environment and biodiversity.

Article 8

Listing of species

The disease-specific rules for listed diseases provided for in this Regulation and the rules adopted pursuant to this Regulation shall apply to listed species.

The Commission shall, by means of implementing acts, establish a list of species as referred to in paragraph 1 of this Article that fulfil the criteria set out in paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

That list shall comprise those animal species, or groups of animal species which pose a considerable risk for the spread of specific listed diseases, based on the following criteria:

(a) the susceptibility of the animal population at risk;

(b) the duration of the incubation period and infective period for the animals concerned;

Animal species or groups of animal species shall be added to the list if they are affected or if they pose a risk for the spread of a specific listed disease because:

(a) they are susceptible to a specific listed disease or scientific evidence indicates that such susceptibility is likely; or

(b) they are vector species or reservoirs for that disease, or scientific evidence indicates that such role is likely.

The Commission shall, by means of implementing acts, remove animal species or groups of animal species from the list when:

(a) the relevant listed disease in relation to which the animal species or group of animal species concerned has been listed has been removed from the list of diseases; or

(b) scientific evidence indicates that the species or group of species concerned no longer fulfils the criteria set out in paragraph 3.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 9

Disease prevention and control rules to be applied to different categories of listed diseases

Disease prevention and control rules shall apply to listed diseases as follows:

(a) As regards listed diseases that do not normally occur in the Union and for which immediate eradication measures must be taken as soon as they are detected, the following rules shall apply, as relevant:
(i) the rules for disease awareness and preparedness provided for in Title I of Part III (Articles 43 to 52);
(ii) the disease control measures provided for in Chapter 1 of Title II of Part III (Articles 53 to 71); and
(iii) the rules for compartmentalisation provided for in Article 37(1). For those listed diseases, the measures referred to in point (b), as appropriate, as well as points (d) and (e), shall also apply, as relevant.

(b) As regards listed diseases which must be controlled in all Member States with the goal of eradicating them throughout the Union, the following rules shall apply, as relevant:
(i) the rules for compulsory eradication programmes provided for in Article 31(1);
(ii) the rules for disease–free Member States and zones provided for in Article 36;
(iii) the rules for compartmentalisation provided for in Article 37(2); and
(iv) the disease control measures provided for in Articles 72 to 75, Articles 77 to 79 and Articles 81 and 83. For those listed diseases, the measures referred to in points (d) and (e) shall also apply, as relevant.

(c) As regards listed diseases which are of relevance to some Member States and for which measures are needed to prevent them from spreading to parts of the Union that are officially disease-free or that have eradication programmes for the listed disease concerned, the following rules shall apply, as relevant:
(i) the rules for optional eradication provided for in Article 31(2);
(ii) the rules for disease–free Member States and zones provided for in Article 36;
(iii) the rules for compartmentalisation provided for in Article 37(2); and
(iv) the rules for disease control measures provided for in Articles 76, 77, 78, 80, 82 and 83. For those listed diseases, the measures referred to in points (d) and (e) shall also apply, as relevant.

(d) As regards listed diseases for which measures are needed to prevent them from spreading on account of their entry into the Union or movements between Member States, the following rules shall apply, as relevant:
(i) the rules for movement within the Union provided for in Chapters 3 to 6 of Title I (Articles 124 to 169), Chapters 2 and 3 of Title II of Part IV (Articles 191 to 225) and Chapters 2 and 3 of Part VI (Articles 247 to 251); and
(ii) the rules for entry into the Union and export from the Union provided for in Part V (Articles 229 to 243). The listed diseases referred to in points (a), (b) and (c) shall also be considered as listed diseases under this point, as well as those referred to in point (e), where the risk posed by the disease in question can be effectively and proportionately mitigated by measures concerning movements of animals and products.

(e) As regards listed diseases for which there is a need for surveillance within the Union, the following rules shall apply, as relevant:
(i) the rules for notification and reporting provided for in Chapter 1 of Part II (Articles 18 to 23); and
(ii) the rules for surveillance provided for in Chapter 2 of Part II (Articles 24 to 30). The listed diseases referred to in points (a), (b) and (c) shall also be considered as listed diseases under this point.

