CELEX ID: 32016R0429

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Document:
31.3.2016
EN
Official Journal of the European Union
L 84/1
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)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2), Article 114 and Article 168(4)(b) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national Parliaments,
Having regard to the opinion of the European Economic and Social Committee 
(
1
)
,
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure 
(
2
)
,
Whereas:
(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.
(2)
As recent experiences have demonstrated, transmissible animal diseases may also have a significant impact on public health and food safety.
(3)
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.
(4)
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.
(5)
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.
(6)
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 
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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.
(7)
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 
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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.
(8)
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.
(9)
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.
(10)
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.
(11)
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.
(12)
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.
(13)
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.
(14)
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.
(15)
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 
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11
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.
(16)
Regulation (EC) No 1069/2009 of the European Parliament and the Council 
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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.
(17)
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 
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13
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, Directive 2003/99/EC of the European Parliament and of the Council 
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14
)
 and Regulation (EC) No 2160/2003 of the European Parliament and of the Council 
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15
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, 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 
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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.
(18)
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.
(19)
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.
(20)
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.
(21)
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.
(22)
Union legislation adopted prior to this Regulation lays down separate animal health rules for terrestrial and aquatic animals. Council Directive 2006/88/EC 
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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.
(23)
Union legislation adopted prior to this Regulation, and in particular Council Directive 92/65/EEC 
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18
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, 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.
(24)
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.
(25)
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.
(26)
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.
(27)
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.
(28)
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.
(29)
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.
(30)
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.
(31)
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.
(32)
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.
(33)
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.
(34)
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.
(35)
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.
(36)
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.
(37)
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.
(38)
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.
(39)
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.
(40)
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.
(41)
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.
(42)
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.
(43)
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.
(44)
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.
(45)
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.
(46)
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.
(47)
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.
(48)
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.
(49)
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.
(50)
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.
(51)
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.
(52)
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.
(53)
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.
(54)
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.
(55)
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.
(56)
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.
(57)
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.
(58)
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.
(59)
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.
(60)
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.
(61)
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.
(62)
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.
(63)
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.
(64)
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.
(65)
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.
(66)
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.
(67)
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.
(68)
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.
(69)
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.
(70)
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.
(71)
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.
(72)
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.
(73)
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.
(74)
Member States should make their disease–free territories, zones and compartments thereof publicly known for the purpose of informing trading partners and facilitating trade.
(75)
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.
(76)
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.
(77)
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.
(78)
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.
(79)
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.
(80)
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.
(81)
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.
(82)
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.
(83)
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.
(84)
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.
(85)
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.
(86)
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.
(87)
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.
(88)
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.
(89)
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.
(90)
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.
(91)
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.
(92)
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.
(93)
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.
(94)
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.
(95)
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.
(96)
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.
(97)
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.
(98)
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.
(99)
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.
(100)
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.
(101)
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.
(102)
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.
(103)
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.
(104)
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.
(105)
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.
(106)
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.
(107)
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.
(108)
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.
(109)
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.
(110)
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.
(111)
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.
(112)
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.
(113)
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.
(114)
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.
(115)
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.
(116)
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.
(117)
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.
(118)
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.
(119)
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.
(120)
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.
(121)
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.
(122)
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.
(123)
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.
(124)
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.
(125)
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.
(126)
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.
(127)
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.
(128)
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.
(129)
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
)
.
(130)
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.
(131)
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.
(132)
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.
(133)
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.
(134)
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.
(135)
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.
(136)
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.
(137)
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.
(138)
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.
(139)
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.
(140)
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.
(141)
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.
(142)
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.
(143)
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.
(144)
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.
(145)
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.
(146)
To encourage Member States to enhance the health status of their aquatic populations, certain adjustments and added flexibility should be introduced in this Regulation.
(147)
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.
(148)
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.
(149)
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.
(150)
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.
(151)
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.
(152)
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.
(153)
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.
(154)
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.
(155)
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.
(156)
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.
(157)
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.
(158)
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.
(159)
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.
(160)
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.
(161)
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.
(162)
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.
(163)
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.
(164)
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.
(165)
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.
(166)
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.
(167)
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:
Directive 64/432/EEC, Council Directive 77/391/EEC 
(
28
)
, Council Directive 78/52/EEC 
(
29
)
, Council Directive 80/1095/EEC 
(
30
)
, Council Directive 82/894/EEC 
(
31
)
, Council Directive 88/407/EEC 
(
32
)
, Council Directive 89/556/EEC 
(
33
)
, Council Directive 90/429/EEC 
(
34
)
,
Directive 91/68/EEC, Council Decision 91/666/EEC 
(
35
)
, Council Directive 92/35/EEC 
(
36
)
, Directive 92/65/EEC, Council Directive 92/66/EEC 
(
37
)
, Council Directive 92/118/EEC 
(
38
)
, Council Directive 92/119/EEC 
(
39
)
, Council Decision 95/410/EC 
(
40
)
, Council Directive 2000/75/EC 
(
41
)
, Council Decision 2000/258/EC 
(
42
)
, Council Directive 2001/89/EC 
(
43
)
,
Council Directive 2002/60/EC 
(
44
)
, Council Directive 2002/99/EC 
(
45
)
, Council Directive 2003/85/EC 
(
46
)
, Council Regulation (EC) No 21/2004 
(
47
)
, Council Directive 2004/68/EC 
(
48
)
, Council Directive 2005/94/EC 
(
49
)
, Directive 2006/88/EC, Council Directive 2008/71/EC 
(
50
)
, Directive 2009/156/EC, Directive 2009/158/EC, Regulation (EU) No 576/2013 of the European Parliament and of the Council 
(
51
)
.
(168)
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.
(169)
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.
(170)
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.
(171)
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
)
.
(172)
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.
(173)
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.
(174)
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.
(175)
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.
(176)
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
)
.
(177)
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.
(178)
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.
(179)
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,
HAVE ADOPTED THIS REGULATION:
PART I
GENERAL RULES
CHAPTER 1
Subject matter, aim, scope and definitions
Article 1
Subject matter and aim
1.   This Regulation lays down rules for the prevention and control of animal diseases which are transmissible to animals or to humans.
Those rules provide for:
(a)
the prioritisation and categorisation of diseases of Union concern and for the establishment of responsibilities for animal health (Part I: Articles 1 to 17);
(b)
the early detection, notification and reporting of diseases, surveillance, eradication programmes and disease–free status (Part II: Articles 18 to 42);
(c)
disease awareness, preparedness and control (Part III: Articles 43 to 83);
(d)
the registration and approval of establishments and transporters, movements and traceability of animals, germinal products and products of animal origin within the Union (Part IV: Articles 84 to 228; and Part VI: Articles 244 to 248 and 252 to 256);
(e)
the entry of animals, germinal products, and products of animal origin into the Union and the export of such consignments from the Union (Part V: Articles 229 to 243; and Part VI: Articles 244 to 246 and 252 to 256);
(f)
non–commercial movements of pet animals into a Member State from another Member State or from a third country or territory, (Part VI: Articles 244 to 256);
(g)
the emergency measures to be taken in the event of a disease emergency situation (Part VII: Articles 257 to 262).
2.   The rules referred to in paragraph 1:
(a)
aim to ensure:
(i)
improved animal health to support sustainable agricultural and aquaculture production in the Union;
(ii)
the effective functioning of the internal market;
(iii)
a reduction in the adverse effects on animal health, public health and the environment of:
—
certain diseases;
—
the measures taken to prevent and control diseases;
(b)
take into account:
(i)
the relationship between animal health and:
—
public health;
—
the environment, including biodiversity and valuable genetic resources, as well as the impact of climate change;
—
food and feed safety;
—
animal welfare, including the sparing of any avoidable pain, distress or suffering;
—
antimicrobial resistance;
—
food security;
(ii)
the economic, social, cultural and environmental consequences arising from the application of disease control and prevention measures;
(iii)
relevant international standards.
Article 2
Scope
1.   This Regulation shall apply to:
(a)
kept and wild animals;
(b)
germinal products;
(c)
products of animal origin;
(d)
animal by–products and derived products, without prejudice to the rules laid down in Regulation (EC) No 1069/2009;
(e)
facilities, means of transport, equipment and all other paths of infection and material involved or potentially involved in the spread of transmissible animal diseases.
2.   This Regulation shall apply to transmissible diseases, including zoonoses, without prejudice to the rules laid down in:
(a)
Decision No 1082/2013/EU;
(b)
Regulation (EC) No 999/2001;
(c)
Directive 2003/99/EC;
(d)
Regulation (EC) No 2160/2003.
Article 3
Scope of Parts IV, V and VI
1.   Title I of Part IV (Articles 84 to 171) shall apply to:
(a)
terrestrial animals, and animals which are not terrestrial animals but which may transmit diseases affecting terrestrial animals;
(b)
germinal products from terrestrial animals;
(c)
products of animal origin from terrestrial animals.
2.   Title II of Part IV (Articles 172 to 226) shall apply to:
(a)
aquatic animals, and animals which are not aquatic animals but which may transmit diseases affecting aquatic animals;
(b)
products of animal origin from aquatic animals.
3.   Title III of Part IV (Articles 227 and 228) shall apply to:
(a)
other animals;
(b)
germinal products and products of animal origin from the other animals referred to in point (a).
4.   Parts IV and V shall not apply to non–commercial movements of pet animals as referred to in paragraph 6 of this Article or to non–commercial movements of pet animals within a Member State.
5.   Movements of pet animals, other than non–commercial movements, shall comply with the animal health requirements laid down in Parts IV and V.
The Commission shall adopt delegated acts in accordance with Article 264 concerning the adaptations which are necessary in order to ensure that Parts IV and V are correctly applied to pet animals, in particular to take account of the fact that pet animals are kept in households by pet keepers.
6.   Part VI shall only apply to non–commercial movements of pet animals that comply with the requirements laid down in Articles 245 and 246 as regards the maximum number of animals that may accompany their owner and the maximum number of days elapsing between the movement of the owner and the movement of the animal.
Article 4
Definitions
For the purposes of this Regulation, the following definitions apply:
(1)
‘animals’ means vertebrate and invertebrate animals;
(2)
‘terrestrial animals’ means birds, terrestrial mammals, bees and bumble bees;
(3)
‘aquatic animals’ means animals of the following species, at all life stages, including eggs, sperm and gametes:
(a)
fish belonging to the superclass 
Agnatha
 and to the classes 
Chondrichthyes
, 
Sarcopterygii
 and 
Actinopterygii
;
(b)
aquatic molluscs belonging to the phylum 
Mollusca
;
(c)
aquatic crustaceans belonging to the subphylum 
Crustacea
;
(4)
‘other animals’ means animals of species other than those falling within the definition of terrestrial or aquatic animals;
(5)
‘kept animals’ means animals which are kept by humans, including, in the case of aquatic animals, aquaculture animals;
(6)
‘aquaculture’ means the keeping of aquatic animals where the animals remain the property of one or more natural or legal persons throughout the rearing or culture stages, up to and including harvesting, excluding the harvesting or catching for the purposes of human consumption of wild aquatic animals which are subsequently temporarily kept while awaiting slaughter without being fed;
(7)
‘aquaculture animals’ means any aquatic animals subject to aquaculture,
(8)
‘wild animals’ means animals which are not kept animals;
(9)
‘poultry’ means birds that are reared or kept in captivity for:
(a)
the production of:
(i)
meat;
(ii)
eggs for consumption;
(iii)
other products;
(b)
restocking supplies of game birds;
(c)
the purpose of breeding of birds used for the types of production referred to in points (a) and (b);
(10)
‘captive birds’ means any birds other than poultry that are kept in captivity for any reason other than those referred to in point (9), including those that are kept for shows, races, exhibitions, competitions, breeding or selling;
(11)
‘pet animal’ means a kept animal of the species listed in Annex I which is kept for private non–commercial purposes;
(12)
‘pet keeper’ means a natural person, and may include a pet owner, keeping a pet animal;
(13)
‘pet owner’ means a natural person indicated as the owner in the identification document referred to in point (c) of Article 247, point (c) of Article 248(2), point (c) of Article 249(1) and point (c) of Article 250(2);
(14)
‘non–commercial movement’ means any movement of a pet animal accompanying its owner and which
(a)
does not have as its aim either the sale of or another form of transfer of ownership of the pet animal concerned; and
(b)
is part of the movement of the pet owner:
(i)
either under his direct responsibility; or
(ii)
under the responsibility of an authorised person, in cases where the pet animal is physically separated from the pet owner;
(15)
‘authorised person’ means any natural person who has authorisation in writing from the pet owner to carry out the non–commercial movement of the pet animal on behalf of the pet owner;
(16)
‘disease’ means the occurrence of infections and infestations in animals, with or without clinical or pathological manifestations, caused by one or more disease agents;
(17)
‘disease agent’ means a pathogen transmissible to animals or to humans which is capable of causing a disease in animals;
(18)
‘listed diseases’ means diseases listed in accordance with Article 5(1);
(19)
‘disease profile’ means the criteria of a disease referred to in point (a) of Article 7;
(20)
‘listed species’ means an animal species or group of animal species listed in accordance with Article 8(2), or, in the case of emerging diseases, an animal species or group of animal species which meets the criteria for listed species laid down in Article 8(2);
(21)
‘hazard’ means a disease agent in, or a condition of, an animal or product with the potential to have an adverse effect on the health of humans or animals;
(22)
‘risk’ means the likelihood of the occurrence and the likely magnitude of the biological and economic consequences of an adverse effect on animal or public health;
(23)
‘biosecurity’ means the sum of management and physical measures designed to reduce the risk of the introduction, development and spread of diseases to, from and within:
(a)
an animal population, or
(b)
an establishment, zone, compartment, means of transport or any other facilities, premises or location;
(24)
‘operator’ means any natural or legal person having animals or products under his responsibility, including for a limited duration of time, but excluding pet keepers and veterinarians;
(25)
‘transporter’ means an operator transporting animals on his own account or on account of a third party;
(26)
‘animal professional’ means a natural or legal person having an occupational relationship with animals or products, other than operators or veterinarians;
(27)
‘establishment’ means any premises, structure, or, in the case of open-air farming, any environment or place, where animals or germinal products are kept, on a temporary or permanent basis, except for:
(a)
households where pet animals are kept;
(b)
veterinary practices or clinics;
(28)
‘germinal products’ means:
(a)
semen, oocytes and embryos intended for artificial reproduction;
(b)
hatching eggs;
(29)
‘products of animal origin’ means:
(a)
food of animal origin, including honey and blood;
(b)
live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods, intended for human consumption; and
(c)
animals other than those referred to in point (b) intended to be prepared with a view to being supplied live to the final consumer;
(30)
‘animal by–products’ means entire bodies or parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption, excluding germinal products;
(31)
‘derived products’ means products obtained from one or more treatments, transformations or steps in the processing of animal by–products;
(32)
‘products’ means:
(a)
germinal products;
(b)
products of animal origin;
(c)
animal by–products and derived products;
(33)
‘official control’ means any form of control carried out by a competent authority for the purpose of verifying compliance with this Regulation;
(34)
‘health status’ means the disease status as regards the listed diseases relevant for a particular listed species with respect to:
(a)
an animal;
(b)
animals within:
(i)
an epidemiological unit;
(ii)
an establishment;
(iii)
a zone;
(iv)
a compartment;
(v)
a Member State;
(vi)
a third country or territory;
(35)
‘zone’ means:
(a)
for terrestrial animals, an area of a Member State, third country or territory with a precise geographical delimitation, containing an animal subpopulation with a distinct health status with respect to a specific disease or specific diseases subject to appropriate surveillance, disease control and biosecurity measures;
(b)
for aquatic animals, a contiguous hydrological system with a distinct health status with respect to a specific disease or specific diseases that forms an area that is referred to in one of the following:
(i)
an entire water catchment from the source of a waterway to the estuary or lake;
(ii)
more than one water catchment;
(iii)
part of a water catchment from the source of a waterway to a barrier that prevents the introduction of a specific disease or diseases;
(iv)
part of a coastal area with a precise geographical delimitation;
(v)
an estuary with a precise geographical delimitation;
(36)
‘water catchment’ means an area or basin of land bounded by natural features such as hills or mountains, into which all run–off water flows;
(37)
‘compartment’ means an animal subpopulation contained in one or more establishments and, in the case of aquatic animals, in one or more aquaculture establishments, under a common biosecurity management system with a distinct health status with respect to a specific disease or specific diseases subject to appropriate surveillance, disease control and biosecurity measures;
(38)
‘quarantine’ means the keeping of animals in isolation with no direct or indirect contact with animals outside the epidemiological unit, for the purpose of ensuring that there is no spread of one or more specified diseases while the animals in isolation are undergoing observation for a specified length of time and, if appropriate, testing and treatment;
(39)
‘epidemiological unit’ means a group of animals with the same likelihood of exposure to a disease agent;
(40)
‘outbreak’ means the officially confirmed occurrence of a listed disease or an emerging disease in one or more animals in an establishment or other place where animals are kept or located;
(41)
‘restricted zone’ means a zone in which restrictions on the movements of certain animals or products and other disease control measures are applied, with a view to preventing the spread of a particular disease into areas where no restrictions are applied; a restricted zone may, when relevant, include protection and surveillance zones;
(42)
‘protection zone’ means a zone around and including the location of an outbreak, where disease control measures are applied in order to prevent the spread of the disease from that zone;
(43)
‘surveillance zone’ means a zone which is established around the protection zone, and where disease control measures are applied in order to prevent the spread of the disease from the protection zone;
(44)
‘hatching eggs’ means eggs, laid by poultry or captive birds, intended for incubation;
(45)
‘ungulates’ means the animals listed in Annex III;
(46)
‘germinal product establishment’ means:
(a)
in relation to semen, an establishment where semen is collected, produced, processed or stored;
(b)
in relation to oocytes and embryos, a group of professionals or structure supervised by a team veterinarian competent to perform the collection, production, processing and storage of oocytes and embryos;
(c)
in relation to hatching eggs, a hatchery;
(47)
‘hatchery’ means an establishment which collects, stores, incubates and hatches eggs for the supply of:
(a)
hatching eggs;
(b)
day–old chicks or hatchlings of other species;
(48)
‘confined establishment’ means any permanent, geographically limited establishment, created on a voluntary basis and approved for the purpose of movements, where the animals are:
(a)
kept or bred for the purposes of exhibitions, education, the conservation of species or research;
(b)
confined and separated from the surrounding environment; and
(c)
subject to animal health surveillance and biosecurity measures;
(49)
‘assembly operation’ means the assembling of kept terrestrial animals from more than one establishment for a period shorter than the required residency period for the species of animals concerned;
(50)
‘residency period’ means the minimum period necessary in order to ensure that an animal which has been introduced into an establishment is not of a lower health status than that of the animals in that establishment;
(51)
‘Traces’ means the integrated computerised veterinary system with a single architecture provided for in Decisions 2003/24/EC and 2004/292/EC;
(52)
‘disease control aquatic food establishment’ means a food business approved in accordance with Article 179;
(53)
‘official veterinarian’ means a veterinarian authorised by the competent authority and appropriately qualified to perform official activities in accordance with this Regulation;
(54)
‘official veterinarian in a third country or territory’ means a veterinarian in a third country or territory corresponding to an official veterinarian as referred to in point (53);
(55)
‘competent authority’ means the central veterinary authority of a Member State responsible for the organisation of official controls and any other official activities in accordance with this Regulation or any other authority to which that responsibility has been delegated;
(56)
‘competent authority of a third country or territory’ means the authority in a third country or territory corresponding to the competent authorities referred to in point (55).
CHAPTER 2
Listed diseases and emerging diseases and listed species
Article 5
Listing of diseases
1.   The disease-specific rules for the prevention and control of diseases provided for in this Regulation shall apply to:
(a)
the following listed diseases:
(i)
foot and mouth disease;
(ii)
classical swine fever;
(iii)
African swine fever;
(iv)
highly pathogenic avian influenza;
(v)
African horse sickness; and
(b)
the listed diseases set out in the list in Annex II.
2.   The Commission shall adopt delegated acts in accordance with Article 264 concerning amendments to the list referred to in point (b) of paragraph 1 of this Article.
3.   A disease shall be included on the list referred to in point (b) of paragraph 1 of this Article if it has been assessed in accordance with Article 7 and it meets:
(a)
all of the following criteria:
(i)
scientific evidence indicates that the disease is transmissible;
(ii)
animal species are either susceptible to the disease or vectors and reservoirs thereof exist in the Union;
(iii)
the disease causes negative effects on animal health or poses a risk to public health due to its zoonotic character;
(iv)
diagnostic tools are available for the disease; and
(v)
risk-mitigating measures and, where relevant, surveillance of the disease are effective and proportionate to the risks posed by the disease in the Union; and
(b)
at least one of the following criteria:
(i)
the disease causes or could cause significant negative effects in the Union on animal health, or poses or could pose a significant risk to public health due to its zoonotic character;
(ii)
the disease agent has developed resistance to treatments which poses a significant danger to public and/or animal health in the Union;
(iii)
the disease causes or could cause a significant negative economic impact affecting agriculture or aquaculture production in the Union;
(iv)
the disease has the potential to generate a crisis or the disease agent could be used for the purpose of bioterrorism; or
(v)
the disease has or could have a significant negative impact on the environment, including biodiversity, of the Union.
4.   The Commission shall adopt delegated acts in accordance with Article 264 concerning the removal of a disease from the list referred to in point (b) of paragraph 1 of this Article when that disease no longer fulfils the criteria provided for in paragraph 3 of this Article.
5.   The Commission shall review the listing of each disease in the light of newly available significant scientific data.
Article 6
Emerging diseases
1.   The rules for the prevention and control of diseases shall apply to emerging diseases as provided for in this Regulation.
2.   A disease other than a listed disease shall be considered to be an emerging disease (‘emerging disease’) provided it has the potential to meet the criteria for listing diseases provided for in Article 5(3) and:
(a)
results from the evolution or change of an existing disease agent;
(b)
is a known disease spreading to a new geographic area, species or population;
(c)
is diagnosed for the first time in the Union; or
(d)
is caused by an unrecognised or a previously unrecognised disease agent.
3.   The Commission shall, by means of implementing acts, take the necessary measures regarding an emerging disease which fulfils the criteria set out in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
4.   On duly justified imperative grounds of urgency relating to a disease representing an emerging risk having a highly significant impact, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 266(3).
5.   Any obligation on operators in respect of an emerging disease, as set out in this Regulation, shall only apply if the Commission has adopted an implementing act for that disease in accordance with paragraph 3 of this Article or if the disease is covered by a contingency plan in accordance with Article 43.
Article 7
Assessment parameters for the listing of diseases
The Commission shall use the following assessment parameters in order to determine whether a disease meets the conditions requiring it to be listed in accordance with Article 5(2):
(a)
the disease profile, which shall comprise the following:
(i)
the animal species concerned by the disease;
(ii)
the morbidity and mortality rates of the disease in animal populations;
(iii)
the zoonotic character of the disease;
(iv)
the resistance to treatments, including antimicrobial resistance;
(v)
the persistence of the disease in an animal population or in the environment;
(vi)
the routes and speed of transmission of the disease between animals and, when relevant, between animals and humans;
(vii)
the absence or presence and distribution of the disease in the Union, and, where the disease is not present in the Union, the risk of its introduction into the Union;
(viii)
the existence of diagnostic and disease control tools;
(b)
the impact of the disease on:
(i)
agricultural and aquaculture production and other parts of the economy, as regards:
—
the level of presence of the disease in the Union;
—
the loss of production due to the disease;
—
other losses;
(ii)
human health, as regards:
—
transmissibility between animals and humans;
—
transmissibility between humans;
—
the severity of human forms of the disease;
—
the availability of effective prevention or medical treatment in humans;
(iii)
animal welfare;
(iv)
biodiversity and the environment;
(c)
its potential to generate a crisis situation and its potential use in bioterrorism;
(d)
the feasibility, availability and effectiveness of the following disease prevention and control measures:
(i)
diagnostic tools and capacities;
(ii)
vaccination;
(iii)
medical treatments;
(iv)
biosecurity measures;
(v)
restrictions on the movement of animals and products;
(vi)
killing of animals;
(vii)
disposal of carcasses and other relevant animal by–products;
(e)
the impact of disease prevention and control measures, as regards:
(i)
the direct and indirect costs for the affected sectors and the economy as a whole;
(ii)
their societal acceptance;
(iii)
the welfare of affected subpopulations of kept and wild animals;
(iv)
the environment and biodiversity.
Article 8
Listing of species
1.   The disease-specific rules for listed diseases provided for in this Regulation and the rules adopted pursuant to this Regulation shall apply to listed species.
2.   The Commission shall, by means of implementing acts, establish a list of species as referred to in paragraph 1 of this Article that fulfil the criteria set out in paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
That list shall comprise those animal species, or groups of animal species which pose a considerable risk for the spread of specific listed diseases, based on the following criteria:
(a)
the susceptibility of the animal population at risk;
(b)
the duration of the incubation period and infective period for the animals concerned;
(c)
the capability of those animals to carry those specific diseases.
3.   Animal species or groups of animal species shall be added to the list if they are affected or if they pose a risk for the spread of a specific listed disease because:
(a)
they are susceptible to a specific listed disease or scientific evidence indicates that such susceptibility is likely; or
(b)
they are vector species or reservoirs for that disease, or scientific evidence indicates that such role is likely.
4.   The Commission shall, by means of implementing acts, remove animal species or groups of animal species from the list when:
(a)
the relevant listed disease in relation to which the animal species or group of animal species concerned has been listed has been removed from the list of diseases; or
(b)
scientific evidence indicates that the species or group of species concerned no longer fulfils the criteria set out in paragraph 3.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 9
Disease prevention and control rules to be applied to different categories of listed diseases
1.   Disease prevention and control rules shall apply to listed diseases as follows:
(a)
As regards listed diseases that do not normally occur in the Union and for which immediate eradication measures must be taken as soon as they are detected, the following rules shall apply, as relevant:
(i)
the rules for disease awareness and preparedness provided for in Title I of Part III (Articles 43 to 52);
(ii)
the disease control measures provided for in Chapter 1 of Title II of Part III (Articles 53 to 71); and
(iii)
the rules for compartmentalisation provided for in Article 37(1).
For those listed diseases, the measures referred to in point (b), as appropriate, as well as points (d) and (e), shall also apply, as relevant.
(b)
As regards listed diseases which must be controlled in all Member States with the goal of eradicating them throughout the Union, the following rules shall apply, as relevant:
(i)
the rules for compulsory eradication programmes provided for in Article 31(1);
(ii)
the rules for disease–free Member States and zones provided for in Article 36;
(iii)
the rules for compartmentalisation provided for in Article 37(2); and
(iv)
the disease control measures provided for in Articles 72 to 75, Articles 77 to 79 and Articles 81 and 83.
For those listed diseases, the measures referred to in points (d) and (e) shall also apply, as relevant.
(c)
As regards listed diseases which are of relevance to some Member States and for which measures are needed to prevent them from spreading to parts of the Union that are officially disease-free or that have eradication programmes for the listed disease concerned, the following rules shall apply, as relevant:
(i)
the rules for optional eradication provided for in Article 31(2);
(ii)
the rules for disease–free Member States and zones provided for in Article 36;
(iii)
the rules for compartmentalisation provided for in Article 37(2); and
(iv)
the rules for disease control measures provided for in Articles 76, 77, 78, 80, 82 and 83.
For those listed diseases, the measures referred to in points (d) and (e) shall also apply, as relevant.
(d)
As regards listed diseases for which measures are needed to prevent them from spreading on account of their entry into the Union or movements between Member States, the following rules shall apply, as relevant:
(i)
the rules for movement within the Union provided for in Chapters 3 to 6 of Title I (Articles 124 to 169), Chapters 2 and 3 of Title II of Part IV (Articles 191 to 225) and Chapters 2 and 3 of Part VI (Articles 247 to 251); and
(ii)
the rules for entry into the Union and export from the Union provided for in Part V (Articles 229 to 243).
The listed diseases referred to in points (a), (b) and (c) shall also be considered as listed diseases under this point, as well as those referred to in point (e), where the risk posed by the disease in question can be effectively and proportionately mitigated by measures concerning movements of animals and products.
(e)
As regards listed diseases for which there is a need for surveillance within the Union, the following rules shall apply, as relevant:
(i)
the rules for notification and reporting provided for in Chapter 1 of Part II (Articles 18 to 23); and
(ii)
the rules for surveillance provided for in Chapter 2 of Part II (Articles 24 to 30).
The listed diseases referred to in points (a), (b) and (c) shall also be considered as listed diseases under this point.
2.   The Commission shall, by means of implementing acts, determine the application of the disease prevention and control rules referred to in paragraph 1 to the respective listed diseases on the basis of the criteria set out in Annex IV, also in the light of newly available significant scientific data.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
3.   The Commission shall, by means of implementing acts, modify the application of the disease prevention and control rules referred to in paragraph 2 to the respective listed diseases when the disease in question no longer fulfils the criteria laid down in the relevant Section of Annex IV, also in the light of newly available significant scientific data.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
4.   On duly justified imperative grounds of urgency relating to a listed disease representing an emerging risk having a highly significant impact, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 266(3).
CHAPTER 3
Responsibilities for animal health
Section 1
Operators, animal professionals and pet keepers
Article 10
Responsibilities for animal health and biosecurity measures
1.   Operators shall:
(a)
as regards kept animals and products under their responsibility, be responsible for:
(i)
the health of kept animals;
(ii)
prudent and responsible use of veterinary medicines, without prejudice to the role and responsibility of veterinarians,
(iii)
minimising the risk of the spread of diseases;
(iv)
good animal husbandry;
(b)
where appropriate, take such biosecurity measures regarding kept animals, and products under their responsibility, as are appropriate for:
(i)
the species and categories of kept animals and products;
(ii)
the type of production; and
(iii)
the risks involved, taking into account:
—
geographical location and climatic conditions; and
—
local circumstances and practices;
(c)
where appropriate, take biosecurity measures regarding wild animals.
2.   Animal professionals shall take action to minimise the risk of the spread of diseases in the context of their occupational relationship with animals and products.
3.   Point (a) of paragraph 1 shall also apply to pet keepers.
4.   The biosecurity measures referred to in point (b) of paragraph 1 shall be implemented, as appropriate, through:
(a)
physical protection measures, which may include:
(i)
enclosing, fencing, roofing, netting, as appropriate;
(ii)
cleaning, disinfection and control of insects and rodents;
(iii)
in the case of aquatic animals, where appropriate:
—
measures concerning the water supply and discharge;
—
natural or artificial barriers to surrounding water courses that prevent aquatic animals from entering or leaving the establishment concerned, including measures against flooding or infiltration of water from surrounding water courses;
(b)
management measures, which may include:
(i)
procedures for entering and exiting the establishment for animals, products, vehicles and persons;
(ii)
procedures for using equipment;
(iii)
conditions for movement based on the risks involved;
(iv)
conditions for introducing animals or products into the establishment;
(v)
quarantine, isolation or separation of newly introduced or sick animals;
(vi)
a system for safe disposal of dead animals and other animal by–products.
5.   Operators, animal professionals and pet keepers shall cooperate with the competent authority and veterinarians in the application of the disease prevention and control measures provided for in this Regulation.
6.   The Commission may, by means of implementing acts, lay down minimum requirements necessary for the uniform application of this Article.
Such implementing acts shall reflect the matters referred to in point (b) of paragraph 1.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 11
Knowledge of animal health
1.   Operators and animal professionals shall have adequate knowledge of:
(a)
animal diseases, including those that are transmissible to humans;
(b)
biosecurity principles;
(c)
the interaction between animal health, animal welfare and human health;
(d)
good practice of animal husbandry for the animal species under their care;
(e)
resistance to treatments, including antimicrobial resistance, and its implications.
2.   The content and the level of knowledge required in accordance with paragraph 1 shall depend on:
(a)
the species and categories of kept animals or products under the responsibility of the operators and animal professionals concerned and the nature of their occupational relationship with those animals or products;
(b)
the type of production;
(c)
the tasks performed.
3.   The knowledge provided for in paragraph 1 shall be acquired in one of the following ways:
(a)
professional experience or training;
(b)
existing programmes in agricultural or aquaculture sectors that are relevant for animal health;
(c)
formal education;
(d)
other experience or other training which results in the same level of knowledge as that covered by points (a), (b) or (c).
4.   Operators selling or otherwise transferring the ownership of future pet animals shall provide basic information to the future pet keeper, regarding the matters referred to in paragraph 1, as relevant for the pet animal in question.
Section 2
Veterinarians and aquatic animal health professionals
Article 12
Responsibilities of veterinarians and aquatic animal health professionals
1.   Veterinarians shall in the course of their activities which fall within the scope of this Regulation:
(a)
take all appropriate measures to prevent the introduction, development and spread of diseases;
(b)
take action to ensure the early detection of diseases by carrying out proper diagnosis and differential diagnosis to rule out or confirm a disease;
(c)
play an active role in:
(i)
raising animal health awareness, and awareness of the interaction between animal health, animal welfare and human health;
(ii)
disease prevention;
(iii)
the early detection of, and rapid response to, diseases.
(iv)
raising awareness of resistance to treatments, including antimicrobial resistance, and its implications;
(d)
cooperate with the competent authority, operators, animal professionals and pet keepers in the application of the disease prevention and control measures provided for in this Regulation.
2.   Aquatic animal health professionals may undertake activities assigned to veterinarians under this Regulation in relation to aquatic animals provided that they are authorised to do so by the Member State concerned under national law. In that event, paragraph 1 shall apply to those aquatic animal health professionals.
3.   Veterinarians and aquatic animal health professionals shall maintain and develop their professional capacities related to their areas of activities which fall within the scope of this Regulation.
Section 3
Member States
Article 13
Member States' responsibilities
1.   In order to ensure that the competent authority for animal health has the capability to take the necessary and appropriate measures, and to carry out the activities, required by this Regulation, each Member State shall, at the appropriate administrative level, ensure that competent authority has:
(a)
qualified personnel, facilities, equipment, financial resources and an effective organisation covering the whole territory of the Member State;
(b)
access to laboratories with the qualified personnel, facilities, equipment and financial resources needed to ensure the rapid and accurate diagnosis and differential diagnosis of listed diseases and emerging diseases;
(c)
sufficiently trained veterinarians involved in performing the activities referred to in Article 12.
2.   Member States shall encourage operators and animal professionals to acquire, maintain and develop the adequate knowledge of animal health provided for in Article 11 through relevant programmes in agricultural or aquaculture sectors or formal education.
Article 14
Delegation by a competent authority of official activities
1.   The competent authority may delegate one or more of the following activities to veterinarians other than official veterinarians:
(a)
practical application of measures under the eradication programmes provided for in Article 32;
(b)
supporting the competent authority in carrying out surveillance as provided for in Article 26 or in relation to surveillance programmes as provided for in Article 28;
(c)
activities related to:
(i)
disease awareness, preparedness and control as provided for in Part III, concerning:
—
sampling activities and implementation of investigations and epidemiological enquiries within the framework of Article 54, points (b) to (g) of Article 55(1), and Articles 57, 73, 74, 79 and 80 in the event of the suspected presence of a disease, and any implementing and delegated acts adopted pursuant to those Articles;
—
carrying out activities relating to disease control measures in the event of an outbreak of disease, as regards activities listed in Article 61, points (a), (b), (e), (f) and (i) of Article 65(1), Article 70(1), Articles 79 and 80, and Article 81(1) and (2), and any implementing and delegated acts adopted pursuant to those Articles;
—
carrying out emergency vaccination in accordance with Article 69;
(ii)
registration, approval, traceability and movements as provided for in Part IV;
(iii)
issuing and completing the identification documents for pet animals as provided for in point (c) of Article 247, point (c) of Article 248(2), point (c) of Article 249(1) and point (c) of Article 250(2);
(iv)
the application and use of means of identification as referred to in point (a)(ii) of Article 252(1).
2.   Member States may provide for natural or legal persons to be authorised to perform activities referred to in points (a), (b) and (c)(i), (ii) and (iv) of paragraph 1 for specifically identified tasks for which those persons have sufficient specific knowledge. In that event, paragraph 1 of this Article and the responsibilities laid down in Article 12 shall apply to those persons.
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning other activities which may be delegated to veterinarians in addition to those provided for in paragraph 1, and, as appropriate, to prescribe the necessary circumstances and conditions for such delegation.
The Commission shall take account of the nature of those activities and of relevant international standards when adopting those delegated acts.
Article 15
Public information
Where there are reasonable grounds to suspect that animals or products originating from within the Union or entering from outside the Union may present a risk, the competent authority shall take appropriate steps to inform the public of the nature of the risk and the measures which are taken or about to be taken to prevent or control that risk, taking into account the nature, seriousness and extent of that risk and the public interest in being informed.
Section 4
Laboratories, facilities and other natural and legal persons handling disease agents, vaccines and other biological products
Article 16
Obligations of laboratories, facilities and others handling disease agents, vaccines and other biological products
1.   Laboratories, facilities and other natural or legal persons handling disease agents for the purpose of research, education, diagnosis or the production of vaccines and other biological products shall, whilst taking into account any relevant international standards:
(a)
take appropriate biosecurity, biosafety and bio–containment measures to prevent the escape of the disease agents and their subsequent contact with animals outside the laboratory or other facility handling disease agents for those purposes;
(b)
ensure that the movement of disease agents, vaccines and other biological products between laboratories or other facilities does not give rise to a risk of the spread of listed and emerging diseases.
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the safety measures for the prevention and control of listed and emerging diseases as regards laboratories, facilities and other natural or legal persons handling the disease agents, vaccines and other biological products in relation to:
(a)
biosecurity, biosafety and bio–containment measures;
(b)
movement requirements for disease agents, vaccines and other biological products.
Article 17
Animal health laboratories
1.   Official laboratories for animal health, consisting of Union reference laboratories, national reference laboratories and official animal health laboratories, shall, in fulfilling their tasks and responsibilities, cooperate within a network of Union animal health laboratories.
2.   The laboratories referred to in paragraph 1 shall cooperate under the coordination of the Union reference laboratories, to ensure that the surveillance, notification and reporting of diseases, eradication programmes, the definition of disease–free status, and the movements of animals and products within the Union, their entry into the Union and exports to third countries or territories provided for in this Regulation, are based on state–of–the–art, solid and reliable laboratory analyses, tests and diagnoses.
3.   The results and reports provided by the official laboratories shall be subject to the principles of professional secrecy and confidentiality and the duty of notification to the competent authority which designated them, irrespective of the natural or legal person who requested the laboratory analyses, tests or diagnoses.
4.   In the event that an official laboratory in one Member State conducts diagnostic analyses on samples from animals originating in another Member State, that official laboratory shall notify the competent authority of the Member State from which the samples originated:
(a)
immediately of any results indicating the suspicion or detection of a listed disease as referred to in point (a) of Article 9(1);
(b)
without undue delay of any results indicating the suspicion or detection of a listed disease as referred to in point (e) of Article 9(1) other than those referred to in point (a) of Article 9(1).
PART II
DISEASE NOTIFICATION AND REPORTING, SURVEILLANCE, ERADICATION PROGRAMMES, DISEASE–FREE STATUS
CHAPTER 1
Disease notification and reporting
Article 18
Notification within Member States
1.   Member States shall ensure that operators and other relevant natural or legal persons:
(a)
immediately notify the competent authority where there are any reasons to suspect the presence in animals of a listed disease as referred to in point (a) of Article 9(1), or where the presence of such a disease is detected in animals;
(b)
as soon as practicable notify the competent authority where there are any reasons to suspect the presence in animals of a listed disease as referred to in point (e) of Article 9(1) other than those referred to in point (a) of Article 9(1), or where the presence of such a disease is detected in animals;
(c)
notify a veterinarian of abnormal mortalities and other signs of serious disease or significant decreased production rates with an undetermined cause, for further investigation, including sampling for laboratory examination when the situation so requires.
2.   Member States may decide that the notifications provided for in point (c) of paragraph 1 may be directed to the competent authority.
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
criteria to determine whether the circumstances requiring notification described in point (c) of paragraph 1 occur;
(b)
detailed rules for the further investigation provided for in point (c) of paragraph 1.
Article 19
Union notification
1.   Member States shall immediately notify the Commission and the other Member States of any outbreaks of listed diseases as referred to in point (e) of Article 9(1) for which an immediate notification is required in order to ensure the timely implementation of necessary risk management measures, taking into account the disease profile.
2.   The notification provided for in paragraph 1 shall contain the following information on the outbreak:
(a)
the disease agent and, where relevant, the subtype;
(b)
the relevant dates, in particular those of the suspicion and the confirmation of the outbreak;
(c)
the type and location of the outbreak;
(d)
any related outbreaks;
(e)
the animals involved in the outbreak;
(f)
any disease control measures taken in relation to the outbreak;
(g)
the possible or known origin of the listed disease;
(h)
the diagnostic methods used.
Article 20
Union reporting
1.   Member States shall report to the Commission and to the other Member States the information on listed diseases referred to in in point (e) of Article 9(1) for which:
(a)
immediate notification of an outbreak is not required under Article 19(1);
(b)
immediate notification of an outbreak is required under Article 19(1), but additional information is required to be reported to the Commission and the other Member States on:
(i)
surveillance in accordance with the rules laid down in an implementing act adopted in accordance with Article 30;
(ii)
an eradication programme in accordance with the rules laid down in an implementing act adopted in accordance with Article 35.
2.   The reports provided for in paragraph 1 shall include information on:
(a)
the detection of the listed diseases referred to in paragraph 1;
(b)
the results of surveillance when required in accordance with rules adopted in accordance with point (d)(ii) of Article 29 or point (b)(ii) of Article 30(1);
(c)
the results of surveillance programmes when required in accordance with Article 28(3) and rules adopted in accordance with point (d)(ii) of Article 29 or point (b)(ii) of Article 30(1);
(d)
eradication programmes when required in accordance with Article 34 and rules laid down in an implementing act adopted in accordance with Article 35.
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning provisions supplementing the requirements of paragraph 2 and reporting on other matters concerning surveillance and eradication programmes where necessary in order to ensure an efficient application of the disease prevention rules and control rules laid down in this Regulation.
Article 21
Notification and reporting regions
The Member States shall establish notification and reporting regions for the purpose of the notification and reporting provided for in Articles 19 and 20.
Article 22
Computerised information system for Union notification and Union reporting of diseases
The Commission shall set up and manage a computerised information system for the operation of the mechanisms and tools for the notification and reporting requirements provided for in Articles 19, 20 and 21.
Article 23
Implementing powers concerning Union notification and Union reporting and the computerised information system
The Commission shall, by means of implementing acts, lay down rules for the notification and reporting requirements and the computerised information system provided for in Articles 19 to 22 with respect to:
(a)
those listed diseases referred to in point (e) of Article 9(1) which are to be subject to immediate notification by the Member States as well as the necessary measures relating to the notification, in accordance with Article 19;
(b)
the information to be provided by the Member States in the reporting provided for in Article 20;
(c)
procedures for the establishment and use of the computerised information system provided for in Article 22 and transitional measures for the migration of the data and the information from existing systems into the new system and its full operability;
(d)
the format and structure of the data to be entered into the computerised information system provided for in Article 22;
(e)
the deadlines and frequencies of the notification and reporting provided for in Articles 19 and 20, which shall be done at times and frequencies which ensure transparency and the timely application of the necessary risk management measures, based on the disease profile and the type of outbreak.
(f)
the listing of notification and reporting regions provided for in Article 21.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
CHAPTER 2
Surveillance
Article 24
Operators' surveillance obligation
For the purpose of detecting the presence of listed diseases and emerging diseases, operators shall:
(a)
observe the health and behaviour of animals under their responsibility;
(b)
observe any changes in the normal production parameters in the establishments, animals or germinal products under their responsibility that may give rise to a suspicion of being caused by a listed disease or emerging disease;
(c)
look for abnormal mortalities and other signs of serious disease in animals under their responsibility.
Article 25
Animal health visits
1.   Operators shall ensure that establishments under their responsibility receive animal health visits from a veterinarian when appropriate due to the risks posed by the establishment in question, taking into account:
(a)
the type of establishment;
(b)
the species and categories of kept animals on the establishment;
(c)
the epidemiological situation in the zone or region as regards listed and emerging diseases to which the animals in the establishment are susceptible;
(d)
any other relevant surveillance, or official controls to which the kept animals and type of establishment are subject.
Such animal health visits shall take place at frequencies that are proportionate to the risks posed by the establishment concerned.
They may be combined with visits for other purposes.
2.   The animal health visits provided for in paragraph 1 shall be made for the purpose of disease prevention, in particular through:
(a)
the provision of advice to the operator concerned on biosecurity and other animal health matters, as relevant for the type of establishment and the species and categories of kept animals on the establishment.
(b)
the detection of, and information on, signs indicative of the occurrence of listed diseases or emerging diseases;
3.   The Commission may, by means of implementing acts, lay down minimum requirements necessary for the uniform application of this Article.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 26
The competent authority's surveillance obligation
1.   The competent authority shall conduct surveillance to detect the presence of listed diseases as referred to in point (e) of Article 9(1) and relevant emerging diseases.
2.   The surveillance shall be designed in such a way as to ensure the timely detection of the presence of the listed diseases referred to in point (e) of Article 9(1) and emerging diseases by means of the collection, collation and analysis of relevant information relating to the disease situation.
3.   The competent authority shall, whenever possible and appropriate, make use of the results of the surveillance conducted by operators and the information obtained through animal health visits in accordance with Articles 24 and 25, respectively.
4.   The competent authority shall ensure that surveillance meets the requirements provided for in Article 27 and in any rules adopted pursuant to point (a) of Article 29.
5.   The competent authority shall ensure that the information obtained through the surveillance provided for in paragraph 1 is collected and used in an effective and efficient manner.
Article 27
Methodology, frequency and intensity of surveillance
The design, means, diagnostic methods, frequency, intensity, targeted animal population, and sampling patterns of the surveillance provided for in Article 26 shall be appropriate and proportionate to the objectives of the surveillance, taking into account:
(a)
the disease profile;
(b)
the risk factors involved;
(c)
the health status in:
(i)
the Member State, zone or compartment thereof subject to the surveillance;
(ii)
the Member States and third countries or territories which either border on, or from which animals and products enter into, that Member State, zone or compartment thereof;
(d)
surveillance conducted by operators in accordance with Article 24, including animal health visits as referred to in Article 25, or by other public authorities.
Article 28
Union surveillance programmes
1.   The competent authority shall undertake surveillance as provided for in Article 26(1) within the framework of a surveillance programme when a disease is relevant for the Union in accordance with point (c) of Article 29.
2.   Member States establishing a surveillance programme in accordance with paragraph 1 shall submit it to the Commission.
3.   Member States implementing a surveillance programme in accordance with paragraph 1 shall submit regular reports on the results of the implementation of that programme to the Commission.
Article 29
Delegation of powers
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
the design, means, diagnostic methods, frequency, intensity, targeted animal population, and sampling patterns of the surveillance provided for in Article 27;
(b)
the criteria for the official confirmation and case definitions of listed diseases as referred to in point (e) of Article 9(1), and, where relevant, of emerging diseases;
(c)
the criteria used to establish the relevance of a disease which is to be subject to a surveillance programme relevant for the Union for the purposes of point (a) of Article 30(1), taking into account the disease profile and the risk factors involved;
(d)
requirements for surveillance programmes as provided for in Article 28(1) regarding:
(i)
the contents of surveillance programmes;
(ii)
the information to be included in the submission of surveillance programmes in accordance with Article 28(2) and regular reports in accordance with Article 28(3);
(iii)
the period of application of surveillance programmes.
Article 30
Implementing powers
1.   The Commission shall, by means of implementing acts, lay down requirements concerning surveillance and surveillance programmes as provided for in Articles 26 and 28 and in the rules adopted pursuant to Article 29, as regards:
(a)
establishing which of the listed diseases referred to in point (e) of Article 9(1) are to be subject to surveillance programmes in accordance with Article 28, including the geographical scope of such programmes;
(b)
the format and procedure for:
(i)
the submission of those surveillance programmes for information to the Commission and other Member States;
(ii)
the reporting to the Commission on the results of the surveillance.
2.   The Commission may, by means of implementing acts, lay down the criteria to be used for evaluating the surveillance programmes referred to in Article 28.
3.   The implementing acts referred to in paragraphs 1 and 2 of this Article shall be adopted in accordance with the examination procedure referred to in Article 266(2).
CHAPTER 3
Eradication programmes
Article 31
Compulsory and optional eradication programmes
1.   Member States which are not free, or not known to be free, from one or more of the listed diseases referred to in point (b) of Article 9(1) throughout their territory, or in zones or compartments thereof, shall:
(a)
establish a programme for the eradication of, or demonstration of freedom from, that listed disease, to be carried out in the animal populations concerned by that disease and covering the relevant parts of their territory or the relevant zones or compartments thereof (‘compulsory eradication programme’), to apply until the conditions for the grant of disease–free status in the territory of the Member State or zone concerned, as provided for in Article 36(1), or compartment, as provided for in Article 37(2), are fulfilled;
(b)
submit the draft compulsory eradication programme to the Commission for approval.
2.   Member States which are not free, or not known to be free, from one or more of the listed diseases referred to in point (c) of Article 9(1) and which decide to establish a programme for the eradication of that listed disease, to be carried out in the animal populations concerned by the disease in question and covering the relevant parts of their territory or zones or compartments thereof (‘optional eradication programme’), shall submit a draft of that programme to the Commission for approval, where the Member State concerned asks for the recognition, within the Union, of animal health guarantees as regards the disease in question for movements of animals or products.
Such an optional eradication programme shall apply until:
(a)
the conditions for the grant of disease–free status in the territory of the Member State or zone concerned, as provided for in Article 36(1), or compartment, as provided for in Article 37(2), are fulfilled; or
(b)
it is established that the conditions for the grant of disease–free status cannot be achieved and that the programme no longer fulfils its purpose; or
(c)
the Member State concerned withdraws the programme.
3.   The Commission shall, by means of implementing acts, approve:
(a)
draft compulsory eradication programmes submitted to it for approval in accordance with paragraph 1;
(b)
draft optional eradication programmes submitted to it for approval in accordance with paragraph 2,
if the conditions set out in this Chapter are met.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
4.   On duly justified imperative grounds of urgency relating to a listed disease representing a risk having a highly significant impact, the Commission shall adopt immediately applicable implementing acts provided for in point (a) of paragraph 3 of this Article in accordance with the procedure referred to in Article 266(3).
The Commission may, for duly justified reasons, by means of implementing acts, approve an amendment proposed by the Member State concerned or withdraw the approval of eradication programmes approved in accordance with points (a) and (b) of paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
5.   The Commission shall adopt delegated acts in accordance with Article 264 concerning:
(a)
the disease control strategies, intermediate and final targets for specific diseases, and period of application of eradication programmes;
(b)
derogations from the requirement for the submission of eradication programmes for approval, as provided for in point (b) of paragraph 1 of this Article and in paragraph 2 thereof, where such approval is not necessary due to the adoption of rules regarding those programmes in accordance with Articles 32(2) and 35;
(c)
the information to be provided by Member States to the Commission and to the other Member States concerning derogations from the requirement for approval of eradication programmes as provided for in point (b) of this paragraph.
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 amending or discontinuing rules adopted pursuant to point (b) of this paragraph.
Article 32
Measures under compulsory and optional eradication programmes
1.   Eradication programmes shall consist of at least the following measures:
(a)
disease control measures for the eradication of the disease agent from establishments, compartments and zones in which a disease occurs and to prevent re–infection;
(b)
surveillance to be carried out in accordance with the rules laid down in Articles 26 to 30 to demonstrate:
(i)
the effectiveness of the disease control measures provided for in point (a);
(ii)
freedom from the listed disease;
(c)
disease control measures to be taken in the event of positive surveillance results.
2.   The Commission shall adopt delegated acts in accordance with Article 264 concerning the following elements to ensure the effectiveness of eradication programmes:
(a)
disease control measures as provided for in point (a) of paragraph 1;
(b)
disease control measures to be taken to avoid re–infection of the targeted animal population with the disease in question in establishments, zones and compartments;
(c)
surveillance design, means, diagnostic methods, frequency, intensity, targeted animal population and sampling patterns;
(d)
disease control measures to be taken in the event of positive surveillance results for the listed disease as provided for in point (c) of paragraph 1;
(e)
criteria for vaccination, where relevant and appropriate for the disease or species in question.
Article 33
Content of compulsory and optional eradication programmes submitted for approval to the Commission
Member States shall include the following information in applications for approval of compulsory and optional eradication programmes submitted to the Commission in accordance with Article 31(1) and (2):
(a)
a description of the epidemiological situation of the listed disease covered by the compulsory or optional eradication programme in question;
(b)
a description and demarcation of the geographical and administrative area or the compartment covered by the eradication programme;
(c)
a description of the disease control measures of the eradication programme as provided for in Article 32(1) and in the rules adopted pursuant to Article 32(2);
(d)
a description of the organisation, supervision and roles of the parties involved in the eradication programme;
(e)
the estimated duration of the eradication programme;
(f)
the intermediate targets of, and the disease control strategies for implementing, the eradication programme.
Article 34
Reporting
Member States implementing eradication programmes shall submit to the Commission:
(a)
reports enabling the Commission to monitor achievement of the intermediate targets of the on-going eradication programmes as referred to in point (f) of Article 33;
(b)
a final report after completion of the eradication programme in question.
Article 35
Implementing powers
The Commission shall, by means of implementing acts, lay down rules concerning the information, format and procedural requirements provided for in Articles 31 to 34 as regards:
(a)
the submission of draft compulsory and draft optional eradication programmes for approval;
(b)
performance indicators;
(c)
reporting to the Commission and other Member States on the results of the implementation of compulsory or optional eradication programmes.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
CHAPTER 4
Disease–free status
Article 36
Disease–free Member States and zones
1.   A Member State may apply to the Commission for approval of disease–free status for one or more of the listed diseases referred to in points (b) and (c) of Article 9(1), for one or more of the relevant animal species, for its entire territory or for one or more zones thereof, provided that one or more of the following conditions are fulfilled:
(a)
none of the listed species for the disease covered by the application for disease–free status is present anywhere in the territory of the Member State concerned or in the relevant zone or zones covered by the application;
(b)
the disease agent is known not to be able to survive in the entire territory of the Member State, or in the relevant zone or zones covered by the application, according to the criteria referred to in point (a)(ii) of Article 39;
(c)
in the case of listed diseases only transmitted by vectors, none of the vectors are present, or they are known not to be able to survive in the entire territory of the Member State, or in the relevant zone or zones covered by the application, according to the criteria referred to in point (a)(ii) of Article 39;
(d)
freedom from the listed disease has been demonstrated by:
(i)
an eradication programme complying with the rules laid down in Article 32(1) and rules adopted pursuant to paragraph 2 of that Article; or
(ii)
historical and surveillance data.
2.   Applications by Member States for disease–free status shall include evidence demonstrating that the conditions for disease–free status laid down in paragraph 1 are fulfilled.
3.   A Member State may in certain specific cases apply to the Commission for approval of disease–free status for one or more of the listed diseases referred to in point (a) of Article 9(1), and in particular for approval of non–vaccination status for the entire territory, or for one or more zones thereof, provided that the following conditions are fulfilled:
(a)
freedom from the listed disease has been demonstrated by:
(i)
an eradication programme complying with the rules laid down in Article 32(1) and rules adopted pursuant to paragraph 2 of that Article; or
(ii)
historical and surveillance data;
(b)
it has been demonstrated that vaccination against the disease would lead to costs which would exceed those resulting from maintaining freedom from disease without vaccination.
4.   The Commission shall, by means of implementing acts, approve, subject to amendments where necessary, applications by Member States for disease–free status or non-vaccination status when the conditions referred to in paragraphs 1 and 2 and, as relevant, paragraph 3 are fulfilled.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 37
Compartments
1.   A Member State may apply to the Commission for recognition of the disease–free status of compartments for listed diseases referred to in point (a) of Article 9(1), and for the protection of the disease–free status of such a compartment in the event of an outbreak of one or more of those listed diseases in its territory, provided that:
(a)
the introduction of the listed disease or listed diseases covered by the application can be effectively prevented at compartment level, taking into account the disease profile;
(b)
the compartment covered by the application is subject to a single common biosecurity management system designed to ensure the disease–free status of all establishments forming part of it; and
(c)
the compartment covered by the application has been approved by the competent authority for the purposes of movements of animals and products thereof in accordance with:
(i)
Articles 99 and 100 for compartments keeping terrestrial animals and products thereof;
(ii)
Articles 183 and 184 for compartments keeping aquaculture animals and products thereof.
2.   A Member State may apply to the Commission for recognition of the disease–free status of compartments for one or more of the listed diseases referred to in points (b) and (c) of Article 9(1), provided that:
(a)
the introduction of the listed disease or listed diseases covered by the application can be effectively prevented at compartment level, taking into account the disease profile;
(b)
one or more of the following conditions are complied with:
(i)
the conditions laid down in Article 36(1) are fulfilled;
(ii)
the establishments of the compartment covered by the application have started or resumed their activities and have established a common biosecurity management system designed to ensure the freedom from disease of that compartment;
(c)
the compartment covered by the application is subject to a single common biosecurity management system designed to ensure the disease–free status of all establishments forming part of it; and
(d)
the compartment covered by the application has been approved by the competent authority for the purposes of movements of animals and products thereof in accordance with:
(i)
Articles 99 and 100 for compartments keeping terrestrial animals and products thereof;
(ii)
Articles 183 and 184 for compartments keeping aquaculture animals and products thereof.
3.   Applications by Member States for recognition of the disease–free status of compartments in accordance with paragraphs 1 and 2 shall include evidence demonstrating that the conditions laid down in those paragraphs are fulfilled.
4.   The Commission shall, by means of implementing acts:
(a)
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;
(b)
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.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
5.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning provisions supplementing those contained in this Article, on:
(a)
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:
(i)
surveillance results and other evidence needed to substantiate freedom from disease;
(ii)
biosecurity measures;
(b)
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
(c)
rules concerning compartments which are located in the territory of more than one Member State.
Article 38
Lists of disease–free Member States, zones or compartments
Each Member State shall establish and maintain an up-to-date list of its territory or zones with disease–free status as provided for in Article 36(1) and (3), and of its compartments with disease-free status, as provided for in Article 37(1) and (2), when applicable.
Member States shall make those lists publicly available. The Commission shall assist the Member States in making the information contained in those lists available to the public by providing on its internet page the links to the internet–based information pages of the Member States.
Article 39
Delegation of powers concerning the disease–free status of Member States and zones
The Commission shall adopt delegated acts in accordance with Article 264 concerning:
(a)
detailed rules for the disease–free status of Member States and zones thereof, based on the different disease profiles, concerning:
(i)
the criteria to be used to substantiate claims by Member States that no listed species are present or able to survive in their territory and the evidence required to substantiate such claims, as provided for in point (a) of Article 36(1);
(ii)
the criteria to be used, and the evidence required, to substantiate claims that a disease agent or vector is not able to survive, as provided for in points (b) and (c) of Article 36(1);
(iii)
the criteria to be used, and the conditions to be applied, to determine freedom from the disease in question, as referred to in point (d) of Article 36(1);
(iv)
surveillance results and other evidence needed to substantiate freedom from disease;
(v)
biosecurity measures;
(vi)
restrictions and conditions for vaccination in disease-free Member States and zones thereof;
(vii)
the establishment of zones separating disease–free zones or zones under the eradication programme from restricted zones (‘buffer zones’);
(viii)
zones which are located in the territory of more than one Member State;
(b)
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;
(c)
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.
Article 40
Implementing powers
The Commission shall, by means of implementing acts, lay down detailed requirements concerning the information to be provided by Member States to the Commission and the other Member States to substantiate declarations of disease–free status of territories, zones and compartments in accordance with Articles 36 to 39, and the format and procedures for:
(a)
applications for recognition of disease–free status of the entire territory of the Member State concerned, or zones and compartments thereof;
(b)
exchanges of information between the Member States and the Commission on disease-free Member States, or zones and compartments thereof.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 41
Maintenance of disease–free status
1.   Member States shall only maintain disease–free status for their territories, or zones or compartments thereof, as long as:
(a)
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;
(b)
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;
(c)
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;
(d)
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.
2.   A Member State shall immediately inform the Commission if the conditions referred to in paragraph 1 for maintaining disease–free status are no longer met.
3.   The Commission shall adopt delegated acts in accordance with Article 264 concerning the following conditions for maintaining disease–free status:
(a)
surveillance as provided for in point (b) of paragraph 1;
(b)
biosecurity measures as provided for in point (d) of paragraph 1.
Article 42
Suspension, withdrawal and restoration of disease–free status
1.   Where a Member State becomes aware, or has reason to suspect, that any of the conditions for maintaining its status as a disease–free Member State or zone or compartment thereof, have been breached, it shall immediately:
(a)
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;
(b)
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.
2.   The measures provided for in paragraph 1 shall be lifted where further investigation confirms that:
(a)
the suspected breach has not taken place; or
(b)
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.
3.   Where further investigation by the Member State concerned confirms that there has been an outbreak of the listed disease for which it obtained disease–free status, or that other significant breaches of the conditions for maintaining disease–free status as referred to in Article 41(1) have occurred, or where there is a significant likelihood of this having occurred, the Member State shall immediately inform the Commission thereof.
4.   The Commission shall, by means of implementing acts, withdraw without undue delay the approval of the disease–free status of a Member State or zone granted in accordance with Article 36(4) or the recognition of the disease–free status of a compartment granted in accordance with Article 37(4) after obtaining the information from the Member State concerned that the conditions for maintaining the disease–free status are no longer met.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
5.   On duly justified imperative grounds of extreme urgency, where the listed disease referred to in paragraph 3 of this Article spreads in a rapid manner, carrying with it the risk of a highly significant impact on animal or public health, the economy or society, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure provided for in Article 266(3).
6.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning provisions supplementing the rules for the suspension, withdrawal and restoration of disease–free status set out in paragraphs 1 and 2 of this Article.
PART III
DISEASE AWARENESS, PREPAREDNESS AND CONTROL
TITLE I
DISEASE AWARENESS AND PREPAREDNESS
CHAPTER 1
Contingency plans and simulation exercises
Article 43
Contingency plans
1.   The Member States shall, after appropriate consultation of experts and relevant stakeholders, draw up, and keep up to date, contingency plans and, where necessary, detailed instruction manuals laying down the measures to be taken in the Member State concerned in the event of the occurrence of a listed disease referred to in point (a) of Article 9(1) or, as the case may be, of an emerging disease, in order to ensure a high level of disease awareness and preparedness and the ability to launch a rapid response.
2.   Those contingency plans and, where applicable, detailed instruction manuals shall cover at least the following matters:
(a)
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;
(b)
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;
(c)
access to:
(i)
facilities;
(ii)
laboratories;
(iii)
equipment;
(iv)
personnel;
(v)
emergency funds;
(vi)
all other appropriate materials and resources necessary for the rapid and efficient eradication of the listed diseases referred to in point (a) of Article 9(1) or of emerging diseases;
(d)
the availability of the following centres and groups with the necessary expertise to assist the competent authority:
(i)
a functional central disease control centre;
(ii)
regional and local disease control centres, as appropriate for the administrative and geographical situation of the Member State concerned;
(iii)
operational expert groups;
(e)
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;
(f)
provisions on emergency vaccination, where appropriate;
(g)
principles for the geographical demarcation of the restricted zones established by the competent authority in accordance with Article 64(1);
(h)
coordination with neighbouring Member States and neighbouring third countries and territories, where appropriate.
Article 44
Implementing powers for contingency plans
The Commission shall, by means of implementing acts, lay down necessary measures concerning the implementation in the Member States of the contingency plans provided for in Article 43(1).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 45
Simulation exercises
1.   The competent authority shall ensure that simulation exercises concerning the contingency plans provided for in Article 43(1) are carried out regularly or at appropriate intervals:
(a)
to ensure a high level of disease awareness and preparedness and the ability to launch a rapid response in the Member State concerned;
(b)
to verify the functionality of those contingency plans.
2.   Where feasible and appropriate, simulation exercises shall be carried out in close collaboration with the competent authorities of neighbouring Member States and neighbouring third countries and territories.
3.   Member States shall make available to the Commission and to the other Member States, on request, a report on the main results of the simulation exercises carried out.
4.   When appropriate and necessary, the Commission shall, by means of implementing acts, lay down rules concerning the practical implementation of simulation exercises in the Member States, relating to:
(a)
the frequencies of simulation exercises;
(b)
simulation exercises covering more than one listed disease referred to in point (a) of Article 9(1).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
CHAPTER 2
The use of veterinary medicinal products for disease prevention and control
Article 46
The use of veterinary medicinal products for disease prevention and control
1.   The Member States may take measures concerning the use of veterinary medicinal products for listed diseases, to ensure the most efficient prevention or control of those diseases, provided that such measures are appropriate or necessary.
Those measures may cover the following:
(a)
prohibitions and restrictions on the use of veterinary medicinal products;
(b)
the compulsory use of veterinary medicinal products.
2.   Member States shall take the following criteria into consideration when determining whether or not to use, and how to use, veterinary medicinal products as prevention and control measures for a specific listed disease:
(a)
the disease profile;
(b)
the distribution of the listed disease in:
(i)
the Member State concerned;
(ii)
the Union;
(iii)
where relevant, neighbouring third countries and territories;
(iv)
third countries and territories from which animals and products are brought into the Union;
(c)
the availability and effectiveness of the veterinary medicinal products in question, and the risks attaching to them;
(d)
the availability of diagnostic tests for detecting infections in animals treated with the veterinary medicinal products concerned;
(e)
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.
3.   Member States shall take appropriate preventive measures concerning the use of veterinary medicinal products for scientific studies or for the purposes of developing and testing them under controlled conditions to protect animal and public health.
Article 47
Delegation of powers for the use of veterinary medicinal products
1.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning what might constitute appropriate and necessary measures as set out in Article 46, in relation to:
(a)
prohibitions and restrictions on the use of veterinary medicinal products;
(b)
specific conditions for the use of veterinary medicinal products for a specific listed disease;
(c)
risk-mitigation measures to prevent the spread of listed diseases through animals treated with the veterinary medicinal products or products from such animals;
(d)
surveillance for specific listed diseases following the use of vaccines and other veterinary medicinal products.
2.   The Commission shall take into account the criteria set out in Article 46(2) when laying down the rules provided for in paragraph 1 of this Article.
3.   Where, in the case of emerging risks, imperative grounds of urgency so require, the procedure provided for in Article 265 shall apply to rules adopted pursuant to paragraph 1 of this Article.
CHAPTER 3
Antigen, vaccine and diagnostic reagent banks
Article 48
The establishment of Union antigen, vaccine and diagnostic reagent banks
1.   For listed diseases referred to in point (a) of Article 9(1) in respect of which vaccination is not prohibited by a delegated act adopted pursuant to Article 47, the Commission may establish and be responsible for managing Union antigen, vaccine and diagnostic reagent banks for the storage and replacement of stocks of one or more of the following biological products:
(a)
antigens;
(b)
vaccines;
(c)
vaccine master seed–stocks;
(d)
diagnostic reagents.
2.   The Commission shall ensure that the Union antigen, vaccine and diagnostic reagent banks provided for in paragraph 1:
(a)
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);
(b)
receive regular supplies and timely replacements of antigens, vaccines, vaccine master seed–stocks and diagnostic reagents;
(c)
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);
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
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;
(b)
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).
Article 49
Access to the Union antigen, vaccine and diagnostic reagent banks
1.   The Commission shall, upon request, provide for the delivery of the biological products referred to in Article 48(1) from the Union antigen, vaccine and diagnostic reagent banks, provided that stocks are available, to:
(a)
in the first place, Member States; and
(b)
third countries or territories, provided that such delivery is primarily intended to prevent the spread of a disease into the Union.
2.   The Commission shall, in the event of the limited availability of stocks, prioritise access to the stocks to be delivered pursuant to paragraph 1 based on:
(a)
the disease circumstances under which the request is made;
(b)
the existence of a national antigen, vaccine and diagnostic reagent bank in the requesting Member State or third country or territory;
(c)
the existence of Union measures for compulsory vaccination laid down in delegated acts adopted pursuant to Article 47.
Article 50
Implementing powers concerning the Union antigen, vaccine and diagnostic reagent banks
1.   The Commission shall, by means of implementing acts, lay down rules for Union antigen, vaccine and diagnostic reagent banks, specifying for the biological products referred to in Article 48(1):
(a)
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);
(b)
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;
(c)
the requirements concerning the supply, storage and replacement of those biological products;
(d)
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;
(e)
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.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
2.   On duly justified imperative grounds of urgency relating to a listed disease referred to in point (a) of Article 9(1) representing a risk of a highly significant impact, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure provided for in Article 266(3).
Article 51
Confidentiality of information concerning the Union antigen, vaccine and diagnostic reagent banks
Information on the quantities and subtypes of the biological products referred to in Article 48(1) stored in the Union antigen, vaccine and diagnostic reagent banks shall be treated by the Commission as classified information and shall not be published.
Article 52
National antigen, vaccine and diagnostic reagent banks
1.   Member States that have established national antigen, vaccine and diagnostic reagent banks for listed diseases referred to in point (a) of Article 9(1) for which Union antigen, vaccine and diagnostic reagent banks exist, shall ensure that their national antigen, vaccine and diagnostic reagent banks comply with the biosecurity, biosafety and bio–containment requirements laid down in point (a) of Article 16(1) and in delegated acts adopted in accordance with Article 16(2) and point (b) of Article 48(3).
2.   Member States shall provide the Commission with up–to–date information on:
(a)
the existence or the establishment of the national antigen, vaccine and diagnostic reagent banks referred to paragraph 1;
(b)
the types of antigens, vaccines, vaccine master-seed stocks and diagnostic reagents and the quantities thereof held in such banks;
(c)
any changes in the operation of such banks.
That information shall be treated as classified information by the Commission and shall not be published.
3.   The Commission may, by means of implementing acts, lay down rules specifying the content, frequency and format of the submission of the information provided for in paragraph 2.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
TITLE II
DISEASE CONTROL MEASURES
CHAPTER 1
Disease control measures for listed diseases as referred to in point (a) of Article 9(1)
Section 1
Disease control measures in the event of suspicion of a listed disease in kept animals
Article 53
Obligations on operators and other relevant natural and legal persons concerned
1.   In the event of suspicion of a listed disease as referred to in point (a) of Article 9(1) in kept animals, in addition to complying with the notification obligation laid down in Article 18(1) and pending any disease control measures being taken by the competent authority in accordance with Articles 54(1) and 55(1), Member States shall take measures to ensure that operators and other relevant natural and legal persons concerned take the appropriate disease control measures provided for in points (c), (d) and (e) of Article 55(1), to prevent the spread of that listed disease from the affected animals, establishments and locations under their responsibility to other unaffected animals or to humans.
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning detailed rules for supplementing the disease control measures provided for in paragraph 1 of this Article.
Article 54
Investigation by the competent authority in the event of suspicion of a listed disease
1.   In the event of suspicion of a listed disease as referred to in point (a) of Article 9(1) in kept animals, the competent authority shall conduct without delay an investigation to confirm or rule out the presence of that listed disease.
2.   For the purpose of the investigation provided for in paragraph 1, the competent authority shall, when appropriate, ensure that:
(a)
official veterinarians carry out a clinical examination of a representative sample of the kept animals of listed species for the listed disease in question;
(b)
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;
(c)
such designated laboratories carry out examinations to confirm or rule out the presence of the listed disease in question.
3.   The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed rules supplementing the rules for investigations by competent authorities as provided for in paragraph 1 of this Article.
Article 55
Preliminary disease control measures by competent authorities
1.   The competent authority shall, in the event that it suspects the presence of a listed disease as referred to in point (a) of Article 9(1) in kept animals, carry out the following preliminary disease control measures, subject to national requirements for gaining access to private residences, pending the results of the investigation provided for in Article 54(1) and the carrying-out of the disease control measures provided for in Article 61(1):
(a)
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;
(b)
compile an inventory of:
(i)
the kept animals in the establishment, food and feed business, or animal by–products establishment concerned, or in any other location;
(ii)
the products in that establishment, food and feed business, or animal by–products establishment, or in any other location, where relevant for the spread of that listed disease;
(c)
ensure that appropriate biosecurity measures are applied to prevent the spreading of that listed disease agent to other animals or to humans;
(d)
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;
(e)
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;
(f)
take any other necessary disease control measures, taking into account the disease control measures provided for in Section 4 of this Chapter, concerning:
(i)
the application of the investigation by the competent authority provided for in Article 54(1) and disease control measures provided for in points (a) to (d) of this paragraph to other establishments, food and feed businesses, or animal by–products establishments, or to any other location;
(ii)
the establishment of any temporary restricted zones which are appropriate, taking into account the disease profile;
(g)
initiate the epidemiological enquiry provided for in Article 57(1).
2.   The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed rules supplementing those laid down in paragraph 1 of this Article as regards the specific and detailed disease control measures to be taken depending on the listed disease referred to in point (a) of Article 9(1), based on the risks involved for:
(a)
the species or category of animals concerned;
(b)
the type of production concerned.
Article 56
Review and extension of the preliminary disease control measures
The disease control measures provided for in Article 55(1) shall be:
(a)
reviewed by the competent authority, as appropriate, following the findings of:
(i)
the investigation provided for in Article 54(1);
(ii)
the epidemiological enquiry provided for in Article 57(1);
(b)
further extended to other locations as referred to in point (a) of Article 55(1), where necessary.
Section 2
Epidemiological enquiry
Article 57
Epidemiological enquiry
1.   The competent authority shall carry out an epidemiological enquiry in the event of the confirmation of a listed disease as referred to in point (a) of Article 9(1) in animals.
2.   The epidemiological enquiry provided for in paragraph 1 shall aim to:
(a)
identify the likely origin of the listed disease in question and the means of its spread;
(b)
calculate the likely length of time that the listed disease has been present;
(c)
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;
(d)
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;
(e)
obtain information on the likely spread of the listed disease in the surrounding environment, including the presence and distribution of disease vectors.
Section 3
Disease confirmation in kept animals
Article 58
Official confirmation by the competent authority of a listed disease as referred to in point (a) of Article 9(1)
1.   The competent authority shall base an official confirmation of a listed disease as referred to in point (a) of Article 9(1) on the following information:
(a)
the results of the clinical and laboratory examinations provided for in Article 54(2);
(b)
the preliminary or final results of the epidemiological enquiry provided for in Article 57(1);
(c)
other available epidemiological data.
2.   The Commission shall adopt delegated acts in accordance with Article 264 concerning the requirements to be fulfilled for the official confirmation referred to in paragraph 1 of this Article.
Article 59
Lifting of preliminary disease control measures where the presence of the listed disease has been ruled out
The competent authority shall continue to apply the preliminary disease control measures provided for in Article 55(1) and Article 56 until the presence of the listed disease in question, as referred to in point (a) of Article 9(1), has been ruled out on the basis of the information referred to in Article 58(1) or rules adopted pursuant to Article 58(2).
Section 4
Disease control measures in the event of confirmation of disease in kept animals
Article 60
Immediate disease control measures to be taken by the competent authority
In the event of an official confirmation in accordance with Article 58(1) of an outbreak of a listed disease as referred to in point (a) of Article 9(1) in kept animals, the competent authority shall immediately:
(a)
declare the affected establishment, food or feed business, animal by–products establishment or other location as officially infected with that listed disease;
(b)
establish a restricted zone appropriate for that listed disease;
(c)
implement the contingency plan provided for in Article 43(1) to ensure full coordination of the disease control measures.
Article 61
Affected establishments and other locations
1.   In the event of an outbreak of a listed disease as referred to in point (a) of Article 9(1) in kept animals, the competent authority shall immediately take one or more of the following disease control measures, subject to national requirements for gaining access to private residences, in an establishment, food or feed business, animal by–products establishment, or any other location referred to in point (a) of Article 60, in order to prevent the further spread of that listed disease:
(a)
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;
(b)
the killing and disposal or slaughtering of animals that may be contaminated or contribute to the spread of the listed disease;
(c)
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;
(d)
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;
(e)
the isolation, quarantine or treatment of animals and products that are likely to be contaminated and contribute to the spread of the listed disease;
(f)
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;
(g)
the taking of a sufficient number of appropriate samples needed to complete the epidemiological enquiry provided for in Article 57(1);
(h)
the laboratory examination of samples;
(i)
any other appropriate measures.
2.   When determining which of the disease control measures provided for in paragraph 1 are appropriate to take, the competent authority shall take the following into account:
(a)
the disease profile;
(b)
the type of production, and epidemiological units within the affected establishment, food or feed business, animal by–products establishment or other location;
3.   The competent authority shall only authorise the repopulation of the establishment concerned, or of any other location, when:
(a)
all appropriate disease control measures and laboratory examinations provided for in paragraph 1 have been successfully completed;
(b)
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.
Article 62
Epidemiologically linked establishments and locations
1.   The competent authority shall extend the disease control measures provided for in Article 61(1) to other establishments, epidemiological units therein, food or feed businesses, or animal by–products establishments, or any other location, or means of transport where the epidemiological enquiry provided for in Article 57(1) or the results of clinical or laboratory investigations or other epidemiological data, give reason to suspect the spread to, from or through them of the listed disease referred to in point (a) of Article 9(1) in respect of which such measures were taken.
2.   If the epidemiological enquiry provided for in Article 57(1) shows that the likely origin of the listed disease referred to in point (a) of Article 9(1) is another Member State, or if it is likely that that listed disease has spread to another Member State, the competent authority shall inform that Member State and the Commission without delay.
3.   Should any of the events referred to in paragraph 2 occur, the competent authorities of the different Member States shall cooperate in a further epidemiological enquiry and in the application of disease control measures.
Article 63
Delegation of powers in respect of disease control measures in affected and epidemiologically linked establishments and other locations
The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed rules on the disease control measures to be taken by the competent authority in accordance with Articles 61 and 62 in affected and epidemiologically linked establishments, food or feed businesses, or animal by–products establishments, and other locations in respect of any listed disease referred to in point (a) of Article 9(1), including rules on which disease control measures referred to in Article 61(1) are to be applied in relation to each listed disease.
Those detailed rules shall cover the following matters:
(a)
the conditions and requirements for the disease control measures provided for in points (a) to (e) of Article 61(1);
(b)
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;
(c)
the conditions and requirements for sampling and laboratory examination as provided for in points (g) and (h) of Article 61(1);
(d)
the detailed conditions and requirements in respect of repopulation as provided for in Article 61(3);
(e)
the carrying-out of the necessary disease control measures provided for in Article 62 in epidemiologically linked establishments, other locations and means of transport.
Article 64
Establishment of restricted zones by the competent authority
1.   The competent authority shall establish a restricted zone as referred to in point (b) of Article 60 around the affected establishment, food or feed business, animal by–products establishment or other location where the outbreak of a listed disease as referred to in point (a) of Article 9(1) in kept animals has occurred, where appropriate taking into account:
(a)
the disease profile;
(b)
the geographical situation of the restricted zone;
(c)
the ecological and hydrological factors of the restricted zone;
(d)
the meteorological conditions;
(e)
the presence, distribution and type of vectors in the restricted zone;
(f)
the results of the epidemiological enquiry provided for in Article 57(1) and other studies carried out and epidemiological data;
(g)
the results of laboratory tests;
(h)
the disease control measures applied;
(i)
other relevant epidemiological factors.
The restricted zone shall include, when appropriate, a protection and surveillance zone of a defined size and configuration.
2.   The competent authority shall continuously assess and review the situation and, when appropriate in order to prevent the spread of the listed disease referred to in point (a) of Article 9(1), shall:
(a)
adapt the boundaries of the restricted zone;
(b)
establish additional restricted zones.
3.   Where restricted zones as provided for in paragraph 1 are situated in the territory of more than one Member State, the competent authorities of those Member States shall cooperate in establishing them.
4.   The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed rules for the establishment and modification of restricted zones, including protection or surveillance zones.
Article 65
Disease control measures in restricted zones
1.   The competent authority shall ensure that, subject to national requirements for gaining access to private residences, one or more of the following disease control measures are taken in the restricted zone concerned, in order to prevent the further spread of a listed disease as referred to in point (a) of Article 9(1):
(a)
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;
(b)
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;
(c)
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;
(d)
biosecurity requirements for:
(i)
the production, processing and distribution of products of animal origin;
(ii)
the collection and disposal of animal by–products;
(iii)
the collection, storage and handling of germinal products;
(e)
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;
(f)
cleaning, disinfection, control of insects and rodents, or other necessary biosecurity measures;
(g)
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;
(h)
the identification and traceability requirements for the movement of animals, germinal products or products of animal origin;
(i)
other necessary biosecurity and risk-mitigating measures to minimise the risk of the spread of that listed disease.
2.   The competent authority shall:
(a)
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;
(b)
impose the necessary obligations on operators in order to prevent the further spread of the listed disease in question.
3.   When determining which of the disease control measures provided for in paragraph 1 are to be taken, the competent authority shall take the following into account:
(a)
the disease profile;
(b)
the types of production;
(c)
the feasibility, availability and effectiveness of those disease control measures.
Article 66
Operators' obligations regarding movements in restricted zones
1.   In restricted zones as provided for in Article 64(1), operators shall only move the kept animals and products with the permission of the competent authority and in accordance with any instructions given by that authority.
2.   Operators keeping animals and products in a restricted zone as provided for in Article 64(1) shall notify to the competent authority intended movements of kept animals and products within or out of the restricted zone in question. In so far as the competent authority has imposed notification obligations in accordance with point (b) of Article 65(2), the operators concerned shall notify in accordance with those obligations.
Article 67
Delegation of powers concerning disease control measures in restricted zones
The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed rules on the disease control measures to be taken in restricted zones as provided for in Article 65(1) for each listed disease referred to in point (a) of Article 9(1), including rules on which disease control measures referred to in Article 65(1) are to be applied in the case of each listed disease.
Those detailed rules shall cover the following matters:
(a)
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);
(b)
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;
(c)
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);
(d)
other specific disease control measures to limit the spread of specific listed diseases as referred to in point (a) of Article 9(1).
Article 68
Maintaining disease control measures in restricted zones and delegated acts
1.   The competent authority shall continue to apply the disease control measures provided for in this Section until the following conditions are met:
(a)
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;
(b)
the final cleaning, disinfection, control of insects and rodents, or other necessary biosecurity measures has been carried out as appropriate for:
(i)
the listed disease referred to in point (a) of Article 9(1) for which the disease control measures have been applied;
(ii)
the affected species of kept animals;
(iii)
the type of production;
(c)
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.
2.   The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed rules for the disease control measures to be taken by the competent authority, as provided for in paragraph 1, in relation to:
(a)
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;
(b)
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;
(c)
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).
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning detailed rules for the disease control measures to be taken by the competent authority, as provided for in paragraph 1, in relation to other disease control measures necessary for the restoration of disease–free status.
Article 69
Emergency vaccination
1.   Where relevant for the effective control of a listed disease as referred to in point (a) of Article 9(1) for which disease control measures apply, the competent authority may:
(a)
develop a vaccination plan;
(b)
establish vaccination zones.
2.   When deciding on the vaccination plan and the establishment of vaccination zones as provided for in paragraph 1, the competent authority shall take the following into account:
(a)
the requirements for emergency vaccination set out in the contingency plans provided for in Article 43;
(b)
the requirements for the use of vaccines as provided for in Article 46(1) and any delegated acts adopted pursuant to Article 47.
3.   Vaccination zones as provided for in point (b) of paragraph 1 of this Article shall meet the requirements in respect of risk-mitigating measures to prevent the spread of listed diseases and surveillance as laid down in any delegated acts adopted in accordance with points (c) and (d) of Article 47(1).
Section 5
Wild animals
Article 70
Wild animals
1.   Where the competent authority of an affected Member State suspects or officially confirms the presence of a listed disease as referred to in point (a) of Article 9(1) in wild animals, it shall:
(a)
conduct, where relevant for that particular listed disease, surveillance in the wild animal population;
(b)
take the necessary disease prevention and control measures.
2.   The disease prevention and control measures provided for in point (b) of paragraph 1 of this Article may include one or more of the measures laid down in Article 53 to 69 and shall take into account the disease profile and the affected wild animals and the risk of transmission of diseases to animals and humans.
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
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;
(b)
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).
When adopting those delegated acts, the Commission shall take into account the disease profile and the listed species for the listed disease referred to paragraph 1 of this Article.
Section 6
Additional disease control measures by the Member States, coordination by the Commission and temporary special disease control rules
Article 71
Additional disease control measures, coordination of measures and temporary special disease control rules concerning Sections 1 to 5 (Articles 53 to 70)
1.   Member States may take disease control measures additional to those provided for in Article 55, Article 61(1), Article 62, Article 65(1) and (2) and Article 68(1) and in any delegated acts adopted pursuant to Article 63, Article 67 and Article 68(2), provided that such measures respect the rules laid down in this Regulation and are necessary and proportionate to control the spread of a listed disease as referred to in point (a) of Article 9(1), taking into account:
(a)
the particular epidemiological circumstances;
(b)
the type of establishments, other locations and production concerned;
(c)
the species and categories of animals involved;
(d)
economic or social conditions.
2.   Member States shall inform the Commission without delay of:
(a)
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);
(b)
any additional disease control measures taken by them as provided for in paragraph 1.
3.   The Commission shall review the disease situation and the disease control measures taken by the competent authority and any additional disease control measures taken by the Member State concerned, in accordance with this Chapter, and may, by means of implementing acts, lay down special disease control measures for a limited period of time, under conditions appropriate to the epidemiological situation, where:
(a)
those disease control measures are found not to be suited to the epidemiological situation;
(b)
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.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
4.   On duly justified imperative grounds of urgency relating to a disease representing an emerging risk of a highly significant impact, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 266(3).
CHAPTER 2
Disease control measures for listed diseases as referred to in points (b) and (c) of Article 9(1)
Section 1
Disease control measures in the event of suspicion of disease in kept animals
Article 72
Obligations on operators and other relevant natural and legal persons concerned in relation to listed diseases as referred to in point (b) of Article 9(1)
1.   In the event of suspicion of a listed disease as referred to in point (b) of Article 9(1) in kept animals, in addition to complying with the notification obligation laid down in Article 18(1) and pending any disease control measures being taken by the competent authority in accordance with Article 74(1), Member States shall take measures to ensure that operators and other relevant natural and legal persons concerned take disease control measures as referred to in point (a) of Article 74(1) and in any delegated acts adopted pursuant to Article 74(4), to prevent the spread of that listed disease from the affected animals, establishments and other locations under their responsibility to other unaffected animals or to humans.
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning detailed rules for supplementing the disease control measures as provided for in paragraph 1 of this Article.
Article 73
Investigation by the competent authority in the event of suspicion of a listed disease as referred to in point (b) of Article 9(1)
1.   In the event of suspicion of a listed disease as referred to in point (b) of Article 9(1) in kept animals, the competent authority shall conduct without delay an investigation to confirm or rule out the presence of that listed disease.
2.   For the purpose of the investigation provided for in paragraph 1, the competent authority shall ensure that:
(a)
official veterinarians carry out a clinical examination of a representative sample of the kept animals of listed species for the listed disease in question;
(b)
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;
(c)
such designated laboratories carry out examinations to confirm or rule out the presence of the listed disease in question.
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning detailed rules supplementing the rules for investigations as provided for in paragraph 1 of this Article.
Article 74
Preliminary disease control measures by the competent authority for listed diseases as referred to in point (b) of Article 9(1)
1.   The competent authority shall, in the event that it suspects a listed disease as referred to in point (b) of Article 9(1) in kept animals, carry out the following preliminary disease control measures, subject to national requirements for gaining access to private residences, pending the results of the investigation provided for in Article 73(1) and the carrying-out of the disease control measures provided for in Article 79:
(a)
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;
(b)
initiate, where necessary, an epidemiological enquiry, taking into account the rules for such enquiry laid down in Article 57(1).
2.   In addition to the measures referred to in paragraph 1, the competent authority may, in the cases referred to in that paragraph, take additional preliminary disease control measures, provided that those measures respect the provisions of this Regulation and are in accordance with Union law.
3.   The preliminary disease control measures provided for in paragraphs 1 and 2 shall be appropriate and proportionate to the risk posed by the listed disease in question, taking into account the following:
(a)
the disease profile;
(b)
the kept animals affected;
(c)
the health status of the Member State, zone, compartment or establishment in which the listed disease is suspected;
(d)
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).
4.   The Commission shall adopt delegated acts in accordance with Article 264 concerning rules for listed diseases as referred to in point (b) of Article 9(1) supplementing those laid down in paragraph 1 of this Article, while taking into account the matters referred to in paragraph 3, as regards:
(a)
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;
(b)
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;
(c)
the establishment of temporary restricted zones which are appropriate in light of the disease profile.
Article 75
Review and extension of the preliminary disease control measures for listed diseases as referred to in point (b) of Article 9(1)
The disease control measures provided for in Article 74(1) shall be:
(a)
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);
(b)
further extended to other locations, as referred to in point (b) of Article 74(4), where necessary.
Article 76
Obligations of operators and other relevant natural and legal persons and measures to be taken by the competent authority in the event of suspicion of listed diseases as referred to in point (c) of Article 9(1)
1.   In the event of suspicion of a listed disease as referred to in point (c) of Article 9(1) in a Member State that has opted for the eradication programme covering the relevant parts of its territory or zones or compartments thereof, as provided for in Article 31(2), that Member State shall take measures to ensure that operators and other relevant natural and legal persons concerned take appropriate measures as provided for in Article 72(1), pending any disease control measures being taken by the competent authority in accordance with paragraph 2 of this Article.
2.   The competent authority of a Member State that has opted for the eradication of a listed disease as referred to in paragraph 1 shall, in the event that it suspects the disease in question in kept animals:
(a)
conduct without delay an investigation to confirm or rule out the presence of that listed disease in accordance with Article 73(1) and (2);
(b)
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).
3.   The competent authority shall review and extend the preliminary disease control measures referred to in point (b) of paragraph 2, in accordance with Article 75.
4.   Paragraphs 1, 2 and 3 of this Article shall also apply to Member States or zones which have obtained disease–free status, in order to maintain that status, in accordance with Article 36, or to compartments in accordance with Article 37(2).
5.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning detailed rules supplementing rules in respect of:
(a)
the disease control measures provided for in paragraph 1;
(b)
the investigation provided for in point (a) of paragraph 2;
(c)
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.
Section 2
Disease confirmation in kept animals
Article 77
Official confirmation of disease by the competent authority
1.   The competent authority shall base an official confirmation of a listed disease as referred to in point (b) or (c) of Article 9(1) on the following information:
(a)
the results of the clinical and laboratory examinations provided for in Article 73(2);
(b)
the epidemiological enquiry provided for in point (b) of Article 74(1), where relevant;
(c)
other available epidemiological data.
2.   The Commission shall adopt delegated acts in accordance with Article 264 concerning the requirements to be fulfilled for the official confirmation referred to in paragraph 1.
Article 78
Lifting preliminary disease control measures when the occurrence of a disease is ruled out
The competent authority shall continue to apply the preliminary disease control measures provided for in Article 74(1), Article 75 and point (b) of Article 76(2) until the presence of the listed disease in question has been ruled out in accordance with Article 77(1) and any rules adopted pursuant to Article 77(2).
Section 3
Disease control measures in the event of confirmation of disease in kept animals
Article 79
Disease control measures by the competent authority for listed diseases as referred to in point (b) of Article 9(1)
In the event of an official confirmation in accordance with Article 77(1) of an outbreak of a listed disease as referred to in point (b) of Article 9(1) in kept animals, the competent authority shall, in a Member State, zone or compartment, as relevant for that outbreak:
(a)
apply the disease control measures laid down in the compulsory eradication programme provided for in Article 31(1) for that listed disease; or
(b)
where the Member State or zone, or compartment, has obtained disease–free status in accordance with Article 36 or Article 37 respectively:
(i)
take one or more of the measures laid down in Articles 53 to 69 proportionate to the risk posed by the listed disease in question, and
(ii)
where necessary, initiate the compulsory eradication programme for that listed disease.
Article 80
Disease control measures to be taken by the competent authority for listed diseases referred to in Article 9(1)(c)
1.   In the event of an official confirmation in accordance with Article 77(1) of an outbreak of a listed disease as referred to in point (c) of Article 9(1) in kept animals in a Member State that has opted for an eradication programme covering the relevant parts of its territory or zones or compartments thereof, as provided for in Article 31(2), as relevant for that listed disease and that outbreak, the competent authority shall apply the disease control measures laid down in the optional eradication programme.
2.   The competent authority may take disease control measures additional to those provided for in paragraph 1 which may include one or more of the measures laid down in Articles 53 to 69 and shall be proportionate to the risk posed by the listed disease in question and shall take into account:
(a)
the disease profile;
(b)
the kept animals affected;
(c)
economic and social impacts.
3.   In the event of an official confirmation in accordance with Article 77(1) of an outbreak of a listed disease as referred to in point (c) of Article 9(1) in kept animals in a Member State, zone or compartment that has obtained disease–free status in accordance with Article 36 or Article 37, and in order to maintain that status, the competent authority shall take one or more of the measures laid down in Articles 53 to 69. Those measures shall be proportionate to the risk posed by the listed disease in question and shall take into account:
(a)
the disease profile;
(b)
the kept animals affected;
(c)
economic and social impacts.
Section 4
Wild animals
Article 81
Disease control measures for listed diseases as referred to in point (b) of Article 9(1) in wild animals
In the event that the competent authority of an affected Member State suspects or officially confirms the outbreak of a listed disease as referred to in point (b) of Article 9(1) in wild animals, it shall throughout its territory, or in the area or zone concerned, as relevant for that outbreak:
(a)
apply the disease control measures laid down in the compulsory eradication programme provided for in Article 30(1) for that listed disease; or
(b)
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.
Article 82
Disease control measures for listed diseases as referred to in point (c) of Article 9(1) in wild animals
1.   In the event that a competent authority suspects or officially confirms a listed disease as referred to in point (c) of Article 9(1) in wild animals and the affected Member State has opted for the eradication of the disease in question, and provided that measures for wild animals are envisaged in the optional eradication programme provided for in Article 31(2) for that listed disease, the competent authority shall apply the disease control measures laid down in that optional eradication programme throughout the territory of the Member State, area or zone concerned, as relevant for that suspicion or official confirmation.
2.   The competent authority may take disease control measures additional to those provided for in paragraph 1, which may include one or more of the measures laid down in Articles 53 to 69 and shall be proportionate to the risk posed by the listed disease in question and shall take into account:
(a)
the disease profile;
(b)
the affected wild animals and the risk of transmission of diseases to animals and humans; and
(c)
economic, social and environmental impacts.
3.   In the event of an official confirmation of an outbreak of a listed disease as referred to in point (c) of Article 9(1) in wild animals in a Member State, zone or compartment that has obtained disease–free status in accordance with Article 36 or Article 37, and in order to maintain that status, the competent authority shall take one or more of the measures laid down in Articles 53 to 69. Those measures shall be proportionate to the risk posed by the listed disease in question and shall take into account:
(a)
the disease profile;
(b)
the affected wild animals and the risk of transmission of diseases to animals and humans;
(c)
the relevance of the presence of the disease in wild animals in relation to the health status of kept animals; and
(d)
economic, social and environmental impacts.
Section 5
Coordination by the Commission and temporary special disease control rules
Article 83
Coordination of measures by the Commission and temporary special rules concerning Sections 1 to 4
1.   Member States shall inform the Commission of:
(a)
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);
(b)
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).
2.   The Commission shall review the disease situation and the disease control measures taken by the competent authority in accordance with this Chapter and may, by means of implementing acts, lay down special rules for disease control measures for a limited period of time in respect of a listed disease as referred to in point (b) or point (c) of Article 9(1), under conditions appropriate to the epidemiological situation, where:
(a)
those disease control measures taken by the competent authority in question are found not to be suited to the epidemiological situation;
(b)
that listed disease appears to be spreading despite the disease control measures taken in accordance with this Chapter, where relevant.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
3.   On duly justified imperative grounds of urgency relating to a listed disease as referred to in point (b) or point (c) of Article 9(1) representing an emerging risk of a highly significant impact, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 266(3).
PART IV
REGISTRATION, APPROVAL, TRACEABILITY AND MOVEMENTS
TITLE I
TERRESTRIAL ANIMALS, GERMINAL PRODUCTS AND PRODUCTS OF ANIMAL ORIGIN FROM TERRESTRIAL ANIMALS
CHAPTER 1
Registration, approval, record-keeping and registers
Section 1
Registration of establishments and certain types of operators
Article 84
Obligation of operators to register establishments
1.   Operators of establishments keeping terrestrial animals or collecting, producing, processing or storing germinal products shall, in order for their establishments to be registered in accordance with Article 93, before they commence such activities:
(a)
inform the competent authority of any such establishment under their responsibility;
(b)
provide the competent authority with the following information:
(i)
the name and address of the operator concerned;
(ii)
the location of the establishment and a description of its facilities;
(iii)
the categories, species and numbers or quantities of kept terrestrial animals or germinal products which they intend to keep on the establishment, and the capacity of the establishment;
(iv)
the type of establishment; and
(v)
any other aspects of the establishment which are relevant for the purpose of determining the risk posed by it.
2.   Operators of establishments referred to in paragraph 1 shall inform the competent authority of:
(a)
any changes in the establishment in question concerning the matters referred to in point (b) of paragraph 1;
(b)
any cessation of activity by the operator or establishment concerned.
3.   Establishments which are subject to approval in accordance with Article 94(1) shall not be required to provide the information referred to in paragraph 1 of this Article.
Article 85
Derogations from the obligation of operators to register establishments
By way of derogation from Article 84(1), Member States may exempt from the registration requirement certain categories of establishments posing an insignificant risk, as provided for in an implementing act adopted in accordance with Article 86(2). Member States shall inform the Commission of such exemptions.
Article 86
Implementing powers concerning the obligation of operators to register establishments
1.   The Commission may, by means of implementing acts, lay down rules concerning the information to be provided by operators for the purpose of the registration of establishments as provided for in Article 84(1), including the time-limits by which such information is to be provided.
2.   The Commission shall, by means of implementing acts, lay down rules concerning the types of establishments that may be exempted by the Member States from the registration requirement in accordance with Article 85, on the basis of:
(a)
the species, categories and numbers of kept terrestrial animals and germinal products on the establishment in question and the capacity of that establishment;
(b)
the type of establishment; and
(c)
the movements of kept terrestrial animals or germinal products into and out of the establishment.
3.   The implementing acts referred to in this Article shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 87
Registration obligations of transporters of kept ungulates and delegated acts
1.   Transporters of kept ungulates engaged in the transportation of those animals between Member States or between a Member State and a third country shall, in order to be registered in accordance with Article 93, before they commence such activities:
(a)
inform the competent authority of their activity;
(b)
provide that competent authority with information on:
(i)
the name and address of the transporter concerned;
(ii)
the categories, species and numbers of kept ungulates for which transportation is planned;
(iii)
the type of transport;
(iv)
the means of transport.
2.   Transporters as referred to in paragraph 1 shall inform the competent authority of:
(a)
any changes concerning the matters referred to in point (b) of paragraph 1;
(b)
any cessation of the transport activity.
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 supplementing the rules provided for in paragraph 1 of this Article, requiring other types of transporters whose transport activity poses specific and significant risks for certain species or categories of animals to provide adequate information for the purposes of registration of their activity.
Article 88
Derogations from the registration obligation of transporters of kept ungulates
By way of derogation from Article 87(1), Member States may exempt from the registration requirement certain categories of transporters whose transport activity poses an insignificant risk, as provided for in an implementing act adopted in accordance with Article 89(2). Member States shall inform the Commission of such exemptions.
Article 89
Implementing powers concerning the registration obligation of transporters
1.   The Commission may, by means of implementing acts, lay down rules concerning the information to be provided by transporters for the purposes of registration of their activity, as provided for in Article 87(1) and (3), including the time-limits by which such information is to be provided.
2.   The Commission shall, by means of implementing acts, lay down rules concerning the types of transporters that may be exempted by Member States from the registration requirement in accordance with Article 86, on the basis of:
(a)
the distances over which they transport the ungulates in question; and
(b)
the categories, species and number of ungulates which they transport.
3.   The implementing acts referred to in this Article shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 90
Registration obligation of operators conducting assembly operations independently of an establishment
1.   Operators conducting assembly operations for kept ungulates and poultry, independently of an establishment, including those who buy and sell animals, shall, in order to be registered in accordance with Article 93, before they commence their activities, provide the competent authority with information on:
(a)
the name and address of the operator concerned;
(b)
the species and categories of kept ungulates and poultry covered by their activity.
2.   Operators as referred to in paragraph 1 shall inform the competent authority of:
(a)
any changes concerning the matters referred to in paragraph 1;
(b)
any cessation of activity by the operator concerned.
Article 91
Derogations from the registration obligation of operators conducting assembly operations
By way of derogation from Article 90(1), Member States may exempt from the registration requirement certain categories of operators conducting assembly operations posing an insignificant risk, as provided for in an implementing act adopted in accordance with Article 92(2). Member States shall inform the Commission of such exemptions.
Article 92
Implementing powers concerning the registration obligation of operators conducting assembly operations
1.   The Commission may, by means of implementing acts, lay down rules concerning the information to be provided by operators for the purpose of registration as provided for in Article 90(1), including the time-limits by which such information is to be provided.
2.   The Commission shall, by means of implementing acts, lay down rules concerning the types of operators that may be exempted by Member States from the registration requirement in accordance with Article 91, provided that the activity of such operators poses an insignificant risk and on the basis of species, the categories and numbers of kept terrestrial animals covered by their activity.
3.   The implementing acts referred to in this Article shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 93
Obligation of the competent authority concerning registration
A competent authority shall register:
(a)
establishments in the register provided for in Article 101(1), where the operator concerned has provided the information required in accordance with Article 84(1);
(b)
transporters in the register provided for in Article 101(1), where the transporter concerned has provided the information required in accordance with Article 87(1) and (3);
(c)
operators conducting assembly operations independently of an establishment, in the register provided for in Article 101(1), where the operator concerned has provided the information required in accordance with Article 90(1).
The competent authority shall assign each establishment, transporter and operator as referred to in points (a) to (c) of the first paragraph with a unique registration number.
Section 2
Approval of certain types of establishments
Article 94
Approval of certain establishments and delegated acts
1.   Operators of the following types of establishments shall apply to the competent authority for approval in accordance with Article 96(1) and shall not commence their activities until their establishment has been approved in accordance with Article 97(1):
(a)
establishments for assembly operations of ungulates and poultry from which those animals are moved to another Member State or which receive animals from another Member State;
(b)
germinal product establishments for bovine, porcine, ovine, caprine and equine animals from which germinal products of those animals are moved to another Member State;
(c)
hatcheries from which hatching eggs or poultry are moved to another Member State;
(d)
establishments keeping poultry from which poultry intended for purposes other than slaughter or hatching eggs are moved to another Member State;
(e)
any other type of establishment for kept terrestrial animals which poses a significant risk and is required to be approved in accordance with rules laid down in a delegated act adopted in accordance with point (b) of paragraph 3.
2.   Operators shall cease activity at an establishment as referred to in paragraph 1 where:
(a)
the competent authority withdraws or suspends its approval in accordance with Article 100(2); or
(b)
in the event of conditional approval, granted in accordance with Article 99(3), the establishment in question fails to comply with the outstanding requirements referred to in Article 99(3) and does not obtain a final approval in accordance with Article 97(1).
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
derogations from the requirement for operators of the types of establishments referred to in points (a) to (d) of paragraph 1 to apply to the competent authority for approval, where those establishments pose an insignificant risk;
(b)
the types of establishments which must be approved in accordance with point (e) of paragraph 1;
(c)
special rules for the cessation of activities for germinal product establishments as referred to in point (b) of paragraph 1.
4.   When adopting delegated acts as provided for in paragraph 3, the Commission shall base those acts on the following criteria:
(a)
the species and categories of kept terrestrial animals or germinal products in an establishment;
(b)
the number of species and number of kept terrestrial animals or germinal products kept in an establishment;
(c)
the type of establishment and type of production; and
(d)
the movements of kept terrestrial animals or germinal products into and out of those types of establishments.
Article 95
Approval of status of confined establishments
Operators of establishments wishing to obtain the status of a confined establishment shall:
(a)
apply to the competent authority for approval in accordance with Article 96(1);
(b)
move kept animals to or from their establishment in accordance with the requirements provided for in Article 137(1) and any delegated acts adopted in accordance with Article 137(2) only after their establishment has obtained an approval of that status from the competent authority in accordance with Articles 97 and 99.
Article 96
Obligation of operators to provide information with a view to obtaining approval and implementing acts
1.   Operators shall, for the purposes of their application for approval of their establishment as provided for in Article 94(1) and point (a) of Article 95, provide the competent authority with the following information:
(a)
the name and address of the operator concerned;
(b)
the location of the establishment concerned and a description of its facilities;
(c)
the categories, species and number of kept terrestrial animals or germinal products relevant for the approval which are kept on the establishment;
(d)
the type of establishment;
(e)
other aspects of the establishment, related to its specificity, which are relevant in determining the risk, if any, posed by it.
2.   Operators of establishments as referred to in paragraph 1 shall inform the competent authority of:
(a)
any changes in the establishments concerning the matters referred to in points (a), (b) or (c) of paragraph 1;
(b)
any cessation of activity by the operator or establishment concerned.
3.   The Commission may, by means of implementing acts, lay down rules concerning the information to be provided by operators in their application for approval of their establishment in accordance with paragraph 1, and the time-limits by which the information referred to in paragraph 1 and in point (b) of paragraph 2 is to be provided.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 97
Granting of, and conditions for, approval of establishments and delegated acts
1.   Competent authorities shall only grant approval of establishments as provided for in Article 94(1) and point (a) of Article 95 where such establishments:
(a)
comply with the following requirements, where appropriate, in relation to:
(i)
quarantine, isolation and other biosecurity measures taking into account the requirements provided for in point (b) of Article 10(1) and any rules adopted pursuant to Article 10(2);
(ii)
surveillance requirements as provided for in Article 24 and, where relevant for the type of establishment concerned and the risk involved, in Article 25;
(iii)
record-keeping as provided for in Articles 102 and 103 and any rules adopted pursuant to Articles 106 and 107;
(b)
have facilities and equipment that are:
(i)
adequate to reduce the risk of the introduction and spread of diseases to an acceptable level, taking into account the type of establishment concerned;
(ii)
of a capacity adequate for the number of kept terrestrial animals or the volume of germinal products concerned;
(c)
do not pose an unacceptable risk as regards the spread of diseases, taking into account the risk-mitigation measures in place;
(d)
have adequately trained personnel for the activity of the establishment concerned;
(e)
have in place a system which enables the operator concerned to demonstrate to the competent authority compliance with points (a) to (d).
2.   The Commission shall adopt delegated acts in accordance with Article 264 concerning:
(a)
quarantine, isolation and other biosecurity measures as referred to in point (a)(i) of paragraph 1;
(b)
surveillance as referred to in point (a)(ii) of paragraph 1;
(c)
facilities and equipment as referred to in point (b) of paragraph 1;
(d)
responsibilities, competence and specialised training of personnel and veterinarians as provided for in point (d) of paragraph 1 for the activity of germinal products establishments and establishments for assembly operations of ungulates and poultry;
(e)
the necessary supervision by the competent authority of germinal products establishments and establishments for assembly operations of ungulates and poultry.
3.   When establishing the rules to be laid down in the delegated acts to be adopted pursuant to paragraph 2, the Commission shall base those rules on the following matters:
(a)
the risks posed by each type of establishment;
(b)
the species and categories of kept terrestrial animals relevant for the approval;
(c)
the type of production concerned;
(d)
typical movement patterns of the type of establishment and species and categories of animals kept in those establishments.
Article 98
Scope of the approval of establishments
The competent authority shall expressly specify in the approval of an establishment granted pursuant to Article 97(1), following an application made in accordance with Article 94(1) or point (a) of Article 95:
(a)
for which of the types of establishments referred to in Article 94(1) and Article 95, and in the rules adopted pursuant to point (b) of Article 94(3), the approval applies;
(b)
for which species and categories of kept terrestrial animals or germinal products of those species the approval applies.
Article 99
Procedures for the granting of approval by the competent authority
1.   The competent authority shall establish procedures for operators to follow when applying for approval of their establishments in accordance with Article 94(1), Article 95 or Article 96(1).
2.   Upon receipt of an application for approval from an operator, the competent authority shall, in accordance with Article 94(1) or point (a) of Article 95, make an on–site visit.
3.   Provided that the requirements referred to in Article 97 and paragraphs (1) and (2) of this Article are fulfilled, the competent authority shall grant the approval.
4.   Where an establishment does not fulfil all requirements for approval as referred to in Article 97, the competent authority may grant conditional approval of an establishment if it appears, on the basis of the application by the operator concerned and the subsequent on–site visit as provided for in paragraph 2 of this Article, that the establishment meets all the main requirements that provide sufficient guarantees that the establishment does not pose a significant risk.
5.   Where conditional approval has been granted by the competent authority in accordance with paragraph 4 of this Article, it shall grant full approval only where it appears from another on–site visit to the establishment, carried out within three months of the date of the grant of conditional approval, or from documentation provided by the operator within three months from that date, that the establishment meets all the requirements for approval provided for in Article 97(1) and the rules adopted pursuant to Article 97(2).
Where the on–site visit or the documentation referred to in the first subparagraph shows that clear progress has been made but that the establishment still does not meet all of those requirements, the competent authority may prolong the conditional approval. However, conditional approval shall not be granted for a period exceeding, in total, six months.
Article 100
Review, suspension and withdrawal of approvals by the competent authority
1.   The competent authority shall keep approvals of establishments granted in accordance with Articles 97 and 99 under review, at appropriate intervals based on the risk involved.
2.   Where a competent authority identifies serious deficiencies in an establishment as regards compliance with the requirements laid down in Article 97(1) and the rules adopted pursuant to Article 97(2), and the operator of that establishment is not able to provide adequate guarantees that those deficiencies will be eliminated, the competent authority shall initiate procedures to withdraw the approval of the establishment.
However, the competent authority may merely suspend, rather than withdraw, approval of an establishment where the operator can guarantee that it will eliminate those deficiencies within a reasonable period of time.
3.   Approval shall only be granted after withdrawal or restored after suspension in accordance with paragraph 2 when the competent authority is satisfied that the establishment fully complies with all the requirements of this Regulation appropriate for that type of establishment.
Section 3
Registers of the competent authority
Article 101
Registers to be kept by the competent authority
1.   Each competent authority shall establish and keep up to date registers of:
(a)
all establishments and operators registered with it pursuant to Article 93;
(b)
all establishments approved by it in accordance with Articles 97 and 99.
It shall make the registers referred to in points (a) and (b) of the first subparagraph available to the Commission and to the competent authorities of other Member States in so far as the information contained therein is relevant for movements of kept terrestrial animals and germinal products thereof between Member States.
It shall make the register of approved establishments as referred to in point (b) of the first subparagraph available to the public in so far as the information contained therein is relevant for movements of kept terrestrial animals and germinal products thereof between Member States.
2.   Where appropriate and relevant, a competent authority may combine the registration referred to in point (a) of the first subparagraph of paragraph 1 and the approvals referred to in point (b) of the first subparagraph of paragraph 1 with registration for other purposes.
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the detailed information to be included in the registers provided for in points (a) and (b) of the first subparagraph of paragraph 1, and the availability to the public of the register provided for in point (b) of the first subparagraph of paragraph 1.
Section 4
Record-keeping
Article 102
Record-keeping obligations of operators of establishments other than germinal products establishments
1.   Operators of establishments subject to the requirement of registration in accordance with Article 93, or approval in accordance with Article 97(1), shall keep and maintain records containing at least the following information:
(a)
the species, categories, number and, where applicable, identification of kept terrestrial animals on their establishment;
(b)
movements of kept terrestrial animals into and out of their establishment, stating as appropriate:
(i)
their place of origin or destination;
(ii)
the date of such movements;
(c)
the documents required to accompany kept terrestrial animals arriving at or leaving their establishment in accordance with point (b) of Article 112, point (b) of Article 113(1), point (c) of Article 114(1), point (b) of Article 115, point (b) of Article 117, Article 143(1) and (2), Article 164(2) and any rules adopted pursuant to Articles 118 and 120 and points (b) and (c) of Article 144(1);
(d)
mortality of kept terrestrial animals on their establishment;
(e)
biosecurity measures, surveillance, treatments, test results and other relevant information as appropriate for:
(i)
the species and categories of kept terrestrial animals in the establishment;
(ii)
the type of production;
(iii)
the type and size of the establishment;
(f)
the results of any animal health visits required in accordance with Article 25(1).
The records shall be kept and maintained in paper or electronic form.
2.   Establishments presenting a low risk of spreading listed or emerging diseases may be exempted by the Member State concerned from the requirement to keep records of all or some of the information listed in paragraph 1.
3.   Operators of establishments shall keep the records provided for in paragraphs 1 and 2 on their establishment concerned and shall:
(a)
make them immediately available to the competent authority on request;
(b)
retain them for a minimum period to be prescribed by the competent authority, which may not be less than three years.
4.   By way of derogation from paragraph 3, operators may be exempted from the obligation to keep records of some or all of the matters provided for in paragraph 1 when the operator concerned:
(a)
has access to the computerised database referred to in Article 109 for the relevant species and the database already contains the information to be included in the records; and
(b)
has the up–to–date information entered directly into the computerised database.
Article 103
Record-keeping obligations of germinal product establishments
1.   Operators of germinal product establishments shall keep and maintain records containing at least the following information:
(a)
the breed, age, identification and health status of donor animals used for the production of germinal products;
(b)
the time and place of collection, and the processing and storage, of germinal products collected, produced or processed;
(c)
the identification of the germinal products together with details of their place of destination, if known;
(d)
the documents required to accompany germinal products arriving at or leaving the establishment in question in accordance with Article 162 and Article 164(2) and any rules adopted pursuant to Article 162(3) and (4);
(e)
where relevant, the results of clinical and laboratory tests;
(f)
laboratory techniques used.
2.   Establishments presenting a low risk of spreading listed or emerging diseases may be exempted by the Member State concerned from the requirement to keep records of all or some of the information listed in paragraph 1.
3.   Operators of germinal product establishments shall keep the records provided for in paragraphs 1 and 2 on their establishment and:
(a)
make them immediately available to the competent authority on request;
(b)
retain them for a minimum period to be prescribed by the competent authority, which may not be less than three years.
Article 104
Record-keeping obligations of transporters
1.   Transporters shall keep and maintain records containing at least the following information:
(a)
the establishments visited by them;
(b)
the categories, species and number of kept terrestrial animals transported by them;
(c)
the cleaning, disinfection and disinfestation of the means of transport used;
(d)
details of the documents accompanying the animals in question, including their document numbers.
The records shall be kept and maintained in paper or electronic form.
2.   Transporters presenting a low risk of spreading listed or emerging diseases may be exempted by the Member State concerned from the requirement to keep records of all or some of the information listed in paragraph 1.
3.   Transporters shall keep the records provided for in paragraphs 1 and 2:
(a)
in such a manner that they can be made immediately available to the competent authority on request;
(b)
for a minimum period to be prescribed by the competent authority, which may not be less than three years.
Article 105
Record-keeping obligations of operators conducting assembly operations
1.   Operators conducting assembly operations subject to the registration requirement laid down in Article 93 shall keep and maintain records containing at least the following information:
(a)
the species, categories, numbers and identification of kept terrestrial animals under their responsibility;
(b)
movements of kept terrestrial animals under their responsibility, stating as appropriate:
(i)
their place of origin and destination;
(ii)
the date of such movements;
(c)
the documents required to accompany kept terrestrial animals moved under their responsibility in accordance with point (b) of Article 112, point (b) of Article 113(1), point (c) of Article 114(1), point (b) of Article 115, point (b) of Article 117, Article 143(1) and (2), Article 164(2) and any rules adopted pursuant to Articles 118 and 120 and points (b) and (c) of Article 144(1);
(d)
mortality of kept terrestrial animals under their responsibility; and
(e)
biosecurity measures, surveillance, treatments, test results and other relevant information as appropriate for the species and categories of kept terrestrial animals under their responsibility.
The records shall be kept and maintained in paper or electronic form.
2.   Operators whose activities present a low risk of spreading listed or emerging diseases may be exempted by the Member State concerned from the requirement to keep records of all or some of the information listed in paragraph 1.
3.   Operators shall:
(a)
make the records referred to in paragraph 1 available to the competent authority on request;
(b)
retain those records for a minimum period to be prescribed by the competent authority, which may not be less than three years.
Article 106
Delegation of powers concerning record-keeping
1.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules supplementing the record-keeping requirements provided for in Articles 102, 103, 104 and 105, as regards:
(a)
information to be recorded in addition to that provided for in Articles 102(1), 103(1), 104(1) and 105(1);
(b)
additional requirements for record-keeping in respect of germinal products collected, produced or processed in a germinal products establishment after that establishment ceased its activities.
2.   When establishing the rules to be laid down in delegated acts as provided for in paragraph 1, the Commission shall base those rules on the following matters:
(a)
the risks posed by each type of establishment or activity;
(b)
the species and categories of kept terrestrial animals or germinal products in the establishment concerned, or transported to or from that establishment;
(c)
the type of production on the establishment or the type of activity;
(d)
the typical movement patterns and categories of the animals concerned;
(e)
the number of kept terrestrial animals or volume of germinal products under the responsibility of the operator concerned.
Article 107
Implementing powers concerning exemptions from the record-keeping requirements
The Commission may, by means of implementing acts, lay down rules concerning the types of establishments and operators that may be exempted by Member States from the record-keeping requirements provided for in Articles 102, 103, 104 and 105, as regards:
(a)
establishments keeping, or operators handling or transporting, a small number of kept terrestrial animals or a small volume or number of germinal products;
(b)
species or categories of kept terrestrial animals or germinal products.
When adopting those implementing acts, the Commission shall base those acts on the criteria laid down in Article 106(2).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
CHAPTER 2
Traceability requirements for kept terrestrial animals and germinal products
Section 1
Kept terrestrial animals
Article 108
Member States' responsibility for establishing a system for the identification and registration of kept terrestrial animals
1.   Member States shall have in place a system for the identification and registration of those species of kept terrestrial animals for which such a system is required by this Regulation and by any rules adopted pursuant to it. Such a system shall, when appropriate, provide for the recording of the movements of such animals.
2.   When establishing the system referred to in paragraph 1, Member States shall take into account:
(a)
the species or categories of kept terrestrial animals concerned;
(b)
the risk posed by that species or category.
3.   The system provided for in paragraph 1 shall include the following elements:
(a)
the means to identify kept terrestrial animals individually or in groups;
(b)
identification documents, movement documents and other documents for identifying and tracing kept terrestrial animals as referred to in Article 110;
(c)
up–to–date records in establishments as provided for in points (a) and (b) of Article 102(1);
(d)
a computer database of kept terrestrial animals as provided for in Article 109(1).
4.   The system provided for in paragraph 1 shall be designed in such a manner that it:
(a)
ensures the efficient application of the disease prevention and control measures provided for in this Regulation;
(b)
facilitates the traceability of kept terrestrial animals and their movements within and between Member States and their entry into the Union;
(c)
ensures the efficient interoperability, integration and compatibility of the elements of that system;
(d)
ensures that the system, to the extent appropriate, is adapted to:
(i)
the computerised information system for Union notification and reporting provided for in Article 22;
(ii)
TRACES;
(e)
ensures a coherent approach in respect of the different animal species covered by the system.
5.   Member States may when appropriate:
(a)
use the whole or part of the system provided for in paragraph 1 for purposes other than those referred to in points (a) and (b) of paragraph 4;
(b)
integrate the identification documents, movement documents and other documents referred to in Article 110 with the animal health certificates or self–declaration document provided for in Article 143(1) and (2) and Article 151(1) and in any rules adopted pursuant to points (b) and (c) of Article 144(1) and Article 151(3) and (4);
(c)
designate another authority or authorise another body or a natural person to ensure the practical application of the identification and registration system provided for in paragraph 1 of this Article, including the issuing of identification documents and the drawing-up of models as provided for in points (a), (b) and (c) of Article 110(1).
Article 109
Member States' obligation to establish and maintain a computer database of kept terrestrial animals
1.   The Member States shall establish and maintain a computer database for the recording of at least:
(a)
the following information related to kept animals of the bovine species:
(i)
their individual identification as provided for in point (a) of Article 112;
(ii)
the establishments keeping them;
(iii)
their movements into and from those establishments;
(b)
the following information related to kept animals of the ovine and caprine species:
(i)
information on their identification as provided for in point (a) of Article 113(1) and the number of animals at the establishments keeping them;
(ii)
the establishments keeping them;
(iii)
their movements into and from those establishments;
(c)
the following information related to kept animals of the porcine species:
(i)
information on their identification as provided for in Article 115 and the number of animals at the establishments keeping them;
(ii)
the establishments keeping them;
(iii)
their movements into and from those establishments;
(d)
the following information related to kept animals of the equine species:
(i)
their unique code as provided for in Article 114;
(ii)
the method of identification provided for in point (b) of Article 114(1) linking the animal concerned with the identification document referred to in point (iii) where relevant;
(iii)
the relevant identification details from the identification document provided for in point (c) of Article 114(1), as determined in the rules adopted pursuant to Articles 118 and 120;
(iv)
the establishments where those animals are habitually kept;
(e)
information related to kept terrestrial animals of species other than those referred to in points (a), (b), (c) and (d) of this paragraph, when this is provided for in the rules adopted pursuant to paragraph 2.
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the recording of information related to animal species other than those referred to in points (a), (b), (c) and (d) of paragraph 1 of this Article in the computer database provided for in that paragraph where necessary, due to the specific and significant risks posed by those species, in order to:
(a)
ensure the efficient application of the disease prevention measures and control measures provided for in this Regulation;
(b)
facilitate the traceability of kept terrestrial animals, their movements between Member States and their entry into the Union.
Article 110
Obligation of the competent authority in respect of identification documents, movement documents and other documents for the identification and tracing of kept terrestrial animals
1.   Each competent authority shall:
(a)
issue identification documents in respect of kept terrestrial animals where those documents are required by point (c) of Article 114(1) and point (b) of Article 117 and by rules adopted pursuant to Articles 118 and 120;
(b)
issue identification documents in respect of bovine animals as required by point (b) of Article 112, unless Member States exchange electronic data with other Member States within the framework of an electronic exchange system from the date when the Commission recognises the full operability of that system;
(c)
draw up models of movement documents and other documents for the identification and tracing of kept terrestrial animals, when required by point (b) of Article 113(1), point (b) of Article 115, point (b) of Article 117 and any rules adopted pursuant to Articles 118 and 120.
2.   Point (b) of paragraph (1) is without prejudice to the right of Member States to adopt national rules on the issuing of passports for animals not intended for movement between Member States.
Article 111
Public availability of information on means of identification
Each competent authority shall inform the Commission of, and make publicly available, information on:
(a)
contact points for the computer databases established by the Member States in accordance with Article 109(1);
(b)
the authorities or bodies responsible for issuing identification documents, movement documents and other documents in accordance with Article 110, taking into account point (c) of Article 108(5);
(c)
the means of identification that are to be used for each species and category of kept terrestrial animals in accordance with point (a) of Article 112, point (a) of Article 113(1), Article 114(1), point (a) of Article 115, point (a) of Article 117 and any rules adopted pursuant to Articles 118 and 120;
(d)
the prescribed format for the issuing of the identification documents and other documents referred to in Article 110.
Article 112
Operators' obligations in respect of the identification of kept animals of the bovine species
Operators keeping animals of the bovine species shall:
(a)
ensure that those kept animals are identified individually by a physical means of identification;
(b)
ensure that those kept animals, when they are moved between Member States, are issued with an identification document from the competent authority or designated authority or authorised body of origin, unless the conditions laid down in point (b) of Article 110(1) are met;
(c)
ensure that that identification document:
(i)
is kept, correctly completed and updated by the operator concerned; and
(ii)
accompanies those kept terrestrial animals at the time of movement, when such document is required by point (b);
(d)
transmit the information on movements of those kept animals from and to the establishment concerned, and all births and deaths in that establishment, to the computer database provided for in Article 109(1).
Article 113
Operators' obligations in respect of the identification of kept animals of the ovine and caprine species
1.   Operators keeping kept animals of the ovine and caprine species shall:
(a)
ensure that those kept animals are each identified by a physical means of identification;
(b)
ensure that those kept animals are accompanied by a correctly completed movement document based on the model drawn up by the competent authority in accordance with Article 110 when they are moved from the establishment keeping those animals within the Member State concerned;
(c)
transmit the information on movements of those kept animals from and to the establishment to the computer database provided for in Article 109(1).
2.   Member States may exempt operators from the requirement to ensure that kept animals of the ovine and caprine species are accompanied by movement documents during movements within their territory, provided that:
(a)
the information contained in the relevant movement document is included in the computer database provided for in Article 109(1);
(b)
the system for the identification and registration of kept animals of the ovine and caprine species provides level of traceability equivalent to that provided by movement documents.
Article 114
Operators' obligations in respect of the identification and registration of kept animals of the equine species
1.   Operators keeping kept animals of the equine species shall ensure that those animals are individually identified by:
(a)
a unique code which is recorded in the computer database provided for in Article 109(1);
(b)
a physical means of identification or other method which unequivocally links the kept animal with the identification document provided for in point (c) of this paragraph and issued by the competent authority in accordance with Article 110;
(c)
a correctly completed single lifetime identification document.
2.   Operators of kept animals of the equine species shall ensure that the information on those animals is transmitted to the computer database provided for in Article 109(1).
Article 115
Operators' obligations in respect of the identification and registration of kept animals of the porcine species
Operators keeping kept animals of the porcine species shall:
(a)
ensure that those kept animals are each identified by a physical means of identification;
(b)
ensure that those kept animals are accompanied by a correctly completed movement document based on the model drawn up by the competent authority in accordance with point (b) of Article 110(1) when they are moved from the establishment keeping those animals within the Member State concerned;
(c)
transmit the information relating to the establishment keeping those animals to the computer database provided for in Article 109(1).
Article 116
Derogations concerning movements of kept animals of the porcine species
By way of derogation from point (b) of Article 115, Member States may exempt operators from the requirement to ensure that kept animals of the porcine species are accompanied by correctly completed movement documents based on the model drawn up by the competent authority for movements within the Member State concerned, provided that:
(a)
the information contained in such movement documents is included in the computer database established by that Member State in accordance with Article 109(1);
(b)
the system for the identification and registration of kept terrestrial animals of the porcine species provides a level of traceability equivalent to that provided by such movement documents.
