aim to ensure:

take into account:

kept and wild animals;

germinal products;

products of animal origin;

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

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

Decision No 1082/2013/EU;

Regulation (EC) No 999/2001;

Directive 2003/99/EC;

Regulation (EC) No 2160/2003.

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

germinal products from terrestrial animals;

products of animal origin from terrestrial animals.

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

products of animal origin from aquatic animals.

other animals;

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

the following listed diseases:

the listed diseases set out in the list in Annex II.

all of the following criteria:

at least one of the following criteria:

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

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

is diagnosed for the first time in the Union; or

is caused by an unrecognised or a previously unrecognised disease agent.

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

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

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

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

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:

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.

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:

For those listed diseases, the measures referred to in points (d) and (e) shall also apply, as relevant.

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:

For those listed diseases, the measures referred to in points (d) and (e) shall also apply, as relevant.

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:

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.

As regards listed diseases for which there is a need for surveillance within the Union, the following rules shall apply, as relevant:

The listed diseases referred to in points (a), (b) and (c) shall also be considered as listed diseases under this point.

as regards kept animals and products under their responsibility, be responsible for:

where appropriate, take such biosecurity measures regarding kept animals, and products under their responsibility, as are appropriate for:

where appropriate, take biosecurity measures regarding wild animals.

physical protection measures, which may include:

management measures, which may include:

animal diseases, including those that are transmissible to humans;

biosecurity principles;

the interaction between animal health, animal welfare and human health;

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

resistance to treatments, including antimicrobial resistance, and its implications.

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;

the type of production;

the tasks performed.

professional experience or training;

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

formal education;

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

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

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

play an active role in:

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.

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

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;

sufficiently trained veterinarians involved in performing the activities referred to in Article 12.

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

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;

activities related to:

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;

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.

biosecurity, biosafety and bio–containment measures;

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

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

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).

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;

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;

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.

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

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

the disease agent and, where relevant, the subtype;

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

the type and location of the outbreak;

any related outbreaks;

the animals involved in the outbreak;

any disease control measures taken in relation to the outbreak;

the possible or known origin of the listed disease;

the diagnostic methods used.

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

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:

the detection of the listed diseases referred to in paragraph 1;

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);

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);

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

the type of establishment;

the species and categories of kept animals on the establishment;

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

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

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.

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

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;

the format and procedure for:

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;

submit the draft compulsory eradication programme to the Commission for approval.

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

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

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

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;

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.

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;

surveillance to be carried out in accordance with the rules laid down in Articles 26 to 30 to demonstrate:

disease control measures to be taken in the event of positive surveillance results.

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

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;

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

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;

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

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;

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;

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;

freedom from the listed disease has been demonstrated by:

freedom from the listed disease has been demonstrated by:

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 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;

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

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:

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;

one or more of the following conditions are complied with:

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

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:

recognise, subject to amendments where necessary, the disease–free status of compartments, when the conditions laid down in paragraph 1 or paragraph 2 and in paragraph 3 are fulfilled;

determine for which of the listed diseases referred to in points (a), (b) and (c) of Article 9(1) the disease–free compartments may be established.

the requirements for recognition of the disease-free status of compartments as provided for in paragraphs 1 and 2 of this Article, based on the profile of the listed diseases referred to in points (a), (b) and (c) of Article 9(1), concerning at least:

the detailed rules for the approval by the competent authority of the disease–free status of compartments as provided for in paragraphs 1 and 2; and

rules concerning compartments which are located in the territory of more than one Member State.

the conditions for disease–free status laid down in Article 36(1) and Article 37(1) and (2), and rules laid down pursuant to paragraph 3 of this Article and Article 39, continue to be fulfilled;

surveillance, taking into account the requirements provided for in Article 27, is undertaken to verify that the territory, zone or compartment concerned continues to be free of the listed disease for which it was approved or recognised as having disease–free status;

restrictions are applied on movements of animals, and where relevant products derived therefrom, of listed species for the listed disease for which the disease–free status was approved or recognised, into the territory, zone or compartment concerned, in accordance with the rules laid down in Parts IV and V;

other biosecurity measures are applied to prevent the introduction of the listed disease for which it was approved or recognised as having disease–free status.

surveillance as provided for in point (b) of paragraph 1;

biosecurity measures as provided for in point (d) of paragraph 1.

where relevant, depending on the risk, suspend or restrict movements of the listed species, for the listed disease for which it was approved or recognised as having disease-free status, to other Member States, zones or compartments with a higher health status for that listed disease;

where relevant for the prevention of the spread of a listed disease for which disease–free status has been approved or recognised, apply the disease control measures provided for in Title II of Part III.

the suspected breach has not taken place; or

the suspected breach has not had a significant impact and the Member State concerned can provide assurances that the conditions for maintaining its disease–free status are again fulfilled.

the establishment of a chain of command within the competent authority and with other public authorities, to ensure a rapid and effective decision–making process at Member State, regional and local level;

the framework for cooperation between the competent authority and the other public authorities and relevant stakeholders involved, to ensure that actions are taken in a coherent and coordinated manner;

access to:

the availability of the following centres and groups with the necessary expertise to assist the competent authority:

implementation of the disease control measures provided for in Chapter 1 of Title II for the listed diseases referred to in point (a) of Article 9(1) and for emerging diseases;

provisions on emergency vaccination, where appropriate;

principles for the geographical demarcation of the restricted zones established by the competent authority in accordance with Article 64(1);

coordination with neighbouring Member States and neighbouring third countries and territories, where appropriate.

