P7_TA(2014)0381

Animal health ***I

European Parliament legislative resolution of 15 April 2014 on the proposal for a regulation of the European Parliament and of the Council on Animal Health (COM(2013)0260 — C7-0124/2013 — 2013/0136(COD))

(Ordinary legislative procedure: first reading)

(2017/C 443/60)

The European Parliament,

having regard to the Commission proposal to Parliament and the Council (COM(2013)0260),

having regard to Article 294(2) and Articles 43(2) and 114(3) and point (b) of Article 168(4) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0124/2013),

having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Austrian Federal Council, asserting that the draft legislative act does not comply with the principle of subsidiarity,

having regard to the opinion of the European Economic and Social Committee of 10 December 2013 (1) ,

after consulting the Committee of the Regions,

having regard to Rules 55 and 37 of its Rules of Procedure,

having regard to the report of the Committee on Agriculture and Rural Development and the opinions of the Committee on the Environment, Public Health and Food Safety and the Committee on Fisheries (A7-0129/2014),

Adopts its position at first reading hereinafter set out;

Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

Instructs its President to forward its position to the Council, the Commission and the national parliaments.

(1) Not yet published in the Official Journal.

P7_TC1-COD(2013)0136

Position of the European Parliament adopted at first reading on 15 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council on Animal Health the prevention and control of animal diseases which are transmissible among animals or to humans [Am. 1]

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(3) 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 these diseases can be devastating for individual animals, animal populations, animal keepers and the economy and can have a major influence on public health and food safety. [Am. 2]

(2) As recent experiences have demonstrated, transmissible animal diseases may also have a significant impact on public health and food safety , as for example in the case of avian influenza and salmonella. [Am. 3]

(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.

(3a) Proper control of infectious animal diseases, including zoonotic diseases, is a prerequisite for a functioning single market for trade in live animals, animal products and food. [Am. 4]

(4) In order to ensure high standards of animal and public health in the Union, the rational development of the agriculture and aquaculture sectors and to increase productivity, animal health rules should be laid down at Union level. These rules are necessary, inter alia, to contribute to the completion of the internal market, and to avoid the spread of infectious diseases.

(4a) Article 13 of the Treaty on the Functioning of the European Union (TFEU) recognises that animals are sentient beings. Union legislation on animal welfare requires animal owners, animal keepers and competent authorities to respect animal welfare requirements guaranteeing their humane treatment and avoiding them unnecessary pain and suffering. Such rules are based on scientific evidence and may improve animal health. [Am. 5]

(5) The current Union animal health legislation 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, providing harmonised principles across the sector is missing.

(5a) With a view to making the provisions of Union animal health legislation as clear as possible, and thus ensuring that they are fully and correctly implemented, a criterion and principle for organising the delegated and implemented acts adopted pursuant to this Regulation needs to be laid down. [Am. 6]

(6) The Animal Health Strategy for the Union (2007– 2013) proposes that ‘Prevention is better than cure’ and was adopted by the Commission in its Communication of 19 September 2007 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. It aims to put promote animal health through putting greater focus 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 to international standards while ensuring a firm commitment to high standards of animal health. [Am. 7]

(7) 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.

(7a) The Commission Communication on the new Animal Health Strategy for the European Union stresses that a joint approach should be taken to prevention and biosecurity measures, given that contagious disease agents can spread easily from one farm to another. [Am. 8]

(8) Animals may suffer from a broad range of infectious or non-infectious diseases. Many diseases can be treated, 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 on a population level. The animal health rules laid down in this Regulation should only be limited to those latter diseases.

(9) In laying down those animal health rules, it is essential that considerations are given to the link between animal health and public health, the environment, food and feed safety, animal welfare, food security, economic, social and cultural aspects , cultural aspects and especially animal welfare, given the interdependency of animal welfare and animal health [Am. 9].

(10) Council Decision 94/800/EC (3) approved on behalf of the then European Community, with regard to that portion of those matters which falls within its competence the Agreement establishing the World Trade Organization (WTO), and also the Agreements set out in Annexes 1, 2 and 3 to that Agreement which include the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). The SPS Agreement 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 WTO members. If international standards exist, they are required to be used as a basis. However, the members have the right to set their own relevant standards provided that such standards are based on scientific evidence.

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

(12) 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 Communication from the Commission of 2 February 2000 on the precautionary principle allows a Member of that agreement to adopt provisional measures on the basis of available pertinent information. In such circumstances, the WTO Member is required to obtain the additional information necessary for a more objective assessment of risk and review the measure accordingly within a reasonable period of time.

(13) 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 established by Regulation (EC) No 178/2002 of the European Parliament and of the Council (4).

(14) Regulation (EC) No 1069/2009 of the European Parliament and the Council (5) 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 these issues are duly covered by this Regulation.

(15) 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 (6), Directive 2003/99/EC of the European Parliament and of the Council (7) and Regulation (EC) No 2160/2003 of the European Parliament and of the Council (8), and specific rules on communicable diseases in humans in Decision No 2119/98/EC of the European Parliament and of the Council (9). 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.

(16) Diseases occurring in wild animal populations may have a detrimental effect on the agriculture and aquaculture sectors, on public health, the environment and 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.

