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) - Main contents

EN

Official Journal of the European Union

L 84/1

The impact of transmissible animal diseases and the measures necessary to control those diseases can be devastating for individual animals, animal populations, animal keepers and the economy.

As recent experiences have demonstrated, transmissible animal diseases may also have a significant impact on public health and food safety.

In addition, adverse interactive effects can be observed with regard to biodiversity, climate change and other environmental aspects. Climate change may influence the emergence of new diseases, the prevalence of existing diseases and the geographic distribution of disease agents and vectors, including those affecting wildlife.

In order to ensure high standards of animal and public health in the Union and the rational development of the agriculture and aquaculture sectors, and to increase productivity, animal health rules should be laid down at Union level. Those rules are necessary in order, inter alia, to contribute to the completion of the internal market and to avoid the spread of infectious diseases. Those rules should also ensure, as far as possible, that the existing animal health status in the Union is maintained and that consequent improvement of that status is supported.

The current Union legislation on animal health consists of a series of linked and interrelated basic acts that lay down rules on animal health applying to intra–Union trade, entry into the Union of animals and products, disease eradication, veterinary controls, notification of diseases and financial support in relation to different animal species, but an overarching legal framework, laying down harmonised principles across the sector, is missing.

Financial rules relating to the support of animal health objectives are provided for in Regulation (EU) No 652/2014 of the European Parliament and of the Council (3) and do not form part of this Regulation. In addition, the rules covering the official controls of animal health measures provided for in Regulation (EC) No 882/2004 of the European Parliament and of the Council (4) and in Council Directives 89/662/EEC (5), 90/425/EEC (6), 91/496/EEC (7) and 97/78/EC (8) should be used to regulate official controls in the area of animal health.

This Regulation does not contain provisions which regulate animal welfare. However, animal health and welfare are linked: better animal health promotes better animal welfare, and vice versa. When disease prevention and control measures are carried out in accordance with this Regulation, their effect on animal welfare, understood in the light of Article 13 of the Treaty on the Functioning of the European Union (TFEU), should be considered in order to spare the animals concerned any avoidable pain, distress or suffering. Animal welfare legislation, such as Council Regulations (EC) No 1/2005 (9) and (EC) No 1099/2009 (10), should necessarily continue to apply and should be properly implemented. The rules laid down in this Regulation should not duplicate, or overlap with, the rules laid down in that legislation.

The Commission's communication of 19 September 2007 on a new Animal Health Strategy for the European Union (2007-2013) where ‘Prevention is better than cure’ aims to promote animal health by placing greater emphasis on preventive measures, disease surveillance, disease control and research, in order to reduce the incidence of animal diseases and minimise the impact of outbreaks when they do occur. It proposes the adoption of a single and simplified regulatory framework for animal health seeking convergence with international standards while ensuring a firm commitment to high standards of animal health.

The aim of this Regulation is to implement the commitments and visions provided for in that Animal Health Strategy, including the ‘One health’ principle, and to consolidate the legal framework for a common Union animal health policy through a single, simplified and flexible regulatory framework for animal health.

Animals may suffer from a broad range of infectious or non–infectious diseases. Many diseases can be treated, or have an impact only on the individual animal concerned, or do not spread to other animals or to humans. On the other hand, transmissible diseases may have a broader impact on animal or public health, with effects felt at population level. The animal health rules laid down in this Regulation should be limited to those latter diseases alone.

In laying down those animal health rules, it is essential that consideration be given to the links between animal health and public health, the environment, food and feed safety, animal welfare, food security, economic, social and cultural aspects.

The Sanitary and Phytosanitary Measures (SPS) Agreement, to which the Union is a party, regulates the use of measures necessary to protect human, animal or plant life or health so that they do not arbitrarily or unjustifiably discriminate between World Trade Organisation (WTO) members. If international standards exist, they are required to be used as a basis for Union measures. However, the parties to the SPS Agreement have the right to set their own relevant standards, provided that such standards are based on scientific evidence.

As regards animal health, the SPS Agreement refers to the standards of the World Organisation for Animal Health (OIE) relating to animal health conditions for international trade. In order to reduce the risk of trade disruption, Union animal health measures should aim at an appropriate level of convergence with OIE standards.

In specific circumstances where a significant animal or public health risk exists but scientific uncertainty persists, Article 5(7) of the SPS Agreement, which has been interpreted for the Union in the Commission communication of 2 February 2000 on the precautionary principle, allows members of that Agreement to adopt provisional measures on the basis of available pertinent information. In such circumstances, the member concerned is required to obtain the additional information necessary for a more objective assessment of risk and to review the measure accordingly within a reasonable period of time.

The risk assessment on the basis of which the measures under this Regulation are taken should be based on the available scientific evidence and undertaken in an independent, objective and transparent manner. Due account should also be taken of the opinions of the European Food Safety Authority (EFSA) established by Article 22(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (11).

Regulation (EC) No 1069/2009 of the European Parliament and the Council (12) lays down both public and animal health rules for certain animal by–products and derived products in order to prevent and minimise risks to public and animal health arising from those products, and in particular to protect the safety of the food and feed chain. In order to avoid any overlap of Union legislation, this Regulation should therefore only apply to animal by-products and derived products where specific rules are not laid down in Regulation (EC) No 1069/2009, and where an animal health risk is involved. For instance, Regulation (EC) No 1069/2009 does not regulate how to handle animal by–products and derived products in the context of disease control measures, and so those issues are duly covered by this Regulation.

In addition, specific rules on transmissible animal diseases, including those transmissible to humans (‘zoonoses’), are already laid down in Regulation (EC) No 999/2001 of the European Parliament and of the Council (13), Directive 2003/99/EC of the European Parliament and of the Council (14) and Regulation (EC) No 2160/2003 of the European Parliament and of the Council (15), and specific rules on communicable diseases in humans are laid down in Decision No 1082/2013/EU of the European Parliament and of the Council (16). Those acts should remain in force following the adoption of this Regulation. Accordingly, in order to avoid any overlap of Union legislation, this Regulation should only apply to zoonoses to the extent that specific rules are not already laid down in those other Union acts. In addition, this Regulation applies without prejudice to the rules provided for in other Union legislative acts, such as in the fields of veterinary medicine and animal welfare.

Diseases occurring in animals which are kept by humans can have severe impacts on the agriculture and aquaculture sectors, on public health, on the environment and on biodiversity. However, as such animals are kept by humans, disease prevention and control measures are often easier to apply to them than to wild animals.

Nevertheless, diseases occurring in wild animal populations may have a detrimental effect on the agriculture and aquaculture sectors, on public health, on the environment and on biodiversity. It is therefore appropriate that the scope of this Regulation should, in such cases, cover wild animals, both as potential victims of those diseases and as their vectors. For the purposes of this Regulation, the term ‘wild animals’ covers all animals that are not kept by humans, including stray and feral animals, even if they are of species that are normally domesticated.

Animal diseases are not only transmitted through direct contact between animals or between animals and humans. They are also carried further afield through water and air systems, vectors such as insects, or the semen, oocytes and embryos used in artificial insemination, oocyte donation or embryo transfer. Disease agents may also be contained in food and other products of animal origin such as leather, fur, feathers, horn and any other material derived from the body of an animal. Moreover, various other objects such as transport vehicles, equipment, fodder and hay and straw may diffuse disease agents. Therefore, effective animal health rules need to cover all paths of infection and material involved therein.

Animal diseases may have detrimental effects on the distribution of animal species in the wild, and thus affect biodiversity. Microorganisms causing such animal diseases can therefore be considered as invasive alien species within the framework of the United Nations Convention on Biological Diversity. The measures provided for in this Regulation also take account of biodiversity and thus this Regulation should cover animal species and disease agents, including those defined as invasive animal species, which play a role in the transmission of, or are affected by, diseases covered by this Regulation.

Union legislation adopted prior to this Regulation lays down separate animal health rules for terrestrial and aquatic animals. Council Directive 2006/88/EC (17) lays down specific rules for aquatic animals. Yet in most cases, the main principles for good animal health governance and good animal husbandry are applicable to both groups of animal species. Accordingly, this Regulation should cover both terrestrial and aquatic animals and should align those animal health rules where applicable. However, for certain aspects, in particular the registration and approval of establishments and the traceability and movements of animals within the Union, this Regulation adheres to the approach adopted in the past, which was to lay down different sets of animal health rules for terrestrial and aquatic animals due to their different environments and accordingly different requirements to safeguard health.