to ensure a high level of disease awareness and preparedness and the ability to launch a rapid response in the Member State concerned;

to verify the functionality of those contingency plans.

the frequencies of simulation exercises;

simulation exercises covering more than one listed disease referred to in point (a) of Article 9(1).

the disease profile;

the distribution of the listed disease in:

the availability and effectiveness of the veterinary medicinal products in question, and the risks attaching to them;

the availability of diagnostic tests for detecting infections in animals treated with the veterinary medicinal products concerned;

the economic, social, animal welfare and environmental impact of the use of the veterinary medicinal products concerned compared to other available disease prevention and control strategies.

prohibitions and restrictions on the use of veterinary medicinal products;

specific conditions for the use of veterinary medicinal products for a specific listed disease;

risk-mitigation measures to prevent the spread of listed diseases through animals treated with the veterinary medicinal products or products from such animals;

surveillance for specific listed diseases following the use of vaccines and other veterinary medicinal products.

antigens;

vaccines;

vaccine master seed–stocks;

diagnostic reagents.

store sufficient stocks of the appropriate type of antigens, vaccines, vaccine master seed–stocks and diagnostic reagents for the specific listed disease in question, taking into account the needs of Member States estimated in the context of the contingency plans provided for in Article 43(1);

receive regular supplies and timely replacements of antigens, vaccines, vaccine master seed–stocks and diagnostic reagents;

are maintained and moved in conformity with the appropriate biosecurity, biosafety and bio–containment requirements laid down in Article 16(1) and in accordance with delegated acts adopted pursuant to Article 16(2);

the management, storage and replacement of stocks of the Union antigen, vaccine and diagnostic reagent banks as provided for in paragraphs 1 and 2 of this Article;

the biosecurity, biosafety and bio–containment requirements for the operation of those banks, respecting the requirements provided for in Article 16(1) and taking into account the delegated acts adopted pursuant to Article 16(2).

in the first place, Member States; and

third countries or territories, provided that such delivery is primarily intended to prevent the spread of a disease into the Union.

the disease circumstances under which the request is made;

the existence of a national antigen, vaccine and diagnostic reagent bank in the requesting Member State or third country or territory;

the existence of Union measures for compulsory vaccination laid down in delegated acts adopted pursuant to Article 47.

which of those biological products are to be included in the Union antigen, vaccine and diagnostic reagent banks and for which of the listed diseases referred to in point (a) of Article 9(1);

the types of those biological products that are to be included in the Union antigen, vaccine and diagnostic reagent banks and in what quantities for each specific listed disease referred to in point (a) of Article 9(1) for which the bank in question exists;

the requirements concerning the supply, storage and replacement of those biological products;

the delivery of those biological products from the Union antigen, vaccine and diagnostic reagent banks to the Member States and to third countries and territories;

procedural and technical requirements for the inclusion of those biological products in the Union antigen, vaccine and diagnostic reagent banks and for requesting access to them.

the existence or the establishment of the national antigen, vaccine and diagnostic reagent banks referred to paragraph 1;

the types of antigens, vaccines, vaccine master-seed stocks and diagnostic reagents and the quantities thereof held in such banks;

any changes in the operation of such banks.

official veterinarians carry out a clinical examination of a representative sample of the kept animals of listed species for the listed disease in question;

official veterinarians take appropriate samples from those kept animals of listed species and other samples for examination in laboratories designated for that purpose by the competent authority;

such designated laboratories carry out examinations to confirm or rule out the presence of the listed disease in question.

place the establishment, food and feed business or animal by–products establishment concerned, or any other location where the disease is suspected of having occurred, including locations where the suspected disease may have originated, under official surveillance;

compile an inventory of:

ensure that appropriate biosecurity measures are applied to prevent the spreading of that listed disease agent to other animals or to humans;

when appropriate to prevent the further spread of the disease agent, ensure that the kept animals of listed species for that listed disease are isolated, and that they are prevented from coming into contact with wildlife;

restrict the movements of kept animals, products and, if appropriate, people, vehicles and any material or other means by which the disease agent could have spread to or from the establishment, food and feed business or animal by–products establishment, or from any other location where that listed disease is suspected, as far as necessary to prevent its spread;

take any other necessary disease control measures, taking into account the disease control measures provided for in Section 4 of this Chapter, concerning:

initiate the epidemiological enquiry provided for in Article 57(1).

the species or category of animals concerned;

the type of production concerned.

identify the likely origin of the listed disease in question and the means of its spread;

calculate the likely length of time that the listed disease has been present;

identify establishments and epidemiological units therein, food and feed businesses or animal by–products establishments, or other locations, where animals of listed species for the suspected listed disease may have become infected, infested or contaminated;

obtain information on the movements of kept animals, persons, products, vehicles, any material or other means by which the disease agent could have been spread during the relevant period preceding the notification of the suspicion or confirmation of the listed disease;

obtain information on the likely spread of the listed disease in the surrounding environment, including the presence and distribution of disease vectors.

