3.6.2020 |
EN |
Official Journal of the European Union |
L 174/211 |
COMMISSION DELEGATED REGULATION (EU) 2020/689
of 17 December 2019
supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law (1)’), and in particular Article 29, Article 31(5), 32(2), 37(5), Article 39, Article 41(3), Article 42(6) and Article 280(4) thereof,
Whereas:
(1) |
The Animal Health Law lays down rules for the prevention and control of animal diseases transmissible to animals or to humans. The rules laid down in this Regulation are required to supplement those laid down in Chapters 2, 3 and 4 of Part II of the Animal Health Law on surveillance, eradication programmes and disease-free status, as well as those in Part IX on transitional arrangements concerning existing surveillance or eradication programmes and existing disease-free status. |
(2) |
These rules are substantially linked with many intended to be applied together. In the interest of simplicity and transparency, as well as to facilitate their application and avoid a multiplication of rules, they should therefore be laid down in a single act rather than in a number of separate acts with many cross-references and the risk of duplication. |
(3) |
Indeed, surveillance represents an intrinsic part of any eradication programme and disease-free status is in most cases an outcome of a successful surveillance and eradication process. Moreover, surveillance is needed, besides other measures, as a key tool for maintaining the disease-free status after its achievement. The rules on surveillance, eradication programmes and disease-free status, including transitional rules, often serve common purposes and refer to complementary activities of operators, veterinarians and competent authorities. Therefore it is appropriate to group together these rules in a single delegated regulation. |
(4) |
Surveillance is a key element of an efficient and effective disease prevention and control policy. It should be implemented jointly by operators and the competent authority. It should also be designed to meet the objectives of early detection of outbreaks of any listed and emerging disease and to demonstrate compliance with the criteria for the granting, maintaining, suspension or withdrawal of disease-free status. |
(5) |
The competent authority should put in place a basic general surveillance system for listed and emerging diseases of terrestrial animals based on notification and investigations of disease events in targeted animal population. |
(6) |
These general surveillance requirements for terrestrial animals should be complemented by more specific requirements depending on the expected output of surveillance. They should be designed to serve different specific purposes such as Union surveillance programmes, compulsory and optional eradication programmes, demonstration of disease-free status, disease control measures, in the context of the approval of certain establishments and the movements of animals and animal products. |
(7) |
The approach to designing general surveillance requirements for aquatic animals is similar to that for terrestrial animals, although not identical. All aquaculture establishments need to implement a basic surveillance system based on notification and investigation of disease events in a targeted animal population. In addition, surveillance for listed and emerging diseases of aquatic animal needs to incorporate certain disease control measures, when it is necessary to take such measures in aquaculture establishments. |
(8) |
In addition to the general surveillance requirements, which apply to all aquaculture establishments, specific surveillance requirements apply to certain approved aquaculture establishments. These specific measures include implementing a risk-based surveillance scheme based on assessment of the risk that an establishment has of contracting and spreading an aquatic disease, be it listed or non-listed. |
(9) |
The specific surveillance requirements also relate to the implementation of eradication programmes for certain listed diseases in order to obtain disease-free status from that disease and to maintain that status once achieved. |
(10) |
In addition, Member States should be given the possibility to implement surveillance, in the form of ‘surveillance programmes’ for Category C diseases of aquatic animals at establishment level, without opting for a disease eradication programme. Surveillance programmes differ from eradication programmes in that they are based on a system of targeted surveillance which is comprehensive but which does not encompass all the elements of an eradication programme. Unlike eradication programmes, surveillance programmes do not offer the possibility to achieve official disease-free status. |
(11) |
The specific eradication and surveillance programmes set out in this Regulation serve to substantiate health requirements for certain movements of animals and products of animal origin within the Union and in certain cases, of animals and products of animal origin entering the Union. |
(12) |
The Animal Health Law requires rules for listed diseases to apply to listed species. Surveillance may not be relevant for all categories of animals of listed species, in particular as regards wild animals or certain categories of kept animals. Therefore this Regulation should provide rules to specify the relevant targeted animal population for the purpose of surveillance. It should also be possible to expand the targeted animal population to non-listed kept species to ensure early detection of emerging diseases. |
(13) |
Derogations should also make possible to further limit targeted terrestrial animal populations to specific surveillance purposes, namely: (i) Union surveillance programmes; (ii) compulsory or optional eradication programmes; and (iii) surveillance-based animal health requirements for movements within the Union or for entry into the Union. |
(14) |
Diagnostic methods, together with the subsequent collection of samples to perform them, techniques, validation and interpretation are of a very technical nature and are subject to frequent modifications due to developments in scientific standards. Therefore to ensure that they are up to date, the rules on diagnostic methods should indicate in a flexible manner which methods should be used and how. In the area of animal diseases, there are different possible sources of scientific standards for diagnostic methods. It is therefore important to indicate the hierarchical order in which the methods should be considered, taking into account the general principles of sampling, analyses, tests and diagnoses laid down in Regulation (EU) 2017/625 of the European Parliament and of the Council (2). |
(15) |
To ensure optimal use of all resources and to avoid unnecessary administrative burdens and costs for operators and the competent authorities, the detection of listed and emerging diseases should draw on sources of information gathered during official controls and other official activities not primarily intended for the surveillance of those diseases. |
(16) |
The confirmation of a disease according to its case definition is the responsibility of the competent authority; it should be supported by appropriate investigations to confirm or rule out the presence of a suspected disease. Such investigations are relevant where the confirmation of the disease triggers disease control measures, as well as in certain other circumstances depending on the consequences of the confirmation of the disease. It is therefore important that this Regulation should lay down the additional circumstances where the confirmation of the disease is necessary. |
(17) |
The definitions of a suspected case and confirmed case of a listed disease and, where relevant, an emerging disease are of key importance. These enable operators, veterinarians and other stakeholders involved in surveillance to identify circumstances where it is necessary to notify the competent authority and for the competent authority to apply disease control measures. Therefore it is necessary to provide general criteria for the definitions of a suspected case and a confirmed case and to provide, where needed, disease-specific definitions, depending on the specific characteristics of certain diseases. |
(18) |
A Union surveillance programme is a surveillance programme relevant for the Union as a whole. This is necessary in order to achieve greater harmonisation of surveillance of a specific disease across the Union due to its specific public or animal health concerns. Therefore it is necessary to lay down the criteria that diseases eligible for Union surveillance programme should meet. |
(19) |
Commission Decision 2010/367/EU (3) lays down minimal requirements for surveillance programmes for avian influenza in poultry and in wild birds and sets out technical guidelines in its annexes. This Regulation should provide for similar technical guidelines in an annex. However, the level of detail in this Regulation is lower to ensure a good capacity to adapt to changes in the situation as regards surveillance of avian influenza. Therefore the technical requirements for the Union surveillance programme for avian influenza focus exclusively on the objectives, the scope and the methodological principles to follow. |
(20) |
The Animal Health Law sets out rules for the application of compulsory and optional eradication programmes for category B and category C diseases in Member States. These diseases, or groups of them, have their own characteristics. Their eradication should be based on a disease control strategy specific for the disease in question. This should include at least: (i) the surveillance that needs to be performed in order to achieve disease-free status as the ultimate goal; (ii) the timeframe; (iii) a definition of the animal population that is subject to the eradication programme; (iv) the territory in which this eradication programme will apply; and (v) specific disease prevention and control measures that will apply to the disease during the eradication phase. |
(21) |
If the territory in which an eradication programme will be implemented includes the external border of the Member State, the competent authority should make efforts to address the risk of introduction of the disease from outside its borders. |
(22) |
The purpose of an eradication programme is to achieve disease-free status on the territory covered by the programme. Ideally, for terrestrial animals it should cover the whole territory of the Member State where the disease is present. If this is not possible, the minimum area that is acceptable should be defined. The minimum surface of the area should take into account the experience gained through previous eradication programmes and allow for flexibility depending on the specific characteristics of the disease. |
(23) |
The programme’s qualitative or quantitative targets should be set by the competent authority. Final targets should be based on the criteria for granting disease-free status, while intermediate targets may also comprise other activities or steps important for achieving the disease-free status, reflecting the evolution of the programme. |
(24) |
The competent authority should determine the period of application of the eradication programmes. In the case of optional eradication programmes for category C diseases, a maximum period of application of the programme is laid down in order to prevent disproportionate and long lasting disruption of movements within the Union. Nevertheless, the competent authority may start the eradication programme before its approval by the Commission but should not implement restrictions to the movements within the Union at that stage. A possibility should also be provided for Member States to request that the Commission extend this period where justified circumstances exist. |
(25) |
The eradication strategy of certain diseases might be based on granting disease-free status at establishment level. The disease-specific measures for such diseases should be grouped and spell out obligations for the operators and for the competent authorities. |
(26) |
The targeted animal population to be included in the disease eradication programme should be set out on a disease-specific basis. The possibility for the competent authority to include in the programme certain additional animal populations should also be set out on a disease-specific basis. |
(27) |
The primary responsibility for obtaining and maintaining the establishment’s disease-free status lies with the operator as it is the primary recipient of the benefits linked to the disease-free status. Therefore the operator should comply with certain obligations in order to be granted and maintain disease-free status. |
(28) |
Once the general and disease specific criteria for achieving disease-free status have been met by the operator, it is for the competent authority to grant that status. When these specific criteria are no longer met, it is also for the competent authority to either suspend or withdraw the status. |
(29) |
Moreover, the obligations for operators and competent authorities in the context of eradication programmes should, where necessary, be detailed considering the specific disease profile. The disease-specific requirements are of a technical nature and are set out for each specific disease in annexes to this Regulation. |
(30) |
Commission Implementing Regulation (EU) 2018/1882 (4) lists infection with Brucella abortus, B. melitensis and B. suis and infection with Mycobacterium tuberculosis complex for compulsory eradication programmes and lists enzootic bovine leukosis, infection with Aujeszky’s disease virus, infectious bovine rhinotracheitis/infectious pustular vulvovaginitis and bovine viral diarrhoea for optional eradication programmes. For these diseases, eradication programmes should be based on the granting of establishment disease-free status. |
(31) |
Eradication programmes based on granting disease-free status at establishment level should include all establishments keeping animals from the targeted animal population. However, the competent authority should have the possibility to exclude certain specific types of establishments and slaughterhouses from the eradication programme provided appropriate risk mitigating measures are implemented. |
(32) |
In the case of eradication programmes based on granting disease-free status at establishment level, the competent authority should have the possibility to attribute different health status to different epidemiological units. |
(33) |
In the case of terrestrial animals, the requirements to demonstrate disease-free status at establishment level are based on the absence of infection supported by the testing and surveillance regime, by the conditions for introducing animals and germinal products into the establishments and, if necessary, by restrictions on the use of vaccination. When the conditions for maintaining the disease-free status are no longer satisfied, specific requirements apply to suspend, withdraw and restore this status. Due to their technical nature, the disease-specific detailed requirements and the list of diagnostic methods to be used for granting and maintenance of the status are laid down in annexes. |
(34) |
Conditions for granting, maintaining, suspending and withdrawing disease-free status at establishment level were set out in the following Union rules in place before the date of application of this Regulation: Council Directive 64/432/EEC (5) for bovine brucellosis and bovine tuberculosis and Council Directive 91/68/EEC (6) for brucellosis in sheep and goats. The Animal Health Law repealed those provisions. Also, Commission Delegated Regulation (EU) 2018/1629 (7) has aligned the scope of disease agents involved in brucellosis and bovine tuberculosis with the Terrestrial Animal Health Code of the World Organisation for Animal Health (8) (OIE) (‘the Terrestrial Code’). They are now infection with Brucella abortus, Brucella melitensis and Brucella suis and infection with Mycobacterium tuberculosis complex. It is therefore appropriate to revise the technical requirements related to the status of these diseases, so as to seek alignment with the Terrestrial Code while taking into account the experience gained in previous eradication programmes for these diseases. |
(35) |
In the case of disease eradication programmes for terrestrial animals based on granting disease-free status at establishment level, if a disease is suspected or confirmed, the competent authority should implement measures to prevent its spread. These measures are to be implemented primarily in the establishment where the suspected case is kept but the competent authority should have the possibility to expand the measures to other animals or establishments when there is a risk of spreading the disease. |
(36) |
When applying the disease control measures in response to a suspected or confirmed case, the competent authority should introduce certain prohibitions on movements of animals. However, the competent authority should also have the possibility to allow the movement of certain animals from the establishment where a suspected or confirmed case is kept, to take account of animal welfare conditions and to facilitate the sustainability of the disease control measures. |
(37) |
Following the confirmation of a case, at least all animals recognised as confirmed cases should be removed. When these animals are put to death, the competent authority should have the possibility to decide whether this is done by slaughtering, meaning that their meat is intended to enter the food chain, or by killing, meaning that the meat is not intended for that purpose. |
(38) |
For certain diseases that can be spread by infected products of animal origin or fomites, or which may have a potential public health impact, the competent authority should introduce measures in infected establishments to prevent the spread of those diseases through these products or fomites. The measures to mitigate such risks should therefore be set out in this Regulation. |
(39) |
In the case of terrestrial animals, once disease-free status has been achieved at establishment level, for the sake of programme efficiency, it should be possible to carry out a stepwise reduction in the level of surveillance activities after a certain period of continuous disease-free status in the establishment. |
(40) |
Enzootic bovine leukosis (EBL) was subject to compulsory eradication under the Union rules in place before the date of application of this Regulation. This disease is now categorised for optional eradication in accordance with Implementing Regulation (EU) 2018/1882. |
(41) |
Union rules in place before the date of application of this Regulation contained well-established and effective principles and criteria for the recognition, maintenance, suspension and restoring of officially EBL-free status. Many Member States successfully applied these rules during the implementation of past EBL eradication programmes. The rules have been reviewed against the Terrestrial Code and included in this Regulation. |
(42) |
Member States or zones which have been free from EBL for several years and have therefore reached a steady animal health situation free of EBL, should continue to demonstrate the absence of infection. Risk-based surveillance is an appropriate means of ensuring early detection if the disease is reintroduced and of substantiating freedom from EBL. Member States should therefore establish a suitable surveillance system from the date of application of this Regulation. |
(43) |
Additional guarantees for intra-Union trade of pigs in relation to infection with Aujeszky’s disease virus (ADV) were part of Union rules in place before the date of application of this Regulation. A number of Member States have successfully applied those rules and eradicated infection with ADV in the pig population kept in their territory. The strategy for the eradication of infection with ADV in this Regulation takes account of the Terrestrial Code and of criteria that have proven successful in eradicating the infection with ADV. |
(44) |
The rules in this Regulation on infectious bovine rhinotracheitis/Infectious pustular vulvovaginitis (IBR/IPV) are based on Commission Decision 2004/558/EC (9) with provisions on additional guarantees for intra-Community trade of bovine animals. These include requirements to obtain, maintain and restore freedom at establishment level from bovine herpesvirus 1 (BoHV-1). The rules have been developed taking into consideration the standards of the Terrestrial Code and the EFSA scientific opinion (10). |
(45) |
Union rules in place before the date of application of this Regulation do not contain provisions for bovine viral diarrhoea (BVD) with the exception of provisions related to the trade of germinal products. In Implementing Regulation (EU) 2018/1882, BVD is now listed as a ‘category C disease’ for optional eradication. Therefore provisions on eradication programmes and the granting and maintenance of disease-free status with regard to BVD are laid down in this Regulation. |
(46) |
The Terrestrial Code lacks a chapter on BVD and criteria for BVD freedom and related animal movements. However, a chapter on BVD is available in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the OIE. These diagnostic standards have been considered for the provisions related to BVD in this Regulation. |
(47) |
Implementing Regulation (EU) 2018/1882 lists infection with the rabies virus as a category B disease. Therefore this Regulation includes provisions on compulsory eradication programmes and the granting and maintenance of disease-free status with regard to infection with the rabies virus. |
(48) |
Wild foxes constitute the main reservoir of infection with the rabies virus in the EU. It is therefore appropriate that the measures in eradication programmes are primarily focused on the wild fox population. However, all other mammal species are susceptible and many other animal species are listed in Implementing Regulation (EU) 2018/1882 for this disease. The competent authorities should address other animal populations in the eradication programmes when there is a risk to human or animal health. |
(49) |
For infection with rabies eradication programmes, the disease control strategy is primarily based on vaccination of the relevant targeted animal population, supported by other important activities such as surveillance, implementation of disease control measures, the control of pet movements and monitoring of the effectiveness of the vaccination. As the vaccination provisions are of a very technical nature, they are laid down in an annex. |
(50) |
Implementing Regulation (EU) 2018/1882 lists infection with bluetongue virus (serotypes 1-24) (infection with BTV) as a category C disease for optional eradication programme. This implies a change in the policy against this disease as Council Directive 2000/75/EC (11), applicable prior to this Regulation, provided for its immediate eradication. New provisions are laid down in this Regulation to address the new status of the disease. |
(51) |
For infection with BTV, the disease control strategy is primarily based on vaccination of the relevant targeted animal population supported by other activities such as surveillance, implementation of disease control measures, control of the movements of animals and germinal products, and minimising exposure to vectors. |
(52) |
In its opinion (12) on the control, surveillance and movement of animals in the case of infection with BTV, EFSA indicates that for eradication to succeed, vaccination coverage should be at least 95 % of susceptible bovine and ovine animals for a minimum period of 5 years. It is therefore expected that the eradication programmes for infection with BTV include a vaccination campaign, although flexibility should be provided for in this Regulation to take into account the specific circumstances of each case. |
(53) |
A Member State or zone thereof free from infection with BTV or under an eradication programme for infection with BTV should be protected from the introduction of any BTV serotypes by the movement of kept animals or germinal products. Therefore requirements for the introduction of kept animals or germinal products into Member States or zones thereof free from infection with BTV or under an eradication programme for infection with BTV should be part of the provisions on eradication programmes. This should also be reflected in the criteria for the maintenance of the disease-free status. The same principles should apply to movements of animals through the Member States or zones thereof free from infection with BTV or under an eradication programme for infection with BTV. |
(54) |
In addition, because of the diversity of the local situations that may prevail, the competent authority should have the possibility to allow the introduction of animals or germinal products based on ad hoc requirements, provided that such introduction does not jeopardise the health status at the destination. It is therefore appropriate that this Regulation provides for the requirements and conditions under which such introduction may be authorised. Such requirements should be based on the status of animals or germinal products, independently of the Member State or zone of origin. |
(55) |
An eradication programme for a category B or category C disease of aquatic animals should take account of the type of surveillance requirements required to obtain and maintain disease-free status, of details of the territory and the animal population to be covered by the programme; and of the programme’s intermediate and final targets. The eradication programme should include the control measures to be implemented in infected establishments of aquatic animals. |
(56) |
The eradication programme for aquatic animal diseases should include intermediate and final targets which will be used to assess progress towards achieving disease-free status. Where relevant, these targets should take account of the risk wild animals pose to the success of the eradication programme. In particular, any possibility of deviation from the proposed period of application of 6 years should be taken in to account when devising the programme’s intermediate and final targets. |
(57) |
In the case of aquatic animals, the population which is to be included in the eradication programme consists of those species which are listed in Implementing Regulation (EU) 2018/1882. However, the competent authority should have the possibility to exclude from the programme the species listed as a vector in Implementing Regulation (EU) 2018/1882 if it has carried out a risk assessment which has resulted in the risk posed by those animals being deemed negligible. |
(58) |
The competent authority should have the possibility to include additional aquatic animal populations when such animals pose a significant risk to the health status. It also should be able to exclude certain low-risk establishments from the eradication programme if their exclusion does not jeopardise its successful completion. |
(59) |
When a Member State has decided to participate in an eradication programme for a category C disease, operators are obliged to comply with conditions for introductions of animals of listed species, to notify suspicion of listed diseases, to comply with disease control measures when a disease is suspected or confirmed and to take any other measures that may be required by the competent authority, including vaccination. |
(60) |
When the presence of a listed disease of aquatic animals is suspected or confirmed in a disease-free Member State, zone or compartment, or in one which is subject to a eradication programme, the competent authority should take appropriate measures to control the disease. These rules should therefore be laid down in this Regulation. These include establishing a restricted zone when the presence of a listed disease has been confirmed in an establishment participating in the eradication programme or in an establishment which has been declared disease-free. This also includes the minimum requirements applying to geographical demarcation of a restricted zone and the factors affecting it. |
(61) |
Following the confirmation of a listed aquatic disease in a disease-free Member State, zone or compartment, or in one which is subject to a eradication programme, the competent authority carries out strict controls in infected establishments and in other establishments located in the restricted zone. The nature of the controls and the level of flexibility the competent authority applies to movements are set out in this Regulation. Where flexibility is applied, it is limited to circumstances where the health status of aquatic animals at the establishment of destination or enroute to that destination is not jeopardised. |
(62) |
Once an aquatic disease outbreak has occurred in an establishment and that establishment remains or commences an eradication programme, it is important to remove aquatic animals that are dead, moribund or showing clinical signs within a period set by the competent authority and in accordance with Regulation (EC) No 1069/2009 of the European Parliament and of the Council (13). In this way, the disease can be successfully controlled. |
(63) |
The Animal Health Law requires the Commission to develop detailed rules for the granting of disease-free status to Member States, zones and compartments. These rules should include disease-specific criteria to demonstrate the absence of the disease in the targeted animal population and the general criteria that support effective control of the health status of that targeted animal population. |
(64) |
The general criteria comprise the territorial scope, surveillance, biosecurity, disease control measures and consistent implementation of other operational rules set out in the Animal Health Law as regards the registration and approval of establishments, traceability of animals and movement requirements. |
(65) |
This Regulation lays down disease-specific criteria based on the absence of listed species or based on the disease agent or vector’s incapacity to survive. These criteria should be drawn up in a flexible way to allow the competent authority to justify the case for obtaining disease-free status based on the specific situation. Therefore general requirements are laid down in this Regulation to indicate on what basis Member States may request the granting of disease-free status for their entire territory or a zone thereof or, in the case of aquaculture animals, for compartments. |
(66) |
This Regulation lays down disease-specific criteria based on the outcome of eradication programme and on historical and surveillance data. These criteria are based on results of the surveillance, the implementation of measures to prevent introduction of the disease and conditions for the use of vaccines. |
(67) |
Because of their technical nature these criteria are laid down in annexes and grouped by disease with the criteria for maintaining the disease-free statuses. |
(68) |
It is appropriate that this Regulation lay down modernised requirements for the granting and maintenance of disease-free status taking account of the Union rules in place before the date of application of this Regulation, the Terrestrial Code, the Aquatic Animal Health Code of the OIE and, in the absence of existing provisions, the best available scientific evidence. |
(69) |
Implementing Regulation (EU) 2018/1882 lists infestation with Varroa spp. as a category C disease for optional eradication. This Regulation lays down provisions for achieving and maintaining infestation with Varroa spp.-free status. |
(70) |
Implementing Regulation (EU) 2018/1882 lists infection with Newcastle disease virus as a category A disease for immediate eradication measures. Therefore this Regulation does not contain provisions for an eradication programme for infection with Newcastle disease virus. However, it should be possible for the competent authority to grant the status free from infection with Newcastle disease virus without vaccination on the basis of historical and surveillance data. |
(71) |
Two different types of compartments are possible in the case of aquatic animals. Independent compartments operate under strictly defined conditions which ensure they operate independently of the health status of the surrounding waters. Dependent compartments on the other hand, are influenced by the health status of the surrounding waters and operate therefore, under more flexible conditions. Dependent compartments are however, only established once the competent authority has assessed a number of epidemiological factors and put in place whatever risk mitigating measures are necessary to prevent the introduction of disease into the compartment. |
(72) |
In the case of aquatic animals, and given the lower level of risk associated with individual establishments which are independent of the surrounding waters, special provisions are laid down in this Regulation for independent compartments when they commence aquaculture activities for the first time or when they recommence aquaculture activities after a break in production. In such cases, disease-free status should be declared immediately provided certain conditions are met. Provisions are also laid down for independent compartments where a disease outbreak has occurred. To ensure that such outbreaks have been successfully dealt with by the cleaning, disinfection and fallowing which have been carried out after de-population, a sample of the animals used to repopulate the compartment should be tested before disease-free status can be declared. |
(73) |
When conditions to maintain disease-free status are no longer fulfilled because of suspicion or confirmation of the disease, the competent authority should apply disease control measures. These measures should apply during the different steps of disease control from when an outbreak of the disease is suspected to when the event is resolved and the disease-free status restored. |
(74) |
If the competent authority detects a breach of the conditions required to maintain disease-free status in the Member State, zone or compartment, measures should be implemented to remedy the situation. The competent authority should have the option to suspend the disease-free status when it is still possible to satisfactorily resolve the breach and therefore not to have the disease-free status withdrawn by the Commission. |
(75) |
When a Member State wishes to obtain disease-free status for a listed aquatic disease for its entire territory or for a zone thereof accounting for more than 75 % of its territory, or which is shared with another Member State or third country, it will apply to the Commission for approval. In all other cases, a system of self-declaration is followed. |
(76) |
Self-declaration of freedom from aquatic animal diseases for zones and compartments other than those which are Commission-approved follows a system which is designed to give transparency to the process and which will make it easier and potentially quicker for Member States to declare disease-free status. The entire process will be completed electronically unless another Member State or the Commission indicate concerns which cannot be resolved satisfactorily. If there are concerns that cannot be resolved satisfactorily, the declaration is brought to the Standing Committee on Plants, Animals, Food and Feed. |
(77) |
This Regulation contains provisions on the approval of disease-free status of Member States or zones thereof. These rules may differ from the rules in force before the date of application of this Regulation. Appropriate transitional rules are needed to ensure a smooth transition from the existing regime on the approval of disease-free status to the new requirements. |
(78) |
With a view to the uniform application of Union legislation on surveillance, eradication programmes and disease-free status and to ensure that it is clear and transparent, Commission Decision 2000/428/EC (14), Commission Decision 2002/106/EC (15); Commission Decision 2003/422/EC (16), Commission Decision 2006/437/EC (17), Commission Regulation (EC) No 1266/2007 (18), Commission Decision 2008/896/EC (19) and Commission Implementing Decision (EU) 2015/1554 (20) should be repealed by this Regulation. |
(79) |
The Animal Health Law applies from 21 April 2021. Accordingly, the rules laid down in this Regulation should also apply from that date, |
HAS ADOPTED THIS REGULATION:
PART I
GENERAL PROVISIONS
Article 1
Subject-matter and scope
1. This Regulation supplements the rules on surveillance, eradication programmes and disease-free status for certain listed and emerging diseases of terrestrial, aquatic and other animals as provided for in Regulation (EU) 2016/429.