Union legislation adopted prior to this Regulation, and in particular Council Directive 92/65/EEC (18), also lays down basic animal health rules for other animal species not regulated in other Union acts, such as reptiles, amphibians, marine mammals, and others which are not aquatic or terrestrial animals as defined in this Regulation. Usually, such species do not present a significant health risk for humans or other animals and therefore only a few animal health rules, if any, apply. In order to avoid unnecessary administrative burdens and costs, this Regulation should adhere to the approach adopted in the past, namely to provide the legal framework enabling detailed animal health rules to be laid down for movements of such animals and their products if the risks involved so require.

Humans often keep certain animals as pets in their households to keep them company. The keeping of such pet animals for purely private purposes, including ornamental aquatic animals in households, both indoors and outdoors, generally poses a lower health risk compared to other ways of keeping or moving animals on a broader scale, such as those common in agriculture, aquaculture, animal shelters and the transport of animals more generally. Therefore, it is not appropriate that the general requirements concerning registration, record keeping and movements within the Union should apply to such pet animals, as this would represent an unjustified administrative burden and cost. Registration and record keeping requirements should therefore not apply to pet keepers. In addition, specific rules should apply to non–commercial movements of pet animals within the Union.

Some defined groups of animals, for which special animal health rules exist in this Regulation, need to be listed as species in an annex, due to the varied nature of the group concerned. This is the case for the group of hoofed mammals classified as ungulates. The list of such animals may need to be changed in the future due to reasons of changed taxonomy. Therefore, in order to take account of such changes, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the list of ungulates set out in Annex III to this Regulation.

Not all transmissible animal diseases can or should be prevented and controlled through regulatory measures, for example if the disease is too widespread, if diagnostic tools are not available, or if the private sector can take measures to control the disease by itself. Regulatory measures to prevent and control transmissible animal diseases may have important economic consequences for the relevant sectors and may disrupt trade. It is therefore essential that such measures are applied only when they are proportionate and necessary, such as when a disease presents, or is suspected to present, a significant risk to animal or public health.

Furthermore, the preventive and control measures for each transmissible animal disease should be ‘tailor–made’ in order to address its unique epidemiological profile, its consequences and its distribution within the Union. The preventive and control rules applying to each of them should therefore be disease-specific.

For transmissible animal diseases, a disease condition is usually associated with clinical or pathological manifestation of the infection. However, for the purpose of this Regulation, which aims to control the spread of, and eradicate, certain transmissible animal diseases, the disease definition should be wider in order to include other carriers of the disease agent.

Some transmissible animal diseases do not easily spread to other animals or to humans and thus do not cause economic or biodiversity damage on a wide scale. Therefore, they do not represent a serious threat to animal or public health in the Union and can thus, if desired, be addressed by means of national rules.

For transmissible animal diseases that are not subject to measures laid down at Union level, but which are of some economic importance for the private sector at a local level, the latter should, with the assistance of the competent authorities of the Member States, take action to prevent or control such diseases, for instance through self–regulatory measures or the development of codes of practice.

In contrast to the transmissible animal diseases described in recitals 29 and 30, highly transmissible animal diseases may easily spread across borders and, if they are also zoonoses, they may also have an impact on public health and food safety. Hence highly transmissible animal diseases and zoonoses should be covered by this Regulation.

Antimicrobial resistance, understood as the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to inhibit or kill microorganisms of the same species, is increasing. Action No 5 advocated in the Communication from the Commission to the European Parliament and the Council entitled ‘Action plan against the rising threats from antimicrobial resistance’ emphasises the preventive role to be played by this Regulation and the consequent expected reduction of the use of antibiotics in animals. This resistance of microorganisms to antimicrobials to which they were previously responsive complicates the treatment of infectious diseases in humans and animals and may thus pose a threat to human or animal health. As a result, microorganisms that have developed resistance to antimicrobials should be treated as if they were transmissible diseases, and thus covered by the scope of this Regulation. This will enable action to be taken against antimicrobial-resistant organisms where appropriate and necessary.

New hazards associated with certain diseases or species may develop in particular due to changes in trade patterns, the environment, the climate, animal husbandry and farming traditions, but also as a result of social changes. Scientific progress may also lead to new knowledge concerning, and increased awareness of, existing diseases. Furthermore, diseases and species that are important today may be marginalised in the future. Therefore the scope of this Regulation should be broad and the rules laid down should be focused on diseases with high public relevance. The OIE has, with the support of the European Commission, produced a study on the ‘Listing and categorisation of priority animal diseases, including those transmissible to humans’ and a tool for such an exercise, which aims to develop a system of disease prioritisation and categorisation. That tool is an example of a systematic approach to the collection and assessment of information about animal diseases.

It is necessary to establish a harmonised list of transmissible animal diseases (‘listed diseases’) which pose a risk to animal or public health in the Union, whether across the whole Union or only in parts. The five diseases already identified in this Regulation should be supplemented by a list of diseases set out in an annex. The Commission should review and amend that annex in accordance with a set of criteria. The power to adopt acts amending the annex should therefore be delegated to the Commission in accordance with Article 290 TFEU.

Diseases with the potential to pose serious risks to public or animal health and to result in impacts on health, the economy or the environment may emerge in the future. Implementing powers to lay down disease prevention and control measures for such emerging diseases should be conferred on the Commission to adopt adequate measures to address potential negative consequences of those diseases even if they have not been fully assessed in view of their potential listing. Such measures are without prejudice to emergency measures and could continue to apply to emerging diseases pending a decision on their listing.

Listed diseases will require different management approaches. Some highly contagious diseases which are currently not present in the Union require stringent measures to immediately eradicate them as soon as they occur. In cases where such diseases are not promptly eradicated and become endemic, a long-term compulsory eradication programme will be required. For other diseases that may already be present in parts of the Union, compulsory or optional eradication is required. In these cases, it is appropriate to put in place restrictions on movements of animals and products, such as a prohibition of movements to and from affected areas, or simply to test the animals or products concerned prior to dispatch. In other instances it might be appropriate merely to implement a programme of surveillance of the distribution of the disease in question, without taking further measures.

Criteria should be laid down to ensure that all relevant aspects are considered when determining which transmissible animal diseases should be listed for the purposes of this Regulation.

The rules laid down by this Regulation for the prevention and control of a specific transmissible animal disease should apply to species of animals which can transmit the disease in question, by virtue of being susceptible to it or by acting as its vector. In order to ensure uniform conditions for the implementation of this Regulation, it is necessary to establish a harmonised list of species to which the measures for specific listed diseases are to apply at Union level (‘listed species’) and implementing powers to lay down such a list should thus be conferred on the Commission.

The categorisation process should be based on predefined criteria such as the profile of the listed disease in question, the level of its impact on animal and public health, animal welfare and the economy of the Union, the risk of its spreading and the availability of disease prevention and control measures in respect of that listed disease. Implementing powers should be conferred on the Commission to lay down which listed diseases are to be subject to which rules.

Such rules should apply as regards listed diseases that do normally not occur in the Union and for which immediate eradication measures need imperatively to be taken as soon as they are detected, such as classical swine fever, as regards listed diseases that need to be controlled in all Member States with the goal of eradicating them throughout the Union, which could include diseases such as brucellosis, 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 free of, or that have eradication programmes for that, listed disease, which could include diseases such as infectious bovine rhinotracheitis, 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, which could include diseases such as equine infectious anaemia, and as regards listed diseases for which there is a need for surveillance within the Union, which could include diseases such as anthrax.

The disease profile of a given disease may change, as well as the risks associated with the disease and other circumstances. For such cases, the implementing powers conferred on the Commission should also include the power to modify the category into which a particular listed disease falls, and therefore the measures to which it is subject.

Operators working with animals are in the best position to observe and ensure the health of the animals and to monitor products under their responsibility. They should therefore bear primary responsibility for carrying out measures for the prevention and control of the spread of diseases among animals and the monitoring of products under their responsibility.

Biosecurity is one of the key prevention tools at the disposal of operators and others working with animals to prevent the introduction, development and spread of transmissible animal diseases to, from and within an animal population. The role of biosecurity is also recognised in the impact assessment for the adoption of this Regulation, in which possible impacts are specifically assessed. The biosecurity measures adopted should be sufficiently flexible, suit the type of production and the species or categories of animals involved and take account of the local circumstances and technical developments. Implementing powers should be conferred on the Commission to lay down minimum requirements necessary for the uniform application of biosecurity measures in the Member States. Nevertheless, it should always remain within the power of operators, Member States or the Commission to promote prevention of transmissible diseases through higher biosecurity standards by developing their own guides to good practice. While biosecurity may require some upfront investment, the resulting reduction in animal disease should be a positive incentive for operators.

Biocidal products, such as disinfectants for veterinary hygiene or food and feed areas, insecticides, repellents or rodenticides, play an important role in biosecurity strategies, both at farm level and during animal transport. They should therefore be considered part of biosecurity.