the results of the clinical and laboratory examinations provided for in Article 54(2);

the preliminary or final results of the epidemiological enquiry provided for in Article 57(1);

other available epidemiological data.

the imposition of restrictions on movements of persons, animals, products, vehicles or any other material or substance that may be contaminated and contribute to the spread of the listed disease;

the killing and disposal or slaughtering of animals that may be contaminated or contribute to the spread of the listed disease;

the destruction, processing, transformation or treatment of products, feed, or any other substances, or the treatment of equipment, means of transport, plants or plant products, or water which may be contaminated, as appropriate to ensure that any disease agent or vector of the disease agent is destroyed;

the vaccination or treatment with other veterinary medicinal products of kept animals in accordance with Article 46(1) and Article 69 and any delegated acts adopted pursuant to Article 47;

the isolation, quarantine or treatment of animals and products that are likely to be contaminated and contribute to the spread of the listed disease;

the cleaning, disinfection, control of insects and rodents, or other necessary biosecurity measures to be applied to the affected establishment, food or feed business, animal by–products establishment or other locations to minimise the risk of spread of the listed disease;

the taking of a sufficient number of appropriate samples needed to complete the epidemiological enquiry provided for in Article 57(1);

the laboratory examination of samples;

any other appropriate measures.

the disease profile;

the type of production, and epidemiological units within the affected establishment, food or feed business, animal by–products establishment or other location;

all appropriate disease control measures and laboratory examinations provided for in paragraph 1 have been successfully completed;

a sufficient period of time has elapsed to prevent re–contamination of the affected establishment, food or feed business, animal by–products establishment or other location with the listed disease that caused the outbreak referred to in paragraph 1.

the disease profile;

the geographical situation of the restricted zone;

the ecological and hydrological factors of the restricted zone;

the meteorological conditions;

the presence, distribution and type of vectors in the restricted zone;

the results of the epidemiological enquiry provided for in Article 57(1) and other studies carried out and epidemiological data;

the results of laboratory tests;

the disease control measures applied;

other relevant epidemiological factors.

adapt the boundaries of the restricted zone;

establish additional restricted zones.

the identification of establishments, food or feed businesses, animal by–products establishments or other locations with kept animals of listed species for that listed disease;

visits to establishments, food or feed businesses, animal by–products establishments or other locations with kept animals of listed species for that listed disease, and, where necessary, examinations, sampling and laboratory examination of the samples taken;

the imposition of conditions for the movement of persons, animals, products, feed, vehicles and any other material or substance that may be contaminated or contribute to the spread of that listed disease within and from the restricted zone and transport through the restricted zone;

biosecurity requirements for:

the vaccination and treatment with other veterinary medicinal products of kept animals in accordance with Article 46(1) and any delegated acts adopted pursuant to Article 47;

cleaning, disinfection, control of insects and rodents, or other necessary biosecurity measures;

the designation or where relevant, approval of a food business establishment for the purposes of the slaughtering of animals or the treatment of products of animal origin originating from the restricted zone;

the identification and traceability requirements for the movement of animals, germinal products or products of animal origin;

other necessary biosecurity and risk-mitigating measures to minimise the risk of the spread of that listed disease.

take all necessary measures to fully inform persons in the restricted zone of the restrictions in force and the nature of the disease control measures;

impose the necessary obligations on operators in order to prevent the further spread of the listed disease in question.

the disease profile;

the types of production;

the feasibility, availability and effectiveness of those disease control measures.

the disease control measures appropriate to the listed disease referred to in point (a) of Article 9(1) for which they were applied have been carried out;

the final cleaning, disinfection, control of insects and rodents, or other necessary biosecurity measures has been carried out as appropriate for:

adequate surveillance, as appropriate for the listed disease referred to in point (a) of Article 9(1) for which the disease control measures have been applied, and for the type of establishment or location concerned, has been carried out in the restricted zone substantiating the eradication of that listed disease.

the final procedures for cleaning, disinfection, control of insects and rodents, or other necessary biosecurity measures and, where appropriate, the use of biocidal products for those purposes;

the design, means, methods, frequency, intensity, targeted animal population and sampling patterns of surveillance aimed at the restoration of disease–free status after the outbreak;

repopulation of the restricted zone concerned after the completion of the disease control measures provided for in paragraph 1 of this Article, taking into account the conditions for repopulation provided for in Article 61(3).

develop a vaccination plan;

establish vaccination zones.

the requirements for emergency vaccination set out in the contingency plans provided for in Article 43;

the requirements for the use of vaccines as provided for in Article 46(1) and any delegated acts adopted pursuant to Article 47.

conduct, where relevant for that particular listed disease, surveillance in the wild animal population;

take the necessary disease prevention and control measures.

criteria and procedures for surveillance pursuant to point (a) of paragraph 1 of this Article in the case of official confirmation of a listed disease as referred to in point (a) of Article 9(1), in accordance with Article 27;

detailed rules supplementing the disease prevention and control measures to be taken pursuant to point (b) of paragraph 1 of this Article in the case of official confirmation of a listed disease as referred to in point (a) of Article 9(1).

the particular epidemiological circumstances;

the type of establishments, other locations and production concerned;

the species and categories of animals involved;

economic or social conditions.