(17) 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, ova and embryos used in artificial insemination, ovum 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.

(18) Animal diseases may have detrimental effects on the distribution of animal species in the wild, and thus affect biodiversity. Microorganisms causing animal diseases can therefore fall within the definition of invasive alien species 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.

(19) In Union legislation adopted prior to this Regulation separate animal health rules are laid down for terrestrial and aquatic animals. Council Directive 2006/88/EC (10) 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, the scope of this Regulation should cover both terrestrial and aquatic animals and aligns 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. [Am. 10]

(20) Union legislation adopted prior to this Regulation and in particular Council Directive 92/65/EEC (11) 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 represent 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 for detailed animal health rules for movements of such animals and their products to be laid down if the risks involved so require.

(21) The keeping of pet animals, including ornamental aquatic animals in households and non-commercial ornamental aquaria, both indoors and outdoors, generally represents a lower health risk compared to other ways of keeping or moving animals on a broader scale, such as those common in agriculture. Therefore, it is not appropriate that the general requirements concerning registration, record keeping and movements within the Union apply to such 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 be laid down for non-commercial movements of pet animals within the Union.

(22) 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 broad scope of the group. This is the case for the group of hoofed mammals classified as ungulates. This list may need to be changed in the future due to reasons of changed taxonomy, scientific development or technical updates justified by science. Similarly, the list of species of pet animals may need to be adjusted due to developments in society, or changed habits of keeping pet animals, in particular where these animals transmit diseases. 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 lists of pet animals and ungulates set out in Annexes I and II to this Regulation.

(23) Not all transmissible animal diseases can or should be prevented and controlled through regulatory measures, for example, if the disease is too widespread, 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 disrupt trade. It is therefore essential that such measures are only applied when proportionate and necessary, such as when a disease presents or is suspected to present a significant risk to animal or public health.

(24) Furthermore, the preventive and control measures for each transmissible animal disease should be ‘tailor-made’ in order to address its unique epidemiological profile and its consequences. The preventive and control rules applying to each of them should therefore be disease specific , and strict attention should be paid to different regional conditions . [Am. 11]

(25) 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.

(26) 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 national rules.

(27) 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 actions to prevent or control such diseases, for instance through self-regulatory measures or the development of codes of practice.

(28) In contrast to the transmissible animal diseases described in recitals 26 and 27, highly transmissible animal diseases may easily spread across borders and, if they are also a zoonosis, 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.

(29) Action No. 5 of the Communication from the Commission to the European Parliament and the Council — Action plan against the rising threats from Antimicrobial Resistance emphasises the preventive role of this Regulation and the consequent expected reduction of the use of antibiotics in animals. Resistance of microorganisms to antimicrobials to which they were previously responsive is increasing. This resistance complicates the treatment of infectious diseases in humans and animals. 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.

(30) New hazards associated with certain diseases or species may develop in particular due to changes in the environment, the climate, animal husbandry, farming traditions but also through social changes and changes in economic and trade relations inside and outside the Union . Unless they are totally eradicated, diseases currently confined to limited geographical areas could spread and cause economic damage over wider areas . Furthermore, scientific progress may also lead to new knowledge and increased awareness concerning existing diseases. Furthermore At the same time , 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, developed a system of disease prioritisation and categorisation, by producing a study on the ‘Listing and categorisation of priority animal diseases, including those transmissible to humans’ and a tool for such an exercise. This Regulation should introduce such an approach in Union legislation. [Am. 12]

(31) In order to ensure uniform conditions for the implementation of this Regulation in relation to transmissible animal diseases at Union level, It is necessary to establish a harmonised list of transmissible animal diseases (‘listed diseases’). Thus implementing powers to lay down such a list should be conferred on the Commission. , which should be set out in a table in an Annex attached to this Regulation. The power to adopt acts amending or supplementing such a list should be delegated to the Commission in accordance with Article 290 TFEU. [Am. 13]

(32) Emerging diseases with the potential to cause serious public or animal health risks and impacts on health, the economy or the environment may appear in the future. Following the assessment of such diseases and after adopting temporary emergency measures, when relevant, a quick reaction and insertion of such diseases in the list of listed diseases may be necessary. Therefore the power to adopt acts in accordance with the urgency procedure should be delegated to the Commission in these duly justified cases of risks to public or animal health.

(33) 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. For other diseases that might already be present in parts of the Union, compulsory or voluntary eradication is required. In both 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 testing prior to dispatch. In other instances it might be appropriate only to implement surveillance of the disease's distribution, without taking further measures. This would be the case, in particular, in the event of an emerging disease for which there is limited information.

(34) 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 and to determine the applicability of disease prevention and control rules of the Regulation to the different listed diseases to ensure coherence and consistency. In order to ensure that technical and scientific progress and developments of relevant international standards are taken into account, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission with respect to the possible amendments of those criteria.