Knowledge of animal health, including of disease symptoms, consequences of diseases and possible means of prevention including biosecurity, treatment and control, is a prerequisite for efficient animal health management and essential in ensuring the early detection of animal diseases. Operators and animal professionals should therefore acquire such knowledge as appropriate. That knowledge may be acquired by different means, for example formal education, but also through the Farm Advisory System existing in the agricultural sector or by informal training to which national and Union farmer organisations and other organisations may be valuable contributors.

Veterinarians and aquatic animal health professionals play a crucial role in all aspects of animal health management, and general rules concerning their roles and responsibilities should be laid down in this Regulation.

Veterinarians have the education and the professional qualifications attesting to their having acquired the knowledge, skills and competencies necessary, inter alia, to diagnose diseases and treat animals. In addition, in some Member States for historical reasons, or due to the lack of veterinarians dealing with aquatic diseases, there exists a specialised profession called ‘aquatic animal health professionals’. These professionals are traditionally not veterinarians but they practice aquatic animal medicine. This Regulation should therefore respect the decision of those Member States which recognise that profession. In those cases, aquatic animal health professionals should have the same responsibilities and obligations as veterinarians concerning their specific area of work. This approach is in line with the OIE Aquatic Animal Health Code.

Member States, and in particular their competent authorities responsible for animal health, are amongst the key actors in the prevention and control of transmissible animal diseases. The competent authority for animal health plays an important role in relation to surveillance, eradication, disease control measures, contingency planning and raising disease awareness, in the facilitation of animal movements, and in international trade by the issuing of animal health certificates. In order to be able to perform their duties under this Regulation, Member States depend on having access to adequate financial, infrastructural and personnel resources throughout their territories, including laboratory capacity and scientific and other relevant know–how.

The competent authority cannot always perform all the activities required to be carried out by them under this Regulation due to limited resources. For that reason, it is necessary to provide a legal basis for the delegation of the performance of certain activities to veterinarians who are not official veterinarians. For the same reason, Member States should also be allowed to authorise natural or legal persons to perform certain activities under certain conditions.

In order to ensure that the necessary conditions are laid down for the general application of disease prevention and control measures across the Union, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the delegation of the performance of other activities which the competent authority may delegate to veterinarians other than official veterinarians.

Optimal animal health management can only be achieved in cooperation with animal keepers, operators, veterinarians, animal health professionals, other stakeholders and trading partners. In order to secure their support, it is necessary to organise decision-making procedures and the application of the measures provided for in this Regulation in a clear, transparent and inclusive manner.

The competent authority should also take appropriate steps to keep the public informed, especially when there are reasonable grounds to suspect that animals or products may present a risk for animal or public health or when a case is of public interest. In those cases, the animals or products concerned may originate from within the Union or enter the Union from outside. The latter may also be brought into the Union by persons travelling from outside the Union with their personal luggage. Thus, the information provided to citizens should also cover the risks involved with such situations.

In order to avoid the release of disease agents from laboratories, institutes and other facilities handling disease agents, it is vital that they take appropriate biosecurity, biosafety and bio–containment measures. This Regulation should therefore provide for safety measures to be observed during the handling or transportation of such disease agents, vaccines and other biological products. The obligation imposed in that regard should also apply to any legal or natural person who is involved in such an activity. In order to ensure that safety standards are respected in the handling of highly contagious biological agents, vaccines and other biological products, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the safety measures in those laboratories, institutes and facilities and for movements of disease agents.

Early detection and a clear chain of disease notification and reporting are crucial for effective disease control. In order to achieve an efficient and quick response, Member States should ensure that any suspicion or confirmation of an outbreak of certain listed diseases should be immediately notified to the competent authority.

Veterinarians are key actors in the investigation of diseases and a key link between operators and the competent authority. They should therefore be notified by the operator concerned in cases of abnormal mortalities, other serious disease problems, or significantly decreased production rates with an undetermined cause.

In order to ensure the effective and efficient notification of, and to clarify different circumstances related to, abnormal mortalities and other signs of serious diseases, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of criteria to determine when relevant circumstances for notification occur and to lay down the rules for further investigation, where this is relevant.

For certain listed diseases, it is vital that a Member State should immediately notify the Commission and the other Member States about an outbreak in its territory. Such notification will enable neighbouring or other affected Member States to take precautionary measures when appropriate.

On the other hand, for some diseases immediate notification and action are not necessary. In those cases, the gathering of information and reporting in relation to the occurrence of those diseases is essential in order to control the disease situation and where necessary to take disease prevention and control measures. This reporting requirement may also apply to diseases which are subject to Union-wide notification but where additional information is needed for the implementation of effective disease prevention and control measures. In order to ensure that the correct information and data needed to prevent the spread or to control each particular disease are collected in the right timeframe, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission concerning the matters to be reported.

A key purpose of disease notification and reporting is to generate reliable, transparent and accessible epidemiological data. A computerised interactive information system for the effective collection and management of surveillance data should be established at Union level for listed diseases and, when relevant, for emerging diseases or antimicrobial-resistant pathogens. That system should promote optimal data availability, facilitation of data exchange, and reduction of administrative burdens for the competent authorities of the Member States by merging disease notification and reporting within the Union and at international level into a single process operated through the database of the OIE. Steps should also be taken to ensure consistency in exchanges of information in accordance with Directive 2003/99/EC.

In order to ensure uniform conditions for the implementation of the Union disease notification and reporting rules, implementing powers should be conferred on the Commission to establish a list of diseases which are subject to Union notification and Union reporting rules as provided for in this Regulation and to establish the necessary procedures, formats, data and information exchanges regarding disease notification and reporting.

Surveillance is a key element of disease control policy. It should provide for the early detection of transmissible animal diseases and efficient notification thereof, thereby enabling the sector concerned and the competent authority to implement, where feasible, timely disease prevention and control measures, and allowing the disease in question to be eradicated. Furthermore, it should supply information on the animal health status of each Member State and of the Union, thereby substantiating certification of freedom from disease and facilitating trade with third countries.

Operators observe their animals on a regular basis and are best positioned to detect abnormal mortalities or other serious disease symptoms. Operators are therefore the cornerstone of any surveillance and essential for the surveillance undertaken by the competent authority.

To ensure close collaboration and exchange of information between operators and veterinarians or aquatic animal health professionals, and to supplement the surveillance undertaken by operators, establishments should, as appropriate for the type of production concerned and other relevant factors, be subject to animal health visits. In order to ensure uniform conditions for the carrying-out of animal health visits, implementing powers should be conferred on the Commission to lay down minimum requirements.

It is essential that the competent authority have in place a system of surveillance for the listed diseases which are subject to surveillance. This should also apply to emerging diseases, where the potential health risks of the disease concerned should be assessed and epidemiological data collected for that assessment. In order to ensure the best use of resources, information should be collected, shared and used in the most effective and efficient manner possible.

The surveillance methodology, frequency and intensity should be adapted to each specific disease and should take into account the specific purpose of the surveillance, the animal health status in the zone concerned and any additional surveillance conducted by operators. The appropriate epidemiological surveillance actions could range from a simple notification and reporting of the occurrence or suspicion of a listed or an emerging disease, or other anomalies, such as abnormal mortalities and other signs of disease, to a specific and comprehensive surveillance programme, which would normally include additional sampling and testing regimes.

Depending on the epidemiological profile of a disease and the relevant risk factors, a specific surveillance programme comprising defined and structured activities may need to be put in place. In such cases, it is appropriate that Member States develop targeted surveillance programmes. Where such programmes are relevant for the Union as a whole, rules should be laid down providing for harmonised application of such programmes.

Such programmes should be consistent with Union objectives and therefore coordinated at Union level. To that end, they should be submitted to the Commission. Furthermore, Member States implementing such specific surveillance programmes should also submit regular reports on the results of those programmes to the Commission. In order to ensure uniform conditions for the implementation of surveillance programmes, implementing powers should be conferred on the Commission to establish a list of diseases subject to surveillance programmes and to set up harmonised procedures, formats, data, information exchange and criteria to be used for the evaluation of the surveillance programmes.

It will often be necessary to provide details about the appropriate format of surveillance for different diseases, ranging from those diseases where surveillance can be limited to activities such as reporting and notification to diseases where an in–depth Union–wide specific surveillance programme needs to be established. Therefore, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission concerning the surveillance design, the criteria to establish the relevance of a disease to be subject to a surveillance programme relevant for the Union and for official confirmation of outbreaks, the case definitions of the diseases concerned and requirements for surveillance programmes in relation to their content, the information to be included in such programmes and their period of application.