the disease control measures taken by their competent authority as provided for in Articles 58, 59, 61, 62, 64 and 65, Article 68(1), Article 69 and Article 70(1) and (2) and in any delegated acts adopted pursuant to Articles 63 and 67 and Articles 68(2) and 70(3);

any additional disease control measures taken by them as provided for in paragraph 1.

those disease control measures are found not to be suited to the epidemiological situation;

the listed disease referred to in point (a) of Article 9(1) appears to be spreading despite the disease control measures taken in accordance with this Chapter.

official veterinarians carry out a clinical examination of a representative sample of the kept animals of listed species for the listed disease in question;

official veterinarians take appropriate samples from those kept animals of listed species and other samples for examination in laboratories designated for that purpose by the competent authority;

such designated laboratories carry out examinations to confirm or rule out the presence of the listed disease in question.

apply disease control measures to limit the spread of that listed disease from the affected territory, establishment, food or feed business, animal by–products establishment or other location;

initiate, where necessary, an epidemiological enquiry, taking into account the rules for such enquiry laid down in Article 57(1).

the disease profile;

the kept animals affected;

the health status of the Member State, zone, compartment or establishment in which the listed disease is suspected;

the preliminary disease control measures provided for in Article 55(1) and Article 56 and in any delegated act adopted pursuant to Article 55(2).

the preliminary disease control measures to be taken to prevent the spread of the listed disease, as provided for in point (a) of paragraph 1;

the application of the preliminary disease control measures provided for in point (a) of paragraph 1 to other establishments, epidemiological units therein, food or feed businesses and animal by–products establishments or other locations;

the establishment of temporary restricted zones which are appropriate in light of the disease profile.

conduct without delay an investigation to confirm or rule out the presence of that listed disease in accordance with Article 73(1) and (2);

pending the results of the investigation provided for in point (a) and the carrying-out of disease control measures in accordance with Article 80(1), carry out the preliminary disease control measures provided for in Article 74(1) and (2).

the disease control measures provided for in paragraph 1;

the investigation provided for in point (a) of paragraph 2;

the preliminary disease control measures to be taken to prevent the spread of the listed disease, as provided for in point (b) of paragraph 2.

the results of the clinical and laboratory examinations provided for in Article 73(2);

the epidemiological enquiry provided for in point (b) of Article 74(1), where relevant;

other available epidemiological data.

the disease profile;

the kept animals affected;

economic and social impacts.

the disease profile;

the kept animals affected;

economic and social impacts.

the disease profile;

the affected wild animals and the risk of transmission of diseases to animals and humans; and

economic, social and environmental impacts.

the disease profile;

the affected wild animals and the risk of transmission of diseases to animals and humans;

the relevance of the presence of the disease in wild animals in relation to the health status of kept animals; and

economic, social and environmental impacts.

disease control measures taken by their competent authorities in accordance with Articles 77(1), 78, 79 and 81 and with any delegated acts adopted pursuant to Article 77(2) in respect of a listed disease as referred to in point (b) of Article 9(1);

disease control measures taken by their competent authorities in accordance with Articles 77(1), 78, 80(1) and 82 and with any delegated acts adopted pursuant to Article 77(2) in respect of a listed disease as referred to in point (c) of Article 9(1).

those disease control measures taken by the competent authority in question are found not to be suited to the epidemiological situation;

that listed disease appears to be spreading despite the disease control measures taken in accordance with this Chapter, where relevant.

inform the competent authority of any such establishment under their responsibility;

provide the competent authority with the following information:

any changes in the establishment in question concerning the matters referred to in point (b) of paragraph 1;

any cessation of activity by the operator or establishment concerned.

the species, categories and numbers of kept terrestrial animals and germinal products on the establishment in question and the capacity of that establishment;

the type of establishment; and

the movements of kept terrestrial animals or germinal products into and out of the establishment.

inform the competent authority of their activity;

provide that competent authority with information on:

any changes concerning the matters referred to in point (b) of paragraph 1;

any cessation of the transport activity.

the distances over which they transport the ungulates in question; and

the categories, species and number of ungulates which they transport.

the name and address of the operator concerned;

the species and categories of kept ungulates and poultry covered by their activity.

any changes concerning the matters referred to in paragraph 1;

any cessation of activity by the operator concerned.

establishments for assembly operations of ungulates and poultry from which those animals are moved to another Member State or which receive animals from another Member State;

germinal product establishments for bovine, porcine, ovine, caprine and equine animals from which germinal products of those animals are moved to another Member State;

hatcheries from which hatching eggs or poultry are moved to another Member State;

establishments keeping poultry from which poultry intended for purposes other than slaughter or hatching eggs are moved to another Member State;

any other type of establishment for kept terrestrial animals which poses a significant risk and is required to be approved in accordance with rules laid down in a delegated act adopted in accordance with point (b) of paragraph 3.

the competent authority withdraws or suspends its approval in accordance with Article 100(2); or

in the event of conditional approval, granted in accordance with Article 99(3), the establishment in question fails to comply with the outstanding requirements referred to in Article 99(3) and does not obtain a final approval in accordance with Article 97(1).

derogations from the requirement for operators of the types of establishments referred to in points (a) to (d) of paragraph 1 to apply to the competent authority for approval, where those establishments pose an insignificant risk;

the types of establishments which must be approved in accordance with point (e) of paragraph 1;

special rules for the cessation of activities for germinal product establishments as referred to in point (b) of paragraph 1.