Article 117
Operators' obligation in respect of the identification of kept terrestrial animals other than animals of the bovine, ovine, caprine, porcine and equine species
Operators shall ensure that kept terrestrial animals of species other than those of the bovine, ovine, caprine, porcine and equine species fulfil the following requirements, when required by the rules adopted pursuant to Articles 118 and 120:
(a)
they are identified, either individually or in groups;
(b)
they are accompanied by correctly completed and updated identification documents, movement documents or other documents for the identification and tracing of animals, as appropriate for the animal species concerned.
Article 118
Delegation of powers concerning identification and registration
1.   The Commission shall adopt delegated acts in accordance with Article 264 concerning:
(a)
detailed requirements for the means and methods of identification of kept terrestrial animals provided for in point (a) of Article 112, point (a) of Article 113(1), Article 114(1), point (a) of Article 115 and point (a) of Article 117, including their application and use;
(b)
rules on the information to be included in:
(i)
the computer databases provided for in points (a) to (d) of Article 109(1);
(ii)
the identification and movement documents provided for in point (b) of Article 112, point (b) of Article 113(1), point (c) of Article 114(1), and point (b) of Article 115;
(c)
rules on the exchange of electronic data between computer databases of Member States as referred to in point (b) of Article 110(1).
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
detailed requirements for alternative means and methods of identification to those referred to in point (a) of paragraph 1 of this Article, as well as exemptions and special provisions for certain categories of animals or circumstances and conditions for such exemptions;
(b)
specific provisions for the identification or movement documents provided for in point (b) of Article 112, point (b) of Article 113(1), point (c) of Article 114(1), point (b) of Article 115 and point (b) of Article 117 that have to accompany animals when they are moved;
(c)
detailed requirements for the identification and registration of kept terrestrial animals of species other than the bovine, ovine, caprine, porcine and equine species where necessary, taking into account the risks posed by the species concerned, in order to:
(i)
ensure the efficient application of the disease prevention and control measures provided for in this Regulation;
(ii)
facilitate the traceability of kept terrestrial animals, and their movements within and between Member States and their entry into the Union;
(d)
rules on the information to be included in:
(i)
the computer databases provided for in point (e) of Article 109(1);
(ii)
the identification and movement documents provided for in point (b) of Article 117;
(e)
rules on the identification and registration of kept terrestrial animals as referred to in Articles 112 to 117 after their entry into the Union.
3.   When establishing the rules to be laid down in the delegated acts provided for in this Article, the Commission shall base those rules on the considerations provided for in Article 119(2).
Article 119
Delegation of powers concerning derogations from the traceability requirements
1.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning derogations for operators from the identification and registration requirements provided for in Articles 112, 113, 114 and 115:
(a)
in cases where one or more of the elements listed in Article 108(3) are not necessary in order to meet the requirements provided for in points (a) and (b) of Article 108(4); and
(b)
when other traceability measures in place in the Member States guarantee that the level of traceability of the animals in question is not compromised,
as well as transitional measures required for the practical application of such derogations.
2.   When establishing the rules to be laid down in the delegated acts provided for in paragraph 1, the Commission shall base those rules on the following considerations:
(a)
the species and categories of kept terrestrial animals concerned;
(b)
the risks involved for those kept terrestrial animals;
(c)
the number of animals in the establishments concerned;
(d)
the type of production in the establishments where those terrestrial animals are kept;
(e)
movement patterns for the species and categories of kept terrestrial animals concerned;
(f)
considerations concerning the protection and conservation of the species of kept terrestrial animals concerned;
(g)
the performance of the other traceability elements of the system for the identification and registration of kept terrestrial animals referred to in Article 108(3).
Article 120
Implementing powers concerning the traceability of kept terrestrial animals
1.   The Commission shall, by means of implementing acts, adopt rules:
(a)
for uniform access to data contained in, and the technical specifications and operational rules of, the computer databases referred to in points (a) to (d) of Article 109(1);
(b)
on the technical conditions and modalities for the exchange of electronic data between computer databases of Member States and the recognition of full operability of the data exchange systems referred to in point (b) of Article 110(1).
2.   The Commission may, by means of implementing acts, adopt rules:
(a)
for the uniform application of the identification and registration system provided for in Article 108(1) for different species or categories of kept terrestrial animals, in order to ensure its efficient operation;
(b)
for the uniform application of point (c) of Article 108(5) concerning the authorised bodies or natural persons referred to in Article 108(5) and the conditions for their designation;
(c)
on the technical specifications and procedures, formats, design and operational rules for the means and methods of identification, including:
(i)
the time periods for the application of the means and methods of identification;
(ii)
the removal, modification or replacement of the means and methods of identification and the deadlines for such operations; and
(iii)
the configuration of the identification code;
(d)
on the technical specifications, formats and operational rules for the identification and movement documents provided for in point (b) of Article 112, point (b) of Article 113(1), point (c) of Article 114(1), point (b) of Article 115 and point (b) of Article 117;
(e)
for uniform access to data contained in, and the technical specifications and operational rules of, the computer databases referred to in point (e) of Article 109(1);
(f)
on the deadlines, obligations and procedures for the transmission of information by operators or other natural or legal persons and for the registration of kept terrestrial animals in the computer databases;
(g)
on guidelines and procedures for electronic identification of animals, where relevant;
(h)
on the practical application of exemptions from the identification and registration requirements provided for in the rules adopted pursuant to Article 119(1).
3.   The implementing acts referred to in this Article shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Section 2
Germinal products
Article 121
Traceability requirements for germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species
1.   Operators producing, processing or storing germinal products shall mark germinal products of kept animals of the bovine, caprine, ovine, porcine and equine species in such a way that they can be clearly traced to:
(a)
the donor animals;
(b)
the date of collection; and
(c)
the germinal product establishments where they were collected, produced, processed and stored.
2.   The marking provided for in paragraph 1 shall be designed in such a way as to ensure:
(a)
the efficient application of the disease prevention and control measures provided for in this Regulation;
(b)
the traceability of the germinal products, their movements within and between Member States and their entry into the Union.
Article 122
Delegation of powers concerning traceability requirements for germinal products
1.   The Commission shall adopt delegated acts in accordance with Article 264 concerning traceability requirements for germinal products of kept terrestrial animals of the bovine, caprine, ovine, porcine and equine species supplementing the rules laid down in Article 121;
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning traceability requirements for germinal products of kept terrestrial animals of species other than of the bovine, caprine, ovine, porcine and equine species, where necessary for:
(a)
the efficient application of the disease prevention and control measures provided for in this Regulation;
(b)
the traceability of those germinal products, their movements within and between Member States and their entry into the Union.
3.   When adopting the delegated acts provided for in paragraph 1, the Commission shall base those acts on the following matters:
(a)
the species of kept terrestrial animals from which the germinal products originate;
(b)
the health status of donor animals;
(c)
the risk involved with such germinal products;
(d)
the type of germinal products;
(e)
the type of collection, production, processing or storage of germinal products;
(f)
the movement patterns for the relevant species and categories of kept terrestrial animals and their germinal products;
(g)
considerations concerning the protection and conservation of species of kept terrestrial animals;
(h)
other elements that may contribute to the traceability of germinal products.
Article 123
Implementing powers concerning traceability requirements for germinal products
The Commission shall, by means of implementing acts, lay down rules concerning:
(a)
technical requirements and specifications for marking as provided for in Article 121(1);
(b)
operational requirements for the traceability provided for in delegated acts adopted pursuant to Article 122(1).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
CHAPTER 3
Movements within the Union of kept terrestrial animals
Section 1
General requirements for movements
Article 124
General requirements for movements of kept terrestrial animals
1.   Operators shall take appropriate preventive measures to ensure that the movement of kept terrestrial animals does not jeopardise the health status at the place of destination with regard to:
(a)
the listed diseases referred to in point (d) of Article 9(1);
(b)
emerging diseases.
2.   Operators shall only move kept terrestrial animals from their establishments and receive such animals if the animals in question fulfil the following conditions:
(a)
they come from establishments that have been:
(i)
registered by the competent authority in accordance with Article 93; or
(ii)
approved by the competent authority in accordance with Articles 97(1) and 98, when required by Article 94(1) or Article 95; or
(iii)
granted a derogation from the registration requirement laid down in Article 84;
(b)
they fulfil the identification and registration requirements laid down in Articles 112, 113, 114, 115 and 117 and the rules adopted pursuant to Articles 118 and 120.
Article 125
Disease prevention measures in relation to transport
1.   Operators shall take the appropriate and necessary preventive measures to ensure that:
(a)
the health status of kept terrestrial animals is not jeopardised during transport;
(b)
transport operations of kept terrestrial animals do not cause the potential spread of listed diseases as referred to in point (d) of Article 9(1) to humans and animals;
(c)
cleaning and disinfection of, and control of insects and rodents with respect to, equipment and means of transport and other adequate biosecurity measures are taken, as appropriate to the risks involved with the transport operations concerned.
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
the conditions and requirements for cleaning and disinfection of, and control of insects and rodents with respect to, equipment and means of transport and the use of biocidal products for those purposes;
(b)
other appropriate biosecurity measures as provided for in point (c) of paragraph 1 of this Article.
Section 2
Movements between Member States
Article 126
General requirements for movements of kept terrestrial animals between Member States
1.   Operators shall only move kept terrestrial animals to another Member State if the animals in question fulfil the following conditions:
(a)
they show no disease symptoms;
(b)
they come from a registered or approved establishment:
(i)
where there are no abnormal mortalities with an undetermined cause;
(ii)
which is not subject to movement restrictions affecting the species to be moved in accordance with the rules laid down in Article 55(1), point (a) of Article 61(1), Article 62, point (c) of Article 65(1), Article 74(1) and Article 79 and the rules adopted pursuant to Article 55(2), Articles 63 and 67, Articles 71(3), 74(4), and 83(2) or the emergency measures provided for in Articles 257 and 258 and any rules adopted pursuant to Article 259, unless derogations from movement restrictions have been granted in accordance with those rules;
(iii)
which is not situated in a restricted zone in accordance with rules laid down in point (f)(ii) of Article 55(1), Articles 64 and 65, Article 74(1), Article 79 and any rules adopted pursuant to Article 67, Article 71(3), Article 74(4) and Article 83(2) or the emergency measures provided for in Articles 257 and 258 and any rules adopted pursuant to Article 259, unless derogations have been granted in accordance with those rules;
(c)
they have not been in contact with kept terrestrial animals which are subject to movement restrictions as referred to in point (b)(ii) and (iii) or kept terrestrial animals of a listed species of a lower health status, for an adequate period of time prior to the date of the intended movement to another Member State, thereby minimising the possibility of spreading disease, taking into account the following matters:
(i)
the incubation period and routes of transmission of the listed diseases and emerging diseases in question;
(ii)
the type of establishment concerned;
(iii)
the species and category of kept terrestrial animals moved;
(iv)
other epidemiological factors;
(d)
they fulfil the relevant requirements provided for in Sections 3 to 8 (Articles 130 to 154).
2.   Operators shall take all necessary measures to ensure that kept terrestrial animals moved to another Member State are consigned directly to their place of destination in that other Member State unless they need to stop at a place of resting for animal welfare reasons.
Article 127
Obligations of operators at the place of destination
1.   Operators of establishments and slaughterhouses receiving kept terrestrial animals from another Member State shall:
(a)
check that:
(i)
the means or methods of identification provided for in point (a) of Article 112, point (a) of Article 113(1), points (a) and (b) Article 114(1), point (a) of Article 115 and point (a) of Article 117 and the rules adopted pursuant to Articles 118 and 120 are in place;
(ii)
the identification documents provided for in point (b) of Article 112, point (b) of Article 113(1), point (c) of Article 114(1), point (b) of Article 117 and the rules adopted pursuant to Articles 118 and 120 are in place and are correctly completed;
(b)
check that the animal health certificates provided for in Article 143 and in any rules adopted pursuant to points (b) and (c) of Article 144(1) or the self–declaration documents provided for in Article 151 and the rules adopted pursuant to Article 151(3) and (4) are in place;
(c)
inform the competent authority of the place of destination, after checking the kept terrestrial animals received, of any irregularity with regard to:
(i)
the kept terrestrial animals received;
(ii)
the means or methods of identification referred to in point (a)(i);
(iii)
the documents referred to in points (a)(ii) and (b).
2.   In the event of any irregularity as referred to in point (c) of paragraph 1, the operator shall isolate the animals concerned by that irregularity until the competent authority of the place of destination has taken a decision regarding them.
Article 128
Prohibition on movements of kept terrestrial animals for disease eradication purposes outside the territory of a Member State
Operators shall not move kept terrestrial animals intended to be slaughtered for disease eradication purposes as part of an eradication programme, as provided for in Article 31(1) or (2), to another Member State unless the Member State of destination and, where relevant, the Member State of passage authorise the movement in advance.
Article 129
General requirement applicable to operators in respect of movements of kept terrestrial animals passing through Member States but intended for export from the Union to third countries or territories
Operators shall ensure that kept terrestrial animals intended for export to a third country or territory and passing through the territory of another Member State fulfil the requirements laid down in Articles 124, 125, 126 and 128.
Section 3
Specific requirements in respect of movements to other Member States of ungulates and poultry
Article 130
Movements of kept ungulates and poultry to other Member States
Operators shall only move kept ungulates and poultry from an establishment in one Member State to another Member State if the animals in question fulfil the following conditions as regards the listed diseases referred to in point (d) of Article 9(1):
(a)
they show no clinical symptoms or signs of listed diseases as referred to in point (d) of Article 9(1) at the time of movement;
(b)
they have been subject to a residency period appropriate to those listed diseases, taking into account the species and category of kept ungulates and poultry to be moved;
(c)
for a period of time appropriate for those listed diseases and the species and category of ungulates or poultry to be moved, no kept ungulates or poultry have been introduced into the establishment of origin when a requirement to that effect is laid down in the rules adopted in accordance with Article 131 or Article 135;
(d)
they are presumed not to pose a significant risk of spreading of those listed diseases at the place of destination, based on:
(i)
the health status concerning relevant diseases for species or categories of kept ungulates and poultry moved, taking into account the health status at the place of destination;
(ii)
the results of laboratory or other examinations necessary in order to provide guarantees regarding the health status required for the movement in question;
(iii)
the application of vaccination or other disease prevention or risk-mitigation measures aimed at limiting the spread of the relevant disease to the places of destination or passage.
Article 131
Delegation of powers in respect of movements of kept ungulates and poultry to other Member States
1.   The Commission shall adopt delegated acts in accordance with Article 264 concerning:
(a)
residency periods as referred to in point (b) of Article 130;
(b)
the period of time necessary in order to limit the introduction of kept ungulates or poultry into establishments prior to movement as provided for in point (c) of Article 130;
(c)
supplementary requirements to ensure that kept ungulates and poultry do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1), as provided for in point (d) of Article 130);
(d)
other necessary risk-mitigation measures supplementing the requirements laid down in Article 130.
2.   When establishing the rules to be laid down in the delegated acts provided for in paragraph 1, the Commission shall base those rules on the following considerations:
(a)
the listed diseases referred to in point (d) of Article 9(1) relevant for the listed species or the category of kept ungulates or poultry to be moved;
(b)
the health status as regards listed diseases referred to in point (d) of Article 9(1) in the establishments, compartments, zones and Member States of origin and destination;
(c)
the type of establishment concerned and the type of production at the places of origin and destination;
(d)
the type of movement concerned;
(e)
the species and categories of kept ungulates or poultry to be moved;
(f)
the age of the kept ungulates or poultry to be moved;
(g)
other epidemiological factors.
Article 132
Kept ungulates and poultry moved to another Member State and intended for slaughter
1.   Operators of slaughterhouses receiving kept ungulates and poultry from another Member State shall slaughter those animals as soon as possible following their arrival and at the latest within a timeframe to be laid down in delegated acts adopted pursuant to paragraph 2.
2.   The Commission shall adopt delegated acts in accordance with Article 264 concerning the time of slaughter provided for in paragraph 1 of this Article.
Section 4
Assembly operations in respect of kept ungulates and poultry
Article 133
Derogation in respect of assembly operations
1.   By way of derogation from Article 126(2), operators may subject kept ungulates and poultry to a maximum of three assembly operations during a movement from a Member State of origin to another Member State.
2.   The assembly operations provided for in paragraph 1 of this Article shall only take place in an establishment approved for that purpose in accordance with Article 97(1) and Article 99(3) and (4).
However, the Member State of origin may allow an assembly operation on its territory to take place on a means of transport, collecting kept ungulates or poultry directly from their establishments of origin, provided that those animals are not unloaded again during that operation and before arriving:
(a)
at the establishment or final place of destination; or
(b)
for the subsequent assembly operation in an establishment approved for that purpose in accordance with Article 97(1) and Article 99(4) and (5).
Article 134
Disease prevention requirements in respect of assembly operations
Operators conducting assembly operations shall ensure that:
(a)
the kept ungulates and poultry assembled have the same health status; where they do not, the lower health status applies to all such animals assembled;
(b)
the kept ungulates and poultry are assembled and moved to their final place of destination in another Member State as soon as possible after leaving their establishment of origin, and at the latest within a timeframe to be laid down in delegated acts adopted pursuant to point (c) of Article 135;
(c)
the necessary biosecurity measures are taken to ensure that the kept ungulates and poultry assembled:
(i)
do not come into contact with kept ungulates or poultry having a lower health status;
(ii)
do not pose a significant risk for the spread of the listed diseases referred to in point (d) of Article 9(1) to the kept ungulates or poultry at the place where the assembly operation takes place;
(d)
the kept ungulates and poultry are identified where so required by this Regulation and are accompanied by the following documents:
(i)
the identification and movement documents as provided for in point (b) of Article 112, point (b) of Article 113(1), point (c) of Article 114(1), point (b) of Article 115 and point (b) of Article 117 and any rules adopted pursuant to Articles 118 and 120, unless derogations are provided for in accordance with Articles 113(2) and 119;
(ii)
the animal health certificates as provided for in Article 143 and point (c) of Article 144(1), unless derogations are provided for in the rules adopted pursuant to point (a) of Article 144(1);
(iii)
the self–declaration document as provided for in Article 151.
Article 135
Delegation of powers concerning assembly operations
The Commission shall adopt delegated acts in accordance with Article 264 concerning:
(a)
specific rules for assembly operations, where other risk-mitigation measures, in addition to those provided for in points (b) and (c) of Article 134, are in place;
(b)
criteria under which Member States of origin may allow assembly operations to take place on means of transport, as provided for in the second subparagraph of Article 133(2);
(c)
the timeframe between the time of departure of the kept ungulates or poultry from their establishment of origin and their departure from the assembly operation to their final destination in another Member State, as referred to in point (b) of Article 134;
(d)
detailed rules as regards the biosecurity measures provided for in point (c) of Article 134.
Section 5
Movements to other Member States of kept terrestrial animals other than kept ungulates and poultry
Article 136
Movements of kept terrestrial animals other than kept ungulates and poultry to other Member States and delegated acts
1.   Operators shall only move kept terrestrial animals other than kept ungulates or poultry from an establishment in one Member State to another Member State if the animals in question do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) at the place of destination.
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning detailed rules to ensure that kept terrestrial animals other than kept ungulates or poultry do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1), as provided for in paragraph 1 of this Article.
3.   When establishing the detailed rules to be laid down in the delegated acts provided for in paragraph 2, the Commission shall base those rules on the following considerations:
(a)
the listed diseases referred to in point (d) of Article 9(1) relevant for the listed species or the category of kept terrestrial animals to be moved;
(b)
the health status as regards the listed diseases referred to in point (d) of Article 9(1) in the establishments, compartments, zones and Member States of origin and the place of destination;
(c)
the types of establishment and the types of production at the place of origin and the place of destination;
(d)
the types of movement in respect of the final use of animals at the place of destination;
(e)
the species and categories of kept terrestrial animals to be moved;
(f)
the age of the kept terrestrial animals to be moved;
(g)
other epidemiological factors.
Section 6
DErogating from, and supplementing, risk-mitigation measures for movements of kept terrestrial animals
Article 137
Kept terrestrial animals intended for confined establishments and delegated acts
1.   Operators shall only move kept terrestrial animals to a confined establishment if the animals in question fulfil the following conditions:
(a)
they originate from another confined establishment;
(b)
they do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) to listed species or to categories of animals at the confined establishment of destination, except where the movement in question is authorised for scientific purposes.
2.   The Commission shall adopt delegated acts in accordance with Article 264 concerning:
(a)
detailed rules for movements of kept terrestrial animals into confined establishments in addition to those provided for in paragraph 1 of this Article;
(b)
specific rules for movements of kept terrestrial animals into confined establishments where the risk-mitigation measures in place guarantee that such movements do not pose a significant risk for the health of kept terrestrial animals within that confined establishment and the surrounding establishments.
Article 138
Movements of kept terrestrial animals for scientific purposes and delegated acts
1.   The competent authority of the place of destination may, subject to the agreement of the competent authority of the place of origin, authorise movements of kept terrestrial animals into the territory of the Member State of destination, for scientific purposes, where those movements do not comply with the requirements of Sections 1 to 5 (Articles 124 to 136), with the exception of Articles 124 and 125, point (b)(ii) of Article 126(1) and Article 127.
2.   The competent authority of the place of destination shall only grant derogations as provided for in paragraph 1 under the following conditions:
(a)
the competent authorities of the places of destination and origin:
(i)
have agreed on the conditions for such movements;
(ii)
ensure that the necessary risk-mitigation measures are in place so that those movements do not jeopardise the health status in places en route and in the place of destination with regard to the listed diseases referred to in point (d) of Article 9(1); and
(iii)
have notified, where relevant, the competent authorities of the Member States of passage of the derogation granted and of the conditions under which it is granted; and
(b)
those movements of those animals take place under the supervision of the competent authorities of the places of origin and destination, and where relevant, the competent authorities of the Member States of passage.
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules for the granting of derogations by competent authorities, supplementing those provided for in paragraphs 1 and 2 of this Article.
Article 139
Derogations concerning recreational use, sporting and cultural events, work near borders and grazing
1.   The competent authority of the place of destination may grant derogations from the requirements of Sections 2 to 5 (Articles 126 to 136), with the exception of points (a),(b) and (c) of Article 126(1) and Articles 127 and 128, for intra–Union movements of kept terrestrial animals between Member States where such movements are for:
(a)
recreational use near borders;
(b)
exhibitions, and sporting, cultural and similar events, organised near borders;
(c)
grazing of kept terrestrial animals in grazing areas shared between Member States; or
(d)
work done by kept terrestrial animals near borders of Member States.
2.   Derogations by the competent authority of the place of destination for movements of kept terrestrial animals for the purposes provided for in paragraph 1 shall be agreed on between the Member States of origin and destination and appropriate risk-mitigation measures shall be taken to ensure that such movements do not pose a significant risk.
3.   The Member States referred to in paragraph 2 shall inform the Commission of the granting of derogations as provided for in paragraph 1.
4.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules for the granting of derogations by the competent authority of the place of destination, supplementing those provided for in paragraph 1 of this Article.
Article 140
Delegation of power concerning circuses, exhibitions, sporting events and recreational use, zoos, pet shops, animal shelters and wholesalers
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
specific requirements supplementing the rules laid down in Sections 2 to 5 (Articles 126 to 136) for movements of kept terrestrial animals for the following purposes:
(i)
circuses, zoos, pet shops, animal shelters and wholesalers;
(ii)
exhibitions and sporting, cultural and similar events;
(b)
derogations from Sections 2 to 5 (Articles 126 to 136), with the exception of points (a), (b) and (c) of Article 126(1) and Articles 127 and 128, for movements of kept terrestrial animals as referred to in point (a) of this Article.
Article 141
Implementing power to adopt temporary rules for movements of specific species or categories of kept terrestrial animals
1.   The Commission may, by means of implementing acts, lay down temporary rules, by way of addition or alternative to those laid down in this Chapter, for movements of specific species or categories of kept terrestrial animals where:
(a)
the movement requirements provided for in Article 130, Article 132(1), Articles 133 and 134, Articles 136(1), 137(1) and 138(1) and (2) and Article 139 and the rules adopted pursuant to Articles 131(1) and 132(2), Article 135, Articles 136(2), 137(2), 138(3) and 139(4) and Article 140 are not effectively mitigating the risks posed by the movement of such animals; or
(b)
a listed disease as referred to in point (d) of Article 9(1) appears to be spreading despite the movement requirements laid down in accordance with Sections 1 to 6 (Articles 124 to 142).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
2.   On duly justified imperative grounds of urgency relating to diseases representing a risk of a highly significant impact and taking into account the matters referred to in Article 142, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure provided for in Article 266(3).
Article 142
Matters to be taken into account in the adoption of delegated and implementing acts as provided for in this Section
When establishing the rules to be laid down in the delegated and implementing acts provided for in Articles 137(2), 138(3) and 139(4) and Articles 140 and 141, the Commission shall base those rules on the following matters:
(a)
the risks involved with the movements referred to in those provisions;
(b)
the health status as regards the listed diseases referred to in point (d) of Article 9(1) at the places of origin, passage and destination;
(c)
listed animal species for the listed diseases referred to in point (d) of Article 9(1);
(d)
biosecurity measures in place at the places of origin, passage and destination
(e)
any specific conditions in establishments under which the kept terrestrial animals are kept;
(f)
specific movement patterns of the type of establishment and the species and category of kept terrestrial animals concerned;
(g)
other epidemiological factors.
Section 7
Animal health certification
Article 143
Obligation of operators to ensure that animals are accompanied by an animal health certificate
1.   Operators shall only move the following species and categories of kept terrestrial animals to another Member State if the animals in question are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Article 149(1):
(a)
ungulates;
(b)
poultry;
(c)
kept terrestrial animals other than ungulates and poultry, intended for a confined establishment;
(d)
kept terrestrial animals other than those referred to in points (a), (b) and (c) of this paragraph, when required in accordance with delegated acts adopted pursuant to point (c) of Article 144(1).
2.   In cases where kept terrestrial animals are allowed to leave a restricted zone as provided for in point (f)(ii) of Article 55(1), Article 56 and Article 64(1) and are subject to disease control measures as provided for in Articles 55(1), 65(1), 74(1), Article 79 or Article 80 or rules adopted pursuant to Article 55(2), Article 67, Articles 71(3) and 74(4), Article 83(3) or Article 259, and the animals in question are of species subject to those disease control measures, operators shall only move such kept terrestrial animals within a Member State or from one Member State to another Member State when the animals to be moved are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Article 149(1).
The competent authority may decide that such a certificate does not have to be issued for movements of kept terrestrial animals within the Member State in question when that authority considers that an alternative system is in place ensuring that the consignment of such animals is traceable and that those animals fulfil the animal health requirements for such movement.
3.   Operators shall take all necessary measures to ensure that the animal health certificate referred to in paragraph 1 of this Article accompanies the kept terrestrial animals from their place of origin to their final place of destination, unless specific measures are provided for in rules adopted pursuant to Article 147.
Article 144
Delegation of powers concerning the obligation of operators to ensure that animals are accompanied by an animal health certificate
1.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
derogations from the animal health certification requirements provided for in Article 143(1), for movements of kept terrestrial animals which do not pose a significant risk for the spread of a disease on account of:
(i)
the species or categories of the kept terrestrial animals that are being moved and the listed diseases referred to in point (d) of Article 9(1) for which they are listed species;
(ii)
the methods of keeping and the type of production of those species and categories of kept terrestrial animals;
(iii)
the intended use of the kept terrestrial animals; or
(iv)
the place of destination of the kept terrestrial animals; including those cases where their place of destination is in the same Member State as their place of origin but they pass through another Member State in order to reach their place of destination;
(b)
special rules for animal health certification as provided for in Article 143(1) where specific risk-mitigation measures concerning surveillance or biosecurity are taken, taking into account the matters provided for in paragraph 2 of this Article, which ensure:
(i)
the traceability of the kept terrestrial animals being moved;
(ii)
that the kept terrestrial animals being moved fulfil the animal health requirements for movements provided for in Sections 1 to 6 (Articles 124 to 142);
(c)
the requirement for animal health certification for movements of species and categories of kept terrestrial animals other than those referred to in points (a), (b) and (c) of Article 143(1) in cases where animal health certification is imperative in order to ensure that the movement in question complies with the animal health requirements for movements provided for in Sections 1 to 6 (Articles 124 to 142).
2.   When establishing the special rules provided for in point (b) of paragraph 1, the Commission shall take the following matters into account:
(a)
the assessment by the competent authority of the biosecurity put in place by operators as provided for in point (b) of Article 10(1) and any rules adopted pursuant Article 10(6);
(b)
the ability of the competent authority, in so far as may be necessary and appropriate, to take measures and to engage in activities required by this Regulation as provided for in Article 13(1);
(c)
the level of knowledge of animal health as provided for in Article 11 and the encouragement thereof provided for in Article 13(2);
(d)
the carrying-out of the animal health visits provided for in Article 25 or other relevant surveillance or official controls in place;
(e)
the performance by the competent authority of its obligations under the Union notification and reporting system provided for in Articles 19 to 22 and in the rules adopted pursuant to Article 20(3) and Article 23;
(f)
the application of surveillance as provided for in Article 26 and surveillance programmes as provided for in Article 28 and in any rules adopted pursuant to Articles 29 and 30.
3.   The Commission shall take the matters referred to in point (a)(i) to (iv) of paragraph 1 into account when establishing the requirements for animal health certification provided for in point (c) of paragraph (1).
Article 145
Contents of animal health certificates
1.   The animal health certificate referred to in Article 143 shall contain the following information:
(a)
the establishment or place of origin, the establishment or place of destination and, where relevant, establishments for assembly operations or for rests, of the kept terrestrial animals concerned;
(b)
the means of transport and the transporter;
(c)
a description of the kept terrestrial animals;
(d)
the number of kept terrestrial animals;
(e)
the identification and registration of kept terrestrial animals, where required by Articles 112, 113, 114, 115 and 117 and by any rules adopted pursuant to Articles 118 and 120, unless derogations are provided for in accordance with Article 119; and
(f)
the information needed to demonstrate that the kept terrestrial animals fulfil the relevant animal health requirements in respect of movements provided for in Sections 1 to 6 (Articles 124 to 142).
2.   The animal health certificate may include other information required under other Union legislation.
Article 146
Delegation of powers and implementing acts concerning the content of animal health certificates
1.   The Commission shall adopt delegated acts in accordance with Article 264 concerning:
(a)
detailed rules on the content of animal health certificates as provided for in Article 145(1) for different species and categories of kept terrestrial animals and for specific types of movements as provided for in the rules adopted pursuant to Article 147;
(b)
additional information to be contained in the animal health certificate provided for in Article 145(1).
2.   The Commission may, by means of implementing acts, lay down rules for model forms of animal health certificates. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 147
Delegation of powers concerning specific types of movements of kept terrestrial animals
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning specific measures derogating from, or supplementing, the obligation of operators to ensure that animals are accompanied by an animal health certificate as provided for in Article 143 and in the rules adopted pursuant to Article 144, for the following types of movements of kept terrestrial animals:
(a)
movements of kept ungulates and poultry passing through the assembly operations provided for in Article 133 prior to reaching their final place of destination;
(b)
movements of kept terrestrial animals which are required to return to their place of origin or to be moved to a different destination, for one or more of the following reasons:
(i)
their intended journey was unexpectedly interrupted for animal welfare reasons;
(ii)
unforeseen accidents or events during the journey;
(iii)
they were rejected at the place of destination in a Member State or at the external border of the Union;
(iv)
they were rejected at a place of assembly or resting;
(v)
they were rejected in a third country or territory;
(c)
movements of kept terrestrial animals intended for exhibitions, and sporting, cultural and similar events, and their subsequent return to their place of origin.
Article 148
Operators' obligations to cooperate with the competent authority for the purposes of animal health certification
Operators shall:
(a)
provide the competent authority with all the information necessary to complete the animal health certificate provided for in Article 143(1) and (2) and in any rules adopted pursuant to Article 146(1) or Article 147, in advance of the intended movement;
(b)
where necessary, ensure that the kept terrestrial animals in question are subjected to documentary, identity and physical checks as provided for in Article 149(3).
Article 149
Responsibility of the competent authority for animal health certification
1.   The competent authority shall, upon request by an operator, issue an animal health certificate for the movement of kept terrestrial animals, where required by Article 143 or by delegated acts adopted pursuant to Article 144(1), provided that the following movement requirements have been complied with:
(a)
those provided for in Article 124, Article 125(1), Articles 126, 128, 129, 130, 133 and 134, Articles 136(1) and 137(1), Article 138 and Article 139;
(b)
those provided for in delegated acts adopted pursuant to Articles 125(2) and 131(1), Article 135, Articles 136(2), 137(2), 138(4) and 139(4) and Article 140;
(c)
those provided for in implementing acts adopted pursuant to Article 141.
2.   Animal health certificates shall:
(a)
be verified, stamped and signed by an official veterinarian;
(b)
remain valid for the period of time provided for in the rules adopted pursuant to point (c) of paragraph 4, during which the kept terrestrial animals covered by it continue to fulfil the animal health guarantees contained in it.
3.   Before signing an animal health certificate, the official veterinarian concerned shall verify, by means of documentary, identity and physical checks as provided for by delegated acts adopted pursuant to paragraph 4, that the kept terrestrial animals covered by it fulfil the requirements of this Chapter.
4.   The Commission shall adopt delegated acts in accordance with Article 264 laying down rules concerning:
(a)
the types of documentary, identity and physical checks and examinations in relation to different species and categories of kept terrestrial animals that must be carried out by the official veterinarian in accordance with paragraph 3 in order to verify compliance with the requirements of this Chapter;
(b)
the timeframes for the carrying-out of such documentary, identity and physical checks and examinations and the issuing of animal health certificates by the official veterinarian prior to the movement of consignments of kept terrestrial animals;
(c)
the duration of the validity of animal health certificates.
Article 150
Electronic animal health certificates
Electronic animal health certificates, produced, handled and transmitted by means of Traces, may replace accompanying animal health certificates as provided for in Article 149(1) where:
(a)
such electronic animal health certificates contain all the information that the model form of animal health certificate is required to contain in accordance with Article 145 and any rules adopted pursuant to Article 146;
(b)
the traceability of the kept terrestrial animals in question and the link between those animals and the electronic animal health certificate is ensured;
(c)
the competent authorities of the Member States of origin, passage and destination are able to have access to the electronic documents at all times during the transport.
Article 151
Self–declaration by operators for movements to other Member States
1.   Operators at the place of origin shall issue a self–declaration document for movements of kept terrestrial animals from their place of origin in one Member State to their place of destination in another Member State, and shall ensure that it accompanies such animals, where they are not required to be accompanied by an animal health certificate as provided for in Article 143(1) and (2).
2.   The self–declaration document provided for in paragraph 1 shall contain the following information concerning the kept terrestrial animals in question:
(a)
their place of origin, their place of destination and, when relevant, any places of assembly or rest;
(b)
the means of transport and the transporter;
(c)
a description of the kept terrestrial animals, their species, category and quantity;
(d)
identification and registration where required in accordance with Articles 112, 113, 114 and 115, point (a) of Article 117 and any rules adopted pursuant to Articles 118 and 120;
(e)
the information needed to demonstrate that the kept terrestrial animals fulfil the animal health requirements for movements provided for in Sections 1 to 6 (Articles 124 to 142).
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
detailed rules on the content of the self–declaration document provided for in paragraph 2 of this Article for different species and categories of animals;
(b)
information to be contained in the self–declaration document in addition to that provided for in paragraph 2 of this Article.
4.   The Commission may, by means of implementing acts, lay down rules for the model forms of the self–declaration document provided for in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Section 8
Notification of movements of kept terrestrial animals to other Member States
Article 152
Obligation of operators concerning the notification of movements of kept terrestrial animals to other Member States
Operators other than transporters shall notify the competent authority in their Member State of origin in advance of intended movements of kept terrestrial animals from that Member State to another Member State where:
(a)
the animals must be accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Articles 149 and 150 and any rules adopted pursuant to Article 149(4);
(b)
the animals must be accompanied by an animal health certificate for kept terrestrial animals where they are being moved from a restricted zone and are subject to disease control measures as referred to in Article 143(2);
(c)
the animals are granted a derogation from the animal health certification requirement provided for in point (a) of Article 144(1) or are subject to special rules as provided for in point (b) of Article 144(1);
(d)
notification is required in accordance with delegated acts adopted pursuant to Article 154(1).
For the purposes of the first paragraph of this Article, operators shall provide the competent authority of their Member State of origin with all the necessary information to enable it to notify the movements of the kept terrestrial animals to the competent authority of the Member State of destination in accordance with Article 153(1).
Article 153
Responsibility of the competent authority to notify movements to other Member States
1.   The competent authority of the Member State of origin shall notify the competent authority of the Member State of destination of movements of kept terrestrial animals as referred to in Article 152.
2.   The notification referred to in paragraph 1 shall be carried out prior to the movement in question and, whenever possible, through Traces.
3.   Member States shall designate regions for the management of notifications of movements as provided for in paragraph 1.
4.   By way of derogation from paragraph 1, the competent authority of the Member State of origin may authorise the operator concerned to notify, partially or completely, movements of kept terrestrial animals through Traces to the competent authority of the Member State of destination.
Article 154
Delegation of power and implementing acts for the notification of movements by operators and by the competent authority
1.   The Commission shall adopt delegated acts in accordance with Article 264 concerning:
(a)
the requirement for advance notification by operators, in accordance with Article 152, of movements between Member States of kept terrestrial animals of species or categories other than those referred to in points (a) and (b) of that Article, where traceability of such movements of those species or categories is necessary in order to ensure compliance with the animal health requirements for movements laid down in Sections 1 to 6 (Articles 124 to 142);
(b)
the information needed in order to notify movements of kept terrestrial animals as provided for in Articles 152 and 153;
(c)
the emergency procedures for the notification of movements of kept terrestrial animals in the event of power cuts and other disturbances of Traces;
(d)
the requirements for the designation of regions by Member States for the management of notifications of movements, as provided for in Article 153(3).
2.   The Commission may, by means of implementing acts, lay down rules concerning:
(a)
the details concerning notifications of movements of kept terrestrial animals by:
(i)
operators to the competent authority of their Member State of origin in accordance with Article 152;
(ii)
the competent authority of the Member State of origin to the Member State of destination in accordance with Article 153;
(b)
the deadlines for:
(i)
the provision by the operator of the necessary information referred to in Article 152 to the competent authority of the Member State of origin;
(ii)
the notification of movements of kept terrestrial animals by the competent authority of the Member State of origin as referred to in Article 153(1).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
CHAPTER 4
Movements of wild terrestrial animals
Article 155
Wild terrestrial animals
1.   Operators shall only move wild animals from a habitat in one Member State to a habitat or an establishment in another Member State where:
(a)
the movements of the wild animals in question from their habitat are carried out in such a way that they do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) or emerging diseases en route or at the place of destination;
(b)
the wild animals do not come from a habitat in a restricted zone which is subject to movement restrictions concerning the animal species to which they belong due to the occurrence of a listed disease as referred to in point (d) of Article 9(1) or of an emerging disease, as provided for in Article 70(2) and in any rules adopted pursuant to point (b) of Article 70(3), Article 71(3) and Article 83(3) or the emergency measures provided for in Articles 257 and 258 and any rules adopted pursuant to Article 259, unless derogations have been granted in accordance with those rules;
(c)
the wild animals are accompanied by an animal health certificate or other documents where animal health certification is necessary in order to ensure compliance with the animal health requirements for movements provided for in points (a) and (b) of this paragraph and the rules adopted pursuant to points (c) and (d) of Article 156(1);
(d)
the movements are notified by the competent authority of the Member State of origin to the competent authority of the Member State of destination, where animal health certification is required by the rules adopted pursuant to point (c) of Article 156(1); and
(e)
the competent authority of the Member State of origin and the competent authority of the Member State of destination have agreed to such movement.
2.   When animal health certification is required by the rules adopted pursuant to point (c) of Article 156(1), the requirements provided for in Articles 145 and 148, Article 149(1), (2) and (3) and Article 150, and in the rules adopted pursuant to Articles 146 and 147 and Article 149(4) shall apply to movements of wild terrestrial animals.
3.   When notification of movements is required in accordance with point (d) of paragraph 1 of this Article, the requirements provided for in Articles 152 and 153 and in the delegated acts adopted pursuant to Article 154(1) shall apply to movements of wild terrestrial animals.
Article 156
Empowerments concerning the movement of wild terrestrial animals
1.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
the animal health requirements for movements of wild terrestrial animals provided for in points (a) and (b) of Article 155(1);
(b)
the animal health requirements for the introduction of wild terrestrial animals when they are moved from the wild into establishments;
(c)
the types of movements of wild terrestrial animals for which, or the situations in which, an animal health certificate or other document is required to accompany such movements, and the requirements concerning the contents of such certificates or other documents;
(d)
the notification by the competent authority of the Member State of origin to the competent authority of the Member State of destination in the case of movements of wild terrestrial animals between Member States, and the information to be included in such notification.
2.   The Commission may, by means of implementing acts, lay down rules specifying the requirements provided for in Article 155 and in the delegated acts adopted pursuant to paragraph 1 of this Article, concerning:
(a)
model forms of animal health certificates and other documents which are required to accompany movements of wild terrestrial animals, when provided for in delegated acts adopted pursuant to point (c) of paragraph 1 of this Article;
(b)
the details of the notification to be given by the competent authority of the Member State of origin and the deadlines for such notifications, when provided for in rules adopted pursuant to point (d) of paragraph 1 of this Article.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
CHAPTER 5
Movements within the Union of germinal products
Section 1
General requirements
Article 157
General requirements for movements of germinal products
1.   Operators shall take appropriate preventive measures to ensure that movements of germinal products do not jeopardise the health status of kept terrestrial animals at the place of destination with regard to:
(a)
the listed diseases referred to in point (d) of Article 9(1);
(b)
emerging diseases.
2.   Operators shall only move germinal products from their establishments, and receive such germinal products, if the products in question fulfil the following conditions:
(a)
they come from establishments that have been:
(i)
entered in the register of establishments by the competent authority in accordance with point (a) of the first paragraph of Article 93 and no derogation has been granted by the Member State of origin in accordance with Article 85;
(ii)
approved by the competent authority in accordance with Article 97(1), when such approval is required by Article 94(1) or Article 95;
(b)
they fulfil the traceability requirements of Article 121(1) and any rules adopted pursuant to Article 122(1).
3.   Operators shall comply with the requirements of Article 125 for the transport of germinal products of kept terrestrial animals.
4.   Operators shall not move germinal products from an establishment in one Member State to an establishment in another Member State unless the competent authority of the Member State of destination gives its express authorisation for such movement, where those germinal products are required to be destroyed for disease eradication purposes as part of an eradication programme as provided for in Article 31(1) or (2).
Article 158
Obligations for operators at the place of destination
1.   Operators of establishments at the place of destination receiving germinal products from an establishment in another Member State shall:
(a)
check for the presence of:
(i)
marks in accordance with Article 121 and with rules adopted pursuant to Article 122;
(ii)
animal health certificates as provided for in Article 161;
(b)
after checking the germinal products received, inform the competent authority of the place of destination of any irregularity with regard to;
(i)
the germinal products received;
(ii)
the marks referred to in point (a)(i);
(iii)
the animal health certificates referred to in point (a)(ii).
2.   In the event of an irregularity as referred to in point (b) of paragraph 1, the operator concerned shall keep the germinal products stored separately until the competent authority has taken a decision regarding them.
Section 2
Movements to other Member States of germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry
Article 159
Operators' obligations in respect of movements to other Member States of germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry
1.   Operators shall only move germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry to another Member State if those germinal products fulfil the following conditions:
(a)
they are collected, produced, processed and stored in germinal product establishments approved for that purpose in accordance with Article 97(1) and Article 99;
(b)
they have been collected from donor animals which fulfil the necessary animal health requirements, in order to ensure that the germinal products do not spread listed diseases;
(c)
they have been collected, produced, processed, stored and transported in such a way as to ensure that they do not spread listed diseases as referred to in point (d) of Article 9(1).
2.   Operators shall not move germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry from a germinal product establishment which is subject to movement restrictions affecting the listed species in question in accordance with:
(a)
points (a), (c) and (e) of Article 55(1), point (f)(ii) of Article 55(1), Article 56, point (a) of Article 61(1), Article 62(1), point (c) of Article 65(1), Article 74(1), and Articles 79 and 80;
(b)
rules adopted pursuant to Article 55(2), Articles 63 and 67, and Articles 71(3), 74(4) and 83(2); and
(c)
emergency measures as provided for in Articles 257 and 258 and rules adopted pursuant to Article 259, unless derogations have been provided for in rules adopted pursuant to Article 258.
The restrictions provided for in this paragraph shall not apply to cases where the germinal products were collected before the outbreak in question occurred and those products have been stored separately from other germinal products.
Article 160
Delegation of power in respect of movements to other Member States of germinal products of kept animals of the bovine, porcine, ovine, caprine and equine species and germinal products of poultry
1.   The Commission shall adopt delegated acts in accordance with Article 264 concerning the animal health requirements for movements of germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry to other Member States as provided for in Article 159, specifying:
(a)
rules for the collection, production, processing and storage of germinal products of those kept animals in approved establishments as referred to in point (a) of Article 159(1);
(b)
animal health requirements as provided for in point (b) of Article 159(1) for kept donor animals from which germinal products were collected, and concerning isolation or quarantine for those animals;
(c)
laboratory and other tests to be carried out on kept donor animals and germinal products;
(d)
animal health requirements for the collection, production, processing, storage or other procedures and transport provided for in point (c) of Article 159(1).
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the animal health requirements for movements of germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry to other Member States as provided for in Article 159, specifying derogations for operators from the rules provided for in Article 159, taking into account the risks attached to such germinal products and any risk-mitigation measures in place.
Section 3
Animal health certification and notification of movements
Article 161
Operators' obligations concerning animal health certification for movements of germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry and delegated acts
1.   Operators shall only move germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry to another Member State where such products are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with paragraph 3;
2.   In cases where germinal products of kept animals are allowed to leave a restricted zone subject to:
(a)
disease control measures as provided for in point (f)(ii) of Article 55(1), Articles 56, 64 and 65, Article 74(1) and Article 79, and the rules adopted pursuant to Article 55(2), Article 67, Articles 71(3) and 74(4), Article 83(2), or
(b)
emergency measures as provided for in Articles 257 and 258 and the rules adopted pursuant to Article 259,
and those germinal products are of species subject to those disease control or emergency measures, operators shall only move such germinal products within a Member State or from one Member State to another Member State when they are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Article 149(1), unless derogations have been granted from the animal health certification requirement in accordance with the rules referred in this subparagraph.
The competent authority may decide that such a certificate does not have to be issued for movements of germinal products within the Member State concerned when that authority considers that an alternative system is in place ensuring that the consignment of such germinal products is traceable and that those germinal products comply with the animal health requirements for such movement.
3.   Operators shall take all necessary measures to ensure that the animal health certificate referred to in paragraph 1 accompanies the germinal products from their place of origin to their place of destination.
4.   The competent authority shall, upon request by an operator, issue an animal health certificate for the movements of germinal products referred to in paragraph 1, provided that the relevant requirements referred to in Chapter 5 of Title I of Part IV have been complied with.
5.   Articles 148, 149 and 150, and the rules adopted pursuant to Articles 146 and 147 and Article 149(4), shall apply to the animal health certification of the germinal products referred to in paragraph 1 of this Article. Article 151(1) and the rules adopted pursuant to Article 151(3) shall apply to the self–declaration of movements of germinal products.
6.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning derogations from the animal health certificate requirements provided for in paragraph 1 of this Article as regards movements of germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry which do not pose a significant risk for the spread of listed diseases due to:
(a)
the nature of the germinal products concerned or the species of animal that those products come from;
(b)
the methods of production and processing at the germinal product establishment;
(c)
the intended use of the germinal products;
(d)
alternative risk-mitigation measures in place for the type and category of germinal products and the germinal product establishment;
(e)
the place of destination of the germinal products, when the place of destination is in the same Member State as the place of origin but the germinal products pass through another Member State in order to reach the place of destination.
Article 162
Content of animal health certificates
1.   The animal health certificate for the germinal products provided for in Article 161 shall contain at least the following information:
(a)
the germinal product establishment of origin and the establishment or place of destination;
(b)
the type of the germinal products and the species of kept donor animals;
(c)
the volume or number of the germinal products;
(d)
the marking of the germinal products, when required by Articles 121(1) and by any rules adopted pursuant to Article 122(1);
(e)
the information needed to demonstrate that the germinal products of the consignment fulfil the movement requirements for the relevant species as provided for in Articles 157 and 159 and in any rules adopted pursuant to Article 160.
2.   The animal health certificate for germinal products as provided for in Article 161 may include other information required under other Union legislation.
3.   The Commission shall adopt delegated acts in accordance with Article 264 concerning the information to be contained in the animal health certificate pursuant to paragraph 1 of this Article;
4.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning animal health certification for different types of germinal products and of different animal species.
5.   The Commission may, by means of implementing acts, lay down rules concerning model forms of animal health certificates for germinal products. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 163
Notification of movements of germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry to other Member States
1.   Operators shall:
(a)
inform the competent authority in their Member State of origin in advance of the intended movement of germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry to another Member State when:
(i)
the germinal products in question are required to be accompanied by an animal health certificate in accordance with Article 161(1) or (2);
(ii)
notification of movement is required in accordance with delegated acts adopted pursuant to point (a) of paragraph 5 of this Article for germinal products, taking into account paragraph 3 of this Article;
(b)
provide all the necessary information to enable the competent authority of the Member State of origin to notify the movement of the germinal products to the competent authority of the Member State of destination in accordance with paragraph 2.
2.   The competent authority of the Member State of origin shall notify, prior to the movement in question and whenever possible through Traces, the competent authority of the Member State of destination of any movement of germinal products of kept animals of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry in accordance with the rules adopted pursuant to paragraphs 5 and 6.
3.   Member States shall use, for the management of notifications, regions designated in accordance with Article 153(3).
4.   Article 153(4) shall apply to the notification of germinal products by operators.
5.   The Commission shall adopt delegated acts in accordance with Article 264 concerning:
(a)
the requirement for advance notification by operators of movements of germinal products between Member States in accordance with point (a)(ii) of paragraph 1 of this Article, where traceability of such movements is necessary in order to ensure compliance with the animal health requirements for movements laid down in Sections 1 and 2 (Articles 157 to 160);
(b)
information necessary to notify movements of germinal products as provided for in paragraph 1 of this Article;
(c)
the emergency procedures for the notification of movements of germinal products in the event of power cuts and other disturbances of Traces.
6.   The Commission may, by means of implementing acts, lay down rules concerning:
(a)
the provision of information on movements of germinal products by operators to the competent authority of their Member State of origin in accordance with paragraph 1;
(b)
notification by the competent authority of the Member State of origin to the Member State of destination of movements of germinal products in accordance with paragraph 2;
(c)
the deadlines for:
(i)
the provision of the information referred to in paragraph 1 by the operator to the competent authority of the Member State of origin;
(ii)
notification by the competent authority of the Member State of origin of movements of germinal products as referred to in paragraph 2.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Section 4
Movements to other Member States of germinal products of kept terrestrial animals of species other than bovine, ovine, caprine, porcine and equine species and germinal products of poultry
Article 164
Germinal products of kept terrestrial animals other than those of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry
1.   Operators shall only move germinal products of kept terrestrial animals of species other than those of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry to another Member State if those products do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) to listed species at the place of destination, taking into account the health status at the place of destination.
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning animal health requirements, animal health certification and notification requirements for movements of germinal products of kept terrestrial animals of species other than those of the bovine, ovine, caprine, porcine and equine species and germinal products of poultry, taking into account the following matters:
(a)
listed diseases as referred to in point (d) of Article 9(1) for the listed species concerned;
(b)
the species of animals from which the germinal products have been collected and the type of germinal product;
(c)
the health status at the places of origin and of destination;
(d)
the type of collection, production, processing and storage;
(e)
other epidemiological factors.
3.   Where animal health certification and notification of movements of germinal products are required in accordance with paragraph 2:
(a)
the rules provided for in Articles 161(1) to (5), 162 (1) and (2) and the rules adopted pursuant to Articles 161(6) and 162(3) to (5) shall apply for such certification;
(b)
the rules provided for in Article 163(1), (2) and (4) and the rules adopted pursuant to Article 163(5) shall apply for notification of movements.
Section 5
Derogations
Article 165
Germinal products intended for scientific purposes and delegated acts
1.   The competent authority of the place of destination may, subject to the agreement of the competent authority of the place of origin, authorise movements of germinal products into the territory of the Member State of destination, for scientific purposes, where those movements do not fulfil the requirements of Articles 159 to 164.
2.   The competent authority shall only grant derogations provided for in paragraph 1 under the following conditions:
(a)
the competent authorities of the places of destination and origin:
(i)
have agreed on the conditions for the movements proposed;
(ii)
ensure that necessary risk-mitigation measures are in place so that those movements do not jeopardise the health status en route and in the place of destination with regard to the listed diseases referred to in point (d) of Article 9(1);
(iii)
have notified, where relevant, the competent authorities of Member States of passage of the derogation granted and of the conditions under which it is granted;
(b)
those movements take place under the supervision of the competent authorities of the places of origin and destination, and where relevant, of the competent authorities of any Member States of passage.
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the rules for the granting of derogations by competent authorities, supplementing those provided for in paragraphs 1 and 2 of this Article.
CHAPTER 6
Production, processing and distribution within the Union of products of animal origin
Article 166
General animal health obligations for operators and delegated acts
1.   Operators shall take appropriate preventive measures to ensure that, during all stages of the production, processing and distribution of products of animal origin in the Union, such products do not cause the spread of:
(a)
listed diseases as referred to in point (d) of Article 9(1), taking into account the health status of the place of production, processing or destination;
(b)
emerging diseases.
2.   Operators shall ensure that products of animal origin do not come from establishments or food businesses, or are not obtained from animals which come from establishments, that are subject to:
(a)
emergency measures as provided for in Articles 257 and 258 or any rules adopted pursuant to Article 259, unless derogations from the requirement provided for in paragraph 1 of this Article are provided for in rules adopted pursuant to Article 259;
(b)
movement restrictions applicable to kept terrestrial animals and products of animal origin, as provided for in point (c) of Article 32(1), point (e) of Article 55(1), Article 56, point (a) of Article 61(1), Article 62(1), point (c) of Article 65(1), point (b) of Article 70(1), point (a) of Article 74(1), point (b) of Article 76(2), Article 76(3), Article 79, Article 81 and Article 82(2) and (3) and in the rules adopted pursuant to Article 55(2), Articles 63 and 67, Article 70(3), Article 71(3), Article 74(4), Article 76(5) and Article 83(2), unless derogations from those movement restrictions have been provided for in those rules.
3.   The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed requirements supplementing those referred to:
(a)
in paragraph 1 of this Article on preventive measures, including risk-mitigation measures, and
(b)
in paragraph 2 of this Article in relation to restrictions on movements of products of animal origin.
4.   When adopting the delegated acts referred to in paragraph 3, the Commission shall base those acts on:
(a)
the listed disease in question, as referred to in point (d) of Article 9(1), and species concerned by it and
(b)
the risks involved.
Article 167
Operators' obligations with regard to animal health certificates and delegated acts
1.   Operators shall only move the following products of animal origin within a Member State or to another Member State where the products in question are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with paragraph 3:
(a)
products of animal origin that:
(i)
are allowed to be moved from a restricted zone subject to emergency measures as provided for in rules adopted pursuant to Article 259;
(ii)
originate from animals of species subject to those emergency measures;
(b)
products of animal origin that:
(i)
are allowed to be moved from a restricted zone subject to disease control measures in accordance with Article 32(1), point (f)(ii) of Article 55(1), Article 56, point (a) of Article 61(1), Article 62(1), Article 64, point (c) of Article 65(1), point (b) of Article 70(1), point (a) of Article 74(1) and Articles 79 and 80 and any rules adopted pursuant to Article 55(2), Articles 63 and 67 and Articles 71(3), 74(4) and 83(2),
(ii)
originate from animals of species subject to those disease control measures.
The competent authority may decide that such a certificate does not have to be issued for movements of products of animal origin within the Member State concerned when that authority considers that an alternative system is in place ensuring that consignments of such products are traceable and that those products fulfil the animal health requirements for such movements.
2.   Operators shall take all necessary measures to ensure that the animal health certificate referred to in paragraph 1 accompanies the products of animal origin from their place of origin to their place of destination.
3.   The competent authority shall, upon request by the operator concerned, issue an animal health certificate for movements of products of animal origin as referred to in paragraph 1, provided that the relevant requirements referred to in this Article have been complied with.
4.   Articles 148, 149 and 150 and the rules adopted pursuant to Articles 146 and 147 and Article 149(4) shall apply to the animal health certification of movements of products of animal origin as referred to in paragraph 1 of this Article.
5.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning derogations from the animal health certificate requirements provided for in paragraph 1 of this Article and the conditions for such derogations, in respect of movements of products of animal origin which do not pose a significant risk for the spread of diseases due to:
(a)
the types of products of animal origin concerned;
(b)
the risk-mitigation measures applied to the products of animal origin, thereby reducing the risks of the spread of diseases;
(c)
the intended use of the products of animal origin;
(d)
the place of destination of the products of animal origin.
Article 168
Content of animal health certificates and delegated and implementing acts
1.   The animal health certificate for products of animal origin provided for in Article 167(1) shall contain at least the following information:
(a)
the establishment or place of origin and the establishment or place of destination;
(b)
a description of the products of animal origin concerned;
(c)
the quantity of the products of animal origin;
(d)
the identification of the products of animal origin, when required by point (h) of Article 65(1) or by any rules adopted pursuant to point (a) of the second paragraph of Article 67;
(e)
the information needed to demonstrate that the products of animal origin fulfil the movement restriction requirements provided for in Article 166(2) and in any rules adopted pursuant to Article 166(3).
2.   The animal health certificate referred to in paragraph 1 may include other information required under other Union legislation.
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the information to be contained in the animal health certificate provided for in paragraph 1 of this Article.
4.   The Commission may, by means of implementing acts, lay down rules concerning model forms of animal health certificates for products of animal origin referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 169
Notification of movements of products of animal origin to other Member States
1.   Operators shall:
(a)
inform the competent authority in their Member State of origin in advance of intended movements of products of animal origin when the consignments in question are required to be accompanied by an animal health certificate in accordance with Article 167(1);
(b)
provide all necessary information to enable the competent authority of the Member State of origin to notify the movement in question to the competent authority of the Member State of destination in accordance with paragraph 2.
2.   The competent authority of the Member State of origin shall, prior to the movement and whenever possible through Traces, notify the competent authority of the Member State of destination of movements of products of animal origin in accordance with the rules adopted pursuant to paragraphs 5 and 6.
3.   Member States shall use, for the management of notifications, regions designated in accordance with Article 153(3).
4.   Article 153(4) shall apply to the notification of movements of products of animal origin by operators.
5.   The Commission shall adopt delegated acts in accordance with Article 264 concerning:
(a)
the information needed for the notification of movements of products of animal origin as provided for in paragraph 1 of this Article;
(b)
the emergency procedures for the notification of movements of products of animal origin in the event of power cuts and other disturbances of Traces.
6.   The Commission may, by means of implementing acts, lay down rules concerning:
(a)
the information to be provided by operators to the competent authority of their Member State of origin concerning movements of products of animal origin in accordance with paragraph 1;
(b)
notification of movements of products of animal origin to be given by the competent authority of the Member State of origin to the Member State of destination in accordance with paragraph 2;
(c)
the deadlines for:
(i)
provision of the information referred to in paragraph 1 by the operator concerned to the competent authority of the Member State of origin;
(ii)
notification of movements of products of animal origin to be given by the competent authority of the Member State of origin as referred to in paragraph 2.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
CHAPTER 7
Scope of national measures
Article 170
National measures concerning disease control and movements of animals and germinal products
1.   Member States shall remain free to take national measures to control listed diseases as referred to in points (d) and (e) of Article 9(1) with regard to movements of terrestrial animals and germinal products thereof within their own territories.
2.   Those national measures shall:
(a)
take account of the rules on movements of animals and germinal products laid down in Chapters 3 (Articles 124 to 154), 4 (Articles 155 and 156) and 5 (Articles 157 to 165), and shall not be inconsistent with those rules;
(b)
not hinder the movement of animals and products between Member States;
(c)
not exceed the limits of what is appropriate and necessary in order to prevent the introduction and spread of the listed diseases referred to in points (d) and (e) of Article 9(1).
Article 171
National measures designed to limit the impact of diseases other than listed diseases
Where a disease other than a listed disease constitutes a significant risk for the health of kept terrestrial animals in a Member State, the Member State concerned may take national measures to control that disease and may restrict movements of kept terrestrial animals and germinal products, provided those measures do not:
(a)
hinder the movement of animals and products between Member States;
(b)
exceed the limits of what is appropriate and necessary in order to control that disease.
TITLE II
AQUATIC ANIMALS AND PRODUCTS OF ANIMAL ORIGIN FROM AQUATIC ANIMALS
CHAPTER 1
Registration, approval, record-keeping and registers
Section 1
Registration of aquaculture establishments
Article 172
Obligation of operators to register aquaculture establishments
1.   Operators of aquaculture establishments shall, in order for their establishments to be registered in accordance with Article 173, before they commence such activities:
(a)
inform the competent authority of any aquaculture establishment under their responsibility;
(b)
provide the competent authority with the following information:
(i)
the name and address of the operator concerned;
(ii)
the location of the establishment and a description of its facilities;
(iii)
the species, categories and quantities (numbers, volume or weight) of aquaculture animals which they intend to keep on the aquaculture establishment and the capacity of the aquaculture establishment;
(iv)
the type of aquaculture establishment; and
(v)
any other aspects of the establishment which are relevant for the purpose of determining the risk posed by it.
2.   Operators of aquaculture establishments referred to in paragraph 1 shall inform the competent authority in advance of:
(a)
any significant changes in the aquaculture establishment in question concerning the matters referred to in point (b) of paragraph 1;
(b)
any cessation of activity by the operator or aquaculture establishment concerned.
3.   Aquaculture establishments which are subject to approval in accordance with Article 176(1) and Article 177 shall not be required to provide the information referred to in paragraph 1 of this Article.
4.   An operator may apply for registration as provided for in paragraph 1 to cover a group of aquaculture establishments, provided that they fulfil either of the following conditions:
(a)
they are located in an epidemiologically linked area and all operators in that area operate under a common biosecurity system;
(b)
they are under the responsibility of the same operator and operate under a common biosecurity system, and the aquaculture animals of the establishments concerned form part of a single epidemiological unit.
Where an application for registration covers a group of establishments, the rules laid down in paragraphs 1 to 3 of this Article and in point (b) of the first paragraph of Article 173, and the rules adopted pursuant to Article 175 which are applicable to a single aquaculture establishment, shall be applicable to the group of aquaculture establishments as a whole.
Article 173
Obligations of the competent authority concerning the registration of aquaculture establishments
A competent authority shall register:
(a)
aquaculture establishments in the register of aquaculture establishments provided for in Article 185(1), where the operator concerned has provided the information required in accordance with Article 172(1);
(b)
groups of aquaculture establishment in that register, provided that the criteria laid down in Article 172(4) are complied with.
The competent authority shall assign each establishment or group of establishments as referred to in this Article with a unique registration number.
Article 174
Derogations from the obligation of operators to register aquaculture establishments
By way of derogation from Article 172(1), Member States may exempt from the registration requirement certain aquaculture establishments posing an insignificant risk, as provided for in an implementing act adopted in accordance with Article 175.
Article 175
Implementing powers concerning derogations from the obligation to register aquaculture establishments
1.   The Commission may, by means of implementing acts, lay down rules concerning the information to be provided by operators for the purpose of the registration of aquaculture establishments as provided for in Article 172(1), including the time-limits by which such information is to be provided.
2.   The Commission shall, by means of implementing acts, lay down rules concerning the types of aquaculture establishments that may be exempted by Member States from the registration requirement in accordance with Article 174, based on:
(a)
the species, categories and quantity (number, volume or weight) of aquaculture animals on the aquaculture establishment in question and the capacity of that establishment;
(b)
the movements of aquaculture animals into and out of the aquaculture establishment.
3.   The implementing acts referred to in this Article shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Section 2
Approval of certain types of aquaculture establishments
Article 176
Approval of certain aquaculture establishments and delegated acts
1.   Operators of the following types of aquaculture establishments shall apply to the competent authority for approval in accordance with Article 180(1):
(a)
aquaculture establishments where aquaculture animals are kept with a view to their being moved therefrom, either alive or as products of aquaculture animal origin;
(b)
other aquaculture establishments which pose a significant risk due to:
(i)
the species, categories and number of aquaculture animals kept there;
(ii)
the type of aquaculture establishment concerned;
(iii)
movements of aquaculture animals into and out of the aquaculture establishment concerned.
2.   By way of derogation from paragraph 1, Member States may exempt from the obligation to apply for approval operators of the following types of establishment:
(a)
aquaculture establishments producing a small quantity of aquaculture animals for supply for human consumption either:
(i)
to the final consumer directly; or
(ii)
to local retail establishments directly supplying the final consumer;
(b)
ponds and other installations where the population of aquatic animals is maintained only for recreational fishing purposes, by restocking with aquaculture animals which are confined and unable to escape;
(c)
aquaculture establishments keeping aquaculture animals for ornamental purposes in closed facilities,
provided that the establishment in question does not pose a significant risk.
3.   Unless a derogation has been granted under paragraph 4 of this Article, operators shall not commence activity at an aquaculture establishment as referred to in paragraph 1 of this Article until that establishment has been approved in accordance with Article 181(1), and shall cease such activity at an aquaculture establishment referred to in paragraph 1 of this Article where:
(a)
the competent authority withdraws or suspends its approval in accordance with Article 184(2); or
(b)
in the event of conditional approval, granted in accordance with Article 183(3), the aquaculture establishment concerned fails to comply with the outstanding requirements referred to in Article 183(4) and does not obtain a final approval in accordance with Article 183(3).
4.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
derogations from the requirement for operators to apply to the competent authority for approval of the types of aquaculture establishments referred to in point (a) of paragraph 1, concerning types of establishments other than those specified in points (a)(i) and (ii) of paragraph 2, where those establishments do not pose a significant risk;
(b)
the types of aquaculture establishments which must be approved in accordance with point (b) of paragraph 1.
5.   When adopting delegated acts as provided for in paragraph 4, the Commission shall base those acts on the following criteria:
(a)
the species and categories of aquaculture animals kept in an aquaculture establishment;
(b)
the type of aquaculture establishment and the type of production; and
(c)
typical movement patterns of the type of aquaculture establishment concerned and of the species or category of aquaculture animals concerned.
6.   An operator may apply for approval of a group of aquaculture establishments, provided that the requirements provided for in points (a) and (b) of the first paragraph of Article 177 are complied with.
Article 177
Approval by the competent authority of groups of aquaculture establishments
The competent authority may grant approval as provided for in Article 181(1) covering a group of aquaculture establishments, provided that the aquaculture establishments in question comply with either of the following conditions:
(a)
they are located in an epidemiologically linked area and all operators in that area operate under a common biosecurity system; however, any on–shore or off–shore establishment for the reception, conditioning, washing, cleaning, grading, wrapping and packaging of live bivalve molluscs intended for human consumption (so-called ‘dispatch centres’), establishment with tanks fed by clean seawater in which live bivalve molluscs are placed for the time necessary to reduce contamination to make them fit for human consumption (so-called ‘purification centres’) and similar establishments located inside such an epidemiologically linked area must be approved individually;
(b)
they are under the responsibility of the same operator; and
(i)
operate under a common biosecurity system; and
(ii)
the aquaculture animals of the establishments concerned form part of the same epidemiological unit.
When a single approval is granted for a group of aquaculture establishments, the rules laid down in Article 178 and Articles 180 to 184 and the rules adopted pursuant to Articles 180(2) and 181(2), which are applicable to a single aquaculture establishment, shall be applicable to the whole group of aquaculture establishments.
Article 178
Approval of status of confined aquaculture establishments
Operators of aquaculture establishments wishing to obtain the status of a confined establishment shall:
(a)
apply to the competent authority for approval in accordance with Article 180(1);
(b)
move aquaculture animals to or from their establishment in accordance with the requirements provided for in Article 203(1) and any delegated acts adopted in accordance with Article 203(2) only after their establishment has obtained an approval of that status from the competent authority in accordance with Article 181 or 183.
Article 179
Approval of disease control aquatic food establishments
Operators of disease control aquatic food establishments shall:
(a)
ensure that the necessary approval in accordance with Article 4 of Regulation (EC) No 853/2004 of the European Parliament and of the Council 
(
62
)
 has been obtained; and
(b)
apply to the competent authority, in accordance with Article 180(1), for approval to slaughter or process aquatic animals for disease control purposes in accordance with point (b) of Article 61(1), Article 62 and Articles 68(1), 79 and 80 and the rules adopted pursuant to Article 63 and Articles 70(3) and 71(3).
Article 180
Obligation of operators to provide information with a view to obtaining approval
1.   Operators shall, for the purposes of their application for approval of their establishment as provided for in Article 176(1), Article 177, point (a) of Article 178 and Article 179, provide the competent authority with the following information:
(a)
the name and address of the operator concerned;
(b)
the location of the establishment concerned and a description of its facilities;
(c)
the species, categories and quantities (numbers, volume or weight) of aquaculture animals relevant for the approval which are kept on the establishment;
(d)
the type of aquaculture establishment;
(e)
in cases of approval of a group of aquaculture establishments, details showing that the group in question complies with the conditions laid down in Article 177;
(f)
other aspects of the mode of operation of the aquaculture establishment in question which are relevant for determining the risk, posed by it;
(g)
the water supply to, and discharge of water from, the establishment;
(h)
the establishment's biosecurity measures.
2.   Operators of establishments as referred to in paragraph 1 shall inform the competent authority in advance of:
(a)
any changes in the establishments concerning the matters referred to in paragraph 1;
(b)
any cessation of activity by the operator or establishment concerned.
3.   The Commission may, by means of implementing acts, lay down rules concerning the information to be provided by operators in their application for approval of their establishment, in accordance with paragraph 1, including the time-limits by which such information is to be provided.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 181
Granting of, and conditions for, approval and delegated acts
1.   The competent authority shall only grant approvals of aquaculture establishments as referred to in Article 176(1) and point (a) of Article 178, groups of aquaculture establishments as referred to in Article 177 and disease control aquatic food establishments as referred to in Article 179, where such establishments:
(a)
comply with the following requirements, where appropriate, in relation to:
(i)
quarantine, isolation and other biosecurity measures taking into account the requirements provided for in point (b) of Article 10(1)) and any rules adopted pursuant to Article 10(6);
(ii)
surveillance requirements as provided for in Article 24, where relevant for the type of establishment concerned and the risk involved, in Article 25;
(iii)
record-keeping as provided for in Articles 186 to 188 and any rules adopted pursuant to Articles 189 and 190;
(b)
have facilities and equipment that are:
(i)
adequate to reduce the risk of the introduction and spread of diseases to an acceptable level, taking into account the type of establishment concerned;
(ii)
of a capacity adequate for the species, categories and quantity (numbers, volume or weight) of aquatic animals concerned;
(c)
do not pose an unacceptable risk as regards the spread of diseases, taking into account the risk-mitigation measures in place;
(d)
have in place a system which enables the operator concerned to demonstrate to the competent authority that the requirements laid down in points (a), (b) and (c) are fulfilled.
2.   The Commission shall adopt delegated acts in accordance with Article 264 concerning:
(a)
quarantine, isolation and other biosecurity measures as referred to in point (a)(i) of paragraph 1;
(b)
surveillance as referred to in point (a)(ii) of paragraph 1;
(c)
facilities and equipment as referred to in point (b) of paragraph 1.
3.   When establishing the rules to be laid down in the delegated acts to be adopted pursuant to paragraph 2, the Commission shall base those rules on the following matters:
(a)
the risks posed by each type of establishment;
(b)
the species and categories of aquaculture or aquatic animals relevant for the approval;
(c)
the type of production concerned;
(d)
typical movement patterns of the type of aquaculture establishment and species and categories of animals kept in those establishments.
Article 182
Scope of the approval of establishments
The competent authority shall expressly specify in the approval of an aquaculture establishment or a disease control aquatic food establishment granted pursuant to Article 181(1) following an application made in accordance with Article 176, Article 177, point (a) of Article 178 or Article 179:
(a)
for which of the types of aquaculture establishments referred to in Article 176(1) and point (a) of Article 178, groups of aquaculture establishments referred to in Article 177 and disease control aquatic food establishments referred to in Article 179, and in any rules adopted pursuant to point (b) of Article 176(4), the approval applies;
(b)
for which species and categories of aquaculture animals the approval applies.
Article 183
Procedures for the granting of approval by the competent authority
1.   The competent authority shall establish procedures for operators to follow when applying for approval of their establishments in accordance with Article 176(1) and Articles 178 and 179.
2.   Upon receipt of an application for approval from an operator in accordance with Article 176(1), Article 178 or Article 179, the competent authority shall make an on–site visit.
3.   Provided that the requirements referred to in Article 181 are fulfilled, the competent authority shall grant the approval.
4.   Where an establishment does not fulfil all requirements for approval as referred to in Article 181, the competent authority may grant conditional approval of an establishment if it appears, on the basis of the application by the operator concerned and the subsequent on-site visit provided for in paragraph 2 of this Article, that the establishment meets all the main requirements that provide sufficient guarantees that the establishment does not pose a significant risk.
5.   Where conditional approval has been granted by the competent authority in accordance with paragraph 4 of this Article, it shall grant full approval only where it appears from another on–site visit to the establishment, carried out within three months from the date of the grant of conditional approval, or from documentation provided by the operator within three months from that date, that the establishment meets all the requirements for approval provided for in Article 181(1) and the rules adopted pursuant to Article 181(2).
Where the on–site visit or the documentation referred to in the first subparagraph shows that clear progress has been made but that the establishment still does not meet all of those requirements, the competent authority may prolong the conditional approval. However, conditional approval shall not be granted for a period exceeding, in total, six months.
Article 184
Review, suspension and withdrawal of approvals by the competent authority
1.   The competent authority shall keep approvals of establishments granted in accordance with Article 181(1) under review, at appropriate intervals based on the risk involved.
2.   Where a competent authority identifies serious deficiencies in an establishment as regards compliance with the requirements laid down in Article 181(1) and the rules adopted pursuant to Article 181(2), and the operator of that establishment is not able to provide adequate guarantees that those deficiencies will be eliminated, the competent authority shall initiate procedures to withdraw the approval of the establishment.
However, the competent authority may merely suspend, rather than withdraw, approval of an establishment where the operator can guarantee that it will eliminate those deficiencies within a reasonable period of time.
3.   Approval shall only be granted after withdrawal or restored after suspension in accordance with paragraph 2 when the competent authority is satisfied that the establishment fully complies with all the requirements of this Regulation appropriate for that type of establishment.
Section 3
Register of aquaculture establishments and disease control aquatic food establishments
Article 185
Register of aquaculture establishments and disease control aquatic food establishments
1.   Each competent authority shall establish and keep up to date a register of:
(a)
all aquaculture establishments registered in accordance with Article 173;
(b)
all aquaculture establishments approved in accordance with Article 181(1);
(c)
all disease control aquatic food establishments approved in accordance with Article 181(1).
2.   The register of aquaculture establishments provided for in paragraph 1 shall contain the following information:
(a)
the name and address of the operator and the registration number of the establishment in question;
(b)
the location of the aquaculture establishment or, as the case may be, of the group of aquaculture establishments concerned;
(c)
the type of production at the establishment;
(d)
the water supply to, and discharge from, the establishment, when relevant;
(e)
the species of aquaculture animals kept at the establishment;
(f)
up–to–date information on the health status of the registered aquaculture establishment, or, as the case may be, of the group of establishments, as regards the listed diseases referred to in point (d) of Article 9(1).
3.   For establishments approved in accordance with Article 181(1), the competent authority shall make publicly available by electronic means at least the information referred to in points (a), (c), (e) and (f) of paragraph 2 of this Article, subject to data protection requirements.
4.   Where appropriate and relevant, a competent authority may combine the registration provided for in paragraph 1 with registration for other purposes.
5.   The Commission shall adopt delegated acts in accordance with Article 264 concerning:
(a)
the relevant detailed information to be included in the register of aquaculture establishments provided for in paragraph 1 of this Article;
(b)
the public availability of that register.
Section 4
Record-keeping and traceability
Article 186
Record-keeping obligations of operators of aquaculture establishments
1.   Operators of aquaculture establishments subject to the requirement of registration in accordance with Article 173, or approval in accordance with Article 181(1), shall keep and maintain records containing at least the following information:
(a)
the species, categories and quantities (numbers, volume or weight) of aquaculture animals on their establishment;
(b)
movements of aquaculture animals and products of animal origin obtained from those animals into and out of their establishment, stating as appropriate:
(i)
their place of origin or destination;
(ii)
the date of such movements;
(c)
the animal health certificates, in paper or electronic form, required to accompany movements of aquaculture animals arriving at the aquaculture establishment in accordance with Article 208 and the rules adopted pursuant to points (a) and (c) of Article 211(1) and Article 213(2);
(d)
mortality in each epidemiological unit and other disease problems at the aquaculture establishment as relevant for the type of production;
(e)
biosecurity measures, surveillance, treatments, test results and other relevant information as appropriate for:
(i)
the species and categories of the aquaculture animals on the establishment;
(ii)
the type of production at the aquaculture establishment;
(iii)
the type and size of the aquaculture establishment;
(f)
the results of any animal health visits required in accordance with Article 25(1).
The records shall be kept and maintained in paper or electronic form.
2.   Aquaculture establishments presenting a low risk of spreading listed or emerging diseases may be exempted by the Member State concerned from the requirement to keep records of all or some of the information listed in points (c), (d) and (e) of paragraph 1, provided that traceability is ensured.
3.   Operators of aquaculture establishments shall keep the records provided for in paragraph 1 on their aquaculture establishment concerned and shall:
(a)
keep them in such a way that the tracing of the place of origin and destination of aquatic animals can be guaranteed;
(b)
make them available to the competent authority on request;
(c)
retain them for a minimum period to be prescribed by the competent authority, which may not be less than three years.
By way of derogation from the requirement that the records are to be kept on their establishment concerned, as set out in the first subparagraph, when it is physically not possible to keep the records on that establishment, they shall be kept in the office from which the business is administered.
Article 187
Record-keeping obligations of disease control aquatic food establishments
1.   Operators of disease control aquatic food establishments subject to approval in accordance with Article 179 shall keep and maintain records of:
(a)
all movements into and from their establishment of aquaculture animals and products of animal origin obtained from such animals;
(b)
discharge of water and relevant biosecurity measures.
2.   Operators of disease control aquatic food establishments shall:
(a)
keep the records provided for in paragraph 1 on their establishment and shall make them available to the competent authority on request;
(b)
retain those records for a minimum period to be prescribed by the competent authority, which may not be less than three years.
The records shall be kept and maintained in paper or electronic form.
Article 188
Record-keeping obligations of transporters
1.   Transporters of aquatic animals intended for aquaculture establishments or to be released into the wild shall keep and maintain records in relation to:
(a)
the species, categories and quantities (numbers, volume or weight) of aquatic animals transported by them;
(b)
mortality rates of the aquaculture animals and wild aquatic animals in question during transport, in so far as is practicable for the type of transport and the species of aquaculture animals and wild aquatic animals transported;
(c)
aquaculture establishments and disease control aquatic food establishments visited by the means of transport;
(d)
any exchange of water that took place during transport, specifying the sources of new water and sites of release of water;
(e)
the cleaning and disinfection of the means of transport.
The records shall be kept and maintained in paper or electronic form.
2.   Transporters presenting a low risk of spreading listed or emerging diseases may be exempted by the Member State concerned from the requirement to keep records of all or some of the information listed in paragraph 1, provided that traceability is ensured.
3.   Transporters shall keep the records provided for in paragraph 1:
(a)
in such a manner that they can be made immediately available to the competent authority on request;
(b)
for a minimum period to be prescribed by the competent authority, which may not be less than three years.
Article 189
Delegation of powers concerning record-keeping
1.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules supplementing the record-keeping requirements provided for in Articles 186, 187 and 188, as regards information to be recorded by operators in addition to that provided for in Articles 186(1), 187(1) and 188(1).
2.   The Commission shall take the following matters into account when adopting the delegated acts provided for in paragraph 1:
(a)
the risks posed by each type of aquaculture establishment or transport;
(b)
the species and categories of aquatic animals kept on the aquaculture establishment concerned, or transported to or from that establishment;
(c)
the type of production of the establishment;
(d)
typical movement patterns for the type of aquaculture establishment or disease control aquatic food establishment;
(e)
the numbers, volume or weight of aquatic animals kept on the establishment or transported to or from it.
Article 190
Implementing powers concerning exemptions from the record-keeping requirements
The Commission may, by means of implementing acts, lay down rules concerning the types of aquaculture establishments and operators that may be exempted by Member States from the record-keeping requirements provided for in Articles 186 and 188, as regards:
(a)
operators of certain categories of aquaculture establishments and transporters;
(b)
aquaculture establishments keeping, or transporters transporting, respectively, a small number of aquaculture animals or a small number of aquatic animals;
(c)
certain species and categories of aquatic animals.
When adopting those implementing acts, the Commission shall base those acts on the criteria provided for in Article 189(2).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
CHAPTER 2
Movements within the Union of aquatic animals
Section 1
General requirements for movements
Article 191
General requirements for movements of aquatic animals
1.   Operators shall take appropriate measures to ensure that the movement of aquatic animals does not jeopardise the health status at the place of destination with regard to:
(a)
the listed diseases referred to in point (d) of Article 9(1);
(b)
emerging diseases.
2.   Operators shall only move aquatic animals into an aquaculture establishment or for human consumption purposes, or release them into the wild, if the animals in question fulfil the following conditions:
(a)
they come, except in the case of wild aquatic animals, from establishments that have been:
(i)
registered by the competent authority in accordance with Article 173,
(ii)
approved by that competent authority in accordance with Articles 181 and 182, when required by Article 176(1), Article 177 or Article 178, or
(iii)
granted a derogation from the registration requirement laid down in Article 173.
(b)
they are not subject to:
(i)
movement restrictions affecting the species and categories concerned in accordance with the rules laid down in Article 55(1), Article 56, Article 61(1), Articles 62, 64 and 65, point (b) of Article 70(1), Article 74(1), Article 79 and Article 81 and the rules adopted pursuant to Article 55(2), Articles 63 and 67 and Articles 70(3), 71(3), 74(4) and 83(2); or
(ii)
the emergency measures laid down in Articles 257 and 258 and the rules adopted pursuant to Article 259.
However, operators may move those aquatic animals where derogations from the movement restrictions for such movements or release are provided for in Title II of Part III (Articles 53–83) or derogations from emergency measures are provided for in rules adopted pursuant to Article 259.
3.   Operators shall take all necessary measures to ensure that aquatic animals, after leaving their place of origin, are consigned directly to the final place of destination.
Article 192
Disease prevention measures in relation to transport
1.   Operators shall take the appropriate and necessary disease prevention measures to ensure that:
(a)
the health status of aquatic animals is not jeopardised during transport;
(b)
transport operations of aquatic animals do not cause the potential spread of listed diseases as referred to in point (d) of Article 9(1) to humans or animals en route, and at places of destination;
(c)
cleaning and disinfection of equipment and means of transport and other adequate biosecurity measures are taken, as appropriate to the risks involved with the transport operations concerned;
(d)
any exchanges of water and discharges of water during the transport of aquatic animals intended for aquaculture or release into the wild are carried out at places and under conditions which do not jeopardise the health status with regard to the listed diseases referred to in point (d) of Article 9(1) of:
(i)
the aquatic animals being transported;
(ii)
any aquatic animals en route to the place of destination;
(iii)
aquatic animals at the place of destination.
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
the conditions and requirements for cleaning and disinfection of equipment and means of transport in accordance with point (c) of paragraph 1 of this Article and the use of biocidal products for such purposes;
(b)
other appropriate biosecurity measures during transport as provided for in point (c) of paragraph 1 of this Article;
(c)
water exchanges and discharges of water during transport as provided for in point (d) of paragraph 1 of this Article.
Article 193
Change of intended use
1.   Aquatic animals which are moved for destruction or slaughter in accordance with the following measures shall not be used for any other purpose:
(a)
any of the disease control measures provided for in point (c) of Article 32(1) and Article 55(1), Articles 56, 61, 62, 64, 65 and 70, Articles 74(1) and (2) and Articles 79, 80, 81 and 82 and in the rules adopted pursuant to Article 55(2), Articles 63 and 67, Articles 70(3), 71(3) and 74(4), and Article 83(2);
(b)
emergency measures as provided for in Articles 257 and 258 and in rules adopted pursuant to Article 259.
2.   Aquatic animals moved for human consumption, aquaculture, release into the wild or any other purpose, shall not be used for any purpose other than the intended one.
3.   By way of derogation from paragraph 2, the competent authority of the place of destination may authorise a change of use of aquatic animals for a purpose other than that originally intended, provided that the new use does not pose a higher risk to the health status of the aquatic animals at the place of destination than the originally intended use.
Article 194
Obligations of operators at the place of destination
1.   Operators of aquaculture establishments and disease control aquatic food establishments receiving aquatic animals and operators receiving aquatic animals for release into the wild shall, before the aquatic animals are unloaded:
(a)
check that, where required, one of the following documents is present:
(i)
the animal health certificates provided for in Article 208(1), Article 209 and Article 223(1) and in the rules adopted pursuant to Articles 189, 211 and 213;
(ii)
the self–declaration documents provided for in Article 218(1) and in the rules adopted pursuant to Article 218(3) and (4);
(b)
inform the competent authority of the place of destination, after checking the aquatic animals received, of any irregularity with regard to:
(i)
the aquatic animals received;
(ii)
the documents referred to in point (a)(i) and (ii).
2.   In the event of any irregularity as referred to in point (b) of paragraph 1, the operator shall isolate the aquatic animals concerned by that irregularity until the competent authority of the place of destination has taken a decision regarding them.
Article 195
General requirements in respect of movements of aquaculture animals passing through Member States but intended for export from the Union to third countries or territories
Operators shall ensure that aquaculture animals intended for export to a third country or territory and passing through the territory of another Member State fulfil the requirements laid down in Articles 191, 192 and 193.
Section 2
Aquatic animals intended for aquaculture establishments or release into the wild
Article 196
Abnormal mortalities or other serious disease symptoms
1.   Operators shall only move aquatic animals from an aquaculture establishment or from the wild to another aquaculture establishment, or release them into the wild, if the animals in question:
(a)
show no disease symptoms; and
(b)
originate from an aquaculture establishment or environment where there are no abnormal mortalities with an undetermined cause.
2.   By way of derogation from paragraph 1, the competent authority may, on the basis of an evaluation of the risks involved, authorise the movement or release of aquatic animals as referred to in that paragraph, provided that the animals in question originate from a part of the aquaculture establishment or from the wild that is independent of the epidemiological unit where the abnormal mortalities or other disease symptoms have occurred.
If the movement or release referred to in this paragraph is to be made to another Member State, it shall only be authorised by the competent authority if the competent authorities of the Member State of destination and, where relevant, of the Member States of passage have given their consent to such movement or release.
Article 197
Movements of aquaculture animals intended for Member States, zones or compartments which have been declared disease-free or which are subject to an eradication programme, and delegated acts
1.   Operators shall only move aquaculture animals of listed species relevant for one or more of the listed diseases referred to in points (b) or (c) of Article 9(1) to an aquaculture establishment, or for release into the wild, in a Member State, zone or compartment which has been declared free of those listed diseases in accordance with Article 36(4) or 37(4), if the animals in question originate from a Member State, or a zone or compartment thereof, which has been declared free of those diseases.
2.   Operators shall only move aquaculture animals of listed species relevant for one or more of the listed diseases referred to in points (b) or (c) of Article 9(1) to an aquaculture establishment, or for release into the wild, in a Member State, zone or compartment subject to an eradication programme for one or more of those listed diseases as provided for in Article 31(1) or (2), if the animals in question originate from a Member State, or a zone or compartment thereof, which has been declared free of those listed diseases.
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning derogations from the movement or release requirements laid down in paragraphs 1 and 2 of this Article which do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) on account of:
(a)
the species, categories, and life stage of the aquaculture animals concerned;
(b)
the type of establishment of origin and of destination;
(c)
the intended use of the aquaculture animals;
(d)
the place of destination of the aquaculture animals;
(e)
treatments, processing methods and other special risk-mitigation measures applied at the place of origin or destination.
Article 198
Derogations by Member States concerning the obligation of operators for movement of aquaculture animals between Member States, zones or compartments which are subject to an eradication programme
By way of derogation from Article 197(1) and (2), Member States may authorise operators to move aquaculture animals into a zone or compartment for which an eradication programme has been established in accordance with Article 31(1) and (2) as regards the listed diseases referred to in points (b) and (c) of Article 9(1), from another zone or compartment for which such a programme has also been established for the same listed diseases, provided that such movement will not jeopardise the health status of the Member State, zone or compartment of destination.
If such movements are to be made to another Member State, the competent authority shall only authorise them if the competent authorities of the Member State of destination and, where relevant, of the Member States of passage, have given their consent to them.
Article 199
Member States' measures concerning the release of aquatic animals into the wild
Member States may require that aquatic animals may be released into the wild only if they originate from a Member State, or a zone or compartment thereof, which has been declared disease–free in accordance with Article 36(1) or Article 37(1) as regards one or more of the listed diseases referred to in points (b) and (c) of Article 9(1) for which the species of aquatic animals to be moved is a listed species, regardless of the health status of the area where those aquatic animals are to be released.
Article 200
Movements of wild aquatic animals intended for Member States, or zones or compartments thereof, which have been declared disease–free or which are subject to an eradication programme, and delegated acts
1.   Articles 196, 197 and 198 shall apply to movements of wild aquatic animals intended for an aquaculture establishment or for release into the wild.
2.   Operators shall take the appropriate and necessary disease prevention measures when moving wild aquatic animals between habitats to ensure that:
(a)
such movements do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) to aquatic animals at the place of destination; and
(b)
risk-mitigation or other adequate biosecurity measures are in place where necessary to ensure compliance with point (a).
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the disease prevention and risk-mitigation measures to be taken by operators as provided for in paragraph 2 of this Article. Pending the adoption of such delegated acts, the competent authority of the place of destination may decide on such measures.
Section 3
Aquatic animals intended for human consumption
Article 201
Movements of live aquaculture animals intended for human consumption in Member States, or in zones or compartments thereof, which have been declared disease–free or which are subject to an eradication programme, and delegated acts
1.   Operators shall only move live aquaculture animals of listed species relevant for listed diseases as referred to in points (b) or (c) of Article 9(1) intended for human consumption to a Member State, or to a zone or compartment thereof, which has been declared disease-free in accordance with Article 36(4) or Article 37(4) or for which a eradication programme has been established in accordance with Article 31(1) or (2), as regards one or more of the listed diseases referred to in points (b) and (c) of Article 9(1), if the animals in question originate from a Member State, or a zone or compartment thereof, which has been declared disease–free in accordance with Article 36(4) or Article 37(4).
2.   By way of derogation from paragraph 1 of this Article, Member States may authorise operators to introduce live aquaculture animals into a zone or compartment for which an eradication programme has been established in accordance with Article 31(1) or (2) as regards the listed diseases referred to in points (b) and (c) of Article 9(1), from another zone or compartment for which such a programme has also been established as regards the same diseases within that Member State, provided that such movement will not jeopardise the health status of the Member State or of the zone or compartment thereof.
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the derogations provided for in paragraph 2 of this Article in respect of movements of live aquaculture animals which do not pose a significant risk of spreading of diseases on account of:
(a)
the species, categories, and live stage of the aquaculture animals concerned;
(b)
the methods of keeping the aquaculture animals and the type of production in the aquaculture establishments of origin and of destination;
(c)
the intended use of the aquaculture animals;
(d)
the place of destination of the aquaculture animals;
(e)
treatments, processing methods and other special risk-mitigation measures applied at the place of origin or the place of destination.
Article 202
Movements of live wild aquatic animals intended for Member States, or zones or compartments thereof, which have been declared disease–free or which are subject to an eradication programme, and delegated acts
1.   Article 201(1) and (2) and the rules adopted pursuant to Article 201(3) shall apply to movements of live wild aquatic animals intended for human consumption and which are intended for Member States, or zones or compartments thereof, which have been declared disease–free in accordance with Articles 36(4) or 37(4) or which are subject to an eradication programme in accordance with Article 31(1) or (2), where the measures adopted pursuant thereto are necessary in order to ensure that the animals in question do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) to aquatic animals at the place of destination.
2.   Paragraph 1 of this Article shall also apply to live aquatic animals not covered by the definition of aquaculture animals contained in Article 4(7).
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning movement requirements for wild aquatic animals intended for human consumption, supplementing paragraphs 1 and 2 of this Article.
Section 4
Derogations from Sections 1 to 3 (Articles 191 to 202) and additional risk-mitigation measures
Article 203
Aquatic animals intended for confined establishments for aquaculture and delegated acts
1.   Operators shall only move aquatic animals to a confined establishment for aquaculture if the animals in question fulfil the following conditions:
(a)
they originate from another confined establishment for aquaculture;
(b)
they do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) to listed species of animals at the confined establishment for aquaculture of destination, except where the movement in question is authorised for scientific purposes.
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
detailed rules for movements of aquaculture animals to confined establishments for aquaculture in addition to those provided for in paragraph 1 of this Article;
(b)
specific rules for movements of aquaculture animals to confined establishments for aquaculture where the risk-mitigation measures in place guarantee that such movements do not pose a significant risk for the health of aquaculture animals within that confined establishment for aquaculture and the surrounding establishments.
Article 204
Movements of aquatic animals for scientific purposes and delegated acts
1.   The competent authority of the place of destination may, subject to the agreement of the competent authority of the place of origin, authorise movements of aquatic animals into the territory of the Member State of destination, for scientific purposes, where those movements do not fulfil the requirements of Sections 1 to 3 (Articles 191 to 202), with the exception of Article 191(1) and (3) and Articles 192, 193 and 194.
2.   The competent authority referred to in paragraph 1 shall only grant derogations as provided for in that paragraph under the following conditions:
(a)
the competent authorities of the places of destination and origin:
(i)
have agreed on the conditions for such movements;
(ii)
ensure that the necessary risk-mitigation measures are in place so that movements of the aquatic animals in question do not jeopardise the health status in places en route and in the places of destination with regard to the listed diseases referred to in point (d) of Article 9(1);
(iii)
have notified, where relevant, the competent authorities of the Member States of passage of the derogation granted and of the conditions under which it is granted;
(b)
those movements take place under the supervision of the competent authorities of the places of origin and destination, and where relevant, the competent authorities of the Member States of passage.
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules for the granting of derogations by competent authorities, supplementing those provided for in paragraphs 1 and 2 of this Article.
Article 205
Other specific uses of aquatic animals, specific requirements and derogations and delegation of powers
1.   Operators shall take the necessary preventive measures to ensure that movements of aquatic animals intended for the specific purposes or uses listed in point (a)(i) to (vi) of paragraph 2 of this Article do not pose a risk for the spread of listed diseases as referred to in point (d) of Article 9(1) to aquatic animals at the place of destination.
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
specific requirement supplementing the rules laid down in Sections 1 to 3 (Articles 191 to 202) and for movements of aquatic animals for the following purposes:
(i)
zoos, pet shops, wholesalers and garden ponds;
(ii)
exhibitions;
(iii)
sports fishing, including fishing baits;
(iv)
cultural and similar events;
(v)
commercial aquaria; or
(vi)
health care and other similar uses.
(b)
derogations from Sections 1 to 3 (Articles 191 to 202) with the exception of Article 191(1) and (3) and Articles 192, 193 and 194 for the movements of aquatic animals referred to in point (a) of this paragraph, provided that adequate biosecurity provisions are in place to ensure that those movements do not pose a significant risk to the health status of the place of destination.
Article 206
Implementing power to adopt temporary rules for movements of specific species or categories of aquatic animals
1.   The Commission may, by means of implementing acts, lay down temporary rules, by way of addition or alternative to those laid down in this Chapter, for movements of specific species or categories of aquatic animals where:
(a)
the movement requirements provided for in Article 196, Article 197(1), Articles 198 and 199, Article 200(1) and (2), Article 201 and Articles 202(1), 203(1), 204(1) and (2) and the rules adopted pursuant to Articles 197(3), 200(3), 202(3), 203(2) and 204(3) and Article 205 do not efficiently mitigate the risks posed by the movement of those aquatic animals; or
(b)
a listed disease as referred to in point (d) of Article 9(1) appears to be spreading despite the movement requirements laid down in accordance with Sections 1 to 4 (Articles 191 to 207).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
2.   On duly justified imperative grounds of urgency relating to a listed disease representing a risk of a highly significant impact and taking into account the matters referred to in Article 205, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure provided for in Article 266(3).
Article 207
Matters to be taken into account in the adoption of delegated and implementing acts as provided for in this Section
When establishing the rules to be laid down in the delegated and implementing acts provided for in Article 203(2), Article 204(3) and Articles 205 and 206, the Commission shall base those rules on:
(a)
the risks involved with the movements referred to in those provisions;
(b)
the health status as regards the listed diseases referred to in point (d) of Article 9(1) at the places of origin, passage and destination;
(c)
listed aquatic animal species for the listed diseases referred to in point (d) of Article 9(1);
(d)
biosecurity measures in place at the places of origin, passage and destination;
(e)
any specific conditions under which the aquaculture animals are kept;
(f)
specific movement patterns of the type of aquaculture establishment and the species or category of aquatic animals concerned;
(g)
other epidemiological factors.
Section 5
Animal health certification
Article 208
Obligation of operators to ensure that aquaculture animals are accompanied by an animal health certificate
1.   Operators shall only move aquaculture animals if they are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Article 216(1), where the animals in question are of listed species for the listed diseases referred to in points (b) and (c) of Article 9(1) and are intended for introduction into a Member State, or a zone or compartment thereof, which has been declared disease–free in accordance with Articles 36(4) and 37(4) or for which an eradication programme has been established as provided for in Article 31(1) or (2) as regards one or more of the listed diseases referred to in points (b) and (c) of Article 9(1).
2.   Operators shall only move aquaculture animals if they are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Article 216(1), where the animals in question are of listed species for the relevant disease(s) referred to in points (a) and (b) of Article 9(1) and are allowed to leave a restricted zone subject to disease control measures as provided for in point (f)(ii) of Article 55(1), Articles 56 and 64 or Articles 65(1), 74(1), 79 and rules adopted pursuant to Article 55(2), Articles 67 and 68, Articles 71(3), 74(4) and 83(2) and Article 259 for one or more of the listed diseases referred to in points (a) and (b) of Article 9(1).
3.   Operators shall take all necessary measures to ensure that the animal health certificate accompanies the aquaculture animals from their place of origin to their final place of destination, unless specific measures are provided for in rules adopted pursuant to Article 214.
Article 209
Obligation of operators to ensure that other aquatic animals are accompanied by an animal health certificate and implementing power
1.   In cases where, due to the risk involved with the movement of aquatic animals other than aquaculture animals, animal health certification is required in accordance with the rules provided for in point (a) of Article 211(1), operators shall only move those aquatic animals if the animals in question are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Article 216(1).
2.   Article 208 shall also apply to aquatic animals other than aquaculture animals intended for an aquaculture establishment or release into the wild. Where the competent authority of the Member State of origin concludes that certification is not feasible due to the nature of the place of origin of the aquatic animals in question, it may authorise their movement without an animal health certificate subject to the consent of the competent authority of the place of destination.
3.   This Article shall not apply to wild aquatic animals harvested or caught for direct human consumption.
Article 210
Grant of derogations by Member States in respect of national animal health certification
By way of derogation from the animal health certification requirements laid down in Articles 208 and 209, Member States may grant derogations for movements of certain consignments of aquatic animals without an animal health certificate within their territories provided that they have in place an alternative system to ensure that consignments of such animals are traceable and those consignments comply with the animal health requirements for such movements provided for in Sections 1 to 4 (Articles 191 to 207).
Article 211
Delegation of powers and implementing acts concerning animal health certification in respect of aquatic animals
1.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
the requirement for animal heath certification for movements of aquatic animals other than aquaculture animals as referred to in Article 209(1), in cases where animal health certification is imperative in order to ensure that the movement in question complies with the following animal health requirements for the listed species of animals concerned:
(i)
the requirements provided for in Sections 1 to 4 (Articles 191 to 207) and the rules adopted pursuant to those Sections;
(ii)
disease control measures as provided for in Article 55(1), Article 56, Article 61(1), Articles 62 and 64, and Article 65(1), Article 74(1), and Articles 79 and 80 or the rules adopted pursuant to Article 55(2), Articles 63, 67 and 68, and Articles 71(3), 74(4) and 83(2);
(iii)
emergency measures as provided for in the rules adopted pursuant to Article 259;
(b)
special rules for animal health certification as provided for in Articles 208 and 209 where specific risk-mitigation measures are taken by the competent authority to ensure:
(i)
the traceability of the aquatic animals being moved;
(ii)
that the aquatic animals being moved fulfil the animal health requirements for movements provided for in Sections 1 to 4 (Articles 191 to 207);
(c)
derogations from the animal health certificate requirements provided for in Articles 208 and 209 and the conditions for such derogations for movements of aquatic animals which do not pose a significant risk of the spread of diseases, on account of:
(i)
species, the categories or live stage of the aquatic animals concerned;
(ii)
the methods of keeping and the type of production of those species and categories of aquaculture animals;
(iii)
the intended use of the aquatic animals; or
(iv)
the place of destination of the aquatic animals.
2.   The Commission shall, by means of implementing acts, lay down rules concerning the obligation of operators, as provided for in Article 209(2), to ensure that wild aquatic animals intended for an aquaculture establishment are accompanied by an animal health certificate.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 212
Contents of animal health certificates
1.   The animal health certificate referred to in Articles 208, 209 and 210 shall contain at least the following information:
(a)
the establishment or place of origin, the establishment or place of destination and, where relevant for the spread of diseases, any establishment or place visited en route;
(b)
a description, including the species and category, of the aquatic animals concerned;
(c)
the quantity (number, volume or weight) of aquatic animals;
(d)
the information needed to demonstrate that the aquatic animals fulfil the relevant animal health requirements in respect of movements provided for in Sections 1 to 4 (Articles 191 to 207).
2.   The animal health certificate may include other information required under other Union legislation.
Article 213
Delegation of powers and implementing acts concerning the content of animal health certificates
1.   The Commission shall adopt delegated acts in accordance with Article 264 concerning the content of animal health certificates as provided for in Article 212(1):
(a)
detailed rules on the content of those animal health certificates provided for in Article 212(1) for different species and categories of aquatic animals;
(b)
additional information to be contained in the animal health certificate provided for in Article 212(1).
2.   The Commission may, by means of implementing acts, lay down rules concerning the model forms for the animal health certificates.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 214
Delegation of powers concerning specific types of movements of aquatic animals to the place of destination
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning specific measures supplementing the requirements for animal health certification provided for in Article 208 and 209 for the following types of movements of aquatic animals:
(a)
movements of aquatic animals which are required to return to their place of origin or to be moved to a different destination, for one or more of the following reasons:
(i)
their intended journey was unexpectedly interrupted for animal welfare reasons;
(ii)
unforeseen accidents or events during the journey;
(iii)
they were rejected at the place of the destination in another Member State or at the external border of the Union;
(iv)
they were rejected in a third country or territory;
(b)
movements of aquaculture animals intended for exhibitions and for sporting, cultural and similar events, and their subsequent return to their place of origin.
Article 215
Operators' obligations to cooperate with the competent authorities for the purposes of animal health certification
Operators shall:
(a)
provide the competent authority with all the information necessary to complete the animal health certificate provided for in Articles 208 and 209 and in the rules adopted pursuant to Articles 211, 213 and 214, in advance of the intended movement;
(b)
where necessary, ensure that the aquatic animals in question are subjected to documentary, identity and physical checks as provided for in Article 216(3) and in the rules adopted pursuant to Article 216(4).
Article 216
Responsibility of the competent authority for animal health certification and delegated acts
1.   The competent authority shall, upon request by an operator, issue an animal health certificate for the movement of aquatic animals, where required by Articles 208 and 209, or by rules adopted pursuant to Articles 211 and Article 214, provided that the following animal health requirements have been complied with, as relevant:
(a)
those provided for in Article 191, Article 192(1), Articles 193, 195 and 196, Article 197(1), Articles 198 and 199, Article 200(1) and (2), Article 201, Article 203(1) and Article 204(1) and (2);
(b)
those provided for in delegated acts adopted pursuant to Articles 192(2), 197(3), 200(3), 201(3), 202(3), 203(2) and 204(3) and Article 205;
(c)
those provided for in implementing acts adopted pursuant to Article 206.
2.   Animal health certificates shall:
(a)
be verified, stamped and signed by an official veterinarian;
(b)
remain valid for the period of time, provided for in the rules adopted pursuant to point (c) of paragraph 4, during which the aquatic animals covered by it must continue to fulfil the animal health guarantees contained in it.
3.   Before signing an animal health certificate, the official veterinarian concerned shall verify, by means of documentary, identity and physical checks as provided for by delegated acts adopted pursuant to paragraph 4 where appropriate, that the aquatic animals covered by it fulfil the requirements of this Chapter, taking into account the species and categories of aquatic animals concerned and the animal health requirements.
4.   The Commission shall adopt delegated acts in accordance with Article 264 laying down rules concerning:
(a)
the types of documentary, identity and physical checks and examinations in relation to different species and categories of aquatic animals that must be carried out by the official veterinarian in accordance with paragraph 3 in order to verify compliance with the requirements of this Chapter;
(b)
the timeframes for the carrying-out of such documentary, identity and physical checks and examinations, and the issuing of animal health certificates by the official veterinarian prior to the movement of consignments of aquatic animals;
(c)
the duration of the validity of animal health certificates.
Article 217
Electronic animal health certificates
Electronic animal health certificates, produced, handled and transmitted by means of Traces, may replace accompanying animal health certificates as provided for in Article 216(1) where such electronic animal health certificates:
(a)
contain all the information that the model form of animal health certificate is required to contain in accordance with Article 212(1) and the rules adopted pursuant to Article 213;
(b)
ensure the traceability of the aquatic animals in question and the link between those animals and the electronic animal health certificate;
(c)
ensure that the competent authorities of the Member States of origin, passage and destination are able to have access to the electronic documents at all times during the transport.
Article 218
Self–declaration by operators for movements of aquaculture animals to other Member States and delegated acts
1.   Operators at the place of origin shall issue a self–declaration document for movements of aquaculture animals from their place of origin in one Member State to their place of destination in another Member State, and shall ensure that it accompanies such aquaculture animals, where they are not required to be accompanied by an animal health certificate as provided for in Articles 208 and 209 or in any rules adopted pursuant to Articles 211 and Article 214.
2.   The self–declaration document provided for in paragraph 1 shall contain at least the following information concerning the aquaculture animals in question:
(a)
their places of origin and destination, and, when relevant, any places en route;
(b)
the means of transport
(c)
a description of the aquaculture animals, and their categories, species and quantity (numbers, volume or weight), as relevant for the animals concerned;
(d)
the information needed to demonstrate that the aquaculture animals fulfil the movement requirements provided for in Sections 1 to 4 (Articles 191 to 207).
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
detailed rules on the content of the self–declaration document provided for in paragraph 2 of this Article for different species and categories of aquaculture animals;
(b)
additional information to be contained in the self–declaration document to the one provided for in paragraph 2 of this Article.
4.   The Commission may, by means of implementing acts, lay down rules for a model form of the self–declaration document provided for in paragraph 1.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Section 6
Notification of movements of aquatic animals to other Member States
Article 219
Obligation of operators concerning the notification of movements of aquatic animals to other Member States
1.   Operators other than transporters shall notify the competent authority in their Member State of origin in advance of intended movements of aquatic animals from one Member State to another Member State where:
(a)
the aquatic animals are required to be accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Articles 208 and 209 and any rules adopted pursuant to Article 211 and Article 214(2);
(b)
the aquatic animals are required to be accompanied by an animal health certificate for aquatic animals when they are being moved from a restricted zone as referred to in Article point (a) of 208(2);
(c)
the aquaculture animals and wild aquatic animals being moved are intended for:
(i)
an establishment subject to registration in accordance with Article 173 or approval in accordance with Articles 176 to 179;
(ii)
release into the wild;
(d)
notification is required in accordance with delegated acts adopted pursuant to Article 221.
2.   For the purposes of the notification provided for in paragraph 1 of this Article, operators shall provide the competent authority of their Member State of origin with all the necessary information to enable it to notify the movement to the competent authority of the Member State of destination in accordance with Article 220(1).
Article 220
Responsibility of the competent authority to notify movements of aquatic animals to other Member States
1.   The competent authority of the Member State of origin shall notify the competent authority of the Member State of destination of movements of aquatic animals as referred to in Article 219, unless a derogation has been granted in accordance with point (c) of Article 221(1) as regards such notification.
2.   The notification referred to in paragraph 1 shall be carried out prior to the movement in question and, whenever possible, through Traces.
3.   Member States shall designate regions for the management of notifications of movements as provided for in paragraph 1.
4.   By way of derogation from paragraph 1, the competent authority of Member State of origin may authorise the operator concerned to notify, partially or completely, movements of aquatic animals through Traces to the competent authority of the Member State of destination.
Article 221
Delegation of powers and implementing acts for the notification of movements of aquatic animals by operators and by the competent authority
1.   The Commission shall adopt delegated acts in accordance with Article 264 concerning:
(a)
the requirement for advance notification by operators, in accordance with Article 219, of movements between Member States of aquatic animals of species or categories other than those referred to in points (a), (b) and (c) of Article 219(1), where traceability of such movements is necessary in order to ensure compliance with the animal health requirements laid down in this Chapter;
(b)
the information needed in order to notify movements of aquatic animals as provided for in Articles 219 and 220(1);
(c)
derogations from the notification requirements provided for in point (c) of Article 219(1) for species and categories of aquatic animals or types of movements which pose an insignificant risk;
(d)
the emergency procedures for notification of movements of aquatic animals in the event of power cuts or other disturbances of Traces;
(e)
the requirements for the designation of regions by Member States as provided for in Article 220(3).
2.   The Commission may, by means of implementing acts, lay down rules concerning:
(a)
the details of notifications by:
(i)
operators to the competent authority of the Member State of origin of movements of aquatic animals in accordance with Article 219;
(ii)
the competent authority of the Member State of origin to the Member State of destination of movements of aquatic animals in accordance with Article 220(1);
(b)
the deadlines for:
(i)
the provision by operators of the necessary information referred to in Article 219(2) to the competent authority of the Member State of origin;
(ii)
the notification of movements by the competent authority of the Member State of origin as referred to in Article 220(1).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
CHAPTER 3
Production, processing and distribution within the Union of products of animal origin from aquatic animals, other than live aquatic animals
Article 222
General animal health obligations for operators and delegated acts
1.   Operators shall take appropriate preventive measures to ensure that, during all stages of the production, processing and distribution of products of animal origin from aquatic animals, other than live aquatic animals, those products do not cause the spread of:
(a)
listed diseases as referred to in point (d) of Article 9(1), taking into account the health status of the place of production, processing and destination;
(b)
emerging diseases.
2.   Operators shall ensure that products of animal origin from aquatic animals, other than live aquatic animals, do not come from establishments or food businesses, or are not obtained from animals which come from such establishments or food businesses, that are subject to:
(a)
emergency measures as provided for in Articles 257 and 258 and any rules adopted pursuant to Article 259, unless derogations have been provided for in respect of those rules in Part VII (Articles 257 to 262);
(b)
movement restrictions applicable to aquatic animals and products of animal origin from aquatic animals, as provided for in point (c) of Article 32(1), point (e) of Article 55(1), Article 56, point (a) of Article 61(1), Article 62(1), point (c) of Article 65(1), point (b) of Article 70(1), point (a) of Article 74(1), point (b) of Article 76(2), Article 76(3), Article 79, Article 81 and Article 82(2) and (3) and the rules adopted pursuant to Article 55(2), Articles 63 and 67, and Articles 70(3), 71(3), 74(4), 76(5) and 83(2), unless derogation from those movement restrictions have been provided for in those rules.
3.   The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed requirements supplementing those referred to in paragraph 2 of this Article in relation to movements of products of animal origin from aquatic animals other than live aquatic animals, as regards:
(a)
the diseases, and species of aquatic animals concerned by the diseases, for which emergency measures or movement restrictions as referred to in paragraph 2 of this Article apply;
(b)
the types of products of animal origin from aquatic animals;
(c)
the risk-mitigation measures applied to the products of animal origin from aquatic animals at the places of origin and destination;
(d)
the intended use of the products of animal origin from aquatic animals;
(e)
the place of destination of the products of animal origin from aquatic animals.
4.   This Article shall not apply to products of animal origin from wild aquatic animals harvested or caught for direct human consumption.
Article 223
Animal health certificates and delegated acts
1.   Operators shall only move the following products of animal origin from aquatic animals other than live aquatic animals where those products are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with paragraph 3:
(a)
products of animal origin from aquatic animals that:
(i)
are allowed to leave a restricted zone subject to emergency measures as provided for in rules adopted pursuant to Article 259; and
(ii)
originate from aquatic animals of species subject to those emergency measures;
(b)
products of animal origin from aquatic animals that:
(i)
are allowed to leave a restricted zone subject to disease control measures in accordance with point (c) of Article 32(1), point (c) of Article 55(1), Article 56, point (a) of Article 61(1), Articles 62(1) and 63(1), point (c) of Article 65(1), point (b) of Article 70(1), point (a) of Article 74(1) and Article 79 and the rules adopted pursuant to Article 55(2), Articles 63 and 67 and Articles 71(3), 74(4) and 83(2); and
(ii)
originate from aquatic animals of species subject to those disease control measures.
2.   By way of derogation from paragraph 1, such a certificate shall not be required for movements of products of animal origin from wild aquatic animals, provided that:
(a)
alternative risk-mitigation measures authorised by the competent authority are in place to ensure that those movements do not pose a risk of the spread of listed diseases;
(b)
consignments of such products are traceable.
3.   Operators shall take all necessary measures to ensure that the animal health certificate referred to in paragraph 1 accompanies the products of animal origin from their place of origin to their place of destination.
4.   The competent authority shall, upon request by the operator concerned, issue an animal health certificate for movements of products of animal origin other than live aquatic animals as referred to in paragraph 1, provided that the relevant requirements referred to in this Article have been complied with.
5.   Article 212 and Articles 214 to 217 and the rules adopted pursuant to Article 213 and Article 216(4) shall apply to the animal health certification of movements of products of animal origin other than live aquatic animals as referred to in paragraph 1 of this Article.
6.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning requirements and detailed rules on the animal health certificate to accompany products of animal origin other than live aquatic animals, as referred to in paragraph 1 of this Article, taking into account:
(a)
the types of products of animal origin concerned;
(b)
the risk-mitigation measures applied to the products concerned which reduce the risks of the spread of diseases;
(c)
the intended use of those products;
(d)
the place of destination of those products.
Article 224
Content of animal health certificates and delegated and implementing acts
1.   The animal health certificate for products of animal origin from aquatic animals, other than live aquatic animals, shall contain at least the following information:
(a)
the establishment or place of origin and the establishment or place of destination;
(b)
a description of the products of animal origin concerned;
(c)
the quantity (numbers, volume or weight) of the products of animal origin;
(d)
the identification of the products of animal origin, when required by point (h) of Article 65(1) or by any rules adopted pursuant to Article 67;
(e)
the information needed to demonstrate that the products concerned fulfil the movement restriction requirements provided for in Article 222(2) and in any rules adopted pursuant to Article 222(3).
2.   The animal health certificate referred to in paragraph 1 may include other information required under other Union legislation.
3.   The Commission shall adopt delegated acts in accordance with Article 264 concerning amending and supplementing the information to be contained in the animal health certificate as provided for in paragraph 1 of this Article.
4.   The Commission may, by means of implementing acts, lay down rules concerning model forms of animal health certificates as provided for in paragraph 1 of this Article.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 225
Notification of movements of products of animal origin to other Member States
1.   Operators shall:
(a)
inform the competent authority in the Member State of origin in advance of intended movements of products of animal origin from aquatic animals, other than live aquatic animals, when the consignments in question are required to be accompanied by an animal health certificate in accordance with Article 223(1);
(b)
provide all necessary information to enable the competent authority of the Member State of origin to notify the movement in question to the Member State of destination in accordance with paragraph 2 of this Article.
2.   The competent authority of the Member State of origin shall notify the competent authority of the Member State of destination of movements of products of animal origin from aquatic animals, other than live aquatic animals, in accordance with Article 220(1).
3.   Articles 219 and 220 and any rules adopted pursuant to Article 221 shall be applicable to the notification of products of animal origin from aquatic animals, other than live aquatic animals.
CHAPTER 4
National measures
Article 226
National measures designed to limit the impact of diseases other than listed disease
1.   Where a disease other than a listed disease as referred to in point (d) of Article 9(1) constitutes a significant risk for the health of aquatic animals in a Member State, the Member State concerned may take national measures to prevent the introduction, or to control the spread, of that disease.
Member States shall ensure that those national measures do not exceed the limits of what is appropriate and necessary in order to prevent the introduction, or to control the spread, of the disease in question within the Member State concerned.
2.   Member States shall notify the Commission in advance of any proposed national measures as referred to in paragraph 1 that may affect movements of aquatic animals and products of animal origin from aquatic animals between Member States.
3.   The Commission shall approve and, if necessary, amend the national measures referred to in paragraph 2 of this Article by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
4.   The approval referred to in paragraph 3 shall only be granted where the establishment of movement restrictions between Member States is necessary in order to prevent the introduction, or to control the spread, of the disease referred to in paragraph 1, taking into account the overall impact on the Union of the disease in question and of the measures taken.
TITLE III
ANIMALS OF SPECIES OTHER THAN THOSE DEFINED AS TERRESTRIAL AND AQUATIC ANIMALS, AND GERMINAL PRODUCTS AND PRODUCTS OF ANIMAL ORIGIN FROM SUCH OTHER ANIMALS
Article 227
Animal health requirements concerning other animals, and germinal products and products of animal origin of such other animals
Where other animals are of a listed species for a listed disease as referred to in point (d) of Article 9(1), and those other animals or their germinal products or products of animal origin represent a risk to public or animal health in the Union, one or more of the following requirements shall apply:
(a)
the requirements concerning registration, approval, record-keeping and registers for establishments and transporters provided for in Chapter 1 of Title I and Chapter 1 of Title II (Articles 84 to 101 and Articles 172 to 175);
(b)
the requirements concerning traceability provided for in Articles 108 to 111 and Article 117 for other animals and Article 122 for germinal products;
(c)
movement requirements:
(i)
as regards other animals mainly living in a terrestrial environment or that are normally affected by diseases of terrestrial animals, taking into account the criteria provided for in points (d) and (e) of Article 228(3), the requirements provided for in Section 1 (Articles 124 and 125) and Section 6 of Chapter 3 of Title I of Part IV (Articles 137 to 142) and Chapter 4 of Title I of Part IV (Articles 155 and 156);
(ii)
as regards other animals mainly living in aquatic environment or that are normally affected by diseases of aquatic animals, taking into account the criteria provided for in points (d) and (e) of Article 228(3), the requirements provided for in Sections 1 to 4 of Chapter 2 of Title II of Part IV (Articles 191 to 207);
(iii)
as regards germinal products, the general requirements for movements provided for in Articles 157 and 158 and the special requirements for movements to other Member States provided for in Articles 164 and 165;
(iv)
as regards products of animal origin, the general animal health obligations incumbent on operators in respect of the production, processing and distribution within the Union of products of animal origin provided for in Articles 166 and 222;
(d)
the animal health certification obligation incumbent on operators and competent authorities and the self–declaration incumbent on operators:
(i)
as regards other animals, pursuant to the rules provided for in Articles 143 to 151 or Articles 208 to 218;
(ii)
as regards germinal products, pursuant to the rules provided for in Articles 161 and 162;
(iii)
as regards products of animal origin, pursuant to the rules provided for in Articles 165 and 168 or Articles 223 and 224;
(e)
the obligation to notify movements incumbent on operators and competent authorities, taking into account the requirements provided for in Articles 152, 153, 154, 163 and 169 and in Articles 219 to 221 and 225.
Article 228
Delegation of powers and implementing acts concerning animal health requirements for other animals, and germinal products and products of animal origin of other animals
1.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning any specific requirements for other animals, and their germinal products or products of animal origin, which are necessary in order to mitigate the risk of the listed diseases referred to in point (d) of Article 9(1), as provided for in Article 227.
2.   The Commission may adopt implementing acts concerning detailed rules for the implementation of the disease control and prevention measures provided for in paragraph 1.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
3.   When adopting the delegated acts and implementing acts provided for in paragraphs 1 and 2, the Commission shall base those acts on the following criteria:
(a)
the species or categories of other animals listed in accordance with Article 8(2) as listed species for one or more listed diseases, for which certain disease prevention and control measures provided for in this Regulation apply;
(b)
the profile of the listed disease in question, which concerns species and categories of other animals referred to in point (a);
(c)
the feasibility, availability and effectiveness of disease prevention and control measures for the listed species concerned by those measures;
(d)
the prevailing terrestrial or aquatic living environment of those other animals;
(e)
the types of diseases that are affecting such other animals, which can be either diseases normally affecting terrestrial or aquatic animals, regardless of the prevailing living environment referred to in point (d).
PART V
ENTRY INTO THE UNION AND EXPORT
CHAPTER 1
Entry into the Union of animals, germinal products and products of animal origin from third countries and territories
Section 1
Requirements for the entry into the Union
Article 229
Requirements for entry into the Union of animals, germinal products and products of animal origin
1.   Member States shall permit the entry into the Union of consignments of animals, germinal products and products of animal origin from third countries or territories only if those consignments fulfil the following requirements, unless such animals, germinal products or products of animal origin are covered by a derogation granted pursuant to Article 239(2):
(a)
without prejudice to Article 230(2), they come from a third country or territory listed in accordance with Article 230(1) for the particular species and category of animals, or germinal products or products of animal origin concerned, or from a zone or compartment thereof;
(b)
they come from establishments which are approved and listed, where such approval and listing is required by Article 233;
(c)
they fulfil the animal health requirements for entry into the Union laid down in Article 234(1) and in any delegated acts adopted pursuant to Article 234(2), where such requirements are laid down for the animal, germinal product or product of animal origin concerned;
(d)
they are accompanied by an animal health certificate and by declarations and other documents where required by Article 237(1) or by rules adopted pursuant to Article 237(4);
2.   The operators responsible for the consignment in question shall present consignments of animals, germinal products and products of animal origin from third countries or territories for the purposes of official control as provided for in Article 3 of Directive 91/496/EEC and Article 3 of Directive 97/78/EC.
Section 2
Listing of third countries and territories
Article 230
Lists of third countries and territories from which the entry into the Union of animals, germinal products and products of animal origin is permitted, and implementing and delegated acts
1.   The Commission may, by means of implementing acts, draw up lists of third countries and territories from which the entry into the Union of specific species and categories of animals, germinal products and products of animal origin is to be permitted, based on the following criteria:
(a)
the animal health legislation of the third country or territory concerned and the rules on the entry into that third country or territory of animals, germinal products and products of animal origin from other third countries and territories;
(b)
the assurances provided by the competent authority of the third country or territory concerned as regards the efficient implementation and control of the animal health legislation referred to in point (a);
(c)
the organisation, structure, resources and legal powers of the competent authority in the third country or territory concerned;
(d)
the animal health certification procedures in the third country or territory concerned;
(e)
the animal health status of the third country or territory concerned, or of zones and compartments thereof, with regard to:
(i)
listed diseases and emerging diseases;
(ii)
any aspects of animal and public health or the environmental situation in the third country or territory concerned, or in a zone or compartment thereof, which may pose a risk to animal or public health or the environmental status of the Union;
(f)
the guarantees which the competent authority of the third country or territory concerned can provide regarding compliance or equivalence with the relevant animal health requirements applicable in the Union;
(g)
the regularity and speed with which the third country or territory concerned supplies information concerning infectious or contagious animal diseases in its territory to the World Organisation for Animal Health (OIE), in particular information concerning the diseases listed in the OIE Codes;
(h)
the results of controls carried out by the Commission in the third country or territory concerned;
(i)
any experience gathered from previous entries of animals, germinal products and products of animal origin from the third country or territory concerned and the results of official controls carried out at the point of entry into the Union on such animals, germinal products and products of animal origin.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
2.   Pending the adoption of the lists provided for in paragraph 1, and provided that such lists have not been drawn up pursuant to the Union legislation referred to in Article 270(2), Member States shall determine from which third countries and territories specific species and categories of animals, germinal products or products of animal origin may enter the Union.
For the purposes of the first subparagraph of this paragraph, Member States shall take into account the criteria for inclusion in the lists of third countries and territories provided for in points (a) to (i) of paragraph 1 of this Article.
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning derogations from paragraph 2 of this Article, limiting the possibility for Member States to decide from which third countries and territories a specific species and category of animal, germinal product or product of animal origin may enter the Union, where necessary due to the risk posed by that specific species and category of animal, germinal product or product of animal origin.
Article 231
Information to be included in the lists of third countries and territories
The Commission shall specify the following information for each third country or territory in the lists provided for in Article 230(1):
(a)
the species and categories of animals, germinal products or products of animal origin that may enter the Union from that third country or territory;
(b)
whether the animals, germinal products or products of animal origin specified in accordance with point (a) may enter the Union from the whole territory of that third country or territory or only from one or more zones or compartments thereof;
(c)
specific conditions and animal health guarantees concerning listed diseases.
Article 232
Suspension and withdrawal from the lists of third countries and territories and implementing acts
1.   The Commission shall, by means of implementing acts, withdraw a country or territory from the lists provided for in Article 230(1), or suspend the entry into the Union of animals, germinal products or products of animal origin from a third country or territory, or from a zone or compartment thereof, for any of the following reasons:
(a)
the third country or territory concerned, or one or more zones or compartments thereof, no longer complies with the criteria laid down in Article 230(1), where relevant for the entry into the Union of a particular species and category of animal, germinal product or product of animal origin;
(b)
the animal health situation in the third country or territory concerned, or in a zone or compartment thereof, is such that a suspension or withdrawal from the lists is necessary in order to protect the animal health status of the Union;
(c)
the Commission has requested the third country or territory concerned to supply up-to–date information on the animal health situation and other matters referred to in Article 230(1), and that third country or territory has not provided such information;
(d)
the third country or territory concerned has refused to agree to controls being carried out by the Commission on behalf of the Union in its territory.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
2.   On duly justified imperative grounds of urgency relating to a serious risk of the introduction into the Union of a listed disease as referred to in point (d) of Article 9(1), the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 266(3).