Member States that are not free or are not known to be free from listed diseases which are subject to eradication measures as provided for in this Regulation should be required to establish compulsory eradication programmes to eradicate those diseases where eradication is compulsory in the Union.

On the other hand, there are some diseases which are of Union concern but for which it is not necessary to require Member States to eradicate the disease in question. It should be open to Member States to establish optional eradication programmes for such diseases if they decide that eradication is important for them. Such optional eradication programmes would be recognised at Union level and would entail the implementation of certain relevant disease control measures. They may also enable the Member State concerned, subject to approval by the Commission, to require certain guarantees when receiving animals from other Member States or from third countries.

In order to ensure uniform conditions for the implementation of disease eradication programmes, implementing powers should be conferred on the Commission to lay down the procedures for the submission of such programmes, performance indicators, and reporting.

Furthermore, a Member State should have the possibility of declaring the whole of its territories, zones or compartments thereof free of one or more of listed diseases which are subject to rules on compulsory or optional eradication programmes, in order to be protected against the introduction of such listed diseases from other parts of the Union or from third countries or territories. A clear harmonised procedure, including the necessary criteria for disease–free status, should be established for that purpose. In order to ensure uniform conditions for the implementation of the recognition of disease–free status within the Union, it is necessary that such a disease–free status be officially approved, and implementing powers to approve such status should therefore be conferred on the Commission.

The OIE has introduced the concept of compartmentalisation in the framework of the Terrestrial and Aquatic Animal Health Codes (‘the OIE Codes’). In Union legislation adopted prior to this Regulation, that concept is recognised only for particular animal species and diseases specified in specific Union legislation, namely for avian influenza and aquatic animal diseases. This Regulation should establish the possibility of using the compartment system for other animal species and diseases. In order to lay down the detailed conditions and rules for the recognition and approval of compartments and the requirements relating to them, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission.

Member States should make their disease–free territories, zones and compartments thereof publicly known for the purpose of informing trading partners and facilitating trade.

In order to lay down the detailed conditions for the recognition of disease–free status, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the criteria and conditions for obtaining such status, the evidence needed to substantiate certification of freedom from disease, special disease prevention and control measures, including non–vaccination status, where relevant, restrictions, information to be provided, derogations, and conditions for the maintenance, suspension, withdrawal or restoration of disease–free status.

In order to ensure uniform conditions for the implementation of procedures to obtain disease-free status, implementing powers should be conferred on the Commission to establish the listed diseases which may be subject to compartmentalisation and to lay down detailed rules on formats for the submission of applications and exchanges of information.

The presence of an entirely non–immune population of animals, susceptible to certain listed diseases, requires permanent disease awareness and preparedness. Contingency plans have proved to be a crucial tool for the successful control of disease emergencies in the past. In order to ensure the availability of this effective and efficient tool for the control of disease emergencies, and that it is sufficiently flexible to adjust to emergency situations, implementing powers should be conferred on the Commission to lay down necessary rules for the implementation of contingency plans.

Past animal health crises have shown the benefits of having specific, detailed and rapid procedures for the management of disease emergencies. Those organisational procedures should ensure a rapid and effective response and should improve coordination of efforts on the part of all parties involved, including in particular the competent authorities and the stakeholders. They should also include cooperation with the competent authorities of neighbouring Member States and third countries and territories, where feasible and relevant.

To ensure the applicability of contingency plans in real emergency situations, it is essential to practise the systems concerned and to test that they are working. To that end, the competent authorities of the Member States should carry out simulation exercises, in cooperation with the competent authorities of the neighbouring Member States and third countries and territories, where feasible and relevant.

In order to ensure uniform conditions for the implementation of contingency plans and simulation exercises, implementing powers should be conferred on the Commission to lay down rules for the practical implementation of those plans and exercises.

Veterinary medicinal products such as vaccines, hyper-immune sera and antimicrobials play an important role in the prevention and control of transmissible animal diseases. The Impact Assessment for the adoption of this Regulation highlights in particular the importance of vaccines as a tool in the prevention, control and eradication of animal diseases.

However, control strategies for some transmissible animal diseases require prohibition or restriction of the use of certain veterinary medicinal products, as their use would hamper the effectiveness of those strategies. For example, certain veterinary medicinal products may mask the manifestation of a disease, make the detection of a disease agent impossible or render a swift and differential diagnosis difficult and thus endanger the correct detection of disease.

However, those control strategies may vary substantially between different listed diseases. This Regulation should therefore provide for rules on the use of veterinary medicinal products for the prevention and control of certain listed diseases and for harmonised criteria to be taken into consideration when determining whether or not to use, and how to use, vaccines, hyper–immune sera and antimicrobials. In order to ensure a flexible approach and to address the specificities of different listed diseases and the availability of effective treatments, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the restrictions on, prohibitions of or obligations to use certain veterinary medicinal products within the framework of the control of certain listed diseases. In urgent cases and in order to address emerging risks with possibly devastating implications for animal or public health, the economy, society or the environment, it should be possible for the measures in this regard to be adopted by means of the urgency procedure.

Following the conclusions of the expert opinion on vaccine and/or diagnostic banks for major animal diseases, steps should also be taken to make it possible for the Union and the Member States to establish reserves of antigens, vaccines and diagnostic reagents for listed diseases that represent a serious threat to animal or public health. The establishment of a Union antigen, vaccine and diagnostic reagent bank would promote attainment of the Union's animal health objectives by permitting a quick and effective response when the resources of the bank are required, and would represent an efficient use of limited resources.

In order to ensure such a quick and effective response, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the establishment and management of such banks, and safety standards and requirements for their operation. However, this Regulation should not provide for the adoption of rules on the financing of the disease prevention and control measures, including vaccination.

Criteria for priority access to the Union antigen, vaccine and diagnostic reagent banks' resources should be established in order to ensure their effective distribution in emergencies.

For reasons of security in relation to bio–terrorism and agro–terrorism, certain detailed information concerning the Union antigen, vaccine and diagnostic reagent banks should be treated as classified information and its publication should be prohibited. As regards the same type of information in relation to national vaccine banks, the constitutional requirements of different Member States as regards freedom of information should be respected while ensuring that the information in question is treated as classified information.

In order to ensure uniform conditions for the management of the Union antigen, vaccine and diagnostic reagent banks, implementing powers should be conferred on the Commission to lay down detailed rules concerning which biological products are to be included in those banks and for which diseases, and detailed rules on the supply, quantities, storage, delivery, procedural and technical requirements for antigens, vaccines and diagnostic reagents and the frequency and content of submissions of information to the Commission.

In the event of an outbreak of a listed disease considered to represent a high risk to animal or public health in the Union, Member States should ensure that immediate disease control measures to eradicate the disease in question are taken in order to protect animal and public health.

The competent authority should be responsible for initiating the first investigations to confirm or rule out an outbreak of a highly contagious listed disease which is considered to represent a high risk to animal or public health in the Union.

The competent authority should put in place preliminary disease control measures to prevent the possible spread of the listed disease, and should undertake an epidemiological enquiry.

As soon as a listed disease is confirmed, the competent authority should take the necessary disease control measures, if necessary including the establishment of restricted zones, to eradicate and prevent the further spread of that disease.

The occurrence of a listed disease in wild animals may pose a risk to public health and the health of kept animals. Special rules should therefore be laid down, where necessary, for measures to control and eradicate diseases in wild animals.

There may be cases where small populations of certain animals, such as rare breeds and species, may be endangered by standard disease control measures in the event of an occurrence of a listed disease. The protection of such breeds and species may require modified measures to be taken by the competent authority. However, such modification should not hamper the overall control of that disease.

For listed diseases which are not highly contagious and which are subject to compulsory rules requiring their eradication, the disease control measures should be implemented in such a way as to prevent the spread of the disease in question, in particular to non–infected areas. However, those measures may possibly be more limited than, or may be different from, those applicable in relation to the most dangerous listed diseases. This Regulation should therefore provide for special rules for those less dangerous diseases. Member States that have an optional eradication programme in place should also implement such disease control measures. In some cases, depending on the disease profile and the epidemiological situation, eradication may be a long-term objective, while the short-term aim may be to control the disease. However, the level and intensity of disease control measures should be proportionate and should take into account the characteristics of the listed disease in question, its distribution and its significance for the Member State concerned by it and for the Union as a whole.

In order to ensure the effective application of the disease control measures provided for in this Regulation by operators, pet keepers and competent authorities, and taking into account the specificities of the disease-control measures for particular listed diseases and the risk factors involved, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the detailed disease-control measures to be implemented in the event of suspicion or confirmation of a listed disease in establishments, other locations and restricted zones.

In order to provide for the possibility for the Commission to adopt special disease control measures on a temporary basis in the event that the disease control measures laid down in this Regulation are not sufficient or appropriate to address the risk involved, implementing powers should be conferred on the Commission concerning the laying down of special disease control measures for a limited period of time.