The Commission shall, by means of implementing acts, determine the application of the disease prevention and control rules referred to in paragraph 1 to the respective listed diseases on the basis of the criteria set out in Annex IV, also in the light of newly available significant scientific data.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

The Commission shall, by means of implementing acts, modify the application of the disease prevention and control rules referred to in paragraph 2 to the respective listed diseases when the disease in question no longer fulfils the criteria laid down in the relevant Section of Annex IV, also in the light of newly available significant scientific data.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

On duly justified imperative grounds of urgency relating to a listed disease representing an emerging risk having a highly significant impact, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 266(3).

CHAPTER 3 Responsibilities for animal health

Section 1 Operators, animal professionals and pet keepers

Article 10

Responsibilities for animal health and biosecurity measures

Operators shall:

(a) as regards kept animals and products under their responsibility, be responsible for:
(i) the health of kept animals;
(ii) prudent and responsible use of veterinary medicines, without prejudice to the role and responsibility of veterinarians,
(iii) minimising the risk of the spread of diseases;
(iv) good animal husbandry;

(b) where appropriate, take such biosecurity measures regarding kept animals, and products under their responsibility, as are appropriate for:
(i) the species and categories of kept animals and products;
(ii) the type of production; and
(iii) the risks involved, taking into account:
— geographical location and climatic conditions; and
— local circumstances and practices;

Animal professionals shall take action to minimise the risk of the spread of diseases in the context of their occupational relationship with animals and products.

Point (a) of paragraph 1 shall also apply to pet keepers.

The biosecurity measures referred to in point (b) of paragraph 1 shall be implemented, as appropriate, through:

(a) physical protection measures, which may include:
(i) enclosing, fencing, roofing, netting, as appropriate;
(ii) cleaning, disinfection and control of insects and rodents;
(iii) in the case of aquatic animals, where appropriate:
— measures concerning the water supply and discharge;
— natural or artificial barriers to surrounding water courses that prevent aquatic animals from entering or leaving the establishment concerned, including measures against flooding or infiltration of water from surrounding water courses;

(b) management measures, which may include:
(i) procedures for entering and exiting the establishment for animals, products, vehicles and persons;
(ii) procedures for using equipment;
(iii) conditions for movement based on the risks involved;
(iv) conditions for introducing animals or products into the establishment;
(v) quarantine, isolation or separation of newly introduced or sick animals;
(vi) a system for safe disposal of dead animals and other animal by–products.

Operators, animal professionals and pet keepers shall cooperate with the competent authority and veterinarians in the application of the disease prevention and control measures provided for in this Regulation.

The Commission may, by means of implementing acts, lay down minimum requirements necessary for the uniform application of this Article.

Such implementing acts shall reflect the matters referred to in point (b) of paragraph 1.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 11

Knowledge of animal health

Operators and animal professionals shall have adequate knowledge of:

(a) animal diseases, including those that are transmissible to humans;

(b) biosecurity principles;

(d) good practice of animal husbandry for the animal species under their care;

(e) resistance to treatments, including antimicrobial resistance, and its implications.

The content and the level of knowledge required in accordance with paragraph 1 shall depend on:

(a) the species and categories of kept animals or products under the responsibility of the operators and animal professionals concerned and the nature of their occupational relationship with those animals or products;

(b) the type of production;

The knowledge provided for in paragraph 1 shall be acquired in one of the following ways:

(a) professional experience or training;

(b) existing programmes in agricultural or aquaculture sectors that are relevant for animal health;

(d) other experience or other training which results in the same level of knowledge as that covered by points (a), (b) or (c).

Operators selling or otherwise transferring the ownership of future pet animals shall provide basic information to the future pet keeper, regarding the matters referred to in paragraph 1, as relevant for the pet animal in question.