3.   The Commission may, by means of implementing acts, reinstate in the lists provided for in Article 230(1) a third country or territory, or a zone or compartment thereof, that has been withdrawn from those lists, or may re–authorise the entry into the Union of animals, germinal products or products of animal origin from a third country or territory, or from a zone or compartment thereof, from which entry into the Union has been suspended, for one of the following reasons:
(a)
for the reasons referred to in point (a) or (c) of paragraph 1 of this Article, provided that the third country or territory concerned demonstrates that it complies with the listing criteria provided for in Article 230(1);
(b)
for the reason referred to in point (b) of paragraph 1 of this Article, provided that the third country or territory concerned provides appropriate guarantees that the animal health situation that gave rise to the suspension or withdrawal has been resolved or no longer represents a threat to animal or public health within the Union;
(c)
for the reason referred to in point (d) of paragraph 1 of this Article, provided that:
(i)
the third country or territory concerned has agreed to controls being carried out by the Commission on behalf of the Union in its territory; and
(ii)
the results of those controls by the Commission show that the third country or territory concerned, and the zones or compartments thereof, comply with the listing criteria provided for in Article 230(1).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Section 3
Approval and listing of establishments in third countries and territories
Article 233
Approval and listing of establishments
1.   Member States shall only permit the entry into the Union of terrestrial animals and germinal products thereof originating from an establishment of a type for which approval is required in the Union in accordance with Article 94(2) and the rules adopted pursuant to Article 94(3) and Article 95, if the establishment in question in the third country or territory concerned:
(a)
complies with animal health requirements in that third country or territory which are equivalent to the rules for establishments of that type applicable in the Union;
(b)
is approved and listed by the competent authority of the third country or territory of dispatch, unless alternative risk-mitigation measures in place in that third country or territory provide equivalent guarantees for animal health within the Union.
2.   The Commission shall collect the lists of approved establishments referred to in point (b) of paragraph 1 received from the competent authorities of the third countries or territories concerned.
3.   The Commission shall provide to the Member States any new or updated lists of approved establishments received from the third countries or territories concerned, and shall make them publicly available.
4.   The Commission shall, by means of implementing acts, adopt any rules necessary in order to ensure uniform application of point (b) of paragraph 1.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Section 4
Entry into the Union of species and categories of animals, germinal products and products of animal origin
Article 234
Animal health requirements for the entry into the Union of species and categories of animals, germinal products and products of animal origin
1.   The animal health requirements for the entry into the Union of species and categories of animals, germinal products and products of animal origin from third countries or territories shall:
(a)
be as stringent as the animal health requirements laid down in this Regulation and in the rules adopted pursuant thereto applicable to movements of the species and categories of animals, germinal products or products of animal origin in question within the Union; or
(b)
offer equivalent guarantees to the animal health requirements applicable to the species and categories of animals, germinal products or products of animal origin provided for in Part IV (Articles 84 to 228) of this Regulation.
2.   The Commission shall adopt delegated acts in accordance with Article 264 concerning the animal health requirements for:
(a)
the entry into the Union of species and categories of animals, germinal products and products of animal origin from third countries or territories;
(b)
the movement within the Union and handling of those animals, germinal products and products of animal origin after their entry into the Union, where this is necessary in order to mitigate the risk involved.
3.   Pending the adoption of delegated acts laying down animal health requirements as regards a particular species and category of animal, germinal product or product of animal origin provided for in paragraph 1 of this Article, Members State may, following an evaluation of the risks involved, apply national rules, provided that those rules comply with the requirements laid down in that paragraph and provided that they take into account the matters referred to in Articles 235 and 236.
Article 235
Matters to be taken into account in delegated acts provided for in Article 234 with regard to the entry into the Union of animals
The Commission shall take the following matters into account when laying down, in delegated acts as provided for in Article 234(2), animal health requirements for the entry into the Union of particular species and categories of animals:
(a)
the listed diseases referred to in point (d) of Article 9(1) and emerging diseases;
(b)
the health status of the Union concerning the listed diseases referred to in point (d) of Article 9(1) and emerging diseases;
(c)
the listed species with regard to those listed diseases referred to in point (d) of Article 9(1) and emerging diseases;
(d)
the age and sex of the animals concerned;
(e)
the origin of the animals concerned;
(f)
the type of establishment concerned and the type of production at the places of origin and of destination;
(g)
the intended place of destination;
(h)
the intended use of the animals concerned;
(i)
any risk-mitigation measures in place in the third countries or territories of origin or transit, or after the arrival of the animals concerned into the territory of the Union;
(j)
animal health requirements applicable to movements of those animals within the Union;
(k)
other epidemiological factors;
(l)
international animal health trade standards, relevant to the species and categories of those animals.
Article 236
Matters to be taken into account in delegated acts as provided for in Article 234 with regard to the entry into the Union of germinal products and products of animal origin
The Commission shall take the following matters into account when laying down, in delegated acts as provided for in Article 234(2), the animal health requirements for the entry into the Union of germinal products and products of animal origin:
(a)
the listed diseases referred to in point (d) of Article 9(1) and emerging diseases;
(b)
the health status of the animals from which the germinal products or products of animal origin originate and of the Union concerning the listed diseases referred to in point (d) of Article 9(1) and emerging diseases;
(c)
the type and nature of particular germinal products or products of animal origin, treatments, processing methods and other risk-mitigation measures that have been applied at the places of origin, dispatch of consignment or destination;
(d)
the type of establishment and the type of production at the places of origin and of destination;
(e)
the intended place of destination;
(f)
the intended use of the germinal products or products of animal origin concerned;
(g)
animal health requirements applicable to movements of the germinal products and products of animal origin concerned within the Union;
(h)
other epidemiological factors;
(i)
international animal health trade standards, relevant for the germinal products and products of animal origin in question.
Section 5
Animal health certificates, declarations and other documents
Article 237
Animal health certificates, declarations and other documents for entry into the Union
1.   Member States shall only permit the entry into the Union of consignments of animals, germinal products and products of animal origin if such consignments are accompanied by one or both of the following:
(a)
an animal health certificate issued by the competent authority of the third country or territory of origin, unless a derogation is provided for in point (a) of paragraph 4;
(b)
declarations or other documents, where required by the rules adopted pursuant to point (b) of paragraph 4.
2.   Member States shall not permit the entry into the Union of consignments of animals, germinal products and products of animal origin unless the animal health certificate referred to in point (a) of paragraph 1 has been verified and signed by an official veterinarian in a third country or territory in compliance with certification requirements equivalent to those laid down in Article 149(3) or 216(3) and any rules adopted pursuant to Article 149(4) or 216(4).
3.   Member States shall permit electronic animal health certificates that are produced, handled and transmitted by means of Traces to replace the accompanying animal health certificates referred to in paragraph 1, where such electronic animal health certificates:
(a)
contain all the information that the animal health certificate referred to in point (a) of paragraph 1 of this Article is required to contain in accordance with Article 238(1) and any rules adopted pursuant to Article 238(3);
(b)
ensure the traceability of the consignments of animals, germinal products and products of animal origin concerned and link those consignments to the electronic animal health certificate.
4.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
derogations from the animal health certificate requirements provided for in point (a) of paragraph 1 and paragraph 2 of this Article, for consignments of animals, germinal products and products of animal origin, and in specific rules for the animal health certification of those consignments, where the consignments in question pose an insignificant risk to animal health or public health within the Union, due to one or more of the following factors:
(i)
the species and categories of animals, germinal products or products of animal origin concerned;
(ii)
the methods of keeping and types of production of the animals, germinal products and products of animal origin concerned;
(iii)
their intended use;
(iv)
alternative risk-mitigation measures which are in place in the third countries or territories of origin or transit, or after their arrival into the territory of the Union, affording equivalent protection of animal health and public health within the Union as provided for in this Regulation;
(v)
the provision by the third country or territory concerned of guarantees of compliance with the requirements for entry into the Union, demonstrated by means other than an animal health certificate;
(b)
rules requiring consignments of animals, germinal products and products of animal origin entering into the Union to be accompanied by declarations or other documents needed to demonstrate that the animals, germinal products and products of animal origin in question meet the animal health requirements for entry into the Union laid down in rules adopted pursuant to Article 234(2).
Article 238
Content of animal health certificates
1.   The animal health certificate referred to in point (a) of Article 237(1) shall contain at least the following information:
(a)
the name and address of:
(i)
the establishment or place of origin;
(ii)
the establishment or place of destination;
(iii)
where applicable, establishments for assembly operations or rest of the kept animals concerned;
(b)
a description of the animals, germinal products or products of animal origin concerned;
(c)
the number or volume of the animals, germinal products or products of animal origin concerned;
(d)
where applicable, the identification and registration of the animals, germinal products or products of animal origin concerned;
(e)
the information needed to demonstrate that the animals, germinal products and products of animal origin concerned fulfil the animal health requirements for entry into the Union provided for in Article 229 and Article 234(1) and in the rules adopted pursuant to Article 234(2) and Article 239.
2.   The animal health certificate referred to in point (a) of Article 237(1) may include other information required under other Union legislation.
3.   The Commission may, by means of implementing acts, lay down rules concerning:
(a)
information to be contained in the animal health certificate referred to in point (a) of Article 237(1) in addition to that referred to in paragraph 1 of this Article;
(b)
information to be contained in declarations or other documents as referred to in point (b) of Article 237(1);
(c)
model forms for the animal health certificates, declarations and other documents referred to in Article 237(1).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
4.   Pending the establishment of rules in implementing acts adopted pursuant to paragraph 3, as regards a particular species and category of animal, germinal product or product of animal origin, Member States may, following an evaluation of the risks involved, apply national rules, provided those national rules comply with the conditions laid down in paragraph 1.
Section 6
Derogations and additional requirements in respect of certain categories of animals, germinal products and products of animal origin
Article 239
Derogations and additional requirements in respect of certain categories of animals, germinal products and products of animal origin
1.   For certain specific types of entry of animals, germinal products and products of animal origin, the application of the rules set out in Article 229(1) and Articles 233 and 237 may not be adequate, and special rules may need to be adopted by the Commission through delegated acts which take into account the particular risks, the final destination, the type of final use and other circumstances.
2.   The Commission shall adopt delegated acts in accordance with Article 264 concerning the special rules referred to in paragraph 1 of this Article regarding derogations from the requirements provided for in Article 229(1) and Articles 233 and 237 and imposing additional requirements for the entry into the Union of the following:
(a)
animals:
(i)
intended for circuses, events, exhibitions, display, shows and confined establishments;
(ii)
intended to be used for scientific or diagnostic purposes;
(iii)
for which the Union is not the final destination;
(iv)
which originate in the Union and which are moved to a third country or territory, and are then moved back to the Union from that third country or territory;
(v)
which originate in the Union and which are transported through a third country or territory en route to another part of the Union;
(vi)
which are intended for grazing purposes on a temporary basis, in the vicinity of the Union's borders;
(vii)
which pose an insignificant risk to the animal health status within the Union;
(b)
products of animal origin:
(i)
intended for personal use;
(ii)
for consumption by the crew and passengers on means of transport arriving from third countries or territories;
(c)
germinal products and products of animal origin:
(i)
intended to be used as trade samples;
(ii)
intended to be used as research and diagnostic samples;
(iii)
for which the Union is not the final destination;
(iv)
which originate in the Union and are moved to a third country or territory, and are then moved back to the Union from that third country or territory;
(v)
which originate in the Union and are transported through a third country or territory en route to another part of the Union;
(vi)
which pose an insignificant risk to the animal health status within the Union.
Those delegated acts shall take into account the matters referred to in Article 235 and 236.
3.   The Commission may, by means of implementing acts, lay down rules:
(a)
concerning model forms for the animal health certificates, declarations and other documents for the categories of animals, germinal products and products of animal origin referred to in paragraph 2 of this Article;
(b)
indicating, for the products referred to in paragraph 1 of this Article, the codes from the Combined Nomenclature, where such codes are not provided for by other relevant Union rules.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
CHAPTER 2
Entry into the Union of certain goods other than animals, germinal products and products of animal origin from third countries and territories
Article 240
Disease agents and delegated acts
1.   Operators, veterinarians, aquatic animal health professionals and animal professionals bringing disease agents into the Union shall:
(a)
take appropriate measures to ensure that the entry of those disease agents into the Union does not pose a risk to animal health or public health within the Union with regard to listed diseases referred to in point (d) of Article 9(1) and emerging diseases;
(b)
take appropriate disease control and preventive measures to ensure that the entry of those disease agents into the Union does not present a risk of bioterrorism.
This paragraph shall also apply to any other natural or legal person bringing such agents into the Union intentionally.
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 laying down requirements for the entry into the Union of disease agents concerning:
(a)
the packaging of disease agents;
(b)
other risk-mitigation measures required in order to prevent the release and spread of disease agents.
Article 241
Plant material and delegated and implementing acts
1.   The Member States shall take measures to restrict the entry into the Union of consignments of plant material in the event of an unfavourable disease situation in third countries or territories concerning listed diseases as referred to in point (d) of Article 9(1) or emerging diseases, where this is required by the rules adopted in accordance with paragraph 3 of this Article.
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the measures referred to in paragraph 1 of this Article, setting out:
(a)
specific animal health requirements for the entry into the Union of plant material which acts as a path of transmission of listed or emerging diseases;
(b)
requirements in relation to:
(i)
animal health certification, taking into account the rules provided for in point (a) of Article 237(1) and Article 237(2) and (3); or
(ii)
declarations or other documents, taking into account the rules provided for in point (b) of Article 237(1).
3.   The Commission shall lay down the animal health requirements provided for in paragraph 2 on the basis of the following criteria:
(a)
whether a listed or emerging disease that can be transmitted by means of plant material represents a serious risk to animal or to human health in the Union;
(b)
the likelihood that animals of listed species for a particular listed disease or emerging disease will come into direct or indirect contact with the plant material referred to in paragraph 2;
(c)
the availability and effectiveness of alternative risk-mitigation measures in relation to that plant material, which may eliminate or minimise the risk of transmission referred to in point (a).
4.   The Commission may, by means of implementing acts, lay down rules indicating, for the plant material referred to in paragraph 2 of this Article, the codes from the Combined Nomenclature, where such indication is not provided for by other relevant Union rules.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 242
Means of transport, equipment, packaging materials, transport water and feed and fodder and delegated and implementing acts
1.   Operators bringing animals and products into the Union shall take the appropriate and necessary disease prevention measures during transport, as provided for in Articles 125(1) and 192(1).
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
specific animal health requirements for the entry into the Union of:
(i)
means of transport for animals and products;
(ii)
equipment, packaging material or transport water for animals and products, or feed and fodder which may transmit animal diseases;
(b)
requirements in relation to:
(i)
animal health certification, taking into account the rules provided for in point (a) of Article 237(1) and Article 237(2) and (3); or
(ii)
declarations or other documents, taking into account the rules provided for in point (b) of Article 237(1).
3.   The Commission shall lay down the animal health requirements provided for in paragraph 2 of this Article in the event of a unfavourable disease situation concerning one or more listed diseases as referred to in point (d) of Article 9(1), or emerging diseases, which present a serious risk to animal and human health in the Union, in:
(a)
a neighbouring third country or territory;
(b)
the third country or territory of origin;
(c)
a third country or territory of transit.
4.   The Commission may, by means of implementing acts, lay down rules indicating, for the goods referred to in point (a) of paragraph 2 of this Article, the codes from the Combined Nomenclature, where such indication is not provided for by other relevant Union rules.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
CHAPTER 3
Export
Article 243
Export from the Union
1.   Member States shall take the appropriate measures to ensure that the export and re–export from the Union to a third country or territory of animals and products takes place in accordance with the rules for the movement of animals and products between Member States provided for in Part IV (Articles 84 to 228), while taking into account the animal health status within the third country or territory of destination, or the relevant zone or compartment thereof, with regard to the listed diseases referred to in point (d) of Article 9(1) and emerging diseases.
2.   By way of derogation from paragraph 1, if so requested by the competent authority of a third country or territory importing the animals and products in question, or if established by the legal and administrative procedures in force in that third country or territory, export and re–export from the Union may take place in accordance with the provisions in force in that third country or territory, provided that such exports or re-exports do not jeopardise public or animal health.
3.   Where the provisions of a bilateral agreement concluded between the Union and a third country or territory are applicable, animals and products exported from the Union to that third country or territory shall comply with those provisions.
PART VΙ
NON–COMMERCIAL MOVEMENTS OF PET ANIMALS INTO A MEMBER STATE FROM ANOTHER MEMBER STATE OR FROM A THIRD COUNTRY OR TERRITORY
CHAPTER 1
General provisions
Article 244
Scope of Part VI
1.   This Part shall apply to the non–commercial movement of pet animals into a Member State from another Member State or from a third country or territory.
2.   It shall apply without prejudice to:
(a)
Council Regulation (EC) No 338/97 
(
63
)
;
(b)
any national measures adopted, published and made available to the public by Member States to restrict the movement of certain species or breeds of pet animals on the basis of considerations other than those relating to animal health.
Article 245
General provisions
1.   Non–commercial movements of pet animals that fulfil the animal health requirements laid down in this Part shall not be prohibited, restricted or impeded on animal health grounds other than those resulting from the application of this Part.
2.   Where the non–commercial movement of a pet animal is carried out by an authorised person, it may only take place within five days from the movement of the pet owner.
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning requirements supplementing the rules laid down in paragraph 2 of this Article in relation to the following:
(a)
documentation of the non–commercial movement of a pet animal carried out by an authorised person;
(b)
granting of derogations from the period referred to in paragraph 2 of this Article.
4.   The Commission may, by means of implementing acts, lay down requirements for the layout, languages and validity of the declaration authorising an authorised person in writing to carry out the non–commercial movement of a pet animal on behalf of the pet owner. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
Article 246
Maximum number of pet animals
1.   The number of pet animals of the species listed in Part A of Annex I which may be moved during a single non–commercial movement shall not exceed five.
2.   By way of derogation from paragraph 1, the number of pet animals of the species listed in part A of Annex I may exceed five if the following conditions are fulfilled:
(a)
the non–commercial movement in question is for the purpose of participating in a competition, exhibition or sporting event or training for such an event;
(b)
the pet owner or the authorised person concerned submits written evidence that the pet animals are registered either to attend an event as referred to in point (a), or with an association organising such events;
(c)
the pet animals are more than six months old.
3.   In order to prevent commercial movements of pet animals of the species listed in Part B of Annex I from being fraudulently disguised as non–commercial movements, the Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules setting the maximum number of pet animals of those species which may be moved during a single non–commercial movement.
CHAPTER 2
Conditions applicable to non–commercial movements of pet animals into a Member State from another Member State
Article 247
Conditions applicable to non–commercial movements of pet animals of the species listed in Part A of Annex I
Pet animals of the species listed in Part A of Annex I shall not be moved into a Member State from another Member State unless:
(a)
they are individually identified by a physical means of identification in accordance with the rules adopted pursuant to point (a) of Article 252(1);
(b)
they fulfil the relevant prevention and risk-mitigation measures adopted pursuant to point (b) of Article 252(1) in relation to listed diseases as referred to in point (d) of Article 9(1);
(c)
they are accompanied by an identification document duly completed and issued in accordance with the rules adopted pursuant to point (d) of Article 254.
Article 248
Conditions applicable to non–commercial movements of pet animals of the species listed in Part B of Annex I
1.   In so far as the Commission has adopted a delegated act pursuant to point (b) of Article 252(1) with regard to pet animals of one of the species listed in Part B of Annex I, non-commercial movements of pet animals of that species into a Member State from another Member State shall be subject to compliance with the conditions laid down in paragraph 2 of this Article.
2.   Pet animals of the species referred to in paragraph 1 may be moved into a Member State from another Member State only if:
(a)
they are identified or described, either individually or in groups, in accordance with the rules adopted pursuant to point (a) of Article 252(1);
(b)
they comply with the relevant prevention and risk-mitigation measures adopted pursuant to point (b) of Article 252(1) in relation to listed diseases as referred to in point (d) of Article 9(1);
(c)
they are accompanied by an identification document duly completed and issued in accordance with the rules adopted pursuant to point (d) of Article 254;
3.   Pending the adoption of the relevant delegated acts referred to in paragraph 1, Member States may apply national rules to non–commercial movements of pet animals of the species listed in Part B of Annex I into their territory from another Member State, provided that such rules are:
(a)
applied proportionately to the risk to public or animal health associated with non–commercial movements of pet animals of those species; and
(b)
not stricter than those applied to movements of animals of those species in accordance with Part IV.
CHAPTER 3
Conditions applicable to non–commercial movements of pet animals into a Member State from a third country or territory
Article 249
Conditions applicable to non–commercial movements of pet animals of the species listed in Part A of Annex I
1.   Pet animals of the species listed in Part A of Annex I shall not be moved into a Member State from a third country or territory unless:
(a)
they are individually identified by a physical means of identification in accordance with the rules adopted pursuant to point (a) of Article 252(1);
(b)
they comply with the relevant prevention and risk-mitigation measures adopted pursuant to point (b) of Article 252(1) in respect of listed diseases as referred to in point (d) of Article 9(1);
(c)
they are accompanied by an identification document duly completed and issued in accordance with the rules adopted pursuant to point (d) of Article 254.
2.   Pet animals of the species listed in Part A of Annex I may be moved into a Member State from a third country or territory other than those listed pursuant to Article 253(1)(d) only through a point of entry listed for that purpose. Each Member State shall draw up a list of those points of entry within its territory and shall make that list available to the public.
3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the conditions for granting derogations from paragraph 2 of this Article.
Article 250
Conditions applicable to non–commercial movements of pet animals of the species listed in Part B of Annex I
1.   In so far as the Commission has adopted a delegated act pursuant to point (b) of Article 252(1) with regard to pet animals of one of the species listed in Part B of Annex I, non–commercial movements of pet animals of that species into a Member State from a third country or territory shall be subject to compliance with the conditions laid down in paragraph 2 of this Article.
2.   Pet animals of the species referred to in paragraph 1 may be moved into a Member State from a third country or territory only if:
(a)
they are identified or described, either individually or in groups, in accordance with the rules adopted pursuant to point (a) of Article 252(1);
(b)
they comply with the relevant prevention and risk-mitigation measures adopted pursuant to point (b) of Article 252(1) in relation to listed diseases as referred to in point (d) of Article 9(1);
(c)
they are accompanied by an identification document duly completed and issued in accordance with the rules adopted pursuant to point (d) of Article 254;
(d)
when coming from a third country or territory other than those listed pursuant to point (d) of Article 253(1), they enter through a point of entry listed for that purpose. Each Member State shall draw up a list of those points of entry within its territory and shall make that list available to the public.
3.   Pending the adoption of the relevant delegated acts referred to in paragraph 1, Member States may apply national rules to non–commercial movements of pet animals of the species listed in Part B of Annex I into their territory from a third country or territory, provided that such rules are:
(a)
applied proportionately to the risk to public or animal health associated with non–commercial movements of pet animals of those species; and
(b)
not stricter than those applied to the entry into the Union of animals of those species in accordance with Part V.
Article 251
Derogation from the conditions applicable to non–commercial movements of pet animals between certain countries and territories
By way of derogation from Articles 249 and 250, non–commercial movements of pet animals between the following countries and territories may continue under the conditions laid down by the national rules of those countries and territories:
(a)
San Marino and Italy;
(b)
the Vatican and Italy;
(c)
Monaco and France;
(d)
Andorra and France;
(e)
Andorra and Spain;
(f)
Norway and Sweden;
(g)
the Faeroe Islands and Denmark;
(h)
Greenland and Denmark.
CHAPTER 4
Identification and prevention and risk-mitigation measures
Article 252
Delegation of powers concerning the identification of pet animals and prevention and risk-mitigation measures
1.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
detailed species–specific requirements for:
(i)
the means of identification of pet animals of the species listed in Annex I provided for in point (a) of Article 247, point (a) of Article 248(2), point (a) of Article 249(1) and point (a) of Article 250(2);
(ii)
the application and use of those means of identification;
(b)
detailed species–specific requirements for the prevention and risk-mitigation measures to ensure that pet animals do not pose a significant risk for the spread of listed diseases as referred to in point (d) of Article 9(1) due to movements of pet animals of the species listed in Annex I as provided for in point (b) of Article 247, point (b) of Article 248(2), point (b) of Article 249(1) and point (b) of Article 250(2).
2.   Where, in the case of emerging risks, imperative grounds of urgency so require, the procedure provided for in Article 265 shall apply to rules adopted pursuant to point (b) of paragraph 1 of this Article.
3.   The species–specific prevention and risk-mitigation measures authorised by a delegated act adopted pursuant to point (b) of paragraph 1 of this Article shall be based on adequate, reliable and validated scientific information and applied proportionately to the risk to public or animal health associated with non–commercial movements of pet animals likely to be affected by listed diseases as referred to in point (d) of Article 9(1).
4.   The delegated acts provided for in point (b) of paragraph 1 may also comprise the following:
(a)
rules for the categorisation of Member States or parts thereof according to their animal health status and their surveillance and reporting systems with regard to certain diseases that are likely to be spread by movements of pet animals of the species listed in Annex I;
(b)
the conditions that Member States are to fulfil in order to remain eligible for the application of the prevention and risk-mitigation measures referred to in point (b) of paragraph 1;
(c)
the conditions for applying and documenting the prevention and risk-mitigation measures referred to in point (b) of paragraph 1;
(d)
the criteria for granting and, where appropriate, documenting derogations in certain specified circumstances from the application of the prevention and risk-mitigation measures referred to in point (b) of paragraph 1;
(e)
the criteria for granting and documenting derogations in certain specified circumstances from the conditions referred to in Articles 247 to 250.
Article 253
Implementing acts concerning prevention and risk-mitigation measures
1.   The Commission shall, by means of implementing acts, as regards pet animals of the species listed in Part A of Annex I:
(a)
lay down rules on the format, layout and languages of any documents required under points (c) and (d) of Article 252(4);
(b)
adopt a list of Member States that comply with the conditions referred to in point (d) of Article 252(4) and remove Member States from that list should any change occur in relation to those conditions;
(c)
adopt a list of Member States that comply with the rules for categorisation of Member States or parts thereof referred to in point (a) of Article 252(4) and remove Member States from that list should any change occur in relation to those rules;
(d)
adopt a list of third countries and territories that comply with the conditions referred to in point (d) of Article 252(4) and remove third countries or territories from that list should any change occur in relation to those conditions.
2.   The Commission may, by means of implementing acts, as regards pet animals of the species listed in Part B of Annex I, adopt a list of third countries and territories that comply with the conditions referred to in point (d) of Article 252(4) and remove third countries or territories from that list should any change occur in relation to those conditions.
3.   The implementing acts referred to in paragraphs 1 and 2 of this Article shall be adopted in accordance with the examination procedure referred to in Article 266(2).
4.   On duly justified imperative grounds of urgency relating to serious risks, the Commission shall adopt immediately applicable implementing acts updating the lists referred to in points (b) and (d) of paragraph 1 of this Article in accordance with the procedure referred to in Article 266(3).
CHAPTER 5
Identification documents
Article 254
Delegation of powers concerning identification documents
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
(a)
entries for the insertion of the information to be included in the identification documents 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);
(b)
the distribution of blank identification documents as referred to in point (c) of Article 247;
(c)
the conditions for granting derogations in relation to the format of the identification documents provided for in point (c) of Article 247 and point (c) of Article 249(1);
(d)
the issue, completion and, where applicable, endorsement of the identification documents provided for in point (c) of Articles 247, point (c) of Article 248(2), point (c) of Article 249(1) and point (c) of Article 250(2).
Article 255
Implementing acts concerning identification documents
1.   The Commission shall adopt implementing acts laying down the model for identification documents as referred to in point (c) of Article 247 and point (c) of Article 249(1). That model shall contain the respective entries referred to in point (a) of Article 254, as well as requirements concerning the languages, layout, validity or security features of those identification documents.
2.   The Commission may, by means of implementing acts, adopt:
(a)
the model for identification documents as referred to in point (c) of Article 248(2) and point (c) of Article 250(2), which are to contain the respective entries referred to in point (a) of Article 254, as well as requirements concerning the languages, layout, validity or security features of those identification documents;
(b)
the rules necessary for transition to the model identification document referred to in point (c) of Article 247.
3.   The implementing acts referred to in paragraphs 1 and 2 of this Article shall be adopted in accordance with the examination procedure referred to in Article 266(2).
CHAPTER 6
Information obligations
Article 256
Information obligations
1.   Member States shall provide the public with clear and easily accessible information concerning the animal health requirements applicable to non–commercial movements of pet animals, including:
(a)
conditions for the grant of certain derogations referred to in point (d) of Article 252(4);
(b)
conditions for the grant of derogations referred to in point (e) of Article 252(4);
(c)
requirements for the application of the means of identification referred to in point (a)(ii) of Article 252(1);
(d)
conditions applicable to non–commercial movements into Member States' territories of pet animals of the species referred to in Part B of Annex I, which are laid down by their national rules as provided for in Articles 248(3) and 250(3);
(e)
conditions applicable to non–commercial movements into Member States' territories of pet animals from certain countries and territories laid down by their national rules as referred to in Article 251;
(f)
any relevant information concerning certain prevention and risk-mitigation measures as referred to in point (b) of Article 252(1).
2.   Member States shall establish internet–based information pages providing the information referred to in paragraph 1, and shall communicate the internet address of those pages to the Commission.
3.   The Commission shall assist the Member States in making that information available to the public by providing on its internet page:
(a)
links to the internet–based information pages of the Member States;
(b)
the information referred to in points (a) and (d) of paragraph 1, and the information made available to the public as referred to in point (b) of Article 244(2) in additional languages, as appropriate.
PART VIΙ
EMERGENCY MEASURES
Section 1
Emergency measures concerning movements of animals and products within the Union and means of transport and other material that may have come into contact with such animals and products
Article 257
Emergency measures to be taken by the competent authority of the Member State in the territory of which an outbreak of a listed disease or emerging disease, or a hazard occurred
1.   In the event of an outbreak of a listed disease or emerging disease, or the occurrence of a hazard which is likely to constitute a serious risk to animal or public health, the competent authority of the Member State where it occurred shall, depending on the gravity of the situation and the disease or hazard in question, immediately take one or more of the following emergency measures to prevent the spread of the disease or hazard:
(a)
for listed diseases:
(i)
referred to in point (a) of Article 9(1), the disease control measures laid down in Chapter 1 of Title II of Part III (Articles 53 to 71);
(ii)
referred to in point (b) of Article 9(1), the disease control measures laid down in Articles 72 to 75 and 77 to 81 of Chapter 2 of Title II of Part III;
(iii)
referred to in point (c) of Article 9(1), the disease control measures laid down in Articles 76 to 78 and Articles 80 and 82 of Chapter 2 of Title II of Part III;
(b)
for emerging diseases and hazards:
(i)
restrictions on the movement of animals and products originating from the establishments, or, where relevant, the restricted zones or compartments, where the outbreak or the hazard occurred, and on means of transport and other material that may have come into contact with those animals or products;
(ii)
quarantine of animals and isolation of products;
(iii)
surveillance and traceability measures;
(iv)
any emergency disease control measures provided for in Chapter 1 of Title II of Part III (Articles 53 to 71) that are appropriate;
(c)
any other emergency measure which it deems appropriate in order to effectively and efficiently control and prevent the spread of the disease or hazard.
2.   The competent authority referred to in paragraph 1 shall inform the Commission and the other Member States:
(a)
immediately of any outbreak or the occurrence of a hazard as referred to in paragraph 1;
(b)
without delay of the emergency measures taken pursuant to paragraph 1.
Article 258
Emergency measures to be taken by a Member State other than the Member State where the outbreak or hazard occurred
1.   The competent authority of a Member State other than the Member State where the outbreak or hazard referred to in Article 257(1) occurred shall, depending on the gravity of the situation and the disease or hazard in question, take one or more of the emergency measures referred to in Article 257(1) where it detects on its territory animals or products from the Member State referred to in Article 257(1) or means of transport or any other material that may have come into contact with such animals and products.
2.   The competent authority referred to in paragraph 1 of this Article may, where a serious risk exists pending the adoption of emergency measures by the Commission in accordance with Article 259, take the emergency measures referred to in Article 257(1) on an interim basis, depending on the gravity of the situation with regard to animals or products originating from the establishments or other locations, or where relevant from the restricted zones of the Member State, where the disease or hazard referred to in Article 257(1) occurred, or means of transport or other material that may have come into contact with such animals.
3.   A Member State may take measures as referred to in Article 257(1) in the event of an outbreak in a third country or territory bordering the Union of a disease referred to in point (a) of Article 9(1) or an emerging disease in such a third country or territory, in so far as those measures are necessary in order to prevent the spread of the disease into the territory of the Union.
4.   The competent authority referred to in paragraph 1 and the competent authority of the Member State referred to in paragraph 3 shall inform the Commission and other Member States:
(a)
immediately of the outbreak or occurrence of a hazard referred to in paragraph 1;
(b)
without delay of the emergency measures taken pursuant to paragraphs 1 and 2.
Article 259
Commission emergency measures
1.   In the event of an outbreak or the occurrence of a hazard as referred to in Article 257(1), and of emergency measures taken by the competent authorities of the Member States in accordance with Article 257(1) and Article 258(1), (2) and (3), the Commission shall review the situation and the emergency measures taken, and shall adopt, by means of an implementing act, one or more of the emergency measures provided for in Article 257(1) concerning the animals and products in question and means of transport and other material that may have come into contact with those animals or products, in any of the following cases:
(a)
where the Commission has not been informed of any measures taken pursuant to Article 257(1) and Article 258(1), (2) and (3);
(b)
where the Commission considers the measures taken pursuant to Article 257(1) and Article 258(1), (2) and (3) to be inadequate;
(c)
where the Commission considers it necessary to approve or replace the measures taken by the competent authorities of the Member States pursuant to Article 257(1) and Article 258(1), (2) and (3) in order to avoid unjustified disruptions in the movement of animals and products.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
2.   On duly justified imperative grounds of urgency relating to serious risks of the spread of a disease or a hazard, the Commission may adopt immediately applicable implementing acts in accordance with Article 266(3).
Section 2
Emergency measures concerning consignments of animals and products originating from third countries and territories, and means of transport and other material, that may have come into contact with such consignments
Article 260
Emergency measures to be taken by the competent authority
Where the competent authority of a Member State becomes aware of animals or products originating from a third country or territory, or of means of transport or materials, which may have come into contact with such animals and products, that are likely to constitute a serious risk in the Union due to possible infection or contamination by listed diseases or emerging diseases or hazards, it shall:
(a)
immediately take one or more of the following emergency measures necessary to mitigate that risk, depending on the gravity of the situation:
(i)
destruction of the animals and products concerned;
(ii)
quarantine of animals and isolation of products;
(iii)
surveillance and traceability measures;
(iv)
any disease control measures referred to in Chapter 1 of Title II of Part III (Articles 53 to 71), where appropriate;
(v)
any other emergency measure which it deems appropriate to prevent the spread of the disease or hazard into the Union;
(b)
immediately inform the Commission and the other Member States of the risks associated with the animals and products in question and of the origin of those animals and products by means of Traces, and without delay of the emergency measures taken pursuant to point (a).
Article 261
Commission emergency measures
1.   Where a listed disease, an emerging disease or a hazard that is likely to constitute a serious risk occurs or spreads in a third country or territory, or if any other serious animal or public health reason so warrants, the Commission may, by means of an implementing act and acting on its own initiative or at the request of a Member State, adopt one or more of the following emergency measures, depending on the gravity of the situation:
(a)
suspend the entry into the Union of consignments of animals and products, and means of transport or other material, that may have come into contact with such consignments, which may spread that disease or hazard into the Union;
(b)
establish special requirements for the entry into the Union of animals and products, and of means of transport and other material that may have come into contact with such animals and products, which may spread that disease or hazard into the Union;
(c)
take any other appropriate emergency disease control measures to prevent the spread of such disease or hazard into the Union.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
2.   On duly justified imperative grounds of urgency relating to serious risks, the Commission shall, after consulting the Member State concerned, adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 266(3).
Article 262
Emergency measures to be taken by Member States when the Commission does not act
1.   Where a Member State has requested the Commission to take emergency measures in accordance with Article 261 and the Commission has not done so, that Member State:
(a)
may, pending the adoption of emergency measures by the Commission in accordance with paragraph 2 of this Article, take one or more of the emergency measures referred to in point (a) of Article 260 on an interim basis in respect of animals and products, and any means of transport and other material that may have come into contact with such animals and products, originating from the third country or territory referred to in Article 261(1), depending on the gravity of the situation within its territory;
(b)
shall inform the Commission and the competent authorities of the other Member States of such emergency measures without delay, giving the reason for their adoption.
2.   The Commission shall review the situation and the emergency measures taken by the Member State concerned in accordance with paragraph 1 of this Article and shall, where necessary, adopt by means of an implementing act one or more of the emergency measures provided for in Article 261.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).
3.   On duly justified imperative grounds of urgency relating to serious risks, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 266(3).
PART VIIΙ
COMMON PROVISIONS
TITLE I
PROCEDURAL PROVISIONS
Article 263
Amendments to Annex III
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning amendments to Annex III, limited exclusively to taking into account changes in taxonomy.
Article 264
Exercise of the delegation
1.   The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2.   It is of particular importance that the Commission carry out consultations with experts, including Member States' experts, before adopting those delegated acts.
3.   The power to adopt delegated acts referred to in Articles 3(5), 5(2) 5(4), 14(3), 16(2), 18(3), 20(3), 29, 31(5), 32(2), 37(5), 39, 41(3), 42(6), 47, 48(3), 53(2), 54(3), 55(2), 58(2), 63, 64(4), 67, 68(2), 68(3), 70(3), 72(2), 73(3), 74(4), 76(5), 77(2), 87(3), 94(3), 97(2), 101(3), 106(1), 109(2), 118, 119, 122(1), 122(2), 125(2), 131(1), 132(2), 135, 136(2), 137(2), 138(3), 139(4), 140, 144(1), 146(1), 147, 149(4), 151(3), 154(1), 156(1), 160(1), 160(2), 161(6), 162(4), 163(5), 164(2), 165(3), 166(3), 167(5), 168(3), 169(5), 176(4), 181(2), 185(5), 189(1), 192(2), 197(3), 200(3), 201(3), 202(3), 203(2), 204(3), 205(2), 211(1), 213(1), 214, 216(4), 218(3), 221(1), 222(3), 223(6), 224(3), 228(1), 230(3), 234(2), 237(4), 239(2), 240(2), 241(2), 242(2), 245(3), 246(3), 249(3), 252(1), 254, 263, 271(2), 272(2), 279(2), and 280(4) shall be conferred on the Commission for a period of five years from 20 April 2016.
The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
4.   The delegation of power referred to in paragraph 3 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the 
Official Journal of the European Union
 or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
5.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6.   A delegated act adopted pursuant to the provisions listed in paragraph 3 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
7.   The Commission shall allow a period of at least six months to elapse between the adoption of the respective initial delegated acts referred to in Articles 3(5), 14(3), 16(2), 20(3), 122(2), 164(2) and 228(1) and the date on which they start to apply.
Article 265
Urgency procedure
1.   Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.
2.   Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 264(6). In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or by the Council.
Article 266
Committee procedure
1.   The Commission shall be assisted by the Standing Committee on Plants, Animals, Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
3.   Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.
4.   The Commission shall allow a period of at least six months to elapse between the adoption of the respective initial implementing acts referred to in Articles 25(3), 120, and 228(2), when those implementing acts relate to the implementation of Article 117, and the date on which they start to apply.
Article 267
Data protection
1.   Member States shall apply Directive 95/46/EC of the European Parliament and of the Council 
(
64
)
 to the processing of personal data carried out in the Member States pursuant to this Regulation.
2.   Regulation (EC) No 45/2001 of the European Parliament and of the Council 
(
65
)
 shall apply to the processing of personal data carried out by the Commission pursuant to this Regulation.
TITLE II
PENALTIES
Article 268
Penalties
The Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that those rules are implemented. The penalties provided for must be effective, proportionate and dissuasive.
The Member States shall notify those provisions to the Commission by 22 April 2022 at the latest and shall notify it without delay of any subsequent amendments affecting them.
TITLE III
MEMBER STATES' MEASURES
Article 269
Additional or more stringent measures by Member States
1.   In addition to what follows from other provisions in this Regulation, allowing the Member States to adopt national measures, Member States may apply within their territories measures that are additional to, or more stringent than, those laid down in this Regulation, concerning:
(a)
responsibilities for animal health as provided for in Chapter 3 of Part I (Articles 10 to 17);
(b)
notification within Member States as provided for in Article 18;
(c)
surveillance as provided for in Chapter 2 of Part II (Articles 24 to 30);
(d)
registration, approval, record-keeping and registers as provided for in Chapter 1 of Title I (Articles 84 to 107), and Chapter 1 of Title II, of Part IV (Articles 172 to 190);
(e)
traceability requirements for kept terrestrial animals and germinal products as provided for in Chapter 2 of Title I of Part IV (Articles 108 to 123).
2.   The national measures referred to in paragraph 1 shall respect the rules laid down in this Regulation and shall not:
(a)
hinder the movement of animals and products between Member States;
(b)
be inconsistent with the rules referred to in paragraph 1.
PART ΙΧ
TRANSITIONAL AND FINAL PROVISIONS
Article 270
Repeals
1.   Decisions 78/642/EEC, 89/455/EEC and 90/678/EEC, and Directives 79/110/EEC, 81/6/EEC, 90/423/EEC, 92/36/EEC and 98/99/EC are repealed.
2.   The following acts are repealed as from 21 April 2021:
—
Directive 64/432/EEC,
—
Directive 77/391/EEC,
—
Directive 78/52/EEC,
—
Directive 80/1095/EEC,
—
Directive 82/894/EEC,
—
Directive 88/407/EEC,
—
Directive 89/556/EEC,
—
Directive 90/429/EEC,
—
Directive 91/68/EEC,
—
Decision 91/666/EEC,
—
Directive 92/35/EEC,
—
Directive 92/65/EEC,
—
Directive 92/66/EEC,
—
Directive 92/118/EEC,
—
Directive 92/119/EEC,
—
Decision 95/410/EC,
—
Directive 2000/75/EC,
—
Decision 2000/258/EC,
—
Directive 2001/89/EC,
—
Directive 2002/60/EC,
—
Directive 2002/99/EC,
—
Directive 2003/85/EC,
—
Regulation (EC) No 21/2004,
—
Directive 2004/68/EC,
—
Directive 2005/94/EC,
—
Directive 2006/88/EC,
—
Directive 2008/71/EC,
—
Directive 2009/156/EC,
—
Directive 2009/158/EC,
—
Regulation (EU) No 576/2013.
References to those repealed acts shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex V hereto.
Article 271
Transitional measures related to the amendment of Regulation (EC) No 1760/2000 and the repeal of Regulation (EC) No 21/2004 and Directive 2008/71/EC
1.   Notwithstanding Article 270(2) and Article 278 of this Regulation, Articles 1 to 10 of Regulation (EC) No 1760/2000, Regulation (EC) No 21/2004, and Directive 2008/71/EC, as well as the acts adopted on the basis thereof, shall continue to apply, instead of the corresponding Articles in this Regulation, until three years after the date of application of this Regulation or an earlier date to be determined in a delegated act adopted in accordance with paragraph 2 of this Article.
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the earlier date referred to in paragraph 1 of this Article.
That date shall be the date of application of the corresponding rules to be adopted pursuant to the delegated acts provided for in Article 109(2) and Article 119 and the implementing acts provided for in Article 118 of this Regulation.
Article 272
Transitional measures related to the repeals of Directives 92/66/EEC, 2000/75/EC, 2001/89/EC, 2002/60/EC, 2003/85/EC and 2005/94/EC
1.   Notwithstanding Article 270(2) of this Regulation, Directives 92/66/EEC, 2000/75/EC, 2001/89/EC, 2002/60/EC, 2003/85/EC and 2005/94/EC, as well as the acts adopted on the basis thereof, shall continue to apply, instead of the corresponding Articles in this Regulation, until three years after the date of application of this Regulation or an earlier date to be determined in a delegated act adopted in accordance with paragraph 2 of this Article.
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the earlier date referred to in paragraph 1 of this Article.
That date shall be the date of application of the corresponding rules to be adopted pursuant to the delegated acts provided for in Article 47, Articles 48(3), 53(2), 54(3), 55(2) and 58(2), Article 63, Article 64(4), Article 67, and Articles 68(2) and 70(3) of this Regulation.
Article 273
Amendment of Regulation (EC) No 2160/2003
In Article 9(3) of Regulation (EC) No 2160/2003 the following wording is added:
‘Those special measures shall include measures based on the provisions contained in Decision 95/410/EC in its last version prior to its repeal and Commission Decisions 2003/644/EC
 (
*1
)
 and 2004/235/EC
 (
*2
)
 in the versions thereof at the time of the repeal of Directive 90/539/EEC.
Article 274
Transitional measures related to the date of adoption of certain delegated and implementing acts
Without prejudice to the date of application provided for in Article 283, the Commission shall adopt the delegated acts referred to in the first subparagraph of Article 31(5), Articles 32(2), 39, 41(3), 54(3), 55(2), 58(2), 64(4), 67, 68(2), 74(4), 77(2) and 97(2), Article 122(2), and Articles 131(1), 132(2), 135, 137(2), 146(1), 149(4), 154(1), 162(3), 163(5), 166(3), 169(5), 181(2), 185(5), 213(1), 216(4), 221(1), 222(3), 224(3), 234(2), 239(1), and the implementing acts referred to in Articles 8 and 9, at the latest on 20 April 2019. In accordance with Article 283, those delegated and implementing acts shall apply from the date of application set out in that Article.
Article 275
Prior review and amendments of Annex II
The Commission shall, at the latest by 20 April 2019, review the list of diseases contained in Annex II. Should it be apparent from that review that an application of the rules set out in this Regulation requires amendments to be made to Annex II, by adding to or deleting from the list contained therein, such amendments shall be adopted by the Commission at the latest by the deadline referred to in the first sentence of this Article.
Article 276
Review
The Commission shall, by 20 April 2019 at the latest, review the existing legislation on the identification and registration of kept animals of the equine species.
The Commission shall take the results of that review into account in the framework of the application of Articles 118, 119 and 120.
Article 277
Transitional measures related to the repeal of Regulation (EU) No 576/2013 on the non–commercial movement of pet animals
Notwithstanding Article 270(2) of this Regulation, Regulation (EU) No 576/2013 shall continue to apply until 21 April 2026 in respect of non–commercial movements of pet animals, in place of Part VI of this Regulation.
Article 278
Amendments to Regulation (EC) No 1760/2000
Regulation (EC) No 1760/2000 is amended as follows:
(1)
Articles 1 to 10 are deleted;
(2)
Article 22 is replaced by the following:
‘Article 22
1.   Member States shall take all the necessary measures to ensure compliance with the provisions of this Regulation.
The controls provided for shall be without prejudice to any controls which the Commission may carry out pursuant to Article 9 of Regulation (EC, Euratom) No 2988/95.
Any penalties imposed by the Member State on an operator or organisation marketing beef shall be effective, dissuasive and proportionate.
2.   Notwithstanding paragraph 1, where operators and organisations marketing beef have labelled beef without complying with their obligations laid down in Title II, Member States shall, as appropriate, and in accordance with the principle of proportionality, require the removal of the beef from the market. In addition to the penalties referred to in paragraph 1, Member States may:
(a)
if the meat concerned conforms with relevant veterinary and hygiene rules, authorise that such beef:
(i)
be placed on the market after being properly labelled in accordance with Union requirements; or
(ii)
be sent directly for processing into products other than those indicated in point 1 of Article 12;
(b)
order the suspension or withdrawal of the approval of the operators and organisations concerned.
3.   Experts from the Commission, in conjunction with the competent authorities, shall:
(a)
verify that Member States comply with the requirements of this Regulation;
(b)
make on–the–spot checks to ensure that the checks are carried out in accordance with this Regulation.
4.   A Member State in whose territory an on–the–spot check is carried out shall provide the experts from the Commission with any assistance they may require in the performance of their tasks. The outcome of the checks made shall be discussed with the competent authority of the Member State concerned before a final report is drawn up and circulated. That report shall, where appropriate, contain recommendations for Member States on the improvement of compliance with this Regulation.’;
(3)
Article 22b is replaced by the following:
‘Article 22b
Exercise of the delegation
1.   The power to adopt delegated acts is conferred on the Commission subject to the conditions under this Article.
2.   The power to adopt delegated acts referred to in Articles 13(6), 14(4) and 15a shall be conferred on the Commission for a period of five years from 20 April 2016. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3.   The delegation of power referred to in Articles 13(6), 14(4) and 15a may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the 
Official Journal of the European Union
 or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5.   A delegated act adopted pursuant to Articles 13(6), 14(4) and 15a shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’;
(4)
Article 23 is replaced by the following:
‘Article 23
Committee procedure
1.   The Commission shall be assisted for the implementing acts adopted pursuant to Article 13(6) of this Regulation by the Standing Committee on Plants, Animals, Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council
 (
*3
)
.
That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council
 (
*4
)
.
2.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the opinion of the Committee is to be obtained by written procedure, that procedure shall be terminated without result when, within the time–limit for delivery of the opinion, the chair of the Committee so decides or a simple majority of committee members so requests.
(
*3
)
  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (
OJ L 31, 1.2.2002, p. 1
)."
(
*4
)
  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (
OJ L 55, 28.2.2011, p. 13
).’."
Article 279
Existing operators and establishments
1.   Establishments and operators registered or approved in accordance with Directive 64/432/EEC, Directive 88/407/EEC, Directive 89/556/EEC, Directive 90/429/EEC, Directive 91/68/EEC, Directive 92/65/EEC, Regulation (EC) No 1760/2000, Regulation (EC) No 21/2004, Directive 2006/88/EC, Directive 2008/71/EC, Directive 2009/156/EC or Directive 2009/158/EC before the date of application of this Regulation shall be deemed to be registered or approved, as required, in accordance with this Regulation and shall, as such, be subject to the relevant obligations provided for under this Regulation.
2.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules necessary to ensure a smooth transition from the rules existing prior to this Regulation referred to in paragraph 1 of this Article, in order in particular to protect acquired rights and legitimate expectations of natural and legal persons concerned.
Article 280
Existing disease–free Member States, zones and compartments and existing Member State eradication and surveillance programmes
1.   Member States and zones with an approved disease–free status for one or more of the listed diseases referred to in points (b) and (c) of Article 9(1), for one or more of the relevant animal species, in accordance with Directive 64/432/EEC, Directive 91/68/EEC, Directive 92/65/EEC, Directive 2006/88/EC, Directive 2009/156/EC or Directive 2009/158/EC, shall be deemed to have an approved disease–free status in accordance with this Regulation and shall, as such, be subject to the relevant obligations provided for under this Regulation.
2.   Member States and zones with an approved eradication programme or surveillance programme for one or more of the listed diseases referred to in points (b) and (c) of Article 9(1), for one or more of the relevant animal species, in accordance with Directive 64/432/EEC, Directive 91/68/EEC, Directive 92/65/EEC, Directive 2006/88/EC, Directive 2009/156/EC or Directive 2009/158/EC, shall be deemed to have an approved eradication programme in accordance with this Regulation and shall, as such, be subject to the relevant obligations provided for under this Regulation.
3.   Approved compartments with an approved disease–free status for one or more of the listed diseases referred to in points (a), (b) or (c) of Article 9(1), in accordance with Directives 2005/94/EC and 2006/88/EC, shall be deemed to have a recognised disease-free status under Article 37 of this Regulation and shall, as such, be subject to the relevant obligations provided for under this Regulation.
4.   The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules necessary in order to ensure a smooth transition from the rules existing prior to this Regulation referred to in paragraphs 1, 2 and 3.
Article 281
Relation with acts concerning official controls
In the event of any conflict between the provisions of this Regulation and the provisions of Regulation (EC) No 882/2004, Council Directives 89/608/EEC 
(
66
)
, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/93/EC 
(
67
)
 and 97/78/EC and Decision 92/438/EEC, the provisions of this Regulation shall prevail.
Article 282
Evaluation
The Commission shall evaluate this Regulation together with the delegated acts referred to in Article 264 and submit the results of the evaluation in a report to the European Parliament and to the Council no later than 22 April 2026.
Article 283
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the 
Official Journal of the European Union
.
It shall apply from 21 April 2021, except for Articles 270(1) and 274, which shall apply from the date of its entry into force.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 9 March 2016.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
J.A. HENNIS-PLASSCHAERT
(
1
)
  
            
OJ C 170, 5.6.2014, p. 104
.
(
2
)
  Position of the European Parliament of 15 April 2014 (not yet published in the Official Journal) and position of the Council at first reading of 14 December 2015.
(
3
)
  Regulation (EU) No 652/2014 of the European Parliament and of the Council of 15 May 2014 laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005 of the European Parliament and of the Council, Directive 2009/128/EC of the European Parliament and of the Council and Regulation (EC) No 1107/2009 of the European Parliament and of the Council and repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC (
OJ L 189, 27.6.2014, p. 1
).
(
4
)
  Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (
OJ L 165, 30.4.2004, p. 1
).
(
5
)
  Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (
OJ L 395, 30.12.1989, p. 13
).
(
6
)
  Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (
OJ L 224, 18.8.1990, p. 29
).
(
7
)
  Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (
OJ L 268, 24.9.1991, p. 56
).
(
8
)
  Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (
OJ L 24, 30.1.1998, p. 9
).
(
9
)
  Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 (
OJ L 3, 5.1.2005, p. 1
).
(
10
)
  Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (
OJ L 303, 18.11.2009, p. 1
).
(
11
)
  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (
OJ L 31, 1.2.2002, p. 1
).
(
12
)
  Regulation (EC) No 1069/2009 of the European Parliament and the Council of 21 October 2009 laying down health rules as regards animal by–products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (
OJ L 300, 14.11.2009, p. 1
).
(
13
)
  Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (
OJ L 147, 31.5.2001, p. 1
).
(
14
)
  Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (
OJ L 325, 12.12.2003, p. 31
).
(
15
)
  Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food–borne zoonotic agents (
OJ L 325, 12.12.2003, p. 1
).
(
16
)
  Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (
OJ L 293, 5.11.2013, p. 1
).
(
17
)
  Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (
OJ L 328, 24.11.2006, p. 14
).
(
18
)
  Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC (
OJ L 268, 14.9.1992, p. 54
).
(
19
)
  Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (
OJ L 276, 20.10.2010, p. 33
).
(
20
)
  Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (
OJ 121, 29.7.1964, p. 1977/64
).
(
21
)
  Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra–Community trade in ovine and caprine animals (
OJ L 46, 19.2.1991, p. 19
).
(
22
)
  Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and importation from third countries of equidae (
OJ L 192, 23.7.2010, p. 1
).
(
23
)
  Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (
OJ L 343, 22.12.2009, p. 74
).
(
24
)
  Council Decision 92/438/EEC of 13 July 1992 on computerization of veterinary import procedures (Shift project), amending Directives 90/675/EEC, 91/496/EEC, 91/628/EEC and Decision 90/424/EEC, and repealing Decision 88/192/EEC (
OJ L 243, 25.8.1992, p. 27
).
(
25
)
  Commission Decision 2003/24/EC of 30 December 2002 concerning the development of an integrated computerised veterinary system (
OJ L 8, 14.1.2003, p. 44
).
(
26
)
  Commission Decision 2004/292/EC of 30 March 2004 on the introduction of the Traces system and amending Decision 92/486/EEC (
OJ L 94, 31.3.2004, p. 63
).
(
27
)
  Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (
OJ L 204, 21.7.1998, p. 37
).
(
28
)
  Council Directive 77/391/EEC of 17 May 1977 introducing Community measures for the eradication of brucellosis, tuberculosis and leucosis in cattle (
OJ L 145, 13.6.1977, p. 44
).
(
29
)
  Council Directive 78/52/EEC of 13 December 1977 establishing the Community criteria for national plans for the accelerated eradication of brucellosis, tuberculosis and enzootic leukosis in cattle (
OJ L 15, 19.1.1978, p. 34
).
(
30
)
  Council Directive 80/1095/EEC of 11 November 1980 laying down conditions designed to render and keep the territory of the Community free from classical swine fever (
OJ L 325, 1.12.1980, p. 1
).
(
31
)
  Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases within the Community (
OJ L 378, 31.12.1982, p. 58
).
(
32
)
  Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intra–Community trade in and imports of semen of domestic animals of the bovine species (
OJ L 194, 22.7.1988, p. 10
).
(
33
)
  Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra–Community trade in and importation from third countries of embryos of domestic animals of the bovine species (
OJ L 302, 19.10.1989, p. 1
).
(
34
)
  Council Directive 90/429/EEC of 26 June 1990 laying down the animal health requirements applicable to intra–Community trade in and imports of semen of domestic animals of the porcine species (
OJ L 224, 18.8.1990, p. 62
).
(
35
)
  Council Decision 91/666/ EEC of 11 December 1991 establishing Community reserves of foot–and–mouth disease vaccines (
OJ L 368, 31.12.1991, p. 21
).
(
36
)
  Council Directive 92/35/EEC of 29 April 1992 laying down control rules and measures to combat African horse sickness (
OJ L 157, 10.6.1992, p. 19
).
(
37
)
  Council Directive 92/66/EEC of 14 July 1992 introducing Community measures for the control of Newcastle disease (
OJ L 260, 5.9.1992, p. 1
).
(
38
)
  Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC (
OJ L 62, 15.3.1993, p. 49
).
(
39
)
  Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease (
OJ L 62, 15.3.1993, p. 69
).
(
40
)
  Council Decision 95/410/EC of 22 June 1995 laying down the rules for the microbiological testing by sampling in the establishment of origin of poultry for slaughter intended for Finland and Sweden (
OJ L 243, 11.10.1995, p. 25
).
(
41
)
  Council Directive 2000/75/EC of 20 November 2000 laying down specific provisions for the control and eradication of bluetongue (
OJ L 327, 22.12.2000, p. 74
).
(
42
)
  Council Decision 2000/258/EC of 20 March 2000 designating a specific institute responsible for establishing the criteria necessary for standardising the serological tests to monitor the effectiveness of rabies vaccines (
OJ L 79, 30.3.2000, p. 40
).
(
43
)
  Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever (
OJ L 316, 1.12.2001, p. 5
).
(
44
)
  Council Directive 2002/60/EC of 27 June 2002 laying down specific provisions for the control of African swine fever and amending Directive 92/119/EEC as regards Teschen disease and African swine fever (
OJ L 192, 20.7.2002, p. 27
).
(
45
)
  Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (
OJ L 18, 23.1.2003, p. 11
).
(
46
)
  Council Directive 2003/85/EC of 29 of September 2003 on Community measures for the control of foot–and–mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC (
OJ L 306, 22.11.2003, p. 1
).
(
47
)
  Council Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the identification and registration of ovine and caprine animals and amending Regulation (EC) No 1782/2003 and Directives 92/102/EEC and 64/432/EEC (
OJ L 5, 9.1.2004, p. 8
).
(
48
)
  Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC (
OJ L 139, 30.4.2004, p. 321
).
(
49
)
  Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza and repealing Directive 92/40/EEC (
OJ L 10, 14.1.2006, p. 16
).
(
50
)
  Council Directive 2008/71/EC of 15 July 2008 on the identification and registration of pigs (
OJ L 213, 8.8.2008, p. 31
).
(
51
)
  Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non–commercial movement of pet animals and repealing Regulation (EC) No 998/2003 (
OJ L 178, 28.6.2013, p. 1
).
(
52
)
  Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97 (
OJ L 204, 11.8.2000, p. 1
).
(
53
)
  Council Decision 78/642/EEC of 25 July 1978 on health protection measures in respect of the Republic of Botswana (
OJ L 213, 3.8.1978, p. 15
).
(
54
)
  Council Directive 79/110/EEC of 24 January 1979 authorizing the Italian Republic to postpone the notification and implementation of its national plans for the accelerated eradication of brucellosis and tuberculosis in cattle (
OJ L 29, 3.2.1979, p. 24
).
(
55
)
  Council Directive 81/6/EEC of 1 January 1981 authorizing the Hellenic Republic to communicate and to implement its national plans for the accelerated eradication of brucellosis and tuberculosis in cattle (
OJ L 14, 16.1.1981, p. 22
).
(
56
)
  Council Decision 89/455/EEC of 24 July 1989 introducing Community measures to set up pilot projects for the control of rabies with a view to its eradication or prevention (
OJ L 223, 2.8.1989, p. 19
).
(
57
)
  Council Directive 90/423/EEC of 26 June 1990 amending Directive 85/511/EEC introducing Community measures for the control of foot–and–mouth disease, Directive 64/432/EEC on animal health problems affecting intra- Community trade in bovine animals and swine and Directive 72/462/EEC on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat or meat products from third countries (
OJ L 224, 18.8.1990, p. 13
).
(
58
)
  Council Decision 90/678/EEC of 13 December 1990 recognizing certain parts of the territory of the Community as being either officially swine fever free or swine fever free (
OJ L 373, 31.12.1990, p. 29
).
(
59
)
  Council Directive 92/36/EEC of 29 April 1992 amending, with regard to African horse sickness, Directive 90/426/EEC on animal health conditions governing the movement and import from third countries of equidae (
OJ L 157, 10.6.1992, p. 28
).
(
60
)
  Council Directive 98/99/EC of 14 December 1998 amending Directive 97/12/EC amending and updating Directive 64/432/EEC on health problems affecting intra–Community trade in bovine animals and swine (
OJ L 358, 31.12.1998, p. 107
).
(
61
)
  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (
OJ L 55, 28.2.2011, p. 13
).
(
62
)
  Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (
OJ L 139, 30.4.2004, p. 55
).
(
63
)
  Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein (
OJ L 61, 3.3.1997, p. 1
).
(
64
)
  Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (
OJ L 281, 23.11.1995, p. 31
).
(
65
)
  Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (
OJ L 8, 12.1.2001, p. 1
).
(
66
)
  Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters (
OJ L 351, 2.12.1989, p. 34
).
(
67
)
  Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products (
OJ L 13, 16.1.1997, p. 28
).
ANNEX I
SPECIES OF PET ANIMALS
PART A
Dogs (
Canis lupus familiaris
)
Cats (
Felis silvestris catus
)
Ferrets (
Mustela putorius furo
)
PART B
Invertebrates (except bees, molluscs belonging to the phylum 
Mollusca
 and crustaceans belonging to the subphylum 
Crustacea
)
Ornamental aquatic animals
Amphibians
Reptiles
Birds: specimens of avian species other than fowl, turkeys, guinea fowl, ducks, geese, quails, pigeons, pheasants, partridges and ratites (
Ratitae
).
Mammals: rodents and rabbits other than those intended for food production.
ANNEX II
LIST OF DISEASES
—
Rinderpest (cattle plague)
—
Sheep and goat plague
—
Swine vesicular disease
—
Bluetongue
—
Teschen disease
—
Sheep pox or goat pox
—
Rift Valley fever
—
Lumpy skin disease
—
Vesicular stomatitis
—
Venezuelan equine viral encephalomyelitis
—
Haemorrhagic disease of deer
—
Contagious bovine pleuropneumonia
—
Newcastle disease
—
Bovine tuberculosis
—
Bovine brucellosis (
B. abortus
)
—
Ovine and caprine brucellosis (
B. melitensis
)
—
Anthrax
—
Rabies
—
Echinococcosis
—
Transmissible spongiform encephalopathies (TSE)
—
Campylobacteriosis
—
Listeriosis
—
Salmonellosis (zoonotic salmonella)
—
Trichinellosis
—
Verotoxigenic 
E. coli
—
Viral haemorrhagic septicæmia (VHS)
—
Infectious haematopoietic necrosis (IHN)
—
Epizootic haematopoietic necrosis in fish (EHN)
—
Epizootic ulcerative syndrome in fish (EUS)
—
Infection with 
Bonamia exitiosa
—
Infection with 
Perkinsus marinus
—
Infection with 
Microcytos mackini
—
Taura syndrome in crustaceans
—
Yellowhead disease in crustaceans
—
Koi herpes virus disease (KHV)
—
Infectious salmon anaemia (ISA)
—
Infection with 
Marteilia refringens
—
Infection with 
Bonamia ostreae
—
White spot disease in crustaceans
ANNEX III
SPECIES OF UNGULATES
Taxon
Order
Family
Genera/Species
Perissodactyla
Equidae
Equus
 spp.
Tapiridae
Tapirus
 spp.
Rhinoceritidae
Ceratotherium
 spp., 
Dicerorhinus
 spp., 
Diceros
 spp., 
Rhinoceros
 spp.
Artiodactyla
Antilocapridae
Antilocapra
 ssp.
Bovidae
Addax
 ssp., 
Aepyceros
 ssp., 
Alcelaphus
 ssp., 
Ammelaphus
 ssp., 
Ammodorcas
 ssp., 
Ammotragus
 ssp., 
Antidorcas
 ssp., 
Antilope
 ssp., 
Arbitragus
 ssp., 
Beatragus
 ssp., 
Bison
 ssp., 
Bos
 ssp.(including 
Bibos, Novibos, Poephagus
), 
Boselaphus
 ssp., 
Bubalus
 ssp. (including 
Anoa
), 
Budorcas
 ssp., 
Capra
 ssp., 
Cephalophus
 ssp., 
Connochaetes
 ssp., 
Damaliscus
 ssp.(including 
Beatragus
), 
Dorcatragus
 ssp., 
Eudorcas
 ssp., 
Gazella
 ssp., 
Hemitragus
 ssp., 
Hippotragus
 ssp., 
Kobus
 ssp., 
Litocranius
 ssp., 
Madoqua
 ssp., 
Naemorhedus
 ssp. (including 
Nemorhaedus
 and 
Capricornis
), 
Nanger
 ssp., 
Neotragus
 ssp., 
Nilgiritragus
 ssp., 
Oreamnos
 ssp., 
Oreotragus
 ssp., 
Oryx
 ssp., 
Ourebia
 ssp., 
Ovibos
 ssp., 
Ovis
 ssp., 
Pantholops
 ssp., 
Philantomba
 ssp., 
Pelea
 ssp., 
Procapra
 ssp., 
Pseudois
 ssp., 
Pseudoryx
 ssp., 
Raphicerus
 ssp., 
Redunca
 ssp., 
Rupicapra
 ssp., 
Saiga
 ssp., 
Sigmoceros–Alecelaphus
 ssp., 
Strepticeros
 ssp., 
Sylvicapra
 ssp., 
Syncerus
 ssp., 
Taurotragus
 ssp., 
Tetracerus
 ssp., 
Tragelaphus
 ssp. (including 
Boocerus
).
Camelidae
Camelus
 ssp., 
Lama
 ssp., 
Vicugna
 ssp.
Cervidae
Alces
 ssp., 
Axis–Hyelaphus
 ssp., 
Blastocerus
 ssp., 
Capreolus
 ssp., 
Cervus
 ssp., 
Dama
 ssp., 
Elaphodus
 ssp., 
Elaphurus
 ssp., 
Hippocamelus
 ssp., 
Hydropotes
 ssp., 
Mazama
 ssp., 
Megamuntiacus
 ssp., 
Muntiacus
 ssp., 
Odocoileus
 ssp., 
Ozotoceros
 ssp., 
Przewalskium
 ssp., 
Pudu
 ssp., 
Rangifer
 ssp., 
Rucervus
 ssp., 
Rusa
 ssp.
Giraffidae
Giraffa
 ssp., 
Okapia
 ssp.
Hippopotamidae
Hexaprotodon–Choeropsis
 ssp., 
Hippopotamus
 ssp.
Moschidae
Moschus
 ssp.
Suidae
Babyrousa
 ssp., 
Hylochoerus
 ssp., 
Phacochoerus
 ssp., 
Porcula
 ssp., 
Potamochoerus
 ssp., 
Sus
 ssp.
Tayassuidae
Catagonus
 ssp., 
Pecari–Tayassu
 ssp.
Tragulidae
Hyemoschus
 ssp., 
Tragulus–Moschiola
 ssp.
Proboscidea
Elephantidae
Elephas
 ssp., 
Loxodonta
 ssp.
ANNEX IV
CRITERIA FOR THE APPLICATION OF THE DISEASE PREVENTION AND CONTROL RULES REFERRED TO IN ARTICLE 9(1) TO DISEASES LISTED IN ACCORDANCE WITH ARTICLE 5
The scope of this Annex is to detail the criteria to be considered by the Commission when determining the disease prevention and control rules to be applied to the different categories of diseases listed in accordance with Article 5.
The process of categorisation shall take into account the profile of the disease in question, the level of the impact of that disease on animal and public health, animal welfare and the economy, and the availability, feasibility and effectiveness of the diagnostic tools and different sets of disease prevention and control measures provided for in this Regulation with respect to the disease.
Section 1
Criteria for the application of the disease prevention and control rules referred to in point (a) of Article 9(1)
The diseases for which the disease prevention and control rules referred to in point (a) of Article 9(1) apply shall be considered to have the most severe animal health, public health, economic, social or environmental impacts on the Union. Those diseases need to fulfil the following criteria:
(a)
the disease in question is:
(i)
not present in the territory of the Union;
(ii)
present only in exceptional cases (irregular introductions); or
(iii)
present in only in a very limited part of the territory of the Union;
and
(b)
the disease in question is highly transmissible; in addition to direct and indirect transmission, there may also be possibilities of airborne, waterborne or vector–borne spread. The disease may affect multiple species of kept and wild animals, or a single species of kept animals of economic importance, and may result in high morbidity and significant mortality rates.
In addition to the criteria set out in points (a) and (b), those diseases need to fulfil one or more of the following criteria:
(c)
the disease in question has a zoonotic potential with significant consequences for public health, including epidemic or pandemic potential or possible significant threats to food safety;
(d)
the disease in question has a significant impact on the economy of the Union, causing substantial costs, mainly related to its direct impact on the health and productivity of animals;
(e)
the disease in question has a significant impact on one or more of the following:
(i)
society, with in particular an impact on labour markets;
(ii)
animal welfare, by causing suffering to large numbers of animals;
(iii)
the environment, due to the direct impact of the disease or due to the measures taken to control it;
(iv)
in the long term, biodiversity or the protection of endangered species or breeds, including the possible disappearance of, or long-term damage to, those species or breeds.
Section 2
Criteria for the application of the disease prevention and control rules referred to in point (b) of Article 9(1)
The diseases for which the disease prevention and control rules referred to in point (b) of Article 9(1) apply shall be controlled in all Member States with the goal of eradicating them throughout the Union.
Those diseases need to fulfil the following criteria:
(a)
the disease in question is endemic in nature and is present in the whole or part of the Union territory. However, several Member States or zones of the Union are free of the disease; and
(b)
the disease is moderately to highly transmissible; in addition to direct and indirect transmission, there may also be possibilities of airborne, waterborne or vector–borne spread. It may affect single or multiple animal species and may result in high morbidity, with in general low mortality.
In addition to the criteria set out in points (a) and (b), those diseases need to fulfil one or more of the following criteria:
(c)
the disease in question has a zoonotic potential with significant consequences for public health, including epidemic potential or possible significant threats to food safety;
(d)
the disease in question has a significant impact on the economy of the Union causing substantial costs, mainly related to its direct impact on the health and productivity of animals;
(e)
the disease has a significant impact on one or more of the following:
(i)
society, with in particular an impact on labour markets;
(ii)
animal welfare, by causing suffering to large numbers of animals;
(iii)
the environment, due to the direct impact of the disease or due to the measures taken to control it;
(iv)
in the long term, biodiversity or the protection of endangered species or breeds, including the possible disappearance of, or long-term damage to, those species or breeds.
A disease to which the measures referred to in point (a) of Article 9(1) apply, which has not been successfully and promptly eradicated in a part of the Union, and has, in that part of the Union, obtained an endemic character, may be subject to disease prevention and control measures under point (b) of Article 9(1), in that part of the Union.
Section 3
Criteria for the application of the disease prevention and control rules referred to in point (c) of Article 9(1)
The diseases for which the disease prevention and control rules referred to in point (c) of Article 9(1) apply are of relevance to some Member States and 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 in question.
Those diseases need to fulfil the following criteria:
(a)
in terrestrial animals, the disease in question is endemic in nature and is present in the whole or part of the Union territory; or in aquatic animals, several Member States or zones of the Union are free of the disease; and
(b)
(i)
in terrestrial animals, the disease in question is moderately to highly transmissible, mainly through direct and indirect transmission. The disease mainly affects multiple or single animal species, usually does not result in high morbidity, and has a negligible or no mortality rate. Often the most observed effect is production loss;
(ii)
in aquatic animals, the disease is moderately to highly transmissible, mainly through direct and indirect transmission. The disease affects multiple or single animal species and may result in high morbidity and usually low mortality. Often the most observed effect is production loss.
In addition to the criteria set out in points (a) and (b), those diseases need to fulfil one or more of the following criteria:
(c)
the disease in question has a zoonotic potential with significant consequences for public health, or possible threats to food safety;
(d)
the disease in question has a significant impact on the economy of parts of the Union, mainly related to its direct impact on certain types of animal production systems.
(e)
the disease in question has a significant impact on one or more of the following:
(i)
society, with, in particular, an impact on labour markets;
(ii)
animal welfare, by causing suffering to large numbers of animals;
(iii)
the environment, due to the direct impact of the disease or of the measures taken to control it;
(iv)
in the long term, biodiversity or the protection of endangered species or breeds, including the possible disappearance of, or long-term damage to, those species or breeds.
Section 4
Criteria for the application of the disease prevention and control rules referred to in point (d) of Article 9(1)
The disease prevention and control rules referred to in point (d) of Article 9(1) shall apply to diseases that fulfil the criteria set out in Section 1, 2 or 3 and to other diseases fulfilling the criteria set out in Section 5 where the risk posed by the disease in question can be effectively and proportionately mitigated by measures concerning movements of animals and products in order to prevent or limit its occurrence and spread.
Section 5
Criteria for the application of the disease prevention and control rules referred to in point (e) of Article 9(1)
The disease prevention and control rules referred to in point (e) of Article 9(1) shall apply to diseases that fulfil the criteria set out in Sections 1, 2 or 3 and to other diseases where surveillance of the disease is necessary for reasons relating to animal health, animal welfare, human health, the economy, society or the environment.
ANNEX V
CORRELATION TABLE REFERRED TO IN ARTICLE 270 (2)
1.   Directive 64/432/EEC
Directive 64/432/EEC
This Regulation
Article 1
—
Article 2
Articles 4 (partially), 21, 153(3) and 220(3)
Article 3(1)
Articles 124 and 126
Article 3(2)
Articles 124 (2), 126(1) and 149(3) and (4)
Article 4(1)
Article 126(1)(c)
Article 4(2) and (3)
Article 125(1) and (2)
Article 5(1)
Articles 143(1), 145 and 146
Article 5(2)
Article 149(3) and (4)
Article 5(2)(a)
Article 147(a)
Article 5(2)(b)
Article 144(1)(b)
Article 5(3)
—
Article 5(4)
Article 153(1) and (2)
Article 5(5)
Article 147(a)
Article 6
Articles 130, 131 and 132
Article 6a
—
Article 7
Articles 126(1)(c),132, 134(a) and 135
Article 8
Articles 18, 19, 20 and 23(a)
Article 9
Articles 31(1), (3)(a) and (5), 32, 33 and 36
Article 10
Articles 31(2) and (3)(b), 32, 33 and 36
Article 11(1)
Articles 94(1)(a), 97 and 98
Article 11(2)
Articles 102, 106 and 107
Article 11(3)
Articles 98 and 99
Article 11(4)
Article 100
Article 11(5) and (6)
Article 97(1)(d) and (2)(d)
Article 12(1)
Article 125
Article 12(2)
Articles 104 and 106
Article 12(3)
Article 125(1)(a) and (b)
Article 12(4)
Article 143
Article 12(5) and (6)
—
Article 13(1) and (2)
Articles 90, 92, 93(c), 94, 97, 98, 99, 102, 106 and 107
Article 13(3)
Article 100
Article 13(4)
—
Article 13(5) and (6)
Article 101
Article 14(1) and (2)
—
Article 14(3)A and B
—
Article 14(3)C
Article 109(1)(a) and (c)
Article 14(4) to (6)
—
Article 15(1)
Article 268
Article 15(2) to (4)
—
Article 16
—
Article 17
—
Article 17a
—
Article 18
Article 109(1)(a) and (c)
Article 19
—
Article 20
—
2.   Directive 77/391/EEC
Directive 77/391/EEC
This Regulation
Article 1
—
Article 2(1)
Article 31(1)
Article 2(2)
Articles 32, 33 and 36(1)
Article 2(3)
Article 34
Article 2(4)
Articles 36 and 41
Article 3(1)
Article 31(1)
Article 3(2)
Articles 32, 33 and 36(1)
Article 3(3)
Article 34
Article 3(4)
Articles 36 and 41
Article 4
Articles 31(1), 32, 33, 34, 36 and 41
Article 5
—
Article 6
—
Article 7
—
Article 8
—
Article 9
—
Article 10
—
Article 11
—
Article 12
—
Article 13
—
Article 14
—
Article 15
—
3.   Directive 78/52/EEC
Directive 78/52/EEC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3(1)
Articles 31(1) and 32
Article 3(2)
—
Article 3(3)
—
Article 3(4)
Articles 31(1) and 32
Article 4
Articles 32, 35, 102(2) and (4) and 112
Article 5
Articles 18, 46 and 47
Article 6(1)
Articles 72 to 76
Article 6(2)
Articles 77 and 78
Article 6(3)
Articles 79 and 80
Article 7
Articles 79 and 80
Article 8
Articles 79 and 80
Article 9
Articles 79 and 80
Article 10
Articles 79 and 80
Article 11
Articles 79 and 80
Article 12
Articles 79 and 80
Article 13
Articles 18, 46 and 47
Article 14(1)
Articles 72 to 76
Article 14(2)
Articles 77 and 78
Article 14(3)
Articles 79 and 80
Article 15
Articles 79 and 80
Article 16
Articles 79 and 80
Article 17
Articles 79 and 80
Article 18
Articles 79 and 80
Article 19
Articles 79 and 80
Article 20
Articles 79 and 80
Article 21
—
Article 22
Articles 18, 19, 20, 46 and 47
Article 23
Articles 79 and 80
Article 24
Articles 79 and 80
Article 25
Articles 79 and 80
Article 26
Articles 79 and 80
Article 27
Articles 124(1) and 126(1)(c)
Article 28
—
Article 29
—
Article 30
—
4.   Directive 80/1095/EEC
Directive 80/1095/EEC
This Regulation
Article 1
Articles 31(1) and 36
Article 2
Article 4 (partially)
Article 3
Articles 31(1) and 35
Article 3a
Articles 31(1) and 35
Article 4
Articles 32, 33 and 35
Article 4a
Articles 32, 33 and 35
Article 5
—
Article 6
Articles 31(1)(b), 31(3) and 32
Article 7
Articles 36, 39 and 40
Article 8
Articles 41 and 42
Article 9
—
Article 11
—
Article 12
—
Article 12a
—
Article 13
—
5.   Directive 82/894/EEC
Directive 82/894/EEC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3
Articles 19, 21, 22 and 23
Article 4
Articles 19, 20, 21, 22 and 23
Article 5
Article 23
Article 6
—
Article 7
—
Article 8
—
6.   Directive 88/407/EEC
Directive 88/407/EEC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3
Articles 159 and 160
Article 4
Article 160
Article 5
Articles 94, 97, 100 and 101
Article 6(1)
Articles 161 and 162
Article 6(2), (3) and (4)
Article 258
Article 8
Articles 229(1)(a) and 230
Article 9
Articles 229(1)(b) and 233
Article 10
Articles 229(1)(c), 234 and 236
Article 11
Articles 229(1)(d), 237 and 238
Article 12
Articles 260 to 262
Article 15
Articles 257 to 259
Article 16
—
Article 17
—
Article 18
—
Article 20
—
Article 21
—
Article 22
—
7.   Directive 89/556/EEC
Directive 89/556/EEC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3
Article 159, 160, 161
Article 5(1)
Articles 94 and 97
Article 5(2)
Article 101
Article 5(2a) and (3)
Articles 97, 98 and 100
Article 6
Articles 161 and 162
Article 7
Articles 229(1)(a) and 230
Article 8
Articles 229(1)(b) and 233
Article 9
Articles 229(1)(c), 234 and 236
Article 10
Articles 229(1)(d), 237 and 238
Article 11
Articles 260 to 262
Article 14
Articles 257 to 259
Article 15
—
Article 16
—
Article 17
—
Article 18
—
Article 19
—
Article 20
—
Article 21
—
8.   Directive 90/429/EEC
Directive 90/429/EEC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3
Articles 159 and 160
Article 4
—
Article 5(1)
Articles 94, 97, 98 and 100
Article 5(2)
Article 101
Article 6(1)
Articles 161 and 162
Article 6(2)
Article 258
Article 7
Articles 229(1)(a) and 230
Article 8
Articles 229(1)(b) and 233
Article 9
Articles 229(1)(c), 234 and 236
Article 10
Article 229(1)(d), 237 and 238
Article 11(1)
Article 229
Article 11(2) and (3)
Article 260
Article 12
Article 237
Article 13
—
Article 14
—
Article 15
Articles 257 to 262
Article 16
—
Article 17
—
Article 18
—
Article 19
—
Article 20
—
Article 21
—
Article 22
—
9.   Directive 91/68/EEC
Directive 91/68/EEC
This Regulation
Article 1
—
Article 2
Articles 4 (partially), 21, 153(3) and 220(3)
Article 3(1), (2), (3) and (5)
Articles 126(1)(b), 130 and 131
Article 3(4)
Article 139
Article 4(1)
Articles 124(2)(b), 126(1), 130, 131 and 149(3) and (4)(a) and (b)
Article 4(2)
Article 128
Article 4(3)
Article 131
Article 4a
Articles 130 and 131
Article 4b(1) and (2)
Articles 130 and 131
Article 4b(3)
Article 126(2)
Article 4b(4)
Article 133
Article 4b(5)
Article 132
Article 4b(6)
Articles 124(1), 125 and 126(1)(b)
Article 4c(1) and (2)
Articles 130 and 131
Article 4c(3)
Articles 133 and 135
Article 5
Article 131
Article 6
Articles 131 and 145(1)(e)
Article 7(1) to (3)
Articles 31, 32, 33 and 35
Article 7(4)
—
Article 8(1) to (3)
Articles 36, 39 and 40
Article 8(4)
—
Article 8a(1)
Articles 94(1)(a), 97, 98 and 134
Article 8a(2)
Article 102 and 106
Article 8a(3)
Articles 98, 99 and 101
Article 8a(4)
Article 100
Article 8a(5)
Article 97(1)(d) and (2)(d)
Article 8b(1)
Articles 84, 90, 92, 93(c), 94(1)(a), 97, 98, 102, 105 and 134
Article 8b(2)
Articles 94(1)(a), 97 and 98
Article 8b(3)
Article 100
Article 8b(4)
—
Article 8c(1)
Articles 87 and 125
Article 8c(2)
Article 104
Article 8c(3)
Articles 125(1)(a) and 126(1)(b)
Article 8c(4) and (5)
—
Article 9(1) to (4)
Articles 143, 145, 146, 147, 148, 149 and 153
Article 9(7)
Article 153
Article 10
—
Article 11
—
Article 12
Article 144(b)
Article 14
—
Article 15
—
Article 17
—
Article 18
—
10.   Decision 91/666/EEC
Decision 91/666/EEC
This Regulation
Article 1
Article 48(1) and (3)
Article 2
—
Article 3
Article 48
Article 4
Articles 48, 49 and 50
Article 5
Articles 48(3) and 50
Article 6
Articles 16 and 48(2)(c) and (3)(b)
Article 7
Articles 48(3) and 50
Article 8
—
Article 9
—
Article 10
—
Article 11
—
Article 12
—
11.   Directive 92/35/EEC
Directive 92/35/EEC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3
Article 18
Article 4
Articles 53 to 57 and 59
Article 5
Articles 46 and 47
Article 6
Articles 60 to 68
Article 7(1)
Article 57
Article 7(2)
Article 43(2)(d)
Article 8
Article 64
Article 9
Articles 65, 66 and 67
Article 10
Articles 65, 66 and 67
Article 11
Articles 67 and 68
Article 12
Article 71(1)
Article 13
Article 65(2)
Article 14
—
Article 15
—
Article 16
—
Article 17
Articles 43 and 44
Article 18
—
Article 19
—
Article 20
—
Article 21
—
Article 22
—
12.   Directive 92/65/EEC
Directive 92/65/EEC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3
Articles 170, 171 and 269
Article 4
Articles 124, 126, 18, 31, 84, 93(a) and 151
Article 5
Articles 95, 97,136, 137, 143, 144 and 149
Article 6(A)
Articles 124, 126, 130, 131, 137, 140 and 143 to 146
Article 6(B)
—
Article 7(A)
Articles 124, 126, 130, 131, 137, 140 and 143 to 146
Article 7(B)
—
Article 8
Articles 124, 126, 136 and 143 to 146
Article 9
Articles 124, 126, 136 and 143 to 146
Article 10(1) to (4)
Articles 124, 126, 136 and 143 to 146
Article 10(5) to (7)
—
Article 10a
—
Article 11(1)
Article 157
Article 11(2) and (3)
Articles 157, 159, 160 and 143 to 146
Article 11(4)
Articles 97 and 101
Article 11(5)
Article 164
Article 12(1)
—
Article 12(2)
Articles 257 to 259
Article 12(3)
Articles 84, 90, 92, 93(c), 102 and 106
Article 12(4)
Articles 143 to 149 and 152 to 154
Article 12(5)
—
Article 12(6)
Article 268
Article 13(1)
Articles 136, 143 to 149 and 151
Article 13(2)
Articles 95, 97 and 98 to 101
Article 14
Articles 31, 32 and 33
Article 15
Articles 36, 39, 40 and 41
Article 16
Articles 229(1) and 234(1)
Article 17(1)
Article 229(1)
Article 17(2)
Articles 229(1)(a), 230 and 233
Article 17(3)
Articles 230, 233 and 234
Article 17(4)
Article 230
Article 17(5) and (6)
—
Article 18(1), first line
Article 237
Article 18(1), 2nd to 4th line
—
Article 18(2)
Article 234(3)
Article 19
Articles 234 and 239
Article 20
Articles 229(2) and 260 to 262
Article 21
Articles 144, 146, 162(4) and (5), 209, 211 and 213
Article 22
—
Article 23
Articles 140 and 205
Article 24
Articles 229(1)(d), 237 and 239(2)
Article 25
—
Article 26
—
Article 27
—
Article 28
—
Article 29
—
Article 30
—
13.   Directive 92/66/EEC
Directive 92/66/EEC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3
Article 18
Article 4
Articles 53 to 56 and 59
Article 5
Articles 60 to 63
Article 6
Article 63
Article 7
Articles 57 and 43(2)(d)
Article 8
Articles 55 and 56
Article 9(1)
Article 64
Article 9(2) to (7)
Articles 65 to 68
Article 10
Articles 65, 66 and 67
Article 11
Articles 67(b) and 68(1)(b) and (2)(a)
Article 12
Articles 54, 61(1)(h) and 63(c)
Article 13
Article 65(2)
Article 14
—
Article 15
—
Article 16
Articles 46, 47 and 69
Article 17
Article 47
Article 18
Articles 65(1)(e), 67(a) and 69
Article 19(1) to (3)
Articles 53 to 56 and 59
Article 19(4)
Articles 57 and 60 to 63
Article 19(5)
Article 71(2)
Article 20
—
Article 21
Articles 43 and 44
Article 22
—
Article 23
—
Article 24
—
Article 25
—
Article 26
—
Article 27
—
14.   Directive 92/118/EEC
Directive 92/118/EEC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3
Articles 166, 222, 227(c)(iv) and 228
Article 4(1)
Articles 166, 222, 227(c)(iv) and 228
Article 4(2)
—
Article 5
Articles 166 and 222
Article 6
Article 16(1)(b) and (2)(b)
Article 7(1)
—
Article 7(2)
Articles 257 to 259
Article 7(3) and (4)
—
Article 7(5)
Article 268
Article 8
—
Article 9
Articles 229 and 234
Article 10(1) to (4) and (6)
Articles 229, 234, 237 and 239
Article 10(5)
—
Article 11
Article 239(2)(c)(ii)
Article 12
—
Article 13
Article 239(2)(c)(i)
Article 14
—
Article 15
—
Article 16
Article 239(2)(c)(v)
Article 17
—
Article 18
—
Article 19
—
Article 20
—
15.   Directive 92/119/EC
Directive 92/119/EC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3
Article 18
Article 4
Articles 53 to 57 and 59
Article 5
Articles 60 to 63
Article 6
Articles 70 and 71(2)
Article 7
Article 63
Article 8
Articles 57 and 43(2)(d)
Article 9
Articles 55 and 57
Article 10
Articles 64 and 71(3)
Article 11
Articles 65 to 68 and 71(2)
Article 12
Articles 65 to 68 and 71(2)
Article 13
Article 67(a)
Article 14
Articles 65(2) and 71(1) and (3)
Article 15
—
Article 16
Articles 63(b), 67(b) and 68(1)(b) and (2)(a)
Article 17
—
Article 18
—
Article 19
Articles 46, 47 and 69
Article 20
Articles 43 and 44
Article 21
—
Article 22
—
Article 23
—
Article 24
—
Article 25
—
Article 26
—
Article 27
—
Article 28
—
16.   Decision 95/410/EC
Decision 95/410/EC
This Regulation
Article 1
Articles 130 to 132 and 273
Article 2
Article 131(1)(c)
Article 3
Articles 143, 145 and 146
Article 4
—
Article 5
—
Article 6
—
17.   Directive 2000/75/EC
Directive 2000/75/EC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3
Article 18
Article 4(1) and (2)
Articles 54 and 55
Article 4(3)
Article 53
Article 4(4)
Article 56
Article 4(5)
Article 70
Article 4(6)
Article 59
Article 5
Articles 46 and 47
Article 6
Articles 60 to 64, 71(2) and 69
Article 7
Article 57
Article 8
Articles 64, 68 and 71(3)
Article 9
Articles 65, 67, 69 and 71(3)
Article 10(1)
Articles 65 and 67
Article 10(2)
Articles 46 and 47
Article 11
—
Article 12
Article 71(3)
Article 13
Article 71(1)
Article 14
Article 65(2)
Article 15
—
Article 16
—
Article 17
—
Article 18
Articles 43 and 44
Article 19
—
Article 20
—
Article 21
—
Article 22
—
Article 23
—
18.   Regulation (EC) No 1760/2000
Regulation (EC) No 1760/2000
This Regulation
Article 1
Article 108
Article 2
Article 4 (partially)
Article 3
Articles 108(3) and 111
Article 4
Articles 112(a), 118, 119 and 120
Article 4a
Article 118(1)(a) and (2)(a)
Article 4b
Article 118(2)(e)
Article 4c
Article 118(1)(a) and (2)(a)
Article 4d
Article 118(1)(a)
Article 5
Articles 109(1)(a) and 118(1)(b)
Article 6
Articles 110(1)(b), 112(b) and 118(1)(c)
Article 6a
Article 110(2)
Article 7(1)
Articles 102, 106, 107 and 112(d)
Article 7(2)
Article 118(2)(a)
Article 7(3) and (4)
Article 102(3)
Article 7(5)
Article 102(4)
Article 7(6)
Article 106
Article 9a
Articles 11 and 13(2)
Article 10(a) to (c)
Articles 118, 119 and 120
Article 10(d) and (e)
—
Article 10(f)
Article 270
Article 11
—
Article 12
—
Article 13
—
Article 14
—
Article 15
—
Article 15a
—
Article 22
—
Article 22a
—
Article 22b
—
Article 23
—
Article 23a
—
Article 23b
—
Article 24
—
Article 25
—
19.   Directive 2001/89/EC
Directive 2001/89/EC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3
Articles 18, 19, 20 and 23
Article 4
Articles 54 to 56 and 59
Article 5
Articles 60 to 63 and 71(2) and (3)
Article 6
Articles 63 and 71
Article 7
Articles 62, 63, 65(1)(b) and 67
Article 8
Article 57
Article 9
Article 64
Article 10
Articles 65 to 68
Article 11
Articles 65 to 68
Article 12
Articles 61(1)(f), 63(b), 65(1)(f), 67(b) and 68(1)(b) and (2)(a)
Article 13
Articles 61(3), 63(d) and 68(2)(a) and (c)
Article 14
Articles 62 and 63
Article 15
Article 70
Article 16
Article 70 and Articles 31 to 35
Article 17
Articles 16, 17(2), 54(2) and (3), 58(2), 61(1)(g) and (h), 63(c), 65(1)(b) and 67(c)
Article 18
Articles 16, 46 47, 48 and 52
Article 19
Articles 65(1)(e), 67 and 69
Article 20
Article 70
Article 21
—
Article 22
Articles 43 and 44
Article 23
Articles 43(2)(d) and 44
Article 24
—
Article 25
—
Article 26
—
Article 27
—
Article 28
—
Article 29
—
Article 30
—
Article 31
—
Article 32
—
20.   Directive 2002/60/EC
Directive 2002/60/EC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3
Articles 18, 19, 20 and 23
Article 4
Articles 54 to 56 and 59
Article 5
Articles 60 to 63 and 71(2) and (3)
Article 6
Articles 63 and 71
Article 7
Articles 62 and 63
Article 8
Article 57
Article 9
Article 64
Article 10
Articles 65 to 68
Article 11
Articles 65 to 68
Article 12
Article 61(1)(f), 63(b), 65(1)(f), 67(b) and 68(1)(b)
Article 13
Articles 61(3), 63(d) and 68(2)(a) and (c)
Article 14
Articles 62 and 63
Article 15
Article 70
Article 16
Article 70 and Articles 31 to 35
Article 17(1)
Articles 61(1)(f), 63, 65(1)(f) and (i), and 67(a) and (d)
Article 17(2) and (3)
Article 71(2) and (3)
Article 18
Articles 16, 17(2), 54(2) and (3), 58(2), 61(1)(g) and (h), 63(c), 65(1)(b) and 67(c)
Article 19
Articles 16, 46 and 47
Article 20
—
Article 21
Articles 43 and 44
Article 22
Articles 43(2)(d) and 44
Article 23
—
Article 24
—
Article 25
—
Article 26
—
Article 27
—
Article 28
—
Article 29
—
Article 30
—
21.   Directive 2002/99/EC
Directive 2002/99/EC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3
Articles 166, 222 and 227(c)(iv)
Article 4
Articles 65(1)(c),(d), (g),(h) and (i), 67, 166, 222, 227(c)(iv) and 228(1)
Article 5
Articles 167, 168, 223, 224 and 227(d)(iii)
Article 6
—
Article 7
Article 234(1) and (2)
Article 8
Articles 230, 231 and 232
Article 9
Articles 237 and 238
Article 10
—
Article 11
—
Article 12
—
Article 13
—
Article 14
—
Article 15
—
Article 16
—
22.   Directive 2003/85/EC
Directive 2003/85/EC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3
Articles 18, 19, 20 and 23
Article 4
Articles 54 to 56
Article 5
Article 55(1)(d),(e) and (2)
Article 6
Articles 55(1)(f)(i) and (2), and 56(b)
Article 7
Article 55(1)(f)(ii)
Article 8
Article 55(1)(f) and (2)
Article 9
Article 59
Article 10
Articles 60, 61 and 63
Article 11
Articles 61(1)(f), 63(b), 65(1)(f), 67(b) and 68(1)(b)
Article 12
Article 65(1)(d), (h) and (i) and Article 67
Article 13
Article 57
Article 14
Articles 61 to 63
Article 15
Articles 61 to 63, 70 and 71(2)
Article 16
Articles 61, 62 and 63
Article 17
Article 71
Article 18
Articles 61 and 63
Article 19
Articles 62 and 63
Article 20
Article 71
Article 21
Articles 43(2)(d), 64, 65(1)(d), (h) and (i) and (2) and 67
Article 22
Articles 65 to 67
Article 23
Articles 65 to 67
Article 24
Articles 67 and 71(1)
Article 25
Articles 65(1)(c), (d)(i), (g), (h) and (i) and 67
Article 26
Articles 65(1)(c), (d)(i), (g), (h) and (i), 67 and 166
Article 27
Articles 65(1)(c), (d)(i), (g), (h) and (i), 67 and 166
Article 28
Articles 65(1)(c) and (d)(iii) and Article 67
Article 29
Articles 65(1)(c) and (d)(ii) and 67
Article 30
Articles 65(1)(c) and (d)(ii) and (iii) and 67
Article 31
Articles 65(1)(c) and (d)(ii) and 67
Article 32
Articles 65(1)(c) and (d) and 67
Article 33
Article 65(1)(c)(d)(ii) and 67
Article 34
Articles 67, 143(2), 161(2) and 167(1)(b)
Article 35
Article 71(1) and (2)
Article 36
Article 68
Article 37
Articles 65 to 67
Article 38
Articles 65 to 67
Article 39
Articles 65(1)(c), (d)(i), (g), (h) and (i), 67 and 166
Article 40
Articles 65(1)(c), (d)(i), (g), (h) and (i), 67 and 166
Article 41
Articles 65(1)(c) and (d)(ii) and 67
Article 42
Articles 65(1)(c) and (d) and 67
Article 43
Article 71(1)
Article 44
Article 68
Article 45
Articles 64, 67 and 71
Article 46
Articles 65 and 67
Article 47
Articles 65(1)(h) and 67
Article 48
Article 66
Article 49
Articles 16, 46 and 47
Article 50
Articles 46, 47 and 69
Article 51
Articles 47 and 69
Article 52
Articles 46 and 47
Article 53
Articles 46 and 47
Article 54
Articles 47, 65, 67 and 69(2) and(3)
Article 55
Articles 47, 65, 67, and 69(2) and (3)
Article 56
Articles 47, 67(c), 68(1)(c) and 69(2) and (3)
Article 57
Articles 47, 67(c), 68(1)(c) and 69(2) and (3)
Article 58
Article 68
Article 59
Articles 36, 38, 39, 40 and 68
Article 60
Articles 36, 38, 39, 40 and 68
Article 61
Articles 36, 38, 39, 40 and 68
Article 62
Article 68
Article 63
Articles 143(2), 161(2) and 167(1)(b)
Article 64
Articles 65(1)(c), 67, 69(3) and 131
Article 65
Article 16
Article 66
—
Article 67
—
Article 68
—
Article 69
—
Article 70
Article 16
Article 71
Articles 54(2) and (3), 58(2), 61(1)(g) and (h), 63(c), 65(1)(b), 67(c) and 68(1)(c) and 2(b)
Article 72
Article 43
Article 73
Article 45
Article 74
Article 43(2)(d)
Article 75
Article 44
Article 76
Articles 43(2)(d) and 44
Article 77
Article 44
Article 78
Article 43(2)(d)
Article 79
Article 52
Article 80
Articles 48 and 51
Article 81
Articles 48(3) and 50
Article 82
Articles 48(3) and 50
Article 83
Article 49
Article 84
Articles 48(3) and 50
Article 85
Articles 70 and 71
Article 86
Article 268
Article 87
—
Article 88
Article 71(3)
Article 89
—
Article 90
—
Article 91
—
Article 92
—
Article 93
—
Article 94
—
Article 95
—
23.   Regulation (EC) No 21/2004
Regulation (EC) No 21/2004
This Regulation
Article 1
Article 108
Article 2
Article 4 (partially)
Article 3(1)
Article 108(3)
Article 3(2)
Article 111
Article 4(1) and (2)
Articles 113(a), 118, 119 and 120
Article 4(3)
Article 118(2)(a)
Article 4(4)
Article 118(2)(e)
Article 4(5) to (7)
Article 118(1)(a) and 2(a)
Article 4(8)
Article 111
Article 4(9)
Article 118(1)(a) and (2)(a)
Article 5
Articles 102, 106, 107 and 111
Article 6
Articles 111(b), 113(1)(b) and (2), 118(1)(b)(ii), 119 and 120(2)(d)
Article 7
Article 101
Article 8(1)
Articles 109(1)(b) and 118(1)(b)
Article 8(2)
Article 113(1)(c)
Article 8(3) to (5)
Articles 109 and 118(1)(b)
Article 9
Article 118(1)(a) and 2(a)
Article 10(1)
—
Article 10(2)
Article 120(2)(c)
Article 11
Articles 11 and 13(2)
Article 12(1)
—
Article 12(2)
Article 268
Article 12(4) to (7)
—
Article 13
—
Article 14
—
Article 15
—
Article 16
—
Article 17
—
24.   Directive 2004/68/EC
Directive 2004/68/EC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3(1)
Articles 229(1)(a) and 231
Article 3(2)
Article 232(1)
Article 4
Article 230(1)
Article 5
Articles 230(1) and (3) and 231
Article 6
Articles 234 and 235
Article 7
Articles 229(2), 234(2)(a), 235 and 238(1)(e)
Article 8
Articles 234, 237(4)(a) and 239(2)(a)
Article 9
Articles 234(2), 235 and 237 (4)(a)
Article 10
Articles 234(2), 235 and 237(4)(a)
Article 11
Articles 229(1)(d), 237 and 238
Article 12
—
Article 13
—
Article 14
—
Article 16
—
Article 17
—
Article 18
—
Article 19
—
Article 20
—
Article 21
—
25.   Directive 2005/94/EC
Directive 2005/94/EC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3
Article 10
Article 4
Articles 26, 28 and 29
Article 5
Articles 18, 19, 20 and 23
Article 6
Article 57
Article 7
Articles 54 to 56
Article 8
Article 55(2)
Article 9
Article 59
Article 10
Articles 55(1)(e) and (f) and 56
Article 11
Articles 61 and 63
Article 12
Articles 63 and 71
Article 13
Articles 61 and 63
Article 14
Article 63(a)
Article 15
Articles 62 and 63(e)
Article 16
Article 64
Article 17
Articles 65 to 67
Article 18
Articles 65(1)(a) and (b) and 67
Article 19
Articles 65 to 67
Article 20
Articles 65(1)(d)(ii) and 67
Article 21
Articles 65(1)(c) and (i) and 67
Article 22
Articles 65(1)(c) and (i) and 67
Article 23
Articles 65(1)(c) and 67
Article 24
Articles 65(1)(c) and 67
Article 25
Articles 65(1)(c) and 67
Article 26
Articles 65(1)(c) and 67
Article 27
Articles 65(1)(d)(ii) and 67
Article 28
Articles 65(1)(f) and 67(b)
Article 29
Article 68
Article 30
Articles 65 to 67
Article 31
Article 68
Article 32
Articles 65, 67 and 71(2) and (3)
Article 33
Articles 67 and 71(3)
Article 34
Article 71
Article 35
Articles 54 and 61
Article 36
Articles 61 to 63
Article 37
Articles 61 to 63
Article 38
Articles 61, 63, 65 and 67
Article 39
Articles 61, 63 and 71(2)
Article 40
Articles 61, 63 and 71
Article 41
Articles 61, 63 and 71(2) and (3)
Article 42
Articles 62 and 63(e)
Article 43
Article 64
Article 44
Articles 65 and 67
Article 45
Article 68
Article 46
Articles 64(4), 67 and 71(2) and (3)
Article 47
Articles 54, 55, 61, 63 and 71
Article 48
Article 68(1)(b) and (2)(a)
Article 49
Articles 61(3) and 68
Article 50
Articles 16, 54(2)(b) and (c) and (3), 58(2), 61(1)(g) and (h), 63(c), 65(1)(b), 67(c), 68(1)(c) and 2(b)
Article 51
—
Article 52
Articles 46 and 47
Article 53
Article 69
Article 54
Articles 47, 65(1)(e), 67, 69 and 71(3)
Article 55
Articles 47, 65(1)(e), 67, 69 and 71(3)
Article 56
Articles 46 and 47
Article 57
Article 47
Article 58
Articles 48 to 50
Article 59
Article 52
Article 60
—
Article 61
Article 268
Article 62
Articles 43 and 44
Article 63
—
Article 64
—
Article 65
—
Article 66
—
Article 67
—
Article 68
—
Article 69
—
26.   Directive 2006/88/EC
Directive 2006/88/EC
This Regulation
Article 1
—
Article 2
Articles 2 and 3(2)
Article 3
Article 4 (partially)
Article 4(1)
Articles 172, 173, 176 and 177
Article 4(2)
Article 179
Article 4(3)
Article 185(2)
Article 4(4)
Articles 172, 173, 174 and 175
Article 4(5)
—
Article 5
Article 181
Article 6
Article 185
Article 7
—
Article 8
Articles 186, 187, 188 and 189
Article 9
Article 181(1)(a)(i), (2) and (3)
Article 10
Article 181(1)(a)(ii), (2) and (3)
Article 11
Articles 191 and 204
Article 12
Article 191
Article 13
Article 192
Article 14(1) and (2)
Articles 208 and 211
Article 14(3) and (4)
Articles 219 and 220
Article 15(1) and (2)
Articles 196 and 197
Article 15(3)
Article 193
Article 15(4)
Articles 196, 197 and 199
Article 16
Article 197
Article 17
Article 197
Article 18
Articles 201 and 202
Article 19
Articles 201 and 202
Article 20
Article 200
Article 21
Articles 200, 203, 205 and 226
Article 22
Article 229(1)(a)
Article 23
Articles 230 and 231
Article 24
Articles 229(1)(d) and 237
Article 25
Articles 234, 237 and 238
Article 26
Article 18
Article 27
Articles 19 and 20
Article 28
Articles 53 to 55 and 72 to 74
Article 29
Articles 57 and 77(1)(b)
Article 30
Articles 59 and 78
Article 31
—
Article 32
Articles 60, 61, 62 and 64
Article 33
Articles 65 to 67
Article 34
Articles 61(1)(b)and (c) and Article 63
Article 35
Articles 61(3) and 63
Article 36
—
Article 37
Article 68
Article 38
Articles 77, 79 and 80(3)
Article 39
Articles 79 and 80
Article 40
Article 81
Article 41
Article 257(1)(b) and (c)
Article 42
Article 71(3)
Article 43
Article 226
Article 44
Articles 27, 28, 31 and 32
Article 45
Article 33
Article 46
Article 31(2)
Article 47
Articles 43 and 44
Article 48
Article 46 and 47
Article 49
Article 36
Article 50
Article 36 and 37
Article 51
Article 38
Article 52
Article 41
Article 53
Article 42
Article 54
—
Article 55
—
Article 56
—
Article 57(a)
—
Article 57(b)
Articles 54(2)(c) and (3), 58, 61(1)(g) and (h), 63(c), 65(1)(b) and 67(c)
Article 57(c)
—
Article 58
—
Article 59
Articles 38 and 185 (partially)
Article 60
Article 268
Article 61
—
Article 62
—
Article 63
—
Article 64
—
Article 65
—
Article 66
—
Article 67
—
27.   Directive 2008/71/EC
Directive 2008/71/EC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3(1)
Articles 101 and 111
Article 3(2)
Articles 118(2) and 119
Article 4(1)
Articles 102, 107 and 119
Article 4(2)
Article 102(3)
Article 5(1)
Articles 115(a), 118(1)(a) and (2)(a) and 120
Article 5(2)
Article 118(1)(a) and (2)(a)
Article 6(1)
Articles 115(a), 118(1)(a) and (2)(a) and 120
Article 6(2)
—
Article 7
Article 109(1)(c) and (2)
Article 8
Article 118(2)(e)
Article 9
Article 268
Article 10
—
Article 11
—
Article 12
—
Article 13
—
28.   Directive 2009/156/EC
Directive 2009/156/EC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3
Articles 126 and 139
Article 4(1)
Articles 130 and 149(3)
Article 4(2)
Articles 130 and 131
Article 4(3)
Article 128
Article 4(4)
Articles 114, 118 and 120
Article 4(5)
Articles 126(1)(b), 130 and 131
Article 4(6)
Articles 31 to 35
Article 5
Articles 130 and 131
Article 6
Articles 130, 131 and 144(1)(b)
Article 7(1)
Articles 126(2) and 133
Article 7(2)
Articles 131 and 132
Article 7(3)
Article 130, 131 and 132
Article 8
Articles 114(1)(c), 118, 120 and 143 to 146
Article 9
Articles 257 to 259 (partially)
Article 10
—
Article 11
—
Article 12(1),(2) and (3)
Articles 229(1)(a), 230 and 231
Article 12(4)
Article 234
Article 12(5)
—
Article 13
Articles 234 and 235
Article 14
Article 234
Article 15
Article 234
Article 16
Articles 234, 235 and 237
Article 17
Article 234
Article 18
—
Article 19(a) to (c)
Articles 234 and 239
Article 19(d)
—
Article 20
—
Article 21
—
Article 22
—
Article 23
—
Article 24
—
29.   Directive 2009/158/EC
Directive 2009/158/EC
This Regulation
Article 1
—
Article 2
Article 4 (partially)
Article 3
—
Article 4
—
Article 5
Articles 126, 130, 131, 159 and 160
Article 6
Articles 124, 126 and 159
Article 7
Article 101
Article 8
Articles 159 and 160
Article 9
Articles 130 and 131
Article 10
Articles 130, 131 and 149(3) and (4)
Article 11
Articles 130, 131 and 149(3) and (4)
Article 12
Articles 130 and 131
Article 13
Articles 131 and 273
Article 14
Article 131
Article 15(1)(a)
Articles 159 and 160
Article 15(1)(b) to (d)
Articles 130 and 131
Article 15(2)
Articles 31 to 35 and 36(3)
Article 15(3)
Article 42
Article 16
Articles 31 to 35
Article 17
Articles 36, 39 and 40
Article 18
Articles 117, 118(2)(e), 122(2), 124, 125, 126(1)(a) and (2), 132 and 157(3)
Article 19
Articles 130 and 131
Article 20
Articles 143(1)(a), 144, 145, 149, 161 and 162
Article 21
Articles 139 and 144(1)(a) and (b)
Article 22
—
Article 23
Articles 229(1)(a), 230 and 231
Article 24
Article 234
Article 25
Article 234
Article 26
Article 237
Article 27
—
Article 28
Articles 234, 235 and 236
Article 29
Articles 234, 235 and 239
Article 30
Article 234
Article 31
Articles 257 to 259
Article 32
—
Article 33
—
Article 34
—
Article 35
—
Article 36
—
Article 37
—
Article 38
—
30.   Regulation (EU) No 576/2013
Regulation (EU) No 576/2013
This Regulation
Article 1
—
Article 2
Articles 3(5) and (6) and 244
Article 3
Article 4 (partially)
Article 4
Article 245(1)
Article 5(1) and (2)
Article 246(1) and (2)
Article 5(3)
—
Article 5(4)
Articles 3(4) to (6)
Article 5(5)
Article 246(3)
Article 5(6)
—
Article 6
Articles 247 and 252(1)(a) and (b)
Article 7
Article 252(1)(b) and (4)(d)
Article 8(1) and (3)
Article 252(1)(b) and (d)
Article 8(2)
Article 253(1)(b)
Article 9
Articles 248 and 252(1)(a) and (b)
Article 10
Articles 249 and 252(1)(a) and (b)
Article 11
Article 252(1)(b) and (4)(d)
Article 12
Article 252(1)(b) and (4)(d)
Article 13
Articles 252(4)(d) and 253(1)(d)
Article 14
Article 250 and 252(1)(a) and (b)
Article 15
Articles 252(4) and 253(1)(d)
Article 16
Article 251
Article 17
Articles 247(a) and 252(1)(a)
Article 18
Articles 252(1)(a)(ii) and 14(1)(c)(iv) and (2)
Article 19
Article 252(1)(a), (2), (3) and(4)(a),(b) and(c)
Article 20
Article 253(1)(c)
Article 21
Articles 254(a) and 255(1) and (2)(b)
Article 22
Article 254(d)
Article 23
Article 254(b)
Article 24
Article 254(c)
Article 25
Articles 254(a) and 255(1)
Article 26
Article 254(d)
Article 27
Article 254(c)
Article 28
Articles 254(a) and 255(2)(a)
Article 29
Article 254(d)
Article 30
Articles 254(a) and 255(2)(a)
Article 31
Article 254(d)
Article 32
Article 252(4)(e)
Article 33
—
Article 34
—
Article 35
—
Article 36
Articles 257 to 262
Article 37
Article 256
Article 38
—
Article 39
—
Article 40
—
Article 41
—
Article 42
Article 268
Article 43
—
Article 44
—
Article 45
—

Summary:
The EU animal health law
SUMMARY OF:
Regulation (EU) 2016/429 on transmissible animal diseases
WHAT IS THE AIM OF THE REGULATION?
It aims to prevent and control animal diseases that can be transmitted to other animals or humans.
The animal health law is part of a 
package of measures
 proposed by the 
European Commission
 in May 2013 to strengthen the enforcement of health and safety standards for the entire agri-food chain.
KEY POINTS
This comprehensive regulation supports the 
European Union
 (EU) livestock and food production sectors and the related EU market in terms of sustainability, competitiveness, growth and jobs. It replaces and extends existing EU rules on animal health, bringing most of them together into one simpler law with a better focus on the key priorities in tackling disease. These priorities include:
clearer responsibilities
 for farmers (livestock, fish and shellfish farms) and other people involved (e.g. vets) regarding early detection in order to prevent major disease outbreaks or prevent diseases from spreading to limit their damage;
simplified administration
 for international trade in certain live animals and animal products (such as semen, ova and embryos);
a 
clearer legal basis
 and 
better tools
 for veterinary authorities to fight potentially devastating transmissible diseases, particularly for surveillance, diagnosis and notification;
more flexibility
 to adjust rules to local circumstances and emerging issues such as climate and social change;
reducing adverse effects
 on animal and human health and the environment.
It sets out requirements for:
disease prevention
 and 
preparation for possible outbreaks
 (e.g. 
biosecurity
1
 measures) such as the use of diagnostic tools, vaccination and medical treatments;
the 
identification and registration
 of animals and certain animal products (e.g. semen, ova, embryos) and the certification and tracing of their consignments;
the 
entry
 of animals and animal products into the EU and their movement within the EU;
disease control and eradication
, including emergency measures such as restrictions on the movement of animals, culling and vaccination.
The rules cover animal diseases in all kept animals (including pets in some cases), wild animals and animal products, both terrestrial and aquatic. They do not directly cover 
animal welfare
, although the link between the health of the animals and their welfare is recognised and taken into account when considering the impact of disease.
The EU animal health law is supplemented by the following:
traceability and animal health requirements for movements within the EU of 
germinal products
 (semen, ova and embryos) of certain kept terrestrial animals, and the approval of 
germinal product establishments
 (establishments which produce or process germinal products);
prevention and control of certain diseases;
animal health requirements for movements within the EU of terrestrial animals and hatching eggs;
surveillance, eradication and disease-free status for certain diseases;
rules for aquaculture establishments and transporters of aquatic animals;
rules for entry into the EU and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin;
rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs;
diseases subject to EU surveillance programmes, their geographical scope and diseases for which disease-free areas may be set up;
animal health requirements for the movements within the EU of aquatic animals and products of animal origin from aquatic animals.
The regulations supplementing or implementing EU animal health law are:
Delegated Regulation (EU) 
2018/1629
 on the listing of diseases;
Implementing Regulation (EU) 
2018/1882
 on categories of listed diseases (see 
consolidated version
);
Delegated Regulation (EU) 
2019/2035
 on establishments keeping terrestrial animals and hatcheries, and traceability (see 
consolidated version
);
Delegated Regulation (EU) 
2020/686
 on movements within the EU of germinal products of certain kept terrestrial animals (see 
consolidated version
);
Delegated Regulation (EU) 
2020/687
 on prevention and control of certain diseases (see 
consolidated version
);
Delegated Regulation (EU) 
2020/688
 on animal health requirements for movements within the EU of terrestrial animals and hatching eggs (see 
consolidated version
);
Delegated Regulation (EU) 
2020/689
 on surveillance and eradication programmes for certain emerging diseases (see 
consolidated version
);
Implementing Regulation (EU) 
2020/690
 on listed diseases subject to EU surveillance programmes;
Delegated Regulation (EU) 
2020/691
 on rules for aquaculture establishments;
Delegated Regulation (EU) 
2020/692
 on rules for entry into the EU and the movement and handling of certain animals, germinal products and products of animal origin (see 
consolidated version
);
Delegated Regulation (EU) 
2020/990
 on animal health and certification requirements for movements within the EU of aquatic animals and products of animal origin;
Implementing Regulation (EU) 
2020/999
 on the approval of germinal product establishments and the traceability of germinal products of bovine, porcine, ovine, caprine and equine animals;
Implementing Regulation (EU) 
2020/2002
 on reporting of listed diseases (see 
consolidated version
);
Delegated Regulation (EU) 
2020/2154
 on animal health, certification and notification requirements for movements within the EU of products of animal origin from terrestrial animals;
Implementing Regulation (EU) 
2020/2235
 on animal health certificates for the entry into the EU and movements within the EU of consignments of certain categories of animals and goods (see 
consolidated version
);
Implementing Regulation (EU) 
2020/2236
 on model animal health certificates for the entry into the EU and movements within the EU of consignments of aquatic animals (see 
consolidated version
);
Implementing Regulation (EU) 
2021/403
 on model animal health certificates for the entry into the EU and movements within the EU of consignments of terrestrial animals (see 
consolidated version
);
Implementing Regulation (EU) 
2021/404
 on the lists of non-EU countries, territories or zones from which the entry into the EU of animals, germinal products and products of animal origin is permitted (see 
consolidated version
);
Implementing Regulation (EU) 
2021/520
 on the traceability of certain kept terrestrial animals (see 
consolidated version
);
Implementing Regulation (EU) 
2021/963
 on the identification and registration of equine animals and establishing model identification documents for those animals;
Implementing Regulation (EU) 
2021/2037
 on obligation exemptions for the registration of aquaculture establishments and record-keeping of operators;
Delegated Regulation (EU) 
2022/139
 on the management, storage and replacement of stocks of the EU antigen, vaccine and diagnostic reagent banks and the biosecurity, biosafety and bio-containment requirements for the operation of those banks;
Implementing Regulation (EU) 
2022/140
 on to the EU antigen, vaccine and diagnostic reagent banks;
Implementing Regulation (EU) 
2022/1345
 on the registration and approval of establishments keeping terrestrial animals and collecting, producing, processing or storing germinal products.
FROM WHEN DOES THE REGULATION APPLY?
The regulation has applied since 
21 April 2021
. However, it includes some transitional measures and repeals of older legislation that has applied since 
21 April 2016
.
BACKGROUND
For further information, see:
Animal health law
 (European Commission).
KEY TERMS
Biosecurity.
 Management procedures, actions or facilities designed to reduce the risk of disease in animals.
MAIN DOCUMENT
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’) (OJ L 84, 
31.3.2016
, 
pp. 1–208
).
Successive amendments to Regulation (EU) 2016/429 have been incorporated into the original document. This 
consolidated version
 is of documentary value only.
last update 
22.3.2023

--- DANISH ---

Document:
31.3.2016
DA
Den Europæiske Unions Tidende
L 84/1
EUROPA-PARLAMENTETS OG RÅDETS FORORDNING (EU) 2016/429
af 9. marts 2016
om overførbare dyresygdomme og om ændring og ophævelse af visse retsakter på området for dyresundhed (»dyresundhedsloven«)
(EØS-relevant tekst)
EUROPA-PARLAMENTET OG RÅDET FOR DEN EUROPÆISKE UNION HAR —
under henvisning til traktaten om Den Europæiske Unions funktionsmåde, særlig artikel 43, stk. 2, artikel 114 og artikel 168, stk. 4, litra b),
under henvisning til forslag fra Europa-Kommissionen,
efter fremsendelse af udkast til lovgivningsmæssig retsakt til de nationale parlamenter,
under henvisning til udtalelse fra Det Europæiske Økonomiske og Sociale Udvalg 
(
1
)
,
efter høring af Regionsudvalget,
efter den almindelige lovgivningsprocedure 
(
2
)
, og
ud fra følgende betragtninger:
(1)
Virkningerne af overførbare dyresygdomme og de foranstaltninger, der er nødvendige for at bekæmpe disse sygdomme, kan være ødelæggende for individuelle dyr, dyrebestande, personer, der holder dyr, og økonomien.
(2)
Som den senere tids erfaringer har vist, kan overførbare dyresygdomme også have væsentlig indvirkning på folkesundheden og fødevaresikkerheden.
(3)
Dertil kommer, at der kan konstateres negative synergetiske virkninger for så vidt angår biodiversitet, klimaændringer og andre miljøaspekter. Klimaændringer kan influere på fremkomsten af nye sygdomme, prævalensen af eksisterende sygdomme og den geografiske fordeling af sygdomsfremkaldende agenser og vektorer, herunder dem, der angriber vildtlevende dyr.
(4)
Med henblik på at sikre høje standarder for dyre- og folkesundhed i Unionen og en rationel udvikling af landbrugs- og akvakultursektorerne samt at øge produktivitet bør der fastsættes dyresundhedsregler på EU-plan. Disse regler er bl.a. nødvendige for at bidrage til gennemførelsen af det indre marked og undgå spredning af infektionssygdomme. Disse regler bør også så vidt muligt sikre, at den nuværende dyresundhedsstatus i Unionen opretholdes, og at efterfølgende forbedring af denne status støttes.
(5)
Den nuværende EU-dyresundhedslovgivning består af en række indbyrdes relaterede og forbundne basisretsakter, som indeholder dyresundhedsregler, der gælder for handel inden for Unionen, indførsel til Unionen af dyr og produkter, sygdomsudryddelse, veterinærkontrol, anmeldelse af sygdomme og tilskud til foranstaltninger vedrørende forskellige dyrearter, men der findes ikke en overordnet retlig ramme med harmoniserede principper for hele sektoren.
(6)
Finansielle regler vedrørende støtte til dyresundhedsmæssige målsætninger er fastsat i Europa-Parlamentets og Rådets forordning (EU) nr. 652/2014 
(
3
)
 og indgår ikke i denne forordning. Desuden bør de regler om offentlig kontrol med dyresundhedsmæssige foranstaltninger, der er fastsat i Europa-Parlamentets og Rådets forordning (EF) nr. 882/2004 
(
4
)
 og i Rådets direktiv 89/662/EØF 
(
5
)
, 90/425/EØF 
(
6
)
, 91/496/EØF 
(
7
)
 og 97/78/EF 
(
8
)
, anvendes til at regulere offentlig kontrol på området for dyresundhed.
(7)
Denne forordning indeholder ikke bestemmelser, der regulerer dyrevelfærd. Dyresundhed og dyrevelfærd hænger imidlertid sammen: Bedre dyresundhed fremmer bedre dyrevelfærd og omvendt. Når sygdomsforebyggelses- og -bekæmpelsesforanstaltninger gennemføres i henhold til denne forordning, bør der tages hensyn til deres virkning på dyrevelfærden, jf. artikel 13 i traktaten om Den Europæiske Unions funktionsmåde (TEUF), for at skåne de pågældende dyr for enhver undgåelig smerte, belastning eller lidelse. Lovgivningen om dyrevelfærd, f.eks. Rådets forordning (EF) nr. 1/2005 
(
9
)
 og (EF) nr. 1099/2009 
(
10
)
, bør nødvendigvis fortsat finde anvendelse og bør gennemføres korrekt. Reglerne fastsat i nærværende forordning bør ikke duplikere eller overlappe reglerne fastsat i nævnte lovgivning.
(8)
Kommissionens meddelelse af 19. september 2007 om en ny dyresundhedsstrategi for Den Europæiske Union (2007-2013), hvorefter: »Det er bedre at forebygge end at helbrede«, sigter mod at fremme dyresundhed ved at lægge større vægt på forebyggende foranstaltninger, sygdomsovervågning og -bekæmpelse og forskning med henblik på at reducere forekomsten af dyresygdomme og at begrænse virkningerne af udbrud mest muligt, når de forekommer. Det foreslås, at der indføres en fælles, forenklet lovramme for dyresundhed med henblik på tilnærmelse til de internationale standarder, samtidig med at der sikres et solidt engagement i høje dyresundhedsstandarder.
(9)
Formålet med denne forordning er at gennemføre tilsagnene og visionerne i nævnte dyresundhedsstrategi, herunder »One Health«-princippet, og at konsolidere den retlige ramme for en fælles EU-dyresundhedspolitik i en enkelt, forenklet og fleksibel retlig ramme for dyresundhed.
(10)
Dyr kan blive ramt af en bred vifte af infektions- og ikkeinfektionssygdomme. Mange sygdomme kan behandles, eller har kun indvirkning på et enkelt dyr eller spredes ikke til andre dyr eller til mennesker. Overførbare sygdomme kan derimod have bredere indvirkning på dyre- eller folkesundheden med mærkbare virkninger for en hel bestand eller befolkning. Dyresundhedsreglerne i denne forordning bør kun gælde for sidstnævnte sygdomme.
(11)
Ved fastsættelsen af disse dyresundhedsregler er det af afgørende betydning, at der tages hensyn til sammenhængene mellem dyresundhed og folkesundhed, miljøet, fødevare- og fodersikkerhed, dyrevelfærd samt økonomiske, sociale og kulturelle aspekter.
(12)
Aftalen om anvendelsen af sundheds- og plantesundhedsforanstaltninger (SPS-aftalen), som Unionen er part i, regulerer anvendelsen af foranstaltninger, der er nødvendige for at beskytte menneskers, dyrs eller planters liv eller sundhed, således at de ikke vilkårligt eller uberettiget forskelsbehandler Verdenshandelsorganisationens (WTO) medlemmer. I det omfang der findes internationale standarder, skal EU-foranstaltninger baseres på disse. Parterne i SPS-aftalen har imidlertid ret til at fastsætte deres egne relevante standarder, forudsat at de er baseret på videnskabelig evidens.
(13)
For så vidt angår dyresundhed henvises der i SPS-aftalen til standarderne fra Verdensorganisationen for Dyresundhed (OIE) vedrørende dyresundhedsmæssige betingelser for international handel. Med henblik på at begrænse risikoen for forstyrrelser i handelen bør EU-foranstaltninger på dyresundhedsområdet tilstræbe en passende grad af tilnærmelse til OIE-standarderne.