(35) The prevention and control rules of this Regulation for a specific transmissible animal disease should apply to species of animals which can transmit the disease in question, by being susceptible to it or by acting as its vector. In order to ensure uniform conditions for the implementation of this Regulation, It is thus necessary to establish a harmonised list of species to which the measures for specific listed diseases should apply at Union level (‘listed species’) and thus implementing powers to lay down such a list should be conferred on the Commission which should be set out in a table in an Annex to this Regulation. The power to adopt acts amending or supplementing such a list should be delegated to the Commission in accordance with Article 290 TFEU . [Am. 14]

(36) Based on the importance and the level of impact of a listed disease, its distribution, prevalence and incidence in the Union , the risk of spreading and the availability of disease prevention and control measures in respect of that listed disease, a different category of specific disease prevention and control rules provided for in this Regulation should apply coherently and consistently to each listed disease. [Am. 15]

(37) In order to ensure uniform conditions for the implementation of this Regulation in relation to the disease prevention and control measures applicable to listed diseases, It is necessary to determine , and lay down in a list, the application of the rules, provided for in this Regulation, to listed diseases at Union level. Thus implementing powers to lay down which listed diseases are to be subject to which rules, should be conferred on the Commission. Such a list should be kept and updated in a table in an Annex to this Regulation. The power to adopt acts amending or supplementing such a list should be delegated to the Commission in accordance with Article 290 TFEU. [Am. 16]

(38) Operators, animal professionals and pet keepers working with animals are in the best position to observe and ensure the health of the animals and products under their responsibility. They should therefore hold primary responsibility for carrying out measures for the prevention and control of the spread of diseases among animals and products under their responsibility , and should work individually and collectively to improve animal health practices [Am. 17].

(39) 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 the EU Animal Health Law and possible impacts are specifically assessed. In order to ensure that the biosecurity measures applied by operators, animal professionals and pet keepers are sufficiently flexible, that they are adjusted to suit the type of production and the species or categories of animals involved and that they take account of the local circumstances and technical developments, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission with respect to supplementary and more detailed biosecurity requirements.

(40) 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 as well as during animal transport. They should therefore be considered a part of biosecurity.

(41) 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 other 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 European farmer organisations and other organisations may be valuable contributors. Those alternative means of acquiring such knowledge should also be recognised by this Regulation. The same may also be said of pet keepers, while bearing in mind their different position and level of responsibility. [Am. 18]

(42) 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.

(43) Veterinarians have the education and the professional qualifications which ensure that they have 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 who 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 Aquatic Animal Health Code of the OIE.

(44) In order to ensure that the veterinarians and aquatic animal health professionals who undertake activities that fall within the scope of this Regulation are adequately qualified and receive appropriate training, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect to their qualification and training.

(45) Member States and in particular the competent authority thereof 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, raising disease awareness, and in the facilitation of animal movements and in international trade by the issuing of animal health certificates. 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.

(46) The competent authority cannot always perform all the activities required to be carried out by it under this Regulation due to the limited resources. For that reason it is necessary to provide a legal basis for the delegation of the performance of those activities to veterinarians and other qualified professionals . For the same reason, it is of utmost importance that those veterinarians and professionals have no conflicts of interest . 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 of the Treaty on the Functioning of the European Union TFEU should be delegated to the Commission in respect to the delegation of the performance of those activities to veterinarians and their appropriate training. [Am. 19]

(47) Optimal animal health management can only be achieved in cooperation with animal keepers, operators, veterinarians, animal health professionals, other stakeholders and trading partners. 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 and transparent manner. Therefore the competent authority should 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 , food safety or the environment and when a case is of public interest. [Am. 20]

(48) To avoid the release of disease agents from laboratories, institutes and other facilities handling diseases 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 while handling or transporting such disease agents, vaccines and other biological products. This obligation 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 when handling 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 diseases agents.

(49) 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 any suspicion or confirmation of an outbreak of certain listed diseases should be immediately notified to the competent authority veterinarians or aquatic animal health professionals . At the same time, a professional approach to notification and reporting must be ensured, in order avoid unnecessary health scares . Those notification obligations should therefore be applicable to any natural and legal person in order to ensure that no disease outbreaks remain unnoticed all operators, animal professionals and pet keepers . [Am. 21]

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

(51) In order to ensure the effective and efficient notification and to clarify different circumstances related to abnormal mortalities and other serious diseases signs, 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 the notification occur and the rules for further investigation, where this is relevant.

(52) For certain listed diseases it is vital that the Commission and the other Member States are immediately notified about diseases. Such Union notification will enable neighbouring or other affected Member States to take precautionary measures when so warranted. In order to ensure uniform conditions for the implementation of such Union notification, implementing powers shall be conferred on the Commission.

(53) 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 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 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, which are necessary 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.

(54) A key purpose of disease notification and reporting is to generate reliable, transparent and accessible epidemiological data. A computerised 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 burden for the competent authorities of the Member States by merging disease notification and reporting within the Union and at international level into one process (that is the WAHIS/WAHID database of the OIE). Consistency with the exchange of information in accordance with Directive 2003/99/EC should also be ensured.

(55) 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 provided for in this Regulation and to establish the necessary procedures, formats, data and information exchanges regarding disease notification and reporting.