Section 2 Veterinarians and aquatic animal health professionals

Article 12

Responsibilities of veterinarians and aquatic animal health professionals

Veterinarians shall in the course of their activities which fall within the scope of this Regulation:

(a) take all appropriate measures to prevent the introduction, development and spread of diseases;

(b) take action to ensure the early detection of diseases by carrying out proper diagnosis and differential diagnosis to rule out or confirm a disease;

(c) play an active role in:
(i) raising animal health awareness, and awareness of the interaction between animal health, animal welfare and human health;
(ii) disease prevention;
(iii) the early detection of, and rapid response to, diseases.
(iv) raising awareness of resistance to treatments, including antimicrobial resistance, and its implications;

(d) cooperate with the competent authority, operators, animal professionals and pet keepers in the application of the disease prevention and control measures provided for in this Regulation.

Aquatic animal health professionals may undertake activities assigned to veterinarians under this Regulation in relation to aquatic animals provided that they are authorised to do so by the Member State concerned under national law. In that event, paragraph 1 shall apply to those aquatic animal health professionals.

Veterinarians and aquatic animal health professionals shall maintain and develop their professional capacities related to their areas of activities which fall within the scope of this Regulation.

Section 3 Member States

Article 13

Member States' responsibilities

In order to ensure that the competent authority for animal health has the capability to take the necessary and appropriate measures, and to carry out the activities, required by this Regulation, each Member State shall, at the appropriate administrative level, ensure that competent authority has:

(a) qualified personnel, facilities, equipment, financial resources and an effective organisation covering the whole territory of the Member State;

(b) access to laboratories with the qualified personnel, facilities, equipment and financial resources needed to ensure the rapid and accurate diagnosis and differential diagnosis of listed diseases and emerging diseases;

Member States shall encourage operators and animal professionals to acquire, maintain and develop the adequate knowledge of animal health provided for in Article 11 through relevant programmes in agricultural or aquaculture sectors or formal education.

Article 14

Delegation by a competent authority of official activities

The competent authority may delegate one or more of the following activities to veterinarians other than official veterinarians:

(a) practical application of measures under the eradication programmes provided for in Article 32;

(b) supporting the competent authority in carrying out surveillance as provided for in Article 26 or in relation to surveillance programmes as provided for in Article 28;

(c) activities related to:
(i) disease awareness, preparedness and control as provided for in Part III, concerning:
— sampling activities and implementation of investigations and epidemiological enquiries within the framework of Article 54, points (b) to (g) of Article 55(1), and Articles 57, 73, 74, 79 and 80 in the event of the suspected presence of a disease, and any implementing and delegated acts adopted pursuant to those Articles;
— carrying out activities relating to disease control measures in the event of an outbreak of disease, as regards activities listed in Article 61, points (a), (b), (e), (f) and (i) of Article 65(1), Article 70(1), Articles 79, 80, 81 and 82, and any implementing and delegated acts adopted pursuant to those Articles;
— carrying out emergency vaccination in accordance with Article 69;
(ii) registration, approval, traceability and movements as provided for in Part IV;
(iii) issuing and completing the identification documents for pet animals as provided for in point (c) of Article 247, point (c) of Article 248(2), point (c) of Article 249(1) and point (c) of Article 250(2);
(iv) the application and use of means of identification as referred to in point (a)(ii) of Article 252(1).

Member States may provide for natural or legal persons to be authorised to perform activities referred to in points (a), (b) and (c)(i), (ii) and (iv) of paragraph 1 for specifically identified tasks for which those persons have sufficient specific knowledge. In that event, paragraph 1 of this Article and the responsibilities laid down in Article 12 shall apply to those persons.

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning other activities which may be delegated to veterinarians in addition to those provided for in paragraph 1, and, as appropriate, to prescribe the necessary circumstances and conditions for such delegation.

The Commission shall take account of the nature of those activities and of relevant international standards when adopting those delegated acts.

Article 15

Public information

Where there are reasonable grounds to suspect that animals or products originating from within the Union or entering from outside the Union may present a risk, the competent authority shall take appropriate steps to inform the public of the nature of the risk and the measures which are taken or about to be taken to prevent or control that risk, taking into account the nature, seriousness and extent of that risk and the public interest in being informed.