The registration of certain transporters and establishments keeping terrestrial animals or handling germinal products or transporting them is necessary in order to allow the competent authority to perform adequate surveillance and to prevent, control and eradicate transmissible animal diseases.

To avoid unjustified administrative burdens and costs, Member States should be able, on a limited basis, to exempt from the registration obligation certain types of establishments posing a low risk. Implementing powers should be conferred on the Commission in order to achieve a harmonised approach to the granting of such exemptions. Such a harmonised approach is particularly necessary in order to prevent certain types of establishments from being excluded from the registration obligation. This is particularly relevant not only as regards those establishments which pose a more than insignificant risk to animal health but also as regards establishments which pose a more than insignificant risk to public health. An example of such risk is the keeping of animals that live in close contact with, or proximity to, humans, such as the breeding of dogs at a level involving a certain continuity of activities and a certain degree of organisation with the primary aim of their being sold for the purpose of becoming pet animals in households.

Where a certain type of establishment keeping terrestrial animals or handling or storing germinal products poses a particular animal health risk, it should be subject to approval by the competent authority.

To avoid unjustified administrative burdens and costs, particularly to enterprises posing a low risk, flexibility should where possible be built into the relevant measures, making it possible to adapt the system of registration and approval to local and regional conditions and production patterns.

In some cases, harmonisation of certain conditions for registration or approval across the Union is desirable or necessary. For example, germinal products establishments and assembly operations should meet certain conditions and should be approved in order to comply with international standards, thereby enabling the Union to provide animal health guarantees to third countries when trading. Such conditions should also involve requirements for specific training or professional qualifications for certain very specific establishments or operations (e.g. for embryo collection teams), or even the obligation for specific supervision by the competent authority. The Commission should therefore be empowered to adopt delegated acts in accordance with Article 290 TFEU concerning those detailed requirements, in order to provide for such specific conditions.

In the interest of reducing administrative burdens, registrations and approvals should, where possible, be integrated into a registration or approval system which the Member State concerned may already have established for other purposes.

Operators have first–hand knowledge of the animals under their care. They should therefore maintain up–to–date records of information which is relevant for assessing the animal health status, for traceability and for an epidemiological enquiry in the event of the occurrence of a listed disease. Those records should be easily accessible to the competent authority.

In order to ensure the availability of up–to–date information concerning registered establishments and operators and approved establishments, competent authorities should establish and keep a register of such establishments and operators. The power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the detailed information to be included in the register of establishments and operators.

In order to be approved by the competent authority, an establishment should have to fulfil certain requirements. Before granting the approval, the competent authority should have to verify by means of an on–site visit whether all requirements have been met. In some cases, not all conditions can be met immediately, but the remaining deficiencies do not present a significant risk to animal or public health. In such cases, it should be possible for the competent authority to grant a conditional approval, followed by another on–site visit to verify that progress has been made. In those cases, the competent authority should provide the necessary effective guidance to the operators of the establishments concerned, in order that the operator in question understands the deficiency and can plan for its successful resolution.

Efficient traceability is a key element of disease control policy. Identification and registration requirements specific to the different species of kept terrestrial animals and germinal products should be in place in order to facilitate the effective application of the disease prevention and control rules provided for in this Regulation. In addition, it is important to provide for the possibility of establishing an identification and registration system for species for which such arrangements do not exist at present, or when changing circumstances and risks so warrant.

For certain animal species for which it is important to be able to trace individual animals or groups, a physical means of identification should be required. This entails the animal in question being physically marked, tagged, microchipped or otherwise identified by means of a method which can be seen or detected on or in its body and which cannot easily be removed.

In order to ensure the smooth operation of the identification and registration system and to ensure traceability, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of obligations concerning databases, detailed identification and registration requirements concerning different animal species, including exemptions and conditions for such exemptions, and documents.

It is appropriate to reduce administrative burdens and costs and to provide for flexibility of the system in circumstances where the traceability requirements can be achieved by means other than those set out in this Regulation. The Commission should therefore be empowered to adopt delegated acts in accordance with Article 290 TFEU concerning derogations from the identification and registration requirements.

In order to ensure uniform conditions for the implementation of the identification and registration system and traceability, implementing powers should be conferred on the Commission to lay down rules concerning the technical specifications for databases, means of identification, documents and formats, and deadlines.

An important tool for preventing the introduction and spread of a transmissible animal disease is the use of restrictions on movements of animals and products that may transmit that disease. However, restricting the movement of animals and products may have a severe economic impact and may interfere with the operation of the internal market. Such restrictions should therefore be applied only where necessary and proportionate to the risks involved. This approach is in line with the principles laid down in the SPS Agreement and the OIE international standards.

The general requirements laid down in this Regulation should apply to all animal movements, such as the prohibition of the movement of animals from an establishment where there are abnormal mortalities or other disease symptoms with an undetermined cause or disease prevention requirements during transport.

The legal framework currently laid down in Union animal health legislation, for the movement of terrestrial animals and products lays down harmonised rules primarily for such movements between Member States, while leaving it up to the Member States to determine the necessary movement requirements within their territory. A comparison between the current situation and an option whereby rules for movements within Member States would also be harmonised at Union level was set out at length in the impact assessment for the adoption of this Regulation. It has been concluded that the current approach should be maintained, as complete harmonisation of all movements would be very complex and the benefits in terms of the facilitation of movements between Member States do not outweigh the negative impact this could have on the ability to control diseases.

For animals that are moved between Member States, a set of basic animal health requirements should apply. In particular, animals should not be moved from establishments with abnormal mortalities or signs of disease of unknown cause. However, mortalities, even if abnormal, which are linked to scientific procedures authorised under Directive 2010/63/EU of the European Parliament and of the Council (19) and which are not of infectious origin related to listed diseases, should not be a reason to prevent movements of animals intended for scientific purposes.

However, this Regulation should provide for flexibility in order to facilitate the movement of species and categories of terrestrial animals that pose a low risk in terms of spreading listed diseases between Member States. In addition, further possibilities for derogations should be provided for in cases where Member States or operators successfully put in place alternative risk-mitigating measures such as high levels of biosecurity and effective surveillance systems.

Ungulates and poultry are groups of animal species of high economic significance and are subject to specific movement requirements under Union legislation adopted prior to this Regulation, namely Council Directives 64/432/EEC (20), 91/68/EEC (21), 2009/156/EC (22), 2009/158/EC (23) and, in part, Directive 92/65/EEC. The main rules governing the movement of animals of those species should be laid down in this Regulation. The detailed requirements which largely depend on the diseases that may be transmitted by different species or categories of animals should be regulated in subsequent Commission acts, taking into account the specificities of the diseases, species and categories of animals in question.

As assembly operations for ungulates and poultry pose a particularly high risk of disease, it is appropriate to limit the number that can be carried out in one movement between Member States, and to lay down specific rules in this Regulation to protect the health of the animals involved and prevent the spread of transmissible animal diseases. Those assembly operations would normally take place in an establishment approved for that purpose, or, when permitted by a Member State of origin, the first assembly operation, on one means of transport such as a lorry, through the collection of animals from different locations in that Member State.

Depending on the listed diseases and listed species concerned, it is necessary to lay down specific animal health requirements for certain animal species other than kept ungulates and poultry. Rules for these species were also laid down in the legal framework applicable prior to this Regulation and in particular in Directive 92/65/EEC. That Directive lays down specific rules for the movement of animal species including bees, bumble bees, apes, dogs and cats and this Regulation should therefore provide a legal basis for the adoption of delegated and implementing acts laying down specific movement rules for those animal species.

Confined establishments, usually used for the keeping of laboratory animals or zoo animals, normally involve a high level of biosecurity and a favourable and well-controlled health status, and are subject to fewer movements or to movements solely within the closed circuits of those establishments. The status of confined establishments, for which operators may apply on a voluntary basis, was first introduced in Directive 92/65/EEC, which lays down rules and requirements for approval and movement requirements for approved bodies, institutes and centres. The system thereby established enables those establishments to exchange animals amongst themselves with fewer movement requirements, at the same time providing health guarantees within the circuit of confined establishments. Consequently, it has been broadly accepted by the operators and used as a voluntary option. It is therefore appropriate in this Regulation to preserve the concept of confined establishments and also to lay down rules for movement between those establishments.

For scientific purposes, such as research or diagnostic purposes, and in particular for those authorised in accordance with Directive 2010/63/EU, it may be necessary to move animals which do not fulfil the general animal health requirements laid down in this Regulation and which represent a higher animal health risk. Those kinds of movements should not be prohibited or unduly restricted by this Regulation, as this could impede otherwise authorised research activities and delay scientific progress. None the less, it is essential that rules be laid down in this Regulation to ensure that movements of those animals take place in a safe manner.

