State veterinary clinics charge fees for vaccinations

31.3.2016   

DE

Official Journal of the European Union

L 84/1


REGULATION (EU) 2016/429 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

dated March 9, 2016

on animal diseases and on the amendment and repeal of certain legal acts in the field of animal health ("animal health law")

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

based on the Treaty on the Functioning of the European Union, in particular Article 43 paragraph 2, Article 114 and Article 168 paragraph 4 letter b,

on the proposal of the European Commission,

after the draft legislative act has been forwarded to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

after consulting the Committee of the Regions,

in accordance with the ordinary legislative procedure (2),

Whereas:

(1)

Animal diseases and the measures required to control them can have devastating effects on individual animals, livestock, animal owners and the economy.

(2)

Recent experience has shown that animal diseases can also have a significant impact on public health and food safety.

(3)

In addition, negative interactions with biodiversity, climate change and other environmental aspects can be observed. Climate change can affect the occurrence of new diseases, the prevalence of existing diseases and the geographical spread of disease pathogens and vectors, including wild animals.

(4)

In order to ensure a high level of human and animal health in the Union, the rational development of agriculture and aquaculture and to increase production, animal health rules should be adopted at Union level. These rules are necessary, among other things, to help complete the internal market and to prevent the spread of infectious diseases. These rules should also ensure, as far as possible, that the existing animal health status is maintained in the Union and subsequently support the improvement of this status.

(5)

Current Union animal health law consists of a set of interlinked and interrelated basic legal acts that set out animal health rules for intra-Union trade, entry of animals and animal products into the Union, disease eradication, veterinary controls, disease notification and financial assistance in the Connection with different animal species are established; however, there is no overarching legal framework to define harmonized principles for the whole sector.

(6)

The financial rules applicable to the promotion of animal health objectives are contained in Regulation (EU) No 652/2014 of the European Parliament and of the Council (3) and are not the subject of this Regulation. In addition, the rules for official controls on animal health measures in Regulation (EC) No 882/2004 of the European Parliament and of the Council (4) and in Directives 89/662 / EEC (5), 90/425 / EEC (6th ), 91/496 / EEC (7) and 97/78 / EC (8) of the Council can be used to regulate official controls in the field of animal health.

(7)

This ordinance does not contain any provisions on animal welfare. Animal health and animal welfare are, however, mutually dependent: better animal health increases animal welfare and vice versa. When preventive and control measures are implemented in accordance with this Regulation, their impact on animal welfare as defined in Article 13 of the Treaty on the Functioning of the European Union (TFEU) should be taken into account in order to protect animals from any avoidable pain, stress and suffering . Animal welfare legislation, such as Council Regulations (EC) No. 1/2005 (9) and (EC) No. 1099/2009 (10), should definitely continue to be applied and properly implemented. The provisions of this Regulation should not duplicate or overlap with the provisions of this legislation.

(8)

The Commission communication of 19 September 2007 on a new animal health strategy for the European Union (2007-2013) with the motto "Prevention is the best medicine" aims to promote animal health by focusing in the future on preventive measures and disease surveillance , Disease control and research is undertaken to reduce the occurrence of animal diseases and to limit the effects of such outbreaks, if they do, as much as possible. The strategy proposes the creation of a single regulatory framework for animal health that seeks approximation to international standards, while at the same time promoting high animal health standards.

(9)

The aim of this regulation is to implement the commitments and visions of this animal health strategy, including the One Health principle, and to consolidate the legal framework for a common Union animal health policy by creating a single, simple, flexible regulatory framework for animal health.

(10)

Animals can suffer from a variety of infectious and non-infectious diseases. Many of these diseases are treatable, affect only the animal in question, or cannot be transmitted to other animals or humans. Infectious diseases, on the other hand, can have greater effects on human and animal health; they can be felt at the population level. The animal health rules set out in this Regulation should only apply to the latter diseases.

(11)

When defining these animal health provisions, it is essential to take into account the relationships between animal health, public health, the environment, food and feed safety, animal welfare, food security and economic, social and cultural aspects.

(12)

The Convention on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), to which the Union is a party, regulates the use of measures necessary to protect the life or health of humans, animals and plants so that they do not discriminate arbitrarily or unjustified between the members of the World Trade Organization (WTO). If there are international standards, these are to be used as a basis for the Union's measures. However, the parties to the SPS Agreement are entitled to set their own relevant standards, provided that these are based on scientific evidence.