Section 4 Laboratories, facilities and other natural and legal persons handling disease agents, vaccines and other biological products

Article 16

Obligations of laboratories, facilities and others handling disease agents, vaccines and other biological products

Laboratories, facilities and other natural or legal persons handling disease agents for the purpose of research, education, diagnosis or the production of vaccines and other biological products shall, whilst taking into account any relevant international standards:

(a) take appropriate biosecurity, biosafety and bio–containment measures to prevent the escape of the disease agents and their subsequent contact with animals outside the laboratory or other facility handling disease agents for those purposes;

(b) ensure that the movement of disease agents, vaccines and other biological products between laboratories or other facilities does not give rise to a risk of the spread of listed and emerging diseases.

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the safety measures for the prevention and control of listed and emerging diseases as regards laboratories, facilities and other natural or legal persons handling the disease agents, vaccines and other biological products in relation to:

(a) biosecurity, biosafety and bio–containment measures;

(b) movement requirements for disease agents, vaccines and other biological products.

Article 17

Animal health laboratories

Official laboratories for animal health, consisting of Union reference laboratories, national reference laboratories and official animal health laboratories, shall, in fulfilling their tasks and responsibilities, cooperate within a network of Union animal health laboratories.

The laboratories referred to in paragraph 1 shall cooperate under the coordination of the Union reference laboratories, to ensure that the surveillance, notification and reporting of diseases, eradication programmes, the definition of disease–free status, and the movements of animals and products within the Union, their entry into the Union and exports to third countries or territories provided for in this Regulation, are based on state–of–the–art, solid and reliable laboratory analyses, tests and diagnoses.

The results and reports provided by the official laboratories shall be subject to the principles of professional secrecy and confidentiality and the duty of notification to the competent authority which designated them, irrespective of the natural or legal person who requested the laboratory analyses, tests or diagnoses.

In the event that an official laboratory in one Member State conducts diagnostic analyses on samples from animals originating in another Member State, that official laboratory shall notify the competent authority of the Member State from which the samples originated:

(a) immediately of any results indicating the suspicion or detection of a listed disease as referred to in point (a) of Article 9(1);

(b) without undue delay of any results indicating the suspicion or detection of a listed disease as referred to in point (e) of Article 9(1) other than those referred to in point (a) of Article 9(1).

PART II

DISEASE NOTIFICATION AND REPORTING, SURVEILLANCE, ERADICATION PROGRAMMES, DISEASE–FREE STATUS

CHAPTER 1 Disease notification and reporting

Article 18

Notification within Member States

Member States shall ensure that operators and other relevant natural or legal persons:

(a) immediately notify the competent authority where there are any reasons to suspect the presence in animals of a listed disease as referred to in point (a) of Article 9(1), or where the presence of such a disease is detected in animals;

(b) as soon as practicable notify the competent authority where there are any reasons to suspect the presence in animals of a listed disease as referred to in point (e) of Article 9(1) other than those referred to in point (a) of Article 9(1), or where the presence of such a disease is detected in animals;

(c) notify a veterinarian of abnormal mortalities and other signs of serious disease or significant decreased production rates with an undetermined cause, for further investigation, including sampling for laboratory examination when the situation so requires.

Member States may decide that the notifications provided for in point (c) of paragraph 1 may be directed to the competent authority.

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) criteria to determine whether the circumstances requiring notification described in point (c) of paragraph 1 occur;

(b) detailed rules for the further investigation provided for in point (c) of paragraph 1.

Article 19

Union notification

Member States shall immediately notify the Commission and the other Member States of any outbreaks of listed diseases as referred to in point (e) of Article 9(1) for which an immediate notification is required in order to ensure the timely implementation of necessary risk management measures, taking into account the disease profile.

The notification provided for in paragraph 1 shall contain the following information on the outbreak:

(a) the disease agent and, where relevant, the subtype;

(b) the relevant dates, in particular those of the suspicion and the confirmation of the outbreak;

(d) any related outbreaks;

(e) the animals involved in the outbreak;

(f) any disease control measures taken in relation to the outbreak;

(g) the possible or known origin of the listed disease;

(h) the diagnostic methods used.

Article 20

Union reporting

Member States shall report to the Commission and to the other Member States the information on listed diseases referred to in in point (e) of Article 9(1) for which:

(a) immediate notification of an outbreak is not required under Article 19(1);

(b) immediate notification of an outbreak is required under Article 19(1), but additional information is required to be reported to the Commission and the other Member States on:
(i) surveillance in accordance with the rules laid down in an implementing act adopted in accordance with Article 30;
(ii) an eradication programme in accordance with the rules laid down in an implementing act adopted in accordance with Article 35.