the species and categories of kept terrestrial animals or germinal products in an establishment;

the number of species and number of kept terrestrial animals or germinal products kept in an establishment;

the type of establishment and type of production; and

the movements of kept terrestrial animals or germinal products into and out of those types of establishments.

the name and address of the operator concerned;

the location of the establishment concerned and a description of its facilities;

the categories, species and number of kept terrestrial animals or germinal products relevant for the approval which are kept on the establishment;

the type of establishment;

other aspects of the establishment, related to its specificity, which are relevant in determining the risk, if any, posed by it.

any changes in the establishments concerning the matters referred to in points (a), (b) or (c) of paragraph 1;

any cessation of activity by the operator or establishment concerned.

comply with the following requirements, where appropriate, in relation to:

have facilities and equipment that are:

do not pose an unacceptable risk as regards the spread of diseases, taking into account the risk-mitigation measures in place;

have adequately trained personnel for the activity of the establishment concerned;

have in place a system which enables the operator concerned to demonstrate to the competent authority compliance with points (a) to (d).

quarantine, isolation and other biosecurity measures as referred to in point (a)(i) of paragraph 1;

surveillance as referred to in point (a)(ii) of paragraph 1;

facilities and equipment as referred to in point (b) of paragraph 1;

responsibilities, competence and specialised training of personnel and veterinarians as provided for in point (d) of paragraph 1 for the activity of germinal products establishments and establishments for assembly operations of ungulates and poultry;

the necessary supervision by the competent authority of germinal products establishments and establishments for assembly operations of ungulates and poultry.

the risks posed by each type of establishment;

the species and categories of kept terrestrial animals relevant for the approval;

the type of production concerned;

typical movement patterns of the type of establishment and species and categories of animals kept in those establishments.

all establishments and operators registered with it pursuant to Article 93;

all establishments approved by it in accordance with Articles 97 and 99.

the species, categories, number and, where applicable, identification of kept terrestrial animals on their establishment;

movements of kept terrestrial animals into and out of their establishment, stating as appropriate:

the documents required to accompany kept terrestrial animals arriving at or leaving their establishment in accordance with point (b) of Article 112, point (b) of Article 113(1), point (c) of Article 114(1), point (b) of Article 115, point (b) of Article 117, Article 143(1) and (2), Article 164(2) and any rules adopted pursuant to Articles 118 and 120 and points (b) and (c) of Article 144(1);

mortality of kept terrestrial animals on their establishment;

biosecurity measures, surveillance, treatments, test results and other relevant information as appropriate for:

the results of any animal health visits required in accordance with Article 25(1).

make them immediately available to the competent authority on request;

retain them for a minimum period to be prescribed by the competent authority, which may not be less than three years.

has access to the computerised database referred to in Article 109 for the relevant species and the database already contains the information to be included in the records; and

has the up–to–date information entered directly into the computerised database.

the breed, age, identification and health status of donor animals used for the production of germinal products;

the time and place of collection, and the processing and storage, of germinal products collected, produced or processed;

the identification of the germinal products together with details of their place of destination, if known;

the documents required to accompany germinal products arriving at or leaving the establishment in question in accordance with Article 162 and Article 164(2) and any rules adopted pursuant to Article 162(3) and (4);

where relevant, the results of clinical and laboratory tests;

laboratory techniques used.

make them immediately available to the competent authority on request;

retain them for a minimum period to be prescribed by the competent authority, which may not be less than three years.

the establishments visited by them;

the categories, species and number of kept terrestrial animals transported by them;

the cleaning, disinfection and disinfestation of the means of transport used;

details of the documents accompanying the animals in question, including their document numbers.

in such a manner that they can be made immediately available to the competent authority on request;

for a minimum period to be prescribed by the competent authority, which may not be less than three years.

the species, categories, numbers and identification of kept terrestrial animals under their responsibility;

movements of kept terrestrial animals under their responsibility, stating as appropriate:

the documents required to accompany kept terrestrial animals moved under their responsibility in accordance with point (b) of Article 112, point (b) of Article 113(1), point (c) of Article 114(1), point (b) of Article 115, point (b) of Article 117, Article 143(1) and (2), Article 164(2) and any rules adopted pursuant to Articles 118 and 120 and points (b) and (c) of Article 144(1);

mortality of kept terrestrial animals under their responsibility; and

biosecurity measures, surveillance, treatments, test results and other relevant information as appropriate for the species and categories of kept terrestrial animals under their responsibility.

make the records referred to in paragraph 1 available to the competent authority on request;

retain those records for a minimum period to be prescribed by the competent authority, which may not be less than three years.

information to be recorded in addition to that provided for in Articles 102(1), 103(1), 104(1) and 105(1);

additional requirements for record-keeping in respect of germinal products collected, produced or processed in a germinal products establishment after that establishment ceased its activities.

the risks posed by each type of establishment or activity;

the species and categories of kept terrestrial animals or germinal products in the establishment concerned, or transported to or from that establishment;

the type of production on the establishment or the type of activity;

the typical movement patterns and categories of the animals concerned;

the number of kept terrestrial animals or volume of germinal products under the responsibility of the operator concerned.

