EXPLANATORY MEMORANDUM

1. JUSTIFICATION AND OBJECTIVE

Animal health is a concern for all European citizens. This concern stems from the public health, food safety and food security aspects, which are related to animal health but also from the economic costs that animal disease outbreaks can trigger and the animal welfare considerations, including the implications of disease control measures on animal welfare.

At the same time, this proposal reflects the priorities of Smart Regulation[1] by aiming to simplify the existing legal framework while reflecting stakeholders' expectations in reducing administrative burdens.

And finally, it reflects Commission priorities such as the smart growth objective of the Europe 2020 strategy[2] by helping the sector to become more resilient due to active prevention measures and more flexible risk management.

Problem analysis

The current EU animal health legislative framework involves almost 50 basic directives and regulations and some 400 pieces of secondary legislation, some of them adopted as early as 1964.

The Commission launched an external evaluation in 2004 to thoroughly review the outcomes of EU action of animal health, leading to a new Animal Health Strategy in 2007. A combination of circumstances made it imperative to re-evaluate our policy:

 The main elements of the existing policy were drawn up largely between 1988 and 1995 when we were still a Community of twelve Member States;

 New challenges have emerged. Diseases which were unknown a decade ago have appeared, while others, such as foot and mouth disease, bluetongue and avian flu, have recently presented new challenges, reminding us that they remain very serious risks;

 Trading conditions have also changed radically with the volume of trade in animals and animal products increasing greatly, both within the EU and with third countries; and

 Science, technology and our institutional framework have evolved substantially.

A number of problems have been identified in respect of the existing legislation. Some relate to the general policy approach, namely:

– The high complexity of the current Community Animal Health Policy (CAHP)

– The lack of an overall strategy

– An insufficient focus on disease prevention, with a particular focus on the need for increased biosecurity.

Others were related to specific problems with the functioning of existing legislation, particularly:

– Issues related to intra-Union trade in live animals.

Both general and specific problems are either rectified in this law, or will be rectified in its delegated and implementing acts.

Objectives of the proposal

The Animal Health Law is the legal framework to support the Animal Health Strategy for the EU, published in 2007. The general objectives as outlined in the Strategy are:

 to ensure a high level of public health and food safety by minimising the incidence of biological and chemical risks to humans;

 to promote animal health by preventing/reducing the incidence of animal diseases, and in this way to support farming and the rural economy;

 to improve economic growth/cohesion/competitiveness assuring free circulation of goods and proportionate animal movements;

 to promote farming practices and animal welfare which prevent animal health related threats and minimise environmental impacts in support of the EU Sustainable Development Strategy.

The specific objectives of this Animal Health Law are:

 to establish a single, simplified, transparent and clear regulatory framework that sets out systematically the objectives, scope and principles of regulatory intervention; based on good governance and compliant with international (e.g. OIE) standards; focusing on long-term preventative measures and working together with all relevant stakeholders;

 to introduce overarching general principles allowing a simplified legal framework in order to be prepared for the new challenges, i.e. to enable quick reaction in case of emerging diseases; whilst ensuring the same quality of reaction as provided for in current legislation;

 to ensure consistency amongst the horizontal principles of the legislation in the field of animal health, animal welfare and food safety policies as well as broader EU policies on climate change, common agricultural policy and sustainability;

 to reduce the impact of animal diseases on animal and public health, animal welfare, economy and society as far as possible by enhancing disease awareness, preparedness, surveillance and emergency response systems at national and EU level;

 to ensure the smooth functioning of the internal market of animals and animal products, with a high level of protection of animal health and public health and supporting the objectives of Europe 2020.

The operational objectives of this Animal Health Law are:

 to integrate the new prevention-driven and incentive-oriented approach into the core of animal health policy;

 to provide for a clear and balanced distribution of roles and responsibilities between competent authorities, EU institutions, the farming sector, animal owners and others;

 to introduce disease categorization as the basis for EU intervention;

 to provide for effective mechanisms for a rapid response to disease events, including new challenges, such as emerging diseases;

 to ensure effective emergency preparedness and early response to animal diseases and zoonoses, including use of vaccines as appropriate;

 to introduce simplified procedures, wherever possible for technical and other reasons, taking into account the specificity of small farmers and micro businesses and releasing unjustified administrative burdens and costs, wherever possible;

 to ensure that the new legal framework provides enough flexibility to adapt smoothly to future scientific and technological developments;

 to reduce the risk of trade disruption by seeking an appropriate level of convergence with relevant international standards, while ensuring a firm commitment to high standards of animal health.