Movement patterns of circus animals, animals kept in zoos, animals intended for exhibition and certain other animals often deviate from the movement patterns of other kept species. In adapting Union rules on animal movements specific consideration should be given to such animals, taking into account specific risks and alternative risk-mitigation measures.

In order to ensure that the objectives referred to in recitals 112 to 122 of this Regulation are achieved, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission concerning disease prevention measures in transport operations, specific rules for the movement of certain animal species and special circumstances, such as assembly operations or rejected consignments, and special requirements or derogations for other types of movements, such as movement for scientific purposes.

In order to ensure the possibility of applying special rules for movements where the usual movement rules are not sufficient or appropriate to limit the spread of a certain disease, implementing powers should be conferred on the Commission to lay down special movement rules for a limited period of time.

Movements of kept terrestrial animals between Member States should comply with the requirements applicable to such movements. In the case of animals of species which present a health risk or which are of greater economic importance, they should be accompanied by an animal health certificate issued by the competent authority.

To the extent technically, practically and financially feasible, there should be recourse to technological developments in order to reduce the administrative burdens on operators and competent authorities in relation to certification and notification by using information technology to replace paper documentation and to facilitate notification procedures, and by using such technology as far as possible for multiple purposes.

In cases where there is no requirement for an animal health certificate to be issued by a competent authority, an operator who moves animals to another Member State should issue a self–declaration document which confirms that the animals meet the movement requirements laid down in this Regulation.

In order to ensure that the objectives referred to in recitals 125, 126 and 127 of this Regulation are achieved, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission concerning rules on the content of animal health certificates, information obligations, derogations from the animal health certification requirements, specific certification rules, and the obligations of official veterinarians to conduct appropriate checks before the signing an animal health certificate.

Notification of movements of animals and germinal products between Member States, and in some cases within the national territories of Member States, is essential in order to ensure the traceability of the animals and germinal products concerned, where these movements may be linked to a risk of spreading transmissible animal diseases. Such movements should therefore be notified and registered by means of an integrated computerised veterinary system (‘Traces’). The Traces system integrates into a single architecture the computerised systems provided for in Article 20 of Directive 90/425/EEC and in Council Decision 92/438/EEC (24) respectively, based on Commission Decisions 2003/24/EC (25) and 2004/292/EC (26).

In order to ensure uniform conditions for the implementation of the rules laid down in this Regulation on animal health certification and movement notification, implementing powers should be conferred on the Commission to lay down rules concerning the model animal health certificates, self–declaration documents, formats and deadlines for movement notification for both terrestrial and aquatic animals, germinal products and, where also relevant, products of animal origin.

The specific nature of movements of pet animals represents an animal health risk which deviates significantly from that of other kept animals. Specific, less stringent rules for such movements should therefore be laid down in this Regulation. Such less stringent rules are only justified, however, if the pet animal genuinely accompanies its owner during the owner's movement, or within a limited period thereafter, and if no more than five pet animals as referred to in Part A of Annex I are moved together with their owner at one time. In order to ensure that pet animals do not pose a significant risk for the spread of transmissible animal diseases, and in order to clarify the exceptional situations in which more than five pet animals may accompany the owner, or when the pet animal is to be moved within a longer time-frame before or after the owner moves, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the detailed rules for movements of those animals. In order to ensure uniform conditions for the implementation of the animal health requirements laid down in this Regulation concerning the movements of pet animals, implementing powers should be conferred on the Commission to lay down rules concerning the disease prevention and control measures to be taken for such movements.

Wild animals may for various reasons represent an animal and public health risk, for example if they are moved into an establishment or from one environment to another environment. Appropriate preventive measures for movement of those animals may need to be taken to avoid the spread of transmissible animal diseases. In order to ensure that wild animals do not pose a significant risk for the spread of transmissible animal diseases, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission concerning the additional requirements for movements of wild terrestrial animals.

Germinal products can represent a similar risk of spreading transmissible animal diseases to live animals. In addition, there are specificities in their production which are related to high health demands for breeding animals and which call for stricter or particular animal health requirements concerning the donor animals. In order to ensure safe movements of germinal products, to maintain their expected high health standard and to take into account certain specific uses of such products, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission concerning the detailed requirements for movement of germinal products of certain animal species, special requirements applicable to, for example, their movement for scientific purposes, and derogations from the animal health certification obligation.

Products of animal origin can represent a risk for the spreading of transmissible animal diseases. Food safety requirements for products of animal origin laid down in Union legislation ensure good hygiene practices and reduce the animal health risks of such products. However, for certain types of products, specific animal health measures, such as disease control and emergency measures, should be laid down in this Regulation in order to ensure that products of animal origin do not spread animal diseases. In order to ensure safe movements of products of animal origin in these particular cases, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission concerning the establishment of detailed rules for movements of products of animal origin in relation to disease control measures taken, the obligations in respect of animal health certification and derogations from those rules where the risk involved with such movements and the risk-mitigation measures in place so permit.

When Member States take national measures concerning movements of animals and germinal products, or decide to take national measures to limit the impact of transmissible animal diseases other than listed diseases within their territory, those national measures should not interfere with the rules on the internal market laid down in Union legislation. It is therefore appropriate to set the framework for such national measures and to ensure that they remain within the limits permitted under Union law.

The registration and approval of aquaculture establishments is necessary in order to allow the competent authority to perform adequate surveillance and to prevent, control and eradicate transmissible animal diseases. Directive 2006/88/EC requires all establishments which move aquatic animals to be authorised. That system of authorisation should be maintained under this Regulation, notwithstanding the fact that, in some official languages of the Union, this Regulation uses different terms to refer to the authorisation system from those used in Directive 2006/88/EC.

The slaughter and processing of aquaculture animals which are subject to disease control measures may spread transmissible animal diseases, for example as a result of the discharge from processing establishments of effluents containing pathogens. It is therefore necessary to approve processing establishments which fulfil the risk-mitigation measures for such slaughter and processing operations. This Regulation should therefore provide for the approval of disease control aquatic food establishments.

In order to ensure the availability to the public of up–to–date information concerning registered and approved establishments, the competent authority should establish and keep a register of such establishments. The power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission concerning the information to be included in registers of aquaculture establishments and the record-keeping requirements for aquaculture establishments and transporters.

In order to ensure uniform conditions for the implementation of the rules laid down in this Regulation concerning the registration and approval of aquaculture establishments and disease control aquatic food establishments, record-keeping and registers of establishments, implementing powers should be conferred on the Commission to lay down rules concerning the information obligations, derogations and other implementing rules in that regard.

As it is not feasible in most cases to individually identify aquatic animals, the keeping of records by aquaculture establishments, disease control aquatic food establishments and transporters is an essential tool in ensuring the traceability of aquatic animals. Records also serve as a valuable tool for the surveillance of the health situation of establishments.

As in the case of terrestrial animals, it is necessary to lay down harmonised rules on the movement of aquatic animals, including rules on animal health certification and movement notification.

Directive 2006/88/EC lays down rules for movements of aquatic animals which apply equally to movements within and between Member States. The key determining factor in relation to rules on the movement of aquatic animals is the health status, as regards listed diseases, of the Member State, zones and compartments of destination.

However, Directive 2006/88/EC excludes from its scope wild aquatic animals caught or harvested for direct entry into the food chain. By contrast, this Regulation retains them within its scope, but excludes them from the definition of aquaculture animals. It should therefore provide for possible measures in relation to such aquatic animals where, taking into account their proportionality, such measures are justified by the risks involved.

Consequently, the principle explained in recital 142 should also apply to movements of aquatic animals that are not defined as aquaculture animals but are covered by the scope of this Regulation. This applies, in particular, to aquatic animals with an unknown or confirmed disease positive health status, regardless of their final use. As movements of live wild aquatic animals with an unknown or confirmed disease positive health status and intended for human consumption may also pose a risk of spreading listed or emerging diseases, the same system of rules should also apply to them. This includes those wild aquatic animals, harvested or caught for human consumption, which are moved and temporarily kept while awaiting slaughter.

However, disproportionate movement restrictions and unnecessary administrative burdens for establishments and operators within the commercial fisheries sector should be avoided. Consequently, in cases where such live wild aquatic animals are intended for human consumption, the rules in question should in principle apply only to movements of live wild aquatic animals which pose a significant risk of spreading listed or emerging diseases into Member States, zones or compartments which have been declared free of certain listed diseases or which are subject to eradication programmes with regard to those diseases.