The reports provided for in paragraph 1 shall include information on:

(a) the detection of the listed diseases referred to in paragraph 1;

(b) the results of surveillance when required in accordance with rules adopted in accordance with point (d)(ii) of Article 29 or point (b)(ii) of Article 30(1);

(c) the results of surveillance programmes when required in accordance with Article 28(3) and rules adopted in accordance with point (d)(ii) of Article 29 or point (b)(ii) of Article 30(1);

(d) eradication programmes when required in accordance with Article 34 and rules laid down in an implementing act adopted in accordance with Article 35.

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning provisions supplementing the requirements of paragraph 2 and reporting on other matters concerning surveillance and eradication programmes where necessary in order to ensure an efficient application of the disease prevention rules and control rules laid down in this Regulation.

Article 21

Notification and reporting regions

The Member States shall establish notification and reporting regions for the purpose of the notification and reporting provided for in Articles 19 and 20.

Article 22

Computerised information system for Union notification and Union reporting of diseases

The Commission shall set up and manage a computerised information system for the operation of the mechanisms and tools for the notification and reporting requirements provided for in Articles 19, 20 and 21.

Article 23

Implementing powers concerning Union notification and Union reporting and the computerised information system

The Commission shall, by means of implementing acts, lay down rules for the notification and reporting requirements and the computerised information system provided for in Articles 19 to 22 with respect to:

(a) those listed diseases referred to in point (e) of Article 9(1) which are to be subject to immediate notification by the Member States as well as the necessary measures relating to the notification, in accordance with Article 19;

(b) the information to be provided by the Member States in the reporting provided for in Article 20;

(c) procedures for the establishment and use of the computerised information system provided for in Article 22 and transitional measures for the migration of the data and the information from existing systems into the new system and its full operability;

(d) the format and structure of the data to be entered into the computerised information system provided for in Article 22;

(e) the deadlines and frequencies of the notification and reporting provided for in Articles 19 and 20, which shall be done at times and frequencies which ensure transparency and the timely application of the necessary risk management measures, based on the disease profile and the type of outbreak.

(f) the listing of notification and reporting regions provided for in Article 21.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

CHAPTER 2 Surveillance

Article 24

Operators' surveillance obligation

For the purpose of detecting the presence of listed diseases and emerging diseases, operators shall:

(a) observe the health and behaviour of animals under their responsibility;

(b) observe any changes in the normal production parameters in the establishments, animals or germinal products under their responsibility that may give rise to a suspicion of being caused by a listed disease or emerging disease;

Article 25

Animal health visits

Operators shall ensure that establishments under their responsibility receive animal health visits from a veterinarian when appropriate due to the risks posed by the establishment in question, taking into account:

(a) the type of establishment;

(b) the species and categories of kept animals on the establishment;

(c) the epidemiological situation in the zone or region as regards listed and emerging diseases to which the animals in the establishment are susceptible;

(d) any other relevant surveillance, or official controls to which the kept animals and type of establishment are subject.

Such animal health visits shall take place at frequencies that are proportionate to the risks posed by the establishment concerned.

They may be combined with visits for other purposes.

The animal health visits provided for in paragraph 1 shall be made for the purpose of disease prevention, in particular through:

(a) the provision of advice to the operator concerned on biosecurity and other animal health matters, as relevant for the type of establishment and the species and categories of kept animals on the establishment.

(b) the detection of, and information on, signs indicative of the occurrence of listed diseases or emerging diseases;

The Commission may, by means of implementing acts, lay down minimum requirements necessary for the uniform application of this Article.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 26

The competent authority's surveillance obligation

The competent authority shall conduct surveillance to detect the presence of listed diseases as referred to in point (e) of Article 9(1) and relevant emerging diseases.

The surveillance shall be designed in such a way as to ensure the timely detection of the presence of the listed diseases referred to in point (e) of Article 9(1) and emerging diseases by means of the collection, collation and analysis of relevant information relating to the disease situation.