2. LEGAL CONTEXT

Legal Basis

Articles 43, 114 and 168 of the Treaty on the Functioning of the European Union (TFEU) provide the legal basis for the EU legislative measures on animal health, as they are an essential part of EU agricultural, public health and consumer protection, trade and single market policy.

– Article 43 provides the basis for the EU legislative measures on the Common Agricultural Policy. This article also became the basis for veterinary legislation as the CAHP is considered from a legal perspective to be part of the Common Agricultural Policy, so adopting the same legislative and administrative procedures.

– Article 114 provides the legal basis for the establishment and functioning of the internal market and the approximation of provisions laid down by the law, regulation or administrative actions in this respect.

– Article 168 on health protection refers to the protection of human health from all causes that may damage it, including those related to animal health. Veterinary measures directly aimed at protecting public health were also adopted under the co-decision procedure as a result of this article.".

Consistency with other Union policies

This set of animal health legislation interacts with the legal framework on animal welfare, food safety, public health, animal nutrition, veterinary medicinal products, environmental protection, official controls, the Common Fisheries Policy (CFP) and the Common Agricultural Policy (CAP).

Relationship to other proposals in the package

The proposal is part of a package of four reviews relating to animal health, health of plants, quality of plant reproductive material and official controls of plants, animals, food and feed.

The revision of the official controls regulation enables official controls to be more consistently applied for the purposes of protection of animal health and links more coherently with animal health regulation.

3. SUBSIDIARITY AND PROPORTIONALITY

Subsidiarity

Good animal health generates not only private benefits but is a public good with wider societal benefits. The transmissible nature of many animal diseases means that a common approach, rather than a series of individual actions, will have the greatest overall benefits.

The value of the harmonised EU approach is widely accepted and has helped to reduce the administrative burden for operators, traders, veterinarians and veterinary-related industries. It has played a key role in the establishment of the single market, facilitating intra-EU trade in animals and animal products (meat, milk, etc.) by setting up harmonised animal health conditions and promoting the success of the CAP.

The benefits of harmonised rules for the prevention, notification, control and eradication of animal diseases at EU level have been demonstrated during animal disease outbreaks in recent times. The response to these crises showed the EU's capability to react quickly, limiting the spread of diseases and minimising their impacts. This was largely due to the harmonised approach to disease control, including providing financial compensation for the losses on farms due to disease eradication measures. Also, taking into account the single market dimension, the failure to control a disease in one Member State, may severely affect the health status of the Union and jeopardise its export potential. In light of these different elements, EU action is justified, as it is clear that MS cannot achieve this satisfactorily acting alone and that the EU would achieve a consistent approach more effectively and efficiently.

Proportionality

The Animal Health Law establishes a general framework for the prevention, control and eradication of animal diseases. This framework is built on outcome-based rules, avoiding over-prescriptiveness, and leaving room for MS to regulate or set more detailed legislation when necessary, so providing for the flexibility to adapt the rules to national, regional or local circumstances. On the other hand, rules on trade must necessarily have a certain level of detail and precision to reduce the risk of different implementation practices by operators and competent authorities and subsequent distortion of competition and possible reduction in the coherence of the approach to tackling disease. Therefore the Animal Health Law tries to achieve the balance of proportional but necessary action.

4. CONSULTATIONS WITH INTERESTED PARTIES AND IMPACT ASSESSMENTS

Consultation process

This Animal Health Law is the result of a long series of considered analyses.

In 2004, the Commission launched an independent evaluation to assess the performance of the Community Animal Health Policy (CAHP)[3] over the previous decade and its coherence with other EU policy interventions. The aim was to identify elements of the CAHP which could be further improved and to propose options to achieve these improvements.