(13)

With regard to animal health, the SPS Agreement refers to the standards for animal health in international trade of the World Organization for Animal Health (OIE). In order to avoid the risk of trade disruption, Union action on animal health should aim at an adequate level of compliance with OIE standards.

(14)

In special cases in which there is a significant risk to animal or public health but no scientific safety, a member may, in accordance with Article 5 (7) of the SPS Agreement, which for the Union in the Commission Communication of February 2 2000 on the applicability of the precautionary principle, take provisional measures on the basis of the relevant information available. In such cases, the WTO member concerned must obtain the information necessary for a more objective risk assessment and review the measure within a reasonable period of time.

(15)

The risk assessment, on the basis of which measures are taken under this Regulation, should be based on the available scientific evidence and should be carried out independently, objectively and transparently. In addition, due account should be taken of the opinions of the European Food Safety Authority (EFSA) established under Article 22 (1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (11).

(16)

Regulation (EC) No. 1069/2009 of the European Parliament and of the Council (12) lays down rules relating to human and animal health for certain animal by-products and derived products that pose a risk to the health of Humans and animals should be avoided or minimized and, in particular, the safety of the food and feed chain should be guaranteed. In order to avoid duplication of Union legislation, this Regulation should only apply to animal by-products and derived products for which no specific provisions are laid down in Regulation (EC) No 1069/2009 and only where there is an animal health risk . For example, Regulation (EC) No. 1069/2009 does not regulate how animal by-products and derived products are to be handled in the context of disease control measures; this point is therefore regulated by this regulation.

(17)

In Regulation (EC) No. 999/2001 of the European Parliament and of the Council (13), in Directive 2003/99 / EC of the European Parliament and of the Council (14) and in Regulation (EC) No. 2160/2003 of the European Parliament and of the Council (15), specific provisions on animal diseases, including so-called zoonoses, which can be transmitted to humans, have already been laid down; for human diseases, the specific provisions of Decision No. 1082/2013 / EU of the European Parliament and of the Council (16) apply. This legislation should continue to apply after this Regulation has been adopted. Accordingly, in order to avoid duplication of Union legislation, this Regulation should only apply to zoonoses if the aforementioned legislation does not already lay down specific provisions. In addition, this Regulation is without prejudice to the provisions provided for in other Union acts, for example in the fields of veterinary medicine and animal welfare.

(18)

Diseases in human-kept animals can have detrimental effects on agriculture and aquaculture, public health, the environment and biodiversity. However, because these animals are kept by humans, disease prevention and control measures are often easier to apply to them than to wild animals.

(19)

However, disease in wildlife populations can have detrimental effects on agriculture and aquaculture, public health, the environment and biodiversity. Therefore, in such cases, the scope of this Regulation should also cover wild animals, both as potential victims and as vectors of the diseases concerned. For the purposes of this Regulation, "wild animals" means any animal that is not kept by humans, including stray and feral animals, even if they are species that are normally kept as pets.

(20)

Animal diseases are not transmitted through direct contact between animals or between humans and animals alone. They are also spread through the water and air systems, through vectors such as insects, through the seeds, ova or embryos used in artificial insemination, and through egg donation or embryo transfers. Disease pathogens can also be contained in food or other products of animal origin, for example in leather, fur, feathers, horn or another material obtained from an animal's body. In addition, pathogens can also be spread through various other objects - transport vehicles, equipment, feed, hay, and straw. To be effective, animal health regulations must therefore cover all possible routes of infection and related materials.

(21)

Animal diseases can have detrimental effects on the distribution of wild animal species and thus affect biodiversity. Microorganisms that cause these animal diseases can therefore be considered "alien species" under the United Nations Convention on Biological Diversity. The measures provided for in this regulation also take biodiversity into account; consequently, this Regulation should also apply to animal species and pathogens, including invasive alien species, which play a role in or may be affected in the transmission of the diseases covered by this Regulation.

(22)

Separate animal health provisions for terrestrial and aquatic animals are laid down in the Union acts adopted prior to this regulation. Council Directive 2006/88 / EC (17) contains specific provisions for aquatic animals. In most cases, however, the principles of good governance and good husbandry practice guidelines for animal health apply to both groups of animal species. Accordingly, this Regulation should cover both terrestrial and aquatic animals and harmonize animal health provisions where appropriate. However, for certain aspects, in particular the registration and approval of establishments, traceability and the movement of animals within the Union, this regulation follows the approach used in the past, according to which different rules due to the different environments and the correspondingly different requirements for maintaining health for terrestrial and aquatic animals.