2. Chapter 1 of Part II of this Regulation lays down the rules for surveillance of the diseases referred to in Article 9(1) of Regulation (EU) 2016/429 and the emerging diseases as defined in Article 6(2) of that Regulation in relation to:
(a) |
the design of the surveillance including the targeted animal population and the diagnostic methods; |
(b) |
the disease confirmation and the case definition; |
(c) |
Union surveillance programmes. |
3. Chapter 2 of Part II of this Regulation lays down the rules for eradication programmes for the diseases of terrestrial animals referred to in points (b) and (c) of Article 9(1) of Regulation (EU) 2016/429 in relation to:
(a) |
the disease control strategy, the territory, the animal populations, the targets and the period of application; |
(b) |
the obligations of operators and competent authorities; |
(c) |
the disease control measures in the event of suspicion and of confirmation. |
4. Chapter 3 of Part II of this Regulation lays down the rules for eradication programmes for the diseases of aquatic animals referred to in points (b) and (c) Article 9(1) of Regulation (EU) 2016/429 in relation to:
(a) |
the disease control strategy, the territory, the animal populations, the targets and the period of application; |
(b) |
the obligations of operators and competent authorities; |
(c) |
the disease control measures in the event of suspicion and of confirmation. |
5. Chapter 4 of Part II of this Regulation lays down the rules for disease-free status with regard to certain diseases of terrestrial and aquatic animals referred to in Article 9(1) of Regulation (EU) 2016/429 in relation to:
(a) |
the criteria for the approval of the disease-free status of Member States and zones; |
(b) |
the criteria for the approval of the disease-free status for compartments keeping aquaculture animals; |
(c) |
the criteria for the maintenance of the disease-free status; |
(d) |
the suspension, the withdrawal and the restoration of disease-free status. |
6. Part III of this Regulation lays down transitional and final provisions in relation to:
(a) |
the approval of the disease-free status of Member States, zones and compartments which are recognised disease-free under the legislation in force before the date of application of this Regulation; |
(b) |
the approval of eradication programmes of Member States, zones and compartments which have an approved eradication or surveillance programme under the legislation in force before the date of application of this Regulation. |
Article 2
Definitions
For the purpose of this Regulation, the following definitions shall apply:
(1) |
‘category E disease’: means a listed disease for which there is a need for surveillance within the Union, as referred to in point (e) of Article 9(1) of Regulation (EU) 2016/429; |
(2) |
‘targeted animal population’ means the population of animals of listed species defined by species and, as appropriate, by categories, relevant for the surveillance activities, the eradication programmes or the disease-free status of a specific disease; |
(3) |
‘additional animal population’ means the population of kept or wild animals of listed species subjected to optional prevention, surveillance and disease control measures necessary to achieve or maintain the disease-free status of a targeted animal population; |
(4) |
‘category A disease’: means a listed disease that does not normally occur in the Union and for which immediate eradication measures must be taken as soon as it is detected, as referred to in point (a) of Article 9(1) of Regulation (EU) 2016/429; |
(5) |
‘category B disease’: means a listed disease which must be controlled in all Member States with the goal of eradicating it throughout the Union, as referred to in point (b) of Article 9(1) of Regulation (EU) 2016/429; |
(6) |
‘category C disease’: means a listed disease which is of relevance to some Member States and for which measures are needed to prevent it from spreading to parts of the Union that are officially disease-free or that have eradication programmes for the listed disease concerned, as referred to in point (c) of Article 9(1) of Regulation (EU) 2016/429; |
(7) |
‘bovine animal’ or ‘animal of the bovine species’ means an animal of the species of ungulates belonging to the genera Bison, Bos (including the subgenera Bos, Bibos, Novibos, Poephagus) and Bubalus (including the subgenus Anoa) and the offspring of crossings of those species; |
(8) |
‘ovine animal’ or ‘animal of the ovine species’ means an animal of the species of ungulates belonging to the genus Ovis and the offspring of crossings of those species; |
(9) |
‘caprine animal’ or ‘animal of the caprine species’ means an animal of the species of ungulates belonging to the genus Capra and the offspring of crossings of those species; |
(10) |
‘travelling circus’ means an exhibition or fair that includes animals or animal acts which is intended to move between Member States; |
(11) |
‘animal acts’ means any act featuring animals kept for the purpose of an exhibition or fair, and which may form part of a circus; |
(12) |
‘porcine animal’ or ‘animal of the porcine species’ means an animal of the species of ungulates of family Suidae listed in Annex III to Regulation (EU) 2016/429; |
(13) |
‘means of transport’ means road or rail vehicles, vessels and aircrafts; |
(14) |
‘dog’ means a kept animal of the Canis lupus species; |
(15) |
‘cat’ means a kept animal of the Felis silvestris species; |
(16) |
‘ferret’ means a kept animal of the Mustela putorius furo species; |
(17) |
‘seasonally BTV-free area’ means the whole territory of a Member State or a zone thereof where the competent authority has established a temporary status of freedom from infection with bluetongue virus (serotype 1-24) (‘infection with BTV’) in accordance with Article 40(3) on the basis of a vector-free period and the demonstration of absence of the disease in listed animal species; |
(18) |
‘vector protected establishment’ means part or all facilities of an establishment that are protected against attacks from Culicoides by appropriate physical and management means, with a status of vector protected establishment being granted by the competent authority in accordance with Article 44; |
(19) |
‘well-boat’ means a vessel used by the aquaculture industry which has a well or tank for the storage and transport of live fish in water; |
(20) |
‘fallowing’ means, for disease management purposes, an operation where an establishment is emptied of aquaculture animals from listed species, and where feasible, of water; |
(21) |
‘eligibility period’ means the period of time before the competent authority submits the application for disease-free status or, when relevant, before the provisional declaration referred to in point (a) of Article 83(1) is published electronically; |
(22) |
‘non-listed species’, means an animal species or group of animal species not listed in the Annex to Commission Implementing Regulation (EU) 2018/1882 for a particular disease; |
(23) |
‘flock’ means all poultry or captive birds of the same health status kept on the same premises or in the same enclosure and constituting a single epidemiological unit; in housed poultry includes all birds sharing the same airspace; |
(24) |
‘DIVA (differentiating infected from vaccinated animals) vaccination’ means a vaccination using vaccines that enable in conjunction with appropriate serological diagnostic methods, the detection of infected animals in a vaccinated population; |
(25) |
‘DIVA vaccinated animals’ means animals that have been vaccinated in the framework of a DIVA vaccination; |
(26) |
‘approved germinal product establishment’ means a semen collection centre, an embryo collection team, an embryo production team, a germinal product processing establishment or a germinal product storage centre, approved in accordance with Article 97(1) of Regulation (EU) 2016/429; |
(27) |
‘semen’ means the ejaculate of an animal or animals, either in the unaltered state or prepared or diluted; |
(28) |
‘oocytes’ means the haploid stages of the ootidogenesis including secondary oocytes and ova; |
(29) |
‘embryo’ means the initial stage of development of an animal while it is capable of being transferred to a recipient dam; |
(30) |
‘vector-free period’ means in a defined area the period of inactivity of Culicoides determined in accordance with Section 5 of Chapter 1 of Part II of Annex V; |
(31) |
‘honeybees’ means animals of the Apis mellifera species; |
(32) |
‘breeding poultry’ means poultry 72 hours old or more, intended for the production of hatching eggs; |
(33) |
‘random annual surveillance’ means a surveillance consisting of at least one survey of a targeted animal population organised during the year for which probability-based sampling methods are used to select units to examine. |
PART II
SURVEILLANCE, ERADICATION PROGRAMMES, DISEASE-FREE STATUS
CHAPTER 1
Surveillance
Article 3
Design of surveillance
1. The competent authority shall design the surveillance for listed and emerging diseases of terrestrial animals and other animals taking into account:
(a) |
general surveillance requirements based on:
|
(b) |
specific surveillance requirements:
|
2. The competent authority shall design the surveillance for listed and emerging diseases of aquatic animals taking into account:
(a) |
general surveillance requirements based on:
|
(b) |
specific surveillance requirements:
|
Article 4
Targeted animal population
1. The competent authority shall specify the targeted animal population relevant to the surveillance referred to in Article 3 for each listed disease and, when relevant, for each emerging disease and shall include:
(a) |
kept animals of listed species; |
(b) |
wild animals of listed species if:
|
2. To ensure the early detection of an emerging disease in species other than those referred to in point (a) of paragraph 1, the competent authority shall include, in the targeted animal population, kept animals of species that are not listed for the purpose of the relevant listed disease if the following criteria apply:
(a) |
they are moved to establishments in another Member State, zone or compartment; and |
(b) |
due to the number of animals or the frequency of the movements, the competent authority considers the animals to constitute a risk that might impair the health status of other kept animals in another Member State, zone or compartment, should a disease emerge in that species. |
Article 5
Exclusion of certain kept terrestrial animals from the targeted animal population
1. By way of derogation from point (a) of Article 4(1), the competent authority may limit the targeted animal population for the surveillance of a disease other than a category A disease to the categories of kept animals of listed species that are subject, for that disease, to:
(a) |
Union surveillance programmes; |
(b) |
compulsory or optional eradication programmes or surveillance necessary for the granting or maintenance of a disease-free status; or |
(c) |
surveillance-based animal health requirements for the movements within the Union or the entry into the Union. |
2. The categories of kept animals referred to in paragraph 1 may be based on the animals’ age, their sex, the location and type of production.
Article 6
Diagnostic methods
1. The competent authority shall ensure that the collection of samples, the techniques, validation and interpretation of the diagnostic methods for the purposes of surveillance shall comply:
(a) |
with the specific legislation adopted in accordance with Regulation (EU) 2016/429 and the relevant details and guidance made available on the websites of the European Union Reference Laboratories (EURL) and of the Commission; |
(b) |
when not covered by the legislation, details and guidance referred to in point (a), with the collection of samples, the techniques, validation and interpretation of the diagnostic methods laid down in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE) (‘the Terrestrial Manual’ (21) as amended or the Manual of Diagnostic Tests for Aquatic Animals of the OIE (‘the Aquatic Manual’ (22) as amended; |
(c) |
when not covered by points (a) and (b) of this paragraph, with the methods laid down in point (b) of Article 34(2) and Article 34(3) of Regulation (EU) 2017/625. |
2. The diagnostic methods for granting and maintaining disease-free status are laid down in:
(a) |
Section 1 of Annex III for infection with Brucella abortus, B. melitensis and B.suis; |
(b) |
Section 2 of Annex III for infection with Mycobacterium tuberculosis complex (Mycobacterium bovis, M.caprae and M. tuberculosis) (MTBC); |
(c) |
Section 3 of Annex III for enzootic bovine leukosis (EBL); |
(d) |
Section 4 of Annex III for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV); |
(e) |
Section 5 of Annex III for infection with Aujeszky’s disease virus (ADV); |
(f) |
Section 6 of Annex III for bovine viral diarrhoea (BVD); |
(g) |
point 2 of Section 5 of Chapter 1 of Part II of Annex VI for viral haemorrhagic septicaemia (VHS); |
(h) |
point 2 of Section 5 of Chapter 1 of Part II of Annex VI for infectious haematopoietic necrosis (IHN); |
(i) |
point 2 of Section 5 of Chapter 2 of Part II of Annex VI for infection with highly polymorphic region deleted infectious salmon anaemia virus (HPR-deleted ISAV); |
(j) |
point 2 of Section 5 of Chapter 3 of Part II of Annex VI for infection with Marteilia refringens; |
(k) |
point 2 of Section 5 of Chapter 4 of Part II of Annex VI for infection with Bonamia exitiosa; |
(l) |
point 2 of Section 5 of Chapter 5 of Part II of Annex VI for infection with Bonamia ostreae; |
(m) |
point 2 of Section 5 of Chapter 6 of Part II of Annex VI for infection with white spot syndrome virus (WSSV). |
Article 7
Contribution of official controls and other official activities to animal health surveillance
1. The competent authority shall, if relevant, include in the design of the surveillance referred to in Article 3 of this Regulation the outcome of the official controls and other official activities defined in Article 2 of Regulation (EU) 2017/625. These official controls and other official activities include:
(a) |
ante-mortem and post-mortem inspections; |
(b) |
inspections at border control posts; |
(c) |
official controls and other official activities at markets and assembly operations; |
(d) |
official controls and other official activities during transport of live animals; |
(e) |
public health related inspections and sampling in establishments; |
(f) |
any other official controls during which establishments, animals or samples are inspected or examined. |
2. When the competent authority suspects a listed disease or an emerging disease in the context of official controls or other official activities referred to in paragraph 1, it shall ensure that all relevant authorities are informed. This shall be done:
(a) |
immediately in case of a category A disease or of an emerging disease; |
(b) |
without delay for other diseases. |
Article 8
Criteria for official confirmation of listed diseases, other than category A diseases, and certain emerging diseases and subsequent confirmation of outbreaks
1. The competent authority shall, on suspicion of listed diseases, other than category A disease, or of an emerging disease, conduct an investigation to confirm or to rule out the presence of that disease when:
(a) |
there is a need to determine the health status of the Member State, zone or compartment thereof; or |
(b) |
there is a need to collect necessary information on the occurrence of the disease for any of the following purposes:
|
2. The competent authority shall confirm an outbreak of any of the diseases referred to in paragraph 1 when it has classified an animal or a group of animals as a confirmed case of these diseases in accordance with Article 9(2).
Article 9
Case definitions
1. The competent authority shall classify an animal or a group of animals as a suspected case of a listed disease or of an emerging disease when:
(a) |
clinical, post-mortem or laboratory examinations conclude that clinical sign(s), post-mortem lesion(s) or histological findings are indicative of that disease; |
(b) |
result(s) from a diagnostic method are indicating the likely presence of the disease in a sample from an animal or from a group of animals; or |
(c) |
an epidemiological link with a confirmed case has been established. |
2. The competent authority shall classify an animal or a group of animals, as a confirmed case of a listed disease or of an emerging disease when:
(a) |
the disease agent, excluding vaccine strains, has been isolated in a sample from an animal or from a group of animals; |
(b) |
an antigen or nucleic acid specific to the disease agent that is not a consequence of vaccination has been identified in a sample from an animal or from a group of animals showing clinical signs consistent with the disease or an epidemiological link with a suspected or confirmed case; or |
(c) |
a positive result from an indirect diagnostic method that is not a consequence of vaccination has been obtained in a sample from an animal or from a group of animals showing clinical signs consistent with the disease or an epidemiological link with a suspected or confirmed case. |
3. Disease specific definitions of a suspected case and a confirmed case of listed diseases are laid down for terrestrial animals in Annex I and for aquatic animals in point 3 of Section 5 of Chapters 1 to 6 of Part II of Annex VI.
4. In the absence of disease specific definitions as provided for in paragraph 3, the criteria laid down in paragraphs 1 and 2 shall apply to definitions of a suspected case and a confirmed case of listed diseases and, if relevant, emerging diseases.
Article 10
Criteria for and contents of Union surveillance programmes
1. A category E disease shall be subject to a Union surveillance programme in accordance with Article 28 of Regulation (EU) 2016/429 if it meets all of the following criteria:
(a) |
it poses a particular threat to animal and possibly human health on the whole Union territory with possible serious economic consequences for the farming community and the wider economy; |
(b) |
it is susceptible to an evolution of the disease profile, in particular with regard to the risk for human health and animal health; |
(c) |
infected wild animals pose a particular threat for the introduction of the disease into a part or the whole of the Union territory; |
(d) |
it is fundamental to obtain, through surveillance, regularly updated information on the evolution of its circulation and on the characterisation of the disease agent, to assess those risks and adapt risk mitigating measures accordingly. |
2. The competent authority shall implement Union surveillance programmes for the relevant disease in accordance with the contents set out in Annex II.
Article 11
Information to be included in the submission of and reporting on Union surveillance programmes
1. The competent authority shall, when submitting a Union surveillance programme, include in that submission at least the following information:
(a) |
description of the epidemiological situation of the disease before the date of the beginning of the implementation of the programme and data on the epidemiological evolution of the disease; |
(b) |
targeted animal population, epidemiological units and zones of the programme; |
(c) |
organisation of the competent authority, supervision of the implementation of the programme, official controls to be applied during the implementation of the programme and the role of all relevant operators, animal health professionals, veterinarians, animal health laboratories and other natural or legal persons concerned; |
(d) |
description and demarcation of the geographical and administrative areas in which the programme is to be implemented; |
(e) |
indicators to measure the progress of the programme; |
(f) |
diagnostic methods used, number of samples tested, frequency of testing and sampling patterns; |
(g) |
risk factors to be considered for the design of a risk-based targeted surveillance. |
2. The competent authority shall, when reporting on a Union surveillance programme, include in that report at least the following information:
(a) |
the description of the measures implemented and the results obtained based on the information referred to in point (b) and points (d) to (f) of paragraph 1; and |
(b) |
the results of the follow-up of the epidemiological evolution of the disease in case of a suspected or confirmed case. |
CHAPTER 2
Eradication programmes for category B and C diseases of terrestrial animals
Article 12
Disease control strategy for the eradication of category B and C diseases of terrestrial animals
1. The competent authority shall, when establishing a compulsory eradication programme for a category B disease or an optional eradication programme for a category C disease of terrestrial animals, base those programmes on a disease control strategy that includes for each disease:
(a) |
the territory and animal population covered by the eradication programme as provided for in Article 13(1); |
(b) |
the duration of the eradication programme as provided for in Article 15, including its final and intermediate targets as provided for in Article 14; and |
(c) |
the disease specific requirements laid down:
|
2. The competent authority may include in the eradication programme coordinated measures at its common land or coastal border with other Member States or third countries to ensure that the objectives of the programme are achieved and that the results will last.
Where such coordination has not been established, the competent authority shall include in the eradication programme, if feasible, effective risk mitigating measures, including intensified surveillance.
Article 13
Territorial scope and animal populations
1. The competent authority shall determine the scope of the eradication programme, including:
(a) |
the territory covered; and |
(b) |
the targeted animal population and, as necessary, additional animal populations. |
2. The territory covered by the eradication programme referred to in point (a) of paragraph 1 shall be:
(a) |
the entire territory of the Member State; or |
(b) |
one or several zones, provided that each zone corresponds to administrative unit(s) of at least 2 000 km2 and includes at least one of the regions established in accordance with Article 21 of Regulation (EU) 2016/429. |
3. By way of derogation from paragraph 2, the competent authority may define zones smaller than 2 000 km2 taking into account:
(a) |
a minimum surface not significantly lower than 2 000 km2; or |
(b) |
the existence of natural barriers relevant to the disease profile. |
Article 14
Final and intermediate targets
1. The competent authority shall include in the eradication programme qualitative and quantitative final targets that are covering all the disease specific requirements laid down in Article 72 for granting disease-free status.
2. The competent authority shall include in the eradication programme qualitative and quantitative intermediate annual or multiannual targets to reflect progress made towards the final targets. These intermediate targets shall include:
(a) |
all of the disease specific requirements referred to in paragraph 1; and |
(b) |
if necessary, additional requirements that are not included in the criteria for granting disease-free status to assess progress towards eradication. |
Article 15
Period of application
1. The competent authority shall include in the eradication programme the period of application taking into account the initial situation and the intermediate targets indicated in Article 14(2).
2. For category C diseases, the period of application of the eradication programme shall not exceed 6 years from the date of its initial approval by the Commission in accordance with Article 31(3) of Regulation (EU) 2016/429. In duly justified cases, the Commission may, upon request of Member States, extend the period of application of the eradication programme for an additional 6-year period.
Article 16
Disease control strategy based on the disease-free status at establishment level
1. The competent authority shall design the disease control strategy of an eradication programme with respect to the targeted animal population kept in establishments for the following diseases of terrestrial animals:
(a) |
infection with Brucella abortus, B. melitensis and B. suis; |
(b) |
infection with MTBC; |
(c) |
EBL; |
(d) |
IBR/IPV; |
(e) |
infection with ADV; |
(f) |
BVD. |
2. Disease control strategies of eradication programmes referred to in paragraph 1 shall be based on:
(a) |
the implementation of disease specific measures laid down in Articles 18 to 31 until all relevant establishments reach disease-free status; |
(b) |
the granting, suspension and withdrawal by the competent authority of the disease-free status of all relevant establishments; |
(c) |
the implementation of biosecurity and other risk mitigating measures; |
(d) |
the optional implementation of vaccination programmes. |
Article 17
Targeted and additional animal populations for eradication programmes for certain diseases
1. The competent authority shall apply a compulsory eradication programme to the following targeted animal populations:
(a) |
for infection with Brucella abortus, B. melitensis and B. suis, kept bovine animals, kept ovine animals and kept caprine animals; |
(b) |
for infection with MTBC, kept bovine animals. |
2. The competent authority shall apply the optional eradication programme to the following targeted animal populations:
(a) |
for EBL, kept bovine animals; |
(b) |
for IBR/IPV, kept bovine animals; |
(c) |
for infection with ADV, kept porcine animals; |
(d) |
for BVD, kept bovine animals. |
3. The competent authority shall include additional animal populations where it considers that such animals pose a significant risk to the health status of animals referred to in paragraphs 1 or 2.
Article 18
Obligations of operators with respect to eradication programmes for certain diseases
1. The operators of establishments where animals from the targeted animal populations referred to in Article 17 are kept, other than slaughterhouses, shall comply with the following general and disease specific requirements to obtain and maintain the disease-free status of the establishments:
(a) |
general requirements:
|
(b) |
disease specific requirements laid down in:
|
2. The operators of slaughterhouses, where animals from the targeted animal populations referred to in Article 17 are kept and slaughtered shall comply with the general requirements laid down in points (a)(i), (iv) and (v) of paragraph 1.
Article 19
Derogation with regard to granting disease-free status to establishments
By way of derogation from Article 18 and provided that the relevant targeted animal populations comply with the general requirements laid down in point (a) of Article 18(1), the competent authority may decide that the obligations of operators to obtain and maintain disease-free status laid down in Article 18(1) do not apply to operators of the following establishments:
(a) |
confined establishments; |
(b) |
establishments where animals are only kept for assembly operations; |
(c) |
establishments where animals are only kept for the purpose of animal acts; |
(d) |
travelling circuses. |
Article 20
Obligation of the competent authority to grant, suspend and withdraw disease-free status
1. The competent authority shall grant disease-free status at establishment level according to the compliance of the establishments’ operators with the requirements laid down in Article 18.
2. The competent authority shall suspend or withdraw disease-free status at establishment level when the conditions for suspension or withdrawal have been met. Those conditions are laid down in:
(a) |
Sections 3 and 4 of Chapters 1 and 2 of Part I of Annex IV for infection with Brucella abortus, B. melitensis and B. suis; |
(b) |
Sections 3 and 4 of Chapter 1 of Part II of Annex IV for infection with MTBC; |
(c) |
Sections 3 and 4 of Chapter 1 of Part III of Annex IV for EBL; |
(d) |
Sections 3 and 4 of Chapter 1 of Part IV of Annex IV for IBR/IPV; |
(e) |
Sections 3 and 4 of Chapter 1 of Part V of Annex IV for infection with ADV; |
(f) |
Sections 3 and 4 of Chapter 1 of Part VI of Annex IV for BVD. |
3. The competent authority shall specify:
(a) |
the details of the testing regime, including as necessary, the disease specific requirements referred to in point (b) of Article 18(1) when the disease-free status is suspended or withdrawn; and |
(b) |
the maximum period of time during which disease-free status may be suspended where there is a breach of the conditions referred to in paragraph 2. |
4. The competent authority may attribute distinct health status to different epidemiological units of the same establishment provided that its operator:
(a) |
has submitted for the consideration of the competent authority the information about the different epidemiological units established within the establishment to be granted distinct health status prior to any suspicion or confirmation of the disease in accordance with Articles 21 and 24; |
(b) |
has set up a system, to which the competent authority has access upon request, to trace the movements of animals and germinal products to, from and between the epidemiological units; and |
(c) |
has separated the epidemiological units by physical and management means and complies with any risk mitigating measures requested by the competent authority for that purpose. |
Article 21
Disease control measures in the event of suspicion of certain diseases
1. The competent authority shall, when it suspects a case of the relevant disease, conduct investigations, initiate an epidemiological enquiry and suspend the disease-free status of the establishment where the suspected case occurred until the investigations and the epidemiological enquiry are concluded.
2. Pending the outcome of the investigations and the epidemiological enquiry referred to in paragraph 1, the competent authority:
(a) |
shall prohibit movement of animals from the relevant targeted animal population out of the establishment unless it has authorised their immediate slaughter in a designated slaughterhouse; |
(b) |
shall, when it considers it necessary for the control of the risk of spreading the disease:
|
3. The competent authority shall maintain the measures referred to in paragraphs 1 and 2 until the presence of the disease has been ruled out or confirmed.
Article 22
Extension of disease control measures in the event of suspicion of certain diseases
1. The competent authority shall, when it considers it necessary, extend the measures laid down in Article 21 to:
(a) |
relevant additional animal populations kept in the establishment; |
(b) |
any establishment which has an epidemiological link with the establishment where the suspected case occurred. |
2. If the presence of the disease is suspected in wild animals, the competent authority shall, when it considers it necessary, extend to the establishments that are at risk of infection the measures laid down in Article 21.
Article 23
Derogations from disease control measures in the event of suspicion of certain diseases
1. By way of derogation from Article 21(1), based on duly justified grounds, the competent authority may decide not to suspend the disease-free status of the whole establishment when there are different epidemiological units as referred to in Article 20(4).
2. By way of derogation from point (a) of Article 21(2), the competent authority may authorise movement of animals from the relevant targeted animal population to an establishment under its official supervision provided that the following requirements are complied with:
(a) |
the animals shall only be moved by direct transport; |
(b) |
in the establishment of destination, the animals shall be kept in closed facilities, with no contact with kept animals of a higher health status or with wild animals of listed species for the relevant disease. |
3. By way of derogation from point (a) of Article 21(2), in the case of a category C disease, the competent authority may authorise movement of animals from the relevant targeted animal population provided that they are moved, if necessary by direct transport, to an establishment located in an area that is neither disease-free nor covered by an optional eradication programme.