Among other things, the CAHP evaluation recommended that a single strategy for animal health be developed to prevent piecemeal and crisis-driven development of policy. The EU Animal Health Strategy 2007-2013 (AHS) "Prevention is better than cure" was the result[4].

The AHS provides for the adoption of a "single regulatory framework for animal health with a greater focus on incentives than penalties, consistent with other EU policies and converging to international standards" and which will "define and integrate common principles and requirements of existing legislation". In their reaction to the Commission Communication on the new Strategy, the European Parliament[5], the Council[6] and the European Economic and Social Committee[7] welcomed this initiative. Subsequently, the Action Plan for the implementation of the Strategy[8] confirmed that "the main objective of the Strategy is the development of an EU Animal Health Law".

From the very start of the process, key stakeholders, Member States (MS), Competent Authorities (CA), international organisations and trading partners have been closely involved and have played a crucial role in the discussion. In addition, economic and social stakeholders such as European associations with an interest in animal health and welfare and the interested public have been consulted on a number of occasions in accordance with the Commission’s standards for consultation.

5. ELEMENTS OF THE PROPOSAL

Part I: General Rules

The Animal Health Law sets out general principles for good animal health in EU legislation. It brings together animal health measures for terrestrial and aquatic animals.

Part I also provides for the prioritisation and listing of diseases which are likely to have a significant impact. For the first time, this will enable Union resources to be systematically prioritised on a scientific and evidential basis.

The responsibilities of all the different actors having a key role in the safeguarding of animal health, such as operators, veterinarians, and pet keepers, are explicitly laid down for the first time. In particular, operators and animal professionals are now required to acquire a basic knowledge of animal health and related matters.

Part II: Notification, Surveillance, Eradication Programmes, Disease Freedom

Part II clarifies the responsibilities for notification and surveillance including animal health visits. It clarifies the roles of operators, competent authorities and others as regards surveillance of the animal health situation in the Union. The new system allows for better use of the synergies between surveillance undertaken by the different actors in the field to ensure the most effective and cost efficient use of surveillance resources.

Another main change here is that compartments, permitted only for Avian Influenza related measures and in aquaculture at present, can now be used more widely. This introduces more flexibility into disease control measures, introducing the possibility of continuing movements and trade under certain circumstances, considered from a risk-based perspective.

Part III: Disease Preparedness, Awareness and Control

Part III continues to require MSs to draw up contingency plans for dealing with certain diseases, and to practise their implementation.

The regulatory framework for vaccination is now explicitly and coherently provided for.

The rules for the use of antigen, vaccine and reagent banks are laid down.

Rules on control measures to be taken in the case of suspicion of or confirmed disease outbreaks of certain diseases are laid down, with little change to the existing system, which is considered to work well.

Part IV: Requirements Concerning Registration, Approval, Traceability and Movements

Part IV is split into three titles, with distinct rules for terrestrial, aquatic, and other animals. It is necessary to consider them separately because of their different production methods and epidemiology. The titles dealing with aquatic and terrestrial animals lay down measures which help to identify and trace animals and establishments. The traceability of animals is of crucial importance during a disease outbreak so that the epidemiology of the disease is understood and can be better controlled. These titles also introduce the possibility for more animals to be registered and traced through electronic means, promoting simplicity and better regulation, and reducing administrative burden through the use of technology. A third title on other animals is introduced only for possible future provision, should new threats emerge in relation to these animals.

Part V: Entry into the Union and Export

Part V sets the standards and requirements for third countries sending animals, germinal products, products of animal origin and other material that may transmit animal diseases into the Union, in order to prevent diseases being introduced. It also sets out requirements for export. No practical changes are envisaged from existing legislation, which is considered to function well.

Part VI: Emergency Measures

Emergency measures are a crucial part of disease management. Part VI lays down the procedures to be followed in case of emergency, ensuring a rapid and consistent Union response. Only a few practical changes are envisaged from existing legislation, which is considered to function very well.

Part VII: Final and Transitional Provisions

The final and transitional provisions set out the national provisions, the conditions for adopting delegated acts, repeals, and other necessary legal provisions.