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

(57) 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. In the context of this Regulation and with respect to wild animals, the role of hunters should also be recognised as instrumental in monitoring diseases due to their experience and knowledge of the diseases affecting wild animals. Similarly hunting associations and holder of hunting rights could also supplement the work of operators in monitoring wild animals. [Am. 22]

(58) 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 and other relevant factors, be subject to animal health visits. In order to ensure a proportionate level of surveillance to the risks involved in different types of establishments, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission concerning the criteria and the content of such animal health visits in different types of establishments.

(59) It is essential that the competent authority has 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 that disease should be assessed and epidemiological data collected for that assessment. To ensure the best use of resources information should be collected, shared and used in the most effective and efficient manner possible.

(60) The surveillance methodology, frequency and intensity should be adapted to each specific disease and take into account the specific purpose of the surveillance, the animal health status in the region concerned and any additional surveillance conducted by operators.

(61) In some cases, and depending on the epidemiological profile of a disease and relevant risk factors, a structured surveillance programme may need to be put in place. In that case it is appropriate that Member States develop epidemiologically based surveillance programmes. The power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission concerning the surveillance design, the criteria for official confirmation of outbreaks and the case definitions of those diseases and requirements for surveillance programmes in relation to their contents, information to be included and the period of application.

(62) To promote coordination between the Member States and ensure that those surveillance programmes are consistent with Union objectives, they should be submitted to the Commission and other Member States for information. Furthermore, the Member State implementing the surveillance programme should also submit regular reports on the results of that surveillance programme 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 and information exchange.

(63) 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 the eradication is compulsory in the Union, or have the possibility to establish voluntary eradication programmes, to eradicate those diseases where the eradication is envisaged in the Union, but is not compulsory. To ensure uniform conditions of general application throughout the Union, it is necessary to lay down harmonised requirements for such compulsory or voluntary eradication programmes. In order to ensure effective disease eradication, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the objectives of disease control strategies, disease control measures under the compulsory or voluntary eradication programmes and requirements of such programmes. [Am. 23]

(63a) 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. Member States have the possibility to establish voluntary eradication programmes for such diseases, if they decide that eradication is important for them. Such voluntary eradication programmes would be recognised at the Union level. This programme would entail implementing certain relevant disease control measures. It may also enable the Member State, subject to approval by the Commission, to require certain guarantees when receiving animals from other Member States or from third countries, such as additional testing for the disease and assurances about those test results in a movement certificate. Their programme may also be eligible for a Union financial contribution, if the disease is listed in Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (12) and they submit an application for funding. [Am. 24]

(63b) To ensure uniform conditions of general application throughout the Union, it is necessary to lay down harmonised requirements for such compulsory or voluntary eradication programmes. In order to ensure effective disease eradication, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the objectives of disease control strategies, disease control measures under the compulsory or voluntary eradication programmes and requirements of such programmes. [Am. 25]

(64) 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.

(65) Furthermore, Member States should have the possibility of declaring the whole of their territories, zones or compartments thereof free of one or more of listed diseases, which are subject to rules on compulsory or voluntary 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 is officially approved and thus implementing powers to approve such status should be conferred on the Commission.

(66) 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 only recognised 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 for the recognition, rules for approval and the requirements for compartments, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission.

(67) Member States should make their disease-free territory, zones and compartments thereof publicly known for the purpose of informing trading partners and facilitating trade.

(68) 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 for obtaining such status, the evidence needed to substantiate freedom from disease, special disease prevention and control measures, restrictions, information to be provided, derogations, and conditions for the maintenance, suspension, withdrawal or restoration of disease-free status.

(69) 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 lay down detailed rules on formats for the submission of applications and information exchange.

(70) 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 this effective and efficient tool for the control of disease emergencies, which is flexible to adjust to the emergency situations, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the detailed requirements and conditions for contingency plans.

(71) Past animal health crises have shown the benefits of having specific, detailed and rapid management procedures for disease emergencies. Those organisational procedures should ensure a rapid and effective response and improve coordination of efforts of all involved parties, and in particular the competent authorities and the stakeholders.

(72) To ensure the applicability of contingency plans in real emergency situations, it is essential to practise and test that the systems are working. For that purpose 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.

(73) 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.

(74) 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 the EU Animal Health Law highlights in particular the importance of vaccines as a tool in the prevention, control and eradication of animal diseases.

(75) 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, hyper immune sera or antimicrobial agents may mask the expression 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 , thereby significantly putting at risk public and animal health . [Am. 26]

(76) However, those control strategies may substantially vary between different listed diseases. Thus this Regulation should provide for rules on the use of veterinary medicinal products for the prevention and control of listed certain diseases and for harmonised criteria for 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 the effective treatments, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union TFEU should be delegated to the Commission in respect of the restrictions, prohibitions or obligations to use certain veterinary medicinal products in the framework of the control of certain listed diseases. In the case of urgency and in order to address emerging risks with possible devastating implications for animal or public health, economy, society or environment, it should be possible for these measures to be adopted by the urgency procedure. [Am. 27]

(77) Following the conclusions of the Expert opinion on vaccine and/or diagnostic banks for major animal diseases (13) it should also be made 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 for animal or public health. The establishment of a Union antigen, vaccine and diagnostic reagent bank would promote the Union's animal health objectives by enabling a quick and effective response when its resources are required and represents an efficient use of limited resources.