(23)

The Union legal acts adopted before this Regulation, in particular Council Directive 92/65 / EEC (18), also lay down basic animal health provisions for animal species that are not covered by other Union legal acts, such as reptiles, amphibians and marine mammals, as well as for animal species, which do not belong to the aquatic or land animals within the meaning of this ordinance. Normally, these species do not pose a significant risk to human or other animal health, so few, if any, provisions apply to them. In order to avoid unnecessary administrative burdens and costs, this Regulation should follow the approach used in the past and merely create a legal framework in which more precise animal health rules can be laid down for the movements of such animals and their products, should the risks involved so require.

(24)

People often keep certain animals as pets in their households for company. Keeping such pets, including ornamental aquatic animals, in households for purely private purposes, both indoors and outdoors, generally poses a lower risk than other types of keeping or large-scale movements such as those in agriculture, aquaculture, in animal shelters and in general are customary for the movement of animals. It would therefore be inappropriate for the general requirements for registration, record keeping and movement within the Union to apply to such pet animals as this would create undue administrative burdens and costs. The registration and record keeping requirements should therefore not apply to pet owners. In addition, specific rules should apply to movements of pet animals for non-commercial purposes within the Union.

(25)

For some specific groups of animals, for which special provisions are laid down in this Ordinance, the individual species must be listed in an annex due to the diversity within the group concerned. This also applies to the group of hoofed mammals, known as ungulates (ungulata). The list of these animals may have to change in the future due to changes in taxonomy. In order to take account of such changes, the power should be conferred on the Commission to adopt acts amending the list of ungulates in Annex II to this Regulation in accordance with Article 290 TFEU.

(26)

Not all animal diseases can or should be prevented or controlled by legally required measures, for example when a disease is too widespread, diagnostic tools are not available or the private sector can take the necessary measures to control the disease itself. Legally required measures to prevent and control animal diseases can have significant economic consequences for the sectors concerned and disrupt trade. It is therefore appropriate to only resort to such measures when they are proportionate and necessary, for example when an epidemic presents or could present a significant risk to human or animal health.

(27)

In addition, prevention and control measures should be tailored to each animal disease in order to address its unique epidemiological profile, its consequences and its spread across the Union. The applicable provisions for prevention and control should therefore be disease-specific.

(28)

In animal diseases, “disease” is usually understood to mean the appearance of clinical or pathological symptoms of the infection. For the purposes of this regulation, however, which aims to combat the spread of certain animal diseases or to eradicate them, the disease definition should be broadened so that other carriers of the disease pathogen are also covered.

(29)

Some animal diseases are slow to spread to other animals or humans and therefore do not cause major economic damage or impairment of biodiversity. They therefore do not pose a serious threat to human or animal health in the Union and can be regulated by the Member States through national provisions if they so wish.

(30)

In the case of animal diseases which are not regulated at Union level but which have some economic significance for the private sector at local level, the private sector, with the support of the competent authorities of the Member States, should take preventive and control measures, for example in the form of self-regulatory measures or codes of conduct.

(31)

In contrast to the animal diseases mentioned in recitals 29 and 30, highly infectious animal diseases can spread rapidly across borders and, if zoonotic, have an impact on public health and food safety. Therefore, highly infectious animal diseases and zoonoses should fall within the scope of this Regulation.

(32)

Antibiotic resistance, in the sense of the ability of a microorganism to survive or grow in a concentration of an antibiotic that is usually sufficient to inhibit or kill microorganisms of the same species, increases. Action 5 proposed in the communication from the Commission to the European Parliament and the Council entitled "Action plan to counter the increasing risk of antibiotic resistance" emphasizes that this regulation has an important role to play in disease prevention and, consequently, in reducing the risk of disease Use of antibiotics in animals is expected. This resistance of microorganisms to antibiotics to which they have previously reacted makes the treatment of infectious diseases in humans and animals more difficult and can thus pose a risk to human or animal health. Therefore, micro-organisms that have developed resistance to antibiotics should be treated as if they were diseases and should therefore fall within the scope of this Regulation. This enables measures to be taken against antibiotic-resistant organisms, insofar as this is appropriate and necessary.