(14)
I særlige tilfælde, hvor der er en betydelig dyre- eller folkesundhedsmæssig risiko, men fortsat videnskabelig usikkerhed, kan medlemmer i henhold til SPS-aftalens artikel 5, stk. 7, som er blevet fortolket for Unionen i Kommissionens meddelelse af 2. februar 2000 om forsigtighedsprincippet, vedtage midlertidige foranstaltninger på grundlag af de disponible relevante oplysninger. Det pågældende medlem skal i sådanne tilfælde indhente de yderligere oplysninger, der er nødvendige til en mere objektiv risikovurdering, og skal derefter revurdere foranstaltningen inden for en rimelig tidsfrist.
(15)
Den risikovurdering, som foranstaltningerne i henhold til denne forordning træffes på grundlag af, bør baseres på den tilgængelige videnskabelige dokumentation og være uafhængig, objektiv og gennemskuelig. Der bør tillige tages behørigt hensyn til udtalelser fra Den Europæiske Fødevaresikkerhedsautoritet (EFSA), som er oprettet ved artikel 22, stk. 1, i Europa-Parlamentets og Rådets forordning (EF) nr. 178/2002 
(
11
)
.
(16)
Ved Europa-Parlamentets og Rådets forordning (EF) nr. 1069/2009 
(
12
)
 er der fastsat både folke- og dyresundhedsregler for visse animalske biprodukter og afledte produkter med henblik på at forebygge og minimere risici for folke- og dyresundheden forårsaget af disse produkter og navnlig at beskytte fødevare- og foderkædens sikkerhed. For at undgå overlapning i EU-lovgivningen bør nærværende forordning derfor kun gælde for animalske biprodukter og afledte produkter, for hvilke der ikke er fastsat specifikke regler i forordning (EF) nr. 1069/2009, og hvor der er en dyresundhedsmæssig risiko. F.eks. indeholder forordning (EF) nr. 1069/2009 ikke regler for, hvordan animalske biprodukter og afledte produkter skal håndteres i forbindelse med sygdomsbekæmpelsesforanstaltninger, og disse spørgsmål er derfor på behørig vis omfattet af denne forordning.
(17)
Dertil kommer, at der allerede er fastsat særlige regler om overførbare dyresygdomme, herunder sygdomme, der kan overføres til mennesker (»zoonoser«), i Europa-Parlamentets og Rådets forordning (EF) nr. 999/2001 
(
13
)
, Europa-Parlamentets og Rådets direktiv 2003/99/EF 
(
14
)
 og Europa-Parlamentets og Rådets forordning (EF) nr. 2160/2003 
(
15
)
, samt at særlige regler om overførbare sygdomme hos mennesker er fastsat i Europa-Parlamentets og Rådets afgørelse nr. 1082/2013/EU 
(
16
)
. Disse retsakter bør fortsat gælde efter vedtagelsen af nærværende forordning. For at undgå overlapning i EU-lovgivningen bør denne forordning i overensstemmelse hermed kun gælde for zoonoser i den udstrækning, hvor der ikke allerede er fastsat særlige regler i de nævnte andre EU-retsakter. Derudover finder denne forordning anvendelse med forbehold af de regler, som er fastsat i andre lovgivningsmæssige EU-retsakter, f.eks. inden for veterinærmedicin og dyrevelfærd.
(18)
Sygdomme, der opstår hos dyr, som holdes af mennesker, kan have alvorlig indvirkning på landbrugs- og akvakultursektoren samt på folkesundheden, miljøet og biodiversiteten. Men eftersom sådanne dyr holdes af mennesker, er sygdomsforebyggelses- og -bekæmpelsesforanstaltninger ofte lettere at anvende på dem end på vildtlevende dyr.
(19)
Ikke desto mindre kan sygdomme, der opstår i bestande af vildtlevende dyr, have en skadelig indvirkning på landbrugs- og akvakultursektoren samt på folkesundheden, miljøet og biodiversiteten. Denne forordnings anvendelsesområde bør derfor i sådanne tilfælde omfatte vildtlevende dyr, både som potentielle ofre for sådanne sygdomme og som vektorer for dem. I denne forordning omfatter udtrykket »vildtlevende dyr« alle dyr, som ikke holdes af mennesker, herunder herreløse og forvildede dyr, selv af arter, som normalt er domesticerede.
(20)
Dyresygdomme overføres ikke kun via direkte kontakt mellem dyr eller mellem dyr og mennesker. De spredes også yderligere via vand- og luftsystemer og vektorer som f.eks. insekter eller via sæd, oocytter og embryoner, der anvendes til kunstig inseminering, donation med oocytter eller embryotransplantation. Sygdomsfremkaldende agenser kan desuden findes i fødevarer og andre animalske produkter såsom læder, pelsværk, fjer, horn og ethvert andet materiale fra en dyrekrop. Sygdomsfremkaldende agenser kan også spredes via en række andre objekter såsom transportkøretøjer, udstyr, foder og hø og halm. Effektive dyresundhedsregler må derfor nødvendigvis dække alle infektionsveje og materialer i tilknytning hertil.
(21)
Dyresygdomme kan have skadelige virkninger for udbredelsen af dyrearter i naturen og således påvirke biodiversiteten. Mikroorganismer, der forårsager sådanne dyresygdomme, kan derfor anses for invasive ikkehjemmehørende arter inden for rammerne af FN's konvention om den biologiske mangfoldighed. De foranstaltninger, der fastsættes i denne forordning, tager også hensyn til biodiversiteten, og forordningen bør således omfatte de dyrearter og sygdomsfremkaldende agenser, herunder dem, der er defineret som invasive dyrearter, som spiller en rolle i forbindelse med overførsel af eller rammes af sygdomme omfattet af denne forordning.
(22)
Der er ved EU-lovgivning vedtaget inden denne forordning fastsat særskilte dyresundhedsregler for henholdsvis landdyr og akvatiske dyr. Ved Rådets direktiv 2006/88/EF 
(
17
)
 er der fastsat særlige regler for akvatiske dyr. I de fleste tilfælde er hovedprincipperne for god forvaltning på dyresundhedsområdet og god zooteknik imidlertid relevante for begge grupper af dyrearter. I overensstemmelse hermed bør denne forordning omfatte både landdyr og akvatiske dyr, og de pågældende dyresundhedsregler bør så vidt muligt bringes i overensstemmelse med hinanden. For visse aspekters vedkommende, navnlig hvad angår registrering og godkendelse af virksomheder og sporbarhed og flytning af dyr inden for Unionen, følger denne forordning dog den tilgang, der tidligere er valgt, og som består i at fastsætte forskellige dyresundhedsregler for henholdsvis landdyr og akvatiske dyr på grund af deres forskellige miljøer og følgelig forskellige sundhedsbeskyttelseskrav.
(23)
Der er ved EU-lovgivning vedtaget inden denne forordning, navnlig Rådets direktiv 92/65/EØF 
(
18
)
, også fastsat grundlæggende dyresundhedsregler for andre dyrearter, som ikke er reguleret i andre EU-retsakter, f.eks. krybdyr, padder, havpattedyr og andre arter, der ikke er akvatiske dyr eller landdyr som defineret i denne forordning. Disse arter udgør normalt ikke en væsentlig sundhedsrisiko for mennesker eller andre dyr og er derfor kun omfattet af få eller ingen dyresundhedsregler. For at undgå unødvendige administrative byrder og omkostninger bør denne forordning følge den tilgang, der tidligere er valgt, nemlig at opstille en retlig ramme, som muliggør fastsættelse af udførlige dyresundhedsregler om flytning af sådanne dyr og produkter deraf, hvis risiciene i forbindelse hermed gør det nødvendigt.
(24)
Mennesker holder ofte visse dyr som selskabsdyr i deres husstand. Hold af sådanne selskabsdyr i rent privat øjemed, herunder vandlevende pryddyr i private husstande, såvel indendørs som udendørs, udgør generelt en lavere sundhedsrisiko end andre former for hold eller flytning af dyr i større omfang, sådan som det er almindeligt inden for landbrug, akvakultur, dyreinternater og transport af dyr generelt. De almindelige krav vedrørende registrering, føring af fortegnelser og flytninger inden for Unionen bør derfor ikke gælde for sådanne selskabsdyr, da det ville medføre uberettigede administrative byrder og omkostninger. Kravene vedrørende registrering og føring af fortegnelser bør således ikke gælde for personer, der holder selskabsdyr. Derudover bør særlige regler finde anvendelse på ikkekommercielle flytninger af selskabsdyr inden for Unionen.
(25)
Visse definerede grupper af dyr, som er omfattet af særlige dyresundhedsregler i denne forordning, bliver på grund af den pågældende gruppes forskelligartede karakter nødt til at opføres som arter i et bilag. Dette er tilfældet for gruppen af hovbærende pattedyr, der klassificeres som hovdyr. Det kan blive nødvendigt at ændre listen over sådanne dyr på et senere tidspunkt som følge af ændret taksonomi. For at tage højde for sådanne ændringer bør beføjelsen til at vedtage retsakter derfor delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår listen over hovdyr i bilag III til denne forordning.
(26)
Ikke alle overførbare dyresygdomme kan eller bør forebygges og bekæmpes ved hjælp af lovgivningsmæssige foranstaltninger; det gælder f.eks., hvis en sygdom har spredt sig for meget, hvis der ikke er diagnosticeringsværktøjer til rådighed, eller hvis den private sektor selv kan træffe foranstaltninger til at bekæmpe sygdommen. Lovgivningsmæssige foranstaltninger til forebyggelse og bekæmpelse af overførbare dyresygdomme kan have store økonomiske konsekvenser for de berørte sektorer og kan gribe forstyrrende ind i handelen. Det er derfor afgørende, at sådanne foranstaltninger kun anvendes, hvis de er forholdsmæssige og nødvendige, f.eks. når en sygdom udgør eller mistænkes for at udgøre en betydelig risiko for dyre- eller folkesundheden.
(27)
Forebyggelses- og bekæmpelsesforanstaltninger bør endvidere være »skræddersyet« til de enkelte overførbare dyresygdomme for at tage hensyn til den pågældende sygdoms unikke epidemiologiske profil, dens konsekvenser og dens udbredelse inden for Unionen. De forebyggelses- og bekæmpelsesregler, der gælder for hver sygdom, bør således være sygdomsspecifikke.
(28)
For overførbare dyresygdomme er en sygdomstilstand normalt forbundet med kliniske eller patologiske tegn på infektionen. Med henblik på anvendelsen af denne forordning, som har til formål at bekæmpe spredning af og udrydde visse overførbare dyresygdomme, bør definitionen af sygdom imidlertid være bredere, således at andre bærere af den sygdomsfremkaldende agens også er omfattet.
(29)
Visse overførbare dyresygdomme spredes ikke let til andre dyr eller til mennesker og er derfor ikke årsag til økonomiske tab eller skader på biodiversiteten i større omfang. De udgør således ikke en alvorlig trussel mod dyrs eller menneskers sundhed i Unionen og kan derfor, hvis det ønskes, gøres til genstand for foranstaltninger i henhold til nationale regler.
(30)
For så vidt angår overførbare dyresygdomme, der ikke er omfattet af EU-foranstaltninger, men som er af en vis økonomisk betydning for den private sektor på lokalt plan, bør sidstnævnte med bistand fra medlemsstaternes kompetente myndigheder træffe foranstaltninger til at forebygge eller bekæmpe sådanne sygdomme, f.eks. i form af selvreguleringsforanstaltninger eller udvikling af kodekser for god praksis.
(31)
I modsætning til de overførbare dyresygdomme, der er beskrevet i betragtning 29 og 30, kan meget let overførbare dyresygdomme let spredes på tværs af grænserne, ligesom de, hvis der er tale om zoonoser, også kan have konsekvenser for folkesundheden og fødevaresikkerheden. Meget let overførbare dyresygdomme og zoonoser bør derfor være omfattet af denne forordning.
(32)
Antimikrobiel resistens, forstået som mikroorganismers evne til at overleve eller udvikle sig i tilstedeværelse af et antimikrobielt middel i en koncentration, som normalt er tilstrækkelig til at hæmme eller dræbe mikroorganismer af samme art, øges. Tiltag nr. 5 i Kommissionens meddelelse til Europa-Parlamentet og Rådet med titlen »Handlingsplan for den voksende trussel fra antimikrobiel resistens« fremhæver denne forordnings forebyggende rolle og den deraf følgende forventede nedbringelse af brugen af antibiotika til dyr. Denne resistens hos mikroorganismer over for antimikrobielle midler, som de tidligere var følsomme over for, vanskeliggør behandlingen af infektionssygdomme hos mennesker og dyr og kan således udgøre en trussel mod menneskers sundhed eller dyresundheden. Derfor bør mikroorganismer, der har udviklet resistens over for antimikrobielle midler, behandles, som om de var overførbare sygdomme, og dermed omfattes af denne forordnings anvendelsesområde. Dette vil, når det er hensigtsmæssigt og nødvendigt, gøre det muligt at træffe foranstaltninger mod organismer, der er resistente over for antimikrobielle midler.
(33)
Nye farer, der knytter sig til bestemte sygdomme eller arter, vil kunne blive aktuelle, især som følge af ændringer i handelsmønstre, miljøet, klimaet, zooteknik og landbrugstraditioner, men også som følge af ændrede samfundsmønstre. Den videnskabelige udvikling kan også føre til ny viden og øget bevidsthed om eksisterende sygdomme. Endvidere vil sygdomme og arter, der er af stor betydning i dag, kunne blive trængt til side i fremtiden. Anvendelsesområdet for denne forordning bør derfor være bredt, ligesom der med de regler, der fastsættes, bør fokuseres på sygdomme af stor offentlig betydning. OIE har med støtte fra Europa-Kommissionen udarbejdet en undersøgelse om listeopførelse og kategorisering af prioriterede dyresygdomme, herunder sygdomme, der kan overføres til mennesker (»Listing and Categorisation of Priority Animal Diseases, including those Transmissible to Humans«), og et redskab til gennemførelse heraf, som har til formål at udvikle et system til prioritering og kategorisering af sygdomme. Dette redskab er et eksempel på en systematisk tilgang til indsamling og vurdering af oplysninger om dyresygdomme.
(34)
Der bør opstilles en harmoniseret liste over overførbare dyresygdomme (»listeopførte sygdomme«), der udgør en risiko for dyre- eller folkesundheden i Unionen, uanset om det er i hele Unionen eller kun dele heraf. De fem sygdomme, der allerede udpeges i denne forordning, bør suppleres af en liste over sygdomme indeholdt i et bilag. Kommissionen bør revidere og ændre bilaget ud fra et sæt kriterier. Beføjelsen til at vedtage retsakter om ændring af bilaget bør derfor i overensstemmelse med artikel 290 i TEUF delegeres til Kommissionen.
(35)
Der vil i fremtiden kunne opstå sygdomme, som potentielt kan være forbundet med alvorlige risici for folke- eller dyresundheden og have konsekvenser for sundheden, økonomien og miljøet. Kommissionen bør tillægges gennemførelsesbeføjelse til at fastlægge sygdomsforebyggelses- og -bekæmpelsesforanstaltninger for sådanne nye sygdomme med henblik på vedtagelse af passende foranstaltninger til håndtering af disse sygdommes potentielle negative konsekvenser, selv hvis de ikke er fuldstændigt vurderet, med henblik på eventuel listeopførelse heraf. Sådanne foranstaltninger berører ikke hasteforanstaltninger og kan fortsat finde anvendelse på nye sygdomme, indtil der træffes afgørelse om listeopførelse heraf.
(36)
Listeopførte sygdomme vil skulle håndteres på forskellig vis. Visse meget smitsomme sygdomme, som ikke forekommer i Unionen i dag, nødvendiggør strenge foranstaltninger til øjeblikkelig udryddelse af dem, så snart de konstateres. I tilfælde, hvor sådanne sygdomme ikke straks udryddes og bliver endemiske, vil der være behov for et langsigtet obligatorisk udryddelsesprogram. For andre sygdomme, som måske allerede forekommer i dele af Unionen, er der behov for obligatorisk eller valgfri udryddelse. I disse tilfælde bør der indføres restriktioner for flytning af dyr og produkter, f.eks. et forbud mod flytning til og fra angrebne områder, eller blot undersøgelse af de pågældende dyr eller produkter forud for afsendelse. I andre tilfælde vil det måske være tilstrækkeligt at indføre et program til overvågning af den pågældende sygdoms udbredelse, uden at der træffes yderligere foranstaltninger.
(37)
Der bør fastsættes kriterier, der sikrer, at alle relevante aspekter tages i betragtning ved fastlæggelsen af, hvilke overførbare dyresygdomme der skal være listeopførte sygdomme i henhold til denne forordning.
(38)
Denne forordnings regler om forebyggelse og bekæmpelse af en bestemt overførbar dyresygdom bør gælde for de dyrearter, der kan overføre den pågældende sygdom, enten fordi de er modtagelige for sygdommen, eller fordi de fungerer som vektor for den. Med henblik på at sikre ensartede betingelser for gennemførelsen af denne forordning er det nødvendigt at opstille en harmoniseret liste over arter, som foranstaltningerne for de forskellige listeopførte sygdomme på EU-plan (»listeopførte arter«) finder anvendelse på, og Kommissionen bør tildeles gennemførelsesbeføjelse til at opstille en sådan liste.
(39)
Kategoriseringen bør baseres på nogle på forhånd fastlagte kriterier, såsom den pågældende listeopførte sygdoms profil, omfanget af dens indvirkning på dyre- og folkesundheden, dyrevelfærden og økonomien i Unionen, risikoen for spredning af den samt tilgængeligheden af sygdomsforebyggelses- og -bekæmpelsesforanstaltninger for sygdommen. Kommissionen bør tildeles gennemførelsesbeføjelse til fastlæggelse af, hvilke listeopførte sygdomme der skal være omfattet af hvilke regler.
(40)
Disse regler bør finde anvendelse på listeopførte sygdomme, som normalt ikke forekommer i Unionen, og for hvilke det er bydende nødvendigt at træffe øjeblikkelige udryddelsesforanstaltninger, så snart de påvises, såsom klassisk svinepest, på listeopførte sygdomme, som bør bekæmpes i alle medlemsstaterne med henblik på at udrydde dem i hele Unionen, hvilket kan omfatte sygdomme som brucellose, på listeopførte sygdomme, som har relevans for nogle medlemsstater, og for hvilke der er behov for foranstaltninger for at hindre spredning heraf til områder i Unionen, der officielt er sygdomsfrie eller har udryddelsesprogrammer for den pågældende listeopførte sygdom, hvilket kan opfatte sygdomme som infektiøs bovin rhinotracheitis, på listeopførte sygdomme, for hvilke det er nødvendigt at træffe foranstaltninger for at hindre spredning som følge af indførsel heraf til Unionen eller flytninger mellem medlemsstaterne, hvilket kan omfatte sygdomme som equin infektiøs anæmi, og på listeopførte sygdomme, for hvilke det er nødvendigt med overvågning i Unionen, hvilket kan omfatte sygdomme som miltbrand.
(41)
Sygdomsprofilen for en given sygdom kan ændre sig ligesom de risici, der er forbundet med sygdommen, og andre omstændigheder. I disse tilfælde bør de gennemførelsesbeføjelser, der tillægges Kommissionen, også omfatte beføjelse til at ændre den kategori, som en bestemt listeopført sygdom henhører under og dermed de foranstaltninger, som den er omfattet af.
(42)
Operatører, der arbejder med dyr, er bedst placeret til at observere og sikre sundheden for de dyr og overvåge produkter, som de er ansvarlige for. De bør derfor have det primære ansvar for gennemførelse af foranstaltninger til forebyggelse og bekæmpelse af spredning af sygdomme blandt de dyr og overvågning af produkter, som de er ansvarlige for.
(43)
Biosikring er et af de vigtigste forebyggelsesredskaber, der er til rådighed for operatører og andre, der arbejder med dyr, til at hindre introduktion, udvikling og spredning af overførbare dyresygdomme til, fra og inden for en dyrebestand. Betydningen af biosikring anerkendes også i konsekvensanalysen med henblik på vedtagelse af denne forordning, hvori de potentielle virkninger vurderes specifikt. De vedtagne biosikringsforanstaltninger bør være tilstrækkelig smidige, passe til produktionstypen og de pågældende arter eller kategorier af dyr og tage hensyn til de lokale forhold og den tekniske udvikling. Kommissionen bør tillægges gennemførelsesbeføjelse til at fastsætte de minimumskrav, der er nødvendige for en ensartet anvendelse af biosikringsforanstaltninger i medlemsstaterne. Dog bør fremme af forebyggelse af overførbare sygdomme gennem højere standarder for biosikring ved udvikling af egne vejledninger i god praksis fortsat altid være omfattet af operatørers, medlemsstaternes og Kommissionens beføjelser. Selv om biosikring kan kræve visse forudgående investeringer, bør den deraf følgende reduktion af dyresygdomme være et positivt incitament for operatører.
(44)
Biocidholdige produkter såsom desinfektionsmidler til veterinærhygiejne eller fødevare- og foderområder, insekticider, afskrækningsmidler og rodenticider spiller en vigtig rolle i biosikringsstrategier både på bedriftsniveau og i forbindelse med transport af dyr. Disse produkter bør derfor anses for at indgå i biosikring.
(45)
Viden om dyresundhed, bl.a. om sygdomssymptomer, konsekvenserne af sygdomme og sygdomsforebyggelsesmidler, herunder biosikring, behandling og bekæmpelse, er en forudsætning for effektiv forvaltning på dyresundhedsområdet og er afgørende for at sikre, at dyresygdomme opdages tidligt. Operatører og dyrefagpersoner bør derfor tilegne sig sådan relevant viden. Denne viden kan tilegnes på forskellige måder, f.eks. gennem formel uddannelse, men også gennem landbrugssektorens bedriftsrådgivningsordning eller uformel uddannelse, som de nationale og EU-landbrugsorganisationer og andre organisationer kan være værdifulde bidragydere til.
(46)
Dyrlæger og fagpersoner med ekspertise i akvatiske dyrs sundhed spiller en afgørende rolle i alle aspekter af forvaltning på dyresundhedsområdet, og der bør fastsættes almindelige regler om deres roller og ansvarsområder i denne forordning.
(47)
Dyrlæger har en uddannelse og faglige kvalifikationer, der bekræfter, at de har tilegnet sig den viden, de færdigheder og de kompetencer, der er nødvendige for bl.a. at kunne diagnosticere sygdomme og behandle dyr. Derudover findes der i nogle medlemsstater — af historiske årsager eller på grund af mangel på dyrlæger, der beskæftiger sig med sygdomme hos akvatiske dyr — specialiserede fagpersoner med ekspertise i akvatiske dyrs sundhed. Disse fagpersoner er traditionelt ikke dyrlæger, men de beskæftiger sig med veterinærmedicin for akvatiske dyr. Denne forordning bør derfor respektere de pågældende medlemsstaters beslutning om at anerkende dette erhverv. I disse tilfælde bør fagpersoner med ekspertise i akvatiske dyrs sundhed have det samme ansvar og de samme forpligtelser som dyrlæger for så vidt angår deres særlige arbejdsområde. Denne tilgang er i overensstemmelse med OIE's sundhedskodeks for akvatiske dyr.
(48)
Medlemsstaterne, og især deres respektive kompetente myndigheder med ansvar for dyresundhed, er nogle af de vigtigste aktører inden for forebyggelse og bekæmpelse af overførbare dyresygdomme. Den kompetente myndighed for dyresundhed spiller en vigtig rolle med hensyn til overvågning, udryddelse og bekæmpelse af sygdomme samt beredskabsplanlægning og foranstaltninger til at øge opmærksomheden om sygdomme og med hensyn til at lette flytning af dyr og inden for international handel ved at udstede dyresundhedscertifikater. For at kunne varetage deres opgaver i henhold til denne forordning er medlemsstaterne afhængige af adgang til tilstrækkelige finansielle, infrastrukturelle og personalemæssige ressourcer overalt på deres område, herunder laboratoriekapacitet og videnskabelig og anden relevant knowhow.
(49)
Den kompetente myndighed vil på grund af begrænsede ressourcer ikke altid være i stand til at udføre alle de aktiviteter, som kræves i henhold til denne forordning. Det er af denne grund nødvendigt at fastlægge et retsgrundlag for delegation af visse aktiviteter til dyrlæger, der ikke er embedsdyrlæger. Af samme grund bør medlemsstaterne også have mulighed for at give fysiske eller juridiske personer tilladelse til at udføre visse aktiviteter på visse betingelser.
(50)
For at sikre, at de nødvendige betingelser for generel anvendelse af sygdomsforebyggelses- og -bekæmpelsesforanstaltninger i hele Unionen fastsættes, bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår delegation af andre aktiviteter, som den kompetente myndighed kan delegere til dyrlæger, der ikke er embedsdyrlæger.
(51)
Optimal forvaltning på dyresundhedsområdet kan kun opnås i samarbejde med personer, der holder dyr, operatører, dyrlæger, dyresundhedsfagpersoner, andre interessenter og handelspartnere. For at sikre deres opbakning er det nødvendigt at tilrettelægge beslutningsprocedurer og anvendelse af foranstaltningerne i denne forordning på en klar, gennemsigtig og inklusiv måde.
(52)
Den kompetente myndighed bør også træffe passende foranstaltninger til at holde offentligheden informeret, især når der er rimelig grund til at formode, at dyr eller produkter kan udgøre en risiko for dyre- eller folkesundheden, eller når et tilfælde er af offentlig interesse. I sådanne tilfælde kan de pågældende dyr eller produkter stamme fra Unionen eller indføres til Unionen udefra. Sidstnævnte kan også indføres til Unionen af personer, der rejser ind i Unionen med deres personlige bagage. Informationen til offentligheden bør derfor omfatte de risici, der er forbundet med sådanne situationer.
(53)
For at undgå udslip af sygdomsfremkaldende agenser fra laboratorier, institutter og andre faciliteter, der håndterer sygdomsfremkaldende agenser, er det af afgørende betydning, at de træffer passende foranstaltninger vedrørende biosikring, biosikkerhed og biologisk indeslutning. Der bør derfor i denne forordning fastsættes regler om sikkerhedsforanstaltninger, som skal overholdes i forbindelse med håndtering eller transport af sådanne sygdomsfremkaldende agenser, vacciner og andre biologiske produkter. Den forpligtelse, der pålægges i den forbindelse, bør også gælde for juridiske og fysiske personer, der er involveret i sådanne aktiviteter. For at sikre, at sikkerhedsstandarderne overholdes i forbindelse med håndtering af meget smitsomme biologiske agenser, vacciner og andre biologiske produkter, bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår sikkerhedsforanstaltninger i sådanne laboratorier, institutter og faciliteter og i forbindelse med flytning af sygdomsfremkaldende agenser.
(54)
Tidlig påvisning af og en klar ansvarskæde for anmeldelse af og rapportering om sygdomme er en forudsætning for effektiv sygdomsbekæmpelse. Med henblik på at sikre en effektiv og hurtig indsats bør medlemsstaterne sikre, at enhver mistanke om eller bekræftelse af et udbrud af visse listeopførte sygdomme øjeblikkelig anmeldes til den kompetente myndighed.
(55)
Dyrlæger er nøgleaktører i forbindelse med sygdomsundersøgelser, ligesom de er et vigtigt forbindelsesled mellem operatører og den kompetente myndighed. De bør derfor underrettes af den pågældende operatør i tilfælde af abnorm dødelighed, andre alvorlige sygdomsproblemer eller markante fald i produktionen af ukendte årsager.
(56)
For at sikre en effektiv anmeldelsesprocedure og for at præcisere forskellige omstændigheder i forbindelse med abnorm dødelighed og andre tegn på alvorlige sygdomme bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår kriterierne for at fastslå, hvornår anmeldelsesomstændigheder gør sig gældende, og fastsætte regler om yderligere undersøgelser, hvis det er relevant.
(57)
For visse listeopførte sygdommes vedkommende er det afgørende, at en medlemsstat øjeblikkeligt underretter Kommissionen og de øvrige medlemsstater om et udbrud på dens område. Sådan anmeldelse vil gøre det muligt for nabomedlemsstater eller andre angrebne medlemsstater at træffe forholdsregler, når det er hensigtsmæssigt.
(58)
For visse andre sygdommes vedkommende er øjeblikkelig anmeldelse og indsats ikke nødvendig. I disse tilfælde er indsamling af oplysninger og rapportering om forekomsten af de pågældende sygdomme af afgørende betydning for at kunne holde sygdomssituationen under kontrol og om nødvendigt træffe sygdomsforebyggelses- og -bekæmpelsesforanstaltninger. Dette rapporteringskrav kan også gælde for sygdomme, der er anmeldelsespligtige på EU-plan, men hvor der er behov for yderligere oplysninger for at kunne gennemføre effektive sygdomsforebyggelses- og -bekæmpelsesforanstaltninger. For at sikre, at de oplysninger og data, der er nødvendige for at forhindre spredning af eller bekæmpe de enkelte sygdomme, er korrekte og indsamles i rette tid, bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår oplysninger, der skal indberettes.
(59)
Et af hovedformålene med anmeldelse af og rapportering om sygdomme er at tilvejebringe pålidelige, gennemskuelige og tilgængelige epidemiologiske data. Der bør indføres et interaktivt IT-system på EU-plan til effektiv indsamling og håndtering af overvågningsdata vedrørende listeopførte sygdomme og, når det er relevant, nye sygdomme eller patogener, der er resistente over for antimikrobielle midler. Dette system bør fremme optimal datatilgængelighed, lette udvekslingen af data og mindske den administrative byrde for medlemsstaternes kompetente myndigheder, ved at anmeldelse af og rapportering om sygdomme inden for Unionen og på internationalt plan slås sammen til én enkelt proces, der gennemføres ved hjælp af OIE's database. Der bør også træffes foranstaltninger med henblik på at sikre overensstemmelse med udvekslingen af oplysninger i henhold til direktiv 2003/99/EF.
(60)
For at sikre ensartede betingelser for gennemførelse af EU-reglerne om anmeldelse af og rapportering om sygdomme bør Kommissionen tildeles gennemførelsesbeføjelse til at opstille en liste over de sygdomme, der er omfattet af denne forordnings regler om EU-anmeldelse og -rapportering, og at fastlægge de nødvendige procedurer, formater, data og udvekslinger af oplysninger vedrørende anmeldelse af og rapportering om sygdomme.
(61)
Overvågning er et centralt element i sygdomsbekæmpelsespolitik. Den bør sikre, at overførbare dyresygdomme opdages hurtigt og anmeldes effektivt, således at den pågældende sektor og den kompetente myndighed, når det er praktisk muligt, rettidigt kan iværksætte sygdomsforebyggelses- og -bekæmpelsesforanstaltninger og muliggøre udryddelse af den pågældende sygdom. Overvågning bør tillige give information om de enkelte medlemsstaters og Unionens dyresundhedsstatus, således at certificering af sygdomsfrihed kan dokumenteres, og samhandelen med tredjelande lettes.
(62)
Operatører fører løbende tilsyn med deres dyr og er bedst placeret til at opdage abnorm dødelighed eller andre alvorlige sygdomssymptomer. Operatører er derfor grundstenen i enhver overvågning og af afgørende betydning for den overvågning, der varetages af den kompetente myndighed.
(63)
For at sikre et tæt samarbejde og udveksling af oplysninger mellem operatører og dyrlæger eller fagpersoner med ekspertise i akvatiske dyrs sundhed og som supplement til den overvågning, der foretages af operatører, bør der aflægges dyresundhedsbesøg på virksomheder i overensstemmelse med den pågældende produktionstype og andre relevante faktorer. For at sikre ensartede betingelser for gennemførelse af dyresundhedsbesøg bør Kommissionen tillægges gennemførelsesbeføjelse til at fastsætte minimumskrav.
(64)
Det er nødvendigt, at den kompetente myndighed har et system til overvågning af de listeopførte sygdomme, der skal overvåges. Dette bør også gælde for nye sygdomme, for hvilke de potentielle sundhedsrisici bør vurderes, og epidemiologiske data indsamles til brug for denne vurdering. For at sikre den bedst mulige udnyttelse af ressourcer bør oplysninger indsamles, udveksles og anvendes så effektivt som muligt.
(65)
Overvågningsmetoderne, -hyppigheden og -intensiteten bør tilpasses til den enkelte sygdom og bør tage hensyn til det specifikke formål med overvågningen, dyresundhedsstatussen i den pågældende zone og eventuel anden overvågning, der foretages af operatører. Passende epidemiologiske overvågningsforanstaltninger kan række fra simpel anmeldelse og rapportering om forekomst af eller mistanke om en listeopført eller ny sygdom eller anden anomali, f.eks. abnorm dødelighed og andre sygdomstegn, til et specifikt og omfattende overvågningsprogram, som normalt vil omfatte yderligere prøveudtagnings- og undersøgelsesforanstaltninger.
(66)
Afhængigt af en sygdoms epidemiologiske profil og relevante risikofaktorer kan det være nødvendigt at indføre et specifikt overvågningsprogram, der omfatter definerede og strukturerede aktiviteter. I sådanne tilfælde bør medlemsstaterne udvikle målrettede overvågningsprogrammer. Når sådanne programmer er relevante for Unionen som helhed, bør der fastsættes regler for harmoniseret anvendelse af dem.
(67)
Sådanne programmer bør være i overensstemmelse med Unionens mål og derfor koordineres på EU-plan. Med henblik herpå bør de forelægges for Kommissionen. Medlemsstater, der gennemfører sådanne specifikke overvågningsprogrammer, bør desuden regelmæssigt aflægge rapport til Kommissionen om resultaterne af programmerne. For at sikre ensartede betingelser for gennemførelse af overvågningsprogrammer bør Kommissionen tildeles gennemførelsesbeføjelse til at opstille en liste over sygdomme, der er omfattet af overvågningsprogrammer, og at fastlægge harmoniserede procedurer, formater, data, udvekslinger af oplysninger og kriterier, der skal anvendes til evaluering af overvågningsprogrammerne.
(68)
Det vil ofte være nødvendigt nærmere at angive et passende overvågningsformat for forskellige sygdomme rækkende fra sygdomme, hvor overvågning kan begrænses til aktiviteter såsom rapportering og anmeldelse, til sygdomme, hvor der bør fastlægges et specifikt overvågningsprogram for hele Unionen. Derfor bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår tilrettelæggelse af overvågning, kriterier for fastsættelse af relevansen af en sygdom, der skal være omfattet af et overvågningsprogram, der er relevant for Unionen, og for officiel bekræftelse af udbrud, definitioner af tilfælde af de pågældende sygdomme samt krav til overvågningsprogrammer for så vidt angår indhold, oplysninger, som skal medtages i sådanne programmer, og anvendelsesperiode.
(69)
Medlemsstater, der ikke er frie eller ikke vides at være frie for listeopførte sygdomme, som er omfattet af udryddelsesforanstaltninger som fastsat i denne forordning, bør skulle udarbejde obligatoriske udryddelsesprogrammer til udryddelse af de pågældende sygdomme, hvis udryddelse er obligatorisk i Unionen.
(70)
Til gengæld er der nogle sygdomme, som har betydning i Unionen, men som det ikke er nødvendigt at pålægge medlemsstaterne at udrydde. Det bør være muligt for medlemsstaterne at udarbejde valgfrie udryddelsesprogrammer for sådanne sygdomme, hvis de beslutter, at udryddelse er vigtigt for dem. Sådanne valgfrie udryddelsesprogrammer vil blive anerkendt på EU-plan, og vil indebære iværksættelse af visse relevante sygdomsbekæmpelsesforanstaltninger. De kan også, med forbehold af Kommissionens godkendelse, gøre det muligt for de pågældende medlemsstater at kræve visse garantier i forbindelse med modtagelse af dyr fra andre medlemsstater eller fra tredjelande.
(71)
For at sikre ensartede betingelser for gennemførelse af programmer for udryddelse af sygdomme bør Kommissionen tildeles gennemførelsesbeføjelse til at fastlægge procedurer for forelæggelse af sådanne programmer, resultatindikatorer og rapportering.
(72)
En medlemsstat bør desuden have mulighed for at erklære hele dens område, zoner eller kompartmenter deri frit/frie for en eller flere listeopførte sygdomme, der er omfattet af regler om obligatoriske eller valgfrie udryddelsesprogrammer, for at beskytte sig mod introduktion af sådanne listeopførte sygdomme fra andre dele af Unionen eller fra tredjelande eller territorier. Der bør til dette formål indføres en klar harmoniseret procedure, herunder de nødvendige kriterier for status som sygdomsfri. For at sikre ensartede betingelser for anerkendelse af status som sygdomsfri i Unionen er det nødvendigt, at en sådan status som sygdomsfri godkendes officielt, og Kommissionen bør derfor tildeles gennemførelsesbeføjelse til at godkende denne status.
(73)
OIE har indført konceptet med afgrænsning af kompartmenter inden for rammerne af sundhedskodeksen for terrestriske dyr og sundhedskodeksen for akvatiske dyr (»OIE-kodekserne«). I EU-lovgivning vedtaget inden denne forordning anerkendes dette koncept kun for bestemte i specifik EU-lovgivning angivne dyrearter og -sygdomme, nemlig for aviær influenza og sygdomme hos akvatiske dyr. Der bør med denne forordning åbnes mulighed for at anvende kompartmentsystemet for andre dyrearter og -sygdomme. For at fastsætte de nærmere betingelser og regler for anerkendelse og godkendelse af kompartmenter og krav dertil bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF.
(74)
Medlemsstaterne bør offentliggøre oplysninger om deres sygdomsfrie områder eller sygdomsfrie zoner og kompartmenter deri for at orientere handelspartnere og lette samhandelen.
(75)
For at fastsætte nærmere betingelser for anerkendelse af status som sygdomsfri bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår kriterierne og betingelserne for opnåelse af denne status, den dokumentation, der er påkrævet til certificering af sygdomsfrihed, særlige sygdomsforebyggelses- og -bekæmpelsesforanstaltninger, herunder ikkevaccinationsstatus, hvis det er relevant, restriktioner, oplysninger, der skal gives, undtagelser og betingelser for opretholdelse, suspension, ophævelse eller generhvervelse af status som sygdomsfri.
(76)
For at sikre ensartede betingelser for anvendelse af procedurer for opnåelse af status som sygdomsfri bør Kommissionen tildeles gennemførelsesbeføjelse til at fastlægge, hvilke listeopførte sygdomme der kan gøres til genstand for afgrænsning af kompartmenter, og fastsætte nærmere regler om de formater, der skal anvendes ved indgivelse af ansøgninger og udveksling af oplysninger.
(77)
Tilstedeværelse af en fuldstændig ikkeimmun bestand af dyr, der er modtagelig for visse listeopførte sygdomme, nødvendiggør konstant sygdomsopmærksomhed og et permanent sygdomsberedskab. Beredskabsplaner har tidligere vist sig at være et vigtigt redskab til vellykket kontrol med sygdomskriser. For at sikre, at dette effektive redskab til kontrol med sygdomskriser er tilgængeligt, og at det i tilstrækkelig grad kan tilpasses krisesituationer, bør Kommissionen tillægges gennemførelsesbeføjelse til at fastsætte de nødvendige regler til gennemførelse af beredskabsplaner.
(78)
Tidligere dyresundhedskriser har vist fordelene ved at have specifikke, detaljerede og hurtige procedurer for håndtering af sygdomskriser. Sådanne organisatoriske procedurer bør sikre en hurtig og effektiv reaktion og bør forbedre koordinering af alle de involverede parters indsats, herunder navnlig de kompetente myndigheder og interessenterne. De bør også omfatte samarbejde med de kompetente myndigheder i nabomedlemsstater og de tilgrænsende tredjelande og territorier, hvis det er praktisk muligt og relevant.
(79)
For at sikre, at beredskabsplanerne er anvendelige i praksis i rigtige krisesituationer, er det nødvendigt at afprøve de pågældende systemer og sikre, at de fungerer. Med henblik herpå bør medlemsstaternes kompetente myndigheder gennemføre simuleringsøvelser i samarbejde med de kompetente myndigheder i nabomedlemsstaterne og de tilgrænsende tredjelande og territorier, hvis det er praktisk muligt og relevant.
(80)
For at sikre ensartede betingelser for gennemførelse af beredskabsplaner og simuleringsøvelser bør Kommissionen tildeles gennemførelsesbeføjelse til at fastsætte regler for gennemførelse af disse planer og øvelser i praksis.
(81)
Veterinærlægemidler såsom vacciner, hyperimmunsera og antimikrobielle midler spiller en vigtig rolle i forbindelse med forebyggelse og bekæmpelse af overførbare dyresygdomme. I konsekvensanalysen vedrørende vedtagelse af denne forordning fremhæves især betydningen af vacciner som et redskab til forebyggelse, bekæmpelse og udryddelse af dyresygdomme.
(82)
For visse overførbare dyresygdommes vedkommende er det imidlertid nødvendigt, at bekæmpelsesstrategierne omfatter forbud mod eller restriktioner for anvendelse af visse veterinærlægemidler, idet brug af disse ville mindske effektiviteten af strategierne. F.eks. kan visse veterinærlægemidler sløre de kliniske sygdomstegn, umuliggøre påvisning af en sygdomsfremkaldende agens eller vanskeliggøre hurtig differentialdiagnosticering og derved bringe en korrekt påvisning af sygdommen i fare.
(83)
Disse bekæmpelsesstrategier kan dog variere betydeligt, alt efter hvilken listeopført sygdom der er tale om. Der bør derfor i denne forordning fastsættes regler for brug af veterinærlægemidler til forebyggelse og bekæmpelse af visse listeopførte sygdomme samt harmoniserede kriterier til brug for stillingtagen til, hvorvidt og hvordan vacciner, hyperimmunsera og antimikrobielle midler skal anvendes. For at sikre en smidig tilgang og for at tage højde for de forskellige listeopførte sygdommes individuelle karakteristika og adgangen til effektive behandlinger bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår restriktioner for, forbud mod eller pligt til anvendelse af bestemte veterinærlægemidler som led i bekæmpelse af visse listeopførte sygdomme. I hastetilfælde bør det med henblik på at håndtere nye risici med potentielle ødelæggende konsekvenser for dyre- eller folkesundheden, økonomien, samfundet eller miljøet være muligt at vedtage de relevante foranstaltninger efter hasteproceduren.
(84)
I forlængelse af konklusionerne i ekspertudtalelsen om vaccine- og/eller diagnostikbanker for alvorlige dyresygdomme bør der tages skridt til, at Unionen og medlemsstaterne kan opbygge lagre af antigener, vacciner og diagnostiske reagenser til listeopførte sygdomme, der udgør en alvorlig trussel mod dyre- eller folkesundheden. Oprettelse af en EU-antigen-, -vaccine- og -diagnostisk reagens-bank ville fremme opnåelse af Unionens dyresundhedsmæssige målsætninger ved at muliggøre en hurtig og effektiv indsats, når der er behov for bankens ressourcer, og ville udgøre en effektiv udnyttelse af begrænsede ressourcer.
(85)
For at sikre en sådan hurtig og effektiv indsats bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår oprettelse og forvaltning af sådanne banker samt sikkerhedsstandarder og krav vedrørende driften af dem. Denne forordning bør dog ikke give mulighed for at vedtage regler om finansiering af sygdomsforebyggelses- og -bekæmpelsesforanstaltningerne, herunder vaccination.
(86)
Der bør fastlægges kriterier for prioriteret adgang til EU-antigen-, -vaccine- og -diagnostisk reagens-bankernes ressourcer for at sikre effektiv distribution heraf i krisesituationer.
(87)
Af hensyn til sikkerheden over for bioterrorisme og agroterrorisme bør visse oplysninger om EU-antigen-, -vaccine- og -diagnostisk reagens-banker behandles som klassificerede informationer og offentliggørelse heraf forbydes. Hvad angår samme type oplysninger vedrørende nationale vaccinebanker bør de forskellige medlemsstaters forfatningsmæssige bestemmelser om informationsfrihed overholdes, samtidig med at det sikres, at de pågældende informationer behandles som klassificerede informationer.
(88)
For at sikre ensartede betingelser for forvaltning af EU-antigen-, -vaccine- og -diagnostisk reagens-banker bør Kommissionen tildeles gennemførelsesbeføjelse til at fastsætte nærmere regler for, hvilke biologiske produkter der skal indgå i disse banker, og hvilke sygdomme de skal dække, nærmere regler om forsyning, mængder, opbevaring og udlevering, proceduremæssige og tekniske krav til antigener, vacciner og diagnostiske reagenser samt hyppigheden og indholdet af indgivelser af oplysninger til Kommissionen.
(89)
I tilfælde af et udbrud af en listeopført sygdom, der anses for at udgøre en høj risiko for dyre- eller folkesundheden i Unionen, bør medlemsstaterne sikre, at der træffes øjeblikkelige sygdomsbekæmpelsesforanstaltninger til udryddelse af den pågældende sygdom for at beskytte dyre- og folkesundheden.
(90)
Den kompetente myndighed bør være ansvarlig for at indlede de første undersøgelser til bekræftelse eller udelukkelse af et udbrud af en meget smitsom listeopført sygdom, der anses for at udgøre en høj risiko for dyre- eller folkesundheden i Unionen.
(91)
Den kompetente myndighed bør iværksætte foreløbige sygdomsbekæmpelsesforanstaltninger for at hindre spredning af den listeopførte sygdom og bør foretage en epidemiologisk undersøgelse.
(92)
Så snart en listeopført sygdom er blevet bekræftet, bør den kompetente myndighed træffe de nødvendige sygdomsbekæmpelsesforanstaltninger, herunder om nødvendigt oprettelse af restriktionszoner, for at udrydde og hindre yderligere spredning af den pågældende sygdom.
(93)
Forekomst af en listeopført sygdom hos vildtlevende dyr kan indebære en risiko for folkesundheden og opdrættede dyrs sundhed. Der bør derfor fastsættes særlige regler om sygdomsbekæmpelses- og udryddelsesforanstaltninger for vildtlevende dyr, når det er nødvendigt.
(94)
Der kan være tilfælde, hvor små bestande af visse dyr, f.eks. sjældne racer og arter, kan bringes i fare af almindelige sygdomsbekæmpelsesforanstaltninger i tilfælde af forekomst af en listeopført sygdom. Beskyttelse af sådanne racer og arter kan kræve ændrede foranstaltninger truffet af den kompetente myndighed. Sådanne ændringer bør imidlertid ikke hæmme den overordnede bekæmpelse af sygdommen.
(95)
For så vidt angår listeopførte sygdomme, der ikke er meget smitsomme, og som er omfattet af obligatoriske regler, der kræver deres udryddelse, bør sygdomsbekæmpelsesforanstaltninger iværksættes på en måde, der forhindrer, at de pågældende sygdomme spredes, især til ikkeangrebne områder. De pågældende foranstaltninger kan dog eventuelt være mere begrænsede eller anderledes end dem, der gælder for de farligste listeopførte sygdomme. Ved denne forordning bør der derfor fastsættes særlige regler for disse mindre farlige sygdomme. Medlemsstater, der har indført et valgfrit udryddelsesprogram, bør også iværksætte sådanne sygdomsbekæmpelsesforanstaltninger. I visse tilfælde kan udryddelse, afhængigt af sygdomsprofilen og den epidemiologiske situation, være et mål på lang sigt, mens målet på kort sigt kan være bekæmpelse af sygdommen. Sygdomsbekæmpelsesforanstaltningernes omfang og intensitet bør dog stå i rimeligt forhold til målene og tage hensyn til den pågældende listeopførte sygdoms karakteristika, fordeling og betydning for den berørte medlemsstat og Unionen som helhed.
(96)
For at sikre, at operatører, personer, der holder selskabsdyr, og de kompetente myndigheder anvender de sygdomsbekæmpelsesforanstaltninger, der fastlægges i denne forordning, på effektiv vis, og under hensyntagen til de særlige karakteristika ved sygdomsbekæmpelsesforanstaltningerne for de enkelte listeopførte sygdomme og de relevante risikofaktorer bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår detaljerede sygdomsbekæmpelsesforanstaltninger, der skal gennemføres, i tilfælde af mistanke om eller bekræftelse af en listeopført sygdom på virksomheder og andre steder samt i restriktionszoner.
(97)
For at gøre det muligt for Kommissionen at vedtage midlertidige særlige sygdomsbekæmpelsesforanstaltninger i tilfælde, hvor de i denne forordning fastlagte sygdomsbekæmpelsesforanstaltninger ikke er tilstrækkelige eller egnede til at håndtere den involverede risiko, bør Kommissionen tildeles gennemførelsesbeføjelse til at fastlægge særlige sygdomsbekæmpelsesforanstaltninger for et begrænset tidsrum.
(98)
Det er nødvendigt at registrere visse transportører og virksomheder, der holder landdyr, håndterer avlsmateriale eller transporterer sådanne dyr/sådant materiale, for at den kompetente myndighed kan foretage passende overvågning og forebygge, bekæmpe og udrydde overførbare dyresygdomme.
(99)
For at undgå uberettigede administrative byrder og omkostninger bør medlemsstaterne have begrænset mulighed for at fritage bestemte typer virksomheder, der udgør en lav risiko, fra registreringsforpligtelsen. For at opnå en harmoniseret tilgang til meddelelse af sådanne fritagelser bør Kommissionen tillægges gennemførelsesbeføjelser. En sådan harmoniseret tilgang er især nødvendig for at hindre, at bestemte typer virksomheder fritages fra registreringsforpligtelsen. Dette er særlig relevant ikke kun for de virksomheder, der udgør mere end en ubetydelig risiko for dyresundheden, men også for virksomheder, der udgør mere end en ubetydelig risiko for folkesundheden. Et eksempel på en sådan risiko er hold af dyr, der lever i tæt kontakt med eller i nærheden af mennesker, som f.eks. hundeopdræt på et niveau, der indebærer en vis kontinuitet og en vis grad af organisation, hvor hovedformålet er salg, med henblik på at hundene bliver selskabsdyr i husstande.
(100)
Hvis en bestemt type virksomhed, der holder landdyr eller håndterer eller opbevarer avlsmateriale, udgør en særlig dyresundhedsmæssig risiko, bør den skulle godkendes af den kompetente myndighed.
(101)
For at undgå uberettigede administrative byrder og omkostninger, navnlig for virksomheder, der udgør en lav risiko, bør der, hvor det er muligt, sikres en fleksibilitet i forbindelse med de relevante foranstaltninger, der gør det muligt at tilpasse ordningen for registrering og godkendelse til lokale og regionale forhold og produktionsmønstre.
(102)
I visse tilfælde er det ønskeligt eller nødvendigt at harmonisere visse betingelser for registrering eller godkendelse i hele Unionen. For eksempel bør avlsmaterialevirksomheder og sammenbringninger opfylde visse betingelser og bør blive godkendt med henblik på at overholde internationale standarder for dermed at gøre det muligt for Unionen at give dyresundhedsmæssige garantier til tredjelande i forbindelse med handel. Sådanne betingelser bør også indebære krav om særlig uddannelse eller erhvervsmæssige kvalifikationer for visse meget specifikke virksomheder eller aktiviteter (f.eks. for embryoopsamlingshold) eller endog en forpligtelse til særligt tilsyn fra den kompetente myndighed. Kommissionen bør derfor tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 290 i TEUF vedrørende disse nærmere krav med henblik på at fastsætte sådanne specifikke betingelser.
(103)
For at mindske de administrative byrder bør registrering og godkendelse så vidt muligt integreres i et registrerings- eller godkendelsessystem, som den enkelte medlemsstat allerede har indført i andet øjemed.
(104)
Operatører har førstehåndskendskab til de dyr, som de er ansvarlige for. De bør derfor have ajourførte fortegnelser over oplysninger, der er relevante for vurdering af dyresundhedsstatussen, for sporbarhed og for en epidemiologisk undersøgelse i tilfælde af forekomst af en listeopført sygdom. Disse fortegnelser bør være lettilgængelige for den kompetente myndighed.
(105)
For at sikre, at der findes ajourførte oplysninger om registrerede virksomheder og operatører og godkendte virksomheder, bør de kompetente myndigheder oprette og føre et register over sådanne virksomheder og operatører. Beføjelsen til at vedtage retsakter bør delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår, hvilke oplysninger der skal indgå i registret over virksomheder og operatører.
(106)
For at blive godkendt af den kompetente myndighed bør en virksomhed skulle opfylde visse krav. Inden den kompetente myndighed giver godkendelse, bør den ved et besøg på stedet kontrollere, om alle kravene er opfyldt. I nogle tilfælde kan alle betingelserne ikke straks opfyldes, men de resterende mangler udgør ikke en betydelig risiko for dyre- eller folkesundheden. I disse tilfælde bør det være muligt for den kompetente myndighed at give betinget godkendelse efterfulgt af endnu et besøg på stedet for at kontrollere, at der er sket fremskridt. I sådanne tilfælde bør den kompetente myndighed give operatørerne af de pågældende virksomheder den nødvendige effektive vejledning, så den pågældende operatør forstår manglen og kan planlægge en vellykket afhjælpning.
(107)
Effektiv sporbarhed er et centralt element i sygdomsbekæmpelsespolitik. Der bør være identifikations- og registreringskrav, der er specifikke for de forskellige arter af opdrættede landdyr og avlsmateriale, med henblik på at lette effektiv anvendelse af denne forordnings regler om forebyggelse og bekæmpelse af sygdomme. Derudover er det vigtigt at fastsætte regler, der giver mulighed for at indføre en ordning for identifikation og registrering af arter, der i dag ikke er omfattet af en sådan ordning, eller når ændrede omstændigheder og risici tilsiger det.
(108)
Med hensyn til visse dyrearter, for hvilke det er vigtigt at kunne spore enkelte dyr eller dyregrupper, bør der stilles krav om et fysisk identifikationsmiddel. Dette indebærer, at det pågældende dyr mærkes fysisk, forsynes med et mærke eller en mikrochip eller på anden måde identificeres ved hjælp af en metode, der kan ses eller spores på eller i dyrets krop, og som ikke let kan fjernes.
(109)
For at sikre, at identifikations- og registreringssystemet fungerer godt, og sikre sporbarhed bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår forpligtelser vedrørende databaser, detaljerede identifikations- og registreringskrav for forskellige dyrearter, herunder fritagelser og betingelser for sådanne fritagelser, og dokumenter.
(110)
Det bør sikres, at de administrative byrder og omkostninger begrænses, og at systemet er smidigt i situationer, hvor sporbarhedskravene kan opfyldes på andre måder end dem, der fastsættes i denne forordning. Beføjelsen til at vedtage retsakter bør derfor delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår undtagelser fra identifikations- og registreringskravene.
(111)
For at sikre ensartede betingelser for gennemførelse af identifikations- og registreringssystemet og sporbarhed bør Kommissionen tillægges gennemførelsesbeføjelse for så vidt angår fastsættelse af regler vedrørende tekniske specifikationer for databaser, identifikationsmidler, dokumenter og formater samt tidsfrister.
(112)
Et vigtigt redskab til at forebygge introduktion og spredning af en overførbar dyresygdom er at fastsætte restriktioner for flytning af dyr og produkter, der kan overføre den pågældende sygdom. Begrænsning af flytning af dyr og produkter kan imidlertid have alvorlige økonomiske konsekvenser og kan gribe forstyrrende ind i det indre markeds funktion. Sådanne restriktioner bør derfor kun anvendes, når det er nødvendigt og står i rimeligt forhold til de relevante risici. Denne tilgang er i tråd med principperne i SPS-aftalen og OIE's internationale standarder.
(113)
De almindelige krav i denne forordning bør gælde for alle flytninger af dyr, såsom forbuddet mod flytning af dyr fra en virksomhed, hvor der er abnorm dødelighed eller andre sygdomssymptomer med ukendte årsager, eller sygdomsforebyggelseskrav i forbindelse med transport.
(114)
Den nuværende retlige ramme, der er fastsat i EU-lovgivningen på området for dyresundhed, om flytning af landdyr og produkter indebærer harmoniserede regler primært for sådan flytning mellem medlemsstaterne, mens det overlades til medlemsstaterne at fastsætte de nødvendige flytningskrav på deres område. Konsekvensanalysen vedrørende denne forordnings vedtagelse omfattede en udførlig sammenligning mellem den nuværende situation og en model, hvor reglerne for flytning inden for de enkelte medlemsstater også ville blive harmoniseret på EU-plan. Det er blevet konkluderet, at den nuværende tilgang bør fastholdes, da fuldstændig harmonisering af alle flytninger vil være meget kompleks, og fordi fordelene i form af lettelse af flytninger imellem medlemsstaterne ikke opvejer den negative indvirkning på muligheden for at bekæmpe sygdomme, som en sådan tilgang kan få.
(115)
Der bør gælde en række grundlæggende dyresundhedsmæssige krav for dyr, der flyttes mellem medlemsstaterne. Først og fremmest bør dyr ikke flyttes fra virksomheder, hvor der er abnorm dødelighed eller sygdomstegn med ukendte årsager. Dødelighed — selv abnorm dødelighed — i forbindelse med videnskabelige procedurer, der er tilladt i henhold til Europa-Parlamentets og Rådets direktiv 2010/63/EU 
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, og som ikke kan tilskrives infektion med listeopførte sygdomme, bør dog ikke være en grund til at hindre flytning af dyr i videnskabeligt øjemed.
(116)
Denne forordning bør imidlertid sikre den fornødne fleksibilitet til at lette flytning af arter og kategorier af landdyr, der udgør en lav risiko for spredning af listeopførte sygdomme mellem medlemsstaterne. Der bør desuden være yderligere muligheder for undtagelser i tilfælde, hvor medlemsstater eller operatører har indført effektive alternative risikobegrænsende foranstaltninger, f.eks. et højt biosikringsniveau og effektive overvågningssystemer.
(117)
Hovdyr og fjerkræ er grupper af dyrearter af stor økonomisk betydning og er omfattet af særlige flytningskrav i henhold til EU-lovgivning vedtaget inden denne forordning, nemlig Rådets direktiv 64/432/EØF 
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, 91/68/EØF 
(
21
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, 2009/156/EF 
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, 2009/158/EF 
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23
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 og til dels direktiv 92/65/EØF. Hovedreglerne for flytning af dyr af nævnte arter bør fastsættes i denne forordning. Detaljerede krav, som i vid udstrækning afhænger af de sygdomme, der kan overføres via forskellige arter eller kategorier af dyr, bør fastsættes i efterfølgende kommissionsretsakter under hensyntagen til de enkelte sygdommes, dyrearters og dyrekategoriers særlige karakteristika.
(118)
Eftersom sammenbringning af hovdyr og fjerkræ er forbundet med en særlig høj sygdomsrisiko, bør det antal dyr, som kan sammenbringes i én flytning mellem medlemsstater, begrænses, og der bør i denne forordning fastsættes særlige regler for at beskytte sundheden for de dyr, der bringes sammen, og hindre spredning af overførbare dyresygdomme. Sammenbringning finder som regel sted på en virksomhed, der er godkendt til formålet, eller, såfremt det er tilladt af oprindelsesmedlemsstaten, den første sammenbringning på et transportmiddel som f.eks. en lastbil ved opsamling af dyr forskellige steder i denne medlemsstat.
(119)
Afhængigt af de pågældende listeopførte sygdomme og arter er det nødvendigt at fastsætte særlige dyresundhedsmæssige krav for visse andre dyrearter end opdrættede hovdyr og fjerkræ. Regler for disse arter er også fastsat inden for den retlige ramme, der har fundet anvendelse inden denne forordning, navnlig direktiv 92/65/EØF. Dette direktiv indeholder særlige regler om flytning af dyrearter såsom bier, humlebier, primater, hunde og katte, og der bør derfor ved denne forordning fastlægges et retsgrundlag for vedtagelse af delegerede retsakter og gennemførelsesretsakter om særlige regler for flytning af de pågældende dyrearter.
(120)
Afgrænsede virksomheder, som sædvanligvis anvendes til hold af laboratoriedyr eller dyr til zoologiske haver, er normalt kendetegnet ved et højt biosikringsniveau og en god og velkontrolleret sundhedsstatus samt færre flytninger eller udelukkende flytninger inden for de pågældende virksomheders lukkede system. Status som afgrænset virksomhed, som operatører frivilligt kan ansøge om, blev indført ved direktiv 92/65/EØF, som fastsætter godkendelsesregler og -krav samt flytningskrav for godkendte organer, institutter og centre. Det dermed etablerede system gør det muligt for de pågældende virksomheder at udveksle dyr indbyrdes med færre flytningskrav, samtidig med at der gives sundhedsgarantier inden for afgrænsede virksomheders lukkede system. Systemet har derfor fået bred tilslutning fra operatører og anvendes som en frivillig mulighed. Begrebet afgrænsede virksomheder bør følgelig opretholdes i denne forordning, som også bør fastsætte regler for flytning mellem sådanne virksomheder.
(121)
Det kan være nødvendigt at flytte dyr, der ikke opfylder de almindelige dyresundhedsmæssige krav i denne forordning, og som udgør en højere dyresundhedsmæssig risiko, i videnskabeligt øjemed, f.eks. til forsknings- eller diagnosticeringsformål, navnlig formål godkendt i henhold til direktiv 2010/63/EU. Sådanne flytninger bør ikke forbydes eller begrænses unødigt ved denne forordning, da dette kan hæmme ellers tilladte forskningsaktiviteter og sinke den videnskabelige udvikling. Ikke desto mindre er det af afgørende betydning, at der i denne forordning fastsættes regler til at sikre, at flytning af sådanne dyr foregår på sikker vis.
(122)
Mønstrene for flytning af cirkusdyr, dyr i zoologiske haver, dyr, der skal udstilles, og visse andre dyr afviger ofte fra flytningsmønstrene for andre opdrættede arter. Tilpasning af EU-reglerne om dyreflytninger til sådanne dyr bør ske på grundlag af særlige overvejelser, hvor der tages hensyn til specifikke risici og alternative risikobegrænsende foranstaltninger.
(123)
For at sikre, at målene omhandlet i betragtning 112-122 nås, bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår sygdomsforebyggende foranstaltninger i forbindelse med transport, særlige regler for flytning af visse dyrearter og særlige situationer, såsom sammenbringning af dyr eller afvisning af sendinger, samt særlige krav til eller undtagelser for andre typer af flytninger, f.eks. flytning i videnskabeligt øjemed.
(124)
For at sikre mulighed for at anvende særlige regler for flytning i tilfælde, hvor de almindelige flytningsregler ikke er tilstrækkelige eller egnede til at begrænse spredningen af en bestemt sygdom, bør Kommissionen tildeles gennemførelsesbeføjelse til at fastsætte særlige flytningsregler for et begrænset tidsrum.
(125)
Flytninger af opdrættede landdyr mellem medlemsstater bør opfylde kravene til sådanne flytninger. Dyrearter, der udgør en sundhedsrisiko, eller der er af større økonomisk betydning, bør ledsages af et dyresundhedscertifikat udstedt af den kompetente myndighed.
(126)
I det omfang det er teknisk, praktisk og økonomisk muligt, bør der drages nytte af den teknologiske udvikling til at mindske de administrative byrder for operatører og de kompetente myndigheder i forbindelse med certificering og anmeldelse ved at anvende informationsteknologi som erstatning for papirdokumentation og til at lette anmeldelsesprocedurerne og så vidt muligt anvende sådan teknologi til flere forskellige formål.
(127)
I tilfælde, hvor der ikke er et krav om, at et dyresundhedscertifikat udstedes af en kompetent myndighed, bør en operatør, der flytter dyr til en anden medlemsstat, udfærdige en personlig erklæring, som bekræfter, at dyrene opfylder flytningskravene i denne forordning.
(128)
For at sikre, at målene i denne forordnings betragtning 125, 126 og 127 nås, bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår regler om indholdet af dyresundhedscertifikater, oplysningsforpligtelser, undtagelser fra kravene vedrørende dyresundhedscertificering, særlige certificeringsregler og embedsdyrlægers pligt til at foretage behørig kontrol forud for underskrivelse af et dyresundhedscertifikat.
(129)
Anmeldelse af flytninger af dyr og avlsmateriale mellem medlemsstater og i visse tilfælde på medlemsstaters nationale område er af afgørende betydning for at sikre sporbarheden af de(t) pågældende dyr og avlsmateriale, når sådanne flytninger kan være forbundet med en risiko for spredning af overførbare dyresygdomme. Sådanne flytninger bør derfor anmeldes og registreres ved hjælp af det integrerede veterinærinformationssystem (»Traces«). Traces-systemet integrerer de EDB-systemer, der er omhandlet i artikel 20 i henholdsvis direktiv 90/425/EØF og Rådets beslutning 92/438/EØF 
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, i en fælles struktur på grundlag af Kommissionens beslutning 2003/24/EF 
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 og 2004/292/EF 
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.
(130)
For at sikre ensartede betingelser for gennemførelse af denne forordnings regler om dyresundhedscertificering og anmeldelse af flytninger bør Kommissionen tildeles gennemførelsesbeføjelse til at fastsætte regler vedrørende standarddyresundhedscertifikater, personlige erklæringer, formater og tidsfrister for anmeldelse af flytninger for både landdyr og akvatiske dyr, avlsmateriale og, hvis det også er relevant, animalske produkter.
(131)
De særlige karakteristika for flytninger af selskabsdyr udgør en dyresundhedsmæssig risiko, som afviger betydeligt fra risikoen ved andre opdrættede dyr. Der bør derfor i denne forordning fastsættes særlige, mindre strenge, regler for sådanne flytninger. Disse mindre strenge regler er imidlertid kun berettigede, hvis det pågældende selskabsdyr reelt ledsager ejeren under ejerens flytning eller i en begrænset periode derefter, og hvis højst fem selskabsdyr, jf. bilag I, del A, flyttes sammen med ejeren på én gang. For at sikre, at selskabsdyr ikke udgør en signifikant risiko for spredning af overførbare dyresygdomme, og for at præcisere de ekstraordinære situationer, hvor mere end fem selskabsdyr må ledsage ejeren, eller hvor et selskabsdyr vil skulle flyttes i et længere tidsrum før eller efter ejerens flytning, bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår nærmere regler om flytning af sådanne dyr. For at sikre ensartede betingelser for gennemførelse af denne forordnings dyresundhedsmæssige krav vedrørende flytning af selskabsdyr bør Kommissionen tildeles gennemførelsesbeføjelse til at fastsætte regler om sygdomsforebyggelses- og -bekæmpelsesforanstaltninger, der skal træffes med henblik på sådanne flytninger.
(132)
Vildtlevende dyr kan af forskellige årsager udgøre en dyre- og folkesundhedsmæssig risiko, f.eks. hvis de flyttes ind på en virksomhed eller fra ét miljø til et andet. Det kan være nødvendigt at træffe passende forebyggende foranstaltninger vedrørende flytning af de pågældende dyr for at undgå spredning af overførbare dyresygdomme. For at sikre, at vildtlevende dyr ikke udgør en signifikant risiko for spredning af overførbare dyresygdomme, bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår yderligere krav vedrørende flytning af vildtlevende landdyr.
(133)
Avlsmateriale kan udgøre en tilsvarende risiko for spredning af overførbare dyresygdomme til levende dyr. Dertil kommer, at der til produktion af sådant materiale knytter sig særlige aspekter, som vedrører høje sundhedskrav til avlsdyr, og som nødvendiggør strengere eller særlige dyresundhedsmæssige krav til donordyr. For at garantere sikre flytninger af avlsmateriale, for at bevare den forventede høje sundhedsstandard i forbindelse hermed og for at tage hensyn til visse særlige anvendelsesformål for sådant materiale bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår nærmere krav til flytning af avlsmateriale af visse dyrearter, særlige krav for f.eks. flytning af sådant materiale i videnskabeligt øjemed, og undtagelser fra dyresundhedscertificeringsforpligtelsen.
(134)
Animalske produkter kan udgøre en risiko for spredning af overførbare dyresygdomme. De fødevaresikkerhedsmæssige krav til animalske produkter, der er fastsat i EU-lovgivningen, sikrer god hygiejnepraksis og mindsker de dyresundhedsmæssige risici ved disse produkter. Der bør imidlertid i denne forordning fastlægges særlige dyresundhedsforanstaltninger, såsom sygdomsbekæmpelses- og hasteforanstaltninger, som skal anvendes for visse typer af produkter for at sikre, at dyresygdomme ikke spredes med animalske produkter. For at sikre sikker flytning af animalske produkter i disse særlige tilfælde bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår fastsættelse af nærmere regler om flytning af animalske produkter i relation til de sygdomsbekæmpelsesforanstaltninger, der træffes, forpligtelserne vedrørende dyresundhedscertificering og undtagelser fra disse regler, hvis den risiko, der er forbundet med den pågældende flytning, og de indførte risikobegrænsende foranstaltninger tillader det.
(135)
Når medlemsstaterne træffer nationale foranstaltninger vedrørende flytning af dyr og avlsmateriale eller beslutter at træffe nationale foranstaltninger for at begrænse virkningerne af andre overførbare dyresygdomme end listeopførte sygdomme på deres område, bør de pågældende nationale foranstaltninger ikke være i strid med EU-lovgivningen om det indre marked. Der bør derfor fastlægges en ramme for sådanne nationale foranstaltninger, ligesom det bør sikres, at foranstaltningerne ligger inden for de grænser, der er tilladt i henhold til EU-retten.
(136)
Det er nødvendigt at registrere og godkende akvakulturvirksomheder, for at den kompetente myndighed kan foretage en passende overvågning og forebygge, bekæmpe og udrydde overførbare dyresygdomme. I henhold til direktiv 2006/88/EF skal alle virksomheder, der flytter akvatiske dyr, autoriseres. Dette autorisationssystem bør opretholdes i henhold til denne forordning, selv om der på nogle af Unionens officielle sprog anvendes andre udtryk for autorisationssystemet i denne forordning end dem, der anvendes i direktiv 2006/88/EF.
(137)
Overførbare dyresygdomme kan spredes i forbindelse med slagtning og forarbejdning af akvakulturdyr, der er omfattet af sygdomsbekæmpelsesforanstaltninger, f.eks. som følge af udledning af spildevand, der indeholder patogener, fra forarbejdningsvirksomheder. Det er derfor nødvendigt at godkende forarbejdningsvirksomheder, der overholder de risikobegrænsende foranstaltninger vedrørende sådan slagtning og forarbejdning. Denne forordning bør således indeholde regler om godkendelse af sygdomsbekæmpelsesvirksomheder for akvatiske fødevarer.
(138)
For at sikre, at offentligheden har adgang til ajourførte oplysninger om registrerede og godkendte virksomheder, bør den kompetente myndighed oprette og føre et register over sådanne virksomheder. Beføjelsen til at vedtage retsakter bør delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår de oplysninger, der skal indgå i registre over akvakulturvirksomheder, og kravene til akvakulturvirksomheder og transportører vedrørende føring af fortegnelser.
(139)
For at sikre ensartede betingelser for gennemførelse af denne forordnings regler vedrørende registrering og godkendelse af akvakulturvirksomheder og sygdomsbekæmpelsesvirksomheder for akvatiske fødevarer samt føring af fortegnelser og registre over virksomheder bør Kommissionen tildeles gennemførelsesbeføjelse til at fastsætte regler vedrørende oplysningsforpligtelser, undtagelser og andre gennemførelsesregler i den forbindelse.
(140)
Eftersom det i de fleste tilfælde ikke er muligt at identificere individuelle akvatiske dyr, er akvakulturvirksomheders, sygdomsbekæmpelsesvirksomheder for akvatiske fødevarers og transportørers føring af fortegnelser et vigtigt redskab til at sikre sporbarhed af akvatiske dyr. Fortegnelser fungerer også som et værdifuldt værktøj i forbindelse med overvågning af sundhedssituationen på virksomhederne.
(141)
Som det er tilfældet for landdyr, er det nødvendigt at fastsætte harmoniserede regler for flytning af akvatiske dyr, herunder regler om dyresundhedscertificering og anmeldelse af flytninger.
(142)
Der er ved direktiv 2006/88/EF fastsat regler om flytning af akvatiske dyr, som gælder for både flytning inden for den enkelte medlemsstat og mellem medlemsstaterne. Den afgørende faktor i forbindelse med reglerne om flytning af akvatiske dyr er sundhedsstatussen for så vidt angår de listeopførte sygdomme i den medlemsstat, de zoner og de kompartmenter, der er bestemmelsessted.
(143)
Direktiv 2006/88/EF udelader imidlertid vildtlevende akvatiske dyr, der fanges eller høstes for direkte at indgå i fødevarekæden, fra sit anvendelsesområde. De er derimod omfattet af denne forordnings anvendelsesområde, men er ikke omfattet af definitionen af akvakulturdyr. Der bør derfor ved denne forordning fastsættes mulige foranstaltninger for sådanne akvatiske dyr, hvor de relevante risici berettiger hertil, under hensyntagen til forholdsmæssigheden af sådanne foranstaltninger.
(144)
Derfor bør det princip, der forklares i betragtning 142, også finde anvendelse på flytning af akvatiske dyr, der ikke defineres som akvakulturdyr, men er omfattet af denne forordnings anvendelsesområde. Dette gælder især for akvatiske dyr med en ukendt eller bekræftet sygdomspositiv sundhedsstatus uanset deres endelige anvendelse. Da flytning af vildtlevende akvatiske dyr med en ukendt eller bekræftet sygdomspositiv sundhedsstatus, der er bestemt til konsum, også kan udgøre en risiko for spredning af listeopførte eller nye sygdomme, bør samme regler også gælde for dem. Dette omfatter også de vildtlevende akvatiske dyr, der høstes eller fanges med henblik på konsum, og som flyttes og midlertidig holdes indtil slagtetidspunktet.
(145)
Uforholdsmæssige flytningsrestriktioner og unødvendige administrative byrder for virksomheder og operatører inden for den kommercielle fiskerisektor bør imidlertid undgås. I tilfælde, hvor sådanne levende vildtlevende akvatiske dyr er bestemt til konsum, bør de pågældende regler derfor i princippet kun gælde for flytninger af levende vildtlevende akvatiske dyr, som udgør en betydelig risiko for spredning af listeopførte eller nye sygdomme ind i medlemsstater, zoner eller kompartmenter, der er erklæret frie for visse listeopførte sygdomme eller er omfattet af udryddelsesprogrammer for disse sygdomme.
(146)
For at tilskynde medlemsstaterne til at forbedre sundhedsstatussen for deres bestande af akvatiske dyr bør der indføres visse justeringer og øget fleksibilitet ved denne forordning.
(147)
For at sikre kontrol med flytning af akvatiske dyr bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår sygdomsforebyggende foranstaltninger i forbindelse med transport, særlige regler for flytning af visse kategorier af akvatiske dyr til forskellige formål, særlige krav eller undtagelser for visse typer af flytning, f.eks. flytning i videnskabeligt øjemed, og yderligere krav til flytning af vildtlevende akvatiske dyr.
(148)
For at sikre mulighed for midlertidige undtagelser og særlige krav til flytning af akvatiske dyr i tilfælde, hvor de i denne forordning fastsatte flytningsregler ikke er tilstrækkelige eller egnede til at begrænse spredningen af en bestemt listeopført sygdom, bør Kommissionen tildeles gennemførelsesbeføjelse til at fastsætte særlige flytningsregler eller undtagelser for et begrænset tidsrum.
(149)
Unionens akvakulturproduktion er særdeles forskelligartet med hensyn til arter og produktionssystemer, og denne forskelligartethed øges hastigt. Dette kan kræve at de enkelte medlemsstater vedtager nationale foranstaltninger vedrørende andre sygdomme end dem, der betragtes som listeopførte i henhold til denne forordning. Sådanne nationale foranstaltninger bør dog være begrundede, nødvendige og stå i rimeligt forhold til de mål, der skal nås. Endvidere bør de ikke påvirke flytninger mellem medlemsstater, medmindre de er nødvendige for at forhindre introduktion af eller bekæmpe spredning af sygdomme. Nationale foranstaltninger, der påvirker handelen mellem medlemsstater, bør skulle godkendes og løbende revurderes på EU-plan.
(150)
I dag er andre dyrearter end dem, der er defineret som landdyr eller akvatiske dyr i denne forordning, f.eks. krybdyr, padder, insekter mv., kun i meget begrænset omfang berørt af listeopførte sygdomme. Det bør derfor ikke kræves, at alle denne forordnings bestemmelser finder anvendelse på de pågældende dyrearter. Hvis en sygdom, der berører andre arter end landdyr og akvatiske dyr, imidlertid bliver listeopført, bør de relevante dyresundhedsmæssige krav i denne forordning gælde for de pågældende arter, så det sikres, at der kan træffes passende sygdomsforebyggelses- og -bekæmpelsesforanstaltninger, som står i rimeligt forhold til de mål, der skal nås.
(151)
For at sikre, at det er muligt at fastsætte regler for flytning af dyr, der ikke falder ind under definitionen af landdyr eller akvatiske dyr i denne forordning, og avlsmateriale og animalske produkter af sådanne dyr, når en risiko tilsiger det, bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår registrering og godkendelse af virksomheder, føring af fortegnelser og registre, identifikation og registrering, krav vedrørende flytning med hensyn til sporbarhed, dyresundhedscertificering og udfærdigelse af personlige erklæringer og forpligtelser vedrørende anmeldelse af flytninger af dyr samt avlsmateriale og animalske produkter af de pågældende arter.
(152)
Når det er nødvendigt for at sikre ensartede betingelser for gennemførelse af de dyresundhedsmæssige krav for de pågældende andre dyrearter samt avlsmateriale og animalske produkter deraf, bør Kommissionen tildeles gennemførelsesbeføjelse til at fastsætte nærmere regler vedrørende disse krav.
(153)
For at forhindre introduktion af listeopførte sygdomme og nye sygdomme i Unionen er det nødvendigt at have effektive regler for indførsel til Unionen af dyr, avlsmateriale og animalske produkter, der kan overføre sådanne sygdomme.
(154)
For at garantere Unionens sundhedsstatus fastsætter denne forordning bestemmelser vedrørende flytning af dyr og produkter inden for Unionen. For ikke at bringe denne status i fare er det derfor hensigtsmæssigt at pålægge betingelser for indførsel af dyr og produkter til Unionen, som ikke er mindre strenge end dem, der gælder for flytninger inden for Unionen.
(155)
For at sikre, at dyr, avlsmateriale og animalske produkter fra tredjelande eller territorier opfylder de dyresundhedsmæssige krav, der giver garantier, som svarer til dem, der foreskrives i EU-lovgivningen, er det nødvendigt, at de(t) underkastes passende kontrol af den kompetente myndighed i det tredjeland eller territorium, hvorfra de(t) eksporteres til Unionen. Hvis det er relevant, bør et oprindelsestredjelands eller oprindelsesterritoriums sundhedsstatus verificeres, inden der gives tilladelse til indførsel til Unionen af de(t) pågældende dyr, avlsmateriale eller animalske produkter. Følgelig bør kun tredjelande og territorier, der kan godtgøre, at de opfylder de dyresundhedsmæssige standarder for indførsel af dyrene og produkterne til Unionen, være berettiget til at eksportere dem til Unionen og listeopføres i overensstemmelse hermed.
(156)
For visse arter og kategorier af dyr, avlsmateriale og animalske produkter er der ikke i EU-retsakter vedtaget inden denne forordning opstillet EU-lister over tredjelande og territorier, hvorfra indførsel til Unionen er tilladt. I disse tilfælde bør medlemsstaterne, indtil der er vedtaget regler i henhold til denne forordning, kunne beslutte, fra hvilke lande og territorier de(t) pågældende dyr, avlsmateriale og animalske produkter kan indføres til deres område. Medlemsstaterne bør i forbindelse med sådanne beslutninger tage hensyn til de i denne forordning fastsatte kriterier for EU-listerne over tredjelande og territorier.
(157)
For at sikre, at de dyresundhedsmæssige krav i denne forordning vedrørende indførsel til Unionen opfyldes, og at de er i overensstemmelse med principperne i OIE-kodekserne, bør alle dyr, alt avlsmateriale og alle animalske produkter, der indføres til Unionen, ledsages af et dyresundhedscertifikat udstedt af oprindelsestredjelandets eller oprindelsesterritoriets kompetente myndighed, som bekræfter, at alle de dyresundhedsmæssige krav vedrørende indførsel til Unionen er opfyldt. Der bør dog være mulighed for at fravige denne regel for produkter, der udgør en lav dyresundhedsmæssig risiko.
(158)
Dyresundhedscertifikater kan være fyldestgørende i sig selv, men EU-lovgivningen foreskriver ofte certificering til andre formål, f.eks. til attestering af, at folkesundheds- eller dyrevelfærdsmæssige krav for dyr eller produkter er opfyldt. Det er nødvendigt at tage hensyn til dette. Med henblik på at minimere de administrative byrder og omkostninger bør de pågældende dyresundhedscertifikater også kunne indeholde oplysninger, der kræves i henhold til anden EU-lovgivning vedrørende fødevare- og fodersikkerhed og dyrevelfærd.
(159)
Sygdomme kan spredes på andre måder end med dyr, avlsmateriale, animalske produkter, animalske biprodukter og afledte produkter. F.eks. kan køretøjer, transportcontainere, hø, halm, planteprodukter, materialer, der kan have været i kontakt med inficerede dyr, og udstyr også sprede sygdomme. Når det er nødvendigt, bør der træffes foranstaltninger til at forhindre, at sygdomme overføres på disse måder.
(160)
For at sikre en passende detaljeringsgrad i kravene vedrørende indførsel til Unionen bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår vedtagelse af supplerende regler om godkendelse af virksomheder i tredjelande og territorier og undtagelser herfra, dyresundhedsmæssige krav vedrørende indførsel til Unionen af sendinger fra tredjelande og territorier samt dyresundhedsmæssige krav vedrørende sygdomsfremkaldende agenser, andet materiale, transportmidler og udstyr, der kan overføre dyresygdomme.
(161)
For at sikre ensartede betingelser for gennemførelse af de dyresundhedsmæssige krav vedrørende indførsel til Unionen af sendinger af dyr, avlsmateriale og animalske produkter bør Kommissionen tildeles gennemførelsesbeføjelse til at fastsætte regler om bl.a. listen over tredjelande og territorier, hvorfra det er tilladt at indføre dyr, avlsmateriale og animalske produkter til Unionen, og indholdet og udformningen af standarddyresundhedscertifikater.
(162)
Erfaringer har vist, at det ved udbrud af en alvorlig sygdom i medlemsstater eller i tredjelande eller territorier, hvorfra dyr eller produkter indføres til Unionen, er nødvendigt øjeblikkelig at træffe sygdomsforebyggelses- og -bekæmpelsesforanstaltninger for at forhindre introduktion og begrænse spredning af sygdommen. En sådan krisesituation kan omfatte listeopførte sygdomme, nye sygdomme eller andre farer for dyrs sundhed. Det bør i denne forbindelse præciseres, hvilke af de i denne forordning fastlagte sygdomsforebyggelses- og -bekæmpelsesforanstaltninger der kan anvendes i tilfælde af forekomst af en listeopført eller ny sygdom eller en fare. I alle sådanne tilfælde er det af afgørende betydning, at foranstaltninger kan træffes med meget kort varsel og uden forsinkelser. Eftersom sådanne foranstaltninger vil begrænse flytninger inden for eller til Unionen, bør de iværksættes på EU-plan, når det er muligt.
(163)
For at sikre en effektiv og hurtig indsats over for nye risici bør Kommissionen tildeles gennemførelsesbeføjelse til at fastlægge hasteforanstaltninger.
(164)
Kommissionen bør i behørigt begrundede tilfælde vedtage gennemførelsesretsakter, der straks finder anvendelse, om bl.a. foranstaltninger vedrørende nye sygdomme, lageropbygning, forsyning, opbevaring, udlevering og andre procedurer for EU-antigen-, -vaccine- og -diagnostisk reagens-banker, fastlæggelse af særlige sygdomsbekæmpelsesforanstaltninger og undtagelser for et begrænset tidsrum, særlige regler om flytninger af landdyr og akvatiske dyr for et begrænset tidsrum, hasteforanstaltninger samt listeopførelse af tredjelande og territorier med hensyn til indførsel til Unionen.
(165)
Ved denne forordning fastsættes der almindelige og særlige regler om forebyggelse og bekæmpelse af overførbare dyresygdomme, ligesom der sikres en harmoniseret tilgang til dyresundhed i hele Unionen. På visse områder, f.eks. overordnede ansvarsområder vedrørende dyresundhed, anmeldelse, overvågning, registrering og godkendelse eller sporbarhed, bør medlemsstaterne have tilladelse til eller tilskyndes til at anvende supplerende eller strengere nationale foranstaltninger. Sådanne nationale foranstaltninger bør dog kun være tilladt, hvis de ikke bringer de dyresundhedsmæssige målsætninger fastsat i denne forordning i fare, ikke er i strid med denne forordning og ikke er til hinder for flytning af dyr og produkter mellem medlemsstaterne, medmindre det er nødvendigt for at forhindre introduktion af eller bekæmpe sygdomme.
(166)
Nationale foranstaltninger som omhandlet i betragtning 165 bør være underkastet en forenklet anmeldelsesprocedure for at begrænse den administrative byrde. Erfaringen har vist, at den generelle anmeldelsesprocedure, der er fastlagt i Europa-Parlamentets og Rådets direktiv 98/34/EF 
(
27
)
, har været et vigtigt redskab som rettesnor for og til forbedring af kvaliteten af nationale tekniske forskrifter — i form af øget gennemskuelighed, læsbarhed og effektivitet — på ikkeharmoniserede eller delvis harmoniserede områder. Den generelle anmeldelsesprocedure bør derfor finde anvendelse.
(167)
EU-reglerne om dyresundhed er i dag indeholdt i følgende retsakter fra Europa-Parlamentet og Rådet og i senere kommissionsretsakter vedtaget i henhold til dem:
direktiv 64/432/EØF, Rådets direktiv 77/391/EØF 
(
28
)
, Rådets direktiv 78/52/EØF 
(
29
)
, Rådets direktiv 80/1095/EØF 
(
30
)
, Rådets direktiv 82/894/EØF 
(
31
)
, Rådets direktiv 88/407/EØF 
(
32
)
, Rådets direktiv 89/556/EØF 
(
33
)
, Rådets direktiv 90/429/EØF 
(
34
)
,
direktiv 91/68/EØF, beslutning 91/666/EØF 
(
35
)
, Rådets direktiv 92/35/EØF 
(
36
)
, direktiv 92/65/EØF, Rådets direktiv 92/66/EØF 
(
37
)
, Rådets direktiv 92/118/EØF 
(
38
)
, Rådets direktiv 92/119/EØF 
(
39
)
, Rådets beslutning 95/410/EF 
(
40
)
, Rådets direktiv 2000/75/EF 
(
41
)
, Rådets beslutning 2000/258/EF 
(
42
)
, Rådets direktiv 2001/89/EF 
(
43
)
,
Rådets direktiv 2002/60/EF 
(
44
)
, Rådets direktiv 2002/99/EF 
(
45
)
, Rådets direktiv 2003/85/EF 
(
46
)
, Rådets forordning (EF) nr. 21/2004 
(
47
)
, Rådets direktiv 2004/68/EF 
(
48
)
, Rådets direktiv 2005/94/EF 
(
49
)
, direktiv 2006/88/EF, Rådets direktiv 2008/71/EF 
(
50
)
, direktiv 2009/156/EF, direktiv 2009/158/EF, Europa-Parlamentets og Rådets forordning (EU) nr. 576/2013 
(
51
)
.
(168)
Denne forordning fastsætter regler om identifikation og registrering af kvæg, hvorimod regler om mærkning af oksekød ikke er omfattet af dens anvendelsesområde. Europa-Parlamentets og Rådets forordning (EF) nr. 1760/2000 
(
52
)
 fastsætter regler om identifikation og registrering af kvæg og om mærkning af oksekød. Den bør derfor ændres for at ophæve bestemmelserne heri om identifikation og registrering af kvæg, mens bestemmelserne om mærkning af oksekød fortsat skal gælde.
(169)
For sikre troværdigheden af foranstaltningerne i de gældende forordninger om ordninger for identifikation og registrering af kvæg, får og geder, fordrer denne lovgivning, at medlemsstaterne gennemfører relevante og effektive kontrolforanstaltninger. Sådanne relevante og effektive offentlige kontrolforanstaltninger bør også bevares i fremtiden. Som en del af forslagspakken om mere intelligent lovgivning med henblik på sikrere fødevarer fastsættes der i denne forordning ikke bestemmelser om offentlig kontrol, da sådanne regler bør fastsættes inden for rammerne af den foreslåede horisontale lovgivning om offentlig kontrol. Selv hvis de foreslåede nye horisontale regler om offentlig kontrol ikke måtte træde i kraft på samme tid som denne forordning, vil Kommissionen imidlertid ved hjælp af de gældende horisontale regler om offentlig kontrol kunne sikre et tilsvarende kontrolniveau.
(170)
Reglerne i de lovgivningsmæssige retsakter, der er nævnt i betragtning 167, skal erstattes af denne forordning og efterfølgende retsakter fra Kommissionen vedtaget i henhold til denne forordning. Nævnte lovgivningsmæssige retsakter bør derfor ophæves. For at sikre juridisk klarhed og undgå et retligt tomrum bør ophævelsen dog først få virkning, når de relevante delegerede retsakter og gennemførelsesretsakter er vedtaget i henhold til denne forordning. Det er derfor nødvendigt at tillægge Kommissionen beføjelse til at fastlægge, hvornår ophævelsen af de pågældende lovgivningsmæssige retsakter får virkning, mens lovgiver bør fastsætte en frist.
(171)
Følgende rådsretsakter på dyresundhedsområdet er forældede og bør udtrykkeligt ophæves af hensyn til klarheden i EU-lovgivningen: Rådets beslutning 78/642/EØF 
(
53
)
, Rådets direktiv 79/110/EØF 
(
54
)
, Rådets direktiv 81/6/EØF 
(
55
)
, Rådets beslutning 89/455/EØF 
(
56
)
, Rådets direktiv 90/423/EØF 
(
57
)
, Rådets beslutning 90/678/EØF 
(
58
)
, Rådets direktiv 92/36/EØF 
(
59
)
, Rådets direktiv 98/99/EF 
(
60
)
.
(172)
Kravene fastsat i denne forordning bør ikke finde anvendelse, før de vigtigste delegerede retsakter og gennemførelsesretsakter er vedtaget af Kommissionen i henhold til denne forordning, således at der afsættes en periode på 24 måneder fra vedtagelsen af de vigtigste retsakter før datoen, hvorfra de finder anvendelse, hvorved medlemsstaterne og operatører får mulighed for at tilpasse sig de nye regler på behørig vis. Derudover bør Kommissionen gives en periode på mindst 36 måneder til at udarbejde disse nye regler.
(173)
For at sikre retlig klarhed for så vidt angår anvendelse af reglerne om identifikation og registrering af dyr og sygdomsbekæmpelsesforanstaltninger for bestemte dyresygdomme og zoonoser bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for så vidt angår den dato, fra hvilken forordning (EF) nr. 21/2004 samt direktiv 92/66/EØF, 2000/75/EF, 2001/89/EF, 2002/60/EF, 2003/85/EF, 2005/94/EF og 2008/71/EF ophører med at finde anvendelse, idet der i den henseende bør fastsættes en frist i denne forordning.
(174)
I overensstemmelse med den forebyggende tilgang til dyresundhed, som fremmes med denne forordning, bør de særlige foranstaltninger vedrørende salmonella, der fandt anvendelse på levende dyr afsendt til Finland og Sverige inden den 20. april 2016, fortsat gælde, og forordning (EF) nr. 2160/2003 bør ændres i overensstemmelse hermed.
(175)
I betragtning af vedtagelsen for nylig af forordning (EU) nr. 576/2013 er det ønskeligt at fastsætte en lang overgangsperiode, før de tilsvarende regler i nærværende forordning finder anvendelse.
(176)
Gennemførelsesbeføjelserne i henhold til denne forordning bør udøves i overensstemmelse med Europa-Parlamentets og Rådets forordning (EU) nr. 182/2011 
(
61
)
.
(177)
Det er navnlig vigtigt, at Kommissionen gennemfører relevante høringer under sit forberedende arbejde, herunder på ekspertniveau. Kommissionen bør i forbindelse med forberedelsen og udarbejdelsen af delegerede retsakter sørge for samtidig, rettidig og hensigtsmæssig fremsendelse af relevante dokumenter til Europa-Parlamentet og Rådet.
(178)
Denne forordning bør ikke medføre uforholdsmæssigt store administrative byrder eller økonomiske konsekvenser for små og mellemstore virksomheder. Der er i denne forordning på grundlag af høringer af interessenter taget hensyn til små og mellemstore virksomheders særlige situation. En eventuel generel undtagelse fra denne forordnings krav for sådanne virksomheder er i betragtning af de samfundsmæssige målsætninger om at beskytte dyre- og folkesundheden ikke blevet overvejet. Disse virksomheder bør imidlertid fritages for en række af kravene i denne forordning under hensyntagen til de relevante risici.
(179)
Målene for denne forordning, nemlig at fastsætte dyresundhedsregler for dyr, avlsmateriale, animalske produkter, animalske biprodukter og afledte produkter, i det omfang de(t) ikke er omfattet af særlige regler i anden EU-lovgivning, og for andet materiale, der kan være med til at sprede overførbare dyresygdomme, kan ikke i tilstrækkelig grad opfyldes af medlemsstaterne, men kan bedre nås på EU-plan via en fælles, koordineret retlig ramme for dyresundhed; Unionen kan derfor vedtage foranstaltninger i overensstemmelse med nærhedsprincippet, jf. artikel 5 i traktaten om Den Europæiske Union. I overensstemmelse med proportionalitetsprincippet, jf. nævnte artikel, går denne forordning ikke videre, end hvad der er nødvendigt for at nå disse mål —
VEDTAGET DENNE FORORDNING:
DEL I
ALMINDELIGE REGLER
KAPITEL 1
Genstand, formål, anvendelsesområde og definitioner
Artikel 1
Genstand og formål
1.   Ved denne forordning fastsættes regler om forebyggelse og bekæmpelse af dyresygdomme, der kan overføres til dyr eller mennesker.
Reglerne vedrører:
a)
prioritering og kategorisering af sygdomme af betydning for Unionen samt for fastlæggelse af ansvarsområder inden for dyresundhed (del I: artikel 1-17)
b)
tidlig opdagelse og anmeldelse af samt rapportering om sygdomme, overvågning, udryddelsesprogrammer og status som sygdomsfri (del II: artikel 18-42)
c)
sygdomsberedskab og -bekæmpelse (del III: artikel 43-83)
d)
registrering og godkendelse af virksomheder og transportører samt flytning af og sporbarhed af dyr, avlsmateriale og animalske produkter inden for Unionen (del IV: artikel 84-228 og del VI: artikel 244-248 og 252-256)
e)
indførsel af dyr, avlsmateriale og animalske produkter til Unionen og eksport af sådanne sendinger fra Unionen (del V: artikel 229-243 og del VI: artikel 244-246 og 252-256)
f)
ikkekommercielle flytninger af selskabsdyr til en medlemsstat fra en anden medlemsstat eller fra et tredjeland eller territorium (del VI: artikel 244-256)
g)
hasteforanstaltninger, der skal træffes i tilfælde af en sygdomskrisesituation, (del VII: artikel 257-262).
2.   De i stk. 1 omhandlede regler
a)
har til formål at sikre:
i)
forbedret dyresundhed for at støtte bæredygtig landbrugs- og akvakulturproduktion i Unionen
ii)
et velfungerende indre marked
iii)
begrænsning af de negative virkninger for dyresundheden, folkesundheden og miljøet af:
—
visse sygdomme
—
de foranstaltninger, der træffes til forebyggelse og bekæmpelse af sygdomme
b)
tager hensyn til:
i)
sammenhængen mellem dyresundhed og
—
folkesundheden
—
miljøet, herunder biodiversitet og værdifulde genetiske ressourcer, samt virkningerne af klimaændringer
—
fødevare- og fodersikkerhed
—
dyrevelfærd, herunder forskånelse for enhver undgåelig smerte, belastning eller lidelse
—
antimikrobiel resistens
—
fødevaresikring
ii)
de økonomiske, sociale, kulturelle og miljømæssige konsekvenser af anvendelse af sygdomsbekæmpelses- og -forebyggelsesforanstaltninger
iii)
relevante internationale standarder.
Artikel 2
Anvendelsesområde
1.   Denne forordning finder anvendelse på:
a)
opdrættede og vildtlevende dyr
b)
avlsmateriale
c)
animalske produkter
d)
animalske biprodukter og afledte produkter, uden at det berører reglerne i forordning (EF) nr. 1069/2009
e)
faciliteter, transportmidler, udstyr og alle andre infektionsveje og materialer, hvormed overførbare dyresygdomme spredes eller kan spredes.
2.   Denne forordning finder anvendelse på overførbare sygdomme, herunder zoonoser, uden at det berører reglerne i:
a)
afgørelse nr. 1082/2013/EU
b)
forordning (EF) nr. 999/2001
c)
direktiv 2003/99/EF
d)
forordning (EF) nr. 2160/2003.
Artikel 3
Anvendelsesområde for del IV, V og VI
1.   Del IV, afsnit I (artikel 84-171), finder anvendelse på:
a)
landdyr og dyr, der ikke er landdyr, men som kan overføre sygdomme, der angriber landdyr
b)
avlsmateriale af landdyr
c)
animalske produkter af landdyr.
2.   Del IV, afsnit II (artikel 172-226), finder anvendelse på:
a)
akvatiske dyr og dyr, der ikke er akvatiske dyr, men som kan overføre sygdomme, der angriber akvatiske dyr
b)
animalske produkter af akvatiske dyr.
3.   Del IV, afsnit III (artikel 227 og 228), finder anvendelse på:
a)
andre dyr
b)
avlsmateriale og animalske produkter af de i litra a) omhandlede andre dyr.
4.   Del IV og V finder ikke anvendelse på ikkekommercielle flytninger af selskabsdyr som omhandlet i denne artikels stk. 6 og ikkekommercielle flytninger af selskabsdyr i en medlemsstat.
5.   Flytninger af selskabsdyr, bortset fra ikkekommercielle flytninger, skal opfylde de dyresundhedsmæssige krav i del IV og V.
Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende de ændringer, der er nødvendige for at sikre, at del IV og V er korrekt anvendt på selskabsdyr, navnlig for at tage hensyn til, at selskabsdyr holdes i husstande af personer, der holder selskabsdyr.
6.   Del VI finder kun anvendelse på ikkekommercielle flytninger af selskabsdyr, der opfylder de krav, der er fastsat i artikel 245 og 246 om det maksimale antal dyr, der kan ledsage deres ejer, og det maksimale antal dage, der forløber, mellem ejerens flytning og flytningen af dyret.
Artikel 4
Definitioner
I denne forordning forstås ved:
1)   
»dyr«
: hvirveldyr og hvirvelløse dyr
2)   
»landdyr«
: fugle, landpattedyr, bier og humlebier
3)   
»akvatiske dyr«
: dyr af følgende arter på alle udviklingstrin, herunder æg, sæd og gameter:
a)
fisk, der tilhører overklassen 
Agnatha
 og klasserne 
Chondrichthyes, Sarcopterygii
 og 
Actinopterygii
b)
akvatiske bløddyr, der tilhører rækken 
Mollusca
c)
akvatiske krebsdyr, der tilhører underrækken 
Crustacea
4)   
»andre dyr«
: dyr af andre arter end arter, der er omfattet af definitionen af landdyr eller akvatiske dyr
5)   
»opdrættede dyr«
: dyr, der holdes af mennesker; herunder for akvatiske dyrs vedkommende akvakulturdyr
6)   
»akvakultur«
: opdræt af akvatiske dyr, hvor dyrene forbliver en eller flere fysiske eller juridiske personers ejendom i alle opdræts- eller dyrkningsfaserne, indtil de er høstet, bortset fra høst eller fangst med henblik på konsum af vildtlevende akvatiske dyr, der efterfølgende holdes midlertidigt indtil slagtetidspunktet uden at blive fodret
7)   
»akvakulturdyr«
: alle akvatiske dyr, der indgår i akvakultur
8)   
»vildtlevende dyr«
: dyr, der ikke er opdrættede dyr
9)   
»fjerkræ«
: fugle, der opdrættes eller holdes i fangenskab med henblik på:
a)
produktion af:
i)
kød
ii)
konsumæg
iii)
andre produkter
b)
fornyelse af fjervildtbestande
c)
avl af fugle, der anvendes til de i litra a) og b) omhandlede produktionstyper
10)   
»fugle i fangenskab«
: fugle, bortset fra fjerkræ, som holdes i fangenskab til ethvert andet formål end de i nr. 9) nævnte, herunder med henblik på opvisninger, kapflyvninger, udstillinger, konkurrencer, avl eller salg
11)   
»selskabsdyr«
: dyr af de i bilag I opførte arter, som holdes i privat ikkekommercielt øjemed
12)   
»person, der holder selskabsdyr«
: fysisk person, der holder selskabsdyr, hvilket kan omfatte en ejer af selskabsdyr
13)   
»ejer af selskabsdyr«
: fysisk person, der er angivet som ejer i identifikationsdokumentet, jf. artikel 247, litra c), artikel 248, stk. 2, litra c), artikel 249, stk. 1, litra c), og artikel 250, stk. 2, litra c)
14)   
»ikkekommerciel flytning«
: enhver flytning af et selskabsdyr, der ledsager sin ejer, som
a)
hverken har til formål at sælge eller på anden måde at overdrage ejendomsretten til det pågældende selskabsdyr, og
b)
indgår i selskabsdyrets ejers flytning
i)
enten under dennes direkte ansvar eller
ii)
under ansvar af en bemyndiget person, hvis selskabsdyret er fysisk adskilt fra sin ejer
15)   
»bemyndiget person«
: fysisk person, der har skriftlig bemyndigelse fra ejeren af et selskabsdyr til at foretage ikkekommerciel flytning af selskabsdyret på ejerens vegne
16)   
»sygdom«
: forekomsten af infektion eller parasitangreb hos dyr, med eller uden kliniske eller patologiske tegn, forårsaget af en eller flere sygdomsfremkaldende agenser
17)   
»sygdomsfremkaldende agens«
: patogen, der kan overføres til dyr eller mennesker, og som kan forårsage sygdom hos dyr
18)   
»listeopførte sygdomme«
: sygdomme, der er listeopført i henhold til artikel 5, stk. 1
19)   
»sygdomsprofil«
: kriterierne for en sygdom, jf. artikel 7, litra a)
20)   
»listeopført art«
: en dyreart eller gruppe af dyrearter, der er opført på den i artikel 8, stk. 2, omhandlede liste, eller, for så vidt angår nye sygdomme, en dyreart eller gruppe af dyrearter, der opfylder kriterierne for listeopførte arter i artikel 8, stk. 2
21)   
»fare«
: sygdomsfremkaldende agens i eller tilstand for et dyr eller et produkt, der potentielt kan fremkalde en sundhedsskadelig virkning på mennesker eller dyr
22)   
»risiko«
: sandsynligheden for indtræffen og det sandsynlige omfang af biologiske og økonomiske konsekvenser af en skadelig virkning på dyre- eller folkesundheden
23)   
»biosikring«
: summen af håndteringsforanstaltninger og fysiske foranstaltninger til begrænsning af risikoen for introduktion, udvikling og spredning af sygdomme til, fra og inden for:
a)
en dyrebestand eller
b)
en virksomhed, en zone, et kompartment, et transportmiddel eller en hvilken som helst anden facilitet, lokalitet eller et hvilket som helst andet sted
24)   
»operatør«
: enhver fysisk eller juridisk person, som er ansvarlig for dyr eller produkter, herunder for et begrænset tidsrum, bortset fra personer, der holder selskabsdyr, og dyrlæger
25)   
»transportør«
: operatør, der transporterer dyr for egen regning eller for tredjemands regning
26)   
»dyrefagperson«
: fysisk eller juridisk person, der i erhvervsøjemed beskæftiger sig med dyr eller produkter, bortset fra operatører og dyrlæger
27)   
»virksomhed«
: lokalitet, struktur eller i tilfælde af frilandsopdræt omgivelser eller sted, hvor der midlertidigt eller permanent holdes dyr eller opbevares avlsmateriale, bortset fra:
a)
husstande, hvor der holdes selskabsdyr
b)
dyrlægepraksisser eller -klinikker
28)   
»avlsmateriale«
:
a)
sæd, oocytter og embryoner bestemt til kunstig reproduktion
b)
rugeæg
29)   
»animalske produkter«
:
a)
animalske fødevarer, herunder honning og blod
b)
levende toskallede bløddyr, levende pighuder, levende sækdyr og levende havsnegle, der er bestemt til konsum, og
c)
dyr, bortset fra dyr som omhandlet i litra b), der er bestemt til at blive klargjort med henblik på at blive leveret levende til den endelige forbruger
30)   
»animalske biprodukter«
: hele kroppe eller dele af dyr, animalske produkter eller andre produkter fra dyr, som ikke er bestemt til konsum, bortset fra avlsmateriale
31)   
»afledte produkter«
: produkter, der er fremstillet ved en eller flere behandlinger, omdannelser eller trin i forarbejdningen af animalske biprodukter
32)   
»produkter«
:
a)
avlsmateriale
b)
animalske produkter
c)
animalske biprodukter og afledte produkter
33)   
»offentlig kontrol«
: alle former for kontrol udført af en kompetent myndighed med henblik på verifikation af overholdelse af denne forordning
34)   
»sundhedsstatus«
: sygdomsstatus med hensyn til de listeopførte sygdomme, der er relevante for en bestemt listeopført art, for så vidt angår:
a)
et dyr
b)
dyrene i:
i)
en epidemiologisk enhed
ii)
en virksomhed
iii)
en zone
iv)
et kompartment
v)
en medlemsstat
vi)
et tredjeland eller territorium
35)   
»zone«
:
a)
for landdyret geografisk klart afgrænset område i en medlemsstat, et tredjeland eller territorium med en delbestand af dyr med en særlig sundhedsstatus for så vidt angår en eller flere specifikke sygdomme, der er omfattet af passende overvågnings-, sygdomsbekæmpelses- og biosikringsforanstaltninger
b)
for akvatiske dyr et sammenhængende hydrologisk system med en særlig sundhedsstatus for så vidt angår en eller flere specifikke sygdomme, som udgør et område, der kan beskrives på en af følgende måder:
i)
et helt afvandingsområde fra et vandløbs udspring til udmundingen i havet eller en sø
ii)
mere end ét afvandingsområde
iii)
en del af et afvandingsområde fra et vandløbs udspring til en barriere, der forhindrer introduktion af en eller flere specifikke sygdomme
iv)
en geografisk klart afgrænset del af et kystområde
v)
en geografisk klart afgrænset udmunding i havet
36)   
»afvandingsområde«
: område eller forsænkning på landjorden, som afgrænses af naturlige elementer i landskabet såsom bakker eller bjerge, og som alt afstrømningsvand løber ud i
37)   
»kompartment«
: delbestand af dyr på en eller flere virksomheder — og for akvatiske dyrs vedkommende på en eller flere akvakulturvirksomheder — som er omfattet af et fælles biosikringsforvaltningssystem og har en særlig sundhedsstatus for så vidt angår en eller flere specifikke sygdomme, der er omfattet af passende overvågnings-, sygdomsbekæmpelses- og biosikringsforanstaltninger
38)   
»karantæne«
: dyrehold i isolation uden direkte eller indirekte kontakt med dyr uden for den pågældende epidemiologiske enhed med henblik på at sikre, at der ikke forekommer spredning af en eller flere angivne sygdomme, mens de isolerede dyr er under observation i et nærmere fastsat tidsrum og, hvis det er relevant, underkastes undersøgelser og behandling
39)   
»epidemiologisk enhed«
: en gruppe dyr med samme sandsynlighed for at blive eksponeret for en sygdomsfremkaldende agens
40)   
»udbrud«
: officielt bekræftet forekomst af en listeopført sygdom eller en ny sygdom hos et eller flere dyr på en virksomhed eller et andet sted, hvor der holdes eller befinder sig dyr
41)   
»restriktionszone«
: zone, hvor der gælder restriktioner for flytning af visse dyr eller produkter og andre sygdomsbekæmpelsesforanstaltninger, der har til formål at forhindre spredning af en bestemt sygdom til områder, der ikke er omfattet af restriktioner; en restriktionszone zone kan, hvis det er relevant, omfatte beskyttelses- og overvågningszoner
42)   
»beskyttelseszone«
: zone rundt om og inklusive stedet for et udbrud, hvor der anvendes sygdomsbekæmpelsesforanstaltninger for at forhindre spredning af sygdommen fra den pågældende zone
43)   
»overvågningszone«
: zone, der er etableret rundt om beskyttelseszonen, og hvor der anvendes sygdomsbekæmpelsesforanstaltninger for at forhindre spredning af sygdommen fra beskyttelseszonen
44)   
»rugeæg«
: æg lagt af fjerkræ eller fugle i fangenskab og bestemt til udrugning
45)   
»hovdyr«
: dyr, der er opført i bilag III
46)   
»avlsmaterialevirksomhed«
:
a)
i forbindelse med sæd en virksomhed, hvor sæd indsamles, produceres, forarbejdes eller opbevares
b)
i forbindelse med oocytter og embryoner en gruppe fagpersoner eller en struktur, der er under tilsyn af en teamdyrlæge, som har kompetence til at indsamle, producere, forarbejde og opbevare oocytter og embryoner
c)
i forbindelse med rugeæg et rugeri
47)   
»rugeri«
: virksomhed, der beskæftiger sig med indsamling, opbevaring, udrugning og klækning af æg med henblik på levering af:
a)
rugeæg
b)
daggamle kyllinger eller nyudklækkede unger af andre arter
48)   
»afgrænset virksomhed«
: en permanent geografisk afgrænset virksomhed, der er oprettet på frivillig basis og godkendt med hensyn til flytninger, hvor dyrene:
a)
opdrættes eller avles med henblik på udstillinger, uddannelse, bevaring af arter eller forskning
b)
holdes afgrænset og adskilt fra de omkringliggende omgivelser og
c)
er omfattet af dyresundhedsovervågning og biosikringsforanstaltninger
49)   
»sammenbringning«
: sammenbringning af opdrættede landdyr fra mere end én virksomhed i en kortere periode end den krævede opholdsperiode for den pågældende dyreart
50)   
»opholdsperiode«
: den minimumsperiode, der er nødvendig for at sikre, at et dyr, som er ført ind på en virksomhed, ikke har en lavere sundhedsstatus end dyrene på den pågældende virksomhed
51)   
»Traces«
: det integrerede veterinærinformationssystem med en fælles struktur, der er omhandlet i beslutning 2003/24/EF og 2004/292/EF
52)   
»sygdomsbekæmpelsesvirksomhed for akvatiske fødevarer«
: fødevarevirksomhed, der er godkendt i henhold til artikel 179
53)   
»embedsdyrlæge«
: dyrlæge, der er bemyndiget af den kompetente myndighed og tilstrækkeligt kvalificeret til at udføre officielle aktiviteter i overensstemmelse med denne forordning
54)   
»embedsdyrlæge i et tredjeland eller territorium«
: dyrlæge i et tredjeland eller territorium, der svarer til den i nr. 53) omhandlede embedsdyrlæge
55)   
»kompetent myndighed«
: en medlemsstats centrale veterinærmyndighed, som er ansvarlig for tilrettelæggelse af officiel kontrol og alle andre officielle aktiviteter i overensstemmelse med denne forordning, eller enhver anden myndighed, til hvilken dette ansvar er delegeret
56)   
»kompetent myndighed i et tredjeland eller territorium«
: myndighed i et tredjeland eller territorium, der svarer til den i nr. 55) omhandlede kompetente myndighed.
KAPITEL 2
Listeopførte sygdomme, nye sygdomme og listeopførte arter
Artikel 5
Listeopførelse af sygdomme
1.   De sygdomsspecifikke regler i denne forordning vedrørende forebyggelse og bekæmpelse af sygdomme finder anvendelse på:
a)
følgende listeopførte sygdomme:
i)
mund- og klovesyge
ii)
klassisk svinepest
iii)
afrikansk svinepest
iv)
højpatogen aviær influenza
v)
afrikansk hestepest og
b)
de listeopførte sygdomme i bilag II.
2.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende ændringer til listen omhandlet i nærværende artikels stk. 1, litra b).
3.   En sygdom opføres på listen i denne artikels stk. 1, litra b), hvis den er blevet vurderet i overensstemmelse med artikel 7, og den opfylder:
a)
alle de følgende kriterier:
i)
videnskabelig dokumentation viser, at sygdommen kan overføres
ii)
dyrearter er enten modtagelige for den pågældende sygdom, eller vektorer for og reservoirer af sygdommen findes i Unionen
iii)
sygdommen har negative virkninger på dyresundheden, eller udgør en risiko for folkesundheden på grund af dens zoonotiske karakter
iv)
diagnosticeringsværktøjer er til rådighed for sygdommen
v)
risikobegrænsende foranstaltninger og, hvor det er relevant, overvågning af sygdommen er effektiv(e) og står i et rimeligt forhold til de risici, der er forbundet med sygdommen i Unionen og
b)
mindst ét af følgende kriterier:
i)
sygdommen har eller kan have betydelige negative virkninger på dyresundheden i Unionen eller udgør eller kan udgøre en betydelig risiko for folkesundheden på grund af dens zoonotiske karakter
ii)
den sygdomsfremkaldende agens har udviklet resistens over for behandlingsmetoder, hvilket udgør en alvorlig fare for folkesundheden og/eller dyresundheden i Unionen
iii)
sygdommen har eller kan få betydelig negativ økonomisk indvirkning på landbrugs- eller akvakulturproduktionen i Unionen
iv)
sygdommen har potentialet til at skabe en krise, eller den sygdomsfremkaldende agens kan anvendes til bioterrorisme, eller
v)
sygdommen har eller kan få en betydelig negativ indvirkning på miljøet, herunder biodiversiteten i Unionen.
4.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende fjernelse af en sygdom fra den liste, der er omhandlet i nærværende artikels stk. 1, litra b), når denne sygdom ikke længere opfylder kriterierne i nærværende artikels stk. 3.
5.   Kommissionen tager listeopførelsen af hver enkelt sygdom op til revision på baggrund af nyligt tilgængelige signifikante videnskabelige data.
Artikel 6
Nye sygdomme
1.   Reglerne om forebyggelse og bekæmpelse af sygdomme finder anvendelse på nye sygdomme som fastsat i denne forordning.
2.   En sygdom, bortset fra en listeopført sygdom, anses for at være en ny sygdom (»ny sygdom«), hvis den har potentialet til at opfylde de kriterier for listeopførelse af sygdomme, der er fastlagt i artikel 5, stk. 3, og
a)
er resultatet af udvikling eller ændring af en eksisterende sygdomsfremkaldende agens
b)
er en kendt sygdom, der spredes til et nyt geografisk område, en ny art eller en ny bestand
c)
diagnosticeres for første gang i Unionen eller
d)
skyldes en ukendt eller tidligere ukendt sygdomsfremkaldende agens.
3.   Kommissionen træffer ved hjælp af gennemførelsesretsakter de nødvendige foranstaltninger vedrørende en ny sygdom, der opfylder kriterierne i nærværende artikels stk. 2. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
4.   I behørigt begrundede særligt hastende tilfælde vedrørende en sygdom, der udgør en ny risiko af meget betydeligt omfang, vedtager Kommissionen efter proceduren i artikel 266, stk. 3, gennemførelsesretsakter, der straks finder anvendelse.
5.   Enhver forpligtelse for operatører i forbindelse med en ny sygdom, der er fastsat i denne forordning, finder kun anvendelse, hvis Kommissionen har vedtaget en gennemførelsesretsakt vedrørende denne sygdom i overensstemmelse med denne artikels stk. 3, eller hvis sygdommen er omfattet af en beredskabsplan i overensstemmelse med artikel 43.
Artikel 7
Vurderingsparametre for listeopførelse af sygdomme
Kommissionen anvender følgende vurderingsparametre for at afgøre, om en sygdom opfylder de betingelser, der gør det nødvendigt at listeopføre den i henhold til artikel 5, stk. 2:
a)
sygdomsprofilen, som omfatter følgende:
i)
de dyrearter, der kan rammes af sygdommen
ii)
sygelighed og dødelighed forårsaget af sygdommen i dyrebestande
iii)
sygdommens zoonotiske karakter
iv)
resistens over for behandlingsmetoder, herunder antimikrobiel resistens
v)
sygdommens persistens i en dyrebestand eller i omgivelserne
vi)
sygdommens overførselsveje og -hastighed fra dyr til dyr og, hvis det er relevant, fra dyr til mennesker
vii)
fravær af sygdommen eller dens forekomst og udbredelse i Unionen samt, hvis sygdommen ikke forekommer i Unionen, risikoen for introduktion af den i Unionen
viii)
tilgængelige diagnosticerings- og sygdomsbekæmpelsesværktøjer
b)
sygdommens indvirkning på:
i)
landbrugs- og akvakulturproduktionen og andre dele af økonomien for så vidt angår:
—
omfanget af sygdommens forekomst i Unionen
—
produktionstab som følge af sygdommen
—
andre tab
ii)
menneskers sundhed for så vidt angår:
—
overførbarhed mellem dyr og mennesker
—
overførbarhed mellem mennesker
—
alvorligheden af de humane former af sygdommen
—
muligheden for effektiv forebyggelse hos eller medicinsk behandling af mennesker
iii)
dyrevelfærden
iv)
biodiversiteten og miljøet
c)
sygdommens potentiale til at forårsage en krisesituation og dens potentielle anvendelse i bioterrorisme
d)
gennemførligheden, tilgængeligheden og effektiviteten af følgende sygdomsforebyggelses- og -bekæmpelsesforanstaltninger:
i)
diagnosticeringsværktøjer og -kapacitet
ii)
vaccination
iii)
medicinsk behandling
iv)
biosikringsforanstaltninger
v)
restriktioner for flytning af dyr og produkter
vi)
aflivning af dyr
vii)
bortskaffelse af kadavere og andre relevante animalske biprodukter
e)
virkningerne af sygdomsforebyggelses- og -bekæmpelsesforanstaltninger for så vidt angår:
i)
de direkte og indirekte omkostninger for de berørte sektorer og økonomien som helhed
ii)
den samfundsmæssige accept af dem
iii)
velfærden for de ramte delbestande af opdrættede og vildtlevende dyr
iv)
miljøet og biodiversiteten.
Artikel 8
Listeopførelse af arter
1.   De sygdomsspecifikke regler for listeopførte sygdomme i denne forordning og reglerne vedtaget i henhold til denne forordning finder anvendelse på listeopførte arter.
2.   Kommissionen opstiller ved hjælp af gennemførelsesretsakter en liste over arter, jf. denne artikels stk. 1, som opfylder kriterierne i denne artikels stk. 3. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Denne liste skal indeholde de dyrearter eller grupper af dyrearter, der udgør en betydelig risiko for spredning af bestemte listeopførte sygdomme, ud fra følgende kriterier:
a)
den risikoudsatte dyrebestands modtagelighed
b)
varigheden af inkubationstiden og infektionstiden for de pågældende dyr
c)
de pågældende dyrs evne til at være bærere af disse bestemte sygdomme.
3.   Dyrearter eller grupper af dyrearter føjes til listen, hvis de er angrebet, eller hvis de udgør en risiko for spredning af en bestemt listeopført sygdom, fordi:
a)
de er modtagelige for en bestemt listeopført sygdom, eller videnskabelig dokumentation viser, at en sådan modtagelighed er sandsynlig, eller
b)
de er vektorarter eller reservoirer for denne sygdom, eller videnskabelig dokumentation viser, at en sådan rolle er sandsynlig.
4.   Kommissionen fjerner ved hjælp af gennemførelsesretsakter dyrearter eller grupper af dyrearter fra listen, når:
a)
den pågældende listeopførte sygdom, i forbindelse med hvilken den pågældende dyreart eller gruppe af dyrearter er blevet opført på listen, er blevet fjernet fra listen over sygdomme, eller
b)
videnskabelig dokumentation viser, at den pågældende art eller gruppe af arter ikke længere opfylder kriterierne i stk. 3.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 9
Sygdomsforebyggelses- og -bekæmpelsesregler, som skal finde anvendelse på forskellige kategorier af listeopførte sygdomme
1.   Sygdomsforebyggelses- og -bekæmpelsesregler finder anvendelse på listeopførte sygdomme som følger:
a)
For så vidt angår listeopførte sygdomme, som normalt ikke forekommer i Unionen, og for hvilke der skal træffes øjeblikkelige udryddelsesforanstaltninger, så snart de påvises, finder følgende regler anvendelse, hvor det er relevant:
i)
reglerne for sygdomsberedskab i del III, afsnit I (artikel 43-52)
ii)
sygdomsbekæmpelsesforanstaltningerne i del III, afsnit II, kapitel 1 (artikel 53-71), og
iii)
reglerne for afgrænsning af kompartmenter i artikel 37, stk. 1.
For disse listeopførte sygdomme finder de foranstaltninger, der er omhandlet i litra b) efter omstændighederne samt i litra d) og e), ligeledes anvendelse, hvor det er relevant.
b)
For så vidt angår listeopførte sygdomme, som skal bekæmpes i alle medlemsstaterne med henblik på at udrydde dem i hele Unionen, finder følgende regler anvendelse, hvor det er relevant:
i)
reglerne for obligatoriske udryddelsesprogrammer i artikel 31, stk. 1
ii)
reglerne for sygdomsfrie medlemsstater og zoner i artikel 36
iii)
reglerne for afgrænsning af kompartmenter i artikel 37, stk. 2, og
iv)
sygdomsbekæmpelsesforanstaltningerne i artikel 72-75, 77-79 samt 81 og 83.
For disse listeopførte sygdomme finder de foranstaltninger, der er omhandlet i litra d) og e), ligeledes anvendelse, hvor det er relevant.
c)
For så vidt angår listeopførte sygdomme, som har relevans for nogle medlemsstater, og for hvilke der er behov for foranstaltninger for at hindre spredning til de områder i Unionen, der officielt er sygdomsfrie eller har udryddelsesprogrammer for den pågældende listeopførte sygdom, finder følgende regler anvendelse, hvor det er relevant:
i)
reglerne for valgfri udryddelse i artikel 31, stk. 2
ii)
reglerne for sygdomsfrie medlemsstater og zoner i artikel 36
iii)
reglerne for afgrænsning af kompartmenter i artikel 37, stk. 2, og
iv)
reglerne for sygdomsbekæmpelsesforanstaltninger i artikel 76, 77, 78, 80, 82 og 83.
For disse listeopførte sygdomme finder de foranstaltninger, der er omhandlet i litra d) og e), ligeledes anvendelse, hvor det er relevant.
d)
For så vidt angår listeopførte sygdomme, for hvilke det er nødvendigt at træffe foranstaltninger for at hindre spredning som følge af sygdommenes indførsel i Unionen eller flytninger mellem medlemsstaterne, finder følgende regler anvendelse, hvor det er relevant:
i)
reglerne for flytning inden for Unionen i del IV, afsnit I, kapitel 3-6 (artikel 124-169), del IV, afsnit II, kapitel 2 og 3 (artikel 191-225), og del VI, kapitel 2 og 3 (artikel 247-251) og
ii)
reglerne for indførsel til og eksport fra Unionen i del V (artikel 229-243).
De listeopførte sygdomme omhandlet i litra a), b) og c) anses ligeledes for at være listeopførte sygdomme efter nærværende litra ligesom de i litra e) omhandlede listeopførte sygdomme, hvis den risiko, som den pågældende sygdom udgør, effektivt og forholdsmæssigt kan begrænses gennem foranstaltninger vedrørende flytning af dyr og produkter.
e)
For så vidt angår listeopførte sygdomme, for hvilke det er nødvendigt med overvågning i Unionen, finder følgende regler anvendelse, hvor det er relevant:
i)
reglerne for anmeldelse og rapportering i del II, kapitel 1 (artikel 18-23), og
ii)
reglerne for overvågning i del II, kapitel 2 (artikel 24-30).
De listeopførte sygdomme omhandlet i litra a), b) og c) betragtes også som listeopførte sygdomme efter nærværende litra.
2.   Kommissionen fastlægger ved hjælp af gennemførelsesretsakter anvendelsen af de i stk. 1 omhandlede sygdomsforebyggelses- og -bekæmpelsesregler på de respektive listeopførte sygdomme ud fra de kriterier, der er fastlagt i bilag IV, også på baggrund af nyligt tilgængelige signifikante videnskabelige data.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
3.   Kommissionen ændrer ved hjælp af gennemførelsesretsakter anvendelsen af sygdomsforebyggelses- og -bekæmpelsesreglerne i stk. 2 på de respektive listeopførte sygdomme, når en given sygdom ikke længere opfylder de kriterier, der er fastlagt i den relevante afdeling i bilag IV, også på baggrund af nyligt tilgængelige signifikante videnskabelige data.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
4.   I behørigt begrundede særligt hastende tilfælde vedrørende en listeopført sygdom, der udgør en ny risiko af meget betydeligt omfang, vedtager Kommissionen efter proceduren i artikel 266, stk. 3, gennemførelsesretsakter, der straks finder anvendelse.
KAPITEL 3
Ansvarsområder inden for dyresundhed
Afdeling 1
Operatører, dyrefagpersoner og personer, der holder selskabsdyr
Artikel 10
Ansvar for dyresundheds- og biosikringsforanstaltninger
1.   Operatører
a)
er for så vidt angår opdrættede dyr og produkter, som de har ansvaret for, ansvarlige for:
i)
de opdrættede dyrs sundhed
ii)
forsigtig og ansvarsbevidst brug af veterinærlægemidler, uden at dette berører dyrlægers rolle og ansvar
iii)
at minimere risikoen for spredning af sygdomme
iv)
god zooteknik
b)
træffer efter omstændighederne sådanne biosikringsforanstaltninger i forhold til opdrættede dyr og produkter, som de er ansvarlige for, for så vidt som det er relevant af hensyn til:
i)
de pågældende arter og kategorier af opdrættede dyr og produkter
ii)
produktionstypen og
iii)
de relevante risici under hensyntagen til:
—
geografisk beliggenhed og klimaforhold og
—
lokale forhold og lokal praksis
c)
træffer, hvor det er relevant, biosikringsforanstaltninger for så vidt angår vildtlevende dyr.
2.   Dyrefagpersoner tager skridt til at minimere risikoen for spredning af sygdomme, i forbindelse med at de i erhvervsøjemed beskæftiger sig med dyr og produkter.