the species or categories of kept terrestrial animals concerned;

the risk posed by that species or category.

the means to identify kept terrestrial animals individually or in groups;

identification documents, movement documents and other documents for identifying and tracing kept terrestrial animals as referred to in Article 110;

up–to–date records in establishments as provided for in points (a) and (b) of Article 102(1);

a computer database of kept terrestrial animals as provided for in Article 109(1).

ensures the efficient application of the disease prevention and control measures provided for in this Regulation;

facilitates the traceability of kept terrestrial animals and their movements within and between Member States and their entry into the Union;

ensures the efficient interoperability, integration and compatibility of the elements of that system;

ensures that the system, to the extent appropriate, is adapted to:

ensures a coherent approach in respect of the different animal species covered by the system.

use the whole or part of the system provided for in paragraph 1 for purposes other than those referred to in points (a) and (b) of paragraph 4;

integrate the identification documents, movement documents and other documents referred to in Article 110 with the animal health certificates or self–declaration document provided for in Article 143(1) and (2) and Article 151(1) and in any rules adopted pursuant to points (b) and (c) of Article 144(1) and Article 151(3) and (4);

designate another authority or authorise another body or a natural person to ensure the practical application of the identification and registration system provided for in paragraph 1 of this Article, including the issuing of identification documents and the drawing-up of models as provided for in points (a), (b) and (c) of Article 110(1).

the following information related to kept animals of the bovine species:

the following information related to kept animals of the ovine and caprine species:

the following information related to kept animals of the porcine species:

the following information related to kept animals of the equine species:

information related to kept terrestrial animals of species other than those referred to in points (a), (b), (c) and (d) of this paragraph, when this is provided for in the rules adopted pursuant to paragraph 2.

ensure the efficient application of the disease prevention measures and control measures provided for in this Regulation;

facilitate the traceability of kept terrestrial animals, their movements between Member States and their entry into the Union.

issue identification documents in respect of kept terrestrial animals where those documents are required by point (c) of Article 114(1) and point (b) of Article 117 and by rules adopted pursuant to Articles 118 and 120;

issue identification documents in respect of bovine animals as required by point (b) of Article 112, unless Member States exchange electronic data with other Member States within the framework of an electronic exchange system from the date when the Commission recognises the full operability of that system;

draw up models of movement documents and other documents for the identification and tracing of kept terrestrial animals, when required by point (b) of Article 113(1), point (b) of Article 115, point (b) of Article 117 and any rules adopted pursuant to Articles 118 and 120.

ensure that those kept animals are each identified by a physical means of identification;

ensure that those kept animals are accompanied by a correctly completed movement document based on the model drawn up by the competent authority in accordance with Article 110 when they are moved from the establishment keeping those animals within the Member State concerned;

transmit the information on movements of those kept animals from and to the establishment to the computer database provided for in Article 109(1).

the information contained in the relevant movement document is included in the computer database provided for in Article 109(1);

the system for the identification and registration of kept animals of the ovine and caprine species provides level of traceability equivalent to that provided by movement documents.

a unique code which is recorded in the computer database provided for in Article 109(1);

a physical means of identification or other method which unequivocally links the kept animal with the identification document provided for in point (c) of this paragraph and issued by the competent authority in accordance with Article 110;

a correctly completed single lifetime identification document.

detailed requirements for the means and methods of identification of kept terrestrial animals provided for in point (a) of Article 112, point (a) of Article 113(1), Article 114(1), point (a) of Article 115 and point (a) of Article 117, including their application and use;

rules on the information to be included in:

rules on the exchange of electronic data between computer databases of Member States as referred to in point (b) of Article 110(1).

detailed requirements for alternative means and methods of identification to those referred to in point (a) of paragraph 1 of this Article, as well as exemptions and special provisions for certain categories of animals or circumstances and conditions for such exemptions;

specific provisions for the identification or movement documents provided for in point (b) of Article 112, point (b) of Article 113(1), point (c) of Article 114(1), point (b) of Article 115 and point (b) of Article 117 that have to accompany animals when they are moved;

detailed requirements for the identification and registration of kept terrestrial animals of species other than the bovine, ovine, caprine, porcine and equine species where necessary, taking into account the risks posed by the species concerned, in order to:

rules on the information to be included in:

rules on the identification and registration of kept terrestrial animals as referred to in Articles 112 to 117 after their entry into the Union.

in cases where one or more of the elements listed in Article 108(3) are not necessary in order to meet the requirements provided for in points (a) and (b) of Article 108(4); and

when other traceability measures in place in the Member States guarantee that the level of traceability of the animals in question is not compromised,

the species and categories of kept terrestrial animals concerned;

the risks involved for those kept terrestrial animals;

the number of animals in the establishments concerned;

the type of production in the establishments where those terrestrial animals are kept;

movement patterns for the species and categories of kept terrestrial animals concerned;

considerations concerning the protection and conservation of the species of kept terrestrial animals concerned;

the performance of the other traceability elements of the system for the identification and registration of kept terrestrial animals referred to in Article 108(3).

for uniform access to data contained in, and the technical specifications and operational rules of, the computer databases referred to in points (a) to (d) of Article 109(1);

on the technical conditions and modalities for the exchange of electronic data between computer databases of Member States and the recognition of full operability of the data exchange systems referred to in point (b) of Article 110(1).