(33)

New threats in connection with certain epidemics or species can develop in particular as a result of changes in trade flows, the environment, the climate, animal breeding, agricultural practice, but also as a result of changes in society. Scientific progress can lead to new knowledge about existing diseases and lead to greater awareness of them. In addition, epidemics and species that are currently significant may become less important in the future. Therefore, the scope of this Regulation should be broad and the provisions set out in it should focus on diseases of major public concern. With the support of the European Commission, the OIE has carried out a study on the listing and categorization of particularly significant animal diseases, including those diseases that can be transmitted to humans ("Listing and categorization of priority animal diseases, including those transmissible to humans"), as well as an instrument for carrying out this Activities presented to develop a system for prioritizing and categorizing epidemics. This tool is an example of a systematic approach to the collection and evaluation of information on animal diseases.

(34)

It is necessary to establish a harmonized list of animal diseases ("listed diseases") that pose a risk to human or animal health in the Union, whether in the whole or in part of the Union. The five disease types already listed in this Regulation should be supplemented by an annex with a list of disease types. The Commission should review and amend this Annex against a number of criteria. The power to adopt acts amending the Annex should therefore be conferred on the Commission in accordance with Article 290 TFEU.

(35)

It is possible that new diseases may emerge in the future that pose serious risks to public or animal health and have an impact on health, the economy or the environment. Implementing powers to determine disease prevention and control measures for emerging diseases should be conferred on the Commission so that it can adopt adequate measures to deal with the possible negative effects of those diseases, even if there has not yet been a full assessment of their possible inclusion in the list be included. Such measures remain unaffected by immediate measures and can continue to be used in the event of newly emerging epidemics, as long as no decision has been made regarding their listing.

(36)

The diseases listed require different approaches. For some highly infectious diseases that are not currently present in the Union, strict measures need to be put in place so that they can be eradicated immediately if they occur. If such diseases are not promptly eradicated and become endemic, a long-term mandatory eradication program is required. For other diseases that may already be present in parts of the Union, compulsory or optional eradication measures should be foreseen. In these cases it is advisable to put in place restrictions on the movement of animals and products, such as a ban on movements into or out of the areas concerned, or simply to carry out appropriate inspections of the animals and products before dispatch. In other cases, it may be appropriate to simply run a surveillance program to monitor the spread of the disease without taking any further action.

(37)

In order that all relevant aspects are taken into account when deciding which animal diseases are to be included in the list for the purposes of this Regulation, criteria should be established.

(38)

The prevention and control rules set out in this Regulation for a given disease should apply to all animal species that can transmit the disease in question, either because they are susceptible to the disease or because they can act as vectors. In order to ensure uniform conditions for the implementation of this Regulation, it is necessary to establish a harmonized list at Union level of the species to which the measures apply in relation to certain listed diseases ("listed species"); therefore, implementing powers should be conferred on the Commission to draw up such a list.

(39)

The categorization should be based on predetermined criteria such as the profile of the listed disease concerned, the extent of its impact on animal health, public health, animal welfare and the economy in the Union, the risk of its spread and the availability of preventive and control measures against that listed disease. Implementing powers should be conferred on the Commission to determine which listed disease should be subject to which provisions.

(40)

These provisions should apply to the following listed diseases: Listed diseases which do not normally occur in the Union and which must under all circumstances require immediate eradication measures as soon as they are detected, such as: B. the classic swine fever; for listed diseases that must be combated in all Member States with the aim of eradicating them across the Union, which may include diseases such as brucellosis; for listed diseases that are relevant for some Member States and for which measures must be taken to prevent them from spreading to other parts of the Union that are officially disease-free or that have eradication programs for the listed disease in question, including diseases such as infectious cattle -Rhinotracheitis can count; for listed diseases against which measures must be taken to prevent their spread as a result of entry into the Union or movements between Member States, which may include diseases such as equine infectious anemia; for listed diseases that need to be monitored within the Union, which may include diseases such as anthrax.

(41)

The disease profile of a given disease can change; the same applies to the risks associated with the epidemic and other circumstances. In such cases, the implementing powers conferred on the Commission should also include the power to change the category under which a particular listed disease falls and which measures it is therefore subject to.

(42)

Entrepreneurs who work with animals are best placed to monitor and ensure the health of the animals and products for which they are responsible. Therefore, these persons should be primarily responsible for implementing the measures to prevent and control the spread of disease in the animals and products for which they are responsible.