4. When making use of the derogation laid down in paragraph 2, the competent authority shall:
(a) |
suspend the disease-free status of the establishment of destination of the animals that are subject to the derogations, until the end of the investigations referred to in Article 21(1); |
(b) |
prohibit, until the end of the investigations referred to in Article 21(1), the movement of animals from that establishment, unless it has authorised their direct transport to a designated slaughterhouse for immediate slaughter; |
(c) |
in case of suspicion of infection with Brucella abortus, B. melitensis and B. suis or with MTBC, maintain the prohibition laid down in point (b) after the end of the investigation until all the animals that moved in the establishment following the derogation laid down in paragraph 2 have been slaughtered. |
5. The competent authority may use the derogations provided for in paragraphs 1 to 3 only if operators of establishments of origin and of destination and transporters of the animals that are subject to the derogations:
(a) |
apply appropriate biosecurity and other risk mitigating measures necessary to prevent the spread of the disease; and |
(b) |
provide the competent authority with guarantees that all the necessary biosecurity and other risk mitigating measures have been taken. |
Article 24
Official confirmation of certain diseases and disease control measures
1. If a case is confirmed, the competent authority shall:
(a) |
withdraw the disease-free status of the infected establishment(s); |
(b) |
adopt the measures laid down in Articles 25 to 31 in the infected establishment(s). |
2. By way of derogation from point (a) of paragraph 1, the competent authority may limit the withdrawal of the disease-free status to the epidemiological units where a case was confirmed.
3. If the disease is confirmed in wild animals, the competent authority shall conduct, if necessary, an epidemiological enquiry and investigations as provided for in Article 25. If it considers it necessary in order to prevent the spread of the disease, it shall:
(a) |
order relevant disease control measures as provided for in Articles 21 to 25 and in Article 30 in establishments keeping the targeted animal population and the additional animal populations; |
(b) |
conduct or order other proportionate and necessary prevention, surveillance and disease control measures with respect to the relevant wild animal population or in its habitat. |
Article 25
Epidemiological enquiry and investigations in case of confirmation of certain diseases
1. When the disease is confirmed, the competent authority shall:
(a) |
conduct an epidemiological enquiry; |
(b) |
conduct investigations and apply the measures laid down in Article 21 in all epidemiologically linked establishments; and |
(c) |
adapt the surveillance to the identified risk factors, taking into account the conclusions of the epidemiological enquiry. |
2. The competent authority shall consider the need to conduct an investigation on wild animals from additional animal populations where the epidemiological enquiry reveals epidemiological links between kept and wild animals.
3. The competent authority shall as soon as possible inform about the situation:
(a) |
operators and relevant authorities from the Member States concerned by the epidemiological links with the confirmed case; and |
(b) |
the competent authorities from other Member States or third countries that may be concerned by the epidemiological links with the infected establishment(s). |
Article 26
Movement of animals to or from infected establishments
1. The competent authority shall prohibit movements of animals from targeted animal population out of the infected establishment unless it has authorised their immediate slaughter in a designated slaughterhouse.
2. When the competent authority considers it necessary in order to prevent the spread of the disease, it shall:
(a) |
order the isolation of the suspected and confirmed cases in the establishment where technically possible; |
(b) |
restrict the movements of animals from targeted animal population within the establishment; |
(c) |
restrict the introduction of animals from targeted animal population in the establishment; |
(d) |
restrict the movement of products of animals from targeted animal population from and to the infected establishment. |
3. The competent authority shall, when it considers it necessary, extend the measures in paragraphs 1 and 2 to animals and products from additional animal populations to prevent the spread of the disease.
Article 27
Testing and removal of animals from infected establishments
1. Following confirmation of the disease, the competent authority shall order that in infected establishments the following testing is conducted within a maximum period of time to be determined by it:
(a) |
testing of those animals whose testing is considered necessary to complete the epidemiological enquiry; |
(b) |
testing to restore the disease-free status as laid down in:
|
(c) |
any additional testing it considers necessary to ensure the swift detection of infected animals that may contribute to the spreading of the disease. |
2. By way of derogation from point (b) of paragraph 1, testing shall not be ordered when disease-free status is restored in accordance with:
(i) |
point 2 of Section 1 of Chapters 1 and 2 of Part I of Annex IV for infection with Brucella abortus, B. melitensis and B. suis; |
(ii) |
point 2 of Section 1 of Chapter 1 of Part II of Annex IV for infection with MTBC; |
(iii) |
point 2 of Section 1 of Chapter 1 of Part III of Annex IV for EBL; |
(iv) |
point 2 of Section 1 of Chapter 1 of Part IV of Annex IV for IBR/IPV; |
(v) |
point 2 of Section 1 of Chapter 1 of Part V of Annex IV for infection with ADV; |
(vi) |
point 2 of Section 1 of Chapter 1 of Part VI of Annex IV for BVD. |
3. The competent authority shall order that in infected establishments all animals recognised as confirmed cases and, if necessary, as suspected cases are slaughtered within a maximum period of time it determines.
4. The slaughtering of the animals referred to in paragraph 3 shall be carried out under official supervision in a designated slaughterhouse.
5. The competent authority may order the killing and destruction of some or all of the animals referred to in paragraph 3 instead of their slaughtering.
6. The competent authority shall extend the measures laid down in this Article to animals from additional animal populations when this is necessary to eradicate the disease in the infected establishments.
Article 28
Management of products from infected establishments
1. The competent authority shall in all establishments infected with Brucella abortus, B. melitensis and B. suis or with MTBC, order that:
(a) |
milk from confirmed cases shall either be fed only to animals in the same establishment after it has been processed to ensure the inactivation of the disease agent, or it shall be disposed of; |
(b) |
manure, straw, feed or any other matter and substance which has come into contact with a confirmed case or with contaminated material shall be either collected and disposed of as soon as possible or, following an appropriate risk assessment, stored and processed to reduce to an acceptable level the risk of spreading of the disease. |
2. In the event of infection with Brucella abortus, B. melitensis and B. suis, the competent authority shall order that in all infected establishments foetuses, still-born animals, animals which have died from the disease after birth and placentae shall be collected and disposed of.
3. In the event of infection with a category C disease, the competent authority shall when it considers it necessary, order any appropriate measures provided for paragraphs 1 and 2.
4. The competent authority shall, when it considers it necessary, order the trace-back, the processing or the disposal of any products from infected establishments that may constitute a risk of spreading the disease or affect human health.
Article 29
Derogations from the restriction of movement of animals from infected establishments
1. By way of derogation from Article 26(1), the competent authority may authorise movement of clinically healthy animals, other than confirmed cases, to an establishment under its official supervision provided that the following requirements are complied with:
(a) |
the movement does not jeopardise the health status of animals at the establishment of destination or enroute to that destination; |
(b) |
the animals shall only be moved by direct transport; and |
(c) |
in the establishment of destination, the animals shall be kept, in closed facilities, with no contact with kept animals of a higher health status or with wild animals of listed species for the relevant disease. |
2. By way of derogation from Article 26(1) in the case of a category C disease, the competent authority may authorise movement of clinically healthy animals from the relevant targeted animal population, other than confirmed cases, provided that:
(a) |
they are moved, if necessary by direct transport, to an establishment located in an area that is neither disease-free nor covered by an optional eradication programme; and |
(b) |
the movement does not jeopardise the health status of targeted or additional animal populations at the establishment of destination or enroute to that destination. |
3. When making use of the derogation laid down in paragraph 1, the competent authority shall withdraw the disease-free status of the establishment of destination of the animals that are subject to the derogation and shall:
(a) |
order the movement of the animals by direct transport, within a maximum period of time it determines, from the establishment of destination to a designated slaughterhouse for immediate slaughter; or |
(b) |
in case of a category C disease order the disease control measures laid down in Articles 26 to 30 until the disease-free status of the establishment is regained. |
4. The competent authority may use the derogations provided for in paragraphs 1 and 2 only if operators of establishments of origin and of destination and transporters of the animals that are subject to the derogations:
(a) |
apply appropriate biosecurity and other risk mitigating measures necessary to prevent the spread of the disease; and |
(b) |
provide the competent authority with the guarantees that all the necessary biosecurity and other risk mitigating measures have been taken. |
Article 30
Cleaning and disinfection and other measures to prevent the spread of infection
1. The competent authority shall order the operators of all infected establishments and those receiving animals from infected establishments the cleaning and disinfection or, where relevant, the safe disposal of:
(a) |
all parts of the establishments that may have been contaminated after the removal of the confirmed and suspected cases and before repopulation; |
(b) |
any feed, materials, substances, husbandry related equipment, medicinal equipment and production related equipment that may have been contaminated; |
(c) |
any protective clothing or safety equipment used by operators and visitors; |
(d) |
all means of transport, containers and equipment after the transport of animals or products from infected establishments; |
(e) |
loading areas for animals after each use. |
2. The competent authority shall approve the protocol for the cleaning and disinfection.
3. The competent authority shall supervise the cleaning and disinfection, or where relevant, the safe disposal and shall not restore or grant again disease-free status to the establishment until it considers that the cleaning and disinfection, or where relevant, the safe disposal, has been completed.
4. The competent authority may, based on a risk assessment, regard a pasture as contaminated and prohibit its use for kept animals of higher health status than that of the targeted animal population or, if epidemiologically relevant, additional animal populations, for a period of time sufficient to consider the risk of persistence of the disease agent to be negligible.
Article 31
Risk mitigating measures to prevent reinfection
Before or upon lifting of the disease control measures, the competent authority shall order proportionate risk mitigating measures to prevent the reinfection of the establishment taking into account relevant risk factors as indicated by the results of the epidemiological enquiry. These measures shall at least take account of:
(a) |
persistence of the disease agent in the environment or in wild animals; and |
(b) |
biosecurity measures that are adapted to the specificities of the establishment. |
Article 32
Disease control strategy of eradication programmes for infection with RABV
1. The competent authority shall, when establishing an eradication programme for infection with RABV, base it on a disease control strategy that includes:
(a) |
vaccination of the animals from the targeted animal population that it considers relevant; |
(b) |
implementation of measures to reduce the risk of contact with infected animals; |
(c) |
control of the risk of spread and introduction of the disease in the territory of its Member State. |
2. The competent authority shall implement the eradication programme taking into account that it shall be:
(a) |
based on a risk assessment, updated, as necessary, according to the evolution of the epidemiological situation; |
(b) |
supported by public information campaigns involving all relevant stakeholders; |
(c) |
coordinated, if necessary, with relevant authorities in charge of public health, wild animal populations or hunting; |
(d) |
scaled according to a territorial risk-based approach. |
3. The competent authority may be involved in the implementation of eradication programmes for infection with RABV in a third country or territory, to prevent the risk of spread and introduction of RABV in the territory of its Member State.
Article 33
Targeted animal population for eradication programmes for infection with RABV
1. The competent authority shall apply the eradication programme for infection with RABV to the following targeted animal population: kept and wild animals of species of the following families: Carnivora, Bovidae, Suidae, Equidae, Cervidae and Camelidae.
2. The competent authority shall address the measures in the eradication programme primarily to wild foxes, being the main reservoir of RABV.
3. The competent authority shall subject other targeted animal populations than wild foxes to the measures of the eradication programme when it considers that such animals pose a significant risk.
4. The competent authority may include wild animals of species of the order Chiroptera in the targeted animal population relevant to surveillance referred to in Article 4.
Article 34
Obligations of the competent authority in the context of eradication programmes for infection with RABV
1. The competent authority shall:
(a) |
conduct surveillance of infection with RABV for the purposes of:
|
(b) |
carry out disease control measures in the event of suspicion or confirmation of infection with RABV as laid down in Articles 35 and 36; |
(c) |
apply, if necessary, risk mitigating measures to prevent the spread of RABV by movements of dogs, cats and ferrets. |
2. The competent authority shall, when it considers it necessary, order:
(a) |
vaccination, and the monitoring of the effectiveness of vaccination, in accordance with Section 2 of Chapter 1 of Part I of Annex V of wild foxes and, if relevant, of other animals referred to in Article 33(3); |
(b) |
the identification and registration of dogs, cats and ferrets; |
(c) |
movement restrictions of relevant kept animals of species referred to in Article 33(3) that are not vaccinated against infection with RABV in accordance with Section 1 of Chapter 1 of Part I of Annex V; |
(d) |
the measures provided for in Article 35 when an animal of a listed species wounded a person or an animal without an understandable reason and in contradiction with its normal behaviour or presented an unexplained change in behaviour followed by death within 10 days. |
Article 35
Disease control measures in the event of suspicion of infection with RABV
When infection with RABV is suspected, the competent authority shall:
(a) |
conduct further investigations to confirm or rule out the presence of the disease; |
(b) |
order relevant movement restrictions or killing of suspected cases to protect humans and animals against the risk of being infected pending the results of the investigations; |
(c) |
order any risk mitigating measures justified to reduce the risk of further transmission of RABV to humans or to animals. |
Article 36
Disease control measures in the event of confirmation of infection with RABV
When infection with RABV is confirmed, the competent authority shall take measures to prevent further transmission of the disease to animals and to humans, for which:
(a) |
it shall conduct an epidemiological enquiry, which shall include the identification of the RABV strain involved, to identify the likely source of the infection and epidemiological links; |
(b) |
it shall, unless it considers further investigations are necessary, rule out an infection with RABV in animals with an epidemiological link when:
|
(c) |
it shall, when it considers it necessary, take one or more of the measures laid down in Articles 34 and 35; |
(d) |
it shall ensure that carcasses of confirmed cases of infected wild animals are disposed of or processed in accordance with the rules laid down in Article 12 of Regulation (EC) No 1069/2009. |
Article 37
Disease control strategy of eradication programmes for infection with BTV
1. The competent authority shall, when establishing an optional eradication programme for infection with BTV, base the programme on a disease control strategy that includes:
(a) |
surveillance of infection with BTV in accordance with the requirements set out in Chapter 1 of Part II of Annex V; |
(b) |
vaccination of the relevant targeted animal population for eradicating the disease by means of regular vaccination campaigns to be implemented, as relevant, in accordance with a long-term strategy; |
(c) |
movement restrictions of the targeted animal population in accordance with the requirements laid down in Articles 43 and 45; |
(d) |
risk mitigating measures to minimise transmission of infection with BTV through vectors. |
2. The competent authority shall implement the eradication programme taking into account that:
(a) |
it shall detect and eradicate all the serotypes 1-24 present in the territory covered by the eradication programme; |
(b) |
the territory covered by the eradication programme shall be:
|
3. By way of derogation from point (b)(ii) of paragraph 2, the competent authority may adapt the zone(s) covered by the eradication programme in accordance with:
(a) |
the geographical situation of the infected establishment(s) and the boundaries of the corresponding administrative units; |
(b) |
the ecological and meteorological conditions; |
(c) |
the abundance, activity and distribution of the vectors present in the zone(s); |
(d) |
the BTV serotype involved; |
(e) |
the results of the epidemiological enquiry provided for in Article 42; |
(f) |
the results of the surveillance activities. |
Article 38
Targeted and additional animal populations for eradication programmes for infection with BTV
1. The competent authority shall apply the eradication programme for infection with BTV to the following targeted animal population: kept animals from species of families of Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Moschidae and Traguilidae.
2. The competent authority shall, when it considers it is necessary, apply the eradication programme to the following additional animal populations: wild animals from species of families of Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Moschidae and Traguilidae.
Article 39
Obligations of operators in the context of eradication programmes for infection with BTV
1. The operators of establishments, other than slaughterhouses, where animals from the targeted animal population referred to in Article 38(1) are kept shall:
(a) |
comply with the requirements ordered by the competent authority as regards the surveillance of animals from the targeted animal population; |
(b) |
comply with the requirements ordered by the competent authority as regards the entomological surveillance; |
(c) |
have animals from the targeted animal population vaccinated following the orders of the competent authority; |
(d) |
implement disease control measures in the event the disease is suspected or confirmed following the orders of the competent authority; |
(e) |
comply with movement requirements following the orders of the competent authority; |
(f) |
implement any additional measures considered necessary by the competent authority which may include, if relevant, protection of kept animals from attacks by vectors in accordance with the animals’ health status. |
2. The operators of slaughterhouses, where animals from the targeted animal population referred to in Article 38(1) are kept and slaughtered, shall:
(a) |
comply with the requirements ordered by the competent authority as regards the surveillance of animals from the targeted animal population; |
(b) |
implement disease control measures in the event the disease is suspected or confirmed following the orders of the competent authority; |
(c) |
implement any additional measures considered necessary by the competent authority which may include, if relevant, protection of kept animals from attacks by vectors in accordance with the animals’ health status. |
Article 40
Obligations of the competent authority in the context of eradication programmes for infection with BTV
1. The competent authority shall in the territory covered by an eradication programme for infection with BTV referred to in point (b) of Article 37(2):
(a) |
map the territory covered in a set of geographical units in accordance with point 1 of Section 4 of Chapter 1 of Part II of Annex V; |
(b) |
conduct surveillance of infection with BTV in each geographical unit, as relevant with regard to the epidemiological situation, according to the requirements laid down in Chapter 1 of Part II of Annex V; |
(c) |
apply the disease control measures laid down in Articles 41 and 42 in the event of suspicion or confirmation of the disease; |
(d) |
order operators of establishments of bovine, ovine or caprine animals and, if necessary, other targeted animal populations to have their animals vaccinated; and |
(e) |
apply the requirements laid down in Articles 43 and 45 to the movements of animals from the targeted animal population. |
2. By way of derogation from point (d) of paragraph 1, the competent authority may decide not to order operators to have their animals vaccinated if following a risk assessment, it duly justifies that the implementation of other measures is sufficient to eradicate the disease.
3. The competent authority shall, when it considers it necessary and if possible, establish a seasonally BTV-free area as provided for in Chapter 5 of Part II of Annex V. In that event, the competent authority shall make available to the Commission and to the other Member States:
(a) |
information demonstrating the fulfilment of the specific criteria for determining the seasonally BTV-free period; |
(b) |
the start and end dates of the period; |
(c) |
information demonstrating the cessation of the transmission of BTV in the area; and |
(d) |
the delimitation of the area which complies with the minimum requirements laid down in Article 13. |
Article 41
Disease control measures in the event of suspicion of infection with BTV
1. In the event of suspicion of infection with BTV, the competent authority shall conduct an investigation to confirm or rule out the disease.
2. Pending the outcome of the investigation referred to in paragraph 1, the competent authority shall:
(a) |
restrict movement of animals and germinal products from the targeted animal population from the establishment where they are kept unless authorised for the purpose of immediate slaughter; |
(b) |
order relevant risk mitigating measures, when necessary and technically feasible, to prevent or reduce exposure of animals from the targeted animal population to attacks by vectors. |
3. The competent authority shall, when it considers it necessary, extend the measures provided for in paragraphs 1 and 2 to establishments where animals from the targeted animal population had a similar exposure to infectious vectors to that of the suspected cases.
4. The measures provided for in this Article may be withdrawn when the competent authority considers that they are no longer necessary to limit the risk of spreading the disease.
Article 42
Disease control measures in the event of confirmation of infection with BTV
1. In the event of confirmation of infection with BTV, the competent authority shall:
(a) |
confirm the outbreak and, if necessary, establish or extend the zone under eradication programme; |
(b) |
conduct an epidemiological enquiry, if necessary; |
(c) |
restrict movement of animals of the targeted animal population from the establishment where they are kept unless authorised for the purpose of immediate slaughter; |
(d) |
restrict movement of germinal products of animals from the targeted animal population from the establishment where they are kept; |
(e) |
order relevant risk mitigating measures, when it considers it necessary and technically feasible, to prevent or reduce exposure of animals from the targeted animal population to attacks by vectors; |
(f) |
apply the disease control measures provided for in Article 41 to all establishments having an epidemiological link with the confirmed case, including those keeping animals from the targeted animal population having a similar exposure to infectious vectors to that of the confirmed case. |
2. In addition to measures laid down in paragraph 1 and in order to prevent the disease from spreading, the competent authority shall, when it considers it necessary:
(a) |
order operators of establishments of bovine, ovine or caprine animals and, if necessary, other targeted animal populations to have their animals vaccinated against the infection with the relevant BTV serotype(s) as provided for in point (d) of Article 40(1); |
(b) |
investigate and monitor the health status of the targeted animal population in the proximity of the establishment where the confirmed case is kept. |
3. The measures provided for in this Article may be withdrawn when the competent authority considers that they are no longer necessary to limit the risk of spreading the disease.
Article 43
Movement of kept animals and germinal products from the targeted animal population to Member States or zones covered by eradication programmes for infection with BTV
1. The competent authority shall only authorise the introduction of animals from the targeted animal population in the territory covered by an eradication programme for infection with BTV referred to in point (b) of in Article 37(2) if they comply with at least one of the requirements set out in points 1 to 4 of Section 1 of Chapter 2 of Part II of Annex V.
2. By way of derogation from paragraph 1, the competent authority may also authorise the introduction of animals from the targeted animal population in the territory covered by the eradication programme for infection with BTV if:
(a) |
it has assessed the risk that the introduction poses to the health status of the place of destination as regards infection with BTV, taking into account possible risk mitigating measures it may adopt at the place of destination; |
(b) |
it prohibits the movement of these animals to another Member State:
|
(c) |
it adapts, if necessary, the surveillance in accordance with point 6 of Section 4 of Chapter 1 of Part II of Annex V; and |
(d) |
the animals comply with any one of the requirements set out in points 5 to 8 of Section 1 of Chapter 2 of Part II of Annex V. |
3. The competent authority shall only authorise the introduction of germinal products from the targeted animal population in the territory covered by an eradication programme for infection with BTV referred to in point (b) of Article 37(2) if they comply with at least one of the requirements set out in points 1 to 3 of Section 2 of Chapter 2 of Part II of Annex V.
4. By way of derogation from paragraph 3, the competent authority may also authorise the introduction of germinal products from the targeted animal population in the territory covered by an eradication programme for infection with BTV if:
(a) |
it has assessed the risk that the introduction poses to the health status of the place of destination as regards infection with BTV, taking into account possible risk mitigating measures it may adopt at the place of destination; |
(b) |
it prohibits the movement of these germinal products to another Member State; and |
(c) |
the germinal products comply with the requirements set out in point 4 of Section 2 of Chapter 2 of Part II of Annex V. |
5. When the competent authority receiving the animals or the germinal products uses the derogations provided for in paragraphs 2 or 4, it shall:
(a) |
inform the Commission thereof as soon as possible; |
(b) |
accept animals or germinal products from the targeted animal population that comply with the requirements for the relevant derogation regardless of the Member State or zone of origin of the animal or germinal products. |
6. When the competent authority receiving the animals or the germinal products no longer uses the derogations provided for in paragraphs 2 or 4, it shall inform the Commission as soon as possible.
Article 44
Vector protected establishment
1. The competent authority may, upon request by the operator, grant the status ‘vector protected establishment’ to establishments or facilities complying with the criteria laid down in Chapter 3 of Part II of Annex V.
2. The competent authority shall verify at the appropriate frequency, but at least at the beginning, during and at the end of the required protection period, the effectiveness of the measures carried out by means of a vector trap inside the establishment.
3. The competent authority shall immediately withdraw the status vector protected establishment when the conditions referred to in paragraph 1 are no longer complied with.
Article 45
Movement of animals through Member States or zones covered by eradication programmes for infection with BTV
1. The competent authority shall only authorise movement of animals from the targeted animal population through the territory covered by an eradication programme for infection with BTV referred to in point (b) of Article 37(2) if:
(a) |
the animals from the targeted animal population comply with at least one of the requirements set out in points 1 to 3 of Section 1 of Chapter 2 of Part II of Annex V; or |
(b) |
the means of transport onto which the animals are loaded have been protected from attacks by vectors and the journey does not include the unloading of the animals for a period longer than 1 day, or the animals are unloaded for a period longer than 1 day in a vector protected establishment or during the vector-free period. |
2. By way of derogation from paragraph 1, the competent authority may also authorise the movement of animals from targeted animal population through the territory covered by an eradication programme for infection with BTV if the requirements laid down in points (a), (c) and (d) of Article 43(2) are complied with.
CHAPTER 3
Eradication programmes for category B and C diseases of aquatic animals
Article 46
Disease control strategy for the eradication of category B and C diseases of aquatic animals
1. The competent authority shall, when establishing a compulsory eradication programme for a category B disease or an optional eradication programme for a category C disease of aquatic animals, base those programmes on a disease control strategy that includes for each disease:
(a) |
the type of surveillance requirements necessary to achieve the conditions for granting and maintaining disease-free status taking into account point (b)(ii) of Article 3(2); |
(b) |
the territory and animal population covered by the eradication programme as provided for in Articles 47 and 51; |
(c) |
the duration of the eradication programme provided for in Article 49 including its final and intermediate targets as provided for in Article 48; |
(d) |
the disease specific preventive and control measures laid down in Articles 55 to 65. |
2. The competent authority may include in the eradication programme coordinated measures at its common land or coastal border with other Member States or third countries to ensure that the objective of the programmes are achieved and will last.
Where such coordination has not been established, the competent authority shall include in the eradication programme, if feasible, effective risk mitigating measures including intensified surveillance.
Article 47
Territorial scope and animal population
1. The competent authority shall determine the scope of the eradication programme including:
(a) |
the territory covered; and |
(b) |
the targeted animal population and, if necessary, additional animal populations. |
2. The territory covered by the eradication programme referred to in point (a) of paragraph 1 may be:
(a) |
the entire territory of the Member State; |
(b) |
one or several zones; or |
(c) |
the geographical location of the establishments of which the compartment or compartments are comprised. |
3. All establishments located within the Member State, zone or compartment covered by the eradication programme shall be included in the eradication programme.
4. By way of derogation from paragraph 3 the competent authority may exclude from the eradication programme, aquaculture establishments which do not pose a significant risk to the success of that programme and which are exempted from the obligation to apply for approval.
Article 48
Final and intermediate targets
1. The competent authority shall include in the eradication programme qualitative and quantitative final targets that cover all the disease specific requirements laid down in Article 72 for granting disease-free status.
2. Where this is technically possible, the competent authority implementing an eradication programme shall also include in that programme qualitative and quantitative final targets based on the health status of wild animal populations that constitute a threat to the achievement of disease-free status.
