# 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), Introduction: Introductory text

Extent: E+W+S+N.I.

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’), 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.
(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 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 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 for bovine brucellosis and bovine tuberculosis and Council Directive 91/68/EEC for brucellosis in sheep and goats. The Animal Health Law repealed those provisions. Also, Commission Delegated Regulation (EU) 2018/1629 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 (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 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.
(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, 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 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. 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, Commission Decision 2002/106/EC; Commission Decision 2003/422/EC, Commission Decision 2006/437/EC, Commission Regulation (EC) No 1266/2007, Commission Decision 2008/896/EC and Commission Implementing Decision (EU) 2015/1554 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,
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Source: https://www.legislation.gov.uk/eur/2020/689/introduction (the official version)
Page: https://openlegislation.uk/eu-regulation-2020-689/introduction
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