(43)

Measures to protect against biological hazards are among the most important preventive instruments available to entrepreneurs and other people working with animals to prevent the introduction, development and spread of animal diseases in an animal population, starting from or within an animal population. The role of protection against biological hazards is also recognized in the impact assessment carried out in the framework of the adoption of this Regulation and its possible impact is specifically assessed. The measures taken to protect against biological hazards should be sufficiently flexible and tailored to the type of production and the animal species and categories concerned, and should take into account local conditions and technical developments. Implementing powers should be conferred on the Commission to lay down the minimum requirements necessary for the uniform application of the biological hazard protection measures. Nevertheless, business operators, Member States and the Commission should retain the power to support disease prevention through higher standards of protection against biological hazards by developing their own guides to best practice. While protecting against biological hazards requires some upfront investment, the resulting reduction in animal diseases should be a positive incentive for business owners.

(44)

Biocidal products such as disinfectants for veterinary hygiene or for food and feed sectors, insecticides, repellants or rodenticides, play an important role in strategies for protecting against biological hazards, both at farm level and during animal transport. Therefore, they should fall under the umbrella term of protection against biological hazards.

(45)

Knowledge of animal health, including symptoms and effects of epidemics and prevention options (including protection against biological hazards, treatment and control of epidemics) are a prerequisite for effective animal health management and essential for the early detection of animal diseases. Entrepreneurs and members of the professions dealing with animals should therefore acquire such knowledge to the extent required. This knowledge can be acquired in a number of ways, for example through formal training, but also through the farm advisory services that exist in the agricultural sector, or through informal training that may include national agricultural associations and those of the Union and other organizations.

(46)

Veterinarians and aquatic animal health professionals play an extremely important role in all areas of animal health management and this Regulation should therefore lay down general provisions on their roles and responsibilities.

(47)

The training and professional qualifications of veterinarians ensure that they have the knowledge, skills and competencies required, among other things, to diagnose diseases and treat animals. In addition, in some Member States, for historical reasons or due to a lack of veterinarians to deal with aquatic animal diseases, there is a special professional group called “professionals involved in aquatic animal health”. These individuals are usually not veterinarians, but do practice veterinary work on aquatic animals. This Regulation should therefore respect the decision of those Member States which recognize these professions. In such cases, aquatic animal health professionals should have the same responsibilities and obligations as veterinarians in their specific area of ​​work. This approach is also in line with the OIE's Aquatic Animal Health Code.

(48)

Member States, and in particular their animal health authorities, are key players in the prevention and control of animal diseases. By issuing animal health certificates, the authority responsible for animal health has an important function in monitoring, eradication, disease control measures, emergency planning and in raising awareness of the disease as well as in facilitating animal movements and in international trade. In order to fulfill their obligations under this Regulation, Member States must have adequate financial, infrastructure and human resources throughout their territory, including laboratory and scientific and other relevant expertise.

(49)

Due to limited resources, the competent authorities may not be able to carry out all the activities required by this Regulation. It is therefore necessary to create a legal basis for delegating certain activities to non-official veterinarians. For the same reason, Member States should also be able to allow natural and legal persons to carry out certain activities under certain conditions.

(50)

In order to ensure that the necessary conditions for the application of disease prevention and control measures are in place throughout the Union, the power should be conferred on the Commission to delegate other activities which the competent authorities to veterinarians other than official veterinarians in accordance with Article 290 TFEU can, to enact.

(51)

An optimal animal health management can only be achieved in cooperation with the animal owners, entrepreneurs, veterinarians, members of the professions dealing with animal health, other actors and trading partners. In order to be sure of their support, the decision-making processes and the application of the measures provided for in this regulation must be structured in a clear, transparent and integrative manner.

(52)

The competent authority should also take appropriate measures to inform the public, in particular when there is reason to believe that animals or products pose a risk to human or animal health or when there are cases of public interest. These can be animals or products that originate in the Union or that are imported into the Union from outside. The latter can also be brought into the Union by persons entering the Union from outside with personal luggage. Therefore, citizens should also be made aware of the risks involved in such cases.

(53)

In order to prevent disease pathogens from escaping from laboratories, institutes and other facilities in which pathogens are handled, it is essential that suitable measures to protect against biological hazards as well as appropriate biosecurity and bio-containment measures are taken. This Regulation should therefore provide for safety measures to be observed when transporting or handling such pathogens, vaccines or other biological products. The obligations thereby imposed should also apply to all natural and legal persons involved in such activities. In order to ensure that safety standards are complied with when handling highly infectious biological agents, vaccines and other biological products, the Commission should be empowered to grant legislative acts in accordance with Article 290 TFEU with regard to the use of such laboratories, institutes and facilities and the transport of pathogens to adopt effective security measures.