3. The competent authority shall include in the eradication programme qualitative and quantitative intermediate annual or multiannual targets to reflect progress made towards the final targets. These intermediate targets shall include:
(a) |
all of the disease specific requirements referred to in paragraph 1 and the targets provided for in paragraph 2; and |
(b) |
if necessary, additional requirements that are not included in the requirements for granting disease-free status to assess progress towards eradication. |
Article 49
Period of application
1. The period of application of eradication programmes for listed aquatic animal diseases are laid down in Part II of Annex VI, specifically Sections 2 and 3 of:
(a) |
Chapter 1 for VHS and IHN; |
(b) |
Chapter 2 for infection with HPR-deleted ISAV; |
(c) |
Chapter 3 for infection with Marteilia refringens; |
(d) |
Chapter 4 for infection with Bonamia exitiosa; |
(e) |
Chapter 5 for infection with Bonamia ostreae; |
(f) |
Chapter 6 for infection with WSSV. |
2. For category C diseases, the period of application of an eradication programme shall not exceed 6 years from the date of its initial approval by the Commission in accordance with Article 31(3) of Regulation (EU) 2016/429. In duly justified cases, the Commission may, upon request of Member States, extend the period of application of the eradication programme for an additional 6-year period.
Article 50
Minimum requirements for an eradication programme
The competent authority shall base the eradication programme for a specific category B or C disease in a Member State, zone, or compartment on:
(a) |
the determination of the health status of the Member State, zone or compartment by ascertaining the health status of all establishments where animals from the listed species are kept; |
(b) |
the implementation of disease control measures in all establishments where suspected and confirmed cases are detected; |
(c) |
the implementation of biosecurity and other risk mitigating measures to reduce the risk of the listed species in an establishment becoming infected; |
(d) |
in certain cases, vaccination, as part of the eradication programme. |
Article 51
Animal population to be included in eradication programmes for category B and C diseases
1. The competent authority shall apply the eradication programme to listed species kept in establishments within the territory of the Member State, the zone or compartment.
2. By way of derogation from paragraph 1, the competent authority may decide to exclude from the eradication programme, based on a risk assessment, establishments keeping only vector species referred to in the table set out in the Annex to Implementing Regulation (EU) 2018/1882.
3. Where technically feasible, the competent authority shall include in the eradication programme additional animal populations when such animals:
(a) |
pose a significant risk to the health status of animals referred to in paragraph 1; |
(b) |
are included due to the small number of aquaculture establishments in the eradication programme and when their inclusion is necessary to obtain a satisfactory epidemiological coverage of the Member State, zone or compartment. |
Article 52
Measures to be taken in Member States, zones or compartments covered by eradication programmes
1. In order to monitor the progress of eradication programmes, the competent authority shall classify the health status of all establishments where animals from the listed species are kept according to:
(a) |
the health status of each establishment as known at the time the eradication programme commences; |
(b) |
the compliance with conditions for the introduction of animals from listed species into the establishment; |
(c) |
the compliance by the operator with the obligation to notify the competent authority of any suspicion or detection of the disease; |
(d) |
the fulfilment of disease control measures to be applied if the disease is suspected or confirmed; |
(e) |
the vaccination regimes that may apply to animals from listed species kept in the establishment; |
(f) |
any additional measures considered necessary by the competent authority. |
2. The competent authority shall:
(a) |
commence, maintain, or withdraw the eradication programme according to the compliance or non-compliance of establishments with the requirements laid down in paragraph 1; |
(b) |
inform the operators of the relevant establishments about the evolution of the health status and the necessary measures for granting disease-free status. |
3. Operators shall comply with the requirements set out in points (b) to (f) of paragraph 1 so that the eradication programme can be implemented until such time as it has been successfully completed or is withdrawn.
Article 53
Derogation from classification of the health status of confined establishments
By way of derogation from Article 52(1), the competent authority may decide not to classify the health status of confined establishments, if the animal population kept in these confined establishments is subjected to appropriate risk mitigating measures and disease control measures to ensure that it does not constitute a risk of spreading the disease.
Article 54
Vaccination
The competent authority may, include in eradication programmes under its official supervision:
(a) |
vaccination of listed species; |
(b) |
vaccination of an additional animal population of kept animals; |
(c) |
vaccination of an additional animal population of wild animals. |
Article 55
Disease control measures in the event of suspicion of certain diseases
1. The competent authority shall, when it suspects a case of the relevant disease in an establishment, conduct the necessary investigation.
2. Pending the outcome of the investigation referred to in paragraph 1, the competent authority shall:
(a) |
prohibit the introduction of animals or products of animal origin into the establishment; |
(b) |
where technically possible, order the isolation of units in the establishment where suspected animals are kept; |
(c) |
prohibit the movement of animals and products of animal origin out of the establishment unless authorised by the competent authority for the purpose of immediate slaughter or processing in a disease control aquatic food establishment, or for direct human consumption in the case of molluscs or crustacea which are sold live for that purpose; |
(d) |
prohibit the movement of equipment, feed and animal by-products from the establishment unless authorised by the competent authority. |
3. The competent authority shall maintain the measures referred to in paragraphs 1 and 2 until the presence of the disease has been ruled out or confirmed.
Article 56
Extension of disease control measures in the event of suspicion of certain diseases
1. The competent authority shall, when it considers it necessary, extend the measures laid down in Article 55 to:
(a) |
any establishment which due to hydrodynamic conditions, has an increased risk of contracting the disease from the suspected establishment; |
(b) |
any establishment which has a direct epidemiological link with the suspected establishment. |
2. If the presence of the disease is suspected in wild aquatic animals, the competent authority shall, when it considers it necessary, extend the measures laid down in Article 55 to the concerned establishments.
Article 57
Derogation from disease control measures in the event of suspicion of disease
1. By way of derogation from point (c) of Article 55(2) the competent authority may authorise the movement of aquaculture animals to an establishment under its official supervision provided that the following requirements are complied with:
(a) |
only animals showing no symptoms of disease are moved; |
(b) |
the health status of aquaculture animals at the establishment of destination or aquatic animals enroute to that establishment is not jeopardised by the movement; |
(c) |
in the establishment of destination they have no contact with aquaculture animals of a higher health status with respect to the relevant disease; and |
(d) |
the animals are kept in the establishment of destination for a maximum period of time to be determined by the competent authority. |
2. When making use of the derogation laid down in paragraph 1, the competent authority shall:
(a) |
re-classify the health status of the establishment of destination, if relevant, in accordance with the criteria laid down in Article 52(1), until the end of the investigation referred to in Article 55(1); |
(b) |
prohibit the movement of animals from the establishment of destination until the end of the investigation, unless it has authorised their transport to a disease control aquatic food establishment for immediate slaughter or processing or for direct human consumption, in the case of molluscs or crustacea which are sold live for that purpose. |
3. The competent authority may use the derogation provided for in paragraph 1 only if operators of establishments of origin and of destination and transporters of the animals that are subject to the derogation:
(a) |
apply appropriate biosecurity and other risk mitigating measures necessary to prevent the spread of the disease; |
(b) |
provide the competent authority with guarantees that all the necessary biosecurity and other risk mitigating measures have been taken; and |
(c) |
provide the competent authority with guarantees that animal by-products as defined in point (1) of Article 3 of Regulation (EC) No 1069/2009 from the aquatic animals referred to in paragraph 1(c) of this Article are processed or disposed of as Category 1 or Category 2 material in accordance with Articles 12 or 13 of that Regulation. |
Article 58
Official confirmation of certain diseases and disease control measures
1. If a case is confirmed, the competent authority shall:
(a) |
declare the establishment(s) infected; |
(b) |
reclassify the health status of the infected establishment(s); |
(c) |
establish a restricted zone which is of an appropriate size; |
(d) |
adopt the measures laid down in Articles 59 to 65 in the infected establishment(s). |
2. The minimum requirements that shall apply with regard to the establishment(s) of the restricted zone are set out in Part II of Annex VI, specifically in:
(a) |
point 1(a) of Section 3 of Chapter 1 for VHS and IHN; |
(b) |
point 1(a) of Section 3 of Chapter 2 for infection with HPR-deleted ISAV; |
(c) |
point 1(a) of Section 3 of Chapter 3 for infection with Marteilia refringens; |
(d) |
point 1(a) of Section 3 of Chapter 4 for infection with Bonamia exitiosa; |
(e) |
point 1(a) of Section 3 of Chapter 5 for infection with Bonamia ostreae; |
(f) |
point 1(a) of Section 3 of Chapter 6 for infection with WSSV. |
3. By way of derogation from point (c) of paragraph 1, the competent authority may decide not to establish a restricted zone:
(a) |
when an infected establishment does not discharge untreated effluent into surrounding waters; and |
(b) |
where the biosecurity measures which exist at the establishment are of a standard which ensures that infection is fully contained within it. |
4. The competent authority may take risk mitigating measures relating to the following activities in the restricted zone:
(a) |
the movement of well-boats through the restricted zone; |
(b) |
fishing activities; |
(c) |
other activities that may pose a risk of disease spread. |
5. If the disease is confirmed in wild aquatic animals, the competent authority may:
(a) |
develop and implement the prevention, surveillance and disease control measures that are necessary to prevent the spread of the disease to kept animals of listed species or to additional animal populations; |
(b) |
apply intensified surveillance of wild aquatic animal populations and in establishments having a direct epidemiological link with the confirmed case; |
(c) |
take measures to eradicate the disease from the relevant wild aquatic animal population, where feasible. |
Article 59
Epidemiological enquiry and investigations in case of confirmation of certain diseases
1. When the disease is confirmed, the competent authority shall:
(a) |
conduct an epidemiological enquiry; |
(b) |
conduct investigations and apply the measures laid down in Article 55(2) in all epidemiologically linked establishments; |
(c) |
adapt the surveillance to the identified risk factors, taking into account the conclusions of the epidemiological enquiry. |
2. The competent authority shall consider the need to conduct an investigation on wild animals where the epidemiological enquiry reveals epidemiological links between kept and wild animals.
3. The competent authority shall as soon as possible inform:
(a) |
operators and relevant authorities from the Member State concerned by the epidemiological links with the confirmed case; and |
(b) |
the competent authorities from other Member States or third countries that may be concerned by the epidemiological links with the infected establishment(s). |
Article 60
Movements to or from an infected establishment and any other establishment located in the restricted zone
1. The competent authority shall in all infected establishment(s) and any other establishment(s) located in the restricted zone:
(a) |
where technically possible, order the isolation of suspected and confirmed cases; |
(b) |
prohibit the movement of animals or products of animal origin from the listed species for the relevant disease out of the establishment(s) unless authorised by the competent authority for immediate slaughter or processing in a disease control aquatic food establishment or for direct human consumption in the case of molluscs or crustacea which are sold live for that purpose; |
(c) |
prohibit the introduction of animals from the listed species for the relevant disease to the establishment(s) unless authorised by the competent authority on duly justified grounds; |
(d) |
prohibit the movement of equipment, feed and animal by-products from the establishment(s) unless authorised by the competent authority. |
2. The competent authority shall extend the measures in points (a) to (c) of paragraph 1 to kept animals from additional animal populations if they present a risk of spreading the disease.
Article 61
Derogations from the restriction of movement of animals and products of animal origin from infected establishments
1. By way of derogation from point (b) Article 60(1), the competent authority may authorise the movement of aquaculture animals to an establishment under its official supervision located within the same restricted zone provided that:
(a) |
only animals showing no symptoms of disease are moved; |
(b) |
the health status of aquaculture animals at the establishment of destination or aquatic animals enroute to that establishment is not jeopardised by the movement; |
(c) |
in the establishment of destination they have no contact with aquaculture animals of a higher health status with respect to the relevant disease; |
(d) |
the animals are kept in the establishment of destination for a maximum period of time to be determined by the competent authority. |
2. When making use of the derogation laid down in paragraph 1, the competent authority shall:
(a) |
re-classify the health status of the establishment of destination, if relevant, in accordance with the criteria laid down in Article 52(1); |
(b) |
prohibit the movement of animals from the establishment of destination, unless it has authorised their transport to a disease control aquatic food establishment for immediate slaughter or processing or for direct human consumption, in the case of molluscs or crustacea which are sold live for that purpose. In all cases, animal by- products as defined in point (1) of Article 3 of Regulation (EC) No 1069/2009 shall be processed or disposed of as Category 1 or Category 2 material in accordance with Articles 12 or 13 of that Regulation. |
(c) |
keep the establishment of destination under its official supervision until the completion of cleaning, disinfection and appropriate fallowing of the establishment. |
3. By way of derogation from point (b) Article 60(1), the competent authority may authorise the movement of aquaculture animals to other infected establishments which are not implementing an eradication programme for that specific disease provided that:
(a) |
only animals showing no symptoms of disease are moved; |
(b) |
the health status of aquaculture animals at the establishment of destination or aquatic animals enroute to that establishment is not jeopardised by the movement; and |
(c) |
the movement complies with the certification requirements set out in Article 208(2) of Regulation (EU) 2016/429. |
4. By way of derogation from point (b) of Article 60(1), the competent authority may authorise the movement of aquaculture animals and products of animal origin to slaughtering and processing facilities other than disease control aquatic food establishments provided that:
(a) |
only animals showing no symptoms of disease are moved; |
(b) |
the slaughtering and processing facility is not located in a Member State, zone or compartment which is implementing an eradication programme for that specific disease or which has been declared disease-free; |
(c) |
the health status of aquatic animals enroute for the slaughtering and processing facility or in its vicinity is not jeopardised by the movement; |
(d) |
the movement complies with the certification requirements set out in Article 208(2) of Regulation (EU) 2016/429. |
5. By way of derogation from point (b) of Article 60(1), the competent authority may authorise the movement of animals and products of animal origin from additional animal populations from the infected establishment(s) to other establishments without further restrictions provided that:
(a) |
a risk assessment has been completed; |
(b) |
risk mitigating measures are implemented, where necessary, to ensure that the health status of the aquatic animals at the establishment of destination or enroute to that destination is not jeopardised; and |
(c) |
the movement complies with the certification requirements set out in Article 208(2) of Regulation (EU) 2016/429. |
Article 62
Removal of infected animals
1. Following confirmation of the disease, the competent authority shall in all infected establishments order, within a maximum period of time to be determined by the competent authority, the following measures in relation to aquatic animals from listed species for the relevant disease:
(a) |
removal of all dead animals; |
(b) |
removal and killing of all moribund animals; |
(c) |
removal and killing of all animals showing symptoms of disease; |
(d) |
slaughtering for human consumption, or in the case of molluscs or crustacea which are sold live, removal from the water of the animals that remain at the establishment(s) after the measures in points (a) to (c) have been completed. |
2. The competent authority may order, based on duly justified grounds, the slaughtering for human consumption, or in the case of molluscs or crustacea which are sold live, removal from the water of:
(a) |
all animals from listed species for the relevant disease in the infected establishment(s), without testing these animals; |
(b) |
suspected animals which have an epidemiological link with a confirmed case. |
3. Slaughtering for human consumption or removal from the water of the animals referred to in paragraph 1 shall be carried out under official supervision either in the infected establishment(s) with subsequent processing in a disease control aquatic food establishment, or in a disease control aquatic food establishment, as appropriate.
4. The competent authority shall extend the measures laid down in this Article to aquaculture animals of additional animal populations when it is necessary to control the disease.
5. The competent authority may order the killing and destruction of some or all the animals referred to in paragraph 1 and animals of non-listed species in the infected establishment(s) instead of their slaughter for human consumption.
6. All animal by-products from animals that are slaughtered or killed in compliance with this Article shall be processed or disposed of as Category 1 or Category 2 material in accordance with Articles 12 or 13 of Regulation (EC) No 1069/2009.
Article 63
Cleaning and disinfection
1. The competent authority shall for all infected establishments order the cleaning and disinfection of the following structures and items prior to repopulation:
(a) |
the establishments, in so far as this is technically possible, after the removal of the animals referred to in Article 62(1) and of all feed that may have been contaminated; |
(b) |
any husbandry related equipment including but not limited to feeding, grading, treatment and vaccination equipment, and workboats; |
(c) |
any production related equipment including but not limited to cages, netting, trestles, bags and longlines; |
(d) |
any protective clothing or safety equipment used by operators and visitors; |
(e) |
all means of transport including tanks and other equipment used to move infected animals or personnel who have been in contact with infected animals. |
2. The competent authority shall approve the protocol for the cleaning and disinfection.
3. The competent authority shall supervise the cleaning and disinfection and shall not restore or grant again disease-free status to the establishments until it considers that the cleaning and disinfection has been completed.
Article 64
Fallowing
1. The competent authority shall order the fallowing of all infected establishments. The fallowing shall be carried out following completion of the cleaning and disinfection process laid down in Article 63.
2. The duration of the fallowing shall be appropriate to the relevant pathogen and to the type of production system used in the infected establishments. Certain fallowing periods are laid down in Part II of Annex VI, specifically in:
(a) |
point 1(c) of Section 3 of Chapter 1 for VHS and IHN; |
(b) |
point 1(c) of Section 3 of Chapter 2 for infection with HPR-deleted ISAV; |
(c) |
point 1(c) of Section 3 of Chapter 3 for infection with Marteilia refringens; |
(d) |
point 1(c) of Section 3 of Chapter 4 for infection with Bonamia exitiosa; |
(e) |
point 1(c) of Section 3 of Chapter 5 for infection with Bonamia ostreae; |
(f) |
point 1(c) of Section 3 of Chapter 6 for infection with WSSV. |
3. The competent authority shall order synchronous fallowing of the infected establishments within the protection zone or where no protection zone has been established, within the restricted zone. Synchronous fallowing may also be extended to other establishments based on risk assessment. The duration of the synchronous fallowing and the extent of the area within which such fallowing shall take place are laid down in Part II of Annex VI, specifically in:
(a) |
point 1 of Section 3 of Chapter 1 for VHS and IHN; |
(b) |
point 1 of Section 3 of Chapter 2 for infection with HPR-deleted ISAV; |
(c) |
point 1 of Section 3 of Chapter 3 for infection with Marteilia refringens; |
(d) |
point 1 of Section 3 of Chapter 4 for infection with Bonamia exitiosa; |
(e) |
point 1 of Section 3 of Chapter 5 for infection with Bonamia ostreae; |
(f) |
point 1 of Section 3 of Chapter 6 for infection with WSSV. |
Article 65
Risk mitigating measures to prevent reinfection
Before or upon removal of the disease control measures, the competent authority shall order proportionate risk mitigating measures to prevent the reinfection of the establishment taking into account relevant risk factors as indicated by the results of the epidemiological enquiry. These measures shall at least take account of:
(a) |
persistence of the disease agent in the environment or in wild animals; |
(b) |
biosecurity measures that are adapted to the specificities of the establishment. |
CHAPTER 4
Disease-free status
Article 66
Criteria for the granting of disease-free status
Disease-free status may only be granted to Member States or zones thereof when the following general and specific criteria are complied with:
(a) |
general criteria:
|
(b) |
specific criteria for granting disease-free status based on Articles 67 to 71. |
Article 67
Disease-free status based on the absence of listed species
1. The criteria to recognise the disease-free status of a Member State or of a zone because of the absence of the listed species for that disease are as follows:
(a) |
the general criteria laid down in point (a)(i) and (a)(ii) of Article 66 have been fulfilled for an eligibility period of at least 5 years and the disease was not detected; and |
(b) |
the listed species relevant to the disease in question are absent from kept and wild animal populations. |
2. The Member State shall provide documentary evidence to substantiate the fulfilment of the criteria in paragraph 1. The documentary evidence shall demonstrate the sustainability of disease-free status considering that:
(a) |
the likelihood of the presence of animals from listed species in the Member State’s territory or a zone thereof was assessed and was found to be negligible; and |
(b) |
the likelihood of introduction of animals from listed species into the Member State’s territory or a zone thereof was found to be negligible. |
Article 68
Disease-free status based on the disease agent’s incapacity to survive
1. The criteria to recognise the disease-free status of a Member State or of a zone because of the disease agent’s incapacity to survive are as follows:
(a) |
the general criteria laid down in points (a)(i) and (a)(ii) of Article 66 have been fulfilled for an eligibility period of at least 5 years and the disease was not detected; |
(b) |
the disease has never been reported or, if reported, it has been demonstrated that the disease agent did not survive; |
(c) |
the value of at least one critical environmental parameter that is not compatible with the survival of the disease agent is reached; |
(d) |
the disease agent is exposed to that critical environmental parameter for a period of time that is sufficient to destroy it. |
2. The Member State shall provide the following evidence to substantiate the fulfilment of the criteria in paragraph 1:
(a) |
with respect to the fulfilment of the criteria set out in points (a) and (b) of paragraph 1, documentary evidence; |
(b) |
with respect to the fulfilment of the criteria set out in points (c) and (d) of paragraph 1, scientific evidence. |
Article 69
Disease-free status of terrestrial animals based on the incapacity to survive of listed vectors for listed diseases of terrestrial animals
1. The criteria to recognise the disease-free status of a Member State or of a zone because of the incapacity to survive of listed vectors for that listed disease are as follows:
(a) |
the general criteria laid down in points (a)(i) and (a)(ii) of Article 66 have been fulfilled for an eligibility period of at least 5 years and the disease was not detected; |
(b) |
the disease has never been reported, or, if reported, it has been demonstrated that the disease agent has not been transmitted; |
(c) |
the transmission of the disease agent is entirely dependent on the presence of listed vectors and no other mode of natural transmission is known to occur; |
(d) |
the listed vectors are not naturally present in the Member State or zones thereof; |
(e) |
the accidental or intentional introduction of listed vectors is unlikely to have occurred in the past or to occur in the future; |
(f) |
the value of at least one critical environmental parameter that is not compatible with the survival of the listed vectors is reached; |
(g) |
the listed vectors are exposed to that critical environmental parameter for a period of time that is sufficient to destroy it. |
2. The Member State shall provide the following evidence to substantiate the fulfilment of the criteria in paragraph 1:
(a) |
with respect to the fulfilment of the criteria set out in points (a) and (b) of paragraph 1, documentary evidence; |
(b) |
with respect to the fulfilment of the criteria set out in points (c) to (g) of paragraph 1, scientific evidence. |
If the disease has occurred, the Member State shall provide documentary evidence that surveillance has demonstrated with a 95 % level of confidence that the prevalence rate of the disease was lower than 1 %.
Article 70
Disease-free status based on historical and surveillance data
1. The criteria to recognise the disease-free status of a Member State or a zone thereof based on historical and surveillance data are as follows:
(a) |
the disease has never been reported in the Member State or in the zone thereof or it has been eradicated in the Member State or the zone thereof and not reported for at least 25 years; |
(b) |
the disease has been reported in the past 25 years, it has been eradicated from the Member State or zone thereof and the disease specific requirements referred to in Article 72 are complied with. |
2. A Member State wishing to obtain the approval of disease-free status for its entire territory or for a zone thereof on the basis of the provisions set out in point (a) of paragraph 1 shall have implemented the following measures for an eligibility period of at least 10 years:
(a) |
disease surveillance of kept animals of listed species; |
(b) |
prevention to control the introduction of the disease agent; |
(c) |
ban on vaccination against the disease unless it is compliant with the disease specific requirements referred to in Article 72; |
(d) |
disease surveillance substantiating the fact that the disease is not known to be established in wild animals from listed species within the Member State or zone. |
3. By way of derogation from point (b) of paragraph 1 the Commission may, for a period of two years following the entry of application of this Regulation, grant disease-free status to Member States or zones as regards:
(a) |
infection with RABV, if it was notifiable in accordance with Article 8 of Directive 64/432/EEC and, when necessary monitoring was implemented in accordance with Article 4 of Directive 2003/99/EC (23) of the European Parliament and of the Council, and no case was reported in listed animals species for the past two years; |
(b) |
infection with BTV, if all restricted zones have been lifted in accordance with Article 6 of Regulation (EC) No 1266/2007 before the date of application of this Regulation. |
4. The criteria provided for in paragraph 1 to obtain disease-free status shall only apply:
(a) |
in a new Member State, during a maximum period of two years following its accession to the Union; or |
(b) |
for a maximum period of two years following the date of application of the implementing acts adopted in accordance with Article 9(2) of Regulation (EU) 2016/429 that categorise for the first time the relevant disease as a category B or C disease. |
5. By way of derogation from paragraph 4, the granting of disease-free status based on historical and surveillance data shall not be subject to the maximum two-year period for the following statuses:
(a) |
status free from infestation with Varroa spp.; |
(b) |
status free from infection with Newcastle disease virus without vaccination. |
6. By way of derogation from point (b) of paragraph 4, the granting of disease-free status based on historical and surveillance data shall not apply to the following diseases:
(a) |
infection with Brucella abortus, B. melitensis and B. suis; |
(b) |
infection with MTBC; |
(c) |
EBL; |
(d) |
IBR/IPV; |
(e) |
infection with ADV; |
(f) |
VHS; |
(g) |
IHN; |
(h) |
infection with HPR-deleted ISAV; |
(i) |
infection with Bonamia ostreae; |
(j) |
infection with Marteilia refringens. |
Article 71
Disease-free status based on eradication programmes
1. The criteria to recognise the disease-free status of a Member State or a zone based on eradication programmes are as follows:
(a) |
the competent authority has been running an approved eradication programme as referred to in Articles 12 or 46; and |
(b) |
the competent authority has completed the eradication programme and submitted to the Commission an application for recognition of disease-free status that demonstrates that the disease specific requirements laid down in Article 72 are complied with. |
2. By way of derogation from paragraph 1, in the case of aquatic animals where a zone covers less than 75 % of the territory of a Member State and is not shared with another Member State or third country, disease-free status may be achieved in accordance with Article 83.