for the uniform application of the identification and registration system provided for in Article 108(1) for different species or categories of kept terrestrial animals, in order to ensure its efficient operation;

for the uniform application of point (c) of Article 108(5) concerning the authorised bodies or natural persons referred to in Article 108(5) and the conditions for their designation;

on the technical specifications and procedures, formats, design and operational rules for the means and methods of identification, including:

on the technical specifications, formats and operational rules for the identification and movement documents provided for in point (b) of Article 112, point (b) of Article 113(1), point (c) of Article 114(1), point (b) of Article 115 and point (b) of Article 117;

for uniform access to data contained in, and the technical specifications and operational rules of, the computer databases referred to in point (e) of Article 109(1);

on the deadlines, obligations and procedures for the transmission of information by operators or other natural or legal persons and for the registration of kept terrestrial animals in the computer databases;

on guidelines and procedures for electronic identification of animals, where relevant;

on the practical application of exemptions from the identification and registration requirements provided for in the rules adopted pursuant to Article 119(1).

the donor animals;

the date of collection; and

the germinal product establishments where they were collected, produced, processed and stored.

the efficient application of the disease prevention and control measures provided for in this Regulation;

the traceability of the germinal products, their movements within and between Member States and their entry into the Union.

the efficient application of the disease prevention and control measures provided for in this Regulation;

the traceability of those germinal products, their movements within and between Member States and their entry into the Union.

the species of kept terrestrial animals from which the germinal products originate;

the health status of donor animals;

the risk involved with such germinal products;

the type of germinal products;

the type of collection, production, processing or storage of germinal products;

the movement patterns for the relevant species and categories of kept terrestrial animals and their germinal products;

considerations concerning the protection and conservation of species of kept terrestrial animals;

other elements that may contribute to the traceability of germinal products.

the listed diseases referred to in point (d) of Article 9(1);

emerging diseases.

they come from establishments that have been:

they fulfil the identification and registration requirements laid down in Articles 112, 113, 114, 115 and 117 and the rules adopted pursuant to Articles 118 and 120.

the health status of kept terrestrial animals is not jeopardised during transport;

transport operations of kept terrestrial animals do not cause the potential spread of listed diseases as referred to in point (d) of Article 9(1) to humans and animals;

cleaning and disinfection of, and control of insects and rodents with respect to, equipment and means of transport and other adequate biosecurity measures are taken, as appropriate to the risks involved with the transport operations concerned.

the conditions and requirements for cleaning and disinfection of, and control of insects and rodents with respect to, equipment and means of transport and the use of biocidal products for those purposes;

other appropriate biosecurity measures as provided for in point (c) of paragraph 1 of this Article.

they show no disease symptoms;

they come from a registered or approved establishment:

they have not been in contact with kept terrestrial animals which are subject to movement restrictions as referred to in point (b)(ii) and (iii) or kept terrestrial animals of a listed species of a lower health status, for an adequate period of time prior to the date of the intended movement to another Member State, thereby minimising the possibility of spreading disease, taking into account the following matters:

they fulfil the relevant requirements provided for in Sections 3 to 8 (Articles 130 to 154).

check that:

check that the animal health certificates provided for in Article 143 and in any rules adopted pursuant to points (b) and (c) of Article 144(1) or the self–declaration documents provided for in Article 151 and the rules adopted pursuant to Article 151(3) and (4) are in place;

inform the competent authority of the place of destination, after checking the kept terrestrial animals received, of any irregularity with regard to:

residency periods as referred to in point (b) of Article 130;

the period of time necessary in order to limit the introduction of kept ungulates or poultry into establishments prior to movement as provided for in point (c) of Article 130;

supplementary requirements to ensure that kept ungulates and poultry do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1), as provided for in point (d) of Article 130);

other necessary risk-mitigation measures supplementing the requirements laid down in Article 130.

the listed diseases referred to in point (d) of Article 9(1) relevant for the listed species or the category of kept ungulates or poultry to be moved;

the health status as regards listed diseases referred to in point (d) of Article 9(1) in the establishments, compartments, zones and Member States of origin and destination;

the type of establishment concerned and the type of production at the places of origin and destination;

the type of movement concerned;

the species and categories of kept ungulates or poultry to be moved;

the age of the kept ungulates or poultry to be moved;

other epidemiological factors.

the listed diseases referred to in point (d) of Article 9(1) relevant for the listed species or the category of kept terrestrial animals to be moved;

the health status as regards the listed diseases referred to in point (d) of Article 9(1) in the establishments, compartments, zones and Member States of origin and the place of destination;

the types of establishment and the types of production at the place of origin and the place of destination;

the types of movement in respect of the final use of animals at the place of destination;

the species and categories of kept terrestrial animals to be moved;

the age of the kept terrestrial animals to be moved;

other epidemiological factors.

they originate from another confined establishment;

they do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) to listed species or to categories of animals at the confined establishment of destination, except where the movement in question is authorised for scientific purposes.

detailed rules for movements of kept terrestrial animals into confined establishments in addition to those provided for in paragraph 1 of this Article;

specific rules for movements of kept terrestrial animals into confined establishments where the risk-mitigation measures in place guarantee that such movements do not pose a significant risk for the health of kept terrestrial animals within that confined establishment and the surrounding establishments.