The competent authority shall, whenever possible and appropriate, make use of the results of the surveillance conducted by operators and the information obtained through animal health visits in accordance with Articles 24 and 25, respectively.

The competent authority shall ensure that surveillance meets the requirements provided for in Article 27 and in any rules adopted pursuant to point (a) of Article 29.

The competent authority shall ensure that the information obtained through the surveillance provided for in paragraph 1 is collected and used in an effective and efficient manner.

Article 27

Methodology, frequency and intensity of surveillance

The design, means, diagnostic methods, frequency, intensity, targeted animal population, and sampling patterns of the surveillance provided for in Article 26 shall be appropriate and proportionate to the objectives of the surveillance, taking into account:

(a) the disease profile;

(b) the risk factors involved;

(c) the health status in:
(i) the Member State, zone or compartment thereof subject to the surveillance;
(ii) the Member States and third countries or territories which either border on, or from which animals and products enter into, that Member State, zone or compartment thereof;

(d) surveillance conducted by operators in accordance with Article 24, including animal health visits as referred to in Article 25, or by other public authorities.

Article 28

Union surveillance programmes

The competent authority shall undertake surveillance as provided for in Article 26(1) within the framework of a surveillance programme when a disease is relevant for the Union in accordance with point (c) of Article 29.

Member States establishing a surveillance programme in accordance with paragraph 1 shall submit it to the Commission.

Member States implementing a surveillance programme in accordance with paragraph 1 shall submit regular reports on the results of the implementation of that programme to the Commission.

Article 29

Delegation of powers

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:

(a) the design, means, diagnostic methods, frequency, intensity, targeted animal population, and sampling patterns of the surveillance provided for in Article 27;

(b) the criteria for the official confirmation and case definitions of listed diseases as referred to in point (e) of Article 9(1), and, where relevant, of emerging diseases;

(c) the criteria used to establish the relevance of a disease which is to be subject to a surveillance programme relevant for the Union for the purposes of point (a) of Article 30(1), taking into account the disease profile and the risk factors involved;

(d) requirements for surveillance programmes as provided for in Article 28(1) regarding:
(i) the contents of surveillance programmes;
(ii) the information to be included in the submission of surveillance programmes in accordance with Article 28(2) and regular reports in accordance with Article 28(3);
(iii) the period of application of surveillance programmes.

Article 30

Implementing powers

The Commission shall, by means of implementing acts, lay down requirements concerning surveillance and surveillance programmes as provided for in Articles 26 and 28 and in the rules adopted pursuant to Article 29, as regards:

(a) establishing which of the listed diseases referred to in point (e) of Article 9(1) are to be subject to surveillance programmes in accordance with Article 28, including the geographical scope of such programmes;

(b) the format and procedure for:
(i) the submission of those surveillance programmes for information to the Commission and other Member States;
(ii) the reporting to the Commission on the results of the surveillance.

The Commission may, by means of implementing acts, lay down the criteria to be used for evaluating the surveillance programmes referred to in Article 28.

The implementing acts referred to in paragraphs 1 and 2 of this Article shall be adopted in accordance with the examination procedure referred to in Article 266(2).

CHAPTER 3 Eradication programmes

Article 31

Compulsory and optional eradication programmes

Member States which are not free, or not known to be free, from one or more of the listed diseases referred to in point (b) of Article 9(1) throughout their territory, or in zones or compartments thereof, shall:

(a) establish a programme for the eradication of, or demonstration of freedom from, that listed disease, to be carried out in the animal populations concerned by that disease and covering the relevant parts of their territory or the relevant zones or compartments thereof (‘compulsory eradication programme’), to apply until the conditions for the grant of disease–free status in the territory of the Member State or zone concerned, as provided for in Article 36(1), or compartment, as provided for in Article 37(2), are fulfilled;

(b) submit the draft compulsory eradication programme to the Commission for approval.

Member States which are not free, or not known to be free, from one or more of the listed diseases referred to in point (c) of Article 9(1) and which decide to establish a programme for the eradication of that listed disease, to be carried out in the animal populations concerned by the disease in question and covering the relevant parts of their territory or zones or compartments thereof (‘optional eradication programme’), shall submit a draft of that programme to the Commission for approval, where the Member State concerned asks for the recognition, within the Union, of animal health guarantees as regards the disease in question for movements of animals or products.