(54)

Early detection and a clear chain of disease notification and reporting are essential for effective disease control. In order to ensure an effective and rapid response, Member States should ensure that any suspicion or confirmation of an outbreak of certain listed diseases is promptly reported to the competent authority.

(55)

Veterinarians play a key role in disease investigation and are the main link between entrepreneurs and the competent authority. Therefore, they should be informed by the entrepreneurs concerned about abnormal mortalities, other serious disease problems or significantly reduced production rates for which there is no reason is recognizable, be taught.

(56)

In order to ensure that such reporting is effective and efficient, and to clarify the causes of abnormal mortalities or other signs of serious illness, the power should be conferred on the Commission to adopt legislative acts relating to the criteria for determining, in accordance with Article 290 TFEU the circumstances under which a report must be made and rules that may apply to further investigations.

(57)

For certain listed diseases, it is essential that a Member State immediately notifies the Commission and the other Member States of any occurrence on its territory. Such a notification enables neighboring or other relevant Member States to take precautionary measures if this appears appropriate.

(58)

On the other hand, some epidemics do not need to be reported immediately, and immediate action is not required. In such cases, it is important to collect and report on the occurrence of these diseases so that the disease situation can be controlled and, if necessary, disease prevention and control measures can be taken. This reporting requirement may also apply to diseases that are subject to reporting at Union level if additional information is required for the implementation of effective disease prevention and control measures. In order to ensure that the precise data and information necessary to prevent the spread or control of each disease are collected and that this is done in a timely manner, the Commission should be empowered to issue reporting acts in accordance with Article 290 TFEU enact.

(59)

One of the main purposes of disease notification and reporting is to collect reliable, transparent and easily accessible epidemiological data. A computerized interactive information system should be set up at Union level for the effective collection and management of surveillance data, both for the listed diseases and for emerging diseases or antibiotic-resistant pathogens, should this be necessary. The aim of the system was to promote optimal data availability, easier data exchange and a reduction in administrative burdens for the competent authorities of the Member States by making disease notification and reporting in a single operation at Union and international level (using the OIE database ). Steps should be taken to ensure that the exchange of information is in line with Directive 2003/99 / EC.

(60)

In order to ensure uniform conditions for the implementation of the Union's reporting and reporting rules, implementing powers should be conferred on the Commission to draw up a list of diseases subject to the Union's reporting and reporting rules set out in this Regulation and to determine which diseases are to be observed Disease notification and reporting procedures, formats and the exchange of data and information.

(61)

A surveillance system is a key element of disease control policy. It should enable early detection of animal diseases and efficient reporting so that the affected sector and the competent authority can take disease prevention and control measures and eradicate them in good time, as far as possible. In addition, information on the animal health status in each individual Member State and in the Union should be collected as part of the surveillance system, so that disease-free status can be demonstrated and trade with third countries can be facilitated.

(62)

Business owners monitor their animals regularly and are therefore best placed to identify abnormal mortalities or other symptoms of serious illness. Entrepreneurs therefore form the foundation of every monitoring system and their participation is essential for the monitoring by the competent authority.

(63)

Appropriate animal health visits should be carried out on all holdings, depending on the type of production and other relevant factors, to ensure close cooperation and exchange of experience between entrepreneurs, veterinarians and members of the aquatic animal health professions and to complement supervision by the entrepreneurs. In order to ensure uniform conditions for the organization of animal health visits, implementing powers should be conferred on the Commission to lay down minimum requirements.

(64)

It is imperative that the competent authority has a monitoring system in place that records all the listed diseases to be monitored. This should also apply to emerging diseases that require an assessment of the potential health risks for which data need to be collected. In the interests of optimal use of resources, information should be collected, passed on and used as efficiently and effectively as possible.

(65)

The method, frequency and intensity of surveillance should be tailored to the individual disease; this should take into account the specific purpose of the surveillance, the health status of the zone and any additional surveillance measures carried out by the operators. Appropriate epidemiological surveillance activities could range from simply reporting the occurrence or suspicion of a listed or emerging disease or other abnormalities, such as abnormal mortalities and other signs of disease, to a specific and comprehensive surveillance program for the would normally include additional sampling and additional testing.