the competent authorities of the places of destination and origin:

those movements of those animals take place under the supervision of the competent authorities of the places of origin and destination, and where relevant, the competent authorities of the Member States of passage.

recreational use near borders;

exhibitions, and sporting, cultural and similar events, organised near borders;

grazing of kept terrestrial animals in grazing areas shared between Member States; or

work done by kept terrestrial animals near borders of Member States.

the movement requirements provided for in Article 130, Article 132(1), Articles 133 and 134, Articles 136(1), 137(1) and 138(1) and (2) and Article 139 and the rules adopted pursuant to Articles 131(1) and 132(2), Article 135, Articles 136(2), 137(2), 138(3) and 139(4) and Article 140 are not effectively mitigating the risks posed by the movement of such animals; or

a listed disease as referred to in point (d) of Article 9(1) appears to be spreading despite the movement requirements laid down in accordance with Sections 1 to 6 (Articles 124 to 142).

ungulates;

poultry;

kept terrestrial animals other than ungulates and poultry, intended for a confined establishment;

kept terrestrial animals other than those referred to in points (a), (b) and (c) of this paragraph, when required in accordance with delegated acts adopted pursuant to point (c) of Article 144(1).

derogations from the animal health certification requirements provided for in Article 143(1), for movements of kept terrestrial animals which do not pose a significant risk for the spread of a disease on account of:

special rules for animal health certification as provided for in Article 143(1) where specific risk-mitigation measures concerning surveillance or biosecurity are taken, taking into account the matters provided for in paragraph 2 of this Article, which ensure:

the requirement for animal health certification for movements of species and categories of kept terrestrial animals other than those referred to in points (a), (b) and (c) of Article 143(1) in cases where animal health certification is imperative in order to ensure that the movement in question complies with the animal health requirements for movements provided for in Sections 1 to 6 (Articles 124 to 142).

the assessment by the competent authority of the biosecurity put in place by operators as provided for in point (b) of Article 10(1) and any rules adopted pursuant Article 10(6);

the ability of the competent authority, in so far as may be necessary and appropriate, to take measures and to engage in activities required by this Regulation as provided for in Article 13(1);

the level of knowledge of animal health as provided for in Article 11 and the encouragement thereof provided for in Article 13(2);

the carrying-out of the animal health visits provided for in Article 25 or other relevant surveillance or official controls in place;

the performance by the competent authority of its obligations under the Union notification and reporting system provided for in Articles 19 to 22 and in the rules adopted pursuant to Article 20(3) and Article 23;

the application of surveillance as provided for in Article 26 and surveillance programmes as provided for in Article 28 and in any rules adopted pursuant to Articles 29 and 30.

the establishment or place of origin, the establishment or place of destination and, where relevant, establishments for assembly operations or for rests, of the kept terrestrial animals concerned;

the means of transport and the transporter;

a description of the kept terrestrial animals;

the number of kept terrestrial animals;

the identification and registration of kept terrestrial animals, where required by Articles 112, 113, 114, 115 and 117 and by any rules adopted pursuant to Articles 118 and 120, unless derogations are provided for in accordance with Article 119; and

the information needed to demonstrate that the kept terrestrial animals fulfil the relevant animal health requirements in respect of movements provided for in Sections 1 to 6 (Articles 124 to 142).

detailed rules on the content of animal health certificates as provided for in Article 145(1) for different species and categories of kept terrestrial animals and for specific types of movements as provided for in the rules adopted pursuant to Article 147;

additional information to be contained in the animal health certificate provided for in Article 145(1).

those provided for in Article 124, Article 125(1), Articles 126, 128, 129, 130, 133 and 134, Articles 136(1) and 137(1), Article 138 and Article 139;

those provided for in delegated acts adopted pursuant to Articles 125(2) and 131(1), Article 135, Articles 136(2), 137(2), 138(3) and 139(4) and Article 140;

those provided for in implementing acts adopted pursuant to Article 141.

be verified, stamped and signed by an official veterinarian;

remain valid for the period of time provided for in the rules adopted pursuant to point (c) of paragraph 4, during which the kept terrestrial animals covered by it continue to fulfil the animal health guarantees contained in it.

the types of documentary, identity and physical checks and examinations in relation to different species and categories of kept terrestrial animals that must be carried out by the official veterinarian in accordance with paragraph 3 in order to verify compliance with the requirements of this Chapter;

the timeframes for the carrying-out of such documentary, identity and physical checks and examinations and the issuing of animal health certificates by the official veterinarian prior to the movement of consignments of kept terrestrial animals;

the duration of the validity of animal health certificates.

their place of origin, their place of destination and, when relevant, any places of assembly or rest;

the means of transport and the transporter;

a description of the kept terrestrial animals, their species, category and quantity;

identification and registration where required in accordance with Articles 112, 113, 114 and 115, point (a) of Article 117 and any rules adopted pursuant to Articles 118 and 120;

the information needed to demonstrate that the kept terrestrial animals fulfil the animal health requirements for movements provided for in Sections 1 to 6 (Articles 124 to 142).

detailed rules on the content of the self–declaration document provided for in paragraph 2 of this Article for different species and categories of animals;

information to be contained in the self–declaration document in addition to that provided for in paragraph 2 of this Article.