Such an optional eradication programme shall apply until:

(a) the conditions for the grant of disease–free status in the territory of the Member State or zone concerned, as provided for in Article 36(1), or compartment, as provided for in Article 37(2), are fulfilled; or

(b) it is established that the conditions for the grant of disease–free status cannot be achieved and that the programme no longer fulfils its purpose; or

The Commission shall, by means of implementing acts, approve:

(a) draft compulsory eradication programmes submitted to it for approval in accordance with paragraph 1;

(b) draft optional eradication programmes submitted to it for approval in accordance with paragraph 2,

if the conditions set out in this Chapter are met.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

On duly justified imperative grounds of urgency relating to a listed disease representing a risk having a highly significant impact, the Commission shall adopt immediately applicable implementing acts provided for in point (a) of paragraph 3 of this Article in accordance with the procedure referred to in Article 266(3).

The Commission may, for duly justified reasons, by means of implementing acts, approve an amendment proposed by the Member State concerned or withdraw the approval of eradication programmes approved in accordance with points (a) and (b) of paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

The Commission shall adopt delegated acts in accordance with Article 264 concerning:

(a) the disease control strategies, intermediate and final targets for specific diseases, and period of application of eradication programmes;

(b) derogations from the requirement for the submission of eradication programmes for approval, as provided for in point (b) of paragraph 1 of this Article and in paragraph 2 thereof, where such approval is not necessary due to the adoption of rules regarding those programmes in accordance with Articles 32(2) and 35;

(c) the information to be provided by Member States to the Commission and to the other Member States concerning derogations from the requirement for approval of eradication programmes as provided for in point (b) of this paragraph.

The Commission shall be empowered to adopt delegated acts in accordance with Article 264 amending or discontinuing rules adopted pursuant to point (b) of this paragraph.

Article 32

Measures under compulsory and optional eradication programmes

Eradication programmes shall consist of at least the following measures:

(a) disease control measures for the eradication of the disease agent from establishments, compartments and zones in which a disease occurs and to prevent re–infection;

(b) surveillance to be carried out in accordance with the rules laid down in Articles 26 to 30 to demonstrate:
(i) the effectiveness of the disease control measures provided for in point (a);
(ii) freedom from the listed disease;

The Commission shall adopt delegated acts in accordance with Article 264 concerning the following elements to ensure the effectiveness of eradication programmes:

(a) disease control measures as provided for in point (a) of paragraph 1;

(b) disease control measures to be taken to avoid re–infection of the targeted animal population with the disease in question in establishments, zones and compartments;

(c) surveillance design, means, diagnostic methods, frequency, intensity, targeted animal population and sampling patterns;

(d) disease control measures to be taken in the event of positive surveillance results for the listed disease as provided for in point (c) of paragraph 1;

(e) criteria for vaccination, where relevant and appropriate for the disease or species in question.

Article 33

Content of compulsory and optional eradication programmes submitted for approval to the Commission

Member States shall include the following information in applications for approval of compulsory and optional eradication programmes submitted to the Commission in accordance with Article 31(1) and (2):

(a) a description of the epidemiological situation of the listed disease covered by the compulsory or optional eradication programme in question;

(b) a description and demarcation of the geographical and administrative area or the compartment covered by the eradication programme;

(c) a description of the disease control measures of the eradication programme as provided for in Article 32(1) and in the rules adopted pursuant to Article 32(2);

(d) a description of the organisation, supervision and roles of the parties involved in the eradication programme;

(e) the estimated duration of the eradication programme;

(f) the intermediate targets of, and the disease control strategies for implementing, the eradication programme.

Article 34

Reporting

Member States implementing eradication programmes shall submit to the Commission:

(a) reports enabling the Commission to monitor achievement of the intermediate targets of the on-going eradication programmes as referred to in point (f) of Article 33;

(b) a final report after completion of the eradication programme in question.