3.   Stk. 1, litra a), finder også anvendelse på personer, der holder selskabsdyr.
4.   De i stk. 1, litra b), omhandlede biosikringsforanstaltninger gennemføres efter omstændighederne gennem:
a)
fysiske beskyttelsesforanstaltninger, som kan omfatte:
i)
efter omstændighederne indelukning, indhegning, tagdækning og net
ii)
rengøring, desinfektion og bekæmpelse af insekter og gnavere
iii)
for akvatiske dyr, hvis det er relevant:
—
foranstaltninger vedrørende vandforsyning og -udledning
—
naturlige eller kunstige barrierer for omkringliggende vandløb, som hindrer akvatiske dyr i at komme ind på eller forlade den pågældende virksomhed, herunder foranstaltninger mod oversvømmelse eller indtrængning af vand fra omkringliggende vandløb
b)
håndteringsforanstaltninger, der kan omfatte:
i)
procedurer for, hvordan dyr, produkter, køretøjer og personer kommer ind på og ud af virksomheden
ii)
procedurer for anvendelse af udstyr
iii)
betingelser for flytning baseret på de involverede risici
iv)
betingelser for indførsel af dyr eller produkter på virksomheden
v)
karantæne, isolation eller adskillelse af nyligt indførte eller syge dyr
vi)
et system til sikker bortskaffelse af døde dyr og andre animalske biprodukter.
5.   Operatører, dyrefagpersoner og personer, der holder selskabsdyr, samarbejder med den kompetente myndighed og dyrlæger om gennemførelsen af sygdomsforebyggelses- og -bekæmpelsesforanstaltningerne i denne forordning.
6.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte de minimumskrav, der er nødvendige for en ensartet anvendelse af denne artikel.
Sådanne gennemførelsesretsakter skal afspejle de forhold, der er omhandlet i stk. 1, litra b).
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 11
Viden om dyresundhed
1.   Operatører og dyrefagpersoner skal have passende viden om:
a)
dyresygdomme, herunder sygdomme, der kan overføres til mennesker
b)
biosikringsprincipper
c)
sammenhængen mellem dyresundhed, dyrevelfærd og menneskers sundhed
d)
god zooteknikpraksis for de dyrearter, der er i deres varetægt
e)
resistens over for behandlingsmetoder, herunder antimikrobiel resistens, og følgerne heraf.
2.   Arten og omfanget af den viden, der kræves i henhold til stk. 1, afhænger af:
a)
hvilke arter og kategorier af opdrættede dyr eller produkter de pågældende operatører og dyrefagpersoner er ansvarlige for, og hvordan de beskæftiger sig med disse dyr eller produkter i erhvervsøjemed
b)
produktionstypen
c)
hvilke opgaver de udfører.
3.   Den i stk. 1 omhandlede viden skal tilegnes på en af følgende måder:
a)
erhvervserfaring eller -uddannelse
b)
eksisterende programmer i landbrugs- eller akvakultursektoren af relevans for dyresundhed
c)
formel uddannelse
d)
anden erfaring eller uddannelse, som resulterer i samme niveau af viden som omhandlet i litra a), b) eller c).
4.   Operatører, der sælger eller på anden måde overdrager ejendomsretten til fremtidige selskabsdyr, giver den person, der skal holde selskabsdyr, grundlæggende oplysninger om forholdene i stk. 1, alt efter hvad der er relevant for det pågældende selskabsdyr.
Afdeling 2
Dyrlæger og fagpersoner med ekspertise i akvatiske dyrs sundhed
Artikel 12
Ansvarsområder for dyrlæger og fagpersoner med ekspertise i akvatiske dyrs sundhed
1.   Dyrlæger skal som led i udførelsen af aktiviteter, der falder ind under denne forordnings anvendelsesområde:
a)
træffe alle fornødne foranstaltninger til at forhindre introduktion, udvikling og spredning af sygdomme
b)
træffe foranstaltninger for at sikre, at sygdomme opdages tidligt, ved at foretage korrekt diagnosticering og differentialdiagnosticering til udelukkelse eller bekræftelse af en sygdom
c)
spille en aktiv rolle for så vidt angår:
i)
bevidstgørelse om dyresundhed og bevidsthed om sammenhængen mellem dyresundhed, dyrevelfærd og menneskers sundhed
ii)
sygdomsforebyggelse
iii)
tidlig opdagelse af og hurtig indsats over for sygdomme
iv)
bevidstgørelse om resistens over for behandlingsmetoder, herunder antimikrobiel resistens, og følgerne heraf
d)
samarbejde med den kompetente myndighed, operatører, dyrefagpersoner og personer, der holder selskabsdyr, om gennemførelsen af sygdomsforebyggelses- og -bekæmpelsesforanstaltningerne i denne forordning.
2.   Fagpersoner med ekspertise i akvatiske dyrs sundhed kan varetage aktiviteter, der i henhold til denne forordning henhører under dyrlæger, vedrørende akvatiske dyr, hvis de er bemyndiget hertil af den pågældende medlemsstat i henhold til national ret. I så fald finder stk. 1 anvendelse på de pågældende fagpersoner med ekspertise i akvatiske dyrs sundhed.
3.   Dyrlæger og fagpersoner med ekspertise i akvatiske dyrs sundhed skal opretholde og udvikle deres faglige kapacitet vedrørende de af deres aktivitetsområder, der er omfattet af denne forordning.
Afdeling 3
Medlemsstaterne
Artikel 13
Medlemsstaternes ansvarsområder
1.   For at sikre, at den kompetente myndighed for dyresundhed har kapacitet til at træffe nødvendige og relevante foranstaltninger og udføre de aktiviteter, der kræves i henhold til denne forordning, sørger hver medlemsstat på det relevante administrative niveau for, at den kompetente myndighed har:
a)
kvalificeret personale, faciliteter, udstyr, økonomiske ressourcer og en effektiv organisation, der dækker hele medlemsstatens område
b)
adgang til laboratorier med kvalificeret personale, faciliteter, udstyr og økonomiske ressourcer, der muliggør hurtig og præcis diagnosticering og differentialdiagnosticering af listeopførte sygdomme og nye sygdomme
c)
dyrlæger med den fornødne uddannelse, som deltager i udførelsen af de i artikel 12 omhandlede aktiviteter.
2.   Medlemsstaterne tilskynder operatører og dyrefagpersoner til at erhverve, opretholde og udvikle den i artikel 11 omhandlede passende viden om dyresundhed gennem relevante programmer i landbrugs- eller akvakultursektoren eller formel uddannelse.
Artikel 14
Den kompetente myndigheds delegation af officielle aktiviteter
1.   Den kompetente myndighed kan delegere en eller flere af følgende aktiviteter til dyrlæger, der ikke er embedsdyrlæger:
a)
den praktiske gennemførelse af foranstaltninger i udryddelsesprogrammerne, jf. artikel 32
b)
støtte til den kompetente myndighed til at foretage overvågning som omhandlet i artikel 26 eller vedrørende overvågningsprogrammer som omhandlet i artikel 28
c)
aktiviteter vedrørende:
i)
sygdomsberedskab og -bekæmpelse som omhandlet i del III vedrørende:
—
prøveudtagningsaktiviteter og gennemførelse af afdækkende og epidemiologiske undersøgelser inden for rammerne af artikel 54, artikel 55, stk. 1, litra b)-g), og artikel 57, 73, 74, 79 og 80 i tilfælde af mistanke om forekomst af en sygdom samt af enhver gennemførelsesretsakt og delegeret retsakt, der vedtages i henhold til disse artikler
—
udførelse af aktiviteter vedrørende sygdomsbekæmpelsesforanstaltninger i tilfælde af et sygdomsudbrud for så vidt angår aktiviteter anført i artikel 61, artikel 65, stk. 1, litra a), b), e), f) og i), artikel 70, stk. 1, artikel 79 og 80 og artikel 81, stk. 1 og 2, samt i enhver gennemførelsesretsakt og delegeret retsakt, der vedtages i henhold til disse artikler
—
foretagelse af nødvaccination i overensstemmelse med artikel 69
ii)
registrering, godkendelse, sporbarhed og flytning som omhandlet i del IV
iii)
udstedelse og udfyldelse af identifikationsdokumenter for selskabsdyr som omhandlet i artikel 247, litra c), artikel 248, stk. 2, litra c), artikel 249, stk. 1, litra c), og artikel 250, stk. 2, litra c)
iv)
anbringelse og anvendelse af identifikationsmidler som omhandlet i artikel 252, stk. 1, litra a), nr. ii).
2.   Medlemsstaterne kan bemyndige fysiske eller juridiske personer til at udføre de aktiviteter, der er omhandlet i stk. 1, litra a) og b), og stk. 1, litra c), nr. i), ii) og iv), for så vidt angår specifikt fastlagte opgaver, som disse personer har tilstrækkelig særlig viden om. I så fald finder stk. 1 i nærværende artikel og de i artikel 12 fastsatte ansvarsområder anvendelse på disse personer.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende andre aktiviteter, som ud over dem, der er omhandlet i stk. 1, kan delegeres til dyrlæger, og til, hvor det er relevant, at foreskrive de nødvendige vilkår og betingelser for en sådan delegation.
Kommissionen tager i forbindelse med vedtagelse af disse delegerede retsakter hensyn til arten af de pågældende aktiviteter og til de relevante internationale standarder.
Artikel 15
Information af offentligheden
Hvis der er begrundet mistanke om, at dyr eller produkter, der stammer fra Unionen, eller som indføres til Unionen udefra, kan udgøre en risiko, træffer den kompetente myndighed passende foranstaltninger til at informere offentligheden om arten af risikoen og de foranstaltninger, der træffes eller skal træffes for at forebygge eller bekæmpe den pågældende risiko, idet der tages hensyn til arten, alvorligheden og omfanget af risikoen og den offentlige interesse i at blive informeret.
Afdeling 4
Laboratorier, faciliteter og andre fysiske og juridiske personer, der håndterer sygdomsfremkaldende agenser, vacciner og andre biologiske produkter
Artikel 16
Forpligtelser for laboratorier, faciliteter og andre, der håndterer sygdomsfremkaldende agenser, vacciner og andre biologiske produkter
1.   Laboratorier, faciliteter og andre fysiske eller juridiske personer, der håndterer sygdomsfremkaldende agenser som led i forskning, uddannelse, diagnosticering eller fremstilling af vacciner og andre biologiske produkter, skal under hensyntagen til de relevante internationale standarder:
a)
træffe passende foranstaltninger vedrørende biosikring, biosikkerhed og biologisk indeslutning for at forhindre, at sygdomsfremkaldende agenser slipper ud og efterfølgende kommer i kontakt med dyr uden for laboratoriet eller andre faciliteter, der håndterer disse agenser i sådanne øjemed
b)
sikre, at flytning af sygdomsfremkaldende agenser, vacciner og andre biologiske produkter mellem laboratorier eller andre faciliteter ikke medfører risiko for spredning af listeopførte eller nye sygdomme.
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende sikkerhedsforanstaltninger til forebyggelse og bekæmpelse af listeopførte og nye sygdomme for laboratorier, faciliteter og andre fysiske eller juridiske personer, der håndterer sygdomsfremkaldende agenser, vacciner og andre biologiske produkter, for så vidt angår:
a)
foranstaltninger vedrørende biosikring, biosikkerhed og biologisk indeslutning
b)
krav vedrørende flytning af sygdomsfremkaldende agenser, vacciner og andre biologiske produkter.
Artikel 17
Dyresundhedslaboratorier
1.   Officielle laboratorier for dyresundhed, der består af EU-referencelaboratorier, nationale referencelaboratorier og officielle dyresundhedslaboratorier, samarbejder i forbindelse med varetagelsen af deres opgaver og ansvarsområder i et netværk af EU-dyresundhedslaboratorier.
2.   Laboratorierne, jf. stk. 1, samarbejder under koordinering af EU-referencelaboratorierne for at sikre, at den overvågning og anmeldelse af samt rapportering om sygdomme, de udryddelsesprogrammer, den definition af status som sygdomsfri tillige med de flytninger af dyr og produkter inden for Unionen, disses indførsel til Unionen og eksport til tredjelande eller til territorier, der er fastsat i denne forordning, er baseret på de seneste velfunderede og pålidelige laboratorieanalyser, -undersøgelser og -diagnoser.
3.   De officielle laboratoriers resultater og rapporter er underlagt principperne om tavshedspligt og fortrolighed samt anmeldelsespligt til den kompetente myndighed, som har udpeget dem, uden hensyn til den fysiske eller juridiske person, der anmodede om laboratorieanalyserne, -undersøgelserne eller -diagnoserne.
4.   Hvis et officielt laboratorium i en medlemsstat foretager diagnostiske analyser af prøver fra dyr med oprindelse i en anden medlemsstat, underretter det pågældende officielle laboratorium den kompetente myndighed i den medlemsstat, hvor prøverne kommer fra:
a)
straks om eventuelle resultater, der indikerer mistanke om eller påvisning af en listeopført sygdom som omhandlet i artikel 9, stk. 1, litra a)
b)
uden unødig forsinkelse om eventuelle resultater, der indikerer mistanke om eller påvisning af en listeopført sygdom som omhandlet i artikel 9, stk. 1, litra e), bortset fra dem, der er omhandlet i artikel 9, stk. 1, litra a).
DEL II
ANMELDELSE AF OG RAPPORTERING OM SYGDOMME, OVERVÅGNING, UDRYDDELSESPROGRAMMER OG STATUS SOM SYGDOMSFRI
KAPITEL 1
Anmeldelse af og rapportering om sygdomme
Artikel 18
Anmeldelse inden for medlemsstaterne
1.   Medlemsstaterne sikrer, at operatører og andre relevante fysiske eller juridiske personer
a)
øjeblikkelig underretter den kompetente myndighed, hvis der er grund til mistanke om forekomst af en listeopført sygdom som omhandlet i artikel 9, stk. 1, litra a), hos dyr, eller hvis forekomst af en sådan sygdom opdages hos dyr
b)
hurtigst muligt underretter den kompetente myndighed, hvis der er grund til mistanke om forekomst af andre listeopførte sygdomme, jf. artikel 9, stk. 1, litra e), end dem, der er omhandlet i artikel 9, stk. 1, litra a), hos dyr, eller hvis forekomst af en sådan sygdom opdages hos dyr
c)
underretter en dyrlæge om abnorm dødelighed og andre tegn på alvorlig sygdom eller markante fald i produktionen af ukendte årsager med henblik på yderligere undersøgelser, herunder prøveudtagning til laboratorieundersøgelse, når situationen kræver det.
2.   Medlemsstaterne kan beslutte, at anmeldelser som omhandlet i stk. 1, litra c), kan indgives direkte til den kompetente myndighed.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
kriterier for fastlæggelse af, hvorvidt de omstændigheder, der udløser krav om anmeldelse, jf. stk. 1, litra c), forekommer
b)
nærmere regler om yderligere undersøgelse som omhandlet i stk. 1, litra c).
Artikel 19
EU-anmeldelse
1.   Medlemsstaterne underretter øjeblikkelig Kommissionen og de øvrige medlemsstater om ethvert udbrud af listeopførte sygdomme som omhandlet i artikel 9, stk. 1, litra e), hvor øjeblikkelig anmeldelse er påkrævet for at sikre rettidig gennemførelse af de fornødne risikohåndteringsforanstaltninger under hensyntagen til sygdomsprofilen.
2.   En anmeldelse som omhandlet i stk. 1 skal indeholde følgende oplysninger om udbruddet:
a)
den sygdomsfremkaldende agens og, hvis det er relevant, subtypen
b)
de relevante datoer, navnlig datoen for henholdsvis opstået mistanke om og bekræftelse af udbruddet
c)
typen af og stedet for udbruddet
d)
eventuelle tilknyttede udbrud
e)
de dyr, der er berørt af udbruddet
f)
alle sygdomsbekæmpelsesforanstaltninger truffet i forbindelse med udbruddet
g)
den listeopførte sygdoms mulige eller kendte oprindelse
h)
de diagnosticeringsmetoder, der er benyttet.
Artikel 20
EU-rapportering
1.   Medlemsstaterne rapporterer til Kommissionen og de øvrige medlemsstater om listeopførte sygdomme som omhandlet i artikel 9, stk. 1, litra e), som:
a)
ikke er omfattet af krav om øjeblikkelig anmeldelse af udbrud i henhold til artikel 19, stk. 1
b)
er omfattet af krav om øjeblikkelig anmeldelse af udbrud i henhold til artikel 19, stk. 1, men for hvilke der skal gives yderligere oplysninger til Kommissionen og de øvrige medlemsstater om:
i)
overvågning i overensstemmelse med reglerne i en gennemførelsesretsakt vedtaget i henhold til artikel 30
ii)
et udryddelsesprogram i overensstemmelse med reglerne i en gennemførelsesretsakt vedtaget i henhold til artikel 35.
2.   De i stk. 1 omhandlede rapporter skal indeholde oplysninger om:
a)
påvisningen af de listeopførte sygdomme som omhandlet i stk. 1
b)
resultaterne af overvågningen, hvis der er krav herom i medfør af regler vedtaget i henhold til artikel 29, litra d), nr. ii), eller artikel 30, stk. 1, litra b), nr. ii)
c)
resultaterne af overvågningsprogrammerne, hvis der er krav herom i medfør af artikel 28, stk. 3, og regler vedtaget i henhold til artikel 29, litra d), nr. ii), eller artikel 30, stk. 1, litra b), nr. ii)
d)
udryddelsesprogrammerne, hvis der er krav herom i medfør af artikel 34 og regler fastsat i en gennemførelsesretsakt vedtaget i henhold til artikel 35.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende supplering af kravene i stk. 2 og rapportering om andre spørgsmål vedrørende overvågning og udryddelsesprogrammer, hvis det er nødvendigt for at sikre effektiv anvendelse af denne forordnings sygdomsforebyggelses- og -bekæmpelsesregler.
Artikel 21
Anmeldelses- og rapporteringsregioner
Medlemsstaterne fastlægger anmeldelses- og rapporteringsregioner med henblik på anmeldelse og rapportering som omhandlet i artikel 19 og 20.
Artikel 22
IT-system til EU-anmeldelser af og EU-rapportering om sygdomme
Kommissionen opretter og forvalter et IT-system til de mekanismer og værktøjer, der anvendes i forbindelse med anmeldelses- og rapporteringskravene i artikel, 19, 20 og 21.
Artikel 23
Gennemførelsesbeføjelser vedrørende EU-anmeldelse og -rapportering og IT-systemet
Kommissionen fastsætter ved hjælp af gennemførelsesretsakter regler om anmeldelses- og rapporteringskravene og IT-systemet som omhandlet i artikel 19-22 for så vidt angår:
a)
de i artikel 9, stk. 1, litra e), omhandlede listeopførte sygdomme, som medlemsstaterne skal anmelde øjeblikkelig, og de nødvendige foranstaltninger vedrørende anmeldelsen i overensstemmelse med artikel 19
b)
de oplysninger, som medlemsstaterne skal give i rapporteringen omhandlet i artikel 20
c)
procedurer for oprettelse og anvendelse af det i artikel 22 omhandlede IT-system og overgangsforanstaltninger vedrørende overførsel af data og oplysninger fra eksisterende systemer til det nye system og systemets fulde funktionsdygtighed
d)
formatet og strukturen af de data, der skal indlæses i det i artikel 22 omhandlede IT-system
e)
tidsfrister og hyppighed for anmeldelse og rapportering som omhandlet i artikel 19 og 20, som skal foretages på tidspunkter og med en hyppighed, der sikrer gennemsigtighed og rettidig anvendelse af de fornødne risikohåndteringsforanstaltninger, baseret på sygdomsprofilen og typen af udbrud
f)
listeopførelsen af anmeldelses- og rapporteringsregioner som omhandlet i artikel 21.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
KAPITEL 2
Overvågning
Artikel 24
Operatørers overvågningsforpligtelser
Med henblik på at opdage forekomst af listeopførte sygdomme og nye sygdomme skal operatører:
a)
observere sundheden og adfærden blandt de dyr, som de er ansvarlige for
b)
observere alle ændringer i de sædvanlige produktionsparametre på de virksomheder, hos de dyr eller i det avlsmateriale, som de er ansvarlige for, og som kan give anledning til mistanke om, at ændringerne skyldes en listeopført sygdom eller en ny sygdom
c)
være opmærksomme på abnorm dødelighed og andre tegn på alvorlig sygdom hos dyr, som de er ansvarlige for.
Artikel 25
Dyresundhedsbesøg
1.   Operatører skal sikre, at en dyrlæge aflægger dyresundhedsbesøg på de virksomheder, som de er ansvarlige for, hvis det er relevant på grund af de risici, som den givne virksomhed udgør, under hensyntagen til:
a)
virksomhedstypen
b)
arterne og kategorierne af opdrættede dyr på virksomheden
c)
den epidemiologiske situation i zonen eller regionen for så vidt angår listeopførte eller nye sygdomme, som dyrene på virksomheden er modtagelige over for
d)
eventuel anden relevant overvågning eller offentlig kontrol, som de opdrættede dyr og den pågældende type virksomhed er omfattet af.
Sådanne dyresundhedsbesøg aflægges med en hyppighed, der står i rimeligt forhold til de risici, som den pågældende virksomhed udgør.
De kan kombineres med besøg i andet øjemed.
2.   Dyresundhedsbesøg som omhandlet i stk. 1 aflægges med henblik på sygdomsforebyggelse, navnlig ved:
a)
at rådgive den pågældende operatør om biosikring og andre dyresundhedsspørgsmål af relevans for den pågældende type virksomhed og de pågældende arter og kategorier af opdrættede dyr på virksomheden
b)
at opdage og oplyse om tegn på forekomst af listeopførte eller nye sygdomme.
3.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte de minimumskrav, der er nødvendige for ensartet anvendelse af denne artikel.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 26
Den kompetente myndigheds overvågningsforpligtelser
1.   Den kompetente myndighed foretager overvågning med henblik på opdagelse af forekomst af listeopførte sygdomme som omhandlet i artikel 9, stk. 1, litra e), og relevante nye sygdomme.
2.   Overvågningen tilrettelægges med henblik på at sikre rettidig opdagelse af forekomst af listeopførte sygdomme som omhandlet i artikel 9, stk. 1, litra e), og nye sygdomme ved at indsamle, sammenholde og analysere relevante oplysninger om sygdomssituationen.
3.   Den kompetente myndighed gør, når det er muligt og relevant, brug af resultaterne af operatørers overvågning og oplysninger fra dyresundhedsbesøg i overensstemmelse med henholdsvis artikel 24 og 25.
4.   Den kompetente myndighed sikrer, at overvågning opfylder kravene i artikel 27 og i andre regler, der er vedtaget i medfør af artikel 29, litra a).
5.   Den kompetente myndighed sikrer, at de i stk. 1 omhandlede oplysninger fra overvågning indsamles og anvendes på effektiv og virkningsfuld vis.
Artikel 27
Overvågningsmetoder, -hyppighed og -intensitet
Tilrettelæggelse, midler, diagnosticeringsmetoder, hyppighed, intensitet, måldyrebestande og prøveudtagningsmønstre for den i artikel 26 omhandlede overvågning skal være hensigtsmæssig(e) og stå i rimeligt forhold til målene for overvågningen under hensyntagen til:
a)
sygdomsprofilen
b)
de relevante risikofaktorer
c)
sundhedsstatussen i:
i)
medlemsstaten eller zonen eller kompartmentet deri, der er omfattet af overvågningen
ii)
medlemsstater og tredjelande eller territorier, der grænser op til, eller hvorfra dyr og produkter kommer ind i denne medlemsstat eller zone eller dette kompartment
d)
overvågning, der foretages af operatører i henhold til artikel 24, herunder dyresundhedsbesøg som omhandlet i artikel 25, eller af andre offentlige myndigheder.
Artikel 28
EU-overvågningsprogrammer
1.   Den kompetente myndighed foretager overvågning i henhold til artikel 26, stk. 1, inden for rammerne af et overvågningsprogram, når en sygdom er relevant for Unionen i henhold til artikel 29, litra c).
2.   Medlemsstater, der fastlægger et overvågningsprogram i henhold til stk. 1, forelægger det for Kommissionen.
3.   Medlemsstater, der gennemfører et overvågningsprogram i henhold til stk. 1, aflægger regelmæssigt rapport til Kommissionen om resultaterne af gennemførelsen af programmet.
Artikel 29
Delegation af beføjelser
Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
tilrettelæggelse, midler, diagnosticeringsmetoder, hyppighed, intensitet, måldyrebestande og prøveudtagningsmønstre for den i artikel 27 omhandlede overvågning
b)
kriterierne for officiel bekræftelse og definitioner af tilfælde af listeopførte sygdomme som omhandlet i artikel 9, stk. 1, litra e), og, hvis det er relevant, nye sygdomme
c)
kriterierne for at fastslå relevansen af en sygdom, der skal være omfattet af et overvågningsprogram, der er relevant for Unionen med henblik på artikel 30, stk. 1, litra a), under hensyntagen til sygdomsprofilen og risikofaktorerne i denne forbindelse
d)
krav til overvågningsprogrammer som omhandlet i artikel 28, stk. 1, for så vidt angår:
i)
overvågningsprogrammernes indhold
ii)
de oplysninger, der skal inkluderes ved forelæggelsen af overvågningsprogrammer, jf. artikel 28, stk. 2, og regelmæssige rapporter, jf. artikel 28, stk. 3
iii)
overvågningsprogrammers anvendelsesperiode.
Artikel 30
Gennemførelsesbeføjelser
1.   Kommissionen fastsætter ved hjælp af gennemførelsesretsakter krav vedrørende overvågning og overvågningsprogrammer som omhandlet i artikel 26 og 28 samt i regler vedtaget i henhold til artikel 29 for så vidt angår:
a)
fastlæggelse af, hvilke af de i artikel 9, stk. 1, litra e), omhandlede listeopførte sygdomme der skal være omfattet af overvågningsprogrammer, jf. artikel 28, herunder det geografiske anvendelsesområde for sådanne programmer
b)
formatet og proceduren for:
i)
forelæggelse af disse overvågningsprogrammer til orientering for Kommissionen og de øvrige medlemsstater
ii)
rapportering til Kommissionen om resultaterne af overvågningen.
2.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte de kriterier, der skal anvendes til evaluering af de overvågningsprogrammer, der er omhandlet i artikel 28.
3.   De i nærværende artikels stk. 1 og 2 omhandlede gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
KAPITEL 3
Udryddelsesprogrammer
Artikel 31
Obligatoriske og valgfrie udryddelsesprogrammer
1.   Medlemsstater, der ikke er frie for eller ikke vides at være frie for en eller flere af de i artikel 9, stk. 1, litra b), omhandlede listeopførte sygdomme på hele deres område eller i zoner eller kompartmenter deri, skal:
a)
fastlægge et program for udryddelse af eller påvisning af frihed for den pågældende listeopførte sygdom, som skal gennemføres for de dyrebestande, der er berørt af sygdommen, og som skal dække de relevante dele af medlemsstaternes område eller de relevante zoner eller kompartmenter deri (»obligatorisk udryddelsesprogram«) og finde anvendelse, indtil betingelserne for at kunne meddele status som sygdomsfri på den pågældende medlemsstats område eller i den pågældende zone i henhold til artikel 36, stk. 1, eller det pågældende kompartment i henhold til artikel 37, stk. 2, er opfyldt
b)
forelægge udkastet til obligatorisk udryddelsesprogram for Kommissionen til godkendelse.
2.   Medlemsstater, der ikke er frie eller ikke vides at være frie for en eller flere af de i artikel 9, stk. 1, litra c), omhandlede listeopførte sygdomme, og som beslutter at fastlægge et program for udryddelse af den pågældende listeopførte sygdom, som skal gennemføres for de dyrebestande, der er berørt af den pågældende sygdom, i alle de relevante dele af medlemsstaternes område eller i de relevante zoner eller kompartmenter deri (»valgfrit udryddelsesprogram«), forelægger et udkast til programmet for Kommissionen til godkendelse, når den berørte medlemsstat for den pågældende sygdom anmoder om anerkendelse af dyresundhedsmæssige garantier inden for Unionen med hensyn til flytninger af dyr eller produkter.
Et sådant valgfrit udryddelsesprogram finder anvendelse, indtil:
a)
betingelserne for at kunne meddele status som sygdomsfri på den pågældende medlemsstats område eller i den pågældende zone i henhold til artikel 36, stk. 1, eller det pågældende kompartment i henhold til artikel 37, stk. 2, er opfyldt, eller
b)
det er fastslået, at betingelserne for at kunne meddele status som sygdomsfri ikke kan opfyldes, og det pågældende program ikke længere tjener sit formål, eller
c)
den pågældende medlemsstat ophæver programmet.
3.   Kommissionen godkender ved hjælp af gennemførelsesretsakter:
a)
udkast til obligatoriske udryddelsesprogrammer, som den har fået forelagt til godkendelse i henhold til stk. 1
b)
udkast til valgfri udryddelsesprogrammer, som den har fået forelagt til godkendelse i henhold til stk. 2
såfremt de betingelser, der er fastsat i dette kapitel, er opfyldt.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
4.   I behørigt begrundede særligt hastende tilfælde vedrørende en listeopført sygdom, der udgør en risiko af meget betydeligt omfang, vedtager Kommissionen efter proceduren i artikel 266, stk. 3, gennemførelsesretsakter som omhandlet i nærværende artikels stk. 3, litra a), der straks finder anvendelse.
Kommissionen kan af behørigt begrundede årsager ved hjælp af gennemførelsesretsakter godkende en ændring foreslået af den pågældende medlemsstat eller trække godkendelsen tilbage for udryddelsesprogrammer, der er godkendt i henhold til denne artikels stk. 3, litra a) og b). Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
5.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
sygdomsbekæmpelsesstrategier, delmål og endelige mål for bestemte sygdomme samt udryddelsesprogrammers anvendelsesperiode
b)
undtagelser fra kravet i denne artikels stk. 1, litra b), og stk. 2 om forelæggelse af udryddelsesprogrammer til godkendelse, hvis en sådan godkendelse ikke er nødvendig, fordi der er vedtaget regler om de pågældende programmer i henhold til artikel 32, stk. 2, og artikel 35
c)
de oplysninger, som medlemsstaterne skal give Kommissionen og de øvrige medlemsstater om undtagelser fra kravet om godkendelse af udryddelsesprogrammer som omhandlet i dette stykkes litra b).
Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 om ændring eller ophævelse af regler vedtaget i henhold til dette stykkes litra b).
Artikel 32
Foranstaltninger i obligatoriske og valgfrie udryddelsesprogrammer
1.   Udryddelsesprogrammer skal mindst omfatte følgende foranstaltninger:
a)
sygdomsbekæmpelsesforanstaltninger til udryddelse af den sygdomsfremkaldende agens på virksomheder, i kompartmenter og i zoner, hvor en sygdom forekommer, og forebyggelse af reinfektion
b)
overvågning i overensstemmelse med reglerne i artikel 26-30 til påvisning af:
i)
effektiviteten af de i litra a) omhandlede sygdomsbekæmpelsesforanstaltninger
ii)
frihed for den pågældende listeopførte sygdom
c)
sygdomsbekæmpelsesforanstaltninger, der skal træffes i tilfælde af positive overvågningsresultater.
2.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende følgende elementer for at sikre udryddelsesprogrammers effektivitet:
a)
sygdomsbekæmpelsesforanstaltninger som omhandlet i stk. 1, litra a)
b)
sygdomsbekæmpelsesforanstaltninger, der skal træffes for at undgå reinfektion i måldyrebestanden med den pågældende sygdom på virksomheder, i zoner og i kompartmenter
c)
tilrettelæggelse af overvågningen, midler, diagnosticeringsmetoder, hyppighed, intensitet, måldyrebestande og prøveudtagningsmønstre
d)
sygdomsbekæmpelsesforanstaltninger, der skal træffes i tilfælde af positive resultater fra overvågningen for den pågældende listeopførte sygdom, jf. stk. 1, litra c)
e)
kriterier for vaccination, hvor det er relevant og hensigtsmæssigt for den pågældende sygdom eller art.
Artikel 33
Indhold af obligatoriske og valgfrie udryddelsesprogrammer, der er forelagt for Kommissionen til godkendelse
Medlemsstaterne medtager følgende oplysninger i ansøgninger om godkendelse af obligatoriske og valgfrie udryddelsesprogrammer, der forelægges for Kommissionen i henhold til artikel 31, stk. 1 og 2:
a)
en beskrivelse af den epidemiologiske situation for den listeopførte sygdom, der er omfattet af det pågældende obligatoriske eller valgfrie udryddelsesprogram
b)
en beskrivelse og afgrænsning af det geografiske og administrative område eller det kompartment, der er omfattet af udryddelsesprogrammet
c)
en beskrivelse af de sygdomsbekæmpelsesforanstaltninger, der indgår i udryddelsesprogrammet, jf. artikel 32, stk. 1, og reglerne vedtaget i henhold til artikel 32, stk. 2
d)
en beskrivelse af organisationen af, tilsynet med og rollerne for de parter, der deltager i udryddelsesprogrammet
e)
den anslåede varighed af udryddelsesprogrammet
f)
delmål og sygdomsbekæmpelsesstrategier for gennemførelse af udryddelsesprogrammet.
Artikel 34
Rapportering
Medlemsstater, der gennemfører udryddelsesprogrammer, forelægger Kommissionen:
a)
rapporter, der gør det muligt for Kommissionen at overvåge opnåelse af de i artikel 33, litra f), omhandlede delmål for de iværksatte udryddelsesprogrammer
b)
en endelig rapport efter det pågældende udryddelsesprograms afslutning.
Artikel 35
Gennemførelsesbeføjelser
Kommissionen fastsætter ved hjælp af gennemførelsesretsakter regler vedrørende de oplysninger, formater og proceduremæssige krav, som er fastsat i artikel 31-34 for så vidt angår:
a)
forelæggelse af udkast til obligatoriske og valgfrie udryddelsesprogrammer til godkendelse
b)
resultatindikatorer
c)
rapportering til Kommissionen og de øvrige medlemsstater om resultaterne af gennemførelsen af obligatoriske eller valgfrie udryddelsesprogrammer.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
KAPITEL 4
Status som sygdomsfri
Artikel 36
Sygdomsfrie medlemsstater og zoner
1.   En medlemsstat kan ansøge Kommissionen om godkendelse af status som sygdomsfri for en eller flere af de i artikel 9, stk. 1, litra b) og c), omhandlede listeopførte sygdomme for så vidt angår en eller flere af de relevante dyrearter for hele medlemsstatens område eller en eller flere zoner deri, hvis en eller flere af følgende betingelser er opfyldt:
a)
Ingen af de listeopførte arter for den sygdom, der er omfattet af ansøgningen om status som sygdomsfri, forekommer nogetsteds på den pågældende medlemsstats område eller i den eller de relevante zoner, der er omfattet af ansøgningen.
b)
Den sygdomsfremkaldende agens vides ikke at kunne overleve på medlemsstatens område eller i den eller de relevante zoner, der er omfattet af ansøgningen, ud fra kriterierne i artikel 39, litra a), nr. ii).
c)
Hvis der er tale om listeopførte sygdomme, der kun overføres af vektorer, forekommer ingen af vektorerne, eller de vides ikke at kunne overleve, på medlemsstatens område eller i den eller de relevante zoner, der er omfattet af ansøgningen, ud fra kriterierne i artikel 39, litra a), nr. ii).
d)
Frihed for den pågældende listeopførte sygdom er påvist ved:
i)
et udryddelsesprogram, der opfylder reglerne i artikel 32, stk. 1, og regler vedtaget i henhold til samme artikels stk. 2, eller
ii)
historiske data og overvågningsdata.
2.   Ansøgninger fra medlemsstaterne om status som sygdomsfri skal indeholde dokumentation, der påviser, at betingelserne for at opnå status som sygdomsfri, jf. stk. 1, er opfyldt.
3.   En medlemsstat kan i visse specifikke tilfælde ansøge Kommissionen om godkendelse af status som sygdomsfri for en eller flere af de i artikel 9, stk. 1, litra a), omhandlede listeopførte sygdomme, navnlig om godkendelse af ikkevaccinationsstatus for hele området eller for en eller flere zoner deri, hvis følgende betingelser er opfyldt:
a)
Frihed for den pågældende listeopførte sygdom er godtgjort ved:
i)
et udryddelsesprogram, der overholder reglerne i artikel 32, stk. 1, og regler vedtaget i henhold til samme artikels stk. 2, eller
ii)
historiske data og overvågningsdata.
b)
Det er godtgjort, at vaccination mod sygdommen ville føre til omkostninger, der ville overstige omkostningerne ved opretholdelse af sygdomsfrihed uden vaccination.
4.   Kommissionen godkender ved hjælp af gennemførelsesretsakter, som om nødvendigt kan ændres, ansøgninger fra medlemsstaterne om status som sygdomsfri eller ikkevaccinationsstatus, når betingelserne i stk. 1 og 2 og, hvor det er relevant, stk. 3 er opfyldt.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 37
Kompartmenter
1.   En medlemsstat kan ansøge Kommissionen om anerkendelse af status som sygdomsfri for kompartmenter med hensyn til listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra a), og om beskyttelse af statussen som sygdomsfri for sådant et kompartment i tilfælde af et udbrud af en eller flere af de pågældende listeopførte sygdomme på sit område, hvis:
a)
introduktion af den eller de listeopførte sygdomme, der er omfattet af ansøgningen, effektivt kan forhindres på kompartmentniveau, under hensyntagen til sygdomsprofilen
b)
det kompartment, der er omfattet af ansøgningen, er underlagt et fælles biosikringsforvaltningssystem, der er udviklet til at sikre statussen som sygdomsfri for alle virksomheder, der indgår i det, og
c)
det kompartment, der er omfattet af ansøgningen, er godkendt af den kompetente myndighed med hensyn til flytninger af dyr og produkter deraf i henhold til:
i)
artikel 99 og 100 for så vidt angår kompartmenter, hvor der holdes landdyr og produkter deraf
ii)
artikel 183 og 184 for så vidt angår kompartmenter, hvor der holdes akvakulturdyr og produkter deraf.
2.   En medlemsstat kan ansøge Kommissionen om anerkendelse af status som sygdomsfri for kompartmenter med hensyn til en eller flere af de i artikel 9, stk. 1, litra b) og c), omhandlede listeopførte sygdomme, hvis:
a)
introduktion af den eller de listeopførte sygdomme, der er omfattet af ansøgningen, effektivt kan forhindres på kompartmentniveau, under hensyntagen til sygdomsprofilen
b)
en eller flere af følgende betingelser er opfyldt:
i)
betingelserne fastsat i artikel 36, stk. 1
ii)
virksomhederne i det kompartment, der er omfattet af ansøgningen, har indledt eller genoptaget deres aktiviteter og har indført et fælles biosikringsforvaltningssystem, der er udviklet til at sikre sygdomsfrihed i det pågældende kompartment
c)
det kompartment, der er omfattet af ansøgningen, er underlagt et enkelt fælles biosikringsforvaltningssystem, der er udviklet til at sikre statussen som sygdomsfri for alle virksomheder, der indgår i det, og
d)
det kompartment, der er omfattet af ansøgningen, er godkendt af den kompetente myndighed med hensyn til flytninger af dyr og produkter deraf i henhold til:
i)
artikel 99 og 100 for så vidt angår kompartmenter, hvor der holdes landdyr og produkter deraf
ii)
artikel 183 og 184 for så vidt angår kompartmenter, hvor der holdes akvakulturdyr og produkter deraf.
3.   Ansøgninger fra medlemsstaterne om anerkendelse af status som sygdomsfri for kompartmenter i henhold til stk. 1 og 2 skal indeholde dokumentation, der påviser, at betingelserne fastsat i disse stykker er opfyldt.
4.   Kommissionen skal ved hjælp af gennemførelsesretsakter
a)
anerkende, med forbehold af nødvendige ændringer, kompartmenters status som sygdomsfrie, når betingelserne fastsat i stk. 1 eller 2 og stk. 3 er opfyldt
b)
fastlægge, for hvilke af de i artikel 9, stk. 1, litra a), b) og c), omhandlede listeopførte sygdomme sygdomsfrie kompartmenter kan oprettes.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
5.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende bestemmelser, der supplerer bestemmelserne i nærværende artikel, om:
a)
kravene vedrørende anerkendelse af status som sygdomsfri for kompartmenter i nærværende artikels stk. 1 og 2 baseret på sygdomsprofilen for de i artikel 9, stk. 1, litra a), b) og c), omhandlede listeopførte sygdomme, som minimum hvad angår:
i)
resultater af overvågning og anden dokumentation, der er nødvendig til at underbygge sygdomsfrihed
ii)
biosikringsforanstaltninger
b)
nærmere regler om den kompetente myndigheds godkendelse af status som sygdomsfri for kompartmenter, jf. stk. 1 og 2, og
c)
regler vedrørende kompartmenter, der ligger på mere end én medlemsstats område.
Artikel 38
Lister over sygdomsfrie medlemsstater, zoner eller kompartmenter
Hver medlemsstat opstiller og ajourfører en liste over sit område eller sine zoner med status som sygdomsfri, jf. artikel 36, stk. 1 og 3, og sine kompartmenter med status som sygdomsfri, jf. artikel 37, stk. 1 og 2, hvis det er relevant.
Medlemsstaterne gør disse lister offentligt tilgængelige. Kommissionen bistår medlemsstaterne med at gøre oplysningerne på disse lister tilgængelige for offentligheden ved på sit websted at angive link til medlemsstaternes informationssider på internettet.
Artikel 39
Delegation af beføjelser vedrørende status som sygdomsfri for medlemsstater og zoner
Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
nærmere regler om status som sygdomsfri for medlemsstater og zoner heri baseret på de forskellige sygdomsprofiler for så vidt angår:
i)
de kriterier, der skal anvendes til underbygning af påstande fra medlemsstater om, at der ikke forekommer listeopførte arter, eller at disse ikke kan overleve på deres område, samt den dokumentation, der skal fremlægges til underbygning af sådanne påstande, jf. artikel 36, stk. 1, litra a)
ii)
de kriterier, der skal anvendes, og den krævede dokumentation til underbygning af påstande om, at en sygdomsfremkaldende agens eller vektor ikke er i stand til at overleve, jf. artikel 36, stk. 1, litra b) og c)
iii)
de kriterier, der skal anvendes til, og betingelserne for at fastslå frihed fra den pågældende sygdom, jf. artikel 36, stk. 1, litra d)
iv)
resultater af overvågning og anden dokumentation, der er nødvendig til at underbygge sygdomsfrihed
v)
biosikringsforanstaltninger
vi)
restriktioner og betingelser for vaccination i sygdomsfrie medlemsstater og zoner deri
vii)
oprettelse af zoner, der adskiller sygdomsfrie zoner eller zoner omfattet af udryddelsesprogrammer fra restriktionszoner (»stødpudezoner«)
viii)
zoner, der omfatter flere medlemsstaters område
b)
undtagelser fra kravet om godkendelse fra Kommissionen af status som sygdomsfri for en eller flere af de i artikel 9, stk. 1, litra b) og c), omhandlede listeopførte sygdomme, jf. artikel 36, stk. 1, hvis en sådan godkendelse ikke er nødvendig, fordi der er fastsat nærmere regler om sygdomsfrihed i regler vedtaget i henhold til nærværende artikels litra a)
c)
oplysninger, som medlemsstaterne skal give Kommissionen og de øvrige medlemsstater til underbygning af erklæringer om status som sygdomsfri, uden at der vedtages en gennemførelsesretsakt i henhold til artikel 36, stk. 4, jf. nærværende artikels litra b).
Artikel 40
Gennemførelsesbeføjelser
Kommissionen fastsætter ved hjælp af gennemførelsesretsakter nærmere krav vedrørende de oplysninger, som medlemsstaterne skal give Kommissionen og de øvrige medlemsstater til underbygning af erklæringer om status som sygdomsfri for områder, zoner og kompartmenter, i overensstemmelse med artikel 36-39, samt formatet og procedurerne for:
a)
ansøgninger om anerkendelse af status som sygdomsfri for hele den pågældende medlemsstats område eller zoner eller kompartmenter deri
b)
udveksling af oplysninger mellem medlemsstaterne og Kommissionen om sygdomsfrie medlemsstater eller zoner og kompartmenter deri.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 41
Opretholdelse af status som sygdomsfri
1.   Medlemsstaterne kan kun opretholde status som sygdomsfri for deres område eller zoner eller kompartmenter deri, så længe
a)
betingelserne for status som sygdomsfri fastsat i artikel 36, stk. 1, og artikel 37, stk. 1 og 2, er opfyldt, og reglerne fastsat i henhold til nærværende artikels stk. 3 og artikel 39 er overholdt
b)
der foretages overvågning under hensyntagen til kravene i artikel 27 for at kontrollere, at området, zonen eller kompartmentet fortsat er fri(t) for den listeopførte sygdom, for hvilken statussen som sygdomsfri blev godkendt eller anerkendt
c)
der gælder restriktioner for flytning af dyr og, hvis det er relevant deraf afledte produkter, af listeopførte arter for så vidt angår den listeopførte sygdom, for hvilken statussen som sygdomsfri blev godkendt eller anerkendt, til området, zonen eller kompartmentet i overensstemmelse med del IV og V
d)
der anvendes andre biosikringsforanstaltninger for at forhindre introduktion af den listeopførte sygdom, for hvilken statussen som sygdomsfri blev godkendt eller anerkendt.
2.   En medlemsstat underretter øjeblikkelig Kommissionen, hvis betingelserne i stk. 1 for opretholdelse af status som sygdomsfri ikke længere er opfyldt.
3.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende følgende betingelser for opretholdelse af status som sygdomsfri:
a)
overvågning som omhandlet i stk. 1, litra b)
b)
biosikringsforanstaltninger som omhandlet i stk. 1, litra d).
Artikel 42
Suspension, ophævelse og generhvervelse af status som sygdomsfri
1.   Hvis en medlemsstat får kendskab til eller har grund til at formode, at en af betingelserne for opretholdelse af dens status som sygdomsfri medlemsstat, eller zone eller kompartment heri, er blevet tilsidesat, skal den øjeblikkelig:
a)
hvor det er relevant, og afhængigt af risikoen, suspendere eller begrænse flytninger af de listeopførte arter — for så vidt angår den listeopførte sygdom, for hvilken statussen som sygdomsfri blev godkendt eller anerkendt — til andre medlemsstater, zoner eller kompartmenter med en højere sundhedsstatus for så vidt angår den pågældende listeopførte sygdom
b)
anvende de i del III, afsnit II, omhandlede sygdomsbekæmpelsesforanstaltninger, hvis det er relevant for at forhindre spredning af en listeopført sygdom, for hvilken statussen som sygdomsfri blev godkendt eller anerkendt.
2.   Foranstaltningerne i stk. 1 ophæves, hvis yderligere undersøgelser bekræfter, at:
a)
den formodede tilsidesættelse ikke har fundet sted, eller
b)
den formodede tilsidesættelse ikke har haft væsentlige konsekvenser, og den pågældende medlemsstat kan forsikre, at betingelserne for opretholdelse af dens status som sygdomsfri igen er opfyldt.
3.   Hvis den pågældende medlemsstats yderligere undersøgelser bekræfter, at tilfælde af den listeopførte sygdom, for hvilken statussen som sygdomsfri er opnået, eller at andre væsentlige tilsidesættelser af betingelserne for opretholdelse af statussen som sygdomsfri som omhandlet i artikel 41, stk. 1, er forekommet, eller hvis der er stor sandsynlighed for, at dette er forekommet, underretter medlemsstaten øjeblikkelig Kommissionen herom.
4.   Kommissionen tilbagekalder uden unødig forsinkelse ved hjælp af gennemførelsesretsakter godkendelsen af en medlemsstats eller en zones status som sygdomsfri i henhold til artikel 36, stk. 4, eller anerkendelsen af et kompartments status som sygdomsfrit i henhold til artikel 37, stk. 4, efter at have modtaget oplysninger fra den pågældende medlemsstat om, at betingelserne for opretholdelse af statussen som sygdomsfri ikke længere er opfyldt.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
5.   I behørigt begrundede særligt hastende tilfælde, hvor den i denne artikels stk. 3 omhandlede listeopførte sygdom spredes hurtigt med risiko for en meget betydelig indvirkning på dyre- eller folkesundheden, økonomien eller samfundet, vedtager Kommissionen efter proceduren i artikel 266, stk. 3, gennemførelsesretsakter, der straks finder anvendelse.
6.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende bestemmelser, der supplerer de regler for suspension, ophævelse og generhvervelse af status som sygdomsfri, der er fastsat i nærværende artikels stk. 1 og 2.
DEL III
SYGDOMSBEREDSKAB OG -BEKÆMPELSE
AFSNIT I
SYGDOMSBEREDSKAB
KAPITEL 1
Beredskabsplaner og simuleringsøvelser
Artikel 43
Beredskabsplaner
1.   Medlemsstaterne udarbejder og ajourfører efter passende høring af eksperter og relevante interessenter beredskabsplaner og om nødvendigt detaljerede vejledninger, der fastlægger de foranstaltninger, der skal træffes i den pågældende medlemsstat i tilfælde af forekomst af en listeopført sygdom som omhandlet i artikel 9, stk. 1, litra a), eller, hvis det er relevant, nye sygdomme for at sikre en høj grad af sygdomsberedskab og muligheden for at iværksætte en hurtig reaktion.
2.   Disse beredskabsplaner og, hvis det er relevant, detaljerede vejledninger skal mindst omfatte følgende:
a)
etablering af en kommandovej hos den kompetente myndighed og i forhold til andre offentlige myndigheder for at sikre hurtig og effektiv beslutningstagning på nationalt, regionalt og lokalt plan
b)
rammerne for samarbejde mellem den kompetente myndighed og de øvrige involverede offentlige myndigheder og relevante interessenter, som sikrer, at foranstaltninger gennemføres på sammenhængende vis og koordineres
c)
adgang til:
i)
faciliteter
ii)
laboratorier
iii)
udstyr
iv)
personale
v)
krisemidler
vi)
alle andre relevante materialer og ressourcer, der er nødvendige for at sikre hurtig og effektiv udryddelse af de listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra a), eller nye sygdomme
d)
adgang til følgende centre og grupper med den fornødne ekspertise til at bistå den kompetente myndighed:
i)
et funktionelt centralt sygdomsbekæmpelsescenter
ii)
regionale og lokale sygdomsbekæmpelsescentre, alt efter hvad der er relevant for de administrative og geografiske forhold i den pågældende medlemsstat
iii)
operationelle ekspertgrupper
e)
gennemførelse af de i afsnit II, kapitel 1, omhandlede sygdomsbekæmpelsesforanstaltninger for de i artikel 9, stk. 1, litra a), omhandlede listeopførte sygdomme og for nye sygdomme
f)
bestemmelser om nødvaccination, hvis det er relevant
g)
principper for den geografiske afgrænsning af de restriktionszoner, der oprettes af den kompetente myndighed i henhold til artikel 64, stk. 1
h)
koordinering med nabomedlemsstater og tilgrænsende tredjelande og territorier, hvis det er relevant.
Artikel 44
Gennemførelsesbeføjelser vedrørende beredskabsplaner
Kommissionen fastsætter ved hjælp af gennemførelsesretsakter nødvendige foranstaltninger vedrørende gennemførelsen i medlemsstaterne af de i artikel 43, stk. 1, omhandlede beredskabsplaner.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 45
Simuleringsøvelser
1.   Den kompetente myndighed sikrer, at der regelmæssigt eller med passende mellemrum gennemføres simuleringsøvelser for de i artikel 43, stk. 1, omhandlede beredskabsplaner
a)
for at sikre en høj grad af sygdomsberedskab og muligheden for at iværksætte en hurtig reaktion i den pågældende medlemsstat
b)
for at efterprøve beredskabsplanernes funktionalitet.
2.   Simuleringsøvelser gennemføres, hvis det er muligt og hensigtsmæssigt, i tæt samarbejde med de kompetente myndigheder i nabomedlemsstater og tilgrænsende tredjelande og territorier.
3.   Medlemsstaterne forelægger for Kommissionen og de øvrige medlemsstater efter anmodning en rapport om de vigtigste resultater af de gennemførte simuleringsøvelser.
4.   Kommissionen fastsætter, hvis det er hensigtsmæssigt og nødvendigt, ved hjælp af gennemførelsesretsakter regler om den praktiske gennemførelse af simuleringsøvelser i medlemsstaterne for så vidt angår:
a)
simuleringsøvelsers hyppighed
b)
simuleringsøvelser, der omfatter mere end én af de i artikel 9, stk. 1, litra a), omhandlede listeopførte sygdomme.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
KAPITEL 2
Brug af veterinærlægemidler til forebyggelse og bekæmpelse af sygdomme
Artikel 46
Brug af veterinærlægemidler til forebyggelse og bekæmpelse af sygdomme
1.   Medlemsstaterne kan træffe foranstaltninger vedrørende brug af veterinærlægemidler til listeopførte sygdomme for at sikre en så effektiv forebyggelse eller bekæmpelse som muligt af de pågældende sygdomme, forudsat at sådanne foranstaltninger er hensigtsmæssige eller nødvendige.
De pågældende foranstaltninger kan omfatte følgende:
a)
forbud mod og restriktioner for brug af veterinærlægemidler
b)
obligatorisk brug af veterinærlægemidler.
2.   Medlemsstaterne tager følgende kriterier i betragtning, når de beslutter, hvorvidt og hvordan veterinærlægemidler skal anvendes som forebyggelses- og bekæmpelsesforanstaltninger over for en bestemt listeopført sygdom:
a)
sygdomsprofilen
b)
den listeopførte sygdoms udbredelse i:
i)
den pågældende medlemsstat
ii)
Unionen
iii)
tilgrænsende tredjelande og territorier, hvis det er relevant
iv)
tredjelande og territorier, hvorfra dyr og produkter bringes ind i Unionen
c)
adgangen til og effektiviteten af de pågældende veterinærlægemidler samt de dertil knyttede risici
d)
tilgængeligheden af diagnosticeringstest til påvisning af infektioner hos dyr, der er behandlet med de pågældende veterinærlægemidler
e)
de økonomiske, sociale, dyrevelfærdsmæssige og miljømæssige virkninger af brugen af de pågældende veterinærlægemidler i forhold til andre tilgængelige sygdomsforebyggelses- og -bekæmpelsesstrategier.
3.   Medlemsstaterne træffer passende forebyggende foranstaltninger vedrørende brug af veterinærlægemidler til videnskabelige undersøgelser eller med henblik på udvikling og afprøvning af dem under kontrollerede forhold for at beskytte dyre- og folkesundheden.
Artikel 47
Delegation af beføjelser vedrørende brug af veterinærlægemidler
1.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 om, hvad hensigtsmæssige og nødvendige foranstaltninger som fastsat i artikel 46 kan bestå i, for så vidt angår:
a)
forbud mod og restriktioner for brug af veterinærlægemidler
b)
særlige betingelser for brug af veterinærlægemidler til bestemte listeopførte sygdomme
c)
risikobegrænsende foranstaltninger til at forhindre spredning af listeopførte sygdomme via dyr, der er behandlet med de pågældende veterinærlægemidler, eller produkter af sådanne dyr
d)
overvågning for så vidt angår bestemte listeopførte sygdomme efter brug af vacciner og andre veterinærlægemidler.
2.   Kommissionen tager kriterierne fastlagt i artikel 46, stk. 2, i betragtning i forbindelse med fastsættelse af de i nærværende artikels stk. 1 omhandlede regler.
3.   Hvis det i tilfælde af nye risici på grund af sagens hastende karakter er bydende nødvendigt, anvendes proceduren i artikel 265 på regler vedtaget i henhold til nærværende artikels stk. 1.
KAPITEL 3
Antigen-, vaccine- og diagnostisk reagens-banker
Artikel 48
Oprettelse af EU-antigen-, -vaccine- og -diagnostisk reagens-banker
1.   Kommissionen kan for listeopførte sygdomme som omhandlet i artikel 9, stk. 1, litra a), som det ikke er forbudt at vaccinere mod i medfør af en delegeret retsakt vedtaget i henhold til artikel 47, oprette og varetage forvaltningen af EU-antigen-, -vaccine- og -diagnostisk reagens-banker til opbevaring og genopbygning af lagre af et eller flere af følgende biologiske produkter:
a)
antigener
b)
vacciner
c)
lager af vaccinebasisudgangsmateriale
d)
diagnostiske reagenser.
2.   Kommissionen sikrer, at de i stk. 1 omhandlede EU-antigen-, -vaccine- og -diagnostisk reagens-banker:
a)
har tilstrækkelige lagre af de relevante typer af antigener, vacciner, lager af vaccinebasisudgangsmateriale og diagnostiske reagenser for den pågældende listeopførte sygdom under hensyntagen til medlemsstaternes behov som anslået i forbindelse med udarbejdelsen af de i artikel 43, stk. 1, omhandlede beredskabsplaner
b)
løbende modtager forsyninger af og i god tid får udskiftet antigener, vacciner, lager af vaccinebasisudgangsmateriale og diagnostiske reagenser
c)
forvaltes og flyttes i overensstemmelse med de relevante krav til biosikring, biosikkerhed og biologisk indeslutning som fastsat i artikel 16, stk. 1, og i overensstemmelse med de delegerede retsakter vedtaget i henhold til artikel 16, stk. 2.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
forvaltning, opbevaring og udskiftning af lagrene i de i nærværende artikels stk. 1 og 2 omhandlede EU-antigen-, -vaccine- og -diagnostisk reagens-banker
b)
krav til drift af disse banker med hensyn til biosikring, biosikkerhed og biologisk indeslutning, der opfylder kravene i artikel 16, stk. 1, og tager hensyn til de delegerede retsakter vedtaget i henhold til artikel 16, stk. 2.
Artikel 49
Adgang til EU-antigen-, -vaccine- og -diagnostisk reagens-bankerne
1.   Kommissionen sørger på anmodning for, at biologiske produkter som omhandlet i artikel 48, stk. 1, såfremt de ligger på lager, leveres fra EU-antigen-, -vaccine- og -diagnostisk reagens-banker til:
a)
først og fremmest medlemsstaterne og
b)
tredjelande eller territorier, forudsat at formålet med en sådan levering primært er at forhindre, at en sygdom spredes til Unionen.
2.   I tilfælde af begrænsede lagerbeholdninger prioriterer Kommissionen adgangen til de lagre, der skal leveres, jf. stk. 1, baseret på:
a)
de sygdomsomstændigheder, under hvilke anmodningen er fremsat
b)
om der findes en national antigen-, vaccine- og diagnostisk reagens-bank i den medlemsstat eller det tredjeland eller territorium, der fremsætter anmodningen
c)
om der findes EU-foranstaltninger om obligatorisk vaccination fastsat i delegerede retsakter vedtaget i henhold til artikel 47.
Artikel 50
Gennemførelsesbeføjelser vedrørende EU-antigen-, -vaccine- og -diagnostisk reagens-banker
1.   Kommissionen fastsætter ved hjælp af gennemførelsesretsakter regler om EU-antigen-, -vaccine- og -diagnostisk reagens-banker, der for de i artikel 48, stk. 1, omhandlede biologiske produkter angiver:
a)
hvilke af de pågældende biologiske produkter der skal indgå i EU-antigen-, -vaccine- og -diagnostisk reagens-bankerne, og for hvilke af de i artikel 9, stk. 1, litra a), omhandlede listeopførte sygdomme
b)
hvilke typer og hvor store mængder af de pågældende biologiske produkter der skal indgå i EU-antigen-, -vaccine- og -diagnostisk reagens-bankerne for hver af de i artikel 9, stk. 1, litra a), omhandlede listeopførte sygdomme, som den enkelte bank er oprettet for
c)
krav vedrørende forsyning, opbevaring og udskiftning af de pågældende biologiske produkter
d)
levering af de pågældende biologiske produkter fra EU-antigen-, -vaccine- og -diagnostisk reagens-bankerne til medlemsstaterne og til tredjelande og territorier
e)
proceduremæssige og tekniske krav vedrørende optagelse af de pågældende biologiske produkter i EU-antigen-, -vaccine- og -diagnostisk reagens-bankerne og vedrørende anmodning om adgang til dem.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
2.   I behørigt begrundede særligt hastende tilfælde vedrørende en listeopført sygdom omhandlet i artikel 9, stk. 1, litra a), der udgør en risiko af meget betydeligt omfang, vedtager Kommissionen efter proceduren i artikel 266, stk. 3, gennemførelsesretsakter, der straks finder anvendelse.
Artikel 51
Fortrolig behandling af oplysninger om EU-antigen-, -vaccine- og -diagnostisk reagens-banker
Oplysninger om mængder og subtyper af de i artikel 48, stk. 1, omhandlede biologiske produkter, der opbevares i EU-antigen-, -vaccine- og -diagnostisk reagens-banker, behandles af Kommissionen som klassificerede oplysninger og offentliggøres ikke.
Artikel 52
Nationale antigen-, vaccine- og diagnostisk reagens-banker
1.   Medlemsstater, der har oprettet nationale antigen-, vaccine- og diagnostisk reagens-banker for listeopførte sygdomme som omhandlet i artikel 9, stk. 1, litra a), for hvilke der eksisterer EU-antigen-, -vaccine- og -diagnostisk reagens-banker, sikrer, at deres nationale antigen-, vaccine- og diagnostisk reagens-banker opfylder de krav vedrørende biosikring, biosikkerhed og biologisk indeslutning, der er fastsat i artikel 16, stk. 1, litra a), og delegerede retsakter vedtaget i henhold til artikel 16, stk. 2, og artikel 48, stk. 3, litra b).
2.   Medlemsstaterne giver Kommissionen ajourførte oplysninger om:
a)
nationale antigen-, vaccine- og diagnostisk reagens-banker som omhandlet i stk. 1, der oprettes eller er oprettet
b)
typerne og mængderne af antigener, vacciner, lager af vaccinebasisudgangsmateriale og diagnostiske reagenser i sådanne banker
c)
eventuelle ændringer i driften af sådanne banker.
Disse oplysninger behandles som klassificerede oplysninger af Kommissionen og offentliggøres ikke.
3.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte nærmere regler om indholdet, hyppigheden og formatet af de i stk. 2 omhandlede oplysninger.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
AFSNIT II
SYGDOMSBEKÆMPELSESFORANSTALTNINGER
KAPITEL 1
Sygdomsbekæmpelsesforanstaltninger for listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra a)
Afdeling 1
Sygdomsbekæmpelsesforanstaltninger i tilfælde af mistanke om en listeopført sygdom hos opdrættede dyr
Artikel 53
Forpligtelser for berørte operatører og andre relevante fysiske og juridiske personer
1.   I tilfælde af mistanke om en listeopført sygdom som omhandlet i artikel 9, stk. 1, litra a), hos opdrættede dyr skal medlemsstaterne ud over at anmelde dette, jf. artikel 18, stk. 1, og indtil den kompetente myndighed eventuelt har truffet sygdomsbekæmpelsesforanstaltninger i overensstemmelse med artikel 54, stk. 1, og artikel 55, stk. 1, træffe foranstaltninger for at sikre, at berørte operatører og andre relevante fysiske og juridiske personer træffer passende sygdomsbekæmpelsesforanstaltninger som omhandlet i artikel 55, stk. 1, litra c), d) og e), for at hindre, at den pågældende listeopførte sygdom spredes fra de angrebne dyr, virksomheder og steder, som de er ansvarlige for, til andre ikkeangrebne dyr eller til mennesker.
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende nærmere regler til supplering af sygdomsbekæmpelsesforanstaltningerne i nærværende artikels stk. 1.
Artikel 54
Den kompetente myndigheds undersøgelse i tilfælde af mistanke om en listeopført sygdom
1.   I tilfælde af mistanke om en listeopført sygdom omhandlet i artikel 9, stk. 1, litra a), hos opdrættede dyr foretager den kompetente myndighed hurtigst muligt en undersøgelse for at bekræfte eller udelukke forekomst af den pågældende listeopførte sygdom.
2.   I forbindelse med den i stk. 1 omhandlede undersøgelse sikrer den kompetente myndighed, hvis det er relevant, at:
a)
en embedsdyrlæge foretager en klinisk undersøgelse af en repræsentativ stikprøve af de opdrættede dyr af listeopførte arter for den pågældende listeopførte sygdom
b)
en embedsdyrlæge udtager relevante prøver fra de pågældende opdrættede dyr af listeopførte arter og andre prøver til undersøgelse i laboratorier, der er udpeget til formålet af den kompetente myndighed
c)
der i sådanne udpegede laboratorier foretages undersøgelser for at bekræfte eller udelukke forekomst af den pågældende listeopførte sygdom.
3.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende nærmere regler, der supplerer reglerne i nærværende artikels stk. 1 om den kompetente myndigheders undersøgelser.
Artikel 55
Kompetente myndigheders foreløbige sygdomsbekæmpelsesforanstaltninger
1.   Hvis den kompetente myndighed har mistanke om forekomst af en listeopført sygdom som omhandlet i artikel 9, stk. 1, litra a), hos opdrættede dyr, træffer den med forbehold af nationale krav til opnåelse af adgang til private bopæle i afventning af resultaterne af den i artikel 54, stk. 1, omhandlede undersøgelse og gennemførelsen af de i artikel 61, stk. 1, omhandlede sygdomsbekæmpelsesforanstaltninger følgende foreløbige sygdomsbekæmpelsesforanstaltninger:
a)
Den sætter den pågældende virksomhed, den pågældende fødevare- og foderstofvirksomhed eller virksomhed, der beskæftiger sig med animalske biprodukter, eller ethvert andet sted, hvor der er mistanke om sygdommen, herunder steder, hvor den sygdom, der er mistanke om, kan være opstået, under officiel overvågning.
b)
Den udarbejder en liste over:
i)
de opdrættede dyr, der befinder sig på den pågældende virksomhed, den pågældende fødevare- og foderstofvirksomhed eller virksomhed, der beskæftiger sig med animalske biprodukter, eller på det pågældende andet sted
ii)
de produkter, der befinder sig på den pågældende virksomhed, den pågældende fødevare- og foderstofvirksomhed eller virksomhed, der beskæftiger sig med animalske biprodukter, eller på det pågældende andet sted, hvis det er relevant for den pågældende listeopførte sygdoms spredning.
c)
Den sikrer, at der iværksættes passende biosikringsforanstaltninger for at forhindre, at den pågældende listeopførte sygdomsfremkaldende agens spredes til andre dyr eller til mennesker.
d)
Hvis det er nødvendigt for at forhindre yderligere spredning af den sygdomsfremkaldende agens, sikrer den, at de opdrættede dyr af de for den pågældende listeopførte sygdom listeopførte arter isoleres, og at dyrene forhindres i at komme i kontakt med vildtlevende dyr.
e)
Den begrænser flytninger af opdrættede dyr, produkter og, hvis det er relevant, personer, køretøjer og andre materialer eller midler, hvormed den sygdomsfremkaldende agens kan være blevet spredt til eller fra den pågældende virksomhed, den pågældende fødevare- og foderstofvirksomhed eller virksomhed, der beskæftiger sig med animalske biprodukter, eller andre steder, hvor der er mistanke om den pågældende listeopførte sygdom, for så vidt det er nødvendigt for at forhindre dens spredning.
f)
Den træffer alle andre nødvendige sygdomsbekæmpelsesforanstaltninger under hensyntagen til de i dette kapitel, afdeling 4, omhandlede sygdomsbekæmpelsesforanstaltninger vedrørende:
i)
anvendelse af den kompetente myndigheds undersøgelse, jf. artikel 54, stk. 1, og iværksættelse af sygdomsbekæmpelsesforanstaltninger som omhandlet i nærværende stykkes litra a)-d) på andre virksomheder, fødevare- og foderstofvirksomheder eller virksomheder, der beskæftiger sig med animalske biprodukter, eller på ethvert andet sted
ii)
oprettelse af passende midlertidige restriktionszoner under hensyntagen til sygdomsprofilen.
g)
Den indleder den i artikel 57, stk. 1, omhandlede epidemiologiske undersøgelse.
2.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende nærmere regler, der supplerer reglerne i nærværende artikels stk. 1, for så vidt angår fastlæggelse af de specifikke sygdomsbekæmpelsesforanstaltninger, der skal træffes, afhængigt af hvilken af de i artikel 9, stk. 1, litra a), omhandlede listeopførte sygdomme der er tale om, baseret på de relevante risici i tilknytning til:
a)
den pågældende dyreart eller -kategori
b)
den pågældende produktionstype.
Artikel 56
Evaluering og forlængelse af foreløbige sygdomsbekæmpelsesforanstaltninger
De i artikel 55, stk. 1, omhandlede sygdomsbekæmpelsesforanstaltninger skal:
a)
evalueres af den kompetente myndighed, for så vidt det er relevant, på grundlag af resultaterne af:
i)
den i artikel 54, stk. 1, omhandlede undersøgelse
ii)
den i artikel 57, stk. 1, omhandlede epidemiologiske undersøgelse
b)
om nødvendigt udvides til også at omfatte andre steder, jf. artikel 55, stk. 1, litra a).
Afdeling 2
Epidemiologisk undersøgelse
Artikel 57
Epidemiologisk undersøgelse
1.   Den kompetente myndighed foretager en epidemiologisk undersøgelse i tilfælde af bekræftelse af en listeopført sygdom som omhandlet i artikel 9, stk. 1, litra a), hos dyr.
2.   Den i stk. 1 omhandlede epidemiologiske undersøgelse har til formål at:
a)
fastlægge, hvor det er sandsynligt, at den pågældende listeopførte sygdom er opstået, og hvordan den er blevet spredt
b)
beregne, hvor længe det er sandsynligt, at den listeopførte sygdom har været til stede
c)
identificere virksomheder og epidemiologiske enheder deri, fødevare- og foderstofvirksomheder, virksomheder, der beskæftiger sig med animalske biprodukter, eller andre steder, hvor dyr af listeopførte arter for så vidt angår den listeopførte sygdom, der er mistanke om, kan være blevet inficeret, infesteret eller kontamineret
d)
indhente oplysninger om flytning af opdrættede dyr, personer, produkter, køretøjer og andre materialer eller midler, hvormed den sygdomsfremkaldende agens kan være blevet spredt i det relevante tidsrum forud for anmeldelsen af mistanken om eller bekræftelsen af den listeopførte sygdom
e)
indhente oplysninger om den sandsynlige spredning af den listeopførte sygdom i det omgivende miljø, herunder forekomst og fordeling af sygdomsvektorer.
Afdeling 3
Bekræftelse af sygdomme hos opdrættede dyr
Artikel 58
Officiel bekræftelse fra den kompetente myndighed af en listeopført sygdom omhandlet i artikel 9, stk. 1, litra a)
1.   Den kompetente myndighed baserer en officiel bekræftelse af en listeopført sygdom omhandlet i artikel 9, stk. 1, litra a), på følgende oplysninger:
a)
resultaterne af kliniske undersøgelser og laboratorieundersøgelser som omhandlet i artikel 54, stk. 2
b)
de foreløbige eller endelige resultater af den i artikel 57, stk. 1, omhandlede epidemiologiske undersøgelse
c)
andre tilgængelige epidemiologiske data.
2.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende krav, der skal være opfyldt for en officiel bekræftelse som omhandlet i stk. 1.
Artikel 59
Ophævelse af foreløbige sygdomsbekæmpelsesforanstaltninger, når forekomst af en listeopført sygdom er blevet udelukket
Den kompetente myndighed fortsætter med at anvende de i artikel 55, stk. 1, og artikel 56 omhandlede foreløbige sygdomsbekæmpelsesforanstaltninger, indtil forekomst af de i artikel 9, stk. 1, litra a), omhandlede listeopførte sygdomme er blevet udelukket på grundlag af oplysningerne omhandlet i artikel 58, stk. 1, eller regler vedtaget i henhold til artikel 58, stk. 2.
Afdeling 4
Sygdomsbekæmpelsesforanstaltninger i tilfælde af bekræftelse af sygdom hos opdrættede dyr
Artikel 60
Øjeblikkelige sygdomsbekæmpelsesforanstaltninger, som skal træffes af den kompetente myndighed
I tilfælde af en officiel bekræftelse i henhold til artikel 58, stk. 1, af udbrud af en listeopført sygdom omhandlet i artikel 9, stk. 1, litra a), hos opdrættede dyr skal den kompetente myndighed øjeblikkelig:
a)
officielt erklære den angrebne virksomhed, fødevare- eller foderstofvirksomhed, virksomhed, der beskæftiger sig med animalske biprodukter, eller det angrebne andet sted for inficeret med den pågældende listeopførte sygdom
b)
oprette en restriktionszone, der er relevant for den pågældende listeopførte sygdom
c)
gennemføre den i artikel 43, stk. 1, omhandlede beredskabsplan for at sikre fuldstændig koordinering af sygdomsbekæmpelsesforanstaltningerne.
Artikel 61
Angrebne virksomhed og andre steder
1.   I tilfælde af udbrud af en listeopført sygdom omhandlet i artikel 9, stk. 1, litra a), hos opdrættede dyr træffer den kompetente myndighed med forbehold af nationale krav til opnåelse af adgang til private bopæle øjeblikkelig en eller flere af følgende sygdomsbekæmpelsesforanstaltninger på en virksomhed, en fødevare- eller foderstofvirksomhed, en virksomhed, der beskæftiger sig med animalske biprodukter, eller ethvert andet sted, jf. artikel 60, litra a), for at hindre yderligere spredning af den pågældende listeopførte sygdom:
a)
pålæggelse af flytningsrestriktioner for personer, dyr, produkter, køretøjer eller andre materialer eller stoffer, der kan være kontaminerede og medvirke til at sprede den listeopførte sygdom
b)
aflivning og bortskaffelse eller slagtning af dyr, der kan være kontaminerede eller medvirke til at sprede den listeopførte sygdom
c)
destruktion, forarbejdning, omdannelse eller behandling af produkter, foder eller andre stoffer eller behandling af udstyr, transportmidler, planter eller planteprodukter eller vand, der kan være kontamineret, for så vidt det er nødvendigt for at sikre, at eventuelle sygdomsfremkaldende agenser eller vektorer for den sygdomsfremkaldende agens destrueres
d)
vaccination eller behandling med andre veterinærlægemidler af opdrættede dyr i overensstemmelse med artikel 46, stk. 1, og artikel 69 og eventuelle delegerede retsakter vedtaget i henhold til artikel 47
e)
isolering, anbringelse i karantæne eller behandling af dyr og produkter, der sandsynligvis er kontaminerede og medvirker til at sprede den listeopførte sygdom
f)
rengøring, desinfektion, bekæmpelse af insekter og gnavere eller andre nødvendige biosikringsforanstaltninger, der skal anvendes på den angrebne virksomhed, den angrebne fødevare- eller foderstofvirksomhed, virksomhed, der beskæftiger sig med animalske biprodukter, eller andre steder for at minimere risikoen for spredning af den listeopførte sygdom
g)
udtagning af et tilstrækkeligt antal relevante prøver, som gør det muligt at afslutte den i artikel 57, stk. 1, omhandlede epidemiologiske undersøgelse
h)
laboratorieundersøgelse af prøver
i)
andre relevante foranstaltninger.
2.   Den kompetente myndighed tager følgende i betragtning, når den beslutter, hvilke af de i stk. 1 omhandlede sygdomsbekæmpelsesforanstaltninger det er hensigtsmæssigt at træffe:
a)
sygdomsprofilen
b)
produktionstypen og de epidemiologiske enheder på den angrebne virksomhed, den angrebne fødevare- eller foderstofvirksomhed eller virksomhed, der beskæftiger sig med animalske biprodukter, eller et andet sted.
3.   Den kompetente myndighed tillader kun genindsættelse af dyr på den pågældende virksomhed eller ethvert andet sted, hvis:
a)
alle relevante sygdomsbekæmpelsesforanstaltninger og laboratorieundersøgelser som omhandlet i stk. 1 er afsluttet på tilfredsstillende vis
b)
der er gået tilstrækkelig lang tid til at forhindre rekontaminering af den angrebne virksomhed, den angrebne fødevare- eller foderstofvirksomhed, virksomhed, der beskæftiger sig med animalske biprodukter, eller det angrebne andet sted med den listeopførte sygdom, der var årsag til udbruddet, jf. stk. 1.
Artikel 62
Epidemiologisk forbundne virksomheder og steder
1.   Den kompetente myndighed udvider de i artikel 61, stk. 1, omhandlede sygdomsbekæmpelsesforanstaltninger til andre virksomheder, epidemiologiske enheder deri, fødevare- eller foderstofvirksomheder eller virksomheder, der beskæftiger sig med animalske biprodukter, eller andre steder eller transportmidler, hvis den i artikel 57, stk. 1, omhandlede epidemiologiske undersøgelse eller resultaterne af kliniske undersøgelser eller laboratorieundersøgelser eller andre epidemiologiske data giver anledning til mistanke om, at den listeopførte sygdom omhandlet i artikel 9, stk. 1, litra a), mod hvilken de pågældende foranstaltninger er truffet, er blevet spredt til, fra eller via dem.
2.   Hvis den i artikel 57, stk. 1, omhandlede epidemiologiske undersøgelse viser, at den sandsynlige oprindelse af den listeopførte sygdom omhandlet i artikel 9, stk. 1, litra a), er en anden medlemsstat, eller at det er sandsynligt, at den pågældende listeopførte sygdom er blevet spredt til en anden medlemsstat, underretter den kompetente myndighed hurtigst muligt den pågældende medlemsstat og Kommissionen herom.
3.   I de i stk. 2 omhandlede tilfælde samarbejder de kompetente myndigheder i de forskellige medlemsstater om gennemførelse af yderligere en epidemiologisk undersøgelse og sygdomsbekæmpelsesforanstaltninger.
Artikel 63
Delegation af beføjelser vedrørende sygdomsbekæmpelsesforanstaltninger på angrebne og epidemiologisk forbundne virksomheder og andre steder
Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende nærmere regler om de sygdomsbekæmpelsesforanstaltninger, som den kompetente myndighed skal træffe i henhold til artikel 61 og 62 for en listeopført sygdom omhandlet i artikel 9, stk. 1, litra a), på angrebne og epidemiologisk forbundne virksomheder, fødevare- eller foderstofvirksomheder eller virksomheder, der beskæftiger sig med animalske biprodukter, og andre steder, herunder regler om, hvilke af de i artikel 61, stk. 1, omhandlede sygdomsbekæmpelsesforanstaltninger der skal anvendes for hver af de listeopførte sygdomme.
De pågældende nærmere regler skal omfatte følgende:
a)
betingelser og krav vedrørende sygdomsbekæmpelsesforanstaltninger som omhandlet i artikel 61, stk. 1, litra a)-e)
b)
procedurer for rengøring, desinfektion, bekæmpelse af insekter og gnavere eller andre nødvendige biosikringsforanstaltninger som omhandlet i artikel 61, stk. 1, litra f), eventuelt med fastsættelse af anvendelse af biocidholdige produkter til disse formål
c)
betingelser og krav vedrørende prøveudtagning og laboratorieundersøgelse som omhandlet i artikel 61, stk. 1, litra g)-h)
d)
gennemførelse af nærmere betingelser for og mere detaljerede krav til genindsættelse af dyr som omhandlet i artikel 61, stk. 3
e)
nødvendige sygdomsbekæmpelsesforanstaltninger som omhandlet i artikel 62 i/på epidemiologisk forbundne virksomheder, andre steder og transportmidler.
Artikel 64
Den kompetente myndigheds oprettelse af restriktionszoner
1.   Den kompetente myndighed opretter, hvis det er relevant, en restriktionszone, jf. artikel 60, litra b), omkring den angrebne virksomhed, den angrebne fødevare- eller foderstofvirksomhed eller virksomhed, der beskæftiger sig med animalske biprodukter, eller det angrebne andet sted, hvor der er udbrudt en listeopført sygdom omhandlet i artikel 9, stk. 1, litra a), hos opdrættede dyr, under hensyntagen til:
a)
sygdomsprofilen
b)
de geografiske forhold i restriktionszonen
c)
de økologiske og hydrologiske faktorer i restriktionszonen
d)
vejrforholdene
e)
forekomst og fordeling af vektorer samt vektortype i restriktionszonen
f)
resultaterne af den i artikel 57, stk. 1, omhandlede epidemiologiske undersøgelse og andre undersøgelser og epidemiologiske data
g)
resultaterne af laboratorietest
h)
de sygdomsbekæmpelsesforanstaltninger, der anvendes
i)
andre relevante epidemiologiske faktorer.
Restriktionszonen skal, hvis det er relevant, omfatte en beskyttelses- og overvågningszone af en bestemt størrelse og form.
2.   Den kompetente myndighed skal løbende vurdere og gennemgå situationen og, når det er hensigtsmæssigt for at forhindre spredning af den pågældende listeopførte sygdom omhandlet i artikel 9, stk. 1, litra a):
a)
tilpasse afgrænsningen af restriktionszonen
b)
oprette yderligere restriktionszoner.
3.   Hvis restriktionszoner som omhandlet i stk. 1 ligger på mere end én medlemsstats område, samarbejder de pågældende medlemsstaters kompetente myndigheder om at oprette dem.
4.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende nærmere regler om oprettelse og ændring af restriktionszoner, herunder beskyttelses- og overvågningszoner.
Artikel 65
Sygdomsbekæmpelsesforanstaltninger i restriktionszoner
1.   Den kompetente myndighed sikrer, at der med forbehold af nationale krav til opnåelse af adgang til private bopæle træffes en eller flere af følgende sygdomsbekæmpelsesforanstaltninger i den pågældende restriktionszone for at forhindre yderligere spredning af en listeopført sygdom omhandlet i artikel 9, stk. 1, litra a):
a)
identificering af virksomheder, fødevare- eller foderstofvirksomheder, virksomheder, der beskæftiger sig med animalske biprodukter, eller andre steder med opdrættede dyr af for den pågældende listeopførte sygdom listeopførte arter
b)
besøg på virksomheder, fødevare- eller foderstofvirksomheder, virksomheder, der beskæftiger sig med animalske biprodukter, eller andre steder med opdrættede dyr af for den pågældende listeopførte sygdom listeopførte arter, og om nødvendigt undersøgelser, prøveudtagning og laboratorieundersøgelse af foretagne prøver
c)
fastsættelse af betingelser for flytning af personer, dyr, produkter, foder, køretøjer og andre materialer eller stoffer, der kan være kontaminerede eller medvirke til at sprede den pågældende listeopførte sygdom i eller fra restriktionszonen, og for transport gennem restriktionszonen
d)
fastsættelse af biosikringskrav til:
i)
produktion, forarbejdning og distribution af animalske produkter
ii)
indsamling og bortskaffelse af animalske biprodukter
iii)
indsamling, opbevaring og håndtering af avlsmateriale
e)
vaccination og behandling af opdrættede dyr med andre veterinærlægemidler i overensstemmelse med artikel 46, stk. 1, og eventuelle delegerede retsakter vedtaget i henhold til artikel 47
f)
rengøring, desinfektion og bekæmpelse af insekter og gnavere eller andre nødvendige biosikringsforanstaltninger
g)
udpegelse eller, hvis det er relevant, godkendelse af en fødevarevirksomhed til slagtning af dyr eller behandling af animalske produkter fra restriktionszonen
h)
fastsættelse af krav vedrørende identifikation og sporbarhed til flytning af dyr, avlsmateriale eller animalske produkter
i)
andre nødvendige biosikringsforanstaltninger og risikobegrænsende foranstaltninger til minimering af risiciene for spredning af den pågældende listeopførte sygdom.
2.   Den kompetente myndighed:
a)
træffer alle nødvendige foranstaltninger til på fyldestgørende vis at informere personer i restriktionszoner om gældende restriktioner og om arten af sygdomsbekæmpelsesforanstaltningerne
b)
pålægger operatører de nødvendige forpligtelser for at forhindre yderligere spredning af den pågældende listeopførte sygdom.
3.   Den kompetente myndighed tager følgende i betragtning, når den beslutter, hvilke af de i stk. 1 omhandlede sygdomsbekæmpelsesforanstaltninger der skal træffes:
a)
sygdomsprofilen
b)
produktionstyperne
c)
gennemførligheden, tilgængeligheden og effektiviteten af de pågældende sygdomsbekæmpelsesforanstaltninger.
Artikel 66
Operatørers forpligtelser vedrørende flytninger i restriktionszoner
1.   I den i artikel 64, stk. 1, omhandlede restriktionszone må operatører kun flytte opdrættede dyr og produkter med tilladelse fra den kompetente myndighed og i overensstemmelse med eventuelle instrukser fra denne myndighed.
2.   Operatører, der holder dyr og opbevarer produkter i den i artikel 64, stk. 1, omhandlede restriktionszone, skal anmelde enhver påtænkt flytning af opdrættede dyr og produkter inden for eller ud af den pågældende restriktionszone til den kompetente myndighed. Såfremt den kompetente myndighed har pålagt anmeldelsespligt i henhold til artikel 65, stk. 2, litra b), skal berørte operatører anmelde i overensstemmelse hermed.
Artikel 67
Delegation af beføjelser vedrørende sygdomsbekæmpelsesforanstaltninger i restriktionszoner
Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende nærmere regler om de sygdomsbekæmpelsesforanstaltninger, der skal træffes i restriktionszoner, jf. artikel 65, stk. 1, for de enkelte listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra a), herunder regler om, hvilke af de i artikel 65, stk. 1, omhandlede sygdomsbekæmpelsesforanstaltninger der skal anvendes for hver af de listeopførte sygdomme.
De pågældende nærmere regler skal omfatte følgende:
a)
betingelser og krav vedrørende sygdomsbekæmpelsesforanstaltninger som omhandlet i artikel 65, stk. 1, litra a), c), d), e), g), h) og i)
b)
procedurer for rengøring, desinfektion, bekæmpelse af insekter og gnavere eller andre nødvendige biosikringsforanstaltninger som omhandlet i artikel 65, stk. 1, litra f), eventuelt med angivelse af anvendelse af biocidholdige produkter til disse formål
c)
den nødvendige overvågning, der skal foretages efter gennemførelse af de i artikel 65, stk. 1, litra b), omhandlede sygdomsbekæmpelsesforanstaltninger og laboratorieundersøgelser
d)
andre sygdomsbekæmpelsesforanstaltninger til begrænsning af spredning af bestemte listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra a).
Artikel 68
Opretholdelse af sygdomsbekæmpelsesforanstaltninger i restriktionszoner samt delegerede retsakter
1.   Den kompetente myndighed fortsætter med at anvende de i denne afdeling omhandlede sygdomsbekæmpelsesforanstaltninger, indtil følgende betingelser er opfyldt:
a)
De sygdomsbekæmpelsesforanstaltninger, der er relevante for den listeopførte sygdom omhandlet i artikel 9, stk. 1, litra a), for hvilken restriktionerne blev fastsat, er gennemført.
b)
Den endelige rengøring, desinfektion, bekæmpelse af insekter og gnavere eller andre nødvendige biosikringsforanstaltninger er gennemført som relevant for:
i)
den pågældende listeopførte sygdom omhandlet i artikel 9, stk. 1, litra a), for hvilken de pågældende sygdomsbekæmpelsesforanstaltninger er truffet
ii)
de angrebne arter af opdrættede dyr
iii)
produktionstypen
c)
Den fornødne overvågning, der er relevant for den listeopførte sygdom omhandlet i artikel 9, stk. 1, litra a), for hvilken sygdomsbekæmpelsesforanstaltningerne er truffet, og for den pågældende type virksomhed eller sted, er gennemført i restriktionszonen og underbygger, at den pågældende listeopførte sygdom er udryddet.
2.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende nærmere regler om de sygdomsbekæmpelsesforanstaltninger, der skal træffes af den kompetente myndighed, jf. stk. 1, for så vidt angår:
a)
de endelige procedurer for rengøring, desinfektion, bekæmpelse af insekter og gnavere eller andre nødvendige biosikringsforanstaltninger og, hvor det er relevant, anvendelse af biocidholdige produkter til disse formål
b)
tilrettelæggelse, midler, metoder, hyppighed, intensitet, måldyrebestande og prøveudtagningsmønstre for overvågning med henblik på generhvervelse af status som sygdomsfri efter udbruddet
c)
genindsættelse af dyr i de pågældende restriktionszoner efter afslutningen af de i nærværende artikels stk. 1 omhandlede sygdomsbekæmpelsesforanstaltninger under hensyntagen til betingelserne for genindsættelse i artikel 61, stk. 3.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende nærmere regler om de sygdomsbekæmpelsesforanstaltninger, der skal træffes af den kompetente myndighed, jf. stk. 1, for så vidt angår andre sygdomsbekæmpelsesforanstaltninger, der er nødvendige for at generhverve status som sygdomsfri.
Artikel 69
Nødvaccination
1.   Den kompetente myndighed kan, hvis det er relevant for en effektiv bekæmpelse af en listeopført sygdom omhandlet i artikel 9, stk. 1, litra a), for hvilken sygdomsbekæmpelsesforanstaltningerne finder anvendelse:
a)
udarbejde en vaccinationsplan
b)
oprette vaccinationszoner.
2.   Den kompetente myndighed tager følgende i betragtning, når den træffer beslutning om en vaccinationsplan og oprettelse af vaccinationszoner i henhold til stk. 1:
a)
de krav vedrørende nødvaccination, der er fastsat i de i artikel 43 omhandlede beredskabsplaner
b)
de krav vedrørende brug af vacciner, der er fastsat i artikel 46, stk. 1, og eventuelle delegerede retsakter vedtaget i henhold til artikel 47.
3.   Vaccinationszoner som omhandlet i nærværende artikels stk. 1, litra b), skal opfylde kravene i eventuelle delegerede retsakter vedtaget i henhold til artikel 47, stk. 1, litra c) og d), vedrørende risikobegrænsende foranstaltninger til at hindre spredning af listeopførte sygdomme samt overvågning.
Afdeling 5
Vildtlevende dyr
Artikel 70
Vildtlevende dyr
1.   Hvis den kompetente myndighed i en angrebet medlemsstat har mistanke om eller officielt bekræfter forekomst af en listeopført sygdom omhandlet i artikel 9, stk. 1, litra a), hos vildtlevende dyr, skal den:
a)
hvis det er relevant for den pågældende listeopførte sygdom, foretage overvågning i bestanden af vildtlevende dyr
b)
træffe de nødvendige sygdomsforebyggelses- og -bekæmpelsesforanstaltninger.
2.   Sygdomsforebyggelses- og -bekæmpelsesforanstaltningerne i nærværende artikels stk. 1, litra b), kan omfatte en eller flere af foranstaltningerne i artikel 53-69 og skal tage hensyn til sygdomsprofilen og de angrebne vildtlevende dyr samt risikoen for overførsel af sygdomme til dyr og mennesker.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
kriterier og procedurer for overvågning i henhold til nærværende artikels stk. 1, litra a), i tilfælde af officiel bekræftelse af en listeopført sygdom omhandlet i artikel 9, stk. 1, litra a), i overensstemmelse med artikel 27
b)
nærmere regler, der supplerer de sygdomsforebyggelses- og bekæmpelsesforanstaltninger, der skal træffes i henhold til nærværende artikels stk. 1, litra b), i tilfælde af officiel bekræftelse af en listeopført sygdom som omhandlet i artikel 9, stk. 1, litra a).
I forbindelse med vedtagelse af disse delegerede retsakter tager Kommissionen hensyn til sygdomsprofilen og de listeopførte arter for så vidt angår den i nærværende artikels stk. 1 omhandlede listeopførte sygdom.
Afdeling 6
Medlemsstaternes yderligere sygdomsbekæmpelsesforanstaltninger, Kommissionens koordinering og midlertidige særlige sygdomsbekæmpelsesregler
Artikel 71
Yderligere sygdomsbekæmpelsesforanstaltninger, koordinering af foranstaltninger og midlertidige særlige sygdomsbekæmpelsesregler vedrørende afdeling 1-5 (artikel 53-70)
1.   Medlemsstaterne kan træffe yderligere sygdomsbekæmpelsesforanstaltninger ud over dem, der er omhandlet i artikel 55, artikel 61, stk. 1, artikel 62, artikel 65, stk. 1 og 2, og artikel 68, stk. 1, og i delegerede retsakter vedtaget i henhold til artikel 63, artikel 67 og artikel 68, stk. 2, forudsat at sådanne foranstaltninger overholder reglerne i denne forordning og er nødvendige og rimelige med henblik på at bekæmpe spredning af en listeopført sygdom omhandlet i artikel 9, stk. 1, litra a), under hensyntagen til:
a)
de nærmere epidemiologiske omstændigheder
b)
de(n) pågældende type af virksomheder, andre steder og produktion
c)
hvilke arter og kategorier af dyr, der er tale om
d)
de økonomiske eller sociale forhold.
2.   Medlemsstaterne underretter hurtigst muligt Kommissionen om:
a)
sygdomsbekæmpelsesforanstaltninger, der er truffet af deres kompetente myndighed i medfør af artikel 58, artikel 59, artikel 61, artikel 62, artikel 64, artikel 65, artikel 68, stk. 1, artikel 69 og artikel 70, stk. 1 og 2, samt eventuelle delegerede retsakter vedtaget i henhold til artikel 63, artikel 67, artikel 68, stk. 2, og artikel 70, stk. 3
b)
eventuelle yderligere sygdomsbekæmpelsesforanstaltninger, der er truffet af dem i henhold til stk. 1.
3.   Kommissionen vurderer sygdomssituationen og de sygdomsbekæmpelsesforanstaltninger, der er truffet af den kompetente myndighed, og de eventuelle yderligere sygdomsbekæmpelsesforanstaltninger, der er truffet af den pågældende medlemsstat, i henhold til dette kapitel og kan ved hjælp af gennemførelsesretsakter fastlægge særlige sygdomsbekæmpelsesforanstaltninger, som finder anvendelse i et begrænset tidsrum, på betingelser, der er passende i forhold til den epidemiologiske situation, hvis:
a)
de pågældende sygdomsbekæmpelsesforanstaltninger ikke anses for egnede i forhold til den epidemiologiske situation
b)
den pågældende listeopførte sygdom omhandlet i artikel 9, stk. 1, litra a), ser ud til at spredes trods de sygdomsbekæmpelsesforanstaltninger, der er truffet i henhold til dette kapitel.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
4.   I behørigt begrundede særligt hastende tilfælde vedrørende en sygdom, der udgør en ny risiko af et meget betydeligt omfang, vedtager Kommissionen efter proceduren i artikel 266, stk. 3, gennemførelsesretsakter, der straks finder anvendelse.
KAPITEL 2
Sygdomsbekæmpelsesforanstaltninger for listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra b) og c)
Afdeling 1
Sygdomsbekæmpelsesforanstaltninger i tilfælde af mistanke om sygdom hos opdrættede dyr
Artikel 72
Forpligtelser for berørte operatører og andre relevante fysiske og juridiske personer i forbindelse med listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra b)
1.   I tilfælde af mistanke om en listeopført sygdom omhandlet i artikel 9, stk. 1, litra b), hos opdrættede dyr skal medlemsstaterne ud over at anmelde dette, jf. artikel 18, stk. 1, og indtil den kompetente myndighed eventuelt har truffet sygdomsbekæmpelsesforanstaltninger i overensstemmelse med artikel 74, stk. 1, træffe foranstaltninger for at sikre, at berørte operatører og andre relevante fysiske og juridiske personer træffer sygdomsbekæmpelsesforanstaltninger som omhandlet i artikel 74, stk. 1, litra a), og eventuelle delegerede retsakter vedtaget i henhold til artikel 74, stk. 4, for at hindre, at den pågældende listeopførte sygdom spredes fra de angrebne dyr, virksomheder og andre steder, som de er ansvarlige for, til andre ikkeangrebne dyr eller til mennesker.
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende nærmere regler til supplering af sygdomsbekæmpelsesforanstaltningerne i nærværende artikels stk. 1.
Artikel 73
Den kompetente myndigheds undersøgelse i tilfælde af mistanke om en listeopført sygdom omhandlet i artikel 9, stk. 1, litra b)
1.   I tilfælde af mistanke om en listeopført sygdom omhandlet i artikel 9, stk. 1, litra b), hos opdrættede dyr, foretager den kompetente myndighed hurtigst muligt en undersøgelse for at bekræfte eller udelukke forekomst af den pågældende listeopførte sygdom.
2.   I forbindelse med den i stk. 1 omhandlede undersøgelse sikrer den kompetente myndighed, at:
a)
en embedsdyrlæge foretager en klinisk undersøgelse af en repræsentativ stikprøve af de opdrættede dyr af listeopførte arter for den pågældende listeopførte sygdom
b)
en embedsdyrlæge udtager relevante prøver fra disse opdrættede dyr af listeopførte arter og andre prøver til undersøgelse i laboratorier, der er udpeget til formålet af den kompetente myndighed
c)
sådanne udpegede laboratorier foretager undersøgelser for at bekræfte eller udelukke forekomst af den pågældende listeopførte sygdom.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende nærmere regler, der supplerer reglerne om undersøgelser i nærværende artikels stk. 1.
Artikel 74
Den kompetente myndigheds foreløbige sygdomsbekæmpelsesforanstaltninger for listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra b)
1.   Hvis den kompetente myndighed har mistanke om en listeopført sygdom omhandlet i artikel 9, stk. 1, litra b), hos opdrættede dyr, træffer den med forbehold af nationale krav til opnåelse af adgang til private bopæle i afventning af resultaterne af den i artikel 73, stk. 1, omhandlede undersøgelse og gennemførelsen af de i artikel 79 omhandlede sygdomsbekæmpelsesforanstaltninger følgende foreløbige sygdomsbekæmpelsesforanstaltninger:
a)
Den anvender sygdomsbekæmpelsesforanstaltninger for at begrænse spredningen af den pågældende listeopførte sygdom fra det/den angrebne område, virksomhed, fødevare- eller foderstofvirksomhed, virksomhed, der beskæftiger sig med animalske biprodukter, eller andet sted.
b)
Den indleder om nødvendigt en epidemiologisk undersøgelse under hensyntagen til de regler om sådanne undersøgelser, der er fastlagt i artikel 57, stk. 1.
2.   Foruden foranstaltningerne i stk. 1 kan den kompetente myndighed i de i stk. 1 nævnte tilfælde træffe yderligere foreløbige sygdomsbekæmpelsesforanstaltninger, forudsat at disse foranstaltninger overholder bestemmelserne i denne forordning og er i overensstemmelse med EU-retten.
3.   De i stk. 1 og 2 omhandlede foreløbige sygdomsbekæmpelsesforanstaltninger skal være hensigtsmæssige og stå i rimeligt forhold til den risiko, som den listeopførte sygdom, udgør, under hensyntagen til følgende:
a)
sygdomsprofilen
b)
de angrebne opdrættede dyr
c)
sundhedsstatussen i den medlemsstat, den zone, det kompartment eller den virksomhed, hvor der er mistanke om forekomst af den pågældende listeopførte sygdom
d)
de foreløbige sygdomsbekæmpelsesforanstaltninger omhandlet i artikel 55, stk. 1, og artikel 56 samt eventuelle delegerede retsakter vedtaget i henhold til artikel 55, stk. 2.
4.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende regler for listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra b), der supplerer reglerne i nærværende artikels stk. 1, under hensyntagen til de i stk. 3 omhandlede forhold for så vidt angår:
a)
de foreløbige sygdomsbekæmpelsesforanstaltninger, der skal træffes for at forhindre spredning af den listeopførte sygdom i henhold til stk. 1, litra a)
b)
anvendelse af de i stk. 1, litra a), omhandlede foreløbige sygdomsbekæmpelsesforanstaltninger på andrevirksomheder, epidemiologiske enheder deri, fødevare- eller foderstofvirksomheder og virksomheder, der beskæftiger sig med animalske biprodukter, eller andre steder
c)
oprettelse af passende midlertidige restriktionszoner under hensyntagen til sygdomsprofilen.
Artikel 75
Evaluering og udvidelse af foreløbige sygdomsbekæmpelsesforanstaltninger for listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra b)
De i artikel 74, stk. 1, omhandlede sygdomsbekæmpelsesforanstaltninger skal:
a)
evalueres af den kompetente myndighed, hvis det er relevant, på baggrund af resultaterne af den i artikel 73, stk. 1, omhandlede undersøgelse og eventuelt den i artikel 74, stk. 1, litra b), omhandlede epidemiologiske undersøgelse
b)
om nødvendigt udvides til også at omfatte andre steder, jf. artikel 74, stk. 4, litra b).
Artikel 76
Operatørers og andre relevante fysiske og juridiske personers forpligtelser og den kompetente myndigheds foranstaltninger i tilfælde af mistanke om listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra c)
1.   I tilfælde af mistanke om en listeopført sygdom omhandlet i artikel 9, stk. 1, litra c), i en medlemsstat, der har valgt et udryddelsesprogram, som dækker de relevante dele af dets område eller zoner eller kompartmenter deri, jf. artikel 31, stk. 2, træffer den pågældende medlemsstat foranstaltninger for at sikre, at berørte operatører og andre relevante fysiske og juridiske personer træffer passende foranstaltninger, jf. artikel 72, stk. 1, i afventning af at den kompetente myndighed træffer eventuelle sygdomsbekæmpelsesforanstaltninger i overensstemmelse med nærværende artikels stk. 2.
2.   Den kompetente myndighed i en medlemsstat, der har valgt at udrydde en listeopført sygdom omhandlet i stk. 1, skal, hvis den har mistanke om, at den pågældende sygdom forekommer hos opdrættede dyr:
a)
hurtigst muligt foretage en undersøgelse for at bekræfte eller udelukke forekomst af den pågældende listeopførte sygdom i overensstemmelse med artikel 73, stk. 1 og 2
b)
i afventning af resultaterne af den i litra a) omhandlede undersøgelse og gennemførelsen af sygdomsbekæmpelsesforanstaltninger i overensstemmelse med artikel 80, stk. 1, træffe de foreløbige sygdomsbekæmpelsesforanstaltninger, der er omhandlet i artikel 74, stk. 1 og 2.
3.   Den kompetente myndighed evaluerer og udvider de foreløbige sygdomsbekæmpelsesforanstaltninger i stk. 2, litra b), i overensstemmelse med artikel 75.
4.   Nærværende artikels stk. 1, 2 og 3 finder også anvendelse på medlemsstater eller zoner, der har opnået status som sygdomsfrie, for at bevare denne status i overensstemmelse med artikel 36 eller på kompartmenter i overensstemmelse med artikel 37, stk. 2.
5.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende nærmere regler, der supplerer reglerne om:
a)
sygdomsbekæmpelsesforanstaltninger som omhandlet i stk. 1
b)
den undersøgelse, der er omhandlet i stk. 2, litra a)
c)
de foreløbige sygdomsbekæmpelsesforanstaltninger, der skal træffes for at hindre spredning af den listeopførte sygdom i henhold til stk. 2, litra b).
Afdeling 2
Bekræftelse af sygdomme hos opdrættede dyr
Artikel 77
Den kompetente myndigheds officielle bekræftelse af sygdom
1.   Den kompetente myndighed baserer en officiel bekræftelse af en listeopført sygdom omhandlet i artikel 9, stk. 1, litra b) eller c), på følgende oplysninger:
a)
resultaterne af kliniske undersøgelser og laboratorieundersøgelser som omhandlet i artikel 73, stk. 2
b)
den i artikel 74, stk. 1, litra b), omhandlede epidemiologiske undersøgelse, hvis det er relevant
c)
andre tilgængelige epidemiologiske data.
2.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende krav, der skal være opfyldt for en officiel bekræftelse som omhandlet i stk. 1.
Artikel 78
Ophævelse af foreløbige sygdomsbekæmpelsesforanstaltninger, når forekomst af sygdom er udelukket
Den kompetente myndighed fortsætter med at anvende de i artikel 74, stk. 1, artikel 75 og artikel 76, stk. 2, litra b), omhandlede foreløbige sygdomsbekæmpelsesforanstaltninger, indtil forekomst af den pågældende listeopførte sygdom er blevet udelukket i overensstemmelse med artikel 77, stk. 1, og eventuelle regler vedtaget i henhold til artikel 77, stk. 2.
Afdeling 3
Sygdomsbekæmpelsesforanstaltninger i tilfælde af bekræftelse af sygdom hos opdrættede dyr
Artikel 79
Den kompetente myndigheds sygdomsbekæmpelsesforanstaltninger for listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra b)
I tilfælde af officiel bekræftelse i henhold til artikel 77, stk. 1, af et udbrud af en listeopført sygdom omhandlet i artikel 9, stk. 1, litra b), hos opdrættede dyr skal den kompetente myndighed i en medlemsstat, en zone eller et kompartment, alt efter hvad der er relevant for det pågældende udbrud:
a)
anvende sygdomsbekæmpelsesforanstaltningerne i det obligatoriske udryddelsesprogram, jf. artikel 31, stk. 1, for den pågældende listeopførte sygdom, eller
b)
hvis den pågældende medlemsstat eller zone eller kompartment har opnået status som sygdomsfri i henhold til henholdsvis artikel 36 eller 37:
i)
træffe en eller flere af de foranstaltninger, der er fastsat i artikel 53-69 og står i rimeligt forhold til den risiko, som den pågældende listeopførte sygdom udgør, og
ii)
hvis det er nødvendigt, iværksætte det obligatoriske udryddelsesprogram for den pågældende listeopførte sygdom.
Artikel 80
Sygdomsbekæmpelsesforanstaltninger, der skal træffes af den kompetente myndighed for listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra c)
1.   I tilfælde af officiel bekræftelse i henhold til artikel 77, stk. 1, af udbrud af en listeopført sygdom omhandlet i artikel 9, stk. 1, litra c), hos opdrættede dyr i en medlemsstat, der har valgt et udryddelsesprogram, som dækker de relevante dele af dets område eller zoner eller kompartmenter deri, jf. artikel 31, stk. 2, alt efter hvad der er relevant for den pågældende listeopførte sygdom og det pågældende udbrud, anvender den kompetente myndighed sygdomsbekæmpelsesforanstaltningerne i det valgfrie udryddelsesprogram.
2.   Den kompetente myndighed kan træffe yderligere sygdomsbekæmpelsesforanstaltninger i forhold til dem, er omhandlet i stk. 1, som kan omfatte en eller flere af de foranstaltninger, der er fastsat i artikel 53-69, og som skal stå i rimeligt forhold til den risiko, som den pågældende listeopførte sygdom, udgør, samt skal tage hensyn til:
a)
sygdomsprofilen
b)
de angrebne opdrættede dyr
c)
økonomiske og sociale konsekvenser.
3.   I tilfælde af officiel bekræftelse i henhold til artikel 77, stk. 1, af et udbrud af en listeopført sygdom omhandlet i artikel 9, stk. 1, litra c), hos opdrættede dyr i en medlemsstat, en zone eller et kompartment, der har opnået status som sygdomsfri i henhold til artikel 36 eller 37, og for at bevare denne status træffer den kompetente myndighed en eller flere af de foranstaltninger, der er fastsat i artikel 53-69. Disse foranstaltninger skal stå i et rimeligt forhold til den risiko, som den pågældende listeopførte sygdom, udgør, under hensyntagen til:
a)
sygdomsprofilen
b)
de angrebne opdrættede dyr
c)
økonomiske og sociale konsekvenser.
Afdeling 4
Vildtlevende dyr
Artikel 81
Sygdomsbekæmpelsesforanstaltninger for listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra b), hos vildtlevende dyr
Såfremt en berørt medlemsstats kompetente myndighed får mistanke om eller officielt bekræfter udbrud af en listeopført sygdom omhandlet i artikel 9, stk. 1, litra b), hos vildtlevende dyr, skal den på hele sit område, på den berørte del deraf eller i den berørte zone, alt efter hvad der er relevant for det pågældende udbrud:
a)
anvende sygdomsbekæmpelsesforanstaltningerne i det obligatoriske udryddelsesprogram, der er omhandlet i artikel 30, stk. 1, for den pågældende listeopførte sygdom eller
b)
iværksætte et obligatorisk udryddelsesprogram, hvis udryddelsesprogrammet i artikel 31, stk. 1, for den pågældende listeopførte sygdom endnu ikke har været anvendt som følge af hidtidigt fravær af eller frihed for denne sygdom, og hvis foranstaltninger for vildtlevende dyr er nødvendige for at bekæmpe og hindre spredning af den pågældende sygdom.
Artikel 82
Sygdomsbekæmpelsesforanstaltninger for listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra c), hos vildtlevende dyr
1.   Såfremt en kompetent myndighed får mistanke om eller officielt bekræfter en listeopført sygdom omhandlet i artikel 9, stk. 1, litra c), hos vildtlevende dyr, og den berørte medlemsstat har valgt at udrydde den pågældende sygdom, og forudsat at det valgfrie udryddelsesprogram, jf. artikel 31, stk. 2, indeholder foranstaltninger for vildtlevende dyr for så vidt angår den pågældende sygdom, anvender den kompetente myndighed sygdomsbekæmpelsesforanstaltningerne i dette valgfrie udryddelsesprogram på hele den pågældende medlemsstats område, den berørte del deraf eller i den berørte zone, alt efter hvad der er relevant for den pågældende mistanke eller officielle bekræftelse.
2.   Den kompetente myndighed kan træffe yderligere sygdomsbekæmpelsesforanstaltninger i forhold til dem, der er omhandlet i stk. 1, som kan omfatte en eller flere af de foranstaltninger, der er fastsat i artikel 53-69, og som skal stå i rimeligt forhold til den risiko, som den pågældende listeopførte sygdom udgør, samt skal tage hensyn til:
a)
sygdomsprofilen
b)
de angrebne vildtlevende dyr og risikoen for overførsel af sygdomme til dyr og mennesker samt
c)
økonomiske, sociale og miljømæssige konsekvenser.
3.   I tilfælde af officiel bekræftelse af et udbrud af en listeopført sygdom omhandlet i artikel 9, stk. 1, litra c), hos vildtlevende dyr i en medlemsstat, en zone eller et kompartment, der har opnået status som sygdomsfri i henhold til artikel 36 eller 37, og for at bevare denne status træffer den kompetente myndighed en eller flere af de foranstaltninger, der er fastsat i artikel 53-69. Disse foranstaltninger skal stå i et rimeligt forhold til den risiko, som den pågældende listeopførte sygdom udgør, under hensyntagen til:
a)
sygdomsprofilen
b)
de angrebne vildtlevende dyr og risikoen for overførsel af sygdomme til dyr og mennesker
c)
relevansen af sygdommens forekomst hos vildtlevende dyr for opdrættede dyrs sundhedsstatus og
d)
økonomiske, sociale og miljømæssige konsekvenser.
Afdeling 5
Kommissionens koordinering og midlertidige særlige sygdomsbekæmpelsesregler
Artikel 83
Kommissionens koordinering af foranstaltninger samt midlertidige særlige regler vedrørende afdeling 1-4
1.   Medlemsstaterne underretter Kommissionen om:
a)
sygdomsbekæmpelsesforanstaltninger, som deres kompetente myndigheder har truffet i overensstemmelse med artikel 77, stk. 1, og artikel 78, 79 og 81 samt eventuelle delegerede retsakter vedtaget i henhold artikel 77, stk. 2, med hensyn til en listeopført sygdom omhandlet i artikel 9, stk. 1, litra b)
b)
sygdomsbekæmpelsesforanstaltninger, som deres kompetente myndigheder har truffet i overensstemmelse med artikel 77, stk. 1, artikel 78, artikel 80, stk. 1, og artikel 82 samt eventuelle delegerede retsakter vedtaget i henhold til artikel 77, stk. 2, med hensyn til en listeopført sygdom omhandlet i artikel 9, stk. 1, litra c).
2.   Kommissionen vurderer sygdomssituationen og de sygdomsbekæmpelsesforanstaltninger, der er truffet af den kompetente myndighed i henhold til dette kapitel, og kan ved hjælp af gennemførelsesretsakter fastsætte særlige regler om sygdomsbekæmpelsesforanstaltninger for et begrænset tidsrum over for en listeopført sygdom omhandlet i artikel 9, stk. 1, litra b) eller c), på betingelser, der er passende i forhold til den epidemiologiske situation, hvis:
a)
de sygdomsbekæmpelsesforanstaltninger, der er truffet af den pågældende kompetente myndighed, ikke anses for egnede i forhold til den epidemiologiske situation
b)
den pågældende listeopførte sygdom ser ud til at spredes trods de sygdomsbekæmpelsesforanstaltninger, der er truffet i henhold til dette kapitel, hvis det er relevant.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
3.   I behørigt begrundede særligt hastende tilfælde vedrørende en listeopført sygdom omhandlet i artikel 9, stk. 1, litra b) eller c), der udgør en ny risiko af et meget betydeligt omfang, vedtager Kommissionen efter proceduren i artikel 266, stk. 3, gennemførelsesretsakter, der straks finder anvendelse.
DEL IV
REGISTRERING, GODKENDELSE, SPORBARHED OG FLYTNING
AFSNIT I
LANDDYR, AVLSMATERIALE OG ANIMALSKE PRODUKTER AF LANDDYR
KAPITEL 1
Registrering, godkendelse, føring af fortegnelser samt registre
Afdeling 1
Registrering af virksomheder og visse typer operatører
Artikel 84
Forpligtelse for operatører til at få virksomheder registreret
1.   Operatører af virksomheder, som holder landdyr eller indsamler, producerer, forarbejder eller opbevarer avlsmateriale, skal for at få deres virksomheder registreret i henhold til artikel 93, inden de indleder sådanne aktiviteter:
a)
underrette den kompetente myndighed om enhver virksomhed, som de er ansvarlige for
b)
give den kompetente myndighed følgende oplysninger:
i)
den pågældende operatørs navn og adresse
ii)
virksomhedens beliggenhed og beskrivelse af dens faciliteter
iii)
kategorierne, arterne og antallet eller mængden af opdrættede landdyr eller avlsmateriale, som de agter at holde på virksomheden, samt virksomhedens kapacitet
iv)
virksomhedstypen og
v)
andre aspekter af virksomheden af relevans for formålet med fastlæggelse af, hvilken risiko den udgør.
2.   Operatører af virksomheder, jf. stk. 1, skal underrette den kompetente myndighed om:
a)
ændringer på den pågældende virksomhed for så vidt angår de i stk. 1, litra b), omhandlede forhold
b)
indstilling af den pågældende operatørs eller den pågældende virksomheds aktiviteter.
3.   Virksomheder, der skal godkendes i henhold til artikel 94, stk. 1, har ikke pligt til at meddele de i nærværende artikels stk. 1 omhandlede oplysninger.
Artikel 85
Dispensation fra forpligtelsen for operatører til at få virksomheder registreret
Uanset artikel 84, stk. 1, kan medlemsstaterne fritage visse kategorier af virksomheder, der udgør en ubetydelig risiko, fra kravet om registrering som fastsat i en gennemførelsesretsakt vedtaget i overensstemmelse med artikel 86, stk. 2. Medlemsstaterne underretter Kommissionen om sådanne fritagelser.
Artikel 86
Gennemførelsesbeføjelser vedrørende forpligtelsen for operatører til at få virksomheder registreret
1.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler om oplysninger, som operatører skal give for at få registreret virksomheder, jf. artikel 84, stk. 1, herunder om tidsfristerne for afgivelse af sådanne oplysninger.
2.   Kommissionen fastsætter ved hjælp af gennemførelsesretsakter regler vedrørende typer af virksomheder, som medlemsstaterne kan fritage fra kravet om registrering i henhold til artikel 85, på grundlag af:
a)
arterne, kategorierne og antallet eller mængden af opdrættede landdyr og avlsmateriale på den pågældende virksomhed samt virksomhedens kapacitet
b)
virksomhedstypen og
c)
flytninger af opdrættede landdyr eller avlsmateriale til og fra virksomheden.
3.   De i denne artikel omhandlede gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 87
Registreringsforpligtelser for transportører af opdrættede hovdyr samt delegerede retsakter
1.   Transportører, der transporterer opdrættede hovdyr mellem medlemsstater eller mellem en medlemsstat og et tredjeland, skal for at blive registreret i henhold til artikel 93, inden de indleder sådanne aktiviteter:
a)
underrette den kompetente myndighed om deres aktiviteter
b)
give den kompetente myndighed oplysninger om:
i)
den pågældende transportørs navn og adresse
ii)
kategorierne, arterne og antallet af opdrættede hovdyr, som de planlægger at transportere
iii)
transporttypen
iv)
transportmidlet.
2.   Transportører omhandlet i stk. 1 skal underrette den kompetente myndighed om:
a)
ændringer i de i stk. 1, litra b), omhandlede forhold
b)
indstilling af transportaktiviteterne.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende supplering af reglerne i nærværende artikels stk. 1 for så vidt angår forpligtelsen for andre typer af transportører, hvis transportaktiviteter udgør specifikke og betydelige risici for så vidt angår visse arter eller kategorier af dyr, til at give relevante oplysninger med henblik på registrering af deres aktiviteter.
Artikel 88
Dispensation fra registreringsforpligtelsen for transportører af opdrættede hovdyr
Uanset artikel 87, stk. 1, kan medlemsstaterne fritage visse kategorier af transportører, hvis transportaktiviteter udgør en ubetydelig risiko, fra kravet om registrering som fastsat i en gennemførelsesretsakt vedtaget i overensstemmelse med artikel 89, stk. 2. Medlemsstaterne underretter Kommissionen om sådanne fritagelser.
Artikel 89
Gennemførelsesbeføjelser vedrørende registreringsforpligtelsen for transportører
1.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler om oplysninger, som transportører skal give for at få registreret deres aktiviteter, jf. artikel 87, stk. 1 og 3, herunder om tidsfristerne for afgivelse af sådanne oplysninger.
2.   Kommissionen fastsætter ved hjælp af gennemførelsesretsakter regler vedrørende typer af transportører, som medlemsstaterne kan fritage fra kravet om registrering i henhold til artikel 86, på grundlag af:
a)
transportafstande for de pågældende hovdyr og
b)
kategorierne, arterne og antallet af transporterede hovdyr.
3.   De i denne artikel omhandlede gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 90
Registreringsforpligtelse for operatører, der beskæftiger sig med sammenbringning, som er uafhængig af en virksomhed
1.   Operatører, der beskæftiger sig med sammenbringning af opdrættede hovdyr og fjerkræ uafhængigt af en virksomhed, herunder operatører, der køber og sælger dyr, skal for at blive registreret i overensstemmelse med artikel 93, inden de indleder deres aktiviteter, give den kompetente myndighed oplysninger om:
a)
den pågældende operatørs navn og adresse
b)
hvilke arter og kategorier af opdrættede hovdyr og fjerkræ, der er omfattet af deres aktiviteter.
2.   De i stk. 1 omhandlede operatører skal underrette den kompetente myndighed om:
a)
ændringer i de i stk. 1 omhandlede forhold
b)
indstilling af den pågældende operatørs aktiviteter.
Artikel 91
Dispensation fra registreringsforpligtelsen for operatører, der beskæftiger sig med sammenbringning
Uanset artikel 90, stk. 1, kan medlemsstaterne fritage visse kategorier af operatører, der beskæftiger sig med sammenbringning, fra kravet om registrering, når de udgør en ubetydelig risiko som fastsat i en gennemførelsesretsakt vedtaget i overensstemmelse med artikel 92, stk. 2. Medlemsstaterne underretter Kommissionen om sådanne fritagelser.
Artikel 92
Gennemførelsesbeføjelser vedrørende registreringsforpligtelsen for operatører, der beskæftiger sig med sammenbringning
1.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler om oplysninger, som operatører skal give for at blive registreret, jf. artikel 90, stk. 1, herunder om tidsfristerne for afgivelse af sådanne oplysninger.
2.   Kommissionen fastsætter ved hjælp af gennemførelsesretsakter regler vedrørende typer af operatører, som medlemsstaterne kan fritage fra kravet om registrering i henhold til artikel 91, forudsat at operatørernes aktiviteter udgør en ubetydelig risiko og baseret på de arter, de kategorier og det antal opdrættede landdyr, der er omfattet af deres aktiviteter.
3.   De i denne artikel omhandlede gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 93
Den kompetente myndigheds registreringsforpligtelser
En kompetent myndighed registrerer:
a)
virksomheder i det i artikel 101, stk. 1, omhandlede register, hvis den pågældende operatør har givet de oplysninger, der kræves i henhold til artikel 84, stk. 1
b)
transportører i det i artikel 101, stk. 1, omhandlede register, hvis den pågældende transportør har givet de oplysninger, der kræves i henhold til artikel 87, stk. 1 og 3
c)
operatører, der beskæftiger sig med sammenbringning, som er uafhængig af en virksomhed, i det i artikel 101, stk. 1, omhandlede register, hvis den pågældende operatør har givet de oplysninger, der kræves i henhold til artikel 90, stk. 1.
Den kompetente myndighed tildeler hver af de i stk. 1, litra a), b) og c), omhandlede virksomheder, transportører og operatører et unikt registreringsnummer.
Afdeling 2
Godkendelse af visse typer virksomheder
Artikel 94
Godkendelse af visse virksomheder samt delegerede retsakter
1.   Operatører af følgende typer virksomheder skal ansøge den kompetente myndighed om godkendelse i overensstemmelse med artikel 96, stk. 1, og må ikke indlede deres aktiviteter, før deres virksomhed er blevet godkendt i henhold til artikel 97, stk. 1:
a)
virksomheder, der beskæftiger sig med sammenbringning af hovdyr og fjerkræ, og hvorfra disse dyr flyttes til en anden medlemsstat, eller som modtager dyr fra en anden medlemsstat
b)
virksomheder for avlsmateriale for kvæg, svin, får, geder og heste, hvorfra avlsmateriale af disse dyr flyttes til en anden medlemsstat
c)
rugerier, hvorfra rugeæg eller fjerkræ flyttes til en anden medlemsstat
d)
virksomheder, hvor der holdes fjerkræ, og hvorfra fjerkræ bestemt til anden anvendelse end slagtning eller rugeæg flyttes til en anden medlemsstat
e)
enhver anden type virksomhed, der beskæftiger sig med opdrættede landdyr, og som udgør en betydelig risiko og skal godkendes i medfør af en delegeret retsakt vedtaget i henhold til stk. 3, litra b).
2.   Operatører skal indstille deres aktiviteter på en virksomhed som omhandlet i stk. 1, hvis:
a)
den kompetente myndighed inddrager eller suspenderer sin godkendelse i henhold til artikel 100, stk. 2, eller
b)
den pågældende virksomhed i tilfælde af betinget godkendelse i henhold til artikel 99, stk. 3, ikke opfylder de resterende krav omhandlet i artikel 99, stk. 3, og ikke opnår endelig godkendelse i henhold til artikel 97, stk. 1.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
undtagelser fra kravet om, at operatører af de i stk. 1, litra a)-d), omhandlede typer virksomheder skal ansøge den kompetente myndighed om godkendelse, hvis de pågældende virksomheder udgør en ubetydelig risiko
b)
typer af virksomheder, der skal godkendes i henhold til stk. 1, litra e)
c)
særlige regler om indstilling af aktiviteter for avlsmaterialevirksomheder omhandlet i stk. 1, litra b).
4.   Kommissionen baserer delegerede retsakter i henhold til stk. 3 på følgende kriterier:
a)
arterne og kategorierne af opdrættede landdyr eller avlsmateriale på en virksomhed
b)
antallet af arter og antallet eller mængden af opdrættede landdyr eller avlsmateriale, der holdes eller opbevares på en virksomhed
c)
virksomheds- og produktionstypen og
d)
flytninger af opdrættede landdyr eller avlsmateriale til og fra de pågældende typer virksomheder.
Artikel 95
Godkendelse af status som afgrænset virksomhed
Operatører af virksomheder, som ønsker at opnå status som en afgrænset virksomhed:
a)
skal ansøge den kompetente myndighed om godkendelse i henhold til artikel 96, stk. 1
b)
må først flytte opdrættede dyr til eller fra deres virksomhed i overensstemmelse med kravene i artikel 137, stk. 1, og eventuelle delegerede retsakter vedtaget i henhold til artikel 137, stk. 2, efter at deres virksomhed har fået godkendt denne status af den kompetente myndighed i henhold til artikel 97 og 99.
Artikel 96
Forpligtelse for operatører til at give oplysninger med henblik på at få godkendelse og gennemførelsesretsakter
1.   Operatører skal i forbindelse med ansøgning om godkendelse af deres virksomhed i henhold til artikel 94, stk. 1, og artikel 95, litra a), give den kompetente myndighed følgende oplysninger:
a)
den pågældende operatørs navn og adresse
b)
den pågældende virksomheds beliggenhed og en beskrivelse af dens faciliteter
c)
kategorierne, arterne og antallet eller mængden af opdrættede landdyr eller avlsmateriale, som er relevante for godkendelsen, på virksomheden
d)
virksomhedstypen
e)
andre aspekter af virksomheden for så vidt angår dens særlige karakteristika af relevans for fastlæggelsen af, hvilken eventuel risiko den udgør.
2.   Operatører af virksomheder, jf. stk. 1, skal underrette den kompetente myndighed om:
a)
ændringer på virksomheden for så vidt angår de i stk. 1, litra a), b) og c), omhandlede forhold
b)
indstilling af den pågældende operatørs eller den pågældende virksomheds aktiviteter.
3.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler om oplysninger, som operatører skal give i deres ansøgning om godkendelse af deres virksomhed i overensstemmelse med stk. 1, og om tidsfristerne for afgivelse af de i stk. 1 og stk. 2, litra b), omhandlede oplysninger.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 97
Godkendelse af og betingelser for godkendelse af virksomheder samt delegerede retsakter
1.   Kompetente myndigheder godkender kun virksomheder, jf. artikel 94, stk. 1, og artikel 95, litra a), som:
a)
opfylder følgende krav, alt efter hvad der er relevant, vedrørende:
i)
karantæne, isolation og andre biosikringsforanstaltninger under hensyntagen til kravene i artikel 10, stk. 1, litra b), og eventuelle regler vedtaget i henhold til artikel 10, stk. 2
ii)
overvågning som omhandlet i artikel 24 og, hvis det er relevant for den pågældende type virksomhed og den involverede risiko, i artikel 25
iii)
føring af fortegnelser som omhandlet i artikel 102 og 103 samt eventuelle regler vedtaget i henhold til artikel 106 og 107
b)
har faciliteter og udstyr, der:
i)
i tilstrækkelig grad begrænser risikoen for introduktion og spredning af sygdomme til et acceptabelt niveau under hensyntagen til den pågældende virksomhedstype
ii)
har en tilstrækkelig kapacitet i forhold til antallet af opdrættede landdyr eller mængden af avlsmateriale
c)
ikke udgør en uacceptabel risiko for spredning af sygdomme under hensyntagen til de risikobegrænsende foranstaltninger, der anvendes
d)
råder over et personale, der har den fornødne uddannelse til at kunne varetage den pågældende virksomheds aktiviteter
e)
har et system, der sætter den pågældende operatør i stand til over for den kompetente myndighed at godtgøre, at betingelserne i litra a)-d) er opfyldt.