(66)

Depending on the epidemiological profile of the disease and relevant risk factors, it may be necessary to set up a specific surveillance program that includes defined and structured activities. In such cases, Member States should develop targeted monitoring programs. If these programs are relevant for the Union as a whole, rules should be laid down for the uniform application of these programs.

(67)

These programs should be in line with Union objectives and should therefore be coordinated at Union level. To this end, the programs should be submitted to the Commission for information. In addition, Member States implementing such specific monitoring programs should report regularly to the Commission on the results of these programs. In order to ensure uniform conditions for the implementation of the surveillance programs, implementing powers should be conferred on the Commission to draw up a list of diseases subject to surveillance programs and to establish harmonized procedures, formats and data, a harmonized exchange of information and harmonized criteria for the evaluation of the surveillance programs become.

(68)

It is often necessary to clarify the level of surveillance that is appropriate for different diseases, from diseases where surveillance can be limited to activities such as reporting to diseases where a thorough Union-wide specific surveillance program needs to be put in place. The Commission should therefore be empowered to adopt, in accordance with Article 290 TFEU, legal acts concerning the organization of surveillance, the criteria for determining the relevance of a disease subject to a Union-relevant surveillance program and the criteria for an official confirmation of disease outbreaks the case definitions for the diseases concerned and the requirements for surveillance programs with regard to their content, the information to be contained in such programs and their duration.

(69)

For diseases listed in this Regulation as mandatory eradication programs, Member States which are not free from those diseases or for which it is not known whether they are free should have to establish mandatory eradication programs.

(70)

On the other hand, there are a number of diseases which, although of concern to the Union, do not require the Member States to be obliged to eradicate them. Member States have the option to set up optional eradication programs for such diseases if they decide that eradication is important to them. Such optional eradication programs would then be recognized at Union level and entail the implementation of certain relevant disease control measures. Subject to the approval of the Commission, such a program may also enable the Member State concerned to request certain guarantees when animals are imported from other Member States or from third countries.

(71)

In order to ensure uniform conditions for the implementation of disease eradication programs, implementing powers should be conferred on the Commission to determine the procedures for submitting such programs, performance indicators and reporting.

(72)

In addition, a Member State should be able to declare its entire territory or zones and compartments thereof free of one or more listed diseases that are subject to mandatory or optional eradication rules in order to avoid the introduction of such listed diseases from other parts of the Union or to protect from third countries or areas of third countries. A clear, harmonized procedure should be put in place for this; the criteria required for obtaining “disease-free” status should also be specified. In order to ensure that there is a uniform approach to the recognition of disease-free status in the Union, this status must be officially approved; therefore implementing powers should be conferred on the Commission to approve this status.

(73)

The OIE has introduced the concept of compartmentalization within the framework of the health codes for aquatic and terrestrial animals (“OIE codes”). In the Union legislation adopted before this Regulation, this concept is only used for certain animal species or diseases which are mentioned in the respective specific legal acts, namely avian influenza and aquatic diseases. This regulation should provide for the possibility of using the compartment system for other animal species and diseases. The Commission should be empowered to adopt acts in accordance with Article 290 TFEU laying down the precise conditions for the recognition of compartments, the licensing rules and the requirements for compartments.

(74)

In order to inform their trading partners and to facilitate trade, Member States should publicly announce whether their territory is disease-free or which zones and compartments of their territory are disease-free.

(75)

In order to determine the precise conditions for recognition of disease-free status, the Commission should be empowered to adopt, in accordance with Article 290 TFEU, legal acts on the criteria and conditions for granting this status, the evidence necessary to support the certification of disease-free status, specific disease prevention measures and adopt control measures, including, where appropriate, non-vaccination status, restrictions, information to be provided, exceptions and conditions for maintaining, suspending, withdrawing or restoring disease-free status.

(76)

In order to ensure uniform conditions for the implementation of the procedures for obtaining disease-free status, implementing powers should be conferred on the Commission to determine the list of listed diseases to which compartmentalisation can be applied and the detailed rules for submitting applications and exchanging information become.

(77)

The presence of an entirely non-immune population of animals susceptible to certain diseases requires constant awareness of the disease and a constant readiness for it. In the past, contingency plans have proven to be an indispensable tool for successfully fighting disease emergencies. In order to ensure that this emergency disease control tool is usable and effective, efficient and at the same time flexible enough to be adapted to emergency situations, implementing powers should be conferred on the Commission to determine the necessary rules for the implementation of the contingency plans.