Article 35

Implementing powers

The Commission shall, by means of implementing acts, lay down rules concerning the information, format and procedural requirements provided for in Articles 31 to 34 as regards:

(a) the submission of draft compulsory and draft optional eradication programmes for approval;

(b) performance indicators;

(c) reporting to the Commission and other Member States on the results of the implementation of compulsory or optional eradication programmes.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

CHAPTER 4 Disease–free status

Article 36

Disease–free Member States and zones

A Member State may apply to the Commission for approval of disease–free status for one or more of the listed diseases referred to in points (b) and (c) of Article 9(1), for one or more of the relevant animal species, for its entire territory or for one or more zones thereof, provided that one or more of the following conditions are fulfilled:

(a) none of the listed species for the disease covered by the application for disease–free status is present anywhere in the territory of the Member State concerned or in the relevant zone or zones covered by the application;

(b) the disease agent is known not to be able to survive in the entire territory of the Member State, or in the relevant zone or zones covered by the application, according to the criteria referred to in point (a)(ii) of Article 39;

(c) in the case of listed diseases only transmitted by vectors, none of the vectors are present, or they are known not to be able to survive in the entire territory of the Member State, or in the relevant zone or zones covered by the application, according to the criteria referred to in point (a)(ii) of Article 39;

(d) freedom from the listed disease has been demonstrated by:
(i) an eradication programme complying with the rules laid down in Article 32(1) and rules adopted pursuant to paragraph 2 of that Article; or
(ii) historical and surveillance data.

Applications by Member States for disease–free status shall include evidence demonstrating that the conditions for disease–free status laid down in paragraph 1 are fulfilled.

A Member State may in certain specific cases apply to the Commission for approval of disease–free status for one or more of the listed diseases referred to in point (a) of Article 9(1), and in particular for approval of non–vaccination status for the entire territory, or for one or more zones thereof, provided that the following conditions are fulfilled:

(a) freedom from the listed disease has been demonstrated by:
(i) an eradication programme complying with the rules laid down in Article 32(1) and rules adopted pursuant to paragraph 2 of that Article; or
(ii) historical and surveillance data;

(b) it has been demonstrated that vaccination against the disease would lead to costs which would exceed those resulting from maintaining freedom from disease without vaccination.

The Commission shall, by means of implementing acts, approve, subject to amendments where necessary, applications by Member States for disease–free status or non-vaccination status when the conditions referred to in paragraphs 1 and 2 and, as relevant, paragraph 3 are fulfilled.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 37

Compartments

A Member State may apply to the Commission for recognition of the disease–free status of compartments for listed diseases referred to in point (a) of Article 9(1), and for the protection of the disease–free status of such a compartment in the event of an outbreak of one or more of those listed diseases in its territory, provided that:

(a) the introduction of the listed disease or listed diseases covered by the application can be effectively prevented at compartment level, taking into account the disease profile;

(b) the compartment covered by the application is subject to a single common biosecurity management system designed to ensure the disease–free status of all establishments forming part of it; and

(c) the compartment covered by the application has been approved by the competent authority for the purposes of movements of animals and products thereof in accordance with:
(i) Articles 99 and 100 for compartments keeping terrestrial animals and products thereof;
(ii) Articles 183 and 184 for compartments keeping aquaculture animals and products thereof.

A Member State may apply to the Commission for recognition of the disease–free status of compartments for one or more of the listed diseases referred to in points (b) and (c) of Article 9(1), provided that:

(a) the introduction of the listed disease or listed diseases covered by the application can be effectively prevented at compartment level, taking into account the disease profile;

(b) one or more of the following conditions are complied with:
(i) the conditions laid down in Article 36(1) are fulfilled;
(ii) the establishments of the compartment covered by the application have started or resumed their activities and have established a common biosecurity management system designed to ensure the freedom from disease of that compartment;

(c) the compartment covered by the application is subject to a single common biosecurity management system designed to ensure the disease–free status of all establishments forming part of it; and

(d) the compartment covered by the application has been approved by the competent authority for the purposes of movements of animals and products thereof in accordance with:
(i) Articles 99 and 100 for compartments keeping terrestrial animals and products thereof;
(ii) Articles 183 and 184 for compartments keeping aquaculture animals and products thereof.

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