2.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
karantæne, isolation og andre biosikringsforanstaltninger som omhandlet i stk. 1, litra a), nr. i)
b)
overvågning som omhandlet i stk. 1, litra a), nr. ii)
c)
faciliteter og udstyr som omhandlet i stk. 1, litra b)
d)
personales og dyrlægers ansvarsområder, kompetence og specialuddannelse, jf. stk. 1, litra d), med henblik på aktiviteter i avlsmaterialevirksomheder og virksomheder, der beskæftiger sig med sammenbringning af hovdyr og fjerkræ
e)
den kompetente myndigheds nødvendige tilsyn med avlsmaterialevirksomheder og virksomheder, der beskæftiger sig med sammenbringning af hovdyr og fjerkræ.
3.   Kommissionen baserer de regler, der skal fastsættes i delegerede retsakter i henhold til stk. 2, på følgende:
a)
de risici, som hver type virksomhed udgør
b)
de arter og kategorier af opdrættede landdyr, der er relevante for godkendelsen
c)
den pågældende produktionstype
d)
de typiske flytningsmønstre for så vidt angår den pågældende type virksomheder og de arter og kategorier af dyr, der holdes på disse virksomheder.
Artikel 98
Virksomhedsgodkendelsens omfang
Den kompetente myndighed angiver udtrykkeligt følgende i godkendelsen af en virksomhed i henhold til artikel 97, stk. 1, på grundlag af en ansøgning i henhold til artikel 94, stk. 1, eller artikel 95, litra a):
a)
hvilken type virksomhed som omhandlet i artikel 94, stk. 1, og artikel 95 samt regler vedtaget i henhold til artikel 94, stk. 3, litra b), godkendelsen gælder for
b)
hvilke arter og kategorier af opdrættede landdyr eller avlsmateriale af de pågældende arter godkendelsen gælder for.
Artikel 99
Den kompetente myndigheds godkendelsesprocedurer
1.   Den kompetente myndighed fastlægger procedurer, som operatører skal følge, når de ansøger om godkendelse af deres virksomhed i henhold til artikel 94, stk. 1, artikel 95 eller artikel 96, stk. 1.
2.   Efter at have modtaget en ansøgning om godkendelse fra en operatør aflægger den kompetente myndighed et besøg på stedet, jf. artikel 94, stk. 1, eller artikel 95, litra a).
3.   Hvis kravene i artikel 97 og i nærværende artikels stk. 1 og 2 er opfyldt, giver den kompetente myndighed godkendelse.
4.   Såfremt en virksomhed ikke opfylder alle godkendelseskravene i artikel 97, kan den kompetente myndighed give en virksomhed betinget godkendelse, hvis det på baggrund af operatørens ansøgning og det efterfølgende besøg på stedet, jf. nærværende artikels stk. 2, fremgår, at virksomheden opfylder alle de væsentligste krav, der giver tilfredsstillende garantier for, at virksomheden ikke udgør en betydelig risiko.
5.   Hvis den kompetente myndighed har givet betinget godkendelse i henhold til nærværende artikels stk. 4, giver den kun fuld godkendelse, hvis det af endnu et besøg på virksomheden aflagt inden for tre måneder efter datoen for betinget godkendelse eller af den dokumentation, som operatøren forelægger inden for tre måneder efter nævnte dato, fremgår, at virksomheden opfylder alle kravene til godkendelse i artikel 97, stk. 1, og regler vedtaget i henhold til artikel 97, stk. 2.
Hvis besøget på stedet eller den i første afsnit omhandlede dokumentation viser, at der er gjort klare fremskridt, men at virksomheden stadig ikke opfylder alle kravene, kan den kompetente myndighed forlænge den betingede godkendelse. En betinget godkendelse kan dog ikke gives for mere end seks måneder i alt.
Artikel 100
Den kompetente myndigheds revurdering, suspension og inddragelse af godkendelser
1.   Den kompetente myndighed tager godkendelser af virksomheder i henhold til artikel 97 og 99 op til fornyet vurdering med passende mellemrum baseret på de involverede risici.
2.   Hvis den kompetente myndighed konstaterer alvorlige mangler på en virksomhed for så vidt angår opfyldelse af kravene i artikel 97, stk. 1, og regler vedtaget i henhold til artikel 97, stk. 2, og den pågældende virksomheds operatør ikke kan give tilstrækkelige garantier for, at de pågældende mangler vil blive afhjulpet, indleder den kompetente myndighed procedurer med henblik på at inddrage virksomhedens godkendelse.
Den kompetente myndighed kan dog blot suspendere frem for at inddrage en virksomheds godkendelse, hvis operatøren kan garantere, at vedkommende vil afhjælpe manglerne inden for en rimelig frist.
3.   Godkendelse kan først gives efter inddragelse eller generhverves efter suspension i henhold til stk. 2, når den kompetente myndighed finder det godtgjort, at virksomheden fuldt ud opfylder alle kravene for den pågældende type virksomhed i denne forordning.
Afdeling 3
Den kompetente myndigheds registre
Artikel 101
Registre, der skal føres af den kompetente myndighed
1.   Den enkelte kompetente myndighed opretter og ajourfører et register over:
a)
alle virksomheder og operatører, der er registreret i henhold til artikel 93
b)
alle virksomheder, der er godkendt i henhold til artikel 97 og 99.
Den stiller registrene omhandlet i første afsnit, litra a) og b), til rådighed for Kommissionen og for de kompetente myndigheder i andre medlemsstater, for så vidt de oplysninger, der er indeholdt deri, er relevante for flytning af opdrættede landdyr og avlsmateriale deraf mellem medlemsstater.
Den kompetente myndighed stiller registret over godkendte virksomheder omhandlet i første afsnit, litra b), til rådighed for offentligheden, for så vidt de oplysninger, der er indeholdt deri, er relevante for flytning af opdrættede landdyr og avlsmateriale deraf mellem medlemsstater.
2.   En kompetent myndighed kan, hvis det er hensigtsmæssigt og relevant, kombinere registreringen som omhandlet i stk. 1, første afsnit, litra a), og godkendelserne som omhandlet i stk. 1, første afsnit, litra b), med registrering til andre formål.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende, hvilke oplysninger registrene i stk. 1, første afsnit, litra a) og b), skal indeholde, og vedrørende offentlig adgang til registret i stk. 1, første afsnit, litra b).
Afdeling 4
Føring af fortegnelser
Artikel 102
Forpligtelser vedrørende føring af fortegnelser for operatører af andre virksomheder end avlsmaterialevirksomheder
1.   Operatører af virksomheder, som skal registreres i henhold til artikel 93 eller godkendes i henhold til artikel 97, stk. 1, skal føre og vedligeholde fortegnelser, der mindst indeholder følgende oplysninger:
a)
arter, kategorier, antal og, hvor det er relevant, identifikation af opdrættede landdyr på deres virksomhed
b)
flytning af opdrættede landdyr til og fra deres virksomhed med angivelse af følgende:
i)
dyrenes oprindelses- eller bestemmelsessted
ii)
datoen for flytning
c)
den dokumentation, der skal ledsage opdrættede landdyr, som ankommer til eller forlader deres virksomhed, jf. artikel 112, litra b), artikel 113, stk. 1, litra b), artikel 114, stk. 1, litra c), artikel 115, litra b), artikel 117, litra b), artikel 143, stk. 1 og 2, og artikel 164, stk. 2, samt eventuelle regler vedtaget i henhold til artikel 118 og 120 og artikel 144, stk. 1, litra b) og c)
d)
dødeligheden blandt opdrættede landdyr på deres virksomhed
e)
biosikringsforanstaltninger, overvågning, behandlinger, undersøgelsesresultater og andre relevante oplysninger vedrørende:
i)
arter og kategorier af opdrættede landdyr på virksomheden
ii)
produktionstypen
iii)
virksomhedens type og størrelse
f)
resultaterne af eventuelle krævede dyresundhedsbesøg i henhold til artikel 25, stk. 1.
Fortegnelserne skal føres og vedligeholdes i papir eller elektronisk form.
2.   Virksomheder, der udgør en lav risiko for spredning af listeopførte eller nye sygdomme, kan af den pågældende medlemsstat fritages fra kravet om føring af fortegnelser over alle eller nogle af de i stk. 1 omhandlede oplysninger.
3.   Operatører af virksomheder skal opbevare de i stk. 1 og 2 omhandlede fortegnelser på den pågældende virksomhed og
a)
efter anmodning øjeblikkelig stille dem til rådighed for den kompetente myndighed
b)
opbevare dem i et minimumstidsrum, der fastsættes af den kompetente myndighed, dog mindst tre år.
4.   Uanset stk. 3 kan operatører fritages fra forpligtelsen til at føre fortegnelser over alle eller nogle af de forhold, der er omhandlet i stk. 1, når den pågældende operatør:
a)
har adgang til den elektroniske database, der er omhandlet i artikel 109, for de relevante arter, og databasen allerede indeholder de oplysninger, der skal medtages i fortegnelserne, og
b)
sørger for, at de ajourførte oplysninger indlæses direkte i den elektroniske database.
Artikel 103
Forpligtelser vedrørende føring af fortegnelser for avlsmaterialevirksomheder
1.   Operatører af avlsmaterialevirksomheder skal føre og vedligeholde fortegnelser, der mindst indeholder følgende oplysninger:
a)
race, alder og identifikation af og sundhedsstatus for de donordyr, der anvendes til produktion af avlsmateriale
b)
tidspunkt og sted for indsamling, forarbejdning og opbevaring af indsamlet, produceret eller forarbejdet avlsmateriale
c)
identifikation af avlsmaterialet tillige med nærmere oplysninger om dets bestemmelsessted, hvis dette er kendt
d)
de dokumenter, der skal ledsage avlsmateriale, som ankommer til eller forlader den pågældende virksomhed, i henhold til artikel 162 og artikel 164, stk. 2, samt eventuelle regler vedtaget i henhold til artikel 162, stk. 3 og 4
e)
hvor det er relevant, resultaterne af kliniske undersøgelser og laboratorietest
f)
anvendte laboratoriemetoder.
2.   Virksomheder, der udgør en lav risiko for spredning af listeopførte eller nye sygdomme, kan af den pågældende medlemsstat fritages fra kravet om at føre fortegnelser over alle eller nogle af de i stk. 1 omhandlede oplysninger.
3.   Operatører af avlsmaterialevirksomheder skal opbevare de i stk. 1 og 2 omhandlede fortegnelser på deres virksomhed og
a)
efter anmodning øjeblikkelig stille dem til rådighed for den kompetente myndighed
b)
opbevare dem i et minimumstidsrum, der fastsættes af den kompetente myndighed, dog mindst tre år.
Artikel 104
Forpligtelser vedrørende føring af fortegnelser for transportører
1.   Transportører skal føre og vedligeholde fortegnelser, der mindst indeholder følgende oplysninger:
a)
virksomheder, som de har været på
b)
kategorierne, arterne og antallet af opdrættede landdyr, som de har transporteret
c)
rengøring, desinfektion og frigørelse for parasitter og gnavere af de anvendte transportmidler
d)
nærmere oplysninger om de dokumenter, der ledsager de pågældende dyr, herunder dokumentnumre.
Fortegnelserne føres og vedligeholdes i papir eller elektronisk form.
2.   Transportører, som der er en lav risiko for spredning af listeopførte eller nye sygdomme forbundet med, kan af den pågældende medlemsstat fritages fra kravet om at føre fortegnelser over alle eller nogle af de i stk. 1 omhandlede oplysninger.
3.   Transportører skal opbevare de i stk. 1 og 2 omhandlede fortegnelser
a)
på en sådan måde, at de efter anmodning øjeblikkelig kan stilles til rådighed for den kompetente myndighed
b)
i et minimumstidsrum, der fastsættes af den kompetente myndighed, dog mindst tre år.
Artikel 105
Forpligtelser vedrørende føring af fortegnelser for operatører, der beskæftiger sig med sammenbringning
1.   Operatører, der beskæftiger sig med sammenbringning, som skal registreres i henhold til artikel 93, skal føre og vedligeholde fortegnelser, der mindst indeholder følgende oplysninger:
a)
arter, kategorier, antal og identifikation af opdrættede landdyr under deres ansvar
b)
flytning af opdrættede landdyr under deres ansvar med angivelse af følgende:
i)
dyrenes oprindelses- og bestemmelsessted
ii)
datoen for flytningerne
c)
de dokumenter, der skal ledsage opdrættede landdyr flyttet under deres ansvar, jf. artikel 112, litra b), artikel 113, stk. 1, litra b), artikel 114, stk. 1, litra c), artikel 115, litra b), artikel 117, litra b), artikel 143, stk. 1 og 2, og artikel 164, stk. 2, samt eventuelle regler vedtaget i henhold til artikel 118 og 120 og artikel 144, stk. 1, litra b) og c)
d)
dødeligheden blandt opdrættede landdyr, som de er ansvarlige for, og
e)
biosikringsforanstaltninger, overvågning, behandlinger, undersøgelsesresultater og andre relevante oplysninger for arterne og kategorierne af opdrættede landdyr, som de er ansvarlige for.
Fortegnelserne skal føres og vedligeholdes på papir eller i elektronisk form.
2.   Operatører, hvis aktiviteter udgør en lav risiko for spredning af listeopførte eller nye sygdomme, kan af den pågældende medlemsstat fritages fra kravet om føring af fortegnelser over alle eller nogle af de i stk. 1 omhandlede oplysninger.
3.   Operatører skal:
a)
efter anmodning stille de i stk. 1 omhandlede fortegnelser til rådighed for den kompetente myndighed
b)
opbevare disse fortegnelser i et minimumstidsrum, der fastsættes af den kompetente myndighed, dog mindst tre år.
Artikel 106
Delegation af beføjelser vedrørende føring af fortegnelser
1.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 om regler, der supplerer kravene vedrørende føring af fortegnelser i artikel 102, 103, 104 og 105, for så vidt angår:
a)
oplysninger, der skal registreres, ud over de i artikel 102, stk. 1, artikel 103, stk. 1, artikel 104, stk. 1, og artikel 105, stk. 1, omhandlede oplysninger
b)
supplerende krav vedrørende føring af fortegnelser for avlsmateriale, der er indsamlet, fremstillet eller forarbejdet på en avlsmaterialevirksomhed, efter den pågældende virksomhed har indstillet sine aktiviteter.
2.   Kommissionen baserer de regler, der skal fastsættes i delegerede retsakter som omhandlet i stk. 1, på følgende:
a)
de risici, som hver type virksomhed eller aktivitet udgør
b)
arterne og kategorierne af opdrættede landdyr eller avlsmateriale på den pågældende virksomhed, eller som transporteres til eller fra denne virksomhed
c)
produktionstypen på virksomheden eller aktivitetstypen
d)
de pågældende dyrs typiske flytningsmønstre og kategorier
e)
antallet af opdrættede landdyr eller mængden af avlsmateriale, som den pågældende operatør har ansvaret for.
Artikel 107
Gennemførelsesbeføjelser vedrørende fritagelser fra kravene om føring af fortegnelser
Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler vedrørene typer af virksomheder og operatører, som medlemsstater kan fritage fra kravene om føring af fortegnelser i artikel 102, 103, 104 og 105 for så vidt angår:
a)
virksomheder, hvor der holdes, eller operatører, der håndterer eller transporterer et lille antal opdrættede landdyr eller en lille mængde avlsmateriale
b)
arter eller kategorier af opdrættede landdyr eller avlsmateriale.
Kommissionen baserer disse gennemførelsesretsakter på kriterierne i artikel 106, stk. 2.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
KAPITEL 2
Sporbarhedskrav for opdrættede landdyr og avlsmateriale
Afdeling 1
Opdrættede landdyr
Artikel 108
Medlemsstaternes forpligtelse til at indføre en ordning for identifikation og registrering af opdrættede landdyr
1.   Medlemsstaterne indfører en ordning for identifikation og registrering af de arter af opdrættede landdyr, som denne forordning og eventuelle regler, der vedtages i henhold til den, kræver en ordning for. En sådan ordning skal, hvis det er relevant, sikre registrering af flytninger af disse dyr.
2.   I forbindelse med indførelsen af den ordning, der er omhandlet i stk. 1, tager medlemsstaterne hensyn til:
a)
arterne eller kategorierne af de pågældende opdrættede landdyr
b)
risikoen ved den pågældende art eller kategori.
3.   Den i stk. 1 omhandlede ordning skal omfatte følgende:
a)
midler til at identificere opdrættede landdyr individuelt eller gruppevis
b)
identifikationsdokumenter, flytningsdokumenter og andre dokumenter til identifikation og sporing af opdrættede landdyr som omhandlet i artikel 110
c)
ajourførte fortegnelser på virksomhederne, jf. artikel 102, stk. 1, litra a) og b)
d)
en elektronisk database over opdrættede landdyr som omhandlet i artikel 109, stk. 1.
4.   Den i stk. 1 omhandlede ordning skal være udformet på en sådan måde, at den:
a)
sikrer effektiv gennemførelse af de ved denne forordning fastlagte sygdomsforebyggelses- og -bekæmpelsesforanstaltninger
b)
letter sporbarheden af opdrættede landdyr, flytninger af dem inden for og mellem medlemsstater og indførsel af dem til Unionen
c)
sikrer effektiv interoperabilitet mellem, integrering af og kompatibilitet mellem ordningens elementer
d)
sikrer, at ordningen i det omfang, hvor det er hensigtsmæssigt, er tilpasset til:
i)
det i artikel 22 omhandlede IT-system til EU-anmeldelser og -rapportering
ii)
Traces
e)
sikrer en sammenhængende tilgang for de forskellige dyrearter, der er omfattet af ordningen.
5.   Medlemsstaterne kan, når det er hensigtsmæssigt:
a)
anvende hele eller dele af den i stk. 1 omhandlede ordning til andre formål end dem, der er nævnt i stk. 4, litra a) og b)
b)
integrere identifikationsdokumenter, flytningsdokumenter og andre dokumenter som omhandlet i artikel 110 i dyresundhedscertifikaterne eller den personlige erklæring omhandlet i artikel 143, stk. 1 og 2, og artikel 151, stk. 1, samt eventuelle regler vedtaget i henhold til artikel 144, stk. 1, litra b) og c), og artikel 151, stk. 3 og 4
c)
udpege en anden myndighed eller bemyndige et andet organ eller en fysisk person til at varetage anvendelsen i praksis af den i denne artikels stk. 1 omhandlede ordning for identifikation og registrering, herunder udstedelse af identifikationsdokumenter og udarbejdelse af modeller som omhandlet i artikel 110, stk. 1, litra a), b) og c).
Artikel 109
Medlemsstaternes forpligtelse til at oprette og vedligeholde en elektronisk database over opdrættede landdyr
1.   Medlemsstaterne opretter og vedligeholder en elektronisk database til registrering af mindst:
a)
følgende oplysninger vedrørende opdrættede dyr af kvægarterne:
i)
deres individuelle identifikation, jf. artikel 112, litra a)
ii)
de virksomheder, hvor de holdes
iii)
flytning af dem til og fra disse virksomheder
b)
følgende oplysninger vedrørende opdrættede dyr af fåre- og gedearterne:
i)
oplysninger om deres identifikation, jf. artikel 113, stk. 1, litra a), og antallet af dyr på de virksomheder, hvor de holdes
ii)
de virksomheder, hvor de holdes
iii)
flytninger af dem til og fra disse virksomheder
c)
følgende oplysninger vedrørende opdrættede dyr af svinearterne:
i)
oplysninger om deres identifikation, jf. artikel 115, og antallet af dyr på virksomhederne, hvor de holdes
ii)
de virksomheder, hvor de holdes
iii)
flytninger af dem til og fra disse virksomheder
d)
følgende oplysninger vedrørende opdrættede dyr af hestearterne:
i)
deres unikke kode som omhandlet i artikel 114
ii)
den identifikationsmetode som omhandlet i artikel 114, stk. 1, litra b), der forbinder det pågældende dyr med det i nr. iii) omhandlede identifikationsdokument, hvis det er relevant
iii)
de relevante identifikationsoplysninger i identifikationsdokumentet omhandlet i artikel 114, stk. 1, litra c), som fastsat i de regler, der er vedtaget i henhold til artikel 118 og 120
iv)
de virksomheder, hvor de pågældende dyr sædvanligvis holdes
e)
oplysninger vedrørende opdrættede landdyr af andre arter end dem, der er nævnt i dette stykkes litra a), b), c) og d), hvis dette er fastsat i regler vedtaget i henhold til stk. 2.
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende registrering af oplysninger om andre dyrearter end dem, der er nævnt i nærværende artikels stk. 1, litra a), b), c) og d), i den i samme stykke omhandlede elektroniske database, hvis det er nødvendigt på grund af de specifikke og betydelige risici, som de pågældende arter udgør, med henblik på at:
a)
sikre effektiv gennemførelse af de ved denne forordning fastlagte sygdomsforebyggelses- og -bekæmpelsesforanstaltninger
b)
lette sporbarheden af opdrættede landdyr, flytninger af dem mellem medlemsstater og indførsel af dem til Unionen.
Artikel 110
Den kompetente myndigheds forpligtelser vedrørende identifikationsdokumenter, flytningsdokumenter og andre dokumenter til identifikation og sporing af opdrættede landdyr
1.   Enhver kompetent myndighed:
a)
udsteder identifikationsdokumenter for opdrættede landdyr, hvis sådanne dokumenter kræves i henhold til artikel 114, stk. 1, litra c), og artikel 117, litra b), og regler vedtaget i henhold til artikel 118 og 120
b)
udsteder identifikationsdokumenter for kvæg som krævet i artikel 112, litra b), medmindre medlemsstaterne udveksler elektroniske data med andre medlemsstater inden for rammerne af et elektronisk udvekslingssystem fra den dato, hvor Kommissionen anerkender systemets fulde funktionsdygtighed
c)
udarbejder modeller af flytningsdokumenter og andre dokumenter til identifikation og sporing af opdrættede landdyr, hvis det kræves i henhold til artikel 113, stk. 1, litra b), artikel 115, litra b), og artikel 117, litra b), og eventuelle regler vedtaget i henhold til artikel 118 og 120.
2.   Stk. 1, litra b), berører ikke medlemsstaternes ret til at vedtage nationale regler om udstedelse af pas til dyr, der ikke er bestemt til flytning mellem medlemsstater.
Artikel 111
Offentliggørelse af oplysninger om identifikationsmidler
Enhver kompetent myndighed meddeler Kommissionen og offentliggør oplysninger om:
a)
kontaktpunkter for de elektroniske databaser, som medlemsstaterne har oprettet i henhold til artikel 109, stk. 1
b)
de myndigheder eller organer, der er ansvarlige for at udstede identifikationsdokumenter, flytningsdokumenter og andre dokumenter i henhold til artikel 110, under hensyntagen til artikel 108, stk. 5, litra c)
c)
det identifikationsmiddel, der skal anvendes for hver art og kategori af opdrættede landdyr, jf. artikel 112, litra a), artikel 113, stk. 1, litra a), artikel 114, stk. 1, artikel 115, litra a), og artikel 117, litra a), samt eventuelle regler vedtaget i henhold til artikel 118 og 120
d)
det foreskrevne format for udstedelse af identifikationsdokumenter og andre dokumenter i henhold til artikel 110.
Artikel 112
Operatørers forpligtelser vedrørende identifikation af opdrættede dyr af kvægarterne
Operatører, der holder opdrættede dyr af kvægarterne, skal:
a)
sikre, at hvert af de pågældende opdrættede dyr er identificeret med et fysisk identifikationsmiddel
b)
sikre, at der for de pågældende opdrættede dyr, når de flyttes mellem medlemsstater, er udstedt et identifikationsdokument af den kompetente myndighed, den udpegede myndighed eller det bemyndigede organ på oprindelsesstedet, medmindre betingelserne i artikel 110, stk. 1, litra b), er opfyldt
c)
sikre, at dette identifikationsdokument:
i)
opbevares, er behørigt udfyldt og holdes ajourført af den pågældende operatør og
ii)
ledsager de pågældende opdrættede landdyr på tidspunktet for flytningen, hvis dette dokument kræves i henhold til litra b)
d)
overføre oplysningerne om flytninger af de pågældende opdrættede dyr fra og til den pågældende virksomhed og om alle fødsler og dødsfald på virksomheden til den elektroniske database, der er omhandlet i artikel 109, stk. 1.
Artikel 113
Operatørers forpligtelser vedrørende identifikation af opdrættede dyr af fåre- og gedearterne
1.   Operatører, der holder opdrættede dyr af fåre- og gedearterne, skal:
a)
sikre, at hvert af de pågældende opdrættede dyr er identificeret med et fysisk identifikationsmiddel
b)
sikre, at de pågældende opdrættede dyr ledsages af et korrekt udfyldt flytningsdokument, der er baseret på den model, som udarbejdes af den kompetente myndighed i henhold til artikel 110, når dyrene flyttes fra den virksomhed, hvor de holdes, inden for den pågældende medlemsstat
c)
overføre oplysningerne om flytninger af de pågældende opdrættede dyr fra og til virksomheden til den elektroniske database omhandlet i artikel 109, stk. 1.
2.   Medlemsstaterne kan fritage operatører fra kravet om at sikre, at opdrættede dyr af fåre- og gedearterne ledsages af flytningsdokumenter under flytninger inden for deres område, hvis:
a)
oplysningerne i det relevante flytningsdokument indgår i den i artikel 109, stk. 1, omhandlede elektroniske database
b)
ordningen for identifikation og registrering af opdrættede dyr af fåre- og gedearterne sikrer et niveau af sporbarhed, der svarer til det, der opnås med flytningsdokumenter.
Artikel 114
Operatørers forpligtelser vedrørende identifikation og registrering af opdrættede dyr af hestearterne
1.   Operatører, der holder opdrættede dyr af hestearterne, skal sikre, at hvert dyr er identificeret ved:
a)
en unik kode, som er registreret i den i artikel 109, stk. 1, omhandlede elektroniske database
b)
et fysisk identifikationsmiddel eller en anden metode, der utvetydigt forbinder det opdrættede dyr med det i litra c) omhandlede identifikationsdokument, som er udstedt af den kompetente myndighed i henhold til artikel 110
c)
et enkelt korrekt udfyldt identifikationsdokument i hele dyrets levetid.
2.   Operatører, der holder opdrættede dyr af hestearterne, skal sikre, at oplysningerne om de pågældende dyr overføres til den elektroniske database, der er omhandlet i artikel 109, stk. 1.
Artikel 115
Operatørers forpligtelser vedrørende identifikation og registrering af opdrættede dyr af svinearterne
Operatører, der holder opdrættede dyr af svinearterne, skal:
a)
sikre, at hvert af de pågældende opdrættede dyr er identificeret med et unikt fysisk identifikationsmiddel
b)
sikre, at de pågældende opdrættede dyr ledsages af et korrekt udfyldt flytningsdokument, der er baseret på den model, som udarbejdes af den kompetente myndighed i henhold til artikel 110, stk. 1, litra b), når dyrene flyttes fra den virksomhed, hvor de holdes, inden for den pågældende medlemsstat
c)
overføre oplysningerne om den virksomhed, hvor de pågældende dyr holdes, til den elektroniske database, der er omhandlet i artikel 109, stk. 1.
Artikel 116
Dispensation vedrørende flytning af opdrættede dyr af svinearterne
Uanset artikel 115, litra b), kan medlemsstaterne fritage operatører fra kravet om at sikre, at opdrættede dyr af svinearterne ledsages af korrekt udfyldte flytningsdokumenter, der er baseret på den model, som udarbejdes af den kompetente myndighed til flytning inden for den pågældende medlemsstat, hvis:
a)
oplysningerne i de pågældende flytningsdokumenter indgår i den elektroniske database, som medlemsstaten har oprettet i henhold til artikel 109, stk. 1
b)
ordningen for identifikation og registrering af opdrættede svin sikrer et niveau af sporbarhed, der svarer til det, der opnås med sådanne flytningsdokumenter.
Artikel 117
Operatørers forpligtelser vedrørende identifikation af opdrættede landdyr, bortset fra dyr af arterne kvæg, får, geder, svin og heste
Operatører sikrer, at opdrættede landdyr, bortset fra dyr af arterne kvæg, får, geder, svin og heste, opfylder følgende krav, hvis det kræves i medfør af regler vedtaget i henhold til artikel 118 og 120:
a)
De er identificeret individuelt eller gruppevis.
b)
De ledsages af for den pågældende dyreart relevante korrekt udfyldte og ajourførte identifikationsdokumenter, flytningsdokumenter eller andre dokumenter til identifikation og sporing af dyr.
Artikel 118
Delegation af beføjelser vedrørende identifikation og registrering
1.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
nærmere krav til midlet og metoden til identifikation af opdrættede landdyr som omhandlet i artikel 112, litra a), artikel 113, stk. 1, litra a), artikel 114, stk. 1, artikel 115, litra a), og artikel 117, litra a), herunder anbringelse og anvendelse heraf
b)
regler om de oplysninger, der skal medtages i:
i)
de elektroniske databaser, jf. artikel 109, stk. 1, litra a)-d)
ii)
identifikations- og flytningsdokumenterne omhandlet i artikel 112, litra b), artikel 113, stk. 1, litra b), artikel 114, stk. 1, litra c), og artikel 115, litra b)
c)
regler om udveksling af data mellem elektroniske databaser i medlemsstaterne som omhandlet i artikel 110, stk. 1, litra b).
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
nærmere krav til andre midler og metoder til identifikation end dem, der er nævnt i nærværende artikels stk. 1, litra a), samt fritagelser og særlige bestemmelser for visse kategorier af dyr eller omstændigheder og betingelser for sådanne fritagelser
b)
specifikke bestemmelser om identifikations- og flytningsdokumenterne omhandlet i artikel 112, litra b), artikel 113, stk. 1, litra b), artikel 114, stk. 1, litra c), artikel 115, litra b), og artikel 117, litra b), der skal ledsage dyr, når de flyttes
c)
nærmere krav til identifikation og registrering af opdrættede landdyr, bortset fra dyr af arterne kvæg, får, geder, svin og heste, hvor det er nødvendigt, under hensyntagen til de risici, som den pågældende art udgør, for at:
i)
sikre effektiv anvendelse af de i denne forordning fastlagte sygdomsforebyggelses- og -bekæmpelsesforanstaltninger
ii)
lette sporbarhed af opdrættede landdyr, flytninger af dem inden for og mellem medlemsstater og deres indførsel til Unionen
d)
regler om de oplysninger, der skal medtages i:
i)
de elektroniske databaser, jf. artikel 109, stk. 1, litra e)
ii)
identifikations- og flytningsdokumenterne omhandlet i artikel 117, litra b)
e)
regler om identifikation og registrering af opdrættede landdyr, jf. artikel 112-117, efter deres indførsel til Unionen.
3.   Kommissionen baserer de regler, der skal fastsættes i delegerede retsakter som omhandlet i denne artikel, på de i artikel 119, stk. 2, omhandlede hensyn.
Artikel 119
Delegation af beføjelser vedrørende undtagelser fra sporbarhedskravene
1.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende undtagelser for operatører fra identifikations- og registreringskravene i artikel 112, 113, 114 og 115
a)
i tilfælde, hvor et eller flere af de i artikel 108, stk. 3, opførte elementer ikke er nødvendige for at opfylde kravene i artikel 108, stk. 4, litra a) og b), og
b)
hvis andre sporbarhedsforanstaltninger i medlemsstaterne garanterer, at sporbarhedsniveauet for de pågældende dyr ikke bringes i fare,
samt de overgangsforanstaltninger, der er nødvendige til den praktiske anvendelse af sådanne undtagelser.
2.   Kommissionen baserer de regler, der skal fastsættes i delegerede retsakter som omhandlet i stk. 1, på følgende hensyn:
a)
arterne og kategorierne af de pågældende opdrættede landdyr
b)
risiciene i tilknytning til de pågældende opdrættede landdyr
c)
antallet af dyr på de pågældende virksomheder
d)
produktionstypen på de virksomheder, hvor de pågældende landdyr holdes
e)
flytningsmønstre for de pågældende arter og kategorier af opdrættede landdyr
f)
hensyn vedrørende beskyttelse og bevaring af de pågældende arter af opdrættede landdyr
g)
effektiviteten af de øvrige sporbarhedselementer i ordningen for identifikation og registrering af opdrættede landdyr som omhandlet i artikel 108, stk. 3.
Artikel 120
Gennemførelsesbeføjelser vedrørende sporbarhed for opdrættede landdyr
1.   Kommissionen vedtager ved hjælp af gennemførelsesretsakter regler
a)
for ensartet adgang til data indeholdt i de elektroniske databaser og tekniske specifikationer og praktiske regler for de elektroniske databaser, jf. artikel 109, stk. 1, litra a)-d)
b)
om tekniske betingelser og nærmere bestemmelser om udveksling af data mellem elektroniske databaser i medlemsstaterne og anerkendelse af, at dataudvekslingssystemer er fuldt funktionsdygtige, jf. artikel 110, stk. 1, litra b).
2.   Kommissionen kan ved hjælp af gennemførelsesretsakter vedtage regler
a)
for ensartet anvendelse af identifikations- og registreringssystemet omhandlet i artikel 108, stk. 1, til forskellige arter og kategorier af opdrættede landdyr for at sikre, at det fungerer effektivt
b)
for ensartet anvendelse af artikel 108, stk. 5, litra c), vedrørende bemyndigede organer eller fysiske personer som omhandlet i artikel 108, stk. 5, og betingelserne for udpegelse heraf
c)
om tekniske specifikationer og procedurer for, formater for og udformning af samt praktiske regler for midler og metoder til identifikation, herunder:
i)
tidsrum for anvendelse af midlerne og metoderne til identifikation
ii)
fjernelse, ændring eller udskiftning af midler og metoder til identifikation og frister herfor samt
iii)
konfiguration af identifikationskoden
d)
om tekniske specifikationer, formater og praktiske regler for de identifikations- og flytningsdokumenter, der er omhandlet i artikel 112, litra b), artikel 113, stk. 1, litra b), artikel 114, stk. 1, litra c), artikel 115, litra b), og artikel 117, litra b)
e)
for ensartet adgang til data indeholdt i de elektroniske databaser og tekniske specifikationer og praktiske regler for de elektroniske databaser, jf. artikel 109, stk. 1, litra e)
f)
om frister, forpligtelser og procedurer for operatørers eller andre fysiske eller juridiske personers overførsel af oplysninger og for registrering af opdrættede landdyr i den elektroniske database
g)
om retningslinjer og procedurer for elektronisk identifikation af dyr, hvor det er relevant
h)
om anvendelse i praksis af fritagelser fra identifikations- og registreringskravene i medfør af reglerne vedtaget i henhold til artikel 119, stk. 1.
3.   De i denne artikel omhandlede gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Afdeling 2
Avlsmateriale
Artikel 121
Sporbarhedskrav for avlsmateriale af opdrættede dyr af arterne kvæg, får, geder, svin og heste
1.   Operatører, der producerer, forarbejder eller opbevarer avlsmateriale, skal mærke avlsmateriale af opdrættede dyr af arterne kvæg, geder, får, svin og heste på en sådan måde, at det præcist kan spores tilbage til:
a)
donordyrene
b)
indsamlingsdatoen og
c)
de avlsmaterialevirksomheder, hvor det er indsamlet, produceret, forarbejdet og opbevaret.
2.   Den i stk. 1 omhandlede mærkning skal foretages på en måde, der sikrer:
a)
effektiv gennemførelse af de ved denne forordning fastlagte sygdomsforebyggelses- og -bekæmpelsesforanstaltninger
b)
sporbarhed for avlsmaterialet, flytning af det inden for og mellem medlemsstater og indførsel af det til Unionen.
Artikel 122
Delegation af beføjelser vedrørende sporbarhedskrav for avlsmateriale
1.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende sporbarhedskrav for avlsmateriale af opdrættede landlevende dyr af kvægarterne og opdrættede landlevende dyr af arterne geder, får, svin og heste, som supplerer reglerne i artikel 121.
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende sporbarhedskrav for avlsmateriale af opdrættede landdyr, bortset fra arter af kvæg, geder, får, svin og heste, hvis det er nødvendigt for:
a)
effektiv gennemførelse af de ved denne forordning fastlagte sygdomsforebyggelses- og -bekæmpelsesforanstaltninger
b)
sporbarhed for det pågældende avlsmateriale, flytninger af det inden for og mellem medlemsstater og indførsel af det til Unionen.
3.   Kommissionen baserer de delegerede retsakter, der er omhandlet i stk. 1, på følgende forhold:
a)
hvilke arter af opdrættede landdyr avlsmaterialet hidrører fra
b)
donordyrenes sundhedsstatus
c)
den risiko, der er forbundet med det pågældende avlsmateriale
d)
typen af avlsmateriale
e)
indsamlings-, produktions-, forarbejdnings- eller opbevaringsform for avlsmateriale
f)
flytningsmønstrene for de relevante arter og kategorier af opdrættede landdyr og avlsmateriale deraf
g)
hensyn vedrørende beskyttelse og bevaring af arter af opdrættede landdyr
h)
andet, der kan bidrage til sporbarhed for avlsmateriale.
Artikel 123
Gennemførelsesbeføjelser vedrørende sporbarhedskrav for avlsmateriale
Kommissionen fastsætter ved hjælp af gennemførelsesretsakter regler vedrørende:
a)
tekniske krav og specifikationer for mærkning i henhold til artikel 121, stk. 1
b)
praktiske krav vedrørende sporbarhed i delegerede retsakter vedtaget i henhold til artikel 122, stk. 1.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
KAPITEL 3
Flytninger af opdrættede landdyr inden for Unionen
Afdeling 1
Almindelige krav vedrørende flytninger
Artikel 124
Almindelige krav vedrørende flytninger af opdrættede landdyr
1.   Operatører skal træffe passende forebyggende foranstaltninger for at sikre, at flytning af opdrættede landdyr ikke bringer sundhedsstatussen på bestemmelsesstedet i fare for så vidt angår:
a)
de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme
b)
nye sygdomme.
2.   Operatører må kun flytte opdrættede landdyr fra deres virksomheder og modtage sådanne dyr, hvis de pågældende dyr opfylder følgende betingelser:
a)
De kommer fra virksomheder, som:
i)
er registreret af den kompetente myndighed i henhold til artikel 93 eller
ii)
er godkendt af den kompetente myndighed i henhold til artikel 97, stk. 1, og artikel 98, hvis det kræves i artikel 94, stk. 1, eller artikel 95, eller
iii)
har fået dispensation fra registreringskravet i artikel 84.
b)
De opfylder identifikations- og registreringskravene i artikel 112, 113, 114, 115 og 117 samt regler vedtaget i henhold til artikel 118 og 120.
Artikel 125
Sygdomsforebyggende foranstaltninger i forbindelse med transport
1.   Operatører skal træffe relevante forebyggende foranstaltninger, der er nødvendige for at sikre, at:
a)
opdrættede landdyrs sundhedsstatus ikke bringes i fare under transport
b)
transport af opdrættede landdyr ikke er årsag til potentiel spredning af listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), til mennesker eller dyr
c)
rengøring og desinfektion af og bekæmpelse af insekter og gnavere i forbindelse med udstyr og transportmidler og andre passende biosikringsforanstaltninger gennemføres i overensstemmelse med de risici, som transporten er forbundet med.
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
betingelser og krav vedrørende rengøring og desinfektion af og bekæmpelse af insekter og gnavere i forbindelse med udstyr og transportmidler og anvendelse af biocidholdige produkter til disse formål
b)
andre passende biosikringsforanstaltninger, jf. nærværende artikels stk. 1, litra c).
Afdeling 2
Flytninger mellem medlemsstater
Artikel 126
Almindelige krav vedrørende flytninger af opdrættede landdyr mellem medlemsstater
1.   Operatører må kun flytte opdrættede landdyr til en anden medlemsstat, hvis de pågældende dyr opfylder følgende betingelser:
a)
De har ingen sygdomssymptomer.
b)
De kommer fra en registreret eller godkendt virksomhed,
i)
hvor der ikke er abnorm dødelighed af ukendte årsager
ii)
der ikke er omfattet af flytningsrestriktioner, som berører de arter, der skal flyttes, jf. artikel 55, stk. 1, artikel 61, stk. 1, litra a), artikel 62, artikel 65, stk. 1, litra c), artikel 74, stk. 1, og artikel 79 samt regler vedtaget i henhold til artikel 55, stk. 2, artikel 63, artikel 67, artikel 71, stk. 3, artikel 74, stk. 4, og artikel 83, stk. 2, eller hasteforanstaltningerne omhandlet i artikel 257 og 258 samt eventuelle regler vedtaget i henhold til artikel 259, medmindre der gælder undtagelser fra de pågældende flytningsrestriktioner i medfør af disse regler
iii)
der ikke ligger i en restriktionszone i medfør af artikel 55, stk. 1, litra f), nr. ii), artikel 64, artikel 65, artikel 74, stk. 1, og artikel 79 samt eventuelle regler vedtaget i henhold til artikel 67, artikel 71, stk. 3, artikel 74, stk. 4, og artikel 83, stk. 2, eller hasteforanstaltningerne omhandlet i artikel 257 og 258 samt eventuelle regler vedtaget i henhold til artikel 259, medmindre der gælder undtagelser i medfør af disse regler.
c)
De har i et tilstrækkelig langt tidsrum forud for den påtænkte flytning til en anden medlemsstat ikke været i kontakt med opdrættede landdyr, der er omfattet af flytningsrestriktioner som omhandlet i litra b), nr. ii) og iii), eller opdrættede landdyr af en listeopført art med en lavere sundhedsstatus, hvorved sandsynligheden for spredning af sygdom minimeres, under hensyntagen til følgende:
i)
inkubationstid og overførselsveje for de pågældende listeopførte sygdomme og nye sygdomme
ii)
den pågældende virksomhedstype
iii)
arten og kategorien af de opdrættede landdyr, der flyttes
iv)
andre epidemiologiske faktorer.
d)
De opfylder de relevante krav i afdeling 3-8 (artikel 130-154).
2.   Operatører træffer alle fornødne foranstaltninger til at sikre, at opdrættede landdyr, der flyttes til en anden medlemsstat, sendes direkte til deres bestemmelsessted i den anden medlemsstat, medmindre det af dyrevelfærdshensyn er nødvendigt at gøre holdt på et hvilested.
Artikel 127
Operatørers forpligtelser på bestemmelsesstedet
1.   Operatører af virksomheder og slagterier, som modtager opdrættede landdyr fra en anden medlemsstat, skal:
a)
kontrollere, at:
i)
identifikationsmidlet eller -metoden som omhandlet i artikel 112, litra a), artikel 113, stk.1, litra a), artikel 114, stk. 1, litra a) og b), artikel 115, litra a), og artikel 117, litra a), samt regler vedtaget i henhold til artikel 118 og 120 forefindes
ii)
de i artikel 112, litra b), artikel 113, stk. 1, litra b), artikel 114, stk. 1, litra c), og artikel 117, litra b), samt regler vedtaget i henhold til artikel 118 og 120 omhandlede identifikationsdokumenter foreligger og er korrekt udfyldt
b)
kontrollere, at de i artikel 143 og i eventuelle regler vedtaget i henhold til artikel 144, stk. 1, litra b) og c), omhandlede dyresundhedscertifikater eller den i artikel 151 og i regler vedtaget i henhold til artikel 151, stk. 3 og 4, omhandlede personlige erklæring foreligger
c)
efter at have kontrolleret de modtagne opdrættede landdyr underrette bestemmelsesstedets kompetente myndighed om eventuelle uregelmæssigheder med hensyn til:
i)
de modtagne opdrættede landdyr
ii)
identifikationsmidlet eller -metoden, jf. litra a), nr. i)
iii)
de i litra a), nr. ii), og litra b) omhandlede dokumenter.
2.   I tilfælde af en uregelmæssighed som omhandlet i stk. 1, litra c), skal operatøren holde de dyr, som den pågældende uregelmæssighed vedrører, isoleret, indtil bestemmelsesstedets kompetente myndighed har truffet en afgørelse vedrørende dyrene.
Artikel 128
Forbud mod flytning af opdrættede landdyr med henblik på sygdomsudryddelse uden for en medlemsstats område
Operatører må ikke flytte opdrættede landdyr, der er bestemt til slagtning med henblik på sygdomsudryddelse som led i et udryddelsesprogram som omhandlet i artikel 31, stk. 1 eller 2, til en anden medlemsstat, medmindre bestemmelsesmedlemsstaten og i givet fald den medlemsstat, som dyrene passerer igennem, på forhånd tillader flytningen.
Artikel 129
Almindelige krav til operatører vedrørende flytning af opdrættede landdyr, der passerer igennem medlemsstater, men er bestemt til eksport fra Unionen til tredjelande eller territorier
Operatører sikrer, at opdrættede landdyr bestemt til eksport til et tredjeland eller territorium, som passerer igennem en anden medlemsstats område, opfylder kravene i artikel 124, 125, 126 og 128.
Afdeling 3
Særlige krav vedrørende flytning af hovdyr og fjerkræ til andre medlemsstater
Artikel 130
Flytning af opdrættede hovdyr og fjerkræ til andre medlemsstater
Operatører må kun flytte opdrættede hovdyr og fjerkræ fra en virksomhed i en medlemsstat til en anden medlemsstat, hvis de pågældende dyr opfylder følgende betingelser for så vidt angår de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme:
a)
De er på tidspunktet for flytningen frie for kliniske symptomer eller tegn på de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme.
b)
De har gennemgået en opholdsperiode af en passende længde i forhold til, hvilke listeopførte sygdomme der er tale om, og hvilken art og kategori af opdrættede hovdyr og fjerkræ der skal flyttes.
c)
I et tidsrum, der er passende for de pågældende listeopførte sygdomme og for den art og kategori af hovdyr eller fjerkræ, der skal flyttes, er der ikke ført opdrættede hovdyr eller fjerkræ ind på oprindelsesvirksomheden, hvis et krav herom er fastsat i de regler, der er vedtaget i henhold til artikel 131 eller 135.
d)
De på følgende grundlag formodes ikke at udgøre en betydelig risiko for spredning af de pågældende listeopførte sygdomme på bestemmelsesstedet:
i)
sundhedsstatussen for så vidt angår relevante sygdomme for arter eller kategorier af opdrættede hovdyr og fjerkræ, der flyttes, under hensyntagen til sundhedsstatussen på bestemmelsesstedet
ii)
resultatet af laboratorieundersøgelser eller andre undersøgelser, der er nødvendige for at garantere den sundhedsstatus, der kræves for den pågældende flytning
iii)
anvendelsen af vaccination eller andre foranstaltninger til sygdomsforebyggelse eller risikobegrænsning, der har til formål at begrænse spredningen af den relevante sygdom til bestemmelses- eller passagestedet.
Artikel 131
Delegation af beføjelser vedrørende flytning af opdrættede hovdyr og fjerkræ til andre medlemsstater
1.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
opholdsperioder, jf. artikel 130, litra b)
b)
det nødvendige tidsrum for begrænsning af indførelse af opdrættede hovdyr og fjerkræ på virksomheder forud for flytning, jf. artikel 130, litra c)
c)
yderligere krav med henblik på at sikre, at opdrættede hovdyr og fjerkræ ikke udgør en betydelig risiko for spredning af listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), jf. artikel 130, litra d)
d)
andre nødvendige risikobegrænsende foranstaltninger, der supplerer kravene i artikel 130.
2.   Kommissionen baserer de regler, der skal fastsættes i delegerede retsakter som omhandlet i stk. 1, på følgende hensyn:
a)
hvilke af de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme der er relevante for den listeopførte art eller den kategori af opdrættede hovdyr eller fjerkræ, der skal flyttes
b)
sundhedsstatussen for så vidt angår listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), på oprindelses- og bestemmelsesvirksomheder og i oprindelses- og bestemmelseskompartmenterne, -zonerne og -medlemsstaterne
c)
den pågældende virksomhedstype og produktionstypen på oprindelses- og bestemmelsesstedet
d)
den pågældende flytningstype
e)
hvilke arter og kategorier af opdrættede hovdyr eller fjerkræ, der skal flyttes
f)
alderen af de(t) opdrættede hovdyr eller fjerkræ, der skal flyttes
g)
andre epidemiologiske faktorer.
Artikel 132
Opdrættede hovdyr og fjerkræ, der flyttes til en anden medlemsstat med henblik på slagtning
1.   Operatører af slagterier, som modtager opdrættede hovdyr og fjerkræ fra en anden medlemsstat, skal slagte de pågældende dyr hurtigst muligt efter deres ankomst og senest inden for en frist, der fastsættes i delegerede retsakter vedtaget i henhold til stk. 2.
2.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende slagtetidspunktet omhandlet i nærværende artikels stk. 1.
Afdeling 4
Sammenbringning af opdrættede hovdyr og fjerkræ
Artikel 133
Undtagelse vedrørende sammenbringning
1.   Uanset artikel 126, stk. 2, kan operatører højst tre gange gøre opdrættede hovdyr og fjerkræ til genstand for sammenbringning under en flytning fra en oprindelsesmedlemsstat til en anden medlemsstat.
2.   Sammenbringning i henhold til nærværende artikels stk. 1 må kun finde sted på en virksomhed, der er godkendt til formålet i henhold til artikel 97, stk. 1, og artikel 99, stk. 3 og 4.
Oprindelsesmedlemsstaten kan dog tillade, at en sammenbringning på dens område finder sted på et transportmiddel, hvor opdrættede hovdyr eller fjerkræ samles direkte fra deres oprindelsesvirksomhed, forudsat at dyrene under denne sammenbringning ikke aflæsses igen inden:
a)
ankomsten til bestemmelsesvirksomheden eller det endelige bestemmelsessted eller
b)
den efterfølgende sammenbringning på en virksomhed, der er godkendt til dette formål i henhold til artikel 97, stk. 1, og artikel 99, stk. 4 og 5.
Artikel 134
Sygdomsforebyggelseskrav i forbindelse med sammenbringning
Operatører, der beskæftiger sig med sammenbringning, skal sikre, at:
a)
de(t) opdrættede hovdyr og fjerkræ, der bringes sammen, har samme sundhedsstatus; hvis de ikke har, finder den laveste sundhedsstatus anvendelse på alle de sammenbragte dyr
b)
de(t) opdrættede hovdyr og fjerkræ bringes sammen og flyttes til deres endelige bestemmelsessted i en anden medlemsstat, hurtigst muligt efter at de har forladt deres oprindelsesvirksomhed, og senest inden udløbet af en frist, der skal fastsættes i delegerede retsakter vedtaget i henhold til artikel 135, litra c)
c)
de fornødne biosikringsforanstaltninger træffes for at sikre, at de(t) opdrættede hovdyr og fjerkræ, der bringes sammen:
i)
ikke kommer i kontakt med opdrættede hovdyr eller fjerkræ, der har en lavere sundhedsstatus
ii)
ikke udgør en betydelig risiko for spredning af de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme til opdrættede hovdyr eller fjerkræ på det sted, hvor sammenbringning finder sted
d)
de(t) pågældende opdrættede hovdyr og fjerkræ er identificeret, når det kræves i denne forordning, og er ledsaget af følgende dokumenter:
i)
identifikations- og flytningsdokumenter, når det kræves i henhold til artikel 112, litra b), artikel 113, stk. 1, litra b), artikel 114, stk. 1, litra c), artikel 115, litra b), og artikel 117, litra b), samt eventuelle regler vedtaget i henhold til artikel 118 og 120, medmindre der gælder undtagelser i medfør af artikel 113, stk. 2, og artikel 119
ii)
dyresundhedscertifikater, når det kræves i henhold til artikel 143 og artikel 144, stk. 1, litra c), medmindre der gælder undtagelser i medfør af regler vedtaget i henhold til artikel 144, stk. 1, litra a)
iii)
en personlig erklæring, når det kræves i henhold til artikel 151.
Artikel 135
Delegation af beføjelser vedrørende sammenbringning
Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
særlige regler om sammenbringning, når der anvendes risikobegrænsende foranstaltninger ud over dem, der er fastsat i artikel 134, litra b) og c)
b)
kriterier for, hvornår oprindelsesmedlemsstaten kan tillade sammenbringning på transportmidler, jf. artikel 133, stk. 2, andet afsnit
c)
hvor lang tid der må gå fra afsendelsen af de(t) opdrættede hovdyr eller fjerkræ fra deres oprindelsesvirksomhed og afsendelsen af dem fra sammenbringningen til deres endelige bestemmelsessted i en anden medlemsstat, jf. artikel 134, litra b)
d)
nærmere regler vedrørende biosikringsforanstaltninger som omhandlet i stk. 134, litra c).
Afdeling 5
Flytning af opdrættede landdyr, bortset fra opdrættede hovdyr og fjerkræ, til andre medlemsstater
Artikel 136
Flytning af opdrættede landdyr, bortset fra opdrættede hovdyr og fjerkræ, til andre medlemsstater samt delegerede retsakter
1.   Operatører må kun flytte opdrættede landdyr, bortset fra opdrættede hovdyr og fjerkræ, fra en virksomhed i en medlemsstat til en anden medlemsstat, hvis de pågældende dyr ikke udgør en betydelig risiko for spredning af listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), på bestemmelsesstedet.
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende nærmere regler, der skal sikre, at de pågældende opdrættede landdyr, bortset fra opdrættede hovdyr eller fjerkræ, ikke udgør en betydelig risiko for spredning af listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), jf. nærværende artikels stk. 1.
3.   Kommissionen baserer de nærmere regler, der skal fastsættes i delegerede retsakter i henhold til stk. 2, på følgende hensyn:
a)
hvilke af de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme der er relevante for den listeopførte art eller den kategori af opdrættede landdyr, der skal flyttes
b)
sundhedsstatussen for så vidt angår de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme på oprindelsesvirksomhederne og i oprindelseskompartmenterne, -zonerne og -medlemsstaterne samt på bestemmelsesstedet
c)
virksomheds- og produktionstyperne på oprindelses- og bestemmelsesstedet
d)
flytningstyperne i relation til den endelige anvendelse af dyrene på bestemmelsesstedet
e)
hvilke arter og kategorier af opdrættede landdyr, der skal flyttes
f)
alderen af de opdrættede landdyr, der skal flyttes
g)
andre epidemiologiske faktorer.
Afdeling 6
Undtagelser fra og supplering af risikobegrænsende foranstaltninger i forbindelse med flytninger af opdrættede landdyr
Artikel 137
Opdrættede landdyr bestemt til afgrænsede virksomheder samt delegerede retsakter
1.   Operatører må kun flytte opdrættede landdyr til en afgrænset virksomhed, hvis de pågældende dyr opfylder følgende betingelser:
a)
De hidrører fra en anden afgrænset virksomhed.
b)
De udgør ikke en betydelig risiko for spredning af listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), til listeopførte arter eller til kategorier af dyr på den afgrænsede bestemmelsesvirksomhed, medmindre der er givet tilladelse til den pågældende flytning i videnskabeligt øjemed.
2.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
nærmere regler om flytninger af opdrættede landdyr til afgrænsede virksomheder ud over dem, som er fastsat i nærværende artikels stk. 1
b)
særlige regler om flytninger af opdrættede landdyr til afgrænsede virksomheder, når de risikobegrænsende foranstaltninger, der anvendes, garanterer, at sådanne flytninger ikke er forbundet med en betydelig sundhedsrisiko for opdrættede landdyr på den pågældende afgrænsede virksomhed eller på omkringliggende virksomheder.
Artikel 138
Flytning af opdrættede landdyr i videnskabeligt øjemed samt delegerede retsakter
1.   Den kompetente myndighed på bestemmelsesstedet kan efter samtykke fra den kompetente myndighed på oprindelsesstedet tillade flytning af opdrættede landdyr ind på bestemmelsesmedlemsstatens område i videnskabeligt øjemed, i tilfælde hvor sådan flytning ikke opfylder kravene i afdeling 1-5 (artikel 124-136), bortset fra artikel 124, artikel 125, artikel 126, stk. 1, litra b), nr. ii), og artikel 127.
2.   Bestemmelsesstedets kompetente myndighed må kun meddele dispensation i henhold til stk. 1 på følgende betingelser:
a)
De kompetente myndigheder på oprindelses- og bestemmelsesstedet
i)
har aftalt betingelserne for sådanne flytninger
ii)
sikrer de fornødne risikobegrænsende foranstaltninger, således at de pågældende flytninger ikke bringer sundhedsstatussen i fare på steder undervejs eller på bestemmelsesstederne for så vidt angår de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme og
iii)
har, hvis det er relevant, underrettet de kompetente myndigheder i medlemsstaterne, som dyrene passerer igennem, om den pågældende dispensation og om betingelserne herfor og
b)
den pågældende flytning af dyrene foregår under tilsyn udøvet af de kompetente myndigheder på oprindelses- og bestemmelsesstedet og, hvis det er relevant, de kompetente myndigheder i de medlemsstater, som dyrene eventuelt passerer igennem.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende reglerne om meddelelse af dispensation fra de kompetente myndigheder som supplement til de regler, der er fastsat i nærværende artikels stk. 1 og 2.
Artikel 139
Dispensation vedrørende rekreative udfoldelser, sportsbegivenheder, kulturelle arrangementer, arbejde nær grænser og græsning
1.   Den kompetente myndighed på bestemmelsesstedet kan dispensere fra kravene i afdeling 2-5 (artikel 126-136), bortset fra artikel 126, stk. 1, litra a), b) og c), samt artikel 127 og 128, for flytning inden for Unionen af opdrættede landdyr mellem medlemsstater, hvis formålet med sådanne flytninger er:
a)
rekreative udfoldelser i nærheden af grænser
b)
udstillinger, sportsbegivenheder, kulturelle arrangementer eller lignende arrangementer i nærheden af grænser
c)
opdrættede landdyrs græsning på græsningsarealer, der deles af flere medlemsstater, eller
d)
opdrættede landdyrs arbejde i nærheden af medlemsstaters grænser.
2.   Dispensation, der meddeles af den kompetente myndighed på bestemmelsesstedet for flytning af opdrættede landdyr til formål som omhandlet i stk. 1, skal være aftalt mellem oprindelses- og bestemmelsesmedlemsstaten, og der skal træffes passende risikobegrænsende foranstaltninger for at sikre, at de pågældende flytninger ikke er forbundet med en betydelig risiko.
3.   De i stk. 2 omhandlede medlemsstater underretter Kommissionen om dispensation meddelt i henhold til stk. 1.
4.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende regler om meddelelse af dispensation fra den kompetente myndighed på bestemmelsesstedet som supplement til de regler, der er fastsat i nærværende artikels stk. 1.
Artikel 140
Delegation af beføjelser vedrørende cirkusser, udstillinger, sportsbegivenheder, rekreative udfoldelser, zoologiske haver, dyrehandler, dyreinternater og grossister
Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
særlige krav som supplement til reglerne i afdeling 2-5 (artikel 126-136) for flytning af opdrættede landdyr med følgende formål:
i)
cirkusser, zoologiske haver, dyrehandler, dyreinternater og grossister
ii)
udstillinger, sportsbegivenheder, kulturelle arrangementer og lignende arrangementer
b)
undtagelser fra afdeling 2-5 (artikel 126-136), bortset fra artikel 126, stk. 1, litra a), b) og c), samt artikel 127 og 128, vedrørende flytninger af opdrættede landdyr som omhandlet i nærværende artikels litra a).
Artikel 141
Gennemførelsesbeføjelser vedrørende midlertidige regler for flytninger af bestemte arter eller kategorier af opdrættede landdyr
1.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte midlertidige regler, som supplerer eller udgør et alternativ til reglerne i dette kapitel for flytninger af bestemte arter eller kategorier af opdrættede landdyr, hvis:
a)
flytningskravene i artikel 130, artikel 132, stk. 1, artikel 133, artikel 134, artikel 136, stk. 1, artikel 137, stk. 1, artikel 138, stk. 1 og 2, og artikel 139 samt regler vedtaget i henhold til artikel 131, stk. 1, artikel 132, stk. 2, artikel 135, artikel 136, stk. 2, artikel 137, stk. 2, artikel 138, stk. 3, artikel 139, stk. 4, og artikel 140 ikke effektivt begrænser de risici, der er forbundet med den pågældende flytning af sådanne dyr, eller
b)
en listeopført sygdom omhandlet i artikel 9, stk. 1, litra d), ser ud til at spredes trods de flytningskrav, der er fastsat i overensstemmelse med afdeling 1-6 (artikel 124-142).
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
2.   I behørigt begrundede særligt hastende tilfælde vedrørende sygdomme, der udgør en risiko af meget betydeligt omfang, vedtager Kommissionen efter proceduren i artikel 266, stk. 3, under hensyntagen til de i artikel 142 omhandlede forhold gennemførelsesretsakter, der straks finder anvendelse.
Artikel 142
Forhold, der skal tages i betragtning i forbindelse med vedtagelse af delegerede retsakter og gennemførelsesretsakter i henhold til denne afdeling
Kommissionen baserer de regler, der skal fastsættes i delegerede retsakter og gennemførelsesretsakter i henhold til artikel 137, stk. 2, artikel 138, stk. 3, artikel 139, stk. 4, artikel 140 og artikel 141, på følgende forhold:
a)
de risici, der er forbundet med flytninger som omhandlet i nævnte bestemmelser
b)
sundhedsstatussen for så vidt angår de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme på oprindelses-, passage- og bestemmelsesstedet
c)
de listeopførte dyrearter for så vidt angår de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme
d)
biosikringsforanstaltningerne på oprindelses-, passage- og bestemmelsesstedet
e)
eventuelle særlige forhold på virksomhederne, som de opdrættede landdyr holdes under
f)
særlige flytningsmønstre for den pågældende type virksomhed og de pågældende opdrættede landdyrs art og kategori
g)
andre epidemiologiske faktorer.
Afdeling 7
Dyresundhedscertificering
Artikel 143
Operatørers forpligtelse til at sikre, at dyr ledsages af et dyresundhedscertifikat
1.   Operatører må kun flytte følgende arter og kategorier af opdrættede landdyr til en anden medlemsstat, hvis de pågældende dyr ledsages af et dyresundhedscertifikat udstedt af oprindelsesmedlemsstatens kompetente myndighed i henhold til artikel 149, stk. 1:
a)
hovdyr
b)
fjerkræ
c)
opdrættede landdyr, bortset fra hovdyr og fjerkræ, bestemt til en afgrænset virksomhed
d)
opdrættede landdyr, bortset fra dyr omhandlet i dette stykkes litra a), b) og c), hvis det kræves i medfør af delegerede retsakter vedtaget i henhold til artikel 144, stk. 1, litra c).
2.   I tilfælde, hvor det er tilladt at føre opdrættede landdyr ud af en restriktionszone som omhandlet i artikel 55, stk. 1, litra f), nr. ii), artikel 56 og artikel 64, stk. 1, og dyrene er omfattet af sygdomsbekæmpelsesforanstaltninger som omhandlet i artikel 55, stk. 1, artikel 65, stk. 1, artikel 74, stk. 1, artikel 79 eller artikel 80 eller regler vedtaget i henhold til artikel 55, stk. 2, artikel 67, artikel 71, stk. 3, artikel 74, stk. 4, artikel 83, stk. 3, eller artikel 259, og de pågældende dyr er af arter, der er omfattet af disse sygdomsbekæmpelsesforanstaltninger, må operatører kun flytte sådanne opdrættede landdyr inden for en medlemsstat eller fra en medlemsstat til en anden medlemsstat, hvis dyrene ledsages af et dyresundhedscertifikat udstedt af oprindelsesmedlemsstatens kompetente myndighed i henhold til artikel 149, stk. 1.
Den kompetente myndighed kan beslutte, at det ikke er nødvendigt at udstede et sådant certifikat til flytning af opdrættede landdyr inden for den pågældende medlemsstat, hvis myndigheden er af den opfattelse, at et alternativt system sikrer, at sendingen af de pågældende dyr er sporbar, og at dyrene opfylder de dyresundhedsmæssige krav til flytningen.
3.   Operatører skal træffe alle fornødne foranstaltninger til at sikre, at det i nærværende artikels stk. 1 omhandlede dyresundhedscertifikat ledsager de opdrættede landdyr fra deres oprindelsessted til deres endelige bestemmelsessted, medmindre der er fastsat særlige foranstaltninger i regler vedtaget i henhold til artikel 147.
Artikel 144
Delegation af beføjelser vedrørende operatørers forpligtelse til at sikre, at dyr ledsages af et dyresundhedscertifikat
1.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
undtagelser fra kravene i artikel 143, stk. 1, vedrørende dyresundhedscertificering for flytninger af opdrættede landdyr, som ikke udgør en væsentlig risiko for spredning af en sygdom under hensyntagen til:
i)
arterne eller kategorierne af de opdrættede landdyr, der flyttes, og de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme, for hvilke de er listeopførte arter
ii)
opdrætsmetoderne og produktionstypen for de pågældende arter og kategorier af opdrættede landdyr
iii)
den påtænkte anvendelse af de opdrættede landdyr eller
iv)
de opdrættede landdyrs bestemmelsessted, herunder tilfælde, hvor deres bestemmelsessted er i den samme medlemsstat som deres oprindelsessted, men de passerer gennem en anden medlemsstat for at nå frem til deres bestemmelsessted
b)
særlige regler vedrørende dyresundhedscertificering i artikel 143, stk. 1, når der træffes specifikke risikobegrænsende foranstaltninger vedrørende overvågning eller biosikring, under hensyntagen til de i nærværende artikels stk. 2 omhandlede forhold, som sikrer:
i)
sporbarhed for de opdrættede landdyr, der flyttes
ii)
at de opdrættede landdyr, der flyttes, opfylder de dyresundhedsmæssige krav vedrørende flytninger i afdeling 1-6 (artikel 124-142)
c)
kravet om dyresundhedscertificering i forbindelse med flytninger af andre arter og kategorier af opdrættede landdyr end dem, der er omhandlet i artikel 143, stk. 1, litra a), b) og c), i tilfælde, hvor dyresundhedscertificering er bydende nødvendigt for at sikre, at den pågældende flytning opfylder de dyresundhedsmæssige krav vedrørende flytninger i afdeling 1-6 (artikel 124-142).
2.   Ved fastsættelsen af særlige regler som omhandlet i stk. 1, litra b), tager Kommissionen hensyn til følgende:
a)
den kompetente myndigheds vurdering af de biosikringsforanstaltninger, der anvendes af operatører i henhold til artikel 10, stk. 1, litra b), og eventuelle regler vedtaget i henhold til artikel 10, stk. 6
b)
den kompetente myndigheds evne til at iværksætte de relevante foranstaltninger og aktiviteter, der er nødvendige i henhold til denne forordning, jf. artikel 13, stk. 1
c)
omfanget af viden om dyresundhed, jf. artikel 11, og tilskyndelse hertil, jf. artikel 13, stk. 2
d)
gennemførelsen af dyresundhedsbesøg som omhandlet i artikel 25 eller andre relevante overvågningsforanstaltninger eller anden relevant offentlig kontrol
e)
den kompetente myndigheds gennemførelse af sine forpligtelser i forbindelse med EU-anmeldelses- og -rapporteringsordningen som omhandlet i artikel 19-22 og regler vedtaget i henhold til artikel 20, stk. 3, og artikel 23
f)
overvågning som omhandlet i artikel 26 og overvågningsprogrammer som omhandlet i artikel 28 og eventuelle regler vedtaget i henhold til artikel 29 og 30.
3.   Kommissionen tager hensyn til de i stk. 1, litra a), nr. i)-iv), omhandlede forhold ved fastsættelsen af krav vedrørende dyresundhedscertificering som omhandlet i stk. 1, litra c).
Artikel 145
Dyresundhedscertifikaters indhold
1.   Det i artikel 143 omhandlede dyresundhedscertifikat skal indeholde følgende oplysninger:
a)
oprindelsesvirksomheden eller -stedet, bestemmelsesvirksomheden eller -stedet og, hvis det er relevant, virksomheder, hvor de pågældende opdrættede landdyr har været genstand for sammenbringning eller har hvilet
b)
transportmiddel og transportør
c)
en beskrivelse af de opdrættede landdyr
d)
antallet af opdrættede landdyr
e)
identifikation og registrering af opdrættede landdyr, hvis dette kræves i henhold til artikel 112, 113, 114, 115 og 117 samt eventuelle regler vedtaget i henhold til artikel 118 og 120, medmindre der gælder undtagelser i medfør af artikel 119, og
f)
de oplysninger, der er nødvendige for at godtgøre, at de opdrættede landdyr opfylder de relevante dyresundhedsmæssige krav vedrørende flytninger i afdeling 1-6 (artikel 124-142).
2.   Dyresundhedscertifikatet kan indeholde andre oplysninger, som kræves i henhold til anden EU-lovgivning.
Artikel 146
Delegation af beføjelser og gennemførelsesretsakter vedrørende dyresundhedscertifikaters indhold
1.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
nærmere regler om dyresundhedscertifikaters indhold, jf. artikel 145, stk. 1, for forskellige arter og kategorier af opdrættede landdyr og for særlige typer af flytninger som omhandlet i regler vedtaget i henhold til artikel 147
b)
yderligere oplysninger, som dyresundhedscertifikater skal indeholde, jf. artikel 145, stk. 1.
2.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler vedrørende standarddyresundhedscertifikater. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 147
Delegation af beføjelser vedrørende særlige typer af flytninger af opdrættede landdyr
Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende særlige foranstaltninger, der fraviger eller supplerer forpligtelsen for operatører til at sikre, at dyr ledsages af et dyresundhedscertifikat som omhandlet i artikel 143 og i regler vedtaget i henhold til artikel 144 i forbindelse med følgende typer af flytninger af opdrættede landdyr:
a)
flytning af opdrættede landdyr og fjerkræ, der er genstand for sammenbringning som omhandlet i artikel 133, inden de når deres endelige bestemmelsessted
b)
flytning af opdrættede landdyr, der af en eller flere af følgende årsager skal sendes tilbage til deres oprindelsessted eller flyttes til et andet bestemmelsessted:
i)
Den planlagte rejse blev uventet afbrudt af dyrevelfærdshensyn.
ii)
Der var uforudsete uheld eller hændelser under rejsen.
iii)
De blev afvist på bestemmelsesstedet i en medlemsstat eller ved Unionens ydre grænse.
iv)
De blev afvist på et sammenbringnings- eller hvilested.
v)
De blev afvist i et tredjeland eller territorium
c)
flytning af opdrættede landdyr bestemt til udstillinger, sportsbegivenheder, kulturelle arrangementer eller lignende arrangementer, og som efterfølgende sendes tilbage til deres oprindelsessted.
Artikel 148
Operatørers forpligtelse til at samarbejde med den kompetente myndighed i forbindelse med dyresundhedscertificering
Operatører skal:
a)
forud for den påtænkte flytning give den kompetente myndighed alle de oplysninger, der er nødvendige for at udfylde det dyresundhedscertifikat, der er omhandlet i artikel 143, stk. 1 og 2, og eventuelle regler vedtaget i henhold til artikel 146, stk. 1, eller artikel 147
b)
om fornødent sikre, at de pågældende opdrættede landdyr er genstand for dokumentkontrol, identitetskontrol og fysisk kontrol, jf. artikel 149, stk. 3.
Artikel 149
Den kompetente myndigheds ansvar for dyresundhedscertificering
1.   Den kompetente myndighed udsteder efter anmodning fra en operatør et dyresundhedscertifikat til flytning af opdrættede landdyr, hvis dette kræves i henhold til artikel 143 eller delegerede retsakter vedtaget i henhold til artikel 144, stk. 1, såfremt følgende krav vedrørende flytning er opfyldt:
a)
kravene i artikel 124, artikel 125, stk. 1, artikel 126, artikel 128, artikel 129, artikel 130, artikel 133, artikel 134, artikel 136, stk. 1, artikel 137, stk. 1, artikel 138 og artikel 139
b)
krav fastsat i delegerede retsakter vedtaget i henhold til artikel 125, stk. 2, artikel 131, stk. 1, artikel 135, artikel 136, stk. 2, artikel 137, stk. 2, artikel 138, stk. 4, artikel 139, stk. 4, og artikel 140
c)
krav fastsat i gennemførelsesretsakter vedtaget i henhold til artikel 141.
2.   Dyresundhedscertifikater skal:
a)
kontrolleres, stemples og underskrives af en embedsdyrlæge
b)
være gyldige i den periode, der er fastsat i regler vedtaget i henhold til stk. 4, litra c), hvori de opdrættede landdyr, der er omfattet af certifikatet, opfylder de dyresundhedsmæssige garantier deri.
3.   Embedsdyrlægen skal, inden vedkommende underskriver et dyresundhedscertifikat, ved hjælp af dokumentkontrol, identitetskontrol og fysisk kontrol i overensstemmelse med delegerede retsakter vedtaget i henhold til stk. 4 kontrollere, at de opdrættede landdyr, der er omfattet af certifikatet, opfylder kravene i dette kapitel.
4.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende regler om:
a)
typer af dokumentkontrol, identitetskontrol og fysisk kontrol og undersøgelser, som en embedsdyrlæge skal foretage af forskellige arter og kategorier af opdrættede landdyr, jf. stk. 3, for at verificere, at kravene i dette kapitel er opfyldt
b)
frister for embedsdyrlægens foretagelse af sådan dokumentkontrol, identitetskontrol og fysisk kontrol og undersøgelser og udstedelse af dyresundhedscertifikat forud for flytning af sendinger af opdrættede landdyr
c)
dyresundhedscertifikaters gyldighedsperiode.
Artikel 150
Elektroniske dyresundhedscertifikater
Elektroniske dyresundhedscertifikater, som udfærdiges, håndteres og overføres ved hjælp af Traces, kan erstatte ledsagende dyresundhedscertifikater som omhandlet i artikel 149, stk. 1, hvis:
a)
sådanne elektroniske dyresundhedscertifikater indeholder alle de oplysninger, som standarddyresundhedscertifikatet skal indeholde i medfør af artikel 145 og eventuelle regler vedtaget i henhold til artikel 146
b)
sporbarheden for de pågældende opdrættede landdyr og forbindelsen mellem disse dyr og det elektroniske dyresundhedscertifikat er sikret
c)
de kompetente myndigheder i oprindelses-, passage- og bestemmelsesmedlemsstaterne er sikret adgang til de elektroniske dokumenter under hele transporten.
Artikel 151
Personlig erklæring fra operatører i forbindelse med flytninger til andre medlemsstater
1.   Operatører på oprindelsesstedet skal udfærdige en personlig erklæring i forbindelse med flytning af opdrættede landdyr fra deres oprindelsessted i en medlemsstat til deres bestemmelsessted i en anden medlemsstat og sikre, at erklæringen ledsager dyrene, hvis det ikke kræves, at de ledsages af et dyresundhedscertifikat som omhandlet i artikel 143, stk. 1 og 2.
2.   Den i stk. 1 omhandlede personlige erklæring skal indeholde følgende oplysninger om de pågældende opdrættede landdyr:
a)
oprindelsessted, bestemmelsessted og, hvis det er relevant, sammenbringnings- eller hvilesteder
b)
transportmiddel og transportør
c)
en beskrivelse af de opdrættede landdyr samt deres art, kategori og mængde
d)
identifikation og registrering, hvis det kræves i henhold til artikel 112, 113, 114 og 115, artikel 117, litra a), samt eventuelle regler vedtaget i henhold til artikel 118 og 120
e)
de oplysninger, der er nødvendige for at godtgøre, at de opdrættede landdyr opfylder de dyresundhedsmæssige krav vedrørende flytning i afdeling 1-6 (artikel 124-142).
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
nærmere regler om indholdet af den i nærværende artikels stk. 2 omhandlede personlige erklæring for forskellige arter og kategorier af dyr
b)
oplysninger, som den personlige erklæring skal indeholde, ud over de i nærværende artikels stk. 2 omhandlede oplysninger.
4.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler vedrørende standardmodeller til den i nærværende artikels stk. 2 omhandlede personlige erklæring. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Afdeling 8
Anmeldelse af flytninger af opdrættede landdyr til andre medlemsstater
Artikel 152
Operatørers forpligtelser vedrørende anmeldelse af flytninger af opdrættede landdyr til andre medlemsstater
Operatører, bortset fra transportører, skal på forhånd anmelde påtænkte flytninger af opdrættede landdyr fra den pågældende medlemsstat til en anden medlemsstat til den kompetente myndighed i deres oprindelsesmedlemsstat, hvis:
a)
dyrene skal ledsages af et dyresundhedscertifikat udstedt af oprindelsesmedlemsstatens kompetente myndighed i medfør af artikel 149 og 150 samt eventuelle regler vedtaget i henhold til artikel 149, stk. 4
b)
dyrene skal ledsages af et dyresundhedscertifikat for opdrættede landdyr, når de flyttes fra en restriktionszone og er omfattet af sygdomsbekæmpelsesforanstaltninger, jf. artikel 143, stk. 2
c)
dyrene har fået dispensation fra kravet om dyresundhedscertificering, jf. artikel 144, stk. 1, litra a), eller de er omfattet af særlige regler i henhold til artikel 144, stk. 1, litra b)
d)
anmeldelse kræves i medfør af delegerede retsakter vedtaget i henhold til artikel 154, stk. 1.
Med henblik på nærværende artikels stk. 1 skal operatører give oprindelsesmedlemsstatens kompetente myndighed alle de oplysninger, der er nødvendige, for at den kan anmelde flytningerne af de opdrættede landdyr til bestemmelsesmedlemsstatens kompetente myndighed i henhold til artikel 153, stk. 1.
Artikel 153
Den kompetente myndigheds ansvar for anmeldelse af flytninger til andre medlemsstater
1.   Oprindelsesmedlemsstatens kompetente myndighed anmelder flytninger af opdrættede landdyr til bestemmelsesmedlemsstatens kompetente myndighed, jf. artikel 152.
2.   Anmeldelser som omhandlet i stk. 1 foretages forud for en given flytning og så vidt muligt via Traces.
3.   Medlemsstaterne udpeger regioner med henblik på forvaltning af anmeldelser af flytninger som omhandlet i stk. 1.
4.   Uanset stk. 1 kan oprindelsesmedlemsstatens kompetente myndighed tillade, at den pågældende operatør helt eller delvis anmelder flytninger af opdrættede landdyr via Traces til bestemmelsesmedlemsstatens kompetente myndighed.
Artikel 154
Delegation af beføjelser og gennemførelsesretsakter vedrørende operatørers og den kompetente myndigheds anmeldelse af flytninger
1.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
kravet om, at operatører på forhånd i henhold til artikel 152 skal anmelde flytninger mellem medlemsstater af opdrættede landdyr af andre arter eller kategorier end dem, der er omhandlet nævnte artikels litra a) og b), hvis sporbarhed for sådanne flytninger af de pågældende arter eller kategorier er nødvendig for at sikre opfyldelse af de dyresundhedsmæssige krav vedrørende flytning i afdeling 1-6 (artikel 124-142)
b)
oplysninger, der er nødvendige for at kunne anmelde flytninger af opdrættede landdyr i henhold til artikel 152 og 153
c)
hasteprocedurer for anmeldelse af flytninger af opdrættede landdyr i tilfælde af strømsvigt og andre forstyrrelser i Traces
d)
kravene vedrørende medlemsstaternes udpegelse af regioner med henblik på forvaltning af anmeldelser af flytninger som omhandlet i artikel 153, stk. 3.
2.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler vedrørende:
a)
nærmere oplysninger om anmeldelser af flytninger af opdrættede landdyr fra:
i)
operatører til oprindelsesmedlemsstatens kompetente myndighed i henhold til artikel 152
ii)
oprindelsesmedlemsstatens kompetente myndighed til bestemmelsesmedlemsstaten i henhold til artikel 153
b)
frister for:
i)
operatørens meddelelse af de i artikel 152 omhandlede nødvendige oplysninger til oprindelsesmedlemsstatens kompetente myndighed
ii)
oprindelsesmedlemsstatens kompetente myndigheds anmeldelse af flytninger af opdrættede landdyr i henhold til artikel 153, stk. 1.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
KAPITEL 4
Flytninger af vildtlevende landdyr
Artikel 155
Vildtlevende landdyr
1.   Operatører må kun flytte vildtlevende dyr fra et levested i en medlemsstat til et levested eller en virksomhed i en anden medlemsstat, hvis:
a)
flytningerne af de pågældende vildtlevende dyr fra deres levested foregår på en sådan måde, at de ikke udgør en væsentlig risiko for spredning af listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), eller nye sygdomme undervejs eller på bestemmelsesstedet
b)
de vildtlevende dyr ikke kommer fra et levested i en restriktionszone, der er omfattet af flytningsrestriktioner for den pågældende dyreart som følge af forekomst af en listeopført sygdom omhandlet i artikel 9, stk. 1, litra d), eller af en ny sygdom som fastsat i artikel 70, stk. 2, samt eventuelle regler vedtaget i henhold til artikel 70, stk. 3, litra b), artikel 71, stk. 3, og artikel 83, stk. 3, eller hasteforanstaltninger som omhandlet i artikel 257 og 258 og eventuelle regler vedtaget i henhold til artikel 259, medmindre der gælder undtagelser i medfør af disse regler
c)
de vildtlevende dyr ledsages af et dyresundhedscertifikat eller andre dokumenter, hvis dyresundhedscertificering er nødvendigt for at sikre opfyldelse af de dyresundhedsmæssige krav til flytninger i nærværende stykkes litra a) og b) og reglerne vedtaget i henhold til artikel 156, stk. 1, litra c) og d)
d)
oprindelsesmedlemsstatens kompetente myndighed har anmeldt flytningen til bestemmelsesmedlemsstatens kompetente myndighed, hvis dyresundhedscertifikat kræves i medfør af regler vedtaget i henhold til artikel 156, stk. 1, litra c), og
e)
den kompetente myndighed i oprindelsesmedlemsstaten og den kompetente myndighed i bestemmelsesmedlemsstaten har aftalt en sådan flytning.
2.   Hvis dyresundhedscertificering kræves i medfør af regler vedtaget i henhold til artikel 156, stk. 1, litra c), gælder kravene i artikel 145, artikel 148, artikel 149, stk. 1, 2 og 3, og artikel 150 samt regler vedtaget i henhold til artikel 146, artikel 147 og artikel 149, stk. 4, for flytning af vildtlevende landdyr.
3.   Hvis anmeldelse af flytninger kræves i henhold til nærværende artikels stk. 1, litra d), gælder kravene i artikel 152 og 153 samt i delegerede retsakter vedtaget i henhold til artikel 154, stk. 1, for flytning af vildtlevende landdyr.
Artikel 156
Beføjelser vedrørende flytning af vildtlevende landsdyr
1.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
dyresundhedsmæssige krav vedrørende flytning af vildtlevende landdyr som omhandlet i artikel 155, stk. 1, litra a) og b)
b)
dyresundhedsmæssige krav vedrørende indførsel af vildtlevende landdyr, hvis de flyttes fra naturen til virksomheder
c)
typer af flytninger af vildtlevende landdyr eller situationer, hvor de pågældende dyr i forbindelse med sådanne flytninger skal ledsages af et dyresundhedscertifikat eller et andet dokument, samt krav til indholdet af sådanne certifikater og andre dokumenter
d)
anmeldelse fra oprindelsesmedlemsstatens kompetente myndighed til bestemmelsesmedlemsstatens kompetente myndighed i tilfælde af flytning af vildtlevende landdyr mellem medlemsstater samt de oplysninger, som sådanne anmeldelser skal indeholde.
2.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte nærmere regler om kravene i artikel 155 og i delegerede retsakter vedtaget i henhold til nærværende artikels stk. 1 for så vidt angår:
a)
standarddyresundhedscertifikater og standardmodeller til de andre dokumenter, der skal ledsage vildtlevende landdyr under flytning, når dette er fastsat i en delegeret retsakt vedtaget i henhold til nærværende artikels stk. 1, litra c)
b)
de nærmere enkeltheder for anmeldelsen fra oprindelsesmedlemsstatens kompetente myndighed og fristerne for sådanne anmeldelser, når dette er fastsat i regler vedtaget i henhold til nærværende artikels stk. 1, litra d).
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
KAPITEL 5
Flytning af avlsmateriale inden for Unionen
Afdeling 1
Almindelige krav
Artikel 157
Almindelige krav vedrørende flytning af avlsmateriale
1.   Operatører skal træffe passende forebyggende foranstaltninger for at sikre, at flytning af avlsmateriale ikke bringer sundhedsstatussen for opdrættede landdyr på bestemmelsesstedet i fare for så vidt angår:
a)
de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme
b)
nye sygdomme.
2.   Operatører må kun flytte avlsmateriale fra deres virksomhed og modtage avlsmateriale, hvis det pågældende materiale opfylder følgende betingelser:
a)
Det kommer fra virksomheder, som:
i)
af den kompetente myndighed er opført i virksomhedsregistret i henhold til artikel 93, stk. 1, litra a), og oprindelsesmedlemsstaten har ikke dispenseret i henhold til artikel 85
ii)
er godkendt af den kompetente myndighed i henhold til artikel 97, stk. 1, hvis dette kræves i henhold til artikel 94, stk. 1, eller artikel 95.
b)
Det opfylder sporbarhedskravene i artikel 121, stk. 1, og eventuelle regler vedtaget i henhold til artikel 122, stk. 1.
3.   Operatører skal opfylde kravene i artikel 125 vedrørende transport af avlsmateriale af opdrættede landdyr.
4.   Operatører må ikke flytte avlsmateriale fra en virksomhed i en medlemsstat til en virksomhed i en anden medlemsstat, medmindre bestemmelsesmedlemsstatens kompetente myndighed udtrykkeligt giver tilladelse hertil, hvis det pågældende avlsmateriale skal destrueres i sygdomsudryddelsesøjemed som led i et udryddelsesprogram som omhandlet i artikel 31, stk. 1 eller 2.
Artikel 158
Operatørers forpligtelser på bestemmelsesstedet
1.   Operatører af virksomheder på bestemmelsesstedet, som modtager avlsmateriale fra en virksomhed i en anden medlemsstat, skal:
a)
kontrollere, at følgende er til stede:
i)
mærker som omhandlet i artikel 121 og regler vedtaget i henhold til artikel 122
ii)
dyresundhedscertifikater som omhandlet i artikel 161
b)
efter kontrol af det modtagne avlsmateriale underrette den kompetente myndighed på bestemmelsesstedet om eventuelle uregelmæssigheder med hensyn til:
i)
det modtagne avlsmateriale
ii)
mærker, jf. litra a), nr. i)
iii)
dyresundhedscertifikater, jf. litra a), nr. ii).
2.   I tilfælde af uregelmæssigheder som omhandlet i stk. 1, litra b), opbevarer den pågældende operatør avlsmaterialet separat, indtil den kompetente myndighed har truffet en afgørelse vedrørende materialet.
Afdeling 2
Flytning af avlsmateriale af opdrættede dyr af arterne kvæg, får, geder, svin og heste samt avlsmateriale af fjerkræ til andre medlemsstater
Artikel 159
Operatørers forpligtelser vedrørende flytning af avlsmateriale af opdrættede dyr af arterne kvæg, får, geder, svin og heste samt avlsmateriale af fjerkræ til andre medlemsstater
1.   Operatører må kun flytte avlsmateriale af opdrættede dyr af arterne kvæg, får, geder, svin og heste samt avlsmateriale af fjerkræ til en anden medlemsstat, hvis det pågældende avlsmateriale opfylder følgende betingelser:
a)
Det er indsamlet, produceret, forarbejdet og opbevaret på avlsmaterialevirksomheder, der er godkendt til formålet i henhold til artikel 97, stk. 1, og artikel 99.
b)
Det er indsamlet fra donordyr, der opfylder de dyresundhedsmæssige krav, der er nødvendige for at sikre, at der ikke spredes listeopførte sygdomme med avlsmaterialet.
c)
Det er indsamlet, produceret, forarbejdet, opbevaret og transporteret på en måde, der sikrer, at de listeopførte sygdomme, der er omhandlet i artikel 9, stk. 1, litra d), ikke spredes med materialet.
2.   Operatører må ikke flytte avlsmateriale af opdrættede dyr af arterne kvæg, får, geder, svin og heste eller avlsmateriale af fjerkræ fra en avlsmaterialevirksomhed, der er omfattet af flytningsrestriktioner, som berører de pågældende listeopførte arter, jf.
a)
artikel 55, stk. 1, litra a), c) og e), artikel 55, stk. 1, litra f), nr. ii), artikel 56, artikel 61, stk. 1, litra a), artikel 62, stk. 1, artikel 65, stk. 1, litra c), artikel 74, stk. 1, og artikel 79 og 80
b)
regler vedtaget i henhold til artikel 55, stk. 2, artikel 63, artikel 67, artikel 71, stk. 3, artikel 74, stk. 4, og artikel 83, stk. 2, og
c)
hasteforanstaltninger som omhandlet i artikel 257 og 258 samt regler vedtaget i henhold til artikel 259, medmindre der gælder undtagelser i medfør af regler vedtaget i henhold til artikel 258.
De i dette stykke omhandlede restriktioner gælder ikke i tilfælde, hvor avlsmaterialet er indsamlet før et givent udbrud, og det pågældende materiale er opbevaret adskilt fra andet avlsmateriale.
Artikel 160
Delegation af beføjelser vedrørende flytning af avlsmateriale af opdrættede dyr af arterne kvæg, får, geder, svin og heste samt avlsmateriale af fjerkræ til andre medlemsstater
1.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 om dyresundhedsmæssige krav til flytning af avlsmateriale af opdrættede dyr af arterne kvæg, får, geder, svin og heste samt avlsmateriale af fjerkræ til andre medlemsstater i overensstemmelse med artikel 159 med fastlæggelse af følgende:
a)
regler om indsamling, produktion, forarbejdning og opbevaring af avlsmateriale af de pågældende opdrættede dyr på godkendte virksomheder som omhandlet i artikel 159, stk. 1, litra a)
b)
dyresundhedsmæssige krav som omhandlet i artikel 159, stk. 1, litra b), for opdrættede donordyr, som avlsmateriale er indsamlet fra, og vedrørende isolering eller anbringelse i karantæne af disse dyr
c)
laboratorietest og andre test, der skal udføres på opdrættede donordyr og avlsmateriale
d)
dyresundhedsmæssige krav til indsamling, produktion, forarbejdning, opbevaring eller andre procedurer samt transport som omhandlet i artikel 159, stk. 1, litra c).
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 om dyresundhedsmæssige krav til flytning af avlsmateriale af opdrættede dyr af arterne kvæg, får, geder, svin og heste samt avlsmateriale af fjerkræ til andre medlemsstater i overensstemmelse med artikel 159 med fastlæggelse af undtagelser for operatører fra reglerne i artikel 159 under hensyntagen til risiciene forbundet med sådant avlsmateriale og eventuelle indførte risikobegrænsende foranstaltninger.
Afdeling 3
Dyresundhedscertificering og anmeldelse af flytninger
Artikel 161
Operatørers forpligtelser vedrørende dyresundhedscertificering i forbindelse med flytning af avlsmateriale af opdrættede dyr af arterne kvæg, får, geder, svin og heste og avlsmateriale af fjerkræ samt delegerede retsakter
1.   Operatører må kun flytte avlsmateriale af opdrættede dyr af arterne kvæg, får, geder, svin og heste samt avlsmateriale af fjerkræ til en anden medlemsstat, hvis sådant materiale ledsages af et dyresundhedscertifikat udstedt af oprindelsesmedlemsstatens kompetente myndighed i henhold til stk. 3.
2.   I tilfælde, hvor det er tilladt at føre avlsmateriale af opdrættede dyr ud af en restriktionszone, der er omfattet af:
a)
sygdomsbekæmpelsesforanstaltninger som omhandlet i artikel 55, stk. 1, litra f), nr. ii), artikel 56, artikel 64, artikel 65, artikel 74, stk. 1, og artikel 79 samt regler vedtaget i henhold til artikel 55, stk. 2, artikel 67, artikel 71, stk. 3, artikel 74, stk. 4, og artikel 83, stk. 2, eller
b)
hasteforanstaltningerne omhandlet i artikel 257 og 258 samt eventuelle regler vedtaget i henhold til artikel 259,
og det pågældende avlsmateriale er af arter, der er omfattet af disse sygdomsbekæmpelses- eller hasteforanstaltninger, må operatører kun flytte sådant avlsmateriale inden for en medlemsstat eller fra en medlemsstat til en anden medlemsstat, hvis det ledsages af et dyresundhedscertifikat udstedt af oprindelsesmedlemsstatens kompetente myndighed i henhold til artikel 149, stk. 1, medmindre der gælder undtagelser fra kravet om dyresundhedscertificering i medfør af de i nærværende afsnit nævnte regler.
Den kompetente myndighed kan beslutte, at det ikke er nødvendigt at udstede et sådant certifikat til flytning af avlsmateriale inden for den pågældende medlemsstat, hvis myndigheden er af den opfattelse, at et alternativt eksisterende system sikrer, at sendingen af det pågældende avlsmateriale er sporbar, og at avlsmaterialet opfylder de dyresundhedsmæssige krav til en sådan flytning.
3.   Operatører skal træffe alle fornødne foranstaltninger for at sikre, at det i stk. 1 omhandlede dyresundhedscertifikat ledsager avlsmaterialet fra dets oprindelsessted til dets bestemmelsessted.
4.   Den kompetente myndighed udsteder efter anmodning fra en operatør et dyresundhedscertifikat til flytning af avlsmateriale som omhandlet i stk. 1, forudsat at de relevante krav i del IV, afsnit I, kapitel 5 (artikel 157-165), er opfyldt.
5.   Artikel 148, 149 og 150 samt regler vedtaget i henhold til artikel 146, artikel 147 og artikel 149, stk. 4, finder anvendelse på dyresundhedscertificeringen i det i nærværende artikels stk. 1 omhandlede avlsmateriale. Artikel 151, stk. 1, og regler vedtaget i henhold til artikel 151, stk. 3, finder anvendelse på personlige erklæringer om flytning af avlsmateriale.
6.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 om undtagelser fra kravene i nærværende artikels stk. 1 vedrørende dyresundhedscertifikat til flytninger af avlsmateriale af opdrættede dyr af arterne kvæg, får, geder, svin og heste samt avlsmateriale af fjerkræ, som på grund af følgende ikke udgør en væsentlig risiko for spredning af listeopførte sygdomme:
a)
arten af det pågældende avlsmateriale eller den dyreart, som det pågældende materiale kommer fra
b)
produktions- og forarbejdningsmetoderne på avlsmaterialevirksomheden
c)
den påtænkte anvendelse af avlsmaterialet
d)
alternative indførte risikobegrænsende foranstaltninger for den pågældende type og kategori af avlsmateriale og avlsmaterialevirksomheden
e)
avlsmaterialets bestemmelsessted, når bestemmelsesstedet er i den samme medlemsstat som oprindelsesstedet, men avlsmaterialet passerer gennem en anden medlemsstat for at nå frem til bestemmelsesstedet.
Artikel 162
Dyresundhedscertifikaters indhold
1.   Dyresundhedscertifikater for avlsmaterialet omhandlet i artikel 161 skal mindst indeholde følgende oplysninger:
a)
oprindelsesavlsmaterialevirksomheden og bestemmelsesvirksomheden eller -stedet
b)
typen af avlsmateriale og de opdrættede donordyrs art
c)
mængden af avlsmateriale
d)
mærkningen af avlsmaterialet, hvis dette kræves i henhold til artikel 121, stk. 1, og regler vedtaget i henhold til artikel 122, stk. 1
e)
de oplysninger, der er nødvendige for at godtgøre, at avlsmaterialet i sendingen opfylder kravene vedrørende flytning af de relevante arter i artikel 157 og 159 samt eventuelle regler vedtaget i henhold til artikel 160.
2.   Dyresundhedscertifikatet for avlsmaterialet som omhandlet i artikel 161 kan indeholde andre oplysninger, som kræves i henhold til anden EU-lovgivning.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende oplysninger, som dyresundhedscertifikatet i henhold til nærværende artikels stk. 1 skal indeholde.
4.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 om dyresundhedscertificering for forskellige typer avlsmateriale af forskellige dyrearter.
5.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler vedrørende standarddyresundhedscertifikater for avlsmateriale. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 163
Anmeldelse af flytninger af avlsmateriale af opdrættede dyr af arterne kvæg, får, geder, svin og heste samt avlsmateriale af fjerkræ til andre medlemsstater
1.   Operatører skal:
a)
på forhånd anmelde en påtænkt flytning af avlsmateriale af opdrættede dyr af arterne kvæg, får, geder, svin og heste samt avlsmateriale af fjerkræ til en anden medlemsstat til den kompetente myndighed i deres oprindelsesmedlemsstat, hvis:
i)
det pågældende avlsmateriale skal ledsages af et dyresundhedscertifikat i henhold til artikel 161, stk. 1 eller 2
ii)
anmeldelse af flytningen kræves i medfør af delegerede retsakter vedtaget i henhold til nærværende artikels stk. 5, litra a), for avlsmateriale under hensyntagen til nærværende artikels stk. 3
b)
give alle de oplysninger, der er nødvendige, for at oprindelsesmedlemsstatens kompetente myndighed kan anmelde flytningen af avlsmaterialet til bestemmelsesmedlemsstatens kompetente myndighed i henhold til stk. 2.
2.   Forud for den pågældende flytning og så vidt muligt via Traces anmelder oprindelsesmedlemsstatens kompetente myndighed flytninger af avlsmateriale af opdrættede dyr af arterne kvæg, får, geder, svin og heste samt avlsmateriale af fjerkræ til bestemmelsesmedlemsstatens kompetente myndighed i overensstemmelse med regler vedtaget i henhold til stk. 5 og 6.
3.   Med henblik på forvaltning af anmeldelser anvender medlemsstaterne de regioner, der er udpeget i henhold til artikel 153, stk. 3.
4.   Artikel 153, stk. 4, finder anvendelse på operatørers anmeldelse af avlsmateriale.
5.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
kravet om, at operatører i medfør af nærværende artikels stk. 1, litra a), nr. ii), på forhånd skal anmelde flytninger af avlsmateriale mellem medlemsstater, hvis sporbarhed for sådanne flytninger er nødvendigt for at sikre opfyldelse af de dyresundhedsmæssige krav til flytninger i afdeling 1 og 2 (artikel 157-160)
b)
oplysninger, der er nødvendige for at kunne anmelde flytninger af avlsmateriale som omhandlet i nærværende artikels stk. 1
c)
hasteprocedurer for anmeldelse af flytninger af avlsmateriale i tilfælde af strømsvigt eller andre forstyrrelser i Traces.
6.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler vedrørende:
a)
operatørers meddelelse af oplysninger om flytninger af avlsmateriale til oprindelsesmedlemsstatens kompetente myndighed i henhold til stk. 1
b)
oprindelsesmedlemsstatens kompetente myndigheds anmeldelse af flytninger af avlsmateriale til bestemmelsesmedlemsstatens kompetente myndighed i henhold til stk. 2
c)
frister for:
i)
operatørens meddelelse af de i stk. 1 omhandlede oplysninger til oprindelsesmedlemsstatens kompetente myndighed
ii)
oprindelsesmedlemsstatens kompetente myndigheds anmeldelse af flytninger af avlsmateriale i henhold til stk. 2.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Afdeling 4
Flytning af avlsmateriale af andre opdrættede landdyr end arter af kvæg, får, geder, svin og heste samt avlsmateriale af fjerkræ til andre medlemsstater
Artikel 164
Avlsmateriale af andre opdrættede landdyr end arter af kvæg, får, geder, svin og heste samt avlsmateriale af fjerkræ
1.   Operatører må kun flytte avlsmateriale af andre opdrættede landdyr end arter af kvæg, får, geder, svin og heste samt avlsmateriale af fjerkræ til en anden medlemsstat, hvis avlsmaterialet ikke udgør en væsentlig risiko for spredning af listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), til listeopførte arter på bestemmelsesstedet under hensyntagen til sundhedsstatussen på bestemmelsesstedet.
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 om dyresundhedsmæssige krav, dyresundhedscertificering og anmeldelseskrav vedrørende flytning af avlsmateriale af andre opdrættede landdyr end arter af kvæg, får, geder, svin og heste samt avlsmateriale af fjerkræ under hensyntagen til følgende forhold:
a)
listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), for de pågældende listeopførte arter
b)
hvilke dyrearter avlsmaterialet indsamles fra, og avlsmaterialetype
c)
sundhedsstatussen på oprindelses- og bestemmelsesstedet
d)
indsamlings-, produktions-, forarbejdnings- og opbevaringsform
e)
andre epidemiologiske faktorer.
3.   Hvis dyresundhedscertificering og anmeldelse af flytninger af avlsmateriale kræves i henhold til stk. 2,
a)
finder reglerne i artikel 161, stk. 1-5, og i artikel 162, stk. 1-2, samt regler vedtaget i henhold til artikel 161, stk. 6, og artikel 162, stk. 3-5, anvendelse på sådan certificering
b)
finder reglerne i artikel 163, stk. 1, 2 og 4, samt regler vedtaget i henhold til artikel 163, stk. 5, anvendelse på anmeldelse af flytninger.
Afdeling 5
Dispensation
Artikel 165
Avlsmateriale til videnskabelige formål samt delegerede retsakter
1.   Den kompetente myndighed på bestemmelsesstedet kan med samtykke fra den kompetente myndighed på oprindelsesstedet tillade flytninger af avlsmateriale ind på bestemmelsesmedlemsstatens område til videnskabelige formål, hvis disse flytninger ikke opfylder kravene i artikel 159-164.
2.   Den kompetente myndighed må kun give dispensation i henhold til stk. 1 på følgende betingelser:
a)
De kompetente myndigheder på oprindelses- og bestemmelsesstedet
i)
har aftalt betingelserne for de foreslåede flytninger
ii)
sikrer, at der er truffet de fornødne risikobegrænsende foranstaltninger, således at de pågældende flytninger ikke bringer sundhedsstatussen undervejs eller på bestemmelsesstederne i fare for så vidt angår de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme
iii)
har, hvor det er relevant, underrettet de kompetente myndigheder i medlemsstater, som dyrene passerer igennem, om den pågældende dispensation og om betingelserne herfor.
b)
De pågældende flytninger foregår under tilsyn af de kompetente myndigheder på oprindelses- og bestemmelsesstederne og, hvor det er relevant, de kompetente myndigheder i de medlemsstater, som avlsmaterialet passerer igennem.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende regler om meddelelse af dispensation fra kompetente myndigheder som supplement til de regler, der er fastsat i nærværende artikels stk. 1 og 2.
KAPITEL 6
Produktion, forarbejdning og distribution af animalske produkter i Unionen
Artikel 166
Almindelige dyresundhedsmæssige forpligtelser for operatører samt delegerede retsakter
1.   Operatører skal træffe passende forebyggende foranstaltninger for på alle stadier af produktion, forarbejdning og distribution af animalske produkter i Unionen at sikre, at sådanne produkter ikke er årsag til spredning af:
a)
listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), under hensyntagen til sundhedsstatussen på produktions-, forarbejdnings- eller bestemmelsesstedet
b)
nye sygdomme.
2.   Operatører skal sikre, at animalske produkter ikke kommer fra virksomheder eller fødevarevirksomheder eller hidrører fra dyr, der kommer fra virksomheder, som er omfattet af:
a)
hasteforanstaltninger som omhandlet i artikel 257 og 258 eller eventuelle regler vedtaget i henhold til artikel 259, medmindre der gælder undtagelser fra kravet i nærværende artikels stk. 1 i medfør af regler vedtaget i henhold til artikel 259
b)
flytningsrestriktioner for opdrættede landdyr og animalske produkter som omhandlet i artikel 32, stk. 1, litra c), artikel 55, stk. 1, litra e), artikel 56, artikel 61, stk. 1, litra a), artikel 62, stk. 1, artikel 65, stk. 1, litra c), artikel 70, stk. 1, litra b), artikel 74, stk. 1, litra a), artikel 76, stk. 2, litra b), og stk. 3, artikel 79, artikel 81 og artikel 82, stk. 2 og 3, samt regler vedtaget i henhold til artikel 55, stk. 2, artikel 63 og 67, artikel 70, stk. 3, artikel 71, stk. 3, artikel 74, stk. 4, artikel 76, stk. 5, og artikel 83, stk. 2, medmindre der gælder undtagelser fra de pågældende flytningsrestriktioner i medfør af disse regler.
3.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende nærmere krav, der supplerer de krav, der er omhandlet
a)
i nærværende artikels stk. 1 om forebyggende foranstaltninger, herunder risikobegrænsende foranstaltninger, og
b)
i nærværende artikels stk. 2 om flytningsrestriktioner for animalske produkter.
4.   Kommissionen baserer de delegerede retsakter omhandlet i stk. 3 på:
a)
den pågældende listeopførte sygdom omhandlet i artikel 9, stk. 1, litra d), og arter, der er berørt af sygdommen, og
b)
de relevante risici.
Artikel 167
Operatørers forpligtelser vedrørende dyresundhedscertifikater samt delegerede retsakter
1.   Operatører må kun flytte følgende animalske produkter inden for en medlemsstat eller til en anden medlemsstat, hvis de pågældende produkter ledsages af et dyresundhedscertifikat udstedt af oprindelsesmedlemsstatens kompetente myndighed i henhold til stk. 3:
a)
animalske produkter, som:
i)
det er tilladt at flytte fra en restriktionszone, der er omfattet af hasteforanstaltninger fastsat i regler vedtaget i henhold til artikel 259
ii)
hidrører fra dyr af arter, der er omfattet af de pågældende hasteforanstaltninger
b)
animalske produkter, som:
i)
det er tilladt at flytte fra en restriktionszone, der er omfattet af sygdomsbekæmpelsesforanstaltninger som omhandlet i artikel 32, stk. 1, artikel 55, stk. 1, litra f), nr. ii), artikel 56, artikel 61, stk. 1, litra a), artikel 62, stk. 1, artikel 64, artikel 65, stk. 1, litra c), artikel 70, stk. 1, litra b), artikel 74, stk. 1, litra a), og artikel 79 og 80, samt eventuelle regler vedtaget i henhold til artikel 55, stk. 2, artikel 63, artikel 67 samt artikel 71, stk. 3, artikel 74, stk. 4 og artikel 83, stk. 2
ii)
hidrører fra dyr af arter, der er omfattet af de pågældende sygdomsbekæmpelsesforanstaltninger.
Den kompetente myndighed kan beslutte, at det ikke er nødvendigt at udstede et sådant certifikat til flytning af animalske produkter inden for den pågældende medlemsstat, hvis myndigheden er af den opfattelse, at et alternativt eksisterende system sikrer, at sendinger af sådanne produkter er sporbare, og at produkterne opfylder de dyresundhedsmæssige krav til sådanne flytninger.
2.   Operatører skal træffe alle fornødne foranstaltninger til at sikre, at det i stk. 1 omhandlede dyresundhedscertifikat ledsager de animalske produkter fra deres oprindelsessted til deres bestemmelsessted.
3.   Den kompetente myndighed udsteder efter anmodning fra den pågældende operatør et dyresundhedscertifikat til flytning af animalske produkter som omhandlet i stk. 1, forudsat at de relevante krav i denne artikel er opfyldt.
4.   Artikel 148, 149 og 150 samt regler vedtaget i henhold til artikel 146, 147 og artikel 149, stk. 4, finder anvendelse på dyresundhedscertificering af flytninger af animalske produkter som omhandlet i nærværende artikels stk. 1.
5.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 om undtagelser fra kravene i nærværende artikels stk. 1 vedrørende udstedelse af dyresundhedscertifikat og om betingelserne for sådanne undtagelser for flytninger af animalske produkter, som på grund af følgende ikke udgør en væsentlig risiko for spredning af sygdomme:
a)
typerne af pågældende animalske produkter
b)
de risikobegrænsende foranstaltninger, der anvendes for de animalske produkter, og som reducerer risikoen for spredning af sygdomme
c)
den påtænkte anvendelse af de animalske produkter
d)
de animalske produkters bestemmelsessted.
Artikel 168
Dyresundhedscertifikaters indhold samt delegerede retsakter og gennemførelsesretsakter
1.   Dyresundhedscertifikatet for animalske produkter omhandlet i artikel 167, stk. 1, skal mindst indeholde følgende oplysninger:
a)
oprindelsesvirksomheden eller -stedet og bestemmelsesvirksomheden eller -stedet
b)
en beskrivelse af de pågældende animalske produkter
c)
mængden af animalske produkter
d)
identifikation af de animalske produkter, hvis det kræves i henhold til artikel 65, stk. 1, litra h), eller eventuelle regler vedtaget i henhold til artikel 67, stk. 2, litra a)
e)
oplysninger, der er nødvendige for at godtgøre, at de animalske produkter opfylder kravene vedrørende flytningsrestriktioner i artikel 166, stk. 2, og eventuelle regler vedtaget i henhold til artikel 166, stk. 3.
2.   Dyresundhedscertifikatet som omhandlet i stk. 1 kan indeholde andre oplysninger, som kræves i henhold til anden EU-lovgivning.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende oplysninger, som dyresundhedscertifikatet skal indeholde, jf. nærværende artikels stk. 1.
4.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler vedrørende standarddyresundhedscertifikater for animalske produkter som omhandlet i nærværende artikels stk. 1. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 169
Anmeldelse af flytninger af animalske produkter til andre medlemsstater
1.   Operatører skal:
a)
forud for en påtænkt flytning af animalske produkter underrette den kompetente myndighed i deres oprindelsesmedlemsstat herom, hvis de pågældende sendinger skal ledsages af et dyresundhedscertifikat i henhold til artikel 167, stk. 1
b)
give alle de oplysninger, der er nødvendige, for at oprindelsesmedlemsstatens kompetente myndighed kan anmelde den pågældende flytning til bestemmelsesmedlemsstatens kompetente myndighed i henhold til stk. 2.
2.   Forud for flytningen og så vidt muligt via Traces anmelder oprindelsesmedlemsstatens kompetente myndighed flytninger af animalske produkter til bestemmelsesmedlemsstatens kompetente myndighed i overensstemmelse med regler vedtaget i henhold til stk. 5 og 6.
3.   Med henblik på forvaltning af anmeldelser anvender medlemsstaterne de regioner, der er udpeget i henhold til artikel 153, stk. 3.
4.   Artikel 153, stk. 4, finder anvendelse på operatørers anmeldelse af flytning af animalske produkter.
5.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
oplysninger, der er nødvendige for at kunne anmelde flytninger af animalske produkter i henhold til nærværende artikels stk. 1
b)
hasteprocedurer for anmeldelse af flytninger af animalske produkter i tilfælde af strømsvigt eller andre forstyrrelser i Traces.
6.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler vedrørende:
a)
de oplysninger om flytninger af animalske produkter, som operatører skal meddele til oprindelsesmedlemsstatens kompetente myndighed i henhold til stk. 1
b)
oprindelsesmedlemsstatens kompetente myndigheds anmeldelse af flytninger af animalske produkter til bestemmelsesmedlemsstaten i henhold til stk. 2
c)
frister for:
i)
den pågældende operatørs meddelelse af de i stk. 1 omhandlede oplysninger til oprindelsesmedlemsstatens kompetente myndighed
ii)
oprindelsesmedlemsstatens kompetente myndigheds anmeldelse af flytninger af animalske produkter som omhandlet i stk. 2.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
KAPITEL 7
Rammerne for nationale foranstaltninger
Artikel 170
Nationale foranstaltninger vedrørende sygdomsbekæmpelse og flytning af dyr og avlsmateriale
1.   Medlemsstaterne kan træffe nationale foranstaltninger til bekæmpelse af de i artikel 9, stk. 1, litra d) og e), omhandlede listeopførte sygdomme med hensyn til flytninger af landdyr og avlsmateriale deraf på deres eget område.
2.   Sådanne nationale foranstaltninger
a)
skal tage hensyn til reglerne om flytning af dyr og avlsmateriale i kapitel 3 (artikel 124-154), kapitel 4 (artikel 155 og 156) og kapitel 5 (artikel 157-165) og må ikke være i strid med disse regler
b)
må ikke være til hinder for flytning af dyr og produkter mellem medlemsstater
c)
må ikke gå videre, end hvad der er hensigtsmæssigt og nødvendigt for at forhindre introduktion og spredning af de i artikel 9, stk. 1, litra d) og e), omhandlede listeopførte sygdomme.
Artikel 171
Nationale foranstaltninger med henblik på at begrænse virkningerne af sygdomme, der ikke er listeopførte sygdomme
Hvis en sygdom, der ikke er en listeopført sygdom, udgør en væsentlig risiko for sundheden for opdrættede landdyr i en medlemsstat, kan den pågældende medlemsstat træffe nationale foranstaltninger til bekæmpelse af sygdommen og begrænsning af flytninger af opdrættede landdyr og avlsmateriale, forudsat at disse foranstaltninger ikke:
a)
er til hinder for flytning af dyr og produkter mellem medlemsstater
b)
går videre, end hvad der er hensigtsmæssigt og nødvendigt for at bekæmpe den pågældende sygdom.
AFSNIT II
AKVATISKE DYR OG ANIMALSKE PRODUKTER DERAF
KAPITEL 1
Registrering, godkendelse, føring af fortegnelser og registre
Afdeling 1
Registrering af akvakulturvirksomheder
Artikel 172
Operatørers forpligtelse til at få akvakulturvirksomheder registreret
1.   Operatører af akvakulturvirksomheder skal for at få deres virksomhed registreret i henhold til artikel 173, inden de indleder sådanne aktiviteter:
a)
underrette den kompetente myndighed om enhver akvakulturvirksomhed, som de er ansvarlige for
b)
give den kompetente myndighed følgende oplysninger:
i)
den pågældende operatørs navn og adresse
ii)
virksomhedens beliggenhed og en beskrivelse af dens faciliteter
iii)
arterne, kategorierne og mængden (antal, volumen eller vægt) af akvakulturdyr, som de agter at holde på akvakulturvirksomheden, samt akvakulturvirksomhedens kapacitet
iv)
akvakulturvirksomhedstypen og
v)
andre aspekter af virksomheden af relevans for fastlæggelsen af, hvilken risiko den udgør.
2.   Operatører af akvakulturvirksomheder, jf. stk. 1, skal på forhånd underrette den kompetente myndighed om:
a)
væsentlige ændringer på den pågældende akvakulturvirksomhed for så vidt angår de i stk. 1, litra b), omhandlede forhold
b)
indstilling af den pågældende operatørs eller akvakulturvirksomheds aktiviteter.
3.   Akvakulturvirksomheder, der skal godkendes i henhold til artikel 176, stk. 1, og artikel 177, har ikke pligt til at give de i nærværende artikels stk. 1 omhandlede oplysninger.
4.   En operatør kan ansøge om registrering i henhold til stk. 1 for en gruppe af akvakulturvirksomheder, hvis de opfylder en af følgende betingelser:
a)
De ligger i et epidemiologisk forbundet område, og alle operatører i dette område er omfattet af et fælles biosikringssystem.
b)
De henhører under den samme operatørs ansvar og opererer inden for et fælles biosikringssystem, og de pågældende virksomheds akvakulturdyr tilhører en enkelt epidemiologisk enhed.
Hvis en ansøgning om registrering omfatter en gruppe af virksomheder, finder reglerne i nærværende artikels stk. 1, 2 og 3 og artikel 173, stk. 1, litra b), samt regler vedtaget i henhold til artikel 175, der gælder for en enkelt akvakulturvirksomhed, anvendelse på gruppen af akvakulturvirksomheder som helhed.
Artikel 173
Den kompetente myndigheds forpligtelser vedrørende registrering af akvakulturvirksomheder
En kompetent myndighed registrerer:
a)
akvakulturvirksomheder i det i artikel 185, stk. 1, omhandlede register over akvakulturvirksomheder, hvis den pågældende operatør har givet de oplysninger, der kræves i henhold til artikel 172, stk. 1
b)
grupper af akvakulturvirksomheder i det nævnte register, forudsat at kriterierne i artikel 172, stk. 4, er opfyldt.
Den kompetente myndighed tildeler hver virksomhed eller gruppe af virksomheder som omhandlet i denne artikel et unikt registreringsnummer.
Artikel 174
Dispensation fra operatørers forpligtelse til at få akvakulturvirksomheder registreret
Uanset artikel 172, stk. 1, kan medlemsstaterne fritage visse akvakulturvirksomheder, der udgør en ubetydelig risiko, fra kravet om registrering i henhold til en gennemførelsesretsakt vedtaget i overensstemmelse med artikel 175.
Artikel 175
Gennemførelsesbeføjelser vedrørende dispensation fra forpligtelsen til at få akvakulturvirksomheder registreret
1.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler om oplysninger, som operatører skal give for at få akvakulturvirksomheder registreret, jf. artikel 172, stk. 1, herunder tidsfristerne for afgivelse af sådanne oplysninger.
2.   Kommissionen fastsætter ved hjælp af gennemførelsesretsakter regler vedrørende de typer af akvakulturvirksomheder, som medlemsstaterne kan fritage fra kravet om registrering i henhold til artikel 174 på grundlag af:
a)
arterne, kategorierne og mængden (antal, volumen eller vægt) af akvakulturdyr på den pågældende akvakulturvirksomhed samt denne virksomheds kapacitet
b)
flytningerne af akvakulturdyr til og fra akvakulturvirksomheden.
3.   De i denne artikel omhandlede gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Afdeling 2
Godkendelse af visse typer akvakulturvirksomheder
Artikel 176
Godkendelse af visse akvakulturvirksomheder samt delegerede retsakter
1.   Operatører af følgende typer akvakulturvirksomheder skal ansøge den kompetente myndighed om godkendelse i henhold til artikel 180, stk. 1:
a)
akvakulturvirksomheder, hvor der holdes akvakulturdyr med henblik på flytning af disse derfra enten levende eller som akvakulturprodukter
b)
andre akvakulturvirksomheder, som på grund af følgende udgør en betydelig risiko:
i)
arterne, kategorierne og antallet af akvakulturdyr, som holdes der
ii)
den pågældende akvakulturvirksomhedstype
iii)
flytningerne af akvakulturdyr til og fra den pågældende akvakulturvirksomhed.
2.   Uanset stk. 1 kan medlemsstaterne fritage operatører af følgende typer virksomheder fra forpligtelsen til at ansøge om godkendelse:
a)
akvakulturvirksomheder, der producerer små mængder af akvakulturdyr til levering med henblik på konsum, enten:
i)
til den endelige forbruger direkte eller
ii)
til lokale detailvirksomheder, der direkte forsyner den endelige forbruger
b)
damme og andre anlæg, hvor bestanden af akvatiske dyr udelukkende opretholdes til sportsfiskeri ved at forny bestanden med akvakulturdyr, som er spærret inde og ikke kan slippe ud
c)
akvakulturvirksomheder, der holder akvakulturdyr til dekorative formål i lukkede anlæg
forudsat at de pågågældende virksomheder ikke udgør en betydelig risiko.
3.   Medmindre der gælder en undtagelse i medfør af nærværende artikels stk. 4, må operatører ikke indlede aktiviteter på en i nærværende artikels stk. 1 omhandlet akvakulturvirksomhed, før denne virksomhed er blevet godkendt i overensstemmelse med artikel 181, stk. 1, og de skal indstille sådanne aktiviteter på en akvakulturvirksomhed som omhandlet i nærværende artikels stk. 1, hvis:
a)
den kompetente myndighed inddrager eller suspenderer sin godkendelse i henhold til artikel 184, stk. 2, eller
b)
det, i tilfælde af betinget godkendelse i henhold til artikel 183, stk. 3, ikke lykkes den pågældende akvakulturvirksomhed at opfylde de resterende krav omhandlet i artikel 183, stk. 4, og den ikke opnår endelig godkendelse i henhold til artikel 183, stk. 3.
4.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
undtagelser fra kravet til operatører om at ansøge den kompetente myndighed om godkendelse af de i stk. 1, litra a), omhandlede typer akvakulturvirksomheder for så vidt angår andre typer virksomheder end dem, der er omhandlet i stk. 2, litra a), nr. i) og ii), såfremt disse virksomheder ikke udgør en betydelig risiko
b)
typer af akvakulturvirksomheder, der skal godkendes i henhold til stk. 1, litra b).
5.   Kommissionen baserer delegerede retsakter i henhold til stk. 4 på følgende kriterier:
a)
hvilke arter og kategorier af akvakulturdyr der holdes på en akvakulturvirksomhed
b)
akvakulturvirksomhedstypen og produktionstypen og
c)
typiske flytningsmønstre for den pågældende type akvakulturvirksomhed og den pågældende art eller kategori af akvakulturdyr.
6.   En operatør kan ansøge om godkendelse af en gruppe af akvakulturvirksomhed, hvis kravene i artikel 177, stk. 1, litra a) og b), er opfyldt.
Artikel 177
Den kompetente myndigheds godkendelse af grupper af akvakulturvirksomheder
Den kompetente myndighed kan give godkendelse som omhandlet i artikel 181, stk. 1, for en gruppe af akvakulturvirksomheder, hvis de pågældende akvakulturvirksomheder opfylder en af følgende betingelser:
a)
De ligger i et epidemiologisk forbundet område, og alle operatørerne i det område er omfattet af et fælles biosikringssystem; landbaserede eller vandbaserede virksomheder til modtagelse, konditionering, vaskning, rengøring, sortering, indpakning og emballering af levende toskallede bløddyr, som er bestemt til konsum (såkaldte »ekspeditionscentre«), virksomheder med tanke, som tilføres rent havvand, og hvori levende toskallede bløddyr anbringes i tilstrækkelig lang tid til, at kontaminationen reduceres, så de bliver egnet til konsum (såkaldte »renseanlæg«), og lignende virksomheder, der ligger i et sådant epidemiologisk forbundet område, skal dog godkendes individuelt.
b)
De henhører under den samme operatørs ansvar og
i)
opererer inden for et fælles biosikringssystem og
ii)
de pågældende virksomheders akvakulturdyr indgår i samme epidemiologiske enhed.
Når en enkelt godkendelse gives for en gruppe af akvakulturvirksomheder, gælder reglerne i artikel 178 og artikel 180-184 samt regler vedtaget i henhold til artikel 180, stk. 2, og artikel 181, stk. 2, som finder anvendelse på individuelle akvakulturvirksomheder, for gruppen af akvakulturvirksomheder som helhed.
Artikel 178
Godkendelse af status som afgrænset akvakulturvirksomhed
Operatører af akvakulturvirksomheder, som ønsker at opnå status som en afgrænset virksomhed:
a)
skal ansøge den kompetente myndighed om godkendelse i henhold til artikel 180, stk. 1
b)
må først flytte akvakulturdyr til eller fra deres virksomhed i overensstemmelse med kravene i artikel 203, stk. 1, og eventuelle delegerede retsakter vedtaget i henhold til artikel 203, stk. 2, efter at deres virksomhed har fået godkendt denne status af den kompetente myndighed i henhold til artikel 181 eller artikel 183.
Artikel 179
Godkendelse af sygdomsbekæmpelsesvirksomheder for akvatiske fødevarer
Operatører af sygdomsbekæmpelsesvirksomheder for akvatiske fødevarer skal:
a)
sikre, at den nødvendige godkendelse i henhold til artikel 4 i Europa-Parlamentets og Rådets forordning (EF) nr. 853/2004 
(
62
)
 er opnået, og
b)
ansøge den kompetente myndighed i henhold til artikel 180, stk. 1, om godkendelse til slagtning eller forarbejdning af akvatiske dyr med henblik på sygdomsbekæmpelse i overensstemmelse med artikel 61, stk. 1, litra b), artikel 62, artikel 68, stk. 1, og artikel 79 og 80, samt regler vedtaget i henhold til artikel 63, artikel 70, stk. 3, og artikel 71, stk. 3.
Artikel 180
Operatørers forpligtelse til at give oplysninger med henblik på at opnå godkendelse
1.   Operatører giver i forbindelse med ansøgning om godkendelse af deres virksomhed, jf. artikel 176, stk. 1, artikel 177, artikel 178, litra a), og artikel 179, den kompetente myndighed følgende oplysninger:
a)
den pågældende operatørs navn og adresse
b)
den pågældende virksomheds beliggenhed og en beskrivelse af dens faciliteter
c)
arterne, kategorierne og mængden (antal, volumen eller vægt) af akvakulturdyr, som er relevante for godkendelse, og som holdes på virksomheden
d)
akvakulturvirksomhedstypen
e)
i tilfælde af godkendelse af en gruppe af akvakulturvirksomheder nærmere oplysninger, som dokumenterer, at den pågældende gruppe opfylder de betingelser, der er fastsat i artikel 177
f)
andre aspekter af den pågældende akvakulturvirksomheds driftsmetode af relevans for fastlæggelsen af den dermed forbundne risiko
g)
vandforsyning til og udledning af vand fra virksomheden
h)
virksomhedens biosikringsforanstaltninger.
2.   Operatører af akvakulturvirksomheder, jf. stk. 1, underretter på forhånd den kompetente myndighed om:
a)
ændringer på virksomheden for så vidt angår de i stk. 1 omhandlede forhold
b)
indstilling af den pågældende operatørs eller virksomheds aktiviteter.
3.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler om oplysninger, som operatører skal give i ansøgningen om godkendelse af deres virksomhed, jf. stk. 1, herunder tidsfristerne for afgivelse af sådanne oplysninger.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 181
Godkendelse og betingelser for godkendelse samt delegerede retsakter
1.   Den kompetente myndighed godkender kun akvakulturvirksomheder, jf. artikel 176, stk. 1, og artikel 178, litra a), grupper af akvakulturvirksomheder, jf. artikel 177, og sygdomsbekæmpelsesvirksomheder for akvatiske fødevarer, jf. artikel 179, hvis de pågældende virksomheder:
a)
opfylder følgende krav, alt efter hvad der er relevant, vedrørende:
i)
karantæne, isolation og andre biosikringsforanstaltninger under hensyntagen til kravene i artikel 10, stk. 1, litra b), og eventuelle regler vedtaget i henhold til artikel 10, stk. 6
ii)
overvågning som omhandlet i artikel 24 og, hvis det er relevant for den pågældende type virksomhed og den involverede risiko, i artikel 25
iii)
føring af fortegnelser i henhold til artikel 186-188 og eventuelle regler vedtaget i henhold til artikel 189 og 190
b)
har faciliteter og udstyr, der:
i)
i tilstrækkelig grad begrænser risikoen for introduktion og spredning af sygdomme til et acceptabelt niveau under hensyntagen til den pågældende virksomhedstype
ii)
har en tilstrækkelig kapacitet i forhold til arterne, kategorierne og mængden (antal, volumen eller vægt) af pågældende akvatiske dyr
c)
ikke udgør en uacceptabel risiko for spredning af sygdomme under hensyntagen til de risikobegrænsende foranstaltninger, der anvendes
d)
har et system, der sætter den pågældende operatør i stand til over for den kompetente myndighed at godtgøre, at kravene i litra a), b) og c) er opfyldt.
2.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
karantæne, isolation og andre biosikringsforanstaltninger som omhandlet i stk. 1, litra a), nr. i)
b)
overvågning som omhandlet i stk. 1, litra a), nr. ii)
c)
faciliteter og udstyr som omhandlet i stk. 1, litra b).
3.   Kommissionen baserer de regler, der skal fastsættes i delegerede retsakter i henhold til stk. 2, på følgende:
a)
de risici, som hver type virksomhed udgør
b)
arterne og kategorierne af akvakulturdyr eller akvatiske dyr, der er relevante for godkendelsen
c)
den pågældende produktionstype
d)
typiske flytningsmønstre for den pågældende type akvakulturvirksomhed og de arter og kategorier af dyr, der holdes herpå.
Artikel 182
Virksomhedsgodkendelsens omfang
Den kompetente myndighed angiver udtrykkeligt følgende i godkendelsen af en akvakulturvirksomhed eller en sygdomsbekæmpelsesvirksomhed for akvatiske fødevarer i henhold til artikel 181, stk. 1, på grundlag af en ansøgning i henhold til artikel 176, artikel 177, artikel 178, litra a), eller artikel 179:
a)
hvilken type akvakulturvirksomhed som omhandlet i artikel 176, stk. 1, og artikel 178, litra a), gruppe af akvakulturvirksomheder som omhandlet i artikel 177 og sygdomsbekæmpelsesvirksomhed for akvatiske fødevarer som omhandlet i artikel 179 samt eventuelle regler vedtaget i henhold til artikel 176, stk. 4, litra b), godkendelsen gælder for
b)
hvilke arter og kategorier af akvakulturdyr godkendelsen gælder for.
Artikel 183
Den kompetente myndigheds godkendelsesprocedurer
1.   Den kompetente myndighed fastlægger procedurer, som operatører skal følge, når de ansøger om godkendelse af deres virksomhed i henhold til artikel 176, stk. 1, artikel 178 og artikel 179.
2.   Efter at have modtaget en ansøgning om godkendelse fra en operatør i henhold til artikel 176, stk. 1, artikel 178 eller artikel 179 aflægger den kompetente myndighed et besøg på stedet.
3.   Hvis kravene i artikel 181 er opfyldt, giver den kompetente myndighed godkendelse.
4.   Såfremt en virksomhed ikke opfylder alle godkendelseskravene i artikel 181, kan den kompetente myndighed give en virksomhed betinget godkendelse, hvis det på baggrund af den pågældende operatørs ansøgning og det efterfølgende besøg på stedet, jf. nærværende artikels stk. 2, fremgår, at virksomheden opfylder alle de væsentligste krav, der giver tilfredsstillende garantier for, at virksomheden ikke udgør en betydelig risiko.
5.   Hvis den kompetente myndighed har givet betinget godkendelse i henhold til nærværende artikels stk. 4, giver den kun fuld godkendelse, hvis det af endnu et besøg på virksomheden aflagt inden for tre måneder efter datoen for betinget godkendelse eller af den dokumentation, som operatøren forelægger inden for tre måneder efter denne dato, fremgår, at virksomheden opfylder alle kravene til godkendelse i artikel 181, stk. 1, og regler vedtaget i henhold til artikel 181, stk. 2.
Hvis besøget på stedet eller den i første afsnit omhandlede dokumentation viser, at der er gjort klare fremskridt, men at virksomheden stadig ikke opfylder alle kravene, kan den kompetente myndighed forlænge den betingede godkendelse. En betinget godkendelse kan dog ikke gives for mere end seks måneder i alt.
Artikel 184
Den kompetente myndigheds revurdering, suspension og inddragelse af godkendelser
1.   Den kompetente myndighed tager godkendelser af virksomheder i henhold til artikel 181, stk. 1, op til fornyet vurdering med passende interval baseret på de involverede risici.
2.   Hvis en kompetent myndighed konstaterer alvorlige mangler på en virksomhed for så vidt angår opfyldelse af kravene i artikel 181, stk. 1, og regler vedtaget i henhold til artikel 181, stk. 2, og operatøren af denne virksomhed ikke kan give tilstrækkelige garantier for, at de pågældende mangler vil blive udbedret, indleder den kompetente myndighed procedurer med henblik på at inddrage virksomhedens godkendelse.
Den kompetente myndighed kan dog blot suspendere frem for at inddrage en virksomheds godkendelse, hvis operatøren kan garantere, at vedkommende vil udbedre manglerne inden for en rimelig frist.
3.   Godkendelse kan først gives efter inddragelse eller generhverves efter suspension i henhold til stk. 2, når den kompetente myndighed finder det godtgjort, at virksomheden fuldt ud opfylder alle kravene til den pågældende type virksomhed i denne forordning.
Afdeling 3
Register over akvakulturvirksomheder og sygdomsbekæmpelsesvirksomheder for akvatiske fødevarer
Artikel 185
Register over akvakulturvirksomheder og sygdomsbekæmpelsesvirksomheder for akvatiske fødevarer
1.   Enhver kompetent myndighed opretter og ajourfører et register over:
a)
alle akvakulturvirksomheder, der er registreret i henhold til artikel 173
b)
alle akvakulturvirksomheder, der er godkendt i henhold til artikel 181, stk. 1
c)
alle sygdomsbekæmpelsesvirksomheder for akvatiske fødevarer, der er godkendt i henhold til artikel 181, stk. 1.
2.   Registret over akvakulturvirksomheder omhandlet i stk. 1 skal indeholde oplysninger om:
a)
navn og adresse på operatøren og registreringsnummeret på den pågældende virksomhed
b)
den pågældende akvakulturvirksomheds eller, hvis det er relevant, gruppe af akvakulturvirksomheders beliggenhed
c)
produktionstypen på virksomheden
d)
vandforsyning til og udledning af vand fra virksomheden, hvis det er relevant
e)
hvilke arter af akvakulturdyr der holdes på virksomheden
f)
ajourførte oplysninger om sundhedsstatussen for den registrerede akvakulturvirksomhed eller, hvis det er relevant, gruppen af virksomheder for så vidt angår de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme.
3.   For virksomheder, der er godkendt i henhold til artikel 181, stk. 1, offentliggør den kompetente myndighed mindst de i nærværende artikels stk. 2, litra a), c), e) og f), omhandlede oplysninger elektronisk med forbehold af databeskyttelseskrav.
4.   Den kompetente myndighed kan, hvis det er hensigtsmæssigt og relevant, kombinere registrering som omhandlet i stk. 1 med registrering til andre formål.
5.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
relevante detaljerede oplysninger, som det i nærværende artikels stk. 1 omhandlede register over akvakulturvirksomheder skal indeholde
b)
offentlig adgang til dette register.
Afdeling 4
Føring af fortegnelser og sporbarhed
Artikel 186
Forpligtelser vedrørende føring af fortegnelser for operatører af akvakulturvirksomheder
1.   Operatører af akvakulturvirksomheder, som skal registreres i henhold til artikel 173 eller godkendes i henhold til artikel 181, stk. 1, skal føre og vedligeholde fortegnelser, der mindst indeholder følgende oplysninger:
a)
arterne, kategorierne og mængden (antal, volumen eller vægt) af akvakulturdyr på deres virksomhed
b)
flytninger af akvakulturdyr og animalske produkter, der hidrører fra sådanne dyr, til og fra deres virksomhed med angivelse af følgende:
i)
dyrenes oprindelses- eller bestemmelsessted
ii)
datoen for flytningerne
c)
de dyresundhedscertifikater, der som papirdokumenter eller i elektronisk form skal ledsage akvakulturdyr, der ankommer til akvakulturvirksomheden, under flytning i medfør af artikel 208 og regler vedtaget i henhold til artikel 211, stk. 1, litra a) og c), og artikel 213, stk. 2
d)
dødeligheden i de enkelte epidemiologiske enheder og andre sygdomsproblemer på akvakulturvirksomheden, alt efter hvad der er relevant for den pågældende produktionstype
e)
biosikringsforanstaltninger, overvågning, behandlinger, undersøgelsesresultater og andre relevante oplysninger vedrørende:
i)
arterne og kategorierne af akvakulturdyr på virksomheden
ii)
produktionstypen på akvakulturvirksomheden
iii)
typen og størrelsen af akvakulturvirksomheden
f)
resultaterne af eventuelle påkrævede dyresundhedsbesøg i henhold til artikel 25, stk. 1.
Fortegnelserne skal føres og vedligeholdes i papir eller elektronisk form.
2.   Akvakulturvirksomheder, der udgør en lav risiko for spredning af listeopførte eller nye sygdomme, kan af den pågældende medlemsstat fritages fra kravet om føring af fortegnelser over alle eller nogle af de i stk. 1, litra c), d) og e), omhandlede oplysninger, forudsat at sporbarhed er sikret.
3.   Operatører af akvakulturvirksomheder skal opbevare de i stk. 1 omhandlede fortegnelser på den pågældende akvakulturvirksomhed og
a)
føre dem på en sådan måde, at akvatiske dyrs oprindelses- og bestemmelsessted med sikkerhed kan spores
b)
stille dem til rådighed for den kompetente myndighed efter anmodning
c)
opbevare dem i et minimumstidsrum, der fastsættes af den kompetente myndighed, dog mindst tre år.
Uanset kravet i første afsnit om, at fortegnelserne skal opbevares på den pågældende virksomhed, kan fortegnelserne opbevares på det kontor, hvorfra virksomheden administreres, når det fysisk ikke er muligt at opbevare dem på virksomheden.
Artikel 187
Forpligtelser vedrørende føring af fortegnelser for sygdomsbekæmpelsesvirksomheder for akvatiske fødevarer
1.   Operatører af sygdomsbekæmpelsesvirksomheder for akvatiske fødevarer, som skal godkendes i henhold til artikel 179, skal føre og vedligeholde fortegnelser over:
a)
alle flytninger af akvakulturdyr og animalske produkter af sådanne dyr til og fra deres virksomhed
b)
vandudledning og relevante biosikringsforanstaltninger.
2.   Operatører af sygdomsbekæmpelsesvirksomheder for akvatiske fødevarer skal:
a)
føre de i stk. 1 omhandlede fortegnelser på deres virksomhed og efter anmodning stille dem til rådighed for den kompetente myndighed
b)
opbevare de i stk. 1 omhandlede fortegnelser i et minimumstidsrum, der fastsættes af den kompetente myndighed, dog mindst tre år.
Fortegnelserne skal føres og vedligeholdes på papir eller i elektronisk form.
Artikel 188
Forpligtelser vedrørende føring af fortegnelser for transportører
1.   Transportører af akvatiske dyr bestemt til akvakulturvirksomheder eller udsætning i naturen skal føre og vedligeholde fortegnelser vedrørende:
a)
de arter, kategorier og den mængde (antal, volumen eller vægt) af akvatiske dyr, som de transporterer
b)
dødeligheden blandt de pågældende akvakulturdyr og vildtlevende akvatiske dyr under transporten, for så vidt det er praktisk muligt for den pågældende transportform og de arter af akvakulturdyr og vildtlevende akvatiske dyr, der transporteres
c)
de akvakulturvirksomheder og sygdomsbekæmpelsesvirksomheder for akvatiske fødevarer, hvor transportmidlerne har været
d)
eventuel udskiftning af vand under transporten med angivelse af, hvor det nye vand er kommet fra, og af steder, hvor der er sket udtømning af vand
e)
rengøring og desinfektion af transportmidlerne.
Fortegnelserne skal føres og vedligeholdes i papir eller elektronisk form.
2.   Transportører, der udgør en lav risiko for spredning af listeopførte eller nye sygdomme, kan af den pågældende medlemsstat fritages fra kravet om føring af fortegnelser over alle eller nogle af de i stk. 1 omhandlede oplysninger, forudsat at sporbarhed er sikret.
3.   Transportører skal føre de i stk. 1 omhandlede fortegnelser
a)
på en sådan måde, at fortegnelserne efter anmodning øjeblikkeligt kan stilles til rådighed for den kompetente myndighed
b)
i et minimumstidsrum, der fastsættes af den kompetente myndighed, dog mindst tre år.
Artikel 189
Delegation af beføjelser vedrørende føring af fortegnelser
1.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende regler, der supplerer kravene om føring af fortegnelser i artikel 186, 187 og 188, for så vidt angår oplysninger, der skal registreres af operatører, ud over de i artikel 186, stk. 1, artikel 187, stk. 1 og artikel 188, stk. 1, omhandlede oplysninger.
2.   Kommissionen tager hensyn til følgende i forbindelse med vedtagelse af delegerede retsakter i henhold til stk. 1:
a)
de risici, der er forbundet med hver type akvakulturvirksomhed eller transport
b)
de arter og kategorier af akvatiske dyr, der holdes på den pågældende akvakulturvirksomhed eller transporteres dertil eller derfra
c)
produktionstype på virksomhederne
d)
typiske flytningsmønstre for den pågældende type akvakulturvirksomhed eller sygdomsbekæmpelsesvirksomhed for akvatiske fødevarer
e)
antallet, mængden eller vægten af akvatiske dyr, der holdes på virksomheden eller transporteres til eller fra den.
Artikel 190
Gennemførelsesbeføjelser vedrørende fritagelser fra kravene om føring af fortegnelser
Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler vedrørende typer af akvakulturvirksomheder og operatører, som medlemsstater kan fritage fra kravene om føring af fortegnelser i artikel 186 og 188, for så vidt angår:
a)
operatører af visse kategorier af akvakulturvirksomheder og transportører
b)
henholdsvis akvakulturvirksomheder, der holder et lille antal akvakulturdyr, eller transportører, der transporterer et lille antal akvatiske dyr
c)
visse arter og kategorier af akvatiske dyr.
Kommissionen baserer disse gennemførelsesretsakter på kriterierne i artikel 189, stk. 2.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
KAPITEL 2
Flytning af akvatiske dyr i Unionen
Afdeling 1
Almindelige krav vedrørende flytninger
Artikel 191
Almindelige krav vedrørende flytninger af akvatiske dyr
1.   Operatører skal træffe passende foranstaltninger til at sikre, at flytning af akvatiske dyr ikke bringer sundhedsstatussen på bestemmelsesstedet i fare for så vidt angår:
a)
de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme
b)
nye sygdomme.
2.   Operatører må kun flytte akvatiske dyr ind på en akvakulturvirksomhed eller med henblik på konsum eller sætte dem ud i naturen, hvis de pågældende dyr opfylder følgende betingelser:
a)
Dyrene, bortset fra vildtlevende akvatiske dyr, kommer fra virksomheder, som:
i)
er registreret af den kompetente myndighed i henhold til artikel 173
ii)
er godkendt af den kompetente myndighed i henhold til artikel 181 og 182, hvis dette kræves i henhold til artikel 176, stk. 1, artikel 177 eller artikel 178, eller
iii)
har fået dispensation fra registreringskravet i artikel 173.
b)
Dyrene er ikke omfattet af:
i)
flytningsrestriktioner, der berører de pågældende arter og kategorier, jf. artikel 55, stk. 1, artikel 56, artikel 61, stk. 1, artikel 62, artikel 64, artikel 65, artikel 70, stk. 1, litra b), artikel 74, stk. 1, artikel 79 og artikel 81 samt regler vedtaget i henhold til artikel 55, stk. 2, artikel 63, artikel 67 og artikel 70, stk. 3, artikel 71, stk. 3, artikel 74, stk. 4, og artikel 83, stk. 2, eller
ii)
hasteforanstaltninger som omhandlet i artikel 257 og 258 samt regler vedtaget i henhold til artikel 259.
Operatører må dog flytte de pågældende akvatiske dyr, hvis der gælder undtagelser fra restriktionerne for sådanne flytninger eller sådan udsætning i henhold til del III, afsnit II (artikel 53-83), eller undtagelser fra hasteforanstaltninger fastsat i regler vedtaget i henhold til artikel 259.
3.   Operatører skal træffe alle fornødne foranstaltninger til at sikre, at akvatiske dyr, efter at de har forladt deres oprindelsessted, sendes direkte til det endelige bestemmelsessted.
Artikel 192
Sygdomsforebyggende foranstaltninger i forbindelse med transport
1.   Operatører skal træffe relevante sygdomsforebyggende foranstaltninger, der er nødvendige for at sikre, at:
a)
akvatiske dyrs sundhedsstatus ikke bringes i fare under transport
b)
transport af akvatiske dyr ikke er årsag til potentiel spredning af listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), til mennesker eller dyr undervejs eller på bestemmelsesstedet
c)
rengøring og desinfektion af udstyr og transportmidler og andre passende biosikringsforanstaltninger gennemføres i overensstemmelse med de risici, som den pågældende transport er forbundet med
d)
eventuel udskiftning af vand og udledning af vand under transporten af akvatiske dyr bestemt til akvakultur eller udsætning i naturen foregår på steder og under betingelser, der ikke bringer sundhedsstatussen for så vidt angår de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme i fare for:
i)
de akvatiske dyr, der transporteres
ii)
eventuelle akvatiske dyr undervejs til bestemmelsesstedet
iii)
akvatiske dyr på bestemmelsesstedet.
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
betingelser og krav for så vidt angår rengøring og desinfektion af udstyr og transportmidler i henhold til nærværende artikels stk. 1, litra c), og anvendelse af biocidholdige produkter til sådanne formål
b)
andre passende biosikringsforanstaltninger under transport som omhandlet i nærværende artikels stk. 1, litra c)
c)
udskiftning af vand og udledning af vand under transport som omhandlet i nærværende artikels stk. 1, litra d).
Artikel 193
Ændring af påtænkt anvendelse
1.   Akvatiske dyr, der flyttes med henblik på destruktion eller slagtning i overensstemmelse med følgende foranstaltninger, må ikke anvendes til andre formål:
a)
enhver af de sygdomsbekæmpelsesforanstaltninger som omhandlet i artikel 32, stk. 1, litra c), artikel 55, stk. 1, artikel 56, artikel 61, artikel 62, artikel 64, artikel 65 og artikel 70, artikel 74, stk. 1 og 2, og artikel 79, artikel 80, artikel 81 og artikel 82 samt regler vedtaget i henhold til artikel 55, stk. 2, artikel 63, artikel 67, artikel 70, stk. 3, artikel 71, stk. 3, artikel 74, stk. 4, og artikel 83, stk. 2
b)
hasteforanstaltninger som omhandlet i artikel 257 og 258 samt regler vedtaget i henhold til artikel 259.
2.   Akvatiske dyr, der flyttes med henblik på konsum, akvakultur, udsætning i naturen eller et andet formål, må ikke anvendes til andre formål end det påtænkte.
3.   Uanset stk. 2 kan den kompetente myndighed på bestemmelsesstedet godkende en ændring af anvendelsen af akvatiske dyr til et andet formål end det oprindeligt påtænkte, forudsat at den nye anvendelse ikke udgør en højere risiko for de akvatiske dyrs sundhedsstatus på bestemmelsesstedet end den oprindeligt påtænkte.
Artikel 194
Operatørers forpligtelser på bestemmelsesstedet
1.   Operatører af akvakulturvirksomheder og sygdomsbekæmpelsesvirksomheder for akvatiske fødevarer, der modtager akvatiske dyr, og operatører, der modtager akvatiske dyr til udsætning i naturen, skal, inden de akvatiske dyr aflæsses:
a)
kontrollere, hvis det er påkrævet, at et af følgende dokumenter foreligger:
i)
et dyresundhedscertifikat som omhandlet i artikel 208, stk. 1, artikel 209 og artikel 223, stk. 1, samt regler vedtaget i henhold til artikel 189, 211 og 213
ii)
en personlig erklæring som omhandlet i artikel 218, stk. 1, og regler vedtaget i henhold til artikel 218, stk. 3 og 4
b)
efter kontrol af de modtagne akvatiske dyr underrette den kompetente myndighed på bestemmelsesstedet om eventuelle uregelmæssigheder med hensyn til:
i)
de modtagne akvatiske dyr
ii)
de i litra a), nr. i) og ii), omhandlede dokumenter.
2.   I tilfælde af en uregelmæssighed som omhandlet i stk. 1, litra b), skal operatøren holde de akvatiske dyr, som den pågældende uregelmæssighed vedrører, isoleret, indtil den kompetente myndighed på bestemmelsesstedet har truffet en afgørelse vedrørende dyrene.
Artikel 195
Almindelige krav til flytning af akvakulturdyr, der passerer igennem medlemsstater, men er bestemt til eksport fra Unionen til tredjelande eller territorier
Operatører skal sikre, at akvakulturdyr bestemt til eksport til et tredjeland eller territorium, som passerer gennem en anden medlemsstats område, opfylder kravene i artikel 191, 192 og 193.
Afdeling 2
Akvatiske dyr bestemt til akvakulturvirksomheder eller udsætning i naturen
Artikel 196
Abnorm dødelighed og andre alvorlige sygdomssymptomer
1.   Operatører må kun flytte akvatiske dyr fra en akvakulturvirksomhed eller fra naturen til en andet akvakulturvirksomhed eller udsætte dem i naturen, hvis de pågældende dyr:
a)
ikke udviser sygdomssymptomer og
b)
hidrører fra en akvakulturvirksomhed eller et miljø, hvor der ikke er abnorm dødelighed af ukendte årsager.
2.   Uanset stk. 1 kan den kompetente myndighed på grundlag af en risikovurdering tillade flytning eller udsætning af de i nævnte stykke omhandlede akvatiske dyr, hvis de pågældende dyr hidrører fra en del af akvakulturvirksomheden eller naturområdet, som er uafhængig af den epidemiologiske enhed, hvor den abnorme dødelighed eller andre sygdomssymptomer er konstateret.
Hvis den i dette stykke nævnte flytning eller udsætning skal ske til en anden medlemsstat, tillader den kompetente myndighed kun denne, hvis de kompetente myndigheder i bestemmelsesmedlemsstaten og, hvis det er relevant, i de medlemsstater, som dyrene passerer igennem, har givet deres samtykke til en sådan flytning eller udsætning.
Artikel 197
Flytning af akvakulturdyr bestemt til medlemsstater, zoner eller kompartmenter, der er erklæret sygdomsfrie eller er omfattet af et udryddelsesprogram, samt delegerede retsakter
1.   Operatører må kun flytte akvakulturdyr af listeopførte arter, der er relevante for så vidt angår en eller flere af de listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra b) eller c), til en akvakulturvirksomhed eller til udsætning i naturen i en medlemsstat eller zone eller et kompartment, der er erklæret fri(t) for disse listeopførte sygdomme i henhold til artikel 36, stk. 4, eller artikel 37, stk. 4, hvis de pågældende akvakulturdyr har oprindelse i en medlemsstat eller en zone eller et kompartment deri, der er erklæret fri(t) for disse sygdomme.
2.   Operatører må kun flytte akvakulturdyr af listeopførte arter, der er relevante for så vidt angår en eller flere af de listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra b) eller c), til en akvakulturvirksomhed eller til udsætning i naturen i en medlemsstat eller zone eller et kompartment, der er omfattet af et udryddelsesprogram for en eller flere af disse listeopførte sygdomme i henhold til artikel 31, stk. 1 eller 2, hvis de pågældende akvakulturdyr har oprindelse i en medlemsstat eller zone eller et kompartment deri, der er erklæret fri(t) for disse listeopførte sygdomme.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 om undtagelser fra kravene i nærværende artikels stk. 1 og 2 vedrørende flytning eller udsætning, som ikke udgør en væsentlig risiko for spredning af listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), under hensyntagen til:
a)
de pågældende akvakulturdyrs arter, kategorier og livsstadium
b)
typen af oprindelses- og bestemmelsesvirksomhed
c)
den påtænkte anvendelse af akvakulturdyrene
d)
akvakulturdyrenes bestemmelsessted
e)
behandlinger, forarbejdningsmetoder og andre særlige risikobegrænsende foranstaltninger, der anvendes på oprindelses- eller bestemmelsesstedet.
Artikel 198
Dispensation fra medlemsstaterne for så vidt angår operatørers forpligtelser vedrørende flytning af akvakulturdyr mellem medlemsstater, zoner eller kompartmenter, der er omfattet af et udryddelsesprogram
Uanset artikel 197, stk. 1 og 2, kan medlemsstaterne tillade, at operatører flytter akvakulturdyr ind i en zone eller et kompartment, der er omfattet af et udryddelsesprogram i henhold til artikel 31, stk. 1 og 2, for de i artikel 9, stk. 1, litra b) og c), omhandlede listeopførte sygdomme, fra en anden zone eller et andet kompartment, der også er omfattet af et sådant program for de samme listeopførte sygdomme, forudsat at en sådan flytning ikke vil bringe sundhedsstatussen for bestemmelsesmedlemsstaten, -zonen eller -kompartmentet i fare.
Hvis sådanne flytninger skal ske til en anden medlemsstat, tillader den kompetente myndighed dem kun, hvis de kompetente myndigheder i bestemmelsesmedlemsstaten og, hvis det er relevant, i de medlemsstater, som dyrene passerer igennem, har givet deres samtykke hertil.
Artikel 199
Medlemsstaternes foranstaltninger vedrørende udsætning af akvatiske dyr i naturen
Medlemsstaterne kan kræve, at akvatiske dyr kun udsættes i naturen, hvis de hidrører fra en medlemsstat eller en zone eller et kompartment deri, der er erklæret sygdomsfri(t) i henhold til artikel 36, stk. 1, eller artikel 37, stk. 1, for så vidt angår en eller flere af de i artikel 9, stk. 1, litra b) og c), omhandlede listeopførte sygdomme, for hvilke arterne af akvatiske dyr, der skal flyttes, er listeopførte arter, uanset sundhedsstatussen for det område, hvor disse akvatiske dyr skal udsættes.
Artikel 200
Flytning af vildtlevende akvatiske dyr bestemt til medlemsstater, eller zoner eller kompartmenter deri, der er erklæret sygdomsfrie eller er omfattet af et udryddelsesprogram, samt delegerede retsakter
1.   Artikel 196, 197 og 198 finder også anvendelse på flytning af vildtlevende akvatiske dyr bestemt til en akvakulturvirksomhed eller til udsætning i naturen.
2.   Operatører skal træffe de relevante sygdomsforebyggende foranstaltninger, der er nødvendige, når de flytter vildtlevende akvatiske dyr mellem levesteder, for at sikre, at:
a)
de pågældende flytninger ikke udgør en væsentlig risiko for spredning af listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), til akvatiske dyr på bestemmelsesstedet, og
b)
der er indført risikobegrænsende eller andre passende biosikringsforanstaltninger, når det er nødvendigt for at sikre overholdelse af litra a).
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende sygdomsforebyggende og risikobegrænsende foranstaltninger, som operatører skal træffe i henhold til nærværende artikels stk. 2. Den kompetente myndighed på bestemmelsesstedet kan træffe beslutning om sådanne foranstaltninger, indtil de delegerede retsakter er vedtaget.
Afdeling 3
Akvatiske dyr til konsum
Artikel 201
Flytning af levende akvatiske dyr bestemt til konsum i medlemsstater, eller i zoner eller kompartmenter deri, der er erklæret sygdomsfrie eller er omfattet af et udryddelsesprogram, samt delegerede retsakter
1.   Operatører må kun flytte levende akvakulturdyr til konsum af de listeopførte arter, der er relevante for de listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra b) eller c), til en medlemsstat eller til en zone eller et kompartment deri, som er erklæret sygdomsfri(t) i henhold til artikel 36, stk. 4, eller artikel 37, stk. 4, eller som er omfattet af et udryddelsesprogram i henhold til artikel 31, stk. 1 eller 2, for en eller flere af de i artikel 9, stk. 1, litra b) og c), listeopførte sygdomme, hvis de pågældende akvakulturdyr har oprindelse i en medlemsstat eller i en zone eller et kompartment deri, der er erklæret sygdomsfri(t) i henhold til artikel 36, stk. 4, eller artikel 37, stk. 4.
2.   Uanset nærværende artikels stk. 1 kan medlemsstater tillade, at operatører fører levende akvakulturdyr ind i en zone eller et kompartment, der er omfattet af et udryddelsesprogram i henhold til artikel 31, stk. 1 eller 2, for de i artikel 9, stk. 1, litra b) og c), omhandlede listeopførte sygdomme, fra en anden zone eller et andet kompartment, der i den pågældende medlemsstat også er omfattet af et sådant program for de samme sygdomme, forudsat at en sådan flytning ikke vil bringe sundhedsstatussen for medlemsstaten, zonen eller kompartmentet i fare.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende de undtagelser, der er fastsat i nærværende artikels stk. 2, med hensyn til flytninger af levende akvakulturdyr, som på grund af følgende ikke udgør en væsentlig risiko for spredning af sygdomme:
a)
de pågældende akvakulturdyrs arter, kategorier og livsstadium
b)
de for akvakulturdyrene anvendte opdrætsmetoder og produktionstypen på oprindelses- og bestemmelsesakvakulturvirksomhederne
c)
den påtænkte anvendelse af akvakulturdyrene
d)
akvakulturdyrenes bestemmelsessted
e)
behandlinger, forarbejdningsmetoder og andre særlige risikobegrænsende foranstaltninger, der anvendes på oprindelses- eller bestemmelsesstedet.
Artikel 202
Flytning af levende vildtlevende akvatiske dyr bestemt til medlemsstater, eller zoner eller kompartmenter deri, der er erklæret sygdomsfrie eller er omfattet af et udryddelsesprogram, samt delegerede retsakter
1.   Artikel 201, stk. 1 og 2, og regler vedtaget i henhold til artikel 201, stk. 3, finder anvendelse på flytning af levende vildtlevende akvatiske dyr til konsum, som er bestemt til medlemsstater eller zoner eller kompartmenter deri, der er erklæret sygdomsfrie i henhold til artikel 36, stk. 4, eller artikel 37, stk. 4, eller der er omfattet af et udryddelsesprogram, jf. artikel 31, stk. 1 eller 2, hvis foranstaltningerne vedtaget i henhold hertil er nødvendige for at sikre, at de pågældende dyr ikke udgør en væsentlig risiko for spredning af listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), til akvatiske dyr på bestemmelsesstedet.
2.   Nærværende artikels stk. 1 finder også anvendelse på levende akvatiske dyr, der ikke er omfattet af definitionen af akvakulturdyr indeholdt i artikel 4, nr. 7).
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende flytningskrav for vildtlevende akvatiske dyr til konsum, der supplerer nærværende artikels stk. 1 og 2.
Afdeling 4
Undtagelser fra afdeling 1-3 (artikel 191-202) og supplerende risikobegrænsende foranstaltninger
Artikel 203
Akvatiske dyr bestemt til afgrænsede akvakulturvirksomheder samt delegerede retsakter
1.   Operatører må kun flytte akvatiske dyr til en afgrænset akvakultur virksomhed, hvis de pågældende dyr opfylder følgende betingelser:
a)
De hidrører fra en anden afgrænset akvakulturvirksomhed.
b)
De udgør ikke en væsentlig risiko for spredning af listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), til listeopførte dyrearter på den afgrænsede bestemmelsesakvakulturvirksomhed, medmindre der er givet tilladelse til den pågældende flytning i videnskabeligt øjemed.
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
nærmere regler om flytning af akvakulturdyr til afgrænsede akvakulturvirksomheder ud over de i nærværende artikels stk. 1 omhandlede
b)
særlige regler om flytning af akvakulturdyr til afgrænsede akvakulturvirksomheder, når de risikobegrænsende foranstaltninger, der anvendes, garanterer, at sådanne flytninger ikke udgør en væsentlig sundhedsrisiko for akvakulturdyr på den pågældende afgrænsede akvakulturvirksomheder eller på de omkringliggende virksomheder.
Artikel 204
Flytning af akvatiske dyr i videnskabeligt øjemed samt delegerede retsakter
1.   Den kompetente myndighed på bestemmelsesstedet kan efter samtykke fra den kompetente myndighed på oprindelsesstedet tillade flytninger af akvatiske dyr ind på bestemmelsesmedlemsstatens område af akvatiske dyr til videnskabelige formål, hvis disse flytninger ikke opfylder kravene i afdeling 1-3 (artikel 191-202), bortset fra artikel 191, stk. 1 og 3, og artikel 192, 193 og 194.
2.   Den kompetente myndighed omhandlet i stk. 1 må kun give dispensation i henhold til nævnte stykke, hvis følgende betingelser er opfyldt:
a)
De kompetente myndigheder på bestemmelsesstedet og på oprindelsesstedet:
i)
har aftalt betingelserne for sådanne flytninger
ii)
sikrer de fornødne risikobegrænsende foranstaltninger, således at flytningerne af de pågældende akvatiske dyr ikke bringer sundhedsstatussen på steder undervejs og på bestemmelsesstederne i fare for så vidt angår de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme
iii)
har, hvis det er relevant, underrettet de kompetente myndigheder i medlemsstater, som dyrene passerer igennem, om den pågældende dispensation og om de betingelser, som den er givet på.
b)
De pågældende flytninger foregår under tilsyn af de kompetente myndigheder på oprindelses- og bestemmelsesstederne og, hvis det er relevant, de kompetente myndigheder i medlemsstaterne, som dyrene passerer igennem.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende regler om de kompetente myndigheders dispensation som supplement til de regler, der er fastsat i nærværende artikels stk. 1 og 2.
Artikel 205
Andre særlige anvendelser af akvatiske dyr, særlige krav og undtagelser samt delegation af beføjelser
1.   Operatører skal træffe de fornødne forebyggende foranstaltninger for at sikre, at flytning af akvatiske dyr, der er bestemt til de særlige formål eller anvendelser, som er anført i nærværende artikels stk. 2, litra a), nr. i)- vi), ikke udgør en risiko for spredning af de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme til akvatiske dyr på bestemmelsesstedet.
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
særlige krav, der supplerer reglerne i afdeling 1-3 (artikel 191-202), og vedrørende flytning af akvatiske dyr med følgende formål:
i)
zoologiske haver, dyrehandler, grossister og havedamme
ii)
udstillinger
iii)
sportsfiskeri, herunder fiskemadding
iv)
kulturelle arrangementer og lignende arrangementer
v)
kommercielle akvarier eller
vi)
sundhedspleje og anden lignende anvendelse
b)
undtagelser fra afdeling 1-3 (artikel 191-202), bortset fra artikel 191, stk. 1 og 3, artikel 192, artikel 193 og artikel 194, for flytning af akvatiske dyr som omhandlet i nærværende stykkes litra a), forudsat at der er indført tilstrækkelige biosikringsbestemmelser til sikring af, at sådanne flytninger ikke udgør en væsentlig risiko for bestemmelsesstedets sundhedsstatus.
Artikel 206
Gennemførelsesbeføjelser til at vedtage midlertidige regler for flytning af bestemte arter eller kategorier af akvatiske dyr
1.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte midlertidige regler, som supplerer eller udgør et alternativ til reglerne i dette kapitel for flytning af bestemte arter eller kategorier af akvatiske dyr i dette kapitel, hvis:
a)
flytningskravene i artikel 196, artikel 197, stk. 1, artikel 198, artikel 199, artikel 200, stk. 1 og 2, artikel 201, artikel 202, stk. 1, artikel 203, stk. 1, og artikel 204, stk. 1 og 2, samt regler vedtaget i henhold til artikel 197, stk. 3, artikel 200, stk. 3, artikel 202, stk. 3, artikel 203, stk. 2, artikel 204, stk. 3, og artikel 205 ikke effektivt begrænser de risici, der er forbundet med flytningen af de pågældende akvatiske dyr, eller
b)
de listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), ser ud til at spredes trods de flytningskrav, der er fastsat i overensstemmelse med afdeling 1-4 (artikel 191-207).
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
2.   I behørigt begrundede særligt hastende tilfælde vedrørende en listeopført sygdom, der udgør en risiko af meget betydeligt omfang, vedtager Kommissionen efter proceduren i artikel 266, stk. 3, under hensyntagen til de i artikel 205 omhandlede forhold gennemførelsesretsakter, der straks finder anvendelse.
Artikel 207
Forhold, der skal tages i betragtning i forbindelse med vedtagelse af delegerede retsakter og gennemførelsesretsakter i henhold til denne afdeling
Kommissionen baserer de regler, der skal vedtages ved delegerede retsakter og gennemførelsesretsakter i henhold til artikel 203, stk. 2, artikel 204, stk. 3, artikel 205 og artikel 206, på:
a)
de risici, der er forbundet med de flytninger, der er omhandlet i de nævnte bestemmelser
b)
sundhedsstatussen for så vidt angår de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme på oprindelses-, passage- og bestemmelsesstedet
c)
de listeopførte arter af akvatiske dyr for de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme
d)
de biosikringsforanstaltninger, der er indført på oprindelses-, passage- og bestemmelsesstedet
e)
eventuelle særlige betingelser, som akvakulturdyr holdes under
f)
særlige flytningsmønstre for de pågældende typer akvakulturvirksomhed og de pågældende arter eller kategorier af akvatiske dyr
g)
andre epidemiologiske faktorer.
Afdeling 5
Dyresundhedscertificering
Artikel 208
Forpligtelse for operatører til at sikre, at akvakulturdyr ledsages af et dyresundhedscertifikat
1.   Operatører må kun flytte akvakulturdyr, hvis dyrene ledsages af et dyresundhedscertifikat udstedt af den kompetente myndighed i oprindelsesmedlemsstaten i henhold til artikel 216, stk. 1, hvor de pågældende dyr er af listeopførte arter for de i artikel 9, stk. 1), litra b) og c), omhandlede listeopførte sygdomme, og dyrene skal føres ind i en medlemsstat eller i en zone eller et kompartment deri, som er erklæret sygdomsfri(t) i henhold til artikel 36, stk. 4, eller artikel 37, stk. 4, eller som er omfattet af et udryddelsesprogram i henhold til artikel 31, stk. 1 eller 2, for en eller flere af de i artikel 9, stk. 1, litra b) og c), omhandlede listeopførte sygdomme.
2.   Operatører må kun flytte akvakulturdyr, hvis dyrene ledsages af et dyresundhedscertifikat udstedt af den kompetente myndighed på oprindelsesstedet i henhold til artikel 216, stk. 1, hvor de pågældende dyr er af listeopførte arter for den eller de i artikel 9, stk. 1, litra a) og b), omhandlede relevante sygdomme, og det er tilladt at føre dyrene ud af en restriktionszone, der er omfattet af sygdomsbekæmpelsesforanstaltninger som omhandlet i artikel 55, stk. 1, litra f), nr. ii), artikel 56, artikel 64, artikel 65, stk. 1, artikel 74, stk. 1, eller artikel 79 og regler vedtaget i henhold til artikel 55, stk. 2, artikel 67, artikel 68, artikel 71, stk. 3, artikel 74, stk. 4, artikel 83, stk. 2, og artikel 259 for en eller flere af de i artikel 9, stk. 1, litra a) og b), omhandlede listeopførte sygdomme.
3.   Operatører skal træffe alle fornødne foranstaltninger til at sikre, at dyresundhedscertifikatet ledsager akvakulturdyrene fra deres oprindelsessted til deres endelige bestemmelsessted, medmindre der er fastsat særlige foranstaltninger i regler vedtaget i henhold til artikel 214.
Artikel 209
Forpligtelse for operatører til at sikre, at andre akvatiske dyr ledsages af et dyresundhedscertifikat, samt gennemførelsesbeføjelser
1.   I tilfælde, hvor dyresundhedscertificering på grund af den risiko, der er forbundet med flytningen af andre akvatiske dyr end akvakulturdyr, kræves i medfør af regler vedtaget i henhold til artikel 211, stk. 1, litra a), må operatører kun flytte disse akvatiske dyr, hvis de pågældende dyr ledsages af et dyresundhedscertifikat udstedt af den kompetente myndighed i oprindelsesmedlemsstaten i henhold til artikel 216, stk. 1.
2.   Artikel 208 finder også anvendelse på andre akvatiske dyr end akvakulturdyr, der er bestemt til en akvakulturvirksomhed eller udsætning i naturen. Hvis den kompetente myndighed i oprindelsesmedlemsstaten konkluderer, at certificering på grund af arten af de pågældende akvatiske dyrs oprindelsessted ikke er mulig, kan den efter samtykke fra den kompetente myndighed på bestemmelsesstedet tillade flytningen uden et dyresundhedscertifikat.
3.   Denne artikel finder ikke anvendelse på vildtlevende akvatiske dyr, der høstes eller fanges til direkte konsum.
Artikel 210
Medlemsstaters meddelelse af dispensation med hensyn til national dyresundhedscertificering
Uanset dyresundhedscertificeringskravene i artikel 208 og 209 kan medlemsstaterne give dispensation til flytning af visse sendinger af akvatiske dyr uden dyresundhedscertifikat på deres område, hvis de har et alternativt system til sikring af, at sendinger af sådanne dyr kan spores, og sendingerne opfylder de dyresundhedsmæssige krav vedrørende sådanne flytninger i afdeling 1-4 (artikel 191-207).
Artikel 211
Delegation af beføjelser og gennemførelsesretsakter vedrørende dyresundhedscertificering for akvatiske dyr
1.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
kravet om dyresundhedscertificering i forbindelse med flytning af andre akvatiske dyr end akvakulturdyr som omhandlet i artikel 209, stk. 1, i tilfælde, hvor dyresundhedscertificering er bydende nødvendigt for at sikre, at den pågældende flytning opfylder følgende dyresundhedsmæssige krav for de pågældende listeopførte dyrearter:
i)
kravene i afdeling 1-4 (artikel 191-207) og regler vedtaget i henhold til disse afdelinger
ii)
sygdomsbekæmpelsesforanstaltninger som omhandlet i artikel 55, stk. 1, artikel 56, artikel 61, stk. 1, artikel 62, artikel 64, artikel 65, stk. 1, artikel 74, stk. 1, og artikel 79 og 80 eller regler vedtaget i henhold til artikel 55, stk. 2, artikel 63, artikel 67, artikel 68, artikel 71, stk. 3, artikel 74, stk. 4, og artikel 83, stk. 2
iii)
hasteforanstaltninger som omhandlet i regler vedtaget i henhold til artikel 259
b)
særlige regler om dyresundhedscertificering, jf. artikel 208 og 209, såfremt specifikke risikobegrænsende foranstaltninger er truffet af den kompetente myndighed for at sikre:
i)
sporbarhed for de akvatiske dyr, der flyttes
ii)
at de akvatiske dyr, der flyttes, opfylder de dyresundhedsmæssige flytningskrav, der er fastsat i afdeling 1-4 (artikel 191-207)
c)
undtagelser fra dyresundhedscertifikatkravene i artikel 208 og 209, og betingelserne for sådanne undtagelser, for flytninger af akvatiske dyr, der på grund af følgende ikke udgør en væsentlig risiko for spredning af sygdomme:
i)
de pågældende akvatiske dyrs arter, kategorier eller livsstadium
ii)
opdrætsmetoderne og produktionstypen for de pågældende arter og kategorier af akvakulturdyr
iii)
den påtænkte anvendelse af de akvatiske dyr eller
iv)
de akvatiske dyrs bestemmelsessted.
2.   Kommissionen fastsætter ved hjælp af gennemførelsesretsakter regler vedrørende den i artikel 209, stk. 2, omhandlede forpligtelse for operatører til at sikre, at vildtlevende akvatiske dyr bestemt til en akvakulturvirksomhed ledsages af et dyresundhedscertifikat.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 212
Dyresundhedscertifikaters indhold
1.   Det i artikel 208, 209 og 210 omhandlede dyresundhedscertifikat skal mindst indeholde følgende oplysninger:
a)
oprindelsesvirksomheden eller -stedet, bestemmelsesvirksomheden eller -stedet og, for så vidt det er relevant for spredning af sygdomme, enhver virksomhed eller ethvert sted, hvor dyrene undervejs har været
b)
en beskrivelse af de pågældende akvatiske dyr, herunder art og kategori
c)
mængden (antal, volumen eller vægt) af de akvatiske dyr
d)
de oplysninger, der er nødvendige for at godtgøre, at de akvatiske dyr opfylder de relevante dyresundhedsmæssige krav til flytninger i afdeling 1-4 (artikel 191-207).
2.   Dyresundhedscertifikatet kan indeholde andre oplysninger, som kræves i henhold til anden EU-lovgivning.
Artikel 213
Delegation af beføjelser og gennemførelsesretsakter vedrørende dyresundhedscertifikaters indhold
1.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende dyresundhedscertifikaters indhold som omhandlet i artikel 212, stk. 1:
a)
nærmere regler om indholdet af de i artikel 212, stk. 1, omhandlede dyresundhedscertifikater for forskellige arter og kategorier af akvatiske dyr
b)
yderligere oplysninger, som dyresundhedscertifikater skal indeholde, jf. artikel 212, stk. 1.
2.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler vedrørende standarddyresundhedscertifikater.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 214
Delegation af beføjelser vedrørende særlige typer af flytninger af akvatiske dyr til bestemmelsesstedet
Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende særlige foranstaltninger, der supplerer kravene vedrørende dyresundhedscertificering i artikel 208 og 209, for følgende typer af flytninger af akvatiske dyr:
a)
flytning af akvatiske dyr, der af en eller flere af følgende årsager skal sendes tilbage til deres oprindelsessted eller flyttes til et andet bestemmelsessted:
i)
Den planlagte rejse blev uventet afbrudt af dyrevelfærdshensyn.
ii)
Der var uforudsete uheld eller hændelser under rejsen.
iii)
Dyrene blev afvist på bestemmelsesstedet i en anden medlemsstat eller ved Unionens ydre grænse.
iv)
Dyrene blev afvist i et tredjeland eller territorium
b)
flytning af akvakulturdyr bestemt til udstillinger, sportsbegivenheder, kulturelle arrangementer eller lignende arrangementer, og som efterfølgende sendes tilbage til deres oprindelsessted.
Artikel 215
Forpligtelse for operatører til at samarbejde med de kompetente myndigheder i forbindelse med dyresundhedscertificering
Operatører skal:
a)
forud for den påtænkte flytning give den kompetente myndighed alle de oplysninger, der er nødvendige for at udfylde det dyresundhedscertifikat, der er omhandlet i artikel 208 og 209 samt regler vedtaget i henhold til artikel 211, 213 og 214
b)
om nødvendigt sikre, at de pågældende akvatiske dyr underkastes dokumentkontrol, identitetskontrol og fysisk kontrol, jf. artikel 216, stk. 3, og regler vedtaget i henhold til artikel 216, stk. 4.
Artikel 216
Den kompetente myndigheds ansvar for dyresundhedscertificering samt delegerede retsakter
1.   Den kompetente myndighed udsteder efter anmodning fra en operatør et dyresundhedscertifikat til flytning af akvatiske dyr, hvis dette kræves i henhold til artikel 208 og 209 eller regler vedtaget i henhold til artikel 211 og 214, såfremt følgende dyresundhedsmæssige krav er opfyldt, alt efter hvad der er relevant:
a)
kravene i artikel 191, artikel 192, stk. 1, artikel 193, artikel 195, artikel 196, artikel 197, stk. 1, artikel 198, artikel 199, artikel 200, stk. 1 og 2, artikel 201, artikel 203, stk. 1, og artikel 204, stk. 1 og 2
b)
kravene i delegerede retsakter vedtaget i henhold til artikel 192, stk. 2, artikel 197, stk. 3, artikel 200, stk. 3, artikel 201, stk. 3, artikel 202, stk. 3, artikel 203, stk. 2, artikel 204, stk. 3, og artikel 205
c)
krav fastsat i gennemførelsesretsakter vedtaget i henhold til artikel 206.
2.   Dyresundhedscertifikater skal:
a)
kontrolleres, stemples og underskrives af en embedsdyrlæge
b)
være gyldige i den periode, der er fastsat i regler vedtaget i henhold til stk. 4, litra c), hvori de akvatiske dyr, der er omfattet af certifikatet, fortsat skal opfylde de dyresundhedsmæssige garantier deri.
3.   Embedsdyrlægen kontrollerer, inden vedkommende underskriver et dyresundhedscertifikat, ved hjælp af dokumentkontrol, identitetskontrol og fysisk kontrol i overensstemmelse med delegerede retsakter vedtaget i henhold til stk. 4, hvis det er relevant, at de akvatiske dyr, der er omfattet af certifikatet, opfylder kravene i dette kapitel under hensyntagen til arterne og kategorierne af akvatiske dyr og de dyresundhedsmæssige krav.
4.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende regler om:
a)
de typer af dokumentkontrol, identitetskontrol og fysisk kontrol og undersøgelser, som embedsdyrlægen skal foretage for så vidt angår de forskellige arter og kategorier af akvatiske dyr i overensstemmelse med stk. 3 for at verificere, at kravene i dette kapitel er opfyldt
b)
fristerne for embedsdyrlægens foretagelse af dokumentkontrol, identitetskontrol og fysisk kontrol og undersøgelser og for udstedelse af dyresundhedscertifikat forud for flytning af sendinger af akvatiske dyr
c)
dyresundhedscertifikaters gyldighedsperiode.
Artikel 217
Elektroniske dyresundhedscertifikater
Elektroniske dyresundhedscertifikater, som udfærdiges, håndteres og overføres ved hjælp af Traces, kan erstatte ledsagende dyresundhedscertifikater som omhandlet i artikel 216, stk. 1, hvis de pågældende elektroniske dyresundhedscertifikater:
a)
indeholder alle de oplysninger, som standarddyresundhedscertifikatet skal indeholde i henhold til artikel 212, stk. 1, og regler vedtaget i henhold til artikel 213
b)
sikrer sporbarhed for de pågældende akvatiske dyr og forbindelse mellem de pågældende dyr og det elektroniske dyresundhedscertifikat
c)
sikrer at de kompetente myndigheder i oprindelses-, passage- og bestemmelsesmedlemsstaten har adgang til de elektroniske dokumenter under hele transporten.
Artikel 218
Operatørers personlige erklæring i forbindelse med flytning af akvakulturdyr til andre medlemsstater samt delegerede retsakter
1.   Operatører på oprindelsesstedet skal udfærdige en personlig erklæring i forbindelse med flytning af akvakulturdyr fra deres oprindelsessted i en medlemsstat til bestemmelsesstedet i en anden medlemsstat og sikre, at erklæringen ledsager akvakulturdyrene, hvis det ikke er et krav, at dyrene ledsages af et dyresundhedscertifikat som omhandlet i artikel 208 og 209 eller eventuelle regler vedtaget i henhold til artikel 211 og 214.
2.   Den i stk. 1 omhandlede personlige erklæring skal mindst indeholde følgende oplysninger om akvakulturdyrene:
a)
deres oprindelses- og bestemmelsessted og, hvis det er relevant, andre steder, der passeres undervejs
b)
transportmiddel
c)
en beskrivelse af akvakulturdyrene og deres kategori, art, og mængde (antal, volumen eller vægt), alt efter hvad der er relevant for de pågældende dyr
d)
de oplysninger, der er nødvendige for at godtgøre, at akvakulturdyrene opfylder flytningskravene i afdeling 1-4 (artikel 191-207).
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
nærmere regler om indholdet af den i nærværende artikels stk. 2 omhandlede personlige erklæring for forskellige arter og kategorier af akvakulturdyr
b)
yderligere oplysninger, som den personlige erklæring skal indeholde ud over de i nærværende artikels stk. 2 omhandlede oplysninger.
4.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler vedrørende en standardmodel til den i stk. 1 omhandlede personlige erklæring.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Afdeling 6
Anmeldelse af flytninger af akvatiske dyr til andre medlemsstater
Artikel 219
Operatørers forpligtelse vedrørende anmeldelse af flytninger af akvatiske dyr til andre medlemsstater
1.   Operatører, bortset fra transportører, skal på forhånd anmelde enhver påtænkt flytning af akvatiske dyr fra en medlemsstat til en anden medlemsstat til den kompetente myndighed i deres oprindelsesmedlemsstat, hvis:
a)
de akvatiske dyr skal ledsages af et dyresundhedscertifikat udstedt af oprindelsesmedlemsstatens kompetente myndighed i medfør af artikel 208 og 209 eller eventuelle regler vedtaget i henhold til artikel 211 og artikel 214, stk. 2
b)
de akvatiske dyr skal ledsages af et dyresundhedscertifikat for akvatiske dyr, når de flyttes fra en restriktionszone som omhandlet i artikel 208, stk. 2, litra a)
c)
akvakulturdyrene og de vildtlevende akvatiske dyr, der flyttes, er bestemt til:
i)
en virksomhed, der skal registreres i henhold til artikel 173 eller godkendes i henhold til artikel 176-179
ii)
udsætning i naturen
d)
anmeldelse kræves i medfør af delegerede retsakter vedtaget i henhold til artikel 221.
2.   I forbindelse med anmeldelse i henhold til nærværende artikels stk. 1 skal operatører give oprindelsesmedlemsstatens kompetente myndighed alle de oplysninger, der er nødvendige, for at den kan anmelde flytningen til bestemmelsesmedlemsstatens kompetente myndighed i henhold til artikel 220, stk. 1.
Artikel 220
Den kompetente myndigheds ansvar for anmeldelse af flytninger af akvatiske dyr til andre medlemsstater
1.   Oprindelsesmedlemsstatens kompetente myndighed anmelder flytninger af akvatiske dyr til bestemmelsesmedlemsstatens kompetente myndighed, jf. artikel 219, medmindre der gælder en undtagelse for så vidt angår anmeldelse i henhold til artikel 221, stk. 1, litra c).
2.   Anmeldelser som omhandlet i stk. 1 foretages forud for den pågældende flytning og så vidt muligt via Traces.
3.   Medlemsstaterne udpeger regioner med henblik på forvaltning af anmeldelser af flytninger som omhandlet i stk. 1.
4.   Uanset stk. 1 kan oprindelsesmedlemsstatens kompetente myndighed tillade, at den pågældende operatør helt eller delvis anmelder flytninger af akvatiske dyr via Traces til bestemmelsesmedlemsstatens kompetente myndighed.
Artikel 221
Delegation af beføjelser og gennemførelsesretsakter vedrørende operatørers og den kompetente myndigheds anmeldelse af flytninger af akvatiske dyr
1.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
kravet om, at operatører i henhold til artikel 219 på forhånd skal anmelde flytninger mellem medlemsstater af akvatiske dyr af andre arter eller kategorier end dem, der er omhandlet i artikel 219, stk. 1, litra a), b) og c), hvis sporbarhed for sådanne flytninger er nødvendig for at sikre opfyldelse af de dyresundhedsmæssige krav i dette kapitel
b)
oplysninger, der er nødvendige, for at anmelde flytninger af akvatiske dyr i henhold til artikel 219 og artikel 220, stk. 1
c)
undtagelser fra anmeldelseskravene i artikel 219, stk. 1, litra c), for arter og kategorier af akvatiske dyr eller typer af flytninger, der udgør en ubetydelig risiko
d)
hasteprocedurer for anmeldelse af flytninger af akvatiske dyr i tilfælde af strømsvigt eller andre forstyrrelser i Traces
e)
kravene vedrørende medlemsstaternes udpegelse af regioner som omhandlet i artikel 220, stk. 3.
2.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler vedrørende:
a)
nærmere oplysninger om anmeldelser fra:
i)
operatører til oprindelsesmedlemsstatens kompetente myndighed af flytninger af akvatiske dyr i henhold til artikel 219
ii)
oprindelsesmedlemsstatens kompetente myndighed til bestemmelsesmedlemsstaten af flytninger af akvatiske dyr i henhold til artikel 220, stk. 1
b)
frister for:
i)
de nødvendige oplysninger omhandlet i artikel 219, stk. 2, som operatører skal give oprindelsesmedlemsstatens kompetente myndighed
ii)
oprindelsesmedlemsstatens kompetente myndigheds anmeldelse af flytninger i henhold til artikel 220, stk. 1.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
KAPITEL 3
Produktion, forarbejdning og distribution af animalske produkter af akvatiske dyr, bortset fra levende akvatiske dyr, i Unionen
Artikel 222
Almindelige dyresundhedsmæssige forpligtelser for operatører samt delegerede retsakter
1.   Operatører skal træffe passende forebyggende foranstaltninger for på alle stadier af produktion, forarbejdning og distribution af animalske produkter af akvatiske dyr, bortset fra levende akvatiske dyr, at sikre, at de pågældende produkter ikke er årsag til spredning af:
a)
listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), under hensyntagen til sundhedsstatussen på produktions-, forarbejdnings- og bestemmelsesstedet
b)
nye sygdomme.
2.   Operatører skal sikre, at animalske produkter af akvatiske dyr, bortset fra levende akvatiske dyr, ikke kommer fra virksomheder eller fødevarevirksomheder eller hidrører fra dyr, der kommer fra sådanne virksomheder eller fødevarevirksomheder, som er omfattet af:
a)
hasteforanstaltninger som omhandlet i artikel 257 og 258 samt eventuelle regler vedtaget i henhold til artikel 259, medmindre der gælder undtagelser fra disse regler i medfør af del VII (artikel 257-262)
b)
flytningsrestriktioner for de pågældende akvatiske dyr og animalske produkter deraf, jf. artikel 32, stk. 1, litra c), artikel 55, stk. 1, litra e), artikel 56, artikel 61, stk. 1, litra a), artikel 62, stk. 1, artikel 65, stk. 1, litra c), artikel 70, stk. 1, litra b), artikel 74, stk. 1, litra a), artikel 76, stk. 2, litra b), artikel 76, stk. 3, artikel 79, artikel 81, artikel 82, stk. 2 og 3, samt regler vedtaget i henhold til artikel 55, stk. 2, artikel 63, artikel 67 og artikel 70, stk. 3, artikel 71, stk. 3, artikel 74, stk. 4, artikel 76, stk. 5, og artikel 83, stk. 2, medmindre der gælder undtagelser fra disse flytningsrestriktioner i medfør af disse regler.
3.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende nærmere krav, der supplerer kravene i nærværende artikels stk. 2, til flytning af animalske produkter af akvatiske dyr, bortset fra levende akvatiske dyr, for så vidt angår:
a)
de pågældende sygdomme og arter af akvatiske dyr, der er berørt af de sygdomme, for hvilke hasteforanstaltninger eller flytningsrestriktioner som omhandlet i nærværende artikels stk. 2 finder anvendelse
b)
typerne af animalske produkter af akvatiske dyr
c)
de risikobegrænsende foranstaltninger, der anvendes for animalske produkter af akvatiske dyr på oprindelses- og bestemmelsesstedet
d)
den påtænkte anvendelse af animalske produkter af akvatiske dyr
e)
bestemmelsesstedet for animalske produkter af akvatiske dyr.
4.   Denne artikel finder ikke anvendelse på animalske produkter af vildtlevende akvatiske dyr, der høstes eller fanges til direkte konsum.
Artikel 223
Dyresundhedscertifikater og delegerede retsakter
1.   Operatører må kun flytte følgende animalske produkter af akvatiske dyr, bortset fra levende akvatiske dyr, hvis disse produkter ledsages af et dyresundhedscertifikat udstedt af den kompetente myndighed i oprindelsesmedlemsstaten i henhold til stk. 3:
a)
animalske produkter af akvatiske dyr, som:
i)
det er tilladt at føre ud af en restriktionszone, der er omfattet af hasteforanstaltninger i medfør af regler vedtaget i henhold til artikel 259, og
ii)
hidrører fra akvatiske dyr af arter, der er omfattet af de pågældende hasteforanstaltninger
b)
animalske produkter af akvatiske dyr, som:
i)
det er tilladt at føre ud af en restriktionszone, der er omfattet af sygdomsbekæmpelsesforanstaltninger i overensstemmelse med artikel 32, stk. 1, litra c), artikel 55, stk. 1, litra c), artikel 56, artikel 61, stk. 1, litra a), artikel 62, stk. 1, artikel 63, stk. 1, artikel 65, stk. 1, litra c), artikel 70, stk. 1, litra b), artikel 74, stk. 1, litra a), og artikel 79 samt regler vedtaget i henhold til artikel 55, stk. 2, artikel 63, artikel 67, artikel 71, stk. 3, artikel 74, stk. 4, og artikel 83, stk. 2, og
ii)
hidrører fra akvatiske dyr af arter, der er omfattet af de pågældende sygdomsbekæmpelsesforanstaltninger.
2.   Uanset stk. 1 kræves dette certifikat ikke for flytninger af animalske produkter af vildtlevende akvatiske dyr, forudsat at:
a)
der er indført alternative risikobegrænsende foranstaltninger, som er godkendt af den kompetente myndighed, for at sikre, at flytningerne ikke udgør en risiko for spredning af listeopførte sygdomme
b)
sendinger af sådanne produkter kan spores.
3.   Operatører skal træffe alle fornødne foranstaltninger til at sikre, at det i stk. 1 omhandlede dyresundhedscertifikat ledsager de animalske produkter fra deres oprindelsessted til deres bestemmelsessted.
4.   Den kompetente myndighed udsteder efter anmodning fra en given operatør et dyresundhedscertifikat til flytning af animalske produkter, bortset fra levende akvatiske dyr, som omhandlet i stk. 1, forudsat at de relevante krav i denne artikel er opfyldt.
5.   Artikel 212 og artikel 214-217 samt regler vedtaget i henhold til artikel 213 og artikel 216, stk. 4, finder anvendelse på dyresundhedscertificering af flytninger af animalske produkter, bortset fra levende akvatiske dyr, som omhandlet i nærværende artikels stk. 1.
6.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende krav til og nærmere regler om det dyresundhedscertifikat, der skal ledsage animalske produkter, bortset fra levende akvatiske dyr, som omhandlet i nærværende artikels stk. 1 under hensyntagen til:
a)
typerne af de pågældende animalske produkter
b)
de risikobegrænsende foranstaltninger, der anvendes for de pågældende produkter, og som reducerer risikoen for spredning af sygdomme
c)
den påtænkte anvendelse af disse produkter
d)
disse produkters bestemmelsessted.
Artikel 224
Dyresundhedscertifikaters indhold samt delegerede retsakter og gennemførelsesretsakter
1.   Dyresundhedscertifikatet for animalske produkter af akvatiske dyr, bortset fra levende akvatiske dyr, skal mindst indeholde følgende oplysninger:
a)
oprindelsesvirksomheden eller -stedet og bestemmelsesvirksomheden eller -stedet
b)
en beskrivelse af de pågældende animalske produkter
c)
mængden (antal, volumen eller vægt) af animalske produkter
d)
identifikation af de animalske produkter, hvis det kræves i henhold til artikel 65, stk. 1, litra h), eller eventuelle regler vedtaget i henhold til artikel 67
e)
de oplysninger, der er nødvendige for at godtgøre, at de pågældende produkter opfylder kravene vedrørende flytningsrestriktioner i artikel 222, stk. 2, og eventuelle regler vedtaget i henhold til artikel 222, stk. 3.
2.   Dyresundhedscertifikatet omhandlet i stk. 1, kan indeholde andre oplysninger, der kræves i henhold til anden EU-lovgivning.
3.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende ændring og supplering af de oplysninger, som dyresundhedscertifikatet skal indeholde, jf. stk. 1.
4.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler vedrørende standarddyresundhedscertifikater som omhandlet i nærværende artikels stk. 1.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 225
Anmeldelse af flytninger af animalske produkter til andre medlemsstater
1.   Operatører skal:
a)
underrette den kompetente myndighed i oprindelsesmedlemsstaten forud for påtænkte flytninger af animalske produkter af akvatiske dyr, bortset fra levende akvatiske dyr, hvis de pågældende sendinger skal ledsages af et dyresundhedscertifikat i henhold til artikel 223, stk. 1
b)
give alle de oplysninger, der er nødvendige, for at oprindelsesmedlemsstatens kompetente myndighed kan anmelde den pågældende flytning til bestemmelsesmedlemsstaten i henhold til nærværende artikels stk. 2.
2.   Oprindelsesmedlemsstatens kompetente myndighed anmelder flytninger af animalske produkter af akvatiske dyr, bortset fra levende akvatiske dyr, til bestemmelsesmedlemsstatens kompetente myndighed, jf. artikel 220, stk. 1.
3.   Artikel 219 og 220 samt eventuelle regler vedtaget i henhold til artikel 221 finder anvendelse på anmeldelse af animalske produkter af akvatiske dyr, bortset fra levende akvatiske dyr.
KAPITEL 4
Nationale foranstaltninger
Artikel 226
Nationale foranstaltninger til begrænsning af virkningerne af sygdomme, der ikke er listeopførte sygdomme
1.   Hvis en sygdom, der ikke er en listeopført sygdom omhandlet i artikel 9, stk. 1, litra d), udgør en væsentlig risiko for akvatiske dyrs sundhed i en medlemsstat, kan den berørte medlemsstat træffe nationale foranstaltninger til at forhindre introduktion eller bekæmpe spredning af den pågældende sygdom.
Medlemsstaterne sikrer, at sådanne nationale foranstaltninger ikke går videre, end hvad der er hensigtsmæssigt og nødvendigt for at forhindre introduktion eller bekæmpe spredning af sygdommen i den pågældende medlemsstat.
2.   Medlemsstaterne underretter på forhånd Kommissionen om eventuelle påtænkte nationale foranstaltninger som omhandlet i stk. 1, der kan påvirke flytninger af akvatiske dyr eller animalske produkter af akvatiske dyr mellem medlemsstaterne.
3.   Kommissionen godkender og, hvis det er nødvendigt, ændrer nationale foranstaltninger som omhandlet i nærværende artikels stk. 2 ved hjælp af gennemførelsesretsakter. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
4.   Den i stk. 3 omhandlede godkendelse gives kun, hvis det er nødvendigt at indføre restriktioner for flytning mellem medlemsstater for at forhindre introduktion af eller bekæmpe spredning af sygdommen omhandlet i stk. 1, under hensyntagen til den samlede indvirkning på Unionen af den pågældende sygdom og af de trufne foranstaltninger.
AFSNIT III
DYR AF ARTER, DER IKKE ER DEFINERET SOM LANDDYR ELLER AKVATISKE DYR, SAMT AVLSMATERIALE OG ANIMALSKE PRODUKTER AF SÅDANNE ANDRE DYR
Artikel 227
Dyresundhedsmæssige krav vedrørende andre dyr samt avlsmateriale og animalske produkter af sådanne andre dyr
Hvis andre dyr er af listeopførte arter for en listeopført sygdom omhandlet i artikel 9, stk. 1, litra d), og de pågældende andre dyr eller avlsmateriale eller animalske produkter deraf udgør en risiko for folke- eller dyresundheden i Unionen, gælder et eller flere af følgende krav:
a)
kravene vedrørende registrering, godkendelse, føring af fortegnelser og registre for virksomheder og transportører, jf. afsnit I, kapitel 1, afdeling 1-3 (artikel 84-101), og afsnit II, kapitel 1, afdeling 1 (artikel 172-175)
b)
kravene vedrørende sporbarhed i artikel 108-111 og artikel 117 for andre dyr og artikel 122 for avlsmateriale
c)
krav vedrørende flytning
i)
for andre dyr, som primært lever i terrestriske miljøer eller normalt rammes af sygdomme hos landdyr, under hensyntagen til kriterierne i artikel 228, stk. 3, litra d) og e), og kravene i del IV, afsnit I, kapitel 3, afdeling 1 (artikel 124 og 125) og 6 (artikel 137-142), og del IV, afsnit I, kapitel 4 (artikel 155 og 156)
ii)
for andre dyr, som primært lever i akvatiske miljøer eller normalt rammes af sygdomme hos akvatiske dyr, under hensyntagen til kriterierne i artikel 228, stk. 3, litra d) og e), og kravene i del IV, afsnit II, kapitel 2, afdeling 1-4 (artikel 191-207)
iii)
for avlsmateriale de almindelige krav vedrørende flytning i artikel 157 og 158 samt de særlige krav vedrørende flytning til andre medlemsstater i artikel 164 og 165
iv)
for animalske produkter de almindelige dyresundhedsmæssige forpligtelser for operatører vedrørende produktion, forarbejdning og distribution af animalske produkter i Unionen i artikel 166 og 222
d)
forpligtelser for operatører og kompetente myndigheder vedrørende dyresundhedscertificering og for operatører vedrørende personlig erklæring:
i)
reglerne i artikel 143-151 eller artikel 208-218 for så vidt angår andre dyr
ii)
reglerne i artikel 161 og 162 for så vidt angår avlsmateriale
iii)
reglerne i artikel 165 og 168 eller artikel 223 og 224 for så vidt angår animalske produkter
e)
operatørers og kompetente myndigheders forpligtelse til at anmelde flytninger under hensyntagen til kravene i artikel 152, 153, 154, 163 og 169 samt artikel 219-221 og 225.
Artikel 228
Delegation af beføjelser og gennemførelsesretsakter vedrørende dyresundhedsmæssige krav for andre dyr samt avlsmateriale og animalske produkter af andre dyr
1.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende eventuelle særlige krav for andre dyr og avlsmateriale eller animalske produkter deraf, som er nødvendige for at begrænse risikoen for de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme, jf. artikel 227.
2.   Kommissionen kan vedtage gennemførelsesretsakter vedrørende nærmere regler om gennemførelse af de i stk. 1 omhandlede sygdomsbekæmpelses- og -forebyggelsesforanstaltninger.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
3.   Kommissionen baserer de delegerede retsakter og gennemførelsesretsakter, der er omhandlet i stk. 1 og 2, på følgende kriterier:
a)
de pågældende arter eller kategorier af andre dyr er opført på den i artikel 8, stk. 2, omhandlede liste som listeopførte arter for så vidt angår en eller flere listeopførte sygdomme, for hvilke visse sygdomsforebyggelses- og -bekæmpelsesforanstaltninger i henhold til denne forordning finder anvendelse
b)
sygdomsprofilen for den pågældende listeopførte sygdom, som berører andre dyrearter og -kategorier som omhandlet i litra a)
c)
gennemførligheden, tilgængeligheden og effektiviteten af sygdomsforebyggelses- og -bekæmpelsesforanstaltninger for de listeopførte arter, der er omfattet af disse foranstaltninger
d)
det terrestriske eller akvatiske miljø, som de pågældende andre dyr normalt lever i
e)
hvilke typer sygdomme sådanne andre dyr rammes af, som kan være enten sygdomme, der normalt angriber landdyr eller akvatiske dyr, uanset hvilket miljø dyrene normalt lever i, jf. litra d).
DEL V
INDFØRSEL TIL UNIONEN OG EKSPORT
KAPITEL 1
Indførsel af dyr, avlsmateriale og animalske produkter fra tredjelande og territorier til Unionen
Afdeling 1
Krav vedrørende indførsel til Unionen
Artikel 229
Krav vedrørende indførsel af dyr, avlsmateriale og animalske produkter til Unionen
1.   Medlemsstaterne tillader kun indførsel af sendinger af dyr, avlsmateriale og animalske produkter til Unionen fra tredjelande eller territorier, hvis disse sendinger opfylder følgende krav, medmindre dyrene, avlsmaterialet eller de animalske produkter er omfattet af en undtagelse indrømmet i henhold til artikel 239, stk. 2:
a)
De kommer fra et tredjeland eller territorium, der er opført på en liste i henhold til artikel 230, stk. 1, for den pågældende dyreart og -kategori eller det pågældende avlsmateriale eller de pågældende animalske produkter, eller en zone eller et kompartment deri, jf. dog artikel 230, stk. 2.
b)
De kommer fra virksomheder, der er godkendt og listeopført, hvis sådan godkendelse og listeopførelse kræves i medfør af artikel 233.
c)
De opfylder de dyresundhedsmæssige krav til indførsel til Unionen i artikel 234, stk. 1, og eventuelle delegerede retsakter vedtaget i henhold til artikel 234, stk. 2, hvis der er fastsat sådanne krav for de(t) pågældende dyr, avlsmateriale eller animalske produkter i sendingen.
d)
De ledsages af et dyresundhedscertifikat, erklæringer og andre dokumenter, hvis dette kræves i medfør af artikel 237, stk. 1, eller regler vedtaget i henhold til artikel 237, stk. 4.
2.   De operatører, der er ansvarlige for den pågældende sending, skal fremvise sendinger af dyr, avlsmateriale og animalske produkter fra tredjelande eller territorier til offentlig kontrol, jf. artikel 3 i direktiv 91/496/EØF og artikel 3 i direktiv 97/78/EF.
Afdeling 2
Listeopførelse af tredjelande og territorier
Artikel 230
Lister over tredjelande og territorier, hvorfra indførsel af dyr, avlsmateriale og animalske produkter til Unionen er tilladt, samt gennemførelsesretsakter og delegerede retsakter
1.   Kommissionen kan i gennemførelsesretsakter opstille lister over tredjelande og territorier, hvorfra det er tilladt at indføre bestemte arter og kategorier af dyr, avlsmateriale og animalske produkter til Unionen, ud fra følgende kriterier:
a)
dyresundhedslovgivningen i det pågældende tredjeland eller territorium og reglerne om indførsel af dyr, avlsmateriale og animalske produkter til det pågældende tredjeland eller territorium fra andre tredjelande og territorier
b)
forsikringerne fra det pågældende tredjelands eller territoriums kompetente myndighed med hensyn til effektiv gennemførelse og kontrol af den i litra a) omhandlede dyresundhedslovgivning
c)
det pågældende tredjelands eller territoriums kompetente myndigheds organisation, struktur, ressourcer og retlige beføjelser
d)
procedurerne for dyresundhedscertificering i det pågældende tredjeland eller territorium
e)
dyresundhedsstatussen for det pågældende tredjeland eller territorium eller zoner og kompartmenter deri for så vidt angår:
i)
listeopførte sygdomme og nye sygdomme
ii)
ethvert aspekt af dyre- og folkesundheden eller miljøsituationen i det pågældende tredjeland eller territorium eller zonen eller kompartmentet deri, som kan udgøre en risiko for Unionens dyresundheds-, folkesundheds- eller miljøstatus
f)
de garantier, som det pågældende tredjelands eller territoriums kompetente myndighed kan give med hensyn til opfyldelse af eller ækvivalens med de relevante dyresundhedsmæssige krav i Unionen
g)
den regelmæssighed og hurtighed, hvormed det pågældende tredjeland eller territorium meddeler oplysninger om infektiøse eller kontagiøse dyresygdomme på sit område til Verdensorganisationen for Dyresundhed (OIE), navnlig oplysninger om de sygdomme, der er opført i OIE-kodekserne
h)
resultaterne af Kommissionens kontrol i det pågældende tredjeland eller på det pågældende territorium
i)
eventuelle erfaringer fra tidligere indførsler af dyr, avlsmateriale og animalske produkter fra det pågældende tredjeland eller territorium og resultaterne af offentlig kontrol af sådanne dyr, sådant avlsmateriale og sådanne animalske produkter på EU-indførselsstedet.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
2.   Indtil de i stk. 1 omhandlede lister er vedtaget, og forudsat at der ikke er opstillet sådanne lister i henhold til den i artikel 270, stk. 2, omhandlede EU-lovgivning, beslutter medlemsstaterne, fra hvilke tredjelande og territorier bestemte arter og kategorier af dyr, avlsmateriale eller animalske produkter må indføres til Unionen.
Med henblik på nærværende stykkes første afsnit tager medlemsstaterne hensyn til kriterierne for optagelse på listerne over tredjelande og territorier i nærværende artikels stk. 1, litra a)-i).
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende undtagelser fra nærværende stykkes stk. 2, der begrænser medlemsstaternes mulighed for at beslutte, fra hvilke tredjelande og territorier en bestemt art og kategori af dyr, avlsmateriale eller animalske produkter må indføres til Unionen, når det er nødvendigt på grund af den risiko, som den pågældende art og kategori af dyr, avlsmateriale eller animalske produkter udgør.
Artikel 231
Oplysninger, der skal indgå i listerne over tredjelande og territorier
Kommissionen specificerer følgende for hvert tredjeland eller territorium på de i artikel 230, stk. 1, omhandlede lister:
a)
arter og kategorier af dyr, avlsmateriale eller animalske produkter, der må indføres til Unionen fra det pågældende tredjeland eller territorium
b)
hvorvidt de(t) i henhold til litra a) angivne dyr, avlsmateriale eller animalske produkter må indføres til Unionen fra hele det pågældende tredjeland eller territorium eller kun fra en eller flere zoner eller et eller flere kompartmenter deri
c)
særlige betingelser og dyresundhedsmæssige garantier vedrørende listeopførte sygdomme.
Artikel 232
Suspension og fjernelse fra listerne over tredjelande og territorier samt gennemførelsesretsakter
1.   Kommissionen fjerner et tredjeland eller territorium fra de i artikel 230, stk. 1, omhandlede lister eller suspenderer indførsel til Unionen af dyr, avlsmateriale eller animalske produkter fra et tredjeland eller territorium eller fra en zone eller et kompartment deri ved hjælp af gennemførelsesretsakter af en eller flere af følgende årsager:
a)
Det pågældende tredjeland eller territorium eller en eller flere zoner eller et eller flere kompartmenter deri opfylder ikke længere kriterierne i artikel 230, stk. 1, hvis det er relevant for indførsel af en bestemt art og kategori af dyr, avlsmateriale eller animalske produkter til Unionen.
b)
Dyresundhedssituationen i det pågældende tredjeland eller territorium eller zonen eller kompartmentet deri er sådan, at suspension eller fjernelse fra listen er nødvendig for at beskytte Unionens dyresundhedsstatus.
c)
Det pågældende tredjeland eller territorium har ikke efterkommet en anmodning fra Kommissionen om ajourførte oplysninger om dyresundhedssituationen og andre forhold som omhandlet i artikel 230, stk. 1.
d)
Det pågældende tredjeland eller territorium har nægtet at acceptere, at Kommissionen foretager kontrol på dets område på vegne af Unionen.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
2.   I behørigt begrundede særligt hastende tilfælde vedrørende en alvorlig risiko for introduktion af en listeopført sygdom omhandlet i artikel 9, stk. 1, litra d), til Unionen vedtager Kommissionen efter proceduren i artikel 266, stk. 3, gennemførelsesretsakter, der straks finder anvendelse.
3.   Kommissionen kan ved hjælp af gennemførelsesretsakter genopføre et tredjeland eller territorium eller en zone eller et kompartment deri, som er blevet fjernet fra de i artikel 230, stk. 1, omhandlede lister, på listerne eller igen tillade indførsel til Unionen af dyr, avlsmateriale eller animalske produkter fra et tredjeland eller territorium eller en zone eller et kompartment deri, hvorfra indførsel til Unionen er suspenderet, af en af følgende årsager:
a)
de i nærværende artikels stk. 1, litra a) eller c), nævnte årsager, forudsat at det pågældende tredjeland eller territorium godtgør, at det opfylder kriterierne for at være opført på listen i artikel 230, stk. 1
b)
de i nærværende artikels stk. 1, litra b), nævnte årsager, forudsat at det pågældende tredjeland eller territorium giver passende garantier for, at de dyresundhedsmæssige forhold, der var årsag til, at det blev suspenderet eller fjernet fra listen, er afhjulpet eller ikke længere udgør en trussel mod dyre- eller folkesundheden i Unionen
c)
de i nærværende artikels stk. 1, litra d), nævnte årsager, forudsat at:
i)
det pågældende tredjeland eller territorium indvilligede i, at Kommissionen foretog kontrol på dets område på vegne af Unionen, og
ii)
resultaterne af Kommissionens kontrol viser, at det pågældende tredjeland eller territorium og zonerne eller kompartmenterne deri opfylder kriterierne for at være opført på listen i artikel 230, stk. 1.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Afdeling 3
Godkendelse og listeopførelse af virksomheder i tredjelande og territorier
Artikel 233
Godkendelse og listeopførelse af virksomheder
1.   Medlemsstaterne tillader kun indførsel af landdyr og avlsmateriale deraf til Unionen fra en type virksomhed, som der skal søges om godkendelse af i Unionen i henhold til artikel 94, stk. 2, og regler vedtaget i henhold til artikel 94, stk. 3, og artikel 95, hvis den pågældende virksomhed i det pågældende tredjeland eller territorium:
a)
opfylder dyresundhedsmæssige krav i det pågældende tredjeland eller territorium, der er ækvivalente med de regler, der gælder i Unionen for den pågældende type virksomhed
b)
er godkendt og listeopført af afsendelsestredjelandets eller afsendelsesterritoriets kompetente myndighed, medmindre alternative risikobegrænsende foranstaltninger i det pågældende tredjeland eller territorium giver ækvivalente garantier for dyresundheden i Unionen.
2.   Kommissionen samler de lister over godkendte virksomheder som omhandlet i stk. 1, litra b), som den modtager fra de kompetente myndigheder i de pågældende tredjelande eller territorier.
3.   Kommissionen formidler alle nye eller ajourførte lister over godkendte virksomheder, som den har modtaget fra de pågældende tredjelande eller territorier, til medlemsstaterne og offentliggør dem.
4.   Kommissionen vedtager ved hjælp af gennemførelsesretsakter regler, der er nødvendige for at sikre ensartet anvendelse af stk. 1, litra b).
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Afdeling 4
Indførsel af arter og kategorier af dyr, avlsmateriale og animalske produkter til Unionen
Artikel 234
Dyresundhedsmæssige krav til indførsel af arter og kategorier af dyr, avlsmateriale og animalske produkter til Unionen
1.   De dyresundhedsmæssige krav til indførsel af arter og kategorier af dyr, avlsmateriale og animalske produkter til Unionen fra tredjelande eller territorier skal:
a)
være lige så strenge som de dyresundhedsmæssige krav i denne forordning og regler vedtaget i henhold hertil, der gælder for flytning af de pågældende arter og kategorier af dyr, avlsmateriale eller animalske produkter i Unionen, eller
b)
give garantier, som er ækvivalente med de dyresundhedsmæssige krav, der gælder for de pågældende arter og kategorier af dyr, avlsmateriale eller animalske produkter, jf. denne forordnings del IV (artikel 84-228).
2.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende dyresundhedsmæssige krav til:
a)
indførsel af arter og kategorier af dyr, avlsmateriale og animalske produkter til Unionen fra tredjelande eller territorier
b)
flytning i Unionen og håndtering af de(t) pågældende dyr, avlsmateriale og animalske produkter efter indførsel til Unionen, hvis det er nødvendigt for at begrænse den dermed forbundne risiko.
3.   Indtil der er vedtaget delegerede retsakter vedrørende fastsættelse af dyresundhedsmæssige krav for en bestemt art og kategori af dyr, avlsmateriale eller animalske produkter, jf. denne artikels stk. 1, kan medlemsstaterne efter en risikovurdering anvende nationale regler, forudsat at disse regler opfylder kravene i nævnte stykke og tager hensyn til de i artikel 235 og 236 omhandlede forhold.
Artikel 235
Forhold, der skal tages hensyn til i delegerede retsakter som omhandlet i artikel 234 for så vidt angår indførsel af dyr til Unionen
Kommissionen tager hensyn til følgende, når den fastsætter dyresundhedsmæssige krav til indførsel af bestemte arter og kategorier af dyr til Unionen i delegerede retsakter som omhandlet i artikel 234, stk. 2:
a)
de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme samt nye sygdomme
b)
Unionens sundhedsstatus for så vidt angår de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme samt nye sygdomme
c)
de for de pågældende listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), samt nye sygdomme listeopførte arter
d)
de pågældende dyrs alder og køn
e)
de pågældende dyrs oprindelse
f)
den pågældende virksomheds- og produktionstype på oprindelses- og bestemmelsesstedet
g)
det planlagte bestemmelsessted
h)
den påtænkte anvendelse af de pågældende dyr
i)
eventuelle risikobegrænsende foranstaltninger, der anvendes i oprindelses- eller transittredjelandene eller oprindelses- eller transitterritorierne eller efter ankomsten af de pågældende dyr til Unionens område
j)
dyresundhedsmæssige krav vedrørende flytning af de pågældende dyr i Unionen
k)
andre epidemiologiske faktorer
l)
internationale dyresundhedshandelsstandarder, som er relevante for de pågældende arter og kategorier af dyr.
Artikel 236
Forhold, der skal tages hensyn til i delegerede retsakter som omhandlet i artikel 234 for så vidt angår indførsel af avlsmateriale og animalske produkter til Unionen
Kommissionen tager hensyn til følgende, når den fastsætter dyresundhedsmæssige krav til indførsel af avlsmateriale og animalske produkter til Unionen i delegerede retsakter som omhandlet i artikel 234, stk. 2:
a)
de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme samt nye sygdomme
b)
sundhedsstatussen for de dyr, som avlsmaterialet eller de animalske produkter hidrører fra, og for Unionen for så vidt angår de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme samt nye sygdomme
c)
bestemt(e) avlsmateriales eller animalske produkters type og art, behandlinger, forarbejdningsmetoder og andre risikobegrænsende foranstaltninger, der er anvendt på oprindelsesstedet, stedet for afsendelse af sendingen eller bestemmelsesstedet
d)
virksomheds- og produktionstypen på oprindelses- og bestemmelsesstedet
e)
det planlagte bestemmelsessted
f)
den påtænkte anvendelse af de(t) pågældende avlsmateriale eller animalske produkter
g)
dyresundhedsmæssige krav vedrørende flytning af de(t) pågældende avlsmateriale og animalske produkter inden for Unionen
h)
andre epidemiologiske faktorer
i)
internationale dyresundhedshandelsstandarder, som er relevante for de(t) pågældende avlsmateriale og animalske produkter.
Afdeling 5
Dyresundhedscertifikater, erklæringer og andre dokumenter
Artikel 237
Dyresundhedscertifikater, erklæringer og andre dokumenter ved indførsel til Unionen
1.   Medlemsstaterne tillader kun indførsel af sendinger af dyr, avlsmateriale og animalske produkter til Unionen, hvis sådanne sendinger ledsages af følgende:
a)
et dyresundhedscertifikat udstedt af oprindelsestredjelandets eller oprindelsesterritoriets kompetente myndighed, medmindre der gælder en undtagelse i medfør af stk. 4, litra a), og/eller
b)
erklæringer eller andre dokumenter, hvis det kræves i medfør af regler vedtaget i henhold til stk. 4, litra b).
2.   Medlemsstaterne tillader ikke indførsel af sendinger af dyr, avlsmateriale eller animalske produkter til Unionen, medmindre det i stk. 1, litra a), omhandlede dyresundhedscertifikat er blevet kontrolleret og underskrevet af en embedsdyrlæge i et tredjeland eller territorium i overensstemmelse med certificeringskrav, der er ækvivalente med kravene i artikel 149, stk. 3, eller artikel 216, stk. 3, og eventuelle regler vedtaget i henhold til artikel 149, stk. 4, eller artikel 216, stk. 4.
3.   Medlemsstaterne tillader, at elektroniske dyresundhedscertifikater, som udfærdiges, håndteres og overføres ved hjælp af Traces, erstatter ledsagende dyresundhedscertifikater som omhandlet i stk. 1, hvis de pågældende elektroniske dyresundhedscertifikater:
a)
indeholder alle de oplysninger, som det i stk. 1, litra a), omhandlede dyresundhedscertifikat skal indeholde i medfør af artikel 238, stk. 1, og eventuelle regler vedtaget i henhold til artikel 238, stk. 3
b)
sikrer sporbarhed for sendingerne af de(t) pågældende dyr, avlsmateriale og animalske produkter og forbinder disse sendinger med det elektroniske dyresundhedscertifikat.
4.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
undtagelser fra kravene vedrørende dyresundhedscertifikat i nærværende artikels stk. 1, litra a), og stk. 2 for sendinger af dyr, avlsmateriale og animalske produkter og særlige regler vedrørende dyresundhedscertificering for sådanne sendinger, hvis de pågældende sendinger på grund af en eller flere af følgende faktorer udgør en ubetydelig risiko for dyre- og folkesundheden i Unionen:
i)
arterne og kategorierne af de(t) pågældende dyr, avlsmateriale eller animalske produkter
ii)
de for de(t) pågældende dyr, avlsmateriale og animalske produkter anvendte opdræts- eller opbevaringsmetoder og produktionstyper
iii)
den påtænkte anvendelse
iv)
alternative risikobegrænsende foranstaltninger, der anvendes i oprindelses- eller transittredjelandene eller oprindelses- eller transitterritorierne eller efter deres ankomst til Unionens område, og som giver en beskyttelse af dyre- og folkesundheden i Unionen, der er ækvivalent med den, der er fastsat i denne forordning
v)
garantier fra det pågældende tredjeland eller territorium for, at opfyldelse af kravene vedrørende indførsel til Unionen godtgøres ved andre midler end et dyresundhedscertifikat
b)
reglerne om, at sendinger af dyr, avlsmateriale og animalske produkter, der kommer ind i Unionen, skal ledsages af erklæringer eller andre dokumenter, som er nødvendige for at godtgøre, at de(t) pågældende dyr, avlsmateriale og animalske produkter opfylder de dyresundhedsmæssige krav vedrørende indførsel til Unionen i medfør af regler vedtaget i henhold til artikel 234, stk. 2.
Artikel 238
Dyresundhedscertifikaters indhold
1.   Det i artikel 237, stk. 1, litra a), omhandlede dyresundhedscertifikat skal mindst indeholde følgende oplysninger:
a)
navn og adresse på:
i)
oprindelsesvirksomheden eller -stedet
ii)
bestemmelsesvirksomheden eller -stedet
iii)
eventuelt virksomheder, hvor de pågældende opdrættede dyr har været genstand for sammenbringning eller har hvilet
b)
en beskrivelse af de(t) pågældende dyr, avlsmateriale eller animalske produkter
c)
antallet eller mængden af de(t) pågældende dyr, avlsmateriale eller animalske produkter
d)
eventuelt identifikation og registrering af de(t) pågældende dyr, avlsmateriale eller animalske produkter
e)
de oplysninger, der er nødvendige for at godtgøre, at de(t) pågældende dyr, avlsmateriale og animalske produkter opfylder de dyresundhedsmæssige krav vedrørende indførsel til Unionen i artikel 229 og artikel 234, stk. 1, samt regler vedtaget i henhold til artikel 234, stk. 2, og artikel 239.
2.   Det i artikel 237, stk. 1, litra a), omhandlede dyresundhedscertifikat kan indeholde andre oplysninger, som kræves i henhold til anden EU-lovgivning.
3.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler vedrørende:
a)
oplysninger, som det i artikel 237, stk. 1, litra a), omhandlede dyresundhedscertifikat skal indeholde, ud over de i nærværende artikels stk. 1 omhandlede oplysninger
b)
oplysninger, som erklæringer eller andre dokumenter skal indeholde, jf. artikel 237, stk. 1, litra b)
c)
standardmodeller til de i artikel 237, stk. 1, omhandlede dyresundhedscertifikater, erklæringer og andre dokumenter.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
4.   Indtil der er fastsat regler i gennemførelsesretsakter vedtaget i henhold til stk. 3 for så vidt angår en bestemt art og kategori af dyr, avlsmateriale eller animalske produkter, kan medlemsstaterne efter en risikovurdering anvende nationale regler, forudsat at disse nationale regler opfylder betingelserne i stk. 1.
Afdeling 6
Undtagelser og supplerende krav vedrørende visse kategorier af dyr, avlsmateriale og animalske produkter
Artikel 239
Undtagelser og supplerende krav vedrørende visse kategorier af dyr, avlsmateriale og animalske produkter
1.   For visse bestemte former for indførsel af dyr, avlsmateriale og animalske produkter kan anvendelse af reglerne i artikel 229, stk. 1, og artikel 233 og 237 være utilstrækkeligt, og det kan være nødvendigt, at Kommissionen ved hjælp af delegerede retsakter vedtager særlige regler, som tager hensyn til de særlige risici, det endelige bestemmelsessted, typen af den endelige anvendelse og andre omstændigheder.
2.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 264 vedrørende de særlige regler i nærværende artikels stk. 1 om undtagelser fra de krav, som er fastsat i artikel 229, stk. 1, og artikel 233 og 237 og som pålægger supplerende krav vedrørende indførsel til Unionen af følgende:
a)
dyr:
i)
bestemt til cirkusser, arrangementer, udstillinger, fremvisning, opvisninger og afgrænsede virksomheder
ii)
der skal anvendes til videnskabelige eller diagnostiske formål
iii)
for hvilke Unionen ikke er det endelige bestemmelsessted
iv)
som har oprindelse i Unionen, og som flyttes til et tredjeland eller territorium og efterfølgende flyttes tilbage til Unionen fra det pågældende tredjeland eller territorium
v)
som har oprindelse i Unionen, og som undervejs til en anden del af Unionen transporteres gennem et tredjeland eller territorium
vi)
som er bestemt til midlertidig græsning i nærheden af Unionens grænser
vii)
som udgør en ubetydelig risiko for dyresundhedsstatussen i Unionen
b)
animalske produkter:
i)
bestemt til personlig brug
ii)
til konsum af besætning og passagerer på transportmidler, der ankommer fra tredjelande eller territorier
c)
avlsmateriale og animalske produkter:
i)
bestemt til anvendelse som vareprøver
ii)
bestemt til anvendelse som prøver til forskning og diagnosticering
iii)
for hvilke Unionen ikke er det endelige bestemmelsessted
iv)
som har oprindelse i Unionen, og som flyttes til et tredjeland eller territorium og efterfølgende flyttes tilbage til Unionen fra det pågældende tredjeland eller territorium
v)
som har oprindelse i Unionen, og som undervejs til en anden del af Unionen transporteres gennem et tredjeland eller territorium
vi)
som udgør en ubetydelig risiko for dyresundhedsstatussen i Unionen.
Disse delegerede retsakter skal tage hensyn til de i artikel 235 og 236 omhandlede forhold.
3.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler
a)
vedrørende standarddyresundhedscertifikater samt standardmodeller til erklæringer og andre dokumenter for de i nærværende artikels stk. 2 omhandlede kategorier af dyr, avlsmateriale og animalske produkter
b)
med angivelse af koder fra den kombinerede nomenklatur for de i nærværende artikels stk. 1 omhandlede produkter, hvis der ikke er fastsat sådanne koder i andre relevante EU-regler.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
KAPITEL 2
Indførsel af visse andre varer end dyr, avlsmateriale og animalske produkter til Unionen fra tredjelande og territorier
Artikel 240
Sygdomsfremkaldende agenser og delegerede retsakter
1.   Operatører, dyrlæger, fagpersoner med ekspertise i akvatiske dyrs sundhed og dyrefagpersoner, der bringer sygdomsfremkaldende agenser ind i Unionen, skal:
a)
træffe passende foranstaltninger for at sikre, at indførsel af disse sygdomsfremkaldende agenser til Unionen ikke udgør en risiko for dyre- eller folkesundheden i Unionen for så vidt angår de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme og nye sygdomme
b)
træffe passende sygdomsbekæmpelses- og -forebyggelsesforanstaltninger for at sikre, at indførsel af de pågældende sygdomsfremkaldende agenser til Unionen ikke er forbundet med en risiko for bioterrorisme.
Dette stykke finder også anvendelse på enhver anden fysisk eller juridisk person, der forsætligt bringer sådanne agenser ind i Unionen.
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 om krav vedrørende indførsel af sygdomsfremkaldende agenser til Unionen for så vidt angår:
a)
emballering af sygdomsfremkaldende agenser
b)
andre risikobegrænsende foranstaltninger, der er nødvendige for at forhindre udslip og spredning af sygdomsfremkaldende agenser.
Artikel 241
Plantemateriale samt delegerede retsakter og gennemførelsesretsakter
1.   Medlemsstaterne træffer foranstaltninger med henblik på at begrænse indførsel af sendinger af plantemateriale til Unionen i tilfælde af en ugunstig sygdomssituation i tredjelande eller territorier med hensyn til listeopførte sygdomme omhandlet i artikel 9, stk. 1, litra d), eller nye sygdomme, hvis dette kræves i henhold til reglerne vedtaget i overensstemmelse med nærværende artikels stk. 3.
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende de foranstaltninger, der er omhandlet i nærværende artikels stk. 1, med fastsættelse af:
a)
særlige dyresundhedsmæssige krav til indførsel af plantemateriale, med hvilket listeopførte eller nye sygdomme kan overføres, til Unionen
b)
krav vedrørende:
i)
dyresundhedscertificering under hensyntagen til artikel 237, stk. 1, litra a), og stk. 2 og 3, eller
ii)
erklæringer eller andre dokumenter under hensyntagen til artikel 237, stk. 1, litra b).
3.   Kommissionen fastsætter dyresundhedsmæssige krav som omhandlet i stk. 2 ud fra følgende kriterier:
a)
hvorvidt en listeopført eller ny sygdom, som kan overføres med plantemateriale, udgør en alvorlig risiko for dyre- eller folkesundheden i Unionen
b)
sandsynligheden for, at dyr af listeopførte arter for en bestemt listeopført eller ny sygdom vil komme i direkte eller indirekte kontakt med plantemateriale som omhandlet i stk. 2
c)
tilgængeligheden og effektiviteten af alternative risikobegrænsende foranstaltninger vedrørende det pågældende plantemateriale, som vil kunne eliminere eller minimere risikoen for overførsel som omhandlet i litra a).
4.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler med angivelse af koder fra den kombinerede nomenklatur for det i stk. 2 omhandlede plantemateriale, hvis sådanne ikke er fastsat i andre relevante EU-regler.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 242
Transportmidler, udstyr, emballagematerialer, transportvand og foder samt delegerede retsakter og gennemførelsesretsakter
1.   Operatører, der bringer dyr og produkter ind i Unionen, skal træffe relevante sygdomsforebyggende foranstaltninger, der er nødvendige i forbindelse med transport, jf. artikel 125, stk. 1, og artikel 192, stk. 1.
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
særlige dyresundhedsmæssige krav til indførsel til Unionen af:
i)
transportmidler til dyr og produkter
ii)
udstyr, emballagemateriale eller transportvand til dyr og produkter eller foder, der kan overføre dyresygdomme
b)
krav vedrørende:
i)
dyresundhedscertificering under hensyntagen til artikel 237, stk. 1, litra a), og stk. 2 og 3, eller
ii)
erklæringer eller andre dokumenter under hensyntagen til artikel 237, stk. 1, litra b).
3.   Kommissionen fastsætter dyresundhedsmæssige krav som omhandlet i nærværende artikels stk. 2 i tilfælde af en ugunstig sygdomssituation med hensyn til en eller flere af de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme eller nye sygdomme, som udgør en alvorlig risiko for dyre- og folkesundheden i Unionen, i:
a)
et tilgrænsende tredjeland eller territorium
b)
oprindelsestredjelandet eller oprindelsesterritoriet
c)
et transittredjeland eller transitterritorium.
4.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte regler med angivelse af koder fra den kombinerede nomenklatur for de i stk. 2, litra a), omhandlede varer, hvis sådanne koder ikke er fastsat i andre relevante EU-regler.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
KAPITEL 3
Eksport
Artikel 243
Eksport fra Unionen
1.   Medlemsstaterne træffer de fornødne foranstaltninger til at sikre, at eksport og reeksport af dyr og produkter fra Unionen til et tredjeland eller territorium foregår i overensstemmelse med reglerne i del IV (artikel 84-228) om flytning af dyr og produkter mellem medlemsstater, under hensyntagen til dyresundhedsstatussen i bestemmelsestredjelandet eller bestemmelsesterritoriet eller den relevante zone eller kompartment deri for så vidt angår de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme samt nye sygdomme.
2.   Uanset stk. 1 kan eksport og reeksport fra Unionen — efter anmodning fra den kompetente myndighed i et tredjeland eller territorium, der importerer de pågældende dyr og produkter, eller hvis der er hjemmel hertil i de retlige og administrative procedurer, der gælder i det pågældende tredjeland eller territorium — ske i overensstemmelse med de gældende bestemmelser i tredjelandet eller territoriet, forudsat at sådan eksport eller reeksport ikke bringer folke- eller dyresundheden i fare.
3.   Hvis bestemmelserne i en bilateral aftale indgået mellem Unionen og et tredjeland eller territorium finder anvendelse, skal de dyr og produkter, der eksporteres fra Unionen til det pågældende tredjeland eller territorium, overholde disse bestemmelser.
DEL VI
IKKEKOMMERCIELLE FLYTNINGER AF SELSKABSDYR TIL EN MEDLEMSSTAT FRA EN ANDEN MEDLEMSSTAT ELLER FRA ET TREDJELAND ELLER TERRITORIUM
KAPITEL 1
Almindelige bestemmelser
Artikel 244
Anvendelsesområde for del VI
1.   Denne del finder anvendelse på ikkekommerciel flytning af selskabsdyr til en medlemsstat fra en anden medlemsstat eller fra et tredjeland eller territorium.
2.   Den anvendes med forbehold af:
a)
Rådets forordning (EF) nr. 338/97 
(
63
)
b)
eventuelle nationale foranstaltninger, der er vedtaget, offentliggjort og gjort offentligt tilgængelige af medlemsstaterne for at begrænse flytning af visse arter eller racer af selskabsdyr på grundlag af andre hensyn end hensyn, der vedrører dyresundhed.
Artikel 245
Almindelige bestemmelser
1.   Ikkekommerciel flytning af selskabsdyr, der opfylder de dyresundhedsmæssige betingelser, som er fastsat i denne del, må ikke forbydes, begrænses eller hindres af andre dyresundhedsmæssige årsager end dem, der følger af anvendelsen af denne del.
2.   Hvis en ikkekommerciel flytning af et selskabsdyr foretages af en bemyndiget person, må den kun finde sted inden for fem dage efter selskabsdyrets ejers flytning.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 om krav, der supplerer reglerne i nærværende artikels stk. 2, vedrørende følgende:
a)
dokumentation for ikkekommerciel flytning af et selskabsdyr, der foretages af en bemyndiget person
b)
undtagelser fra den i nærværende artikels stk. 2 nævnte periode.
4.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte krav vedrørende udformning, sprog og gyldighed for den skriftlige erklæring om bemyndigelse af en person til at foretage ikkekommerciel flytning af et selskabsdyr på ejerens vegne. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
Artikel 246
Maksimalt antal selskabsdyr
1.   Det antal selskabsdyr af de arter, der er opført i bilag I, del A, som må flyttes i en enkelt ikkekommerciel flytning, må ikke overstige fem.
2.   Uanset stk. 1 må det antal selskabsdyr af de arter, der er opført i bilag I, del A, overstige fem, hvis følgende betingelser er opfyldt:
a)
Den pågældende ikkekommercielle flytning sker med henblik på deltagelse i en konkurrence, udstilling eller et sportsarrangement eller træning til sådant et arrangement.
b)
Selskabsdyrets ejer eller den pågældende bemyndigede person fremlægger skriftlig dokumentation for, at selskabsdyrene er registreret enten til at deltage i et arrangement som omhandlet i litra a) eller hos en forening, der afholder sådanne arrangementer.
c)
Selskabsdyrene er over seks måneder gamle.
3.   For at undgå, at kommerciel flytning af selskabsdyr af de arter, der er opført i bilag I, del B, finder svigagtigt sted under foregivende af, at der er tale om ikkekommerciel flytning, tillægges Kommissionen beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende regler om fastsættelse af det maksimale antal selskabsdyr af de pågældende arter, der må flyttes i en enkelt ikkekommerciel flytning.
KAPITEL 2
Betingelser for ikkekommerciel flytning af selskabsdyr til en medlemsstat fra en anden medlemsstat
Artikel 247
Betingelser for ikkekommerciel flytning af selskabsdyr af de arter, der er opført i bilag I, del A
Selskabsdyr af de arter, der er opført i bilag I, del A, må ikke flyttes til en medlemsstat fra en anden medlemsstat, medmindre:
a)
De er identificeret enkeltvis med et fysisk identifikationsmiddel i overensstemmelse med de regler, der er vedtaget i henhold til artikel 252, stk. 1, litra a).
b)
De opfylder de relevante forebyggende og risikobegrænsende foranstaltninger, der er vedtaget i henhold til artikel 252, stk. 1, litra b), for de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme.
c)
De ledsages af et identifikationsdokument, der er behørigt udfyldt og udstedt i overensstemmelse med de i artikel 254, litra d), vedtagne regler.
Artikel 248
Betingelser for ikkekommerciel flytning af selskabsdyr af de arter, der er opført i bilag I, del B
1.   For så vidt som Kommissionen har vedtaget en delegeret retsakt i medfør af artikel 252, stk. 1, litra b), med hensyn til selskabsdyr af en af de arter, der er opført i bilag I, del B, er ikkekommerciel flytning af selskabsdyr af denne art til en medlemsstat fra en anden medlemsstat underlagt betingelserne i nærværende artikels stk. 2.
2.   Selskabsdyr af de i stk. 1 omhandlede arter må kun flyttes til en medlemsstat fra en anden medlemsstat, hvis:
a)
De er identificeret eller beskrevet enkeltvis eller i grupper i overensstemmelse med de regler, der er vedtaget i medfør af artikel 252, stk. 1), litra a).
b)
De er i overensstemmelse med de relevante forebyggende og risikobegrænsende foranstaltninger, der er vedtaget i henhold til artikel 252, stk. 1, litra b), for de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme.
c)
De ledsages af et identifikationsdokument, der er behørigt udfyldt og udstedt i overensstemmelse med de artikel 254, litra d), vedtagne regler.
3.   Medlemsstaterne kan anvende nationale regler for ikkekommerciel flytning af selskabsdyr af de arter, der er opført i bilag I, del B, til deres område fra en anden medlemsstat, indtil de i stk. 1 omhandlede relevante delegerede retsakter er vedtaget, forudsat at de pågældende regler:
a)
står i rimeligt forhold til den risiko for folke- eller dyresundheden, der er forbundet med ikkekommerciel flytning af selskabsdyr af de pågældende arter, og
b)
ikke er strengere end dem, der gælder for flytninger af dyr af de pågældende arter i henhold til del IV.
KAPITEL 3
Betingelser for ikkekommerciel flytning af selskabsdyr til en medlemsstat fra et tredjeland eller territorium
Artikel 249
Betingelser for ikkekommerciel flytning af selskabsdyr af de arter, der er opført i bilag I, del A
1.   Selskabsdyr af de arter, der er opført i bilag I, del A, må ikke flyttes til en medlemsstat fra et tredjeland eller territorium, medmindre:
a)
de er identificeret enkeltvis med et fysisk identifikationsmiddel i overensstemmelse med de regler, der er vedtaget i henhold til artikel 252, stk. 1, litra a)
b)
de er i overensstemmelse med de relevante forebyggende og risikobegrænsende foranstaltninger, der er vedtaget i henhold til artikel 252, stk. 1, litra b), for de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme
c)
de ledsages af et identifikationsdokument, der er behørigt udfyldt og udstedt i overensstemmelse med de i artikel 254, litra d), vedtagne regler.
2.   Selskabsdyr af de arter, der er opført i bilag I, del A, må kun flyttes til en medlemsstat fra et andet tredjeland eller territorium end dem, der er opført på den i medfør af artikel 253, stk. 1, litra d), opstillede liste, gennem et indførselssted, der er opført på listen til dette formål. Hver medlemsstat udarbejder en liste over disse indførselssteder på sit område og gør listen offentligt tilgængelig.
3.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende betingelserne for at give dispensation fra nærværende artikels stk. 2.
Artikel 250
Betingelser for ikkekommerciel flytning af selskabsdyr af de arter, der er opført i bilag I, del B
1.   For så vidt som Kommissionen har vedtaget en delegeret retsakt i medfør af artikel 252, stk. 1, litra b), med hensyn til selskabsdyr af en af de arter, der er opført i bilag I, del B, er ikkekommerciel flytning af selskabsdyr af denne art til en medlemsstat fra et tredjeland eller territorium underlagt betingelserne i nærværende artikels stk. 2.
2.   Selskabsdyr af de i stk. 1 omhandlede arter må kun flyttes til en medlemsstat fra et tredjeland eller territorium, hvis:
a)
de er identificeret eller beskrevet enkeltvis eller i grupper i overensstemmelse med de regler, der er vedtaget i medfør af artikel 252, stk. 1, litra a)
b)
de er i overensstemmelse med de relevante forebyggende og risikobegrænsende foranstaltninger, der er vedtaget i henhold til artikel 252, stk. 1, litra b), for de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme
c)
de ledsages af et identifikationsdokument, der er behørigt udfyldt og udstedt i overensstemmelse med de i artikel 254, litra d), vedtagne regler
d)
de, når de kommer fra et andet tredjeland eller territorium end dem, der er opført på den i medfør af artikel 253, stk. 1, litra d), opstillede liste, indføres gennem et indførselssted, der er opført på listen til dette formål. Hver medlemsstat udarbejder en liste over disse indførselssteder på sit område og gør listen offentligt tilgængelig.
3.   Medlemsstater kan anvende nationale regler for ikkekommerciel flytning af selskabsdyr af de arter, der er opført i bilag I, del B, til deres område fra et tredjeland eller territorium, indtil de i stk. 1 omhandlede relevante delegerede retsakter er vedtaget, forudsat at de pågældende regler:
a)
står i rimeligt forhold til den risiko for folke- eller dyresundheden, der er forbundet med ikkekommerciel flytning af selskabsdyr af de pågældende arter, og
b)
ikke er strengere end dem, der gælder for indførsel til Unionen af dyr af de pågældende arter i henhold til del V.
Artikel 251
Undtagelse fra betingelserne for ikkekommerciel flytning af selskabsdyr mellem visse lande og territorier
Uanset artikel 249 og 250 kan ikkekommerciel flytning af selskabsdyr mellem følgende lande og territorier fortsætte på de betingelser, der er fastsat i disse landes og territoriers nationale regler:
a)
San Marino og Italien
b)
Vatikanstaten og Italien
c)
Monaco og Frankrig
d)
Andorra og Frankrig
e)
Andorra og Spanien
f)
Norge og Sverige
g)
Færøerne og Danmark
h)
Grønland og Danmark.
KAPITEL 4
Identifikation samt forebyggende og risikobegrænsende foranstaltninger
Artikel 252
Delegation af beføjelser vedrørende identifikation af selskabsdyr samt forebyggende og risikobegrænsende foranstaltninger
1.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
nærmere artsspecifikke krav til:
i)
identifikationsmidlerne for selskabsdyr af de arter, der er opført i bilag I, som omhandlet i artikel 247, litra a), artikel 248, stk. 2, litra a), artikel 249, stk. 1, litra a), og artikel 250, stk. 2, litra a)
ii)
anbringelse og anvendelse af disse identifikationsmidler
b)
nærmere artsspecifikke krav til forebyggende og risikobegrænsende foranstaltninger til at sikre, at selskabsdyr ikke udgør en betydelig risiko for spredning af de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme på grund af flytning af selskabsdyr af de arter, der er opført i bilag I, som omhandlet i artikel 247, litra b), artikel 248, stk. 2, litra b), artikel 249, stk. 1, litra b), og artikel 250, stk. 2, litra b).
2.   Hvis det i tilfælde af nye sundhedsrisici på grund af sagens hastende karakter er bydende nødvendigt, anvendes proceduren i artikel 265 på regler, der vedtages i henhold til nærværende artikels stk. 1, litra b).
3.   De artsspecifikke forebyggende og risikobegrænsende foranstaltninger, der godkendes ved en delegeret retsakt vedtaget i medfør af nærværende artikels stk. 1, litra b), skal baseres på fyldestgørende, pålidelige og validerede videnskabelige oplysninger og anvendes i forhold til den risiko for folke- eller dyresundheden, der er forbundet med ikkekommerciel flytning af selskabsdyr, som vil kunne blive berørt af de i artikel 9, stk. 1, litra d), omhandlede listeopførte sygdomme.
4.   De i stk. 1, litra b), omhandlede delegerede retsakter kan ligeledes omfatte følgende:
a)
regler for kategorisering af medlemsstater eller dele heraf i henhold til deres dyresundhedsstatus samt deres overvågnings- og rapporteringssystemer for så vidt angår visse sygdomme, der vil kunne spredes i forbindelse med flytning af selskabsdyr af de arter, der er opført i bilag I
b)
de betingelser, som medlemsstaterne skal opfylde for fortsat at være berettiget til at anvende de i stk. 1, litra b), omhandlede forebyggende og risikobegrænsende foranstaltninger
c)
betingelserne for anvendelse og dokumentation af de i stk. 1, litra b), omhandlede forebyggende og risikobegrænsende foranstaltninger
d)
kriterierne for at give dispensation og, hvor det er relevant, dokumentation for dispensation under visse nærmere angivne omstændigheder fra anvendelse af de i stk. 1, litra b), omhandlede forebyggende og risikobegrænsende foranstaltninger
e)
kriterierne for at give dispensation og dokumentation for dispensation under visse nærmere angivne omstændigheder fra de i artikel 247-250 omhandlede betingelser.
Artikel 253
Gennemførelsesretsakter vedrørende forebyggende og risikobegrænsende foranstaltninger
1.   Kommissionen skal ved hjælp af gennemførelsesretsakter med hensyn til selskabsdyr af de arter, der er opført i bilag I, del A:
a)
fastsætte regler om format, udformning og sprog for dokumenter, der måtte kræves i henhold til artikel 252, stk. 4, litra c) og d)
b)
vedtage en liste over medlemsstater, der opfylder de i artikel 252, stk. 4, litra d), omhandlede betingelser, og fjerne medlemsstater fra listen i tilfælde af ændringer i forbindelse med disse betingelser
c)
vedtage en liste over medlemsstater, der overholder de i artikel 252, stk. 4, litra a), omhandlede regler for kategorisering af medlemsstater eller dele heraf, og fjerne medlemsstater fra listen i tilfælde af ændringer i forbindelse med disse regler
d)
vedtage en liste over tredjelande og territorier, der opfylder de i artikel 252, stk. 4, litra d), omhandlede betingelser, og fjerne tredjelande eller territorier fra listen i tilfælde af ændringer i forbindelse med disse betingelser.
2.   Kommissionen vedtager ved hjælp af gennemførelsesretsakter med hensyn til selskabsdyr af de arter, der er opført i bilag I, del B, en liste over tredjelande og territorier, der opfylder de betingelser, der er omhandlet i artikel 252, stk. 4, litra d), og fjerner tredjelande eller territorier fra listen i tilfælde af ændringer i forbindelse med disse betingelser.
3.   De i nærværende artikels stk. 1 og 2 omhandlede gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
4.   I behørigt begrundede særlig hastende tilfælde vedrørende alvorlige risici vedtager Kommissionen efter proceduren i artikel 266, stk. 3, gennemførelsesretsakter, der straks finder anvendelse, om ajourføring af de i nærværende artikels stk. 1, litra b) og d), omhandlede lister.
KAPITEL 5
Identifikationsdokumenter
Artikel 254
Delegation af beføjelser vedrørende identifikationsdokumenter
Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende:
a)
rubrikker til angivelse af de oplysninger, som skal medtages i identifikationsdokumenterne omhandlet i artikel 247, litra c), artikel 248, stk. 2, litra c), artikel 249, stk. 1, litra c), og artikel 250, stk. 2, litra c)
b)
distribution af de i artikel 247, litra c), omhandlede blanke identifikationsdokumenter
c)
betingelserne for at give dispensation fra de i artikel 247, litra c), og artikel 249, stk. 1, litra c), omhandlede identifikationsdokumenters format
d)
udstedelse, udfyldelse og, hvor det er relevant, godkendelse af de i artikel 247, litra c), artikel 248, stk. 2, litra c), artikel 249 stk. 1, litra c), og artikel 250, stk. 2, litra c), omhandlede identifikationsdokumenter.
Artikel 255
Gennemførelsesretsakter vedrørende identifikationsdokumenter
1.   Kommissionen vedtager gennemførelsesretsakter om en model for de i artikel 247, litra c), og artikel 249, stk. 1, litra c), omhandlede identifikationsdokumenter. Modellen skal indeholde de rubrikker, der er omhandlet i artikel 254, litra a), samt krav vedrørende identifikationsdokumenternes sprog, udformning, gyldighed og sikkerhedselementer.
2.   Kommissionen kan ved hjælp af gennemførelsesretsakter vedtage:
a)
en model for de i artikel 248, stk. 2, litra c), og artikel 250, stk. 2, litra c), omhandlede identifikationsdokumenter, som skal indeholde de rubrikker, der er omhandlet i artikel 254, litra a), samt krav vedrørende identifikationsdokumenternes sprog, udformning, gyldighed og sikkerhedselementer
b)
de regler, der er nødvendige for overgang til den i artikel 247, litra c), omhandlede identifikationsdokumentmodel.
3.   De i nærværende artikels stk. 1 og 2 omhandlede gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
KAPITEL 6
Oplysningsforpligtelser
Artikel 256
Oplysningsforpligtelser
1.   Medlemsstaterne giver offentligheden klare og lettilgængelige oplysninger om dyresundhedsmæssige krav til ikkekommerciel flytning af selskabsdyr, herunder:
a)
betingelser for at give visse dispensationer, jf. artikel 252, stk. 4, litra d)
b)
betingelser for at give dispensationer, jf. artikel 252, stk. 4, litra e)
c)
krav til anbringelse af de i artikel 252, stk. 1, litra a), nr. ii), omhandlede identifikationsmidler
d)
betingelser for ikkekommerciel flytning til medlemsstaternes områder af selskabsdyr af arterne, der er omhandlet i bilag I, del B, som fastsat i de nationale bestemmelser, jf. artikel 248, stk. 3, og artikel 250, stk. 3
e)
betingelser for ikkekommerciel flytning til medlemsstaternes områder af selskabsdyr fra visse lande og territorier som fastsat i de nationale bestemmelser, jf. artikel 251
f)
relevante oplysninger om visse forebyggende og risikobegrænsende foranstaltninger, jf. artikel 252, stk. 1, litra b).
2.   Medlemsstaterne opretter internetsider, der indeholder de i stk. 1 omhandlede oplysninger, og meddeler Kommissionen internetadressen på disse sider.
3.   Kommissionen bistår medlemsstaterne med at gøre disse oplysninger tilgængelige for offentligheden ved på sin internetside at angive:
a)
link til medlemsstaternes internetsider med oplysninger
b)
de i stk. 1, litra a) og d), omhandlede oplysninger og de oplysninger, der er gjort tilgængelige for offentligheden, jf. artikel 244, stk. 2, litra b), på yderligere relevante sprog.
DEL VII
HASTEFORANSTALTNINGER
Afdeling 1
Hasteforanstaltninger vedrørende flytning af dyr og produkter i Unionen samt transportmidler og andre materialer, der kan have været i kontakt med sådanne dyr og produkter
Artikel 257
Hasteforanstaltninger, som skal træffes af den kompetente myndighed i den medlemsstat, på hvis område et udbrud af en listeopført eller ny sygdom eller en fare forekom
1.   I tilfælde af et udbrud af en listeopført eller en ny sygdom eller forekomst af en fare, der sandsynligvis udgør en alvorlig risiko for dyre- eller folkesundheden, træffer den kompetente myndighed i den medlemsstat, hvor sygdommen eller faren er opstået, afhængigt af alvorligheden af situationen og den pågældende sygdom eller fare, øjeblikkelig en eller flere af følgende hasteforanstaltninger for at forhindre spredning af sygdommen eller faren:
a)
for listeopførte sygdomme
i)
omhandlet i artikel 9, stk. 1, litra a): de i del III, afsnit II, kapitel 1 (artikel 53-71) omhandlede sygdomsbekæmpelsesforanstaltninger
ii)
omhandlet i artikel 9, stk. 1, litra b): de i del III, afsnit II, kapitel 2, artikel 72-75 og 77-81, omhandlede sygdomsbekæmpelsesforanstaltninger
iii)
omhandlet i artikel 9, stk. 1, litra c): de i del III, afsnit II, kapitel 2, artikel 76-78 og 80-82, omhandlede sygdomsbekæmpelsesforanstaltninger
b)
for nye sygdomme og farer:
i)
restriktioner for flytning af dyr og produkter med oprindelse i de virksomheder eller, hvis det er relevant, de restriktionszoner eller kompartmenter, hvor udbruddet eller faren er opstået, og for transportmidler og andre materialer, der kan have været i kontakt med de pågældende dyr eller produkter
ii)
anbringelse af dyrene i karantæne og isolering af produkterne
iii)
overvågnings- og sporbarhedsforanstaltninger
iv)
eventuelle hastesygdomsbekæmpelsesforanstaltninger som omhandlet i del III, afsnit II, kapitel 1 (artikel 53-71), der måtte være relevante
c)
enhver anden hasteforanstaltning, som den finder hensigtsmæssig med henblik på effektivt at bekæmpe og forhindre spredning af sygdommen eller faren.
2.   Den i stk. 1 omhandlede kompetente myndighed underretter Kommissionen og de øvrige medlemsstater:
a)
øjeblikkelig om et sygdomsudbrud eller forekomst af en fare som omhandlet i stk. 1
b)
hurtigst muligt om hasteforanstaltninger truffet i henhold til stk. 1.
Artikel 258
Hasteforanstaltninger, som skal træffes af en anden medlemsstat end den medlemsstat, hvor sygdomsudbruddet eller faren er opstået
1.   Den kompetente myndighed i andre medlemsstater end den medlemsstat, hvor udbruddet eller faren som omhandlet i artikel 257, stk. 1, er opstået, træffer afhængigt af alvorligheden af situationen og den pågældende sygdom eller fare en eller flere af de i artikel 257, stk. 1, omhandlede hasteforanstaltninger, hvis den på sit område konstaterer dyr eller produkter fra den i artikel 257, stk. 1, omhandlede medlemsstat eller transportmidler eller andre materialer, der kan have været i kontakt med sådanne dyr og produkter.
2.   Den kompetente myndighed som omhandlet i stk. 1 kan, hvis en alvorlig risiko gør sig gældende, i afventning af at Kommissionen vedtager hasteforanstaltninger i henhold til artikel 259, og afhængigt af situationens alvorlighed midlertidigt træffe hasteforanstaltninger som omhandlet i artikel 257, stk. 1, vedrørende dyr eller produkter med oprindelse i virksomhederne eller et andet sted eller, hvis det er relevant, restriktionszonerne i den medlemsstat, hvor sygdommen eller faren som omhandlet i artikel 257, stk. 1, er opstået, eller transportmidler eller andre materialer, der kan have været i kontakt med sådanne dyr.
3.   En medlemsstat kan træffe de i artikel 257, stk. 1, omhandlede foranstaltninger i tilfælde af et udbrud i et tredjeland eller territorium, der grænser op til Unionen, af en i artikel 9, stk. 1, litra a), omhandlet sygdom eller en ny sygdom i et sådant tredjeland eller territorium, for så vidt disse foranstaltninger er nødvendige for at hindre spredning af sygdommen til Unionens område.
4.   Den i stk. 1 omhandlede kompetente myndighed og den i stk. 3 omhandlede kompetente myndighed i en medlemsstat underretter Kommissionen og de øvrige medlemsstater:
a)
øjeblikkelig om sygdomsudbruddet eller forekomsten af en fare som omhandlet i stk. 1
b)
hurtigst muligt om hasteforanstaltninger truffet i henhold til stk. 1 og 2.
Artikel 259
Hasteforanstaltninger truffet af Kommissionen
1.   I tilfælde af et sygdomsudbrud eller forekomst af en fare som omhandlet i artikel 257, stk. 1, hvor medlemsstaternes kompetente myndigheder har truffet hasteforanstaltninger i overensstemmelse med artikel 257, stk. 1, og artikel 258, stk. 1, 2 og 3, vurderer Kommissionen situationen og de trufne hasteforanstaltninger og vedtager ved hjælp af en gennemførelsesretsakt en eller flere af de i artikel 257, stk. 1, omhandlede hasteforanstaltninger vedrørende de pågældende dyr og produkter samt transportmidler og andre materialer, der kan have været i kontakt med dyrene eller produkterne, hvis en eller flere af følgende situationer gør sig gældende:
a)
Kommissionen er ikke blevet underrettet om foranstaltninger truffet i henhold til artikel 257, stk. 1, og artikel 258, stk. 1, 2 og 3.
b)
Kommissionen vurderer, at de foranstaltninger, der er truffet i henhold til artikel 257, stk. 1, og artikel 258, stk. 1, 2 og 3, er utilstrækkelige.
c)
Kommissionen finder det nødvendigt at godkende eller erstatte de foranstaltninger, der er truffet af medlemsstaternes kompetente myndigheder i henhold til artikel 257, stk. 1, og artikel 258, stk. 1, 2 og 3, for at undgå uberettigede forstyrrelser i flytningerne af dyr og produkter.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
2.   I behørigt begrundede særligt hastende tilfælde vedrørende alvorlige risici for spredning af en sygdom eller en fare kan Kommissionen i henhold til artikel 266, stk. 3, vedtage gennemførelsesretsakter, der straks finder anvendelse.
Afdeling 2
Hasteforanstaltninger vedrørende sendinger af dyr og produkter fra tredjelande og territorier samt transportmidler og andre materialer, der kan have været i kontakt med sådanne sendinger
Artikel 260
Hasteforanstaltninger, som skal træffes af den kompetente myndighed
Hvis en medlemsstats kompetente myndighed bliver bekendt med dyr eller produkter fra et tredjeland eller territorium eller transportmidler eller materialer, der kan have været i kontakt med sådanne dyr og produkter, som sandsynligvis udgør en alvorlig risiko i Unionen på grund af mulig infektion eller kontaminering med listeopførte sygdomme eller nye sygdomme eller farer, skal den:
a)
øjeblikkelig træffe en eller flere af følgende hasteforanstaltninger, der afhængigt af situationens alvorlighed er nødvendige for at begrænse den pågældende risiko:
i)
destruktion af de pågældende dyr og produkter
ii)
anbringelse af dyrene i karantæne og isolering af produkterne
iii)
overvågnings- og sporbarhedsforanstaltninger
iv)
eventuelle sygdomsbekæmpelsesforanstaltninger som omhandlet i del III, afsnit II, kapitel 1 (artikel 53-71), der måtte være relevante
v)
enhver anden hasteforanstaltning, som den finder hensigtsmæssig med henblik på at forhindre spredning af den pågældende sygdom eller en fare til Unionen
b)
ved hjælp af Traces øjeblikkelig underrette Kommissionen og de øvrige medlemsstater om risiciene ved de pågældende dyr og produkter og om de pågældende dyrs eller produkters oprindelsessted samt hurtigst muligt om de hasteforanstaltninger, der er truffet i medfør af litra a).