Article 72
Disease specific requirements for disease-free status
Disease specific requirements for the granting of disease-free status to a Member State or to a zone are provided in:
(a) |
Section 1 of Chapter 3 of Part I of Annex IV for status free from infection with Brucella abortus, B. melitensis and B. suis in kept bovine animals and Section 1 of Chapter 4 of Part I of Annex IV for status free from infection with Brucella abortus, B. melitensis and B. suis in kept ovine and caprine animals; |
(b) |
Section 1 of Chapter 2 of Part II of Annex IV for status free from infection with MTBC; |
(c) |
Section 1 of Chapter 2 of Part III of Annex IV for status free from EBL; |
(d) |
Section 1 of Chapter 2 of Part IV of Annex IV for status free from IBR/IPV; |
(e) |
Section 1 of Chapter 2 of Part V of Annex IV for status free from infection with ADV; |
(f) |
Section 1 of Chapter 2 of Part VI of Annex IV for status free from BVD; |
(g) |
Section 1 of Chapter 2 of Part I of Annex V for status free from infection with RABV; |
(h) |
Section 1 of Chapter 4 of Part II of Annex V for status free from infection with BTV; |
(i) |
Section 1 of Part III of Annex V for status free from infestation with Varroa spp.; |
(j) |
Section 1 of part IV of Annex V for status free from infection with Newcastle disease virus without vaccination; |
(k) |
Section 2 of Chapter 1 of Part II of Annex VI for status free from VHS; |
(l) |
Section 2 of Chapter 1 of Part II of Annex VI for status free from IHN; |
(m) |
Section 2 of Chapter 2 of Part II of Annex VI for status free from infection with HPR-deleted ISAV; |
(n) |
Section 2 of Chapter 3 of Part II of Annex VI for status free from infection with Marteilia refringens; |
(o) |
Section 2 of Chapter 4 of Part II of Annex VI for status free from infection with Bonamia exitiosa; |
(p) |
Section 2 of Chapter 5 of Part II of Annex VI for status free from infection with Bonamia ostreae; |
(q) |
Section 2 of Chapter 6 of Part II of Annex VI for status free from infection with WSSV. |
Article 73
Criteria for the granting of disease-free status to compartments keeping aquaculture animals
1. Disease-free status may only be granted to a compartment keeping aquaculture animals when the following general and specific criteria are complied with:
(a) |
general criteria:
|
(b) |
specific criteria for granting disease-free status based on the provisions of Articles 74 to 77. |
2. The disease-free status referred to in paragraph 1 may be granted to:
(a) |
compartments which are independent of the health status of the surrounding natural waters; and |
(b) |
compartments which are dependent on the health status of the surrounding natural waters but where conditions exist which create an effective disease specific separation between the compartment and other aquatic animal populations which may be infected. |
3. In the case of the dependent compartments referred to in point (b) of paragraph 2, the competent authority shall:
(a) |
assess at least the following epidemiological factors:
|
(b) |
classify all establishments in the compartment as high risk, in compliance with Chapter 1 of Part I of Annex VI; |
(c) |
impose whatever measures are found to be necessary to prevent the introduction of disease. |
4. When a disease-free declaration for a dependent compartment is made to the Commission in accordance with Article 83, the competent authority shall provide the assessment referred to in point (a) of paragraph 3 and details of any measure which were put in place to prevent the introduction of the disease into the compartment.
The competent authority shall communicate to the Commission without delay any subsequent changes to the epidemiological factors set out in point (a) of paragraph 3 and measures taken to mitigate their impact.
Article 74
Disease-free status based on the absence of listed species
1. The criteria to recognise the disease-free status of a compartment keeping aquaculture animals because of the absence of the listed species for that disease are as follows:
(a) |
the general criteria laid down in points (a)(i) and (a)(ii) of Article 73(1) have been fulfilled for an eligibility period of at least 5 years and the disease was not detected; and |
(b) |
the listed species relevant to the disease in question are absent from kept and wild animal populations. |
2. The Member State shall provide documentary evidence to substantiate the fulfilment of the criteria in paragraph 1. The documentary evidence shall demonstrate the sustainability of the disease-free status considering that:
(a) |
the likelihood of the presence of animals from listed species in the compartment was assessed and found to be negligible; and |
(b) |
the likelihood of introduction of animals from listed species into the compartment was found to be negligible. |
Article 75
Disease-free status based on the disease agent’s incapacity to survive
1. The criteria to recognise the disease-free status of a compartment keeping aquaculture animals because of the disease agent’s incapacity to survive are as follows:
(a) |
the general criteria laid down in points (a)(i) and (a)(ii) of Article 73(1) have been fulfilled for an eligibility period of at least 5 years and the disease was not detected; |
(b) |
the disease has never been reported or if reported, it has been demonstrated that the disease agent did not survive; |
(c) |
the value of at least one critical environmental parameter that is not compatible with the survival of the disease agent is reached; |
(d) |
the disease agent is exposed to that critical parameter during a sufficient period of time to destroy it. |
2. The Member State shall provide the following evidence to substantiate the fulfilment of the criteria in paragraph 1:
(a) |
with respect to the fulfilment of the criteria set out in points (a) and (b) of paragraph 1, documentary evidence; |
(b) |
with respect to the fulfilment of the criteria set out in points (c) and (d) of paragraph 1, scientific evidence. |
Article 76
Disease-free status based on historical and surveillance data
1. The criteria to recognise the disease-free status of a compartment keeping aquaculture animals based on historical and surveillance data are as follows:
(a) |
the disease has never been reported in the compartment or it has been eradicated in the compartment and not reported for at least 25 years; |
(b) |
the disease has been reported in the past 25 years, it has been eradicated from the compartment and the disease specific requirements referred to in Article 78 are complied with. |
2. A Member State wishing to obtain the approval of disease-free status for the compartment on the basis of the provisions set out in point (a) of paragraph 1 shall have implemented the following measures for an eligibility period of at least 10 years:
(a) |
disease surveillance of kept animals of listed species; |
(b) |
prevention to control the introduction of the disease agent; |
(c) |
ban on vaccination against the disease unless it is compliant with the disease specific requirements referred to in Article 78; |
(d) |
disease surveillance substantiating the fact that the disease is not known to be established in wild animals from listed species within the compartment. |
3. The criteria provided for in paragraph 1 shall only apply:
(a) |
in a new Member State, during a maximum period of two years following its accession to the Union; or |
(b) |
for a maximum period of two years following the date of application of the implementing acts adopted in accordance with Article 9(2) of Regulation (EU) 2016/429 that categorise for the first time the relevant disease as a category B or C disease. |
4. By way of derogation from point (b) of paragraph 3, the granting of disease-free status based on historical and surveillance data shall not apply to the following diseases:
(a) |
VHS; |
(b) |
IHN; |
(c) |
infection with HPR-deleted ISAV; |
(d) |
infection with Bonamia ostreae; |
(e) |
infection with Marteilia refringens. |
Article 77
Disease-free status based on eradication programmes
1. The criteria to recognise the disease-free status of a compartment keeping aquaculture animals based on eradication programmes are:
(a) |
the competent authority has been running an approved eradication programme as referred to in Article 46; and |
(b) |
the competent authority has completed the eradication programme and submitted to the Commission the final report that demonstrates that the disease specific requirements laid down in Article 78 are complied with. |
2. By way of derogation from paragraph 1, where a compartment covers less than 75 % of the territory of a Member State and the water catchment supplying the compartment is not shared with another Member State or third country, disease-free status may be achieved in accordance with Article 83.
Article 78
Disease specific requirements for disease-free status
Disease-specific requirements for the granting of disease-free status to a compartment keeping aquaculture animals are provided in:
(a) |
Section 2 of Chapter 1 of Part II of Annex VI for status free from VHS; |
(b) |
Section 2 of Chapter 1 of Part II of Annex VI for status free from IHN; |
(c) |
Section 2 of Chapter 2 of Part II of Annex VI for status free from infection with HPR-deleted ISAV; |
(d) |
Section 2 of Chapter 3 of Part II of Annex VI for status free from infection with Marteilia refringens; |
(e) |
Section 2 of Chapter 4 of Part II of Annex VI for status free from infection with Bonamia exitiosa; |
(f) |
Section 2 of Chapter 5 of Part II of Annex VI for status free from infection with Bonamia ostreae; |
(g) |
Section 2 of Chapter 6 of Part II of Annex VI for status free from infection with WSSV. |
Article 79
Specific requirements for compartments which are independent of the health status of the surrounding natural waters
1. In addition to the general criteria for granting disease-free status to compartments keeping aquaculture animals as set out in Article 73(1), a compartment which comprises one or more individual establishments where the health status regarding a specific disease is independent of the health status of the surrounding natural waters, may obtain disease-free status if it complies with paragraphs 2 to 6.
2. An independent compartment may comprise:
(a) |
an individual establishment which is considered a single epidemiological unit, as it is not influenced by the animal health status of the surrounding natural waters; or |
(b) |
more than one establishment where each establishment in the compartment complies with the criteria laid down in point (a) of this paragraph and paragraphs 3 to 6 but due to extensive movements of animals between establishments, they are considered as a single epidemiological unit, provided that all establishments operate a common biosecurity system. |
3. An independent compartment shall be supplied with water:
(a) |
through a water treatment plant which inactivates the relevant disease agent; or |
(b) |
directly from a well, a borehole or a spring. |
Where such water supply originates from a source outside the establishment, the water shall be supplied directly to the establishment, and be channelled to the establishment by means which afford appropriate protection from infection.
4. There shall be natural or artificial barriers that prevent aquatic animals from entering each establishment in the compartment from the surrounding natural waters.
5. The compartment shall, where appropriate, be protected against flooding and infiltration of water from the surrounding natural waters.
6. The compartment shall comply with the disease-specific requirements referred to in Article 78.
Article 80
Special provisions for compartments which comprise individual establishments which commence or recommence aquaculture activities and where the health status regarding a specific disease is independent of the health status of the surrounding natural waters
1. A new establishment which is to commence aquaculture activities is considered to be disease-free when:
(a) |
it complies with point (a) of paragraph 2 and paragraphs 3 to 5 of Article 79; and |
(b) |
it commences aquaculture activities with aquaculture animals from a disease-free Member State, zone or compartment. |
2. An establishment which recommences aquaculture activities after a break and complies with paragraph 1 is considered to be disease-free without the surveillance referred to in point (a)(ii) of Article 73(1) provided:
(a) |
the health history of the establishment is known to the competent authority and there has been no confirmation in the establishment of a category B or category C disease; |
(b) |
the establishment is cleaned, disinfected and fallowed, if necessary, prior to repopulation. |
3. An establishment which recommences its activities after the confirmation of a category B or category C disease is considered to be disease-free from the confirmed disease, provided:
(a) |
a representative sample of the animals which have been repopulated into the establishment from a disease-free Member State, zone or compartment following cleaning, disinfection and fallowing is tested for the relevant disease no sooner than 3 months and no later than 12 months after they have been exposed to conditions including water temperature, which are conducive to clinical expression of the disease; |
(b) |
the sampling and diagnostic tests set out in the relevant Chapter of Part II of Annex VI are used and samples are taken from the number of animals that will ensure the detection of the relevant disease with a 95 % confidence if the targeted prevalence is 2 %; |
(c) |
results of the testing described in point (b) are negative. |
Article 81
Specific criteria on surveillance and biosecurity measures for the maintenance of disease-free status
1. The Member States, zones or compartments thereof may maintain disease-free status only if, in addition to the criteria laid down in points (a) and (c) of Article 41(1) of Regulation (EU) 2016/429, they comply with:
(a) |
the undertaking of sufficient surveillance activities to enable the early detection of the disease and the demonstration of disease-free status; |
(b) |
the biosecurity measures ordered by the competent authority based on the risks identified to prevent the introduction of the disease; |
(c) |
the operational rules as referred to in points (a)(v), a(vi) and a(vii) of Article 66 or points (a)(v), a(vi) and a(vii) of Article 73(1). |
2. In the case of aquatic animals, when a Member State is declared free from one or more of the listed diseases, it may discontinue targeted surveillance as referred to in points (k) to (q) of paragraph 3 and maintain its disease-free status provided that the risk of introduction of the relevant disease has been assessed and conditions conducive to clinical expression of the disease in question exist.
In disease-free zones or compartments in Member States which are not declared disease-free, or in all cases where conditions conducive to clinical expression of the disease in question do not exist, targeted surveillance shall be continued as referred to in points (k) to (q) of paragraph 3.
3. The disease specific requirements as regards surveillance and biosecurity measures are provided in:
(a) |
Section 2 of Chapter 3 of Part I of Annex IV for status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals or Section 2 of Chapter 4 of Part I of Annex IV for status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals; |
(b) |
Section 2 of Chapter 2 of Part II of Annex IV for status free from infection with MTBC; |
(c) |
Section 2 of Chapter 2 of Part III of Annex IV for status free from EBL; |
(d) |
Section 2 of Chapter 2 of Part IV of Annex IV for status free from IBR/IPV; |
(e) |
Section 2 of Chapter 2 of Part V of Annex IV for status free from infection with ADV; |
(f) |
Section 2 of Chapter 2 of Part VI of Annex IV for status free from BVD; |
(g) |
Section 2 of Chapter 2 of Part I of Annex V for status free from infection with RABV; |
(h) |
Section 2 of Chapter 4 of Part II of Annex V for status free from infection with BTV; |
(i) |
Section 2 of Part III of Annex V for status free from infestation with Varroa spp; |
(j) |
Section 2 of Part IV of Annex V for status free from infection with Newcastle disease virus without vaccination; |
(k) |
Section 4 of Chapter 1 of Part II of Annex VI for status free from VHS; |
(l) |
Section 4 of Chapter 1 of Part II of Annex VI for status free from IHN; |
(m) |
Section 4 of Chapter 2 of Part II of Annex VI for status free from infection with HPR-deleted ISAV; |
(n) |
Section 4 of Chapter 3 of Part II of Annex VI for status free from infection with Marteilia refringens; |
(o) |
Section 4 of Chapter 4 of Part II of Annex VI for status free from infection with Bonamia exitiosa; |
(p) |
Section 4 of Chapter 5 of Part II of Annex VI for status free from infection with Bonamia ostreae; |
(q) |
Section 4 of Chapter 6 of Part II of Annex VI for status free from infection with WSSV. |
Article 82
Suspension, withdrawal and restoration of disease-free status
1. If the disease has been confirmed and therefore the conditions for maintaining the disease-free status of a Member State, a zone or compartment thereof are not fulfilled, the competent authority shall:
(a) |
apply without delay the relevant disease control measures; |
(b) |
conduct specific surveillance to assess the extent of the outbreak; |
(c) |
order any necessary risk mitigating measures. |
2. If the disease has not been confirmed, but there has been a breach of one of the conditions for maintaining the disease-free status of a Member State, a zone or compartment thereof, the competent authority shall take the appropriate corrective measures and assess the risk that the health situation has changed.
3. The competent authority may where necessary, as a transitional measure, suspend the disease-free status of the Member State, a zone or compartment thereof rather than the Commission withdrawing the disease-free status. During that suspension, the competent authority shall:
(a) |
adopt all necessary prevention, surveillance and control measures to manage the situation; |
(b) |
inform without delay the Commission and the other Member States about the measures adopted; and |
(c) |
inform regularly the Commission and the other Member States about the evolution of the situation, of its position as regards the restoration of the disease-free status, the prolongation of its suspension or its withdrawal by the Commission. |
4. Subject to compliance with the provisions of paragraph 3 the competent authority may restore the disease-free status of the Member State, zone or compartment thereof by lifting the suspension.
Article 83
Derogations from approval by the Commission for certain disease-free statuses for aquatic animal diseases
1. By way of derogation from the requirements to obtain approval by the Commission for disease-free status, laid down in Articles 36(4) and 37(4) of Regulation (EU) 2016/429, for aquatic animal diseases of zones or compartments, such approval for zones or compartments which cover less than 75 % of the territory of a Member State, and where the water catchment supplying the zone or compartment is not shared with another Member State or third country, shall be gained in accordance with the following procedure:
(a) |
a Member State makes a provisional declaration of freedom for the zone or compartment which fulfils the requirements for disease-free status as set out in this Regulation; |
(b) |
this provisional declaration is published electronically by the Member State and the Commission and Member States are alerted to the publication; |
(c) |
60 days after publication, the provisional declaration shall take effect and the zone or compartment referred to in this paragraph shall achieve the disease-free status. |
2. Within the 60-day period referred to in point (c) of paragraph 1, the Commission or Member States may seek clarification or additional information in relation to the supporting evidence provided by the Member State making the provisional declaration.
3. Where written comments are made by at least one Member State, or the Commission, within the period referred to in point (c) of paragraph 1 indicating concerns relating to the evidence which supports the declaration, the Commission, the Member State which made the declaration and where relevant, the Member State which has sought clarification or additional information, shall together examine the submitted evidence in order to resolve the concerns.
In such cases, the period referred to in point (c) of paragraph 1 is prolonged automatically for 60 days from the date on which the first concerns were raised. There shall be no further prolongation of this period
4. Where the process referred to in paragraph 3 fails, the provisions laid down in Articles 36(4) and 37(4) of Regulation (EU) 2016/429 shall apply.
PART III
TRANSITIONAL AND FINAL PROVISIONS
Article 84
Transitional provisions concerning existing disease-free status
1. The Member States and zones thereof with an approved disease-free status before the date of application of this Regulation shall be deemed to have an approved disease-free status in accordance with this Regulation for the following statuses:
(a) |
free from infection with Brucella abortus, B. melitensis, B.suis:
|
(b) |
free from infection with MTBC, when the tuberculosis-free status was granted in accordance with Directive 64/432/EEC; |
(c) |
free from EBL, when EBL-free status was granted in accordance with Directive 64/432/EEC; |
(d) |
free from IBR/IPV, when IBR-free status was granted in accordance with Directive 64/432/EEC; |
(e) |
free from infection with ADV, when Aujeszky’s disease-free-status was granted in accordance with Directive 64/432/EEC; |
(f) |
free from infestation with Varroa spp., when varroasis-free status was granted in accordance with Council Directive 92/65/EEC (24); |
(g) |
free from infection with Newcastle disease virus without vaccination when Newcastle disease non-vaccination status was granted in accordance with Directive 2009/158/EC; |
(h) |
free from VHS, when VHS-free status was granted in accordance with Council Directive 2006/88/EC (25); |
(i) |
free from IHN, when IHN-free status was granted in accordance with Directive 2006/88/EC; |
(j) |
free from infection with HPR-deleted ISAV, when infection with HPR-deleted ISAV-free status was granted in accordance with Directive 2006/88/EC; |
(k) |
free from infection with Bonamia ostreae, when infection with Bonamia ostreae-free status was granted in accordance with Directive 2006/88/EC; |
(l) |
free from infection with Marteilia refringens, when infection with Marteilia refringens-free status was granted in accordance with Directive 2006/88/EC; |
(m) |
free from infection with WSSV, when white spot disease–free status was granted in accordance with Directive 2006/88/EC. |
2. The compartments in Member States with an approved disease-free status before the date of application of this Regulation shall be deemed to have an approved disease-free status in accordance with this Regulation for the following statuses:
(a) |
free from highly pathogenic avian influenza, when the compartment has been approved with respect to avian influenza in accordance with Commission Regulation (EC) No 616/2009 (26); |
(b) |
free from VHS, when VHS-free status was granted in accordance with Directive 2006/88/EC; |
(c) |
free from IHN, when IHN-free status was granted in accordance with Directive 2006/88/EC; |
(d) |
free from infection with HPR-deleted ISAV, when infection with HPR-deleted ISAV-free status was granted in accordance with Directive 2006/88/EC; |
(e) |
free from infection with Bonamia ostreae, when infection with Bonamia ostreae-free status was granted in accordance with Directive 2006/88/EC; |
(f) |
free from infection with Marteilia refringens, when infection with Marteilia refringens-free status was granted in accordance with Directive 2006/88/EC; |
(g) |
free from infection with WSSV, when white spot disease–free status was granted in accordance with Directive 2006/88/EC. |
3. The Member States deemed to have an approved disease-free status in accordance with paragraph 1 or 2 shall ensure that the conditions of maintenance of the status conform with those laid down in this Regulation.
Article 85
Transitional provisions concerning existing eradication or surveillance programmes
1. The Member States and zones thereof with an approved eradication programme or an approved surveillance programme before the date of application of this Regulation shall be deemed to have an approved eradication programme in accordance with this Regulation for the following diseases for a period of six years from the date of application of this Regulation:
(a) |
IBR/IPV, when the IBR/IPV eradication programme was approved in accordance with Directive 64/432/EEC; |
(b) |
infection with ADV, when the Aujeszky’s disease eradication programme was approved in accordance with Directive 64/432/EEC; |
(c) |
VHS, when the VHS surveillance or eradication programme was approved in accordance with Directive 2006/88/EC; |
(d) |
IHN, when the IHN surveillance or eradication programme was approved in accordance with Directive 2006/88/EC; |
(e) |
infection with HPR-deleted ISAV, when the infection with HPR-deleted ISAV surveillance or eradication programme was approved in accordance with Directive 2006/88/EC; |
(f) |
infection with Bonamia ostreae, when the infection with Bonamia ostreae surveillance or eradication programme was approved in accordance with Directive 2006/88/EC; |
(g) |
infection with Marteilia refringens, when the infection with Marteilia refringens surveillance or eradication programme was approved in accordance with Directive 2006/88/EC; |
(h) |
infection with WSSV, when the white spot disease eradication programme was approved in accordance with Directive 2006/88/EC. |
2. The compartments in Member States with an approved eradication programme or an approved surveillance programme before the date of application of this Regulation shall be deemed to have an approved eradication programme in accordance with this Regulation for the following diseases for a period of six years from the date of application of this Regulation:
(a) |
VHS, when the VHS surveillance or eradication programme was approved in accordance with Directive 2006/88/EC; |
(b) |
IHN, when the IHN surveillance or eradication programme was approved in accordance with Directive 2006/88/EC; |
(c) |
infection with HPR-deleted ISAV, when the infection with HPR-deleted ISAV surveillance or eradication programme was approved in accordance with Directive 2006/88/EC; |
(d) |
infection with Bonamia ostreae, when the infection with Bonamia ostreae surveillance or eradication programme was approved in accordance with Directive 2006/88/EC; |
(e) |
infection with Marteilia refringens, when the infection with Marteilia refringens surveillance or eradication programme was approved in accordance with Directive 2006/88/EC; |
(f) |
infection with WSSV, when the white spot disease surveillance or eradication programme was approved in accordance with Directive 2006/88/EC. |
3. The Member States deemed to have an approved eradication programme in accordance with paragraphs 1 or 2 shall ensure that the measures in the programme conform with those laid down for eradication programmes in this Regulation.
Article 86
Repeal
The following acts are repealed as from 21 April 2021:
— |
Decision 2000/428/EC; |
— |
Decision 2002/106/EC; |
— |
Decision 2003/422/EC; |
— |
Decision 2006/437/EC; |
— |
Regulation (EC) No 1266/2007; |
— |
Decision 2008/896/EC; |
— |
Implementing Decision (EU) 2015/1554. |
References to those repealed acts shall be construed as references to this Regulation.
Article 87
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 21 April 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 December 2019.
For the Commission
The President
Ursula VON DER LEYEN
(2) Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 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 protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).
(3) Commission Decision 2010/367/EU of 25 June 2010 on the implementation by Member States of surveillance programmes for avian influenza in poultry and wild birds (OJ L 166, 1.7.2010, p. 22).
(4) Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21).
(5) Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (OJ 121, 29.7.1964, p. 1977/64).
(6) Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (OJ L 46, 19.2.1991, p. 19).
(7) Commission Delegated Regulation (EU) 2018/1629 of 25 July 2018 amending the list of diseases set out in Annex II to Regulation (EU) 2016/429 of the European Parliament and of the Council on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (OJ L 272, 31.10.2018, p. 11).
(8) Terrestrial Animal Health Code, World Organisation for Animal Health, 2018.
(9) Commission Decision 2004/558/EC of 15 July 2004 implementing Council Directive 64/432/EEC as regards additional guarantees for intra-Community trade in bovine animals relating to infectious bovine rhinotracheitis and the approval of the eradication programmes presented by certain Member States (OJ L 249, 23.7.2004, p. 20).
(10) The EFSA Journal (2006) 311, Opinion on the ‘Definition of a BoHV-1-free animal and a BoHV-1-free holding, and the procedures to verify and maintain this status’.
(11) Council Directive 2000/75/EC of 20 November 2000 laying down specific provisions for the control and eradication of bluetongue (OJ L 327, 22.12.2000, p. 74).
(12) EFSA AHAW Panel (EFSA Panel on Animal Health and Welfare), 2017. Scientific opinion on bluetongue: control, surveillance and safe movement of animals. EFSA Journal 2017; 15(3):4698, 126.
(13) Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation (OJ L 300, 14.11.2009, p. 1).
(14) Commission Decision 2000/428/EC of 4 July 2000 establishing diagnostic procedures, sampling methods and criteria for the evaluation of the results of laboratory tests for the confirmation and differential diagnosis of swine vesicular disease (OJ L 167, 7.7.2000, p. 22).
(15) Commission Decision 2002/106/EC of 1 February 2002 approving a Diagnostic Manual establishing diagnostic procedures, sampling methods and criteria for evaluation of the laboratory tests for the confirmation of classical swine fever (OJ L 39, 9.2.2002, p. 71).
(16) Commission Decision 2003/422/EC of 26 May 2003 approving an African swine fever diagnostic manual (OJ L 143, 11.6.2003, p. 35).
(17) Commission Decision 2006/437/EC of 4 August 2006 approving a Diagnostic Manual for avian influenza as provided for in Council Directive 2005/94/EC (OJ L 237, 31.8.2006, p. 1).
(18) Commission Regulation (EC) No 1266/2007 of 26 October 2007 on implementing rules for Council Directive 2000/75/EC as regards control, monitoring, surveillance and restrictions on movements of certain animals of susceptible species in relation to bluetongue (OJ L 238, 27.10.2007, p. 37).
(19) Commission Decision 2008/896/EC of 20 November 2008 on guidelines for the purpose of the risk based animal health surveillance scheme provided for in Council Directive 2006/88/EC (OJ L 322, 2.12.2008, p. 30).
(20) Commission Implementing Decision (EU) 2015/1554 of 11 September 2015 laying down rules for the application of Directive 2006/88/EC as regards requirements for surveillance and diagnostic methods (OJ L 247, 23.9.2015, p. 1).
(21) http://www.oie.int/en/standard-setting/terrestrial-manual/access-online/
(22) http://www.oie.int/en/standard-setting/aquatic-manual/access-online/
(23) Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (OJ L 325, 12.12.2003, p. 31).
(24) Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC (OJ L 268, 14.9.1992, p. 54).
(25) Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (OJ L 328, 24.11.2006, p. 14).
(26) Commission Regulation (EC) No 616/2009 of 13 July 2009 implementing Council Directive 2005/94/EC as regards the approval of poultry compartments and other captive birds compartments with respect to avian influenza and additional preventive biosecurity measures in such compartments (OJ L 181, 14.7.2009, p. 16).