To encourage Member States to enhance the health status of their aquatic populations, certain adjustments and added flexibility should be introduced in this Regulation.

In order to ensure control of the movement of aquatic animals, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission concerning the disease prevention measures applicable to transport, specific rules applicable to movements of certain categories of aquatic animals for different purposes, specific requirements or derogations in respect of certain types of movements, such as movements for scientific purposes, and additional requirements for movements of wild aquatic animals.

In order to ensure the possibility of temporary derogations and specific requirements for movements of aquatic animals, where the movement rules laid down in this Regulation are not sufficient or appropriate to limit the spread of a particular listed disease, implementing powers should be conferred on the Commission to lay down special movement rules or derogations for a limited period of time.

Union aquaculture production is extremely diverse as regards species and production systems, and this diversification is rapidly increasing. This may require the adoption at Member State level of national measures concerning diseases other than those regarded as listed diseases in accordance with this Regulation. However, such national measures should be justified, necessary and proportionate to the goals to be achieved. Furthermore, they should not affect movements between Member States unless they are necessary in order to prevent the introduction, or to control the spread, of disease. National measures affecting trade between Member States should be approved and regularly reviewed at Union level.

Currently, listed diseases concern animal species other than those defined by this Regulation as terrestrial and aquatic species, such as reptiles, amphibians, insects and others, only to a very limited extent. It is therefore not appropriate to require that all the provisions of this Regulation should apply to those animal species. However, if a disease which concerns species other than terrestrial and aquatic species should become listed, the relevant animal health requirements of this Regulation should apply to those species, in order to ensure that adequate and proportionate disease prevention and control measures may be taken.

In order to ensure the possibility of laying down movement rules for animals that are not defined as terrestrial or aquatic animals by this Regulation, and germinal products and products of animal origin deriving from such animals, when a risk so warrants, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission concerning the registration and approval of establishments, record-keeping and registers, identification and registration and traceability movement requirements, animal health certification and self–declaration and movement notification obligations in respect of animals, germinal products and products of animal origin deriving from those species.

Whenever necessary in order to ensure uniform conditions for the implementation of the animal health requirements for those other animal species and germinal products and products of animal origin deriving from them, implementing powers should be conferred on the Commission to lay down detailed rules concerning those requirements.

In order to prevent the introduction of listed diseases and emerging diseases into the Union, it is necessary to have in place efficient rules on the entry into the Union of animals, germinal products and products of animal origin that may transmit such diseases.

In order to guarantee the health status of the Union, this Regulation lays down provisions concerning movements of animals and products within the Union. It is therefore appropriate, so as not to jeopardise that status, to impose conditions for the entry of animals and products into the Union that are no less strict than those applicable to movements within the Union.

In order to ensure that animals, germinal products and products of animal origin from third countries or territories fulfil animal health requirements that provide guarantees equivalent to those provided for in Union legislation, it is essential that they be subject to appropriate controls by the competent authority of the third country or territory from which they are exported to the Union. Where relevant, the health status of a third country or territory of origin should be verified prior to accepting entry into the Union of such animals, germinal products and products of animal origin. Consequently, only third countries and territories which can demonstrate that they meet the animal health standards for entry of the animals and products into the Union should be eligible to export them to the Union and be listed for that purpose.

For some species and categories of animals, germinal products and products of animal origin, the Union lists of third countries and territories from which entry into the Union is permitted have not been established in Union acts adopted prior to the date of adoption of this Regulation. In those cases, pending the adoption of rules pursuant to this Regulation, Member States should be permitted to determine from which countries and territories those animals, germinal products and products of animal origin may be permitted to enter their territory. In so determining, Member States should take into account the criteria laid down in this Regulation for the Union lists of third countries and territories.

In order to ensure that the animal health requirements for entry into the Union provided for in this Regulation are complied with, and that they are in line with the principles of the OIE Codes, all animals, germinal products and products of animal origin entering the Union should be accompanied by an animal health certificate issued by the competent authority of the third country or territory of origin confirming that all the animal health requirements for entry into the Union are complied with. However, deviation from this rule should be permitted in respect of commodities which pose a low animal health risk.

Animal health certificates may stand on their own, but certification is often required in Union legislation for other purposes, for example in order to certify that public health or animal welfare requirements of animals or products have been complied with. This has to be taken into account. In order to minimise administrative burdens and costs, those animal health certificates should also be permitted to include information required under other Union legislation concerning food and feed safety and animal welfare.

Diseases may be spread by means other than animals, germinal products, products of animal origin and animal by–products and derived products. For instance, vehicles, transport containers, hay, straw, plant products, materials that may have been in contact with infected animals and equipment may also spread disease. Where necessary, measures should be taken to prevent disease transmission by those means.

In order to ensure the appropriate level of detail for the requirements for entry into the Union, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the adoption of supplementary rules for the approval of establishments in third countries and territories and derogations, animal health requirements for the entry into the Union of consignments from third countries and territories and animal health requirements for disease agents, other materials, means of transport and equipment which may transmit animal diseases.

In order to ensure uniform conditions for the implementation of animal health requirements for the entry into the Union of consignments of animals, germinal products and products of animal origin, implementing powers should be conferred on the Commission to lay down rules on, inter alia, the list of third countries and territories from which the entry into the Union of animals, germinal products and products of animal origin is allowed and on the contents and format of model animal health certificates.

Past experience has shown that when an outbreak of a serious disease occurs in Member States or in third countries or territories from which animals or products enter the Union, disease prevention and control measures have to be taken immediately to prevent its introduction and limit its spread. Such an emergency may involve listed diseases, emerging diseases or other animal health hazards. In that context, it should be made clear which disease prevention and control measures provided for by this Regulation may be used in the event of the occurrence of a listed or emerging disease or hazard. In all such cases, it is essential that measures can be taken at very short notice and without any delay. As such measures would restrict movement within or into the Union, they should be implemented at Union level whenever possible.

In order to ensure an effective and quick reaction to emerging risks, implementing powers should be conferred on the Commission to lay down emergency measures.

The Commission should adopt immediately applicable implementing acts in duly justified cases relating to, inter alia, measures regarding emerging diseases, the stocking, supply, storage, delivery and other procedures of Union antigen, vaccine and diagnostic reagent banks, the laying down of special disease control measures and derogations for a limited period of time, special rules on movements for terrestrial and aquatic animals applying for a limited period of time, emergency measures, and the listing of third countries and territories for the purposes of entry into the Union.

This Regulation lays down general and specific rules for the prevention and control of transmissible animal diseases and ensures a harmonised approach to animal health across the Union. In some areas, such as general responsibilities for animal health, notification, surveillance, registration and approval or traceability, the Member States should be allowed or encouraged to apply additional or more stringent national measures. However, such national measures should be permitted only if they do not compromise the animal health objectives set out in this Regulation and are not inconsistent with the rules laid down herein, and provided that they do not hinder movements of animals and products between Member States, unless this is necessary in order to prevent the introduction, or to control the spread, of disease.

The national measures referred to in recital 165 should be subject to a simplified notification procedure in order to reduce the administrative burden. Experience has shown that the general notification procedure laid down in Directive 98/34/EC of the European Parliament and of the Council (27) has been an important tool for guiding and improving the quality of national technical regulations — in terms of increased transparency, readability and effectiveness — in non–harmonised or partly harmonised areas. It is therefore appropriate that this general notification procedure applies.

Currently, Union rules on animal health are laid down in the following acts of the European Parliament and of the Council and in subsequent Commission acts adopted pursuant to them:

This Regulation provides for the rules on the identification and registration of bovine animals while rules for beef labelling remain outside of its scope. Regulation (EC) No 1760/2000 of the European Parliament and of the Council (52) provides for the rules on the identification and registration of bovine animals and for the rules on beef labelling. It should thus be amended to repeal its provisions on the identification and registration of bovine animals while those concerning beef labelling would have to remain in force.

With a view to guaranteeing the reliability of the arrangements provided for in existing Regulations establishing systems for the identification and registration of bovine, ovine and caprine animals, that legislation requires the Member States to carry out adequate and efficient control measures. Such adequate and efficient official control measures should also be preserved in the future. As part of the ‘Smarter rules for safer food’ package of proposals, this Regulation does not envisage provisions on official controls since those rules should be provided for in the framework of the proposed horizontal legislation on official controls. However, even if the proposed new horizontal rules on official controls were not to enter into force at the same time as this Regulation, the existing horizontal rules on official controls would allow the Commission to ensure an equivalent level of control.

The rules laid down in the legislative acts referred to in recital 167 are to be replaced by this Regulation and by subsequent Commission acts to be adopted pursuant to this Regulation. Accordingly, those legislative acts should be repealed. However, to ensure legal clarity and avoid a legal vacuum, the repeal should in the first place take effect only when the relevant delegated and implementing acts are adopted pursuant to this Regulation. It is therefore necessary to empower the Commission to determine the dates when the repeal of those legislative acts is to take effect, while the legislator should set a deadline.