(78) 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 the management of such banks, and safety standards and requirements for the operation of those. However, this Regulation should not provide for the rules on the financing of the disease preventive and control measures, including vaccination.

(79) 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. Similarly, for those Member States which have not set up national antigen, vaccine and diagnostic reagent banks or which find that stocks are limited in the Union banks, criteria for access to the resources of other Member States should be established. [Am. 28]

(80) 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.

(81) 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 vaccines, antigens and diagnostic reagents and the frequency and content of submissions of information to the Commission.

(82) In the event of an outbreak of a listed disease considered to represent a high risk to animal or public health in the Union, it is necessary to take immediate disease control measures to eradicate that listed disease in order to protect animal and public health and the relevant sectors.

(83) Operators, animal professionals and pet keepers should have the primary responsibility for controlling and preventing the spread of transmissible animal diseases. They should take immediate action in case of suspicion or confirmation of highly contagious diseases.

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

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

(85a) According to Directive 2003/99/EC, Member States is to transmit a report to the Commission every year on trends and sources of zoonoses, zoonotic agents and antimicrobial resistance. Similarly, as part of the control plans and control programme provided for in Regulation (EU) No xxxx/xxxx (official controls Regulation) (14) (*1) and in Regulation (EC) No 2160/2003, Member States should take strategic measures to monitor, prevent and control other infectious animal diseases, including those not listed in the Annex to this Regulation. These measures should include a strategy for good animal husbandry and responsible use of veterinary medicines. [Am. 29]

(86) 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.

(86a) Disease control measures that become necessary in the event of a disease outbreak may adversely affect biodiversity and the conservation of farm animal genetic resources. In keeping with the Convention on Biological Diversity and the EU Biodiversity Strategy, the competent authority should take account of the impact on biodiversity and farm animal genetic resources when determining the application of disease control measures. [Am. 30]

(87) The occurrence of a listed disease in wild animals may pose a risk to public health and the health of kept animals , or vice versa . Special rules should therefore be laid down for disease control and eradication measures in wild animals , or, where needed , in kept animals . [Am. 31]

(88) For listed diseases, which are not highly contagious, and which are subject to compulsory eradication, the disease control measures should be implemented to prevent the spread of those listed diseases, in particular to non-infected areas. However, those measures may be more limited or different comparing to those applicable for the most dangerous listed diseases. This Regulation should therefore provide for special rules for those diseases. Member States that have a voluntary eradication programme in place, should also implement such disease control measures. However, the level and intensity of disease control measures should be proportionate and take into account the characteristics of the listed disease in question, its distribution and its significance for the Member State or region concerned by it and the Union as a whole. [Am. 32]

(89) In order to ensure the effective application of the disease control measures provided for in this Regulation by operators, pet keepers and the 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 in the event of suspicion or confirmation of a listed disease in establishments, other locations and restricted zones.

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

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

(92) 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.

(93) To avoid unjustified administrative burdens and costs, particularly to small and medium size enterprises (SMEs), flexibility should be given to the Member States to adapt the system of registration and approval to local and regional conditions and production patterns.

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

(95) Operators have first-hand knowledge of the animals under their care. They should therefore maintain up-to-date records of information which are 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.

(96) In order to ensure the public availability of up-to-date information concerning the registered establishments and transporters and approved establishments the competent authority should establish and keep a register of such establishments and transporters. The power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission, in respect of the information to be contained in the register of establishments and transporters and the record keeping requirements, as regards the information to be recorded, derogations from the record keeping requirements and the specific additional requirements for germinal products.

(97) In order to ensure uniform conditions for the implementation of the requirements laid down in this regulation on the registration and approval of establishments and on the record keeping and registers, implementing powers should be conferred to the Commission to lay down rules concerning the information obligations, exemptions and other rules, the formats and operational specifications of the registers and records.

(98) Efficient traceability is a key element of disease control policy. Identification and registration requirements specific for 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.

(99) In order to ensure the smooth operation of the identification and registration system and ensure traceability, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission, in respect of the obligations concerning databases, designation of the competent authority, detailed identification and registration requirements for different animal species and documents.

(100) It is appropriate to reduce administrative burdens and costs and 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 the derogations from the identification and registration requirements.

(101) 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, the deadlines, and criteria for derogations from such systems.

(102) 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 interfere with the operation of the internal market. Such restrictions should therefore only be applied 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.

(103) The general requirements laid down in this Regulation should apply to all animal movements, such as the prohibition of 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.

(104) The legal framework, currently laid down in Union legislation for the movement of terrestrial animals lays down harmonised rules primarily for the movement of terrestrial animals and products between Member States, while leaving it up to the Member States to determine the necessary movement requirements within their territory. A comparison of the current situation with an option where rules for movements within Member States would also be harmonised at Union level, was extensively elaborated in the Impact Assessment on the EU Animal Health Law. 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.

(105) For animals that are moved between Member States a set of basic animal health requirements apply. In particular, animals may 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 (15) and which are not of infectious origin related to listed diseases, should not be a reason to prevent the movements of animals intended for scientific purposes. Nonetheless, these mortalities should be registered by the competent authority. [Am. 33]

(106) However, this Regulation should provide for flexibility to facilitate the movement of species and categories of terrestrial animals, which represent a low risk for 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.

(107) 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 Directive 64/432/EEC (16), Council Directive 91/68/EEC (17), Council Directive 2009/156/EC (18), Council Directive 2009/158/EC (19) and partially Directive 92/65/EEC. The main rules for the movement 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.

(108) As movements and assembly operations for ungulates and poultry represent a particularly high disease risk, it is appropriate to lay down specific rules in this Regulation to protect the health of the animals involved and prevent the spread of transmissible animal diseases. [Am. 34]

(109) Depending on the listed diseases and listed species, 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 movement rules for animal species including bees, bumble bees, apes, dogs and cats etc. 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.

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

(111) For scientific purposes, such as research or diagnostic purposes, and in particular those authorised in accordance with Directive 2010/63/EU, it may be necessary to move animals which do not comply with the general animal health requirements laid down in this Regulation and represent a higher animal health risk. Those kinds of movements should not be prohibited or unduly restricted by the provisions of this Regulation, as this could impede otherwise authorised research activities and delay scientific progress. Nonetheless, it is essential that rules are laid down in this Regulation to ensure that movements of those animals take place in a safe manner and are registered by the competent authority . [Am. 35]

(112) 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. Specific consideration should be taken in adapting Union rules on movement to such animals, taking into account specific risks and alternative risk mitigation measures.

(113) In order to ensure that the objectives of recitals 102 to 112 of this Regulation are achieved, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission, concerning the disease preventive measures in transport, specific rules for 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.

(114) In order to ensure the possibility for special rules for movements, where the 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.

(115) Kept terrestrial animals that are moved between Member States should comply with the requirements for such movements. In the case of species presenting a health risk and of greater economic importance, they should be accompanied by an animal health certificate issued by the competent authority.

(116) To the extent technically, practically and financially feasible, technological developments should be availed of to reduce the administrative burdens on operators and the competent authority in relation to certification and notification by using information technology to replace the paper documentation and facilitate notification procedures and using them as far as possible for multiple purposes.

(117) In cases where an animal health certificate issued by the competent authority is not required, 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.

(118) In order to ensure the achievement of the objectives referred to in recitals 115, 116 and 117 of this Regulation the powers to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission, concerning rules on the content, information obligations, and derogations from the animal health certification requirements, specific certification rules and the obligations of official veterinarians to conduct appropriate checks before the signing the animal health certificate.

(119) Notification of movements of animals and germinal products between Member States and in some cases within the national territories of Member States is essential to ensure traceability of animals and those germinal products, where these movements may be linked to a risk of spreading transmissible animal diseases. Therefore, such movements should be notified and registered. The IMSOC system provided for in Article 130(1) of Regulation (EU) No xxxx/xxxx (*2) (Official controls Regulation) should be used for that purpose.

(120) 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.

(121) The specific nature of movements of pet animals represents an animal health risk which deviates significantly from that of other kept animals. Specific rules for Such movements should therefore continue to be laid down in this Regulation. In order to governed by the provisions already adopted . This will ensure that pet animals do not pose a significant risk for the spread of transmissible animal diseases. The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union 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 should be conferred on the Commission in accordance with Article 290 TFEU, without prejudice to the provisions of Regulation (EU) No 576/2013 of the European Parliament and of the Council (20). [Am. 36]

(122) 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.

(123) 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, their expected high health standard and to take into account some specific uses, 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, such as for example their movement for scientific purposes, and derogations from the animal health certification obligation.

(124) 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 cases specific animal health measures, such as disease control and emergency measures should be laid down in this Regulation 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 detailed rules for movements of products of animal origin in relation to disease control measures taken, the obligations for animal health certification and derogations from those rules, where the risk involved with such movements, and the risk mitigating measures in place, permit so.

(125) 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 may only interfere with the rules on the internal market laid down in Union legislation when this is scientifically justified on the grounds of controlling infectious disease and is proportionate in relation to the risk . Therefore, it is appropriate to set the framework for such national measures and ensure that they remain within the limits permitted under Union law. [Am. 37]

(126) The registration and approval of aquaculture establishments is necessary to allow the competent authorities 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 that fact that in some official Union languages, different terms are used for this system of authorisation in this Regulation as compared to Directive 2006/88/EC.

(127) The slaughter and processing of aquaculture animals which are subject to disease control measures may spread transmissible animal disease, for example as a result of effluents containing pathogens being discharged from processing establishments. It is therefore necessary to approve processing establishments which fulfil the risk mitigation measures to undertake such slaughter and processing. Therefore, this Regulation should provide for the approval of disease control aquatic food establishments.

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

(129) In order to ensure uniform conditions for the implementation of the rules laid down in this Regulation for 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, and the format and operational specifications of the registers and records.

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

(131) Similarly to 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.

(132) 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 for movement rules for aquatic animals is the health status as regards the listed diseases of the Member State, zones and compartments of destination.