ANNEX I
SPECIFIC CASE DEFINITION OF DISEASE OF TERRESTRIAL ANIMALS
1. |
An animal or a group of animals must be considered, by the competent authority, as a suspected case of HPAI when it meets the criteria laid down in Article 9(1). |
2. |
An animal or a group of animals must be considered, by the competent authority, as a confirmed case of HPAI when:
|
3. |
For the purposes of this case definition, the disease agent responsible for HPAI must be either
|
1. |
An animal or a group of animals must be considered, by the competent authority, as a suspected case of infection with LPAIV when it meets the criteria laid down in Article 9(1). |
2. |
An animal or a group of animals must be considered, by the competent authority, as a confirmed case of infection with LPAIV when:
|
3. |
For the purposes of this case definition, the disease agent of infection with LPAIV must be any influenza A virus of H5 and H7 subtypes that are not HPAI viruses. |
1. |
An animal or a group of animals must be considered, by the competent authority, as a suspected case of infection with NDV when it meets the criteria laid down in Article 9(1). |
2. |
An animal or a group of animals must be considered, by the competent authority, as a confirmed case of infection with NDV when:
|
3. |
For the purposes of this case definition, the disease agent responsible for infection with NDV must be any avian paramyxovirus type 1 (APMV-1) (avian Avulavirus type 1) that either:
|
ANNEX II
UNION SURVEILLANCE PROGRAMME
PART I
AVIAN INFLUENZA SURVEILLANCE IN POULTRY AND WILD BIRDS
1. TERRITORIAL SCOPE
Surveillance in poultry and wild birds must be implemented in all Member States.
2. PERIOD OF APPLICATION
Until revoked.
3. GENERAL APPROACH
The surveillance system must address the objectives provided for in Section 2 and must be built on a comprehensive approach including different components of surveillance activities complementing each other in poultry and wild bird populations:
— |
Early detection systems as provided for in Sections 3 and 4; |
— |
Risk-based surveillance as provided for in Sections 5 and 6. |
1. |
Early detection of highly pathogenic avian influenza (HPAI) in poultry. |
2. |
Early detection of HPAI in wild birds providing for:
|
3. |
Detection of HPAI in poultry species which generally do not show significant clinical signs. |
4. |
Detection of circulating low pathogenic avian influenza viruses (LPAIV) that may easily spread between poultry flocks in particular in areas with a high density of poultry establishments in view of their potential to mutate to HPAI in order to:
|
5. |
Contribution to increased knowledge on HPAI and LPAIV posing a potential zoonotic risk. |
1. |
The early detection systems for of HPAI in poultry must be part of the general surveillance requirements as provided for in point (a) of Article 3(1) and must be implemented throughout the poultry sector. |
2. |
The surveillance referred to in point 1 must at least include the early detection and investigation in establishments located in an area identified as being at heightened risk for HPAI introduction and spread, of:
|
3. |
Regular testing of samples collected from dead and sick poultry in establishments located in an area identified as being at heightened risk for HPAI introduction and spread may also be relevant when an increased risk has been identified at national, EU or regional level due to outbreaks of HPAI in poultry and/or wild birds. |
1. |
The early detection of HPAI in wild birds must be based on sampling and testing of birds that have been:
This surveillance may need to be increased, when HPAI has been detected in wild birds, by monitoring systems using organised patrols for detecting and collecting dead and sick birds. |
2. |
The design of this surveillance must be risk-based, taking into account at least relevant information on ornithology, virology, epidemiology and environmental matters. |
3. |
The surveillance must apply to birds from targeted wild bird species, as provided for in Section 8. However, all suspected episodes of mortality in wild birds must be investigated to exclude HPAI.
In addition to targeted wild bird species, additional wild bird species may also be included when their specific epidemiological relevance on the Member State’s territory has been assessed. |
4. |
In addition, the surveillance may include, at priority locations and key sites in particular those where birds of targeted wild birds species are entering the Union during their migratory movements, at least from North-East and Eastern routes, the sampling and testing of:
|
5. |
Additional sources of information obtained from investigations of wild birds in the context of HPAI outbreaks in kept birds must be included in the results of the surveillance of HPAI in wild birds. |
1. |
The risk-based surveillance for infection with HPAI in poultry establishments keeping ducks, geese, poultry belonging to the species of Anseriformes for supplies of game or quails to be released into the wild must take into account at least the following risk factors:
|
2. |
Based on scientific justifications, additional risk factors than those listed in points (a) to (h) of point 1 may be included and factors that are not relevant for the specific situation of the Member State may be omitted. |
1. |
The risk-based surveillance for the detection of circulating low pathogenic avian influenza viruses (LPAIV) that may easily spread between poultry flocks in particular in areas with a high density of poultry establishments, as referred to in point 4 of Section 2, must apply to poultry establishments for which the competent authority has assessed that clusters of infection with LPAIV have repeatedly occurred in the past or are deemed more likely to occur. |
2. |
Such clusters are characterised by infection with LPAIV of groups of establishments related in time and geographical proximity. |
3. |
The assessment for the selection of establishments for targeted surveillance must take into account the risk for lateral transmission of the virus due to the structure and complexity of the production system and functional connections between establishments, in particular when operating in areas with a high density of establishments. |
4. |
In addition to the selection criteria for targeted surveillance of establishments referred to in point 3, the following risk factors must be taken into account at the establishment level:
|
1. |
Early detection systems for infection with HPAI referred to in Section 3 must apply to all poultry populations. |
2. |
Complementary surveillance for infection with HPAI referred to in Section 5 in poultry species that do generally not display significant signs when infected with HPAI must apply to:
|
3. |
In addition to the species and categories listed under point 2 the targeting of sampling and testing for infection with LPAIV referred to in Section 6 may apply to the following poultry species and production categories:
|
Targeted wild birds species, in particular migratory water birds have shown to be at higher risk of becoming infected with, and transmitting HPAI.
The list of ‘wild bird targeted species’ compiled and updated in the light of the most recent knowledge is available on the website of the EURL.
1. |
The number of poultry establishments to be sampled and the number of poultry to be tested per establishment and, as appropriate, by epidemiological unit (e.g. poultry flock, shed, etc.) on the concerned establishment must be based on a statistically valid sampling method. This method may be that used for representative sampling; i.e. an estimated prevalence to be detected according to a pre-defined level of confidence determined by the competent authority. |
2. |
Frequency and period for testing:
For virological testing the prevalence and time window for detection of active infection must be taken into account. |
3. |
Samples must be subjected to laboratory testing by serological methods, when taken for:
|
ANNEX III
DIAGNOSTIC METHODS FOR THE GRANTING AND MAINTENANCE OF DISEASE-FREE STATUS FOR CERTAIN DISEASES OF TERRESTRIAL ANIMALS
1. |
Serological tests
|
2. |
Brucellin skin test (BST)
For the testing as referred to in section 1 and 2 of Chapter 1 of Part I of Annex IV, Brucellin skin test (BST) shall only be used in ovine and caprine animals. |
1. |
Tuberculin skin tests
|
2. |
Gamma-interferon assay |
1. |
Serological tests
|
|
Methods: |
Matrix: |
non-vaccinated bovine animals |
BoHV-1 I-ELISA (1) |
individual serum samples (4) |
milk samples |
||
gB B-ELISA (2) |
individual serum samples (4) |
|
individual meat juice samples |
||
DIVA vaccinated bovine animals with a gE-deleted vaccine |
gE B-ELISA (3) |
individual serum samples |
individual meat juice samples |
|
Methods: |
Matrix: |
non-vaccinated porcine animals |
ADV ELISA (5) |
individual or up to 5 pooled serum (or plasma) samples |
individual or up to 5 pooled filter paper samples |
||
individual meat juice samples |
||
DIVA vaccinated porcine animals with a gE-deleted vaccine |
gE ELISA (6) |
individual serum samples |
1. |
Direct methods:
|
2. |
Serological tests:
|
(1) I-ELISA for the detection of antibodies against BoHV-1 whole virus. Pools of up to 50 milk samples (individual or bulk milk) may be used in tests for granting and up to 100 milk samples (individual or bulk milk) may be used in tests for the maintenance of the status free from IBR/IPV.
(2) B-ELISA for the detection of antibodies against BoHV-1-gB protein. When referred to tests for the detection of antibodies against whole BoHV-1 in Part IV of Annex IV this method may also be used.
(3) B-ELISA for the detection of antibodies against BoHV-1-gE protein. Individual milk samples may be used when testing to proof the maintenance of the status free from IBR/IPV. The samples may be pooled whereat the number of samples per pool may be chosen based on documented evidence that the test is under all circumstances of day to day laboratory work sensitive enough to detect one single positive sample in the pool.
(4) When testing is carried out to proof the maintenance of the status free from IBR/IPV individually collected samples may be pooled. The number of samples per pool may be modulated based on documented evidence that the test system is under all circumstances of day to day laboratory work sensitive enough to detect one weak positive sample in the pool of the modulated size.
(5) ELISA for the detection of antibodies against whole ADV, ADV-gB protein or ADV-gD protein. For batch control of ADV-gB kits and ADV-gD kits or whole ADV kits, Community reference serum ADV 1, or sub-standards, must be scored positive at the dilution of 1:2. When referred to tests for the detection of whole ADV in Part V of Annex IV either of these tests may be used.
(6) ELISA for the detection of antibodies against ADV-gE protein. For batch control, Community reference serum ADV 1, or sub-standards, must be scored positive at the dilution 1:8.
ANNEX IV
DISEASE-SPECIFIC REQUIREMENTS FOR THE GRANTING, MAINTENANCE, SUSPENSION AND WITHDRAWAL OF THE DISEASE-FREE STATUS AT THE LEVEL OF ESTABLISHMENTS AND DISEASE-SPECIFIC REQUIREMENTS FOR THE GRANTING AND MAINTENANCE OF THE DISEASE-FREE STATUS AT THE LEVEL OF MEMBER STATES OR ZONES
PART I
INFECTION WITH BRUCELLA ABORTUS, B. MELITENSIS AND B. SUIS
CHAPTER 1
Establishment free from infection with Brucella abortus, B. melitensis and B. suis without vaccination
1. |
The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination may only be granted to an establishment keeping bovine, ovine or caprine animals if:
|
2. |
By way of derogation from point 1, the status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination may be granted to an establishment if all bovine, ovine or caprine animals originate from establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination, or free with vaccination and have not been vaccinated during the past 3 years, and:
|
3. |
By way of derogation from point 1, the status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination may be granted to an establishment with the status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination if:
|
The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination of an establishment keeping bovine, ovine or caprine animals may only be maintained if:
(a) |
the requirements set out in points (a), (b), (d), (e) and (f) of point 1 of Section 1 continue to be fulfilled; and |
(b) |
serological testing is carried out with negative results on samples taken from:
|
1. |
The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination of an establishment keeping bovine, ovine or caprine animals must be suspended if:
|
2. |
The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination may only be restored if:
|
1. |
The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination of an establishment keeping bovine, ovine or caprine animals must be withdrawn if:
|
2. |
If the status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in Section 2 are fulfilled. |
3. |
If the status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination has been withdrawn in accordance with point 1(b), 1(c) or 1(d), it may only be regained if all confirmed cases and all animals that have tested non-negative have been removed and the remaining bovine, ovine or caprine animals fulfil the requirements set out in point 1(c) of Section 1. |
4. |
By way of derogation from point 3, where the infection with B. suis biovar 2 was confirmed in a single bovine, ovine or caprine animal kept in the establishment, the status may be regained after negative testing was obtained on samples taken in accordance with the requirements set out in point 1(c)(i) of Section 1. |
CHAPTER 2
Establishment free from infection with Brucella abortus, B. melitensis and B. suis with vaccination
1. |
The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination may only be granted to an establishment keeping bovine, ovine or caprine animals if:
|
2. |
By way of derogation from point 1, the status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination may be granted to an establishment if all bovine, ovine or caprine animals originate from establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination, or free with vaccination, and:
|
The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination of an establishment keeping bovine, ovine or caprine animals may only be maintained if:
(a) |
the requirements set out in points (b) and (c) of point 1 of Section 1 of this Chapter and in points (a) and (d) of point 1 of Section 1 of Chapter 1 continue to be fulfilled; and |
(b) |
serological testing is carried out with negative results on samples taken from all entire bovine animals over 12 months of age and all entire ovine or caprine animals over 6 months of age at appropriate intervals of not more than 12 months determined by the competent authority taking into account the type of production, the situation of the disease and the identified risk factors. |
1. |
The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination of an establishment keeping bovine, ovine or caprine animals must be suspended if:
|
2. |
The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination may only be restored if:
|
1. |
The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination of an establishment keeping bovine, ovine or caprine animals must be withdrawn if:
|
2. |
If the status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in Section 2 are fulfilled. |
3. |
If the status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination has been withdrawn in accordance with point 1(b), 1(c) or 1(d), it may only be regained if all confirmed cases and all animals that have tested non-negative have been removed and the remaining bovine, ovine or caprine animals fulfil the requirements set out in point 1(c) of Section 1 of Chapter 1. |
4. |
By way of derogation from point 3, where the infection with Brucella suis biovar 2 was confirmed in a single bovine, ovine or caprine animal kept in the establishment, the status may be regained after negative testing was obtained on samples taken in accordance with the requirements set out in point 1(c)(i) of Section 1 of Chapter 1. |
CHAPTER 3
Member State or zone free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals
The status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals may only be granted to a Member State or a zone if:
(a) |
for at least the past 3 years there has been no confirmed case of infection with Brucella abortus, B. melitensis and B. suis in kept bovine animals; |
(b) |
general surveillance requirements have been carried out for the past 3 years in accordance with point (a) of Article 3(1) for the early detection of infection with Brucella abortus, B. melitensis and B. suis in kept bovine animals, which included at least:
|
(c) |
during the past 3 years, at least 99,8 % of the establishments keeping bovine animals, representing at least 99,9 % of the bovine population, have maintained their status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination; |
(d) |
vaccination of bovine animals against Brucella abortus, B. melitensis and B. suis has not taken place at least for the past 3 years and no bovine animal introduced into the Member State or zone has been vaccinated during the past 3 years prior to its introduction. |
1. |
The status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals of a Member State or a zone may only be maintained if:
|
2. |
The status of a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals is not affected by the confirmation of infection of Brucella abortus, B. melitensis and B. suis in an animal population other than kept bovine animals provided that effective measures have been implemented, and are periodically assessed, to prevent transmission of infection with Brucella abortus, B. melitensis and B. suis to kept bovine animals. |
3. |
By way of derogation from point 1(a), the status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals of a Member State or a zone may be maintained in the event of the confirmation of a case of infection with Brucella abortus, B. melitensis and B. suis if:
|
CHAPTER 4
Member State or zone free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals
The status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals may only be granted to a Member State or a zone if:
(a) |
for at least the past 3 years there has been no confirmed case of infection with Brucella abortus, B. melitensis and B. suis in kept ovine and caprine animals; |
(b) |
general surveillance requirements have been carried out for the past 3 years in accordance with point (a) of Article 3(1) for the early detection of infection with Brucella abortus, B. melitensis and B. suis in kept ovine and caprine animals, which included at least:
|
(c) |
during the past 3 years, surveillance has been carried out on the ovine and caprine population and at least 99,8 % of the establishments keeping ovine or caprine animals, representing at least 99,9 % of the ovine and caprine population, have maintained their status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination; and |
(d) |
vaccination of ovine and caprine animals against Brucella abortus, B. melitensis and B. suis has not taken place for at least the past 3 years and no ovine or caprine animal introduced into the Member State or zone has been vaccinated during the past 3 years prior to introduction. |
1. |
The status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals of a Member State or a zone may only be maintained if:
|
2. |
The status of a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals is not affected by the confirmation of infection of Brucella abortus, B. melitensis and B. suis in an animal population other than kept ovine and caprine animals provided that effective measures have been implemented, and are periodically assessed, to prevent transmission of infection with Brucella abortus, B. melitensis and B. suis to kept ovine and caprine animals. |
3. |
By way of derogation from point 1(a), the status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals of a Member State or a zone may be maintained in the event of the confirmation of a case of infection with Brucella abortus, B. melitensis and B. suis if:
|
PART II
INFECTION WITH MYCOBACTERIUM TUBERCULOSIS COMPLEX
CHAPTER 1
Establishment free from infection with Mycobacterium tuberculosis complex
1. |
The status free from infection with Mycobacterium tuberculosis complex (Mycobacterium bovis, Mycobacterium tuberculosis, Mycobacterium caprae) (MTBC) may only be granted to an establishment keeping bovine animals if:
|
2. |
By way of derogation from point 1, the status free from infection with MTBC may be granted to an establishment if all bovine animals originate from establishments free from infection with MTBC and:
|
3. |
By way of derogation from points 1(c) and 2(b), the competent authority may not require the test if:
|
1. |
The status free from infection with MTBC of an establishment keeping bovine animals may only be maintained if:
|
2. |
By way of derogation from point 1(c), the competent authority may modify the testing regime as follows:
|
1. |
The status free from infection with MTBC of an establishment keeping bovine animals must be suspended if:
|
2. |
The status free from infection with MTBC may only be restored, if:
|
1. |
The status free from infection with MTBC of an establishment keeping bovine animals must be withdrawn if:
|
2. |
If the status free from infection with MTBC has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in Section 2 are fulfilled. |
3. |
If the status free from infection with MTBC has been withdrawn in accordance with point 1(b), 1(c) or 1(d), it may only be regained if:
|
4. |
By way of derogation from point 3(b), the status may be regained if:
|
CHAPTER 2
Member State or zone free from infection with MTBC
The status free from infection with MTBC as regards kept bovine animals may only be granted to a Member State or a zone if:
(a) |
during the past 3 years at least 99,8 % of the establishments keeping bovine animals, representing at least 99,9 % of the bovine population, have maintained their status free from infection with MTBC and the incidence rate of establishments confirmed infected during the year did not exceed 0,1 %; and |
(b) |
general surveillance requirements have been carried out for the past 3 years in accordance with point (a) of Article 3(1) for the detection of infection with MTBC in kept bovine animals and included at least:
|
1. |
The status free from infection with MTBC as regards kept bovine animals of a Member State or a zone may only be maintained if:
|
2. |
The status of a Member State or a zone free from infection with MTBC is not affected by the confirmation of infection with MTBC in the animal population other than kept bovine animals, provided that effective measures have been implemented, and are periodically assessed, to prevent transmission of infection with MTBC to kept bovine animals. |
PART III
ENZOOTIC BOVINE LEUKOSIS
CHAPTER 1
Establishment free from enzootic bovine leukosis
1. |
The status free from enzootic bovine leukosis (EBL) may only be granted to an establishment keeping bovine animals if:
|
2. |
By way of derogation from point 1, the status free from EBL may be granted to an establishment if all bovine animals originate from establishments free from EBL located either in a Member State or zone free from EBL or in a Member State or zone covered by an approved eradication programme. |
The status free from EBL of an establishment keeping bovine animals may only be maintained if:
(a) |
the requirements laid down in points (a), (c) and (d) of point 1 of Section 1 continue to be fulfilled; and |
(b) |
serological testing for EBL is carried out, with negative results, on samples taken
|
1. |
The status free from EBL of an establishment keeping bovine animals must be suspended if:
|
2. |
The status free from EBL may only be restored if:
|
1. |
The status free from EBL of an establishment keeping bovine animals must be withdrawn if:
|
2. |
If the status free from EBL has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in points (c) and (d) of point 1 of Section 1 and point (b) of Section 2 are fulfilled. |
3. |
If the status free from EBL has been withdrawn in accordance with point 1(b), it may only be regained if:
|
4. |
By way of derogation from point (3)(a), the offspring of dams that have been tested positive in a serological test for EBL or which have shown lesions of EBL may be kept in the establishment if:
|
CHAPTER 2
Member State or zone free from EBL
The status free from EBL as regards kept bovine animals may only be granted to a Member State or a zone if:
(a) |
at least 99,8 % of the bovine establishments are free from EBL; and |
(b) |
all bovine animals over 24 months of age slaughtered within this Member State or zone are subjected to an official post-mortem examination with samples from all animals with tumours that could be caused by EBL being subjected to laboratory examination to confirm or rule out the presence of EBL. |
The status free from EBL as regards kept bovine animals of a Member State or a zone may only be maintained if:
(a) |
the requirements set out in Section 1 continue to be fulfilled; and |
(b) |
during the first 5 years after the granting of the status free from EBL, surveillance is carried out based on:
|
(c) |
following the first 5 years after the granting of the status free from EBL, surveillance is carried out to demonstrate the absence of infection, taking into account the systems of production and the risk factors identified. |
PART IV
INFECTIOUS BOVINE RHINOTRACHEITIS/INFECTIOUS PUSTULAR VULVOVAGINITIS
CHAPTER 1
Establishment free from infectious bovine rhinotracheitis/infectious pustular vulvovaginitis
1. |
The status free from infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV) may only be granted to an establishment keeping bovine animals if:
|
2. |
By way of derogation from point 1, the status free from IBR/IPV may be granted to an establishment if all bovine animals originate from establishments free from IBR/IPV located either in a Member State or zone free from IBR/IPV or in a Member State or zone under an approved eradication programme, provided they fulfil the requirements set out in points (c) and (d) of Section 2, as relevant. |
The status free from IBR/IPV may only be maintained in an establishment keeping bovine animals if:
(a) |
the requirements laid down in points (a), (b) and (e) of point 1 of Section 1 continue to be fulfilled; |
(b) |
serological testing for the detection of antibodies against whole BoHV-1 or, if necessary, antibodies against BoHV-1-gE is carried out taking into account previous vaccinations with a DIVA vaccine, with negative results,
|
(c) |
only bovine animals that have not been vaccinated against infection with IBR/IPV are introduced into the establishment if it is located in a Member State or zone:
|
(d) |
all bovine animals that are introduced fulfil the requirements laid down in point 1(d)(ii) of Section 1 or originate from establishments free from IBR/IPV and have tested negative in a serological test for the detection of antibodies against whole BoHV-1 or, if necessary, antibodies against BoHV-1-gE on a sample taken in the establishments of origin within 15 days prior to their dispatch, in cases where:
|
1. |
The status free from IBR/IPV of an establishment keeping bovine animals must be suspended if:
|
2. |
The status free from IBR/IPV may only be restored if:
|
1. |
The status free from IBR/IPV of an establishment keeping bovine animals must be withdrawn if:
|
2. |
If the status free from IBR/IPV has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in points (b) and (e) of point 1 of Section 1 and points (b), (c) and (d) of Section 2 are fulfilled. |
3. |
If the status free from IBR/IPV has been withdrawn in accordance with point 1(b), it may only be regained if:
|
CHAPTER 2
Member State or zone free from IBR/IPV
The status free from IBR/IPV as regards kept bovine animals may only be granted to a Member State or a zone if
(a) |
vaccination against IBR/IPV has been prohibited for kept bovine animals; and |
(b) |
at least 99,8 % of the establishments representing at least 99,9 % of the corresponding bovine population are free from IBR/IPV. |
1. |
The status free from IBR/IPV as regards kept bovine animals of a Member State or a zone may only be maintained if:
|
2. |
By way of derogation from point 1(a), the use of DIVA vaccination may be authorised by the competent authority in the event of an outbreak, if:
|
3. |
By way of derogation from point 1(b), surveillance may be carried out to demonstrate yearly the absence of infection with BoHV-1 taking into account the systems of production and the risk factors identified, provided no outbreaks have been detected for 5 consecutive years following the granting of the status free from IBR/IPV in this Member State or zone. |
PART V
INFECTION WITH AUJESZKY’S DISEASE VIRUS
CHAPTER 1
Establishment free from infection with Aujeszky’s disease virus
1. |
The status free from infection with Aujeszky’s disease virus (ADV) may only be granted to an establishment keeping porcine animals if:
|
2. |
By way of derogation from point 1, the status free from infection with ADV may be granted to an establishment if all porcine animals originate from establishments free from infection with ADV located either in a Member State or zone free from infection with ADV or in a Member State or zone covered by an approved eradication programme, provided they fulfil the requirements set out in point (d) of Section 2. |
The status free from infection with ADV of an establishment keeping porcine animals may only be maintained if:
(a) |
the requirements laid down in points (a), (b) and (e) of point 1 of Section 1 continue to be fulfilled; |
(b) |
serological testing is carried out, with negative results, on a representative number of blood or meat juice samples taken from the porcine animals kept in the establishment, to verify the absence of infection with ADV based on a testing regime that takes into account the production cycle and the risk of introduction of ADV:
|
(c) |
provided the establishment is located in a Member State or zone free from infection with ADV, the serological testing referred to in point (b) is carried out, as required, in accordance with the surveillance provided for in point 1(b) of Section 2 of Chapter 2 or point 4 of Section 2 of Chapter 2, if relevant; |
(d) |
all porcine animals, that are introduced:
|
1. |
The status free from infection with ADV of an establishment keeping porcine animals must be suspended if:
|
2. |
The status free from infection with ADV may only be restored if:
|
1. |
The status free from infection with ADV of an establishment keeping porcine animals must be withdrawn if:
|
2. |
If the status free from infection with ADV has been withdrawn in accordance with point 1(a), it may only be regained if the requirements set out in points (b) and (e) of point 1 of Section 1 and point (b) or (c), if relevant, and (d) of Section 2 are fulfilled. |
3. |
If the status free from infection with ADV has been withdrawn in accordance with point 1(b), it may only be regained, if all porcine animals of the establishment have been removed. |
CHAPTER 2
Member State or zone free from infection with Aujeszky’s disease virus
The status free from infection with ADV as regards kept porcine animals may only be granted to a Member State or a zone if:
(a) |
vaccination against AD has been prohibited for kept porcine animals for the previous 12 months; |
(b) |
surveillance has been carried out to demonstrate that no establishment in the respective Member State or zone has had any clinical, virological or serological evidence of infection with ADV for at least the previous 24 months; and |
(c) |
in case, infection with ADV is known to be established in wild porcine animals, measures have been implemented to prevent any transmission of ADV from wild to kept porcine animals. |
1. |
The status free from infection with ADV as regards kept porcine animals of a Member State or a zone may only be maintained if:
|
2. |
By way of derogation from point 1, the status free from infection with ADV in the porcine population of a Member State or zone may be maintained in the event of an outbreak, if:
|
3. |
By way of derogation from point (a) of Section 1, the use of DIVA vaccination may be authorised by the competent authority in the event of an outbreak referred to in point 2, if:
|
4. |
By way of derogation from point 1(b), surveillance may be carried out to demonstrate annually the absence of ADV infection taking into account the systems of production and the risk factors identified, provided no outbreaks have been detected for 2 consecutive years following the granting of the status free from infection with ADV in this Member State or zone. |
PART VI
BOVINE VIRAL DIARRHOEA
CHAPTER 1
Establishment free from bovine viral diarrhoea
1. |
The status free from bovine viral diarrhoea (BVD) may only be granted to an establishment keeping bovine animals if:
|
2. |
By way of derogation from point 1, the status free from BVD may be granted to an establishment if:
|
1. |
The status free from BVD of an establishment keeping bovine animals may only be maintained if:
|
2. |
By way of derogation from point 1, the status free from BVD of an establishment keeping bovine animals referred to in point 2(b) of Section 1 may be maintained without testing the bovine animals in accordance with point 1(c) if:
|
1. |
The status free from BVD of an establishment keeping bovine animals must be suspended if:
|
2. |
The status free from BVD may only be restored if:
|
1. |
The status free from BVD of an establishment keeping bovine animals must be withdrawn if:
|
2. |
If the status free from BVD has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in points (c) and (e) of point 1 of Section 1 and points (b), (c) and (d) of point 1 and, if relevant, point 2 of Section 2 are fulfilled. |
3. |
If the status free from BVD has been withdrawn in accordance with point 1(b), it may only be regained if:
|
CHAPTER 2
Member State or zone free from bovine viral diarrhoea
The status free from BVD as regards kept bovine animals may only be granted to a Member State or a zone if:
(a) |
vaccination against BVD has been prohibited for kept bovine animals; |
(b) |
no case of BVD has been confirmed in a kept bovine animal for at least the previous 18 months; and |
(c) |
at least 99,8 % of the establishments representing at least 99,9 % of the bovine population are free from BVD. |
1. |
The status free from BVD as regards kept bovine animals of a Member State or a zone may only be maintained if:
|
2. |
By way of derogation from point 1(a), the use of vaccination may be authorised by the competent authority in the event of an outbreak, if:
|
3. |
By way of derogation from point 1(b), surveillance may be carried out to demonstrate annually the absence of BVD taking into account the systems of production and the risk factors identified, provided no outbreaks have been detected for 5 consecutive years following the granting of the status free from BVD in this Member State or zone. |
ANNEX V
DISEASE SPECIFIC REQUIREMENTS FOR THE GRANTING AND MAINTENANCE OF THE DISEASE-FREE STATUS AT THE LEVEL OF MEMBER STATES OR ZONES
PART I
INFECTION WITH RABIES VIRUS
CHAPTER 1
Technical requirements for the vaccination against rabies
1. |
For the purpose of eradication programmes for infection with rabies virus (RABV), anti-rabies vaccination must only be carried out on pet animals that are identified and must fulfil the requirements laid down in Annex III to Regulation (EU) No 576/2013 of the European Parliament and of the Council (1). |
2. |
For the purpose of eradication programmes for infection with RABV, anti-rabies vaccination of kept animals, other than those referred to in the first paragraph, must be risk-based and carried out with the purpose of protecting humans from being exposed to rabies virus, using vaccines that meet the requirements laid down in points (1)(a) and (1)(b)of Annex III to Regulation (EU) No 576/2013 of the European Parliament and of the Council. |
1. |
For the purpose of eradication programmes for infection with RABV the oral vaccination against infection with RABV of wildlife must:
|
2. |
For the purpose of eradication programmes for infection with RABV the vaccination against infection with RABV of stray dog populations must:
|
CHAPTER 2
Member State or zone free from infection with rabies virus
1. |
The status free from infection with RABV may only be granted to a Member State or a zone if:
|
2. |
By way of derogation from point 1(b), if a case of infection with RABV has been confirmed, the status may be granted if the infection of the case did not occur in the Member State or in the zone; and
|
The status free from infection with RABV of a Member State or a zone may only be maintained if:
(a) |
surveillance is implemented in accordance with the requirements laid down in Article 3(1) with the objective of an early detection of the disease; and |
(b) |
no case of infection with RABV has been confirmed in the targeted animal population or a case occurred and the conditions laid down in point 2 of Section 1 were complied with. |
PART II
INFECTION WITH BLUETONGUE VIRUS (SEROTYPES 1-24)
CHAPTER 1
Minimum requirements for the surveillance
1. |
The surveillance of infection with bluetongue virus (serotypes 1-24) (infection with BTV) to ensure early detection of introduction or recurrence of infection with any of the serotypes 1-24 of BTV that were not reported during the previous 2 years must include:
|
2. |
The design of the surveillance provided for in point 1 must address:
|
3. |
The surveillance in an area(s) adjacent to any infected Member State, zone or third country must be increased in an area of up to 150 km from the limit with the Member State, zone, or third country. The demarcation of the area of increased surveillance may be adapted to relevant ecological or geographical features likely to facilitate or interrupt the transmission of BTV or adapted due to the implementation of disease control measures that supports the choice between a greater or lesser distance. |
4. |
The surveillance provided for in point 1(b) and point 3 must have the capacity at least to detect, with a 95 % level of confidence, the infection in the targeted animal population at a target prevalence rate of 5 %, unless otherwise specified in Section 2 of Chapter 4. |
1. |
The surveillance of infection with BTV to ensure the timely demarcation of the spread of the infection when one or more serotypes of BTV is present and, if necessary, to monitor the prevalence rate must include:
|
2. |
The design of the surveillance provided for in point 1 must take into account: all available information on the epidemiology of the disease and biology of the vector that prevail on the territory. |
3. |
The target prevalence rate of the surveillance provided for in point 1 must be adapted to the epidemiological situation, taking into the main risk factors such as the targeted animal population and the vector population. |
1. |
The surveillance of infection with BTV to demonstrate the absence of infection with any of the serotypes 1-24 that has been previously detected in the territory must include:
|
2. |
The design of the surveillance provided for in point 1 must address:
|
3. |
The surveillance provided for in point 1(b) must have the capacity at least to detect, with a 95 % level of confidence, the infection in the targeted animal population at a target prevalence rate of 1 %. |
1. |
The geographical units referred to in point (a) of Article 40(1) must be based on a grid of 45 km by 45 km and can be adapted to:
|
2. |
Active surveillance must be based on one or a combination of the following activities:
|
3. |
The frequency of the sampling must:
|
4. |
The animals sampled must:
|
5. |
The sample size in each geographical unit must be calculated in accordance with the target prevalence rate based on the objectives assigned in Sections 1-3. |
6. |
When surveillance must be adapted as provided for in point (c) of Article 43(2), it must at least include a survey:
This survey is not required if the frequency of the sampling is carried out in accordance with point 3(b). |
1. |
Entomological surveillance must consist of at least an active annual programme of vector catching by means of permanently sited aspiration traps intended to determine the population dynamics of the vector and, where relevant, the vector-free period. |
2. |
Aspiration traps equipped with ultraviolet light must be used in accordance with pre-established protocols; the traps must be operated throughout the night and operate at least:
On the basis of the evidence obtained in the first 3 years of operating the aspiration traps, the frequency of operation of those traps may be adjusted. |
3. |
At least one aspiration trap must be placed in each geographical unit referred to in point (a) of Article 40(1) throughout the seasonally BTV-free zone. A proportion of the midges collected in the aspiration traps must be sent to a specialised laboratory capable of counting and identifying the suspected vector species or complexes. |
4. |
When entomological surveillance is organised in the context of determination of a vector-free period, a maximum threshold of Culicoides species must be defined for the interpretation of the results. In the absence of sound evidence supporting the determination of the maximum threshold, total absence of Culicoides imicola specimens and less than five parous Culicoides per trap must be used as maximum threshold. |
CHAPTER 2
Movement of animals and germinal products
1. |
The animals originate from a Member State or a zone free from infection with BTV and have not been vaccinated with a live vaccine against infection with BTV in the last 60 days before the date of movement. |
2. |
The animals originate from a Member State or a zone covered by the eradication programme and at least one of the following requirements is complied with:
|
3. |
The animals originate from a Member State or a zone neither BTV-free nor covered by an eradication programme for infection with BTV and:
|
4. |
The animals originate from a Member State or a zone not BTV-free, are destined for immediate slaughter and the following requirements apply:
|
5. |
The animals originate from a Member State or a zone neither BTV-free nor covered by an eradication programme for infection with BTV and the animals comply with the requirements set out in point 2(a). |
6. |
The animals originate from a Member State or a zone not BTV-free and:
|
7. |
The animals comply with specific animal health requirements defined by the competent authority to ensure they have sufficient immunological protection prior to departure. |
8. |
The animals comply with any of the requirements provided for in points 2, 3 5, 6 or 7 only for the serotypes of BTV reported for the past 2 years in the Member State or zone of origin and not in the Member State or zone of destination during the same period. |
1. |
The donor animals have been kept at least for a period of 60 days prior to and during the collection of germinal products in a Member State or a zone free from infection with BTV. |
2. |
The germinal products originate from a Member State or a zone covered by the eradication programme for infection with BTV and at least one of the requirements set out in point (a) for semen, point (b) for in vivo derived embryos of bovine animals or point (c) for embryos other than in vivo derived embryos of bovine animals and oocytes is complied with:
|
3. |
The germinal products originate from a Member State or a zone neither BTV-free nor covered by an eradication programme for infection with BTV and comply with the requirements set out either in point 2(a)(i), 2(a)(iii), 2(a)(iv), 2(b), 2(c)(i), 2(c)(ii) or 2(c)(iii). |
4. |
The germinal products originate from a Member State or a zone neither BTV-free nor covered by an eradication programme for infection with BTV and must comply with either point 2(a)(ii) or 2(c)(iv). |
CHAPTER 3
Vector protected establishment
The status of vector protected establishment may only be granted to an establishment if:
(a) |
it has appropriate physical barriers at entry and exit points; |
(b) |
openings must be vector screened with mesh of appropriate gauge which must be impregnated regularly with an approved insecticide according to the manufacturers’ instructions; |
(c) |
vector surveillance and control must be carried out within and around the vector protected establishment; |
(d) |
measures must be taken to limit or eliminate breeding sites for vectors in the vicinity of the vector protected establishment; and |
(e) |
standard operating procedures must be in place, including descriptions of back-up and alarm systems, for operation of the vector protected establishment and transport of animals to the place of loading. |
CHAPTER 4
Member State or zone free from infection with BTV
1. |
The status free from infection with BTV may only be granted to a Member State or to a zone, where BTV has never been reported, if:
|
2. |
The status free from infection with BTV may only be granted to a Member State or to a zone where BTV has already been reported if:
|
1. |
The status free from infection with BTV may only be maintained if:
|
2. |
The intensity and frequency of the surveillance referred to in point 1 of Section 1 must be duly adapted to:
|
3. |
If no circulation of the infection has been detected for 2 consecutive years following granting of the status free from infection with BTV of a Member State or of a zone, surveillance must be based on:
|
CHAPTER 5
Seasonally BTV-free Member State or zone
1. |
The seasonally BTV-free status may only be established in a Member State or zone thereof if:
|
2. |
By way of derogation from point 1(a), if the seasonally BTV-free period has been successfully demonstrated for a period of 3 consecutive years, additional criteria such as temperature may replace entomological surveillance to substantiate the beginning and the end of the seasonally BTV-free period on the basis of scientific evidence. |
3. |
The seasonally BTV-free Member State or zone must immediately stop when there is evidence of the end of the vector-free period or of circulation of the virus. |
PART III
INFESTATION WITH VARROA SPP.
The status free from infestation with Varroa spp. may only be granted to the relevant honeybee population of a Member State or of a zone if:
(a) |
a risk assessment has been conducted, identifying all potential factors for Varroa spp. occurrence and its potential presence in the past; |
(b) |
an ongoing awareness programme has been in place for at least one year to encourage reporting of all cases suggestive of Varroa spp.; |
(c) |
there has been no confirmed case of infestation with Varroa spp. either in kept or in wild honeybee colonies; |
(d) |
for at least one year, an annual surveillance has demonstrated the absence of infestations with Varroa spp. on a representative sample of kept honeybees of the Member State or zone thereof that allows at least for the detection, with a 95 % level of confidence, of the infestation with Varroa spp. at a target prevalence rate of 1 % of the apiaries and at a within-apiary target prevalence rate of 5 % of the beehives; |
(e) |
in the presence of a wild self-sustaining population of the species of the genus Apis there has been in place for at least one year an ongoing surveillance programme in the wild population which demonstrates no evidence of infestation with Varroa spp.; and |
(f) |
during the whole duration of the surveillance referred to in point (d) the competent authority makes appropriate arrangements for the survey and further handling of honeybees in any stage of their lifecycle, including honeybee brood, which are moved into that Member State or into that zone to prevent the infestation of its population from introduced honeybees of lesser health status. |
The status free from infestation with Varroa spp. granted to the relevant honeybee population of a Member State or of a zone may only be maintained if:
(a) |
the competent authority maintains a surveillance that:
|
(b) |
all the suspected cases have been investigated and no case of infestation with Varroa spp. has been confirmed, either in kept or in wild honeybee colonies; |
(c) |
either there is no wild self-sustaining population of the species of the genus Apis or there is an ongoing surveillance programme in the wild population which demonstrates no evidence of infestation with Varroa spp.; and |
(d) |
the honeybees in any stage of their lifecycle, including honeybee brood, are only moved into the free area when:
|
PART IV
STATUS FREE FROM INFECTION WITH NEWCASTLE DISEASE VIRUS- WITHOUT VACCINATION
The status free from infection with Newcastle disease virus (NDV) status without vaccination in the population of poultry and captive birds of Galliformes species may only be granted to a Member State or to a zone if for at least the past 12 months:
(a) |
vaccination against infection with NDV in poultry and in captive birds of Galliformes species has been prohibited; |
(b) |
no poultry and no captive birds of Galliformes species vaccinated against infection with NDV has been kept in establishments keeping poultry or captive birds of Galliformes species; |
(c) |
general surveillance requirements have been carried out in accordance with point (a) of Article 3(1) for the early detection of infection with NDV; |
(d) |
one of the following testing regime has applied:
|
(e) |
no case of infection with NDV has been confirmed in poultry and captive birds of Galliformes species. |
1. |
The status free from infection with NDV without vaccination granted to a Member State or to a zone may only be maintained if the requirements in points (a) to (e) of Section 1 continue to be fulfilled. |
2. |
By way of derogation from paragraph 1, the status free from infection with NDV without vaccination granted to a Member State or to a zone may be maintained in the event of the confirmation of a case of infection with NDV if:
|
3. |
The status free from infection with NDV without vaccination granted to a Member State or to a zone is not affected by the confirmation of the infection in another bird population, provided the competent authority has assessed, taking into account the implementation of all necessary measures to prevent transmission of infection with NDV to poultry and captive birds of Galliformes species, that the status was not jeopardised. |
(1) Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non-commercial movement of pet animals and repealing Regulation (EC) N0 998/2003 (OJ L 178, 28.6.2013, p. 1).
(2) Commission Delegated Regulation (EU) 2020/686 of 17 December 2019, supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of germinal product establishments and the traceability and animal health requirements for movements within the Union of germinal products of certain kept terrestrial animals (see page 1 of this Official Journal).
ANNEX VI
SPECIFIC REQUIREMENTS AS REGARDS DISEASES OF AQUATIC ANIMALS
PART I
RISK-BASED SURVEILLANCE
CHAPTER 1
Minimum requirements for risk-based surveillance in certain approved aquaculture establishments
1. General approach
1.1. |
Risk-based health surveillance which includes health visits and possible sampling is applied in certain approved aquaculture establishments and in certain approved groups of aquaculture establishments in a manner that is appropriate to the nature of the production and which has the objective of detecting:
|
1.2. |
The frequency of such visits will depend on the risk the approved aquaculture establishment or approved group of aquaculture establishments poses in relation to contracting and spreading disease. This risk applies to listed diseases and to potential emerging diseases and will therefore include aquaculture establishments and groups of aquaculture establishments keeping listed species and in certain cases, aquaculture establishments and groups of aquaculture establishments keeping non-listed species. The competent authority must determine the risk posed by each approved aquaculture establishment or approved group of aquaculture establishments and rank them as high, medium or low risk.
Chapter 2 provides details of the risk factors to be taken into account during the risk ranking process. Such risk ranking will be repeated and updated if any of the risk factors outlined in points (a) to (l) indicate that the risk posed by the establishment has changed. |
1.3. |
Chapter 3 sets out the minimum frequency of health visits which must be completed, based on whether the competent authority has designated an establishment to be high, medium or low risk. |
1.4. |
Risk-based animal health surveillance in aquaculture establishments and groups of aquaculture establishments may be combined with health visits and sampling which are carried out:
|
CHAPTER 2
Risk ranking to be applied in certain approved aquaculture establishments
The risk ranking referred to in point 1.2 of Chapter 1 must as a minimum, take into account the risk factors referred to in points (a) and (b). Where relevant, points (c) to (l) will also be considered:
(a) |
possibility of the direct spread of pathogens via water; |
(b) |
movements of aquaculture animals; |
(c) |
type of production; |
(d) |
species of aquaculture animals kept; |
(e) |
biosecurity system, including staff competence and training; |
(f) |
density of aquaculture establishments and processing establishments in the area around the establishment concerned; |
(g) |
proximity of establishments with a lower health status than the establishment concerned; |
(h) |
disease history of the establishment concerned and of other local establishments; |
(i) |
presence of infected wild aquatic animals in the area around the establishment concerned; |
(j) |
risk posed by human activities in the proximity of the establishment concerned for example angling, the presence of transport routes, ports at which ballast water is exchanged; |
(k) |
access to the establishment concerned by predators which may cause disease spread; |
(l) |
track record of the establishment as regards compliance with the requirements of the competent authority. |
CHAPTER 3
Frequency of risk-based animal health visits
The frequency of risk-based health visits which must be carried out in certain approved establishments and approved groups of establishments depends upon the risk ranking referred to in Chapter 2 and shall be carried out as follows:
(a) |
at least once per year in high risk establishments; |
(b) |
at least once every two years in medium risk establishments; |
(c) |
at least once every three years in low risk establishments. |
PART II
DISEASE- SPECIFIC REQUIREMENTS FOR DISEASE-FREE STATUS OF AQUATIC ANIMALS
Part II covers the disease-specific requirements for disease-free status as regards the following listed diseases:
Viral haemorrhagic septicaemia (VHS) |
Chapter 1 |
Infectious haematopoietic necrosis (IHN) |
Chapter 1 |
Infection with HPR-deleted infectious salmon anaemia virus |
Chapter 2 |
Infection with Marteilia refringens |
Chapter 3 |
Infection with Bonamia exitiosa |
Chapter 4 |
Infection with Bonamia ostreae |
Chapter 5 |
Infection with white spot syndrome virus (WSSV) |
Chapter 6 |
CHAPTER 1
Eradication, disease-free status and diagnostic methods for viral haemorrhagic septicaemia (VHS) and infectious hematopoietic necrosis (IHN)
Health visits and sampling for the surveillance referred to in point (b)(ii) of Article 3(2) must comply with the following requirements:
(a) |
health visits and, where appropriate sampling, must be carried out during the period of the year when the water temperature is below 14 °C or when temperatures below 14 °C are not reached, samples must be taken at the lowest annual temperatures; |
(b) |
when targeted surveillance in wild populations is required due to the small number of aquaculture establishments in an eradication programme, the number and geographical distribution of sampling points must be determined to obtain a reasonable coverage of the Member State, zone or compartment. The sampling points must be representative of the different ecosystems where wild populations of susceptible species are located; |
(c) |
when establishments or wild populations are to be subject to health visits or sampled more than once per year, in accordance with Sections 2 to 4, the intervals between the health visits and between the collection of samples must be at least 4 months, or as long as possible, taking into account the temperature requirements provided for in point (a); |
(d) |
all production units, such as ponds, tanks and net cages, must be examined for the presence of dead, weak or abnormally behaving fish. Particular attention must be paid to the water outlet area where weak fish tend to accumulate because of the water current; |
(e) |
fish of listed species to be collected as samples must be selected as follows:
|
The status free from VHS or free from IHN may only be granted to a Member State, a zone or a compartment with an unknown health status with regard to VHS or IHN if:
(a) |
all establishments and, when required, sampling points in wild populations selected in accordance with point (b) of Section 1, have been subject to one of the following scheme:
|
(b) |
if VHS or IHN have been detected during the surveillance referred to in point (a); before starting a new 2-year or 4-year scheme, relevant establishments in the Member State, zone or compartment must:
|
Table 1.A
Scheme for Member States, zones and compartments for the 2-year control period referred to in point (a)(i) which precedes the achievement of status free from VHS and status free from IHN
Type of establishment |
Number of health visits per year to each establishment |
Number of samplings per year in each establishment |
Number of fish in the sample (1) |
|||
Number of growing fish |
Number of broodstock fish (2) |
|||||
|
2 |
2 |
50 (first visit) 75 (second visit) |
30 (first or second visit) |
||
|
2 |
1 |
0 |
75 (first or second visit) |
||
|
2 |
2 |
75 (first AND second visit) |
0 |
||
Maximum number of fish per pool: 10 |
Table 1.B
Scheme for Member States, zones or compartments using a reduced sample size for the 4-year control period referred to in point (a)(ii) which precedes the achievement of status free from VHS and status free from IHN
Type of establishment |
Number of health visits per year to each establishment |
Number of samplings per year in each establishment |
Number of fish in the sample (3) |
|||
Number of growing fish |
Number of broodstock fish (4) |
|||||
First 2 years |
||||||
|
2 |
1 |
30 (second visit) |
0 |
||
|
2 |
1 |
0 |
30 (first or second visit) |
||
|
2 |
1 |
30 (first or second visit) |
0 |
||
Last 2 years |
||||||
|
2 |
2 |
30 (first visit) |
30 (second visit) |
||
|
2 |
2 |
|
30 (first AND second visit) |
||
|
2 |
2 |
30 (first AND second visit) |
|
||
Maximum number of fish per pool: 10 |
1. |
The status free from VHS or free from IHN may only be granted to a Member State, a zone or a compartment known to be infected with VHS or IHN, if all establishments keeping listed species within that Member State, zone or compartment have been subject to an eradication programme that complies with the following requirements:
|
2. |
The restricted zone must have been defined on a case-by-case basis and:
|
1. |
When targeted surveillance is required in order to maintain the status free from VHS or free from IHN of a Member State, a zone or a compartment, in accordance with Article 81, all establishments keeping listed species within the Member State, zone or compartment concerned must be subject to health visits and fish must be sampled in accordance with Table 1.C, taking into account the risk level of the establishment for the contraction of VHS or IHN. |
2. |
When determining the frequency of health visits required to maintain the status free from VHS or the status free from IHN of compartments, where the health status regarding VHS or IHN is dependent on the health status of the aquatic animal populations in surrounding natural waters, the risk for the contraction of VHS or IHN must be regarded as high. |
3. |
Disease-free status must only be maintained as long as all samples tested, using the diagnostic methods set out in point 2 of Section 5, have produced negative results for VHS or IHN and any suspicion of VHS or IHN has been ruled out in accordance with the diagnostic methods set out in point 3 of Section 5.
Table 1.C Scheme for Member States, zones or compartments to maintain status free from VHS or status free from IHN
|
1. |
The organs or tissue material to be sampled and examined must be the spleen, the anterior kidney, and either heart or encephalon. When sampling broodstock, ovarian or seminal fluid may also be examined.
In case of small fry, whole fish may be sampled. Samples from a maximum of 10 fish may be pooled. |
2. |
The diagnostic method for the granting or the maintenance status free from VHS or status free from IHN in accordance with Sections 2 to 4 must be:
The detailed procedures to carry out these diagnostic methods must be those approved by the EURL for fish diseases. |
3. |
When a suspicion of VHS or IHN is required to be confirmed or ruled out in accordance with Article 55, the following health visit, sampling and testing procedures must comply with the following requirements:
|
CHAPTER 2
Eradication, disease-free status and diagnostic methods for infection with HPR-deleted infectious salmon anaemia virus (HPR-deleted ISAV)
Health visits and sampling for the surveillance referred to in point (b)(ii) of Article 3(2) must comply with the following requirements:
(a) |
when health visits and sampling of establishments must be carried out more than once per year in accordance with Sections 2 to 4, the intervals between the health visits or collection of samples shall be as long as possible; |
(b) |
when targeted surveillance in wild populations is required due to the low number of aquaculture establishments in the eradication programme, the number and geographical distribution of sampling points must be determined to obtain a reasonable coverage of the Member State, zone or compartment; |
(c) |
the sampling points must be representative of the different ecosystems where the wild populations of susceptible species are located; |
(d) |
all production units, such as ponds, tanks and net cages, must be examined for the presence of dead, weak or abnormally behaving fish. Particular attention must be paid to the edge of cages or the water outlet area as relevant, where weak fish tend to accumulate because of the water current; |
(e) |
fish of listed species to be collected as samples must be selected as follows:
|
The status free from infection with HPR-deleted ISAV may only be granted to a Member State, a zone or a compartment with an unknown health status with regard to infection with HPR-deleted ISAV if all establishments and, when required, selected sampling points in wild populations selected in accordance with (b) of Section 1, have been subject to the following scheme:
(a) |
the establishments or sampling points have been subject to health visits and sampled for a minimum period of 2 consecutive years as laid down in Table 2.A; |
(b) |
during that 2-year period, the testing of all samples using the diagnostic methods set out in point 2 of Section 5 must have produced negative results for HPR-deleted ISAV and any suspicion of infection must have been ruled out in accordance with the diagnostic methods set out in point 3 of Section 5; |
(c) |
If infection with HPR-deleted ISAV is detected during the surveillance referred to in point (a); before re-starting the scheme, relevant establishments within the Member State, zone or compartment must:
|
Table 2.A
Scheme for Member States, zones and compartments for the 2-year control period which precedes the achievement of status free from infection with HPR-deleted ISAV
Year of surveillance |
Number of health visits per year to each establishment |
Number of laboratory examinations per year (8) |
Number of fish in the sample |
Year 1 |
6 |
2 |
75 |
Year 2 |
6 |
2 |
75 |
Maximum number of fish per pool: 5. |
1. |
The status free from infection with HPR-deleted ISAV may only be granted to a Member State, a zone or a compartment known to be infected with HPR-deleted ISAV if all establishments keeping listed species within the Member State, zone or compartment have been subject to an eradication programme that complies with the following requirements:
|
2. |
The restricted zone must have been defined on a case-by-case basis and:
|
1. |
When targeted surveillance is required in order to maintain the status free from infection with HPR-deleted ISAV of a Member State, a zone or a compartment, in accordance with Article 81, all establishments keeping listed species within the Member State, zone or compartment concerned must be subject to health visits and fish must be sampled in accordance with Table 2.B, taking into account the risk level of the establishment for the contraction of infection with HPR-deleted ISAV. |
2. |
When determining the frequency of health visits required to maintain the status free from infection with HPR-deleted ISAV of compartments where the health status is dependent on the health status of the aquatic animal population in surrounding natural waters, the risk for the contraction of infection with HPR-deleted ISAV must be regarded as high. |
3. |
Disease-free status must only be maintained as long as all samples tested, using the diagnostic methods set out in point 2 of Section 5, have produced negative results for HPR-deleted ISAV and any suspicion of infection with HPR-deleted ISAV has been ruled out in accordance with the diagnostic methods set out in point 3 of Section 5.
Table 2.B Scheme for Member States, zones or compartments to maintain status free from infection with HPR-deleted ISAV (9)
|
1. |
The organs or tissue material to be sampled and examined must be:
Organ pieces from a maximum of five fish may be pooled. |
2. |
The diagnostic method to be used to grant or to maintain status free from infection with HPR-deleted ISAV in accordance with Sections 2 to 4 must be RT-qPCR, followed by conventional RT-PCR and sequencing of the HE-gene of positive samples in accordance with the detailed methods and procedures which must be those approved by the EURL for fish diseases.
In the case of a positive RT-qPCR result, further samples must be tested before the implementation of the initial control measures provided for in Articles 55 to 65. Those samples must be tested as follows in accordance with the detailed methods and procedures approved by the EURL for fish diseases:
|
3. |
When a suspicion of infection with HPR-deleted ISAV must be confirmed or ruled out in accordance with Article 55, the following visit, sampling and testing procedure must comply with the following requirements:
|
CHAPTER 3
Eradication, disease-free status and diagnostic methods for infection with Marteilia refringens
Health visits and sampling for the surveillance referred to in point (b)(ii) of Article 3(2) must comply with the following requirements:
(a) |
health visits and, where appropriate, the sampling must be carried out in the period of the year when prevalence of the parasite in the Member State, zone or compartment is known to be maximal. When such data is not available, sampling must be carried out just after the water temperature has exceeded 17 °C; |
(b) |
when molluscs must be sampled in accordance with the requirements set out in Sections 2 to 4, the following selection criteria must apply:
|
1. |
The status free from infection with Marteilia refringens may only be granted to a Member State, a zone or a compartment with an unknown health status with regard to infection with Marteilia refringens if all establishments or groups of establishments keeping listed species within the Member State, zone or compartment and where required, sampling points in wild populations, have been subject to the following 3-year scheme:
|
2. |
If Marteilia refringens is detected during the 3-year scheme set out in point 1, before starting a new 3-year scheme, relevant establishments in the Member State, zone or compartment must:
Table 3.A Scheme for Member States, zones or compartments for the 3-year control period which precedes the achievement of status free from infection with Marteilia refringens
|
1. |
The status free from infection with Marteilia refringens may only be granted to a Member State, a zone or a compartment known to be infected with Marteilia refringens, where the competent authority judges that eradication of this disease to be feasible, if all establishments or groups of establishments keeping listed species within that Member State, zone or compartment have been subject to an eradication programme that complies with the following requirements:
|
2. |
The restricted zone must have been defined on a case-by-case basis and:
|
1. |
When targeted surveillance is required in order to maintain the status free from infection with Marteilia refringens of a Member State, a zone or a compartment, in accordance with Article 81, all establishments keeping listed species within the Member State, zone or compartment concerned must be subject to health visits and molluscs must be sampled in accordance with Table 3.B, taking into account the risk level of the establishment for the contraction of infection with Marteilia refringens. |
2. |
When determining the frequency of health visits required to maintain the status free from infection with Marteilia refringens of compartments, where the health-status regarding that disease is dependent on the health-status of the aquatic animal populations in surrounding natural waters, the risk for the contraction of infection with Marteilia refringens must be regarded as high. |
3. |
The status free from infection with Marteilia refringens may only be maintained as long as all samples tested, using the diagnostic methods set out in point 2 of Section 5 have produced negative results for Marteilia refringens and any suspicion of infection with Marteilia refringens has been ruled out in accordance with the diagnostic methods set out in point 3 of section 5.
Table 3.B Scheme for Member States, zones or compartments to maintain disease-free status for Marteilia refringens
|
1. |
The whole animal must be submitted to the laboratory for the performance of the diagnostic tests provided for in points 2 and 3. |
2. |
The diagnostic methods to be used to grant or maintain status free from infection with Marteilia refringens in accordance with Sections 2 to 4 must follow the detailed diagnostic methods and procedures approved by the EURL for Mollusc Diseases and must be histopathology, tissue imprints or PCR. |
3. |
When a suspicion of infection with Marteilia refringens is required to be confirmed or ruled out in accordance with Article 55 the following visit, sampling and testing procedure must be complied with:
|
CHAPTER 4
Eradication, disease-free status and diagnostic methods for infection with Bonamia exitiosa
Health visits and sampling for the surveillance referred to in point (b)(ii) of Article 3(2) must comply with the following requirements:
(a) |
health visits and, where appropriate, the sampling must be carried out in the period of the year when prevalence of the parasite in the Member State, zone or compartment is known to be maximal. When such data is not available, sampling shall be carried out twice a year, in spring and autumn; |
(b) |
when molluscs are to be sampled in accordance with the requirements set out in Sections 2 to 4, the following criteria must apply:
|
1. |
The status free from infection with Bonamia exitiosa may only be granted to a Member State, a zone or a compartment with an unknown health status with regard to infection with Bonamia exitiosa if all establishments or groups of establishments keeping listed species within the Member State, zone or compartment and where required, sampling points in wild populations, have been subject to the following 3-year scheme:
|
2. |
If infection with Bonamia exitiosa is detected during the 3-year scheme referred to in point 1; before starting a new 3-year scheme, relevant establishments in the Member State, zone or compartment must:
Table 4.A Scheme for Member States, zones or compartments for the 3-year control period which precedes the achievement of status free from infection with Bonamia exitiosa
|
1. |
The status free from infection with Bonamia exitiosa may only be granted to a Member State, a zone or a compartment known to be infected with Bonamia exitiosa, where the competent authority judges that eradication of this disease to be feasible, if all establishments or groups of establishments keeping listed species within that Member State, zone or compartment have been subject to an eradication programme that complies with the following requirements:
|
2. |
The restricted zone must have been defined on a case-by-case basis and:
|
1. |
When targeted surveillance is required in order to maintain the status free from infection with Bonamia exitiosa of a Member State, a zone or a compartment, in accordance with Article 81, all establishments keeping listed species within the Member State, zone or compartment concerned must be subject to health visits and molluscs must be sampled in accordance with Table 4.B, taking into account the risk level of the establishment for the contraction of infection with Bonamia exitiosa |
2. |
When determining the frequency of health visits required to maintain the status free from infection with Bonamia exitiosa of compartments where the health status regarding that disease is dependent on the health status of the aquatic animal populations in surrounding natural waters, the risk for the contraction of infection with Bonamia exitiosa must be regarded as high. |
3. |
The status free from infection with Bonamia exitiosa may only be maintained as long as all samples, using the diagnostic methods set out in point 2 of Section 5 have produced negative results for Bonamia exitiosa and any suspicion of infection with Bonamia exitiosa has been ruled out in accordance with the diagnostic methods set out in point 3 of Section 5.
Table 4.B Scheme for Member States, zones or compartments to maintain status free from infection with Bonamia exitiosa
|
1. |
The whole animal must be submitted to the laboratory for the performance of the diagnostic tests provided for in points 2 and 3. |
2. |
The diagnostic methods to be used to grant or maintain status free from infection with Bonamia exitiosa, in accordance with Sections 2 to 4 must follow the detailed diagnostic methods and procedures approved by the EURL for Mollusc Diseases and must be histopathology, tissue imprints or PCR. |
3. |
When a suspicion of infection with Bonamia exitiosa is required to be confirmed or ruled out in accordance with Article 58, the following visit, sampling and testing procedure must be complied with:
|
CHAPTER 5
Eradication, disease-free status and diagnostic methods for infection with Bonamia ostreae
Health visits and sampling for the surveillance referred to in point (b)(ii) of Article 3(2) must comply with the following requirements:
(a) |
health visits and, where appropriate, the sampling must be carried out in the period of the year when prevalence of the parasite in the Member State, zone or compartment is known to be maximal. When such data is not available, sampling must be carried out in winter or at the beginning of spring; |
(b) |
when molluscs are to be sampled in accordance with the requirements set out in Sections 2 to 4, the following criteria must apply:
|
1. |
The status free from infection with Bonamia ostreae may only be granted to a Member State, a zone or a compartment with an unknown health status with regard to infection with Bonamia ostreae if all establishments or groups of establishments keeping listed species within the Member State, zone or compartment and where required, sampling points in wild populations, have been subject to the following 3-year scheme:
|
2. |
If infection with Bonamia ostreae is detected during the 3-year scheme referred to in point 1; before starting a new 3-year scheme, relevant establishments in the Member State, zone or compartment must:
|
1. |
The status free from infection with Bonamia ostreae may only be granted to a Member State, a zone or a compartment known to be infected with Bonamia ostreae, where the competent authority judges that eradication of this disease to be feasible, if all establishments or groups of establishments keeping listed species within that Member State, zone or compartment have been subject to an eradication programme that complies with the following requirements:
|
2. |
The restricted zone must have been defined on a case-by-case basis and:
Table 5.A Scheme for Member States, zones or compartments for the 3-year control period which precedes the achievement of status free from infection with Bonamia ostreae
|
1. |
When targeted surveillance is required in order to maintain the status free from infection with Bonamia ostreae of a Member State, a zone or a compartment, in accordance with Article 81, all establishments keeping listed species within the Member State, zone or compartment concerned must be subject to health visits and molluscs must be sampled in accordance with Table 5.B, taking into account the risk level of the establishment for the contraction of infection with Bonamia ostreae. |
2. |
When determining the frequency of health visits required to maintain the status free from infection with Bonamia ostreae of compartments where the health status regarding that disease is dependent on the health status of the aquatic animal populations in surrounding natural waters, the risk for the contraction of infection with Bonamia ostreae must be regarded as high. |
3. |
The status free from infection with Bonamia ostreae may only be maintained as long as all samples, using the diagnostic methods set out in point 2 of Section 5 have produced negative results for Bonamia ostreae and any suspicion of infection with Bonamia ostreae has been ruled out in accordance with the diagnostic methods set out in point 3 of Section 5.
Table 5.B Scheme for Member States, zones or compartments to maintain status free from infection with Bonamia ostreae
|
1. |
The whole animal must be submitted to the laboratory for the performance of the diagnostic tests provided for in points 2 and 3. |
2. |
The diagnostic methods to be used to grant or maintain status free from infection with Bonamia ostreae, in accordance with Sections 2 to 4 must follow the detailed diagnostic methods and procedures approved by the EURL for Mollusc Diseases and must be histopathology, tissue imprints or PCR. |
3. |
When a suspicion of infection with Bonamia ostreae is required to be confirmed or ruled out in accordance with Article 58, the following visit, sampling and testing procedure must be complied with:
|
CHAPTER 6
Eradication, disease-free status and diagnostic methods for infection with white spot syndrome virus (WSSV)
Health visits and sampling for the surveillance referred to in point (b)(ii) of Article 3(2) must comply with the following requirements:
(a) |
the sampling of crustaceans for laboratory examination must be carried out whenever the water temperature is likely to reach its highest annual point. That requirement concerning water temperature must also apply to health visits where these are feasible; |
(b) |
when farmed crustaceans must be sampled in accordance with the requirements set out in Sections 2 to 4, the following criteria must apply:
|
(c) |
when targeted surveillance in wild populations is required due to the small number of establishments covered by the eradication programme, the number and geographical distribution of the sampling points must be determined to obtain a reasonable coverage of the Member State, zone or compartment. The sampling points must also be representative of the different ecosystems where the wild populations of susceptible species are located namely marine, estuary, river and lake systems. In such situations, the crustaceans to be sampled must be selected as follows:
|
1. |
The status free from infection with WSSV may only be granted to a Member State, a zone or a compartment with an unknown health status with regard to infection with WSSV if all establishments or groups of establishments keeping listed species within the Member State, zone or compartment and where required, sampling points in wild populations, have been subject to the following 2-year scheme:
|
2. |
If infection with WSSV is detected during the 2-year scheme referred to in point 1, before starting a new 2-year scheme, relevant establishments in the Member State, zone or compartment must:
|
1. |
The status free from infection with WSSV may only be granted to a Member State, a zone or a compartment known to be infected with WSSV if all establishments keeping listed species within that Member State, zone or compartment have been subject to an eradication programme that complies with the following requirements:
|
2. |
The restricted zone must have been defined on a case-by-case basis taking into account factors influencing the risks for the spread of WSSV to farmed and wild crustaceans, such as:
Table 6. A Scheme for Member States, zones and compartments for the 2-year control period which precedes the achievement of status free from infection with WSSV
|
1. |
When targeted surveillance is required in order to maintain the status free from infection with WSSV of a Member State, a zone or a compartment, in accordance with Article 81, all establishments keeping listed species within the Member State, zone or compartment concerned must be subject to health visits and crustaceans must be sampled in accordance with Table 6.B, taking into account the risk level of the establishment for the contraction of infection with WSSV. |
2. |
In Member States, zones or compartments where the number of establishments is limited and targeted surveillance in those establishments does not provide sufficient epidemiological data, the surveillance to maintain disease-free status must include sampling points selected in accordance with the requirements laid down in point (b) of Section 1. |
3. |
When determining the frequency of health visits required to maintain the status free from infection with WSSV of compartments where the health status regarding that disease is dependent on the health status of the aquatic animal populations in surrounding natural waters, the risk for the contraction of infection with WSSV must be regarded as high. |
4. |
The status free from infection with WSSV may only be maintained as long as all samples, using the diagnostic methods set out in point 2 of Section 5 have produced negative results for WSSV and any suspicion of infection with WSSV has been ruled out in accordance with the diagnostic methods set out in point 3 of Section 5.
Table 6. B Scheme for Member States, zones or compartments to maintain status free from infection WSSV
|
1. |
Samples of integumental epidermis, either dissected or contained within walking legs, pleopods, mouthparts or gills of the test animal must be fixed in 95 % ethanol prior to the preparation of samples for PCR.
Other samples, fixed for histology and transmission electron microscopy may be collected to support diagnostic data arising from PCR. |
2. |
The diagnostic method and procedures to be used to grant or to maintain disease-free status with regard to infection with WSSV must be PCR followed by sequencing. When applying these diagnostic methods, the corresponding detailed methods and procedures which have been approved by the EURL for Crustacean Diseases must be followed.
In the case of a positive result from the PCR test, the result must be followed by sequencing of the amplicon before the initial control measures provided for in Article 63 of Regulation (EU) 2016/429 are implemented. |
3. |
When a suspicion of infection with WSSV is required to be confirmed or ruled out in accordance with Article 58, the following visit, sampling and testing procedure must be complied with:
|
PART III
REQUIREMENTS FOR DEMONSTRATING THE IMPLEMENTATION OF SURVEILLANCE PROGRAMMES FOR CATEGORY C DISEASES AND FOR RESTARTING THOSE PROGRAMMES AFTER A DISEASE OUTBREAK
Part III covers the requirements for establishments to demonstrate the implementation of a surveillance programme for a particular disease and the requirements to restart that surveillance programme following a disease outbreak.
Viral haemorrhagic septicaemia (VHS) |
Chapter 1 |
Infectious haematopoietic necrosis (IHN) |
Chapter 1 |
Infection with HPR-deleted infectious salmon anaemia virus |
Chapter 2 |
Infection with Marteilia refringens |
Chapter 3 |
Infection with Bonamia exitiosa |
Chapter 4 |
Infection with Bonamia ostreae |
Chapter 5 |
Infection with white spot syndrome virus (WSSV) |
Chapter 6 |
CHAPTER 1
Requirements for establishments to demonstrate the implementation of a surveillance programme for VHS or IHN and requirements to re-start that programme following a disease outbreak
The health visits and sampling referred to in point (b)(iv) of Article 3(2) must comply with the following requirements:
(a) |
health visits and sampling must be carried out during the period of the year when the water temperature is below 14 °C or when temperatures below 14 °C are not reached, samples must be taken at the lowest annual points; |
(b) |
all production units, such as ponds, tanks and net cages, must be examined for the presence of dead, weak or abnormally behaving fish. Particular attention must be paid to the water outlet area where weak fish tend to accumulate because of the water current; |
(c) |
fish of listed species to be collected as samples must be selected as follows:
|
1. |
Health visits must be carried out and fish must be sampled in accordance with Section 1 and Table 1. |
2. |
Samples which are collected in accordance with Section 1 and Table 1 must be tested using the diagnostic methods set out in point 2 of Section 5 of Chapter 1 of Part II and produce negative results for VHS or IHN. |
An establishment which has been infected with VHS or IHN, may restart a surveillance programme for these diseases provided that:
(a) |
it has been emptied in accordance with Article 62, cleaned and disinfected in accordance with Article 63, and fallowed in accordance with Article 64; and |
(b) |
repopulation occurs using fish that originate from establishments which are:
|
Table 1
Surveillance programme for VHS/IHN
Risk level (17) |
Number of health visits per year to each establishment |
Number of fish in the sample (18) |
High |
1 every year |
30 |
Medium |
1 every 2 years |
30 |
Low |
1 every 3 years |
30 |
CHAPTER 2
Requirements for establishments to demonstrate the implementation of a surveillance programme for HPR-deleted ISAV and to re-start that programme after a disease outbreak
The health visits and sampling referred to in point (b)(iv) of Article 3(2) must comply with the following requirements:
(a) |
health visits and sampling must take into account all production units, such as ponds, tanks and net cages, to determine if dead, weak or abnormally behaving fish are present. Particular attention must be paid to the edge of cages or the water outlet area as relevant, where weak fish tend to accumulate because of the water current; |
(b) |
the fish to be collected as samples must be selected as follows:
|
1. |
Health visits must be carried out and fish must be sampled in accordance with Section 1 and Table 2. |
2. |
Samples which are collected in accordance with Section 1 and Table 2 must be tested using the diagnostic methods set out in point 2 of Section 5 of Chapter 2 of Part II and produce negative results for HPR-deleted ISAV.
Table 2 Surveillance programme for HPR-deleted ISAV
|
An establishment which has been infected with HPR-deleted ISAV may restart a surveillance programme for that diseases provided that:
(a) |
it has been emptied in accordance with Article 62, cleaned and disinfected in accordance with Article 63, and fallowed in accordance with Article 64; and |
(b) |
repopulation occurs using fish that originate from establishments which are:
|
CHAPTER 3
Requirements for establishments to demonstrate the implementation of a surveillance programme for infection with Marteilia refringens and requirements to re-start that programme following a disease outbreak
The health visits and sampling referred to in point (b)(iv) of Article 3(2) must comply with the following requirements:
(a) |
health visits and sampling for laboratory examination must be carried out in the period of the year when prevalence of the parasite in the Member State, zone or compartment is known to be maximal. When such data is not available, sampling shall be carried out just after the water temperature has exceeded 17 °C; |
(b) |
when molluscs are to be sampled in accordance with the requirements set out in Table 3, the following criteria must apply:
|
1. |
Health visits must be carried out and molluscs must be sampled in accordance with Section 1 and Table 3. |
2. |
Samples which are collected in accordance with Section 1 and Table 3 must be tested using the diagnostic methods set out in point 2 of Section 5 of Chapter 3 of Part II and produce negative results for Marteilia refringens.
Table 3 Surveillance programme for Marteilia refringens
|
An establishment which has been infected with Marteilia refringens may re-start a surveillance programme for that disease provided that:
(a) |
it has been emptied in accordance with Article 62, cleaned and disinfected in accordance with Article 63, and fallowed in accordance with Article 64; and |
(b) |
repopulation occurs using fish that originate from establishments which are:
|
CHAPTER 4
Requirements for establishments to demonstrate the implementation of a surveillance programme for infection with Bonamia exitiosa and to re-start that programme following a disease outbreak
The health visits and sampling referred to in point (b)(iv) of Article 3(2) must comply with the following requirements:
(a) |
health visits and sampling of production units must be carried out in the period of the year when prevalence of Bonamia exitiosa in the Member State, zone or compartment is known to be maximal. When such data is not available, sampling shall be carried out twice a year, in spring and autumn; |
(b) |
when molluscs are sampled in accordance with the requirements set out in Table 4, the following criteria must apply:
|
1. |
Health visits must be carried out and molluscs must be sampled in accordance with Section 1 and Table 4. |
2. |
Samples which are collected in accordance with Section 1 and Table 4 must be tested using the diagnostic methods referred to in point 2 of Section 5 of Chapter 4 of Part II and produce negative results for Bonamia exitiosa.
Table 4 Surveillance programme for infection with Bonamia exitiosa
|
An establishment which has been infected with Bonamia exitiosa may re-start a surveillance programme provided that:
(a) |
it has been emptied in accordance with Article 62, cleaned and disinfected in accordance with Article 63, and fallowed in accordance with Article 64; and |
(b) |
repopulation occurs using fish that originate from establishments which are:
|
CHAPTER 5
Requirements for establishments to demonstrate the implementation of a surveillance programme for infection with Bonamia ostreae and to re-start that programme following a disease outbreak
The health visits and sampling referred to in point (b)(iv) of Article 3(2) must comply with the following requirements:
(a) |
health visits and sampling of production units shall be carried out in the period of the year when prevalence of Bonamia ostreae in the Member State, zone or compartment is known to be maximal. When such data is not available, sampling shall be carried out in winter or at the beginning of spring; |
(b) |
when molluscs are to be sampled in accordance with the requirements set out in Table 5, the following criteria must apply:
|
1. |
Health visits must be carried out and molluscs must be sampled in accordance with Section 1 and Table 5. |
2. |
Samples which are collected in accordance with Section 1 and Table 5 must be tested using the diagnostic methods referred to in point 2 of Section 5 of Chapter 5 of Part II and produce negative results for Bonamia ostreae.
Table 5 Surveillance programme for infection with Bonamia ostreae
|
An establishment which has been infected with Bonamia ostreae may re-start the surveillance programme for that disease provided that:
(a) |
it has been emptied in accordance with Article 62, cleaned and disinfected in accordance with Article 63, and fallowed in accordance with Article 64; and |
(b) |
repopulation occurs using fish that originate from establishments which are:
|
CHAPTER 6
Requirements for establishments to demonstrate the implementation of a surveillance programme for infection with WSSV and to re-start that programme following a disease outbreak
The health visits and sampling referred to in point (b)(iv) of Article 3(2) must comply with the following requirements:
(a) |
the sampling of crustaceans for laboratory examination must be carried out whenever the water temperature is likely to reach its highest annual point. That requirement concerning water temperature must also apply to health visits where these are feasible and appropriate; |
(b) |
when farmed crustaceans are to be sampled in accordance with the requirements set out in Table 6, the following criteria must apply:
|
1. |
Health visits shall be carried out and crustaceans shall be sampled in accordance with Section 1 and Table 6. |
2. |
Samples which are collected in accordance with Section 1 and Table 6 must be tested using the diagnostic methods referred to in point 2 of Section 5 of Chapter 6 of Part II and produce negative results for infection with WSSV.
Table 6 Surveillance programme for infection with WSSV
|
An establishment which has been infected with WSSV may re-start a surveillance programme for that disease provided that:
(a) |
it has been emptied in accordance with Article 62, cleaned and disinfected in accordance with Article 63, and fallowed in accordance with Article 64; and |
(b) |
repopulation occurs using fish that originate from establishments which are:
|
(1) In the case of coastal zones or coastal compartments, the samples must be collected no sooner than 3 weeks after the transfer of the fish from fresh to saltwater.
(2) Ovarian or seminal fluid of broodstock shall be collected at the time of maturation, in connection with stripping.
(3) In the case of coastal zones or coastal compartments, the samples must be collected no sooner than 3 weeks after the transfer of the fish from fresh to saltwater.
(4) Ovarian or seminal fluid of broodstock shall be collected at the time of maturation, in connection with stripping.
(5) Risk level assigned to the establishment by the competent authority as set out in Chapter 2 of Part I other than in the case of dependent compartments where all establishments are deemed to be high risk.
(6) One sample to be taken during every health visit.
(7) In the case of coastal zones or coastal compartments, the samples must be collected no sooner than 3 weeks after the transfer of the fish from fresh to saltwater.
(8) Samples must be collected during spring and autumn each year.
(9) Shall not apply to establishments rearing only rainbow trout (Oncorhynchus mykiss) or brown trout (Salmo trutta) or both rainbow trout and brown trout, and where the water supply is exclusively based on fresh water sources which are not populated with Atlantic salmon (Salmo salar).
(10) Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter 2 of Part I other than in the case of dependent compartments where all establishments are deemed to be high risk.
(11) Samples must be collected during spring and autumn when two samples are required each year
(12) Samples must be collected during spring or autumn when one sample per year is required.
(13) Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter 2 of Part I other than in the case of dependent compartments where all establishments are deemed to be high risk.
(14) Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter 2 of Part I other than in the case of dependent compartments where all establishments are deemed to be high risk.
(15) Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter 2 of Part I other than in the case of dependent compartments where all establishments are deemed to be high risk.
(16) Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter 2 of Part I other than in the case of dependent compartments where all establishments are deemed to be high risk.
(17) In the case of coastal zones or coastal compartments, the samples must be collected no sooner than 3 weeks after the transfer of the fish from fresh to saltwater.
(18) Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter 2 of Part I. Maximum number of fish per pool: 10
(19) Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter 2 of Part I
(20) Samples must be collected during spring and autumn when two samples are required each year
(21) Samples must be collected during spring or autumn when only one sample is required per year
(22) Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter 2 of Part I
(23) Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter 2 of Part I.
(24) Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter 2 of Part I
(25) Risk level assigned to the establishment by the competent authority as set out in paragraph 1 of Chapter 2 of Part I