The following Council acts in the area of animal health are obsolete and should be expressly repealed in the interests of clarity of Union legislation: Council Decision 78/642/EEC (53), Council Directive 79/110/EEC (54), Council Directive 81/6/EEC (55), Council Decision 89/455/EEC (56), Council Directive 90/423/EEC (57), Council Decision 90/678/EEC (58), Council Directive 92/36/EEC (59), Council Directive 98/99/EC (60).

The requirements set out in this Regulation should not apply until the key delegated and implementing acts have been adopted by the Commission pursuant to this Regulation, allowing a period of 24 months from the adoption of the key acts until the date when they start to apply, thus permitting Member States and operators to duly adapt to the new rules. In addition, it is appropriate to provide for a period of at least 36 months for the Commission to elaborate the new rules.

In order to ensure legal certainty as regards the application of rules for the identification and registration of animals and disease control measures for certain animal diseases and zoonoses, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the date on which Regulation (EC) No 21/2004 and Directives 92/66/EEC, 2000/75/EC, 2001/89/EC, 2002/60/EC, 2003/85/EC, 2005/94/EC and 2008/71/EC are to cease to apply, whilst a deadline in that regard should be set in this Regulation.

In line with the preventive approach to animal health that is promoted by this Regulation, the special measures concerning salmonella that applied to live animals dispatched to Finland and Sweden prior to 20 April 2016 should continue to apply and Regulation (EC) No 2160/2003 should be amended accordingly.

Considering the recent adoption of Regulation (EU) No 576/2013, it is desirable to allow for a long transitional period before the corresponding rules set out in this Regulation start to apply.

The implementing powers provided for in this Regulation should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (61).

It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

This Regulation should not create a disproportionate administrative burden or economic impact for small and medium-sized enterprises. Under this Regulation, based on consultation with stakeholders, the special situation of small and medium-sized enterprises has been taken into account. A potential universal derogation from the requirements of this Regulation for such enterprises has not been considered, in view of the public policy objectives of protecting animal health and public health. However, a number of derogations for such enterprises should be provided for in relation to the different requirements of this Regulation, taking into account the risks involved.

Since the objectives of this Regulation, namely to lay down animal health rules for animals, germinal products, products of animal origin, animal by–products and derived products to the extent that they are not covered by specific rules in other Union legislation, and other material that may be involved in the spread of transmissible animal diseases, cannot be sufficiently achieved by the Member States but can rather be better achieved at Union level through a common and coordinated legal framework for animal health, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,

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

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

disease awareness, preparedness and control (Part III: Articles 43 to 83);

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);

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);

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);

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

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).

‘animals’ means vertebrate and invertebrate animals;

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

‘aquatic animals’ means animals of the following species, at all life stages, including eggs, sperm and gametes:

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

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

‘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;

‘aquaculture animals’ means any aquatic animals subject to aquaculture,

‘wild animals’ means animals which are not kept animals;

‘poultry’ means birds that are reared or kept in captivity for:

‘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;

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

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

‘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);

‘non–commercial movement’ means any movement of a pet animal accompanying its owner and which

‘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;

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

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

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

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

‘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);

‘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;

‘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;

‘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:

‘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;

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

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

‘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:

‘germinal products’ means:

‘products of animal origin’ means:

‘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;

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

‘products’ means:

‘official control’ means any form of control carried out by a competent authority for the purpose of verifying compliance with this Regulation;

‘health status’ means the disease status as regards the listed diseases relevant for a particular listed species with respect to:

‘zone’ means:

‘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;

‘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;

‘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;

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

‘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;

‘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;

‘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;

‘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;

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

‘ungulates’ means the animals listed in Annex III;

‘germinal product establishment’ means:

‘hatchery’ means an establishment which collects, stores, incubates and hatches eggs for the supply of:

‘confined establishment’ means any permanent, geographically limited establishment, created on a voluntary basis and approved for the purpose of movements, where the animals are:

‘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;

‘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;

‘Traces’ means the integrated computerised veterinary system with a single architecture provided for in Decisions 2003/24/EC and 2004/292/EC;

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

‘official veterinarian’ means a veterinarian authorised by the competent authority and appropriately qualified to perform official activities in accordance with this Regulation;

‘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);

‘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 or any other authority to which that responsibility has been delegated;

‘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).

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.

the disease profile, which shall comprise the following:

the impact of the disease on:

its potential to generate a crisis situation and its potential use in bioterrorism;

the feasibility, availability and effectiveness of the following disease prevention and control measures:

the impact of disease prevention and control measures, as regards:

the susceptibility of the animal population at risk;

the duration of the incubation period and infective period for the animals concerned;

the capability of those animals to carry those specific diseases.

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.

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;

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

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;

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

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.

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

observe the health and behaviour of animals under their responsibility;

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;

look for abnormal mortalities and other signs of serious disease in animals under their responsibility.

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;

the disease profile;

the risk factors involved;

the health status in:

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

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

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;

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;

requirements for surveillance programmes as provided for in Article 28(1) regarding:

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.

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

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 Member State concerned withdraws the programme.

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.

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

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

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);

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

the estimated duration of the eradication programme;

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

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;

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

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

performance indicators;

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

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.

detailed rules for the disease–free status of Member States and zones thereof, based on the different disease profiles, concerning:

derogations from the requirement for approval by the Commission of disease–free status for one or more listed diseases referred to in points (b) and (c) of Article 9(1), as laid down in Article 36(1), where such approval is not necessary on account of detailed rules for freedom from disease having been laid down in rules adopted pursuant to point (a) of this Article;

the information to be provided by Member States to the Commission and the other Member States to substantiate declarations of disease–free status, without the adoption of an implementing act in accordance with Article 36(4), as provided for in point (b) of this Article.

applications for recognition of disease–free status of the entire territory of the Member State concerned, or zones and compartments thereof;

exchanges of information between the Member States and the Commission on disease-free Member States, or zones and compartments thereof.

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).

prohibitions and restrictions on the use of veterinary medicinal products;

the compulsory use of veterinary medicinal products.

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.

reviewed by the competent authority, as appropriate, following the findings of:

further extended to other locations as referred to in point (a) of Article 55(1), where necessary.

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.

declare the affected establishment, food or feed business, animal by–products establishment or other location as officially infected with that listed disease;

establish a restricted zone appropriate for that listed disease;

implement the contingency plan provided for in Article 43(1) to ensure full coordination of the disease control measures.

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 conditions and requirements for the disease control measures provided for in points (a) to (e) of Article 61(1);

the procedures for cleaning, disinfection, control of insects and rodents, or other necessary biosecurity measures as provided for in point (f) of Article 61(1), specifying, where appropriate, the use of biocidal products for those purposes;

the conditions and requirements for sampling and laboratory examination as provided for in points (g) and (h) of Article 61(1);

the detailed conditions and requirements in respect of repopulation as provided for in Article 61(3);

the carrying-out of the necessary disease control measures provided for in Article 62 in epidemiologically linked establishments, other locations and means of transport.

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 conditions and requirements for the disease control measures provided for in points (a), (c), (d), (e), (g), (h) and (i) of Article 65(1);

the procedures for cleaning, disinfection, control of insects and rodents, or other necessary biosecurity measures as provided for in point (f) of Article 65(1), specifying, where appropriate, the use of biocidal products for those purposes;

the necessary surveillance which is to be conducted following the application of the disease control measures and laboratory examinations provided for in point (b) of Article 65(1);

other specific disease control measures to limit the spread of specific listed diseases as referred to in point (a) of Article 9(1).

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.

reviewed by the competent authority, as appropriate, following the findings of the investigation provided for in Article 73(1) and, where relevant, the epidemiological enquiry provided for in point (b) of Article 74(1);

further extended to other locations, as referred to in point (b) of Article 74(4), where necessary.

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.

apply the disease control measures laid down in the compulsory eradication programme provided for in Article 31(1) for that listed disease; or

where the Member State or zone, or compartment, has obtained disease–free status in accordance with Article 36 or Article 37 respectively:

the disease profile;

the kept animals affected;

economic and social impacts.

the disease profile;

the kept animals affected;

economic and social impacts.

apply the disease control measures laid down in the compulsory eradication programme provided for in Article 30(1) for that listed disease; or

initiate a compulsory eradication programme, where the eradication programme provided for in Article 31(1) for that listed disease has not yet been applied due to the previous absence of that disease or freedom from it, and if measures for wild animals are necessary in order to control and prevent the spread of that disease.

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: