3 6 2020 Official Journal of the European Union L 174/211 EN
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, Ar ticle  31(5), 32(2), 37(5), Article  39, Ar ticle  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) T hese 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) Ind eed, 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) Sur veillance 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) T hese 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) T he 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  
(1) OJ L 84, 31  3 2016, p  1 Official Journal of the European Union L 174/212 EN 3 6 2020
(8) In addition t o 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 S tates 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)  Th e 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)  T he 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)  Der ogations 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) sur veillance-based animal health requirements for movements within the Union or for entry into the Union  
(14)  Diagnos tic 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)  T o 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)  T he 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  
(2) R egulation (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) N o 396/2005, (EC) N o 1069/2009, (EC) N o 1107/2009, (EU) N o 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 6 2020 Official Journal of the European Union L 174/213 EN
(17)  T he 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 U nion 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 de tail 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)  T he 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)  Th e 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 er adication 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  
(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) Official Journal of the European Union L 174/214 EN 3 6 2020
(27)  T he 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  long er met, it is also for the competent 
authority to either suspend or withdraw the status  
(29)  Mor eover, 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 Im plementing 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)  Er adication 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 t he 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  long er 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  
(4) Commission Im plementing 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 Directiv e 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 Jul y  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) T errestrial Animal Health Code, World Organisation for Animal Health, 2018  3 6 2020 Official Journal of the European Union L 174/215 EN
(35)  In t he 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)  F ollowing 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)  F or 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 t he 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 sur veillance activities 
after a certain period of continuous disease-free status in the establishment  
(40)  Enzoo tic 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)  U nion 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)  A dditional 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)  T he 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) 
(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) T he 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 ’ Official Journal of the European Union L 174/216 EN 3 6 2020
(45)  U nion 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)  Th e Terrestrial Code lacks a chapter  on B VD and criteria for BVD freedom and related animal movements   However, a 
chapter  on B VD 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)  Im plementing 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)  W ild 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)  F or 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)  Im plementing 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)  F or 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 suscep tible 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 S tate 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  
(11) Council Directiv e 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) EFS A 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  3 6 2020 Official Journal of the European Union L 174/217 EN
(55)  An er adication 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)  Th e 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)  Wh en 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)  Wh en 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)  F ollowing 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 aq uatic 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)  Th e 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 g eneral 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  
(13) R egulation (EC) No  1069/2009 of the European Parliament and of the Council of 21 Oct ober  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) Official Journal of the European Union L 174/218 EN 3 6 2020
(65)  T his 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)  T his 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 t heir technical nature these criteria are laid down in annexes  and g rouped by disease with the criteria for 
maintaining the disease-free statuses  
(68)  It is ap propriate 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)  Im plementing 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)  Im plementing 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)  T wo 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 t he case of aquatic animals, and given the lower level  of r isk 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  long er 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 t he 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  3 6 2020 Official Journal of the European Union L 174/219 EN
(76)  Self-declar ation 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 R egulation 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)  W ith 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 Apr il  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  T his 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  Chap ter  1 of P art 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) t he design of the surveillance including the targeted animal population and the diagnostic methods;
(b) t he disease confirmation and the case definition;
(c) U nion surveillance programmes  
(14) Commission Decision 2000/428/EC of 4 Jul y  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 De cision 2003/422/EC of 26 May  2003  approving an African swine fever diagnostic manual ( OJ L 143, 11  6 2003, p   35) 
(17) Comm ission 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 Oct ober  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) Official Journal of the European Union L 174/220 EN 3 6 2020
3  Ch apter  2 of P art 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) t he disease control strategy, the territory, the animal populations, the targets and the period of application;
(b) t he obligations of operators and competent authorities;
(c) t he disease control measures in the event of suspicion and of confirmation  
4  Cha pter  3 of P art 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) t he disease control strategy, the territory, the animal populations, the targets and the period of application;
(b) t he obligations of operators and competent authorities;
(c) t he disease control measures in the event of suspicion and of confirmation  
5  Cha pter  4 of P art 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) t he criteria for the approval of the disease-free status of Member States and zones;
(b) t he criteria for the approval of the disease-free status for compartments keeping aquaculture animals;
(c) t he criteria for the maintenance of the disease-free status;
(d) t he suspension, the withdrawal and the restoration of disease-free status  
6  P art  III of this Regulation lays down transitional and final provisions in relation to:
(a) t he 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) t he 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 Ar ticle  9(1) of R egulation 
(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;3 6 2020 Official Journal of the European Union L 174/221 EN
 (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 Ar ticle  83(1) is p ublished 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;Official Journal of the European Union L 174/222 EN 3 6 2020
 (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 P art II of Annex  V;
 (31)  ‘honeybees ’ means animals of the Apis mellifera species;
 (32)  ‘breeding poultry ’ means poultry 72  hour s 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
Section  1
Design of surveillance, Targeted animal population and diagnostic methods
Article  3
Design of surveillance
1  The com petent authority shall design the surveillance for listed and emerging diseases of terrestrial animals and other 
animals taking into account:
(a) g eneral surveillance requirements based on:
 (i) no tification as provided for in Article  18(1) of Regulation (EU) 2016/429;
 ( ii) ap propriate veterinary investigation of increased mortalities and other signs of serious diseases or significantly 
decreased production rates with an undetermined cause;
 (iii) in vestigation by the competent authority in the event of the suspicion of a category  E disease or, if relevant, of an 
emerging disease;
 (iv) t argeted animal population for surveillance as provided for in Article  4;
 (v) t he contribution of official controls and other official activities as provided for in Article  7;
(b) specif ic surveillance requirements:
 (i) in Union surveillance programme;
 (ii) as a par t of compulsory or optional eradication programmes;
 (iii) f or demonstrating and maintaining disease-free status;
 (iv) as a par t of disease control measures;
 (v) in the context of approval of certain establishments;
 (vi) f or the movements of terrestrial animals within the Union or their entry into the Union  3 6 2020 Official Journal of the European Union L 174/223 EN
2  T he competent authority shall design the surveillance for listed and emerging diseases of aquatic animals taking into 
account:
(a) g eneral surveillance requirements based on:
 (i) no tification as provided for in Article  18(1) of Regulation (EU) 2016/429;
 ( ii) ap propriate veterinary investigation of increased mortalities and other signs of serious diseases or significantly 
decreased production rates with an undetermined cause;
 (iii) in vestigation by the competent authority in the event of the suspicion of a category  E disease or, if relevant, of an 
emerging disease;
 (iv) t argeted animal population for surveillance as provided for in Article  4;
 (v) t he contribution of official controls and other official activities as provided for in Article  7;
 (vi) disease control measures;
(b) specif ic surveillance requirements:
 (i) as a par t of the risk-based surveillance scheme set out in Chapter  1 of P art I of Anne x VI, in volving a risk ranking 
and regular animal health visits as provided for in Chapters  2 and 3 of Part  I of Annex  VI;
 (ii) as a par t of the eradication programmes provided for in Chapters  1 to 6 of Part  II of Annex  VI;
 (iii) f or demonstrating and maintaining disease-free status;
 (iv) f or demonstrating, in accordance with the surveillance programmes provided for in Chapters  1 to 6 of Part  III of 
Annex  VI, t hat establishments which are not participating in the eradication programme referred to in point  (ii) or 
which have not obtained the disease-free status referred to in point  (iii) are not infected;
 (v) f or the movements of aquatic animals within the Union or their entry into the Union  
Article  4
Targeted animal population
1  Th e 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) k ept animals of listed species;
(b) wild animals of listed species if:
 (i) t hey are subject to a Union surveillance programme, or to a compulsory or an optional eradication programme or 
to the surveillance necessary for the granting or maintenance of a disease-free status;
 (ii) t he competent authority considers that they constitute a risk that may impair the health status of other species in 
a Member State, zone or compartment; or
 (iii) sur veillance is necessary to assess animal health requirements for entry into the Union or movements within the 
Union  
2  T o ensure the early detection of an emerging disease in species other than those referred to in point  (a) of par agraph  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) t hey are moved to establishments in another Member State, zone or compartment; and
(b) due t o 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  Official Journal of the European Union L 174/224 EN 3 6 2020
Article  5
Exclusion of certain kept terrestrial animals from the targeted animal population
1  By wa y 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) U nion surveillance programmes;
(b) com pulsory or optional eradication programmes or surveillance necessary for the granting or maintenance of a disease-
free status; or
(c) sur veillance-based animal health requirements for the movements within the Union or the entry into the Union  
2  The cat egories 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  Th e 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) wit h 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) wh en not covered by the legislation, details and guidance referred to in point  (a), wit h 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 Anne x III for infection with Brucella abortus, B.  melitensis  and B.suis ;
(b) Section  2 of Anne x III for infection with Mycobacterium tuberculosis  complex (Mycobacterium bovis, M.caprae  and 
M. tuberculosis ) (MTBC);
(c) Section  3 of Anne x III for enzootic bovine leukosis (EBL);
(d) Section  4 of Anne x III for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV);
(e) Section  5 of Anne x III for infection with Aujeszky ’s disease virus (ADV);
(f) Section  6 of Anne x III for bovine viral diarrhoea (BVD);
(g) point  2 of Section  5 of Chap ter 1 of P art II of Annex  VI for viral haemorrhagic septicaemia (VHS);
(h) point  2 of Section  5 of Chap ter 1 of P art II of Annex  VI for infectious haematopoietic necrosis (IHN);
(i) p oint  2 of Section  5 of Ch apter  2 of P art 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 Chap ter 3 of P art II of Annex  VI for infection with Marteilia refringens;
(21) http://www  oie int/e n/standard-setting/terrestrial-manual/access-online/
(22) http://www  oie int/e n/standard-setting/aquatic-manual/access-online/3 6 2020 Official Journal of the European Union L 174/225 EN
(k) point  2 of Section  5 of Chap ter 4 of P art II of Annex  VI for infection with Bonamia exitiosa ;
(l) point  2 of Section  5 of Chap ter 5 of P art II of Annex  VI for infection with Bonamia ostreae ;
(m) point  2 of Section  5 of Chap ter 6 of P art 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  T he competent authority shall, if relevant, include in the design of the surveillance referred to in Article  3 of t his 
Regulation the outcome of the official controls and other official activities defined in Article  2 of R egulation (EU) 2017/625   
These official controls and other official activities include:
(a) ant e-mortem and post-mortem inspections;
(b) inspections at border control posts;
(c) of ficial controls and other official activities at markets and assembly operations;
(d) of ficial controls and other official activities during transport of live animals;
(e) public health related inspections and sampling in establishments;
(f) an y other official controls during which establishments, animals or samples are inspected or examined  
2  Wh en 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 sh all ensure that all relevant authorities are informed   This shall be done:
(a) immediat ely in case of a category  A disease or of an emerging disease;
(b) wit hout delay for other diseases  
Section  2
Disease confirmation and case definitions
Article  8
Criteria for official confirmation of listed diseases, other than category  A diseases, and certain emerging 
diseases and subsequent confirmation of outbreaks
1  Th e 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) t here is a need to determine the health status of the Member State, zone or compartment thereof; or
(b) t here is a need to collect necessary information on the occurrence of the disease for any of the following purposes:
 (i) t o implement measures to protect animal or human health;
 (ii) t o implement animal health requirements for movements of animals or products; or
 (iii) t o comply with the requirements laid down in a Union surveillance programme  
2  T he competent authority shall confirm an outbreak of any of the diseases referred to in paragraph  1 wh en it has classified 
an animal or a group of animals as a confirmed case of these diseases in accordance with Article  9(2)  Official Journal of the European Union L 174/226 EN 3 6 2020
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, pos t-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 com petent 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) t he disease agent, excluding vaccine strains, has been isolated in a sample from an animal or from a group of animals;
(b) an antig en 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 positiv e 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 specif ic 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 Chap ters 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  
Section  3
Union surveillance programme
Article  10
Criteria for and contents of Union surveillance programmes
1  A cat egory  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 p articular 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) inf ected 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 3 6 2020 Official Journal of the European Union L 174/227 EN
Article  11
Information to be included in the submission of and reporting on Union surveillance programmes
1  The com petent authority shall, when submitting a Union surveillance programme, include in that submission at least 
the following information:
(a) descr iption 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) t argeted animal population, epidemiological units and zones of the programme;
(c) or ganisation 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) descr iption and demarcation of the geographical and administrative areas in which the programme is to be implemented;
(e) indicat ors to measure the progress of the programme;
(f) diagnos tic methods used, number of samples tested, frequency of testing and sampling patterns;
(g) r isk 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) t he 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) t he 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
Section  1
General provisions
Article  12
Disease control strategy for the eradication of category  B and C diseases of terrestrial animals
1  The com petent 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) t he territory and animal population covered by the eradication programme as provided for in Article  13(1);
(b) t he 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) t he disease specific requirements laid down:
 (i) in Articles  16 t o 31 for infection with Brucella abortus, B.  melitensis  and B. suis, infection with MTBC, EBL, IBR/IPV, 
infection with ADV and BVD;
 (ii) in Articles  32 t o 36 for infection with rabies virus (RABV);
 (iii) in Articles  37 t o 45 for infection with BTV  Official Journal of the European Union L 174/228 EN 3 6 2020
2  T he 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) t he territory covered; and
(b) t he 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) t he 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 wa y 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) t he 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  T he 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 t he disease specific requirements referred to in paragraph  1; and
(b) if necessar y, 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  F or 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  3 6 2020 Official Journal of the European Union L 174/229 EN
Section  2
Requirements for eradication programmes based on granting disease-free  
status at the level  of establishments
Article  16
Disease control strategy based on the disease-free status at establishment level
1  T he 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) inf ection with Brucella abortus, B.  melitensis  and B. suis;
(b) inf ection with MTBC;
(c) EBL;
(d) IBR/IPV;
(e) inf ection with ADV;
(f) BVD  
2  Disease control strategies of eradication programmes referred to in paragraph  1 shall be based on:
(a) t he implementation of disease specific measures laid down in Articles  18 to 31 until all relevant establishments reach 
disease-free status;
(b) t he granting, suspension and withdrawal by the competent authority of the disease-free status of all relevant establishments;
(c) t he implementation of biosecurity and other risk mitigating measures;
(d) t he optional implementation of vaccination programmes  
Article  17
Targeted and additional animal populations for eradication programmes for certain diseases
1  T he competent authority shall apply a compulsory eradication programme to the following targeted animal populations:
(a) f or infection with Brucella abortus, B.  melitensis  and B. suis, kept bovine animals, kept ovine animals and kept caprine 
animals;
(b) f or infection with MTBC, kept bovine animals  
2  T he competent authority shall apply the optional eradication programme to the following targeted animal populations:
(a) f or EBL, kept bovine animals;
(b) f or IBR/IPV, kept bovine animals;
(c) f or infection with ADV, kept porcine animals;
(d) f or BVD, kept bovine animals  
3  Th e 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  Official Journal of the European Union L 174/230 EN 3 6 2020
Article  18
Obligations of operators with respect to eradication programmes for certain diseases
1  The oper ators 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) g eneral requirements:
 ( i) sur veillance of the targeted and additional animal populations for the relevant disease as ordered by the competent 
authority pursuant to Article  3(1);
 (ii) in the case of movement of animals from the targeted animal populations, ensuring that the health status of the 
establishments is not jeopardised due to transport or introduction into the establishments of animals of the targeted 
or additional animal populations or products thereof;
 (iii) v accination of the kept animals of targeted animal populations against the relevant disease;
 (iv) disease control measures in the event the disease is suspected or confirmed;
 (v) an y additional measures considered necessary by the competent authority that may include, if relevant, separation 
of animals according to their health status by physical protection measures and management measures;
(b) disease specific requirements laid down in:
 (i) Chap ters  1 and 2 of Part  I of Annex  IV for infection with Brucella abortus, B.  melitensis  and B. suis;
 (ii) Chap ter  1 of P art II of Annex  IV for infection with MTBC;
 (iii) Chap ter  1 of P art III of Annex  IV for EBL;
 (iv) Chap ter  1 of P art IV of Annex  IV for IBR/IPV;
 (v) Chap ter  1 of P art V of Anne x IV for infection with ADV;
 (vi) Chap ter  1 of P art VI of Annex  IV for BVD  
2  T he operators of slaughterhouses, where animals from the targeted animal populations referred to in Article  17 are k ept 
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 pr ovided that the relevant targeted animal populations comply with the general 
requirements laid down in point  (a) of Ar ticle  18(1), t he competent authority may decide that the obligations of operators to 
obtain and maintain disease-free status laid down in Article  18(1) do no t apply to operators of the following establishments:
(a) conf ined establishments;
(b) es tablishments where animals are only kept for assembly operations;
(c) es tablishments where animals are only kept for the purpose of animal acts;
(d) tr avelling circuses  
Article  20
Obligation of the competent authority to grant, suspend and withdraw disease-free status
1  T he competent authority shall grant disease-free status at establishment level  accor ding to the compliance of the 
establishments’ operators with the requirements laid down in Article  18 3 6 2020 Official Journal of the European Union L 174/231 EN
2  The competent authority shall suspend or withdraw disease-free status at establishment level  when t he 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 P art II of Annex  IV for infection with MTBC;
(c) Sections  3 and 4 of Chapter  1 of P art III of Annex  IV for EBL;
(d) Sections  3 and 4 of Chapter  1 of P art IV of Annex  IV for IBR/IPV;
(e) Sections  3 and 4 of Chapter  1 of P art V of Anne x IV for infection with ADV;
(f) Sections  3 and 4 of Chapter  1 of P art VI of Annex  IV for BVD  
3  The competent authority shall specify:
(a) t he 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) t he 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  T he competent authority may attribute distinct health status to different epidemiological units of the same establishment 
provided that its operator:
(a) has subm itted 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) h as 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) h as 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  T he 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  P ending the outcome of the investigations and the epidemiological enquiry referred to in paragraph  1, the competent 
authority:
(a) sh all 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:
 (i) where t echnically possible, order the isolation of the suspected cases in the establishment;
 (ii) res trict the introduction of animals from the relevant targeted animal population into the establishment;
 (iii) res trict the movement of products from the relevant targeted animal population from or to the establishment  
3  T he competent authority shall maintain the measures referred to in paragraphs  1 and 2 until t he presence of the disease 
has been ruled out or confirmed  Official Journal of the European Union L 174/232 EN 3 6 2020
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) rele vant additional animal populations kept in the establishment;
(b) an y establishment which has an epidemiological link with the establishment where the suspected case occurred  
2  If t he 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 wa y 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 wa y of derogation from point  (a) of Ar ticle  21(2), t he 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) t he animals shall only be moved by direct transport;
(b) in the establishment of destination, the animals shall be kept in closed facilities, with no  cont act with kept animals of 
a higher health status or with wild animals of listed species for the relevant disease  
3  By wa y 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) su spend 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) pr ohibit, until the end of the investigations referred to in Article  21(1), t he 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 ha ve been slaughtered  
5  Th e 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) appl y appropriate biosecurity and other risk mitigating measures necessary to prevent the spread of the disease; and
(b) pr ovide 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) wit hdraw the disease-free status of the infected establishment(s);3 6 2020 Official Journal of the European Union L 174/233 EN
(b) adop t the measures laid down in Articles  25 to 31 in the infected establishment(s)  
2  By wa y 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 t he 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) or der relevant disease control measures as provided for in Articles  21 t o 25 and in Article  30 in es tablishments keeping 
the targeted animal population and the additional animal populations;
(b) cond uct 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 t he 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) adap t 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) oper ators and relevant authorities from the Member States concerned by the epidemiological links with the confirmed 
case; and
(b) t he 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 t he competent authority considers it necessary in order to prevent the spread of the disease, it shall:
(a) or der the isolation of the suspected and confirmed cases in the establishment where technically possible;
(b) res trict the movements of animals from targeted animal population within the establishment;
(c) res trict the introduction of animals from targeted animal population in the establishment;
(d) res trict 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 t o animals 
and products from additional animal populations to prevent the spread of the disease  Official Journal of the European Union L 174/234 EN 3 6 2020
Article  27
Testing and removal of animals from infected establishments
1  F ollowing 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) t esting of those animals whose testing is considered necessary to complete the epidemiological enquiry;
(b) t esting to restore the disease-free status as laid down in:
 (i) Section  4 of Chap ters 1 and 2 of Part  I of Annex  IV for infection with Brucella abortus, B.  melitensis and B.  suis;
 (ii) Section  4 of Chap ter 1 of P art II of Annex  IV for infection with MTBC;
 (iii) Section  4 of Chap ter 1 of P art III of Annex  IV for EBL;
 (iv) Section  4 of Chap ter 1 of P art IV of Annex  IV for IBR/IPV;
 (v) Section  4 of Chap ter 1 of P art V of Annex  IV for infection with ADV;
 (vi) Section  4 of Chap ter 1 of P art VI of Annex  IV for BVD; and
(c) an y additional testing it considers necessary to ensure the swift detection of infected animals that may contribute to the 
spreading of the disease  
2  By wa y of derogation from point  (b) of paragraph  1, testing shall not be ordered when disease-free status is restored in 
accordance with:
 ( i) p oint  2 of Section  1 of Chap ters 1 and 2 of P art I of Annex  IV for infection with Brucella abortus, B.  melitensis  and B. suis;
 (ii) point  2 of Section  1 of Chap ter 1 of P art II of Annex  IV for infection with MTBC;
 (iii) point  2 of Section  1 of Chap ter 1 of P art III of Annex  IV for EBL;
 (iv) point  2 of Section  1 of Chap ter 1 of P art IV of Annex  IV for IBR/IPV;
 (v) point  2 of Section  1 of Chap ter 1 of P art V of Anne x IV for infection with ADV;
 (vi) point  2 of Section  1 of Chap ter 1 of P art VI of Annex  IV for BVD  
3  T he 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  T he slaughtering of the animals referred to in paragraph  3 sh all be carried out under official supervision in a designated 
slaughterhouse  
5  T he 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  T he 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  Th e 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;3 6 2020 Official Journal of the European Union L 174/235 EN
(b) manu re, 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  Th e 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 wa y of derogation from Article  26(1), t he 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) t he movement does not jeopardise the health status of animals at the establishment of destination or enroute to that 
destination;
(b) t he 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  cont act with kept animals of 
a higher health status or with wild animals of listed species for the relevant disease  
2  By wa y of derogation from Article  26(1) in t he 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) t hey 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) t he 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 makin g 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) or der 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 t o 30 until the disease-free 
status of the establishment is regained  
4  T he competent authority may use the derogations provided for in paragraphs  1 and 2 onl y if operators of establishments 
of origin and of destination and transporters of the animals that are subject to the derogations:
(a) appl y appropriate biosecurity and other risk mitigating measures necessary to prevent the spread of the disease; and
(b) p rovide the competent authority with the guarantees that all the necessary biosecurity and other risk mitigating measures 
have been taken  Official Journal of the European Union L 174/236 EN 3 6 2020
Article  30
Cleaning and disinfection and other measures to prevent the spread of infection
1  T he 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 p arts of the establishments that may have been contaminated after the removal of the confirmed and suspected cases 
and before repopulation;
(b) an y feed, materials, substances, husbandry related equipment, medicinal equipment and production related equipment 
that may have been contaminated;
(c) an y protective clothing or safety equipment used by operators and visitors;
(d) all means of tr ansport, 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  T he 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  T he 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) per sistence of the disease agent in the environment or in wild animals; and
(b) biosecur ity measures that are adapted to the specificities of the establishment  
Section  3
Provisions for eradication programmes for infection with RABV
Article  32
Disease control strategy of eradication programmes for infection with RABV
1  T he competent authority shall, when establishing an eradication programme for infection with RABV, base it on a disease 
control strategy that includes:
(a) v accination of the animals from the targeted animal population that it considers relevant;
(b) im plementation of measures to reduce the risk of contact with infected animals;
(c) contr ol 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) suppor ted by public information campaigns involving all relevant stakeholders;3 6 2020 Official Journal of the European Union L 174/237 EN
(c) coor dinated, 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 com petent 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  T he 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  Th e competent authority shall address the measures in the eradication programme primarily to wild foxes, being the 
main reservoir of RABV  
3  T he 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  T he 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:
 (i) ear ly detection of the infection; and
 (ii) f ollow up of the trend in the number of infected animals, which shall include, according to a risk-based approach, 
the collection and testing of wild foxes and other wild carnivores found dead;
(b) car ry out disease control measures in the event of suspicion or confirmation of infection with RABV as laid down in 
Articles  35 and 36;
(c) appl y, 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) v accination, and the monitoring of the effectiveness of vaccination, in accordance with Section  2 of Chap ter 1 of P art I 
of Annex  V of wild foxes and, if relevant, of other animals referred to in Article  33(3);
(b) t he identification and registration of dogs, cats and ferrets;
(c) mo vement restrictions of relevant kept animals of species referred to in Article  33(3) t hat are not vaccinated against 
infection with RABV in accordance with Section  1 of Chap ter 1 of P art I of Annex  V;
(d) t he 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 Official Journal of the European Union L 174/238 EN 3 6 2020
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) or der 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) or der 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 sh all 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 sh all, unless it considers further investigations are necessary, rule out an infection with RABV in animals with an 
epidemiological link when:
 (i) a minimum period of 3  months has lapsed since the epidemiological link with the confirmed case occurred; and
 (ii) no clinical signs have been detected in those animals;
(c) it shall, when it considers it necessary, take one or more of the measures laid down in Articles  34 and 35;
(d) it sh all 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  
Section  4
Provisions for eradication programmes for infection with BTV
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) sur veillance of infection with BTV in accordance with the requirements set out in Chapter  1 of P art II of Annex  V;
(b) v accination 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) mo vement restrictions of the targeted animal population in accordance with the requirements laid down in Articles  43 
and 45;
(d) r isk 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) t he territory covered by the eradication programme shall be:
 (i) t he whole territory of the Member State; or
 (ii) a zone or zones that include a territory within at least a 150-km radius of each infected establishment  3 6 2020 Official Journal of the European Union L 174/239 EN
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) t he geographical situation of the infected establishment(s) and the boundaries of the corresponding administrative units;
(b) t he ecological and meteorological conditions;
(c) t he abundance, activity and distribution of the vectors present in the zone(s);
(d) t he BTV serotype involved;
(e) t he results of the epidemiological enquiry provided for in Article  42;
(f) t he results of the surveillance activities  
Article  38
Targeted and additional animal populations for eradication programmes for infection with BTV
1  T he 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  T he 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  Th e operators of establishments, other than slaughterhouses, where animals from the targeted animal population referred 
to in Article  38(1) are kept shall:
(a) com ply with the requirements ordered by the competent authority as regards the surveillance of animals from the 
targeted animal population;
(b) com ply with the requirements ordered by the competent authority as regards the entomological surveillance;
(c) ha ve animals from the targeted animal population vaccinated following the orders of the competent authority;
(d) im plement disease control measures in the event the disease is suspected or confirmed following the orders of the 
competent authority;
(e) com ply with movement requirements following the orders of the competent authority;
(f) im plement 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) com ply with the requirements ordered by the competent authority as regards the surveillance of animals from the 
targeted animal population;
(b) im plement disease control measures in the event the disease is suspected or confirmed following the orders of the 
competent authority;
(c) im plement 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  Official Journal of the European Union L 174/240 EN 3 6 2020
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 t he 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 sur veillance 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 P art II of Annex  V;
(c) ap ply the disease control measures laid down in Articles  41 and 42 in t he event of suspicion or confirmation of the 
disease;
(d) or der operators of establishments of bovine, ovine or caprine animals and, if necessary, other targeted animal populations 
to have their animals vaccinated; and
(e) ap ply the requirements laid down in Articles  43 and 45 to the movements of animals from the targeted animal population  
2  By wa y of derogation from point  (d) of p aragraph  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 P art II of Annex  V  In that event, the competent authority shall make available to the Commission 
and to the other Member States:
(a) inf ormation demonstrating the fulfilment of the specific criteria for determining the seasonally BTV-free period;
(b) t he start and end dates of the period;
(c) inf ormation demonstrating the cessation of the transmission of BTV in the area; and
(d) t he 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  P ending the outcome of the investigation referred to in paragraph  1, the competent authority shall:
(a) res trict 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) or der 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  Th e 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  3 6 2020 Official Journal of the European Union L 174/241 EN
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) conf irm the outbreak and, if necessary, establish or extend the zone under eradication programme;
(b) conduct an epidemiological enquiry, if necessary;
(c) res trict movement of animals of the targeted animal population from the establishment where they are kept unless 
authorised for the purpose of immediate slaughter;
(d) res trict movement of germinal products of animals from the targeted animal population from the establishment where 
they are kept;
(e) or der 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) appl y 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) or der 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) in vestigate and monitor the health status of the targeted animal population in the proximity of the establishment where 
the confirmed case is kept  
3  Th e 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 Ar ticle  37(2) if t hey 
comply with at least one of the requirements set out in points  1 to 4 of Section  1 of Chap ter 2 of P art II of Annex  V 
2  By wa y 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:
 (i) f or a period of 60  days after the introduction; or
 (ii) until a negative polymerase chain reaction (PCR) test for BTV serotypes 1-24 was carried out on samples collected 
not earlier than 14  days after the introduction;
(c) it adap ts, if necessary, the surveillance in accordance with point  6 of Section  4 of Chap ter 1 of P art II of Annex  V; and
(d) t he animals comply with any one of the requirements set out in points  5 to 8 of Section  1 of Chap ter 2 of P art II of 
Annex  V Official Journal of the European Union L 174/242 EN 3 6 2020
3  T he 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 Chap ter 2 of P art II of Annex  V 
4  By wa y 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) t he germinal products comply with the requirements set out in point  4 of Section  2 of Ch apter  2 of P art II of Annex  V 
5  Wh en the competent authority receiving the animals or the germinal products uses the derogations provided for in 
paragraphs  2 or 4, it shall:
(a) inf orm the Commission thereof as soon as possible;
(b) accep t 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 t he competent authority receiving the animals or the germinal products no  long er 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  T he 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 P art II of Annex  V 
2  Th e 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  T he 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) t he 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 Chap ter 2 of P art II of Annex  V; or
(b) t he 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 wa y 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  3 6 2020 Official Journal of the European Union L 174/243 EN
CHAPTER  3
Eradication programmes for category  B and C diseases of aquatic animals
Section  1
General provisions
Article  46
Disease control strategy for the eradication of category  B and C diseases of aquatic animals
1  The com petent 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) t he 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) t he territory and animal population covered by the eradication programme as provided for in Articles  47 and 51;
(c) t he duration of the eradication programme provided for in Article  49 including its f inal and intermediate targets as 
provided for in Article  48;
(d) t he disease specific preventive and control measures laid down in Articles  55 to 65  
2  T he 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) t he territory covered; and
(b) t he 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 ma y be:
(a) t he entire territory of the Member State;
(b) one or se veral zones; or
(c) t he geographical location of the establishments of which the compartment or compartments are comprised  
3  All es tablishments located within the Member State, zone or compartment covered by the eradication programme shall 
be included in the eradication programme  
4  By wa y 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  T he 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  Official Journal of the European Union L 174/244 EN 3 6 2020
2  Wh ere 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  T he 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 t he disease specific requirements referred to in paragraph  1 and the targets provided for in paragraph  2; and
(b) if necessar y, 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  T he period of application of eradication programmes for listed aquatic animal diseases are laid down in Part  II of 
Annex  VI, specif ically Sections  2 and 3 of:
(a) Chap ter  1 for VHS and IHN;
(b) Chap ter  2 for infection with HPR-deleted ISAV;
(c) Chap ter  3 for infection with Marteilia refringens;
(d) Chap ter  4 for infection with Bonamia exitiosa ;
(e) Chap ter  5 for infection with Bonamia ostreae ;
(f) Chap ter  6 for infection with WSSV  
2  F or 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  
Section  2
Requirements for Eradication programmes
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) t he 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) t he implementation of disease control measures in all establishments where suspected and confirmed cases are detected;
(c) t he 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  T he competent authority shall apply the eradication programme to listed species kept in establishments within the 
territory of the Member State, the zone or compartment  3 6 2020 Official Journal of the European Union L 174/245 EN
2  By wa y 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  Wh ere technically feasible, the competent authority shall include in the eradication programme additional animal 
populations when such animals:
(a) pose a signif icant 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) t he health status of each establishment as known at the time the eradication programme commences;
(b) t he compliance with conditions for the introduction of animals from listed species into the establishment;
(c) t he compliance by the operator with the obligation to notify the competent authority of any suspicion or detection of 
the disease;
(d) t he fulfilment of disease control measures to be applied if the disease is suspected or confirmed;
(e) t he vaccination regimes that may apply to animals from listed species kept in the establishment;
(f) an y additional measures considered necessary by the competent authority  
2  The competent authority shall:
(a) commence, main tain, or withdraw the eradication programme according to the compliance or non-compliance of 
establishments with the requirements laid down in paragraph  1;
(b) inf orm the operators of the relevant establishments about the evolution of the health status and the necessary measures 
for granting disease-free status  
3  Oper ators 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) v accination of listed species;
(b) v accination of an additional animal population of kept animals;
(c) v accination of an additional animal population of wild animals  Official Journal of the European Union L 174/246 EN 3 6 2020
Article  55
Disease control measures in the event of suspicion of certain diseases
1  T he competent authority shall, when it suspects a case of the relevant disease in an establishment, conduct the necessary 
investigation  
2  P ending the outcome of the investigation referred to in paragraph  1, the competent authority shall:
(a) pr ohibit the introduction of animals or products of animal origin into the establishment;
(b) where t echnically possible, order the isolation of units in the establishment where suspected animals are kept;
(c) p rohibit 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) pr ohibit the movement of equipment, feed and animal by-products from the establishment unless authorised by the 
competent authority  
3  T he competent authority shall maintain the measures referred to in paragraphs  1 and 2 until t he 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) an y establishment which due to hydrodynamic conditions, has an increased risk of contracting the disease from the 
suspected establishment;
(b) an y 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 Ar ticle  55(2) t he 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) onl y animals showing no  symptoms of disease are moved;
(b) t he 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 t he establishment of destination they have no  cont act with aquaculture animals of a higher health status with respect 
to the relevant disease; and
(d) t he 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) p rohibit 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 6 2020 Official Journal of the European Union L 174/247 EN
3  Th e competent authority may use the derogation provided for in paragraph  1 onl y if operators of establishments of 
origin and of destination and transporters of the animals that are subject to the derogation:
(a) appl y appropriate biosecurity and other risk mitigating measures necessary to prevent the spread of the disease;
(b) pr ovide the competent authority with guarantees that all the necessary biosecurity and other risk mitigating measures 
have been taken; and
(c) p rovide 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 t his Article  are pr ocessed 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 t he establishment(s) infected;
(b) reclassify the health status of the infected establishment(s);
(c) es tablish a restricted zone which is of an appropriate size;
(d) adop t the measures laid down in Articles  59 to 65 in the infected establishment(s)  
2  T he 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 Chap ter 1 for VHS and IHN;
(b) point  1(a) of Section  3 of Chap ter 2 for infection with HPR-deleted ISAV;
(c) point  1(a) of Section  3 of Chap ter 3 for infection with Marteilia refringens;
(d) point  1(a) of Section  3 of Chap ter 4 for infection with Bonamia exitiosa ;
(e) point  1(a) of Section  3 of Chap ter 5 for infection with Bonamia ostreae ;
(f) point  1(a) of Section  3 of Chap ter 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 t he 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) t he movement of well-boats through the restricted zone;
(b) f ishing activities;
(c) o ther activities that may pose a risk of disease spread  
5  If the disease is confirmed in wild aquatic animals, the competent authority may:
(a) de velop 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) appl y intensified surveillance of wild aquatic animal populations and in establishments having a direct epidemiological 
link with the confirmed case;
(c) t ake measures to eradicate the disease from the relevant wild aquatic animal population, where feasible  Official Journal of the European Union L 174/248 EN 3 6 2020
Article  59
Epidemiological enquiry and investigations in case of confirmation of certain diseases
1  When t he disease is confirmed, the competent authority shall:
(a) conduct an epidemiological enquiry;
(b) conduct in vestigations and apply the measures laid down in Article  55(2) in all ep idemiologically linked establishments;
(c) adap t the surveillance to the identified risk factors, taking into account the conclusions of the epidemiological enquiry  
2  Th e 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) oper ators and relevant authorities from the Member State concerned by the epidemiological links with the confirmed 
case; and
(b) t he 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 t echnically possible, order the isolation of suspected and confirmed cases;
(b) pr ohibit 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) p rohibit 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) pr ohibit 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) t o (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 wa y of derogation from point  (b) Ar ticle  60(1), t he 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) onl y animals showing no  symptoms of disease are moved;
(b) t he 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 t he establishment of destination they have no  cont act with aquaculture animals of a higher health status with respect 
to the relevant disease;
(d) t he animals are kept in the establishment of destination for a maximum period of time to be determined by the competent 
authority  3 6 2020 Official Journal of the European Union L 174/249 EN
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) pr ohibit 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 R egulation (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) k eep the establishment of destination under its official supervision until the completion of cleaning, disinfection and 
appropriate fallowing of the establishment  
3  By wa y of derogation from point  (b) Ar ticle  60(1), t he 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) onl y animals showing no  symptoms of disease are moved;
(b) t he 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) t he 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) onl y animals showing no  symptoms of disease are moved;
(b) t he 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) t he health status of aquatic animals enroute for the slaughtering and processing facility or in its vicinity is not jeopardised 
by the movement;
(d) t he movement complies with the certification requirements set out in Article  208(2) of Regulation (EU) 2016/429  
5  By wa y of derogation from point  (b) of Ar ticle  60(1), t he 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 r isk assessment has been completed;
(b) r isk 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) t he movement complies with the certification requirements set out in Article  208(2) of Regulation (EU) 2016/429  
Article  62
Removal of infected animals
1  F ollowing 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) remo val of all dead animals;
(b) remo val and killing of all moribund animals;
(c) remo val and killing of all animals showing symptoms of disease;
(d) slaught ering 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) t o (c) have been completed  Official Journal of the European Union L 174/250 EN 3 6 2020
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) suspect ed animals which have an epidemiological link with a confirmed case  
3  Slaught ering for human consumption or removal from the water of the animals referred to in paragraph  1 sh all 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  T he 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  T he 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 b y-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  T he competent authority shall for all infected establishments order the cleaning and disinfection of the following structures 
and items prior to repopulation:
(a) t he 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) an y husbandry related equipment including but not limited to feeding, grading, treatment and vaccination equipment, 
and workboats;
(c) an y production related equipment including but not limited to cages, netting, trestles, bags and longlines;
(d) an y protective clothing or safety equipment used by operators and visitors;
(e) all means of tr ansport 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 Chap ter 1 for VHS and IHN;
(b) point  1(c) of Section  3 of Chap ter 2 for infection with HPR-deleted ISAV;
(c) point  1(c) of Section  3 of Chap ter 3 for infection with Marteilia refringens;3 6 2020 Official Journal of the European Union L 174/251 EN
(d) point  1(c) of Section  3 of Chap ter 4 for infection with Bonamia exitiosa ;
(e) point  1(c) of Section  3 of Chap ter 5 for infection with Bonamia ostreae ;
(f) point  1(c) of Section  3 of Chap ter 6 for infection with WSSV  
3  The  competent authority shall order synchronous fallowing of the infected establishments within the protection zone or 
where no  pr otection 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 Chap ter 1 for VHS and IHN;
(b) point  1 of Section  3 of Chap ter 2 for infection with HPR-deleted ISAV;
(c) point  1 of Section  3 of Chap ter 3 for infection with Marteilia refringens;
(d) point  1 of Section  3 of Chap ter 4 for infection with Bonamia exitiosa ;
(e) point  1 of Section  3 of Chap ter 5 for infection with Bonamia ostreae ;
(f) point  1 of Section  3 of Chap ter 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) per sistence of the disease agent in the environment or in wild animals;
(b) biosecur ity measures that are adapted to the specificities of the establishment  
CHAPTER  4
Disease-free status
Section  1
Approval of disease-free status of Member States and zones
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) g eneral criteria:
 (i) t he territorial scope complies with the requirements laid down in Articles  13 or 47 as relevant;
 ( ii) t he surveillance for the disease complies with the requirements laid down in paragraph  1 or 2 of Ar ticle  3 as 
relevant;
 (iii) ope rators comply with obligations as regards biosecurity measures as laid down in Article  10 of Regulation (EU) 
2016/429;
 ( iv) t he disease control measures relevant to the disease in the event of a suspicion or confirmation of the disease 
comply with the requirements laid down for:
— inf ection with Brucella abortus, B.  melitensis  and B. suis, infection with MTBC, EBL, IBR/IPV, infection with ADV 
and BVD in Articles  21 to 31;Official Journal of the European Union L 174/252 EN 3 6 2020
— inf ection with RABV in Articles  35 and 36;
— inf ection with BTV in Articles  41 and 42;
— VHS, IHN , infection with HPR-deleted ISAV, infection with Marteilia refringens , infection with Bonamia exitiosa , 
infection with Bonamia ostreae  and infection with WSSV in Articles  55 to 65;
 (v) t he establishments were registered or approved, as relevant to the type of establishment;
 (vi) iden tification of animals from the targeted animal population and traceability of germinal products were ensured, 
as relevant for the type of animal;
 ( vii)  wh en moved, the animals from the targeted animal population or products thereof complied with the animal health 
requirements for the movement within the Union and entry into the Union of those animals and products thereof;
(b) specif ic 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) t he general criteria laid down in point  (a)(i) and (a)(ii) of Ar ticle  66 h ave been fulfilled for an eligibility period of at least 
5 years and the disease was not detected; and
(b) t he listed species relevant to the disease in question are absent from kept and wild animal populations  
2  T he 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) t he 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) t he 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 cr iteria 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) t he general criteria laid down in points  (a)(i) and (a)(ii) of Ar ticle  66 ha ve been fulfilled for an eligibility period of at least 
5 years and the disease was not detected;
(b) t he disease has never been reported or, if reported, it has been demonstrated that the disease agent did not survive;
(c) t he value of at least one critical environmental parameter that is not compatible with the survival of the disease agent 
is reached;
(d) t he 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) wit h respect to the fulfilment of the criteria set out in points  (a) and (b) of paragraph  1, document ary evidence;
(b) wit h respect to the fulfilment of the criteria set out in points  (c) and (d) of paragraph  1, scientif ic evidence  3 6 2020 Official Journal of the European Union L 174/253 EN
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) t he general criteria laid down in points  (a)(i) and (a)(ii) of Ar ticle  66 ha ve been fulfilled for an eligibility period of at least 
5 years and the disease was not detected;
(b) t he disease has never been reported, or, if reported, it has been demonstrated that the disease agent has not been 
transmitted;
(c) t he 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) t he listed vectors are not naturally present in the Member State or zones thereof;
(e) t he accidental or intentional introduction of listed vectors is unlikely to have occurred in the past or to occur in the 
future;
(f) t he value of at least one critical environmental parameter that is not compatible with the survival of the listed vectors 
is reached;
(g) t he 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) wit h respect to the fulfilment of the criteria set out in points  (a) and (b) of paragraph  1, document ary evidence;
(b) wit h respect to the fulfilment of the criteria set out in points  (c) to (g) of paragraph  1, scientif ic evidence  
If the disease has occurred, the Member State shall provide documentary evidence that surveillance has demonstrated with 
a 95  % le vel  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  T he 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) t he 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) t he 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 S tate 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 par agraph  1 shall ha ve implemented the following measures for an eligibility 
period of at least 10  years:
(a) disease surveillance of kept animals of listed species;
(b) pr evention 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  Official Journal of the European Union L 174/254 EN 3 6 2020
3  By wa y of derogation from point  (b) of p aragraph  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) inf ection with RABV, if it was notifiable in accordance with Article  8 of Directiv e 64/432/EEC and, when necessary 
monitoring was implemented in accordance with Article  4 of Directiv e 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) inf ection with BTV, if all restricted zones have been lifted in accordance with Article  6 of R egulation (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) f or 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 wa y 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) s tatus free from infestation with Varroa  spp  ;
(b) s tatus free from infection with Newcastle disease virus without vaccination  
6  By wa y of derogation from point  (b) of par agraph  4, the granting of disease-free status based on historical and surveillance 
data shall not apply to the following diseases:
(a) inf ection with Brucella abortus, B.  melitensis  and B. suis;
(b) inf ection with MTBC;
(c) EBL;
(d) IBR/IPV;
(e) inf ection with ADV;
(f) VHS;
(g) IHN;
(h) inf ection with HPR-deleted ISAV;
(i) inf ection with Bonamia ostreae ;
(j) inf ection 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) t he competent authority has been running an approved eradication programme as referred to in Articles  12 or 46; and
(b) t he 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 wa y of derogation from paragraph  1, in t he case of aquatic animals where a zone covers less than 75  % of t he 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 
(23) Directiv e 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) 3 6 2020 Official Journal of the European Union L 174/255 EN
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 Cha pter  3 of P art 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 Chap ter 4 of P art 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 Chap ter 2 of P art II of Annex  IV for status free from infection with MTBC;
(c) Section  1 of Chap ter 2 of P art III of Annex  IV for status free from EBL;
(d) Section  1 of Chap ter 2 of P art IV of Annex  IV for status free from IBR/IPV;
(e) Section  1 of Chap ter 2 of P art V of Anne x IV for status free from infection with ADV;
(f) Section  1 of Chap ter 2 of P art VI of Annex  IV for status free from BVD;
(g) Section  1 of Chap ter 2 of P art I of Annex  V for status free from infection with RABV;
(h) Section  1 of Chap ter 4 of P art II of Annex  V for status free from infection with BTV;
(i) Section  1 of P art III of Annex  V for status free from infestation with Varroa  spp  ;
(j) Section  1 of par t IV of Annex  V for status free from infection with Newcastle disease virus without vaccination;
(k) Section  2 of Chap ter 1 of P art II of Annex  VI for status free from VHS;
(l) Section  2 of Chap ter 1 of P art II of Annex  VI for status free from IHN;
(m) Section  2 of Chap ter 2 of P art II of Annex  VI for status free from infection with HPR-deleted ISAV;
(n) Section  2 of Chap ter 3 of P art II of Annex  VI for status free from infection with Marteilia refringens;
(o) Section  2 of Chap ter 4 of P art II of Annex  VI for status free from infection with Bonamia exitiosa ;
(p) Section  2 of Chap ter 5 of P art II of Annex  VI for status free from infection with Bonamia ostreae ;
(q) Section  2 of Chap ter 6 of P art II of Annex  VI for status free from infection with WSSV  
Section  2
Approval of disease-free status for compartments keeping aquaculture animals
Article  73
Criteria for the granting of disease-free status to compartments keeping aquaculture animals
1  Disease-free s tatus may only be granted to a compartment keeping aquaculture animals when the following general and 
specific criteria are complied with:
(a) g eneral criteria:
 (i) t he territorial scope complies with point  (c) of Article  47(2);
 (ii) t he surveillance for the disease complies with the requirements laid down in Articles  3(2), 4 and 6 to 9;
 (iii) ope rators comply with obligations as regards biosecurity measures as laid down in Article  10 of Regulation (EU) 
2016/429;
 (iv) com pliance with the disease control measures relevant to the disease in the event of a suspicion or confirmation;
 (v) t he establishments of which the compartment is comprised are approved;Official Journal of the European Union L 174/256 EN 3 6 2020
 (vi) tr aceability of the animals from the targeted animal population was ensured;
 ( vii)  wh en moved, the animals from the targeted animal population or products thereof complied with the animal health 
requirements for movement within the Union or for entry into the Union of those animals and products thereof;
(b) specif ic 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 ma y be granted to:
(a) com partments which are independent of the health status of the surrounding natural waters; and
(b) com partments 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:
 (i) g eographical location of each establishment in the compartment and the nature of the water supply;
 (ii) healt h status of other aquaculture establishments in the water system;
 (iii) t he location of the establishments referred to in point  (ii) and their distance from the dependent compartment;
 (iv) pr oduction volume  of the establishments referred to in point  (ii) as w ell as their method of production and the 
source of their animals;
 (v) pr esence and abundance of wild aquatic animals from relevant listed species in the water system and their health 
status;
 (vi) de tails of whether the species referred to in point  (v) are sedentary or migratory;
 (vii) possibility of the wild aquatic animals referred to in point  (v) entering the compartment;
 (viii)  g eneral biosecurity measures in the compartment;
 (ix) g eneral hydrological conditions in the water system;
(b) classify all establishments in the compartment as high risk, in compliance with Chapter  1 of P art I of Annex  VI;
(c) im pose whatever measures are found to be necessary to prevent the introduction of disease  
4  Wh en 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 par agraph  3 and de tails 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) t he 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) t he listed species relevant to the disease in question are absent from kept and wild animal populations  3 6 2020 Official Journal of the European Union L 174/257 EN
2  T he 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) t he likelihood of the presence of animals from listed species in the compartment was assessed and found to be negligible; 
and
(b) t he 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) t he 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) t he disease has never been reported or if reported, it has been demonstrated that the disease agent did not survive;
(c) t he value of at least one critical environmental parameter that is not compatible with the survival of the disease agent 
is reached;
(d) t he 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) wit h respect to the fulfilment of the criteria set out in points  (a) and (b) of paragraph  1, document ary evidence;
(b) wit h respect to the fulfilment of the criteria set out in points  (c) and (d) of paragraph  1, scientif ic evidence  
Article  76
Disease-free status based on historical and surveillance data
1  The cr iteria to recognise the disease-free status of a compartment keeping aquaculture animals based on historical and 
surveillance data are as follows:
(a) t he 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) t he 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 S tate wishing to obtain the approval of disease-free status for the compartment on the basis of the provisions 
set out in point  (a) of par agraph  1 sh all have implemented the following measures for an eligibility period of at least 10  years:
(a) disease surveillance of kept animals of listed species;
(b) pr evention 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 onl y apply:
(a) in a new Member State, during a maximum period of two  years following its accession to the Union; or
(b) f or 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  Official Journal of the European Union L 174/258 EN 3 6 2020
4  By wa y of derogation from point  (b) of par agraph  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) inf ection with HPR-deleted ISAV;
(d) inf ection with Bonamia ostreae ;
(e) inf ection with Marteilia refringens  
Article  77
Disease-free status based on eradication programmes
1  T he criteria to recognise the disease-free status of a compartment keeping aquaculture animals based on eradication 
programmes are:
(a) t he competent authority has been running an approved eradication programme as referred to in Article  46; and
(b) t he 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 wa y of derogation from paragraph  1, wh ere a compartment covers less than 75  % of t he 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 Chap ter 1 of P art II of Annex  VI for status free from VHS;
(b) Section  2 of Chap ter 1 of P art II of Annex  VI for status free from IHN;
(c) Section  2 of Chap ter 2 of P art II of Annex  VI for status free from infection with HPR-deleted ISAV;
(d) Section  2 of Chap ter 3 of P art II of Annex  VI for status free from infection with Marteilia refringens;
(e) Section  2 of Chap ter 4 of P art II of Annex  VI for status free from infection with Bonamia exitiosa ;
(f) Section  2 of Chap ter 5 of P art II of Annex  VI for status free from infection with Bonamia ostreae ;
(g) Section  2 of Chap ter 6 of P art 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 t o 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 es tablishment which is considered a single epidemiological unit, as it is not influenced by the animal health 
status of the surrounding natural waters; or3 6 2020 Official Journal of the European Union L 174/259 EN
(b) more t han 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) t hrough a water treatment plant which inactivates the relevant disease agent; or
(b) directl y 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  T here shall be natural or artificial barriers that prevent aquatic animals from entering each establishment in the 
compartment from the surrounding natural waters  
5  T he 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 ne w 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 comme nces aquaculture activities with aquaculture animals from a disease-free Member State, zone or compartment  
2  An es tablishment 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) t he health history of the establishment is known to the competent authority and there has been no  conf irmation in the 
establishment of a category  B or category  C disease;
(b) t he establishment is cleaned, disinfected and fallowed, if necessary, prior to repopulation  
3  An es tablishment 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 represent ative 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  mont hs and no  later than 12  mont hs after they have been exposed to conditions including water temperature, 
which are conducive to clinical expression of the disease;
(b) t he sampling and diagnostic tests set out in the relevant Chapter  of P art 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  % conf idence if the targeted 
prevalence is 2  %;
(c) results of the testing described in point  (b) are negative  Official Journal of the European Union L 174/260 EN 3 6 2020
Section  3
Maintenance, suspension and withdrawal of disease-free status
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) t he undertaking of sufficient surveillance activities to enable the early detection of the disease and the demonstration of 
disease-free status;
(b) t he biosecurity measures ordered by the competent authority based on the risks identified to prevent the introduction 
of the disease;
(c) t he operational rules as referred to in points  (a)(v), a(vi) and a(vii) of Ar ticle  66 or p oints  (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) t o (q) of paragraph  3 and maint ain 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 Ch apter  3 of P art 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 Ch apter  4 of P art 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 Chap ter 2 of P art II of Annex  IV for status free from infection with MTBC;
(c) Section  2 of Chap ter 2 of P art III of Annex  IV for status free from EBL;
(d) Section  2 of Chap ter 2 of P art IV of Annex  IV for status free from IBR/IPV;
(e) Section  2 of Chap ter 2 of P art V of Anne x IV for status free from infection with ADV;
(f) Section  2 of Chap ter 2 of P art VI of Annex  IV for status free from BVD;
(g) Section  2 of Chap ter 2 of P art I of Annex  V for status free from infection with RABV;
(h) Section  2 of Chap ter 4 of P art II of Annex  V for status free from infection with BTV;
(i) Section  2 of P art III of Annex  V for status free from infestation with Varroa spp;
(j) Section  2 of P art IV of Annex  V for status free from infection with Newcastle disease virus without vaccination;
(k) Section  4 of Chap ter 1 of P art II of Annex  VI for status free from VHS;
(l) Section  4 of Chap ter 1 of P art II of Annex  VI for status free from IHN;
(m) Section  4 of Chap ter 2 of P art II of Annex  VI for status free from infection with HPR-deleted ISAV;
(n) Section  4 of Chap ter 3 of P art II of Annex  VI for status free from infection with Marteilia refringens;3 6 2020 Official Journal of the European Union L 174/261 EN
(o) Section  4 of Chap ter 4 of P art II of Annex  VI for status free from infection with Bonamia exitiosa ;
(p) Section  4 of Chap ter 5 of P art II of Annex  VI for status free from infection with Bonamia ostreae ;
(q) Section  4 of Chap ter 6 of P art II of Annex  VI for status free from infection with WSSV  
Article  82
Suspension, withdrawal and restoration of disease-free status
1  If t he 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) appl y without delay the relevant disease control measures;
(b) conduct specific surveillance to assess the extent of the outbreak;
(c) or der any necessary risk mitigating measures  
2  If t he 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  T he 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) adop t all necessary prevention, surveillance and control measures to manage the situation;
(b) inf orm without delay the Commission and the other Member States about the measures adopted; and
(c) inf orm 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  
Section  4
Derogations from approval by the Commission
Article  83
Derogations from approval by the Commission for certain disease-free statuses for aquatic animal diseases
1  By wa y 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 R egulation (EU) 2016/429, for aquatic animal diseases of zones or compartments, such approval 
for zones or compartments which cover less than 75  % of t he 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 S tate 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) t his provisional declaration is published electronically by the Member State and the Commission and Member States are 
alerted to the publication;
(c) 60 da ys after publication, the provisional declaration shall take effect and the zone or compartment referred to in this 
paragraph  shall ac hieve the disease-free status  Official Journal of the European Union L 174/262 EN 3 6 2020
2  W ithin the 60-day period referred to in point  (c) of p aragraph  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  Wher e written comments are made by at least one Member State, or the Commission, within the period referred to in 
point  (c) of par agraph  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 pa ragraph  1 is p rolonged automatically for 60  days from the date on 
which the first concerns were raised   There shall be no  further prolongation of this period
4  Wher e 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  T he 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 fr om infection with Brucella abortus, B.  melitensis, B.suis :
 ( i) in bo vine animal populations when the brucellosis-free status was granted in accordance with Directive 64/432/EEC;
 ( ii) in o vine and caprine animal populations, when the brucellosis-free ( B. melitensis -free) status was granted in accordance 
with Directive 91/68/EEC;
(b) free fr om infection with MTBC, when the tuberculosis-free status was granted in accordance with Directive 64/432/EEC;
(c) free fr om EBL, when EBL-free status was granted in accordance with Directive 64/432/EEC;
(d) free fr om IBR/IPV, when IBR-free status was granted in accordance with Directive 64/432/EEC;
(e) free fr om 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 fr om infection with Newcastle disease virus without vaccination when Newcastle disease non-vaccination status 
was granted in accordance with Directive 2009/158/EC;
(h) free fr om VHS, when VHS-free status was granted in accordance with Council Directive 2006/88/EC  (25);
(i) free fr om IHN, when IHN-free status was granted in accordance with Directive 2006/88/EC;
(j) free fr om infection with HPR-deleted ISAV, when infection with HPR-deleted ISAV-free status was granted in accordance 
with Directive 2006/88/EC;
(24) Council Directiv e 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 Oct ober  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) 3 6 2020 Official Journal of the European Union L 174/263 EN
(k) free fr om infection with Bonamia ostreae , when infection with Bonamia ostreae- free status was granted in accordance with 
Directive 2006/88/EC;
(l) free fr om infection with Marteilia refringens , when infection with Marteilia refringens- free status was granted in accordance 
with Directive 2006/88/EC;
(m) free fr om infection with WSSV, when white spot disease--free status was granted in accordance with Directive 2006/88/EC  
2  T he 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 fr om 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 fr om VHS, when VHS-free status was granted in accordance with Directive 2006/88/EC;
(c) free fr om IHN, when IHN-free status was granted in accordance with Directive 2006/88/EC;
(d) free fr om infection with HPR-deleted ISAV, when infection with HPR-deleted ISAV-free status was granted in accordance 
with Directive 2006/88/EC;
(e) free fr om infection with Bonamia ostreae , when infection with Bonamia ostreae- free status was granted in accordance with 
Directive 2006/88/EC;
(f) free fr om 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) inf ection 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) inf ection 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) inf ection with Bonamia ostreae , when the infection with Bonamia ostreae  surveillance or eradication programme was 
approved in accordance with Directive 2006/88/EC;
(g) inf ection with Marteilia refringens , when the infection with Marteilia refringens  surveillance or eradication programme was 
approved in accordance with Directive 2006/88/EC;
(26) Commission Regulation (EC) No  616/2009 of 13 Jul y  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) Official Journal of the European Union L 174/264 EN 3 6 2020
(h) inf ection with WSSV, when the white spot disease eradication programme was approved in accordance with Directive 
2006/88/EC  
2  Th e 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) inf ection 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) inf ection with Bonamia ostreae , when the infection with Bonamia ostreae  surveillance or eradication programme was 
approved in accordance with Directive 2006/88/EC;
(e) inf ection with Marteilia refringens , when the infection with Marteilia refringens  surveillance or eradication programme was 
approved in accordance with Directive 2006/88/EC;
(f) inf ection with WSSV, when the white spot disease surveillance or eradication programme was approved in accordance 
with Directive 2006/88/EC  
3  T he 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 Apr il  2021 :
— Decision 2000/428/EC;
— Decision 2002/106/EC;
— Decision 2003/422/EC;
— Decision 2006/437/EC;
— R egulation (EC) No  1266/2007;
— Decision 2008/896/EC;
— Im plementing 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 Apr il  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 LEYEN3 6 2020 Official Journal of the European Union L 174/265 EN
ANNEX  I
SPECIFIC CASE DEFINITION OF DISEASE OF TERRESTRIAL ANIMALS
Section  1
Highly pathogenic avian influenza (HPAI)
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:
(a) t he disease agent responsible for HPAI, excluding vaccine strains, has been isolated in a sample from an animal or 
from a group of animals;
(b) nucleic acid specific to the disease agent for HPAI, that is not a consequence of vaccination, has been identified in a 
sample from an animal or from a group of animals; or
(c) p ositive result to an indirect diagnostic method, that is not a consequence of vaccination, has been obtained in a 
sample from a kept animal or from a group of kept animals showing clinical signs consistent with the disease or 
epidemiologically linked to a suspected or confirmed case  
3  F or the purposes of this case definition, the disease agent responsible for HPAI must be either
(a) an inf luenza A virus of H5 and H7 subtypes or any influenza A virus with an intravenous pathogenicity index (IVPI) 
greater than 1,2; or
(b) an inf luenza A virus of H5 and H7 subtypes with a sequence of multiple basic amino  acids pr esent at the cleavage 
site of the haemagglutinin molecule (HA0) that is similar to that observed for other HPAI isolates  
Section  2
Infection with low pathogenic avian influenza viruses (LPAIV)
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:
(a) t he disease agent responsible for infection with LPAIV, excluding vaccine strains, has been isolated in a sample from 
an animal or from a group of animals;
(b) nucleic acid sp ecific to the disease agent for infection with LPAIV, that is not a consequence of vaccination, has been 
identified in a sample from an animal or from a group of animals; or
(c) p ositive result to an indirect diagnostic method, that is not a consequence of vaccination, has been obtained in a 
sample from a kept animal or from a group of kept animals showing clinical signs consistent with the disease or 
epidemiologically linked to a suspected or confirmed case  
3  F or 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  
Section  3
Infection with Newcastle disease virus (NDV)
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)  Official Journal of the European Union L 174/266 EN 3 6 2020
2  An animal or a group of animals must be considered, by the competent authority, as a confirmed case of infection with 
NDV when:
(a) t he disease agent responsible for infection with NDV, excluding vaccine strains, has been isolated in a sample from 
an animal or from a group of animals;
(b) nucleic acid specific to the disease agent for infection with NDV, that is not a consequence of vaccination, has been 
identified in a sample from an animal or from a group of animals; or
(c) p ositive result to an indirect diagnostic method, that is not a consequence of vaccination, has been obtained in a 
sample from a kept animal or from a group of kept animals showing clinical signs consistent with the disease or 
epidemiologically linked to a suspected or confirmed case  
3  F or 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:
(a) has an intracerebral pathogenicity index (ICPI) of 0,7 or greater; or
(b) p resents multiple basic amino  acids at the C-terminus of the F2 protein and phenylalanine at residue 117, which 
is the N-terminus of the F1 protein   The term ‘multiple basic amino  acids ’ refers to at least three arginine or lysine 
residues between residues 113 and 116   Failure to demonstrate the characteristic pattern of amino  acid residues as 
described above would require characterisation of the isolated virus by an ICPI test   In this definition, amino  acid 
residues are numbered from the N-terminus of the amino  acid seq uence deduced from the nucleotide sequence of 
the F0 gene (113–116 corresponds to residues  –4 to –1 from the cleavage site)  3 6 2020 Official Journal of the European Union L 174/267 EN
ANNEX  II
UNION SURVEILLANCE PROGRAMME
PART  I
AVIAN INFLUENZA SURVEILLANCE IN POULTRY AND WILD BIRDS
Section  1
General approach and requirements
1  TERRIT ORIAL SCOPE
Surveillance in poultry and wild birds must be implemented in all Member States  
2  PERIOD OF APPLIC ATION
Until revoked  
3  GENER AL APPROACH
The surveillance system must address the objectives provided for in Section  2 and mus t be built on a comprehensive 
approach including different components of surveillance activities complementing each other in poultry and wild bird 
populations:
— Ear ly detection systems as provided for in Sections  3 and 4;
— Risk -based surveillance as provided for in Sections  5 and 6 
Section  2
Objectives for surveillance in poultry and wild birds
1  Ear ly detection of highly pathogenic avian influenza (HPAI) in poultry  
2  Ear ly detection of HPAI in wild birds providing for:
(a) an ear ly warning for possible HPAI introduction into poultry, in particular when viruses enter the Union through 
migratory movements of wild birds;
(b) inf ormation for the assessment of risks for virus spread following findings of HPAI in wild birds  
3  De tection of HPAI in poultry species which generally do not show significant clinical signs  
4  De tection 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:
(a) identify clusters of infection with LPAIV; and
(b) monit or the risk of spread of LPAIV by movements of poultry and by fomites in certain production systems at risk  
5  Contr ibution to increased knowledge on HPAI and LPAIV posing a potential zoonotic risk  
Section  3
Early detection of HPAI in poultry
1  T he 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  Official Journal of the European Union L 174/268 EN 3 6 2020
2  T he surveillance referred to in point  1 mus t 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:
(a) an y change in normal production and health parameters such as mortality rate, feed and water intake and egg 
production; and
(b) an y clinical sign or post-mortem lesion suggesting HPAI  
3  R egular 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  
Section  4
Early detection of HPAI in wild birds
1  T he early detection of HPAI in wild birds must be based on sampling and testing of birds that have been:
(a) f ound dead;
(b) f ound injured or sick;
(c) hunt ed with clinical signs  
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  T he design of this surveillance must be risk-based, taking into account at least relevant information on ornithology, 
virology, epidemiology and environmental matters  
3  T he 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, t he 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:
(a) bir ds trapped;
(b) hunt ed healthy birds;
(c) sentinel birds  
5  A dditional 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  
Section  5
Risk-based complementary surveillance for HPAI in poultry species which  
generally do not show significant clinical signs
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:
(a) t he historical and current epidemiological situation of the disease and its evolution over time in poultry and wild 
birds;
(b) t he proximity of establishments to water bodies and other places where migratory birds, in particular water birds, 
may gather in higher numbers or have their stop-over places during their movements into and through the Union;3 6 2020 Official Journal of the European Union L 174/269 EN
(c) t he period of increased movements of migratory wild birds of targeted species into and through the Union;
(d) t he structure of poultry farming including the broader sector involved in the different production systems;
(e) t he geographical location of the establishments in an area with a high density of poultry;
(f) t he biosecurity practices on the establishments;
(g) t he type and frequency of movements of poultry, products and vehicles transporting poultry and trade patterns; and
(h) t he risk assessments and scientific advice in relation to the relevance of the spread of HPAI by wild birds  
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  
Section  6
Risk-based surveillance in order to identify clusters of establishments infected  
with lpaiv and with continuous spread of LPAIV
1  T he 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  Suc h clusters are characterised by infection with LPAIV of groups of establishments related in time and geographical 
proximity  
3  Th e 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:
(a) t he kept species;
(b) t he cycle and duration of production;
(c) pr esence of several poultry species;
(d) pr esence of multi-age poultry flocks;
(e) pr esence of long-lived poultry;
(f) pr actice of all-in all-out principle;
(g) lengt h of waiting period between batches; and
(h) biosecur ity practices and housing conditions  
Section  7
Targeted poultry populations
1  Ear ly detection systems for infection with HPAI referred to in Section  3 mus t apply to all poultry populations  
2  Com plementary surveillance for infection with HPAI referred to in Section  5 in p oultry species that do generally not 
display significant signs when infected with HPAI must apply to:
(a) breeding ducks
(b) breeding geese;
(c) f attening ducks;
(d) f attening geese;Official Journal of the European Union L 174/270 EN 3 6 2020
(e) quails;
(f) poultr y of species belonging to Anseriformes  for supplies of game to be released into the wild  
3  In addition t o the species and categories listed under point  2 the targeting of sampling and testing for infection with 
LPAIV referred to in Section  6 ma y apply to the following poultry species and production categories:
(a) la ying hens including those kept in free-range;
(b) breeding turkeys;
(c) f attening turkeys;
(d) t he poultry of species belonging to Galliformes  for supplies of game to be released into the wild  
Section  8
Targeted Wild bird populations
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  
Section  9
Sampling and laboratory testing methods
1  T he 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  poultr y 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 conf idence determined by the competent authority  
2  F requency and period for testing:
(a) t he frequency for sampling and testing of poultry establishments must be determined based on the outcome of a 
risk assessment by the competent authority;
(b) t he time period for sampling must coincide with seasonal production for each production category, but must not 
compromise the risk-based surveillance approach;
(c) when rele vant, the time period for sampling must take into account the period of heightened risk as referred to in 
point  3 of Section  3  Samples must be subjected to laboratory testing by virological methods, when taken for:
 (i) ear ly detection of HPAI in poultry referred to in Section  3;
 (ii) ear ly detection of HPAI in wild birds referred to in Section  4;
 (iii) com plementary surveillance for HPAI in poultry species which generally do not show significant clinical signs 
of HPAI referred to in Section  5;
 (iv) f ollow-up of sero-positive findings referred to in point  4(b)  
For virological testing the prevalence and time window for detection of active infection must be taken into account  
3  Sam ples must be subjected to laboratory testing by serological methods, when taken for:
(a) com plementary surveillance for HPAI in poultry species which generally do not show significant clinical signs of 
HPAI referred to in Section  5 supplementing virological testing, as appropriate;
(b) de tection of clusters of LPAIV infected establishments referred to in Section  6  When for technical reasons or other 
duly justified reasons sampling for serology is not appropriate, virological testing must be performed  3 6 2020 Official Journal of the European Union L 174/271 EN
ANNEX  III
DIAGNOSTIC METHODS FOR THE GRANTING AND MAINTENANCE OF DISEASE-FREE STATUS FOR CERTAIN 
DISEASES OF TERRESTRIAL ANIMALS
Section  1
Infection with Brucella abortus, B.  melitensis  and B. suis
1  Ser ological tests
(a) t ests for blood samples
 (i) buf fered Brucella  antigen tests;
 (ii) com plement fixation test (CFT)
 (iii) indir ect enzyme-linked immunosorbent assay (I-ELISA)
 (iv) f luorescence polarisation assay (FPA)
 (v) com petitive enzyme-linked immunosorbent assay (C-ELISA)
(b) t ests for milk samples
 (i) r ing test (MRT)
 (ii) I-ELIS A
2  Br ucellin skin test (BST)
For the testing as referred to in section  1 and 2 of Chap ter 1 of P art I of Annex  IV, Brucellin skin test (BST) shall only 
be used in ovine and caprine animals  
Section  2
Infection with mycobacterium tuberculosis complex
1  T uberculin skin tests
(a) t he single intradermal tuberculin test (SITT)
(b) t he comparative intradermal tuberculin test (CITT)
2  Gamma-int erferon assay
Section  3
Enzootic bovine leukosis
1  Ser ological tests
(a) t ests for blood samples
 (i) ag ar gel immuno-diffusion test (AGID)
 (ii) bloc king enzyme-linked immunosorbent assay (B-ELISA)
 (iii) I-ELIS A
(b) t ests for milk samples
(i) I-ELIS AOfficial Journal of the European Union L 174/272 EN 3 6 2020
Section  4
Infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV)
Methods: Matrix:
non-vaccinated bovine animalsBoHV-1  I-ELISA  (a)individual serum samples  (d)
milk samples
gB B-ELISA  (b)individual serum samples  (d)
individual meat juice samples
DIVA vaccinated bovine animals 
with a gE-deleted vaccinegE B-ELISA  (c)individual serum samples
individual meat juice samples
(a) I-ELIS A 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  
(b) B-ELIS A 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  
(c) B-ELI SA 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  
(d) When t esting 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  
Section  5
Infection with Aujeszky ’s disease virus (ADV)
Methods: Matrix:
non-vaccinated porcine animals ADV ELISA  (a)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 vaccinegE ELISA  (b) individual serum samples
(a) ELIS A 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  
(b) ELIS A 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  
Section  6
Bovine viral diarrhoea (BVD)
1  Direct methods:
(a) R eal-time reverse transcription PCR
(b) B VDV antigen detection ELISA
2  Ser ological tests:
(a) I-ELISA
(b) B-ELIS A3 6 2020 Official Journal of the European Union L 174/273 EN
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
Section  1
Granting of the status
1  T he 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:
(a) dur ing the past 12  mont hs there has been no  conf irmed case of infection with Brucella abortus, B.  melitensis  and 
B. suis in bovine, ovine or caprine animals kept in the establishment;
(b) dur ing the past 3  years none of the bovine, ovine or caprine animals in the establishment has been vaccinated against 
infection with Brucella abortus, B. melitensis  and B. suis;
(c) t he entire bovine animals over 12  mont hs of age and the entire ovine or caprine animals over 6  mont hs of age 
present in the establishment at the time of sampling have tested negative to serological test, on two occasions as 
follows:
 ( i) t he first test must be carried out on samples taken not earlier than 3  mont hs after the removal of the last 
confirmed case and of the last animal that tested positive in an immunological test;
 (ii) t he  second test must be carried out on samples taken not earlier than 6  mont hs and not later than 12  months 
following the date of sampling referred to in point  (i);
(d) animals showing clinical signs consistent with infection with Brucella abortus , B. melitensis  and B. suis, such as abortions, 
have been subjected to investigations with negative results;
(e) since the beginning of the sampling referred to in point  (c)(i) all bovine, ovine or caprine animals introduced into 
the establishment 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 against infection with Brucella abortus, 
B. melitensis  and B. suis during the past 3  years, and
 (i) or iginate from a Member State or a zone free from infection with Brucella abortus, B.  melitensis  and B. suis for 
the relevant animal population;
 (ii) are entir e bovine animals over 12  mont hs of age or entire ovine or caprine animals over 6  mont hs of age and 
must have tested negative in a serological test carried out on a sample taken:
— dur ing the 30  days prior to their introduction into the establishment; or
— dur ing the 30  days following their introduction provided they have been kept isolated during this period; 
or
 (iii) are p ost-parturient females kept in isolation since their introduction into the establishment until they have tested 
negative in a serological test carried out on a sample taken not earlier than 30  days after parturition; and
(f) since t he beginning of the sampling referred to in point  (c)(i), all g erminal products of bovine, ovine or caprine origin 
introduced into or used in the establishment originate from:
 (i) es tablishments free from infection with Brucella abortus, B.  melitensis  and B. suis without vaccination; or
 (ii) appr oved germinal product establishments  Official Journal of the European Union L 174/274 EN 3 6 2020
2  By wa y 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:
(a) or iginate from a Member State or a zone free from infection with Brucella abortus, B.  melitensis  and B. suis for the 
relevant animal population;
(b) are entir e bovine animals over 12  mont hs of age or entire ovine or caprine animals over 6  mont hs of age and have 
tested negative in a serological test carried out on a sample taken:
— dur ing the 30  days prior to their introduction into the establishment; or
— dur ing the 30  days following their introduction into the establishment provided they have been kept isolated 
during this period; or
(c) are p ost-parturient females kept in isolation since their introduction into the establishment until they tested negative 
in a serological test carried out on a sample taken not earlier than 30  days after parturition  
3  By wa y 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:
(a) t he requirements set out in points  (a), (b), (d), (e) and (f) of point  1 are fulfilled; and
(b) t he requirement set out in point  (b)(i) of Section  2 is fulfilled  
Section  2
Maintenance of the status
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) t he requirements set out in points  (a), (b), (d), (e) and (f) of point  1 of Section  1 continue to be fulfilled; and
(b) ser ological testing is carried out with negative results on samples taken from:
 ( i) all entire bo vine animals over 12  mont hs of age and all entire ovine or caprine animals over 6  mont hs of age at 
appropriate intervals of not more than 12  mont hs determined by the competent authority, taking into account the 
type of production, the situation of the disease and the identified risk factors; or
 ( ii) entire bo vine animals over 12  mont hs of age and entire ovine or caprine animals over 6  mont hs of age kept in 
establishments located in a Member State or in a zone free from infection with Brucella abortus, B.  melit ensis  and B. suis, 
in accordance with a testing regime set up by the competent authority, taking into account the type of production 
and the identified risk factors  
Section  3
Suspension and restoring of the status
1  Th e status free from infection with Brucella abortus, B.  melit ensis  and B. suis without vaccination of an establishment 
keeping bovine, ovine or caprine animals must be suspended if:
(a) one or more of t he requirements set out in Section  2 are no t fulfilled; or
(b) a case of inf ection with Brucella abortus, B.  melitensis  and B. suis is suspected in a bovine, ovine or caprine animal 
kept in the establishment  
2  T he status free from infection with Brucella abortus, B.  melitensis  and B. suis without vaccination may only be restored if:
(a) t he requirements set out in points  (b), (d), (e) and (f) of point  1 of Section  1 and in p oint  (b) of Section  2 are fulf illed;
(b) t he results of further investigations substantiate absence of infection with Brucella abortus, B.  melitensis  and B. suis 
and the status of all suspected cases has been determined  3 6 2020 Official Journal of the European Union L 174/275 EN
Section  4
Withdrawal and regaining of the status
1  Th e status free from infection with Brucella abortus, B.  melit ensis  and B. suis without vaccination of an establishment 
keeping bovine, ovine or caprine animals must be withdrawn if:
(a) one or more of t he requirements set out in Section  2 are no t fulfilled after the maximum period of time referred to 
in point  (b) of Article  20(3) has lapsed since the status was suspended;
(b) t he infection with Brucella abortus , B. melitensis  and B. suis cannot be ruled out in accordance with point  2(b) of 
Section  3;
(c) a case of infection with Brucella abortus, B. melitensis  and B. suis has been confirmed in a bovine, ovine or caprine 
animal kept in the establishment; or
(d) it is justified by other needs to control infection with Brucella abortus, B. melitensis , B. suis 
2  If t he 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 fulf illed  
3  If t he 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 wa y of derogation from point  3, where t he 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
Section  1
Granting of the status
1  T he 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:
(a) t he requirements set out in points  (a), (c) and (d) of point  1 of Section  1 of Chap ter 1 are fulf illed;
(b) since t he beginning of the sampling referred to in point  (c)(i) of p oint  1 of Section  1 of Ch apter  1, all bo vine, ovine, 
or caprine animals introduced into the establishment originate from establishments free from infection with Brucella 
abortus, B.  melitensis  and B. suis without vaccination or free from infection with Brucella abortus, B.  melitensis  and 
B. suis with vaccination and:
 (i) or iginate from a Member State or a zone free from infection with Brucella abortus, B.  melitensis  and B. suis for 
the relevant animal population;
 (ii) are entir e bovine animals over 12  mont hs of age or entire ovine or caprine animals over 6  mont hs of age and 
have tested negative in a serological test on a sample taken
— dur ing the 30  days prior to their introduction into the establishment; or
— dur ing the 30  days following their introduction into the establishment provided they have been kept isolated 
during this period; or
 (iii) are p ost-parturient females kept in isolation since their introduction into the establishment until they have tested 
negative in a serological test carried out on a sample taken not earlier than 30  days after parturition; andOfficial Journal of the European Union L 174/276 EN 3 6 2020
(c) since the beginning of the sampling referred to in point  (c)(i) of point  1 of Section  1 of Chapter  1, all germinal 
products of bovine, ovine or caprine origin introduced into or used in the establishment originate from:
 ( i) es tablishments free from infection with Brucella abortus, B.  melitensis  and B. suis without vaccination or free from 
infection with Brucella abortus, B.  melitensis  and B. suis with vaccination; or
 (ii) appr oved germinal product establishments  
2  By wa y 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:
(a) or iginate from a Member State or a zone free from infection with Brucella abortus, B.  melitensis  and B. suis for the 
relevant animal population;
(b) are entir e bovine animals over 12  mont hs of age or entire ovine or caprine animals over 6  mont hs of age and have 
tested negative in a serological test carried out on a sample taken:
 (i) dur ing the 30  days prior to their introduction into the establishment; or
 (ii) dur ing the 30  days following their introduction into the establishment provided they have been kept isolated 
during this period; or
(c) are po st-parturient females kept in isolation since their introduction into the establishment until they have tested 
negative in a serological test carried out on a sample taken not earlier than 30  days after parturition  
Section  2
Maintenance of the status
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) t he requirements set out in points  (b) and (c) of p oint  1 of Section  1 of t his Chapter  and in p oints  (a) and (d) of p oint  1 
of Section  1 of Chap ter 1 continue to be fulfilled; and
(b) ser ological testing is carried out with negative results on samples taken from all entire bovine animals over 12  mont hs 
of age and all entire ovine or caprine animals over 6  mont hs of age at appropriate intervals of not more than 12  mont hs 
determined by the competent authority taking into account the type of production, the situation of the disease and the 
identified risk factors  
Section  3
Suspension and restoring of the status
1  T he 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:
(a) one or more of t he requirements set out in Section  2 are no t fulfilled; or
(b) a case of inf ection with Brucella abortus, B.  melitensis  and B. suis is suspected in a bovine, ovine or caprine animal 
kept in the establishment  
2  T he status free from infection with Brucella abortus, B.  melitensis  and B. suis with vaccination may only be restored if:
(a) t he requirements set out in point  1(d) of Section  1 of Chap ter 1 and points  (b) and (c) of point  1 of Section  1 and 
point  (b) of Section  2 are fulf illed;
(b) t he results of further investigations substantiate absence of infection with Brucella abortus, B.  melitensis  and B. suis 
and the status of all suspected cases has been determined  3 6 2020 Official Journal of the European Union L 174/277 EN
Section  4
Withdrawal and regaining of the status
1  Th e 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:
(a) one or more of t he requirements set out in Section  2 are no t fulfilled after the maximum period of time referred to 
in point  (b) of Article  20(3) has lapsed since the status was suspended;
(b) t he infection with Brucella abortus , B. melitensis  and B. suis cannot be ruled out in accordance with point  2(b) of 
Section  3;
(c) a case of infection with Brucella abortus, B. melitensis  and B. suis has been confirmed in a bovine, ovine or caprine 
animal kept in the establishment; or
(d) it is justified by other needs to control infection with Brucella abortus, B. melitensis , B. suis 
2  If t he 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 fulf illed  
3  If t he 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 Chap ter 1 
4  By wa y of derogation from point  3, where t he 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 Chap ter 1 
CHAPTER 3
Member State or zone free from infection with Brucella abortus, B. melitensis  and B. suis  as regards kept 
bovine animals
Section  1
Granting of the status 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) f or at least the past 3  years there has been no  conf irmed case of infection with Brucella abortus, B. melitensis  and B. suis 
in kept bovine animals;
(b) g eneral surveillance requirements have been carried out for the past 3  years in accordance with point  (a) of Ar ticle  3(1) 
for the early detection of infection with Brucella abortus, B. melitensis  and B. suis in kept bovine animals, which included 
at least:
 (i) t he regular submission of samples from abortion cases for laboratory testing;
 (ii) t he timely investigation of abortion cases that may have been caused by infection with Brucella abortus, B. melitensis  
and B. suis;
(c) dur ing 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) v accination of bovine animals against Brucella abortus, B.  melitensis  and B. suis has not taken place at least for the past 
3 y ears and no  bovine animal introduced into the Member State or zone has been vaccinated during the past 3  years 
prior to its introduction  Official Journal of the European Union L 174/278 EN 3 6 2020
Section  2
Maintenance of the status as regards  kept bovine animals
1  T he 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:
(a) t he requirements set out in points  (a), (b) and (d) of Section  1 continue to be fulfilled; and
(b) f or the first 2 consecutive  years following granting of the status, annual surveillance based on a representative sample 
of all establishments keeping bovine animals has been carried out that must allow at least for the detection, with 
a 95  % le vel  of conf idence, of infection with Brucella abortus, B.  melitensis  and B. suis, at a target prevalence rate of 
0,2 % of the establishments keeping bovine animals or a target prevalence rate of 0,1 % of the bovine population;
(c) if no  case of inf ection with Brucella abortus, B.  melitensis  and B. suis has been confirmed in kept bovine animals for 
2 consecutive  years following granting of the status, surveillance must be based on:
 ( i) r andom annual surveillance that must allow at least for the detection, with a 95  % le vel of conf idence, of infection 
with Brucella abortus, B.  melitensis  and B. suis, at a target prevalence rate of 0,2  % of t he establishments keeping 
bovine animals or a target prevalence rate of 0,1 % of the bovine population; or
 ( ii) r isk-based annual surveillance to detect infection with Brucella abortus, B.  melitensis  and B. suis taking into account 
the systems of production and the risk factors identified, including spread of infection from other animals than 
kept bovine animals  
2  T he 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.  melit ensis  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:
(a) t he establishment in which the infection with Brucella abortus, B.  melitensis  and B. suis was detected in kept bovine 
animals has been immediately subjected to the relevant disease control measures laid down in Article  24;
(b) wit hin 60  days after the first confirmation of the infection, the competent authority has conducted an epidemiological 
enquiry and investigations, as laid down in Article  25, t o identify the likely source and the distribution of the infection 
and established conclusions on the likely source of infection and only a limited number of establishments were 
infected and those establishments are epidemiologically linked to the first detected outbreak;
(c) t he relevant disease control measures laid down in Article  21 or Article  24 have been immediately implemented in 
each establishment identified with suspected or confirmed cases following implementation of the measures provided 
for in point  (b) until their disease-free status is restored or regained;
(d) t he surveillance referred to in point  1 has been adapted and has demonstrated that the incident has been resolved  
CHAPTER 4
Member State or zone free from infection with Brucella abortus, B. melitensis  and B. suis  as regards kept 
ovine and caprine animals
Section  1
Granting of the status 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) f or at least the past 3  years there has been no  conf irmed case of infection with Brucella abortus, B.  melitensis  and B. suis 
in kept ovine and caprine animals;3 6 2020 Official Journal of the European Union L 174/279 EN
(b) g eneral surveillance requirements have been carried out for the past 3  years in accordance with point  (a) of Ar ticle  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:
 (i) t he regular submission of samples from abortion cases for laboratory testing;
 (ii) t he timely investigation of abortion cases that may have been caused by infection with Brucella abortus, B. melitensis  
and B. suis;
(c) dur ing 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 t he ovine and caprine population, 
have maintained their status free from infection with Brucella abortus, B.  melitensis  and B. suis without vaccination; and
(d) v accination of ovine and caprine animals against Brucella abortus, B.  melitensis  and B. suis has not taken place for at least 
the past 3  y ears and no  ovine or caprine animal introduced into the Member State or zone has been vaccinated during 
the past 3  years prior to introduction  
Section  2
Maintenance of the status as regards kept ovine and caprine animals
1  T he 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:
(a) t he requirements defined in points  (a), (b) and (d) of Section  1 continue to be fulfilled; and
(b) f or the first 2 consecutive  years following granting of the status, annual surveillance based on a representative 
sample of all establishments where ovine or caprine animals are kept shall be carried out that must allow at least for 
the detection, with a 95  % le vel of conf idence, of infection with Brucella abortus, B.  melitensis  and B. suis at a target 
prevalence rate of 0,2 % of t he establishments keeping ovine or caprine animals or a target prevalence rate of 0,1 % 
of the ovine and caprine population;
(c) if no  case of infection with Brucella abortus, B.  melitensis  and B. suis has been confirmed in kept ovine and caprine 
animals for 2 consecutive  years following granting of the status, surveillance must be based on:
 ( i) r andom annual surveillance that must allow at least for the detection, with a 95  % le vel of conf idence, of infection 
with Brucella abortus, B.  melitensis  and B. suis at a target prevalence rate of 0,2  % of t he establishments keeping 
ovine or caprine animals or a target prevalence rate of 0,1 % of the ovine and caprine population; or
 (ii) r isk-based annual surveillance to detect infection with Brucella abortus, B.  melitensis  and B. suis, which takes into 
account the systems of production and the risk factors identified, including spread of infection from other animals 
than kept ovine and caprine animals  
2  T he 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 wa y of derogation from point  1(a), t he 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:
(a) t he establishment in which the infection with Brucella abortus, B.  melitensis  and B. suis was detected in kept ovine and 
caprine animals has been immediately subjected to the relevant disease control measures laid down in Article  24;
(b) wit hin 60  days after the first confirmation of the infection, the competent authority has conducted an epidemiological 
enquiry and investigations, as laid down in Article  25, t o identify the likely source and the distribution of the infection 
and established conclusions on the likely source of infection and only a limited number of establishments were 
infected and those establishments are epidemiologically linked to the first detected outbreak;Official Journal of the European Union L 174/280 EN 3 6 2020
(c) t he relevant disease control measures laid down in Article  21 or Article  24 have been immediately implemented in 
each establishment identified with suspected or confirmed cases following implementation of the measures provided 
for in point  (b) until their disease-free status is restored or regained; and
(d) t he surveillance referred to in point  1 has been adapted and has demonstrated that the incident has been resolved  
PART  II
INFECTION WITH MYCOBACTERIUM TUBERCULOSIS COMPLEX
CHAPTER 1
Establishment free from infection with Mycobacterium tuberculosis complex
Section  1
Granting of the status
1  T he 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:
(a) dur ing the past 12  mont hs there has been no  conf irmed case of infection with MTBC in bovine animals kept in the 
establishment;
(b) t he bovine animals over 6  weeks of age present in the establishment at the time of testing or sampling have tested 
negative to immunological test on two occasions as follows:
 ( i) t he first test must be carried out on bovine animals or samples taken from bovine animals not earlier than 
6 mont hs after the removal of the last confirmed case and of the last animal that tested positive in an 
immunological test;
 ( ii) t he  second t est must be carried out on bovine animals or on samples taken from bovine animals not earlier 
than 6  mont hs and not later than 12  mont hs following the date of testing of the bovine animal or taking of the 
samples referred to in point  (i);
(c) since t he beginning of the testing or sampling referred to in point  (b)(i), all bo vine animals introduced into the 
establishment originate from establishments free from infection with MTBC and:
 (i) or iginate from a Member State or a zone free from infection with MTBC;
 (ii) are bo vine animals over 6  weeks of age and have tested negative in an immunological test:
— dur ing the 30  days prior to their introduction into the establishment; or
— dur ing the 30  days after their introduction provided they have been kept isolated during this period; and
(d) since t he beginning of the testing or sampling referred to in point  (b)(i), all g erminal products of bovine origin 
introduced into or used in the establishment originate from:
 (i) es tablishments free from infection with MTBC; or
 (ii) appr oved germinal product establishments  
2  By wa y 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:
(a) or iginate from a Member State or a zone free from infection with MTBC;
(b) if t hey are bovine animals over 6  weeks of age, they have tested negative to an immunological test:
 (i) dur ing the 30  days prior to their introduction into the establishment; or
 (ii) dur ing the 30  days after their introduction provided they have been kept in isolation during this period  3 6 2020 Official Journal of the European Union L 174/281 EN
3  By wa y of derogation from points  1(c) and 2(b), the competent authority may not require the test if:
(a) t he bovine animals introduced into the establishment:
 (i) ha ve tested negative in an immunological test carried out during the past 6  months; and
 ( ii) or iginate from establishments where the bovine animals have tested negative to a testing regime as provided for 
in points  1(c) or 2 of Section  2 car ried out during the past 6  months; or
(b) t he bovine animals introduced into the establishment:
 (i) ha ve tested negative in an immunological test carried out during the past 12  mont hs; and
 ( ii) or iginate from establishments where the bovine animals have tested negative to a testing regime as provided for 
in point  2(b) or 2 (c) of Section  2 car ried out during the past 12  mont hs 
Section  2
Maintenance of the status
1  T he status free from infection with MTBC of an establishment keeping bovine animals may only be maintained if:
(a) t he requirements set out in points  (a), (c) and (d) of point  1 of Section  1 continue to be fulfilled;
(b) an y suspected case of infection with MTBC in a bovine animal kept on that establishment or introduced from that 
establishment into a slaughterhouse is notified to the competent authority and investigated; and
(c) an immunological t est has been carried out, with negative results, on all bovine animals over 6  weeks of age, at 
intervals of not more than 12  mont hs 
2  By wa y of derogation from point  1(c), the competent authority may modify the testing regime as follows:
(a) in a Membe r State or in a zone where the annual percentage, calculated on 31 December of each  year, of establishments 
infected with MTBC is not more than 1  % dur ing the last 24  mont hs, the interval between tests may be extended to 
24 mont hs;
(b) in a Member S tate or in a zone where the annual percentage, calculated on 31 December of each  year, of establishments 
infected with MTBC is not more than 0,2 % f or the last 48  mont hs, the interval between tests may be extended to 
36 mont hs;
(c) in a Membe r State or in a zone where the annual percentage, calculated on 31 December of each  year, of establishments 
infected with MTBC is not more than 0,1 % f or the last 72  mont hs, the interval between tests may be extended to 
48 mont hs;
(d) in a Member S tate or a zone free from infection with MTBC, if the risk of transmission of MTBC from wild animals 
to bovine animals has been assessed by appropriate surveillance, the interval between tests may be based on the 
type of production and the risk factors identified, taking into account at least the following risks:
 (i) a location associated with suspected or confirmed infection with MTBC in wild animals;
 (ii) a hist ory of infection with MTBC within the last 5  years;
 (iii) an epidemiological link with establishments in any of points  (i) or (ii)  
Section  3
Suspension and restoring of the status
1  T he status free from infection with MTBC of an establishment keeping bovine animals must be suspended if:
(a) one or more of t he requirements laid down in Section  2 are no t fulfilled; or
(b) a case of infection with MTBC is suspected in a bovine animal kept in the establishment  Official Journal of the European Union L 174/282 EN 3 6 2020
2  T he status free from infection with MTBC may only be restored, if:
(a) t he requirements laid down in points  1(c) and 1(d) of p oint  1 of Section  1, 1(b), of Section  2 and, as rele vant, in 
point  1(c) or in point  2 of Section  2 are fulf illed;
(b) t he results of further investigations substantiate absence of infection with MTBC and the status of all suspected cases 
has been determined   In case, suspected bovine animals are slaughtered in that context, investigations must include 
examination of samples with direct diagnostic methods  
Section  4
Withdrawal and regaining of the status
1  T he status free from infection with MTBC of an establishment keeping bovine animals must be withdrawn if:
(a) one or more of the requirements laid down in Section  2 are no t fulfilled after the maximum period of time referred 
to in point  (b) of Article  20(3) has lapsed since the status was suspended;
(b) t he infection with MTBC cannot be ruled out in accordance with point  2(b) of Section  3;
(c) a case of infection with MTBC has been confirmed in a bovine animal kept in the establishment; or
(d) it is justified by other needs to control infection with MTBC  
2  If t he status free from infection with MTBC has been withdrawn in accordance with point  1(a), it ma y only be regained 
if the requirements laid down in Section  2 are fulf illed  
3  If t he 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:
(a) all conf irmed cases and all animals that have tested non negative in a immunological test have been removed; and
(b) t he remaining bovine animals fulfil the requirements set out in point  1(b) of Section  1 
4  By wa y of derogation from point  3(b), the status may be regained if:
(a) all bovine animals over 6  weeks of age present in the establishment at the time of testing have tested negative in 
two immunological tests as follows:
 ( i) t he first test must be carried out on bovine animals or samples taken from bovine animals not earlier than 
2 mont hs after the removal of the last confirmed case and of the last animal that tested positive in an 
immunological test;
 ( ii) t he  second t est must be carried out on bovine animals or on samples taken from bovine animals not earlier 
than 2  mont hs and not later than 12  mont hs following the date of testing or sampling of the bovine animal as 
referred to in point  (i); and
(b) at leas t one of the following conditions apply:
 (i) t he conclusion of the epidemiological enquiry indicates that the infection is due to the introduction of one or 
more infected animals into the establishment during the past 12  mont hs prior to the detection of the infection 
with MTBC; or
 (ii) onl y a single case was confirmed or only a single bovine animal tested positive in an immunological test for 
MTBC since the detection of the infection with MTBC, and the status of the establishment has not been withdrawn 
during the past 3  years; or
 (iii) bo vine animals in the establishment have tested negative in an immunological test carried out less than 12  mont hs 
prior to the detection of the infection with MTBC in accordance with point  1(c) or 2 of Section  2 3 6 2020 Official Journal of the European Union L 174/283 EN
CHAPTER 2
Member State or zone free from infection with MTBC
Section  1
Granting of the status as regards kept bovine animals
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) dur ing the past 3  years at least 99,8  % of t he establishments keeping bovine animals, representing at least 99,9  % of t he 
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) g eneral surveillance requirements have been carried out for the past 3  years in accordance with point  (a) of Ar ticle  3(1) 
for the detection of infection with MTBC in kept bovine animals and included at least:
 ( i) t he systematic research of lesions of infection with MTBC in all bovine animals slaughtered through ante- and post-
mortem surveillance;
 (ii) t he investigations of lesions that could be due to infection with MTBC  
Section  2
Maintenance of the status
1  Th e status free from infection with MTBC as regards kept bovine animals of a Member State or a zone may only be 
maintained if:
(a) t he requirements in point  (b) of Section  1 continue to be fulfilled; and
(b) f or the first 2 consecutive  years following granting of the status random annual surveillance based on a representative 
sampling of all establishments where bovine animals are kept must be carried out to demonstrate with a 95  % le vel of 
confidence, that:
 (i) at least 99,8  % of t he establishments, representing at least 99,9  % of t he bovine population are free from infection 
with MTBC;
 (ii) t he incidence rate of establishment confirmed infected during the  year does not exceed 0,1 %;
(c) if t he conditions in point  (b) were fulfilled for 2 consecutive  years, surveillance is based on:
 (i) r andom annual surveillance to demonstrate at least with a confidence level  of 95  %, that the incidence rate of 
establishments confirmed infected during the  year does not exceed 0,1 %; or
 ( ii) r isk-based annual surveillance carried out to detect infection with MTBC, taking into account the systems of 
production, the risk factors identified, including the spread of infection from other animals than kept bovine 
animals and increased surveillance in establishments associated with at least one of the specific risks referred to 
in point  2(d) of Section  2 of Chap ter 1 
2  T he 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  Official Journal of the European Union L 174/284 EN 3 6 2020
PART  III
ENZOOTIC BOVINE LEUKOSIS
CHAPTER 1
Establishment free from enzootic bovine leukosis
Section  1
Granting of the status
1  T he status free from enzootic bovine leukosis (EBL) may only be granted to an establishment keeping bovine animals if:
(a) dur ing the past 24  mont hs there has been no  confirmed case of EBL in bovine animals kept in the establishment;
(b) dur ing the past 12  mont hs, bovine animals older than 24  mont hs of age kept in the establishment have tested 
negative to a serological test, on at least two occasions at an interval of not less than 4  months;
(c) since the beginning of the sampling referred to in point  (b), all bovine animals introduced into the establishment:
 (i) or iginate from establishments free from EBL; or
 ( ii) or iginate from establishments where there has been no  evidence of EBL either clinical, post-mortem, or as a 
result of a diagnostic test for EBL within the 24  mont hs prior to their dispatch; and
— if o ver 24  mont hs of age,
they have been subjected to serological tests, with negative results, on two occasions at an interval of not 
less than 4  months while kept in isolation from other bovine animals of the establishment; or
they have been subjected to a serological test, with a negative result, within 30  days prior to their introduction 
provided all bovine animals have been tested in accordance with point  (b);
— if less than 24  mont hs of age,
they were born to dams, that have been subjected to a serological test for EBL, with negative results, carried 
out on samples taken during the past 12  mont hs on two occasions at an interval of not less than 4  mont hs; 
and
(d) since t he beginning of the sampling referred to in point  (b), all germinal products of bovine animals introduced into 
the establishment originate from:
 (i) es tablishments free from EBL; or
 (ii) appr oved germinal product establishments  
2  By wa y 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  
Section  2
Maintenance of the status
The status free from EBL of an establishment keeping bovine animals may only be maintained if:
(a) t he requirements laid down in points  (a), (c) and (d) of point  1 of Section  1 continue to be fulfilled; and
(b) ser ological testing for EBL is carried out, with negative results, on samples taken
 (i) at intervals of not more than 36  mont hs from all bovine animals over 24  mont hs of age; or
 ( ii) in accor dance with point  (b) or (c) of Section  2 of Chap ter 2, as rele vant, if the establishment is located in a Member 
State or zone free from EBL  3 6 2020 Official Journal of the European Union L 174/285 EN
Section  3
Suspension and restoring of the status
1  T he status free from EBL of an establishment keeping bovine animals must be suspended if:
(a) one or more of t he requirements laid down in Section  2 are no t fulfilled;
(b) a case of EBL in a bovine animal that is kept on the establishment is suspected  
2  T he status free from EBL may only be restored if:
(a) t he requirements laid down in points  (c) and (d) of point  1 of Section  1 and point  (b) of Section  2 are fulf illed;
(b) t he results of further investigations substantiate absence of EBL and the status of all suspected cases has been 
determined  
Section  4
Withdrawal and regaining of the status
1  T he status free from EBL of an establishment keeping bovine animals must be withdrawn if:
(a) one or more of the requirements laid down in Section  2 are no t fulfilled after the maximum period of time referred 
to in point  (b) of Article  20(3) has lapsed since the status was suspended; or
(b) a case of EBL has been confirmed in a bovine animal kept in the establishment  
2  If t he status free from EBL has been withdrawn in accordance with point  1(a), it ma y 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 fulf illed  
3  If t he status free from EBL has been withdrawn in accordance with point  1(b), it may only be regained if:
(a) an y bovine animal presenting a positive test result for EBL and all of their offspring younger than 24  mont hs of age 
have been removed;
(b) all bo vine animals over 12  mont hs of age have been tested negative in a serological test, on two occasions at an 
interval of not less than 4  mont hs, where the first test must be carried out on samples not taken earlier than 4  mont hs 
after the removal of the last confirmed case  
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:
(a) t hey have been separated from the dam immediately after calving and tested negative in a PCR test, on two occasions, 
where the first sample must be taken within the period of 3 to 5  weeks and the  second wit hin 8 to 10  weeks 
postpartum; and
(b) t hey remain in the establishment until they are 24  mont hs of age and are tested negative in a serological test, or they 
are sent before that test directly to the slaughterhouse in accordance with the requirements laid down in Article  27(4)  
CHAPTER 2
Member State or zone free from EBL
Section  1
Granting of the status
The status free from EBL as regards kept bovine animals may only be granted to a Member State or a zone if:
(a) at leas t 99,8  % of the bovine establishments are free from EBL; andOfficial Journal of the European Union L 174/286 EN 3 6 2020
(b) all bo vine animals over 24  mont hs 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  
Section  2
Maintenance of the status
The status free from EBL as regards kept bovine animals of a Member State or a zone may only be maintained if:
(a) t he requirements set out in Section  1 continue to be fulfilled; and
(b) dur ing the first 5  years after the granting of the status free from EBL, surveillance is carried out based on:
 (i) annual random sampling to detect at least, with a 95  % le vel of conf idence, establishments infected with EBL at a 
target prevalence rate of 0,2  %; or
 (ii) ser ological testing of all bovine animals over 24  mont hs of age on at least one occasion;
(c) f ollowing 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
Section  1
Granting of the status
1  T he status free from infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV) may only be granted to 
an establishment keeping bovine animals if:
(a) dur ing the past 12  mont hs there has been no  conf irmed case of IBR/IPV in bovine animals kept in the establishment;
(b) dur ing the past 2  years none of the bovine animals kept in the establishment has been vaccinated against IBR/IPV;
(c) t he bovine animals kept in the establishment have been subjected to at least one of the following testing regimes 
taking into account previous DIVA vaccinations, where serological tests for the detection of antibodies against whole 
BoHV-1 or, if necessary, antibodies against BoHV-1-gE have been carried out on:
 ( i) a blood, milk or meat juice sam ple taken from each bovine animal over a period of not more than 12  mont hs; 
or
 (ii) blood, milk or meat juice samples taken on at least two occasions at an interval of not less than 2  mont hs and 
not more than 12  mont hs from
— all f emale bovine animals over 12  mont hs of age, and
— all male bovine animals used or intended for breeding over 12  mont hs of age, and
— a r andom sample of male animals not intended for breeding over 12  mont hs of age   The number of animals 
tested must allow at least for the detection, with a 95  % le vel of conf idence, of seropositive animals at a 
target prevalence rate of 10  %; or
 (iii) in the case of an establishment in which at least 30  % of t he bovine animals are lactating,
— bulk milk samples taken on at least three occasions at intervals of not less than 3  mont hs from lactating 
female bovine animals representing all epidemiological units of the establishment, and3 6 2020 Official Journal of the European Union L 174/287 EN
— blood sam ples taken from all non-lactating female bovine animals over 12  mont hs of age, and from all 
male bovine animals used or intended for breeding over 12  mont hs of age, and
— a r andom blood or meat juice sample taken from male bovine animals not intended for breeding older 
than 12  mont hs of age   The number of animals tested must allow at least for the detection, with a 95  % 
level  of confidence, of seropositive animals at a target prevalence rate of 10  %; or
 (iv) in the case of an establishment in which less than 5  % of t he kept bovine animals are male and at least 95  % 
of the female animals over 24  mont hs are intended or used for milk production, bulk milk samples taken on 
at least six occasions at intervals of not less than 2  mont hs from lactating female bovine animals representing 
all epidemiological units of the establishment;
(d) since the beginning of the sampling referred to in point  (c) all bovine animals introduced into the establishment:
 ( i) or iginate from establishments free from IBR/IPV and, in case the establishments of origin are located in a Member 
State or zone that is neither free from IBR/IPV nor covered by an approved eradication programme, 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 after their introduction and before the granting of the status free from 
IBR/IPV; or
 (ii) ha ve been subjected to quarantine prior to their introduction and have tested negative in serological test for the 
detection of antibodies against whole BoHV-1 on a sample taken not earlier than 21  days after the beginning 
of the quarantine; and
(e) since the beginning of the sampling referred to in point  (c) all germinal products of bovine animals introduced into 
the establishment originate from:
 (i) es tablishments free from IBR/IPV; or
 (ii) appr oved germinal product establishments  
2  By wa y 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 rele vant  
Section  2
Maintenance of the status
The status free from IBR/IPV may only be maintained in an establishment keeping bovine animals if:
(a) t he requirements laid down in points  (a), (b) and (e) of point  1 of Section  1 continue to be fulfilled;
(b) ser ological 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,
 (i) on blood, milk or meat juice samples taken annually from all bovine animals older than 24  mont hs of age; or
 (ii) in the case of an establishment, in which at least 30  % of t he bovine animals are lactating, at least annually on:
— bulk  milk samples taken on at least three occasions at intervals of not less than 3  mont hs from lactating female 
bovine animals representing all epidemiological units of the establishment, and
— blood sam ples taken from all breeding male bovine animals older than 24  mont hs of age; or,
 (iii) in the case of an establishment, in which less than 5  % of t he kept bovine animals are male and at least 95  % 
of the female animals over 24  mont hs are intended or used for milk production, at least annually on bulk milk 
samples taken on at least six occasions at intervals of not less than 2  mont hs from lactating female bovine animals 
representing all epidemiological units of the establishment; or
 (iv) pr ovided the status free from IBR/IPV has been maintained for the past 3 consecutive  years, annually on blood or 
milk samples taken from a number of bovine animals that must allow at least for the detection, with a 95  % le vel of 
confidence, of seropositive animals at a target prevalence rate of 10  %; orOfficial Journal of the European Union L 174/288 EN 3 6 2020
 (v) if t he establishment is located in a Member State or zone free from IBR/IPV, on samples taken in accordance with 
point  1(b) of Section  2 of Chap ter 2 or point  3 of Section  2 of Chap ter 2, if rele vant  
(c) onl y 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:
 (i) free fr om IBR/IPV; or
 (ii) wher e a vaccination ban is in place as part of the eradication strategy under an approved eradication programme  
(d) all bo vine animals that are introduced fulfil the requirements laid down in point  1(d)(ii) of Section  1 or or iginate 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 da ys prior to their dispatch, in cases where:
 (i) t he establishment is located in a Member State or zone free from IBR/IPV and the establishments of origin are not 
located in a Member State or zone free from IBR/IPV; or
 ( ii) t he establishment is located in a Member State or zone covered by an approved eradication programme and the 
establishments of origin are located in a Member State or zone that is neither free from IBR/IPV nor covered by an 
approved eradication programme  
Section  3
Suspension and restoring of the status
1  T he status free from IBR/IPV of an establishment keeping bovine animals must be suspended if:
(a) one or more of t he requirements laid down in Section  2 are no t fulfilled;
(b) a case of IBR/IPV is suspected in a bovine animal kept in the establishment  
2  T he status free from IBR/IPV may only be restored if:
(a) t he requirements laid down in points  1(b) and (e) of Section  1 and points  (b), (c) and (d) of Section  2 are fulf illed;
(b) t he results of further investigations substantiate absence of IBR/IPV and the status of all suspected cases has been 
determined  
Section  4
Withdrawal and regaining of the status
1  T he status free from IBR/IPV of an establishment keeping bovine animals must be withdrawn if:
(a) one or more of the requirements laid down in Section  2 are no t fulfilled after the maximum period of time referred 
to in point  (b) of Article  20(3) has lapsed since the status was suspended;
(b) a case of IBR/IPV has been confirmed in a bovine animal kept in the establishment  
2  If t he status free from IBR/IPV has been withdrawn in accordance with point  1(a), it ma y 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 fulf illed  
3  If t he status free from IBR/IPV has been withdrawn in accordance with point  1(b), it may only be regained if:
(a) all conf irmed cases have been removed;
(b) at leas t one of the testing regimes laid down in point  1(c) of Section  1 has been car ried out with negative results on 
samples that have been taken not earlier than 30  days after the removal of the last confirmed case  3 6 2020 Official Journal of the European Union L 174/289 EN
CHAPTER 2
Member State or zone free from IBR/IPV
Section  1
Granting of the status
The status free from IBR/IPV as regards kept bovine animals may only be granted to a Member State or a zone if
(a) v accination against IBR/IPV has been prohibited for kept bovine animals; and
(b) at leas t 99,8  % of t he establishments representing at least 99,9  % of t he corresponding bovine population are free from 
IBR/IPV  
Section  2
Maintenance of the status
1  T he status free from IBR/IPV as regards kept bovine animals of a Member State or a zone may only be maintained if:
(a) t he requirements laid down in Section  1 continue to be fulfilled; and
(b) sur veillance is carried out annually based on random sampling that must allow at least for the detection, with a 
95 % le vel  of conf idence, of the infection of establishments with BoHV-1 at a target prevalence rate of 0,2 % of t he 
establishments or of BoHV-1 infected bovine animals with a target prevalence rate of 0,1 % of t he bovine population  
2  By wa y of derogation from point  1(a), t he use of DIVA vaccination may be authorised by the competent authority in the 
event of an outbreak, if:
(a) t he result of the epidemiological enquiry and investigations according to Article  25 has demonstrated that only a 
limited number of establishments were involved in the outbreak;
(b) its use is limited to controlling this outbreak as deemed necessary by the competent authority;
(c) t he bovine animals are DIVA vaccinated under the supervision of the competent authority and the use of DIVA 
vaccines is documented for each animal;
(d) t he DIVA vaccinated bovine animals are only moved directly to a slaughterhouse or to an establishment in another 
zone or Member State where no  vaccination ban is in place  
3  By wa y of derogation from point  1(b), sur veillance 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  outbr eaks 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
Section  1
Granting of the status
1  T he status free from infection with Aujeszky ’s disease virus (ADV) may only be granted to an establishment keeping 
porcine animals if:
(a) dur ing the past 12  mont hs there has been no  conf irmed case of infection with ADV in porcine animals kept in the 
establishment;Official Journal of the European Union L 174/290 EN 3 6 2020
(b) dur ing the past 12  mont hs none of the porcine animals kept in the establishment has been vaccinated against AD;
(c) dur ing the past 12  mont hs, the porcine animals kept in the establishment have been subjected to one of the following 
testing regimes taking into account previous DIVA vaccinations where serological tests for the detection of antibodies 
against ADV or, if necessary, antibodies against ADV-gE have been carried out, with negative results, on:
 (i) a blood or meat juice sample taken from each porcine animal; or
 (ii) blood or meat juice samples taken on two occasions at an interval of 2 to 3  mont hs from a number of animals 
that must allow at least for the detection, with a 95  % le vel of conf idence, of seropositive animals at a target 
prevalence rate of 10  % 
(d) since the beginning of the sampling referred to in point  (c), all porcine animals introduced into the establishment:
 ( i) or iginate from establishments free from infection with ADV and, in case the establishments of origin are located 
in a Member State or zone that is neither free from infection with ADV nor covered by an approved eradication 
programme, have tested negative in a serological test for the detection of antibodies against whole ADV or, if 
necessary, antibodies against ADV-gE after their introduction and before the granting of the status free from 
infection with ADV; or
 (ii) ha ve been subjected to quarantine for a period of at least 30  days prior to their introduction and have tested 
negative in a serological test for the detection of antibodies against whole ADV on two occasions at an interval 
of not less than 30  days between collection of each sample   The sample for the last test must be taken within 
15 da ys prior to dispatch  
(e) since the beginning of the sampling referred to in point  (c) all germinal products from porcine animals introduced 
into the establishment originate from:
 (i) es tablishments free from infection with ADV; or
 (ii) appr oved germinal product establishments  
2  By wa y 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 
Section  2
Maintenance of the status
The status free from infection with ADV of an establishment keeping porcine animals may only be maintained if:
(a) t he requirements laid down in points  (a), (b) and (e) of point  1 of Section  1 continue to be fulfilled;
(b) ser ological 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:
 (i) at least once a  year, in case all kept porcine animals are not vaccinated against AD, with tests for the detection of 
antibodies against whole ADV; or
 ( ii) at leas t twice a  year, with tests for the detection of antibodies against whole ADV and tests for the detection of 
antibodies against ADV-gE, if necessary;
(c) pr ovided 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 Chap ter 2 or point  4 of Section  2 of Chap ter 2, if rele vant;
(d) all por cine animals, that are introduced:
 (i) fulf il the requirements set out in point  1(d)(ii) of Section  1; or3 6 2020 Official Journal of the European Union L 174/291 EN
 ( ii) or iginate from establishments free from infection with ADV and have been subjected to a serological test for 
antibodies against whole ADV, with a negative result, on a sample collected in the establishments of origin within 
15 da ys prior to their dispatch, in cases where:
— t he establishment is located in a Member State or zone free from infection with ADV and the establishments 
of origin are not located in a Member State or zone free from infection with ADV; or
— t he establishment is located in a Member State or zone covered by an approved eradication programme and 
the establishments of origin are located in a Member State or zone that is neither free from infection with ADV 
nor covered by an approved eradication programme  
The number of porcine animals tested must allow at least for the detection, with a 95  % le vel of conf idence, of 
seropositive animals at a target prevalence rate of 10  % 
By way of derogation from the first subparagraph, for porcine animals less than 4  mont hs old born to DIVA-vaccinated 
dams the serological test for the detection of antibodies against ADV-gE may be used  
Section  3
Suspension and restoring of the status
1  T he status free from infection with ADV of an establishment keeping porcine animals must be suspended if:
(a) one or more of t he requirements laid down in Section  2 are no  longer fulfilled;
(b) a case of infection with ADV is suspected in a porcine animal kept in the establishment  
2  T he status free from infection with ADV may only be restored if:
(a) t he requirements laid down in points  (b) and (e) of point  1 of Section  1 and point  (b) or (c), if relevant, and (d) of 
Section  2 are fulf illed;
(b) t he results of further investigations substantiate absence of infection with ADV and the status of all suspected cases 
has been determined  
Section  4
Withdrawal and regaining of the status
1  T he status free from infection with ADV of an establishment keeping porcine animals must be withdrawn if:
(a) one or more of the requirements laid down in Section  2 are no t fulfilled after the maximum period of time referred 
to in point  (b) of Article  20(3) has lapsed since the status was suspended;
(b) a case of infection with ADV has been confirmed in a porcine animal kept in the establishment  
2  If t he status free from infection with ADV has been withdrawn in accordance with point  1(a), it ma y only be regained if 
the requirements set out in points  (b) and (e) of p oint  1 of Section  1 and point  (b) or (c), if rele vant, and (d) of Section  2 
are fulfilled  
3  If t he 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
Section  1
Granting of the status
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) v accination against AD has been prohibited for kept porcine animals for the previous 12  mont hs;Official Journal of the European Union L 174/292 EN 3 6 2020
(b) su rveillance 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  mont hs; and
(c) in case, inf ection 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  
Section  2
Maintenance of the status
1  T he status free from infection with ADV as regards kept porcine animals of a Member State or a zone may only be 
maintained if:
(a) t he requirements defined in points  (a) and (c) of Section  1 continue to be fulfilled; and
(b) sur veillance is carried out annually based on random sampling to allow at least for the detection, with a 95  % le vel of 
confidence, of establishments infected with ADV at a target prevalence rate of 0,2 %  The number of blood or meat 
juice samples to be taken from the porcine animals kept in an establishment must allow at least for the detection, 
with a 95  % le vel of confidence, of seropositive animals at a target prevalence rate of 20  % 
2  By wa y 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:
(a) all t he porcine animals in the affected establishments have been removed;
(b) an epidemiological enq uiry and investigations including clinical examination and serological or virological testing 
has been carried out by the competent authority:
 (i) in all es tablishments keeping porcine animals that have been directly or indirectly in contact with the infected 
establishment to rule out infection; and
 ( ii) in all es tablishments keeping porcine animals located within at least a 2-kilometre radius of an infected 
establishment, to demonstrate that these establishments are not infected   The number of blood or meat juice 
samples to be taken from porcine animals kept in these establishments must allow at least for the detection, 
with a 95  % le vel of confidence, of seropositive animals at a target prevalence rate of 10  %; or
 (iii) in case a DIVA vaccination has been used, serological testing for antibodies against ADV-gE has been carried 
out on two occasions at an interval of 2  mont hs in establishments keeping porcine animals located within the 
vaccinated radius from the infected establishment to demonstrate the absence of infection;
(c) t he result of the investigation according to point  (b) has demons trated that only a limited number of establishments 
were involved in the outbreak;
(d) t he relevant control measures as referred to in Article  24 ha ve been immediately implemented in each establishment 
infected with ADV, including where necessary vaccination with DIVA vaccines  
3  By wa y 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:
(a) its use is limited to control this outbreak as deemed necessary by the competent authority;
(b) t he porcine animals are DIVA vaccinated under the supervision of the competent authority and the use of DIVA 
vaccines is documented for each animal;
(c) t he DIVA vaccinated porcine animals are only moved directly to a slaughterhouse or to an establishment in another 
Member State or zone where no  vaccination ban is in place  
4  By wa y of derogation from point  1(b), sur veillance 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  outbreak s have been 
detected for 2 consecutive  years following the granting of the status free from infection with ADV in this Member State 
or zone  3 6 2020 Official Journal of the European Union L 174/293 EN
PART  VI
BOVINE VIRAL DIARRHOEA
CHAPTER 1
Establishment free from bovine viral diarrhoea
Section  1
Granting of the status
1  T he status free from bovine viral diarrhoea (BVD) may only be granted to an establishment keeping bovine animals if:
(a) dur ing the past 18  mont hs there has been no  conf irmed case of BVD in a bovine animal kept in the establishment;
(b) t he bovine animals kept in the establishment have been subjected to at least one of the following testing regimes 
taking into account possible previous vaccinations:
 (i) t ests for the detection of BVD virus (BVDV) antigen or genome have been carried out, with negative results, on 
samples of all bovine animals  
At least from all calves born in the previous 12  mont hs, the samples must have been taken after or at the same 
time as official identification, but not later than 20  days postpartum   The dams of those calves with negative 
test results do not need to be tested;
 (ii) ser ological tests for the detection of antibodies against BVDV have been carried out, with negative results, on 
samples taken over a period of not less than 12  mont hs on at least three occasions at intervals of not less than 
4 mont hs from bovine animals which have been kept in the establishment for at least 3  mont hs prior to testing  
The number of animals tested must allow at least for the detection, with a 95  % le vel of conf idence, of seropositive 
animals at a target prevalence rate of 50  % and mus t be at least five animals or all the animals if there are fewer 
than five animals kept  
In case the bovine animals of the establishment are kept in separate groups without direct contact with each 
other, a respective number of animals of each group must be tested;
 (iii) a combina tion of the testing regimes set out in points  (i) and (ii) h as been applied over a period of not less than 
12 mont hs  
The capacity of the combined testing regime to detect the disease must be equivalent to that of the testing 
regimes referred to in points  (i) and (ii);
(c) since the beginning of the sampling referred to in point  1(b), all bovine animals introduced into the establishment:
 (i) or iginate from establishments free from BVD located in a Member State or zone free from BVD; or
 (ii) or iginate from establishments free from BVD, where
— ser ological tests referred to in point  1(c) (ii) or (iii) of Section  2 of Chapter  1 have been carried out, with 
negative results, within the past 4  months; or
— pr ior to their dispatch, they have been tested individually to exclude BVDV transmission into the establishment 
of destination taking into account the testing history and, if relevant, the animal ’s stage of gestation; or
 (iii) ha ve tested negative in a test for BVDV antigen or genome, and
— ha ve been subjected to quarantine for a period of at least 21  days prior to their dispatch and, in case of 
pregnant dams, have tested negative for antibodies against BVDV on samples taken after not less than 
21 da ys of quarantine; or
— ha ve tested positive for antibodies against BVDV either prior to their dispatch or, in case of pregnant dams, 
before insemination preceding the current gestation;Official Journal of the European Union L 174/294 EN 3 6 2020
(d) since t he beginning of the sampling referred to in point  1(b) all g erminal products of bovine animals introduced 
into the establishment originate from:
 (i) es tablishments free from BVD; or
 (ii) appr oved germinal product establishments  
2  By wa y of derogation from point  1, the status free from BVD may be granted to an establishment if:
(a) all bo vine animals originate from establishments free from BVD located in a Member State or zone free from BVD 
or in a Member State or zone covered by an approved eradication programme and fulfil the requirements laid down 
in point  1(c), if relevant; or
(b) all bo vine animals originate from establishments free from BVD, are not intended for breeding and the status free 
from BVD of the establishment is maintained in accordance with point  2 of Section  2 
Section  2
Maintenance of the status
1  T he status free from BVD of an establishment keeping bovine animals may only be maintained if:
(a) t he requirements laid down in point  (a), (c) and (d) of point  1 of Section  1 continue to be fulfilled;
(b) no bo vine animal has been vaccinated against BVD since the status free from BVD was granted to the establishment;
(c) at leas t one of the following testing regimes is carried out with negative results:
 (i) eac h new-born calf is tested negative for BVDV antigen or genome on a sample taken after or at the same time 
as official identification, but not later than 20  days postpartum;
 ( ii) ser ological tests for the detection of antibodies against BVDV are carried out at least annually on samples taken 
from bovine animals that have been kept in the establishment for at least 3  months prior to testing  
The number of animals tested must allow at least for the detection, with a 95  % le vel of conf idence, of seropositive 
animals at a target prevalence rate of 50  % and mus t be at least five animals or all the animals if there are fewer 
than five animals kept;
In case the bovine animals of the establishment are kept in separate groups without direct contact with each 
other, a respective number of animals of each group must be tested;
 (iii) a combinatio n of the testing regimes laid down in points  (i) and (ii) is applied  
The capacity of the combined testing regime to detect the disease must be equivalent to that of the testing 
regimes referred to in points  (i) and (ii);
 ( iv) if t he establishment is located in a Member State or zone free from BVD, tests are carried out on samples taken 
in accordance with point  1(b) of Section  2 of Chap ter 2 or point  3 of Section  2 of Chap ter 2, if rele vant;
(d) onl y bovine animals that have not been vaccinated against BVD are introduced into the establishment if it is located 
in a Member State or zone free from BVD  
2  By wa y 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 ma y be maintained without testing the bovine animals in accordance with point  1(c) if:
(a) t he requirements laid down in point  2(b) of Section  1 continue to be fulfilled;
(b) t hey are not used for breeding;
(c) t hey have no  cont act with animals that are intended or used for breeding and are moved from this establishment to 
a slaughterhouse,
 (i) directl y, or;
 ( ii) via an assembl y operation, which is carried out in the same Member State or zone, and where only animals that 
comply with the requirements laid down in points  (b) and (c) and or iginate from establishments that comply 
with the requirement laid down in point  (a) are assembled  3 6 2020 Official Journal of the European Union L 174/295 EN
Section  3
Suspension and restoring of the status
1  T he status free from BVD of an establishment keeping bovine animals must be suspended if:
(a) one or more of t he requirements laid down in Section  2 are no t fulfilled;
(b) a case of BVD is suspected in a bovine animal kept in the establishment  
2  T he status free from BVD may only be restored if:
(a) t he requirements laid down in points  (c) and (e) of p oint  1 of Section  1 and points  (b), (c), (d) of point  1 and, if 
relevant, point  2 of Section  2 are fulf illed  
(b) t he results of further investigations substantiate absence of BVD and the status of all suspected cases has been 
determined  
Section  4
Withdrawal and regaining of the status
1  T he status free from BVD of an establishment keeping bovine animals must be withdrawn if:
(a) one or more of the requirements laid down in Section  2 are no t fulfilled after the maximum period of time referred 
to in point  (b) of Article  20(3) has lapsed since the status was suspended;
(b) a case of BVD has been confirmed in a bovine animal kept in the establishment  
2  If t he status free from BVD has been withdrawn in accordance with point  1(a), it ma y 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 fulf illed  
3  If t he status free from BVD has been withdrawn in accordance with point  1(b), it may only be regained if:
(a) all animals tested positive for BVDV have been removed;
(b) t he status in relation to infection with BVDV of each bovine animal kept in the establishment has been determined;
(c) all cal ves that might have been infected in utero with BVDV were born and kept in isolation until they tested negative 
for BVDV antigen or genome  
CHAPTER 2
Member State or zone free from bovine viral diarrhoea
Section  1
Granting of the status
The status free from BVD as regards kept bovine animals may only be granted to a Member State or a zone if:
(a) v accination 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  mont hs; and
(c) at leas t 99,8  % of the establishments representing at least 99,9  % of the bovine population are free from BVD  
Section  2
Maintenance of the status
1  T he status free from BVD as regards kept bovine animals of a Member State or a zone may only be maintained if:
(a) t he requirements laid down in point  (a) and (c) of Section  1 continue to be fulfilled; andOfficial Journal of the European Union L 174/296 EN 3 6 2020
(b) sur veillance is carried out annually that must allow at least for the detection, with a 95  % le vel of conf idence, of 
establishments infected with BVDV at a target prevalence rate of 0,2 % of t he establishments or of BVDV infected 
bovine animals with a target prevalence rate of 0,1  % of the bovine population  
2  By wa y of derogation from point  1(a), t he use of vaccination may be authorised by the competent authority in the event 
of an outbreak, if:
(a) t he results of the epidemiological enquiry and investigations according to Article  25 h ave demonstrated that only a 
limited number of establishments were involved in the outbreak;
(b) onl y a limited number of bovine animals deemed necessary by the competent authority to control this outbreak 
are vaccinated under the supervision of the competent authority and the use of vaccination is documented for each 
animal  
3  By wa y of derogation from point  1(b), sur veillance 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  outbr eaks have been detected 
for 5 consecutive  years following the granting of the status free from BVD in this Member State or zone  3 6 2020 Official Journal of the European Union L 174/297 EN
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
Section  1
Vaccination of kept animals
1  F or 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  F or 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 Anne x III 
to Regulation (EU) No  576/2013 of the European Parliament and of the Council  
Section  2
Vaccination of wild animals
1  F or the purpose of eradication programmes for infection with RABV the oral vaccination against infection with RABV 
of wildlife must:
(a) be or ganised and implemented as regular planned or emergency campaigns taking into account the risk assessment 
provided in point  (a) of Article  32(2);
(b) be  subjected to an adequate vaccine distribution in terms of timing and coverage of the vaccination area, taking into 
account the biology of the targeted animal population, the epidemiological situation and the topography of the area;
(c) be subject ed, with the support of geographical information systems, to assessment of the correct geographical 
distribution of vaccine baits with a frequency that allows, if necessary, the adoption of corrective measures; and
(d) be su bjected to monitoring of vaccination effectiveness, that may include the detection of the presence of biomarker 
and serological testing in dead animals from the targeted animal population for the vaccination  
2  F or the purpose of eradication programmes for infection with RABV the vaccination against infection with RABV of 
stray dog populations must:
(a) be or ganised and implemented, if necessary, as part of control and management measures of stray dog populations, 
taking into account the risk assessment provided for in point  (a) of Article  32(2);
(b) com ply with the requirements of Section  1 
CHAPTER 2
Member State or zone free from infection with rabies virus
Section  1
Granting of the status
1  T he status free from infection with RABV may only be granted to a Member State or a zone if:
(a) sur veillance has been implemented in accordance with the requirements laid down in Article  3(1) at leas t for the 
past 24  mont hs; and
(1) R egulation (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) Official Journal of the European Union L 174/298 EN 3 6 2020
(b) no case of inf ection with RABV has been confirmed during the past 24  mont hs in the targeted animal population  
2  By wa y 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
(a) t he case has been officially confirmed and no  epidemiological link may have occurred and resulted in any additional 
case, which includes detection of the case at a border control post, or in a quarantine establishment or the quarantine 
facilities of a confined establishment; or
(b) epidemiological link ma y have occurred and no  additional case was de tected by increased surveillance and 
epidemiological enquiry and investigations during the 6  months following the death of the case  
Section  2
Maintenance of the status
The status free from infection with RABV of a Member State or a zone may only be maintained if:
(a) sur veillance is implemented in accordance with the requirements laid down in Article  3(1) wit h the objective of an early 
detection of the disease; and
(b) no case of inf ection 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 w ere complied with  
PART  II
INFECTION WITH BLUETONGUE VIRUS (SEROTYPES 1-24 )
CHAPTER 1
Minimum requirements for the surveillance
Section  1
Surveillance for the detection of serotypes of Bluetongue virus not reported  
in the previous 2  years
1  T he 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:
(a) g eneral surveillance requirements as provided for in point  (a) of Article  3(1);
(b) activ e surveillance as provided for in Section  4 
2  T he design of the surveillance provided for in point  1 must address:
(a) t he risk of infection with limited clinical manifestations;
(b) t he risk of introduction of BTV serotypes associated with the circulation of any of the serotypes 1-24 of BTV in the 
vicinity; and
(c) an y other identified relevant risk factor for introduction of any of the serotypes 1-24 of BTV not reported in the 
previous 2  years  
3  T he 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 fr om 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  T he surveillance provided for in point  1(b) and point  3 mus t have the capacity at least to detect, with a 95  % le vel of 
confidence, the infection in the targeted animal population at a target prevalence rate of 5  %, unless otherwise specified 
in Section  2 of Chap ter 4 3 6 2020 Official Journal of the European Union L 174/299 EN
Section  2
Surveillance to determine the extent of infection with BTV
1  T he 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:
(a) g eneral surveillance requirements as provided for in point  (a) of Article  3(1); and
(b) activ e surveillance as provided for in Section  4 
2  Th e design of the surveillance provided for in point  1 mus t take into account: all available information on the epidemiology 
of the disease and biology of the vector that prevail on the territory  
3  T he 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  
Section  3
Surveillance to demonstrate absence of infection with BTV
1  T he 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:
(a) g eneral surveillance requirements as provided for in point  (a) of Article  3(1); and
(b) activ e surveillance as provided for in Section  4 
2  T he design of the surveillance provided for in point  1 must address:
(a) t he risk of infection with limited clinical manifestations;
(b) all a vailable information on the epidemiology of the disease and biology of the vector that prevail on the territory; 
and
(c) an y specific risk of persistence of the infection identified  
3  T he surveillance provided for in point  1(b) mus t have the capacity at least to detect, with a 95  % le vel of conf idence, the 
infection in the targeted animal population at a target prevalence rate of 1  % 
Section  4
Requirements for the active surveillance of infection with BTV
1  T he 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:
(a) t he epidemiological situation, how fast the infection is spreading and the shape and size of the zones covered by the 
eradication programme in the event of confirmation of the infection; and
(b) t he zones in accordance with point  (b) of Article  13(2)  
2  A ctive surveillance must be based on one or a combination of the following activities:
(a) monit oring of sentinel animals using serological or virological testing; and
(b) s tructured prevalence surveys, based on a random or risk-based sampling strategy using serological or virological 
testing  
3  T he frequency of the sampling must:
(a) at leas t be annual, in the period of the  year when infection or seroconversion is most likely to be detected; and
(b) be monthly during the vector activity season where regular information is needed due to the risk of the infection 
spreading  Official Journal of the European Union L 174/300 EN 3 6 2020
4  T he animals sampled must:
(a) no t be vaccinated against the serotype(s) of BTV targeted for surveillance;
(b) no longer be covered by maternal immunity in case their mother was vaccinated or infected;
(c) be resident for a sufficient time in the relevant geographical unit and not have been protected from exposure to the 
vector;
(d) be represent ative for the geographical distribution of the targeted animal population in the relevant geographical 
unit; and
(e) be initially seronegative when surveillance is based on serological testing of sentinels  
5  Th e 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 sur veillance must be adapted as provided for in point  (c) of Article  43(2), it must at least include a survey:
(a) on t he introduced animals that:
 (i) mus t be based on the sampling and testing of all introduced animals;
 (ii) mus t take place as soon as possible after their introduction; or
(b) on t he targeted animal population the most at risk due to the possible circulation of the virus that:
 ( i) mu st have a capacity at least to detect, with a 95  % le vel of conf idence, infection with BTV at a target prevalence 
rate of 5  %;
 (ii) mus t either:
— no t take place before 21  days has elapsed after the introduction of animals if it is a one-shot survey; or
— mus t be conducted with a frequency adapted to the frequency of the movements of the animals that may 
jeopardise the health status  
This survey is not required if the frequency of the sampling is carried out in accordance with point  3(b)  
Section  5
Entomological surveillance
1  Ent omological 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  Aspir ation 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:
(a) one nigh t per  week during the  mont h before the expected beginning and during the  mont h before the expected end 
of the vector-free period; and
(b) one night per month during the vector-free period  
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  A t least one aspiration trap must be placed in each geographical unit referred to in point  (a) of Ar ticle  40(1) t hroughout 
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  Wh en 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  3 6 2020 Official Journal of the European Union L 174/301 EN
CHAPTER 2
Movement of animals and germinal products
Section  1
Movement of animals
1  T he 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  Th e 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:
(a) t he animals have been kept in a seasonally BTV-free Member State or zone established in accordance with paragraph  3 
of Article  40:
 (i) f or at least 60  days prior to the date of movement;
 (ii) f or at least 28  days prior to the date of movement and have been subjected to a serological test, with negative 
results, carried out on samples collected at least 28  days following the entry date of the animal into the seasonally 
BTV-free Member State or zone; or
 (iii) f or at least 14  days prior to the date of movement and have been subjected to a PCR test, with negative results, 
carried out on samples collected at least 14  days following the entry date of the animal into the seasonally 
BTV-free Member State or zone;
(b) t he animals have been protected against attacks by the vectors during transportation to the place of destination and 
they have been kept protected against attacks by vectors in a vector protected establishment:
 (i) f or at least 60  days prior to the date of movement; or
 (ii) f or at least 28  days prior to the date of movement and have been subjected to a serological test, with negative 
results, carried out on samples collected at least 28  days following the date of the commencement of the period 
of protection against attacks by vectors; or
 (iii) f or at least 14  days prior to the date of movement and have been subjected to a PCR test, with negative results, 
carried out on samples collected at least 14  days following the date of commencement of the period of protection 
against attacks by vectors;
(c) t he animals have been vaccinated against all serotypes 1-24 of BTV reported during the past 2  years in that Member 
State or zone, the animals are within the immunity period guaranteed in the specifications of the vaccine and meet 
at least one of the following requirements:
 (i) t hey have been vaccinated more than 60  days before the date of movement; or
 ( ii) t hey have been vaccinated with an inactivated vaccine and subjected to a PCR test, with negative results on 
samples collected at least 14  days after the onset of the immunity set in the specifications of the vaccine  
(d) t he animals have been subjected with positive results to a serological test able to detect specific antibodies against 
all serotypes 1-24 of BTV reported during the past 2  years in that Member State or zone and:
 ( i) t he serological test have been carried out on samples collected at least 60  days before the date of movement; or
 ( ii) t he serological test have been carried out on samples collected at least 30  days before the date of the movement 
and the animals have been subjected to a PCR test, with negative results, carried out on samples collected not 
earlier than 14  days before the date of movement  
3  T he animals originate from a Member State or a zone neither BTV-free nor covered by an eradication programme for 
infection with BTV and:
(a) t hey comply with point  2(b); orOfficial Journal of the European Union L 174/302 EN 3 6 2020
(b) t he animals have been kept at least for the last 60  days prior to departure either in an area of at least 150  km 
radius from the establishment where they are kept, or in a Member State, where surveillance in compliance with the 
requirements laid down in Sections  1 and 2 of Chap ter 1 ha ve been carried out at least for the last 60  days prior to 
departure and:
 (i) t hey have been vaccinated in accordance with point  2(c) against all serotypes 1-24 of BTV reported during the 
past 2  years in an area of at least 150  km radius centred on the place where the animals were kept; or
 ( ii) t hey have been immunised in accordance with point  2(d) ag ainst all serotypes 1-24 of BTV reported during the 
past 2  years in an area of at least 150  km radius centred on the place where the animals were kept  
4  T he animals originate from a Member State or a zone not BTV-free, are destined for immediate slaughter and the following 
requirements apply:
(a) no case of inf ection with BTV has been reported in the establishment of origin for a period of at least 30  days prior 
to the date of movement;
(b) t he animals are transported directly from the Member State or zone of origin to the slaughterhouse of destination 
where they are slaughtered within 24  hour s of arrival;
(c) t he operator of the establishment of origin have informed the operator of the slaughterhouse of destination of the 
movement at least 48  hour s prior to the loading of the animals  
5  T he 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  T he animals originate from a Member State or a zone not BTV-free and:
(a) t hey have been protected from vector attacks by insecticides or repellents for at least 14  days prior to the date of 
movement; and
(b) t hey have been subjected during that period to a PCR test, with negative results, carried out on samples collected at 
least 14  da ys following the date of protection from vector attacks  
7  T he animals comply with specific animal health requirements defined by the competent authority to ensure they have 
sufficient immunological protection prior to departure  
8  T he 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  
Section  2
Movement of germinal products
1  T he 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  T he 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) f or 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:
(a) semen have been obtained from donor animals that comply with at least one of the following requirements:
 (i) t hey have been protected against attacks by vectors in a vector protected establishment for a period of at least 
60 da ys before commencement of collection and during collection of the semen;
 ( ii) t hey have been kept in a seasonally BTV-free Member State or zone for a period of at least 60  days before 
commencement of collection and during collection of the semen;
 (iii) t hey have been subjected to a serological test, with negative results, on samples collected between 28 and 60  days 
from the date of each collection of the semen;3 6 2020 Official Journal of the European Union L 174/303 EN
 ( iv) t hey have been subjected, with negative results, to a direct diagnostic method carried out on samples collected:
— at commencement and final collection of the semen to be consigned; and
— dur ing the period of semen collection: at least every 7  days in the case of a virus isolation test, or at least 
every 28  da ys, in the case of a PCR test;
(b) in vivo derived embryos of bovine animals have been obtained from donor animals that do not show any clinical 
signs of infection with BTV on the  day of collection and are collected, processed and stored in accordance with 
Part  2 of Anne x III of Commission Delegated Regulation (EU) 2020/ 686  (2);
(c) embr yos other than in vivo derived embryos of bovine animals and oocytes have been obtained from donor animals 
that comply with at least one of the following requirements:
 ( i) t hey have been protected against attacks by vectors in a vector protected establishment for at least 60  days 
before commencement of collection and during collection of the embryos/oocytes;
 ( ii) t hey have been subjected to a serological test, with negative results, on samples collected between 28 and 60  days 
from the date of each collection of the embryos/oocytes;
 (iii) t hey have been subjected to a PCR test, with negative results, on samples collected on the  day of collection of 
the embryos/oocytes;
 ( iv) t hey have been kept in a seasonally BTV-free Member State or zone for a period of at least 60  days before 
collection of the embryos/oocytes  
3  T he 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  T he 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) op enings must be vector screened with mesh of appropriate gauge which must be impregnated regularly with an approved 
insecticide according to the manufacturers’ instructions;
(c) v ector surveillance and control must be carried out within and around the vector protected establishment;
(d) measu res must be taken to limit or eliminate breeding sites for vectors in the vicinity of the vector protected establishment; 
and
(e) s tandard 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
Section  1
Granting of the status
1  T he 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:
(a) sur veillance in accordance with Section  1 of Chap ter 1 has been conducted at least for the past 24  mont hs; and
(2) Commission Deleg ated 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)  Official Journal of the European Union L 174/304 EN 3 6 2020
(b) no case of infection with BTV has been confirmed during the past 24  mont hs in the targeted animal population  
2  T he 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:
(a) sur veillance in accordance with Section  3 of Chap ter 1 has been conducted at least for the past 24  mont hs; and
(b) no case of infection with BTV has been confirmed during the past 24  mont hs in the targeted animal population  
Section  2
Maintenance of the status
1  T he status free from infection with BTV may only be maintained if:
(a) t he requirements laid down in point  1 of Section  1 are com plied with; and
(b) animals and germinal products from the targeted animal population are only moved into or through the Member 
State or zone when the requirements laid down in Articles  43 and 45 are complied with  
2  T he intensity and frequency of the surveillance referred to in point  1 of Section  1 mus t be duly adapted to:
(a) t he health status of neighbouring Member States, zones or third countries in accordance with point  3 of Section  4 
of Chapter  1;
(b) t he introduction of animals from the targeted animal population that may have jeopardised the health status of the 
Member State or zone, in accordance with point  6 of Section  4 of Chap ter 1 
3  If no  cir culation 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:
(a) r andom annual surveillance at least to detect, with a 95  % le vel of conf idence, the infection with BTV at a target 
prevalence rate of 20  %; or
(b) r isk-based annual surveillance to detect infection with BTV carried out taking into account the systems of production 
and the risk factors identified  
CHAPTER 5
Seasonally BTV-free Member State or zone
1  T he seasonally BTV-free status may only be established in a Member State or zone thereof if:
(a) t he beginning and the end of the vector-free period and therefore of the seasonally BTV-free period has been 
demonstrated based on entomological surveillance in accordance with Section  5 of Chap ter 1; and
(b) t he cessation of the transmission of BTV has been demonstrated by:
 (i) t he implementation of surveillance in accordance with Section  2 of Chap ter 1 at leas t for the past 12  mont hs 
including one full vector activity season; and
 ( ii) t he absence of new cases of infection with any of the serotypes 1-24 of BTV since the end of the vector activity 
season  
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  T he 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  3 6 2020 Official Journal of the European Union L 174/305 EN
PART  III
INFESTATION WITH VARROA SPP.
Section  1
Granting of the status to a Member State or zone as free from 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 r isk 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) t here has been no  confirmed case of infestation with Varroa  spp   either in kept or in wild honeybee colonies;
(d) f or 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  % le vel of conf idence, of the infestation with Varroa  spp   at a target prevalence rate of 1  % of t he 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 y ear an ongoing surveillance programme in the wild population which demonstrates no  evidence of infestation 
with Varroa  spp  ; and
(f) dur ing the whole duration of the surveillance referred to in point  (d) t he 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  
Section  2
Maintenance of the status of a Member State or zone free from infestation  
with varroa spp.
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) t he competent authority maintains a surveillance that:
 (i) demons trates the absence of infestations with Varroa  spp   annually on a representative sample of kept honeybees 
of the free area;
 (ii) enables the early detection of infestation with Varroa  spp   in apiaries and beehives;
 (iii) t akes into consideration specifically target areas with higher likelihood of introduction of or infestation with Varroa  
spp , based on a risk assessment;
(b) all t he 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) eit her there is no  wild self-sus taining 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) t he honeybees in any stage of their lifecycle, including honeybee brood, are only moved into the free area when:
 ( i) t hey come from a Member State or zone thereof or from a third country or territory with disease-free status regarding 
infestation with Varroa  spp  ; and
 (ii) t hey are protected from infestation with Varroa  spp   during transport  Official Journal of the European Union L 174/306 EN 3 6 2020
PART  IV
STATUS FREE FROM INFECTION WITH NEWCASTLE DISEASE VIRUS- WITHOUT VACCINATION
Section  1
Granting of 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) v accination against infection with NDV in poultry and in captive birds of Galliformes species has been prohibited;
(b) no p oultry 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) g eneral surveillance requirements have been carried out in accordance with point  (a) of Ar ticle  3(1) f or the early detection 
of infection with NDV;
(d) one of t he following testing regime has applied:
 (i) all establishments keeping breeding poultry have been tested for the presence of antibodies against infection with 
NDV with negative results, on blood samples from at least 60 birds randomly chosen from each establishment and 
tested serologically by Haemagglutination inhibition (HI) test; or
 ( ii) a sur vey has been conducted on a representative sample of establishments which has at least the capacity at least to 
detect, with a 95  % le vel of conf idence, the infection at a target prevalence rate of 1  % in t he poultry establishments 
and at a within-establishment prevalence rate of seropositive birds of 10  %; and
(e) no case of infection with NDV has been confirmed in poultry and captive birds of Galliformes  species  
Section  2
Maintenance of the status
1  T he 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) t o (e) of Section  1 continue to be fulfilled  
2  By wa y 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:
(a) t he relevant disease control measures have been immediately implemented on each establishment with suspected or 
confirmed cases until the incident has been resolved;
(b) t he competent authority has concluded that only a limited number of establishments, epidemiologically linked to 
the first detected outbreak, were infected; and
(c) dur ing a period of 12  mont hs, the disease control measures referred to in point  (a) were not applied for a duration 
longer than three  months  
3  T he 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  3 6 2020 Official Journal of the European Union L 174/307 EN
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:
(a) increased mortality;
(b) lis ted diseases;
(c) emer ging diseases  
1 2  T he 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  Chap ter  3 se ts 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:
(a) as par t of compulsory or optional eradication programmes for one or more listed diseases; or
(b) t o demonstrate and maintain disease free status for one or more listed diseases; or
(c) as par t of a surveillance programme for one or more category  C diseases  
CHAPTER 2
Risk ranking to be applied in certain approved aquaculture establishments
The risk ranking referred to in point  1 2 of Chapter  1 mus t 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) mo vements of aquaculture animals;
(c) type of pr oduction;
(d) species of aquaculture animals kept;
(e) biosecur ity system, including staff competence and training;Official Journal of the European Union L 174/308 EN 3 6 2020
(f) density of aquaculture establishments and processing establishments in the area around the establishment concerned;
(g) pr oximity of establishments with a lower health status than the establishment concerned;
(h) disease history of the establishment concerned and of other local establishments;
(i) pr esence of infected wild aquatic animals in the area around the establishment concerned;
(j) r isk 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) tr ack 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 leas t once per  year in high risk establishments;
(b) at leas t once every two  years in medium risk establishments;
(c) at leas t 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)
Section  1
General requirements for health visits and sampling
Health visits and sampling for the surveillance referred to in point  (b)(ii) of Ar ticle  3(2) mus t comply with the following 
requirements:
(a) h ealth 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;3 6 2020 Official Journal of the European Union L 174/309 EN
(b) wh en 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  mus t be determined to obtain 
a reasonable coverage of the Member State, zone or compartment   The sampling points  mus t be representative of the 
different ecosystems where wild populations of susceptible species are located;
(c) when es tablishments 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 p roduction 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) f ish of listed species to be collected as samples must be selected as follows:
 ( i) if r ainbow trout are present, only fish of that species must be selected for sampling, except where other susceptible 
species are present which show typical signs of VHS or IHN; if rainbow trout are not present, the sample must be 
representative of all other susceptible species which are present;
 (ii) if weak, abnormally behaving or freshly dead but not decomposed fish are present, such fish must be selected; if 
more than one water source is utilised for fish production, fish representing all water sources must be included in 
the sample;
 (iii) t he fish selected must include fish collected in such a way that all production units, such as net cages, tanks and 
ponds, of the establishment, as well as all  year classes, are proportionally represented in the sample  
Section  2
Granting of the status free from VHS or free from IHN in Member States, zones  
and compartments of unknown health status
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 es tablishments and, when required, sampling points  in wild p opulations selected in accordance with point  (b) of 
Section  1, ha ve been subject to one of the following scheme:
 (i) model A  — 2-year scheme
The establishments or sampling points  mus t have been subject to health visits and sampled for a minimum period 
of 2 consecutive  years as laid down in Table  1 A 
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 VHS or IHN, and any suspicion of VHS or IHN must have been ruled out 
in accordance with the sampling and diagnostic methods set out in point  3 of Section  5;
 (ii) model B  — 4-year scheme with reduced sample size
The establishments or sampling points  mus t have been subject to health visits and sampled for a minimum period 
of 4 consecutive  years as laid down in Table  1 B  Dur ing that 4-year period, the testing of all samples using the 
diagnostic methods set out in point  2 of Section  5 mus t have produced negative results for VHS or IHN and any 
suspicion of VHS or IHN must have been ruled out in accordance with the sampling and diagnostic methods set 
out in point  3 of Section  5;
(b) if VHS or IHN h ave been detected during the surveillance referred to in point  (a); bef ore starting a new 2-year or 4-year 
scheme, relevant establishments in the Member State, zone or compartment must:
 (i) be subject to the minimum disease control measures laid down in Articles  58 to 65;
 ( ii) be rep opulated with fish from an establishment in a Member State, zone or compartment with status free from 
VHS or status free from IHN or from an establishment in a Member State, zone or compartment covered by an 
eradication programme for VHS or IHN  Official Journal of the European Union L 174/310 EN 3 6 2020
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 establishmentNumber of health visits 
per year to each establishmentNumber of samplings per  year 
in each establishmentNumber of fish in the sample  (1)
Number of growing fishNumber of broodstock 
fish (2)
(a) Establishments with 
broodstock2 2 50 (first visit)
75 (second visit)30 (first or  second 
visit)
(b) Establishments with 
broodstock only2 1 0 75 (first or  second 
visit)
(c) Establishments without 
broodstock2 2 75 (first AND  second  
visit)0
Maximum number of fish per pool: 10
(1) In t he case of coastal zones or coastal compartments, the samples must be collected no  sooner t han 3  weeks after the transfer of the fish from 
fresh to saltwater  
(2) Ov arian or seminal fluid of broodstock shall be collected at the time of maturation, in connection with stripping  
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 establishmentNumber of health 
visits per  year to each 
establishmentNumber of samplings 
per year in each 
establishmentNumber of fish in the sample  (1)
Number of 
growing fishNumber of broodstock fish  (2)
First 2  years
(a) Es tablishments with broodstock 2 1 30 (second 
visit)0
(b) Es tablishments with broodstock only 2 1 0 30 (first or  second visit)
(c) Es tablishments without broodstock 2 1 30 (first 
or second visit)0
Last 2  years
(a) Es tablishments with broodstock 2 2 30 (first visit) 30 (second visit)
(b) Es tablishments with broodstock only 2 2 30 (first AND  second visit)
(c) Es tablishments without broodstock 2 2 30 (first 
AND  second 
visit)
Maximum number of fish per pool: 10
(1) In t he case of coastal zones or coastal compartments, the samples must be collected no  sooner t han 3  weeks after the transfer of the fish from 
fresh to saltwater  
(2) Ov arian or seminal fluid of broodstock shall be collected at the time of maturation, in connection with stripping  3 6 2020 Official Journal of the European Union L 174/311 EN
Section  3
Granting of the status free from VHS or free from IHN in Member States, zones  
and compartments known to be infected with either VHS or IHN
1  T he 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:
(a) t he minimum control measures laid down in Articles  55 to 65 must have been effectively applied and a restricted 
zone of an appropriate size as provided for in point  (c) of Ar ticle  58(1), where app ropriate, divided into a protection 
zone and surveillance zone; must have been established in the vicinity of the establishment(s) declared infected with 
VHS or IHN, taking into account the requirements set out in point  2;
(b) all es tablishments keeping listed species within the protection zone, or where a protection zone has not been 
established, the restricted zone, not infected with VHS or IHN must be subject to an investigation comprising at 
least the following elements:
 ( i) t he collection of samples for testing of 10 fish, when clinical signs or post-mortem lesions consistent with infection 
with VHS or IHN are observed or minimum 30 fish, when clinical signs or post-mortem lesions are not observed;
 ( ii) in those establishments where the tests referred to in (i) have produced negative results; health visits must continue 
once per  mont h during the period when the water temperature is below 14  °C, except when fish ponds, tanks, 
raceways or net cages are covered with ice, until the protection zone is withdrawn in accordance with point  (c);
(c) rele vant establishments must be emptied in accordance with Article  62, cleaned and disinfected in accordance with 
Article  63 and fallowed in accordance with Article  64 
The duration of the fallowing period referred to in point  (a) of Ar ticle  64(2) mus t be at least 6  weeks   When all 
establishments infected within the same protection zone, or where a protection zone has not been established, the 
restricted zone, are emptied, at least 3  weeks of synchronised fallowing must be carried out  
When fallowing of the infected establishments is carried out, the restricted zone or the protection zone, when it 
has been established, must be converted into a surveillance zone until the scheme set out in Section  2 is com pleted;
(d) repop ulation may only take place when all infected establishments have been emptied, cleaned, disinfected and 
fallowed in accordance with point  (c);
(e) all establishments other than those referred to in point  (f) which keep listed species within the Member State, zone 
or compartment covered by the eradication programme and when surveillance in wild populations is required, all 
sampling points  select ed in accordance with point  (b) of Section  1, mus t subsequently be subject to the scheme laid 
down in Section  2;
(f) an individual es tablishment which keeps listed species and which has a health status which is independent of the 
health status of the surrounding waters is not required to comply with the scheme laid down in Section  2 following 
a disease outbreak, provided the establishment complies with the requirements set out in paragraph  3 of Ar ticle  80 
and is repopulated with fish sourced from Member States, zones or compartments with status free from VHS or 
status free from IHN  
2  T he restricted zone must have been defined on a case-by-case basis and:
(a) it must take into account factors influencing the risks for the spread of VHS or IHN to kept and wild fish, such as:
 ( i)  t he number, rate and distribution of the mortalities of fish on the establishment infected with VHS or IHN, or 
in other aquaculture establishments;
 (ii) t he distance to and density of neighbouring establishments;
 (iii) t he proximity to slaughterhouses;
 (iv) cont act establishments;
 (v) species present at the establishments;
 (vi) t he farming practices applied in the infected establishments and the neighbouring establishments;Official Journal of the European Union L 174/312 EN 3 6 2020
 (vii) t he hydrodynamic conditions; and
 (viii)  o ther factors of epidemiological significance identified;
(b) t he geographical demarcation in coastal areas must comply with the following minimum requirements:
 (i) t he protection zone must consist of an area included in a circle with a radius of at least one tidal excursion or 
at least 5  km, whic hever is larger, centred on the establishment infected with VHS or IHN, or an equivalent area 
determined according to appropriate hydrodynamic or epidemiological data; and
 (ii) t he surveillance zone must consist of an area surrounding the protection zone, of overlapping tidal excursion 
zones; or an area surrounding the protection zone and included in a circle of radius 10km from the centre of the 
protection zone; or an equivalent area determined according to appropriate hydrodynamic or epidemiological 
data;
 or
 (iii) wh ere separate protection and surveillance zones are not established, the restricted zone must consist of an 
area comprising both the protection zone and the surveillance zone;
(c) t he geographical demarcation in inland areas must comprise the entire water catchment area in which the establishment 
infected with VHS or IHN is located   The competent authority may limit the extent of the restricted zone to parts of 
the water catchment area, provided this limitation does not compromise the disease control measures with respect 
to VHS or IHN  
Section  4
Maintenance of status free from VHS and status free from IHN
1  Wh en 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 es tablishments 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 de termining 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  Dise ase-free status must only be maintained as long as all samples tested, using the diagnostic methods set out in point  2 
of Section  5, h ave 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
Risk level  (1)Number of health visits per  year to each 
establishmentNumber of fish in the sample  (2), (3)
High 1 every  year 30
Medium 1 every 2  years 30
Low 1 every 3  years 30
Maximum number of fish per pool: 10
(1) Risk level  assign ed 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  
(2) One sam ple to be taken during every health visit  
(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  3 6 2020 Official Journal of the European Union L 174/313 EN
Section  5
Diagnostic and sampling methods
1  T he 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  T he 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:
(a) vir us isolation in cell culture with subsequent identification of the virus using ELISA, indirect fluorescent antibody 
test (IFAT), virus neutralisation test or virus genome detection; or
(b) R everse Transcription quantitative PCR (RT-qPCR) detection  
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:
(a) t he suspected establishment must be subject to at least one health visit and one sampling of 10 fish, when clinical 
signs or post-mortem lesions consistent with infection with VHS or IHN are observed or minimum 30 fish, when 
clinical signs or post-mortem  lesions are not observed   Samples shall be tested using one or more of the diagnostic 
methods set out in points  2(a) and 2(b) in accor dance with the detailed diagnostic methods and procedures approved 
by the EURL for fish diseases;
(b) t he presence of VHS must be considered as confirmed, if one or more of those diagnostic methods are positive for 
VHSV   The presence of IHN must be considered as confirmed, if one or more of those diagnostic methods are positive 
for IHNV   The confirmation of the first case of VHS or IHN in Member States, zones or compartments previously 
not infected must be based on conventional virus isolation in cell culture with subsequent immunochemical or 
molecular identification or with genome detection including confirmation by sequencing of the amplification (RT-
PCR) product;
(c) Susp icion of VHS or IHN may be ruled out, if cell cultivation or RT-qPCR tests reveal no  further evidence of the 
presence of VHSV or IHNV  
CHAPTER 2
Eradication, disease-free status and diagnostic methods for infection with HPR-deleted infectious salmon 
anaemia virus (HPR-deleted ISAV)
Section  1
General requirements for health visits and sampling
Health visits and sampling for the surveillance referred to in point  (b)(ii) of Ar ticle  3(2) mus t comply with the following 
requirements:
(a) when healt h visits and sampling of establishments must be carried out more than once per  year in accordance with 
Sections  2 t o 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) t he sampling points  mus t be representative of the different ecosystems where the wild populations of susceptible species 
are located;
(d) all p roduction 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;Official Journal of the European Union L 174/314 EN 3 6 2020
(e) f ish of listed species to be collected as samples must be selected as follows:
 ( i) if A tlantic salmon are present, only fish of that species must be selected for sampling, except where other susceptible 
species are present which show typical signs of infection with HPR- deleted ISAV   If there are no  Atlantic salmon 
in the establishment, the sample must be representative of all other susceptible species which are present;
 ( ii) if mor ibund or freshly dead, but not decomposed fish are present, such fish must be selected, in particular fish 
demonstrating anaemia, haemorrhages or other clinical signs suggesting circulatory disturbances; if more than one 
water source is utilised for fish production, fish representing all water sources must be included in the sample;
 (iii) t he fish selected must include fish collected in such a way that all production units, such as net cages, tanks and 
ponds, of the establishment as well as all  year classes are proportionally represented in the sample  
Section  2
Granting of the status free from infection with HPR-deleted ISAV in Member  
States, zones and compartments of unknown health status
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) t he 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) dur ing 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); bef ore re-starting the 
scheme, relevant establishments within the Member State, zone or compartment must:
 (i) be subject to the minimum disease control measures laid down in Articles  58 to 65;
 (ii) be repopulat ed with fish from an establishment in a Member State, zone or compartment free from infection with 
HPR-deleted ISAV or from an establishment in a Member State, zone or compartment covered by an eradication 
programme for that disease  
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 surveillanceNumber of health visits per  year to each 
establishmentNumber of laboratory 
examinations per  year  (1)Number of fish in the sample
Year 1 6 2 75
Year 2 6 2 75
(1) Sam ples must be collected during spring and autumn each  year  
Maximum number of fish per pool: 5  
Section  3
Granting of the status free from infection with HPR-deleted ISAV in Member  
States, zones and compartments known to be infected with HPR-deleted ISAV
1  T he 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:3 6 2020 Official Journal of the European Union L 174/315 EN
(a) t he minimum control measures laid down in Articles  55 t o Article  65 ha ve been applied and a restricted zone of 
an appropriate size as provided for in point  (c) of Article  58(1), where appropriate, divided into a protection zone 
and a surveillance zone, must have been established in the vicinity of the establishment(s) infected with HPR-deleted 
ISAV, taking into account the requirements set out in point  2;
(b) all es tablishments keeping listed species within the protection zone, or where a protection zone has not been 
established, the restricted zone, not infected with HPR-deleted ISAV must be subject to an investigation comprising 
at least the following elements:
 (i) t he collection of samples for testing of minimum 10 moribund fish, when clinical signs or post-mortem lesions 
consistent with infection with HPR-deleted ISAV are observed, or minimum 30 fish when clinical signs or post 
mortem lesions are not observed;
 (ii) in t hose establishments where the tests referred to in (i) have produced negative results, the health visits must 
continue once per  month until the protection zone is withdrawn in accordance with point  (c);
(c) rele vant establishments must be emptied in accordance with Article  62, cleaned and disinfected in accordance with 
Article  63 and fallowed in accordance with Article  64 
The duration of the fallowing period referred to in point  (b) of Article  64(2) shall be at least 3  mont hs  When all 
establishments infected within the same protection zone, or where a protection zone has not been established, the 
restricted zone, are emptied, at least 6  weeks of synchronised fallowing must be carried out  
When fallowing of the infected establishments is carried out, the restricted zone or the protection zone, when it 
has been established, must be converted into a surveillance zone until the scheme set out in Section  2 is com pleted;
(d) repop ulation may only take place when all infected establishments have been emptied, cleaned, disinfected and 
fallowed in accordance with point  (c);
(e) all establishments other than those referred to in point  (f) which keep listed species within the Member State, zone 
or compartment covered by the eradication programme and when surveillance in wild populations is required, all 
sampling points  select ed in accordance with point  (b) of Section  1, mus t subsequently be subject to the scheme set 
out in Section  2;
(f) an individual es tablishment which keeps listed species and which has a health status which is independent of the 
health status of the surrounding waters is not required to comply with the scheme set out in Section  2 following a 
disease outbreak provided the establishment complies with the requirements set out in paragraph  3 of Article  80 
and is re-populated with fish sourced from Member States, zones or compartments with status free from infection 
with HPR-deleted ISAV  
2  T he restricted zone must have been defined on a case-by-case basis and:
(a) it mu st take into account factors influencing the risks for the spread of infection with HPR-deleted ISAV to kept and 
wild fish, such as:
 (i) t he number, rate and distribution of the mortalities on the establishment infected with HPR-deleted ISAV or 
in other aquaculture establishments;
 (ii) t he distance to and density of neighbouring establishments;
 (iii) t he proximity to slaughterhouses;
 (iv) cont act establishments;
 (v) species present at the establishments;
 ( vi)  t he farming practices applied in the infected establishments and in the neighbouring establishments to the 
infected establishment;
 (vii) t he hydrodynamic conditions; and
 (viii)  o ther factors of epidemiological significance identified;
(b) t he geographical demarcation in coastal areas must comply with the following minimum requirements:
 (i) t he protection zone must consist of an area included in a circle with a radius of at least one tidal excursion or 
at least 5  km, wh ichever is larger, centred on the establishment infected with HPR-deleted ISAV, or an equivalent 
area determined according to appropriate hydrodynamic or epidemiological data; andOfficial Journal of the European Union L 174/316 EN 3 6 2020
 (ii) t he surveillance zone must consist of an area surrounding the protection zone, of overlapping tidal excursion 
zones; or an area surrounding the protection zone and included in a circle of radius 10km from the centre of the 
protection zone; or an equivalent area determined according to appropriate hydrodynamic or epidemiological 
data;
 or
 (iii) wh ere separate protection and surveillance zones are not established, the restricted zone must consist of an 
area comprising both the protection zone and the surveillance zone;
(c) t he geographical demarcation in inland areas must comprise the entire water catchment area in which the establishment 
infected with HPR-deleted ISAV is located   The competent authority may limit the extent of the restricted zone to 
parts of the water catchment area, provided this limitation does not compromise the disease control measures with 
respect to infection with HPR-deleted ISAV  
Section  4
Maintenance of status free from infection with HPR-deleted ISAV
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  Wh en 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  Dise ase-free status must only be maintained as long as all samples tested, using the diagnostic methods set out in point  2 
of Section  5, h ave 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  (1)
Risk level  (2) Number of health visits per  yearNumber of laboratory examinations 
per year  (3), (4)Number of fish in the sample
High 2 2 30
Medium 1 1 30
Low 1 every 2  years 1 every 2  years 30
(1) 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 ) 
(2) Risk level  assign ed 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  
(3) Sam ples must be collected during spring and autumn when two samples are required each  year
(4) Sam ples must be collected during spring or autumn when one sample per  year is required  
Maximum number of fish per pool: 53 6 2020 Official Journal of the European Union L 174/317 EN
Section  5
Diagnostic and sampling methods
1  T he organs or tissue material to be sampled and examined must be:
(a) His tology: anterior-kidney, liver, heart, pancreas, intestine, spleen and gill;
(b) Immunohis tochemistry: mid-kidney and heart including valves and bulbus arteriosus ;
(c) R T-qPCR analysis: mid-kidney and heart;
(d) V irus culture: mid-kidney, heart, liver and spleen  
Organ pieces from a maximum of five fish may be pooled  
2  T he 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:
(a) screening of the samples by RT-qPCR, followed by conventional RT-PCR and sequencing of the HE-gene to verify 
HPR-deletion; and
(b) de tection of ISAV antigen in tissue preparations by means of specific antibodies against ISAV; or
(c) isolation in cell culture and subsequent identification of HPR-deleted ISAV  
3  When a suspi cion 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:
(a) t he suspected establishment must be subject to at least one health visit and one sampling of 10 moribund fish, when 
clinical signs or post-mortem lesions consistent with infection with HPR-deleted ISAV are observed, or minimum 30 
fish when clinical signs or post-mortem  lesions are not observed   Samples shall be tested using one or more of the 
diagnostic methods set out in point  2 in accor dance with the detailed diagnostic methods and procedures approved 
by the EURL for fish diseases;
(b) in t he case of a positive result of RT-qPCR for HPR-deleted ISAV, further samples shall be tested before the 
implementation of the initial control measures provided in Article  58  A suspected case of infection with HPR-
deleted ISAV shall be confirmed in accordance with the following criteria using the detailed methods and procedures 
approved by the EURL for fish diseases:
 (i) De tection of ISAV by RT-qPCR, followed by sequencing of the HE-gene to verify HPR-deletion, and detection of 
ISAV in tissue preparations by means of specific antibodies against ISAV;
 (ii) de tection of ISAV by RT-qPCR, including sequencing of the HE-gene to verify HPR-deletion; and isolation and 
identification of ISAV in cell culture from at least one sample from any fish from the establishment;
(c) where t he presence of clinical, gross pathological or histopathological findings consistent with infection are observed, 
the findings must be corroborated by virus detection by two diagnostic methods with independent principles of 
detection, such as RT-qPCR and IHC, in accordance with the procedures approved by the EURL for fish diseases  
The suspicion of HPR-deleted ISAV may be ruled out, if tests and health visits over a period of 12  mont hs from the 
date of the suspicion are found to reveal no  further evidence of the presence of the virus  Official Journal of the European Union L 174/318 EN 3 6 2020
CHAPTER 3
Eradication, disease-free status and diagnostic methods for infection with Marteilia refringens
Section  1
General requirements for health visits and sampling
Health visits and sampling for the surveillance referred to in point  (b)(ii) of Ar ticle  3(2) mus t comply with the following 
requirements:
(a) healt h 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) wh en molluscs must be sampled in accordance with the requirements set out in Sections  2 to 4, the following selection 
criteria must apply:
 (i) if Ostrea  spp   are pr esent, only oysters of that species must be selected for sampling   If Ostrea  spp   are not present, 
the sample must be representative of all other susceptible species present;
 (ii) if weak, gaping or freshly dead but not decomposed molluscs are present in the production units, such molluscs 
must primarily be selected   If such molluscs are not present, the molluscs selected must include the oldest healthy 
molluscs;
 (iii) when sampling in mollusc establishments which utilise more than one water source for mollusc production, molluscs 
representing all water sources must be included for sampling in such a way that all parts of the establishment are 
proportionally represented in the sample;
 ( iv) wh en sampling in mollusc establishments or groups of establishments, molluscs from a sufficient number of sampling 
points, must be included in the sample in such a way that all parts of the establishment or group of establishments 
are proportionally represented in the sample   The main factors to be considered for the selection of these sampling 
points  are pr evious sampling points  where Marteilia refringens  was detected, stocking density, water flows, presence 
of susceptible species, presence of vector species, bathymetry and management practices   Natural beds within or 
adjacent to the establishment or group of establishments must be included in the sampling  
Section  2
Granting of the status free from infection with Marteilia Refringens in Member  
States, zones and compartments of unknown health status
1  T he 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:
(a) t he establishments or groups of establishments keeping listed species have been subject to health visits and sampled 
for a minimum period of 3 consecutive  years as laid down in Table  3 A;
(b) dur ing that 3-year period, the testing of all samples using the diagnostic methods set out in point  2 of Section  5 
have produced negative results for Marteilia refringens and any suspicion of Marteilia refringens has been ruled out in 
accordance with the diagnostic methods set out in point  3 of Section  5;
(c) when Ostrea edulis sourced from a Member State, zone or compartment of disease-free status are to be included in 
the sample, they must have been introduced into the establishment or group of establishments at least in the spring 
just preceding the period when the scheme is carried out  
2  If Marteilia refringens  is detected during the 3-year scheme set out in point  1, bef ore starting a new 3-year scheme, relevant 
establishments in the Member State, zone or compartment must:
(a) be subject to the minimum disease control measures laid down in Articles  58 to 65;3 6 2020 Official Journal of the European Union L 174/319 EN
(b) be repopulated with molluscs from an establishment in a Member State, zone or compartment free from infection 
with Marteilia refringens  or from an establishment in a Member State, zone or compartment covered by an eradication 
programme for that disease  
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
Year of surveillanceNumber of health visits per  year to each 
establishment/group of establishmentsNumber of laboratory 
examinations per  yearNumber of molluscs in the 
sample
Year 1 1 1 150
Year 2 1 1 150
Year 3 1 1 150
Section  3
Granting of the status free from infection with Marteilia refringens in Member  
States, zones and compartments known to be infected with Marteilia refringens
1  T he 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:
(a) t he minimum control measures laid down in Articles  55 t o 65 have effectively been applied and a restricted zone 
of an appropriate size as provided for in point  (c) of Ar ticle  58(1), where ap propriate divided into a protection zone 
and surveillance zone, must have been established in the vicinity of the establishment(s) or group of establishments 
infected with Marteilia refringens , taking into account the requirements set out in point  2;
(b) all es tablishments and groups of establishments keeping listed species within the protection zone, or where a 
protection zone has not been established, the restricted zone, not infected with Marteilia refringens must be subject 
to an investigation comprising at least the collection of samples for the testing of 150 molluscs after the beginning 
of the transmission period of Marteilia refringens   When the transmission period is not known, the sampling must 
begin in the period after the temperature of the water exceeds 17  °C;
(c) rele vant establishments and groups of establishments must be emptied in accordance with Articles  62, and if possible 
cleaned and disinfected in accordance with Article  63 
Fallowing must be carried out in accordance with Article  64 and t he duration of the fallowing period must be at least:
 ( i) 2 mont hs in case of the establishments and groups of establishments which can be fully drained and thoroughly 
cleaned and disinfected such as hatcheries and nurseries;
 ( ii) 2 mont hs in case of the establishments and groups of establishments which cannot be drained and thoroughly 
cleaned and disinfected provided that the infected molluscs of the listed species and those molluscs of the 
listed species with epidemiological links with the infected establishment or group of establishments have been 
harvested or removed before the period of the  year when the prevalence of Marteilia refringens is known to be 
maximal, or when that period is not known, before the period when water temperature exceeds 17  °C;
 (iii) 14 mont hs in case of the establishments and groups of establishments which cannot be drained and thoroughly 
cleaned and disinfected if the infected molluscs of the listed species and those molluscs of the listed species 
with epidemiological links with the infected establishment or group of mollusc establishments have not been 
harvested or removed before the period of the  year when the prevalence of Marteilia refringens is known to be 
maximal or when such data is not known, when molluscs of the susceptible species have not been harvested 
or removed before the period when water temperature exceeds 17  °C 
When all infected establishments and infected groups of establishments are emptied, at least 4  weeks of synchronised 
fallowing must be carried out;Official Journal of the European Union L 174/320 EN 3 6 2020
(d) repopulation ma y only take place when all infected establishments or infected groups of establishments have been 
emptied, cleaned, disinfected and fallowed in accordance with point  (c);
(e) all es tablishments and groups of establishments other than those referred to in point  (f) which keep listed species 
within the Member State, zone or compartment covered by the eradication programme, must subsequently be subject 
to the scheme set out in Section  2;
(f) an individual es tablishment which keeps listed species and which has a health status which is independent of the 
health status of the surrounding waters is not required to comply with the scheme set out in Section  2 following a 
disease outbreak provided the establishment complies with the requirements set out in paragraph  3 of Ar ticle  80 and 
is repopulated with molluscs sourced from Member States, zones or compartments with status free from infection 
with Marteilia refringens  
2  T he restricted zone must have been defined on a case-by-case basis and:
(a) it mus t take into account factors influencing the risks for the spread of infection with Marteilia refringens including 
other establishments and wild molluscs, such as:
 ( i) t he number, age, rate and distribution of the mortalities of molluscs on the establishment or group of 
establishments infected with Marteilia refringens;
 (ii) t he distance to and density of neighbouring establishments or groups of establishments and wild molluscs;
 (iii) t he proximity to processing establishments, contact establishments or groups of establishments;
 ( iv) t he species, especially susceptible species and vector species, present at the establishments or groups of 
establishments;
 (v) t he farming practices applied in the affected and neighbouring establishments and groups of establishments;
 (vi) t he hydrodynamic conditions; and
 (vii) o ther factors of epidemiological significance identified;
(b) t he geographical demarcation must comply with the following minimum requirements:
 ( i) t he protection zone must consist of an area included in a circle with a radius of at least one tidal excursion or at 
least 5  km, whichever is larger, centred on the establishment infected with Marteilia refringens, or an equivalent 
area determined according to appropriate hydrodynamic or epidemiological data; and
 (ii) t he surveillance zone must consist of an area surrounding the protection zone, of overlapping tidal excursion 
zones; or an area surrounding the protection zone and included in a circle of radius 10km from the centre of the 
protection zone; or an equivalent area determined according to appropriate hydrodynamic or epidemiological 
data;
 or
 (iii) wh ere separate protection and surveillance zones are not established, the restricted zone must consist of an 
area comprising both the protection zone and the surveillance zone  
Section  4
Maintenance of status free from infection with Marteilia refringens
1  When t argeted 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  3 6 2020 Official Journal of the European Union L 174/321 EN
2  When de termining 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  T he 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
Risk level  (1)Number of health visits to each establishment/group of 
establishmentsNumber of laboratory examinationsNumber of molluscs in the 
sample
High 1 every  year 1 every 2  years 150
Medium 1 every 2  years 1 every 2  years 150
Low 1 every 3  years 1 every 3  years 150
(1) Risk level  assign ed 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  
Section  5
Diagnostic and sampling methods
1  Th e whole animal must be submitted to the laboratory for the performance of the diagnostic tests provided for in points  2 
and 3  
2  T he 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  Wh en 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:
(a) t he investigation must include at least one sampling of 30 molluscs of susceptible species if the suspicion is based 
on a mortality report or if not, 150 molluscs of susceptible species after the beginning of the transmission period 
of Marteilia refringens   When the transmission period is not known, the sampling must begin in the period after the 
temperature of the water exceeds 17  °C;
(b) sam ples must be tested using the diagnostic methods set out in point  (i) following the detailed diagnostic methods 
and procedures approved by the EURL for Mollusc Diseases:
 (i) t he presence of Marteilia refringens must be considered as confirmed when a positive result by histopathology, 
tissue imprints or in situ  hybridisation is combined with a positive PCR result completed by sequencing   If 
biological material is not available for histopathology, tissue imprints or in situ hybridisation, the presence of 
Marteilia refringens  must be considered as confirmed when positive results are obtained using two PCR assays 
targeting different fragments of the parasite genome and completed by sequencing;
 ( ii) t he suspicion of infection with Marteilia refringens  may be ruled out, if the tests referred to in (i) reveal no  further 
evidence of the presence of Marteilia refringens  Official Journal of the European Union L 174/322 EN 3 6 2020
CHAPTER 4
Eradication, disease-free status and diagnostic methods for infection with Bonamia exitiosa
Section  1
General requirements for health visits and sampling
Health visits and sampling for the surveillance referred to in point  (b)(ii) of Ar ticle  3(2) mus t comply with the following 
requirements:
(a) healt h 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:
 (i) if Ostrea  spp   are pr esent, only oysters of that species must be selected for sampling   If Ostrea  spp   are not present, 
the sample must be representative of all other susceptible species present;
 ( ii) if w eak, gaping or freshly dead but not decomposed molluscs are present, such molluscs must primarily be selected   
If such molluscs are not present, the molluscs selected must include the oldest healthy molluscs;
 (iii) wh en sampling in establishments or groups of establishments which utilise more than one water source for mollusc 
production, molluscs representing all water sources must be included for sampling in such a way that all parts of 
the establishment are proportionally represented in the sample;
 ( iv) wh en sampling in mollusc establishments or groups of establishments, molluscs from a sufficient number of 
sampling points  mus t be included in the sample in such a way that all parts of the establishment or group of 
establishments are proportionally represented in the sample   The main factors to be considered for the selection of 
those sampling points  are pr evious points  where Bonamia exitiosa  was detected, stocking density, water flows, the 
presence of susceptible species, the presence of vector species (e  g Crassostrea gigas), bathymetry and management 
practices   Natural beds within or adjacent to the establishment or group of establishments shall be included in the 
sampling  
Section  2
Granting of the status free from infection with Bonamia exitiosa in Member  
States, zones and compartments of unknown health status
1  Th e 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:
(a) t he establishments and groups of establishments keeping listed species have been subject to health visits and sampled 
for a minimum period of 3 consecutive  years as laid down in Table  4 A;
(b) dur ing that 3-year period, the testing of 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 Bonamia exitiosa  has been ruled out in accordance 
with the diagnostic methods set out in point  3 of Section  5;
(c) when Ostrea edulis sourced from a Member State, zone or compartment of disease-free status are to be included in 
the sample, they must have been introduced into the establishment or group of establishments at least one  year 
before the scheme is carried out  
2  If inf ection with Bonamia exitiosa  is detected during the 3-year scheme referred to in point  1; bef ore starting a new 3-year 
scheme, relevant establishments in the Member State, zone or compartment must:
(a) be subject to the minimum disease control measures laid down in Articles  58 to 65;3 6 2020 Official Journal of the European Union L 174/323 EN
(b) be repopulated with molluscs from an establishment in a Member State, zone or compartment free from infection 
with Bonamia exitiosa  or from an establishment in a Member State, zone or compartment covered by an eradication 
programme for that disease  
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
Year of surveillanceNumber of health 
visits per  year to each 
establishment or group 
of establishmentsNumber of laboratory examinations 
per yearNumber of molluscs in the sample
Year 1 2 2 150
Year 2 2 2 150
Year 3 2 2 150
Section  3
Granting of the status free from infection with Bonamia exitiosa in Member  
States, zones and compartments known to be infected with Bonamia exitiosa
1  T he 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:
(a) t he minimum control measures laid down in Articles  55 t o 65 must have been effectively applied, and a restricted 
zone of an appropriate size as provided for in point  (c) of Ar ticle  58(1), where app ropriate, divided into a protection 
zone and surveillance zone; must have been established in the vicinity of the establishment or group of establishments 
declared infected with Bonamia exitiosa  taking into account the requirements set out in point  2;
(b) all establishments and groups of establishments keeping listed species within the protection zone or where a protection 
zone has not been established, within the restricted zone, not infected with Bonamia exitiosa  must be subject to an 
investigation comprising at least the collection of samples for testing of 150 molluscs of susceptible species after the 
beginning of the transmission period of Bonamia exitiosa   When the transmission period is not known, the sampling 
must be done on oysters which have spent at least one  year within the protection zone;
(c) rele vant establishments and groups of establishments must be emptied in accordance with Article  62, and if possi ble, 
cleaned and disinfected in accordance with Article  63 
Fallowing must be carried out in compliance with Article  64 and t he duration of the fallowing period must be at 
least 6  months  
When all infected establishments or infected groups of establishments are emptied, at least 4  weeks of synchronised 
fallowing must be carried out;
(d) repopulation ma y only take place when all infected establishments or infected groups of establishments have been 
emptied, cleaned, disinfected and fallowed in accordance with point  (c);
(e) all es tablishments and groups of establishments other than those referred to in point  (f) which keep listed species 
within the Member State, zone or compartment covered by the eradication programme, must subsequently be subject 
to the scheme set out in Section  2;
(f) an individual es tablishment which keeps listed species and which has a health-status which is independent of the 
health-status of the surrounding waters is not required to comply with the scheme set out in Section  2 following a 
disease outbreak provided the establishment complies with the requirements set out in paragraph  3 of Ar ticle  80 and 
is repopulated with molluscs sourced from Member States, zones or compartments with status free from infection 
with Bonamia exitiosa  Official Journal of the European Union L 174/324 EN 3 6 2020
2  T he restricted zone must have been defined on a case-by-case basis and:
(a) it mus t take into account factors influencing the risks for the spread of infection with Bonamia exitiosa  including 
other establishments and wild molluscs, such as:
 ( i) t he number, age, rate and distribution of the mortalities of molluscs on the establishment or group of 
establishments infected with Bonamia exitiosa ;
 (ii) t he distance to and density of neighbouring establishments or groups of establishments and wild molluscs;
 (iii) t he proximity to processing establishments, contact establishments or groups of establishments;
 ( iv) t he species, especially susceptible species and vector species, present at the establishments or groups of 
establishments;
 (v) t he farming practices applied in the affected and neighbouring establishments and groups of establishments;
 (vi) t he hydrodynamic conditions; and
 (vii) o ther factors of epidemiological significance identified;
(b) t he geographical demarcation must comply with the following minimum requirements:
 (i) t he protection zone must consist of an area included in a circle with a radius of at least one tidal excursion or 
at least 5  km, whichever is larger, centred on the establishment infected with Bonamia exitiosa , or an equivalent 
area determined according to appropriate hydrodynamic or epidemiological data; and
 (ii) t he surveillance zone must consist of an area surrounding the protection zone, of overlapping tidal excursion 
zones; or an area surrounding the protection zone and included in a circle of radius 10km from the centre of the 
protection zone; or an equivalent area determined according to appropriate hydrodynamic or epidemiological 
data;
 or
 (iii) wh ere separate protection and surveillance zones are not established, the restricted zone must consist of an 
area comprising both the protection zone and the surveillance zone  
Section  4
Maintenance of status free from infection with Bonamia exitiosa
1  Wh en 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  Wh en 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  T he 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 ha ve 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 3 6 2020 Official Journal of the European Union L 174/325 EN
Table  4.B
Scheme for Member States, zones or compartments to maintain status free from infection with Bonamia exitiosa
Risk level  (1)Number of health visits to each 
establishment/group of establishmentsNumber of laboratory examinationsNumber of molluscs in the 
sample
High 1 every  year 1 every 2  years 150
Medium 1 every 2  years 1 every 2  years 150
Low 1 every 3  years 1 every 3  years 150
(1) Risk level  assign ed 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  
Section  5
Diagnostic and sampling methods
1  Th e whole animal must be submitted to the laboratory for the performance of the diagnostic tests provided for in points  2 
and 3  
2  T he 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  Wh en 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:
(a) t he investigation must include at least one sampling of 30 molluscs of susceptible species if the suspicion is based 
on a mortality report, or if not, 150 molluscs of susceptible species after the beginning of the transmission period 
of Bonamia exitiosa   When the transmission period is not known, the sampling shall be carried out twice a  year, in 
spring and autumn;
(b) t he samples must be tested using the diagnostic methods set out in point  (i) following the detailed diagnostic methods 
and procedures which have been approved by the EURL for Mollusc Diseases:
 ( i) t he presence of Bonamia exitiosa  must be considered as confirmed when a positive result by histopathology, tissue 
imprints or in situ  hybridisation is combined with a positive result by PCR followed by sequencing   If biological 
material is not available for histopathology, tissue imprints or in situ hybridisation, the presence of Bonamia 
exitiosa  must be considered as confirmed when positive results are obtained using two PCR assays targeting 
different fragments of the parasite genome and completed by sequencing;
 ( ii) t he suspicion of the presence of infection with Bonamia exitiosa  must be ruled out, if those tests reveal no  further 
evidence of the presence of Bonamia exitiosa  
CHAPTER 5
Eradication, disease-free status and diagnostic methods for infection with Bonamia  ostreae
Section  1
General requirements for health visits and sampling
Health visits and sampling for the surveillance referred to in point  (b)(ii) of Ar ticle  3(2) mus t comply with the following 
requirements:
(a) healt h 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;Official Journal of the European Union L 174/326 EN 3 6 2020
(b) when molluscs are to be sampled in accordance with the requirements set out in Sections  2 to 4, the following criteria 
must apply:
 (i) i f Ostrea edulis  are present, only oysters of that species must be selected for sampling   If Ostrea edulis are not present, 
the sample must be representative of all other susceptible species present;
 ( ii) if w eak, gaping or freshly dead but not decomposed molluscs are present, such molluscs must primarily be selected   
If such molluscs are not present, the molluscs selected must include the oldest healthy molluscs;
 (iii) wh en sampling in establishments or groups of establishments which utilise more than one water source for mollusc 
production, molluscs representing all water sources must be included for sampling in such a way that all parts of 
the establishment are proportionally represented in the sample;
 ( iv) wh en sampling in mollusc establishments or groups of establishments, molluscs from a sufficient number of 
sampling points  mus t be included in the sample in such a way that all parts of the establishment or group of 
establishments are proportionally represented in the sample   The main factors to be considered for the selection of 
those sampling points  are pr evious points  where Bonamia ostreae was detected, stocking density, water flows, the 
presence of susceptible species, the presence of vector species, bathymetry and management practices   Natural beds 
within or adjacent to the establishment or group of establishments shall be included in the sampling  
Section  2
Granting of the status free from infection with Bonamia ostreae  in Member  
States, zones and compartments of unknown health status
1  T he 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:
(a) t he establishments and groups of establishments keeping listed species have been subject to health visits and sampled 
for a minimum period of 3 consecutive  years as laid down in Table  5 A;
(b) dur ing that 3-year period, the testing of 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 Bonamia ostreae  has been ruled out in accordance 
with the diagnostic methods set out in point  3 of Section  5;
(c) when Ostrea edulis sourced from a Member State, zone or compartment of disease-free status are to be included in 
the sample, they must have been introduced into the establishment or group of establishments at least one  year 
before the scheme is carried out  
2  If inf ection with Bonamia ostreae  is detected during the 3-year scheme referred to in point  1; bef ore starting a new 3-year 
scheme, relevant establishments in the Member State, zone or compartment must:
(a) be subject to the minimum disease control measures laid down in Articles  58 to 65;
(b) be repopulated with molluscs from an establishment in a Member State, zone or compartment free from infection 
with Bonamia ostreae or from an establishment in a Member State, zone or compartment covered by an eradication 
programme for that disease  
Section  3
Granting of the status free from infection with Bonamia ostreae  in Member  
States, zones and compartments known to be infected with Bonamia ostreae
1  T he 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:
(a) t he minimum control measures laid down in Articles  55 t o 65 must have been effectively applied, and a restricted 
zone of an appropriate size as provided for in point  (c) of Ar ticle  58(1), where app ropriate, divided into a protection 
zone and surveillance zone; must have been established in the vicinity of the establishment or group of establishments 
declared infected with Bonamia ostreae  taking into account the requirements set out in point  2;3 6 2020 Official Journal of the European Union L 174/327 EN
(b) all establishments and groups of establishments keeping listed species within the protection zone or where a protection 
zone has not been established, within the restricted zone, not infected with Bonamia ostreae must be subject to an 
investigation comprising at least the collection of samples for testing of 150 molluscs of susceptible species after the 
beginning of the transmission period of Bonamia ostreae   When the transmission period is not known, the sampling 
must begin in winter or at the beginning of spring;
(c) rele vant establishments and groups of establishments must be emptied in accordance with Article  62, and if possi ble, 
cleaned and disinfected in accordance with Article  63 
Fallowing must be carried out in compliance with Article  64 and t he duration of the fallowing period must be at 
least 6  months  
When all infected establishments or infected groups of establishments are emptied, at least 4  weeks of synchronised 
fallowing must be carried out;
(d) repopulation ma y only take place when all infected establishments or infected groups of establishments have been 
emptied, cleaned, disinfected and fallowed in accordance with point  (c);
(e) all es tablishments and groups of establishments other than those referred to in point  (f) which keep listed species 
within the Member State, zone or compartment covered by the eradication programme, must subsequently be subject 
to the scheme set out in Section  2;
(f) an individual es tablishment which keeps listed species and which has a health status which is independent of the 
health status of the surrounding waters is not required to comply with the surveillance scheme set out in Section  2 
following a disease outbreak provided the establishment complies with the requirements set out in paragraph  3 of 
Article  80 and is repopulat ed with molluscs sourced from Member States, zones or compartments with status free 
from infection with Bonamia ostreae  
2  T he restricted zone must have been defined on a case-by-case basis and:
(a) it mu st take into account factors influencing the risks for the spread of infection with Bonamia ostreae  including other 
establishments and wild molluscs, such as:
 ( i) t he number, age, rate and distribution of the mortalities of molluscs on the establishment or group of 
establishments infected with Bonamia ostreae ;
 (ii) t he distance to and density of neighbouring establishments or groups of establishments and wild molluscs;
 (iii) t he proximity to processing establishments, contact establishments or groups of establishments;
 ( iv) t he species, especially susceptible species and vector species, present at the establishments or groups of 
establishments;
 (v) t he farming practices applied in the affected and neighbouring establishments and groups of establishments;
 (vi) t he hydrodynamic conditions; and
 (vii) o ther factors of epidemiological significance identified;
(b) t he geographical demarcation must comply with the following minimum requirements:
 (i) t he protection zone must consist of an area included in a circle with a radius of at least one tidal excursion or 
at least 5  km, whic hever is larger, centred on the establishment infected with Bonamia ostreae, or an equivalent 
area determined according to appropriate hydrodynamic or epidemiological data; and
 (ii) t he surveillance zone must consist of an area surrounding the protection zone, of overlapping tidal excursion 
zones; or an area surrounding the protection zone and included in a circle of radius 10km from the centre of the 
protection zone; or an equivalent area determined according to appropriate hydrodynamic or epidemiological 
data;
 or
 (iii) wh ere separate protection and surveillance zones are not established, the restricted zone must consist of an 
area comprising both the protection zone and the surveillance zone  Official Journal of the European Union L 174/328 EN 3 6 2020
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
Year of surveillanceNumber of health visits per  year to each 
establishment or group of establishmentsNumber of laboratory 
examinations per  yearNumber of molluscs in the 
sample
Year 1 1 1 150
Year 2 1 1 150
Year 3 1 1 150
Section  4
Maintenance of status free from infection with Bonamia ostreae
1  Wh en 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  Wh en 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  T he 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 ha ve 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
Risk level  (1)Number of health visits to each 
establishment/group of establishmentsNumber of laboratory examinationsNumber of molluscs in the 
sample
High 1 every  year 1 every 2  years 150
Medium 1 every 2  years 1 every 2  years 150
Low 1 every 3  years 1 every 3  years 150
(1) Risk level  assign ed 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  
Section  5
Diagnostic and sampling methods
1  Th e whole animal must be submitted to the laboratory for the performance of the diagnostic tests provided for in points  2 
and 3  
2  T he 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 6 2020 Official Journal of the European Union L 174/329 EN
3  Wh en 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:
(a) t he investigation must include at least one sampling of 30 molluscs of susceptible species if the suspicion is based 
on a mortality report, or if not, 150 molluscs of susceptible species after the beginning of the transmission period 
of Bonamia ostreae   When the transmission period is not known, the sampling shall begin in the winter or at the 
beginning of spring;
(b) t he samples must be tested using the diagnostic methods set out in point  (i) following the detailed diagnostic methods 
and procedures which have been approved by the EURL for Mollusc Diseases:
 ( i) t he presence of Bonamia ostreae  must be considered as confirmed when a positive result by histopathology, tissue 
imprints or in situ  hybridisation is combined with a positive result by PCR followed by sequencing   If biological 
material is not available for histopathology, tissue imprints or in situ  hybridisation, the presence of Bonamia ostreae  
must be considered as confirmed when positive results are obtained using two PCR assays targeting different 
fragments of the parasite genome and completed by sequencing;
 ( ii) t he suspicion of the presence of infection with Bonamia ostreae  must be ruled out, if those tests reveal no  further 
evidence of the presence of Bonamia ostreae.
CHAPTER 6
Eradication, disease-free status and diagnostic methods for infection with white spot syndrome virus 
(WSSV)
Section  1
General requirements for health visits and sampling
Health visits and sampling for the surveillance referred to in point  (b)(ii) of Ar ticle  3(2) mus t comply with the following 
requirements:
(a) t he 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) wh en farmed crustaceans must be sampled in accordance with the requirements set out in Sections  2 to 4, the following 
criteria must apply:
 ( i) if w eak or moribund crustaceans are present in the production units, such crustaceans must primarily be selected   If 
such crustaceans are not present, those selected must include crustaceans of different size cohorts namely juveniles 
and adults of the selected susceptible species, proportionally represented in the sample;
 (ii) if more t han one water source is utilised for crustacean production, susceptible crustaceans representing all water 
sources must be included for sampling;
(c) when t argeted 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  mus t be determined to obtain 
a reasonable coverage of the Member State, zone or compartment   The sampling points  mus t 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:
 ( i) in marine and estuary systems areas, one or more of the following species must be selected: Carcinus maenas, Cancer 
pagurus, Eriocheir sinensis, Liocarcinus depurator, Liocarcinus puber, Crangon crangon, Homarus gammarus, Palaemon adspersus  
or penaeid shrimp species namely Penaeus japonicus, Penaeus kerathurus, Penaeus semisulcatus   If those species are not 
present, the sample must be representative of other susceptible decapod species present;
 ( ii) in r iver and lake systems, one or more of the following species must be selected: Pacifastacus leniusculus, Astacus 
leptodactylus, Austropotamobius pallipes  or Orconectes limosus   If those species are not present, the sample must be 
representative of other susceptible decapod species present;
 (iii) if w eak or moribund crustaceans are present, such crustaceans must primarily be selected   If such crustaceans are 
not present, those selected must include crustaceans of different size cohorts namely juveniles and adults of the 
selected susceptible species, proportionally represented in the sample  Official Journal of the European Union L 174/330 EN 3 6 2020
Section  2
Granting of the status free from infection with WSSV  in Member States, zones  
and compartments of unknown health status
1  T he 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:
(a) t he establishments or groups of establishments have been subject to health visits and sampled for a minimum period 
of 2 consecutive  years as laid down in Table  6 A;
(b) dur ing that 2-year period, the testing of all samples using the diagnostic methods set out in point  2 of Section  5 
have produced negative results for infection with 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;
2  If inf ection with WSSV is detected during the 2-year scheme referred to in point  1, bef ore starting a new 2-year scheme, 
relevant establishments in the Member State, zone or compartment must:
(a) be subject to the minimum disease control measures laid down in Articles  58 to 65;
(b) be rep opulated with crustaceans from an establishment in a Member State, zone or compartment free from infection 
with WSSV or from an establishment in a Member State, zone or compartment covered by an eradication programme 
for that disease  
Section  3
Granting of the status free from infection with WSSV in Member States, zones  
and compartments known to be infected with WSSV
1  T he 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:
(a) t he minimum control measures laid down in Articles  55 t o 65 must have been effectively applied, and a restricted 
zone of an appropriate size as provided for in point  (c) of Ar ticle  58(1), where app ropriate, divided into a protection 
zone and surveillance zone; must have been established in the vicinity of the establishment(s) declared infected with 
WSSV taking into account the requirements set out in point  2;
(b) all es tablishments keeping listed species within the protection zone, or where a protection zone has not been 
established, the restricted zone, not infected with WSSV must be subject to an investigation comprising at least the 
following:
 ( i) t he collection of samples for testing of 10 crustaceans, when clinical signs or post-mortem lesions consistent with 
infection WSSV are observed, or 150 crustaceans, when clinical signs or post-mortem lesions are not observed; 
and
 ( ii) h ealth visits; in those establishments where the tests referred to in (i) have produced negative results, health 
visits must continue once per  mont h during the season when the water temperature is likely to reach its highest 
annual points, until the protection zone has been withdrawn in accordance with point  (c);
(c) rele vant establishments must be emptied in accordance with Articles  62, cleaned disinf ected in accordance with 
Article  63 and f allowed in accordance with Article  64  The duration of the fallowing period must be at least 6  weeks   
When all infected establishments are emptied, at least 3  weeks of synchronous fallowing shall be carried out  
When fallowing of the officially declared infected establishments is carried out, the protection zones shall be converted 
into surveillance zones;
(d) repop ulation may only take place when all infected establishments have been emptied, cleaned, disinfected and 
fallowed in accordance with point  (c);3 6 2020 Official Journal of the European Union L 174/331 EN
(e) all establishments other than those referred to in point  (f) which keep listed species within the Member State, zone 
or compartment covered by the eradication programme and, when surveillance in wild populations is required, 
all sampling points  select ed to provide the greatest coverage of the geographical area included in the eradication 
programme must be subject at least to the scheme set out in Section  2;
(f) an individual es tablishment which keeps listed species and which has a health status which is independent of the 
health status of the surrounding waters is not required to comply with the scheme set out in Section  2 following a 
disease outbreak provided the establishment complies with the requirements set out in paragraph  3 of Article  80 
and is repopulated with crustaceans sourced from Member States, zones or compartments with status free from 
infection with WSSV  
2  T he 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:
 ( i)  t he number, age, rate and distribution of the mortalities of crustaceans on the establishment or group of establishments 
infected with WSSV including other establishments and wild crustaceans;
 ( ii) t he distance to and density of neighbouring establishments or groups of establishments including wild crustaceans;
 (iii) t he proximity to processing establishments, contact establishments or groups of establishments;
 ( iv)  t he species, especially susceptible species and vector species, present at the establishments or groups of establishments;
 (v) t he farming practices applied in the affected and neighbouring establishments and groups of establishments;
 (vi) t he hydrodynamic conditions; and
 (vii) o ther factors of epidemiological significance identified  
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
Year of surveillanceNumber of health visits per  year to each 
establishment or group of establishmentsNumber of laboratory 
examinations per  yearNumber of crustaceans in the 
sample
Year 1 1 1 150
Year 2 1 1 150
Section  4
Maintenance of status free from infection with WSSV
1  When t argeted 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 es tablishments 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  select ed in accordance with the requirements laid down in point  (b) of Section  1 
3  When de termining 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  T he 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 ha ve 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 Official Journal of the European Union L 174/332 EN 3 6 2020
Table  6. B
Scheme for Member States, zones or compartments to maintain status free from infection WSSV
Risk level  (1)Number of health visits to each 
establishment/group of establishmentsNumber of laboratory examinationsNumber of crustaceans in the 
sample
High 1 every  year 1 every 2  years 150
Medium 1 every 2  years 1 every 2  years 150
Low 1 every 2  years 1 every 4  years 150
(1) Risk level  assign ed 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  
Section  5
Diagnostic and sampling methods
1  Sam ples 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  T he 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 suspi cion 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:
(a) t he investigation must include at least one health visit and one sampling of 10 crustaceans when clinical signs or 
post-mortem lesions consistent with infection with WSSV are observed or 150 crustaceans when clinical signs or 
post-mortem lesions are not observed   The samples must be tested using the diagnostic method set out in point  2;
(b) t he presence of WSSV must be considered as confirmed when PCR followed by sequencing, carried out in accordance 
with the detailed methods and procedures which have been approved by the EURL for Crustacean Diseases test 
positive for WSSV  
The suspicion of infection with WSSV may be ruled out, if those tests reveal no  further evidence of the presence 
of the virus  
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  63 6 2020 Official Journal of the European Union L 174/333 EN
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
Section  1
General requirements for health visits and sampling for VHS and IHN
The health visits and sampling referred to in point  (b)(iv) of Article  3(2) must comply with the following requirements:
(a) healt h 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 p roduction 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) f ish of listed species to be collected as samples must be selected as follows:
 ( i) if r ainbow trout are present, only fish of that species must be selected for sampling, except where other susceptible 
species are present which show typical signs of VHS or IHN; if rainbow trout are not present, the sample must be 
representative of all other susceptible species which are present;
 (ii) if weak, abnormally behaving or freshly dead but not decomposed fish are present, such fish must be selected; if 
more than one water source is utilised for fish production, fish representing all water sources must be included in 
the sample;
 (iii) t he fish selected must include fish collected in such a way that all parts of the establishment, as well as all  year 
classes, are proportionally represented in the sample  
Section  2
Specific requirements to demonstrate the implementation of a surveillance  
programme
1  Healt h visits must be carried out and fish must be sampled in accordance with Section  1 and Table  1 
2  Sam ples 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 Chap ter 1 of P art II and produce negative results for VHS or IHN  
Section  3
Requirements to re-start a surveillance programme after a disease outbreak
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 disinf ected in accordance with Article  63, and f allowed 
in accordance with Article  64; and
(b) repopulation occur s using fish that originate from establishments which are:
 (i) in a Member State, a zone or a compartment free from VHS or IHN;
 (ii) in a Member State, a zone or a compartment covered by an eradication programme for VHS or IHN; or
 (iii) im plementing a surveillance programme for VHS or IHN  Official Journal of the European Union L 174/334 EN 3 6 2020
Table  1
Surveillance programme for VHS/IHN
Risk level  (1) Number of health visits per  year to each establishment Number of fish in the sample  (2)
High 1 every  year 30
Medium 1 every 2  years 30
Low 1 every 3  years 30
(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) Risk level  assigned to the establishment by the competent authority as set out in paragraph  1 of Chap ter 2 of P art I  Maximum number of 
fish per pool: 10
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
Section  1
General requirements for health visits and sampling for infection with HPR-
deleted ISAV
The health visits and sampling referred to in point  (b)(iv) of Article  3(2) must comply with the following requirements:
(a) h ealth 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) t he fish to be collected as samples must be selected as follows:
 ( i) onl y moribund or freshly dead but not decomposed fish must be selected; in particular fish demonstrating anaemia, 
bleeding or other clinical signs suggesting circulatory disturbances must be prioritised for collection;
 ( ii) if A tlantic salmon are present, only fish of that species must be selected for sampling, except where other susceptible 
species are present which show typical signs of ISA   If there are no  Atlantic salmon in the establishment, other 
listed species must be sampled;
 (iii) if more t han one water source is utilised for fish production, fish representing all water sources must be included 
in the sample;
 (iv) t he fish selected must include fish collected in such a way that all production units, such as net cages, tanks and 
ponds, as well as all  year classes in the establishment are proportionally represented in the sample  
Section  2
Specific requirements to demonstrate the implementation of a surveillance  
programme
1  Healt h visits must be carried out and fish must be sampled in accordance with Section  1 and Table  2 
2  Sam ples 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 Chap ter 2 of P art II and produce negative results for HPR-deleted ISAV  3 6 2020 Official Journal of the European Union L 174/335 EN
Table  2
Surveillance programme for HPR-deleted ISAV
Risk level  (1)Number of health visits per  year to 
each establishmentNumber of laboratory examinations 
per yearNumber of fish in the 
sample
High 2 2 (2) 30
Medium 1 1 (3) 30
Low 1 every 2  years 1 every two  years 30
Maximum number of fish per pool: 5
(1) Risk le vel  assigned to the establishment by the competent authority as set out in paragraph  1 of Chapter  2 of Part  I
(2) Sam ples must be collected during spring and autumn when two samples are required each  year
(3) Sam ples must be collected during spring or autumn when only one sample is required per  year
Section  3
Requirements to re-start a surveillance programme after a disease outbreak
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 disinf ected in accordance with Article  63, and f allowed 
in accordance with Article  64; and
(b) repopulation occur s using fish that originate from establishments which are:
 (i) in a Member State, a zone or a compartment free from infection with HPR-deleted ISAV;
 ( ii) in a Membe r State, a zone or a compartment covered by an eradication programme for infection with HPR-deleted 
ISAV; or
 (iii) im plementing a surveillance programme for infection with HPR-deleted ISAV  
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
Section  1
General requirements for health visits and sampling for infection with  
Marteilia refringens
The health visits and sampling referred to in point  (b)(iv) of Article  3(2) must comply with the following requirements:
(a) healt h 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:
 (i) Ostrea spp.  must be sampled   If Ostrea  spp   are not present, the sample must be representative of all other listed 
species present;Official Journal of the European Union L 174/336 EN 3 6 2020
 (ii) if weak, gaping or freshly dead but not decomposed molluscs are present in the production units, such molluscs 
must primarily be selected   If such molluscs are not present, the molluscs selected must include the oldest healthy 
molluscs;
 (iii) when sampling in mollusc establishments which utilise more than one water source for mollusc production, molluscs 
representing all water sources must be included for sampling in such a way that all parts of the establishment are 
proportionally represented in the sample;
 ( iv) wh en sampling in mollusc establishments or groups of establishments, molluscs from a sufficient number of 
sampling points  mus t be included in the sample in such a way that all parts of the establishment or group of 
establishments are proportionally represented in the sample   The main factors to be considered for the selection of 
those sampling points  are s tocking density, water flows, the presence of susceptible species, the presence of vector 
species, bathymetry and management practices   Natural beds within or adjacent to the establishment or group of 
establishments must be included in the sampling  
Section  2
Specific requirements to demonstrate the implementation of a surveillance  
programme
1  Healt h visits must be carried out and molluscs must be sampled in accordance with Section  1 and Table  3 
2  Sam ples 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 Chap ter 3 of P art II and produce negative results for Marteilia refringens  
Table  3
Surveillance programme for Marteilia refringens
Risk level  (1)Number of health visits to each 
establishment/group of establishmentsNumber of laboratory examinationsNumber of molluscs in the 
sample
High 1 every  year 1 every 2  years 150
Medium 1 every 2  years 1 every 2  years 150
Low 1 every 2  years 1 every 4  years 150
(1) Risk le vel  assigned to the establishment by the competent authority as set out in paragraph  1 of Chapter  2 of Part  I
Section  3
Requirements to re-start a surveillance programme after a disease outbreak
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 disinf ected in accordance with Article  63, and f allowed 
in accordance with Article  64; and
(b) repopulation occur s using fish that originate from establishments which are:
 (i) in a Member State, a zone or a compartment free from infection with Marteilia refringens;
 ( ii) in  a Member State, a zone or a compartment covered by an eradication programme for infection with Marteilia 
refringens; or
 (iii) im plementing a surveillance programme for infection with Marteilia refringens.3 6 2020 Official Journal of the European Union L 174/337 EN
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
Section  1
General requirements for health visits and sampling for infection with Bonamia  
exitiosa
The health visits and sampling referred to in point  (b)(iv) of Article  3(2) must comply with the following requirements:
(a) healt h 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:
 (i) if Ostrea  spp   are pr esent, only oysters of that species must be selected for sampling   If Ostrea spp.  are not present, 
the sample must be representative of all other susceptible species present;
 ( ii) if w eak, gaping or freshly dead but not decomposed molluscs are present, such molluscs must primarily be selected   
If such molluscs are not present, the molluscs selected must include the oldest healthy molluscs;
 (iii) wh en sampling in establishments which utilise more than one water source for mollusc production, molluscs 
representing all water sources must be included for sampling in such a way that all parts of the establishment are 
proportionally represented in the sample;
 ( iv) wh en sampling in establishments or groups of establishments, molluscs from a sufficient number of sampling 
points  mus t be included in the sample in such a way that all parts of the establishment or group of establishments 
are proportionally represented in the sample   The main factors to be considered for the selection of those sampling 
points  are s tocking density, water flows, the presence of susceptible species, the presence of vector species 
(e g Crassostrea gigas ), bathymetry and management practices   Natural beds within or adjacent to the establishment 
or group of establishments must be included in the sampling  
Section  2
Specific requirements to demonstrate the implementation of a surveillance  
programme
1  Healt h visits must be carried out and molluscs must be sampled in accordance with Section  1 and Table  4 
2  Sam ples 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 Chap ter 4 of P art II and produce negative results for Bonamia exitiosa  
Table  4
Surveillance programme for infection with Bonamia exitiosa
Risk level  (1)Number of health visits to each 
establishment/group of establishmentsNumber of laboratory examinationsNumber of molluscs in the 
sample
High 1 every  year 1 every 2  years 150
Medium 1 every 2  years 1 every 2  years 150
Low 1 every 2  years 1 every 4  years 150
(1) Risk le vel  assigned to the establishment by the competent authority as set out in paragraph  1 of Chapter  2 of Part  I Official Journal of the European Union L 174/338 EN 3 6 2020
Section  3
Requirements to re-start a surveillance programme after a disease outbreak
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 disinf ected in accordance with Article  63, and f allowed 
in accordance with Article  64; and
(b) repopulation occur s using fish that originate from establishments which are:
 (i) in a Member State, a zone or a compartment free from infection with Bonamia exitiosa ;
 ( ii) in a Member S tate, a zone or a compartment covered by an eradication programme for infection with Bonamia 
exitiosa ; or
 (iii) im plementing a surveillance programme for infection with Bonamia exitiosa.
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
Section  1
General requirements for health visits and sampling for infection with Bonamia  
ostreae
The health visits and sampling referred to in point  (b)(iv) of Article  3(2) must comply with the following requirements:
(a) healt h 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:
 (i) i f Ostrea edulis  are present, only oysters of that species must be selected for sampling   If Ostrea edulis are not present, 
the sample must be representative of all other susceptible species present;
 ( ii) if w eak, gaping or freshly dead but not decomposed molluscs are present, such molluscs must primarily be selected   
If such molluscs are not present, the molluscs selected must include the oldest healthy molluscs;
 (iii) wh en sampling in establishments which utilise more than one water source for mollusc production, molluscs 
representing all water sources must be included for sampling in such a way that all parts of the establishment are 
proportionally represented in the sample;
 ( iv) wh en sampling in mollusc establishments or groups of establishments, molluscs from a sufficient number of 
sampling points  mus t be included in the sample   The main factors to be considered for the selection of those 
sampling points  are s tocking density, water flows, the presence of susceptible species, the presence of vector 
species, bathymetry and management practices   Natural beds within or adjacent to the establishment or group of 
establishments must be included in the sampling  
Section  2
Specific requirements to demonstrate the implementation of a surveillance  
programme
1  Healt h visits must be carried out and molluscs must be sampled in accordance with Section  1 and Table  5 
2  Sam ples 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 Chap ter 5 of P art II and produce negative results for Bonamia ostreae  3 6 2020 Official Journal of the European Union L 174/339 EN
Table  5
Surveillance programme for infection with Bonamia ostreae
Risk level  (1)Number of health visits to each 
establishment/group of establishmentsNumber of laboratory examinationsNumber of molluscs in the 
sample
High 1 every  year 1 every 2  years 150
Medium 1 every 2  years 1 every 2  years 150
Low 1 every 2  years 1 every 4  years 150
(1) Risk le vel  assigned to the establishment by the competent authority as set out in paragraph  1 of Chapter  2 of Part  I
Section  3
Requirements to re-start a surveillance programme after a disease outbreak
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 disinf ected in accordance with Article  63, and f allowed 
in accordance with Article  64; and
(b) repopulation occur s using fish that originate from establishments which are:
 (i) in a Member State, a zone or a compartment free from infection with Bonamia ostreae ;
 ( ii) in a Member S tate, a zone or a compartment covered by an eradication programme for infection with Bonamia 
ostreae; or
 (iii) im plementing a surveillance programme for infection with Bonamia ostreae.
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
Section  1
General requirements for health visits and sampling for infection with  
infection with WSSV
The health visits and sampling referred to in point  (b)(iv) of Article  3(2) must comply with the following requirements:
(a) t he 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) wh en farmed crustaceans are to be sampled in accordance with the requirements set out in Table  6, the following criteria 
must apply:
 ( i) if w eak or moribund crustaceans are present in the production units, such crustaceans must primarily be selected   If 
such crustaceans are not present, those selected must include crustaceans of different size cohorts namely juveniles 
and adults, of the selected susceptible species, proportionally represented in the sample;
 (ii) if more t han one water source is utilised for crustacean production, susceptible crustaceans representing all water 
sources must be included for sampling  Official Journal of the European Union L 174/340 EN 3 6 2020
Section  2
Specific requirements to demonstrate the implementation of a surveillance  
programme
1  Healt h visits shall be carried out and crustaceans shall be sampled in accordance with Section  1 and Table  6 
2  Sam ples 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 Chap ter 6 of P art II and produce negative results for infection with WSSV  
Table  6
Surveillance programme for infection with WSSV
Risk level  (1)Number of health visits to each 
establishment/group of establishmentsNumber of laboratory examinationsNumber of crustaceans in the 
sample
High 1 every  year 1 every 2  years 150
Medium 1 every 2  years 1 every 2  years 150
Low 1 every 2  years 1 every 4  years 150
(1) Risk le vel  assigned to the establishment by the competent authority as set out in paragraph  1 of Chapter  2 of Part  I
Section  3
Requirements to re-start a surveillance programme after a disease outbreak
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 disinf ected in accordance with Article  63, and f allowed 
in accordance with Article  64; and
(b) repopulation occur s using fish that originate from establishments which are:
 (i) in a Member State, a zone or a compartment free from infection with WSSV;
 (ii) in a Member State, a zone or a compartment covered by an eradication programme for infection with WSSV; or
 (iii) im plementing a surveillance programme for infection with WSSV