6. BUDGETARY IMPLICATIONS

This proposal does not imply expenditures which are not already included in the financial statement of the common financial framework for food chain, animal health and welfare, and relating to plant health and plant reproductive material.

2013/0136 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on Animal Health

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[9],

Having regard to the opinion of the Committee of the Regions[10],

Acting in accordance with the ordinary legislative procedure,

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.

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

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

(4) In order to ensure high standards of animal and public health in the Union, 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.

(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.

(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[11]. It aims to put 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.

(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.

(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.

(10) Council Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations (1986-1994)[12] 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[13] 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 Article 22(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety[14].

(14) Regulation (EC) No 1069/2009 of the European Parliament and the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No. 1774/2002 (Animal by-products Regulation)[15] 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 and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies[16], Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC[17] and Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents[18], and specific rules on communicable diseases in humans in Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community[19]. 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 of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals[20] lays down specific rules for aquatic animals. Yet in most cases, the main principles for good animal health governance 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.

(20) Union legislation adopted prior to this Regulation and in particular Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC[21] 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 of the Treaty on the Functioning of the European Union 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.

(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[22] 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. Scientific progress may also lead to new knowledge and increased awareness concerning existing diseases. Furthermore, diseases and species that are important today may be marginalised in the future. Therefore the scope of this Regulation should be broad and the rules laid down should be focused on diseases with high public relevance. The OIE has, with the support of the European Commission, 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"[23] and a tool for such an exercise. This Regulation should introduce such an approach in Union legislation.

(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.

(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 of the Treaty on the Functioning of the European Union 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 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.

(36) Based on the importance and the level of impact of a listed disease, its distribution, prevalence and incidence in the Union 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.

(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 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.

(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.

(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 of the Treaty on the Functioning of the European Union 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.

(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 of the Treaty on the Functioning of the European Union 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. 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 should be delegated to the Commission in respect to the delegation of the performance of those activities to veterinarians and their appropriate training.

(47) Optimal animal health management can only be achieved in cooperation with animal keepers, operators, 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 and when a case is of public interest.

(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 of the Treaty on the Functioning of the European Union 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. Those notification obligations should be applicable to any natural and legal person in order to ensure that no disease outbreaks remain unnoticed.

(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 of the Treaty on the Functioning of the European Union 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 of the Treaty on the Functioning of the European Union 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[24] 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.

(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 of the Treaty on the Functioning of the European Union 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 of the Treaty on the Functioning of the European Union 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.

(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 of the Treaty on the Functioning of the European Union 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 of the Treaty on the Functioning of the European Union 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 of the Treaty on the Functioning of the European Union 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.

(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 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 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.

(77) Following the conclusions of the Expert opinion on vaccine and/or diagnostic banks for major animal diseases[25] 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 of the Treaty on the Functioning of the European Union 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.

(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.

(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.

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

(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 concerned by it and the Union as a whole.

(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 of the Treaty on the Functioning of the European Union 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 of the Treaty on the Functioning of the European Union 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 of the Treaty on the Functioning of the European Union 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 of the Treaty on the Functioning of the European Union 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 of 22 September 2010 on the protection of animals used for scientific purposes[26] 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.

(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 of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine[27], Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals[28], Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and importation from third countries of equidae[29], Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs[30] and partially Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC[31]. 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 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.

(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.

(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 of the Treaty on the Functioning of the European Union 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 of the Treaty on the Functioning of the European Union 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 the Regulation (EU) No xxx/xxx of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant reproductive material, plant protection products and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU) No 1151/2012, [….]/2013, and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official controls Regulation)[32] [Publication office] 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 be laid down in this Regulation. In order to 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.

(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 of the Treaty on the Functioning of the European Union 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 of the Treaty on the Functioning of the European Union 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 of the Treaty on the Functioning of the European Union 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 interfere with the rules on the internal market laid down in Union legislation. Therefore, it is appropriate to set the framework for such national measures and ensure that they remain within the limits permitted under Union law.

(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 EU 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 of the Treaty on the Functioning of the European Union 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 of the Treaty on the Functioning of the European Union 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 of the Treaty on the Functioning of the European Union 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 of the Treaty on the Functioning of the European Union 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 of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and