Artikel 261
Hasteforanstaltninger truffet af Kommissionen
1.   Hvis en listeopført sygdom, en ny sygdom eller en fare, der sandsynligvis udgør en alvorlig risiko, opstår eller spredes i et tredjeland eller territorium, eller hvis et andet tungtvejende dyre- eller folkesundhedsmæssigt hensyn tilsiger det, kan Kommissionen ved hjælp af en gennemførelsesretsakt på eget initiativ eller efter anmodning fra en medlemsstat vedtage en eller flere af følgende hasteforanstaltninger afhængigt af situationens alvorlighed:
a)
suspendere indførsel til Unionen af sendinger af dyr og produkter samt transportmidler eller andre materialer, der kan have været i kontakt med sådanne sendinger, som vil kunne sprede den pågældende sygdom eller fare til Unionen
b)
fastsætte særlige krav til indførsel til Unionen af dyr og produkter samt transportmidler og andre materialer, der kan have været i kontakt med sådanne dyr og produkter, som vil kunne sprede den pågældende sygdom eller fare til Unionen
c)
træffe de eventuelle yderligere hastesygdomsbekæmpelsesforanstaltninger, der måtte være nødvendige for at forhindre spredning af den pågældende sygdom eller fare til Unionen.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
2.   I behørigt begrundede særligt hastende tilfælde vedrørende alvorlige risici vedtager Kommissionen efter proceduren i artikel 266, stk. 3, og efter høring af den berørte medlemsstat gennemførelsesretsakter, der straks finder anvendelse.
Artikel 262
Hasteforanstaltninger, der træffes af medlemsstaterne i tilfælde, hvor Kommissionen ikke handler
1.   Hvis en medlemsstat har anmodet Kommissionen om at træffe hasteforanstaltninger i henhold til artikel 261, og Kommissionen ikke har truffet disse foranstaltninger:
a)
kan den pågældende medlemsstat, i afventning af at Kommissionen vedtager hasteforanstaltninger i henhold til stk. 2, og afhængigt af alvorligheden af situationen på sit område midlertidigt træffe en eller flere af de i artikel 260, litra a), omhandlede hasteforanstaltninger vedrørende de pågældende dyr og produkter samt transportmidler og andre materialer, der kan have været i kontakt med dyrene og produkterne med oprindelse i det i artikel 261, stk. 1, omhandlede tredjeland eller territorium
b)
skal medlemsstaten hurtigst muligt underrette Kommissionen og de øvrige medlemsstaters kompetente myndigheder om sådanne hasteforanstaltninger og begrunde dem.
2.   Kommissionen vurderer situationen og de hasteforanstaltninger, der er truffet af den pågældende medlemsstat i henhold til nærværende artikels stk. 1, og vedtager ved hjælp af en gennemførelsesretsakt om nødvendigt en eller flere hasteforanstaltninger som omhandlet i artikel 261.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 266, stk. 2.
3.   I behørigt begrundede særligt hastende tilfælde vedrørende alvorlige risici vedtager Kommissionen efter proceduren i artikel 266, stk. 3, gennemførelsesretsakter, der straks finder anvendelse.
DEL VIII
FÆLLES BESTEMMELSER
AFSNIT I
PROCEDUREMÆSSIGE BESTEMMELSER
Artikel 263
Ændring af bilag III
Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende ændringer af bilag III og begrænset til udelukkende at tage hensyn til ændringer i taksonomi.
Artikel 264
Udøvelse af de delegerede beføjelser
1.   Beføjelsen til at vedtage delegerede retsakter tillægges Kommissionen på de i denne artikel fastlagte betingelser.
2.   Det er navnlig vigtigt, at Kommissionen gennemfører høringer med eksperter, herunder eksperter fra medlemsstaterne, før den vedtager disse delegerede retsakter.
3.   Beføjelsen til at vedtage delegerede retsakter i artikel 3, stk. 5, artikel 5, stk. 2 og 4, artikel 14, stk. 3, artikel 16, stk. 2, artikel 18, stk. 3, artikel 20, stk. 3, artikel 29, artikel 31, stk. 5, artikel 32, stk. 2, artikel 37, stk. 5, artikel 39, artikel 41, stk. 3, artikel 42, stk. 6, artikel 47, artikel 48, stk. 3, artikel 53, stk. 2, artikel 54, stk. 3, artikel 55, stk. 2, artikel 58, stk. 2, artikel 63, artikel 64, stk. 4, artikel 67, artikel 68, stk. 2 og 3, artikel 70, stk. 3, artikel 72, stk. 2, artikel 73, stk. 3, artikel 74, stk. 4, artikel 76, stk. 5, artikel 77, stk. 2, artikel 87, stk. 3, artikel 94, stk. 3, artikel 97, stk. 2, artikel 101, stk. 3, artikel 106, stk. 1, artikel 109, stk. 2, artikel 118, artikel 119, artikel 122, stk. 1, artikel 122, stk. 2, artikel 125, stk. 2, artikel 131, stk. 1, artikel 132, stk. 2, artikel 135, artikel 136, stk. 2, artikel 137, stk. 2, artikel 138, stk. 3, artikel 139, stk. 4, artikel 140, artikel 144, stk. 1, artikel 146, stk. 1, artikel 147, artikel 149, stk. 4, artikel 151, stk. 3, artikel 154, stk. 1, artikel 156, stk. 1, artikel 160, stk. 1 og 2, artikel 161, stk. 6, artikel 162, stk. 4, artikel 163, stk. 5, artikel 164, stk. 2, artikel 165, stk. 3, artikel 166, stk. 3, artikel 167, stk. 5, artikel 168, stk. 3, artikel 169, stk. 5, artikel 176, stk. 4, artikel 181, stk. 2, artikel 185, stk. 5, artikel 189, stk. 1, artikel 192, stk. 2, artikel 197, stk. 3, artikel 200, stk. 3, artikel 201, stk. 3, artikel 202, stk. 3, artikel 203, stk. 2, artikel 204, stk. 3, artikel 205, stk. 2, artikel 211, stk. 1, artikel 213, stk. 1, artikel 214, artikel 216, stk. 4, artikel 218, stk. 3, artikel 221, stk. 1, artikel 222, stk. 3, artikel 223, stk. 6, artikel 224, stk. 3, artikel 228, stk. 1, artikel 230, stk. 3, artikel 234, stk. 2, artikel 237, stk. 4, artikel 239, stk. 2, artikel 240, stk. 2, artikel 241, stk. 2, artikel 242, stk. 2, artikel 245, stk. 3, artikel 246, stk. 3, artikel 249, stk. 3, artikel 252, stk. 1, artikel 254, artikel 263, artikel 271, stk. 2, artikel 272, stk. 2, artikel 279, stk. 2, og artikel 280, stk. 4, tillægges Kommissionen for en periode på fem år fra den 20. april 2016.
Kommissionen udarbejder en rapport vedrørende delegationen af beføjelser senest ni måneder inden udløbet af femårsperioden. Delegationen af beføjelser forlænges stiltiende for perioder af samme varighed, medmindre Europa-Parlamentet eller Rådet modsætter sig en sådan forlængelse senest tre måneder inden udløbet af hver periode.
4.   Den i stk. 3 omhandlede delegation af beføjelser kan til enhver tid tilbagekaldes af Europa-Parlamentet eller Rådet. En afgørelse om tilbagekaldelse bringer delegationen af de beføjelser, der er angivet i den pågældende afgørelse, til ophør. Den får virkning dagen efter offentliggørelsen af afgørelsen i 
Den Europæiske Unions Tidende
 eller på et senere tidspunkt, der angives i afgørelsen. Den berører ikke gyldigheden af delegerede retsakter, der allerede er i kraft.
5.   Så snart Kommissionen vedtager en delegeret retsakt, giver den på samme tid Europa-Parlamentet og Rådet meddelelse herom.
6.   En delegeret retsakt vedtaget i henhold til bestemmelserne opregnet i stk. 3 træder kun i kraft, hvis hverken Europa-Parlamentet eller Rådet har gjort indsigelse inden for en frist på to måneder fra meddelelsen af den pågældende retsakt til Europa-Parlamentet og Rådet, eller hvis Europa-Parlamentet og Rådet inden udløbet af denne frist begge har informeret Kommissionen om, at de ikke agter at gøre indsigelse. Fristen forlænges med to måneder på Europa-Parlamentets eller Rådets initiativ.
7.   Kommissionen afsætter en periode på mindst seks måneder mellem datoen for vedtagelse af de pågældende første delegerede retsakter, der er omhandlet i artikel 3, stk. 5, artikel 14, stk. 3, artikel 16, stk. 2, artikel 20, stk. 3, artikel 122, stk. 2, artikel 164, stk. 2, og artikel 228, stk. 1, og datoen for anvendelse heraf.
Artikel 265
Hasteprocedure
1.   Delegerede retsakter vedtaget i henhold til denne artikel træder straks i kraft og anvendes, så længe der ikke er gjort indsigelse i henhold til stk. 2. I meddelelsen til Europa-Parlamentet og Rådet af en delegeret retsakt anføres begrundelsen for anvendelse af hasteproceduren.
2.   Europa-Parlamentet eller Rådet kan efter proceduren i artikel 264, stk. 6, gøre indsigelse mod en delegeret retsakt. I så fald skal Kommissionen ophæve retsakten straks efter Europa-Parlamentets eller Rådets meddelelse af afgørelsen om at gøre indsigelse.
Artikel 266
Udvalgsprocedure
1.   Kommissionen bistås af Den Stående Komité for Planter, Dyr, Fødevarer og Foder, som er nedsat ved artikel 58, stk. 1, i forordning (EF) nr. 178/2002. Denne komité er et udvalg som omhandlet i forordning (EU) nr. 182/2011.
2.   Når der henvises til dette stykke, anvendes artikel 5 i forordning (EU) nr. 182/2011.
3.   Når der henvises til dette stykke, anvendes artikel 8 i forordning (EU) nr. 182/2011 sammenholdt med artikel 5 heri.
4.   Kommissionen afsætter en periode på mindst seks måneder mellem datoen for vedtagelse af de pågældende første gennemførelsesretsakter, der er omhandlet i artikel 25, stk. 3, artikel 120 og artikel 228, stk. 2, når disse gennemførelsesretsakter vedrører gennemførelsen af artikel 117, og datoen for anvendelse heraf.
Artikel 267
Databeskyttelse
1.   Medlemsstaterne anvender Europa-Parlamentets og Rådets direktiv 95/46/EF 
(
64
)
 på behandling af personoplysninger i medlemsstaterne i medfør af denne forordning.
2.   Europa-Parlamentets og Rådets forordning (EF) nr. 45/2001 
(
65
)
 finder anvendelse på Kommissionens behandling af personoplysninger i medfør af denne forordning.
AFSNIT II
SANKTIONER
Artikel 268
Sanktioner
Medlemsstaterne fastsætter regler om sanktioner for overtrædelse af denne forordning og træffer alle nødvendige foranstaltninger for at sikre, at reglerne gennemføres. Sanktionerne skal være effektive, stå i et rimeligt forhold til overtrædelsen og have afskrækkende virkning.
Medlemsstaterne giver senest den 22. april 2022 Kommissionen meddelelse om disse regler og underretter den hurtigst muligt om alle senere ændringer.
AFSNIT III
MEDLEMSSTATERS FORANSTALTNINGER
Artikel 269
Medlemsstaters supplerende eller strengere foranstaltninger
1.   Ud over medlemsstaternes mulighed for at vedtage nationale foranstaltninger i medfør af andre bestemmelser i denne forordning kan medlemsstaterne på deres områder anvende foranstaltninger, som supplerer eller er strengere end dem, der er fastlagt i denne forordning vedrørende:
a)
ansvarsområderne inden for dyresundhed, jf. del I, kapitel 3 (artikel 10-17)
b)
anmeldelse inden for medlemsstaterne, jf. artikel 18
c)
overvågning, jf. del II, kapitel 2 (artikel 24-30)
d)
registrering, godkendelse, føring af fortegnelser samt registre, jf. del IV, afsnit I, kapitel 1 (artikel 84-107), og afsnit II, kapitel 1 (artikel 172-190)
e)
sporbarhedskrav for opdrættede landdyr og avlsmateriale som omhandlet i del IV, afsnit I, kapitel 2 (artikel 108-123).
2.   Nationale foranstaltninger som omhandlet i stk. 1 skal overholde reglerne i denne forordning og må ikke:
a)
være til hinder for flytning af dyr og produkter mellem medlemsstater
b)
være i strid med de i stk. 1 omhandlede bestemmelser.
DEL IX
OVERGANGSBESTEMMELSER OG AFSLUTTENDE BESTEMMELSER
Artikel 270
Ophævelse
1.   Beslutning 78/642/EØF, 89/455/EØF og 90/678/EØF samt direktiv 79/110/EØF, 81/6/EØF, 90/423/EØF, 92/36/EØF og 98/99/EF ophæves.
2.   Følgende retsakter ophæves med virkning fra den 21. april 2021:
—
direktiv 64/432/EØF
—
direktiv 77/391/EØF
—
direktiv 78/52/EØF
—
direktiv 80/1095/EØF
—
direktiv 82/894/EØF
—
direktiv 88/407/EØF
—
direktiv 89/556/EØF
—
direktiv 90/429/EØF
—
direktiv 91/68/EØF
—
beslutning 91/666/EØF
—
direktiv 92/35/EØF
—
direktiv 92/65/EØF
—
direktiv 92/66/EØF
—
direktiv 92/118/EØF
—
direktiv 92/119/EØF
—
beslutning 95/410/EF
—
direktiv 2000/75/EF
—
beslutning 2000/258/EF
—
direktiv 2001/89/EF
—
direktiv 2002/60/EF
—
direktiv 2002/99/EF
—
direktiv 2003/85/EF
—
forordning (EF) nr. 21/2004
—
direktiv 2004/68/EF
—
direktiv 2005/94/EF
—
direktiv 2006/88/EF
—
direktiv 2008/71/EF
—
direktiv 2009/156/EF
—
direktiv 2009/158/EF
—
forordning (EU) nr. 576/2013.
Henvisninger til de ophævede retsakter gælder som henvisninger til denne forordning og læses efter sammenligningstabellen i bilag V.
Artikel 271
Overgangsforanstaltninger vedrørende ændring af forordning (EF) nr. 1760/2000 og ophævelse af forordning (EF) nr. 21/2004 og direktiv 2008/71/EF
1.   Uanset nærværende forordnings artikel 270, stk. 2, og artikel 278 finder artikel 1-10 i forordning (EF) nr. 1760/2000 og forordning (EF) nr. 21/2004 og direktiv 2008/71/EF samt retsakter, der er vedtaget på grundlag heraf, fortsat anvendelse i stedet for de hertil svarende artikler i nærværende forordning indtil tre år efter datoen for anvendelse af nærværende forordning eller en tidligere dato, der fastsættes i en delegeret retsakt vedtaget i henhold til nærværende artikels stk. 2.
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende den tidligere dato, der er omhandlet i nærværende artikels stk. 1.
Denne dato skal være datoen for anvendelse af de hertil svarende regler, der skal vedtages i henhold til de delegerede retsakter, der er omhandlet i artikel 109, stk. 2, og artikel 119, og de gennemførelsesretsakter, der er omhandlet i artikel 118.
Artikel 272
Overgangsforanstaltninger vedrørende ophævelse af direktiv 92/66/EØF, 2000/75/EF, 2001/89/EF, 2002/60/EF, 2003/85/EF og 2005/94/EF
1.   Uanset nærværende forordnings artikel 270, stk. 2, finder direktiv 92/66/EØF, 2000/75/EF, 2001/89/EF, 2002/60/EF, 2003/85/EF og 2005/94/EF samt retsakter, der er vedtaget på grundlag heraf, fortsat anvendelse i stedet for de hertil svarende artikler i nærværende forordning indtil tre år efter datoen for anvendelse af nærværende forordning eller en tidligere dato, der fastsættes i en delegeret retsakt vedtaget i henhold til nærværende artikels stk. 2.
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende den tidligere dato, der er omhandlet i nærværende artikels stk. 1.
Denne dato skal være datoen for anvendelse af de hertil svarende regler, der skal vedtages i henhold til de delegerede retsakter omhandlet i nærværende forordnings artikel 47, artikel 48, stk. 3, artikel 53, stk. 2, artikel 54, stk. 3, artikel 55, stk. 2, artikel 58, stk. 2, artikel 63, artikel 64, stk. 4, artikel 67, artikel 68, stk. 2, og artikel 70, stk. 3.
Artikel 273
Ændring af forordning (EF) nr. 2160/2003
I artikel 9, stk. 3, i forordning (EF) nr. 2160/2003 tilføjes følgende:
»Disse særlige foranstaltninger omfatter foranstaltninger baseret på bestemmelserne i beslutning 95/410/EF i den seneste udgave forud for ophævelsen heraf og Kommissionens beslutning 2003/644/EF
 (
*1
)
 og 2004/235/EF
 (
*2
)
 i udgaverne heraf på tidspunktet for ophævelsen af direktiv 90/539/EØF.
Artikel 274
Overgangsforanstaltninger vedrørende datoen for vedtagelse af visse delegerede retsakter og gennemførelsesretsakter
Med forbehold af anvendelsesdatoen i artikel 283 vedtager Kommissionen de delegerede retsakter, der er omhandlet i artikel 31, stk. 5, første afsnit, artikel 32, stk. 2, artikel 39, artikel 41, stk. 3, artikel 54, stk. 3, artikel 55, stk. 2, artikel 58, stk. 2, artikel 64, stk. 4, artikel 67, artikel 68, stk. 2, artikel 74, stk. 4, artikel 77, stk. 2, artikel 97, stk. 2, artikel 122, stk. 2, artikel 131, stk. 1, artikel 132, stk. 2, artikel 135, artikel 137, stk. 2, artikel 146, stk. 1, artikel 149, stk. 4, artikel 154, stk. 1, artikel 162, stk. 3, artikel 163, stk. 5, artikel 166, stk. 3, artikel 169, stk. 5, artikel 181, stk. 2, artikel 185, stk. 5, artikel 213, stk. 1, artikel 216, stk. 4, artikel 221, stk. 1, artikel 222, stk. 3, artikel 224, stk. 3, artikel 234, stk. 2, og artikel 239, stk. 1, og de i artikel 8 og 9 omhandlede gennemførelsesretsakter senest den 20. april 2019. I henhold til artikel 283 finder disse delegerede retsakter og gennemførelsesretsakter anvendelse fra anvendelsesdatoen i nævnte artikel.
Artikel 275
Forudgående gennemgang og ændringer af bilag II
Kommissionen gennemgår senest den 20. april 2019 de listeopførte sygdomme i bilag II. Viser denne gennemgang, at anvendelse af reglerne i denne forordning kræver, at der foretages ændringer af bilag II i form af en tilføjelse til eller fjernelse fra listen deri, vedtager Kommissionen disse ændringer senest på den i denne artikels første punktum fastsatte dato.
Artikel 276
Gennemgang
Kommissionen gennemgår senest den 20. april 2019 gældende lovgivning om identifikation og registrering af opdrættede dyr af hestearterne.
Kommissionen tager hensyn til resultaterne af denne gennemgang i forbindelse med anvendelsen af artikel 118, 119 og 120.
Artikel 277
Overgangsforanstaltninger vedrørende ophævelsen af forordning (EU) nr. 576/2013 om ikkekommerciel flytning af selskabsdyr
Uanset nærværende forordnings artikel 270, stk. 2, finder forordning (EU) nr. 576/2013 fortsat anvendelse indtil den 21. april 2026 for ikkekommercielle flytninger af selskabsdyr i stedet for nærværende forordnings del VI.
Artikel 278
Ændringer af forordning (EF) nr. 1760/2000
I forordning (EF) nr. 1760/2000 foretages følgende ændringer:
1)
Artikel 1-10 udgår.
2)
Artikel 22 affattes således:
»Artikel 22
1.   Medlemsstaterne træffer alle de foranstaltninger, der er nødvendige for at sikre, at denne forordning overholdes.
Denne kontrol foregriber ikke eventuel kontrol, som Kommissionen foretager i henhold til artikel 9 i forordning (EF, Euratom) nr. 2988/95.
Sanktioner, som en medlemsstat pålægger en erhvervsdrivende eller organisation, der afsætter oksekød, skal være effektive, have afskrækkende virkning og stå i rimeligt forhold til overtrædelsen.
2.   Uanset stk. 1 kræver medlemsstaterne, hvis erhvervsdrivende og organisationer, der afsætter oksekød, har mærket oksekød uden at opfylde deres forpligtelser som fastsat i afsnit II, hvis det er hensigtsmæssigt, og i overensstemmelse med proportionalitetsprincippet, at oksekødet fjernes fra markedet. Ud over de i stk. 1 omhandlede sanktioner kan medlemsstaterne:
a)
hvis det pågældende kød følger de relevante veterinær- og hygiejneforskrifter, give tilladelse til, at dette oksekød:
i)
bringes i omsætning efter at være blevet korrekt mærket i overensstemmelse med EU-kravene eller
ii)
sendes direkte til forarbejdning til andre produkter end dem, der er nævnt i artikel 12, nr. 1)
b)
beordre suspension eller tilbagetrækning af godkendelsen af de pågældende erhvervsdrivende eller organisationer.
3.   Sagkyndige fra Kommissionen skal sammen med de kompetente myndigheder:
a)
kontrollere, om medlemsstaterne overholder bestemmelserne i denne forordning
b)
foretage kontrol på stedet for at sikre, at kontrollen foretages i henhold til denne forordning.
4.   En medlemsstat, på hvis område der foretages kontrol på stedet, yder Kommissionens sagkyndige den bistand, som de måtte ønske for at kunne udføre deres opgaver. Resultatet af kontrollen drøftes med den pågældende medlemsstats kompetente myndighed, før der udarbejdes en endelig rapport, som rundsendes. Denne rapport skal, hvis det er relevant, indeholde anbefalinger til medlemsstaterne vedrørende forbedring af overholdelsen af denne forordning.«
3)
Artikel 22b affattes således:
»Artikel 22b
Udøvelse af de delegerede beføjelser
1.   Beføjelsen til at vedtage delegerede retsakter tillægges Kommissionen på de i denne artikel fastlagte betingelser.
2.   Beføjelsen til at vedtage delegerede retsakter som omhandlet i artikel 13, stk. 6, artikel 14, stk. 4, og artikel 15a tillægges Kommissionen for en periode på fem år fra den 20. april 2016. Kommissionen udarbejder en rapport vedrørende delegationen af beføjelser senest ni måneder inden udløbet af femårsperioden. Delegationen af beføjelser forlænges stiltiende for perioder af samme varighed, medmindre Europa-Parlamentet eller Rådet modsætter sig en sådan forlængelse senest tre måneder inden udløbet af hver periode.
3.   Den i artikel 13, stk. 6, artikel 14, stk. 4, og artikel 15a omhandlede delegation af beføjelser kan til enhver tid tilbagekaldes af Europa-Parlamentet eller Rådet. En afgørelse om tilbagekaldelse bringer delegationen af de beføjelser, der er angivet i den pågældende afgørelse, til ophør. Den får virkning dagen efter offentliggørelsen af afgørelsen i 
Den Europæiske Unions Tidende
 eller på et senere tidspunkt, der angives i afgørelsen. Den berører ikke gyldigheden af delegerede retsakter, der allerede er i kraft.
4.   Så snart Kommissionen vedtager en delegeret retsakt, giver den samtidigt Europa-Parlamentet og Rådet meddelelse herom.
5.   En delegeret retsakt vedtaget i henhold til artikel 13, stk. 6, artikel 14, stk. 4, og artikel 15a træder kun i kraft, hvis hverken Europa-Parlamentet eller Rådet har gjort indsigelse inden for en frist på to måneder fra meddelelsen af den pågældende retsakt til Europa-Parlamentet og Rådet, eller hvis Europa-Parlamentet og Rådet inden udløbet af denne frist begge har informeret Kommissionen om, at de ikke agter at gøre indsigelse. Fristen forlænges med to måneder på Europa-Parlamentets eller Rådets initiativ.«
4)
Artikel 23 affattes således:
»Artikel 23
Udvalgsprocedure
1.   I forbindelse med de gennemførelsesretsakter, der vedtages i henhold til denne forordnings artikel 13, stk. 6, bistås Kommissionen af Den Stående Komité for Planter, Dyr, Fødevarer og Foder, som er nedsat ved artikel 58, stk. 1, i Europa-Parlamentets og Rådets forordning (EF) nr. 178/2002
 (
*3
)
.
Denne komité er et udvalg som omhandlet i Europa-Parlamentets og Rådets forordning (EU) nr. 182/2011
 (
*4
)
.
2.   Når der henvises til dette stykke, anvendes artikel 5 i forordning (EU) nr. 182/2011.
Når komitéens udtalelse skal indhentes ved skriftlig procedure, afsluttes proceduren uden resultat, hvis formanden for komitéen træffer beslutning herom, eller et simpelt flertal af komitéens medlemmer anmoder herom inden for tidsfristen for afgivelse af udtalelse.
(
*3
)
  Europa-Parlamentets og Rådets forordning (EF) nr. 178/2002 af 28. januar 2002 om generelle principper og krav i fødevarelovgivningen, om oprettelse af Den Europæiske Fødevaresikkerhedsautoritet og om procedurer vedrørende fødevaresikkerhed (
EFT L 31 af 1.2.2002, s. 1
)."
(
*4
)
  Europa-Parlamentets og Rådets forordning (EU) nr. 182/2011 af 16. februar 2011 om de generelle regler og principper for, hvordan medlemsstaterne skal kontrollere Kommissionens udøvelse af gennemførelsesbeføjelser (
EUT L 55 af 28.2.2011, s. 13
).«
                                          "
Artikel 279
Eksisterende operatører og virksomheder
1.   Virksomheder og operatører, som er registreret eller godkendt i overensstemmelse med direktiv 64/432/EØF, direktiv 88/407/EØF, direktiv 89/556/EØF, direktiv 90/429/EØF, direktiv 91/68/EØF, direktiv 92/65/EØF, forordning (EF) nr. 1760/2000, forordning (EF) nr. 21/2004, direktiv 2006/88/EF, direktiv 2008/71/EF, direktiv 2009/156/EF eller direktiv 2009/158/EF inden datoen for anvendelse af nærværende forordning, anses for at være registreret eller godkendt, alt efter hvad der kræves, i henhold til denne forordning og er som sådan omfattet af de relevante forpligtelser fastsat i denne forordning.
2.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende regler, der er nødvendige for at sikre en problemfri overgang fra de gældende regler inden denne forordning, jf. nærværende artikels stk. 1, navnlig for at beskytte berørte fysiske og juridiske personers erhvervede rettigheder og berettigede forventninger.
Artikel 280
Eksisterende sygdomsfrie medlemsstater, zoner og kompartmenter samt eksisterende udryddelses- og overvågningsprogrammer i medlemsstaterne
1.   Medlemsstater og zoner med godkendt status som sygdomsfri for en eller flere af de i artikel 9, stk. 1, litra b) og c), omhandlede listeopførte sygdomme for en eller flere af de relevante dyrearter i henhold til direktiv 64/432/EØF, direktiv 91/68/EØF, direktiv 92/65/EØF, direktiv 2006/88/EF, direktiv 2009/156/EF eller direktiv 2009/158/EF anses for at have godkendt status som sygdomsfri i henhold til denne forordning og er som sådan underlagt de relevante forpligtelser i denne forordning.
2.   Medlemsstater og zoner med et godkendt udryddelses- eller overvågningsprogram for en eller flere af de i artikel 9, stk. 1, litra b) og c), omhandlede listeopførte sygdomme for en eller flere af de relevante dyrearter i henhold til direktiv 64/432/EØF, direktiv 91/68/EØF, direktiv 92/65/EØF, direktiv 2006/88/EF, direktiv 2009/156/EF eller direktiv 2009/158/EF anses for at have et godkendt udryddelsesprogram i henhold til denne forordning og er som sådan underlagt de relevante forpligtelser i denne forordning.
3.   Godkendte kompartmenter med godkendt status som sygdomsfri for en eller flere af de i artikel 9, stk. 1, litra a), b) eller c), omhandlede listeopførte sygdomme i henhold til direktiv 2005/94/EF og 2006/88/EF anses for at have anerkendt status som sygdomsfri i henhold til artikel 37 i denne forordning og er som sådan underlagt de relevante forpligtelser i denne forordning.
4.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 264 vedrørende regler, der er nødvendige for at sikre en problemfri overgang fra de gældende regler inden denne forordning, jf. stk. 1, 2 og 3.
Artikel 281
Forbindelse med retsakter om offentlig kontrol
I tilfælde af konflikt mellem bestemmelserne i denne forordning og bestemmelserne i forordning (EF) nr. 882/2004 og Rådets direktiv 89/608/EØF 
(
66
)
, 89/662/EØF, 90/425/EØF, 91/496/EØF, 96/93/EF 
(
67
)
 og 97/78/EF samt beslutning 92/438/EØF gælder bestemmelserne i nærværende forordning.
Artikel 282
Evaluering
Kommissionen evaluerer denne forordning sammen med de i artikel 264 omhandlede delegerede retsakter og forelægger resultaterne af denne evaluering i en rapport til Europa-Parlamentet og Rådet senest den 22. april 2026.
Artikel 283
Ikrafttræden og anvendelse
Denne forordning træder i kraft på tyvendedagen efter offentliggørelsen i 
Den Europæiske Unions Tidende
.
Den anvendes fra den 21. april 2021, bortset fra artikel 270, stk. 1, og artikel 274, der anvendes fra ikrafttrædelsesdatoen.
Denne forordning er bindende i alle enkeltheder og gælder umiddelbart i hver medlemsstat.
Udfærdiget i Strasbourg, den 9. marts 2016.
På Europa-Parlamentets vegne
M. SCHULZ
Formand
På Rådets vegne
J.A.HENNIS-PLASSCHAERT
Formand
(
1
)
  
            
EUT C 170 af 5.6.2014, s. 104
.
(
2
)
  Europa-Parlamentets holdning af 15.4.2014 (endnu ikke offentliggjort i EUT) og Rådets førstebehandlingsholdning af 14.12.2015.
(
3
)
  Europa-Parlamentets og Rådets forordning (EU) nr. 652/2014 af 15. maj 2014 om bestemmelser vedrørende forvaltning af udgifter i tilknytning til fødevarekæden, dyresundhed og dyrevelfærd samt til plantesundhed og planteformeringsmateriale, om ændring af Rådets direktiv 98/56/EF, 2000/29/EF og 2008/90/EF, Europa-Parlamentets og Rådets forordning (EF) nr. 178/2002, (EF) nr. 882/2004 og (EF) nr. 396/2005 og Europa-Parlamentets og Rådets direktiv 2009/128/EF og Europa-Parlamentets og Rådets forordning (EF) nr. 1107/2009 og om ophævelse af Rådets afgørelse 66/399/EØF, afgørelse 76/894/EØF og beslutning 2009/470/EF (
EUT L 189 af 27.6.2014, s. 1
).
(
4
)
  Europa-Parlamentets og Rådets forordning (EF) nr. 882/2004 af 29. april 2004 om offentlig kontrol med henblik på verifikation af, at foderstof- og fødevarelovgivningen samt dyresundheds- og dyrevelfærdsbestemmelserne overholdes (
EUT L 165 af 30.4.2004, s. 1
).
(
5
)
  Rådets direktiv 89/662/EØF af 11. december 1989 om veterinærkontrol i samhandelen i Fællesskabet med henblik på gennemførelse af det indre marked (
EFT L 395 af 30.12.1989, s. 13
).
(
6
)
  Rådets direktiv 90/425/EØF af 26. juni 1990 om veterinærkontrol og zooteknisk kontrol i samhandelen med visse levende dyr og produkter inden for Fællesskabet med henblik på gennemførelse af det indre marked (
EFT L 224 af 18.8.1990, s. 29
).
(
7
)
  Rådets direktiv 91/496/EØF af 15. juli 1991 om fastsættelse af principperne for tilrettelæggelse af veterinærkontrollen for dyr, der føres ind i Fællesskabet fra tredjelande, og om ændring af direktiv 89/662/EØF, 90/425/EØF og 90/675/EØF (
EFT L 268 af 24.9.1991, s. 56
).
(
8
)
  Rådets direktiv 97/78/EF af 18. december 1997 om fastsættelse af principperne for tilrettelæggelse af veterinærkontrollen for tredjelandsprodukter, der føres ind i Fællesskabet (
EFT L 24 af 30.1.1998, s. 9
).
(
9
)
  Rådets forordning (EF) nr. 1/2005 af 22. december 2004 om beskyttelse af dyr under transport og dermed forbundne aktiviteter og om ændring af direktiv 64/432/EØF og 93/119/EF og forordning (EF) nr. 1255/97 (
EUT L 3 af 5.1.2005, s. 1
).
(
10
)
  Rådets forordning (EF) nr. 1099/2009 af 24. september 2009 om beskyttelse af dyr på aflivningstidspunktet (
EUT L 303 af 18.11.2009, s. 1
).
(
11
)
  Europa-Parlamentets og Rådets forordning (EF) nr. 178/2002 af 28. januar 2002 om generelle principper og krav i fødevarelovgivningen, om oprettelse af Den Europæiske Fødevaresikkerhedsautoritet og om procedurer vedrørende fødevaresikkerhed (
EFT L 31 af 1.2.2002, s. 1
).
(
12
)
  Europa-Parlamentets og Rådets forordning (EF) nr. 1069/2009 af 21. oktober 2009 om sundhedsbestemmelser for animalske biprodukter og afledte produkter, som ikke er bestemt til konsum, og om ophævelse af forordning (EF) nr. 1774/2002 (forordningen om animalske biprodukter) (
EUT L 300 af 14.11.2009, s. 1
).
(
13
)
  Europa-Parlamentets og Rådets forordning (EF) nr. 999/2001 af 22. maj 2001 om fastsættelse af regler for forebyggelse af, kontrol med og udryddelse af visse transmissible spongiforme encephalopatier (
EFT L 147 af 31.5.2001, s. 1
).
(
14
)
  Europa-Parlamentets og Rådets direktiv 2003/99/EF af 17. november 2003 om overvågning af zoonoser og zoonotiske agenser, om ændring af Rådets beslutning 90/424/EØF og om ophævelse af Rådets direktiv 92/117/EØF (
EUT L 325 af 12.12.2003, s. 31
).
(
15
)
  Europa-Parlamentets og Rådets forordning (EF) nr. 2160/2003 af 17. november 2003 om bekæmpelse af salmonella og andre bestemte fødevarebårne zoonotiske agenser (
EUT L 325 af 12.12.2003, s. 1
).
(
16
)
  Europa-Parlamentets og Rådets afgørelse nr. 1082/2013/EU af 22. oktober 2013 om alvorlige grænseoverskridende sundhedstrusler og om ophævelse af beslutning nr. 2119/98/EF (
EUT L 293 af 5.11.2013, s. 1
).
(
17
)
  Rådets direktiv 2006/88/EF af 24. oktober 2006 om dyresundhedsbestemmelser for akvakulturdyr og produkter deraf og om forebyggelse og bekæmpelse af visse sygdomme hos vanddyr (
EUT L 328 af 24.11.2006, s. 14
).
(
18
)
  Rådets direktiv 92/65/EØF af 13. juli 1992 om dyresundhedsmæssige betingelser for samhandel med og indførsel til Fællesskabet af dyr samt sæd, æg og embryoner, der for så vidt angår disse betingelser ikke er underlagt specifikke fællesskabsbetingelser som omhandlet i bilag A, del I, til direktiv 90/425/EØF (
EFT L 268 af 14.9.1992, s. 54
).
(
19
)
  Europa-Parlamentets og Rådets direktiv 2010/63/EU af 22. september 2010 om beskyttelse af dyr, der anvendes til videnskabelige formål (
EUT L 276 af 20.10.2010, s. 33
).
(
20
)
  Rådets direktiv 64/432/EØF af 26. juni 1964 om veterinærpolitimæssige problemer ved handel inden for Fællesskabet med kvæg og svin (
EFT 121 af 29.7.1964, s. 1977/64
).
(
21
)
  Rådets direktiv 91/68/EØF af 28. januar 1991 om dyresundhedsmæssige betingelser for samhandelen med får og geder inden for Fællesskabet (
EFT L 46 af 19.2.1991, s. 19
).
(
22
)
  Rådets direktiv 2009/156/EF af 30. november 2009 om dyresundhedsmæssige betingelser for enhovede dyrs bevægelser og indførsel af enhovede dyr fra tredjelande (
EUT L 192 af 23.7.2010, s. 1
).
(
23
)
  Rådets direktiv 2009/158/EF af 30. november 2009 om dyresundhedsmæssige betingelser for samhandelen inden for Fællesskabet med fjerkræ og rugeæg samt for indførsel heraf fra tredjelande (
EUT L 343 af 22.12.2009, s. 74
).
(
24
)
  Rådets beslutning 92/438/EØF af 13. juli 1992 om datamatisering af veterinærprocedurerne ved indførsel (SHIFT-projektet), om ændring af direktiv 90/675/EØF, 91/496/EØF og 91/628/EØF samt beslutning 90/424/EØF og om ophævelse af beslutning 88/192/EØF (
EFT L 243 af 25.8.1992, s. 27
).
(
25
)
  Kommissionens beslutning 2003/24/EF af 30. december 2002 om udvikling af et integreret veterinærinformationssystem (
EFT L 8 af 14.1.2003, s. 44
).
(
26
)
  Kommissionens beslutning 2004/292/EF af 30. marts 2004 om anvendelse af Traces-systemet og om ændring af beslutning 92/486/EØF (
EUT L 94 af 31.3.2004, s. 63
).
(
27
)
  Europa-Parlamentets og Rådets direktiv 98/34/EF af 22. juni 1998 om en informationsprocedure med hensyn til tekniske standarder og forskrifter samt forskrifter for informationssamfundets tjenester (
EFT L 204 af 21.7.1998, s. 37
).
(
28
)
  Rådets direktiv 77/391/EØF af 17. maj 1977 om indførelse af en fællesskabsaktion med henblik på udryddelse af brucellose, tuberkulose og leukose hos kvæg (
EFT L 145 af 13.6.1977, s. 44
).
(
29
)
  Rådets direktiv 78/52/EØF af 13. december 1977 om fastsættelse af fællesskabskriterier for nationale planer til fremme af udryddelse af brucellose, tuberkulose og enzootisk leukose hos kvæg (
EFT L 15 af 19.1.1978, s. 34
).
(
30
)
  Rådets direktiv 80/1095/EØF af 11. november 1980 om bekæmpelse af klassisk svinepest på Fællesskabets område og om vedvarende beskyttelse mod sygdommen (
EFT L 325 af 1.12.1980, s. 1
).
(
31
)
  Rådets direktiv 82/894/EØF af 21. december 1982 om anmeldelse af dyresygdomme inden for Fællesskabet (
EFT L 378 af 31.12.1982, s. 58
).
(
32
)
  Rådets direktiv 88/407/EØF af 14. juni 1988 om fastsættelse af de veterinærpolitimæssige krav i forbindelse med handelen inden for Fællesskabet med tyresæd og indførsel heraf (
EFT L 194 af 22.7.1988, s. 10
).
(
33
)
  Rådets direktiv 89/556/EØF af 25. september 1989 om fastsættelse af veterinærpolitimæssige betingelser i forbindelse med handel inden for Fællesskabet med embryoner af tamkvæg samt med indførsel heraf fra tredjelande (
EFT L 302 af 19.10.1989, s. 1
).
(
34
)
  Rådets direktiv 90/429/EØF af 26. juni 1990 om fastsættelse af de dyresundhedsmæssige krav i forbindelse med handelen inden for Fællesskabet med ornesæd og indførsel heraf (
EFT L 224 af 18.8.1990, s. 62
).
(
35
)
  Rådets beslutning 91/666/EØF af 11. december 1991 om oprettelse af EF-beredskabslagre af mund- og klovesygevacciner (
EFT L 368 af 31.12.1991, s. 21
).
(
36
)
  Rådets direktiv 92/35/EØF af 29. april 1992 om fastsættelse af regler for kontrol med og foranstaltninger til bekæmpelse af hestepest (
EFT L 157 af 10.6.1992, s. 19
).
(
37
)
  Rådets direktiv 92/66/EØF af 14. juli 1992 om fællesskabsforanstaltninger til bekæmpelse af Newcastle disease (
EFT L 260 af 5.9.1992, s. 1
).
(
38
)
  Rådets direktiv 92/118/EØF af 17. december 1992 om dyresundhedsmæssige og sundhedsmæssige betingelser for samhandel med og indførsel til Fællesskabet af produkter, der for så vidt angår disse betingelser ikke er underlagt specifikke fællesskabsbestemmelser, som omhandlet i bilag A, kapitel I, i direktiv 89/662/EØF, og for så vidt angår patogener, i direktiv 90/425/EØF (
EFT L 62 af 15.3.1993, s. 49
).
(
39
)
  Rådets direktiv 92/119/EØF af 17. december 1992 om generelle fællesskabsforanstaltninger til bekæmpelse af visse dyresygdomme samt om specifikke foranstaltninger vedrørende blæreudslæt hos svin (
EFT L 62 af 15.3.1993, s. 69
).
(
40
)
  Rådets beslutning 95/410/EF af 22. juni 1995 om fastsættelse af regler for mikrobiologisk undersøgelse af stikprøver på oprindelsesbedriften af slagtefjerkræ bestemt til Finland og Sverige (
EFT L 243 af 11.10.1995, s. 25
).
(
41
)
  Rådets direktiv 2000/75/EF af 20. november 2000 om vedtagelse af specifikke bestemmelser vedrørende foranstaltninger til bekæmpelse og udryddelse af bluetongue hos får (
EFT L 327 af 22.12.2000, s. 74
).
(
42
)
  Rådets beslutning 2000/258/EF af 20. marts 2000 om udpegning af et institut, der skal opstille de nødvendige kriterier for standardisering af serologiske test til kontrol af rabiesvacciners virkning (
EFT L 79 af 30.3.2000, s. 40
).
(
43
)
  Rådets direktiv 2001/89/EF af 23. oktober 2001 om EF-foranstaltninger til bekæmpelse af klassisk svinepest (
EFT L 316 af 1.12.2001, s. 5
).
(
44
)
  Rådets direktiv 2002/60/EF af 27. juni 2002 om specifikke bestemmelser for bekæmpelse af afrikansk svinepest og om ændring af direktiv 92/119/EØF for så vidt angår Teschenersyge og afrikansk svinepest (
EFT L 192 af 20.7.2002, s. 27
).
(
45
)
  Rådets direktiv 2002/99/EF af 16. december 2002 om dyresundhedsbestemmelser for produktion, tilvirkning, distribution og indførsel af animalske produkter til konsum (
EFT L 18 af 23.1.2003, s. 11
).
(
46
)
  Rådets direktiv 2003/85/EF af 29. september 2003 om EF-foranstaltninger til bekæmpelse af mund- og klovesyge, om ophævelse af direktiv 85/511/EØF og beslutning 89/531/EØF og 91/665/EØF og om ændring af direktiv 92/46/EØF (
EUT L 306 af 22.11.2003, s. 1
).
(
47
)
  Rådets forordning (EF) nr. 21/2004 af 17. december 2003 om indførelse af en ordning for identifikation og registrering af får og geder og om ændring af forordning (EF) nr. 1782/2003 og direktiv 92/102/EØF og 64/432/EØF (
EUT L 5 af 9.1.2004, s. 8
).
(
48
)
  Rådets direktiv 2004/68/EF af 26. april 2004 om dyresundhedsbestemmelser for import til og transit gennem Fællesskabet af visse levende hovdyr, om ændring af direktiv 90/426/EØF og 92/65/EØF og om ophævelse af direktiv 72/462/EØF (
EUT L 139 af 30.4.2004, s. 321
).
(
49
)
  Rådets direktiv 2005/94/EF af 20. december 2005 om fællesskabsforanstaltninger til bekæmpelse af aviær influenza og om ophævelse af direktiv 92/40/EØF (
EUT L 10 af 14.1.2006, s. 16
).
(
50
)
  Rådets direktiv 2008/71/EF af 15. juli 2008 om identifikation og registrering af svin (
EUT L 213 af 8.8.2008, s. 31
).
(
51
)
  Europa-Parlamentets og Rådets forordning (EU) nr. 576/2013 af 12. juni 2013 om ikkekommerciel flytning af selskabsdyr og om ophævelse af forordning (EF) nr. 998/2003 (
EUT L 178 af 28.6.2013, s. 1
).
(
52
)
  Europa-Parlamentets og Rådets forordning (EF) nr. 1760/2000 af 17. juli 2000 om indførelse af en ordning for identifikation og registrering af kvæg og om mærkning af oksekød og oksekødsprodukter og om ophævelse af Rådets forordning (EF) nr. 820/97 (
EFT L 204 af 11.8.2000, s. 1
).
(
53
)
  Rådets beslutning 78/642/EØF af 25. juli 1978 om sundhedsbeskyttelsesforanstaltninger over for Republikken Botswana (
EFT L 213 af 3.8.1978, s. 15
).
(
54
)
  Rådets direktiv 79/110/EØF af 24. januar 1979 om bemyndigelse til Den Italienske Republik til at udsætte fremsendelsen og iværksættelsen af dens nationale planer for fremskyndet udryddelse af brucellose og tuberkulose hos kvæg (
EFT L 29 af 3.2.1979, s. 24
).
(
55
)
  Rådets direktiv 81/6/EØF af 1. januar 1981 om bemyndigelse af Grækenland til at forelægge og iværksætte nationale planer for fremskyndet udryddelse af brucellose og tuberkulose hos kvæg (
EFT L 14 af 16.1.1981, s. 22
).
(
56
)
  Rådets beslutning 89/455/EØF af 24. juli 1989 om indførelse af en fællesskabsaktion for iværksættelse af pilotprojekter til bekæmpelse af rabies med henblik på udryddelse eller forebyggelse heraf (
EFT L 223 af 2.8.1989, s. 19
).
(
57
)
  Rådets direktiv 90/423/EØF af 26. juni 1990 om ændring af direktiv 85/511/EØF om fællesskabsforanstaltninger til bekæmpelse af mund- og klovesyge, direktiv 64/432/EØF om veterinærpolitimæssige problemer ved handel inden for Fællesskabet med kvæg og svin og direktiv 72/462/EØF om sundhedsmæssige og veterinærpolitimæssige problemer i forbindelse med indførsel af kvæg og svin samt fersk kød og kødprodukter fra tredjelande (
EFT L 224 af 18.8.1990, s. 13
).
(
58
)
  Rådets beslutning 90/678/EØF af 13. december 1990 om erklæring af visse dele af Fællesskabets område officielt fri for svinepest eller fri for svinepest (
EFT L 373 af 31.12.1990, s. 29
).
(
59
)
  Rådets direktiv 92/36/EØF af 29. april 1992 om ændring for så vidt angår hestepest af direktiv 90/426/EØF om dyresundhedsmæssige betingelser for enhovede dyrs bevægelser og indførsel af enhovede dyr fra tredjelande (
EFT L 157 af 10.6.1992, s. 28
).
(
60
)
  Rådets direktiv 98/99/EF af 14. december 1998 om ændring af direktiv 97/12/EF om ændring og ajourføring af direktiv 64/432/EØF om veterinærpolitimæssige problemer ved handel inden for Fællesskabet med kvæg og svin (
EFT L 358 af 31.12.1998, s. 107
).
(
61
)
  Europa-Parlamentets og Rådets forordning (EU) nr. 182/2011 af 16. februar 2011 om de generelle regler og principper for, hvordan medlemsstaterne skal kontrollere Kommissionens udøvelse af gennemførelsesbeføjelser (
EUT L 55 af 28.2.2011, s. 13
).
(
62
)
  Europa-Parlamentets og Rådets forordning (EF) nr. 853/2004 af 29. april 2004 om særlige hygiejnebestemmelser for animalske fødevarer (
EUT L 139 af 30.4.2004, s. 55
).
(
63
)
  Rådets forordning (EF) nr. 338/97 af 9. december 1996 om beskyttelse af vilde dyr og planter ved kontrol af handelen hermed (
EFT L 61 af 3.3.1997, s. 1
).
(
64
)
  Europa-Parlamentets og Rådets direktiv 95/46/EF af 24. oktober 1995 om beskyttelse af fysiske personer i forbindelse med behandling af personoplysninger og om fri udveksling af sådanne oplysninger (
EFT L 281 af 23.11.1995, s. 31
).
(
65
)
  Europa-Parlamentets og Rådets forordning (EF) nr. 45/2001 af 18. december 2000 om beskyttelse af fysiske personer i forbindelse med behandling af personoplysninger i fællesskabsinstitutionerne og -organerne og om fri udveksling af sådanne oplysninger (
EFT L 8 af 12.1.2001, s. 1
).
(
66
)
  Rådets direktiv 89/608/EØF af 21. november 1989 om gensidig bistand mellem medlemsstaternes administrative myndigheder og om samarbejde mellem disse og Kommissionen med henblik på at sikre den rette anvendelse af de veterinære og zootekniske bestemmelser (
EFT L 351 af 2.12.1989, s. 34
).
(
67
)
  Rådets direktiv 96/93/EF af 17. december 1996 om udstedelse af certifikater for dyr og animalske produkter (
EFT L 13 af 16.1.1997, s. 28
).
BILAG I
ARTER AF SELSKABSDYR
DEL A
Hunde (
Canis lupus familiaris
)
Katte (
Felis silvestris catus
)
Fritter (
Mustela putorius furo
).
DEL B
Hvirvelløse dyr (bortset fra bier, bløddyr, der tilhører rækken 
Mollusca
, og krebsdyr, der tilhører underrækken 
Crustacea
)
Vandlevende pryddyr
Padder
Krybdyr
Fugle: andre fuglearter end høns, kalkuner, perlehøns, ænder, gæs, vagtler, duer, fasaner, agerhøns og strudsfugle (
Ratitae
)
Pattedyr: gnavere og kaniner, som ikke er bestemt til fødevareproduktion.
BILAG II
LISTE OVER SYGDOMME
—
Kvægpest
—
Fåre- og gedepest
—
Smitsomt blæreudslæt hos svin
—
Bluetongue
—
Smitsom svinelammelse
—
Fåre- og gedekopper
—
Rift Valley-feber
—
Lumpy skin disease
—
Vesikulær stomatitis
—
Venezuelansk hesteencephalomyelitis
—
Epizootisk hæmoragi hos hjorte
—
Oksens ondartede lungesyge
—
Newcastle disease
—
Tuberkulose hos kvæg
—
Brucellose hos kvæg (
B. abortus
)
—
Brucellose hos får og geder (
B. melitensis
)
—
Miltbrand
—
Rabies
—
Hydatidose (ekinokokkose)
—
Transmissibel spongiform encephalopati (TSE)
—
Campylobacteriose
—
Listeriose
—
Salmonellose (zoonotisk salmonella)
—
Trikinose
—
Verotoksinproducerende 
E. coli
—
Viral hæmoragisk septikæmi (VHS) (Egtvedsyge)
—
Infektiøs hæmatopoietisk nekrose (IHN)
—
Epizootisk hæmatopoietisk nekrose hos fisk (EHN)
—
Epizootisk ulcerativt syndrom hos fisk (EUS)
—
Infektion med 
Bonamia exitiosa
—
Infektion med 
Perkinsus marinus
—
Infektion med 
Microcytos mackini
—
Taura-syndrom hos krebsdyr
—
Yellow head disease hos krebsdyr
—
Koi-herpesvirus-sygdom
—
Infektiøs lakseanæmi
—
Infektion med 
Marteilia refringens
—
Infektion med 
Bonamia ostreae
—
White spot disease hos krebsdyr.
BILAG III
ARTER AF HOVDYR
Klassifikation
Orden
Familie
Slægt/art
Perissodactyla
Equidae
Equus
 spp.
Tapiridae
Tapirus
 spp.
Rhinoceritidae
Ceratotherium
 spp., 
Dicerorhinus
 spp., 
Diceros
 spp. og 
Rhinoceros
 spp.
Artiodactyla
Antilocapridae
Antilocapra
 ssp.
Bovidae
Addax
 ssp., 
Aepyceros
 ssp., 
Alcelaphus
 ssp., 
Ammelaphus
 ssp., 
Ammodorcas
 ssp., 
Ammotragus
 ssp., 
Antidorcas
 ssp., 
Antilope
 ssp., 
Arbitragus
 ssp., 
Beatragus
 ssp., 
Bison
 ssp., 
Bos
 ssp. (herunder 
Bibos, Novibos
 og 
Poephagus
), 
Boselaphus
 ssp., 
Bubalus
 ssp. (herunder 
Anoa
), 
Budorcas
 ssp., 
Capra
 ssp., 
Cephalophus
 ssp., 
Connochaetes
 ssp., 
Damaliscus
 ssp. (herunder 
Beatragus
), 
Dorcatragus
 ssp., 
Eudorcas
 ssp., 
Gazella
 ssp., 
Hemitragus
 ssp., 
Hippotragus
 ssp., 
Kobus
 ssp., 
Litocranius
 ssp., 
Madoqua
 ssp., 
Naemorhedus
 ssp. (herunder 
Nemorhaedus
 og 
Capricornis
), 
Nanger
 ssp., 
Neotragus
 ssp., 
Nilgiritragus
 ssp., 
Oreamnos
 ssp., 
Oreotragus
 ssp., 
Oryx
 ssp., 
Ourebia
 ssp., 
Ovibos
 ssp., 
Ovis
 ssp., 
Pantholops
 ssp., 
Philantomba
 ssp., 
Pelea
 ssp., 
Procapra
 ssp., 
Pseudois
 ssp., 
Pseudoryx
 ssp., 
Raphicerus
 ssp., 
Redunca
 ssp., 
Rupicapra
 ssp., 
Saiga
 ssp., 
Sigmoceros-Alecelaphus
 ssp., 
Strepticeros
 ssp., 
Sylvicapra
 ssp., 
Syncerus
 ssp., 
Taurotragus
 ssp., 
Tetracerus
 ssp. og 
Tragelaphus
 ssp. (herunder 
Boocerus
)
Camelidae
Camelus
 ssp., 
Lama
 ssp. og 
Vicugna
 ssp.
Cervidae
Alces
 ssp., 
Axis-Hyelaphus
 ssp., 
Blastocerus
 ssp., 
Capreolus
 ssp., 
Cervus
 ssp., 
Dama
 ssp., 
Elaphodus
 ssp., 
Elaphurus
 ssp., 
Hippocamelus
 ssp., 
Hydropotes
 ssp., 
Mazama
 ssp., 
Megamuntiacus
 ssp., 
Muntiacus
 ssp., 
Odocoileus
 ssp., 
Ozotoceros
 ssp., 
Przewalskium
 ssp., 
Pudu
 ssp., 
Rangifer
 ssp., 
Rucervus
 ssp. og 
Rusa
 ssp.
Giraffidae
Giraffa
 ssp. og 
Okapia
 ssp.
Hippopotamidae
Hexaprotodon-Choeropsis
 ssp. og 
Hippopotamus
 ssp.
Moschidae
Moschus
 spp.
Suidae
Babyrousa
 ssp., 
Hylochoerus
 ssp., 
Phacochoerus
 ssp., 
Porcula
 ssp., 
Potamochoerus
 ssp. 
og Sus
 ssp.
Tayassuidae
Catagonus
 ssp. og 
Pecari-Tayassu
 ssp.
Tragulidae
Hyemoschus
 ssp. og 
Tragulus-Moschiola
 ssp.
Proboscidea
Elephantidae
Elephas
 ssp. og 
Loxodonta
 ssp.
BILAG IV
KRITERIER FOR ANVENDELSE AF SYGDOMSFOREBYGGELSES- OG -BEKÆMPELSESREGLERNE I ARTIKEL 9, STK. 1, PÅ SYGDOMME, SOM ER LISTEOPFØRT I HENHOLD TIL ARTIKEL 5
Formålet med dette bilag er at fastlægge de kriterier, som Kommissionen skal tage i betragtning, når den beslutter, hvilke sygdomsforebyggelses- og -bekæmpelsesregler der skal finde anvendelse på de forskellige kategorier af listeopførte sygdomme i henhold til artikel 5.
Kategoriseringen skal tage hensyn til den pågældende sygdoms profil, omfanget af virkningerne af sygdommen på dyre- og folkesundheden, dyrevelfærden og økonomien samt tilgængeligheden, gennemførligheden og effektiviteten af diagnosticeringsredskaberne og de forskellige sygdomsforebyggelses- og -bekæmpelsesforanstaltninger i denne forordning for så vidt angår den pågældende sygdom.
Afdeling 1
Kriterier for anvendelse af sygdomsforebyggelses- og -bekæmpelsesreglerne i artikel 9, stk. 1, litra a)
De sygdomme, som sygdomsforebyggelses- og -bekæmpelsesreglerne i artikel 9, stk. 1, litra a), finder anvendelse på, skal anses for at have de mest alvorlige dyresundhedsmæssige, folkesundhedsmæssige, økonomiske, sociale eller miljømæssige indvirkninger på Unionen. De pågældende sygdomme skal opfylde følgende kriterier:
a)
den pågældende sygdom
i)
forekommer ikke på Unionens område eller
ii)
forekommer kun i særlige tilfælde (uregelmæssig introduktion) eller
iii)
forekommer kun på en meget begrænset del af Unionens område
og
b)
den pågældende sygdom er meget let overførbar; ud over direkte og indirekte overførsel kan der også være mulighed for luftbåren, vandbåren eller vektorbåren spredning. Sygdommen kan ramme flere arter af opdrættede og vildtlevende dyr eller en enkelt art af opdrættede dyr af økonomisk betydning, og den kan medføre høj sygelighed og betydelig dødelighed.
Ud over kriterierne i litra a) og b) skal de pågældende sygdomme opfylde et eller flere af følgende kriterier:
c)
Den pågældende sygdom har zoonotisk potentiale med betydelige konsekvenser for folkesundheden, herunder epidemisk eller pandemisk potentiale eller en mulig betydelig risiko for fødevaresikkerheden.
d)
Den pågældende sygdom har betydelig indvirkning på Unionens økonomi og medfører store omkostninger, hovedsaglig knyttet til dens direkte indvirkning på dyrs sundhed og produktivitet.
e)
Den pågældende sygdom har betydelig indvirkning på et eller flere af følgende områder:
i)
samfundet, navnlig indvirkning på arbejdsmarkedet
ii)
dyrevelfærden ved at være årsag til lidelser for et stort antal dyr
iii)
miljøet pga. sygdommens direkte indvirkning eller pga. de foranstaltninger, der er truffet for at bekæmpe den
iv)
på lang sigt biodiversiteten eller beskyttelsen af truede arter eller racer, herunder eventuelt forsvinden af eller langsigtede skader på de pågældende arter eller racer.
Afdeling 2
Kriterier for anvendelse af sygdomsforebyggelses- og -bekæmpelsesreglerne i artikel 9, stk. 1, litra b)
De sygdomme, som sygdomsforebyggelses- og -bekæmpelsesreglerne i artikel 9, stk. 1, litra b), finder anvendelse på, skal bekæmpes i alle medlemsstaterne med det formål at udrydde sygdommene overalt i Unionen.
De pågældende sygdomme skal opfylde følgende kriterier:
a)
den pågældende sygdom har endemisk karakter og forekommer på hele eller dele af Unionens område. Flere medlemsstater eller zoner i Unionen er imidlertid frie for sygdommen, og
b)
sygdommen er moderat til meget let overførbar; ud over direkte og indirekte overførsel kan der også være mulighed for luftbåren, vandbåren eller vektorbåren spredning. Den kan ramme en enkelt eller flere dyrearter og kan medføre høj sygelighed og har generelt lav dødelighed.
Ud over kriterierne i litra a) og b) skal de pågældende sygdomme opfylde et eller flere af følgende kriterier:
c)
Den pågældende sygdom har zoonotisk potentiale med betydelige konsekvenser for folkesundheden, herunder epidemisk potentiale eller en mulig betydelig risiko for fødevaresikkerheden.
d)
Den pågældende sygdom har betydelig indvirkning på Unionens økonomi og medfører store omkostninger, hovedsaglig knyttet til dens direkte indvirkning på dyrs sundhed og produktivitet.
e)
Den pågældende sygdom har betydelig indvirkning på et eller flere af følgende områder:
i)
samfundet, navnlig indvirkning på arbejdsmarkedet
ii)
dyrevelfærden ved at være årsag til lidelser for et stort antal dyr
iii)
miljøet pga. sygdommens direkte indvirkning eller pga. de foranstaltninger, der er truffet for at bekæmpe den
iv)
på lang sigt biodiversiteten eller beskyttelsen af truede arter eller racer, herunder eventuelt forsvinden af eller langsigtede skader på de pågældende arter eller racer.
En sygdom, som foranstaltningerne i artikel 9, stk. 1, litra a), finder anvendelse på, som ikke effektivt og hurtigt er blevet udryddet i en del af Unionen, og som i den pågældende del af Unionen har fået endemisk karakter, kan være genstand for sygdomsforebyggelses- og -bekæmpelsesforanstaltningerne i artikel 9, stk. 1, litra b), i denne del af Unionen.
Afdeling 3
Kriterier for anvendelse af sygdomsforebyggelses- og -bekæmpelsesreglerne i artikel 9, stk. 1, litra c)
De sygdomme, som sygdomsforebyggelses- og -bekæmpelsesreglerne i artikel 9, stk. 1, litra c), finder anvendelse på, er af relevans for nogle medlemsstater, og der er behov for foranstaltninger for at forhindre dem i at spredes til dele af Unionen, som officielt er sygdomsfrie, eller som har udryddelsesprogrammer for de pågældende listeopførte sygdomme.
De pågældende sygdomme skal opfylde følgende kriterier:
a)
blandt landdyr har den pågældende sygdom endemisk karakter og forekommer på hele eller i dele af Unionens område, eller blandt akvatiske dyr er flere medlemsstater eller zoner i Unionen frie for den pågældende sygdom, og
b)
i)
blandt landdyr er den pågældende sygdom moderat til meget let overførbar, hovedsaglig ved direkte og indirekte overførsel. Sygdommen rammer hovedsaglig en enkelt eller flere dyrearter og medfører som regel ikke høj sygelighed og har ubetydelig eller ingen dødelighedsrate. Ofte er produktionstab den hyppigst observerede virkning
ii)
blandt akvatiske dyr er den pågældende sygdom moderat til meget let overførbar, hovedsaglig ved direkte og indirekte overførsel. Sygdommen rammer en enkelt eller flere dyrearter, kan medføre høj sygelighed og har som regel lav dødelighed. Ofte er produktionstab den hyppigst observerede virkning.
Ud over kriterierne i litra a) og b) skal de pågældende sygdomme opfylde et eller flere af følgende kriterier:
c)
Den pågældende sygdom har zoonotisk potentiale med betydelige konsekvenser for folkesundheden eller udgør en mulig risiko for fødevaresikkerheden.
d)
Den pågældende sygdom har betydelig indvirkning på økonomien i dele af Unionen, hovedsaglig som følge af dens direkte indvirkning på visse typer af dyreproduktionssystemer.
e)
Den pågældende sygdom har betydelig indvirkning på et eller flere af følgende områder:
i)
samfundet, navnlig indvirkning på arbejdsmarkedet
ii)
dyrevelfærden ved at være årsag til lidelser for et stort antal dyr
iii)
miljøet pga. sygdommens direkte indvirkning eller pga. de foranstaltninger, der er truffet for at bekæmpe den
iv)
på lang sigt biodiversiteten eller beskyttelsen af truede arter eller racer, herunder eventuelt forsvinden af eller langsigtede skader på de pågældende arter eller racer.
Afdeling 4
Kriterier for anvendelse af sygdomsforebyggelses- og -bekæmpelsesreglerne i artikel 9, stk. 1, litra d)
Sygdomsforebyggelses- og -bekæmpelsesreglerne i artikel 9, stk. 1, litra d), finder anvendelse på sygdomme, som opfylder kriterierne i afdeling 1, 2 eller 3, og på andre sygdomme, der opfylder kriterierne i afdeling 5, såfremt den risiko, som den pågældende sygdom udgør, effektivt og forholdsmæssigt kan begrænses gennem foranstaltninger vedrørende flytning af dyr og produkter med henblik på at forebygge eller begrænse forekomst og spredning af sygdommen.
Afdeling 5
Kriterier for anvendelse af sygdomsforebyggelses- og -bekæmpelsesreglerne i artikel 9, stk. 1, litra e)
Sygdomsforebyggelses- og -bekæmpelsesreglerne i artikel 9, stk. 1, litra e), finder anvendelse på sygdomme, som opfylder kriterierne i afdeling 1, 2 eller 3, og på andre sygdomme, hvor det er nødvendigt at overvåge den pågældende sygdom af hensyn til dyresundheden, dyrevelfærden, menneskers sundhed, økonomien, samfundet eller miljøet.
BILAG V
SAMMENLIGNINGSTABEL JF. ARTIKEL 270, STK. 2
1.   Direktiv 64/432/EØF
Direktiv 64/432/EØF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis), artikel 21, artikel 153, stk. 3, og artikel 220, stk. 3
Artikel 3, stk. 1
Artikel 124 og 126
Artikel 3, stk. 2
Artikel 124, stk. 2, artikel 126, stk. 1, og artikel 149, stk. 3 og 4
Artikel 4, stk. 1
Artikel 126, stk. 1, litra c)
Artikel 4, stk. 2 og 3
Artikel 125, stk. 1 og 2
Artikel 5, stk. 1
Artikel 143, stk. 1, og artikel 145 og 146
Artikel 5, stk. 2
Artikel 149, stk. 3 og 4
Artikel 5, stk. 2, litra a)
Artikel 147, litra a)
Artikel 5, stk. 2, litra b)
Artikel 144, stk. 1, litra b)
Artikel 5, stk. 3
—
Artikel 5, stk. 4
Artikel 153, stk. 1 og 2
Artikel 5, stk. 5
Artikel 147, litra a)
Artikel 6
Artikel 130, 131 og 132
Artikel 6a
—
Artikel 7
Artikel 126, stk. 1, litra c), artikel 132, artikel 134, litra a), og artikel 135
Artikel 8
Artikel 18, 19, 20 og artikel 23, stk. 1, litra a)
Artikel 9
Artikel 31, stk. 1, og stk. 3, litra a), og stk. 5, og artikel 32 og 33 og 36
Artikel 10
Artikel 31, stk. 2, og stk. 3, litra b), og artikel 32, 33 og 36
Artikel 11, stk. 1
Artikel 94, stk. 1, litra a), og artikel 97 og 98
Artikel 11, stk. 2
Artikel 102, 106 og 107
Artikel 11, stk. 3
Artikel 98 og 99
Artikel 11, stk. 4
Artikel 100
Artikel 11, stk. 5 og 6
Artikel 97, stk. 1, litra d), og stk. 2, litra d)
Artikel 12, stk. 1
Artikel 125
Artikel 12, stk. 2
Artikel 104 og 106
Artikel 12, stk. 3
Artikel 125, stk. 1, litra a) og b)
Artikel 12, stk. 4
Artikel 143
Artikel 12, stk. 5 og 6
—
Artikel 13, stk. 1 og 2
Artikel 90, 92 og artikel 93, stk. 1, litra c), og artikel 94, 97, 98, 99, 102, 106 og 107
Artikel 13, stk. 3
Artikel 100
Artikel 13, stk. 4
—
Artikel 13, stk. 5 og 6
Artikel 101
Artikel 14, stk. 1 og 2
—
Artikel 14, stk. 3, litra A og B
—
Artikel 14, stk. 3, litra C
Artikel 109, stk. 1, litra a) og c)
Artikel 14, stk. 4-6
—
Artikel 15, stk. 1
Artikel 268
Artikel 15, stk. 2-4
—
Artikel 16
—
Artikel 17
—
Artikel 17a
—
Artikel 18
Artikel 109, stk. 1, litra a) og c)
Artikel 19
—
Artikel 20
—
2.   Direktiv 77/391/EØF
Direktiv 77/391/EØF
Denne forordning
Artikel 1
—
Artikel 2, stk. 1
Artikel 31, stk. 1
Artikel 2, stk. 2
Artikel 32, 33 og artikel 36, stk. 1
Artikel 2, stk. 3
Artikel 34
Artikel 2, stk. 4
Artikel 36 og 41
Artikel 3, stk. 1
Artikel 31, stk. 1
Artikel 3, stk. 2
Artikel 32, 33 og artikel 36, stk. 1
Artikel 3, stk. 3
Artikel 34
Artikel 3, stk. 4
Artikel 36 og 41
Artikel 4
Artikel 31, stk. 1, og artikel 32, 33, 34, 36 og 41
Artikel 5
—
Artikel 6
—
Artikel 7
—
Artikel 8
—
Artikel 9
—
Artikel 10
—
Artikel 11
—
Artikel 12
—
Artikel 13
—
Artikel 14
—
Artikel 15
—
3.   Direktiv 78/52/EØF
Direktiv 78/52/EØF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3, stk. 1
Artikel 31, stk. 1, og artikel 32
Artikel 3, stk. 2
—
Artikel 3, stk. 3
—
Artikel 3, stk. 4
Artikel 31, stk. 1, og artikel 32
Artikel 4
Artikel 32, 35 og artikel 102, stk. 2 og 4, og artikel 112
Artikel 5
Artikel 18, 46 og 47
Artikel 6, stk. 1
Artikel 72-76
Artikel 6, stk. 2
Artikel 77 og 78
Artikel 6, stk. 3
Artikel 79 og 80
Artikel 7
Artikel 79 og 80
Artikel 8
Artikel 79 og 80
Artikel 9
Artikel 79 og 80
Artikel 10
Artikel 79 og 80
Artikel 11
Artikel 79 og 80
Artikel 12
Artikel 79 og 80
Artikel 13
Artikel 18, 46 og 47
Artikel 14, stk. 1
Artikel 72-76
Artikel 14, stk. 2
Artikel 77 og 78
Artikel 14, stk. 3
Artikel 79 og 80
Artikel 15
Artikel 79 og 80
Artikel 16
Artikel 79 og 80
Artikel 17
Artikel 79 og 80
Artikel 18
Artikel 79 og 80
Artikel 19
Artikel 79 og 80
Artikel 20
Artikel 79 og 80
Artikel 21
—
Artikel 22
Artikel 18, 19, 20, 46 og 47
Artikel 23
Artikel 79 og 80
Artikel 24
Artikel 79 og 80
Artikel 25
Artikel 79 og 80
Artikel 26
Artikel 79 og 80
Artikel 27
Artikel 124, stk. 1, og artikel 126, stk. 1, litra c)
Artikel 28
—
Artikel 29
—
Artikel 30
—
4.   Direktiv 80/1095/EØF
Direktiv 80/1095/EØF
Denne forordning
Artikel 1
Artikel 31, stk. 1, og artikel 36
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 31, stk. 1, og artikel 35
Artikel 3a
Artikel 31, stk. 1, og artikel 35
Artikel 4
Artikel 32, 33 og 35
Artikel 4a
Artikel 32, 33 og 35
Artikel 5
—
Artikel 6
Artikel 31, stk. 1, litra b), artikel 31, stk. 3, og artikel 32
Artikel 7
Artikel 36, 39 og 40
Artikel 8
Artikel 41 og 42
Artikel 9
—
Artikel 11
—
Artikel 12
—
Artikel 12a
—
Artikel 13
—
5.   Direktiv 82/894/EØF
Direktiv 82/894/EØF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 19, 21, 22 og 23
Artikel 4
Artikel 19, 20, 21, 22 og 23
Artikel 5
Artikel 23
Artikel 6
—
Artikel 7
—
Artikel 8
—
6.   Direktiv 88/407/EØF
Direktiv 88/407/EØF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 159 og 160
Artikel 4
Artikel 160
Artikel 5
Artikel 94, 97, 100 og 101
Artikel 6, stk. 1
Artikel 161 og 162
Artikel 6, stk. 2, 3 og 4
Artikel 258
Artikel 8
Artikel 229, stk. 1, litra a), og artikel 230
Artikel 9
Artikel 229, stk. 1, litra b), og artikel 233
Artikel 10
Artikel 229, stk. 1, litra c), og artikel 234 og 236
Artikel 11
Artikel 229, stk. 1, litra d), og artikel 237 og 238
Artikel 12
Artikel 260-262
Artikel 15
Artikel 257-259
Artikel 16
—
Artikel 17
—
Artikel 18
—
Artikel 20
—
Artikel 21
—
Artikel 22
—
7.   Direktiv 89/556/EØF
Direktiv 89/556/EØF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 159, 160 og 161
Artikel 5, stk. 1
Artikel 94 og 97
Artikel 5, stk. 2
Artikel 101
Artikel 5, stk. 2a og 3
Artikel 97, 98 og 100
Artikel 6
Artikel 161 og 162
Artikel 7
Artikel 229, stk. 1, litra a), og artikel 230
Artikel 8
Artikel 229, stk. 1, litra b), og artikel 233
Artikel 9
Artikel 229, stk. 1, litra c), og artikel 234 og 236
Artikel 10
Artikel 229, stk. 1, litra d), og artikel 237 og 238
Artikel 11
Artikel 260-262
Artikel 14
Artikel 257-259
Artikel 15
—
Artikel 16
—
Artikel 17
—
Artikel 18
—
Artikel 19
—
Artikel 20
—
Artikel 21
—
8.   Direktiv 90/429/EØF
Direktiv 90/429/EØF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 159 og 160
Artikel 4
—
Artikel 5, stk. 1
Artikel 94, 97, 98 og 100
Artikel 5, stk. 2
Artikel 101
Artikel 6, stk. 1
Artikel 161 og 162
Artikel 6, stk. 2
Artikel 258
Artikel 7
Artikel 229, stk. 1, litra a), og artikel 230
Artikel 8
Artikel 229, stk. 1, litra b), og artikel 233
Artikel 9
Artikel 229, stk. 1, litra c), og artikel 234 og 236
Artikel 10
Artikel 229, stk. 1, litra d), og artikel 237 og 238
Artikel 11, stk. 1
Artikel 229
Artikel 11, stk. 2 og 3
Artikel 260
Artikel 12
Artikel 237
Artikel 13
—
Artikel 14
—
Artikel 15
Artikel 257-262
Artikel 16
—
Artikel 17
—
Artikel 18
—
Artikel 19
—
Artikel 20
—
Artikel 21
—
Artikel 22
—
9.   Direktiv 91/68/EØF
Direktiv 91/68/EØF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis), artikel 21, artikel 153, stk. 3, og artikel 220, stk. 3
Artikel 3, stk. 1, 2, 3 og 5
Artikel 126, stk. 1, litra b), og artikel 130 og 131
Artikel 3, stk. 4
Artikel 139
Artikel 4, stk. 1
Artikel 124, stk. 2, litra b), artikel 126, stk. 1, artikel 130, 131 og artikel 149, stk. 3, og stk. 4, litra a) og b)
Artikel 4, stk. 2
Artikel 128
Artikel 4, stk. 3
Artikel 131
Artikel 4a
Artikel 130 og 131
Artikel 4b, stk. 1 og 2
Artikel 130 og 131
Artikel 4b, stk. 3
Artikel 126, stk. 2
Artikel 4b, stk. 4
Artikel 133
Artikel 4b, stk. 5
Artikel 132
Artikel 4b, stk. 6
Artikel 124, stk. 1, artikel 125 og artikel 126, stk. 1, litra b)
Artikel 4c, stk. 1 og 2
Artikel 130 og 131
Artikel 4c, stk. 3
Artikel 133 og 135
Artikel 5
Artikel 131
Artikel 6
Artikel 131 og artikel 145, stk. 1, litra e)
Artikel 7, stk. 1-3
Artikel 31, 32, 33 og 35
Artikel 7, stk. 4
—
Artikel 8, stk. 1-3
Artikel 36, 39 og 40
Artikel 8, stk. 4
—
Artikel 8a, stk. 1
Artikel 94, stk. 1, litra a), og artikel 97, 98 og 134
Artikel 8a, stk. 2
Artikel 102 og 106
Artikel 8a, stk. 3
Artikel 98, 99 og 101
Artikel 8a, stk. 4
Artikel 100
Artikel 8a, stk. 5
Artikel 97, stk. 1, litra d), og stk. 2, litra d)
Artikel 8b, stk. 1
Artikel 84, 90, 92, artikel 93, stk. 1, litra c), artikel 94, stk. 1, litra a), og artikel 97, 98, 102, 105 og 134
Artikel 8b, stk. 2
Artikel 94, stk. 1, litra a), og artikel 97 og 98
Artikel 8b, stk. 3
Artikel 100
Artikel 8b, stk. 4
—
Artikel 8c, stk. 1
Artikel 87 og 125
Artikel 8c, stk. 2
Artikel 104
Artikel 8c, stk. 3
Artikel 125, stk. 1, litra a), og artikel 126, stk. 1, litra b)
Artikel 8c, stk. 4 og 5
—
Artikel 9, stk. 1-4
Artikel, 143, 145, 146, 147, 148, 149 og 153
Artikel 9, stk. 7
Artikel 153
Artikel 10
—
Artikel 11
—
Artikel 12
Artikel 144, litra b)
Artikel 14
—
Artikel 15
—
Artikel 17
—
Artikel 18
—
10.   Decision 91/666/EØF
Decision 91/666/EØF
Denne forordning
Artikel 1
Artikel 48, stk. 1 og 3
Artikel 2
—
Artikel 3
Artikel 48
Artikel 4
Artikel 48, 49 og 50
Artikel 5
Artikel 48, stk. 3, og artikel 50
Artikel 6
Artikel 16 og artikel 48, stk. 2, litra c), og stk. 3, litra b)
Artikel 7
Artikel 48, stk. 3, og artikel 50
Artikel 8
—
Artikel 9
—
Artikel 10
—
Artikel 11
—
Artikel 12
—
11.   Direktiv 92/35/EØF
Direktiv 92/35/EØF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 18
Artikel 4
Artikel 53-57 og artikel 59
Artikel 5
Artikel 46 og 47
Artikel 6
Artikel 60-68
Artikel 7, stk. 1
Artikel 57
Artikel 7, stk. 2
Artikel 43, stk. 2, litra d)
Artikel 8
Artikel 64
Artikel 9
Artikel 65, 66 og 67
Artikel 10
Artikel 65, 66 og 67
Artikel 11
Artikel 67 og 68
Artikel 12
Artikel 71, stk. 1
Artikel 13
Artikel 65, stk. 2
Artikel 14
—
Artikel 15
—
Artikel 16
—
Artikel 17
Artikel 43 og 44
Artikel 18
—
Artikel 19
—
Artikel 20
—
Artikel 21
—
Artikel 22
—
12.   Direktiv 92/65/EØF
Direktiv 92/65/EØF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 170, 171 og 269
Artikel 4
Artikel 124, 126, 18, 31, 84, artikel 93, stk. 1, litra a), og artikel 151
Artikel 5
Artikel 95, 97, 136, 137, 143, 144 og 149
Artikel 6, litra A
Artikel 124, 126, 130, 131, 137, 140 og 143-146
Artikel 6 litra B
—
Artikel 7 litra A
Artikel 124, 126, 130, 131, 137, 140 og 143-146
Artikel 7 litra B
—
Artikel 8
Artikel 124, 126, 136 og 143-146
Artikel 9
Artikel 124, 126, 136 og 143-146
Artikel 10, stk. 1-4
Artikel 124, 126, 136 og 143-146
Artikel 10, stk. 5-7
—
Artikel 10a
—
Artikel 11, stk. 1
Artikel 157
Artikel 11, stk. 2 og 3
Artikel 157, 159, 160 og 143-146
Artikel 11, stk. 4
Artikel 97 og 101
Artikel 11, stk. 5
Artikel 164
Artikel 12, stk. 1
—
Artikel 12, stk. 2
Artikel 257-259
Artikel 12, stk. 3
Artikel 84, 90, 92, artikel 93, stk. 1, litra c), og artikel 102 og 106
Artikel 12, stk. 4
Artikel 143-149 og artikel 152-154
Artikel 12, stk. 5
—
Artikel 12, stk. 6
Artikel 268
Artikel 13, stk. 1
Artikel 136, artikel 143-149 og artikel 151
Artikel 13, stk. 2
Artikel 95, 97 og artikel 98-101
Artikel 14
Artikel 31, 32 og 33
Artikel 15
Artikel 36, 39, 40 og 41
Artikel 16
Artikel 229, stk. 1, og artikel 234, stk. 1
Artikel 17, stk. 1
Artikel 229, stk. 1
Artikel 17, stk. 2
Artikel 229, stk. 1, litra a), og artikel 230 og 233
Artikel 17, stk. 3
Artikel 230, 233 og 234
Artikel 17, stk. 4
Artikel 230
Artikel 17, stk. 5 og 6
—
Artikel 18, stk. 1, første linje
Artikel 237
Artikel 18, stk. 1, anden-fjerde linje
—
Artikel 18, stk. 2
Artikel 234, stk. 3
Artikel 19
Artikel 234 og 239
Artikel 20
Artikel 229, stk. 2, og artikel 260-262
Artikel 21
Artikel 144, 146, artikel 162, stk. 4 og 5, og artikel 209, 211 og 213
Artikel 22
—
Artikel 23
Artikel 140 og 205
Artikel 24
Artikel 229, stk. 1, litra d), artikel 237 og artikel 239, stk. 2
Artikel 25
—
Artikel 26
—
Artikel 27
—
Artikel 28
—
Artikel 29
—
Artikel 30
—
13.   Direktiv 92/66/EØF
Direktiv 92/66/EØF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 18
Artikel 4
Artikel 53-56 og artikel 59
Artikel 5
Artikel 60-63
Artikel 6
Artikel 63
Artikel 7
Artikel 57 og artikel 43, stk. 2, litra d)
Artikel 8
Artikel 55 og 56
Artikel 9, stk. 1
Artikel 64
Artikel 9, stk. 2-7
Artikel 65-68
Artikel 10
Artikel 65, 66 og 67
Artikel 11
Artikel 67, stk. 2, litra b), og artikel 68, stk. 1, litra b), og stk. 2, litra a)
Artikel 12
Artikel 54, artikel 61, stk. 1, litra h), og artikel 63, stk. 2, litra c)
Artikel 13
Artikel 65, stk. 2
Artikel 14
—
Artikel 15
—
Artikel 16
Artikel 46, 47 og 69
Artikel 17
Artikel 47
Artikel 18
Artikel 65, stk. 1, litra e), artikel 67, stk. 2, litra a), og artikel 69
Artikel 19, stk. 1-3
Artikel 53-56 og artikel 59
Artikel 19, stk. 4
Artikel 57 og artikel 60-63
Artikel 19, stk. 5
Artikel 71, stk. 2
Artikel 20
—
Artikel 21
Artikel 43 og 44
Artikel 22
—
Artikel 23
—
Artikel 24
—
Artikel 25
—
Artikel 26
—
Artikel 27
—
14.   Direktiv 92/118/EØF
Direktiv 92/118/EØF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 166, 222, artikel 227, litra c), nr. iv), og artikel 228
Artikel 4, stk. 1
Artikel 166, 222, artikel 227, litra c), nr. iv), og artikel 228
Artikel 4, stk. 2
—
Artikel 5
Artikel 166 og 222
Artikel 6
Artikel 16, stk. 1, litra b), og stk. 2, litra b)
Artikel 7, stk. 1
—
Artikel 7, stk. 2
Artikel 257-259
Artikel 7, stk. 3 og 4
—
Artikel 7, stk. 5
Artikel 268
Artikel 8
—
Artikel 9
Artikel 229 og 234
Artikel 10, stk. 1-4 og stk. 6
Artikel 229, 234, 237 og 239
Artikel 10, stk. 5
—
Artikel 11
Artikel 239, stk. 2, første afsnit, litra c), nr. ii)
Artikel 12
—
Artikel 13
Artikel 239, stk. 2, første afsnit, litra c), nr. i)
Artikel 14
—
Artikel 15
—
Artikel 16
Artikel 239, stk. 2, første afsnit, litra c), nr. v)
Artikel 17
—
Artikel 18
—
Artikel 19
—
Artikel 20
—
15.   Direktiv 92/119/EØF
Direktiv 92/119/EØF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 18
Artikel 4
Artikel 53-57 og artikel 59
Artikel 5
Artikel 60-63
Artikel 6
Artikel 70 og artikel 71, stk. 2
Artikel 7
Artikel 63
Artikel 8
Artikel 57 og artikel 43, stk. 2, litra d)
Artikel 9
Artikel 55 og 57
Artikel 10
Artikel 64 og artikel 71, stk. 3
Artikel 11
Artikel 65-68 og artikel 71, stk. 2
Artikel 12
Artikel 65-68 og artikel 71, stk. 2
Artikel 13
Artikel 67, stk. 2, litra a)
Artikel 14
Artikel 65, stk. 2, og artikel 71, stk. 1 og 3
Artikel 15
—
Artikel 16
Artikel 63, stk. 2, litra b), artikel 67, stk. 2, litra b), og artikel 68, stk. 1, litra b), og stk. 2, litra a)
Artikel 17
—
Artikel 18
—
Artikel 19
Artikel 46, 47 og 69
Artikel 20
Artikel 43 og 44
Artikel 21
—
Artikel 22
—
Artikel 23
—
Artikel 24
—
Artikel 25
—
Artikel 26
—
Artikel 27
—
Artikel 28
—
16.   Afgørelse 95/410/EF
Afgørelse 95/410/EF
Denne forordning
Artikel 1
Artikel 130-132 og artikel 273
Artikel 2
Artikel 131, stk. 1, litra c)
Artikel 3
Artikel 143, 145 og 146
Artikel 4
—
Artikel 5
—
Artikel 6
—
17.   Direktiv 2000/75/EF
Direktiv 2000/75/EF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 18
Artikel 4, stk. 1 og 2
Artikel 54 og 55
Artikel 4, stk. 3
Artikel 53
Artikel 4, stk. 4
Artikel 56
Artikel 4, stk. 5
Artikel 70
Artikel 4, stk. 6
Artikel 59
Artikel 5
Artikel 46 og 47
Artikel 6
Artikel 60-64, artikel 71, stk. 2, og artikel 69
Artikel 7
Artikel 57
Artikel 8
Artikel 64, 68 og artikel 71, stk. 3
Artikel 9
Artikel 65, 67, 69 og artikel 71, stk. 3
Artikel 10, stk. 1
Artikel 65 og 67
Artikel 10, stk. 2
Artikel 46 og 47
Artikel 11
—
Artikel 12
Artikel 71, stk. 3
Artikel 13
Artikel 71, stk. 1
Artikel 14
Artikel 65, stk. 2
Artikel 15
—
Artikel 16
—
Artikel 17
—
Artikel 18
Artikel 43 og 44
Artikel 19
—
Artikel 20
—
Artikel 21
—
Artikel 22
—
Artikel 23
—
18.   Forordning (EF) nr. 1760/2000
Forordning (EF) nr. 1760/2000
Denne forordning
Artikel 1
Artikel 108
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 108, stk. 3, og artikel 111
Artikel 4
Artikel 112, litra a), og artikel 118, 119 og 120
Artikel 4a
Artikel 118, stk. 1, litra a), og stk. 2, litra a)
Artikel 4b
Artikel 118, stk. 2, litra e)
Artikel 4c
Artikel 118, stk. 1, litra a), og stk. 2, litra a)
Artikel 4d
Artikel 118, stk. 1, litra a)
Artikel 5
Artikel 109, stk. 1, litra a), og artikel 118, stk. 1, litra b)
Artikel 6
Artikel 110, stk. 1, litra b), artikel 112, litra b), og artikel 118, stk. 1, litra c)
Artikel 6a
Artikel 110, stk. 2
Artikel 7, stk. 1
Artikel 102, 106, 107 og artikel 112, litra d)
Artikel 7, stk. 2
Artikel 118, stk. 2, litra a)
Artikel 7, stk. 3 og 4
Artikel 102, stk. 3
Artikel 7, stk. 5
Artikel 102, stk. 4
Artikel 7, stk. 6
Artikel 106
Artikel 9a
Artikel 11 og artikel 13, stk. 2
Artikel 10, litra a)-c)
Artikel 118, 119 og 120
Artikel 10, litra d) og e)
—
Artikel 10, litra f)
Artikel 270
Artikel 11
—
Artikel 12
—
Artikel 13
—
Artikel 14
—
Artikel 15
—
Artikel 15a
—
Artikel 22
—
Artikel 22a
—
Artikel 22b
—
Artikel 23
—
Artikel 23a
—
Artikel 23b
—
Artikel 24
—
Artikel 25
—
19.   Direktiv 2001/89/EF
Direktiv 2001/89/EF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 18, 19, 20 og 23
Artikel 4
Artikel 54-56 og artikel 59
Artikel 5
Artikel 60-63 og artikel 71, stk. 2 og 3
Artikel 6
Artikel 63 og 71
Artikel 7
Artikel 62 og 63 og artikel 65, stk. 1, litra b), og artikel 67
Artikel 8
Artikel 57
Artikel 9
Artikel 64
Artikel 10
Artikel 65-68
Artikel 11
Artikel 65-68
Artikel 12
Artikel 61, stk. 1, litra f), artikel 63, stk. 2, litra b), artikel 65, stk. 1, litra f), artikel 67, stk. 2, litra b), og artikel 68, stk. 1, litra b), og stk. 2, litra a)
Artikel 13
Artikel 61, stk. 3, artikel 63, stk. 2, litra d), og artikel 68, stk. 2, litra a) og c)
Artikel 14
Artikel 62 og 63
Artikel 15
Artikel 70
Artikel 16
Artikel 70 og artikel 31-35
Artikel 17
Artikel 16, artikel 17, stk. 2, artikel 54, stk. 2 og 3, artikel 58, stk. 2, artikel 61, stk. 1, litra g) og h), artikel 63, stk. 2, litra c), artikel 65, stk. 1, litra b), og artikel 67, stk. 2, litra c)
Artikel 18
Artikel 16, 46 47, 48 og 52
Artikel 19
Artikel 65, stk. 1, litra e), og artikel 67 og 69
Artikel 20
Artikel 70
Artikel 21
—
Artikel 22
Artikel 43 og 44
Artikel 23
Artikel 43, stk. 2, litra d), og artikel 44
Artikel 24
—
Artikel 25
—
Artikel 26
—
Artikel 27
—
Artikel 28
—
Artikel 29
—
Artikel 30
—
Artikel 31
—
Artikel 32
—
20.   Direktiv 2002/60/EF
Direktiv 2002/60/EF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 18, 19, 20 og 23
Artikel 4
Artikel 54-56 og artikel 59
Artikel 5
Artikel 60-63 og artikel 71, stk. 2 og 3
Artikel 6
Artikel 63 og 71
Artikel 7
Artikel 62 og 63
Artikel 8
Artikel 57
Artikel 9
Artikel 64
Artikel 10
Artikel 65-68
Artikel 11
Artikel 65-68
Artikel 12
Artikel 61, stk. 1, litra f), artikel 63, stk. 2, litra b), artikel 65, stk. 1, litra f), artikel 67, stk. 2, litra b), og artikel 68, stk. 1, litra b)
Artikel 13
Artikel 61, stk. 3, artikel 63, stk. 2, litra d), og artikel 68, stk. 2, litra a) og c)
Artikel 14
Artikel 62 og 63
Artikel 15
Artikel 70
Artikel 16
Artikel 70 og artikel 31-35
Artikel 17, stk. 1
Artikel 61, stk. 1, litra f), artikel 63, artikel 65, stk. 1, litra f) og i), og artikel 67, stk. 2, litra a) og d)
Artikel 17, stk. 2 og 3
Artikel 71, stk. 2 og 3
Artikel 18
Artikel 16, artikel 17, stk. 2, artikel 54, stk. 2 og 3, artikel 58, stk. 2, artikel 61, stk. 1, litra g) og h), artikel 63, stk. 2, litra c), artikel 65, stk. 1, litra b), og artikel 67, stk. 2, litra c)
Artikel 19
Artikel 16, 46 og 47
Artikel 20
—
Artikel 21
Artikel 43 og 44
Artikel 22
Artikel 43, stk. 2, litra d), og artikel 44
Artikel 23
—
Artikel 24
—
Artikel 25
—
Artikel 26
—
Artikel 27
—
Artikel 28
—
Artikel 29
—
Artikel 30
—
21.   Direktiv 2002/99/EF
Direktiv 2002/99/EF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 166, 222 og artikel 227, litra c), nr. iv)
Artikel 4
Artikel 65, stk. 1, litra c), d), g), h) og i), artikel 67, 166, 222, artikel 227, litra c), nr. iv), og artikel 228, stk. 1
Artikel 5
Artikel 167, 168, 223, 224 og artikel 227, litra d), nr. iii)
Artikel 6
—
Artikel 7
Artikel 234, stk. 1 og 2
Artikel 8
Artikel 230, 231 og 232
Artikel 9
Artikel 237 og 238
Artikel 10
—
Artikel 11
—
Artikel 12
—
Artikel 13
—
Artikel 14
—
Artikel 15
—
Artikel 16
—
22.   Direktiv 2003/85/EF
Direktiv 2003/85/EF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 18, 19, 20 og 23
Artikel 4
Artikel 54-56
Artikel 5
Artikel 55, stk. 1, litra d) og e), og stk. 2
Artikel 6
Artikel 55, stk. 1, litra f), nr. i), og stk. 2, og artikel 56, litra b)
Artikel 7
Artikel 55, stk. 1, litra f), nr. ii)
Artikel 8
Artikel 55, stk. 1, litra f), og stk. 2
Artikel 9
Artikel 59
Artikel 10
Artikel 60, 61 og 63
Artikel 11
Artikel 61, stk. 1, litra f), artikel 63, stk. 2, litra b), artikel 65, stk. 1, litra f), artikel 67, stk. 2, litra b), og artikel 68, stk. 1, litra b)
Artikel 12
Artikel 65, stk. 1, litra d), h) og i), og artikel 67
Artikel 13
Artikel 57
Artikel 14
Artikel 61-63
Artikel 15
Artikel 61-63, artikel 70 og artikel 71, stk. 2
Artikel 16
Artikel 61, 62 og 63
Artikel 17
Artikel 71
Artikel 18
Artikel 61 og 63
Artikel 19
Artikel 62 og 63
Artikel 20
Artikel 71
Artikel 21
Artikel 43, stk. 2, litra d), artikel 64, artikel 65, stk. 1, litra d), h) og i), og stk. 2, og artikel 67
Artikel 22
Artikel 65-67
Artikel 23
Artikel 65-67
Artikel 24
Artikel 67 og 71, stk. 1
Artikel 25
Artikel 65, stk. 1, litra c), litra d), nr. i), og litra g), h) og i), og artikel 67
Artikel 26
Artikel 65, stk. 1, litra c), litra d), nr. i), og litra g), h) og i), og artikel 67 og 166
Artikel 27
Artikel 65, stk. 1, litra c), og litra d), nr. i), og litra g), h) og i), og artikel 67 og 166
Artikel 28
Artikel 65, stk. 1, litra c), og litra d), nr. iii), og artikel 67
Artikel 29
Artikel 65, stk. 1, litra c), og litra d), nr. ii), og artikel 67
Artikel 30
Artikel 65, stk. 1, litra c), og litra d), nr. ii) og iii), og artikel 67
Artikel 31
Artikel 65, stk. 1, litra c), og litra d), nr. ii), og artikel 67
Artikel 32
Artikel 65, stk. 1, litra c) og d), og artikel 67
Artikel 33
Artikel 65, stk. 1, litra c), og litra d), nr. ii), og artikel 67
Artikel 34
Artikel 67, artikel 143, stk. 2, artikel 161, stk. 2, og artikel 167, stk. 1, første afsnit, litra b)
Artikel 35
Artikel 71, stk. 1 og 2
Artikel 36
Artikel 68
Artikel 37
Artikel 65-67
Artikel 38
Artikel 65-67
Artikel 39
Artikel 65, stk. 1, litra c), litra d), nr. i), og litra g), h) og i), og artikel 67 og 166
Artikel 40
Artikel 65, stk. 1, litra c), og litra d), nr. i), og litra g), h) og i), og artikel 67 og 166
Artikel 41
Artikel 65, stk. 1, litra c), og litra d), nr. ii), og artikel 67
Artikel 42
Artikel 65, stk. 1, litra c) og d), og artikel 67
Artikel 43
Artikel 71, stk. 1
Artikel 44
Artikel 68
Artikel 45
Artikel 64, 67 og 71
Artikel 46
Artikel 65 og 67
Artikel 47
Artikel 65, stk. 1, litra h), og artikel 67
Artikel 48
Artikel 66
Artikel 49
Artikel 16, 46 og 47
Artikel 50
Artikel 46,47 og 69
Artikel 51
Artikel 47 og 69
Artikel 52
Artikel 46 og 47
Artikel 53
Artikel 46 og 47
Artikel 54
Artikel 47, 65, 67 og artikel 69, stk. 2 og 3
Artikel 55
Artikel 47, 65, 67 og artikel 69, stk. 2 og 3
Artikel 56
Artikel 47, artikel 67, stk. 2, litra c), artikel 68, stk. 1, litra c), og artikel 69, stk. 2 og 3
Artikel 57
Artikel 47, artikel 67, stk. 2, litra c), artikel 68, stk. 1, litra c), og artikel 69, stk. 2 og 3
Artikel 58
Artikel 68
Artikel 59
Artikel 36, 38, 39, 40 og 68
Artikel 60
Artikel 36, 38, 39, 40 og 68
Artikel 61
Artikel 36, 38, 39, 40 og 68
Artikel 62
Artikel 68
Artikel 63
Artikel 143, stk. 2, artikel 161, stk. 2, og artikel 167, stk. 1, første afsnit, litra b)
Artikel 64
Artikel 65, stk. 1, litra c), artikel 67, artikel 69, stk. 3, og artikel 131
Artikel 65
Artikel 16
Artikel 66
—
Artikel 67
—
Artikel 68
—
Artikel 69
—
Artikel 70
Artikel 16
Artikel 71
Artikel 54, stk. 2 og 3, artikel 58, stk. 2, artikel 61, stk. 1, litra g) og h), artikel 63, stk. 2, litra c), artikel 65, stk. 1, litra b), artikel 67, stk. 2, litra c), og artikel 68, stk. 1, litra c), og stk. 2, litra b)
Artikel 72
Artikel 43
Artikel 73
Artikel 45
Artikel 74
Artikel 43, stk. 2, litra d)
Artikel 75
Artikel 44
Artikel 76
Artikel 43, stk. 2, litra d), og artikel 44
Artikel 77
Artikel 44
Artikel 78
Artikel 43, stk. 2, litra d)
Artikel 79
Artikel 52
Artikel 80
Artikel 48 og 51
Artikel 81
Artikel 48, stk. 3, og artikel 50
Artikel 82
Artikel 48, stk. 3, og artikel 50
Artikel 83
Artikel 49
Artikel 84
Artikel 48, stk. 3, og artikel 50
Artikel 85
Artikel 70 og 71
Artikel 86
Artikel 268
Artikel 87
—
Artikel 88
Artikel 71, stk. 3
Artikel 89
—
Artikel 90
—
Artikel 91
—
Artikel 92
—
Artikel 93
—
Artikel 94
—
Artikel 95
—
23.   Forordning (EF) nr. 21/2004
Forordning (EF) nr. 21/2004
Denne forordning
Artikel 1
Artikel 108
Artikel 2
Artikel 4 (delvis)
Artikel 3, stk. 1
Artikel 108, stk. 3
Artikel 3, stk. 2
Artikel 111
Artikel 4, stk. 1 og 2
Artikel 113, stk. 1, litra a), og artikel 118, 119 og 120
Artikel 4, stk. 3
Artikel 118, stk. 2, litra a)
Artikel 4, stk. 4
Artikel 118, stk. 2, litra e)
Artikel 4, stk. 5-7
Artikel 118, stk. 1), litra a), og stk. 2, litra a)
Artikel 4, stk. 8
Artikel 111
Artikel 4, stk. 9
Artikel 118, stk. 1, litra a), og stk. 2, litra a)
Artikel 5
Artikel 102, 106, 107 og 111
Artikel 6
Artikel 111, litra b), artikel 113, stk. 1, litra b), og stk. 2, artikel 118, stk. 1, litra b), nr. ii), artikel 119 og 120, stk. 2, litra d)
Artikel 7
Artikel 101
Artikel 8, stk. 1
Artikel 109, stk. 1, litra b), og artikel 118, stk. 1, litra b)
Artikel 8, stk. 2
Artikel 113, stk. 1, litra c)
Artikel 8, stk. 3-5
Artikel 109 og artikel 118, stk. 1, litra b)
Artikel 9
Artikel 118, stk. 1, litra a), og stk. 2, litra a)
Artikel 10, stk. 1
—
Artikel 10, stk. 2
Artikel 120, stk. 2, litra c)
Artikel 11
Artikel 11 og artikel 13, stk. 2
Artikel 12, stk. 1
—
Artikel 12, stk. 2
Artikel 268
Artikel 12, stk. 4-7
—
Artikel 13
—
Artikel 14
—
Artikel 15
—
Artikel 16
—
Artikel 17
—
24.   Direktiv 2004/68/EF
Direktiv 2004/68/EF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3, stk. 1
Artikel 229, stk. 1, litra a), og artikel 231
Artikel 3, stk. 2
Artikel 232, stk. 1
Artikel 4
Artikel 230, stk. 1
Artikel 5
Artikel 230, stk. 1 og 3, og artikel 231
Artikel 6
Artikel 234 og 235
Artikel 7
Artikel 229, stk. 2, artikel 234, stk. 2, litra a), artikel 235 og artikel 238, stk. 1, litra e)
Artikel 8
Artikel 234, artikel 237, stk. 4, litra a), og artikel 239, stk. 2, første afsnit, litra a)
Artikel 9
Artikel 234, stk. 2, artikel 235 og artikel 237, stk. 4, litra a)
Artikel 10
Artikel 234, stk. 2, artikel 235 og artikel 237, stk. 4, litra a)
Artikel 11
Artikel 229, stk. 1, litra d), og artikel 237 og 238
Artikel 12
—
Artikel 13
—
Artikel 14
—
Artikel 16
—
Artikel 17
—
Artikel 18
—
Artikel 19
—
Artikel 20
—
Artikel 21
—
25.   Direktiv 2005/94/EF
Direktiv 2005/94/EF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 10
Artikel 4
Artikel 26, 28 og 29
Artikel 5
Artikel 18, 19, 20 og 23
Artikel 6
Artikel 57
Artikel 7
Artikel 54-56
Artikel 8
Artikel 55, stk. 2
Artikel 9
Artikel 59
Artikel 10
Artikel 55, stk. 1, litra e) og f), og artikel 56
Artikel 11
Artikel 61 og 63
Artikel 12
Artikel 63 og 71
Artikel 13
Artikel 61 og 63
Artikel 14
Artikel 63, stk. 2, litra a)
Artikel 15
Artikel 62 og artikel 63, stk. 2, litra e)
Artikel 16
Artikel 64
Artikel 17
Artikel 65-67
Artikel 18
Artikel 65, stk. 1, litra a) og b), og artikel 67
Artikel 19
Artikel 65-67
Artikel 20
Artikel 65, stk. 1, litra d), nr. ii), og artikel 67
Artikel 21
Artikel 65, stk. 1, litra c) og i), og artikel 67
Artikel 22
Artikel 65, stk. 1, litra c) og i), og artikel 67
Artikel 23
Artikel 65, stk. 1, litra c), og artikel 67
Artikel 24
Artikel 65, stk. 1, litra c), og artikel 67
Artikel 25
Artikel 65, stk. 1, litra c), og artikel 67
Artikel 26
Artikel 65, stk. 1, litra c), og artikel 67
Artikel 27
Artikel 65, stk. 1, litra d), nr. ii), og artikel 67
Artikel 28
Artikel 65, stk. 1, litra f), og artikel 67, stk. 2, litra b)
Artikel 29
Artikel 68
Artikel 30
Artikel 65-67
Artikel 31
Artikel 68
Artikel 32
Artikel 65, 67 og artikel 71, stk. 2 og 3
Artikel 33
Artikel 67 og artikel 71, stk. 3
Artikel 34
Artikel 71
Artikel 35
Artikel 54 og 61
Artikel 36
Artikel 61-63
Artikel 37
Artikel 61-63
Artikel 38
Artikel 61, 63, 65 og 67
Artikel 39
Artikel 61, 63 og artikel 71, stk. 2
Artikel 40
Artikel 61, 63 og 71
Artikel 41
Artikel 61, 63 og artikel 71, stk. 2 og 3
Artikel 42
Artikel 62 og artikel 63, stk. 2, litra e)
Artikel 43
Artikel 64
Artikel 44
Artikel 65-67
Artikel 45
Artikel 68
Artikel 46
Artikel 64, stk. 4, artikel 67 og artikel 71, stk. 2 og 3
Artikel 47
Artikel 54, 55, 61, 63 og 71
Artikel 48
Artikel 68, stk. 1, litra b), og stk. 2, litra a)
Artikel 49
Artikel 61, stk. 3, og artikel 68
Artikel 50
Artikel 16, artikel 54, stk. 2, litra b) og c), og stk. 3, artikel 58, stk. 2, artikel 61, stk. 1, litra g) og h), artikel 63, stk. 2, litra c), artikel 65, stk. 1, litra b), artikel 67, stk. 2, litra c), og artikel 68, stk. 1, litra c), og stk. 2, litra b)
Artikel 51
—
Artikel 52
Artikel 46 og 47
Artikel 53
Artikel 69
Artikel 54
Artikel 47, artikel 65, stk. 1, litra e), artikel 67, 69 og artikel 71, stk. 3
Artikel 55
Artikel 47, artikel 65, stk. 1, litra e), artikel 67, 69 og artikel 71, stk. 3
Artikel 56
Artikel 46 og 47
Artikel 57
Artikel 47
Artikel 58
Artikel 48-50
Artikel 59
Artikel 52
Artikel 60
—
Artikel 61
Artikel 268
Artikel 62
Artikel 43 og 44
Artikel 63
—
Artikel 64
—
Artikel 65
—
Artikel 66
—
Artikel 67
—
Artikel 68
—
Artikel 69
—
26.   Direktiv 2006/88/EF
Direktiv 2006/88/EF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 2 og artikel 3, stk. 2
Artikel 3
Artikel 4 (delvis)
Artikel 4, stk. 1
Artikel 172, 173, 176 og 177
Artikel 4, stk. 2
Artikel 179
Artikel 4, stk. 3
Artikel 185, stk. 2
Artikel 4, stk. 4
Artikel 172, 173, 174 og 175
Artikel 4, stk. 5
—
Artikel 5
Artikel 181
Artikel 6
Artikel 185
Artikel 7
—
Artikel 8
Artikel 186, 187, 188 og 189
Artikel 9
Artikel 181, stk. 1, litra a), nr. i), og stk. 2 og 3
Artikel 10
Artikel 181, stk. 1, litra a), nr. ii), og stk. 2 og 3
Artikel 11
Artikel 191 og 204
Artikel 12
Artikel 191
Artikel 13
Artikel 192
Artikel 14, stk. 1 og 2
Artikel 208 og 211
Artikel 14, stk. 3 og 4
Artikel 219 og 220
Artikel 15, stk. 1 og 2
Artikel 196 og 197
Artikel 15, stk. 3
Artikel 193
Artikel 15, stk. 4
Artikel 196, 197 og 199
Artikel 16
Artikel 197
Artikel 17
Artikel 197
Artikel 18
Artikel 201 og 202
Artikel 19
Artikel 201 og 202
Artikel 20
Artikel 200
Artikel 21
Artikel 200, 203, 205 og 226
Artikel 22
Artikel 229, stk. 1, litra a)
Artikel 23
Artikel 230 og 231
Artikel 24
Artikel 229, stk. 1, litra d), og artikel 237
Artikel 25
Artikel 234, 237 og 238
Artikel 26
Artikel 18
Artikel 27
Artikel 19 og 20
Artikel 28
Artikel 53-55 og 72-74
Artikel 29
Artikel 57 og artikel 77, stk. 1, litra b)
Artikel 30
Artikel 59 og 78
Artikel 31
—
Artikel 32
Artikel 60, 61, 62 og 64
Artikel 33
Artikel 65-67
Artikel 34
Artikel 61, stk. 1, litra b) og c), og artikel 63
Artikel 35
Artikel 61, stk. 3, og artikel 63
Artikel 36
—
Artikel 37
Artikel 68
Artikel 38
Artikel 77, 79 og artikel 80, stk. 3
Artikel 39
Artikel 79 og 80
Artikel 40
Artikel 81
Artikel 41
Artikel 257, stk. 1, litra b) og c)
Artikel 42
Artikel 71, stk. 3
Artikel 43
Artikel 226
Artikel 44
Artikel 27, 28, 31 og 32
Artikel 45
Artikel 33
Artikel 46
Artikel 31, stk. 2
Artikel 47
Artikel 43 og 44
Artikel 48
Artikel 46 og 47
Artikel 49
Artikel 36
Artikel 50
Artikel 36 og 37
Artikel 51
Artikel 38
Artikel 52
Artikel 41
Artikel 53
Artikel 42
Artikel 54
—
Artikel 55
—
Artikel 56
—
Artikel 57, litra a)
—
Artikel 57, litra b)
Artikel 54, stk. 2, litra c), og stk. 3, artikel 58, artikel 61, stk. 1, litra g) og h), artikel 63, stk. 2, litra c), artikel 65, stk. 1, litra b), og artikel 67, stk. 2, litra c)
Artikel 57, litra c)
—
Artikel 58
—
Artikel 59
Artikel 38 og artikel 185 (delvis)
Artikel 60
Artikel 268
Artikel 61
—
Artikel 62
—
Artikel 63
—
Artikel 64
—
Artikel 65
—
Artikel 66
—
Artikel 67
—
27.   Direktiv 2008/71/EF
Direktiv 2008/71/EF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3, stk. 1
Artikel 101 og 111
Artikel 3, stk. 2
Artikel 118, stk. 2, og artikel 119
Artikel 4, stk. 1
Artikel 102, 107 og 119
Artikel 4, stk. 2
Artikel 102, stk. 3
Artikel 5, stk. 1
Artikel 115, litra a), artikel 118, stk. 1, litra a), og stk. 2, litra a), og artikel 120
Artikel 5, stk. 2
Artikel 118, stk. 1, litra a), og stk. 2, litra a)
Artikel 6, stk. 1
Artikel 115, litra a), artikel 118, stk. 1, litra a), og stk. 2, litra a), og artikel 120
Artikel 6, stk. 2
—
Artikel 7
Artikel 109, stk. 1, litra c), og stk. 2
Artikel 8
Artikel 118, stk. 2, litra e)
Artikel 9
Artikel 268
Artikel 10
—
Artikel 11
—
Artikel 12
—
Artikel 13
—
28.   Direktiv 2009/156/EF
Direktiv 2009/156/EF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3
Artikel 126 og 139
Artikel 4, stk. 1
Artikel 130 og artikel 149, stk. 3
Artikel 4, stk. 2
Artikel 130 og 131
Artikel 4, stk. 3
Artikel 128
Artikel 4, stk. 4
Artikel 114, 118 og 120
Artikel 4, stk. 5
Artikel 126, stk. 1, litra b), og artikel 130 og 131
Artikel 4, stk. 6
Artikel 31-35
Artikel 5
Artikel 130 og 131
Artikel 6
Artikel 130, 131 og artikel 144, stk. 1, litra b)
Artikel 7, stk. 1
Artikel 126, stk. 2, og artikel 133
Artikel 7, stk. 2
Artikel 131 og 132
Artikel 7, stk. 3
Artikel 130, 131 og 132
Artikel 8
Artikel 114, stk. 1, litra c), artikel 118, 120 og artikel 143-146
Artikel 9
Artikel 257-259 (delvis)
Artikel 10
—
Artikel 11
—
Artikel 12, stk. 1, 2 og 3
Artikel 229, stk. 1, litra a), og artikel 230 og 231
Artikel 12, stk. 4
Artikel 234
Artikel 12, stk. 5
—
Artikel 13
Artikel 234 og 235
Artikel 14
Artikel 234
Artikel 15
Artikel 234
Artikel 16
Artikel 234, 235 og 237
Artikel 17
Artikel 234
Artikel 18
—
Artikel 19, litra a)-c)
Artikel 234 og 239
Artikel 19 litra d)
—
Artikel 20
—
Artikel 21
—
Artikel 22
—
Artikel 23
—
Artikel 24
—
29.   Direktiv 2009/158/EF
Direktiv 2009/158/EF
Denne forordning
Artikel 1
—
Artikel 2
Artikel 4 (delvis)
Artikel 3
—
Artikel 4
—
Artikel 5
Artikel 126, 130, 131, 159 og 160
Artikel 6
Artikel 124, 126 og 159
Artikel 7
Artikel 101
Artikel 8
Artikel 159 og 160
Artikel 9
Artikel 130 og 131
Artikel 10
Artikel 130, 131 og artikel 149, stk. 3 og 4
Artikel 11
Artikel 130, 131 og artikel 149, stk. 3 og 4
Artikel 12
Artikel 130 og 131
Artikel 13
Artikel 131 og 273
Artikel 14
Artikel 131
Artikel 15, stk. 1, litra a)
Artikel 159 og 160
Artikel 15, stk. 1, litra b)-d)
Artikel 130 og 131
Artikel 15, stk. 2
Artikel 31-35 og artikel 36, stk. 3
Artikel 15, stk. 3
Artikel 42
Artikel 16
Artikel 31-35
Artikel 17
Artikel 36, 39 og 40
Artikel 18
Artikel 117, 118, stk. 2, litra e), artikel 122, stk. 2, artikel 124, 125, artikel 126, stk. 1, litra a), og stk. 2, artikel 132 og artikel 157, stk. 3
Artikel 19
Artikel 130 og 131
Artikel 20
Artikel 143, stk. 1, litra a), artikel 144, 145, 149, 161 og artikel 162
Artikel 21
Artikel 139 og artikel 144, stk. 1, litra a) og b)
Artikel 22
—
Artikel 23
Artikel 229, stk. 1, litra a), og artikel 230 og 231
Artikel 24
Artikel 234
Artikel 25
Artikel 234
Artikel 26
Artikel 237
Artikel 27
—
Artikel 28
Artikel 234, 235 og 236
Artikel 29
Artikel 234, 235 og 239
Artikel 30
Artikel 234
Artikel 31
Artikel 257-259
Artikel 32
—
Artikel 33
—
Artikel 34
—
Artikel 35
—
Artikel 36
—
Artikel 37
—
Artikel 38
—
30.   Forordning (EU) nr. 576/2013
Forordning (EU) nr. 576/2013
Denne forordning
Artikel 1
—
Artikel 2
Artikel 3, stk. 5 og 6, og artikel 244
Artikel 3
Artikel 4 (delvis)
Artikel 4
Artikel 245, stk. 1
Artikel 5, stk. 1 og 2
Artikel 246, stk. 1 og 2
Artikel 5, stk. 3
—
Artikel 5, stk. 4
Artikel 3, stk. 4-6
Artikel 5, stk. 5
Artikel 246, stk. 3
Artikel 5, stk. 6
—
Artikel 6
Artikel 247 og artikel 252, stk. 1, litra a) og b)
Artikel 7
Artikel 252, stk. 1, litra b), og stk. 4, litra d)
Artikel 8, stk. 1 og 3
Artikel 252, stk. 1, litra b) og d)
Artikel 8, stk. 2
Artikel 253, stk. 1, litra b)
Artikel 9
Artikel 248 og artikel 252, stk. 1, litra a) og b)
Artikel 10
Artikel 249 og artikel 252, stk. 1, litra a) og b)
Artikel 11
Artikel 252, stk. 1, litra b), og stk. 4, litra d)
Artikel 12
Artikel 252, stk. 1, litra b), og stk. 4, litra d)
Artikel 13
Artikel 252, stk. 4, litra d), og artikel 253, stk. 1, litra d)
Artikel 14
Artikel 250 og artikel 252, stk. 1, litra a) og b)
Artikel 15
Artikel 252, stk. 4, og artikel 253, stk. 1, litra d)
Artikel 16
Artikel 251
Artikel 17
Artikel 247, litra a), og artikel 252, stk. 1, litra a)
Artikel 18
Artikel 252, stk. 1, litra a), nr. ii), og artikel 14, stk. 1, litra c), nr. iv), og stk. 2
Artikel 19
Artikel 252, stk. 1, litra a), stk. 2, 3 og stk. 4, litra a), b) og c)
Artikel 20
Artikel 253, stk. 1, litra c)
Artikel 21
Artikel 254, litra a), og artikel 255, stk. 1 og stk. 2, litra b)
Artikel 22
Artikel 254, litra d)
Artikel 23
Artikel 254, litra b)
Artikel 24
Artikel 254, litra c)
Artikel 25
Artikel 254, litra a), og artikel 255, stk. 1
Artikel 26
Artikel 254, litra d)
Artikel 27
Artikel 254, litra c)
Artikel 28
Artikel 254, litra a), og artikel 255, stk. 2, litra a)
Artikel 29
Artikel 254, litra d)
Artikel 30
Artikel 254, litra a), og artikel 255, stk. 2, litra a)
Artikel 31
Artikel 254, litra d)
Artikel 32
Artikel 252, stk. 4, litra e)
Artikel 33
—
Artikel 34
—
Artikel 35
—
Artikel 36
Artikel 257-262
Artikel 37
Artikel 256
Artikel 38
—
Artikel 39
—
Artikel 40
—
Artikel 41
—
Artikel 42
Artikel 268
Artikel 43
—
Artikel 44
—
Artikel 45
—

Summary:
EU’s dyresundhedslov
RESUMÉ AF:
Forordning (EU) 2016/429 om overførbare dyresygdomme
HVAD ER FORMÅLET MED FORORDNINGEN?
Den sigter mod at forebygge og bekæmpe dyresygdomme, som kan overføres til andre dyr eller mennesker.
Dyresundhedsloven er en del af en 
pakke af foranstaltninger
, som 
Europa-Kommissionen
 foreslog i maj 2013 med henblik på at styrke håndhævelsen af standarder for sundhed og sikkerhed for hele fødevarekæden.
HOVEDPUNKTER
Denne omfattende forordning støtter 
Den Europæiske Unions
 (EU) kreatur- og fødevareproduktionssektorer og det tilhørende EU-marked med hensyn til bæredygtighed, konkurrenceevne, vækst og beskæftigelse. Den erstatter og udvider de eksisterende EU-regler for dyresundhed og samler de fleste i en mere enkel lovgivning med større fokus på de vigtigste prioriteter i forbindelse med bekæmpelse af sygdomme. Disse prioriteringer omfatter:
tydeligere ansvarsområder
for landbrugere (kvæg-, fiske- og skaldyrsopdræt) og andre interessenter (f.eks. dyrlæger) med hensyn til tidlig opdagelse for at forebygge store sygdomsudbrud eller spredning af sygdomme, så skaderne kan begrænses
forenklet administration
 ved international handel med visse levende dyr og dyreprodukter (som f.eks. sæd, æg og embryoner)
et 
tydeligere retsgrundlag
 og 
bedre værktøjer
, så veterinærmyndigheder kan bekæmpe potentielt ødelæggende overførbare dyresygdomme, især vedrørende overvågning, diagnosticering og anmeldelse
mere fleksibilitet
 i forbindelse med tilpasning af regler til lokale forhold og nye problemer som f.eks. klimaforandringer og sociale forandringer
begrænsning af de negative virkninger
 for dyresundheden, folkesundheden og miljøet.
Den fastlægger krav til:
sygdomsforebyggelse
 og 
beredskab i forbindelse med eventuelle udbrud
 (f.eks. 
biosikring
1
 sforanstaltninger) såsom brugen af diagnosticeringsværktøjer, vaccination og medicinsk behandling
identifikation og registrering
 af dyr og visse animalske produkter (f.eks. sæd, æg og embryoner) samt certificering og sporing af sendinger af dem
indførsel
 af dyr og animalske produkter til EU og flytning af disse inden for EU
sygdomsbekæmpelse og -udryddelse
, herunder hasteforanstaltninger som f.eks. begrænsning af flytning af dyr, aflivning og vaccination.
Reglerne omfatter dyresygdomme hos alle opdrættede dyr (herunder i visse tilfælde selskabsdyr), vildtlevende dyr og animalske produkter, både landdyr og akvatiske dyr. De omfatter ikke 
dyrevelfærd
 direkte, men anerkender sammenhængen mellem dyrs sundhed og velfærd og tager hensyn til denne i forbindelse med vurdering af sygdommes virkninger.
EU’s dyresundhedslov suppleres i følgende henseender:
krav til sporbarhed og dyrevelværd ved flytning inden for EU af 
avlsmateriale
 (sæd, æg og embryoner) af visse opdrættede landdyr og godkendelse af 
virksomheder for avlsmateriale
 (virksomheder, der producerer eller forarbejder avlsmateriale)
forebyggelse og bekæmpelse af visse sygdomme
dyresundhedsmæssige krav til flytninger inden for EU af landdyr og rugeæg
overvågning, udryddelse og sygdomsfri status for visse sygdomme
regler for akvakulturvirksomheder og transportører af akvatiske dyr
regler for indførsel i EU og flytning og håndtering efter indførsel af sendinger af visse dyr, avlsmateriale og produkter af animalsk oprindelse
regler for virksomheder, der holder landdyr, og rugerier samt sporbarheden af sådanne landdyr og rugeæg
sygdomme, der er omfattet af EU-overvågningsprogrammer, deres geografiske anvendelsesområde og sygdomme for hvilke der kan oprettes sygdomsfri områder
dyresundhedsmæssige krav til flytninger inden for EU af akvatiske dyr og produkter af animalsk oprindelse fra akvatiske dyr.
Følgende forordninger supplerer eller gennemfører EU’s dyresundhedslov:
Delegeret forordning (EU) 
2018/1629
 om listen over sygdomme
Gennemførelsesforordning (EU) 
2018/1882
 om kategorier af listeopførte sygdomme (se den 
konsoliderede udgave
)
Delegeret forordning (EU) 
2019/2035
 om virksomheder, der holder landdyr, og rugerier samt sporbarhed (som ændret ved delegeret forordning (se den 
konsoliderede udgave
)
Delegeret forordning (EU) 
2020/686
 om flytning inden for EU af avlsmateriale af visse opdrættede landdyr (se den 
konsoliderede udgave
);
Delegeret forordning (EU) 
2020/687
 om forebyggelse og bekæmpelse af visse sygdomme (se den 
konsoliderede udgave
);
Delegeret forordning (EU) 
2020/688
 om dyresundhedsmæssige krav vedrørende flytning inden for EU af landdyr og rugeæg (se den 
konsoliderede udgave
)
Delegeret forordning (EU) 
2020/689
 om overvågning og udryddelsesprogrammer for nye sygdomme (se den 
konsoliderede udgave
)
Gennemførelsesforordning (EU) 
2020/690
 om listeopførte sygdomme, der er omfattet af EU-overvågningsprogrammer
Delegeret forordning (EU) 
2020/691
 om regler for akvakulturvirksomheder
Delegeret forordning (EU) 
2020/692
 om regler vedrørende indførsel til EU og flytning og håndtering af visse dyr, visse typer avlsmateriale og visse animalske produkter (se den 
konsoliderede udgave
)
Delegeret forordning (EU) 
2020/990
 om dyresundhedsmæssige krav, herunder certificeringskrav, vedrørende flytning inden for EU af akvatiske dyr og animalske produkter
Gennemførelsesforordning (EU) 
2020/999
 om godkendelse af avlsmaterialevirksomheder og sporbarhed for avlsmateriale af kvæg, svin, får, geder og dyr af hestefamilien
Gennemførelsesforordning (EU) 
2020/2002
 om kategorier af indberetning af listeopførte sygdomme (se den 
konsoliderede udgave
)
Delegeret forordning (EU) 
2020/2154
 om dyresundheds-, certificerings- og anmeldelseskrav vedrørende flytninger inden for EU af animalske produkter af landdyr
Gennemførelsesforordning (EU) 
2020/2235
 om standarddyresundhedscertifikater ved indførsel til EU og flytning inden for EU af sendinger af visse kategorier af dyr og varer (se den 
konsoliderede udgave
)
Gennemførelsesforordning (EU) 
2020/2236
 om standarddyresundhedscertifikater ved indførsel til EU og flytning inden for EU af sendinger af akvatiske dyr (se den
konsoliderede udgave
)
Gennemførelsesforordning (EU) 
2021/403
 om standarddyresundhedscertifikater ved indførsel til EU og flytning inden for EU af sendinger af akvatiske dyr (se den 
konsoliderede udgave
)
Gennemførelsesforordning (EU) 
2021/404
 om fastlæggelse af lister over tredjelande, territorier eller zoner deri, hvorfra det er tilladt at indføre dyr, avlsmateriale og animalske produkter til EU (se den 
konsoliderede udgave
)
Gennemførelsesforordning (EU) 
2021/520
 om sporbarhed for visse opdrættede landdyr (se den 
konsoliderede udgave
)
Gennemførelsesforordning (EU) 
2021/963
 for så vidt angår identifikation og registrering af dyr af hestefamilien og om fastlæggelse af standardidentifikationsdokumenter for disse dyr
Gennemførelsesforordning (EU) 
2021/2037
 fritagelse for forpligtelser med hensyn til registrering af akvakulturvirksomheder og føring af fortegnelser for operatører
Delegeret forordning (EU) 
2022/139
 forvaltning, opbevaring og udskiftning af lagre i EU-antigen-, -vaccine- og -diagnostisk reagens-bankerne samt krav til driften af disse banker med hensyn til biosikring, biosikkerhed og biologisk indeslutning
Gennemførelsesforordning (EU) 
2022/140
 om EU-antigen-, -vaccine- og -diagnostisk reagens-bankerne
Gennemførelsesforordning (EU) 
2022/1345
 om registrering og godkendelse af virksomheder, der holder landdyr og indsamler, producerer, forarbejder eller opbevarer avlsmateriale.
HVORNÅR GÆLDER FORORDNINGEN FRA?
Forordningen trådte i kraft den 
21. april 2021
. Den omfatter imidlertid visse overgangsforanstaltninger og ophæver ældre lovgivning med virkning fra den 
21. april 2016
.
BAGGRUND
For yderligere oplysninger henvises til:
EU’s dyresundhedslov
 (Europa-Kommissionen).
VIGTIGE BEGREBER
Biosikring.
 Forvaltningsprocedurer, -handlinger eller -faciliteter, som er udarbejdet for at reducere risikoen for dyresygdomme.
HOVEDDOKUMENT
Europa-Parlamentets og Rådets forordning (EU) 
2016/429
 af 
9. marts 2016
 om overførbare dyresygdomme og om ændring og ophævelse af visse retsakter på området for dyresundhed (»dyresundhedsloven«) (EUT L 84 af 
31.3.2016
, 
s. 1-208
).
Efterfølgende ændringer til forordning (EU) 2016/429 er blevet indarbejdet i grundteksten. Denne 
konsoliderede udgave
 har ingen retsvirkning.
seneste ajourføring 
22.3.2023