(78)

Past crises caused by animal diseases have shown the benefits of specific, more accurate and faster crisis management procedures. These organizational procedures should ensure that there is a quick and effective response and encourage the coordination of actions by all parties involved, in particular those of the competent authorities and stakeholders. They should also include cooperation with the competent authorities of neighboring Member States and, where feasible and relevant, with the competent authorities of neighboring third countries and territories.

(79)

In order to ensure that the emergency plans can actually be carried out in an emergency, it is essential to carry out exercises with the systems concerned and to test their effectiveness. To this end, the competent authorities of the Member States should carry out simulations in cooperation with the competent authorities of the neighboring Member States and, where feasible and relevant, with the competent authorities of neighboring third countries and territories.

(80)

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

(81)

Veterinary medicines such as vaccines, hyperimmune serums and antibiotics play an important role in the prevention and control of animal diseases. In particular, the impact assessment carried out for the adoption of this regulation underlines the importance of vaccines in the prevention, control and eradication of animal diseases.

(82)

However, some animal disease control strategies require the prohibition or restriction of the use of certain veterinary medicinal products as their use would reduce the effectiveness of these strategies. So z. For example, certain veterinary medicinal products suppress the symptoms of a disease, making it impossible to identify a disease agent or making a rapid differential diagnosis difficult, which may prevent the disease from being properly identified.

(83)

However, these control strategies can vary greatly from disease to disease. Therefore, this Regulation should contain rules on the use of veterinary medicinal products in the prevention and control of certain listed diseases, as well as rules with harmonized criteria for deciding whether and how vaccines, hyperimmune serums and antibiotics are used. In order to ensure a flexible approach and to take into account the specificities of the different diseases listed and the availability of effective treatments, the Commission should be empowered to adopt acts in accordance with Article 290 TFEU regarding the restriction or prohibition of the use of certain veterinary medicinal products or the obligation to use them in connection with the use of certain veterinary medicinal products To combat certain listed diseases. In emergencies and newly emerging risks with potentially devastating effects on human or animal health, the economy, society or the environment, it should be possible to adopt such measures by means of the urgency procedure.

(84)

According to the conclusions of the opinion on Union banks for vaccines and / or diagnostics for major animal diseases, steps should be taken to enable the Union and Member States to build up stocks of antigens, vaccines and diagnostic reagents for listed diseases that pose a serious health threat depicting humans or animals.The establishment of a Union bank for antigens, vaccines and diagnostic reagents would contribute to the Union’s animal health objectives by enabling a quick and effective response when the bank’s resources are needed and is an efficient use of limited resources.

(85)

In order to ensure such a quick and effective response, the power should be conferred on the Commission to adopt legal acts on the establishment and management of such banks, on security standards and requirements for the operation of such banks in accordance with Article 290 TFEU. However, this Regulation should not contain provisions on the adoption of provisions to finance disease prevention and control measures, including vaccination.

(86)

Criteria should be established for priority access to the Union banks' resources for antigens, vaccines and diagnostic reagents in order to ensure an effective allocation of resources in the event of an emergency.

(87)

In order to protect against bio- and agro-terrorism, certain more detailed information about the Union banks for antigens, vaccines and diagnostic reagents should be kept confidential and its publication prohibited. With regard to the same type of information relating to national vaccine banks, it should be ensured that the information concerned is kept confidential, while respecting the constitutional requirements of each Member State on freedom of information.

(88)

In order to ensure uniform conditions for the management of the Union banks for antigens, vaccines and diagnostic reagents, the Commission should have implementing powers to lay down precise rules on which biological products are to be stored in these banks and for which diseases, as well as precise rules on purchasing, quantities , storage, delivery, procedural and technical requirements for antigens, vaccines and diagnostic reagents, as well as the frequency with which reports are to be submitted to the Commission and the content of these reports.

(89)

In the event of an outbreak of a listed disease which is considered to pose a high risk to human or animal health in the Union, Member States should ensure that disease control measures are taken immediately to eradicate the disease in question for the benefit of human health and protect animal.

(90)

The competent authority should be responsible for initiating the first investigations to confirm or confirm an outbreak of a highly infectious listed disease which is considered to pose a high risk to human or animal health in the Union to exclude.

(91)

The competent authorities should take provisional disease control measures to prevent the listed disease from spreading and conduct an epidemiological investigation.