(133) The same system should also be provided for in this Regulation. However, to encourage Member States to enhance the health status of their aquatic populations, some adjustments and added flexibility should be introduced.

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

(135) 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 certain listed disease, implementing powers should be conferred on the Commission for laying down special movement rules or derogations for a limited period of time.

(136) Union aquaculture production is extremely diverse as regards species and production systems and this diversification is rapidly increasing. This may warrant that national measures concerning diseases other than those that are regarded as listed diseases in accordance with this Regulation are taken at Member State level. 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 it is necessary in order to prevent the introduction of or to control the spread of disease. National measures affecting trade between Member States should be approved and regularly reviewed at Union level.

(137) Currently, listed diseases concern animal species other than those defined as terrestrial and aquatic by this Regulation, 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 apply to those animals. However, if a disease which concerns species other than terrestrial and aquatic should become listed, the relevant animal health requirements of this Regulation should apply to those species to ensure that adequate and proportionate disease prevention and control measures may be taken.

(138) In order to ensure the possibility of laying down movement rules for those animals that are not defined as terrestrial and aquatic animals by this Regulation, and germinal products and products of animal origin from them, 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 for animals, germinal products and products of animal origin of those species.

(139) When necessary 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 from them, implementing powers should be conferred on the Commission to lay down detailed rules concerning those requirements.

(140) 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.

(141) The requirements for entry of animals and products into the Union should mirror the requirements for movements of animal and products of the same category, species and intended use within the Union.

(142) To ensure that animals, germinal products and products of animal origin from third countries or territories comply with the animal health requirements that provide guarantees that are equivalent to those provided for in Union legislation, it is essential that they are subject to appropriate controls by the competent authority of the third countries or territories exporting to the Union. Where relevant, the health status of a third country or territory of origin should be verified prior to accepting the entry 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.

(143) 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 and pending the adoption of rules pursuant to 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.

(144) To ensure that the animal health requirements for the entry into the Union provided for in this Regulation are complied with and are in line with the principles of the OIE Animal Health 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 for commodities which pose a low animal health risk should be permitted.

(145) Animal health certificates may stand on their own, but certification is often required in Union legislation for other purposes, for example 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 food and feed safety legislation.

(146) 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 these routes of disease transmission by those means.

(147) 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, to supplement and amend the criteria for the listing of third countries and territories, criteria for the suspension or withdrawal from that list, supplementing the 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, contents of animal health certificates, and the animal health requirements for disease agents, other materials, means of transport and equipment, which may transmit animal diseases.

(148) In order to ensure uniform conditions for the implementation of the 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 model animal health certificates.

(149) 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 limit its introduction and spread. Such an emergency may involve listed diseases, emerging diseases or other animal health hazards. In that context, it should be made clear which sets of disease prevention and control measures laid down in this Regulation may be used in the event of the occurrence of a listed or emerging disease or hazard. In all these 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.

(150) 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.

(151) The Commission should adopt immediately applicable implementing acts in duly justified cases relating to inter alia the listing of diseases and species, the listed diseases that are to be subject to the sets of disease prevention and control rules, 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, the special movement rules for terrestrial and aquatic animals for a limited period of time, the emergency measures, and the listing of third countries and territories for entry into the Union.

(152) 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 of this Regulation, and if they are not in contradiction with the rules laid down therein and provided that they do not hinder movements of animals and products between Member States, unless it is necessary in order to prevent the introduction of or to control the spread of disease.

(153) The national measures referred to in recital 152 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 (21), 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 laid down in Directive 98/34/EC applies.

(154) 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: — Council Directive 64/432/EEC, — Council Directive 77/391/EEC (22), — Council Directive 78/52/EEC (23), — Council Directive 80/1095/EEC (24), — Council Directive 82/894/EEC (25), — Council Directive 88/407/EEC (26), — Council Directive 89/556/EEC (27), — Council Directive 90/429/EEC (28), — Council Directive 91/68/EEC, — Council Decision 91/666/EEC (29), — Council Directive 92/35/EEC (30), — Council Directive 92/65/EEC, — Council Directive 92/66/EEC (31), — Council Directive 92/118/EEC (32), — Council Directive 92/119/EEC (33), — Council Decision 95/410/EC (34), — Council Directive 2000/75/EC (35), — Council Decision 2000/258/EC (36), — 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 (37) , [Am. 38]] — Council Directive 2001/89/EC (38), — Council Directive 2002/60/EC (39), — Council Directive 2002/99/EC (40), — Council Directive 2003/85/EC (41), — Regulation (EU) No XXX/XXXX of the European Parliament and of the Council of …. on the non-commercial movement of pet animals and repealing Regulation (EC) No 998/2003 (42) , [Am. 39] — Council Regulation (EC) No 21/2004 (43), — Council Directive 2004/68/EC (44), — Council Directive 2005/94/EC (45), — Council Directive 2006/88/EC, — Council Directive 2008/71/EC (46), — Council Directive 2009/156/EC, — Council Directive 2009/158/EC.

(155) The rules laid down in the legislative acts referred to in recital 154 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 only take effect when the relevant delegated and implementing acts are adopted pursuant to this Regulation. It is therefore necessary to provide the Commission with the empowerment to determine the dates when the repeal of those legislative acts should take effect.

(156) 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 (47); Council Directive 79/110/EEC (48); Council Directive 81/6/EEC (49); Council Decision 89/455/EEC (50); Council Directive 90/423/EEC (51) and Council Decision 90/678/EEC (52).

(157) The requirements of this Regulation should not apply until all the delegated and implementing acts to be adopted by the Commission pursuant to this Regulation, have applied. It is appropriate to provide for at least 36 months to elapse between the date of entry into force of this Regulation and the date of application of the new rules, to allow the operators affected sufficient time to adapt.

(158) In order to ensure legal certainty as regards the application of rules for identification and registration of animals, disease control measures for certain zoonoses and non-commercial movements of pet animals, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union TFEU should be delegated to the Commission in respect of the date on which Regulations (EC) No 1760/2000, (EU) No XXX/XXX [Ex-998/2003] and (EC) No 21/2004 and Directives 92/66/EEC, 2000/75/EC, 2001/89/EC, 2002/60/EC, 2003/85/EC, and 2005/94/EC and 2008/71/EC cease to apply. [Am. 40]

(159) 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 (53).

(160) It is of particular importance that the Commission carry out appropriate consultations with stakeholders 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. [Am. 41]

(161) 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 to protect 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.

(162) 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 can be involved in the spread of transmissible animal diseases, cannot be achieved sufficiently by the Member States, but can rather be more efficiently achieved at Union level through a common and coordinated legal framework for animal health. This Regulation is therefore in line with the principle of subsidiarity as set out in Article 5 of the Treaty on the 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, scope and definitions

Article 1

Subject matter

1. This Regulation lays down:

(a) rules for the prevention and control of animal diseases, which are transmissible to animals or to humans.;

(b) instruments and mechanisms to facilitate progress towards the declaration of disease free zones and territories;

(c) priority actions; and

(d) the division of responsibilities in the area of animal health. [Am. 42]

Those rules provide for:

(a) the prioritisation and categorisation of diseases of Union concern and for establishing responsibilities for animal health in Part I;

(b) the early detection, notification and reporting of diseases, surveillance, eradication programmes and disease-free status in Part II;

(c) disease awareness, preparedness and control in Part III;

(d) the registration and approval of establishments and transporters, movements and traceability of consignments of animals, germinal products and products of animal origin within the Union in Part IV;

(e) the entry of consignments of animals, germinal products, and products of animal origin into the Union and the export of such consignments from the Union in Part V;

(f) the emergency measures to be taken in the event of a disease emergency situation in Part VI.

2. The rules referred to in paragraph 1:

(a) ensure (i) a sustainable agricultural and aquaculture production in the Union; (ii) the effective functioning of the internal market , and food and feed safety ; [Am. 43] (iii) a reduction in the adverse effects on animal health, public health and the environment of: [Am. 44] — certain diseases and risk factors leading up to diseases ; [Am. 45] — the measures taken to prevent and control diseases;

(b) take into account (i) the relationship between animal health and: — public health; — the environment as well as the impacts of climate change; — biodiversity; [Am. 46] — food and feed safety; — animal welfare; — antimicrobial resistance; [Am. 47] — food security; — the need to protect and conserve rare animal breeds, and to preserve genetic diversity; [Am. 48] (ii) the economic, social, cultural and environmental consequences arising from the application of disease control and prevention measures.

Article 2

Scope of this Regulation

1. This Regulation shall apply to:

(a) kept , non-kept and wild animals; [Am. 49]

(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 2119/98/EC;

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

(c) Directive 2003/99/EC;

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

Article 3

Scope of Part IV on registration, approval, traceability and movements

1. Title I of Part IV shall apply to:

(a) terrestrial animals, and animals that 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 shall apply to:

(a) aquatic animals, and animals that 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 shall apply to:

(a) animals other than those defined as terrestrial animals and aquatic animals in Article 4(1)(4);

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

4. Chapters 1 and 3 of Title I and Chapters 1 and 2 of Title II of Part IV shall not apply to pet animals.

Article 4

Definitions

1. For the purpose of this Regulation, the following definitions shall 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: (i) fish belonging to the superclass Agnatha and to the classes Chondrichthyes, Sarcopterygii and Actinopterygii; (ii) aquatic molluscs belonging to the phylum Mollusca; (iii) aquatic crustaceans belonging to the subphylum Crustacea;

(4) ‘other animals’ means animals of species other than those defined as terrestrial and aquatic animals;

(5) ‘kept animals’ means living animals which are kept by humans; in the case of aquatic animals, aquaculture animals; [Am. 50]

(5a) ‘non-kept animals of domesticated species’ means animals which are not, or are no longer, under human supervision; [Am. 51]

(6) ‘aquaculture’ means the rearing of aquatic animals using techniques designed to increase the production of those animals beyond the natural capacity of the environment and 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 awaiting slaughter without being fed;

(7) ‘aquaculture animals’ means aquatic animals subject to aquaculture techniques designed to increase production above the natural capacity of the environment in question ; [Am. 52]

(8) ‘wild animals’ means animals which are not neither